BIOTIN HERMES

BIOTIN HERMES 5 mg Tablets

Important notes (mandatory information)

Hermes Biotin 5 mg, tablets. Indications: for the prevention and treatment of biotin deficiency, treatment of 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

Hermes Biotin 5 mg, tablets
Active ingredient: Biotin

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 directed by your doctor or pharmacist.

• Keep the package leaflet. You may need 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 even worse, talk to your doctor.

What this package leaflet contains

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

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

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

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

Hermes Biotin 5 mg must not be taken if you are allergic to the active substance biotin or any of the other ingredients of this medicine listed in section 6.

Taking Hermes Biotin 5 mg with other medicines

There is evidence that medicines for seizures (anticonvulsants) lower the level of biotin in the blood plasma. Tell your doctor or pharmacist if you are taking other medicines, have recently taken other medicines or intend to take other medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

No special precautions are required.

Hermes Biotin 5 mg contains lactose

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

3. HOW TO TAKE HERMES BIOTIN 5 MG?

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: 1/2 to 1 tablet of Hermes Biotin 5 mg daily (equivalent to 2.5 mg to 5 mg of biotin). For prophylaxis, less than 0.2 mg of biotin per day is sufficient. For the treatment of multiple carboxylase deficiency: 1 to 2 tablets of Hermes Biotin 5 mg daily (equivalent to 5 mg to 10 mg of biotin). Preparations with a lower biotin content are available for lower dosages.

Method of administration

Take the tablets whole with sufficient liquid (preferably a glass of water [200ml]).

Duration of use

Take Hermes Biotin 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, the intake is lifelong.

Please talk to your doctor or pharmacist if you have the impression that the effect of Hermes Biotin 5 mg is too strong or too weak.

If you have taken more Hermes Biotin 5 mg than you should

Poisoning and overdose symptoms are not known.

If you forget to take Hermes Biotin 5 mg

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

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. The following categories are used as a basis for the frequency of side effects

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

Possible side effects

Very rarely, allergic skin reactions (hives) have been described.

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 HERMES BIOTIN 5 MG?

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 on the blisters after "Use by". The expiry date refers to the last day of the month indicated. Store dry and not above 25°C. Store in the original package to protect the contents from moisture.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Hermes Biotin 5 mg contains
The active substance is: 5 mg biotin. The other ingredients are: lactose monohydrate, cellulose powder, crospovidone (type A), highly dispersed silicon dioxide, magnesium stearate.

What Hermes Biotin 5 mg looks like and contents of the pack

White, round, curved tablet with a break notch on one side. Hermes Biotin 5 mg is available in blister packs of 30 and 90 tablets.

Pharmaceutical entrepreneur and manufacturer

HERMES ARZNEIMITIEL GMBH
Georg-Kalb-Straße 5-8
82049 Großhesselohe / Munich
Tel.: 089179102-0
Fax: 089179102-280

This package leaflet was last revised in October 2014.

Source: Package leaflet information
Status: 02/2016
Indications: for the prevention and treatment of biotin deficiency, treatment of biotin deficiency in the very rare biotin-dependent, multiple carboxylase deficiency.