Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydrochlorothiazide; Quinapril hydrochloride
Pfizer Ltd
C09BA06
Hydrochlorothiazide; Quinapril hydrochloride
12.5mg ; 10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050501; GTIN: 5013457011241
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER ACCURETIC® 10/12.5 MG FILM-COATED TABLETS quinapril 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 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 Accuretic is and what it is used for 2. What you need to know before you take Accuretic 3. How to take Accuretic 4. Possible side effects 5. How to store Accuretic 6. Contents of the pack and other information 1. WHAT ACCURETIC IS AND WHAT IT IS USED FOR Accuretic contains the active substances quinapril and hydrochlorothiazide. Quinapril belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors. ACE inhibitors work by widening blood vessels in the body, which can help to reduce the pressure in the vessels. Hydrochlorothiazide belongs to a group of medicines called diuretics. Diuretics help the body to get rid of extra fluid and are used in patients with high blood pressure. Because they get rid of fluid diuretics are sometimes called ‘water tablets’. Accuretic is used to treat high blood pressure. You must talk to a doctor if you do not feel better or if you feel worse. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ACCURETIC_ _ _ _ DO NOT TAKE ACCURETIC if you are in your second or third trimester of pregnancy. It is also better to avoid Accuretic in early pregnancy. See section 2 PREGNANCY, BREAST-FEEDING AND FERTILITY if you are allergic to quinapril, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6), similar drugs or to a group of antibioti Read the complete document
OBJECT 1 ACCURETIC FILM COATED TABLETS Summary of Product Characteristics Updated 27-Feb-2018 | Pfizer Limited 1. Name of the medicinal product Accuretic 10/12.5 mg film-coated tablets. 2. Qualitative and quantitative composition Each tablet contains 10 mg quinapril (as 10.85 mg quinapril hydrochloride) and 12.5 mg hydrochlorothiazide (HCTZ). Excipient(s) with known effect: Lactose, 30.7 mg per tablet. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. Pink, oval, biconvex film-coated tablets scored on both sides. 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 For the treatment of all grades of essential hypertension in patients who have been stabilised on the individual components given in the same proportions (see sections 4.3, 4.4, 4.5 and 5.1). 4.2 Posology and method of administration Posology _Adults_ For patients currently not receiving a diuretic, whether or not they have been receiving quinapril monotherapy, the recommended initial dosage of quinapril/HCTZ is 10/12.5 mg. Following initial therapy, the dosage may be increased to 20/25 mg. Effective blood pressure control is usually achieved with a dosage of 10/12.5 mg (see sections 4.3, 4.4, 4.5 and 5.1). Take either with or without food. The dose should always be taken at about the same time of day to help increase compliance. In patients with congestive heart failure, with or without associated renal insufficiency, ACE inhibitor therapy for hypertension may cause an excessive drop in blood pressure. Accuretic therapy should be started under close medical supervision. Patients should be followed closely for the first two weeks of treatment and whenever the dosage is increased. _Renal Impairment_ Accuretic is not recommended for use in patients with creatinine clearance of less than 40 mL/min. _Elderly_ The dose should be kept as low as possible commensurate with achievement of adequate blood pressure cont Read the complete document