Rowatinex Gastro-resistant Capsules, Soft

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

alfa-pinene, beta-pinene, menthol, menthone, borneol, camphene, cineole

Available from:

Rowa Pharmaceuticals Ltd.

INN (International Name):

alfa-pinene, beta-pinene, menthol, menthone, borneol, camphene, cineole

Dosage:

24,8mg+6,2mg+15mg+10mg+4mg+4mg+3mg

Pharmaceutical form:

capsules gastro-resistant, soft

Prescription type:

Prescription

Summary of Product characteristics

Summary of Product Characteristics
1
NAME OF THE MEDICINAL PRODUCT
Rowatinex Gastro-resistant Capsules, Soft
2
QUALITATIVE AND QUANTITATIVE COM POSITION
Each capsule contains:
a + β Pinene 31mg, Camphene 15mg, Cineole 3mg, Fenchone 4mg, Borneol
lOmg, Anethol 4mg.
Each capsule also contains Sodium Ethyl Parahydroxybenzoate (E215),
Sodium Propyl Parahydroxybenzoate (E217) and Sunset
Yellow (E 110).
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant capsules, soft
Yellow, spherical, soft gelatin gastro-resistant capsules containing a
pale yellow to greenish-yellow oral solution with a strong
aromatic odour.
4CLINICAL PARTICULARS
4.1
Therapeutic Indications
In the management of urolithiasis.
4.2
Posology and method of administration
Route of Administration: Oral. Recommended Dosage Schedule:
Adults: The usual dosage is 1-2 capsules 4 to 5 times daily before
meals
Children aged 6 to 14 years: The usual dosage is 1 capsule twice daily
before meals.
4.3
Contraindications
There are no known contraindications to the use of Rowatinex Capsules.
4.4
Special warnings and precautions for use
The product should only be used with caution in patients on
anti-coagulants or drugs dependent on the liver for metabolism and
excretion.
4.5
Interaction with other medicinal products and other forms of
interaction
Rowatinex Capsules should only be used with caution in patients on
anti-coagulants or drugs dependent on the liver for metabolism
and excretion.
4.6
Pregnancy and lactation
There is no information on experience of use during human pregnancy.
There is no evidence of a teratogenic effect in animals.
However, some at least of the ingredients can cross the placenta. The
product should therefore only be used during pregnancy or
lactation if considered essential by the physician.
4.7
Effects on ability to drive and use machines
There is no evidence of impairment of these functions in patients
taking Rowatinex Capsules.
4.8
Undesirable effects
No case of side effects has been reported.
4.9
Overdose