Χώρα: Νότια Αφρική
Γλώσσα: Αγγλικά
Πηγή: South African Health Products Regulatory Authority (SAHPRA)
Adcock Ingram Limited
See ingredients
TABLET
EACH TABLET CONTAINS CAFFEINE 50 mg CODEINE PHOSPHATE 10 mg DOXYLAMINE SUCCINATE 5 mg PARACETAMOL 450 mg
Registered
1974-06-05
DATE OF APPROVAL: 30 NOVEMBER 2021 S2 PATIENT INFORMATION LEAFLET SCHEDULING STATUS: BETAPYN TABLETS EACH TABLET CONTAINS: Codeine phosphate 10 mg Doxylamine succinate 5 mg Paracetamol 450 mg Caffeine anhydrous 50 mg SUGAR FREE READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. BETAPYN is available without a doctor’s prescription, for you to treat a mild illness. Nevertheless, you still need to use BETAPYN carefully to get the best results from it. • Keep this leaflet. You may need to read it again. • Do not share BETAPYN 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. WHAT IS IN THIS LEAFLET: 1. What BETAPYN is and what it is used for 2. What you need to know before you take BETAPYN Sewela Ramaphakela Digitally signed by Sewela Ramaphakela Date: 2023.05.23 20:30:45 +02'00' DATE OF APPROVAL: 30 NOVEMBER 2021 3. How to take BETAPYN 4. Possible side effects 5. How to store BETAPYN 6. Contents of the pack and other information WHAT BETAPYN IS AND WHAT IT IS USED FOR BETAPYN 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, tension and/or fever. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BETAPYN TABLETS Do not take BETAPYN: • if you are hypersensitive (allergic) to any of the above listed ingredients of BETAPYN. • if you have respiratory depression (unusually struggling to breathe), especially in the presence of cyanosis (blueish discoloration of skin) and are coughing up phlegm. • if you suffer from alcoholism, head injuries and conditions in which intracranial (inside skull) pressure is raised. • if you or the person being treated is having an attack of bronchial asthma or in heart failure secondary to chronic lung disease. • if your liver function is severely impaired. • Caffeine should be given with c Διαβάστε το πλήρες έγγραφο
PROFESSIONAL INFORMATION SCHEDULING STATUS: 1. NAME OF THE MEDICINE BETAPYN TABLETS STRENGTH Codeine phosphate 10 mg Doxylamine succinate 5 mg Paracetamol 450 mg Caffeine anhydrous 50 mg PHARMACEUTICAL FORM Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each BETAPYN tablet contains: Codeine phosphate 10 mg Doxylamine succinate 5 mg Paracetamol 450 mg Caffeine anhydrous 50 mg SUGAR FREE For a full list of excipients see section 6.1 S2 Date of approval: 30 November 2021 Sewela Ramaphakela Digitally signed by Sewela Ramaphakela Date: 2023.05.09 10:56:54 +02'00' 3. PHARMACEUTICAL FORM Tablets Round, yellow, flat tablets, bisected on one side of 12,7 mm and embossed with “BETAPYN” on reverse side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic treatment of mild to moderate pain and/or fever. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adults and children over 12 years: 1 or 2 tablets taken orally, repeated 4-hourly if necessary. Do not exceed 8 tablets per day. DO NOT EXCEED THE RECOMMENDED DOSE. 4.3. CONTRAINDICATIONS: Sensitivity to paracetamol or any of the components. Severe liver function impairment. Caffeine should be given with care to patients with peptic ulceration. Safety of BETAPYN during pregnancy and lactation has not been established. Date of approval: 30 November 2021 BETAPYN is contraindicated in respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion. It is also contraindicated in the presence of 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. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients suffering from liver or kidney disease should take paracetamol under medical supervision. Dosages in excess of those recommended may cause severe liver damage. CODEINE should be given with caution to patients with hypothyroidism, adrenocortical in Διαβάστε το πλήρες έγγραφο