NOTICE
ANSM - Updated on : 30/05/2024
Product name
BIOTINE BAYER 0.5%, solution for injection I.M.
Biotin (vitamin H)
Box
Please read this leaflet carefully before this medicine, as it contains important information for you.
You must always use this medicine in strict accordance with the information provided in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well.
What does this leaflet contain?
1. What is BIOTINE BAYER 0.5%, solution for injection I.M. and what is it used for?
2. What do I need to know before using BIOTINE BAYER 0.5%, solution for injection I.M.?
3. How should BIOTINE BAYER 0.5% solution for injection I.M. be used?
4. What are the possible side effects?
5. How to store BIOTINE BAYER 0.5%, solution for injection I.M.
6. Package contents and other information.
1. WHAT IS BIOTINE BAYER 0.5%, solution for injection I.M. AND WHAT IS IT USED FOR?
Pharmacotherapeutic class : VITAMIN H (D: Dermatology)
This medicine contains vitamin H.
It is indicated for the adjunctive treatment of diffuse hair loss in adults.
2. WHAT DO I HAVE TO KNOW BEFORE USING BIOTINE BAYER 0.5%, solution for injection I.M.?
Never use BIOTINE BAYER 0.5%, solution for injection I.M :
- if you are allergic to the active substance or to any of the other ingredients listed in section 6.
Warnings and precautions
Talk to your doctor or pharmacist before using BIOTINE BAYER 0.5%, solution for injection I.M.
BIOTINE BAYER 0.5%, solution for injection I.M. contains 5 mg biotin per ampoule. If you have a blood test, you should inform your doctor or laboratory personnel that you are taking or have recently taken a medicine containing biotin. Biotin may distort the results of certain tests. Depending on the test, results may be falsely high or low. Your doctor may ask you to stop taking BIOTINE BAYER 0.5% before performing these tests. Other products you may be taking, such as multivitamin mixtures or dietary supplements for hair, skin and nails, may contain biotin and affect laboratory test results. Please inform your doctor or laboratory personnel if you are taking such products.
Children and adolescents
Not applicable.
Other medicinal products and BIOTINE BAYER 0.5%, solution for injection I.M.
Not applicable.
BIOTINE BAYER 0.5%, solution for injection I.M. with food and drink
Not applicable.
Pregnancy and breast-feeding
This drug should not be used during pregnancy or while breast-feeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
The effect of biotin on the ability to drive vehicles and use machines has not been studied, but there is no evidence to suggest that biotin may impair these abilities.
BIOTINE BAYER 0.5%, solution for injection I.M. contains 9 mg sodium per ampoule, i.e. less than 1 mmol per dose, making it essentially "sodium-free".
3. HOW TO USE BIOTINE BAYER 0.5%, solution for injection I.M.
Dosage
FOR ADULTS ONLY
The recommended dose is 1 or 2 ampoules. 3 times a week by intramuscular injection.
Method and route of administration
Intramuscular injectable solution.
Duration of treatment
As prescribed by your doctor.
If you have taken more BIOTINE BAYER 0.5%, solution for injection I.M. than you should have :
No specific risk of biotin overdose has been described.
If you forget to take BIOTINE BAYER 0.5%, solution for injection I.M. :
Not applicable.
If you stop taking BIOTINE BAYER 0.5 %, solution for injection I.M. :
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
Allergic skin reactions (itching, rash, urticaria, swelling) have been reported.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: www.signalement-sante.gouv.fr
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO CONSERVE BIOTINE BAYER 0.5%, solution for injection I.M.?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the outer packaging after EXP. The expiration date refers to the last day of that month.
Store at temperatures below 25°C.
Do not dispose of any medicine in the drain or with the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What BIOTINE BAYER 0.5% solution for injection I.M. contains
- The active substance is :
Biotin (vitamin H)................................................................................................................. 5 mg
For 1 ml ampoule
- Other excipients are :
Sodium dihydrogen phosphate dihydrate, sodium bicarbonate, water for injection.
What BIOTINE BAYER 0.5%, solution for injection I.M. is and what it contains
Solution for injection in 1 ml ampoules, box of 6.
Marketing authorization holder
BAYER HEALTHCARE SAS
1 RUE CLAUDE BERNARD
59000 LILLE
Marketing authorization holder
BAYER HEALTHCARE SAS
33, RUE DE LINDUSTRIE
74240 GAILLARD
FRANCE
Manufacturer
DOPPEL FARMACEUTICI S.R.L
VIA VOLTURNO, 48
QUINTO DE STAMPI
20089 ROZZANO (MI)
ITALY
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder]
< {MM/YYYY}>< {month/YYYY}.>
Other
Detailed information on this drug is available on the ANSM (France) website.