Coveram abridged pi

COVERAM® 5MG/5MG, 5MG/10MG, 10MG/5MG, 10MG/10MG – Abridged Product Information



COVERAM® 5MG/5MG, 5MG/10MG, 10MG/5MG, 10MG/10MG (perindopril arginine/amlodipine besylate) Abridged Product
Information. Before prescribing, please refer to Approved Product Information. Indications: substitution therapy for 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 Contraindications: History of
hypersensitivity to perindopril, amlodipine, ACE-Is, dihydropyridines or excipients; pregnancy; lactation; renal artery stenosis; history of
hereditary and/or idiopathic angio-oedema; dialysis using high-flux polyacrylonitrile ("AN69") membranes; severe hypotension; shock;
obstruction of outflow-tract of left ventricle; unstable angina (excluding Prinzmetal's angina); heart failure in first 28 days after acute MI.
Precautions: Lactose intolerance; hyperkalaemia; angioedema (+/- urticaria) to face, extremities, lips, tongue reported with ACEI-s and,
rarely, with perindopril; excessive hypotension in severe salt/volume depletion with impaired renal function, vigorous diuretic treatment or
dialysis (assess renal function). Impaired hepatic function (discontinue if jaundice or marked hepatic enzyme increases); LDL apheresis
and desensitisation treatments; cough; proteinuria (usually mild and/or transient); neutropenia / agranulocytosis / thrombocytopenia /
anaemia (usually transient); hyperkalaemia (>5.5mmol/L) with renal impairment, potassium sparing diuretics or potassium supplements
(especially diabetics, elderly); taste disturbances; agents causing renin release. Valvular stenosis; rarely increased angina frequency,
duration and/or severity at commencement of therapy or dosage increase; Congestive Heart Failure; dose-dependent peripheral oedema
(care to differentiate from left ventricular dysfunction). Use in children. Use in elderly. Use in Pregnancy: Category D. Do not use in
pregnancy. Interactions: Excessive blood pressure reduction with concomitant diuretics, ACE-I+NSAID+thiazide diuretics, intravascular
volume depletion or dialysis. Caution with potassium sparing diuretics and supplements. Caution with lithium (monitor levels). Caution with
drugs with sympathetic activity. May reduce tetracycline absorption. Not recommended with Dantrolene. CYP3A4 inducers and inhibitors
may affect amlodipine plasma concentration (adapt amlodipine dose). Baclofen may cause increase antihypertensive effect (monitor blood
pressure and renal function and adapt amlodpine dose). Antihypertensive agents and vasodilatators, Alpha-blockers (prazosin,
tamsulosin, terazosin), amifostine and tricyclic antidepressants/antipsychotics/anaesthetic may increase antihypertensive effect.
Corticosteroids may decrease antihypertensive effect. Grapefruit juice can affect pharmacokinetics of calcium channel blockers. Adverse
Reactions: Mostly mild and transient not requiring discontinuation. Joint swelling; headache; dyspnoea, asthenia, vertigo, dizziness,
cough, diarrhoea, eczema, erectile dysfunction, peripheral oedema, fatigue, lethargy. Less common reactions: consult Approved
Product Information. Dosage and Administration: one tablet per day in the morning before a meal. Adjustments with separate
perindopril and/or amlodipine products within recommended dose range. Finer adjustments with amlodipine 2.5 mg or dose of perindopril
equivalent to perindopril arginine 2.5 mg. Consult Product Information of individual perindopril and/or amlodipine products when adjusting
dose. Presentation: COVERAM 5MG/5MG- white, rod-shaped tablet containing 5 mg perindopril arginine and 5 mg amlodipine.
COVERAM 5MG/10MG- white, square-shaped tablet containing 5 mg perindopril arginine and 10 mg amlodipine. COVERAM 10MG/5MG-
white, triangular-shaped tablet containing 10 mg perindopril arginine and 5 mg amlodipine. COVERAM 10MG/10MG- white, round tablet
containing 10 mg perindopril arginine and 10 mg amlodipine. All strengths in bottles of 30. Date of Preparation: January 2011. Sponsor:
Servier Laboratories (Australia) Pty. Ltd. 8 Cato Street Hawthorn, VIC 3122. Customer Service (Toll Free) 1800 33 1675.

Source: http://www.drivetimeradio.com.au/test/resources/DriveTimeMedical/Edition102/Coveram_Abridged_PI.pdf