País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Lisinopril (as dihydrate); Hydrochlorothiazide
McDermott Laboratories Ltd t/a Gerard Laboratories
C09BA03
Lisinopril (as dihydrate); Hydrochlorothiazide
10/12.5 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
lisinopril and diuretics
Not marketed
2012-07-13
PAGE 1 OF 11 PACKAGE LEAFLET PAGE 2 OF 11 PACKAGE LEAFLET: INFORMATION FOR THE USER LISINOPRIL/HYDROCHLOROTHIAZIDE 10 MG/12.5 MG TABLETS LISINOPRIL/HYDROCHLOROTHIAZIDE 20 MG/12.5 MG TABLETS Lisinopril and 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, 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. WHAT IS IN THIS LEAFLET: 1. What Lisinopril/Hydrochlorothiazide is and what it is used for 2. What you need to know before you take Lisinopril/Hydrochlorothiazide 3. How to take Lisinopril/Hydrochlorothiazide 4. Possible side effects 5. How to store Lisinopril/Hydrochlorothiazide 6. Contents of the pack and other information 1. WHAT LISINOPRIL/HYDROCHLOROTHIAZIDE IS AND WHAT IT IS USED FOR Lisinopril/Hydrochlorothiazide is used to treat high blood pressure (hypertension). It contains two medicines called lisinopril and hydrochlorothiazide which act together to lower your blood pressure. Lisinopril belongs to a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors. ACE inhibitors lower blood pressure by widening your blood vessels. This allows the blood to flow more easily and reduces the effort needed to pump blood around the body. Hydrochlorothiazide belongs to the group of medicines called thiazide diuretics (water tablets). The medicine works by helping your body to get rid of water and salts (like sodium) by increasing the amount of urine made by your kidneys. Lisinopril/Hydrochlorothiazide is used to treat patients whose blood pressure is not adequately controlled by lisinopril alone or hydrochlorothiazide alone. If high blood pressure Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lisinopril/Hydrochlorothiazide 10 mg/12.5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of lisinopril (as dihydrate) and 12.5 mg of hydrochlorothiazide. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets Lisinopril/Hydrochlorothiazide 10 mg/12.5 mg Tablets: A peach, mottled, 8.73 mm, round, biconvex tablet debossed with M on one side of the tablet and LH1 on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. Lisinopril/Hydrochlorothiazide Tablets fixed dose combination is indicated for the treatment of hypertension in patients whose blood pressure is not adequately controlled by lisinopril alone (or hydrochlorothiazide alone). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Essential Hypertension_ The selection of a suitable antihypertensive dose of lisinopril and hydrochlorothiazide will depend upon the clinical evaluation of the patient. The recommended dose is one tablet administered once daily. As with other medicines that are taken once daily, Lisinopril/Hydrochlorothiazide should be taken at about the same time each day. The administration of the fixed combination lisinopril and hydrochlorothiazide is usually recommended after dosage titration with the individual components. When clinically appropriate a direct change from monotherapy to fixed combination may be considered. 10 mg/12.5 mg tablets may be administered in patients whose blood pressure is not adequately controlled by 10 mg lisinopril alone. A maximum daily dose of 40 mg lisinopril/ 25 mg hydrochlorothiazide should not be exceeded. _Renal Insufficiency_ Thiazides may not be appropriate diuretics for use in patients with renal impairment and are ineffective at creatinine clearance values of 30 ml/min or below (i.e. moderate or severe renal insufficiency). Lisinopril and hydrochlorothiazide combination is not to be used as initial therapy in any patient with renal insuffic Leia o documento completo