Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
empagliflozin, Quantity: 10 mg
Boehringer Ingelheim Pty Ltd
empagliflozin
Tablet, film coated
Excipient Ingredients: magnesium stearate; hyprolose; croscarmellose sodium; microcrystalline cellulose; colloidal anhydrous silica; lactose monohydrate; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 400
Oral
10, 30
(S4) Prescription Only Medicine
Type 2 diabetes mellitus,Glycaemic control,JARDIANCE is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults as:,Monotherapy,When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance.,Add-on combination therapy,In combination with other glucose?lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see Section 5.1 Pharmacodynamic properties - Clinical trials).,Prevention of cardiovascular death,JARDIANCE is indicated in patients with type 2 diabetes mellitus and established cardiovascular disease to reduce the risk of cardiovascular death (see Section 5.1 Pharmacodynamic properties - Clinical trials).,To prevent cardiovascular deaths, JARDIANCE should be used in conjunction with other measures to reduce cardiovascular risk in line with the current standard of care.,Heart failure,JARDIANCE is indicated in adults for the treatment of symptomatic heart failure independent of left ventricular ejection fraction, as an adjunct to standard of care therapy (see Section 5.1 Pharmacodynamic properties - Clinical trials).,Chronic kidney disease,JARDIANCE is indicated to reduce the risk of kidney disease progression in adults with chronic kidney disease (CKD Stages 2 and 3A with urine ACR ?30 mg/g, or CKD Stages 3B, 4 and 5 irrespective of urine ACR).
Visual Identification: Pale yellow, round, biconvex and bevel-edged film-coated tablet, debossed with 'S10' on one side, the other side debossed with the BI company symbol; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius
Licence status A
2014-04-30
JARDIANCE ® J A R D I A N C E C M I 0 1 4 2 - 1 2 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 JARDIANCE? Jardiance tablets contain the active ingredient empagliflozin. Jardiance is used to lower blood sugar levels in people with type 2 diabetes mellitus. Jardiance can be used to help lower the risk of dying from cardiovascular disease in patients with type 2 diabetes mellitus and cardiovascular disease. Jardiance is also used to treat a type of long-term heart failure in patients with or without type 2 diabetes mellitus. For more information, see Section 1. Why am I using Jardiance? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE JARDIANCE? Do not use if you have ever had an allergic reaction to empagliflozin or any of the ingredients listed at the end of the CMI. Do not use if you have poorly functioning kidneys since Jardiance requires good functioning kidneys to work well. 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 Jardiance? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Jardiance 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 JARDIANCE? Your doctor will tell you how many tablets you need to take each day. The usual dose for adults is one tablet a day. More instructions can be found in Section 4. How do I use Jardiance? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING JARDIANCE? THINGS YOU SHOULD DO • Check your blood sugar levels regularly to tell if your diabetes is being controlled properly • Be careful when doing activities that can lower your sugar levels, such as drinking alcohol, not eating enough, or exercising suddenly or vigorously. Read the complete document
JARDIANCE PI0145-15 1 AUSTRALIAN PRODUCT INFORMATION - JARDIANCE® EMPAGLIFLOZIN FILM-COATED TABLETS 1 NAME OF THE MEDICINE empagliflozin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION JARDIANCE 10 mg film-coated tablets contains 10 mg empagliflozin. JARDIANCE 25 mg film-coated tablets contains 25 mg empagliflozin. Excipients with known effect: The JARDIANCE 10 mg tablet contains 162.5 mg of lactose monohydrate and the JARDIANCE 25 mg tablet contains 113 mg of lactose monohydrate per maximum recommended daily dose. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM JARDIANCE are film-coated tablets for oral administration. JARDIANCE 10 mg film-coated tablets are pale yellow, round, biconvex and bevel-edged tablets. One side is debossed with the code ‘S10’, the other side is debossed with the Boehringer Ingelheim company symbol. JARDIANCE 25 mg film-coated tablets are pale yellow, oval, biconvex tablets. One side is debossed with the code ‘S25’, the other side is debossed with the Boehringer Ingelheim company symbol. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TYPE 2 DIABETES MELLITUS Glycaemic control JARDIANCE is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults as: Monotherapy When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance. Add-on combination therapy In combination with other glucose–lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see Section 5.1 Pharmacodynamic properties - Clinical trials). Prevention of cardiovascular death JARDIANCE is indicated in patients with type 2 diabetes mellitus and established cardiovascular disease to reduce the risk of cardiovascular death (see Section 5.1 Pharmacodynamic properties - Clinical trials). JARDIANCE PI0145-15 2 To prevent cardiovascular deaths, JARDIANCE should be used in conjunc Read the complete document