Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Quinapril hydrochloride
Teva UK Ltd
C09AA06
Quinapril hydrochloride
40mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050501; GTIN: 5017007359555
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 of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.. 1. WHAT QUINAPRIL IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUINAPRIL 3. HOW TO TAKE QUINAPRIL 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE QUINAPRIL 6. CONTENTS OF THE PACK AND OTHER INFORMATION WHAT QUINAPRIL IS AND WHAT IT IS USED FOR Quinapril belongs to a group of drugs called Angiotensin Converting Enzyme (ACE) Inhibitors, which are vasodilators (drugs which widen the blood vessels, reduce blood pressure and make it easier for the heart to pump blood around the body). Quinapril is used to treat: • high blood pressure • congestive heart failure (a condition where the heart no longer pumps blood as effectively as it should). WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUINAPRIL DO NOT TAKE QUINAPRIL AND CONTACT YOUR DOCTOR IMMEDIATELY IF YOU : • are allergic to quinapril or any of the other ingredients of this medicine (listed in • section 6). Signs of allergic reaction include itching, a rash on the skin or difficulty in • breathing • are more than 3 months pregnant. (It is also better to avoid quinapril in early • pregnancy- see Pregnancy section below) • have a condition called angioneurotic oedema (a swelling of the face, tongue or throat • which causes difficulty breathing) • have aortic stenosis (narrowing ofthe main blood vessel from the heart). • have kidney disease • have diabetes or impaired kidney function and you are treated with a blood pressure • lowering medicine containing aliskiren • have taken or are Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Quinapril 40 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 40 mg quinapril (as quinapril hydrochloride). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets Yellow, oval film-coated tablets debossed “40” on one side and scoreline on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension Treatment of congestive heart failure 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults For oral use. The dose should be individualised. For the different dosage regimens, appropriate strengths of quinapril are available. ESSENTIAL HYPERTENSION Monotherapy :_ _ The recommended initial dosage is 10 mg once daily in hypertension. Depending upon clinical response, patient's dosage may be titrated (by doubling the dose allowing adequate timefor 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. Take either with or without food. The dose should always be taken at about the same time of day to help increase compliance. Concomitant Diuretics: In order to determine if excess hypotension will occur, an initial dosage of 2.5 mg of Quinapril is recommended in patients who are being treated with a diuretic. After this the dosage of Quinapril should be titrated (as described above) to the optimal response (see sections 4.3, 4.4, 4.5 and 5.1.) 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) given in 1 or 2 doses with concomitant diuretic and/or cardiac glycoside therapy. Patients are usually maintained effectively on doses of 10- 20 mg/day given with concomitant therapy Lire le document complet