Страна: Мальта
Язык: английский
Источник: Medicines Authority
CITRIC ACID, SODIUM CARBONATE, ANHYDROUS, SODIUM CITRATE, DIHYDRATE, SODIUM HYDROGEN
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
G04B
CITRIC ACID 1063 mg SODIUM CARBONATE ANHYDROUS 130 mg SODIUM CITRATE DIHYDRATE 2819 mg SODIUM HYDROGEN CARBONATE 1200 mg
GRANULES FOR ORAL SOLUTION
CITRIC ACID 1063 mg SODIUM CARBONATE ANHYDROUS 130 mg SODIUM CITRATE DIHYDRATE 2819 mg SODIUM HYDROGEN CARBONATE 1200 mg
OTC
UROLOGICALS
Withdrawn
2006-11-02
PACKAGE LEAFLET: INFORMATION FOR THE USER IMPORTANT INFORMATION ABOUT CYMALON LEMON FLAVOUR GRANULES FOR ORAL SOLUTION • This medicine is used to relieve the symptoms of cystitis. • It can be taken by adult females only. • Dissolve the granules in water before swallowing. DO NOT TAKE • If you are a man or child. • If you are pregnant. See section 2. TALK TO YOUR DOCTOR • If you still have symptoms after 4 days or if you get frequent symptoms. See section 2. NOW READ THE REST OF THE LEAFLET BEFORE YOU USE THIS MEDICINE. IT INCLUDES OTHER INFORMATION WHICH MIGHT BE ESPECIALLY IMPORTANT FOR YOU. • Keep this leaflet. Your may need to read it again. • Ask your pharmacist if you need any more information or advice. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 1. What the medicine is for Cymalon Lemon flavour sachets contain granules to dissolve in water. They treat the symptoms of cystitis in women. Cystitis is an inflammation of the bladder which may be caused by an infection. This causes stinging and burning pain when you pass water. The ingredients in Cymalon Lemon make the urine lass acid and help reduce the stinging and burning sensation. 2. Before you use this medicine Do not use the medicine if you have • An ALLERGY to citric acid (anhydrous), sodium citrate, sodium carbonate, sodium bicarbonate or any of the ingredients listed in section 6. • HEART DISEASE. • HIGH BLOOD PRESSURE. • KIDNEY PROBLEMS. • A SALT RESTRICTION in your diet. • Or are PREGNANT. • MEN and CHILDREN should not use this medicine. Cystitis is much less common in men and children. Прочитать полный документ
Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cymalon Lemon flavour Granules for Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of 6.76g of granules contain the following actives: Citric Acid (anhydrous) EP 1063.00mg Sodium Citrate dihydrate EP 2819.00mg Sodium Carbonate EP 130.00mg Sodium Bicarbonate EP 1200.00mg 3 PHARMACEUTICAL FORM Granules for solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cymalon Lemon flavour Granules for Oral Solution is indicated for the relief of symptoms due to cystitis in adult females only. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Oral Adults One sachet to be taken in water, three times a day over 48 hours. Children Cymalon Lemon flavour Granules for Oral Solution is not recommended for children. 4.3 CONTRAINDICATIONS Cymalon Lemon flavour Granules for Oral Solution should not be taken in cases of pregnancy, heart disease, high blood pressure, any form of kidney disease or whenever a restricted salt intake is indicated. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients should be advised against repeated use. If symptoms persist 48 hours after treatment is completed you are advised to consult your doctor. Do not exceed the stated dose. Keep out of the reach of children. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Sodium containing preparations should be avoided by patients on lithium because sodium is preferentially absorbed by the kidney resulting in increased lithium excretion and reduced plasma levels. Page Прочитать полный документ