দেশ: দক্ষিণ আফ্রিকা
ভাষা: ইংরেজি
সূত্র: South African Health Products Regulatory Authority (SAHPRA)
Equity Pharmaceutical (Pty) Ltd
See ingredients
SUPPOSITORY
EACH SUPPOSITORY CONTAINS MESALAZINE 500 mg
Registered
1998-04-06
Page 1 of 10 PATIENT INFORMATION LEAFLET SCHEDULING STATUS: S3 ASACOL SUPPOSITORIES, 500 MG, SUPPOSITORIES MESALAZINE (5-AMINOSALICYLIC ACID) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING ASACOL SUPPOSITORIES - Keep this leaflet. You may need to read it again. - If you have further questions, please ask your doctor, pharmacist, nurse or other healthcare provider. - ASACOL SUPPOSITORIES 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 SUPPOSITORIES is and what it is used for 2. What you need to know before you use ASACOL SUPPOSITORIES 3. How to use ASACOL SUPPOSITORIES 4. Possible side effects 5. How to store ASACOL SUPPOSITORIES 6. Contents of the pack and other information 1. WHAT ASACOL SUPPOSITORIES IS AND WHAT IT IS USED FOR ASACOL SUPPOSITORIES contains mesalazine, which is an anti-inflammatory medicine used for: • The treatment and maintenance of remission in ulcerative colitis. • Treatment of mild to moderate proctitis and proctosigmoiditis. 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 SUPPOSITORIES act locally in the rectum to reduce this inflammation. They can also be used to prevent further episodes of ulcerative Page 2 of 10 colitis. ASACOL SUPPOSITORIES are particularly useful when the symptoms of ulcerative colitis affect the rectum. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ASACOL SUPPOSITORIES DO NOT USE ASACOL SUPPOSITORIES: • If you are hypersensitive (allergic) to mesalazine or to the other ingredient of ASACOL SUPPOSITORIES (listed in 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. • If you have bleeding tendencies. • I সম্পূর্ণ নথি পড়ুন
Page 1 of 13 SCHEDULING STATUS 1. NAME OF THE MEDICINE ASACOL SUPPOSITORIES, (500 mg) Suppositories 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per suppository: Mesalazine (5-aminosalicylic acid) 500 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suppositories An opaque, pale beige, torpedo-shaped suppository with a faint fatty odour. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ASACOL SUPPOSITORIES is used for the treatment and maintenance of remission in ulcerative colitis. The suppositories are used for the treatment of mild to moderate proctitis and proctosigmoiditis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adult dose: _ In proctitis and proctosigmoiditis one suppository to be inserted rectally up to three times daily, after defaecation. The dosage is dependent upon the severity of the disease and it may be possible to reduce the dosage as the condition improves. S3 Page 2 of 13 4.3 CONTRAINDICATIONS Hypersensitivity to mesalazine or to any other excipients, see section 6.1. History of allergy to salicylates. Severe liver impairment. Patients with impaired renal function (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. Bleeding tendencies. History of mesalazine-induced cardiac hypersensitivity. Salicylate sensitive asthma. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Blood tests (differential blood count, liver function parameters such as ALT or AST; serum creatinine) and urinary status (dip sticks) should be determined prior to and during treatment, at the discretion of the treating medical practitioner. As a guideline, follow-up tests are recommended 14 days after commencement of treatment and then every 4 weeks for the following 12 weeks. If the findings are normal, follow-up tests should be carried out every three months. If additional signs appear, these tests should be performed immediately. _ _ _Renal impairment _ ASACOL SUPPOSITORIES should not be used in patie সম্পূর্ণ নথি পড়ুন