Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DARIFENACIN HYDROBROMIDE
Aspen Medical Products Malaysia Sdn Bhd
DARIFENACIN HYDROBROMIDE
28Tablet Tablets
ASPEN BAD OLDESLOE GMBH
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ _ _ 1 ENABLEX PROLONGED-RELEASE TABLETS Darifenacin hydrobromide (7.5mg, 15mg) WHAT IS IN THE LEAFLET 1. What Enablex is used for 2. How Enablex works 3. Before you use Enablex 4. How to use Enablex 5. While you are using it 6. Side effects 7. Storage and Disposal of Enablex 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT ENABLEX IS USED FOR Enablex is used to treat the following symptoms due to a condition called overactive bladder: • Urgency: a strong need to urinate right away • Urge urinary incontinence: a strong need to urinate with leaking or wetting accidents • Frequency: urinating often HOW ENABLEX WORKS Enablex contains the active ingredient called darifenacin hydrobromide. Enablex works by relaxing the bladder smooth muscle and helps to decrease muscle spasm. This delays the initial desire and the urge to urinate. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor's prescription. It is not addictive. Enablex is not recommended for use in children because there have been no studies of its effects in this age group. BEFORE YOU USE ENABLEX - _When you must not use it _ Do not take this medicine if you have an allergy to: • darifenacin, the active ingredient • any of the other ingredients listed at the end of this leaflet Do not take Enablex if you have any of the following medical conditions: • a disorder of eye related to eye pressure called narrow angle glaucoma that is not being controlled with medicine • delayed in stomach emptying • urinary retention • abnormal weakness of certain muscles. • severe liver impairment • severe inflammation and ulcer of large intestine • a very dilated colon (megacolon), accompanied by abdominal bloating Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows Baca dokumen lengkap
Enablex ® (Darifenacin) PRESENTATIONS Enablex® 7.5mg Prolonged- release Tablets are round, shallow, convex, white tablets and are identified with “DF” on one side and “7.5” on the other. Each tablet contains 7.5mg of darifenacin (as hydrobromide). Enablex® 15mg Prolonged-release Tablets are round, shallow, convex, light -peach -coloured tablets and are identified with “DF” on one side and “15” on the reverse. Each tablet contains 15mg of darifenacin (as hydrobromide). THERAPEUTIC INDICATIONS Enablex is indicated for the treatment of overactive bladder. Symptoms of overactive bladder include urgency, urge urinary incontinence and frequency. DOSAGE AND ADMINISTRATION Adults The recommended starting dose is 7.5mg daily. For those patients requiring gr eater symptom relief, the dose may be increased to 15mg daily as early as two weeks after starting therapy, based on individual response. Geriatric patients No dose adjustment is required in elderly patients ( see section CLINICAL PHARMACOLOGY ). Paediatri c patients No studies have been performed in children. Therefore, until more information is available, Enablex is not recommended for use in children. Renal impairment No dose adjustment is required in patients with impaired renal function ( see CLINICAL P HARMACOLOGY ). Hepatic impairment There is a risk of increased exposure in this population ( see section CLINICAL PHARMACOLOGY ), however, no dose adjustment is required in patients with mild hepatic impairment (Child Pugh A). The daily dose of Enablex shoul d not exceed 7.5 mg in patients with moderate hepatic impairment (Child Pugh B). Enablex is not recommended for use in patients with severe hepatic impairment (Child Pugh C). Baca dokumen lengkap