País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
sitagliptin hydrochloride monohydrate, Quantity: 113.373 mg (Equivalent: sitagliptin, Qty 100 mg)
Lupin Australia Pty Limited
Tablet, film coated
Excipient Ingredients: magnesium stearate; croscarmellose sodium; calcium hydrogen phosphate; hyprolose; microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350
Oral
28's
(S4) Prescription Only Medicine
Sitagliptin Lupin 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 antihyperglycaemic agents, including insulin.,(See Section 5.1 Pharmacodynamic Properties - Clinical Trials and Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for available data on different add-on combination therapies.)
Visual Identification: Beige colored, round shaped, biconvex, film-coated tablet debossed STG on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2020-05-21
Sitagliptin Lupin v2 1 SITAGLIPTIN LUPIN 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 USING SITAGLIPTIN LUPIN? Sitagliptin Lupin contains the active ingredient sitagliptin (as hydrochloride monohydrate). Sitagliptin Lupin is used to lower blood sugar levels in adults with type 2 diabetes mellitus. For more information, see Section 1. Why am I using Sitagliptin Lupin? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE SITAGLIPTIN LUPIN? Do not use if you have ever had an allergic reaction to Sitagliptin Lupin 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 use Sitagliptin Lupin? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Sitagliptin Lupin 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 USE SITAGLIPTIN LUPIN? • Take Sitagliptin Lupin once a day by mouth, with or without food. More instructions can be found in Section 4. How do I use Sitagliptin Lupin? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING SITAGLIPTIN LUPIN? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Sitagliptin Lupin. • Call your doctor straight away if you become pregnant while taking Sitagliptin Lupin. THINGS YOU SHOULD NOT DO • Do not stop taking this medicine suddenly. • Do not give Sitagliptin Lupin 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 Sitagliptin Lupin in a cool dry place away from moisture, heat or sunlight. For more information, see Section 5. What should I kno Llegiu el document complet
AUSTRALIAN PRODUCT INFORMATION – SITAGLIPTIN LUPIN (SITAGLIPTIN HYDROCHLORIDE MONOHYDRATE) FILM-COATED TABLET 1 NAME OF THE MEDICINE Sitagliptin hydrochloride monohydrate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Sitagliptin Lupin is available for oral use as film coated tablets containing sitagliptin hydrochloride 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 Sitagliptin Lupin 25 mg tablet: A pink, round, biconvex, film-coated tablet debossed with ”S25” on one side and plain on the other. Sitagliptin Lupin 50 mg tablet: A light beige, round, biconvex, film-coated tablet debossed with ”S50” on one side and plain on the other. Sitagliptin Lupin 100 mg tablet: A beige, round, biconvex, film-coated tablet debossed with ”STG” on one side and plain on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sitagliptin Lupin is indicated for the treatment of diabetes mellitus type 2 in persons 18 years of age and older who have failed dietary measures and exercise: • as monotherapy, as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus, when metformin cannot be used. • as dual combination therapy, with a sulfonylurea. • as triple combination therapy with metformin and a sulfonylurea when combination therapy with both agents does not provide adequate glycaemic control. • as add-on combination therapy with insulin (with or without metformin). 4.2 DOSE AND METHOD OF ADMINISTRATION The recommended dose of sitagliptin is 100 mg once daily as monotherapy, or as combination therapy with a sulfonylurea (clinical experience is with glimepiride as dual therapy), insulin (with or without metformin), or combination therapy with metformin and a sulfonylurea (clinical experience is with addition of sitagliptin to glimepiride or gliclazide and metformin as triple therapy). Sitagliptin can be taken with or without food. Sitagliptin Lupin PI v3 Page 2 of Llegiu el document complet