Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
amlodipine besilate, Quantity: 13.87 mg; perindopril arginine, Quantity: 5 mg
Servier Laboratories (Aust) Pty Ltd
amlodipine besilate,perindopril arginine
Tablet, uncoated
Excipient Ingredients: microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; lactose monohydrate
Oral
10 Tablets, medical sample pack, 10 tablets, commercial pack, 30 Tablets, commercial pack
(S4) Prescription Only Medicine
COVERAM 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, square-shaped tablet with 5/10 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
2010-01-11
COVERAM ® _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 COVERAM. 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 COVERAM 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 COVERAM IS The name of your medicine is COVERAM. 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. COVERAM has been prescribed for you by your doctor to replace the separate tablets of perindopril and amlodipine you were taking. One COVERAM tablet replaces separate tablets of perindopril and amlodipine. WHAT COVERAM IS USED FOR You have been prescribed COVERAM if you have high blood pressure, also known as hypertension. _WHY COVERAM 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 blood pressure. The only way of knowing that you have it is to have your blood pressure checked on a regular basis. If high blood pressure is not treated it can lead to serious health problems. You may feel Lesen Sie das vollständige Dokument
AUSTRALIAN PRODUCT INFORMATION COVERAM® (PERINDOPRIL ARGININE / AMLODIPINE BESILATE) Version: 16 1/36 AUSTRALIAN PRODUCT INFORMATION – COVERAM ® (PERINDOPRIL ARGININE / AMLODIPINE BESILATE) TABLETS 1 NAME OF THE MEDICINE Perindopril arginine / Amlodipine besilate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active components of COVERAM are perindopril arginine and amlodipine besilate. Each COVERAM 5/5 tablet contains 5 mg of perindopril arginine and 5 mg of amlodipine (as besilate ‡ ) Each COVERAM 5/10 tablet contains 5 mg of perindopril arginine and 10 mg of amlodipine (as besilate ‡ ) Each COVERAM 10/5 tablet contains 10 mg of perindopril arginine and 5 mg of amlodipine (as besilate ‡ ) Each COVERAM 10/10 tablet contains 10 mg of perindopril arginine and 10 mg of amlodipine (as besilate ‡ ) Excipient with known effect: contains sugars as lactose For the full list of excipients, _see section 6.1 - List of excipients. _ 3 PHARMACEUTICAL FORM COVERAM 5/5 is a white, rod-shaped tablet engraved with 5/5 on one face and the Servier company logo on the other face. COVERAM 5/10 is a white, square-shaped tablet engraved with 5/10 on one face and the Servier company logo on the other face. COVERAM 10/5 is a white, triangular-shaped tablet engraved with 10/5 on one face and the Servier company logo on the other face. COVERAM 10/10 is a white, round tablet engraved with 10/10 on one face and the Servier company logo on the other face. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS COVERAM 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. 4.2 D OSE AND METHOD OF ADMINISTRATION COVERAM (perindopril arginine/ amlodipine) 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 dose Lesen Sie das vollständige Dokument