Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Losartan potassium; Hydrochlorothiazide
KRKA, d.d., Novo mesto
C09DA; C09DA01
Losartan potassium; Hydrochlorothiazide
50 mg/12.5 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists and diuretics; losartan and diuretics
Marketed
2013-11-08
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LOSARTAN/HYDROCHLOROTHIAZIDE KRKA 50 MG/12.5 MG FILM-COATED TABLETS losartan potassium/hydrochlorothiazide 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 Losartan/Hydrochlorothiazide Krka is and what it is used for 2. What you need to know before you take Losartan/Hydrochlorothiazide Krka 3. How to take Losartan/Hydrochlorothiazide Krka 4. Possible side effects 5. How to store Losartan/Hydrochlorothiazide Krka 6. Contents of the pack and other information 1. WHAT LOSARTAN/HYDROCHLOROTHIAZIDE KRKA IS AND WHAT IT IS USED FOR Losartan/Hydrochlorothiazide Krka is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide). Angiotensin II is a substance produced in the body which binds to receptors in blood vessels, causing them to tighten. This results in an increase in blood pressure. Losartan prevents the binding of angiotensin II to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure. Hydrochlorothiazide works by making the kidneys pass more water and salt. This also helps to reduce blood pressure. Losartan/Hydrochlorothiazide Krka is indicated for the treatment of essential hypertension (high blood pressure). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOSARTAN/HYDROCHLOROTHIAZIDE KRKA DO NOT TAKE LOSARTAN/HYDROCHLOROTHIAZIDE KRKA - if you are allergic to losartan and/or hydrochlorothiazide or any of the other ingredients of this medicine listed in section 6, - if you a Leggi il documento completo
Health Products Regulatory Authority 11 July 2023 CRN00DKRM Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Losartan/Hydrochlorothiazide Krka 50 mg/12.5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg losartan potassium, equivalent to 45.76 mg losartan and 12.5 mg hydrochlorothiazide. Excipient with known effect: lactose 59.98 mg/tablet. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Tablets are yellow oval, moderately biconvex, film-coated tablets with one-sided halving score, tablet dimension 6 mm x 12 mm (oval shape) thickness 3.8 – 4.7 mm. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Losartan/Hydrochlorothiazide Krka is indicated for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Hypertension Losartan and hydrochlorothiazide is not for use as initial therapy, but in patients whose blood pressure is not adequately controlled by losartan potassium or hydrochlorothiazide alone. Dose titration with the individual components (losartan and hydrochlorothiazide) is recommended. When clinically appropriate direct change from monotherapy to the fixed combination may be considered in patients whose blood pressure is not adequately controlled. The usual maintenance dose of Losartan/Hydrochlorothiazide Krka is one tablet of Losartan/Hydrochlorothiazide Krka 50 mg/12.5 mg (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily. For patients who do not respond adequately to Losartan/Hydrochlorothiazide Krka 50 mg/12.5 mg, the dosage may be increased to one tablet of Losartan/Hydrochlorothiazide Krka 100 mg/25 mg (losartan 100 mg/hydrochlorothiazide 25 mg) once daily. The maximum dose is one tablet of Losartan/Hydrochlorothiazide Krka 100 mg/25 m Leggi il documento completo