País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Propiverine hydrochloride
Consilient Health Limited
G04BD; G04BD06
Propiverine hydrochloride
45 milligram(s)
Modified-release capsule, hard
Drugs for urinary frequency and incontinence; propiverine
Marketed
2011-09-30
PACKAGE LEAFLET: INFORMATION FOR THE USER DETRUNORM ® XL 45 MG MODIFIED RELEASE CAPSULES (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, 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 XL 45 MG MODIFIED-RELEASE CAPSULES (referred to as Detrunorm XL 45 mg 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 XL 45 mg is and what it is used for 2. What you need to know before you take Detrunorm XL 45 mg 3. How to take Detrunorm XL 45 mg 4. Possible side effects 5. How to store Detrunorm XL 45 mg 6. Contents of the pack and other information 1. WHAT DETRUNORM XL 45 MG IS AND WHAT IT IS USED FOR Detrunorm XL 45 mg is used for the treatment of people who have difficulty in controlling their bladder due to bladder overactivity or who have problems with the spinal cord. Detrunorm XL 45 mg contains the active substance propiverine hydrochloride. This substance prevents the bladder from contracting and increases the amount that the bladder can hold. Detrunorm XL 45 mg is used to treat the symptoms of overactive bladder. It is a modified-release capsule that needs only to be taken once a day. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DETRUNORM XL 45 MG DO NOT TAKE DETRUNORM XL 45 MG Do not take Detrunorm XL 45 mg if you are allergic (hypersensitive) to propiverine hydrochloride or to any of the other ingredients of Detrunorm XL 45 Leer el documento completo
Health Products Regulatory Authority 04 June 2021 CRN00C9QY Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Detrunorm XL 45 mg Modified-Release Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 45 mg propiverine hydrochloride (equivalent to 40.92 mg propiverine). Excipients with known effect: Lactose monohydrate (8.5 mg), For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Modified-release capsule, hard Orange size 2 capsules containing white to off-white pellets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of urinary incontinence and/or increased urinary frequency and urgency in patients with overactive bladder syndrome or neurogenic detrusor overactivity (detrusor hyperreflexia) from spinal cord injuries. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended daily doses are as follows: Adults: One capsule (= 45 mg propiverine hydrochloride) once daily. As a standard treatment, one Detrunorm XL 30 mg modified-release capsule (= 30 mg propiverine hydrochloride) once a day or one tablet of Detrunorm (= 15 mg of propiverine hydrochloride) twice a day is recommended, this may be increased to one 15 mg tablet three times a day. Some patients may already respond to a dosage of 15 mg propiverine hydrochloride a day. In patients whom Detrunorm (= 15 mg of propiverine hydrochloride) tablet three times daily is indicated, the 15 mg tablet three times daily regimen could be replaced by Detrunorm XL 45 mg modified-release capsules once a day. The maximum daily dose is one Detrunorm XL 45 mg modified-release capsule daily. Elderly: Generally there is no special dose regimen for the elderly (see section 5.2). Paediatric population: Due to a lack of data, this product 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 the treatment of this group of patients cau Leer el documento completo