Maa: Etelä-Afrikka
Kieli: englanti
Lähde: South African Health Products Regulatory Authority (SAHPRA)
Cipla Medpro (Pty) Ltd
See ingredients
GRANULES
EACH 4,0 g GRANULES CONTAINS CITRIC ACID 0,702 g SODIUM BICARBONATE 1,716 g SODIUM CITRATE 0,613 g TARTARIC ACID 0,858 g
Registered
2018-06-09
PATIENT INFORMATION LEAFLET FOR CITROGRAN SCHEDULING STATUS CITROGRAN (EFFERVESCENT GRANULES) EACH (4 G) CONTAINS: SODIUM CITRATE 0,613 G SODIUM BICARBONATE 1,716 G CITRIC ACID ANHYDROUS 0,702 G TARTARIC ACID 0,858 G CONTAINS SUGAR (LIQUID GLUCOSE) 0,252 ML READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU CITROGRAN is available without a doctor’s prescription, for you to treat a mild illness. Nevertheless, you still need to use CITROGRAN carefully to get the best results from it. • Keep this leaflet. You may need to read it again. • Do not share CITROGRAN with any other person. • 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 after 5 days. WHAT IS IN THIS LEAFLET 1. What CITROGRAN is and what it is used for 2. What you need to know before you take CITROGRAN S0 3. How to take CITROGRAN 4. Possible side effects 5. How to store CITROGRAN 6. Contents of the pack and other information. 1. WHAT CITROGRAN IS AND WHAT IT IS USED FOR CITROGRAN belongs to a group of medicines acting on the genito-urinary system. CITROGRAN is used to relieve gastric acidity as well as for its urinary alkalinising properties. CITROGRAN can be used to relieve symptoms of inflammation of the bladder, including prevention of crystals forming in the urine due to the use of sulphonamides. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CITROGRAN Do not take CITROGRAN: • if you are hypersensitive (allergic) to sodium citrate, sodium bicarbonate, citric acid anhydrous and tartaric acid or any of the other ingredients of CITROGRAN (listed in SECTION 6). • if you have severe kidney problems. Please discuss this with your doctor. • If you have metabolic disturbances with alkalosis (rise in the level of alkali in blood resulting in feeling of weakness or cramp, hypocalcaemia (deficiency of calcium in the bloodstream) or hypochlorhydria (an abnormally low level of hydrochloric acid in the stomach). • If yo Lue koko asiakirja
PROFESSIONAL INFORMATION FOR CITROGRAN SCHEDULING STATUS 1. NAME OF THE MEDICINE CITROGRAN (Effervescent granules) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each medicine measures (4 g) contains: Sodium citrate 0,613 g Sodium bicarbonate 1,716 g Citric acid anhydrous 0,702 g Tartaric acid 0,858 g Contains sugar (liquid glucose) 0,252 mL For the full list of excipients, see SECTION 6.1. 3. PHARMACEUTICAL FORM Effervescent granules. White to straw coloured granules with a lemon odour and a sweet/ sour slightly lemon taste. After reconstitution with water a clear to straw coloured solution with a slight lemon odour is obtained. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS S0 CITROGRAN is indicated as a gastric antacid and urinary alkalinising agent. As a urinary alkaliniser, CITROGRAN can be used to alleviate symptoms associated with inflammatory conditions of the bladder. CITROGRAN can be used to prevent crystalluria during sulphonamide treatment. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY ADULTS: One to two 5 mL medicine measures (4 to 8 g) in half a glass of cold water, 3 to 4 times daily, taken on an empty stomach and followed with additional water. Drink after effervescence (see SECTION 4.8). Long-term therapy: One 5 mL (4 g) medicine measure daily. PAEDIATRIC POPULATION CHILDREN (6 - 12 YEARS): One 5 mL medicine measure (4 g) in half a glass of cold water, 2 or 3 times daily, taken on an empty stomach and followed with additional water. Drink after effervescence (see SECTION 4.8). METHOD OF ADMINISTRATION Take on an empty stomach, followed with additional water. Drink after effervescence. 4.3 CONTRAINDICATIONS CITROGRAN is contraindicated in: • Patients with known hypersensitivity to sodium bicarbonate, citric acid, sodium citrate, tartaric acid or to any of the excipients used in the formulation of CITROGRAN (see SECTION 6.1). • In patients with severe renal disease and metabolic disturbances with alkalosis, hypocalcaemia or hypochlorhydria. • When co-administered with urinary tract ant Lue koko asiakirja