SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT

Elevit Film-Coated Tablet

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

One film coated tablet contains

Vitamins:

A	2566 I.U.
B1	1.4 mg
B2	1.4 mg
Nicotinamide	18 mg
B5	6 mg
B6	1.9 mg
Biotin	30 micrograms
B9 800 micrograms in form of Folic Acid	400 micrograms
in form of calcium L-methylfolate	451 micrograms
equivalent to 400 pg of vitamin B9 B12	2.6 micrograms
C	85 mg
D3 (Cholecalciferol)	200 I.U.
E	15 mg
Minerals and trace elements:
Calcium	125 mg
Copper	1 mg
Iodine	220 micrograms
Iron	45 mg
Magnesium	100 mg
Manganese	2 mg
Selenium	50 micrograms
Zinc	11 mg

Excipient with known effect

Each tablet contains approximately 0.3 mg of sucrose. For the full list of excipients, see section 6.1.

PHARMACEUTICAL FORM

Film-coated tablet

Elevit is a white to slightly yellowish oval and biconvex film coated tablet of approximately 17 x 9.5 mm.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Prevention of micronutrient, iron and folate deficiencies during pregnancy and lactation due to unbalanced dietary intake.

4.2    Posology and method of administration

Posology:

One tablet per day. The recommended duration of administration is throughout pregnancy and lactation.

Elderly

There is no relevant use of Elevit in the elderly population.

Patients with Renal Impairment

Elevit is contraindicated in patients with impaired renal function (see section 4.3) Patients with Hepatic Impairment

Patients with hepatic impairment might be more vulnerable to the side effects, toxicity and/or accumulation of nicotinamide, vitamin A, copper, manganese and iron. Therefore, in such cases Elevit should only be used under medical supervision.

Paediatric Population

Female adolescents, who are pregnant or are breastfeeding: One tablet per day.

Method of administration:

For oral use.

The tablet is to be taken whole with a glass of water, preferably with a meal. In case of morning sickness, it is recommended that the tablet is taken at noon or in the evening.

4.3    Contraindications

•    Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

•    Existing hypervitaminosis A.

•    Impaired renal function.

•    Existing hypervitaminosis D.

•    Hypercalcaemia.

•    Hypercalciuria.

•    Iron and/or copper metabolism disorders.

4.4    Special warnings and precautions for use

•    The recommended dosage must not be exceeded. Very high doses of some ingredients, in particular vitamin A, vitamin D, iron and copper, can be harmful to health, see 4.6 and 4.9.

•    Patients receiving other single vitamins or multivitamin preparations, any other medication or those under medical care should consult a health care professional before taking this product.

•    Elevit should be administered with caution to women receiving certain concomitant products, including supplements and/or fortified foods/drinks containing Vitamin D or Vitamin A, due to the risk of hypervitaminosis D or hypervitaminosis A.

•    Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

•    Patients with hepatic impairment might be more vulnerable to the side effects, toxicity and/or accumulation of nicotinamide, vitamin A, copper, manganese and iron. Therefore, in such cases Elevit should only be used under medical supervision.

•    Patients with nephrolithiasis or urolithiasis should use caution when taking vitamin supplements, because calcium, ascorbic acid and Vitamin D may have an effect on stone formation.

•    Lactating women who did not suffer from perinatal blood losses, did not resume regular menstruations during breastfeeding, and do not suffer from anemia or low iron blood levels should consult their health care professional before taking this product.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

The absorption of tetracyclines, fluoroquinolones, bisphosphonates, levothyroxine (thyroxine), trientine and antiviral agents may be affected by the minerals in the product. When taking these medications concomitantly, doses should be separated by two hours to avoid any potential interaction.

Concurrent administration with antacids (aluminium, calcium or magnesium containing products) is not recommended as antacid therapy has been reported to decrease iron absorption. If concurrent use cannot be avoided, doses should be separated by two hours to avoid any potential interaction.

Potential interactions with the following medicinal products have been cited: Levodopa, penicillamine, digitalis. When taking these medications concomitantly, doses should be separated by two hours to avoid any potential interaction.

Thiazide diuretics may decrease calcium excretion and increase magnesium and zinc excretion by the kidneys. If used concomitantly, serum calcium levels should be monitored and attention should be drawn to if administration of Elevit is sufficient to prevent deficiencies of magnesium and zinc.

Drug-Food Interactions:

Since oxalic acid (found in spinach and rhubarb) and phytic acid (found in fiber-containing whole-grain products) may inhibit calcium absorption, it is not recommended to take this product within two hours of foods containing high concentrations of oxalic acid and phytic acid.

4.6 Fertility, pregnancy and lactation

Elevit can be used by women (including adolescents) during pregnancy and lactation.

The recommended dosage must not be exceeded for the following reasons:

Pregnancy

Based on human experience, vitamin A is suspected to cause congenital malformations at doses of more than 10,000 IU per day when administered during the first trimester of pregnancy. Studies in animals have shown reproductive toxicity (see section 5.3).

Elevit contains 2566 IU/tablet or 776 pg/tablet of vitamin A, thus particular caution should be taken when this product is administered together with other products containing vitamin A or betacarotene (a source of vitamin A), due to the risk of hypervitaminosis A and damage to the fetus.

