COPERIL 4

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COMPOSITION: Perindopril erbumine ................. 4 mg
 Excipients q.s ....................... 1 caplet
(Indigo carmine lake, green lake, lactose monohydrate, avicel, sodium starch glycolate, magnesium stearate, PVP K30).
DOSAGE FORM: Caplet.
PRESENTATION: Box of 1 blister x 30 caplets.
PHARMACODYNAMICS: Coperil 4 contains perindopril, which is an ACE (Angiotensin Converting Enzyme) inhibitor and gives its action through perindoprilat activity. Perindopril catalyzes conversion of angiotensin I to angiotensin II, a potent vasoconstrictor. Inhibition of ACE results in decreased plasma angiotensin II, leading to decreased vasoconstriction, increased plasma renin activity and decreased aldosterone secretion. The latter results in natriuresis and may be associated with a small increase of serum potassium. Due to ACE inactivates bradykinin, inhibition of ACE enhances the activity of local Kallikrein-Kinin system in circulation and therefore activating prostaglandin system. This mechanism also helps to lower blood pressure.
In patients with hypertension, blood pressure reduction after perindopril administration was accompanied a reduction in peripheral arterial resistance. Perindopril often causes arteriectasia and phlebectasia.
In patients with congestive heart failure, perindopril reduces left ventricular hypertrophy, cardiac load, left and right ventricular loading pressure, systemic peripheral obstruction, cardiac frequency and increases cardiac output.
In patients of stable angina with no clinical signs of heart failure, perindopril helps to reduce the cardiovascular events.
PHARMACOKINETICS: Perindopril is quickly absorbed after oral administration (peak plasma concentrations occurring 1 hour) and extensively metabolized in the liver to active perindoprilat. The presence of food reduces the biological conversion to perindoprilat and therefore reducing bioavailability. Perindoprilat is excreted in the urine. The half-life elimination is approximately 3 to 5 hours.
INDICATIONS: Hypertension. Congestive heart failure. Chronic ischaemic heart diseases (stable angina).
CONTRAINDICATIONS: Perindodril is contraindicated in:
Patients known to be hypersensitive to this drug.
Patients with a history of angioedema related to previous treatment with an ACE inhibitor.
Children (No study on children has now been reported).
PRECAUTIONS: Perindopril is used with caution in patients with:
Heart failure, water-salt loss, risk of hypotension and/or renal impairment, renal artery stenosis.
Hemodialysis, renal impairment, hypertension due to renal blood vessel, congestive heart failure, surgery, diabetes, stable angina pectoris.
Perindopril should be used with caution when administered to elderly patients.
PREGNANCY AND LACTATION:
The drug is contraindicated in pregnant and nursing women.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
No document has been reported.
INTERACTIONS: Nonsteroidal anti-inflammatory drugs, corticoids, tetracosactide reduce the effect of perindopril. Patients on diuretics may occasionally experience an excessive reduction of blood pressure after initiation of perindopril. Combination of perindopril with tranquillizers and imipramine antidepressant has been reported to increase risk of
postural hypotension. Perindopril increases the hypotensive effect of insulin and hypotensive drugs. Use of perindopril and potassium-sparing diuretics, potassium supplements can increase the risk of hyperkalemia, particularly in patients with renal impairment. Increased serum lithium has been reported in patients receiving concomitant lithium and perindopril therapy.
ADVERSE EFFECTS: Frequent: headache, temper and/or sleep disorders, asthenia; inadequate control at the onset of blood pressure. Gastrointestinal disturbances, taste disorders, dizziness, and cramp. Local rash on skin. Irritation-type dry cough.
Less frequent: impotence, dry mouth; mild decrease in hemoglobin at the onset of treatment, transient hyperkalemia; uraemia, increase in blood creatinine (the symptoms are recoverable when discontinuing the therapy)
Rare: oedema on face, head of legs, lips, tongue, glottis, larynx.
Inform your physician about any adverse effects occur during the treatment.
OVERDOSAGE: Signs and symptoms are related to hypotension.
Treatment of overdosage: gastric lavage, intravenous infusion of normal saline solution should be instituted.
Perindopril can be removed by hemodialysis (70 ml per min)
DOSAGE & ADMINISTRATION: Perindopril should be administered once before breakfast, during fasting time (before meals).
Use in hypertensive patients, the recommended dose is 4 mg a day; if necessary, the dosage can be increased to 8 mg after one month treated.
Use in the elderly patients, the recommended dose is 2 mg a day; if necessary, the dosage can be increased to 4 mg after one month treated.
Use in patients with impaired renal function: The dosage should be adjusted according to degrees of renal impairment.
Creatinine clearance from 30 to 60 ml per minute: 2 mg/ day.
Creatinine clearance from 15 to 30 ml per minute: 2 mg every 2 days.
Creatinine clearance below 15 ml per minute: 2 mg during dialysis.
Use in patients with congestive heart failure, the recommended dose is 2 mg a day and the maintenance dose is 2 - 4 mg a day. For patients having a risk of congestive heart failure, the initial dose should be 1 mg.
Use in patients with stable angina, the drug should be given at an initial dose of 4 mg daily for 2 weeks, and then increased as tolerated, to a maintenance dose of 8 mg once daily. 
Or as prescribed by the physician.
Keep out of the reach of children.
Read the directions carefully before use.
Consult the physician for more information.
The drug is for prescription only.
Shelf-life: 36 months from the manufacturing date.
Storage conditions:
Store in dry places, not exceeding 30oC, protect from light.
Specifications: Manufacturer's.

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