NOTICE
ANSM - Last updated: 14/01/2016
Name of the medicinal product
TANGANIL 500 mg tablet
acetylleucine
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 tanganil 500 mg, tablet and in which case is it used?
2. What should be known before taking tanganil 500 mg tablet ?
3. How to take tanganil 500 mg, tablet ?
4. What are the possible side effects?
5. How to store tanganil 500 mg tablets ?
6. Additional information.
1. WHAT IS tanganil 500 mg, tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
vertigo
Therapeutic indications
This drug is recommended in the symptomatic treatment of the dizzy crisis.
2. BEFORE YOU TAKE tanganil 500 mg tablets?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never take tanganil 500 mg tablets in the following cases:
· allergy to acetylleucine or any of the other ingredients of this medicine,
· if you are allergic (hypersensitive) to wheat, due to the presence of wheat starch.
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 tanganil 500 mg tablet
This medication may be used for celiac disease. Wheat starch can contain gluten, but only trace, and is therefore considered safe for people with celiac disease.
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 lactation.
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
Not applicable.
List of excipients with known effect
Important information about some of the ingredients of TANGANIL 500 mg tablet:
This medicinal product contains wheat starch (see "Never take Tanganil 500 mg tablets in the following cases" and "Take special care with Tanganil 500 mg tablets").
3. HOW TO TAKE tanganil 500 mg tablet?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
In the adult
Frequency of Administration
On average 3 to 4 tablets in two doses morning and evening.
Duration of the treatment
The duration of treatment varies according to the clinical course; at the beginning of treatment or in case of failure, the dosage may be increased.
IN ALL CASES, COMPLY WITH THE ORDER OF YOUR DOCTOR STRICTLY.
Administration mode
Oral use.
Symptoms and Instructions for Overdose
If you have taken more of Tanganil 500 mg tablets you should have : tell your doctor or pharmacist.
Instructions for omission of one or more doses
If you forget to take Tanganil 500 mg tablets : do not take a double dose to make up for a forgotten dose.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Skin reactions (rash, redness, urticaria and itching) were very rarely observed.
Declaration of side effects
If you experience any side effects, talk to 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: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE TANGANIL 500 mg tablet?
Keep out of the reach and sight of children.
Expiration date
Do not use Tanganil 500 mg tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of the month.
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 Tanganil 500 mg contains:
The active substance is :
Acetylleucine ................................................. .................................................. ................................ 500 mg
For a tablet.
The other components are :
Wheat starch, pregelatinized corn starch, calcium carbonate, magnesium stearate.
Pharmaceutical form and content
What is Tanganil 500 mg tablets and contents of the pack?
This medication is in the form of a white and oblong tablet.
Box of 20, 30, 40 or 60.
Not all pack sizes may be marketed.
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
PIERRE FABRE MEDICAMENT
45, PLACE ABEL GANCE
92100 BOULOGNE
exploiting
PIERRE FABRE MEDICAMENT
45, PLACE ABEL GANCE
92100 BOULOGNE
Maker
PIERRE FABRE MEDICAMENT PRODUCTION / PROGIPHARM
RUE DU LYCEE
45500 GIEN
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
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 ANSM website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.