SYSTEM OF MULTIVITAMIN AND MINERAL COMPOSITIONS FOR WOMEN OF

CHILDBEARING AGE

FIELD OF THE INVENTION

The invention relates to a system of multivitamin and mineral compositions for carrying out an administration regime in a woman being in the childbearing or reproductive age, said system comprising compositions adjusted to the phases of the menstrual cycle and the stages of the reproductive period in which conception is not naturally blocked.

BACKGROUND ART

Supporting vitality during her different physiological stages without the use of balanced dietary supplement compositions is increasingly difficult for a woman leading a modern,„out of nature" lifestyle. Dietary supplement compositions, multivitamin and mineral elements compositions are available over the counter and the offer is abundant. Many of these compositions are for general use, not offering special treatment for the special needs of women. Others are specifically designed for the needs of women of different ages (mainly before and after the menopause) or activity levels. Some target typical female problems like PMS and osteoporosis. They all aim to fill in the gaps of the daily diet, to maintain or restore a balanced metabolism, physical and mental well-being and appropriate activity level.

When a given dietary supplement is satisfactory in achieving these goals, it is reasonable to change as little as possible and only the necessary in the composition of the dietary supplement when the physiological phase of the subject is altered, but is is essential that the needs of the new stage are also met. Physiological stages of a woman of the childbearing age change rather frequently and changes may be profound. For example, a woman in childbearing age might not wish to be pregnant, and might use anticonceptive agents (prevention or anticonceptive stage) or might be in a preconception (pre-pregnancy) stage wishing to be pregnant, might be in the pregnancy stage or might be in the lactation (post-pregnancy) stage. A transition into a new physiologial phase is usually a more vulnerable period, when imbalance in nutrition may result in symptoms otherwise easily controlled. This is especially true in cases where a woman wishes to terminate the prevention" stage to enter the preconception stage.

Physical conditions and therefore nutritional needs of a woman in the prevention or the preconception stage, and often during lactation are greatly influenced by the different physiological conditions during the phases of the menstrual cycle.

Several composition for relief of menstrual discomfort and disturbed homeostasis are known in the art and are available as a dietary composition. These are, however, typically not adjusted to the menstrual cycle and/or are not constituting a system supporting the transition between physiological stages of a woman's life. Compositions for a regular monthly cycle to facilitate conception and compositions for women who do not wish to conceive are also numerous.

PregnaCare Conception is an example of a moderate level multi-vitamin and mineral supplement, which is free from any ingredient that is known to cause any delay in the monthly cycle, and thus, is said to help regulating the female cycle. Combined with other PregnaCare products, it may be used as part of a dietary supplement system helping to maintain the metabbolic balance of women wishing to conceive, during pregnancy and even after pregnancy. The Centrum family of multivitamin compositions comprise general compositions recommended for women before the menopause, a pre-pregnancy composition and a prenatal composition. While these compositions may form a system that can be used in the several physiological stages, the general purpose composition and the pre-pregnancy composition do not take into account the different character and needs of the phases of the menstrual cycle, whilst these phases usually sum up to a much longer period of the childbearing age than the pregnancy and lactation (without menstruation) periods.

Pharmaceutical kits comprising multiple compositions in the form of a series of daily dosage units adjusted to the phases of the menstrual cycle are known from field of contraceptives which are to be administered in an anti-conceptive physiological stage. The dosage units are to be administered sequentially. For example, in US 2007/0254858A1 a pharmaceutical blister pack having dosage units arranged sequencially are described wherein the dosage units are in a first phase comprising at least about 21 daily dosage units and a second phase of about 4 to 8 dosage units of different contraceptive compositions. Besides oral contraceptives the composition also comprises a retinoic acid derivative equivalent for treating acne during the menstrual cycle.

Nevertheless, solutions for pharmaceutical kits to adjust vitamin and mineral intake to the menstrual cycle are sparse.

HU-0700029 describes a dietary supplement for women adjusted to the phases of the menstrual cycle. This composition, however, is a general dietary supplement, providing substitution of the microelements lost during bleeding, improving well-being and alleviating PMS. The composition does not provide a solution for a change between the physiological stages of a woman's life as it does not differentiate between women wishing to conceive and women wishing to avoid pregnancy. All three kinds of tablets of the composition recited in HU- 0700029 comprise inter alia vitamin A and vitamin B6, a low amount of selenium (80 μg) and a relatively low amount of folate (300 μg in the first phase tablets and 200 μg in the second phase tablets).

JP 2004262922 A relates to a dietary supplement composition adjusted to the phases of the menstrual cycle to relieve the symptomps PMS or dysmenorrhea. In addition to vitamins, the composition comprises minerals, metals, fruit and plant extract, folic acid, etc. A conception aiding effect or an effect facilitating the transition from the contraceptive stage into the preconception stage is not suggested.

There is a need for dietary supplements, which provide an easy, satisfactory solution for the different needs of the life and physiological stages of a woman of the childbearing age without the need of a substantial change in the diet, or causing major imbalances in metabolism, physical or mental well-being of an individual. A combination of compositions forming a system adjusted to different physiological stages apparently has not been suggested in the art. Such a composition would provide compositions which ensure a subtle transition from a physiological stage to another, without having to get used to a substantially different new composition or a new dosage regime. An appropriate composition would be adjusted not only to the less frequent, although more demanding stages of pregnancy and lactation but also to the daily demands of the phases of the menstrual cycle in both the prevention and the preconception stage, as well as during the transition from the first to the second.

BRIEF DESCRIPTION OF THE FIGURES

Figure LA shows an examplary arrangement of blisters 1 in a kit comprising multivitamin and mineral compositions arranged in sequential daily dosage units without a package. In this example the arrangement comprises four parts parts 2 of identical shape, two of which comprising daily dosage units of composition b) and two of which comprising different daily dosage units of compositions a) and b), respectively. Figure LB shows an examplary arrangement of a kit comprising multivitamin and mineral compositions arranged in sequential daily dosage units with a box package 3 wherein parts 2 of the blister are removable from the box package.

Figure l.C shows an arrangement essentially identical to that shown in Figure LB with a different box package with two wing-like covers 4, which are is suitable for carrying an indication of the content of each composition of daily dosage units of a kit.

Figure l.D shows a drawing of the box package only as shown on Figure l.C wherein the wing-like covers 4 may comprise a label comprising a description of the content of the composition.

Figure 2 shows a further exemplary arrangement wherein the blisters 1 are arranged in a circle and which is placed into a box package analogous to that shown on Figures l.C and l.D.

Figure 3 shows a further exemplary arrangement wherein the blisters 1 are arranged along a spiral line and which is placed into a box package analogous to that shown on Figures l.C and l.D.

BRIEF DESCRIPTION OF THE INVENTION

The invention is defined by the appended claims.

The invention relates to a system of multivitamin and mineral compositions for carrying out an administration regime in a woman being in the reproductive age.

The compositions form a kit for use in a woman in a given physiological stage wherein they are arranged as a series of sequential daily dosage units the composition of which varies according to phases of the menstrual cycle, in particular

- a series of sequential daily dosage units for use in the follicular phase of the menstrual cycle,

- a series of sequential daily dosage units for use in the ovulatory phase of the menstrual cycle,

- a series of sequential daily dosage units for use in the luteal phase of the menstrual cycle.

The invention also relates to a system formed by these kits or their packages wherein elements of the system, i.e. the kits are harmonized to each other and are adjusted to various physiological stages of a woman providing a balanced supply of vitamins and minerals through the stages; in particular, thereby providing, besides other advantages, an event and smooth transition between the stages.

