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ETC / RX - Cardiovascular system - Opecosyl Plus

COMPOSITION:

Perindopril tert-butylamine: 4 mg
Indapamide: 1.25 mg


INDICATIONS:

Treatment for essential hypertension in subjects whose hypertension is not controlled by perindopril tert-butylamine in monotherapy.


ADMINISTRATION AND DOSAGE:

A single oral dose per day, preferably to be taken in the morning, and before a meal.


CONTRAINDICATIONS:

Hypersensitivity to any components of this drug or to sulfonamides.

History of angioneurotic oedema (Quincke’s oedema) associated with previous ACE inhibitor

Hereditary/idiopathic angioneurotic oedema

Pregnancy or lactation

Severe renal failure (creatinine clearance below 30 ml/min)

Hepatic encephalopathy

Severe impairment of liver function

Hypokalaemia

Untreated decompensated cardiac insufficiency.


WARNINGS AND PRECAUTIONS:

Opecosyl Plus should not be used in children as the efficacy and tolerability of perindopril in children, alone or in combination, have not been established.
Cough: Dry cough may occur; in this case the patient must consult again your doctor who will decide if it is reasonable to continue the treatment.
Hypotension: This drug may cause a fall in blood pressure. Symptomatic hypotension is more likely to occur in patients who have been volume-depleted, dietary salt restriction, diarrhoea or vomiting, or who have severe renin-dependent hypertension.

Renal impairment:
In cases of severe renal insufficiency (creatinine clearance <30 ml/min), treatment is contraindicated. It is not necessary to change the dose when creatinine clearance is greater than 60 ml/min. Usual medical follow-up will include frequent monitoring of creatinine and potassium during treatment of Opecosyl Plus in patients with renal insufficiency.
Potassium levels:
The combination of perindopril and indapamide does not prevent the onset of hypokalaemia particularly in diabetic patients or in patients with renal failure.
Hypersensitivity/Angioedema
Angioedema of the face, extremities, lips, mucous membranes, tongue, glottis and/or larynx has been reported rarely in patients treated with ACE inhibitors.
Liver impairment
When liver function is impaired, thiazide diuretics and thiazide-related diuretics may cause hepatic encephalopathy. Administration of the diuretic should be stopped immediately if this occurs.
Known atherosclerosis:
The risk of hypotension exists in all patients but particular care should be taken in patients with ischaemic heart disease or cerebral circulatory insufficiency.

It should be used with caution in patients with disorders of electrolyte balance, diabetes, gout, strict sodium-free diets, heart failure and renal artery stenosis.

Pregnancy and lactation.


SIDE EFFECTS:

Tiredness, dizziness, headache, mood swings and/or sleep disturbances, cramp, orthostatic hypotension, allergic reactions, skin rashes, stomach pain, loss of appetite, nausea, abdominal pain, constipation, taste disturbance, dry cough, dry mouth.
Exceptionally Quincke’s oedema.
Increased risk of dehydration in elderly patients and in patients with heart failure, changes in blood test results may occur, particularly loss of potassium in elderly or malnourished patients.


INTERACTIONS:

You must tell your doctor or pharmacist if you are receiving or have recently taken another drug, in particular lithium, potassium salts, potassium-sparing diuretics, some medicines which can cause heart rhythm disorders, cardiac glycosides, antidiabetic agents, anaesthetics, allopurinol, ciclosporin, cytostatic agents or immunosuppressants treatment, corticosteroids, NSAIDs, antihypertensive agents, even if it is a drug obtained without prescription


PRESENTATION:

Box of 3 blisters x 10 tablets.