Land: Malta
Tungumál: enska
Heimild: Medicines Authority
RAMIPRIL, HYDROCHLOROTHIAZIDE
TAD Pharma GmbH Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Germany
C09BA05
RAMIPRIL 2.5 mg HYDROCHLOROTHIAZIDE 12.5 mg
TABLET
RAMIPRIL 2.5 mg HYDROCHLOROTHIAZIDE 12.5 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Authorised
2016-04-18
PAGE 1 OF 8 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RAMIPRIL/HYDROCHLOROTHIAZIDE TAD 2.5 MG/12.5 MG TABLETS RAMIPRIL/HYDROCHLOROTHIAZIDE TAD 5 MG/25 MG TABLETS ramipril/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 Ramipril/Hydrochlorothiazide TAD is and what it is used for 2. What you need to know before you take Ramipril/Hydrochlorothiazide TAD 3. How to take Ramipril/Hydrochlorothiazide TAD 4. Possible side effects 5. How to store Ramipril/Hydrochlorothiazide TAD 6. Contents of the pack and other information 1. WHAT RAMIPRIL/HYDROCHLOROTHIAZIDE TAD IS AND WHAT IT IS USED FOR Ramipril/Hydrochlorothiazide TAD is a combination of two medicines called ramipril and hydrochlorothiazide. Ramipril belongs to a group of medicines called “ACE inhibitors” (Angiotensin Converting Enzyme Inhibitors). It works by: - Decreasing your body’s production of substances that raise your blood pressure. - Making your blood vessels relax and widen. - Making it easier for your heart to pump blood around your body. Hydrochlorothiazide belongs to a group of medicines called “thiazide diuretics” or water tablets. It works by increasing the amount of water (urine) you produce. This lowers your blood pressure. Ramipril/Hydrochlorothiazide TAD is used to treat high blood pressure. The two active substances work together to lower your blood pressure. They are used together when treatment with just one did not work. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RAMIPRIL/HYDROCHLOROTHIAZIDE TAD Lestu allt skjalið
Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ramipril/Hydrochlorothiazide TAD 2.5 mg/12.5 mg tablets Ramipril/Hydrochlorothiazide TAD 5 mg/25 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Ramipril/Hydrochlorothiazide TAD 2.5 mg/12.5 mg tablets _ Each tablet contains 2.5 mg ramipril and 12.5 mg hydrochlorothiazide. _Ramipril/Hydrochlorothiazide TAD 5 mg/25 mg tablets _ Each tablet contains 5 mg ramipril and 25 mg hydrochlorothiazide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. 2.5 mg/12.5 mg tablets: white to off-white, round tablets, with bevelled edges and engraved with C on one side. Tablet diameter: 5.5 mm. 5 mg/25 mg tablets: white to off-white, round tablets, with bevelled edges, scored on one side and engraved with S on other side of tablet. Tablet diameter: 7.5 mm.The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of hypertension. This fixed dose combination is indicated in patients whose blood pressure is not adequately controlled with ramipril alone or hydrochlorothiazide alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ The dose should be individualised according to the patient profile (see section 4.4) and blood pressure control. The administration of the fixed combination of ramipril and hydrochlorothiazide is usually recommended after dosage titration with one of the individual components. Ramipril/Hydrochlorothiazide TAD should be started at the lowest available dosage. If necessary, the dose can be progressively increased to achieve target blood pressure; the maximum permitted doses are 10 mg of ramipril and 25 mg of hydrochlorothiazide daily. Page 2 of 18 _Special populations _ _Diuretic-treated patients _ In patients concurrently treated with diuretics, as hypotension may occur following initiation of the treatment, caution is recommended. Consideration must be given to reducing the diuretic dose or discontinuing the diuretic before starting t Lestu allt skjalið