In a particular embodiment the system helps a woman in a transition from an anticonceptive stage to a preconception stage, in particular when she wishes to stop administration of contraceptives.

The system also alleviates or prevents inconvenient symptoms of the menstrual cycle like vitamin and mineral deficiency, anemia, middle-pain, crumps, pre-menstrual syndrome (PMS). and if continuously applied allows an administration regime harmonized with the woman's life-style to provide, besides other health benefits, an increased comfort.

The system may be available either as a combination of dietary supplements or a combination of pharmaceutical kits.

DETAILED DESCRIPTION OF THE INVENTION

As used herein the term "system" refers to a combination of compositions. The compositions may form different kits, each kit containing multiple dosage forms of different compositions. The system may be applied in an administration regime adapted to the changes of the cyclic physiological stages and the menstrual phases of a woman in her reproductive age. Numbers of the dosage forms may vary according to need and the specific situation of the user. The term "physiological stage" as used herein refers to metabolic stages of women of the childbearing (reproductive) age (i.e. from the menarche to the menopause) characterized by physiological features mostly defined by the hormonal changes necessary for reproduction. As used herein, the reproductive years of a woman are composed of "anticonceptive stages", "preconception stages" and pregnancies. Lactation periods may fall into the anticonceptive stage (with or without menstruation) or in the preconception stage or may form a separate stage.

In other words, periods in which conception is not naturally blocked (i.e. during pregnancy or in the stage of lactation when this may be the case) are divided herein to "anticonceptive stages" and "preconception stages" depending on the woman's will (state of mind) in respect of a possible conception.)

"Anticonceptive stage" as used herein refers to a period of a woman's life in the reproductive age, when said woman is not pregnant and does not wish to get pregnant. A hormonal contraceptive might be taken in this period or other means of anticonception might be used. In a preferred variant of the invention a hormonal contraceptive is used in the anticonceptive stage. When a (combined) hormonal contraceptive is used, ovulation is prevented, but the menstrual cycle is seemingly "normal", i.e. very similar to that without a hormonal contraceptive. Several symptomps of a "normal" menstrual cycle are also present when taking a hormonal contraceptive, e.g. PMS before bleeding and spasms during bleeding.

Hormonal contraceptives may affect levels of minerals and vitamins, e.g. folic acid, vitamins Bl, B2, B6, B 12, vitamin C and E, magnesium, selenium and zinc.

Long-term (i.e. years) use of hormonal contraceptives often results in the lack of ovulation for months even after ceasing to take the pill. Restoration of the normal menstrual cycle may be supported by the appropriate mineral and vitamin containing compositions, especially when the woman wishes to become pregnant and preparing the body for pregnancy is also desired.

The term anticonceptive stage is also used for women who use other means of anticonception and have a normal menstrual cycle. Women not using hormonal contraceptives often experience more unpleasant symptoms and irregularities during their periods. Bleeding and cramps are usually more severe and last longer, necessitating the use of remedies against discomfort to maintain vitality of everyday life.

"Preconception stage" as used herein refers to a period of a woman's life in the reproductive age, when said woman is not pregnant and wishes to get pregnant. Adequate supplementation of minerals and vitamins as well as other micronutrients may be necessary is this period. The preconception stage may last longer than a few menstrual cycles, in some cases, it may take years to conceive, while a normal menstrual cycle is maintained with all the symptoms and discomfort thereof. It is therefore desirable to balance metabolic homeostasis, substitute nutrient loss and alleviate symptoms and/or discomfort in this stage.

The term "follicular phase of the menstrual cycle" or simply "follicular phase" refers to the part of the menstrual (ovarial) cycle before ovulation. The phase begins with the first day of bleeding (by definition this is the first day of the menstrual cycle) and ends when the level of luteinizing hormone surges. The result of the surge is ovulation. The numbers of days of bleeding differ from woman to woman and even from cycle to cycle. It tends to be more stable and predictable in women taking hormonal contraceptives. 3-10 days of bleeding are considered usual. Bleeding apparently leads to relatively high loss of iron and magnesium and is often accompanied with cramps (spasm), tiredness, weakness or general discomfort.

The term "ovulatory phase of the menstrual cycle" or simply "ovulatory phase" refers to the part of the menstrual cycle beginning when the luteinizing hormone surges. Ovulation occurs and the level of progesterone increases. This phase may last for 10-20 days. Ovulation is often accompanied, preceded or followed by a typical low-abdominal pain. This phase is less demanding as to micronutrient supplementation, although when part of the preconception stage, support of conception - which occurs most likely in this phase - may be desirable.

The term "luteal phase of the menstrual cycle" or simply "luteal phase" refers to the last part of the menstrual cycle, before bleeding. This phase may take 5-14 days. During most of the luteal phase, estrogen and progesterone levels are high. The last few days (if no egg is fertilized) are the premenses period, when premenstrual syndrome is frequently developed. Symptoms of PMS may be mild or more severe, from discomfort to pain causing considerable suffering, e.g. migraine. Rapid emotional (mood) changes, abdominal cramps and fatigue are among the most frequent signs of PMS.

In a first embodiment the invention relates to a system of multivitamin and mineral compositions for carrying out an administration regime in a woman being in the reproductive age, said system comprising i) a kit comprising multivitamin and mineral compositions arranged in sequential daily dosage units, the compositions being adjusted to three phases of the menstrual cycle, said kit designed for use in a woman in an anticonceptive stage, wherein said kit comprises

a) 3 to 8, preferably 5 to 7 highly preferably 7 daily dosage units, each unit comprising

iron in amount higher than in daily dosage units b) and c) of both kits i) and ii),

calcium in an amount lower than in daily dosage units c) of both kits i) and ii),

magnesium in an amount higher than in daily dosage units b) of kit i),

vitamin B6 in an amount lower than in composition c) of kit i),

vitamin C in an amount higher than in daily dosage units b) and c) of kit ii),

folic acid in an amount higher than in daily dosage units c) of kit i), however, in an amount lower than in daily dosage units of kit ii),

vitamin B 12 in an amount higher than in composition b) or c) of kit i)

preferably

to be administered in the follicular phase, preferably from the first day of bleeding of the menstrual cycle,

b) 10 to 20, preferably 12 to 16, highly preferably 14 daily dosage units, each unit comprising

iron in an amount lower than in daily dosage units a) of both kits i) and ii),

calcium in an amount lower than in composition c) of kit i),

magnesium in an amount lower than in composition a) of kit i) vitamin B6 in an amount lower than in composition c) of kit i),

vitamin C in an amount higher than in daily dosage units b) and c) of kit ii),

folic acid in an amount higher than in daily dosage units c) of kit i),

vitamin B 12 in an amount lower than in composition a) of kit i)

preferably

to be administered in the ovulatory phase of the menstrual cycle, after the follicular phase;

c) 5 to 10, preferably 6 to 8, highly preferably 7 daily dosage units of compositions each units comprising iron in an amount lower than in daily dosage units a) of both kits i) and ii);

Ca in higher amounts than in daily dosage units b) of both kits i) and ii);

