Fluimucil tablets effervescent

Negara: Armenia

Bahasa: Inggris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Bahan aktif:

acetylcysteine

Tersedia dari:

Zambon Switzerland Ltd.

Kode ATC:

R05CB01

INN (Nama Internasional):

acetylcysteine

Dosis:

600mg

Bentuk farmasi:

tablets effervescent

Unit dalam paket:

(10/5x2/) in blister

Jenis Resep:

OTC

Status otorisasi:

Registered

Tanggal Otorisasi:

2020-06-19

Karakteristik produk

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 administrati