BIOTIN-RATIOPHARM

BIOTIN-RATIOPHARM 5 mg tablets

Important notes (mandatory information)

Biotin-ratiopharm 5 mg. Active ingredient: Biotin. Areas of application: Therapy and prophylaxis of biotin deficiency and for the therapy of biotin deficiency in the very rare biotin-dependent, multiple carboxylase deficiency. Warning: Contains lactose!

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Biotin-ratiopharm 5 mg tablets
Active ingredient: Biotin

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, Biotin-ratiopharm 5 mg must be taken as directed to ensure the best possible treatment results.

• 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, you must see a doctor in any case.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.

This package leaflet contains

1. WHAT IS BIOTIN-RATIOPHARM 5 MG AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING BIOTIN-RATIOPHARM 5 MG?
3. HOW TO TAKE BIOTIN-RATIOPHARM 5 MG?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE BIOTIN-RATIOPHARM 5 MG?
6. FURTHER INFORMATION

1. WHAT IS BIOTIN-RATIOPHARM 5 MG AND WHAT IS IT USED FOR?

Biotin-ratiopharm 5 mg is a vitamin preparation. Biotin-ratiopharm 5 mg is used to prevent and treat biotin deficiency. (Less than 0.2 mg of biotin per day is sufficient for prevention) and for the treatment of biotin deficiency in the very rare biotin-dependent, multiple carboxylase deficiency.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING BIOTIN-RATIOPHARM 5 MG?

Biotin-ratiopharm 5 mg must not be taken if you are hypersensitive (allergic) to biotin or any of the other ingredients of Biotin-ratiopharm 5 mg

When taking Biotin-ratiopharm 5 mg with other medicines

Please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines. There is evidence that medicines for seizures (anticonvulsants) lower the level of biotin in the blood plasma.

Pregnancy and breast-feeding

There are no restrictions when used as intended. Biotin crosses the placenta and passes into breast milk. Breast milk normally contains 7 - 13 µg biotin/l.

Driving and using machines

So far, no effects on the ability to drive and use machines have become known.

Important information about certain other ingredients of Biotin-ratiopharm 5 mg

This medicine contains lactose. Therefore, please only take Biotin-ratiopharm 5 mg after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE BIOTIN-RATIOPHARM 5 MG?

Always take Biotin-ratiopharm 5 mg exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is: ½ - 1 Biotin-ratiopharm 5 mg tablet daily (equivalent to 2.5 - 5 mg biotin). Less than 0.2 mg of biotin per day is sufficient for prevention.

For the treatment of multiple carboxylase deficiency

1 - 2 Biotin-ratiopharm 5 mg tablets daily (equivalent to 5 mg to 10 mg biotin) Preparations with a lower biotin content are available for lower dosages. Take the tablets whole with sufficient liquid (e.g. 1 glass of water).

Duration of use

Take Biotin-ratiopharm 5 mg until the biotin levels in the blood have normalized. The duration depends on the course of the underlying disease. Please consult your doctor about this. In the very rare biotin-dependent, multiple carboxylase deficiency, it is taken for life. Please talk to your doctor or pharmacist if you have the impression that the effect of Biotin-ratiopharm 5 mg is too strong or too weak.

If you have taken more Biotin-ratiopharm 5 mg than you should

Poisoning and overdose symptoms are not known. If you have any further questions on the use of the medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Biotin-ratiopharm 5 mg can have side effects, although not everybody gets them.

Side effects

Very rarely (less than 1 in 10,000 people treated) allergic skin reactions (hives) have been described.

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 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 BIOTIN-RATIOPHARM 5 MG?

Keep out of reach of children. Do not use the medicine after the expiry date which is stated on the carton and the blister packs. The expiry date refers to the last day of the month. No special storage conditions are required for this medicine.

6. FURTHER INFORMATION

What Biotin-ratiopharm 5 mg contains

The active ingredient is biotin. Each tablet contains 5 mg biotin. The other ingredients are: microcrystalline cellulose, lactose monohydrate, povidone K 30, crospovidone, magnesium stearate (Ph. Eur.).

What Biotin-ratiopharm 5 mg looks like and contents of the pack

White, round, biconvex tablet with a break score on one side. Biotin-ratiopharm 5 mg is available in packs of 30 and 90 tablets.

Pharmaceutical entrepreneur

ratiopharm GmbH
Graf-Arco-Str. 3
89079 Ulm

Manufacturer

Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren

This package leaflet was last revised in September 2014.

Source: Package leaflet information
Status: 04/2018
Active ingredient: Biotin. Areas of application: Therapy and prophylaxis of biotin deficiency and for the therapy of biotin deficiency in the very rare biotin-dependent, multiple carboxylase deficiency. Warning: Contains lactose!