País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
sitagliptin hydrochloride monohydrate, Quantity: 28.34 mg (Equivalent: sitagliptin, Qty 25 mg)
Sandoz Pty Ltd
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; calcium hydrogen phosphate; sodium starch glycollate type A; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350
Oral
28 tablets
(S4) Prescription Only Medicine
SITAGLIPTIN SANDOZ PHARMA 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 Sections 5.1 Pharmacodynamic properties ? Clinical trials and 4.5 Interactions with other medicines and other forms of interactions for available data on different add-on combination therapies].
Visual Identification: Pink, round film-coated tablet with 25 engraved on one side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Registered
2021-12-23
Sitagliptin Sandoz Pharma® Tablets 1 SITAGLIPTIN SANDOZ PHARMA® TABLETS 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 SANDOZ PHARMA? Sitagliptin Sandoz Pharma contains the active ingredient sitagliptin (as hydrochloride monohydrate). Sitagliptin Sandoz Pharma 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 Sandoz Pharma? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE SITAGLIPTIN SANDOZ PHARMA? Do not use if you have ever had an allergic reaction to Sitagliptin Sandoz Pharma 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 Sandoz Pharma? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Sitagliptin Sandoz Pharma 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 SANDOZ PHARMA? • Your doctor will tell you how many tablets to take each day. The standard recommended dose is one 100 mg tablet per day. Your doctor may prescribe a lower dose for you. • Swallow the tablet whole by mouth, with or without food, with a glass of water and take Sitagliptin Sandoz Pharma at about the same time each day More instructions can be found in Section 4. How do I use Sitagliptin Sandoz Pharma? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING SITAGLIPTIN SANDOZ PHARMA? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that yo Llegiu el document complet
211223- sitagliptin sandoz pharma-pi Page 1 of 37 AUSTRALIAN PRODUCT INFORMATION SITAGLIPTIN SANDOZ PHARMA ® (SITAGLIPTIN) FILM-COATED TABLET 1. NAME OF THE MEDICINE Sitagliptin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each SITAGLIPTIN SANDOZ PHARMA film-coated tablet contains either 25 mg, 50 mg or 100 mg sitagliptin (as hydrochloride monohydrate). For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Film-coated tablet. SITAGLIPTIN SANDOZ PHARMA 25 mg film-coated tablet are pink, round, with “25” engraved on one side. SITAGLIPTIN SANDOZ PHARMA 50 mg film-coated tablet are light beige, round, with “50” engraved on one side. SITAGLIPTIN SANDOZ PHARMA 100 mg film-coated tablet are beige, round, with “100” engraved on one side. 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS SITAGLIPTIN SANDOZ PHARMA 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 Sections 5.1 Pharmacodynamic properties – Clinical trials and 4.5 Interactions with other medicines and other forms of interactions for available data on different add-on combination therapies]. 4.2. D OSE AND METHOD OF ADMINISTRATION _Each SITAGLIPTIN SANDOZ PHARMA film-coated tablet contains sitagliptin hydrochloride _ _monohydrate. 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 SANDOZ PHARMA 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 Llegiu el document complet