Država: Zimbabve
Jezik: angleščina
Source: Medicines Control Authority
CODEINE PHOSPHATE; IBUPROFEN; PARACETAMOL
ADCOCK INGRAM LIMITED
CODEINE PHOSPHATE; IBUPROFEN; PARACETAMOL
250; 200; 10 MG
CAPSULE; ORAL
PHARMACY MEDICINES (P.)
ADCOCK INGRAM LIMITED; DATLABS PRIVATE LIMITED;
2014-06-02
MYPRODOL CAPSULES - DUAL LANGUAGE - PIL ADCOCK INGRAM LIMITED, SA TEXT REVISION R-1/28.05/18.06.12(RK) INTERNAL APPROVAL ISSUED ON CD ISSUED ON 1210284 (WOA) PRINTED ON 56 - 60 GSM MAPLITHO PAPER. SINGLE - BLACK 160 X 240 MM (OPEN SIZE) 85% REASON FOR CHANGE: ITEM CODE: CUSTOMER: ADCOCK INGRAM LIMITED ARTWORK SCALE: SUPERSEDED ITEM CODE: COMPONENT: DIMENSION: COLOUR SCHEME: SPECIFICATION: PDC HEAD - TT/PDC HEAD - TECH. SERVICES /PRODUCTION HEAD CQA/QA Prepared by: Date: Checked by: Date: Approved by: Date: Authorized by: Date: ADC/MYP/PIL/02 \\192.168.1.32\pdc\Artworks\Adcock\Product\Myprodol\PIL\1210284.ai SCHEDULING STATUS: S3 PROPRIETARY NAME: MYPRODOL ® CAPSULES (AND DOSAGE FORM) (CAPSULE) COMPOSITION: Each capsule contains: Codeine phosphate 10 mg Ibuprofen 200 mg Paracetamol 250 mg Sugar free PHARMACOLOGICAL CLASSIFICATION: A:2.8 Analgesic combinations PHARMACOLOGICAL ACTION: MYPRODOL CAPSULES have an analgesic, anti-inflammatory and antipyretic action. INDICATIONS: MYPRODOL CAPSULES are indicated for the relief of mild to moderate pain of inflammatory origin with or without fever. CONTRAINDICATIONS: Impaired hepatic and renal function, peptic ulceration or a history of such ulceration. Cardiovascular disease. Hypersensitivity to any of the active ingredients. Contraindicated in respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion, after operations on the biliary tract, acute alcoholism, head injuries and conditions in which intracranial pressure is raised. It should not be given during an attack of bronchial asthma or in heart failure secondary to chronic lung disease. Contraindicated in patients taking monoamine oxidase inhibitors or within fourteen days of stopping such treatment. Caution is advised in those patients who are receiving coumarin anticoagulants. Patients who are sensitive to aspirin should not be given MYPRODOL CAPSULES. WARNINGS: The safety of continuous administration of MYPRODOL CAPSULES has not been established for a period greater than four Preberite celoten dokument