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
Documents
Package Inserts
Mictonorm PI.pdf
Approved: February 21, 2007