VITAMIN

VITAMIN B KOMPLEX forte Hevert tablets

Important notes (mandatory information)

Vitamin B Complex forte Hevert, tablets.

Indications

For the treatment of proven deficiency states of vitamins B1, B6 and B12.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Vitamin B Complex forte Hevert, tablets
Vitamin preparation

Indications

For the treatment of proven deficiency states of vitamins B1, B6 and B12.

Contraindications

When should you not take Vitamin B Complex forte Hevert?
Vitamin B Complex forte Hevert must not be taken in case of hypersensitivity to thiamine nitrate (vitamin B1), pyridoxine hydrochloride (vitamin B6), cyanocobalamin (vitamin B12) or any of the other ingredients of Vitamin B Complex forte Hevert.

Precautions for use

Vitamin B6 can cause permanent nerve damage even in doses of 50 mg/day if taken for months to years. A deficiency of vitamins B1, B6 and B12 must be proven by determining suitable laboratory values. Oral administration of vitamin B12 is only conditionally suitable for the initial treatment of pernicious anaemia; parenteral preparations are recommended for initial treatment to ensure safe treatment.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, this medicine is only useful for treating a proven vitamin B1 and B6 deficiency due to the amount of active ingredient it contains. Therefore, you should only use Vitamin B Complex forte Hevert if your doctor considers it absolutely necessary. The recommended daily intake of vitamin B1 during pregnancy and breast-feeding is 1.4 - 1.6 mg and of vitamin B6 2.4 - 2.6 mg. The safety of using doses higher than the recommended daily dose has not yet been proven. Vitamins B1, B6 and B12 pass into breast milk. High doses of vitamin B6 can inhibit milk production.

Driving and using machines

No special precautions are required.

Interactions with other medicines

Vitamin B1 (thiamine nitrate) is inactivated by 5-fluorouracil, as 5-fluorouracil competitively inhibits the phosphorylation of thiamine to thiamine pyrophosphate. Long-term treatment with furosemide can lead to a thiamine deficiency due to increased renal excretion. Vitamin B6 (pyridoxine) can reduce the effect of L-dopa. The effectiveness of vitamin B6 (pyridoxine hydrochloride) can be reduced by isoniazid, D-penicillamine and cycloserine.

Important information about certain other ingredients

This medicine contains lactose. Therefore, please only take Vitamin B Complex forte Hevert after consulting your doctor if you know that you suffer from lactose intolerance.

Dosage, type and duration of use

For short-term use (up to four weeks) take 1 - 2 tablets daily without chewing during meals. For chronic conditions (longer than four weeks) take 1 tablet daily.

If you have any further questions about the use of the medicine, ask your doctor or pharmacist.

Side effects

Due to the ingredients vitamin B1 (thiamine nitrate) and vitamin B12 (cyanocobalamin), sweating, tachycardia and skin reactions with itching and urticaria may occur in individual cases. Peripheral sensory neuropathies have been observed with long-term intake of daily doses of more than 50 mg vitamin B6 (pyridoxine hydrochloride) and with short-term intake of doses in the gram range. Photosensitivity has been described with very high daily doses. Gastrointestinal disorders have been described with higher intake amounts.

Reporting of

side effects

If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

Notes on shelf life and storage

The medicine should not be used after the expiry date stated on the container and outer carton. Do not store above 25°C! Always keep medicines out of the reach of children!

Composition

1 tablet contains the following active ingredients: Vitamin B1 (thiamine nitrate) 100 mg, vitamin B6 (pyridoxine hydrochloride) 50 mg, vitamin B12 (cyanocobalamin) 500 µg. Other ingredients: Microcrystalline cellulose, citric acid, croscarmellose, lactose monohydrate, magnesium stearate (Ph.Eur.) [vegetable], maltodextrin, povidone K 25, trisodium citrate.

Dosage form and pack sizes
20, 50, 100 and 200 (2 x 100) tablets for oral administration.

Pharmaceutical entrepreneur and manufacturer

Hevert-Arzneimittel GmbH & Co. KG
In der Weiherwiese 1
D-55569 Nussbaum

www.hevert.de

This package leaflet was last revised in October 2015.

Source: Information from the package leaflet
Status: 08/2021
Indications: For the treatment of proven deficiency states of vitamins B1, B6 and B12.