País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
sitagliptin fumarate, Quantity: 64.249 mg
Sun Pharma ANZ Pty Ltd
Tablet, film coated
Excipient Ingredients: calcium hydrogen phosphate; crospovidone; hydrogenated castor oil; glycerol dibehenate; magnesium stearate; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 6000; iron oxide red
Oral
28 tablets
(S4) Prescription Only Medicine
Sitagliptin SUN (sitagliptin fumarate) 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: Light beige colour, round film-coated tablets debossed with F2 on one side and plain on the other side; Container Type: Blister Pack; Container Material: Other composite material; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2021-11-23
SITAGLIPTIN SUN v1.1 SITAGLIPTIN SUN The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. Sitagliptin SUN contains the active ingredient sitagliptin fumarate. Sitagliptin SUN is used to lower blood sugar levels in patients with type 2 diabetes mellitus alone or in combination with certain other medicines, when diet plus exercise or the other medicine(s) do not provide adequate blood sugar level control. For more information, see Section 1. Why am I using Sitagliptin SUN? in the full CMI. Do not use if you have ever had an allergic reaction to Sitagliptin SUN 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 SUN? in the full CMI. Some medicines may interfere with Sitagliptin SUN 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. • Take Sitagliptin SUN only when prescribed by your doctor. • The recommended dose is to take one 100 mg tablet once a day, by mouth, with or without food. More instructions can be found in Section 4. How do I use Sitagliptin SUN? in the full CMI. THINGS YOU SHOULD DO • If you become pregnant while taking Sitagliptin SUN, tell your doctor immediately. • If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking Sitagliptin SUN. THINGS YOU SHOULD NOT DO • Do not stop using this medicine suddenly. • Do not give Sitagliptin SUN to anyone else, even if they have the same condition as you. DRIVING OR USING MACHINES • Sitagliptin SUN is not expected to affect the ability to drive and use machines. LOOKING AFTER YOUR MEDICINE • Keep Sitagliptin SUN in a cool dry place where the temperature stays below 25°C. Do not store it or any other medicine in the bat Leia o documento completo
1 SITAGLIPTRIN SUN v2.0 AUSTRALIAN PRODUCT INFORMATION – SITAGLIPTIN SUN (SITAGLIPTIN FUMARATE) 1 NAME OF THE MEDICINE sitagliptin fumarate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Sitagliptin SUN is available for oral use as film coated tablets containing sitagliptin fumarate 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 SUN Tablet 25 mg - Light pink colour, round film coated tablets debossed with F1 on one side and plain on the other side. Sitagliptin SUN Tablet 50 mg - Light beige colour, round film coated tablets debossed with F2 on one side and plain on the other side. Sitagliptin SUN Tablet 100 mg - Beige colour, round film coated tablets debossed with F3 on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sitagliptin SUN (sitagliptin fumarate) 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 _Each SITAGLIPTIN SUN tablet contains sitagliptin fumarate. The innovator product _ _contains sitagliptin phosphate monohydrate. All clinical data in this product _ _information (including pharmacokinetic, pharmacodynamic and clinical trial data) are _ _based on sitagliptin phosphate monohydrate. Bioequivalence with respect to _ _sitagliptin has been established between the two salt forms. _ The recommended dose of Sitagliptin SUN 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 thiazolidin Leia o documento completo