البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
OXYBUTYNIN CHLORIDE
J-C HEALTH CARE LTD
G04BD04
TABLETS PROLONGED RELEASE
OXYBUTYNIN CHLORIDE 10 MG
PER OS
Required
JANSSEN CILAG S.P.A., ITALY
OXYBUTYNIN
OXYBUTYNIN
Once daily controlled-release tablet indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.
2011-06-30
SIDE EFFECTS: In addition to the desired effect of the medicine, adverse reactions may occur during the course of taking this medicine, such as: Very common side effects (reported in more than 1 in 10 users): Dry mouth. Common side effects (reported in less than 1 in 10 users): Pain on passing urine, delay when passing urine, feeling of incomplete emptying of the bladder; constipation, diarrhea, indigestion, nausea, vomiting, stomach pain, flatulence, heartburn; problems sleeping, feeling drowsy, feeling tired; cough, sore throat, dry throat, dry nose; change in the way things taste; dry eyes, blurred vision; dry skin, itchy skin; dizziness; headache. Uncommon side effects (reported in less than 1 in 100 users): Loss of appetite, more frequent bowel movements, difficulty swallowing; voice problems such as hoarseness; flushing, hot flashes; chest discomfort; water retention; thirst; rash. Rare side effects (reported in less than 1 in 1,000 users): Auditory hallucinations, visual hallucinations; erection problems; irregular heartbeat, increased heart rate; convulsions. Very rare side effects (reported in less than 1 in 10,000 users): Allergic reaction including hives (skin disease) or swelling of the face, lips, tongue or throat; difficulty breathing, feeling agitated, feeling confused, difficulty remembering; heartbeat awareness; urinary tract infection; high blood pressure; mental problems; nasal congestion; glaucoma; falling. Side effects that require special attention: Contact your doctor immediately if you experience an allergic reaction and difficulties breathing. If you take too much of the medicine (overdose) you may experience: restlessness, tremor, irritability, confusion, hallucinations, flushing (usually of the face or neck), fever, dehydration, heart beat irregularities, vomiting, and difficulty emptying your bladder completely. If you have taken an overdose of the medicine, contact your doctor. If any of these symptoms occur, seek medical attention immediately. In the event that you experience side ef اقرأ الوثيقة كاملة
Lyrinel_PI_22_July_12_CL 1 ע עבקנ הז ןולע טמרופ " רשואו קדבנ ונכותו תואירבה דרשמ י ילויב 2012 1. NAME OF THE MEDICINAL PRODUCT TRADENAME LYRINEL 5MG, 10MG ® INTERNATIONAL NON-PROPRIETARY NAME Oxybutynin chloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each extended [ _prolonged_ ] release tablet contains 5 mg or 10 mg of oxybutynin chloride 3. PHARMACEUTICAL FORM Extended [ _prolonged_ ] release tablets for oral use: • 5 mg: Pale yellow, round, tablet with “5 XL” printed on one side with black ink. • 10 mg: Pink, round, tablet with “10 XL” printed on one side with black ink. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Once daily controlled-release tablet indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION LYRINEL is administered orally once daily. The recommended starting dose of LYRINEL is 5 or 10 mg once daily. Dosage may be adjusted in 5-mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 30 mg/day). In general, dosage adjustment may proceed at approximately weekly intervals. [ _Patients _ _already _ _taking _ _immediate _ _release _ _oxybutynin _ _may _ _be _ _switched _ _to _ _the _ _nearest _ _equivalent total daily dose of _ LYRINEL.] Lyrinel_PI_22_July_12_CL 2 LYRINEL must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed. LYRINEL may be administered with or without food (see Section 5.2, Pharmacokinetic Properties). ELDERLY [≥ _65 years old_ ]: Same as for adults. 4.3. CONTRAINDICATIONS LYRINEL is contraindicated: • - Hypersensitivity to oxybutynin or any of the excipients • - Narrow-angle glaucoma or shallow anterior chamber • - Myasthenia gravis • _- _ Urinary retention • - Gastrointestinal obstructive disorder, paralytic ileus or intestinal atony • - Severe ulcerative colitis • - Toxic megacolon • - Urinary frequency and nocturia due to اقرأ الوثيقة كاملة