País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
perindopril arginine, Quantity: 10 mg; amlodipine besilate, Quantity: 6.935 mg
Servier Laboratories (Aust) Pty Ltd
amlodipine besilate,perindopril arginine
Tablet, uncoated
Excipient Ingredients: microcrystalline cellulose; lactose monohydrate; magnesium stearate; colloidal anhydrous silica
Oral
30 tablets
(S4) Prescription Only Medicine
APX-PERINDOPRIL ARGININE/ AMLODIPINE 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, triangular-shaped tablet with 10/5 on one face and servier logo on the other face; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2013-06-21
APX-PERINDOPRIL ARGININE/ AMLODIPINE 1 APX-PERINDOPRIL ARGININE/ AMLODIPINE _5/5; 5/10; 10/5; 10/10 _ _Perindopril/amlodipine [pronounced per-in-do-pril/ am-load-i-peen] _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about APX- PERINDOPRIL ARGININE/ AMLODIPINE. It does not contain all the available information about this medicine. Reading this leaflet 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 taking APX- PERINDOPRIL ARGININE/ AMLODIPINE 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 THE MEDICINE. YOU MAY NEED TO READ IT AGAIN. WHAT APX- PERINDOPRIL ARGININE/ AMLODIPINE IS The name of your medicine is APX- PERINDOPRIL ARGININE/ AMLODIPINE. The medicine contains the active ingredient perindopril arginine. Perindopril belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors. It also contains the active ingredient amlodipine besilate. 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. APX-PERINDOPRIL ARGININE/ AMLODIPINE has been prescribed for you by your doctor to replace the separate tablets of perindopril and amlodipine you were taking. One APX-PERINDOPRIL ARGININE/ AMLODIPINE tablet replaces separate tablets of perindopril and amlodipine. WHAT APX- PERINDOPRIL ARGININE/ AMLODIPINE IS USED FOR You have been prescribed APX- PERINDOPRIL ARGININE/ AMLODIPINE if you have high blood pressure, also known as hypertension. _WHY APX-PERINDOPRIL _ _ARGININE/ 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 p Llegiu el document complet
AUSTRALIAN PRODUCT INFORMATION APX-PERINDOPRIL ARGININE/ AMLODIPINE (PERINDOPRIL ARGININE / AMLODIPINE BESILATE) Version: 1 1/37 AUSTRALIAN PRODUCT INFORMATION – APX-PERINDOPRIL ARGININE/ AMLODIPINE (PERINDOPRIL ARGININE / AMLODIPINE BESILATE) TABLETS 1 NAME OF THE MEDICINE Perindopril arginine / Amlodipine besilate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active components of APX-PERINDOPRIL ARGININE/ AMLODIPINE are perindopril arginine and amlodipine besilate. Each APX-PERINDOPRIL ARGININE/ AMLODIPINE 5/5 tablet contains 5 mg of perindopril arginine and 5 mg of amlodipine (as besilate ‡ ) Each APX-PERINDOPRIL ARGININE/ AMLODIPINE 5/10 tablet contains 5 mg of perindopril arginine and 10 mg of amlodipine (as besilate ‡ ) Each APX-PERINDOPRIL ARGININE/ AMLODIPINE 10/5 tablet contains 10 mg of perindopril arginine and 5 mg of amlodipine (as besilate ‡ ) Each APX-PERINDOPRIL ARGININE/ AMLODIPINE 10/10 tablet contains 10 mg of perindopril arginine and 10 mg of amlodipine (as besilate ‡ ) Excipient with known effect: sugars as lactose For the full list of excipients, _see section 6.1 - List of excipients. _ 3 PHARMACEUTICAL FORM APX-PERINDOPRIL ARGININE/ AMLODIPINE 5/5 is a white, rod-shaped tablet engraved with 5/5 on one face and the Servier company logo on the other face. APX-PERINDOPRIL ARGININE/ AMLODIPINE 5/10 is a white, square-shaped tablet engraved with 5/10 on one face and the Servier company logo on the other face. APX-PERINDOPRIL ARGININE/ AMLODIPINE 10/5 is a white, triangular-shaped tablet engraved with 10/5 on one face and the Servier company logo on the other face. APX-PERINDOPRIL ARGININE/ AMLODIPINE 10/10 is a white, round tablet engraved with 10/10 on one face and the Servier company logo on the other face. ‡ Amlodipine doses are given as active base AUSTRALIAN PRODUCT INFORMATION APX-PERINDOPRIL ARGININE/ AMLODIPINE (PERINDOPRIL ARGININE / AMLODIPINE BESILATE) Version: 1 2/37 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS APX-PERINDOPRIL ARGININE/ AMLODIPINE is indicated as s Llegiu el document complet