NOTICE
ANSM - Updated on : 23/12/2022
Product name
ACETYLLEUCINE VIATRIS 500 mg, tablet
Acetylleucine
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as it is prescribed by your doctor, pharmacist or nurse.
- Keep this leaflet as you may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, please tell your doctor, pharmacist or nurse. 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 after 3 days.
What does this leaflet contain?
1. What is ACETYLLEUCINE VIATRIS 500 mg, tablet and what is it used for?
2. What do I need to know before taking ACETYLLEUCINE VIATRIS 500 mg, tablet?
3. How do I take ACETYLLEUCINE VIATRIS 500 mg, tablet?
4. What are the possible side effects?
5. How to store ACETYLLEUCINE VIATRIS 500 mg, tablet?
6. Package contents and other information.
1. WHAT IS ACETYLLEUCINE VIATRIS 500 mg, tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: Antivertiginous, ATC code: N07CA04.
ACETYLLEUCINE VIATRIS 500 mg, tablet contains the active substance acetylleucine.
This medicine is indicated in adults for the symptomatic treatment of vertiginous attacks.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING ACETYLLEUCINE VIATRIS 500 mg, Tablet?
Never take ACETYLLEUCINE VIATRIS 500 mg, tablet:
- if you are allergic (hypersensitive) to acetylleucine or to any of the other ingredients of this medicine, as listed in section 6.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Warnings and precautions
Caution with ACETYLLEUCINE VIATRIS 500 mg, tablet
If you experience allergic reactions (which may be severe, e.g. allergic shock, laryngeal edema), stop taking ACETYLLEUCINE VIATRIS and consult your doctor immediately (see also section 4).
Ask your doctor, pharmacist or nurse before taking ACETYLLEUCINE VIATRIS 500 mg, tablet.
Children and adolescents
Not applicable.
Other medicinal products and ACETYLLEUCINE VIATRIS 500 mg, tablet
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
ACETYLLEUCINE VIATRIS 500 mg, tablet with food, drink and alcohol
Not applicable.
Pregnancy and 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. It is not recommended to use this medicine during pregnancy.
This medicine should not be used during breast-feeding. If you discover that you are pregnant during treatment, consult your doctor, who is the only person who can decide whether or not to continue treatment.
Driving and use of machinery
Not applicable.
ACETYLLEUCINE VIATRIS 500 mg, tablet contains
Not applicable.
3. HOW DO I TAKE ACETYLLEUCINE VIATRIS 500 mg, tablet?
Always take this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
For adults
The recommended dose is 1.5 g to 2 g per day, i.e. 3 to 4 tablets taken twice, morning and evening.
Duration of treatment
The duration of treatment varies according to the clinical course (from 10 days to 5 or 6 weeks); at the start of treatment or in the event of failure, the dosage may be increased to 3 g or even 4 g per day, i.e. 6 to 8 tablets per day.
Method of administration
Take by mouth.
Take with a full glass of water.
If you have taken more ACETYLLEUCINE VIATRIS 500 mg, tablet than you should have
Consult your doctor or pharmacist immediately. Symptomatic treatment should be given if necessary.
If you forget to take ACETYLLEUCINE VIATRIS 500 mg, tablet
Do not take a double dose to make up for the one you have forgotten to take.
If you stop taking ACETYLLEUCINE VIATRIS 500 mg, tablet
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.
Contact your doctor immediately if you develop any of the following symptoms, as you may require emergency medical treatment.
Allergic reactions, anaphylactoid shock (sudden severe allergic reaction with breathing difficulties, swelling, dizziness, rapid heartbeat, sweating and loss of consciousness) and laryngeal edema (swelling) have been observed at undetermined frequencies.
Other adverse reactions may occur
- Uncommon: may affect up to 1-10,000 patients
Skin reactions (rash, redness, urticaria and itching) o
- Undetermined frequency: cannot be estimated on the basis of available data
Gastrointestinal disorders (abdominal pain).
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
Reporting side effects
If you experience any side effects, please tell your doctor, pharmacist or nurse. 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 are helping to provide more information on drug safety.
5. HOW TO CONSERVE ACETYLLEUCINE VIATRIS 500 mg, tablet?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the box. The expiration date refers to the last day of that month.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What ACETYLLEUCINE VIATRIS 500 mg tablet contains
- The active substance is :
Acetylleucine ........................................................................................................... 500.00 mg
For one tablet.
- The other ingredients are :
Pregelatinized corn starch, heavy calcium carbonate, magnesium stearate.
What ACETYLLEUCINE VIATRIS 500 mg, tablet is and what it contains
White, biconvex, elongated tablet.
Boxes of 30, 60 or 90 tablets.
Not all presentations may be marketed.
Marketing authorization holder
VIATRIS SANTE
1 RUE DE TURIN
69007 LYON
Marketing authorization holder
VIATRIS SANTE
1 RUE DE TURIN
69007 LYON
Manufacturer
LABORATOIRES BTT
Z.I DE KRAFFT
67150 ERSTEIN
OR
VIATRIS SANTE
1 RUE DE TURIN
69007 LYON
OR
VIATRIS SANTE
360 AVENUE HENRI SCHNEIDER
69330 MEYZIEU
Drug 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]
{month YYYY}.
Other
Detailed information on this drug is available on the ANSM (France) website.