Mg in an amount higher than in daily dosage units b) of both kits i) and ii);

vitamin B6 in higher amounts than in daily dosage units a) and b) of both kits i) and ii);

vitamin C in an amount higher than in daily dosage units b) and c) of kit ii),

folic acid in an amount lower than in daily dosage units a) or b) of kit i),

vitamin B 12 in an amount lower than in daily dosage units a) of kit i) or kit ii),

preferably

to be administered in the luteal phase of the menstrual cycle, sequentially after the ovulatory phase; kit comprising sequential daily dosage units of compositions adjusted to three phases of the menstrual cycle, said kit designed for use in women wishing to become pregnant wherein said kit comprises a) 3 to 8, preferably 5 to 7 highly preferably 7 daily dosage units, each unit comprising

iron in an amount higher than in daily dosage forms b) and c) of both kits i) and ii);

calcium in an amount lower than in composition c) of kit i) or kit ii),

magnesium in an amount higher than in composition b) of kit i) or kit ii),

vitamin B6 in an amount lower than in composition c) of kit i) or kit ii),

vitamin C in an amount higher than in daily dosage forms b) and c) of kit ii),

folic acid in an amount higher than in daily dosage forms of kit i); zinc,

selenium in an amount higher than the amount of selenium in dosage units of kit i), if selenium is present in the dosage units of kit i), preferably in an amount of at least 200% of the amount of selenium in dosage units of kit i), when selenium is present in the dosage units of kit i),

preferably

to be administered in the follicular phase, preferably from the first day of bleeding of the menstrual cycle,

b) 10 to 20, preferably 12 to 16, highly preferably 14 daily dosage units, each unit comprising

iron in an amount lower than in daily dosage units a) of both kits i) and ii);

calcium in an amount lower than in composition c) of kit i) or kit ii),

magnesium in an amount lower than in composition a) or c) of kit i) or kit ii)

vitamin B6 in an amount lower than in composition c) of kit i) or kit ii),

vitamin C in an amount lower than in daily dosage units a) of kit ii),

folic acid in an amount higher than in daily dosage units of kit i);

zinc and

selenium in an amount higher than the amount of selenium in dosage units of kit i), if selenium is present in the dosage units of kit i), preferably in an amount of at least 200% of the amount of selenium in dosage units of kit i), when selenium is present in the dosage units of kit i),

preferably

to be administered in the ovulatory phase of the menstrual cycle, sequentially after the follicular phase; c) 5 to 10, preferably 6 to 8, highly preferably 7 daily dosage units of compositions each units comprising iron in an amount lower than in daily dosage units a) of both kits i) and ii);

Ca in higher amount s than in daily dosage units a) and b) of both kits i) and ii); Mg in an amount higher than in daily dosage units b) of kit i) or ii),

B6 vitamin in higher amount s than in daily dosage units a) and b) of both kits i) and ii);

folic acid in an amount higher than in daily dosage units of kit i);

vitamin C in an amount lower than in daily dosage units of a) of kit i) or kit ii)

zinc and

selenium in an amount higher than the amount of selenium in dosage units of kit i), if selenium is present in the dosage units of kit i), preferably in an amount of at least 200% of the amount of selenium in dosage units of kit i), when selenium is present in the dosage units of kit i),

preferably

to be administered in the luteal phase of the menstrual cycle, after the ovulatory phase;

wherein the number of daily dosage units in any or both of kits i) and/or ii) is 24 to 36, preferably 26 to 30, highly preferably 28.

In a preferred embodiment in the dosage units a) of kit i)

the amount of iron is about 125-150% of the amount of iron in the dosage units of b) and c) of any of kits i) and ii),

the amount of folic acid is about 25-75%, preferably 50% of the amount of folic acid in any of the dosage units of kit ii), and about 125-175%, preferably 150% of the amount of folic acid in dosage units c) of kit i),

the amount of vitamin C is about 200-300%, preferably about 250% of the amount of vitamin C in dosage units b) of kit ii), and about 350-500%, preferably 400% of the amount of vitamin C in dosage units c) of kit ii), the amount of calcium is about 45-75% of the amount of calcium in daily dosage units c) of kit i), the amount of magnesium is about 150-300% of the amount of magnesium in dosage units b) of kit i), the amount of vitamin B6 is about 5-30%, preferably about 10-20% of the amount of vitamin B6 in the dosage units c) of kit i), the amount of vitamin B 12 is about 150-300%, preferably about 150-250% of the amount of vitamin B12 in dosage units b) or c) of kit i)

In a preferred embodiment in the dosage units b) of kit i)

the amount of vitamin C is about 200-300%, preferably about 250% of the amount of vitamin C in dosage units b) of kit ii), and about 350-500%, preferably 400% of the amount of vitamin C in dosage units c) of kit ii), the amount of folic acid is about 125-200%, preferably about 150% of the amount of folic acid in the dosage units c) in kit i), the amount of iron is about 50-80% of the amount of iron in dosage units a) of kit i), the amount of calcium is about 45-75% of the amount of calcium in daily dosage units c) of kit i), the amount of magnesium is about 25-75%, preferably about 30-60% of the amount of Mg in the dosage units a) or c) of kit i), the amount of vitamin B6 is about 5-30%, preferably about 10-20% of the amount of vitamin B6 in the dosage units c) of kit i), the amount of vitamin B 12 is about 15-75%, preferably about 30-60% of the amount of vitamin B 12 in the dosage units a) of kit i).

In a preferred embodiment in the dosage units c) of kit i)

the amount of Ca is about 150-250%, preferably about 140% of the amount of Ca in any of the dosage units a) and b) of kit i) and ii),

the amount of Mg is about 150-250, preferably about 200% of the amount of Mg in the dosage units b) of kit i) or ii),

the amount of vitamin B6 is about 500-1000%, preferably about 600-800% of the amount of vitamin B6 in any of the dosage units a) and b) of kit i) and ii), the amount of iron is about 50-80% of the amount of iron in dosage units a) of kit i), the amount of Ca is about 150-250%, preferably about 175-225% of the amount of iron in dosage units a) or b) of kit i), the amount of magnesium is about 150-300% of the amount of magnesium in dosage units b) of kit i), the amount of vitaminB12 is about 15-75%, preferably about 30-60% of the amount of vitamin B 12 in the dosage units a) of kit i) the amount of folic acid is about 50-50%, preferably about 60-80% of the amount of folic acid in dosage units a) orb) of kit i).

In a preferred embodiment in the dosage units a) of kit ii)

the amount of Fe is about 125-150% of the amount of iron in the dosage units of b) and c) of any of kits i) and ii),

the amount of vitamin C is about 200-300%, preferably about 250% of the amount of vitamin C in dosage units b) of kit ii), and about 350-500%, preferably 400% of the amount of vitamin C in dosage units c) of kit ii), the amount of folic acid is 125-200% of the amount of folic acid in any of the dosage units a) and b) of kit i), and/or 150-300, preferably about 200% of the amount of folic acid in the dosage units c) of kit i), and/or substantially the same as in the dosage units of b) and c) of kit ii),

the amount of calcium is about 45-75% of the amount of calcium in daily dosage units c) of kit i) or kit ii), the amount of magnesium is about 150-300% of the amount of magnesium in dosage units b) of kit i) or kit ii), the amount of vitamin B6 is about 5-30%, preferably about 10-20% of the amount of vitamin B6 in the dosage units c) of kit ii).

