Dicetel tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

pinaverium (pinaverium bromide)

Available from:

Mylan Laboratories SAS

ATC code:

A03AX04

INN (International Name):

pinaverium (pinaverium bromide)

Dosage:

50mg

Pharmaceutical form:

tablets film-coated

Units in package:

(20/1x20/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-12-03

Summary of Product characteristics

MASTER SUMMARY OF PRODUCT CHARACTERISTICS (SMPC)
PINAVERIUM BROMIDE
1.
NAME OF THE MEDICINAL PRODUCT
Dicetel 50 mg &100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: pinaverium bromide
Each film-coated tablet contains 50 mg or 100 mg of pinaverium
bromide.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
50 mg Tablets
Round biconvex tablets, film-coated orange, engraved "50" on one side
and marked «
Ñ
» under
the letter «S» on the other side.
100 mg Tablets
Round biconvex tablets, film-coated orange, marked "100" on one side
and marked «
Ñ
» under
the letter «S» on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Symptomatic treatment of pain, transitory disorders and intestinal
discomfort related
to functional intestinal disturbances;
-
Symptomatic treatment of pain related to functional disturbances of
the biliary tract;
-
Preparation for a barium enema.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
For oral use.
Tablets taken with food whole without chewing or dissolving, with a
glass of water to
prevent contact pinaverium bromide with the mucosa of the esophagus
(see. Section
"Special Instructions").
Dicetel®, tablets, film-coated, 50 mg.
The recommended daily dose - 1 tablet 3 times a day, or 2 tablets 2
times per day.
If necessary, the daily dose may be increased to two tablets three
times a day.
In preparation for X-ray examination - 2 tablets 2 times a day for 3
days prior to the study.
Dicetel ®, tablets, film-coated, 100 mg.
The recommended daily dose - 1 tablet 2 times a day.
If necessary, the daily dose may be increased to 1 tablet three times
a day.
In preparation for X-ray examination - 1 tablet 2 times a day for 3
days prior to the study.
4.3 CONTRAINDICATIONS
- Hypersensitivity to any component of the formulation.
- Lactase deficiency, galactose intolerance, glucose-galactose
malabsorption.
MASTER SUMMARY OF PRODUCT CHARACTERISTICS (SMPC)
PINAVERIUM BROMIDE
Due to the lack of data on the efficacy an