Negara: Afrika Selatan
Bahasa: Inggris
Sumber: South African Health Products Regulatory Authority (SAHPRA)
Pharmacorp (Pty) Ltd
See ingredients
SYRUP
EACH 5 ml SYRUP CONTAINS PARACETAMOL 120 mg
Registered
1990-06-11
GO-PAIN P, paracetamol 120 mg per 5 ml syrup Approved Patient Information Leaflet 04 March 2023 Page 1 of 9 SCHEDULING STATUS S0 GO-PAIN P 120 MG/5 ML, SYRUP PARACETAMOL CONTAINS SUGARS AS SUCROSE 1,565 G/5 ML LIQUID GLUCOSE 2,0 G/5 ML CONTAINS SWEETENERS AS SODIUM CYCLAMATE 15 MG/5 ML SACCHARIN SODIUM 5 MG/5 ML READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. GO-PAIN P is available without a doctor’s prescription, for your child treat a mild illness. Nevertheless, you still need to use GO-PAIN P carefully to get the best results from it. • Keep this leaflet. You may need to read it again. • Do not share GO-PAIN P with any other person. • Ask your healthcare provider or pharmacist if you need more information or advice. • You must see a doctor if your symptoms worsen or do not improve after 5 days for pain and for fever 3 days. WHAT IS IN THIS LEAFLET 1 What GO-PAIN P is and what it is used for 2. What you need to know before you give GO-PAIN P 3. How to give GO-PAIN P 4. Possible side effects 5. How to store GO-PAIN P 6. Contents of the pack and other information GO-PAIN P, paracetamol 120 mg per 5 ml syrup Approved Patient Information Leaflet 04 March 2023 Page 2 of 9 1. WHAT GO-PAIN P IS AND WHAT IT IS USED FOR GO-PAIN P contains paracetamol. Paracetamol acts as an analgesic (to relieve pain) and as an antipyretic (to reduces fever). GO-PAIN P can be used in children (3 months to 12 years of age) for the treatment of mild or moderate pain and feverishness. 2. WHAT YOU NEED TO KNOW BEFORE YOU GIVE GO-PAIN P DO NOT GIVE GO-PAIN P • If your child is hypersensitive (allergic) to paracetamol or any of the other ingredients of GO- PAIN P (listed in section 6). • If your child has serious problems with his/her liver. WARNINGS AND PRECAUTIONS GO-PAIN P contains paracetamol which may be fatal in overdose. In the event of over dosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or Poison Centre must Baca dokumen lengkapnya
GO-PAIN P, paracetamol 120 mg per 5 ml Approved Professional Information 04 March 2023 Page 1 of 14 SCHEDULING STATUS S0 1. NAME OF THE MEDICINE GO-PAIN P 120 mg/5 mL Syrup 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mL syrup contains: Paracetamol 120 mg Methyl hydroxybenzoate (Preservative) 0,12 % _m/v_ Propyl hydroxybenzoate (Preservative) 0,02 % _m/v_ Ethanol 96 % _v/v_ 10,56 % _v/v_ ethanol Contains sugar as Sucrose 1,565 g/5 mL Liquid glucose 2,0 g/5 mL Contains sweetener as Sodium cyclamate 15 mg/5 mL Saccharin sodium 5 mg/5 mL GO-PAIN P syrup contains TARTRAZINE. For full list of excipients, see section 6.1. GO-PAIN P, paracetamol 120 mg per 5 ml Approved Professional Information 04 March 2023 Page 2 of 14 3. PHARMACEUTICAL FORM Syrup A green syrup 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS GO-PAIN P is indicated for the symptomatic treatment of mild to moderate pain and fever. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION DO NOT EXCEED THE RECOMMENDED DOSE. Infants 3 to 12 months: 2,5 mL every six to eight hours Children 1 to 6 years: 5 mL to 10 mL every six to eight hours Children 7 to 12 years: 10 mL to 20 mL every six to eight hours While symptoms persist, to be repeated every 4 hours if needed to a maximum of 4 doses per 24 hours for not longer than 5 days. METHOD OF ADMINISTRATION Dose to be taken orally. 4.3 CONTRAINDICATIONS • Hypersensitivity to paracetamol or to any of the excipients listed in section 6.1 • Severe liver function impairment. GO-PAIN P, paracetamol 120 mg per 5 ml Approved Professional Information 04 March 2023 Page 3 of 14 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE GO-PAIN P contains paracetamol which may be fatal in overdose. In the event of over dosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or Poison Centre must be contacted immediately. • Dosages of GO-PAIN P in excess of those recommended may cause severe liver damage. • Consult a medical practitioner if pain or fever persists o Baca dokumen lengkapnya