In a preferred embodiment in the dosage units b) of kit ii)

the amount of vitamin C is about 25-75% of the amount of vitamin C in any of the dosage units a) and b) of kit i) and the dosage units a) of kit ii), and/or about 150-200% of the amount of vitamin C in the dosage units c) ofkit ii),

the amount of folic acid is about 125-200% of the the amount of folic acid in any of the dosage units a) and b) of kit i), and/or 150-300, preferably about 200% of the amount of folic acid in the dosage units c) of kit i), and/or substantially the same as in the dosage units of a) and c) of kit ii), the amount of iron is about 50-80% of the amount of iron in dosage units a) of kit i), the amount of Ca is about 150-250%, preferably about 140% of the amount of Ca in any of the dosage units a) and b) of kit i) and ii), the amount of magnesium is about 25-75%, preferably about 30-60% of the amount of Mg in the dosage units a) or c) of kit i) or kit ii), the amount of vitamin B6 is about 5-30%, preferably about 10-20% of the amount of vitamin B6 in the dosage units c) of kit i). In a preferred embodiment in the dosage units c) of kit ii)

the amount of Ca is about 150-250%, preferably about 140% of the amount of Ca in any of the dosage units a) and b) of kit i) and ii),

the amount of Mg is about 150-250, preferably about 200% of the amount of Mg in any of the dosage units a) and b) of kit i) and ii),

the amount of vitamin B6 is about 500-1000%, preferably about 600-800% of the amount of vitamin B6 in any of the dosage units a) and b) of kit i) and ii), the amount of folic acid is about 125-200% of the the amount of folic acid in any of the dosage units a) and b) of kit i), the amount of vitamin C is about 10-50% of the amount of vitamin C in dosage units a) of kit ii, the amount of iron is about 50-80% of the amount of iron in dosage units a) of kit i) or kit ii).

In a preferred embodiment the daily dosage units of kit i) further comprise selenium in an amount of up to 85 μg, preferably up to 50 μg. In another preferred embodiment the daily dosage units a) of either kit i) or kit ii), or both kit i) and kit ii) also comprise vitamin B 1 in an amount of 0.5 to 1.5 mg, preferably 0.6 to 1 mg.

The amount of selenium in the dosage units of kit ii) is preferably at least 200% of the amount of selenium in any of the dosage units a), b) and c) of kit i), when selenium is present in these dosage units, and highly preferably substantially the same in the dosage units of kit ii).

In a preferred embodiment the dosage units a) of kit i) further comprise any of the following components

Manganese 2 to 3 mg, preferably 2.3 to 2.7 mg;

Pantothenic acid 3 to 9 mg, preferably 4 to 8 mg;

Chromium 10 to 40 μg, preferably 20 to 30 μ

Vitamin D3 2 to 8 μg, preferably 3 to 6 μg

Vitamin B2 1 to 2 mg, preferably 1.3 to 1.8 mg

Vitamin B 1 0.5 to 1.5 mg, preferably 0.6 to 1 mg

Vitamin Kl 20 to 60 μg, preferably 35 to 45 μg

Iodine 100 to 200 μg, preferably 120 to 180 μg

Molybdenum 50 to 100 μg, preferably 65 to 85 μg

Biotin 15 to 45 μ^ preferably 20 to 40 μg

Zinc 5-25 mg; preferably 10 to 20 mg

In a preferred embodiment the dosage units c) of kit i) further comprise any of the followinj components

Vitamin E 5 to 15 mg, preferably 8 to 12 mg;

nicotinamide 10 to 25 mg, preferably 15 to 20 mg;

Copper 1.0 to 2.0 mg, preferably 1.2 to 1.6 mg;

Manganese 2 to 3 mg, preferably 2.3 to 2.7 mg;

Pantothenic acid 3 to 9 mg, preferably 4 to 8 mg;

Chromium 10 to 40 μ^ preferably 20 to 30 μ^

Vitamin D3 2 to 8 μg, preferably 3 to 6 μg

Vitamin B2 1 to 2 mg, preferably 1.3 to 1.8 mg

Vitamin Kl 20 to 60 μg, preferably 35 to 45 μg

Iodine 100 to 200 μg, preferably 120 to 180 μg

Molybdenum 50 to 100 μg, preferably 65 to 855 μg

Biotin 15 to 45 μ^ preferably 20 to 40 μg

Zinc 5-25 mg; preferably 10 to 20 mg

In a preferred embodiment the dosage units a), b) or c) of kit ii) further comprise any of the followin ents

Vitamin E 5 to 15 mg, preferably 8 to 12 mg;

nicotinamide 10 to 25 mg, preferably 15 to 20 mg;

Copper 1.0 to 2.0 mg, preferably 1.2 to 1.6 mg;

Manganese 2 to 3 mg, preferably 2.3 to 2.7 mg;

Pantothenic acid 3 to 9 mg, preferably 4 to 8 mg;

Chromium 10 to 40 μ^ preferably 20 to 30 μ^

Vitamin D3 2 to 8 μg, preferably 3 to 6 μg

Vitamin B2 1 to 2 mg, preferably 1,3 to 1,8 mg

Vitamin Kl 20 to 60 μg, preferably 35 to 45 μg

Iodine 100 to 200 μg, preferably 120 to 180 μg Molybdenum 50 to 100 μg, preferably 65 to 855 μg

Biotin 15 to 45 μ& preferably 20 to 40 μg

Vitamin B 12 0.2 to 0.8 μg

Vitamin B 1 0.5 to 1.5 mg, preferably 0.6 to 1 mg

In a highly preferred embodiment the dosage units comprise the following components

In an alternative of the above embodiment the dosage units a) of kit i) and/or kit ii) comprise about 100 mg or 100 mg of calcium. In yet another alternative of these embodiments the dosage units a) of kit i) and/or kit ii) comprise about 200 mg or 200 mg of magnesium. In these alternative embodiments the dosage units of kit i) may comprise selenium in an amount of at most 80 μg, preferably 0 to 50 μg.

In an embodiment the system additionally comprises one or more further kit(s) comprising sequential daily dosage units of multivitamin and mineral compositions for administration to pregnant women. The kit(s) comprising sequential daily dosage units of multivitamin and mineral compositions for admimstration to pregnant women may comprise one-phase prenatal compositions (i.e. wherein all dosage units have the same composition) or preferably multiple -phase prenatal compositions, wherein the dosage units to be administered are different in their composition and adjusted to the phase of the pregnancy.

In an embodiment the compositions a), b) and c) of kit i) are administered in combination with a hormonal contraceptive. In a preferred embodiment the admistration regime of the hormonal contraceptive and the the admistration regime of the compositions of the present invention are harmonized and/or adjusted to each other.

In another embodiment a spasmolytic agent is also administered either daily or when needed.

In yet another embodiment the compositions a), b) and/or c) of kit ii) and optionally the hormonal contraceptive and/or the spasmolytic agent are administered in combination with myo-inositol, preferably in a daily unit dose of 2000-4000 g/day. In a preferred embodiment the dosage units of kit ii) are administered in combination with myo-inositol, preferably in a daily unit dose of 2000-4000 g/day.

In another embodiment the system also comprises additional daily dosage units of c) of kit i) which are to be administered in the anticonceptive stage up to the first day of the follicular phase of the menstrual cycle, and/or

wherein the system also comprises additional daily dosage units of c) of kit ii) which are to be administered in the preconceptive stage up to the first day of the follicular phase of the menstrual cycle or up to a confirmation of pregnancy.

According to an aspect the system is a dietary supplementation system.

In an embodiment the system is a system of multivitamin and mineral pharmaceutical compositions for carrying out an administration regime in women being in the reproductive age, for use in, during the administration regime:

I. alleviating and/or preventing adverse symptoms of the menstrual cycle and

II. when administering kit ii), preparing the woman's body for conception.

In a preferred embodiment alleviating and/or preventing adverse symptoms of the menstrual cycle comprises one or more of the following:

- alleviating and/or preventing anemia in the follicular phase,

- optionally alleviating and/or preventing middle pain in the follicular phase,

- alleviating and/or preventing PMS,

- alleviating spasms.

Alleviating and/or preventing PMS particularly involves alleviating and/or preventing symptoms of PMS, such as pain occurring before the first bleeding day and/or during the first days of bleeding, such as headache, migraine, abdominal pain, pain in the joints, low back pain, breast tenderness, pain from abdominal cramping, abdominal spasms, mood swings, dysphoria, irritability. Preferably, alleviating and/or preventing PMS involves alleviating and/or preventing headache, abdominal pin, low back pain and pain from abdominal cramping.

