Fluimucil 600mg tablets effervescent

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

acetylcysteine

Available from:

Zambon Switzerland Ltd.

ATC code:

R05CB01

INN (International Name):

acetylcysteine

Dosage:

600mg

Pharmaceutical form:

tablets effervescent

Units in package:

(10/5x2/) blisters

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2015-06-18

Summary of Product characteristics

Core Company Data Sheet_ NACo 2015.02 20 October 2015_
1
1.
NAME OF THE MEDICINAL PRODUCT
Fluimucil effervescent tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One (pharmaceutical form) contains 600 mg Acetylcysteine
Excipient(s):
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Effervescent tablets
4.
CLINICAL PARTICULARS
4 . 1
THERAPEUTIC INDICATIONS
Mucolytic
agent
for
the
treatment
of
respiratory system
such
as
bronchitis,
emphysema,
mucoviscidosis
and
bronchictasia
1, 2, 3, 4, 5, 6
.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
8, 9, 10, 11
600 mg daily.
Method of administration
No
interaction
with
food
has
been
reported;
there
is
no
indication
regarding
product
administration before or after the meals.
4 . 3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Children under 18 years of age.
Active peptic ulcer.
Phenylketonuria.
Fluimucil should not be used during breastfeeding.
_With caution_ - Gastric ulcer and duodenal ulcer, esophageal varices,
hemoptysis,
pulmonary hemorrhage, bronchial asthma, diseases of the adrenal
glands, liver and /
or renal failure, hypertension.
Core Company Data Sheet_ NACo 2015.02 20 October 2015_
2
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Mucolytic agents can induce respiratory obstruction in children under
2 years of
age.
Due to
the physiological
characteristics of the airways in this age group, the ability to
expectorate may
be limited.
Therefore mucolytic agents should not
be used in children under 2 years of
age
(see paragraph 4.3 Contraindications).
Caution is recommended when using the product
in patients with peptic ulcer or history of
it,
especially in case of
concomitant
administration of
other
medicines with a known irritating
effect on the gastric mucosa.
Patients suffering from bronchial
asthma must
be closely monitored during therapy.
Should
bronchospasm occur,
acetylcysteine must
be stopped immediately and appropriate treatment
must be initiated.
The administra