País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
sitagliptin phosphate monohydrate, Quantity: 128.5 mg (Equivalent: sitagliptin, Qty 100 mg)
Merck Sharp & Dohme (Australia) Pty Ltd
sitagliptin phosphate monohydrate
Tablet, film coated
Excipient Ingredients: calcium hydrogen phosphate; magnesium stearate; croscarmellose sodium; microcrystalline cellulose; sodium stearylfumarate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350
Oral
7 tablets (starter pack), 28 tablets
(S4) Prescription Only Medicine
XELEVIA (sitagliptin phosphate monohydrate) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as: - monotherapy when metformin is considered inappropriate due to intolerance; or - in combination with other anti-hyperglycaemic agents, including insulin,(see 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials, 4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS for available data on different add-on combination therapies.
Visual Identification: Beige, round, biconvex, film coated tablet with "277" on one side and plain on the other.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2014-11-19
XELEVIA ® X E L E V I A ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I TAKING XELEVIA? XELEVIA contains the active ingredient sitagliptin (as phosphate monohydrate). XELEVIA is used to lower blood sugar levels in adults with type 2 diabetes mellitus. For more information, see Section 1. Why am I taking XELEVIA? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I TAKE XELEVIA? Do not use if you have ever had an allergic reaction to XELEVIA 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 XELEVIA? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with XELEVIA and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I TAKE XELEVIA? • Take XELEVIA once a day by mouth, with or without food More instructions can be found in Section 4. How do I take XELEVIA? in the full CMI. 5. WHAT SHOULD I KNOW WHILE TAKING XELEVIA? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are taking XELEVIA. • Call your doctor straight away if you become pregnant while taking XELEVIA. THINGS YOU SHOULD NOT DO • Do not stop taking this medicine suddenly. • Do not give XELEVIA to anyone else, even if they have the same condition as you. LOOKING AFTER YOUR MEDICINE • Keep your tablets in the blister pack until it is time to take them. • Store XELEVIA in a cool dry place away from moisture, heat or sunlight. For more information, see Section 5. What should I know while taking XELEVIA? in the full CMI. 6. ARE THERE ANY SIDE EFFECTS? Serious side effects in particular that need to be noted are: • Allergic reactions including ras Leia o documento completo
1 AUSTRALIAN PRODUCT INFORMATION – XELEVIA ® (SITAGLIPTIN PHOSPHATE MONOHYDRATE) 1 NAME OF THE MEDICINE sitagliptin phosphate monohydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION XELEVIA is available for oral use as film coated tablets containing sitagliptin phosphate monohydrate equivalent to 25, 50 or 100 mg of free base. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM XELEVIA 25 mg - a pink, round, film coated tablet with ”221” on one side and plain on the other. XELEVIA 50 mg - a light beige, round, film coated tablet with ”112” on one side and plain on the other. XELEVIA 100 mg - a beige, round, film coated tablet with ”277” on one side and plain on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS XELEVIA (sitagliptin phosphate monohydrate) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as: - monotherapy when metformin is considered inappropriate due to intolerance; or - in combination with other anti-hyperglycaemic agents, including insulin [see 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials, 4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS for available data on different add-on combination therapies]. 4.2 DOSE AND METHOD OF ADMINISTRATION The recommended dose of XELEVIA is 100 mg once daily as monotherapy, or as combination therapy with metformin, or a sulfonylurea (clinical experience is with glimepiride as dual therapy), insulin (with or without metformin), a thiazolidinedione (clinical experience is with pioglitazone as dual therapy), or combination therapy with metformin and a sulfonylurea (clinical experience is with addition of sitagliptin to glimepiride or gliclazide and metformin as triple therapy). XELEVIA can be taken with or without food. When XELEVIA is used in combination with a sulfonylurea or with insulin, reduction in the dose of sulfonylurea or insulin may be considered to reduce the risk of sulfonylurea- or insulin-induced hyp Leia o documento completo