Ülke: Yeni Zelanda
Dil: İngilizce
Kaynak: Medsafe (Medicines Safety Authority)
Hydrochlorothiazide 12.5mg; Quinapril hydrochloride 21.664mg equivalent to 20 mg quinapril free base.;
Pfizer New Zealand Limited
Hydrochlorothiazide 12.5 mg
12.5mg/20mg
Film coated tablet
Active: Hydrochlorothiazide 12.5mg Quinapril hydrochloride 21.664mg equivalent to 20 mg quinapril free base. Excipient: Candelilla wax Crospovidone Heavy magnesium carbonate Lactose monohydrate Magnesium stearate Opadry pink OY-S-6937 Povidone
Aluminium foil, blister, sample pack, 10 tablets
Prescription
Prescription
Cambrex Profarmaco Milano Srl
Package - Contents - Shelf Life: Blister pack, Aluminium foil - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Aluminium foil - 30 tablets - 36 months from date of manufacture stored at or below 25°C
2000-02-25
Accuretic® 1 ACCURETIC® 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 ACCURETIC? Accuretic contains the active ingredients quinapril hydrochloride and hydrochlorothiazide. Accuretic is used to lower high blood pressure (hypertension). For more information, see Section 1. Why am I using Accuretic? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE ACCURETIC? Do not use if you have ever had an allergic reaction to Accuretic, any sulfonamide or sulfur medicines 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 Accuretic? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Accuretic 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 ACCURETIC? For most patients, the usual starting dose is one Accuretic 10 mg/12.5 mg tablet a day. The dose may need to be increased to one Accuretic 20 mg/12.5 mg tablet a day, then two Accuretic 10 mg/12.5 mg tablets a day if necessary. More instructions can be found in Section 4. How do I use Accuretic? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING ACCURETIC? THINGS YOU SHOULD DO Remind any doctor, dentist or pharmacist you visit that you are using Accuretic. 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 Accuretic. Tell your doctor immediately if you feel light-headed or dizzy after taking your first dose of Accuretic, or when your dose is increased. Regularly check your skin for any new or suspicious skin lesions. THINGS YOU SHOULD NOT DO Belgenin tamamını okuyun
Version: pfdacret10622 Supersedes: pfdacret11020 Page 1 of 24 NEW ZEALAND DATA SHEET 1. PRODUCT NAME ACCURETIC 10 mg/12.5 mg film coated tablet. ACCURETIC 20 mg/12.5 mg film coated tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACCURETIC is a fixed-combination tablet that combines an angiotensin-converting enzyme (ACE) inhibitor, quinapril hydrochloride, and a diuretic, hydrochlorothiazide (HCTZ). ACCURETIC is available in two tablet strengths. ACCURETIC 10/12.5 contains 10 mg of quinapril and 12.5 mg of hydrochlorothiazide. ACCURETIC 20/12.5 contains 20 mg of quinapril and 12.5 mg of hydrochlorothiazide. Quinapril hydrochloride is a white to off-white amorphous powder that is freely soluble in aqueous solvents. Hydrochlorothiazide is a white to off-white, crystalline powder that is slightly soluble in water, but freely soluble in sodium hydroxide solution. EXCIPIENT(S) WITH KNOWN EFFECT Lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet ACCURETIC 10/12.5 tablets: Pink, oval, biconvex, film-coated tablets, scored on both sides. ACCURETIC 20/12.5 tablets: Pink, triangular, biconvex, film-coated tablets, scored on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ACCURETIC is indicated for the treatment of hypertension in patients for whom combination therapy with quinapril and a diuretic is appropriate. Version: pfdacret10622 Supersedes: pfdacret11020 Page 2 of 24 4.2 DOSE AND METHOD OF ADMINISTRATION _PATIENTS NOT CURRENTLY RECEIVING A DIURETIC_ For patients not currently receiving a diuretic, whether or not they have been receiving quinapril monotherapy, the recommended initial dosage of ACCURETIC is one ACCURETIC 10/12.5 tablet once daily, taken with or without food. If blood pressure is not adequately controlled, the dose may be increased to one ACCURETIC 20/12.5 tablet once daily and then to two ACCURETIC 10/12.5 tablets once daily if necessary. Further dose increases are not expected to produce any additional reduction in blood pre Belgenin tamamını okuyun