NEUROBION

NEUROBION N forte coated tablets

Important notes (mandatory information)

Neurobion N forte. Areas of application: For neurological system diseases due to proven deficiency of vitamins B1 and B6. Warning: Contains sucrose (sugar) and lactose.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Neurobion N forte
Coated tablets

For use in adults
Active ingredients: 100 mg N,N'-[disulfandiylbis(5-hydroxypent-2-en-2-yl)]bis[N-(4-amino-2-methylpyrimidine-5-ylmethyl)formamide], 100 mg pyridoxine hydrochloride

Please read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, to achieve the best possible treatment results, Neurobion N forte must be taken as directed.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve within 4 weeks, you must consult a doctor.
• If any of the listed side effects affect you significantly or if you notice side effects that are not listed in this package leaflet, please inform your doctor or pharmacist.

This package leaflet contains

1. WHAT IS NEUROBION N FORTE AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING NEUROBION N FORTE?
3. HOW SHOULD NEUROBION N FORTE BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD NEUROBION N FORTE BE STORED?
6. FURTHER INFORMATION

1. WHAT IS NEUROBION N FORTE AND WHAT IS IT USED FOR?

Neurobion N forte is a vitamin B1 + B6 preparation for neurological diseases. It is to be used for neurological system diseases due to proven deficiency of vitamins B1 and B6.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING NEUROBION N FORTE?

Neurobion N forte must not be taken if you are hypersensitive (allergic) to any of the active ingredients or any of the other ingredients of Neurobion N forte.

Special care should be taken when taking Neurobion N forte

Vitamin B6 can cause neuropathies even in daily doses of 50 mg or more over a longer period of time (months to years). If signs of peripheral sensory neuropathy (paraesthesia mainly in the hands and feet) occur, the attending physician must be consulted. This medicine contains sucrose (sugar) and lactose. Therefore, please only take Neurobion N forte after consulting your doctor if you are known to suffer from an intolerance to certain sugars.

When taking Neurobion N forte with other medicines

Therapeutic doses of vitamin B6 can weaken the effect of the antiparkinsonian drug LDopa. The simultaneous administration of so-called pyridoxine antagonists (medicines that have an effect against vitamin B6, such as hydralazine, isoniazid (INH), cycloserine, D-penicillamine) can increase the need for vitamin B6. Neurobion N forte loses its effect when taken at the same time as the cancer drug (cytostatic) 5-fluorouracil. Gastric acid inhibitors reduce the absorption of vitamin B1. Long-term treatment with the diuretic furosemide can lead to a vitamin B1 deficiency because increased amounts of vitamin B1 are excreted in the urine. Please note that this information may also apply to medicines that have been used recently. Please inform your doctor or pharmacist if you are taking or have recently taken other medicines, even if they are non-prescription medicines.

When taking Neurobion N forte with food and drink

Alcohol and black tea reduce the absorption of vitamin B1. Vitamin B1 can be broken down and thus rendered ineffective when consumed at the same time as drinks containing sulphites, such as wine.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. 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. These dosages may only be exceeded during pregnancy if the patient has a proven vitamin B1 and B6 deficiency. Systematic studies on the use of vitamin B1 and B6 are not available. Therefore, the use of this preparation during pregnancy and breast-feeding should only be decided by the attending physician after careful consideration of the benefits and risks. High doses of vitamin B6 can inhibit milk production. Vitamin B1 and vitamin B6 pass into breast milk.

Driving and using machines

No special precautions are required.

Important information about certain other ingredients of Neurobion N forte

This medicine contains sucrose (sugar) and lactose. Therefore, please only take Neurobion N forte after consulting your doctor if you are known to suffer from an intolerance to certain sugars.

3. HOW SHOULD NEUROBION N FORTE BE TAKEN?

Always take Neurobion N forte exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed, adults take one coated Neurobion N forte tablet once a day. In the case of a manifest proven deficiency, the dose can be increased to up to 3 coated tablets once a day after consultation with the attending physician.

How and when should you take Neurobion N forte?
The coated tablets are taken whole with sufficient liquid (e.g. 1 glass of water) with or after meals.

