Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Ertugliflozin L-pyroglutamic acid
MERCK SHARP & DOHME (MALAYSIA) SDN BHD
Ertugliflozin L-pyroglutamic acid
7 Tablets; 28 Tablets
Pfizer Manufacturing Deutschland GmbH.
STEGLATRO ® FILM-COATED TABLET Ertugliflozin (5mg, 15mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What STEGLATRO is used for 2. How STEGLATRO works 3. Before you use STEGLATRO 4. How to use STEGLATRO 5. While you are using STEGLATRO 6. Side effects 7. Storage and Disposal of STEGLATRO 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT STEGLATRO IS USED FOR • STEGLATRO lowers blood sugar levels in adult patients (aged 18 years and older) with type 2 diabetes. • STEGLATRO can be used alone or with some other medicines that lower blood sugar. • You need to keep following your food and exercise plan while taking STEGLATRO. HOW STEGLATRO WORKS STEGLATRO contains the active substance ertugliflozin. STEGLATRO is a member of a group of medicines called sodium glucose co- transporter-2 (SGLT2) inhibitors. Ertugliflozin works by blocking the SGLT2 protein in your kidneys. This causes blood sugar to be removed in your urine. WHAT IS TYPE 2 DIABETES? Type 2 diabetes is a condition in which your body does not make enough insulin or the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems like heart disease, kidney disease, blindness and poor circulation. BEFORE YOU USE STEGLATRO _ _ _WHEN YOU MUST NOT USE IT _ Do not take STEGLATRO: • if you are allergic to ertugliflozin or any of the other ingredients of this medicine (listed in PRODUCT DESCRIPTION ). _ _ _BEFORE YOU START TO USE IT _ Talk to your doctor, pharmacist, or nurse before and while taking STEGLATRO if you: • have kidney problems. • have or have had yeast infections of the vagina or penis. • have ever had serious heart disease or if you have had a stroke. • have type 1 diabetes. STEGLATRO should not be used to treat this condition. • take other diabetes medicines; you are more likely to get lo Baca dokumen lengkap
LPC -MK8835 -T-102018 1. NAME OF THE MEDICINAL PRODUCT Steglatro 5 mg film -coated tablets Steglatro 15 mg film -coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Steglatro 5 mg film -coated tablets Each tablet contains 5 mg ertugliflozin (as ertugliflozin L -pyroglutamic acid). Excipient(s) with known effect Each tablet contains 28 mg of lactose (as monohydrate). Steglatro 15 mg film -coated tablets Each tablet contains 15 mg ertugliflozin (as ertugliflozin L -pyroglutamic acid). Excipient(s) with known effect Each tablet contains 85 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film -coated tablet (tablet). Steglatro 5 mg film -coated tablets Pink, 6.4 x 6.6 mm, triangular -shaped, film -coated tablets debossed with “701” on one side and plain on the other side. Steglatro 15 mg film -coated tablets Red, 9.0 x 9.4 mm, triangular -shaped, film -coated tablets debossed with “70 2” on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Steglatro is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: • as monotherapy in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications. • in addition to other medicinal products for the treatment of diabetes. (For study results with respect to combinations and effects on glycaemic control see sections 4.4, 4.5, and 5.1.) 4.2 Posology and method of administration Posology The recommended starting dose of ertugliflozin is 5 mg once daily. In patients tolerating ertugliflozin 5 mg once daily, the dose can be increased to 15 mg once daily if additional glycaemic control is Baca dokumen lengkap