Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LINAGLIPTIN; Empagliflozin
BOEHRINGER INGELHEIM (MALAYSIA) SDN. BHD.
LINAGLIPTIN; Empagliflozin
3 x 10tablet Tablets
BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ GLYXAMBI ® FILM-COATED TABLETS Empagliflozin/ linagliptin (10mg/5mg and 25mg/5mg) 1 WHAT IS IN THIS LEAFLET 1. What _GLYXAMBI_ is used for 2. How _GLYXAMBI_ works 3. Before you use _GLYXAMBI_ 4. How to use _GLYXAMBI_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _GLYXAMBI_ 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 1. WHAT _GLYXAMBI_ IS USED FOR _Glyxambi_ is used to lower blood sugar level in diabetes patients. _Glyxambi_ can be used when diet, exercise and treatment with one of the mono-component of _Glyxambi_ with/without metformin do not provide adequate glycaemic control. _Glyxambi_ can also be used as a replacement to taking both empagliflozin and linagliptin as single tablets. In this case, do not continue taking any one of those tablets separately if you are taking this medicine. It is important that you continue with your diet and exercise plan as recommended by your doctor, pharmacist or nurse. 2. HOW _GLYXAMBI_ WORKS _Glyxambi_ is an anti-diabetic medicine that contains two active substances called empagliflozin and linagliptin: • Empagliflozin works by blocking a protein in the kidneys called sodium glucose co-transporter 2 (SGLT2). SGLT2 prevents glucose from being excreted in urine by absorbing glucose back into the bloodstream as blood is being filtered in the kidneys. By blocking this protein, the medicine causes glucose (blood sugar), sodium (salt) and water to be removed via the urine. This helps to lower blood glucose levels, which are too high because of your type 2 diabetes. • Linagliptin works in a different way, namely by enabling the pancreas to produce more insulin to lower blood glucose levels. It does this by blocking a protein called DPP-4. 3. BEFORE YOU USE _GLYXAMBI_ - _When you must not use it _ Do not take _Glyxambi_ if you are allergic to empagliflozin, linagliptin, any other SGLT2 inhibitor (e.g. dapagliflozin, canagliflozin), any other DPP-4 inhibitor (e Baca dokumen lengkap
1 Date : 9 Sep 2021 Country : Malaysia Drug substance : Empagliflozin/ Linagliptin References : CCDS 0285-16 Remarks : Inclusion of new Adverse reaction “Constipation” GLYXAMBI ® 1. NAME OF THE MEDICINAL PRODUCT GLYXAMBI Film-Coated Tablets 10mg/5mg GLYXAMBI Film-Coated Tablets 25mg/5mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg or 25mg empagliflozin and 5mg linagliptin For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet GLYXAMBI 10mg/5mg: Pale yellow, arc triangular, flat-faced, bevel-edged, film-coated tablets. One side is debossed with the Boehringer Ingelheim company symbol, the other side is debossed with "10/5". GLYXAMBI 25mg/5mg: Pale pink, arc triangular, flat-faced, bevel-edged, film-coated tablets. One side is debossed with the Boehringer Ingelheim company symbol, the other side is debossed with "25/5". 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS GLYXAMBI is indicated to improve glycaemic control in adults with type 2 diabetes mellitus: • instead of empagliflozin, when diet, exercise and treatment with empagliflozin ± metformin do not provide adequate glycaemic control • instead of linagliptin, when diet, exercise and treatment with linagliptin ± metformin do not provide adequate glycaemic control GLYXAMBI can be used to replace the free combination of empagliflozin and linagliptin in adult patients with type 2 diabetes mellitus who are already being treated with this combination. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended starting dose is 1 film-coated tablet of GLYXAMBI 10 mg/5 mg (10 mg empagliflozin plus 5 mg linagliptin) once daily. 2 In patients who tolerate this starting dose and require additional glycaemic control, the dose can be increased to 1 film-coated tablet of GLYXAMBI 25 mg/5 mg (25 mg empagliflozin plus 5 mg linagliptin) once daily. When GLYXAMBI is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduc Baca dokumen lengkap