Patient information leaflet

Gravida film-coated tablet

Read the patient information leaflet carefully before taking the medicine!
This is a non-prescription medicine.
For the optimal effect, it is essential that this medicinal product is administered carefully.
Please keep the patient information leaflet, because you might need the information in it later on as well.
For further information or advice, consult your pharmacist.
Urgently see your doctor if your symptoms do not ease or get more severe.

Contents of the Patient information leaflet:

1. What type of medicine is Gravida film-coated tablet and what is it recommended for?
2. Before taking Gravida film-coated tablet
3. How to apply Gravida film-coated tablet?
4. Possible side effects
5. Storage.

The preparation contains vitamins and minerals.
Composition per film-coated tablet:
Active substances in 1 film-coated tablet:

Vitamin A 2000 NE
Beta carotene 2000 NE
Vitamin B₁ (thiamine, in the form of thiamine nitrate) 1,5 mg
Vitamin B₂ (riboflavin) 1,8 mg
B₃-vitamin (nicotinamide) 20 mg
B₅-vitamin (pantothenic acid, in the form of pantothenic acid) 10 mg
Vitamin B₆ (pyridoxine, in the form of pyridoxine hydrochloride) 2,6 mg
Vitamin B₁₂ (cyano-cobalamin) 0,0026 mg
Folic acid 0,8 mg
Vitamin H (biotin) (biotin) 0,15 mg
Vitamin C (ascorbic acid) 125 mg
Vitamin D₃ (colecalciferol) 400 NE
Vitamin E (α−tokoferol, the form of tocopheryl acetate) 20 NE
K₁-vitamin (fitomenadion) 0,055 mg
Calcium 250 mg
(in the form of calcium carbonate and water-free dicalcium phosphate)
Phosphorous (in the form of water-free dicalcium phosphate) 96,8 mg
Magnesium (in the form of heavy magnesium-oxide) 125 mg
Zinc (in the form of zinc oxide) 15 mg
Iron (in the form of iron(II)-sulphate) 30 mg
Manganese (in the form of manganese(II)-sulfate monohydrate) 2 mg
Copper (in the form of copper gluconate) 1,8 mg
Iodine (in the form of potassium iodate) 0,15 mg
Molybdenum (in the form of ammonium molybdate) 0,025 mg
Chromium (in the form of chromium picolinate) 0,025 mg
Selenium (in the form of selenic acid) 0,025 mg

Auxiliary materials: Mannitol, magnesium stearate, crospovidonee, microcrystalline cellulose.
In mixture: gelatine, sucrose, butyl hydroxy toulene (E 321), maize starch, α-tocopherol, ascorbyl palmitate, sodium ascorbate,
trisodium citrate, citric acid, maltodextrin, ethyl cellulose, dissolved starch, sodium aluminium silicate (E 554), triglycerides of medium carbon cycled fatty acids, calcium silicate, silicon dioxide, calcium phasphate, glucose syrup dried pulverized, gum arabic, polysorbate 80..
Coating: "Sepifilm 003" [hypromellose, microcrystalline cellulose, macrogol-40 stearate (E 431)], "Sepisperse Dry 5221 Pink" [hypromellose, microcrystalline cellulose, titanium dioxide (E171), Ponceau 4R (E 124)].
Description: Film-coated tablet: pink, oval shape, film-coated tablet with a bisecting line on each side of the tablet.

Packaging: 30 and 90 film-coated tablets in a white HDPE container closed with Alu/PE closing foil and a white PP screw cap. 1 container in a box.

Marketing authorisation holder and manufacturer: Béres Gyógyszergyár Zrt., 1037 Budapest, Mikoviny u. 2-4., www.beres.hu

1. WHAT TYPE OF MEDICINE IS GRAVIDA FILM-COATED TABLET AND WHAT IS IT RECOMMENDED FOR?

Its application is recommended for:

Before conception: to prevent and reduce the occurrence of particular disturbances of development (e.g. spina bifida, neural tube closure defects);
During pregnancy and lactation: to prevent vitamin, mineral and trace element deficiencies owing to increased requirements;
To help the baby develop appropriately;
For mothers not nursing their babies after giving birth for a period of 3 months.

2. IMPORTANT NOTES BEFORE TAKING GRAVIDA FILM-COATED TABLET

Do not take the preparation in the cases of:

hypersensitivity (allergy) to any of the active substances and auxiliary materials,
liver and kidney disorders,
increased iron storage disease,
anaemia accompanied by increased abnormal breakdown of red blood cells (hemolityc anaemia),
Vitamin A or D overdose,
high calcium level in the blood,
simultaneous retinoid treatment.

Important information before starting the treatment:
Do not take it with other multivitamin-type preparations, because the intakes of vitamins A, D and E may exceed the recommended intake. The recommended daily intake of Vitamin A is 5500 IU, so it is not recommended to take more than one Gravida tablet a day. A high dose of Vitamin A may be harmful for your baby. Vitamin B2 may colour urine yellow and stool black. In the cases of particular gastrointestinal diseases (peptic ulcer, colitis ulcerosa and Crohn‘s disease) iron dosing may make these diseases more severe. Optimally, start taking the preparation prior to conception.

Application of other medicines (interaction between medicines):
At least 2 hours should pass between taking antacids, medicines containing tetracycline, sodium fluoride, fluoroquinolones, phenytoin, penicillamine, biphosponate and Gravida (owing to the possible inhibition of absorption). It can be taken with medicines containing l-thyroxine only under medical supervision. Taken together with other preparations containing Vitamin A, the risk of vitamin overdose increases. It is prohibited to take with: preparations containing Vitamin A derivatives, because their toxicity increases. In the case of taking other preparations containing Vitamin D3 or calcium, the risk of the high calcium level in the blood may increase. Vitamin K in the preparation may reduce the effect of anticoagulants.

Pregnancy and lactation:
Both vitamin D and vitamin A are secreted with mother’s milk. During pregnancy and lactation vitamin A intake exceeding 5500 IU per day and vitamin D intake exceeding 600 IU a day is not recommended, so do not take more than the daily dose (1 film-coated tablet).

The effects of the preparation on driving capabilities and capabilities of the operation of machines: No such effects are known if taken in the recommended dose.

3. HOW TO APPLY GRAVIDA FILM-COATED TABLET?

For adults: its usual dose is 1 film-coated tablet per day.
Take the preparation with little liquid at the same time of the day if possible.

For children: Children cannot take this preparation.

If you took more film-coated tablets (overdose):
Fat-soluble vitamins A, D, E and K may accumulate in the organism and may be harmful in a high dose taken for a long time.

If you missed a dose:
Do not take a double dose the next time, because the omitted quantity cannot be substituted this way, but the probability of adverse effects may increase. Continue the treatment as prescribed.

4. POSSIBLE SIDE EFFECTS

As every medicine, Gravida film-coated tablet may also have side effects. Hypersensitivity reactions may occur. In such cases, stop taking the preparation and contact your doctor.

5. Storage

Store it below 25°C in a dry place.
Do not take the medicine after its expiry date printed on the packaging.
The medicine is to be stored out of reach of children!
OGYI-T-20022/01-03
OGYI approval number of the patient information leaflet: 27 744/40/2005

For risks and side effects, please read the patient information leaflet or consult your doctor, pharmacist!