BISOLVON Tab. 8 mg

Χώρα: Ιορδανία

Γλώσσα: Αγγλικά

Πηγή: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

Δραστική ουσία:

Bromhexine Hcl 8 mg

Διαθέσιμο από:

شركة مستودع الادوية العربي - THE ARAB DRUG STORE P.S.C

Φαρμακολογική κατηγορία (ATC):

R05CB02

INN (Διεθνής Όνομα):

Bromhexine Hcl 8 mg

Δοσολογία:

8 mg

Μονάδες σε πακέτο:

20

Κατασκευάζεται από:

Delpharm Remis S.A.S (فرنسا)

Περίληψη προϊόντος:

1.97 :سعر الجمهور + الضريبة

Φύλλο οδηγιών χρήσης

Status:
FRE_v12_12.03.2012
Bisolvon tablets 8 mg
Record no.:
5407952011
Product information
Page 1 of 7
PRODUCT INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Bisolvon
®
tablets
8 mg/tablet
Active substance: Bromhexine hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains 8 mg bromhexine hydrochloride.
Excipient: Lactose (see section 4.4)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets for oral use
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Secretolytic therapy of acute and chronic bronchopulmonary diseases
associated with impaired mucus
formation and transport
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Unless otherwise prescribed, the following dosages are recommended for
Bisolvon tablets:
Adults and adolescents over 14 years:
1 - 2 tablets 3 times a day (equivalent to 24 - 48 mg bromhexine
hydrochloride a day)
Children and adolescents between 6 and 14 years and patients under 50
kg bodyweight:
1 tablet 3 times a day (equivalent to 24 mg bromhexine hydrochloride a
day)
More appropriate pharmaceutical forms of lower strength are available
for children under 6 years of
age.
Method of administration and duration of treatment
The duration of treatment should be determined on an individual basis
depending on the indication and
the course of the disease.
Bisolvon tablets should not be taken for more than 4 - 5 days without
medical advice.
The tablets should be taken with plenty of liquid after meals.
L13514
Status:
FRE_v12_12.03.2012
Bisolvon tablets 8 mg
Record no.:
5407952011
Product information
Page 2 of 7
4.3
CONTRAINDICATIONS
Bisolvon tablets are contraindicated in patients with known
hypersensitivity to any of the components.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In a very small number of cases, there have been reports of severe
skin reactions such as Stevens-Jo-
hnson syndrome and toxic epidermal necrolysis (TEN) occurring in
temporal association with the use
of expectorants such as bromhexine.
Most of these cases were attributable to the unde