BIO-H-TIN

BIO-H-TIN Vitamin H 5 mg for 4 months tablets

Important notes (mandatory information)

Bio-H-Tin Vitamin H 5 mg Tablets. Active ingredient: Biotin (Vitamin H). Areas of application: for the prevention and treatment of a biotin deficiency (less than 0.2 mg biotin per day is sufficient for prevention) and for the treatment of a biotin deficiency in the very rare biotin-dependent, multiple carboxylase deficiency.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Bio-H-Tin Vitamin H 5 mg Tablets
Active ingredient: Biotin (Vitamin H)
Vitamin preparation

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package 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 notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.

What this package leaflet contains

1. WHAT IS BIO–H–TIN VITAMIN H AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING BIO–H–TIN VITAMIN H?
3. HOW TO TAKE BIO–H–TIN VITAMIN H?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE BIO–H–TIN VITAMIN H?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS BIO-H-TIN VITAMIN H AND WHAT IS IT USED FOR?

Bio-H-Tin Vitamin H is a vitamin preparation. Bio-H-Tin Vitamin H is used for the prevention and treatment of a biotin deficiency (less than 0.2 mg biotin per day is sufficient for prevention) and for the treatment of a biotin deficiency in the very rare biotin-dependent, multiple carboxylase deficiency.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING BIO–H–TIN VITAMIN H?

Bio-H-Tin Vitamin H must not be taken if you are allergic to biotin 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 Bio-H-Tin Vitamin H.

Children

Use in children should only be carried out under medical supervision due to the limited data available.

Taking Bio-H-Tin Vitamin H 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. There is evidence that anticonvulsants (anticonvulsants) lower the level of biotin in the blood plasma.

Pregnancy and breast-feeding

Bio-H-Tin Vitamin H can be taken during pregnancy and breast-feeding.

Driving and using machines

No impairments are known.

Bio-H-Tin Vitamin H contains lactose

Therefore, please only take Bio-H-Tin Vitamin H after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE BIO–H–TIN VITAMIN H?

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 is:

• For prophylaxis, take 1/2 tablet daily (corresponding to 2.5 mg biotin). Less than 0.2 mg biotin per day is sufficient.
• For the treatment of multiple carboxylase deficiency: Take 1 to 2 tablets daily (corresponding to 5 to 10 mg biotin).

Preparations with a lower biotin content are available for lower dosages, e.g. Bio-H-Tin Vitamin H 2.5 mg with a content of 2.5 mg biotin per tablet. To halve exactly, please place the tablet with the break notch facing up on a solid surface and press down on it with your finger.

Method of administration

Take Bio-H-Tin Vitamin H unchewed with sufficient liquid (preferably a glass of drinking water).

Duration of use

Bio-H-Tin Vitamin H is taken 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, the intake is lifelong.

If you have taken more Bio-H-Tin Vitamin H than you should

Poisoning and overdose symptoms are not known.

If you forget to take Bio-H-Tin Vitamin H

Do not take twice the amount if you have forgotten to take the previous dose.

If you stop taking Bio-H-Tin Vitamin H

There are no special features to be observed when Bio-H-Tin Vitamin H is used as intended.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Bio-H-Tin Vitamin H can have side effects, although not everybody gets them.

Very rare, affects less than 1 in 10,000 users

Allergic skin reactions (hives).

Reporting 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. 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 TO STORE BIO–H–TIN VITAMIN H?

Keep this medicine out of the reach of children. Do not use the medicine after the expiry date which is stated on the carton and the container. The expiry date refers to the last day of the month. This medicine does not require any special storage conditions.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What one tablet of Bio-H-Tin Vitamin H contains

The active ingredient is: 5 mg biotin The other ingredients are: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate (Ph.Eur.) [vegetable], highly dispersed silicon dioxide.

What Bio-H-Tin Vitamin H looks like and contents of the pack

White, round tablet, divisible into equal halves with the aid of a break notch (SNAP TAB); Packs of 15, 30, 60 and 90 tablets.

Pharmaceutical entrepreneur
Bio-H-Tin Pharma GmbH & Co. KG
Emil-Kemmer-Straße 33
D-96103 Hallstadt
Phone: 0951/6043-0
Fax: 0951/604329

Manufacturer and distributor

Dr. R. Pfleger Chemische Fabrik GmbH
D-96045 Bamberg
Phone: 0951/6043-0
Fax: 0951/604329
E-mail: info@dr-pfleger.de

This leaflet was last revised in November 2014.

Source: Package leaflet information
Status: 05/2018
Active ingredient: Biotin (Vitamin H). Areas of application: for the prevention and treatment of a biotin deficiency (less than 0.2 mg biotin per day is sufficient for prevention) and for the treatment of a biotin deficiency in the very rare biotin-dependent, multiple carboxylase deficiency.