VITAMIN

VITAMIN B6 20 mg Jenapharm tablets

Important notes (mandatory information)

Vitamin B6 20 mg JENAPHARM. Active ingredients: Pyridoxine hydrochloride. Areas of application: For the treatment of vitamin B6 deficiency. Warning: Contains lactose and sunset yellow FCF.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Vitamin B6 20 mg JENAPHARM® Tablets
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 package leaflet or exactly as your doctor or pharmacist has told you.
- 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 package leaflet. See section 4.
- If you do not feel better or if you feel worse, contact your doctor.

What this package leaflet contains
1. WHAT IS VITAMIN B6 20 MG JENAPHARM AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING VITAMIN B6 20 MG JENAPHARM?
3. HOW TO TAKE VITAMIN B6 20 MG JENAPHARM?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE VITAMIN B6 20 MG JENAPHARM?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS VITAMIN B6 20 MG JENAPHARM AND WHAT IS IT USED FOR?

Vitamin B6 20 mg JENAPHARM belongs to the group of B vitamins. Vitamin B6 20 mg JENAPHARM is used to treat vitamin B6 deficiency. If you do not feel better or if you feel worse, contact your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING VITAMIN B6 20 MG JENAPHARM?

Vitamin B6 20 mg JENAPHARM must not be taken if you are allergic to pyridoxine hydrochloride (vitamin B6), sunset yellow FCF 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 20 mg. Tingling and numbness in the hands and feet (signs of peripheral sensory neuropathy or paraesthesia) have been observed with long-term intake of daily doses over 50 mg and with short-term intake of doses in the gram range. If you experience tingling and numbness, please contact your doctor. He will check the amount you are taking and, if necessary, discontinue the medication.

Taking Vitamin B6 20 mg JENAPHARM with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

Vitamin B6 20 mg JENAPHARM is affected as follows

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.

Vitamin B6 20 mg JENAPHARM affects the effect of the following medicines

Vitamin B6 in daily doses of 5 mg or more can reduce the effect of levodopa (a medicine used to treat Parkinson's disease).

Pregnancy and

breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. During pregnancy and breastfeeding, the daily vitamin requirement should be met with a balanced diet.

Pregnancy

This medicine (due to the amount of active ingredient it contains) is only useful for treating a vitamin deficiency and should therefore only be taken after careful consideration of the benefits and risks by the doctor. There are no systematic studies on taking Vitamin B6 20 mg JENAPHARM during pregnancy.

Breastfeeding

Vitamin B6 passes into breast milk.

Driving and using machines

No special precautions are required.

Vitamin B6 20 mg JENAPHARM contains lactose

Therefore, please only take Vitamin B6 20 mg JENAPHARM after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE VITAMIN B6 20 MG JENAPHARM?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose for the treatment of a confirmed vitamin B6 deficiency is one Vitamin B6 20 mg JENAPHARM tablet daily (equivalent to 20 mg pyridoxine hydrochloride).

Method of administration

Please take the tablet whole with sufficient liquid (preferably a glass of drinking water [200 ml]).

Duration of use

The duration of use depends on the type and severity of the underlying disease. Please consult your doctor. Please talk to your doctor or pharmacist if you have the impression that the effect of Vitamin B6 20 mg JENAPHARM is too strong or too weak.

If you have taken more Vitamin B6 20 mg JENAPHARM than you should

Signs of overdose: High doses of vitamin B6 can inhibit milk production. Long-term intake (months to years) of vitamin B6 in doses over 50 mg/day and short-term intake (2 months) of doses over 1 g/day can lead to neurotoxic effects (see section 2. "Warnings and precautions"). An overdose is mainly manifested by sensory polyneuropathy, possibly with ataxia (coordination disorders). Extremely high doses can manifest themselves in convulsions. In newborns and infants, severe sedation (calming), hypotension (low blood pressure) and respiratory disorders (dyspnoea [shortness of breath], apnoea [respiratory arrest]) can occur (see section 2. "Warnings and precautions").

Treatment of an overdose

If doses of more than 150 mg/kg body weight have been taken acutely (at once), 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 20 mg JENAPHARM

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 20 mg JENAPHARM

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. No side effects are known in the specified dose range for the prevention and treatment of vitamin B6 deficiency. Daily doses over 50 mg can cause peripheral sensory neuropathy (a disease of the nerves with tingling and numbness) (see section 2. "Warnings and precautions"). Sunset yellow FCF can cause allergic reactions.

Reporting of side effects

If you experience any side effects, talk to 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 on the safety of this medicine.

5. HOW TO STORE VITAMIN B6 20 MG JENAPHARM?

Keep this medicine out of the reach of children.

Storage conditions

Store in the original package to protect the contents from light and moisture. Do not use this medicine after the expiry date which is stated on the carton and container after "Use by:" or "Use by:". The expiry date refers to the last day of the month indicated. Do not dispose of the medicine in wastewater. Ask your doctor or pharmacist how to dispose of the medicine when you stop using it. In doing so, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Vitamin B6 20 mg JENAPHARM contains

The active ingredient is: Pyridoxine hydrochloride.
One tablet contains 20 mg pyridoxine hydrochloride.
The other ingredients are: Lactose monohydrate, potato starch, talc, sodium carboxymethyl starch, gelatine, magnesium stearate (Ph.Eur.), quinoline yellow (E 104), sodium chloride, indigo carmine (E 132), sunset yellow FCF (E 110).

What Vitamin B6 20 mg JENAPHARM looks like and contents of the pack

Greenish-yellow, curved, round tablet Vitamin B6 20 mg JENAPHARM is available in packs of 20 tablets and 100 tablets. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Tel.: 034954/247-0
Fax: 034954/247-100

This leaflet was last revised in July 2015.

Source: Information from the package leaflet
Status: 12/2015
Active ingredients: Pyridoxine hydrochloride. Areas of application: For the treatment of vitamin B6 deficiency. Warning: Contains lactose and sunset yellow FCF.