How long should you take Neurobion N forte?
After a maximum of 4 weeks, the attending physician should decide whether the administration of vitamin B6 and vitamin B1 in the high concentration present here is still indicated. If necessary, a preparation with a lower active ingredient strength should be used to reduce the risk of neuropathy associated with vitamin B6.

If you have taken more Neurobion N forte than you should

Long-term intake (months to years) of vitamin B6 in doses over 50 mg/day and short-term intake (2 months) of doses over 1g/day can lead to neurotoxic effects (see warnings). An overdose is mainly manifested by sensory polyneuropathy, possibly with ataxia. Extremely high doses can manifest themselves in convulsions. If doses of over 150 mg/kg body weight have been taken acutely, artificially induced vomiting and the administration of activated charcoal are recommended. Vomiting is most effective in the first 30 minutes after ingestion. Intensive medical measures may be necessary. High doses of vitamin B6 can inhibit milk production during breast-feeding. If physical symptoms occur, you should consult a doctor.

If you forget to take Neurobion N forte

Do not take a double dose to make up for a forgotten dose. Continue taking as described in the dosage instructions.

If you stop taking Neurobion N forte

It is important for successful treatment that you take Neurobion N forte for the entire period of time recommended by your doctor. If you have any further questions on the use of this medicine, please ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Neurobion N forte can have side effects, although not everybody gets them. Significant side effects or signs to watch out for, and what to do if you are affected: If you are affected by any of the following side effects, stop taking Neurobion N forte and see your doctor as soon as possible. Very rarely, hypersensitivity reactions (sweating, rapid heartbeat (tachycardia), skin reactions with itching and hives (urticaria)) can occur after oral thiamine (vitamin B1) administration.

The following categories are used as a basis for the frequency of side effects:
Very common:	more than 1 in 10 treated patients
Common:	1 to 10 in 100 treated patients
Uncommon:	1 to 10 in 1,000 treated patients
Rare:	1 to 10 in 10,000 treated patients
Very rare:	less than 1 in 10,000 treated patients
Not known:	frequency cannot be estimated from the available data.

Other possible side effects

In the case of long-term overdose of vitamin B6 (more than 2 months in a dose of over 1g/day), nerve-damaging effects can occur. Long-term intake (more than 6 - 12 months) of daily doses of over 50 mg of vitamin B6 can cause peripheral sensory neuropathy (paraesthesia mainly in the hands and feet) (see precautions for use and warnings).

What countermeasures should be taken if necessary?
If side effects occur, stop taking Neurobion N forte and contact your doctor. If you notice any side effects, please contact your doctor or pharmacist or the medical professional. 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, Department 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.

5. HOW SHOULD NEUROBION N FORTE BE STORED?

Keep out of reach of children. The expiry date of this pack is printed on the side flap of the folding box and on the blister. Do not use this pack after the stated date!

Storage conditions

Do not store above 25 °C.

6. FURTHER INFORMATION

The active ingredients are

1 coated Neurobion N forte tablet contains N,N'-[disulfandiylbis(5-hydroxypent-2-en-2-yl)]bis[N-(4-amino-2-methylpyrimidine-5-ylmethyl)formamide] (thiamine disulphide) 100mg, pyridoxine hydrochloride 100mg.
The other ingredients are: magnesium stearate (Ph. Eur.), hypromellose, sucrose (saccharose), talc, maize starch, lactose monohydrate, montan glycol wax, methylcellulose, light magnesium oxide, basic butyl methacrylate copolymer (Ph. Eur.), glycerol 85%, povidone (K 25), calcium carbonate, highly dispersed silicon dioxide, white clay, titanium dioxide (E 171).

What Neurobion N forte looks like and contents of the pack

Pack of 20, 50 or 100 coated tablets

Pharmaceutical entrepreneur

Merck Selbstmedikation GmbH
Frankfurter Str. 250
64293 Darmstadt
Tel. no.: 0 61 51/8 56-2260
Fax no.: 0 61 51/8 56-2203
www.merckselbstmedikation.de

Manufacturer

Merck Kommanditgesellschaft
auf Aktien + Co.,
Werk Spittal,
A-9800 Spittal/Drau

This package leaflet was last revised in May 2014.

Source: Information from the package leaflet
Status: 02/2016
Areas of application: For neurological system diseases due to proven deficiency of vitamins B1 and B6. Warning: Contains sucrose (sugar) and lactose.