Coveram

Coveram

perindopril + amlodipine

Manufacturer:

Servier

Distributor:

Maxxcare
Full Prescribing Info
Contents
Perindopril arginine, amlodipine.
Description
Coveram 5/5 mg: Perindopril arginine 5 mg equiv to perindopril 3.395 mg, amlodipine besylate 6.935 mg equiv to amlodipine 5 mg.
Coveram 5/10 mg: Perindopril arginine 5 mg equiv to perindopril 3.395 mg, amlodipine besylate 13.87 mg equiv to amlodipine 10 mg.
Coveram 10/5 mg: Perindopril arginine 10 mg equiv to perindopril 6.79 mg, amlodipine besylate 6.935 mg equiv to amlodipine 5 mg.
Coveram 10/10 mg: Perindopril arginine 10 mg equiv to perindopril 6.79 mg, amlodipine besylate 13.87 mg equiv to amlodipine 10 mg.
Excipients/Inactive Ingredients:
Lactose monohydrate, magnesium stearate (E470B), microcrystalline cellulose (E460) and anhydrous colloidal silica (E551).
Action
Pharmacology: Perindopril is an inhibitor of the enzyme that converts angiotensin I into angiotensin II (Angiotensin Converting Enzyme ACE). Amlodipine is a calcium ion influx inhibitor of the dihydropyridine group (slow channel blocker or calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle.
Indications/Uses
Substitution therapy for treatment of essential hypertension and/or stable coronary artery disease, in patients already controlled with perindopril and amlodipine given concurrently at the same dose level.
Dosage/Direction for Use
One tablet per day in the morning before a meal. Coveram is not suitable for initial therapy. If a change of posology is required, the dose could be modified or individual titration with free combination may be considered.
Elderly and patients with renal failure: frequent monitoring of creatinine and potassium. Clcr < 60 ml/min: not suitable.
Hepatic impairment: individual titration with the free combination of amlodipine and perindopril.
Children and adolescents: should not be used.
Contraindications
Hypersensitivity to the active substances or to any other ACE inhibitor, or to dihydropyridines derivatives, or to any of the excipients, history of angioedema associated with previous ACE inhibitor therapy, hereditary or idiopathic angioedema, second and third trimesters of pregnancy (see Warnings and Use in Pregnancy & Lactation), concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see Pharmacology: Pharmacodynamics under Actions and Interactions), severe hypotension, shock, including cardiogenic shock, obstruction of the outflow-tract of the left ventricle (e.g. high grade aortic stenosis), haemodynamically unstable heart failure after acute myocardial infarction, concomitant use with sacubitril/valsartan (see Warnings and Interactions), extracorporeal treatments leading to contact of blood with negatively charged surfaces (see Interactions), significant bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney (see Warnings).
Warnings
Hypersensitivity/Angioedema/Intestinal angioedema: stop treatment and monitor until complete resolution of symptoms. Angioedema associated with laryngeal oedema may be fatal. Combination with sacubitril/valsartan (contraindicated due to the increased risk of angioedema). Sacubitril/valsartan must not be initiated until 36 hours after taking the last dose of perindopril therapy. Perindopril therapy must not be started until 36 hours after the last dose of sacubitril/valsartan. Concomitant use of other NEP inhibitors (e.g. racecadotril) and ACE inhibitors may also increase the risk of angioedema. Concomitant use of mTOR inhibitors may be at increased risk for angioedema.
Anaphylactoid reactions during low-density lipoproteins (LDL) apheresis: rarely, patients have experienced life-threatening anaphylactoid reactions, temporarily withhold treatment prior to exams.
Anaphylactoid reactions during desensitisation: temporarily withhold treatment prior to exams. These reactions reappeared upon inadvertent rechallenge.
Neutropenia/agranulocytosis/thrombocytopenia/anaemia: extreme caution in patients with collagen vascular disease, immunosuppressant therapy, treated with allopurinol or procainamide, periodic monitor of white blood cell counts advised.
Renovascular hypertension: increased risk of hypotension and renal insufficiency in patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney.
Diuretics may be a contributory factor. Loss of renal function may occur (minor changes in serum creatinine) even in patients with unilateral renal artery stenosis.
Dual blockade of the renin-angiotensin-aldosterone system (RAAS): concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Dual blockade of RAAS is therefore not recommended. ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
Primary aldosteronism: use not recommended in patients with primary hyperaldosteronism (not responding to drugs acting through inhibition of the renin-angiotensin system).
Pregnancy: stop treatment. If appropriate, start alternative therapy.
Special Precautions
Hypotension: monitor blood pressure, renal function and potassium in patients at high risk of symptomatic hypotension (volume depleted or who have severe renin-dependent hypertension) or with ischaemic heart or cerebrovascular disease.
A transient hypotensive response is not a contraindication to further doses once the blood pressure has increased after volume expansion.
Aortic and mitral valve stenosis/hypertrophic cardiomyopathy: use with caution.
Patients with cardiac failure: use with caution.
Renal impairment: monitor potassium and creatinine; individual dose titration with the monocomponents recommended if Clcr <60 ml/min. In patients with renal artery stenosis, blood urea and creatinine may increase; with renovascular hypertension, risk of severe hypotension and renal insufficiency.
