البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
TROSPIUM CHLORIDE
TEC-O-PHARM-LIBRA LTD
G04BD09
FILM COATED TABLETS
TROSPIUM CHLORIDE 15 MG
PER OS
Required
DR. PFLEGER ARZNEIMITTEL GMBH, GERMANY
TROSPIUM
TROSPIUM
For the treatment of vegetative bladder dysfunction accompanied by urgency and/or frequency and/or urinary incontinence.
2015-01-31
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is sold with a doctor’s prescription only SPASMEX ® 15 SPASMEX ® 30 ACTIVE INGREDIENT AND ITS QUANTITY: Each tablet of Spasmex 15 contains: Trospium chloride 15 mg Each tablet of Spasmex 30 contains: Trospium chloride 30 mg THIS MEDICINE CONTAINS LACTOSE. For further information, see section 6. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, refer to the doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. THIS MEDICINE IS INTENDED FOR ADULTS AND ADOLESCENTS OVER 12 YEARS OLD. 1. WHAT IS THE MEDICINE INTENDED FOR? This medicine is used for the treatment of impaired function of the urinary bladder, accompanied by urgency and/or frequency and/or urinary incontinence. THERAPEUTIC GROUP: Anticholinergic, Antimuscarinic. 2. BEFORE USING THE MEDICINE X DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient or any of the other ingredients of this medicine (see section 6 – "further information"). You suffer from: • urinary retention (urination is less frequent than usual). • narrow-angle glaucoma. • arrhythmia (increased and irregular heartbeat). • myasthenia gravis. • severe chronic inflammatory bowel disease (Crohn’s disease, ulcerative colitis). • toxic megacolon. • renal disease requiring dialysis (Creatinine clearance < 10 ml/min/1.73 m 2 ). SPECIAL WARNINGS REGARDING USE OF THE MEDICINE ! BEFORE STARTING THE TREATMENT WITH SPASMEX TELL THE DOCTOR IF YOU SUFFER OR HAVE SUFFERED IN THE PAST FROM: • An obstruction in the digestive system (e.g. due to narrowing of the pylorus - pyloric stenosis). • Urine outflow obstruction or disturbance that may cause residual urine. • Hiatus hernia with an inflammation of the esophagus. • Dis اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS SPASMEX ® 30 mg film-coated tablets SPASMEX ® 15 mg film-coated tablets. 1. N AME OF THE MEDICINAL PRODUCT Spasmex ® 30 film-coated tablets Spasmex ® 15 film-coated tablets 2. Q UALITATIVE AND QUANTITATIVE COMPOSITION 1 film-coated tablet of Spasmex 30 contains 30 mg trospium chloride. 1 film-coated tablet of Spasmex 15 contains 15 mg trospium chloride. Excipients with known effect: 1 film-coated tablet contains 100 mg lactose-monohydrate For the complete list of excipients see chapter 6.1. 3. P HARMACEUTICAL FORM Film-coated tablet. Spasmex 30: White, round, biconvex film-coated tablets with a special score line (“SNAP-TAB”) on one side. The tablet may be divided into two equal doses. Spasmex 15: White, round, biconvex film-coated tablets, special score line (“SNAP-TAB”) on one side and the stamp “0” on the other side. 4. C LINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of vegetative bladder dysfunction accompanied by urgency and/or frequency and/or urinary incontinence. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 15 mg (one tablet of Spasmex 15 or half a tablet of Spasmex 30) should be taken three times a day, or 30 mg in the morning (two tablets of Spasmex 15 or one tablet of Spasmex 30) and 15 mg in the evening. Patients with reduced kidney function In patients with severely impaired renal function (Creatinine clearance between 10 and 30 ml/ min/ 1.73 m 2 ) a daily dose of 15 mg should not be exceeded. Patients with reduced liver function Dose adjustment does not appear necessary in patients with a mild to moderate impairment in liver function (Child-Pugh 5-6 or 7-9) (see section 5.2 Pharmacokinetic properties). Studies for patients with severe liver dysfunction (Child-Pugh > 10; class C) have not been carried out meaning that treatment cannot be recommended in these cases. Use in children Treatment in children under 12 years old is not recommended as no data exist. Mode and duration of treatment The film-coated tablets should be swallowed wh اقرأ الوثيقة كاملة