Fluimucil granules for oral solution

Χώρα: Αρμενία

Γλώσσα: Αγγλικά

Πηγή: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Δραστική ουσία:

acetylcysteine

Διαθέσιμο από:

Zambon Switzerland Ltd.

Φαρμακολογική κατηγορία (ATC):

R05CB01

INN (Διεθνής Όνομα):

acetylcysteine

Δοσολογία:

200mg

Φαρμακοτεχνική μορφή:

granules for oral solution

Μονάδες σε πακέτο:

(20) and (60) sachet 1g

Τρόπος διάθεσης:

OTC

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2016-12-08

Αρχείο Π.Χ.Π.

Core Company Data Sheet_ NACo 2015.02 20 October 2015_
1
1.
NAME OF THE MEDICINAL PRODUCT
Fluimucil granules for oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One sachet contains 200 mg Acetylcysteine
Excipient(s):
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Granules for oral solution
4.
CLINICAL PARTICULARS
4 . 1
THERAPEUTIC INDICATIONS
Mucolytic agent for the treatment of respiratory conditions associated
with excessive
mucus production
1, 2, 3, 4, 5, 6
.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Children from 2 to 6 years of age: one 200 mg sachet twice daily.
Children over 6 years of age and adults: 200 mg sachet 2-3 times
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 2 years of age.
Active peptic ulcer.
Phenylketonuria.
Fructose intolerance
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,