Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
METFORMIN HYDROCHLORIDE; Alogliptin
Takeda Malaysia Sdn Bhd
METFORMIN HYDROCHLORIDE; Alogliptin
4 x 7tablet Tablets; 8 x 7tablet Tablets
TAKEDA PHARMACEUTICAL COMPANY LIMITED
_Consumer Medication Information Leaflet (RiMUP) _ NESINA MET FILM-COATED TABLET _ _ ALOGLIPTIN/METFORMIN 12.5MG/500MG AND 12.5MG/1000MG ___________________________________________________________________________ pg. 1 WHAT IS IN THIS LEAFLET 1. What Nesina Met is used for 2. How Nesina Met works 3. Before you use Nesina Met 4. How to use Nesina Met 5. While you are using it 6. Side Effects 7. Storage and Disposal of Nesina Met 8. Manufacturer and Product Registration Holder 9. Date of Revision WHAT NESINA MET IS USED FOR Nesina Met can be used to improve blood sugar levels in adult patients with type 2 diabetes in addition to diet and exercise: • In combination of alogliptin and metformin • In combination with pioglitazone • In combination with insulin HOW NESINA MET WORKS Nesina Met is used when your blood sugar cannot be adequately controlled by diet, exercise and one or more of these other oral antidiabetic medicines. It is important that you continue to take your other antidiabetic medications, and continue to follow the advice on diet and exercise that your nurse or doctor has given you. BEFORE YOU USE NESINA MET - When you must not use it Do not take Nesina Met: • If you are allergic to alogliptin and/ or metformin or any of the other ingredients of this medicine. • If you have severely reduced kidney function. • If you have lactic acidosis [too much lactic acid in the blood (see “Risk of lactic acidosis” below)] or ketoacidosis. Ketoacidosis is a condition in which substances called “ketone bodies” accumulate in the blood and which can lead to diabetic pre-coma. Symptoms of acidosis may include stomach pain, abnormal breathing and drowsiness (if severe). - Before you start to use it Before you take Nesina Met, tell your doctor if you : • Have type 1 diabetes (your body does not produce insulin) • Have kidney or liver problems • Have congestive heart failure that required treatment with medicine • Older patient should not take Nesina Met unless your kidneys have been checked and Baca dokumen lengkap
1 D3 Proposed Package Insert 1. NAME OF THE MEDICINAL PRODUCT Nesina Met 12. 5mg/ 5 00mg Film -Coated Tablet Nesina Met 12. 5mg/ 1000mg Film -Coated Tablet 2. NAME AND STRENGTH OF ACTIVE SUBSTANCES Nesina Met is available as a tablet for oral administration containing 17 mg alogliptin benzoate equivalent to 12.5 mg alogliptin and: • 500 mg metformin hydrochloride ( 12.5 mg/ 500 mg) or • 1000 mg metformin hydrochloride ( 12.5 mg/ 1000 mg) Nesina Met tablet contain the following excipients: mannitol, microcrystalline cellulose, povidone, crospovidone, magnesium stearate, hypromellose 2910, talc, titanium dioxide and ferric oxide yellow . 3. PRODUCT DESCRIPTION Nesina Met is supplied as tablets that are pale yellow, oblong , film -coated and are distinguished both by dose specific imprinted markings on both side. • 12. 5mg/5 00mg tablet – debossed with “12.5/500” on one side and “322M” on the other side • 12.5mg/ 1000mg tablet – debossed with “ 12.5/1000” on one side and “ 322M” on the other side 4. INDICATION Nesina Met is indicated to improve glycemic control in adult patients with type 2 diabetes mellitus (T2DM): . • As and adjunct to diet and exercise in patients inadequately controlled on metformin or in patients already being treated with the combination of alogliptin and metformin • In combination with pioglitazone when diet and exercise plus dual therapy with metformin and pioglitazone do not provide adequate glycemic control • In combination with insulin, when insulin and metformin do not provide adequate glycemic control 5. DOSAGE AND ADMINISTRATION 5.1 Recommend ations for All Patients • Healthcare providers should individualize the starting dose of Nesina Met based on the patient’s current regimen. • Nesina Met should be taken twice daily with food with gradual dose escalation to reduce the gastrointestinal (GI) side effects due to metformin. Nesina Met tablets must not be split before swallowing. • Dosing may be adjusted based on effectiveness and tolerabilit y Baca dokumen lengkap