国家: 南非
语言: 英文
来源: South African Health Products Regulatory Authority (SAHPRA)
Johnson & Johnson (Pty) Ltd û East London
See ingredients
LIQUID
EACH 5 ml LIQUID CONTAINS AMMONIUM CHLORIDE 125 mg CODEINE PHOSPHATE 10 mg DIPHENHYDRAMINE HYDROCHLORIDE 12,5 mg
Registered
1995-05-12
Johnson & Johnson (Pty) Ltd EXPECTALIN WITH CODEINE Liquid 12,5 mg diphenhydramine hydrochloride 10,0 mg codeine phosphate 125,0 mg ammonium chloride DATE OF APPROVAL: 12.05.2022 Page 1 of 12 EXPECTALIN WITH CODEINE PATIENT INFORMATION LEAFLET SCHEDULING STATUS S2 EXPECTALIN WITH CODEINE LIQUID DIPHENHYDRAMINE HYDROCHLORIDE / CODEINE PHOSPHATE / AMMONIUM CHLORIDE CONTAINS SUGAR ALCOHOL: EACH 5 ML CONTAINS 2,5 G SORBITOL. CONTAINS SWEETENER: EACH 5 ML CONTAINS 1,5 MG SACCHARIN SODIUM AND 20 MG SODIUM CYCLAMATE. SUGAR FREE. READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. EXPECTALIN WITH CODEINE is available without a doctor’s prescription, for you to treat a mild illness. Nevertheless, you still need to use EXPECTALIN WITH CODEINE carefully to get the best results from it. • Keep this leaflet. You may need to read it again. • Do not share EXPECTALIN WITH CODEINE with any other person. • Ask your health care provider or pharmacist if you need more information or advice. • You must see your doctor if your symptoms worsen or do not improve after 3 days. WHAT IS IN THIS LEAFLET 1. What EXPECTALIN WITH CODEINE is and what it is used for. 2. What you need to know before you use EXPECTALIN WITH CODEINE. 3. How to use EXPECTALIN WITH CODEINE. Johnson & Johnson (Pty) Ltd EXPECTALIN WITH CODEINE Liquid 12,5 mg diphenhydramine hydrochloride 10,0 mg codeine phosphate 125,0 mg ammonium chloride DATE OF APPROVAL: 12.05.2022 Page 2 of 12 4. Possible side effects. 5. How to store EXPECTALIN WITH CODEINE. 6. Contents of the pack and other information. 1. WHAT EXPECTALIN WITH CODEINE IS AND WHAT IT IS USED FOR EXPECTALIN WITH CODEINE is a medicine which is used to help relieve coughing and related congestion symptoms in adults. The liquid contains diphenhydramine (an antihistamine) that helps relieve coughing and dry secretions in the nose and levomenthol which helps you breathe more easily by relieving congestion. It also contains ammonium chloride, an expectorant, that helps loosen m 阅读完整的文件
Johnson & Johnson (Pty) Ltd EXPECTALIN WITH CODEINE Liquid 12,5 mg diphenhydramine hydrochloride 10,0 mg codeine phosphate 125,0 mg ammonium chloride DATE OF APPROVAL: 12.05.2022 Page 1 of 20 PROFESSIONAL INFORMATION FOR EXPECTALIN WITH CODEINE SCHEDULING STATUS S2 1. NAME OF THE MEDICINE EXPECTALIN WITH CODEINE LIQUID 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mL contains: Diphenhydramine hydrochloride 12,5 mg Codeine phosphate 10,0 mg Ammonium chloride 125,0 mg _ _ _Excipients with known effect: _ Preservative: Sodium benzoate 0,5 % _m/v _ Contains sugar alcohol: Each 5 mL contains 2,5 g sorbitol. Contains sweetener: Each 5 mL contains 1,5 mg saccharin sodium and 20 mg sodium cyclamate. Sugar free. Alcohol free. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Liquid. A clear, light brown liquid with a raspberry odour and taste. Johnson & Johnson (Pty) Ltd EXPECTALIN WITH CODEINE Liquid 12,5 mg diphenhydramine hydrochloride 10,0 mg codeine phosphate 125,0 mg ammonium chloride DATE OF APPROVAL: 12.05.2022 Page 2 of 20 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS EXPECTALIN WITH CODEINE is indicated for the relief of cough. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION A maximum of four doses per day should not be exceeded. Shake the bottle before use. Adults 18 years and older: One to two 5 mL medicine measures every four hours. Use the lowest effective dose for the shortest duration. DO NOT USE FOR LONGER THAN 3 DAYS. 4.3 CONTRAINDICATIONS Known hypersensitivity to diphenhydramine hydrochloride, codeine phosphate, ammonium chloride or to any of the other ingredients in EXPECTALIN WITH CODEINE (see section 6.1). Neither diphenhydramine hydrochloride nor codeine phosphate should be used with monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping treatment with monoamine oxidase inhibitor (see section 4.5). Contraindicated during acute asthmatic attacks, in the presence of acute alcoholism, head injuries and raised intracranial pressure, and in patients with impaired 阅读完整的文件