In an embodiment the alleviating and/or preventing adverse symptoms of the menstrual cycle during administration of kit i) comprises compensating the effects of any of decreased vitamin B6, vitamin E, folic acid and magnesium levels caused by a hormonal contraceptive.

In another embodiment the alleviating and/or preventing adverse symptoms of the menstrual cycle during administration of kit i) comprises facilitating the effects of a hormonal contraceptive. In a preferred embodiment the hormonal contraceptive is a hormonal contraceptive comprising low level(s) of hormone(s).

Another aspect of the invention is a method for carrying out a long term administration regime in women being in the reproductive age for maintaining health both in an anticonceptive stage and in a preconception stage of said woman,

said method comprising

administering sequential daily dosage units of compositions of kit i) as defined in any of the above paragraphs in the anticonceptive stage during one or more menstrual cycles, and

administering sequential daily dosage units of compositions of kit ii) as defined in any of the above paragraphs in the preconception stage during one or more menstrual cycles preferably at least up to the date of a confirmation of conception.

The term "long term" when referring to the administration regime refers to a period lasting from months to years or decades. As anticonceptive and preconception stages may alter each other throughout the whole period of the childbearing age, the long-term administration regime of the present combination of compositions (system of kits) may be applied to the whole period, a part or multiple parts thereof, with or without intervals. It may be applied for years or for months. It may be applied e.g. from the menarche to the first pregnancy or from the birth of the first child or termination of lactation to the second pregnancy. When combined with a mineral and vitamin composition for administration to pregnant women, the administration regime may be extended to and applied during pregnancy. Due to the composition of the system, the periods of administration of the individual kits may differ significantly, e.g. the first kit may be applied for months or for years, even decades while the second kit may be applied in the necessary period, i.e. from the time the user decides to prepare herself for pregnancy till the conception of confirmation of pregnancy or till the change to a prenatal composition or to a composition for pregnant woman. No administration free period is necessary, although termination of or a temporary pause in the use of the system is possible.

Administration of the system may start at any point of a physiological stage.

In a preferred embodiment the method further comprises administering sequential daily dosage units of a hormonal contraceptive together with the sequential daily dosage units of compositions of kit i) as defined in any of the above paragraphs in the anticonceptive stage during one or more menstrual cycles.

In a preferred embodiment the method further comprises administering a spasmolytic agent in the follicular phase and/or in the luteal phase, preferably in the follicular phase and/or in the luteal phase of the anticonceptive stage. In some embodiments the spasmolytic agent is administered when necessary.

Preferably the further spasmolytic agent is administered daily together with the daily dosage units of a) and c), more preferably of together with the daily dosage units of a) and c) of kit i) in the anticonceptive stage.

In preferred embodiments the spasmolytic agent is selected from natural oils, preferably from the group consisting of fish oil and linseed oil.

In another preferred embodiment the method, for use in alleviating and/or preventing symptoms of the menstrual cycle comprises one or more of the following:

- alleviating and/or preventing anemia in the follicular phase,

- optionally alleviating and/or preventing middle pain in the follicular phase,

- alleviating and/or preventing PMS phase, - alleviating spasms.

The symptoms of the menstrual cycle are to be understood as adverse, unpleasant symptoms.

In a preferred embodiment the method for use in alleviating and/or preventing symptoms of the menstrual cycle during administration of kit i) comprises compensating the effect of a hormonal contraceptive. In particular, the effects of any of decreased vitamin B6, vitamin E, folic acid and magnesium levels caused by a hormonal contraceptive may be compensated. In another embodiment facilitation of the effects of a hormonal contraceptive is comprised.

According to another aspect the invention also relates to a kit of multivitamin and mineral compositions arranged in sequential daily dosage units, the compositions being adjusted to three phases of the menstrual cycle, said kit designed for use in women in an anticonceptive stage, wherein said kit comprises

a) 3 to 8, preferably 5 to 7 highly preferably 7 daily dosage units, each unit comprising

iron in amount higher than in daily dosage units b) and c);

calcium in an amount lower than in daily dosage units c),

magnesium in an amount higher than in daily dosage units b),

vitamin B6 in an amount lower than in composition c),

vitamin C,

folic acid in an amount higher than in daily dosage units c) of kit i),;

vitamin B 12 in an amount higher than in composition b) or c),

preferably

to be administered in the follicular phase, preferably from the first day of bleeding of the menstrual cycle,

b) 10 to 20, preferably 12 to 16, highly preferably 14 daily dosage units, each unit comprising

iron in an amount lower than in daily dosage units a);

calcium in an amount lower than in composition c),

magnesium in an amount lower than in composition a),

vitamin B6 in an amount lower than in composition c),

vitamin C,

folic acid in an amount higher than in daily dosage units c);

vitamin B 12 in an amount lower than in composition a),

preferably Magnesium 50 to 300 mg, preferably 80 to 150 mg;

Vitamin B6 0.5 to 3 mg, preferably 0.8 to 2 mg;

Vitamin C 100 to 400 mg, preferably 150 to 300 mg;

Folic acid 200 to 350 μg, preferably 270 to 330 μg

Vitamin B 12 0.5 to 1.5 μg, preferably 0.8 to 1.2 μg,

to be administered in the ovulatory phase of the menstrual cycle, after the follicular phase;

c) 5 to 10, preferably 6 to 8, highly preferably 7 daily dosage units of compositions each units comprising iron in an amount lower than in daily dosage units a);

Ca in higher amounts than in daily dosage units b);

Mg in an amount higher than in daily dosage units b);

vitamin B6 in higher amounts than in daily dosage units a) and b);

vitamin C,

folic acid in an amount lower than in daily dosage units a) or b),

vitamin B 12 in an amount lower than in daily dosage units a),

preferably

to be administered in the luteal phase of the menstrual cycle, sequentially after the ovulatory phase, wherein the number of daily dosage units in the kit is 24 to 36, preferably 26 to 30, highly preferably 28.

In a preferred embodiment in the dosage units a) of said kit

the amount of iron is about 125-150% of the amount of iron in the dosage units of b) and c) of the kit, the amount of folic acid is about 125-175%, preferably 150% of the amount of folic acid in dosage units c) of the kit,

the amount of calcium is about 45-75% of the amount of calcium in daily dosage units c) of the kit, the amount of magnesium is about 150-300% of the amount of magnesium in dosage units b) of the kit, the amount of vitamin B6 is about 5-30%, preferably about 10-20% of the amount of vitamin B6 in the dosage units c) of the kit, the amount of vitamin B 12 is about 150-300%, preferably about 150-250% of the amount of vitamin B 12 in dosage units b) or c) of the kit.

In a preferred embodiment in the dosage units b) of said kit

the amount of folic acid is about 125-200%, preferably about 150% of the amount of folic acid in the dosage units c) of the kit, the amount of iron is about 50-80% of the amount of iron in dosage units a) of the kit, the amount of calcium is about 45-75% of the amount of calcium in daily dosage units c) of the kit, the amount of magnesium is about 25-75%, preferably about 30-60% of the amount of Mg in the dosage units a) or c) of the kit, the amount of vitamin B6 is about 5-30%, preferably about 10-20% of the amount of vitamin B6 in the dosage units c) of the kit, the amount of vitamin B 12 is about 15-75%, preferably about 30-60% of the amount of vitamin B 12 in the dosage units a) of the kit.

