البلد: جنوب أفريقيا
اللغة: الإنجليزية
المصدر: South African Health Products Regulatory Authority (SAHPRA)
Cipla Medpro (Pty) Ltd
See ingredients
SYRUP
EACH 5 ml SYRUP CONTAINS INVERT SUGAR 3 g
Registered
1990-12-07
Page 1 of 6 PATIENT INFORMATION LEAFLET EMEX SCHEDULING STATUS EMEX 3,0 G/5 ML SYRUP INVERT SUGAR 3,0 G/5 ML CONTAINS SUGAR: INVERT SUGAR (DEXTROSE AND FRUCTOSE) 3,0 G/5 ML READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU EMEX is available without a doctor’s prescription, for you to treat a mild illness. Nevertheless, you still need to use EMEX carefully to get the best results from it. • K eep this leaflet. You may need to read it again. • Do not share EMEX 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 one hour (five doses). WHAT IS IN THIS LEAFLET 1. What EMEX is and what it is used for 2. What you need to know before you take EMEX 3. How to take EMEX 4. Possible side effects 5. How to store EMEX 6. Contents of the pack and other information. 1. WHAT EMEX IS AND WHAT IT IS USED FOR EMEX belongs to a group of medicines called anti-emetics (medicines used to treat S0 Page 2 of 6 nausea) and anti-vertigo (medicines used to treat dizziness) preparations. EMEX is use for the symptomatic relief of nausea in motion sickness and for nausea in early pregnancy. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EMEX DO NOT TAKE EMEX : • If you are hypersensitive (allergic) to invert sugar or any of the other ingredients of EMEX (listed in SECTION 6) • If you are suffering from methyl alcohol poisoning • If you have renal failure • If you have diabetes • If you have hereditary fructose intolerance. WARNINGS AND PRECAUTIONS Special care should be taken with EMEX: • If you are still nauseous after taking five doses of EMEX. If nausea continues or recurs frequently, consult a physician promptly since this may be a sign of a serious condition. • Fluids must not be taken immediately prior to or for at least fifteen (15) minutes after a dose of EMEX because of the diluting effects • In children less than 3 years of age, the use of EMEX is not re اقرأ الوثيقة كاملة
Page 1 of 4 PROFESSIONAL INFORMATION EMEX SCHEDULING STATUS 1 NAME OF THE MEDICINE EMEX (3,0 g/5 mL syrup) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mL syrup contains invert sugar 3,0 g. Contains sugar: Invert sugar (dextrose and fructose) 3,0 g Contains preservative: Methylparaben 0,1 % _m/v _ For the full list of excipients, see SECTION 6.1 3 PHARMACEUTICAL FORM A colourless to slightly opalescent spearmint flavoured syrup. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS EMEX is indicated for the symptomatic relief of nausea in motion sickness and in early pregnancy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _MOTION SICKNESS (CAR, AIR, ETC.): _ Adults: Three to six (15 to 30 mL) medicine measures. Dose may be repeated every fifteen minutes until distress subsides but should not be taken for more than one hour (five doses) without consulting a doctor. Children over 3 years of age: One to two (5 to 10 mL) medicine measures. Dose may be repeated every fifteen minutes until distress subsides but should not be taken for more than one hour (five doses) without consulting a doctor. S0 Page 2 of 4 _MORNING SICKNESS: _ Three to six (15 to 30 mL) medicine measures. Dose should be taken on arising and repeated every three hours as needed. PAEDIATRIC POPULATION Children under 3 years of age: Use is not recommended. METHOD OF ADMINISTRATION Do not dilute the dosage since the optimal pH for functioning will be destroyed. Oral fluids should not be taken immediately before or for at least 15 minutes after the dose. 4.3 CONTRAINDICATIONS EMEX should not be used in: • Patients suffering from methyl alcohol poisoning • Renal failure • Diabetes • Hereditary fructose intolerance. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE EMEX syrup must not be taken for more than 1 hour (5 doses) without consulting a doctor. If nausea continues or recurs frequently, consult a physician promptly since this may be a sign of a serious condition. Fluids must not be taken immediately prior to or for at least 15 minutes aft اقرأ الوثيقة كاملة