Χώρα: Ισραήλ
Γλώσσα: Αγγλικά
Πηγή: Ministry of Health
LINAGLIPTIN
BOEHRINGER INGELHEIM ISRAEL LTD.
A10BH05
FILM COATED TABLETS
LINAGLIPTIN 5 MG
PER OS
Required
BOEHRINGER INGELHEIM INTERNATIONAL GMBH, GERMANY
LINAGLIPTIN
LINAGLIPTIN
As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. TRAJENTA 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 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.
2018-05-31
Each film-coated tablet of Trajenta contains: 5 mg linagliptin. Inactive ingredients and allergens in this preparation - see section 6 ‘Additional information’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, contact the doctor 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. 1. WHAT IS THIS MEDICINE INTENDED FOR? In addition to diet and physical activity, Trajenta is intended to improve control of blood sugar levels in adults with type 2 diabetes. Trajenta can be given as monotherapy or in combination with additional medicinal products to reduce blood sugar levels. LIMITATIONS OF USE: Do not use Trajenta to treat type 1 diabetes or diabetic ketoacidosis, because Trajenta is not effective with these conditions. Trajenta has not been studied in patients who have previously had inflammation of the pancreas (pancreatitis). It is not known whether patients who have previously suffered from pancreatitis are at an increased risk of developing pancreatitis during the treatment with Trajenta. THERAPEUTIC GROUP: inhibitors of the enzyme DPP-4 (dipeptidyl peptidase-4). 2. BEFORE USING THIS MEDICINE DO NOT USE THE MEDICINE IF: • You are sensitive (allergic) to the active ingredient linagliptin or to any of the additional ingredients in the medicine (for a list of inactive ingredients, please see section 6 ‘Additional information’). Symptoms of severe allergic reaction to Trajenta may include skin rash, itching, flaking or peeling of the skin, raised red patches on your skin (hives), swelling of your face, lips, tongue and throat which may cause difficulty breathing or swallowing, difficulty swallowing or breathing. If you experience any of these symptoms, stop taking Trajenta and call your doctor immediately or go to the emergency room in the nearest hospital. SPECIAL Διαβάστε το πλήρες έγγραφο
Trajenta Updated Prescribing Information File coated tablets 5 mg November 2023 Page 1 of 26 TRAJENTA Linagliptin 5 mg FILM COATED TABLETS PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Trajenta 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient is linagliptin 5 mg. For the full list of excipients, see section "DESCRIPTION" below. 3. PHARMACEUTICAL FORM Film coated tablets. 4. INDICATIONS AND USAGE 4.1. Monotherapy and Combination Therapy TRAJENTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus _[see Clinical Studies (16.1)]. _ 4.2. Important Limitations of Use TRAJENTA 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 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 _[see Warnings and Precautions (8.1)]. _ 5. DOSAGE AND ADMINISTRATION 5.1. Recommended Dosing The recommended dose of TRAJENTA is 5 mg once daily. TRAJENTA tablets can be taken with or without food. Trajenta Updated Prescribing Information File coated tablets 5 mg November 2023 Page 2 of 26 5.2. Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin When TRAJENTA is used in combination with an insulin secretagogue (e.g., sulfonylurea) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia _[see Warnings and Precautions (8.2)]_. 6. DOSAGE FORMS AND STRENGTHS TRAJENTA (linagliptin) 5 mg tablets are light red, round, biconvex, bevel-edged, film-coated tablets with “D5” debossed on one side and the Boehringer Ingelheim logo debossed on the other side. 7. CONTRAINDICATIONS TRAJENTA is contraindicated in patients with hypersensitivity to linagliptin or any of the excipients in Trajenta listed in section 13, re Διαβάστε το πλήρες έγγραφο