Flavamed cough tablets tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

ambroxol (ambroxol hydrochloride)

Available from:

Berlin-Chemie AG

ATC code:

R05CB06

INN (International Name):

ambroxol (ambroxol hydrochloride)

Dosage:

30mg

Pharmaceutical form:

tablets

Units in package:

(20/2x10/) in blister

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2020-05-16

Summary of Product characteristics

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S UM M A RY O F P RO DU C T C H A R AC TE R I S TI CS
1.
NAME OF THE MEDICINAL PRODUCT
FLAVAMED
® COUGH TABLETS 30 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains 30 mg ambroxol hydrochloride.
Excipients with known effect
40 mg lactose monohydrate per tablet
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White, round, biplane tablets with bevelled edges and a break-mark on
one side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mucolytic therapy in acute and chronic bronchopulmonary diseases that
are accompanied by a
disturbance to mucus formation and transport.
Flavamed
®
cough tablets are indicated in children from six years, adolescents
and adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Unless otherwise prescribed, the following dosages are recommended for
Flavamed
®
cough
tablets:
_Children up to 6 years: _
Flavamed
®
cough tablets are contraindicated in children under 6 years (see
section 4.3).
_Children from 6 to 12 years: _
As a rule, ½ a Flavamed
®
cough tablets each is taken 2 - 3 times daily (equivalent to 15 mg
ambroxol hydrochloride 2 - 3 times).
_Adults and adolescents above 12 years: _
As a rule, 1
Flavamed
®
cough tablets each is taken 3 times daily during the first 2 - 3 days
(equivalent to 30 mg ambroxol hydrochloride 3 times); after that, 1
Flavamed
®
cough tablets
each is taken twice daily (equivalent to 30 mg ambroxol hydrochloride
twice).
Note:
For adults, doses might be increased up to 60 mg twice daily
(equivalent to 120 mg ambroxol
hydrochloride/day) if needed.
_Paediatric population _
See section 4.3 for use in children under 6 years.
Method of administration
Flavamed cough tablets are for oral use.
The tablets are best swallowed whole after meals with sufficient
liquid.
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Flavamed cough tablets should not be taken for longer than 4 - 5 days
without the advice of a
doctor.
See section 4.4 for dosage in renal and hepatic diseases.
4.3