VITAMIN

VITAMIN B6-RATIOPHARM 40 mg film-coated tablets

Important notes (mandatory information)

Vitamin B6-ratiopharm 40 mg film-coated tablets. Active ingredient: Pyridoxine hydrochloride. Areas of application: Vitamin B6-ratiopharm 40 mg is used for: Adults: Prevention of peripheral neuropathy (nerve inflammation) due to vitamin B6 deficiency caused by taking medication (medicines with active ingredients such as isoniazid, D-penicillamine, cycloserine), treatment of peripheral neuropathy (nerve inflammation) due to vitamin B6 deficiency caused by taking medication (medicines with active ingredients such as isoniazid, D-penicillamine, cycloserine), treatment of pyridoxine-dependent disorders (rare diseases, some of which can be treated with increased doses of vitamin B6: primary hyperoxaluria type I, homocystinuria, cystathioninuria, xanthurenic aciduria, sideroblastic anemia (from 200 mg), hypochromic microcytic anemia due to vitamin B6 deficiency). Children and adolescents: Treatment of peripheral neuropathy (nerve inflammation) due to vitamin B6 deficiency caused by taking medication (medicines with active ingredients such as isoniazid, D-penicillamine, cycloserine), maintenance therapy after vitamin B6 deficiency-related cramps in newborns and infants, treatment of pyridoxine-dependent disorders in children over 1 year of age (rare diseases, some of which can be treated with increased doses of vitamin B6: primary hyperoxaluria type I, homocystinuria, cystathioninuria, xanthurenic aciduria, sideroblastic anemia, hypochromic microcytic anemia due to vitamin B6 deficiency).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Vitamin B6-ratiopharm 40 mg film-coated tablets
Active ingredient: Pyridoxine hydrochloride

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. See section 4.
• If you do not feel better or if you feel worse, talk to your doctor.

What is in this leaflet

1. WHAT IS VITAMIN B6-RATIOPHARM 40 MG AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING VITAMIN B6-RATIOPHARM 40 MG?
3. HOW TO TAKE VITAMIN B6-RATIOPHARM 40 MG?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD VITAMIN B6-RATIOPHARM 40 MG BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS VITAMIN B6-RATIOPHARM 40 MG AND WHAT IS IT USED FOR?

Vitamin B6-ratiopharm 40 mg is a vitamin preparation. Vitamin B6-ratiopharm 40 mg is used for: Adults: Prevention of peripheral neuropathy (nerve inflammation) due to vitamin B6 deficiency caused by taking medication (medicines with active ingredients such as isoniazid, D-penicillamine, cycloserine), treatment of peripheral neuropathy (nerve inflammation) due to vitamin B6 deficiency caused by taking medication (medicines with active ingredients such as isoniazid, D-penicillamine, cycloserine), treatment of pyridoxine-dependent disorders (rare diseases, some of which can be treated with increased doses of vitamin B6: primary hyperoxaluria type I, homocystinuria, cystathioninuria, xanthurenic aciduria, sideroblastic anemia (from 200 mg), hypochromic microcytic anemia due to vitamin B6 deficiency). Children and adolescents: Treatment of peripheral neuropathy (nerve inflammation) due to vitamin B6 deficiency caused by taking medication (medicines with active ingredients such as isoniazid, D-penicillamine, cycloserine), maintenance therapy after vitamin B6 deficiency-related cramps in newborns and infants, treatment of pyridoxine-dependent disorders in children over 1 year of age (rare diseases, some of which can be treated with increased doses of vitamin B6: primary hyperoxaluria type I, homocystinuria, cystathioninuria, xanthurenic aciduria, sideroblastic anemia, hypochromic microcytic anemia due to vitamin B6 deficiency).

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING VITAMIN B6-RATIOPHARM 40 MG?

Vitamin B6-ratiopharm 40 mg must not be taken if you are allergic to pyridoxine hydrochloride or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Vitamin B6-ratiopharm 40 mg. Tingling and pins and needles in the hands and feet (signs of peripheral sensory neuropathy, or paresthesia) have been observed with long-term use of daily doses over 50 mg and with short-term use of doses in the gram range. If you experience tingling and pins and needles, please contact your doctor. They will check the amount you are taking and stop the medication if necessary.

