Elevit

Elevit is a white to slightly greyish oval and biconvex film coated tablet.
Qualitative composition in terms of the active ingredient(s) (INN): Elevit is a preparation containing multivitamins in combination with minerals and trace elements.
Quantitative composition in terms of the active ingredient(s) per dosage form: Vitamins: Vitamin B1 (Thiamine as Thiamine nitrate) 1.4 mg, Vitamin B2 (Riboflavin) 1.4 mg, Vitamin B3 (Nicotinamide) 18 mg, Vitamin B5 (Pantothenic acid as Calcium pantothenate) 6 mg, Vitamin B6 (Pyridoxine as Pyridoxine hydrochloride) 1.9 mg, Vitamin B7 (Biotin) 0.03 mg, Vitamin B9 (Folate as - folic acid and L-methylfolate calcium) 800 mcg, Vitamin B12 (Cyanocobalamin) 2.6 mcg, Vitamin C (Ascorbic acid) 85 mg, Vitamin D3 (Colecalciferol) 1000 IU, Vitamin E (dl-alpha-tocopherol as dl-alpha-tocopheryl acetate) 15 mg.
Minerals and trace elements: Calcium (as Calcium hydrogen phosphate, Calcium pantothenate and L-methylfolate calcium) 125 mg, Copper (as Cupric sulfate anhydrous) 1 mg, Iodine (as Potassium iodide) 220 mcg, Iron (as Ferrous bisglycinate) 27 mg, Magnesium (as Magnesium oxide, heavy) 100 mg, Manganese (as Manganese sulfate monohydrate) 2 mg, Selenium (as Sodium selenite) 50 mcg, Zinc (as Zinc citrate trihydrate) 11 mg.
Excipients/Inactive Ingredients: Of the core: Microcrystalline cellulose; Croscarmellose sodium; Silica colloidal anhydrous; Talc; Magnesium stearate; Povidone K90.
Of the coating: Hypromellose; Microcrystalline cellulose, Stearic acid; Titanium dioxide.

Multivitamin/multimineral preparation for the prevention and correction of vitamin and mineral deficiencies in preparation for pregnancy as doctor recommendation, during pregnancy and lactation.

Method of administration: For oral use.
Dosage regimen: One tablet daily to be taken as a 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.
The recommended duration of administration is one month before conception (when planning a pregnancy), throughout pregnancy and lactation.
Additional information on special populations: Geriatric patients: Elevit is indicated in women of child-bearing age. There is no relevant use of Elevit in the elderly population.
Patients with hepatic impairment: Elevit should be administered with caution under medical supervision in patients with hepatic impairment.
Patients with renal impairment: Elevit is contraindicated in patients with severe impaired renal function (see Contraindications).
Other special populations: Information for diabetics: These film-coated tablets do not contain sucrose. Therefore, they can be administered to diabetic patients.

There is no evidence that this product can lead to an overdose when used as recommended. Most, if not all reports concerning overdoses of vitamins and minerals are associated with concomitant intake of high dosed single and/or multivitamin preparations. Acute or long-term overdose can cause hypervitaminosis D and hypercalcemia as well as iron and copper toxicity.
Uncharacteristic initial symptoms, such as abrupt onset of headache, confusion, and gastrointestinal disturbances such as constipation, diarrhea, nausea, and vomiting might be indicative for an acute overdose.
If such symptoms occur, treatment must be stopped and a health care professional consulted.
Vitamin C overdose (over 15 g) may cause hemolytic anemia in certain individuals with a deficiency of glucose-6-phosphate dehydrogenase.

Known hypersensitivity to any component in the product; Severe impaired renal function; Existing hypervitaminosis D; Hypercalcaemia; Severe hypercalciuria; Iron and/or copper metabolism disorders.

The recommended dosage must not be exceeded. Very high doses of some ingredients, in particular vitamin D, iron and copper, can be harmful to health. (See Overdosage.)
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. (See Interactions.)
This preparation must be taken with particular caution together with other products, including supplements and/or fortified foods/drinks containing Vitamin D, since large daily doses may cause hypervitaminosis D. (See Overdosage.)
As calcium, ascorbic acid and Vitamin D may have an effect on stone formation, patients with nephrolithiasis or urolithiasis should use caution when using vitamin supplements.
Effects on ability to drive or use machines: No effects on ability to drive and use machines have been observed.

