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** COVERSYL (perindopril arginine) 10 mg 15 film-coated tablets. Oral use. (ACE inhibitor, prodrug).
** Composition:
Each film-coated tablet contains:
perindopril arginine 10 mg eq. to perindopril 6.790 mg.
Contains lactose monohydrate.
** Therapeutic Indications:
– Treatment of arterial hypertension (high blood pressure).
– Stable coronary artery disease: Coversyl reduces the risk of cardiac events in patients who have already suffered at a heart attack and/or a heart bypass& or a dilation of the coronary arteries.
** Contraindications:
– Known allergy to perindopril, to any of the other ingredients or to any other medicine belonging to the same class (angiotensin converting enzyme inhibitors).
– a history of angioedema (allergic reaction with sudden wheezing, swelling of the face or tongue, intense itching or severe skin rashes) associated with previous ACE inhibitor therapy,
– a history of hereditay or idiopathic angioedema.
– during the second and third trimesters of pregnancy.
In case of doubt, consult your own doctor.
This medicine should generally not be used in children and adolescents or in pregnant women in their first trimester or in breast-feeding women.
This medicine is generally not recommended in combination with potassium-sparing diuretics, potassium salts and lithium.
** Precautions for use:
A dry cough may occur; in this case you must consult again your doctor who will decide if it is reasonable to continue the treatment.
Risk of allergic reactions, of oedema of the face, glottis and/or larynx.
Risk of allergic reactions in patients during desensitisation treatment (e.g. hymenoptera venom: bees, wasps).
Risk of allergic reactions in patients undergoing haemodialysis: inform your doctor in the case of:
– hypotension (low blood pressure) possibly in the form of dizziness or vertigo;
– salt restricted diet or prolonged diuretic treatment;
– heart, kidney or liver failure;
– renal artery stenosis or cardiac valve stenosis;
– atherosclerosis (narrowing of the arteries);
– diabetes.
If you have to undergo surgery, tell the anaesthetist that you taking this medicine.
Due to the presence of lactose, this medicine should not be used in the case of galactosaemia, the syndrome of malabsorption of glucose and galactose or a deficit in lactose (rare metabolic diseases).
** Pregnancy and Breast-feeding:
– Pregnancy:
This medicine should not be used during the first trimester of pregnancy.
If you find out that you are pregnant when taking this medicine, treatment should be discontinued and an alternative anti-hypertensive treatment should be initiated.
Inform your doctor rapidly and follow his advice.
Also inform your doctor if you wish to become pregnant.
Use of this medicine is contraindicated during the second and third trimesters of pregnancy.
Ask your doctor or pharmacist for advice before taking any medicine.
– Breast-Feeding:
There are no data about the passage of this medicine into maternal milk. Consequently administration of this medicine is not recommended in women who are breastfeeding.
Seek the advice of your doctor or pharmacist before taking any medicine.
** Drivers and people operating machinery:
Caution is recommended when driving or operating machines due to the possibility of dizziness or weariness.
** List of excipientswith a known effect:
Lactose monohydrate.
** Usual Instructions for proper use:
– Dosage: Coversyl 10 mg, film-coated tablet.
– Method and route of administration: Oral route.
– Frequency and time at which the drug should be taken: FOR ADULTS ONLY.
The recommended daily dose varies from 2.5 to 10 mg.
It is adjusted for your individual needs; it is important that you respect the doses prescribed by your doctor. The doses that you take at the start of and during the treatment are based on your state of health and on any other medicines that you are taking.
If you think that the effect of Coversyl 5 mg, film coated tablet is too strong or too weak, talk to your doctor or pharmacist.
Tablets should be swallowed with a glass of water, once daily in the morning before a meal.
– Treatment Duration: always follow your doctor’s prescription. If in doubt, consult your doctor or pharmacist.
** Please respect the prescribed doses.
** On doctor’s prescription only. Warnings in insert leaflet must be revised. Read the package leaflet before use.
** Storage conditions:
Store at temperatures below 30 degrees C. Keep the container tightly closed.
Keep out of the reach of children.
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