In a preferred embodiment in the dosage units c) of said kit

the amount of Ca is about 150-250%, preferably about 140% of the amount of Ca in any of the dosage units a) and b) of the kit,

the amount of Mg is about 150-250, preferably about 200% of the amount of Mg in the dosage units b) of the kit,

the amount of vitamin B6 is about 500-1000%, preferably about 600-800% of the amount of vitamin B6 in any of the dosage units a) and b) of the kit, the amount of iron is about 50-80% of the amount of iron in dosage units a) of the kit, the amount of Ca is about 150-250%, preferably about 175-225% of the amount of iron in dosage units a) or b) of the kit, the amount of magnesium is about 150-300% of the amount of magnesium in dosage units b) of the kit, the amount of vitamin B 12 is about 15-75%, preferably about 30-60% of the amount of vitamin B12 in the dosage units a) of the kit, the amount of folic acid is about 50-50%, preferably about 60-80% of the amount of folic acid in dosage units a) or b) of the kit.

In a preferred embodiment the dosage units a) of said kit further comprise any of the following components

Vitamin D3 2 to 8 μg, preferably 3 to 6 μg

Vitamin B2 1 to 2 mg, preferably 1,3 to 1,8 mg

Vitamin B 1 0.5 to 1.5 mg, preferably 0.6 to 1 mg

Vitamin Kl 20 to 60 μg, preferably 35 to 45 μg

Iodine 100 to 200 μg, preferably 120 to 180 μg

Molybdenum 50 to 100 μg, preferably 65 to 855 μg

Biotin 15 to 45 μ^ preferably 20-40 μg

Zinc 5-25 mg; preferably 10-20 mg

[n a preferred embodiment the dosage units c) of said kit further comprise any of the following ents

Vitamin E 5 to 15 mg, preferably 8 to 12 mg;

nicotinamide 10 to 25 mg, preferably 15 to 20 mg;

Copper 1.0 to 2.0 mg, preferably 1.2 to 1.6 mg;

Manganese 2 to 3 mg, preferably 2.3 to 2.7 mg;

Pantothenic acid 3 to 9 mg, preferably 4 to 8 mg;

Chromium 10 to 40 μ^ preferably 20 to 30 μ^

Vitamin D3 2 to 8 μg, preferably 3 to 6 μg

Vitamin B2 1 to 2 mg, preferably 1,3 to 1,8 mg

Vitamin Kl 20 to 60 μg, preferably 35 to 45 μg

Iodine 100 to 200 μg, preferably 120 to 180 μg

Molybdenum 50 to 100 μg, preferably 65 to 855 μg

Biotin 15 to 45 μ^ preferably 20-40 μg

Zinc 5-25 mg; preferably 10-20 mg

In a higly preferred embodiment the kit comprises the following components

Vitamin B 1 0.8 mg 0.8 mg 0.8 mg

Vitamin Kl 40 μ _§ 40 μ _§ 40 μ _§

Folic acid 300 μg 300 μg 200 μ _§

Iodine 150 μ _§ 150 μ _§ 150 μ _§

Molybdenum 75 μ _β 75 μ _β 75 μ _β

Bio tin 30 μ _§ 30 μ _§ 30 μ _§

Vitamin B 12 0.5 μ _§ 0.5 μ _§

Selenium - - -

Zinc 15 mg 15 mg 15 mg

In an alternative of the above embodiment the dosage units a) of the kit comprise about 100 mg or 100 mg of calcium. In yet another alternative of these embodiments the dosage units a) of the kit comprise about 200 mg or 200 mg of magnesium. In these alternative embodiments the dosage units of the kit may comprise selenium in an amount of at most 80 μg, preferably 0 to 50 μg.

According to an aspect the kit is a dietary supplementation kit.

In an embodiment the compositions a), b) and c) of the kit are administered in combination with a hormonal contraceptive.

In another embodiment a spasmolytic agent is also administered either daily or when needed.

In an embodiment the system is a system of multivitamin and mineral pharmaceutical compositions for carrying out an administration regime in women being in the reproductive age, for use in, during the administration regime: alleviating and/or preventing adverse symptoms of the menstrual cycle.

In a preferred embodiment alleviating and/or preventing adverse symptoms of the menstrual cycle comprises one or more of the following:

- alleviating and/or preventing anemia in the follicular phase,

- optionally alleviating and/or preventing middle pain in the follicular phase,

- alleviating and/or preventing PMS,

- alleviating spasms.

Alleviating and/or preventing PMS particularly involves alleviating and/or preventing symptoms of PMS, such as pain occurring before the first bleeding day and/or during the first days of bleeding, such as headache, migraine, abdominal pain, pain in the joints, low back pain, breast tenderness, pain from abdominal cramping, abdominal spasms, mood swings, dysphoria, irritability. Preferably, alleviating and/or preventing PMS involves alleviating and/or preventing headache, abdominal pin, low back pain and pain from abdominal cramping.

In an embodiment the alleviating and/or preventing adverse symptoms of the menstrual cycle during administration of kit i) comprises compensating the effects of any of decreased vitamin B6, vitamin E, folic acid and magnesium levels caused by a hormonal contraceptive.

In another embodiment the alleviating and/or preventing adverse symptoms of the menstrual cycle during administration of the kit comprises facilitating the effects of a hormonal contraceptive. In a preferred embodiment the hormonal contraceptive is a hormonal contraceptive comprising low level(s) of hormone(s).

According to another aspect, the invention also relates to a kit of multivitamin and mineral compositions arranged in sequential daily dosage units, the compositions being adjusted to three phases of the menstrual cycle, said kit designed for use in women in a preconception stage, wherein said kit comprises

a) 3 to 8, preferably 5 to 7 highly preferably 7 daily dosage units, each unit comprising

iron in amount higher than in daily dosage units b) and c);

calcium in an amount lower than in daily dosage units c),

magnesium in an amount higher than in dosage units b),

vitamin B6 in an amount lower than in dosage units c),

vitamin C in an amount higher than in daily dosage units b) and c),

folic acid;

vitamin B 12 in an amount higher than in dosage units b) or c)

preferably

to be administered in the follicular phase, preferably from the first day of bleeding of the menstrual cycle,

10 to 20, preferably 12 to 16, highly preferably 14 daily dosage units, each unit comprising

iron in an amount lower than in daily dosage units a);

calcium in an amount lower than in composition c),

magnesium in an amount lower than in composition c),

vitamin B6 in an amount lower than in composition c),

vitamin C in an amount higher than in daily dosage units b) and c),

folic acid;

vitamin B 12 in an amount lower than in composition a),

preferably

to be administered in the ovulatory phase of the menstrual cycle, after the follicular phase;

c) 5 to 10, preferably 6 to 8, highly preferably 7 daily dosage units of compositions each units comprising iron in an amount lower than in daily dosage units a); Ca in higher amounts than in daily dosage units b);

Mg in an amount higher than in daily dosage units b);

vitamin B6 in higher amounts than in daily dosage units a) and b);

vitamin C in an amount lower than in daily dosage units b),

folic acid,

vitamin B 12 in an amount lower than in daily dosage units a),

preferably

to be administered in the luteal phase of the menstrual cycle, sequentially after the ovulatory phase _^ wherein the number of daily dosage units in the kit is 24 to 36, preferably 26 to 30, highly preferably 28.

In a preferred embodiment in the dosage units a) of said kit

the amount of Fe is about 125-150% of the amount of iron in the dosage units of b) and c) of the kit, the amount of vitamin C is about 200-300%, preferably about 250% of the amount of vitamin C in dosage units b) the kit, and about 350-500%, preferably 400% of the amount of vitamin C in dosage units c) of the kit,

the amount of folic acid is substantially the same as in the dosage units of b) and c) of kit ii), the amount of calcium is about 45-75% of the amount of calcium in daily dosage units c) the kit, the amount of magnesium is about 150-300% of the amount of magnesium in dosage units b) the kit, the amount of vitamin B6 is about 5-30%, preferably about 10-20% of the amount of vitamin B6 in the dosage units c) of the kit.