Breastfeeding

Vitamin D and calcium are excreted into breast milk (see section 4.9).

Fertility

There are no data on the effect of Elevit on fertility.

4.7 Effects on ability to drive and use machines

ELEVIT has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

The most common undesirable effects are gastrointestinal.

If an allergic reaction occurs, treatment must be stopped and a health care professional consulted.

Adverse events are categorised by frequency as follows: very common ( 1/10), common ( 1/100, <1/10), uncommon ( 1/1000, <1/100), rare ( 1/10,0000, <1/1000) and very rare (<1/10,000). Not known (cannot be estimated from the available data).

System Organ Class (SOC)	Frequency	Undesirable effects
Gastrointestinal disorders	Common	Abdominal discomfort, constipation, flatulence, vomiting, diarrhoea, nausea.
General disorders and administration site reactions	Rare	Allergic reactions (hypersensitivity), hives (urticaria), facial swelling, wheezing, erythema, rash, blisters.
Vascular disease	Rare	Shock

A slight yellow discoloration of urine may be noticed. This effect is harmless and is due to the vitamin B2 contained in the product.

The product contains iron, which may lead to a black colouring of the stool. This effect is harmless and does not have any clinical relevance.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Chronic overdose of vitamin D might be harmful to the fetus. Studies in animals have shown reproductive toxicity (see section 5.3). For pregnant women, the Institute of Medicine (USA) has set the safe Tolerable Upper Intake Level of vitamin D at 4000 IU (100 pg) per day. Elevit contains 200 IU/tablet (5 pg/tablet).

Vitamin D and calcium are excreted into breast milk. A risk to the suckling child cannot be excluded and this must be taken into consideration if the infant is receiving any supplements.

For lactating women the Institute of Medicine (USA) has set the safe Tolerable Upper Intake Level of vitamin D at 4000 IU (100 pg) per day. Elevit contains 200 IU/tablet (5 pg/tablet).

Most, if not all reports concerning overdoses of vitamins and minerals are associated with concomitant intake of high dosage single and/or multi-vitamin/-mineral preparations. Acute or long-term overdose can cause hypervitaminosis A and D and hypercalcaemia as well as iron and copper toxicity.

Uncharacteristic initial symptoms, such as abrupt onset of headache, confusion, and gastrointestinal disturbances such as constipation, diarrhoea, nausea, and vomiting might be indicative for an acute overdose.

If such symptoms occur, treatment must be stopped and a health care professional consulted.

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: Multivitamins, combinations;

Multivitamins and other minerals incl. combinations, ATC code: A11A A03

This preparation is a multivitamin/multimineral formula containing vitamins in combination with minerals and trace elements to ensure an adequate micronutrient supply for both the fetus and pregnant woman in case of unbalanced dietary intake.

Pregnancy and lactation represent periods with increased micronutrient requirements and, as a consequence, carry increased risks of micronutrient deficiencies for both the mother and the child.

Paediatric population

No pharmacodynamic studies have been conducted in children. The information provided above is relevant to use in adolescents.

5.2    Pharmacokinetic properties

The active ingredients of this preparation, vitamins, minerals and trace elements, are essential micronutrients, which are widely distributed in the human body.

The plasma and tissue levels of micronutrients are homeostatically regulated and affected by various factors such as diurnal fluctuations, nutritional status, growth, and pregnancy and lactation.

Paediatric population

No pharmacokinetic studies have been conducted in children.

The information provided above is relevant to use in adolescents.

5.3 Preclinical safety data

Effects in non-clinical studies of active ingredients were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.

Vitamin A is teratogenic in animals, with the following order of increasing susceptibility: rat and mouse, hamster, monkey, and rabbit. The lowest teratogenic doses reported in rat, monkey and rabbit are 35,000, 6,000 and 2,500 pg retinol equivalent (RE)/kg bw/day, respectively.

Excess vitamin D during gestation in rats and rabbits led to a number of adverse reproductive effects including: in rodents: retarded fetal and placental growth, delayed ossification and facial malformations; in rabbits: decreased fetal viability, increased abortion and offspring supravalvular lesions.

6.1    List of excipients

Tablet core:

Calcium carbonate (E 170)

Citric acid (E 330)

Corn starch Gelatin

Magnesium stearate Maltodextrin Microcrystalline cellulose Modified food starch

Mono- and diglycerides of fatty acids (E 471)

Povidone K90

Silica, colloidal anhydrous

Sodium ascorbate (E 301)

Sodium croscarmellose

Sucrose

Talc (E 553b)

Triglycerides medium chain Trisodium citrate (E 331)

Tablet coating:

Hypromellose Microcrystalline cellulose Stearic acid

Titanium dioxide (E 171)

6.2    Incompatibilities

Not applicable

6.3    Shelf life

2 years

6.4    Special precautions for    storage

Do not store above 25°C

Store in the original package to protect from light and moisture

6.5    Nature and contents of    container

30, 60, 90 or 100 film coated tablets in PVC/PU/PVDC-aluminium foiled blister.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Bayer plc,

Consumer Care Division Newbury,

RG14 1JA,

UK

8    MARKETING AUTHORISATION NUMBER(S)

PL 00010/0632

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10/04/2013

10    DATE OF REVISION OF THE TEXT

28/07/2016