Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Propiverine hydrochloride
Consilient Health Ltd
G04BD06
Propiverine hydrochloride
30mg
Modified-release capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07040200; GTIN: 5060064170717
(Propiverine hydrochloride) Package leaflet: information for the patient 200553/LF/2 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 pharmacist. - This leaflet provides a summary of the information available on your medicine. - This medicine has been prescribed for you, do not pass it on to others, it may harm them, even if their symptoms 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. IN THIS LEAFLET: 1. What Detrunorm XL 30 mg Modified Release Capsules are and what they are used for 2. What you need to know before you take Detrunorm XL 30 mg Modified Release capsules 3. How to take Detrunorm XL 30 mg Modified Release Capsules 4. Possible Side Effects 5. How to store Detrunorm XL 30 mg Modified Release Capsules 6. Contents of the pack and other information 1. WHAT DETRUNORM XL 30 MG MODIFIED RELEASE CAPSULES ARE AND WHAT THEY ARE USED FOR The name of your medicine is Detrunorm XL 30 mg Modified Release Capsules (to be referred to as Detrunorm throughout the leaflet). Detrunorm is used for the treatment of people who have difficulty in controlling their bladders due to bladder overactivity. 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. It is a modified-release capsule that needs only be taken once a day. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DETRUNORM XL 30 MG MODIFIED RELEASE CAPSULES 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 incl Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Detrunorm XL 30 mg Modified Release Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 30 mg propiverine hydrochloride (equivalent to 27.28 mg propiverine). Excipients with known effect: Lactose monohydrate (5.7 mg/tablet)_ _ For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Modified-release capsules, hard. Orange and white size 3 capsules containing white to off-white pellets. 4.1 THERAPEUTIC INDICATIONS Detrunorm XL 30 mg Modified Release Capsules are indicated in adults for the symptomatic treatment of urinary incontinence and/or increased urinary frequency and urgency in patients with overactive bladder syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended daily doses are as follows: Adults: As a standard dose one capsule (= 30 mg propiverinehydrochloride) once a day is recommended. 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 or moderate impairment of renal function no dose adjustment is required. (see section 5.2). Use in hepatic impairment In patients with mildly impaired hepatic function there is no need for a dose adjustment however, treatment should proceed with caution . No studies have been performed to investigate the use of propiverine in patients with moderately or severely impaired hepatic function. Its use is therefore not recommended in these patients. (see section 5.2). Patients receiving concomitant treatment with drugs that are potent inhibitors of CYP 3A4 combined with methimazole In patients receiving drugs that are potent flavin-containing monooxygenase (FMO) inhibi Прочитать полный документ