Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
amlodipine besilate, Quantity: 13.87 mg (Equivalent: amlodipine, Qty 10 mg); perindopril arginine, Quantity: 5 mg
Arrotex Pharmaceuticals Pty Ltd
amlodipine besilate,perindopril arginine
Tablet
Excipient Ingredients: colloidal anhydrous silica; croscarmellose sodium; microcrystalline cellulose; magnesium stearate
Oral
30
(S4) Prescription Only Medicine
Perindopril arginine and amlodipine combination tablet is indicated as substitution therapy for the treatment of hypertension and/or stable coronary heart disease in patients already controlled with separate doses of perindopril and amlodipine, given concurrently at the same dose level. Treatment should not be initiated with this combination.
Visual Identification: White to off-white coloured, square-shaped biconvex tablets engraved with 'APO' on one side and '5/10' on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2016-01-12
APO- PERINDOPRIL/AMLODIPINE 5/5, 5/10, 10/5 & 10/10 TABLETS 1 APO- PERINDOPRIL/AMLODIPINE 5/5, 5/10, 10/5 & 10/10 TABLETS _Contains the active ingredient perindopril arginine and amlodipine besilate _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is APO- Perindopril/Amlodipine 5/5, 5/10, 10/5 & 10/10 tablets. It contains the active ingredient perindopril arginine and amlodipine besilate. Perindopril belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors. Amlodipine belongs to a group of medicines called calcium channel blockers. Calcium channel blockers do not change the amount of calcium in your blood or bones. Perindopril/Amlodipine Tablets has been prescribed to you by your doctor to replace the separate tablets of perindopril and amlodipine you were taking. One Perindopril/Amlodipine tablet replaces separate tablets of perindopril and amlodipine. You have been prescribed Perindopril/Amlodipine tablets if you have high blood pressure, also known as hypertension. _WHY PERINDOPRIL/AMLODIPINE _ _IS USED FOR HIGH BLOOD _ _PRESSURE _ Everyone has blood pressure. This pressure helps get your blood all around the body. Your blood pressure may be different at different times of the day, depending on how busy or stressed you are. You have high blood pressure when your blood pressure stays higher than is needed, even when you are calm or relaxed. There are usually no symptoms of high bloo Prečítajte si celý dokument
1 AUSTRALIAN PRODUCT INFORMATION APO-PERINDOPRIL ARGININE/AMLODIPINE (PERINDOPRIL ARGININE AND AMLODIPINE (AS BESILATE)) TABLETS 1 NAME OF THE MEDICINE Perindopril arginine and amlodipine besilate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Perindopril arginine and amlodipine (as besilate) combination tablets contains the following amount of perindopril arginine and amlodipine (as besilate 1 ) respectively: 5 mg/5 mg, 5 mg/10 mg, 10 mg/5 mg & 10 mg/10 mg. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM 5 MG/5 MG TABLET White to off-white coloured, oval-shaped biconvex tablets engraved with “APO” on one side and “5/5” on the other side. 5 MG/10 MG TABLET White to off-white coloured, square-shaped biconvex tablets engraved with “APO” on one side and “5/10” on the other side. 10 MG/5 MG TABLET White to off-white coloured, triangular-shaped biconvex tablets engraved with “APO” on one side and “10/5” on the other side. 10 MG/10 MG TABLET White to off-white coloured, round-shaped biconvex tablets engraved with “APO” on one side and “10/10” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Perindopril arginine and amlodipine combination tablets are indicated as substitution therapy for the treatment of hypertension and/or stable coronary heart disease in patients already controlled with separate doses of perindopril and amlodipine, given concurrently at the same dose level. Treatment should not be initiated with this combination. 4.2 DOSE AND METHOD OF ADMINISTRATION Perindopril Arginine/Amlodipine tablets are intended for oral administration. 1 Amlodipine doses are given as the active base. 2 Perindopril arginine and amlodipine (as besilate) combination tablet is available in strengths of 5 mg/5 mg, 5 mg/10 mg, 10 mg/5 mg and 10 mg/10 mg as substitution therapy for patients already controlled with separate doses of perindopril (5 mg or 10 mg) and amlodipine (5 mg or 10 mg), given concurrently at the dose level as indicated in Prečítajte si celý dokument