Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
PROPIVERINE HYDROCHLORIDE
Amdipharm Limited
G04BD06
PROPIVERINE HYDROCHLORIDE
15 Milligram
Coated Tablets
Product subject to prescription which may be renewed (B)
Drugs for urinary frequency and incontinence
Authorised
2008-12-12
page 2of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER DETRUNORM ® 15 MG FILM-COATED TABLETS (PROPIVERINE HYDROCHLORIDE) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or your pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects gets, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet (see section 4). The name of your medicine is DETRUNORM 15 MG FILM-COATED TABLETS (referred to as Detrunorm throughout this leaflet). The active substance is propiverine hydrochloride and the other ingredients are listed at the end of the leaflet (section 6, Contents of the pack and other information). WHAT IS IN THIS LEAFLET: 1. What Detrunorm is and what it is used for 2. What you need to know before you take Detrunorm 3. How to take Detrunorm 4. Possible side effects 5. How to store Detrunorm 6. Contents of the pack and other information 1. WHAT DETRUNORM IS AND WHAT IT IS USED FOR Detrunorm is used for the treatment of people who have difficulty in controlling their bladder due to bladder overactivity or, in some cases, problems with the spinal cord. Detrunorm contains the active substance propiverine hydrochloride. This substance prevents the bladder from contracting and increases the amount that the bladder can hold. Detrunorm is used to treat the symptoms of overactive bladder. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DETRUNORM DO NOT TAKE DETRUNORM Do not take Detrunorm if you are allergic (hypersensitive) to propiverine hydrochloride or to any of the other ingredients of Detrunorm (these are listed in section 6). Do not take Detrunorm if you suffer from any of the following conditions: - obstruction of the bowel - obstruction to the bladder outlet (difficulty Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Detrunorm 15 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 15 mg propiverine hydrochloride (equivalent to 13.64 mg propiverine). Excipients with known effect: Lactose monohydrate (100.7 mg). For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablets White, biconvex, round film-coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of urinary incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome or neurogenic detrusor overactivity (detrusor hyperreflexia) from spinal cord injuries, e.g. transverse lesion paraplegia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Film-coated tablets for oral use. The recommended daily doses are as follows: Adults: As a standard dose one film-coated tablet (= 15 mg propiverine hydrochloride) twice daily is recommended, this may be increased to three times daily. Some patients may already respond to a dosage of 15 mg daily. For neurogenic detrusor overactivity a dose of one film-coated tablet three times daily is recommended. The maximum recommended daily dose is 45 mg. Elderly: Generally there is no special dosage regimen for the elderly (see section 5.2). Paediatric population: Due to a lack of data Detrunorm should not be used in children. Caution should be exercised and physicians should monitor patients carefully for side effects in the following dispositions (see sections 4.4, 4.5, 5.2): Use in renal impairment In patients with mild or moderate impairment of renal function, no dose adjustment is required; however, they should be treated with caution. In patients with severely impaired renal function (creatinine clearance < 30 ml/min), the maximum daily dose is 30 mg. Use in hepatic impairment In patients with mildly impaired hepatic function, there is no need for dose adjustment; however, treatment should proceed with caution. No studies Citiți documentul complet