국가: 남아프리카
언어: 영어
출처: South African Health Products Regulatory Authority (SAHPRA)
Johnson & Johnson (Pty) Ltd û East London
See ingredients
TABLET
EACH TABLET CONTAINS DIPHENHYDRAMINE HYDROCHLORIDE 12,5 mg PARACETAMOL 500,O mg PSEUDOEPHEDRINE HYDROCHLORIDE 22,5 mg
Registered
2005-05-09
Johnson & Johnson (Pty) Ltd BENYLIN FOUR FLU TABLETS Film-coated tablet Each tablet contains: 12,5 mg Diphenhydramine HCL 22,5 mg Pseudoephedrine HCL 500,0 mg Paracetamol DATE OF APPROVAL: 1 MARCH 2022 Page 1 of 11 PROPOSED PATIENT INFORMATION LEAFLET FOR BENYLIN FOUR FLU TABLETS PATIENT INFORMATION LEAFLET SCHEDULING STATUS S2 BENYLIN FOUR FLU TABLETS DIPHENHYDRAMINE HYDROCHLORIDE / PSEUDOEPHEDRINE HYDROCHLORIDE / PARACETAMOL SUGAR FREE. READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • BENYLIN FOUR FLU TABLETS is available without a doctor’s prescription, for you to treat a mild illness. Nevertheless, you still need to give BENYLIN FOUR FLU TABLETS carefully to get the best results from it. • Do not share BENYLIN FOUR FLU TABLETS with any other person. • Keep this leaflet. You may need to read it again. • 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 BENYLIN FOUR FLU TABLETS is and what it is used for. 2. What you need to know before you take BENYLIN FOUR FLU TABLETS. 3. How to take BENYLIN FOUR FLU TABLETS. 4. Possible side effects. 5. How to store BENYLIN FOUR FLU TABLETS. 6. Contents of the pack and other information. Johnson & Johnson (Pty) Ltd BENYLIN FOUR FLU TABLETS Film-coated tablet Each tablet contains: 12,5 mg Diphenhydramine HCL 22,5 mg Pseudoephedrine HCL 500,0 mg Paracetamol DATE OF APPROVAL: 1 MARCH 2022 Page 2 of 11 1. WHAT BENYLIN FOUR FLU TABLETS IS AND WHAT IT IS USED FOR BENYLIN FOUR FLU TABLETS contains an analgesic (paracetamol), an antihistamine (diphenhydramine) and a decongestant (pseudoephedrine). It belongs to a class of medicines which is used to relieve the symptoms of colds and flu. BENYLIN FOUR FLU TABLETS is used to help relieve cough, congestion, fever and body pains. Paracetamol is an analgesic and an antipyretic which acts to relieve pain and fever (high temperature). Diphenhydramine is an ant 전체 문서 읽기
Johnson & Johnson (Pty) Ltd BENYLIN FOUR FLU TABLETS Film-coated tablets Each film-coated tablet contains: 12,5 mg Diphenhydramine HCL 22,5 mg Pseudoephedrine HCL 500,0 mg Paracetamol DATE OF APPROVAL: 1 March 2022 Page 1 of 21 PROFESSIONAL INFORMATION FOR BENYLIN FOUR FLU TABLETS SCHEDULING STATUS S2 1. NAME OF THE MEDICINE BENYLIN FOUR FLU TABLETS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains: Diphenhydramine hydrochloride 12,5 mg Pseudoephedrine hydrochloride 22,5 mg Paracetamol 500,0 mg _ _ _Excipients with known effect: _ Contains Sunset Yellow FCF (E110). Sugar free. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. Orange, oval, biconvex film-coated tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Johnson & Johnson (Pty) Ltd BENYLIN FOUR FLU TABLETS Film-coated tablets Each film-coated tablet contains: 12,5 mg Diphenhydramine HCL 22,5 mg Pseudoephedrine HCL 500,0 mg Paracetamol DATE OF APPROVAL: 1 March 2022 Page 2 of 21 For the relief of symptoms associated with colds and flu; including coughing, fever, headache, minor aches and pains and nasal congestion. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults, the elderly and children 12 years and older: Two tablets four times daily. Do not exceed 8 tablets in 24 hours. Children aged 6 to less than 12 years: One tablet four times daily. Do not exceed 4 tablets in 24 hours. Children under 6 years: Not recommended. For oral use only. _ _ HEPATIC DYSFUNCTION Caution should be exercised when administrating BENYLIN FOUR FLU TABLETS to patients with severe hepatic impairment. RENAL DYSFUNCTION Caution should be exercised when administering BENYLIN FOUR FLU TABLETS to patients with moderate to severe renal impairment. _ _ 4.3 CONTRAINDICATIONS • Hypersensitivity to diphenhydramine hydrochloride, pseudoephedrine hydrochloride, paracetamol or to any of the other ingredients in BENYLIN FOUR FLU TABLETS (see section 6.1) • Most types of cardiovascular disease, including angina and h 전체 문서 읽기