国: マルタ
言語: 英語
ソース: Malta Medicines Authority
PharmaPath S.A. 28is Oktovriou 1, Agia Varvara, 123 51, , Greece
A10BH05
LINAGLIPTIN 5 mg
FILM-COATED TABLET
LINAGLIPTIN 5 mg
POM
DRUGS USED IN DIABETES
Authorised
2024-02-06
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LINATHAN 5 MG FILM-COATED TABLETS linagliptin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Linathan is and what it is used for 2. What you need to know before you take Linathan 3. How to take Linathan 4. Possible side effects 5. How to store Linathan 6. Contents of the pack and other information 1. WHAT LINATHAN IS AND WHAT IT IS USED FOR Linathan contains the active substance linagliptin which belongs to a group of medicines called “oral anti-diabetics”. Oral anti-diabetics are used to treat high blood sugar levels. They work by helping the body reduce the level of sugar in your blood. Linathan is used for ‘type 2 diabetes’ in adults, if the disease cannot be adequately controlled with one oral anti-diabetic medicine (metformin or sulphonylureas) or diet and exercise alone. Linathan may be used together with other anti-diabetic medicines e.g. metformin, sulphonylureas (e.g. glimepiride, glipizide), empagliflozin, or insulin. It is important to keep following the advice about diet and exercise that you have been given by your doctor or nurse. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LINATHAN DO NOT TAKE LINATHAN - if you are allergic to linagliptin or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before taking Linathan if you: • have type 1 diabetes (your body does not produce any insulin) or diabetic ketoacidosis (a complica 完全なドキュメントを読む
Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Linathan 5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of linagliptin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Light red, round (diameter of approx. 8 mm), biconvex, film-coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ _ Linathan is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control as: monotherapy • when metformin is inappropriate due to intolerance, or contraindicated due to renal impairment. combination therapy • in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations). _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose of linagliptin is 5 mg once daily. When linagliptin is added to metformin, the dose of metformin should be maintained, and linagliptin administered concomitantly. When linagliptin is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin, may be considered to reduce the risk of hypoglycaemia (see section 4.4) _Special populations _ _Renal impairment _ For patients with renal impairment, no dose adjustment for linagliptin is required. _Hepatic impairment _ Pharmacokinetic studies suggest that no dose adjustment is required for patients with hepatic impairment but clinical experience in such patients is lacking. _Elderly _ No dose adjustment is necessary based on age. _Paediatric population _ A clinical trial did not establish efficacy in paediatric patients 10 to 17 years of age (see section 4.8, 5.1 and 5.2). Therefore, treatment of children and adolescents with linagliptin is not recommended. Page 2 of 14 Linagliptin has not been studied in paediatric patients under 10 years of age. _ _ Method 完全なドキュメントを読む