Vitamin B Komplex forte Hevert

Important instructions for use. Read carefully before taking this medicine!

Therapeutic indications

For the treatment of confirmed deficiencies of vitamins B1, B6 and B12

Contraindications

When not to take Vitamin B Komplex forte Hevert:
Do not take Vitamin B Komplex forte Hevert in case of hypersensitivity to: thiamine mononitrate (vitamin B1), pyridoxine hydrochloride (vitamin B6), cyanocobalamin (vitamin B12) or any of the other ingredients of Vitamin B Komplex forte Hevert.

Precautions for use

When taken over months and years, a vitamin B6 dose as low as 50 mg/day may result in permanent nerve damage.

Deficiency of vitamins B1, B6, and B12 must be confirmed by appropriate laboratory tests. Oral administration of vitamin B12 is not that well suited in the initial treatment of pernicious anemia; when instituting treatment, parenteral preparations will ensure reliable treatment.

Pregnancy and lactation

If you are pregnant or breastfeeding, this medicine is only recommended in confirmed vitamin B1 and B6 deficiency because of the amount of active ingredients it contains. Therefore you should only take Vitamin B Komplex forte Hevert if your attending physician considers this absolutely necessary.

In pregnancy and breastfeeding, the recommended daily dose of vitamin B1 is 1.4 mg to 1.6 mg, and for vitamin B6 2.4 mg to 2.6 mg. The safety of doses higher than the recommended daily dose has not been demonstrated to date.

Vitamins B1, B6, and B12 are excreted in breast milk. High-dose vitamin B6 may inhibit milk production.

Driving and using machines

No special precautions are needed.

Interactions with other medicines

Vitamin B1 (thiamine mononitrate) is inactivated by 5-fluorouracil, since 5-fluorouracil competitively inhibits the phosphorylation of thiamine to thiamine pyrophosphate.

The increased renal excretion in long-term treatment with furosemide may result in thiamine deficiency.

Vitamin B6 (pyridoxine) may decrease the effect of L-dopa. Isoniazid, D-penicillamine, and cycloserine may decrease the effect of vitamin B6 (pyridoxine hydrochloride).

Important information on certain excipients

This medicine contains lactose. Please do not take Vitamin B Komplex forte Hevert if you know that you suffer from lactose intolerance and talk to your healthcare provider first.

Posology, method and duration of administration

For short-term administration (up to four weeks), take 1-2 tablets daily, swallowing them whole during meals. For chronic illness (longer than four weeks), take 1 tablet daily.

If you have any further questions on the use of this medicine, talk to your healthcare provider.

Side effects

In isolated cases, the ingredients vitamin B1 (thiamine mononitrate) and vitamin B12 (cyanocobalamin) may cause sweating, rapid heart beat, and skin reactions with itching and hives.

In long-term administration of vitamin B6 (pyridoxine hydrochloride) dosed higher than 50 mg/day, as well as in short-term administration of gram doses, peripheral sensory neuropathy has been reported. Photosensitivity has been noted at very high daily doses. Gastrointestinal complaints have been reported at higher doses.

Reporting side effects

If you get any side effects, talk to your healthcare provider. This includes any possible sides effects not listed in this leaflet.

You can also report side effects directly to the Bundesinstitut für Arzneimittel und Medizinprodukte [Federal Institute for Drug and Medical Devices], Kurt-Georg-Kiesinger Allee 3, 53175 Bonn, Germany

website:
www.bfarm.de .

By reporting side effects you can help provide more information on the safety of this medicine.

Information on shelf-life and storage

Do not take this medicine after the expiry date which is stated on the container and carton.

Do not store above 25°C!

Medicinal products: Always keep out of the sight and reach of children!

Composition

1 tablet contains:

Active substances:

  • Vitamin B1 (thiamine mononitrate) 100 mg
  • Vitamin B6 (pyridoxine hydrochloride) 50 mg
  • Vitamin B12 (cyanocobalamin) 500 µg

Other excipients:
Microcrystalline cellulose, citric acid, croscarmellose, lactose monohydrate, magnesium stearate (Ph.Eur.) [vegetable], maltodextrin, povidone K 25, trisodium citrate.

Pharmaceutical form and pack sizes

20 (sample) / 20 / 50 / 100 / 200 (2x100) tablets for oral administration.

Marketing authorization holder

Hevert-Arzneimittel GmbH & Co. KG
In der Weiherwiese 1
D-55569 Nussbaum / Germany
www.hevert.com

Manufactured in Germany by

Hevert-Arzneimittel GmbH & Co. KG

Date of revision of the text
October 2015
Approval No.: 6288053.00.00

Important note:
All information on Vitamin B Komplex forte Hevert is based on the registration of the medicinal product in Germany.

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