Rowachol capsules gastro-resistant, soft

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

a-pinene, b-pinene, menthol, menthone, borneol, camphene, cineole

Available from:

Rowa Pharmaceuticals Ltd.

ATC code:

առկա չէ բուսական դեղի հաջորդ արտադրատարածք

INN (International Name):

a-pinene, b-pinene, menthol, menthone, borneol, camphene, cineole

Dosage:

13,6mg+ 3,4mg+ 32mg+ 6mg+ 5mg+ 5mg+ 2mg (100/10x10/) in blister

Pharmaceutical form:

capsules gastro-resistant, soft

Units in package:

13,6mg+3,4mg+32mg+6mg+5mg+5mg+2mg (100/10x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-11-20

Summary of Product characteristics

-1-
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Rowachol Gastro-resistant Capsules, Soft
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
α-Pinene 13.6 mg, ß-Pinene 3.4 mg, Menthol 32 mg, Menthone 6 mg,
Borneol 5 mg, Cineole 2 mg and
Camphene 5 mg.
Excipient(s) with known effect:
Each capsule also contains Sodium Ethyl Parahydroxybenzoate (E215) and
Sodium Propyl
Parahydroxybenzoate (E217).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Gastro-resistant soft capsules.
Spherical, green, soft gelatin, gastro-resistant capsules containing a
greenish yellow oral solution with a
strong aromatic odour.
4. CLINICAL PARTICULARS
_4.1 THERAPEUTIC INDICATIONS _
In the management and dissolution of radiolucent gallstones in the
functioning gall bladder where a
definite diagnosis has been made by a doctor especially in the case of
children.
_4.2 POSOLOGY AND METHOD OF ADMINISTRATION _
Method of administration: Oral.
Posology
_Adults_: 1 to 2 capsules three times daily before meals.
_Paediatric Population _
Children aged 0 to 6 years: No data are available.
-2-
Children aged 6 to 14 years: 1 capsule twice daily before meals.
Adolescents aged 14 to 18 years: 1 to 2 capsules three times daily
before meals.
_4.3 CONTRAINDICATIONS _
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section 6.1.
_4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE _
Definite diagnosis of radiolucent gallstones must be made before
taking this product to rule out other
possible conditions.
The product should only be used with caution in patients on
anti-coagulants or drugs dependent on the
liver for metabolism and excretion.
Conservative medical management of cholelithiasis should be initiated
with the awareness that stones
can give rise to serious clinical complications, especially if the
stones obstruct the common bile duct
such as obstructive jaundice, ascending cholangitis, sepsis, acute
pancreatitis. The physician should be
aware of the necessity of be