Riik: Austraalia
keel: inglise
Allikas: Department of Health (Therapeutic Goods Administration)
quinapril hydrochloride, Quantity: 5.42 mg (Equivalent: quinapril, Qty 5 mg)
Pfizer Australia Pty Ltd
Tablet, film coated
Excipient Ingredients: Candelilla Wax; lactose monohydrate; magnesium stearate; crospovidone; magnesium carbonate hydrate; Gelatin; titanium dioxide; hypromellose; hyprolose; iron oxide red; macrogol 400
Oral
30 tablets
(S4) Prescription Only Medicine
Hypertension. ACCUPRIL is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. Sufficient data have not been provided to support the use of ACCUPRIL in renovascular hypertension. Congestive Heart Failure. ACCUPRIL is indicated as an adjunctive treatment of mild to moderate congestive heart failure when given concomitantly with a diuretic and/or cardiac glycoside.
Visual Identification: Reddish-brown, oval, biconvex film-coated tablet with bisecting score on both sides and debossing '5' on both sides in opposite direction.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1992-08-06
ACCUPRIL ® A C C U P R I L ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING ACCUPRIL? Accupril contains the active ingredient quinapril hydrochloride. Accupril is used to lower high blood pressure (hypertension). It is also used to treat heart failure. For more information, see Section 1. Why am I using Accupril? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE ACCUPRIL? Do not use if you have ever had an allergic reaction to Accupril, another ACE inhibitor, or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use Accupril? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Accupril and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE ACCUPRIL? For high blood pressure, the usual starting dose is 5 mg to 10 mg taken once a day. The dose may need to be increased. Most patients take between 10 mg and 40 mg each day. For heart failure, the usual starting dose is 5 mg taken once a day. In most patients, effective doses are between 10 mg and 20 mg a day. More instructions can be found in Section 4. How do I use Accupril? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING ACCUPRIL? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Accupril. • Make sure you drink enough water during exercise and hot weather, especially if you sweat a lot. • Tell your doctor if you have excess vomiting and/or diarrhoea while taking Accupril. • Tell your doctor immediately if you feel light-headed or dizzy after taking your first dose of Accupril, or when your dose is increased. • Have your blood pres Lugege kogu dokumenti
Version: pfpaccut10822 Supersedes: pfpaccut10220 Page 1 of 23 AUSTRALIAN PRODUCT INFORMATION – ACCUPRIL ® (QUINAPRIL HYDROCHLORIDE) 1. NAME OF THE MEDICINE Quinapril hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACCUPRIL (quinapril hydrochloride) 5 mg, 10 mg and 20 mg tablets. EXCIPIENT(S) WITH KNOWN EFFECT Lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Film-coated tablet. 5 MG TABLET: Reddish-brown, oval, biconvex, film-coated tablet, with bisecting score on both sides and debossing “5” on both sides in opposite direction. 10 MG TABLET: Reddish-brown, triangular, biconvex film-coated tablet, with bisecting score on both sides and debossing “10” on one side. 20 MG TABLET: Reddish-brown, round, biconvex film-coated tablet, with bisecting score on both sides and debossing “20” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HYPERTENSION ACCUPRIL is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. Sufficient data have not been provided to support the use of ACCUPRIL in renovascular hypertension. CONGESTIVE HEART FAILURE ACCUPRIL is indicated as an adjunctive treatment of mild to moderate congestive heart failure when given concomitantly with a diuretic and/or cardiac glycoside. 4.2 DOSE AND METHOD OF ADMINISTRATION ACCUPRIL should preferably be taken before meals as food with a high fat content may diminish the rate and extent of absorption of the drug. Version: pfpaccut10822 Supersedes: pfpaccut10220 Page 2 of 23 HYPERTENSION MONOTHERAPY The recommended initial dosage of ACCUPRIL in patients not on diuretics is 5 to 10 mg once daily. Dosage should be adjusted according to blood pressure response measured at peak (2 to 6 hours after dosing) and trough (predosing). Generally, dosage adjustments should be made at intervals of at least 4 weeks. Most patients have required dosages of 10 to 40 mg/day, given as a single dose or in two equally divided dose Lugege kogu dokumenti