País: Reino Unido
Língua: inglês
Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)
Propiverine hydrochloride
Alliance Healthcare (Distribution) Ltd
G04BD06
Propiverine hydrochloride
15mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07040200
DETRUNORM 15MG COATED TABLETS (propiverine hydrochloride) PATIENT INFORMATION LEAFLET 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, pharmacist or nurse. * 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. The name of your medicine is Detrunorm 15 mg Coated Tablets (referred to as Detrunorm throughout this leaflet). WHAT IS IN THIS LEAFLET: What Detrunorm are and what they are used for What you need to know before you take Detrunorm How to take Detrunorm Possible side effects How to store Detrunorm Contents of the pack and other information WHAT DETRUNORM ARE AND WHAT THEY ARE USED FOR Detrunorm is used for the treatment of people who have difficulty in controlling their bladders 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DETRUNORM DO NOT TAKE DETRUNORM: * if you are allergic to propiverine hydrochloride or any of the other ingredients of this medicine listed in section 6 (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing); * if you have obstruction of the bowel; * if you have obstruction to the bladder outlet (difficulty in passing urine); * if you have myasthenia gravis (a disease causing muscle weakness); * if you have a loss of function of Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Detrunorm 15 mg Coated Tablets Propiverine Hydrochloride 15mg Coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each coated tablet contains 15 mg propiverine hydrochloride equivalent to 13.64 mg propiverine. Excipients with known effect: Lactose monohydrate (63.4 mg/ tablet) Sucrose (49.0 mg/ tablet) Glucose monohydrate (0.6 mg/ tablet) Cochineal red A (E124, lake) (0.2 mg/ tablet) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Coated tablets Rose-coloured, lenticular glazing coated tablets. 4.1 THERAPEUTIC INDICATIONS Detrunorm 15 mg Coated Tablets are indicated in adults for the 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, e.g. transverse lesion paraplegia . 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 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. Some patients may already respond to a dose of 15 mg a day. For neurogenic detrusor overactivity a dose of one coated tablet three times a day is recommended. The maximum recommended daily dose is 45 mg. Paediatric population The safety and efficacy of propiverine in children has not yet been established. Hence this product should not be used in children. Elderly Generally there is no special dose regimen for the elderly (see section 5.2). 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 to moderate impaired renal function no dose adjustment is required. In patients with severe renal impairment (creatinine clearance < 30 ml/min) the maximum daily dose is 30 mg (see section 5.2). Use in he Leia o documento completo