País: República de Sud-àfrica
Idioma: anglès
Font: South African Health Products Regulatory Authority (SAHPRA)
Adcock Ingram Limited
See ingredients
TABLET
EACH TABLET CONTAINS CAFFEINE 45 mg CODEINE PHOSPHATE 10 mg DOXYLAMINE SUCCINATE 5 mg PARACETAMOL 450 mg
Registered
1973-02-06
Date of Approval: 18 May 2023 Page 1 of 7 PATIENT INFORMATION LEAFLET SCHEDULING STATUS: PYNSTOP, 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. PYNSTOP is available without a doctor’s prescription, for you to treat a mild illness. Nevertheless, you still need to use PYNSTOP carefully to get the best results from it. • Keep this leaflet. You may need to read it again. • Do not share PYNSTOP with any other person • Ask your pharmacist or healthcare provider if you need more information or advice • You must see a doctor if your symptoms worsen or do not improve after 10 days.. WHAT IS IN THIS LEAFLET: 1. What PYNSTOP is and what it is used for 2. What you need to know before you take PYNSTOP 3. How to take PYNSTOP 4. Possible side effects 5. How to store PYNSTOP 6. Contents of the pack and other information 1. WHAT PYNSTOP IS AND WHAT IT IS USED FOR PYNSTOP contains codeine phosphate, doxylamine succinate paracetamol and caffeine which belongs to a group of medicine referred to as analgesic combinations(pain ,fever and allergic medication). S2 Date of Approval: 18 May 2023 Page 2 of 7 PYNSTOP is used for the symptomatic relief of mild to moderate pain associated with tension and fever. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PYNSTOP TABLETS DO NOT TAKE PYNSTOP • If you are allergic to codeine phosphate, doxylamine succinate paracetamol and caffeine, or any of the other ingredients of PYNSTOP tablets (listed in section 6.1). • If you have severe liver function impairment • If you have respiratory depression • If you have bronchial asthma • If you have lung disease could lead to heart failure • If you have head injuries • If you have acute alcoholism • If you have just had a biliary tract operation. • If you are under the age of 12 years WARNINGS AND PRECAUTIONS Special care should be taken with PYNSTOP: • This product contains parac Llegiu el document complet
Date of Approval: 18 May 2023 Page 1 of 10 PROFESSIONAL INFORMATION SCHEDULING STATUS: S2 1. NAME OF THE MEDICINE PYNSTOP STRENGTH Each tablet contains: Codeine phosphate 10 mg Doxylamine succinate 5 mg Paracetamol 450 mg Caffeine 45 mg PHARMACEUTICAL FORM Tablets 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 3. PHARMACEUTICAL FORM Green, circular, flat tablet with score line on one side and a diameter of 12,7 mm. Date of Approval: 18 May 2023 Page 2 of 10 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PYNSTOP tablet for adults are indicated for the symptomatic relief of mild to moderate pain and pain associated with tension and fever. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Not recommended for children under twelve years. Adults and children over 12 years: one or two tablets repeated four hourly if necessary. Do not exceed eight tablets per day. Consult your doctor if no relief is obtained with the recommended dosage. DO NOT EXCEED THE RECOMMENDED DOSE 4.3. CONTRAINDICATIONS: PYNSTOP tablets are contraindicated in: • Sensitivity (allergy) to the active ingredients. • Severe liver function impairment. • Respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion. • During an attack of bronchial asthma. • Heart failure secondary to lung disease. • Head injuries and conditions in which intracranial pressure is raised. • The presence of acute alcoholism. • After operations on the biliary tract. Date of Approval: 18 May 2023 Page 3 of 10 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE THIS PRODUCT CONTAINS PARACETAMOL WHICH MAY BE FATAL IN OVERDOSE. IN THE EVENT OF OVERDOSAGE OR SUSPECTED OVERDOSE AND NOTWITHSTANDING THE FACT THAT THE PERSON MAY BE DOCTOR, HOSPITAL OR POISON CENTRE MUST BE CONTACTED IMMEDIATELY. CODEINE: EXCEEDING THE PRESCRIBED DOSE, TOGETHER WITH PROLONGED AND CONTINUOUS USE OF THIS M Llegiu el document complet