Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
mesalazine, Quantity: 500 mg
Ferring Pharmaceuticals Pty Ltd
Tablet, modified release
Excipient Ingredients: purified talc; ethylcellulose; povidone; microcrystalline cellulose; magnesium stearate
Oral
100 tablets, 30 tablets
(S4) Prescription Only Medicine
Treatment of mild to moderate ulcerative Colitis and Crohn's Disease and maintenance of remission.
Visual Identification: White-grey to pale brown, specked round tablets. Breakmark and embossing: 500mg on one side, PENTASA on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2007-01-02
PENTASA ® (TABLETS) P E N T A S A ® ( t a b l e t s ) CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about taking this medicine, speak to your doctor or pharmacist. 1. WHY AM I TAKING PENTASA? PENTASA contains the active ingredient mesalazine. PENTASA is taken to treat Crohn's disease and ulcerative colitis, diseases associated with inflammation, ulcers and sores in the bowel causing bleeding, stomach pain, and diarrhoea. For more information, see Section 1. Why am I taking PENTASA? in the full CMI, starting from page 2. 2. WHAT SHOULD I KNOW BEFORE I TAKE PENTASA? Do not take if you have ever had an allergic reaction to PENTASA or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I take PENTASA? in the full CMI, starting from page 2. 3. WHAT IF I AM TAKING OTHER MEDICINES? Care may be needed when taking PENTASA with some other medicines. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI, starting from page 2. 4. HOW DO I TAKE PENTASA? • Swallow the tablets whole without chewing or crushing. You can also place the tablets in 50mL of cold water, stir rapidly and drink immediately • Do not cut, crush or chew the tablets. More instructions can be found in Section 4. How do I take PENTASA? in the full CMI, starting from page 2. 5. WHAT SHOULD I KNOW WHILE TAKING PENTASA? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are taking PENTASA • Have all blood tests recommended by your doctor • If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine • IF YOU BECOME PREGNANT WHILE TAKING THIS MEDICINE, TELL YOUR DOCTOR IMMEDIATELY. THINGS YOU SHOULD NOT DO • Do not stop taking this medicine or lower the dosa read_full_document
PRODUCT INFORMATION Page 1 of 15 #10223-V33A AUSTRALIAN PRODUCT INFORMATION – PENTASA ® (MESALAZINE) PROLONGED RELEASE TABLETS AND GRANULES 1 NAME OF THE MEDICINE Mesalazine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION PENTASA prolonged release tablets contain either 0.5 g or 1 g mesalazine as the active ingredient, and the following inactive excipients: magnesium stearate, purified talc, povidone, ethylcellulose, microcrystalline cellulose. PENTASA prolonged release granules in sachets contain either 1 g, 2 g or 4 g mesalazine as the active ingredient, and the following inactive excipients: ethylcellulose, povidone. 3 PHARMACEUTICAL FORM PENTASA 0.5 g prolonged release tablets are presented as white grey to pale brown, speckled round tablets with break mark and embossing: 500 mg on one side, PENTASA on the other side. PENTASA 1 g prolonged release tablets are presented as white-grey to pale brown, speckled, oval tablets. Embossing on both sides: PENTASA. PENTASA 1 g, 2 g, and 4 g prolonged release granules are presented as cylindrical shaped granules that are white-grey to pale white brown in colour. 4 CLINICAL PARTICULARS T HERAPEUTIC INDICATIONS Treatment of mild to moderate ulcerative colitis and Crohn’s disease and maintenance of remission. PRODUCT INFORMATION Page 2 of 15 #10223-V33A D OSE AND METHOD OF ADMINISTRATION ULCERATIVE COLITIS _Treatment of active disease: _ Adults:_ _ Individual dosage, up to 4 g given once daily or in divided doses _ _ _Maintenance treatment: _ Adults:_ _ 2 g once daily OR individual dosage, starting with 1.5-2 g daily in divided doses CROHN’S DISEASE _Treatment of active disease: _ Adults: Individual dosage, up to 4 g daily in divided doses _Maintenance treatment: _ Adults: Individual dosage, up to 4 g daily in divided doses The contents of the sachet should be emptied onto the tongue and washed down with some water or juice. To facilitate swallowing, the tablets may be dispersed in 50 mL of cold water. Stir and drink immediately. Do not crush or chew the tablets or granul read_full_document