국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FLAVOXATE HYDROCHLORIDE
DCH AURIGA (MALAYSIA) SDN. BHD.
FLAVOXATE HYDROCHLORIDE
90Tablet Tablets
RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A.
URISPAS 200 TABLET Flavoxate hydrochloride (200mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What URISPAS is used for 2. How URISPAS works 3. Before you use URISPAS 4. How to use URISPAS 5. While you are using it 6. Side effects 7. Storage and Disposal of URISPAS 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT URISPAS IS USED FOR URISPAS is used to treat urinary tract symptoms which may be a result of inflammation. URISPAS can also be used to relieve symptoms which may occur as a result of surgery and procedures such as cystoscopy or catheterization. HOW URISPAS WORKS URISPAS contains flavoxate hydrochloride which works by relaxing the muscles in the bladder and helps to relieve symptoms such as painful urination, excessive urination at night, inability to control urine flow and associated pain. BEFORE YOU USE URISPAS - _When you must not use it _ ˗ if you are allergic to flavoxate hydrochloride or any of the other ingredients of this medicine (listed in section inactive ingredients) ˗ if you have a gastrointestinal obstruction/ bleeding ˗ if you have inability to swallow ˗ If you are not able to completely empty your bladder (urinary retention) ˗ if you have increased pressure in your eye (glaucoma) ˗ if you have muscle weakness _ _ _Pregnancy and lactation _ If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The safety of this medicine use during pregnancy and lactation has not been established. If you are pregnant or breast- feeding, this medicine is not recommended. _ _ - _Before you start to use it _ Talk to your doctor or pharmacist before taking URISPAS: - If you have impaired kidney function. Children - URISPAS should not be used in children younger than 12 years of age. - _Taking other medicines _ Tell your doctor if you are taking any other medicines, including any that you buy without a prescriptio 전체 문서 읽기
URISPAS 200 Flavoxate hydrochloride PRESENTATION: Each tablet contains 200 mg flavoxate hydrochloride. MANUFACTURED BY: Recordati Industria Chimica e Farmaceutica S.p.A., Via Matteo Civitali 1, 20148, Milan, Italy The white, film-coated tablets are embossed with “F200”. USES: Urispas is indicated for the symptomatic relief of dysuria, urgency, nocturia, vesical supra-pubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitits and urethrotrigonitis. In addition, the preparation is indicated for the relief of vesico-urethral spams due to the catheterization, cystoscopy or indwelling catheters; prior to cystoscopy or catheterization; sequelae of surgical intervention of the lower urinary tract. DOSAGE AND ADMINISTRATION: Oral administration. _Adults (including the elderly): _The recommended adult dosage is 200 mg three times a day for as long as required. _Children: _Not recommended for children under 12 years of age. CONTRA-INDICATIONS: - Hypersensitivity to the active substance or to any of the excipients - Gastrointestinal obstructive conditions or ileus - Gastro-intestinal haemorrhage - Achalasia - Urinary retention - Glaucoma - Myasthenia gravis. SPECIAL PRECAUTIONS: The use in children below the age of <12 years is not recommended. Since the renal clearance of the active metabolite accounts more than 50% of the dose, renal impairment may significantly affect the product kinetics. Caution is therefore required in patients with renal impairment. As the tablets contain lactose, its use is not recommended in patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption. SIDE EFFECTS: The source of the below ADRs frequencies is represented by data collected through clinical trials, observational studies and spontaneous reporting. In the table below, adverse reactions are reported and listed by MedDRA system organ class and frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/ 전체 문서 읽기