Bronchobos capsules

Country: Armenía

Tungumál: enska

Heimild: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Virkt innihaldsefni:

carbocisteine

Fáanlegur frá:

Bosnalijek d.d.

ATC númer:

R05CB03

INN (Alþjóðlegt nafn):

carbocisteine

Skammtar:

375mg

Lyfjaform:

capsules

Einingar í pakka:

(30/3x10/) in blister

Gerð lyfseðils:

OTC

Leyfisstaða:

Registered

Leyfisdagur:

2016-08-30

Vara einkenni

1.
TRADE NAME OF THE MEDICINAL PRODUCT
BRONCHOBOS
®
capsules 375 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
Carbocisteine 375.00 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Opaque, yellow No 0 hard gelatine capsules, filled with a white
powder.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATION
Acute and chronic bronchopulmonary diseases accompanied with formation
of viscous
sputum (tracheitis, bronchitis, tracheobronchitis, bronchial asthma,
multiple bronchiectasis)
and mucus (inflammatory diseases of the middle ear and sinuses -
rhinitis, otitis media,
sinusitis); preparation of the patient for bronchoscopy or
bronchography.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
_ _
_ _
Adults and children over 15 years of age: 750 mg (2 capsules) three
times a day. After
achieving of the therapeutic effect daily dose should be reduced to
1.5 g: 750 mg (2
capsules) twice a day. Without consulting a doctor treatment should
not last more than 8-10
days. 4.3. CONTRAINDICATIONS
Hypersensitivity to carbocisteine or other components of the medicinal
product, gastric and
duodenal ulcers during the exacerbation phase; chronic
glomerulonephritis (during the
exacerbation phase); cystitis, children below 15 years of age,
pregnancy (first trimester).
4.4. SPECIAL WARNINGS AND SPECIAL PRECAUTION MEASURES
Chronic glomerulonephritis (in history), gastric and duodenal ulcers
(in history), pregnancy
(II - III trimester) and lactation.
4.5. DRUG INTERACTION OR OTHER INTERACTION FORMS
Carbocisteine
increases
efficiency
of
glucocorticosteroid
and
antibacterial
therapy
of
inflammatory diseases of the upper and lower respiratory tract,
potentiates bronchodilator
effect of theophylline. Carbocisteine activity is reduced by
antitussive and atropine-like
agents. 4.6. PREGNANCY AND LACTATION
_ _
_PREGNANCY _
During pregnancy (II and III trimester) the medicinal product can be
administered only
when the expected benefit to the mother outweighs the potential risk
to the fetus.
_LACTATION _
If