Țară: Regatul Unit
Limbă: engleză
Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)
Quinapril hydrochloride
Phoenix Healthcare Distribution Ltd
C09AA06
Quinapril hydrochloride
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050501
1 _Version 4, 02/2016 _ PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER QUINAPRIL 5MG, 10MG, 20MG AND 40MG TABLETS QUINAPRIL HYDROCHLORIDE 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 Quinapril tablets are and what they are used for. 2. What you need to know before you take Quinapril tablets. 3. How to take Quinapril tablets. 4. Possible side effects 5. How to store Quinapril tablets. 6. Contents of the pack and other information. 1. WHAT QUINAPRIL TABLETS IS AND WHAT IT IS USED FOR THE ACTIVE INGREDIENT in Quinapril Tablets is quinapril (present as quinapril hydrochloride). This belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors. ACE inihibitors work by widening blood vessels in the body, which can reduce the pressure in the vessels. FOR THE OTHER INGREDIENTS IN QUINAPRIL TABLETS, (SEE SECTION 6.) Quinapril is an ACE inhibitor used to treat high blood pressure (hypertension) and to help treat heart failure. Quinapril is effective alone or together with water tablets (diuretics) in patients with hypertension. Quinapril can also be used for the treatment of heart failure when given together with a diuretic and/or cardiac glycoside such as digoxin. Treatment of heart failure with quinapril should always be started under close medical supervision. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUINAPRIL TABLETS DO NOT TAKE QUINAPRIL TABLETS IF: • you are allergic to quinapril, any other ACE inhibitor or any of the other ingredients (listed in section 6) Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Quinapril 5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mg tablet contains quinapril hydrochloride 5.416 mg equivalent to 5 mg Quinapril For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated Tablet Quinapril Tablets 5mg are Yellow coloured, Oval shaped, film-coated tablets debossed with ‘5’ on one side and score line on the other side. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HYPERTENSION For the treatment of all grades of essential hypertension. Quinapril Tablet is effective as monotherapy or concomitantly with diuretics in patients with hypertension. CONGESTIVE HEART FAILURE For the treatment of congestive heart failure when given concomitantly with a diuretic and/or cardiac glycoside. Treatment of congestive heart failure with Quinapril Tablets should always be initiated under close medical supervision. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use. ADULTS HYPERTENSION Monotherapy: The recommended initial dosage is 10 mg once daily in uncomplicated hypertension. Depending upon clinical response, patient's dosage may be titrated (by doubling the dose allowing adequate time for dosage adjustment) to a maintenance dosage of 20 to 40 mg/day given as a single dose or divided into 2 doses. Long-term control is maintained in most patients with a single daily dosage regimen. Patients have been treated with dosages up to 80 mg/day. Concomitant Diuretics: In order to determine if excess hypotension will occur, an initial dosage of 2.5 mg of Quinapril Tablets is recommended in patients who are being treated with a diuretic. After this the dosage of Quinapril Tablets should be titrated (as described above) to the optimal response. CONGESTIVE HEART FAILURE In order to closely monitor patients for symptomatic hypotension, a single 2.5 mg initial dosage is recommended. After this, patients should be titrated to an effective dose: (up to 40 mg/day) g Citiți documentul complet