Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
CAPSULE
**Dosage and administration** Adults Take one capsule twice daily, one in the morning and one in the evening. The capsules should be swallowed with a sufficient amount of water (at least 100 ml of water). They should not be chewed because the coating is intended to ensure a prolonged release mechanism. Treatment Duration Symptom relief occurs after a minimum of 2 to 4 weeks of treatment and greater effects can be observed after a prolonged therapy of 6 to 8 weeks. Always take Duspatalin retard exactly as your doctor has prescribed. If you have any questions, check with your doctor or pharmacist. In case of one or more dose(s) is (are) missed, you should continue with the next dose as prescribed; the missed dose(s) is (are) not to be taken in addition to the regular dose. Paediatric Population Duspatalin retard 200 mg capsules are not recommended for use in children and adolescents below 18, due to insufficient data on safety and efficacy. Special Population No posology studies in elderly, renal and/or hepatic impaired patients have been performed. However, no specific risk for elderly, renal and/or hepatic impaired patients could be identified from available post-marketing data. No dosage adjustment is deemed necessary in these patients.
ORAL
Medical Information
**Indications** Symptomatic treatment of abdominal pain and cramps, bowel disturbances and intestinal discomfort related to irritable bowel syndrome. Treatment of gastro-intestinal spasm secondary to organ diseases.
**Contraindications** Do not take this medicine if you are allergic (Hypersensitivity) to the active substance or to any of the excipients.
A03AA04
mebeverine
Manufacturer Information
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
ABBOTT BIOLOGICALS B.V.
Mylan Laboratories SAS
Active Ingredients
Documents
Patient Information Leaflets
1.4.4 PIL_Proposed Pristine.pdf
Approved: January 3, 2022