Riik: Lõuna-Aafrika Vabariik
keel: inglise
Allikas: South African Health Products Regulatory Authority (SAHPRA)
Equity Pharmaceutical (Pty) Ltd
See ingredients
ENEMA
EACH 50,0 ml SUSPENSION CONTAINS MESALAZINE 2,0 g
Registered
1998-03-06
Page 1 of 9 PATIENT INFORMATION LEAFLET SCHEDULING STATUS: ASACOL ENEMA, 2 G/50 ML, RECTAL SUSPENSION . MESALAZINE (5-AMINOSALICYLIC ACID). ANTIOXIDANT: SODIUM METABISULPHITE 0,05 G READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING ASACOL ENEMA • Keep this leaflet. You may need to read it again. • If you have any further questions, please ask your doctor, pharmacist, nurse or other healthcare provider. • ASACOL ENEMA has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. WHAT IS IN THIS LEAFLET 1. What ASACOL ENEMA is and what it is used for 2. What you need to know before you use ASACOL ENEMA 3. How to use ASACOL ENEMA 4. Possible side effects 5. How to store ASACOL ENEMA 6. Contents of the pack and other information 1. WHAT ASACOL ENEMA IS AND WHAT IT IS USED FOR ASACOL ENEMA contains mesalazine, which is an anti-inflammatory medicine used for: The treatment and maintenance of remission in ulcerative colitis. Ulcerative colitis is a disease of the large bowel (colon) and back passage (rectum), in which the lining of the bowel becomes inflamed (red and swollen). ASACOL ENEMA act locally in the rectum to reduce this inflammation. ASACOL ENEMA can also be used to prevent further episodes of ulcerative colitis. S3 Page 2 of 9 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ASACOL ENEMA DO NOT USE ASACOL ENEMA: • If you are hypersensitive (allergic) to mesalazine or to the other ingredients of ASACOL ENEMA (see section 6). • If you are hypersensitive (allergic) to aspirin or other salicylates. • If you have had serious kidney or liver problems. • If you are pregnant or breastfeeding your infant. • This medicine should not be used by children. WARNINGS AND PRECAUTIONS Take special care with ASACOL ENEMA: When you start using ASACOL ENEMA and during treatment with ASACOL ENEMA, your doctor may consider regular examinations to check that your blood, liver, kidneys and lungs are functioning normal. I Lugege kogu dokumenti
Page 1 of 11 SCHEDULING STATUS S3 1. NAME OF THE MEDICINE ASACOL ENEMA (2 g, rectal suspension) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per 50 ml enema: Mesalazine (5-aminosalicylic acid) 2 g Antioxidant: Sodium metabisulphite 0,05 g Preservative: Sodium benzoate 0,1 % m/v For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Rectal suspension. Brownish suspension with a characteristic odour. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ASACOL ENEMA is used for the treatment and maintenance of remission in ulcerative colitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adult dose: Two gram administered at night per rectum. METHOD OF ADMINISTRATION Rectal use. _Before using the enema_ : The bottle should be warmed to body temperature in a basin or bowl of warm water for about 10 minutes. The bottle should be shaken well immediately before inserting the enema. _Inserting the enema:_ The screw cap must be twisted off from the bottle and the applicator tip must be twisted on. The applicator tip can be lubricated with vaseline. For the enema administration the patient should lie on the left side Page 2 of 11 with the left leg extended and the right leg bent. After inserting the applicator tip into the rectum the liquid should be pressed out gently and slowly. The tip should be withdrawn with the container still compressed. The patients should try to stay in the administration position for 5 to 10 minutes or until the urge to pass the enema has disappeared. The enema should be retained in the bowel if possible without evacuation of the bowels until the next morning. 4.3 CONTRAINDICATIONS Hypersensitivity to mesalazine or to any of the excipients (see section 6.1). History of allergy to salicylates. Severe liver impairment. Severe renal impairment (GFR less than 30 ml per minute). Safety in pregnancy and lactation has not been established. Safety and efficacy have not been established in children. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Blood tests (differential blood count, liver f Lugege kogu dokumenti