In a preferred embodiment in the dosage units b) of the kit

the amount of vitamin C is about 25-75% of the amount of vitamin C in the dosage units a) of of the kit, and/or about 150-200% of the amount of vitamin C in the dosage units c) of of the kit,

the amount of folic acid is substantially the same as in the dosage units of a) and c) of the kit, the amount of Ca is about 150-250%, preferably about 140% of the amount of Ca in the dosage units a) and b) of the kit, the amount of magnesium is about 25-75%, preferably about 30-60% of the amount of Mg in the dosage units a) or c) of the kit, the amount of vitamin B6 is about 5-30%, preferably about 10-20% of the amount of vitamin B6 in the dosage units c) of the kit).

In a preferred embodiment in the dosage units c) of said kit

the amount of Ca is about 150-250%, preferably about 140% of the amount of Ca in the dosage units a) and b) of the kit,

the amount of Mg is about 150-250, preferably about 200% of the amount of Mg in the dosage units a) and b) of the kit, the amount of vitamin B6 is about 500-1000%, preferably about 600-800% of the amount of vitamin B6 in the dosage units a) and b) of the kit, the amount of vitamin C is about 10-50% of the amount of vitamin C in dosage units a) of the kit, the amount of iron is about 50-80% of the amount of iron in dosage units a) of the kit. In a preferred embodiment the dosage units a), b) or c) of the kit further comprise any of the following components

In a highly preferred embodiment the dosage units comprise the following components

Folic acid 400 μg 400 μg 400 μg

Iodine 150 μ _§ 150 μ _§ 150 μ _§

Molybdenum 75 μ _β 75 μ _β 75 μΕ

Bio tin 30 μ _§ 30 μ _§ 30 μ _§

Vitamin B 12 0.5 μ _§ 0.5 μ _§

Selenium 170 μ _§ 170 μ _§ 170 μ _§

Zinc 15 mg 15 mg 15 mg

In an alternative of the above embodiment the dosage units a) of the kit comprise about 100 mg or 100 mg of calcium. In yet another alternative of these embodiments the dosage units a) of the kit comprise about 200 mg or 200 mg of magnesium.

In an embodiment the compositions a), b) and c) of the kit are administered in combination with a spasmolytic agent, which may be administered either daily or when needed.

In yet another embodiment the compositions a), b) and/or c) of the kit and optionally the spasmolytic agent are administered in combination with myo-inositol, preferably in a daily unit dose of 2000-4000 g / day. In a preferred embodiment the dosage units of kit ii) are administered in combination with myo-inositol, preferably in a daily unit dose of 2000-4000 g / day.

According to an aspect the kit is a dietary supplementation kit.

In an embodiment the system is a system of multivitamin and mineral pharmaceutical compositions for carrying out an administration regime in women being in the reproductive age, for use in, during the administration regime:

I. alleviating and/or preventing adverse symptoms of the menstrual cycle and

II. preparing the woman's body for conception.

In a preferred embodiment alleviating and/or preventing adverse symptoms of the menstrual cycle comprises one or more of the following:

- alleviating and/or preventing anemia in the follicular phase,

- optionally alleviating and/or preventing middle pain in the follicular phase,

- alleviating and/or preventing PMS,

- alleviating spasms.

Alleviating and/or preventing PMS particularly involves alleviating and/or preventing symptoms of PMS, such as pain occurring before the first bleeding day and/or during the first days of bleeding, such as headache, migraine, abdominal pain, pain in the joints, low back pain, breast tenderness, pain from abdominal cramping, abdominal spasms, mood swings, dysphoria, irritability. Preferably, alleviating and/or preventing PMS involves alleviating and/or preventing headache, abdominal pin, low back pain and pain from abdominal cramping.

According to a further aspect of the invention, in the system described above the daily dosage units are arranged in a blister pack as defined the following numbered paragraphs.

The invention further relates to a method as described in the claims, wherein the daily dosage units are arranged in a blister pack as defined in any numbered paragraphs 1 to 4 and wherein said administration regime is carried out by sequential administration of the daily dosage units from the blisters as arranged in the blister pack.

The invention also relates to the solutions defined in the following numbered paragraphs (paragraph 1 to 4). 1. A system of multivitamin and mineral compositions for carrying out an administration regime in a woman being in the reproductive age, said system comprising

i) a kit comprising multivitamin and mineral compositions arranged in sequential daily dosage units, the compositions being adjusted to three phases of the menstrual cycle, said kit designed for use in women in an anticonceptive stage, wherein said kit comprises

a) 3 to 8, preferably 5 to 7, highly preferably 7 daily dosage units in a first series of blisters of kit i) forming a blister pack or part thereof,

b) 10 to 20, preferably 12 to 16, highly preferably 14 daily dosage units in a second series of blisters of kit i) forming a blister pack or part thereof,

c) 5 to 10, preferably 6 to 8, highly preferably 7 daily dosage units in a third series of blisters of kit i) forming a blister pack or part thereof,

wherein the daily dosage units of a), b) and c) for different menstrual phases are marked in different colors, respectively,

and wherein the first, second and third series of blisters are arranged corresponding to the sequence of administration of the daily dosage units in the first, second and third series of blisters; and

ii) a kit comprising multivitamin and mineral compositions arranged in sequential daily dosage units, the compositions being adjusted to three phases of the menstrual cycle, said kit designed for use in women in preconceptive stage, wherein said kit comprises

a) 3 to 8, preferably 5 to 7, highly preferably 7 daily dosage units in a first series of blisters of kit ii) forming a blister pack or part thereof,

b) 10 to 20, preferably 12 to 16, highly preferably 14 daily dosage units in a second series of blisters of kit ii) forming a blister pack or part thereof,

c) 5 to 10, preferably 6 to 8, highly preferably 7 daily dosage units in a third series of blisters of kit ii) forming a blister pack or part thereof,

wherein the daily dosage units of a), b) and c) for different menstrual phases are marked in different colors, respectively,

and wherein the first, second and third series of blisters are arranged corresponding to the sequence of administration of the daily dosage units in the first, second and third series of blisters;

wherein the number of daily dosage units in any or both of kits i) and/or ii) is 24 to 36, preferably 26 to 30, highly preferably 28.

2. The system according to paragraph 1 wherein the blisters comprise the daily dosage units as defined above, in the first embodiment of the invention wherein the system (combination of composition) is defined.

Preferably, the blisters comprise the daily dosage units as defined in the tables specified in the first embodiment of the invention.

In a preferred embodiment in the dosage units in the blisters comprise vitamins and minerals as defined above as percentage ratios,

in a preferred embodiment in the dosage units a) of kit i) in a preferred embodiment in the dosage units b) of kit i)

in a preferred embodiment in the dosage units c) of kit i)

in a preferred embodiment in the dosage units a) of kit ii)

in a preferred embodiment in the dosage units b) of kit ii) and/or

in a preferred embodiment in the dosage units c) of kit ii).

3. The system according to any of paragraphs 1 to 2 wherein, both in the anticonceptive stage and in the preconceptive stage,

the number of daily dosage units in the blisters is n and is identical in the follicular phase a) and luteal phase c) and

the number of daily dosage units in the ovulatory phase b) is 2n.

4. The system according to paragraph 3 wherein the blisters comprising daily dosage units of the follicular phase a) and luteal phase c) and two times n number of blisters comprising daily dosage units of the ovulatory phase b) form four blister packs of identical shape and each one of the blister packs are arranged in separate quarters on the bottom large side of a flat box which can be opened at or from its top large side.

