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HSA Approval

Mictonorm 15mg Tablet

SIN13235P

Mictonorm 15mg Tablet

Mictonorm 15mg Tablet

February 22, 2007

PHARMAFORTE SINGAPORE PTE LTD

PHARMAFORTE SINGAPORE PTE LTD

Regulatory Information

PHARMAFORTE SINGAPORE PTE LTD

PHARMAFORTE SINGAPORE PTE LTD

Therapeutic

Prescription Only

Formulation Information

TABLET, COATED

**4.2 Posology and method of administration** Coated tablets for oral application. The recommended daily doses are as follows: Adults: As a standard dose one coated tablet (= 15 mg propiverine hydrochloride) twice a day is recommended, this may be increased to three times a day. Elderly: Generally there is no special dosage regimen for the elderly (see 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). There is no clinically relevant effect of food on the pharmacokinetics of propiverine (see 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Accordingly, there is no particular recommendation for the intake of propiverine in relation to food. This medicinal product contains 0.61 mg of glucose. Accordingly, a daily dose of 2 coated tablets supplies 1.22 mg of glucose.

ORAL

Medical Information

**4.1 Therapeutic indications** The treatment of urinary incontinence, as well as urgency and frequency in patients who have idiopathic detrusor overactivity (overactive bladder).

**4.3 Contraindications** The drug is contraindicated in patients who have demonstrated hypersensitivity to the active substance or to any of the excipients and in patients suffering from one of the following disorders: - obstruction of the bowel - significant degree of bladder outflow obstruction where urinary retention may be anticipated - myasthenia gravis - intestinal atony - severe ulcerative colitis - toxic megacolon - uncontrolled angle closure glaucoma - moderate or severe hepatic impairment - tachyarrhythmias - pregnant or nursing woman.

G04BD06

propiverine

Manufacturer Information

PHARMAFORTE SINGAPORE PTE LTD

Apogepha Arzneimittel GmbH

Active Ingredients

Propiverine Hydrochloride

15.000 mg

Propiverine

Documents

Package Inserts

Mictonorm PI.pdf

Approved: February 21, 2007

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