Taking Vitamin B6-ratiopharm 40 mg with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or plan to take/use any other medicines. The simultaneous administration of so-called pyridoxine antagonists (medicines with active ingredients that have an effect against vitamin B6, such as hydralazine, isoniazid (INH), cycloserine, D-penicillamine or oral contraceptives [the "pill"]) can increase the need for vitamin B6.

Medicines whose effect is influenced by Vitamin B6-ratiopharm 40 mg

Vitamin B6 can reduce the effect of L-dopa (a medicine used to treat Parkinson's disease).

Pregnancy and breast-feeding

The recommended daily intake of vitamin B6 during pregnancy (from the 4th month) and breast-feeding is 1.9 mg. So far, no risks have become known when using vitamin B6 in the dosages recommended for Vitamin B6-ratiopharm 40 mg. Systematic studies on the use of vitamin B6 in dosages above the specified daily requirement 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 B6 passes into breast milk.

Driving and using machines

No special precautions are required.

Vitamin B6-ratiopharm 40 mg contains lactose

Therefore, please only take Vitamin B6-ratiopharm 40 mg after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE VITAMIN B6-RATIOPHARM 40 MG?

Always take this medicine exactly as described in this leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is

Adults:

• Prevention of peripheral neuropathy due to vitamin B6 deficiency caused by taking medication: The dosage is to be determined individually by the attending physician. As a rule, 25 to 50 mg of vitamin B6 per day are recommended (1 film-coated tablet of Vitamin B6-ratiopharm 40 mg contains 40 mg of vitamin B6).
• Treatment of peripheral neuropathy due to vitamin B6 deficiency caused by taking medication: The dosage is to be determined individually by the attending physician. As a rule, 50 to 300 mg of vitamin B6 per day are recommended (1 film-coated tablet of Vitamin B6-ratiopharm 40 mg contains 40 mg of vitamin B6).
• Treatment of pyridoxine-dependent disorders (primary hyperoxaluria type I, homocystinuria, cystathioninuria, xanthurenic aciduria, hypochromic microcytic anemia due to vitamin B6 deficiency): The dosage is to be determined individually by the attending physician. As a rule, 10 to 250 mg, in individual cases up to 600 mg or more of vitamin B6 per day are recommended (1 film-coated tablet of Vitamin B6-ratiopharm 40 mg contains 40 mg of vitamin B6).
• Treatment of pyridoxine-dependent disorders (sideroblastic anemia): The dosage is to be determined individually by the attending physician. As a rule, dosages of 200 mg of vitamin B6 per day or more are recommended (1 film-coated tablet of Vitamin B6-ratiopharm 40 mg contains 40 mg of vitamin B6).

Children and adolescents:

• Treatment of peripheral neuropathy due to vitamin B6 deficiency caused by taking medication: The dosage is to be determined individually by the attending physician. As a rule, 50 to 200 mg of vitamin B6 per day are recommended (1 film-coated tablet of Vitamin B6-ratiopharm 40 mg contains 40 mg of vitamin B6).
• Maintenance therapy after vitamin B6 deficiency-related cramps in newborns and infants: The dosage is to be determined individually by the attending physician. As a rule, dosages of 2 to 200 mg of vitamin B6 per day are recommended. The requirement increases depending on age and any other illnesses (1 film-coated tablet of Vitamin B6-ratiopharm 40 mg contains 40 mg of vitamin B6).
• Treatment of pyridoxine-dependent disorders in children over 1 year of age: The dosage is to be determined individually by the attending physician. As a rule, 10 to 250 mg (2 to 15 mg in the first year of life) of vitamin B6 per day are recommended (1 film-coated tablet of Vitamin B6-ratiopharm 40 mg contains 40 mg of vitamin B6). Note: 25 mg of pyridoxine hydrochloride (vitamin B6) is sufficient to treat simple vitamin B6 deficiency conditions.

Method of administration

For oral use. The film-coated tablets are taken whole with sufficient liquid.