In a preferred embodiment of the system the four blister packs of identical shape are attached to the bottom large side, e.g. back side of a flat box in a reversible (removable and re-attachable) way for ease of handling.

This can be made by any reversible attachment means e.g. by any selfadhesive fastener, or e.g by a sticky surface combined with a surface sticking to it. This may be used several times provided that it is kept clean. An alternative means is a velcro-type (hook-and-loop) tightening system. Still alternatively, the fastening can be carried out by an elasticated band attached to the box. A further simple solution may be formed from the material of the box, e.g. from paper, e.g. a slot or cut made on the paper of the box. This may be made on the large back side of the box or on a second (further) layer of paper attached to the large back side of the box.

An example for such an arrangement is shown on Figures LA (without the flat box package) and LB (together with the flat box package). Figure l.C and D show an alternative packaging of the same arrangement which is suitable for carrying an indication of the content of each composition of daily dosage units of a kit. A possible advantage of this arrangement is that in the packaging each series of daily dosage units are replaceable. Thus series of daily dosage units for a given phase are replacable with series for the corresponding phase of another kit in the system which may allow transition from one stage to another, e.g. anticonceptive stage to preconceptive stage in the system.

Preferably in this embodiment each of kits i) and ii) have identical arrangement and preferably wherein each of kits i) and ii) are packaged separately in a box of identical shape and form.

In a further embodiment the blisters comprising daily dosage units of the follicular phase a), ovulatory phase b) and luteal phase c) of kit i) form a single blister pack and

wherein the blisters comprising daily dosage units of the follicular phase a), ovulatory phase b) and luteal phase c) of kit ii) form a further single blister pack,

wherein each of kits i) and ii) have identical arrangement and preferably wherein each of kits i) and ii) are packaged separately in a box of identical shape and form.

Such exemplary arrangements are shown on Figure 2, wherein the blisters are arranged in a circle or on Figure 3 wherein the blisters are arranged along a spiral line indicating the order or sequence of administration of the daily dosage units.

In a preferred embodiment a daily dosage unit is composed of a single tablet.

In a further embodiment the daily dosage units may be composed of two or three tablets.

EXAMPLES

The following compositions are for exemplary purposes. The skilled person will acknowledge the potential use of other excipients, forms of active agents, etc.

An exemplary composition of dosage units a) of kit i) is given in table 1.

Table 1

Vitamin B 1 0.80 mg Thiamine mononitrate 1.0912 mg

Polyethyleneglycol 1.0680 mg

Vitamin Kl 0.040 mg vitamin Kl 5% 0.8800 mg

Folic acid 0.30 mg Folic acid 0.3450 mg

Iodine 0.15000 mg Potassium iodate 0.28 mg

Molybdenum 0.075 mg Ammonium molybdenate 0.1449 mg

Bio tin 0.03 mg Bio tin 0.0345 mg

Vitamin B 12 0.001 mg Cyanocobolamin 0.0012 mg

An exemplary composition of dosage units b) of kit i) is given in table 2.

Table 2

Vitamin B 1 0.80 mg Thiamine mononitrate 1.0912 mg

Polyethyleneglycol 1.068 mg

Vitamin Kl 0.040 mg vitamin Kl 5% 0.88 mg

Folic acid 0.30 mg Folic acid 0.3450 mg

Iodine 0.15 mg Potassium iodate 0.28 mg

Molybdenum 0.075 mg Ammonium molybdenate 0.1449 mg

Bio tin 0.03 mg Bio tin 0.0345 mg

Vitamin B 12 0.0005 mg Cyanocobolamin 0.006 mg

An exemplary composition of dosage units c) of kit i) is given in table 3.

Table 3

Vitamin B 1 0.80 mg Thiamine mononitrate 1.0912 mg

Polyethyleneglycol 1.068 mg

Vitamin Kl 0.040 mg vitamin Kl 5% 0.88 mg

Folic acid 0.20 mg Folic acid 0.2350 mg

Iodine 0.15 mg Potassium iodate 0.28 mg

Molybdenum 0.075 mg Ammonium molybdenate 0.1449 mg

Bio tin 0.03 mg Bio tin 0.0345 mg

Vitamin B 12 0.0005 mg Cyanocobolamin 0.006 mg

An exemplary composition of dosage units a) of kit ii) is given in table 4.

Table 4

Vitamin B 1 0.80 mg Thiamine mononitrate 1.0912 mg

Polyethyleneglycol 1.0680 mg

Vitamin Kl 0.040 mg vitamin Kl 5% 0.8800 mg

Folic acid 0.40 mg Folic acid 0.470 mg

Iodine 0.15000 mg Potassium iodate 0.28 mg

Molybdenum 0.075 mg Ammonium molybdenate 0.1449 mg

Bio tin 0.03 mg Bio tin 0.0345 mg

Vitamin B 12 0.001 mg Cyanocobolamin 0.0012 mg

Selenium 0, 170 mg Sodium selenite 1,039 mg

An exemplary composition of dosage units b) of kit ii) is given in table 5.

Table 5

Vitamin B2 1.60 mg Riboflavin 1.7600 mg

Vitamin B 1 0.80 mg Thiamine mononitrate 1.0912 mg

Polyethyleneglycol 1.0680 mg

Vitamin Kl 0.040 mg vitamin Kl 5% 0.8800 mg

Folic acid 0.40 mg Folic acid 0.470 mg

Iodine 0.15000 mg Potassium iodate 0.28 mg

Molybdenum 0.075 mg Ammonium molybdenate 0.1449 mg

Bio tin 0.03 mg Bio tin 0.0345 mg

Vitamin B 12 0.0005 mg Cyanocobolamin 0.0006 mg

Selenium 0, 170 mg Sodium selenite 1,039 mg

An exemplary composition of dosage units c) of kit ii) is given in table 6.

Table 6

Iron oxide (red) 1.900 mg

Vitamin B2 1.60 mg Riboflavin 1.7600 mg

Vitamin B 1 0.80 mg Thiamine mononitrate 1.0912 mg

Polyethyleneglycol 1.0680 mg

Vitamin Kl 0.040 mg vitamin Kl 5% 0.8800 mg

Folic acid 0.40 mg Folic acid 0.47 mg

Iodine 0.15000 mg Potassium iodate 0.28 mg

Molybdenum 0.075 mg Ammonium molybdenate 0.1449 mg

Bio tin 0.03 mg Bio tin 0.0345 mg

Vitamin B 12 0.0005 mg Cyanocobolamin 0.006 mg

Selenium 0,170 mg Sodium selenite 1,039 mg

The product is prepared in accordance with the above product sheets in accordance with standard procedure for preparing multivitamin and mineral compositions.

An exemplary administration regime for a woman in a child-bearing age.

The woman is a subject of 25 years old in early years of her career with an intensive life-style and with a demanding job. She spends as an average about 9 to 10 hours at work. Her diet often comprises fast food despite efforts to compensate this by consumption of vegetables and fruits in the evening. She is married and her husband has a similar life-style. She has taken oral contraceptives for 2 years. Due to feeling of weakness and fatigue she decides to take multivitamin and mineral supplement compositions of kit i). As an additional benefit crumps and symtoms of PMS are alleviated allowing an increased concentration in her job. After one year the couple decides to assume a child and she wishes to become pregnant. Therefore she shifts to taking multivitamin and mineral supplement compositions of kit ii) regularly and continuosly without changing here life-style and diet. The experienced benefits of the dietary supplementation remain. She becomes pregnant after two menstrual cycles and after further one months shifts to taking a multivitamin and mineral composition designed for pregnant women.