Tavegyl tablets

Država: Armenija

Jezik: engleski

Izvor: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivni sastojci:

clemastine (clemastine fumarate)

Dostupno od:

SmithKline Beecham S.A. Ctra. de Ajalvir

ATC koda:

R06AA04

INN (International ime):

clemastine (clemastine fumarate)

Doziranje:

1mg

Farmaceutski oblik:

tablets

Jedinice u paketu:

(20/1x20/) in blister, (60/3x20/) in blister

Tip recepta:

OTC

Status autorizacije:

Registered

Datum autorizacije:

2021-06-29

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Tavegyl
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains: _ active ingredient_ – 1 mg of clemastine
equivalent to 1.34 mg of clemastine
fumarate.
Excipient with known effect: lactose monohydrate.
_For the full list of excipients, see Section 6.1. _
3. DOSAGE FORM
Tablets.
Whitish round flat bevelled-edged tablets.
Scored on one side and coded “OT”.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Tavegyl is indicated for the relief of hay fever (allergic
rhinoconjunctivitis) and other allergic
rhinitis, urticaria of various genesis, itching, puritic dermatoses
and insect stings and bites.
Tavegyl is also indicated as an adjuvant in acute and chronic eczema,
contact dermatitis and drug
eruptions.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY _
_ For adults and children over 12 years_: 1 tablet in the morning and
in the evening, unless
otherwise instructed by a doctor.
You should not take more than 6 tablets during 24 hours.
The highest single dose is 2 tablets at a time.
_For children from 6 to 12 years_: 1/2 to 1 tablet in the morning and
evening.
Maximum duration of use: should not be taken for more than 14 days
without consulting a
doctor.
Do not exceed the recommended dose.
_METHOD OF ADMINISTRATION _
For oral administration. The tablets should be taken with water before
meals.
4.3. CONTRAINDICATIONS
Hypersensitivity to clemastine or other similar antihistamines or to
any of the excipients.
Tavegyl should not be given to patients suffering from porphyria.
Tavegyl in tablet form should not be given to children below 6 year of
age.
4.4. WARNINGS AND PRECAUTIONS
Use with caution in elderly patients, who are more likely to
experience adverse effects such as
paradoxical excitation.
Avoid use in elderly patients with confusion.
Do not exceed recommended dosage and duration of use without
consulting a doctor (See
_Posology and Method of Administration_).
Antihistamines should be used with caution in patients with:

ep