Duration of use

The duration of use depends on the type and severity of the underlying disease. Please consult your doctor about this. Please talk to your doctor or pharmacist if you have the impression that the effect of Vitamin B6-ratiopharm 40 mg is too strong or too weak.

If you have taken more Vitamin B6-ratiopharm 40 mg than you should

The maximum daily dose should not be exceeded. Long-term use (months to years) of vitamin B6 in doses over 50 mg per day and short-term use (2 months) of doses over 1 g per day can lead to neurotoxic effects (nerve damage) (see section 2. "Warnings and precautions"). High doses of vitamin B6 over a long period of time can lead to the development of severe peripheral neuropathy (sensory disturbances, especially in the hands and feet), possibly with ataxia (movement disorders). Extremely high doses can manifest themselves in cramps. If doses 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.

If you forget to take Vitamin B6-ratiopharm 40 mg

Do not take twice the amount if you have forgotten to take the previous dose. Continue taking as described in the dosage instructions.

If you stop taking Vitamin B6-ratiopharm 40 mg

Please contact your doctor.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Not known (frequency cannot be estimated from the available data)

Hypersensitivity reactions. Cases of vitamin B6 dependency have been described with higher intake amounts. Peripheral sensory neuropathies (diseases of the nerves with tingling and pins and needles) have been observed with long-term use of daily doses over 50 mg of vitamin B6 and with short-term use of doses in the gram range (see section 2. "Warnings and precautions"). Gastrointestinal disorders have been described with higher intake amounts. Hypersensitivity to sunlight has been described with very high daily doses.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this 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 on the safety of this medicine.

5. HOW SHOULD VITAMIN B6-RATIOPHARM 40 MG BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and the blister packs after "Use by". The expiry date refers to the last day of the month indicated. Store in the original package in order to protect from light.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Vitamin B6-ratiopharm 40 mg contains

The active ingredient is pyridoxine hydrochloride. Each film-coated tablet contains 40 mg of pyridoxine hydrochloride. The other ingredients are: cellulose powder, lactose monohydrate, corn starch, macrogol 8000, copovidone, talc, highly dispersed silicon dioxide, magnesium stearate, hypromellose, glycerol 85%, titanium dioxide, iron(III) oxide.

What Vitamin B6-ratiopharm 40 mg looks like and contents of the pack

Pink, round film-coated tablet with a cross-breaking notch on one side. Vitamin B6-ratiopharm 40 mg is available in packs of 100 film-coated tablets.

Pharmaceutical entrepreneur

ratiopharm GmbH
Graf-Arco-Str. 3
89079 Ulm

Manufacturer

Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren

This leaflet was last revised in July 2013.

Source: Information from the package leaflet
Status: 05/2018
Active ingredient: Pyridoxine hydrochloride. Areas of application: Vitamin B6-ratiopharm 40 mg is used for: Adults: Prevention of peripheral neuropathy (nerve inflammation) due to vitamin B6 deficiency caused by taking medication (medicines with active ingredients such as isoniazid, D-penicillamine, cycloserine), treatment of peripheral neuropathy (nerve inflammation) due to vitamin B6 deficiency caused by taking medication (medicines with active ingredients such as isoniazid, D-penicillamine, cycloserine), treatment of pyridoxine-dependent disorders (rare diseases, some of which can be treated with increased doses of vitamin B6: primary hyperoxaluria type I, homocystinuria, cystathioninuria, xanthurenic aciduria, sideroblastic anemia (from 200 mg), hypochromic microcytic anemia due to vitamin B6 deficiency). Children and adolescents: Treatment of peripheral neuropathy (nerve inflammation) due to vitamin B6 deficiency caused by taking medication (medicines with active ingredients such as isoniazid, D-penicillamine, cycloserine), maintenance therapy after vitamin B6 deficiency-related cramps in newborns and infants, treatment of pyridoxine-dependent disorders in children over 1 year of age (rare diseases, some of which can be treated with increased doses of vitamin B6: primary hyperoxaluria type I, homocystinuria, cystathioninuria, xanthurenic aciduria, sideroblastic anemia, hypochromic microcytic anemia due to vitamin B6 deficiency).