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HSA Approval

DUSPATALIN RETARD CAPSULE 200 mg

SIN07666P

DUSPATALIN RETARD CAPSULE 200 mg

DUSPATALIN RETARD CAPSULE 200 mg

March 10, 1994

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

ABBOTT LABORATORIES (SINGAPORE) PRIVATE LIMITED

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Licence HolderABBOTT LABORATORIES (SINGAPORE) PRIVATE LIMITED

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Pharmacy Only
HSA Singapore 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

MEBEVERINE HCl

200 mg

Mebeverine

Documents

Patient Information Leaflets

1.4.4 PIL_Proposed Pristine.pdf

Approved: January 3, 2022

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DUSPATALIN RETARD CAPSULE 200 mg - HSA Approval | MedPath