VITAMIN

VITAMIN B KOMPLEX forte Hevert tablets

Important Information (Mandatory Details)

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 if you are hypersensitive 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, even in doses of 50 mg/day, can cause permanent nerve damage when used for months to years. A deficiency of vitamins B1, B6, and B12 must be proven by determining appropriate laboratory values. For the initial therapy of pernicious anemia, oral administration of vitamin B12 is only conditionally suitable; to ensure safe treatment, parenteral preparations are recommended for initial therapy.

Pregnancy and Breastfeeding

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

Driving ability and operating machinery

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. In long-term treatment with furosemide, a thiamine deficiency can arise due to increased renal excretion. Vitamin B6 (pyridoxine) can lead to a weakening of 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. Please therefore only take Vitamin B Complex forte Hevert after consulting your doctor if you know that you suffer from lactose intolerance.

Dosage instructions, type and duration of use

For short-term use (up to four weeks), take 1 - 2 tablets daily, unchewed, 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 over 50 mg of vitamin B6 (pyridoxine hydrochloride) as well as with short-term intake of gram-range doses. Photosensitivity has been described with very high daily doses. Gastrointestinal disturbances 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. 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 use.

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.