This preparation is indicated during preparation for pregnancy, pregnancy and lactation; however, the recommended dosage must not be exceeded (see Overdosage). As for every medicinal product, consult the health care professional.
Pregnancy: Chronic overdose of vitamin D might be harmful to the fetus.
For pregnant women, the Institute of Medicine (USA) has set the Tolerable Upper Intake Levels (UL) of vitamin D of 100 mcg (4000IU) per day, which is considered as safe. Elevit contains 1000 IU/tablet.
An overdose of vitamin D must be avoided as permanent hypercalcaemia can lead to physical and mental retardation, supravalvular, aortic stenosis and retinopathy in the child.
In animals, overdoses of vitamin D during pregnancy have been shown to have teratogenic effects. There is no evidence that vitamin D at the recommended dose is teratogenic in humans.
Before, during pregnancy and lactation the daily intake should not exceed 2500mg calcium and 4000IU (100μg) vitamin D.
Intake of food rich in vitamin D and intake of fortified foods and drinks, which may contain high levels of these vitamins, must be taken into account.
General remark: Adequate maternal micronutrient status is especially critical during preparation for pregnancy, pregnancy and lactation and the requirements for most micronutrients are higher in these periods. A complete multivitamin product containing folic acid and safe amounts of vitamin D, as well as of the other ingredients can thus be used during preparation for pregnancy, pregnancy and lactation to ensure sufficient micronutrient intakes.
Lactation: Permanent overdose of vitamin D might be harmful to the neonate.
The vitamins and minerals in this preparation are excreted into breast milk. This must be taken into consideration if the infant is receiving any respective supplements.
For lactating women the Institute of Medicine (USA) has set the Tolerable Upper Intake Levels (UL) of vitamin D of 100mcg (4000IU) per day, which is considered as safe. Elevit contains 1000IU/tablet.
Fertility: There are no data on the effect of the medicinal product on fertility.

The following adverse reactions have been identified during post-approval use of Elevit. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.
Gastrointestinal Disorders: Gastrointestinal and abdominal pain, constipation, diarrhea, nausea and vomiting may occur.
Immune system disorders: In isolated cases this product may cause allergic or anaphylactic reaction. Symptoms may include hives, facial swelling, wheezing, skin reddening, rash, blisters, and shock. If an allergic reaction occurs, treatment must be stopped and a health care professional consulted.
In a placebo controlled clinical trial in 2471 pregnant women who took Elevit (one tablet daily for 1 to 6 months), the percent of subjects reporting adverse events was as follows: Constipation (1.8%), diarrhea (1.4%) and exanthema (0.08%). The percentages of subjects reporting these events in the placebo group were not statistically different.
A slight yellow discoloration of urine may be noticed. This effect is harmless and is due to the vitamin B2 contained in the preparation.
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.
Metabolism and nutrition disorders: Hypercalciuria.
Nervous system disorders: Headache, dizziness, insomnia, nervousness may occur.

When used as recommended no specific interactions are expected. However, potential interactions for single ingredients are reported in the literature, thus patients receiving any other medication or those under medical care should consult a physician or healthcare professional before taking this medicinal product.
Drug-Drug interactions: The absorption of iron may be decreased by concurrent administration with antacids, gastric acid suppressive medications, fluoroquinolone, bisphosphonates, levodopa, levothyroxine, penicillamine, tetracycline antibiotics or trientine. If simultaneous use of one of these medications is necessary, administration should be separated by 2 to 3 hours.
Products containing calcium, magnesium, iron, copper or zinc may interact with orally administered antacids, antibiotics (tetracyclines, fluoroquinolones), levodopa, biphosphonates, penicillamine, thyroxine, trientine, digitalis, antiviral agents and thiazide diuretics. If simultaneous use is necessary, administration of the two products should be separated by 2 hours.
Drug-Food interactions: Since oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole cereals) may inhibit calcium absorption, it is not recommended to take this product within two hours of eating foods containing high oxalic acid or phytic acid concentrations.

Incompatibilities: None are known.
Instructions for use/handling: No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Store below 30°C.
Shelf life: 24 months.

Vitamins & Minerals (Pre & Post Natal) / Antianemics

B03AE02 - iron, multivitamins and folic acid ; Belongs to the class of iron in other combinations. Used in the treatment of anemia.

B