País: Israel
Idioma: inglés
Fuente: Ministry of Health
LINAGLIPTIN; METFORMIN HYDROCHLORIDE
BOEHRINGER INGELHEIM ISRAEL LTD.
A10BA02
FILM COATED TABLETS
LINAGLIPTIN 2.5 MG; METFORMIN HYDROCHLORIDE 1000 MG
PER OS
Required
DRAGENOPHARM APOTHEKER PUSCHL GMBH, GERMANY
METFORMIN
As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate. TRAJENTA-DUO should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. TRAJENTA-DUO has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using TRAJENTA-DUO.
2020-04-06
Trajenta Duo 2.5/500 mg, 2.5/850 mg, 2.5/1000 mg Patient information Film-coated tablets September 2023 2 Patient leaflet in accordance with the Pharmacists' Regulations (Preparations) – 1986 This medicine is dispensed with a physician’s prescription only Trajenta Duo ® 2.5 mg/500 mg Trajenta Duo ® 2.5 mg/850 mg Trajenta Duo ® 2.5 mg/1000 mg Film-coated tablets Each Trajenta Duo 2.5 mg/500 mg film-coated tablet contains: Each Trajenta Duo 2.5 mg/850 mg film-coated tablet contains: Each Trajenta Duo 2.5 mg/1000 mg film-coated tablet contains: 2.5 mg linagliptin, 500 mg metformin hydrochloride 2.5 mg linagliptin, 850 mg metformin hydrochloride 2.5 mg linagliptin, 1000 mg metformin hydrochloride Inactive ingredients and allergens in this medicine – see section 6 ‘Additional information’. Read the entire leaflet carefully before you start using this medicine. This leaflet contains concise information about this medicine. If you have any further questions, contact your physician or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. Important information: Metformin, one of the ingredients in Trajenta Duo, can cause a rare but serious side effect called lactic acidosis (a build-up of lactic acid in the blood) which may cause death. Lactic acidosis is a medical emergency and must be treated in hospital. Stop taking Trajenta Duo and contact your physician right away or go to the nearest hospital emergency room if you experience symptoms of lactic acidosis (see also section 4 - ‘Side effects’). 1. What is this medicine intended for? Trajenta Duo is intended, in addition to diet and physical exercise, to improve control of blood sugar levels in adults with type 2 diabetes mellitus for whom combined treatment with two active ingredients, linagliptin and metformin hydrochloride, is appropriate. Limitations of use: Trajenta Duo should not be used for the treatment of type 1 diabetes Leer el documento completo
Trajenta duo Prescribing Information File coated tablets 2.5mg/500mg, 2.5mg/850mg, 2.5mg/1,000mg September 2023 PRESCRIBING INFORMATION 1 NAME OF THE MEDICINAL PRODUCT TRAJENTA DUO 2.5 mg/500 mg TRAJENTA DUO 2.5 mg/850 mg TRAJENTA DUO 2.5 mg/1,000 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Linagliptin 2.5 mg and 500/850/1000 mg Metformin HCl. For the full list of excipients, see section “Description”. 3 PHARMACEUTICAL FORM Film coated tablets. WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin- associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin- associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL [see Warnings and Precautions (8.1)]. Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the full prescribing information [see Dosage and Administration (5.2), Contraindications (7), Warnings and Precautions (8.1), Drug Interactions (10), and Use in Specific Populations (11.6, 11.7)]. If metformin-associated lactic acidosis is suspected, immediately discontinue Trajenta Duo and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended [see Warnings and Precautions (8.1)]. Leer el documento completo