Renal failure: amlodipine not dialysable.
Hepatic failure: rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death: stop treatment if jaundice or marked elevations of hepatic enzymes.
Impaired hepatic function: slow dose titration and careful monitoring if severe hepatic impairment.
Black people: perindopril may be less effective and cause a higher rate of angioedema than in non-Black. Non-productive cough.
Surgery/Anaesthesia: stop treatment one day prior to surgery.
Hyperkaliemia: frequent monitoring of blood potassium if renal insufficiency, worsening of renal function, age (>70 years), diabetes mellitus, dehydration, acute cardiac decompensation, metabolic acidosis, and concomitant use of potassium-sparing diuretics and potassium salts.
Diabetic patients: monitor glycaemia during first month.
Hypertensive crisis: safety and efficacy not established.
Elderly patients: dosage increase with care.
Galactose intolerance/glucose-galactose malabsorption/total lactase deficiency: should not be taken.
Drive and Use Machines: May be impaired if dizziness, headache, fatigue, weariness or nausea.
Use In Pregnancy & Lactation
Pregnancy and Breastfeeding: Not recommended during the first trimester of pregnancy and lactation. Contraindicated during the second and third trimesters of pregnancy.
Fertility: Reversible biochemical changes of spermatozoa in some patients treated by calcium channel blockers.
Adverse Reactions
Very common: oedema.
Common: somnolence, dizziness, headache, dysgeusia, paraesthesia, vertigo, visual impairment, diplopia, tinnitus, palpitations, flushing, hypotension, dyspnea, cough, abdominal pain, nausea, vomiting, dyspepsia, change of bowel habit, diarrhoea, constipation, pruritus, rash, exanthema, joint swelling (ankle swelling), muscle spasms, fatigue, asthenia.
Uncommon: rhinitis, eosinophilia, hypersensitivity, hypoglycaemia, hyperkalaemia, hyponatraemia, insomnia, mood altered, anxiety, depression, sleep disorder, tremor, hypoaesthesia, syncope, tachycardia, arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation), vasculitis, bronchospasm, dry mouth, angioedema of face, extremities, lips, mucous membranes, tongue, glottis and/or larynx, alopecia, purpura, skin discolouration, hyperhidrosis, urticaria, photosensitivity reactions, pemphigoid, arthralgia, myalgia, back pain, micturition disorders, nocturia, pollakiuria, renal failure, erectile dysfunction, gynaecomastia, oedema peripheral, chest pain, pain, malaise, pyrexia, weight increased, weight decreased, blood urea increased, blood creatinine increased, fall.
Rare: confusional state, psoriasis aggravation, blood bilirubin increase, hepatic enzyme increase.
Very rare: leukopenia/neutropenia, agranulocytosis or pancytopenia, thrombocytopenia, haemolytic anaemia enzyme specific in patients with a congenital deficiency of G-6PDH, hyperglycaemia, hypertonia, neuropathy peripheral, cerebrovascular accident possibly secondary to excessive hypotension in high-risk patients, angina pectoris, myocardial infarction, eosinophilic pneumonia, gingival hyperplasia, pancreatitis, gastritis, hepatitis, jaundice, hepatitis either cytolitic or cholestatic, hepatic enzymes increased, Quincke's oedema, erythema multiform, Stevens-Johnson Syndrome, exfoliative dermatitis, renal failure acute, haemoglobin decreased and haematocrit decreased.
Not known: extrapyramidal disorder (extrapyramidal syndrome) and toxic epidermal necrolysis. Syndrome of inappropriate antidiuretic hormone secretion (SIADH) can be considered as a very rare complication associated with ACE inhibitor therapy.
Drug Interactions
Contra-indicated: aliskiren in diabetic or impaired renal patients, Extracorporeal treatments, Sacubitril/Valsartan.
Not recommended: aliskiren, (in other patients) angiotensin-receptor blocker, estramustine, Co-trimoxazole (trimethoprim/sulfamethoxazole), potassium sparing diuretics (triamterene, amiloride), potassium salts, lithium, dantrolene (infusion), grapefruit or grapefruit juice.
Special care: antidiabetic agents (insulins, oral hypoglycaemic agents), non-potassium-sparing diuretics, potassium sparing diuretics (eplerenone, spironolactone), racecadotril, mTOR inhibitors (sirolimus, everolimus, temsirolimus), non-steroidal anti-inflammatory medicinal products (NSAIDs) including aspirin ≥3 g/day, CYP3A4 inducers, CYP3A4 inhibitors, baclofen.
To be taken into consideration: gliptines (linagliptine, saxagliptine, sitagliptine, vildagliptine), sympathomimetics, gold, tacrolimus, cyclosporine, simvastatin, antihypertensive agents and vasodilatators, corticosteroids, tetracosactide, alpha-blockers (prazosin, alfuzosin, doxazosin, tamsulosin, terazosin), amifostine, tricyclic antidepressants, antipsychotics, anaesthetics, other medicinal products with antihypertensive properties.
Storage
Store below 30°C. Protect from moisture.
Shelf-Life: 2 years.
ATC Classification
C09BB04 - perindopril and amlodipine ; Belongs to the class of ACE inhibitors and calcium channel blockers. Used in the treatment of cardiovascular diseases.
Presentation/Packing
Tab 5/5 mg (white, rod-shaped, engraved with 5/5 on one face and
Click on icon to see table/diagram/image
on the other) x 10's, 30's. 5/10 mg (white, square-shaped, engraved with 5/10 on one face and
Click on icon to see table/diagram/image
on the other) x 10's, 30's. 10/5 mg (white, triangular-shaped, engraved with 10/5 on one face and
Click on icon to see table/diagram/image
on the other) x 10's, 30's. 10/10 mg (white, round, engraved with 10/10 on one face and
Click on icon to see table/diagram/image
on the other) x 10's, 30's.
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