البلد: جنوب أفريقيا
اللغة: الإنجليزية
المصدر: South African Health Products Regulatory Authority (SAHPRA)
Adcock Ingram Limited
See ingredients
TABLET
EACH TABLET CONTAINS CAFFEINE 45,0 mg CODEINE PHOSPHATE 10,0 mg DOXYLAMINE SUCCINATE 5,0 mg PARACETAMOL 450 mg
Registered
1989-04-08
PATIENT INFORMATION LEAFLET SCHEDULING STATUS: S2 ADCO-DOL TABLETS EACH TABLET CONTAINS: Codeine phosphate 10 mg Doxylamine succinate 5 mg Paracetamol 450 mg Caffeine 45 mg SUGAR FREE. READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. ADCO-DOL is available without a doctor’s prescription, for you to treat a mild illness. Nevertheless, you still need to use ADCO-DOL carefully to get the best results from it. • Keep this leaflet. You may need to read it again. • Do not share ADCO-DOL with any other person. • Ask your health care provider or pharmacist if you need more information or advice. • You must see a doctor if your symptoms worsen or do not improve. WHAT IS IN THIS LEAFLET: 1. What ADCO-DOL is and what it is used for 2. What you need to know before you take ADCO-DOL 3. How to take ADCO-DOL 4. Possible side effects 5. How to store ADCO-DOL 6. Contents of the pack and other information Date of Approval: 28 September 2021 1 of 8 1. WHAT ADCO-DOL IS AND WHAT IT IS USED FOR: ADCO-DOL is a pain and fever combination of paracetamol with codeine phosphate. Doxylamine succinate has sedating and antihistamine properties. In combination these all treat mild to moderate pain and fever. ADCO-DOL is used for symptomatic relief of mild to moderate pain, pain associated with tension, and fever in adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ADCO-DOL Do not take ADCO-DOL: • If you are hypersensitive (allergic) to any of the above listed ingredients of ADCO-DOL. • If you have respiratory depression (unusual breathing), especially in the presence of cyanosis (blueish discolourisation of skin) and excessive bronchial secretion. • After operations on the biliary tract, acute alcoholism, head injuries and conditions in which intracranial (inside skull) pressure is raised. • It should not be given during an attack of bronchial asthma or in heart failure secondary to chronic lung disease. WARNINGS AND PRECAUTIONS Special care should be taken with ADCO-DOL • This product co اقرأ الوثيقة كاملة
PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE SCHEDULING STATUS: S2 1. NAME OF MEDICINE ADCO-DOL STRENGTH Each tablet contains: Codeine phosphate 10 mg Doxylamine succinate 5 mg Paracetamol 450 mg Caffeine 45 mg PHARMACEUTICAL FORM: Tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION: Each tablet contains: Codeine phosphate 10 mg Doxylamine succinate 5 mg Paracetamol 450 mg Caffeine 45 mg SUGAR FREE. For a full list of excipients see section 6.1 Date of approval: 28 September 2021 1 of 13 3. PHARMACEUTICAL FORM Yellow, circular, flat tablet, scored on one side only, and embossed with "ADCO" above and "DOL" below the score line. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS: ADCO-DOL tablets for adults: Symptomatic relief of mild to moderate pain, pain associated with tension, and fever. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children over 12 years: One or two tablets repeated four hourly if necessary. Do not exceed eight tablets per day. “DO NOT EXCEED THE RECOMMENDED DOSE. 4.3 CONTRAINDICATIONS: Sensitivity to 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. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Date of approval: 28 September 2021 2 of 13 Paracetamol dosages in excess of those recommended may cause severe liver damage. Patients suffering from liver or kidney disease should take paracetamol under medical supervision. The effects of atropine and tricyclic antidepressants may be enhanced This medicine may lead to drowsiness and impaired concentration which is aggravated by the simultaneous intake of alcohol or other central nervous system dep اقرأ الوثيقة كاملة