NOTICE
ANSM - Updated on: 23/07/2014
Name of the medicinal product
BIOTINE BAYER 5 mg tablet
framed
Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.
· If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult your doctor.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT IS BIOTINE BAYER 5 mg, tablet AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE BIOTINE BAYER 5 Mg, tablet?
3. HOW TO TAKE BIOTINE BAYER 5 Mg, tablet?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE BIOTINE BAYER 5 mg tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS BIOTINE BAYER 5 mg, tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
VITAMIN H.
(D: Dermatology).
Therapeutic indications
Supplemental treatment of diffuse alopecia.
2. BEFORE YOU TAKE BIOTINE BAYER 5 Mg, tablet?
List of information needed before taking the medication
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Cons-indications
Never use BIOTINE BAYER 5 mg tablet :
· in case of known allergy to any of the components.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST
Precautions for use; special warnings
Take special care with BIOTINE BAYER 5 mg tablet:
The use of this medication is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
Interaction with other medicines
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
It is best not to use this medication during pregnancy or during breastfeeding.
If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Driving and using machines:
The effect of biotin on the ability to drive and use machines has not been studied, but there is no evidence to suggest that biotin is likely to alter these abilities.
List of excipients with known effect
Important information about some of the ingredients of BIOTINE BAYER 5 mg, tablet:
Lactose.
3. HOW TO TAKE BIOTINE BAYER 5 Mg, tablet?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
RESERVED FOR ADULTS.
3 tablets daily for 6 weeks.
Method and route of administration
Oral use.
The tablets should be swallowed with a glass of water.
Symptoms and Instructions for Overdose
No specific risk of overdosage in biotin has been described.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, BIOTINE BAYER 5 mg tablet is likely to have side effects, although not everyone is subject to it.
Allergic skin reactions (itching, rash, urticaria, edema) have been reported.
If you notice any side effects, or if any of the side effects gets serious, inform your doctor or pharmacist.
5. HOW TO STORE BIOTINE BAYER 5 mg tablet?
Keep out of the reach and sight of children.
Expiration date
Do not use BIOTINE BAYER 5 mg tablets after the expiry date which is stated on the carton.
Storage conditions
No special storage conditions.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does BIOTINE BAYER 5 mg contain?
The active substance is :
Biotin (vitamin H) ............................................. .................................................. ............................... 5 mg
For one tablet
The other components are :
Lactose monohydrate, corn starch, talc, stearic acid, magnesium stearate.
Pharmaceutical form and content
What is BIOTINE BAYER 5 mg tablets and contents of the pack?
This medicine comes in tablet form.
Box of 20 or 60 tablets.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
BAYER HEALTHCARE SAS
220 AVENUE OF RESEARCH
59120 LOOS
exploiting
BAYER HEALTHCARE SAS
33 STREET OF INDUSTRY
74240 GAILLARD
Maker
Cenexi
52, rue Marcel and Jacques Gaucher
94122 FONTENAY-SOUS-BOIS
or
GP GRENZACH PRODUKTIONS GMBH
Emil-Barell-Strasse 7
79639 GRENZACH-WYHLEN
GERMANY
or
ROCHE PRODUCTS Limited
40 Broadwater Road
Welwyn Garden City
Hertfordshire - AL7 3AY
ENGLAND
or
BAYER SANTE FAMILIALE
33 rue de l'Industrie
74240 GAILLARD
Names of the medicinal product in the Member States of the European Economic Area
In accordance with the regulations.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.