Tanganil

Tanganil

Nhà sản xuất:

Pierre Fabre Medicament

Nhà phân phối:

DKSH
Thông tin kê toa chi tiết tiếng Anh
Contents
Acetylleucine.
Description
Each 5 mL ampoule contains acetylleucine 500 mg.
Excipients/Inactive Ingredients: Tablet: wheat starch, pregelatinised maize starch, calcium carbonate, magnesium stearate.
Injection: monoethanolamine (aqueous vehicle) 175 mg, water for injections 5 mL.
Action
Pharmacotherapeutic Group: Antivertigo preparation. ATC Code: N07CA04.
Pharmacology: Pharmacodynamics: Antivertigo preparation with an unknown mechanism of action.
Pharmacokinetics: Tablet: Following oral administration, the peak of plasma Acetylleucine concentration is reached after approximately 2 hours.
Injection: Following intravenous administration of 1 g of Tanganil, two-compartment kinetics is observed with a very rapid distribution phase (mean half-life of 0.11 hours) and a rapid elimination phase (mean half-life of 1.08 hours).
Indications/Uses
Tablet: This medicine is recommended in the treatment of dizziness.
Injection: This medicine is recommended for the symptomatic treatment of vertigo attacks.
Dosage/Direction for Use
Tablet: Adults: 1.5 to 2 g daily: 3 to 4 tablets to be taken as two divided doses, in the morning and in the evening.
At the beginning of the treatment or if there is no improvement, the dosage may be increased up to 3 g to 4 g (6 to 8 tablets) per day.
Route of administration: oral route. The tablets must be swallowed with water.
Treatment duration: the duration of treatment is variable according to the clinical progress (between 10 days and 5 to 6 weeks).
Do not exceed the recommended dosage.
Injection:
Adults: 2 ampoules per day (up to 4 if necessary) for direct intravenous injection.
Treatment duration varies according to clinical outcome.
In all cases, strictly follow the doctor's prescription.
Method of administration: Intravenous injection.
Overdosage
If the patient takes more than prescribed, inform the doctor or pharmacist.
Contraindications
This medicine must not be used in the following cases: known allergy to acetylleucine or to any of the ingredients in this medicine.
If the patient has any doubts, it is essential to ask the doctor or pharmacist for advice.
Tablet: this medicinal product is contraindicated in patients presenting wheat allergy (other than coeliac disease).
Special Precautions
Tablet: Take special care with Tanganil.
This medicine contains wheat starch but it can be administered to patients suffering from coeliac disease. As wheat starch may contain very small amount of gluten, this medicine is considered like safe for subjects with coeliac disease.
Effects on Ability to Drive and Use Machines: No studies on the effects on the ability to drive and use machines have been performed.
However, caution is advised considering the treated illness (vertigo attacks).
Use In Pregnancy & Lactation
Pregnancy & Lactation: Use of this medicine should preferably be avoided during pregnancy or breast-feeding. If the patient discovers that she is pregnant while taking the medicine, consult the doctor because he/she is the only person who can decide whether it is necessary to pursue treatment. As a general rule, during pregnancy or while breastfeeding, the patient should always ask the advice of the doctor or pharmacist before taking any medicine.
Adverse Reactions
As with any active substance, this medicine may have effects with varying degrees of discomfort in some patients: Skin reactions (rash, redness, urticaria [skin rashes similar to nettle stings] and itching) have been very rarely observed.
Reporting of side effects: If the patient gets any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed in this leaflet. One can also report side effects directly via the national reporting system.
By reporting side effects it can help provide more information on the safety of this medicine.
Drug Interactions
To avoid possible interactions between several medicines, you must systematically inform the doctor or pharmacist of any other treatment the patient may be taking.
Caution For Usage
After opening: the product should be used immediately.
Do not use Tanganil after expiry date which is stated in the box.
Storage
Store below 30°C.
Shelf-Life: Tablet: 36 months from the manufacture date.
Injection: 5 years from manufacture date.
Patient Counseling Information
Prescription only medicine.
Read all of this leaflet carefully before you start taking this medicine. The leaflet contains important information for you. If you have any further questions, if you have a doubt, ask your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
If you need further information or advice, ask your pharmacist.
You must contact a doctor if your symptoms worsen or do not improve.
If you notice any side effect not listed in this leaflet or if any of the side effects get serious, please tell your doctor or pharmacist.
Keep out of reach of children.
MIMS Class
ATC Classification
N07CA04 - acetylleucine ; Belongs to the class of antivertigo preparations.
Presentation/Packing
Tab 500 mg x 3 x 10's. Soln for inj (amp) 500 mg/5 mL x 5's.
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