国: スウェーデン
言語: スウェーデン語
ソース: Läkemedelsverket (Medical Products Agency)
indapamidhemihydrat; perindoprilarginin
Actavis Group PTC ehf.
C09BA04
indapamidhemihydrat; perindopril arginine
2,5 mg/0,625 mg
Filmdragerad tablett
laktosmonohydrat Hjälpämne; indapamidhemihydrat 0,625 mg Aktiv substans; perindoprilarginin 2,5 mg Aktiv substans
Receptbelagt
Förpacknings: Burk, 30 tabletter; Burk, 60 tabletter; Burk, 90 tabletter; Burk, 100 tabletter; Blister, 30 tabletter; Blister, 60 tabletter; Blister, 90 tabletter; Blister, 100 tabletter
Avregistrerad
2016-01-14
1 PACKAGE LEAFLET: INFORMATION FOR THE USER AVANCARDO 2.5 MG/0.625 MG FILM-COATED TABLETS perindopril arginine/indapamide hemihydrate 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 or pharmacist. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Avancardo is and what it is used for 2. What you need to know before you take Avancardo 3. How to take Avancardo 4. Possible side effects 5. How to store Avancardo 6. Contents of the pack and other information 1. WHAT AVANCARDO IS AND WHAT IT IS USED FOR Avancardo is a combination of two active ingredients, perindopril and indapamide. It is an antihypertensive and is used in the treatment of high blood pressure (hypertension). Perindopril belongs to a class of medicines called ACE inhibitors. These work by widening the blood vessels, which makes it easier for your heart to pump blood through them. Indapamide is a diuretic. Diuretics increase the amount of urine produced by the kidneys. However, indapamide is different from other diuretics, as it only causes a slight increase in the amount of urine produced. Each of the active ingredients reduces blood pressure and they work together to control your blood pressure. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AVANCARDO DO NOT TAKE AVANCARDO - if you are allergic to perindopril or any other ACE inhibitor, or to indapamide or any other sulphonamides or any of the other ingredients of this medicine (listed in section 6). - if you have experienced symptoms such as wheezing, swelling of the face or tongue, intense itching or severe skin rashes with previous ACE inhibitor treat 完全なドキュメントを読む
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Avancardo 2.5 mg/0.625 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2.5 mg perindopril arginine corresponding to 1.6975 mg perindopril and 0.625 mg indapamide hemidydrate. Excipient with known effect: Each film-coated tablet contains 87 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Avancardo 2.5 mg/0.625 mg film-coated tablets are white, 8.5 mm x 4.3 mm oval and biconvex 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Essential hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology One Avancardo 2.5 mg/0.625 mg film-coated tablet per day as a single dose, preferably to be taken in the morning and before a meal. If blood pressure is not controlled after one month of treatment, the dose can be doubled _._ _Elderly (see section 4.4)_ Treatment should be started at the normal dose of one Avancardo 2.5 mg/0.625 mg film-coated tablet per day _Patients with renal impairment (see section 4.4)_ In severe renal impairment (creatinine clearance below 30 ml/min), treatment is contra-indicated. In patients with moderate renal impairment (creatinine clearance 30-60 ml/min), the maximum dose should be one tablet of Avancardo 2.5 mg/0.625 mg per day. In patients with creatinine clearance greater than or equal to 60 ml/min, no dose modification is required. Usual medical follow-up will include frequent monitoring of creatinine and potassium. _Patients with hepatic impairment (see sections 4.3, 4.4 and 5.2)_ In severe hepatic impairment, treatment is contraindicated. In patients with moderate hepatic impairment, no dose modification is required. 2 _Paediatric population_ Avancardo should not be used in children and adolescents as the efficacy and tolerability of perindopril in children and adolescents, alone or in combination, have not been established. Method of administration Oral use. 4.3 CONTRAINDICATIONS - Hypersensitivi 完全なドキュメントを読む