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Stop taking COVERSYL ARGININE and contact the doctor immediately if the patient experiences any of the following: swelling of the face, lips, tongue and/or larynx, which result in difficulty in breathing or swallowing.
If any of the following applies to the patient, please talk to the doctor or pharmacist or nurse before taking Coversyl, if the patient: has aortic stenosis (narrowing of the main blood vessel leading from the heart) or hypertrophic cardiomyopathy (cardiac muscle disease) or renal artery stenosis (narrowing of the artery supplying the kidney with blood); has any other heart problems; has liver problems; has kidney problems or if the patient is receiving dialysis; suffers from a collagen vascular disease (disease of the connective tissue) such as systemic lupus erythematosus or scleroderma; has diabetes; is on a salt restricted diet or use salt substitutes which contain potassium; is to undergo anaesthesia and/or major surgery; is to undergo LDL apheresis (which is removal of cholesterol from the blood by a machine); is going to have treatment to make the patient less sensitive to the effects of an allergy to bee or wasp stings; has recently suffered from diarrhoea or vomiting, or is dehydrated; has been told by the doctor that the patient has an intolerance to some sugars; has been told by the doctor that the patient has phenylketonuria; is taking any of the following medicines used to treat high blood pressure: an "angiotensin II receptor blocker" (ARBs) (also known as sartans - for example valsartan, telmisartan, irbesartan), in particular if the patient has diabetes-related kidney problems; Aliskiren.
The doctor may check the kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in the blood at regular intervals. See also information under "Contraindications".
Hyperkalaemia; patients taking other drugs associated with increases in serum potassium (e.g. heparin, co-trimoxazole also known as trimethoprim/sulfamethoxazole); is of black origin since the patient may have a higher risk of angioedema and this medicine may be less effective in lowering the blood pressure than in non-black patients; is taking any of the following medicines, the risk of angioedema is increased: racecadotril (used to treat diarrhea); sirolimus, everolimus, temsirolimus and other drugs belonging to the class of so-called mTor inhibitors (used to avoid rejection of transplanted organs).
Angioedema: Angioedema (a severe allergic reaction with swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing) has been reported in patients treated with ACE inhibitors, including Coversyl. This may occur at any time during treatment. If the patient develops such symptoms, the patient should stop taking Coversyl and see a doctor immediately (see "Adverse Reactions").
The combination of perindopril with sacubitril/valsartan is contraindicated due to the increased risk of angioedema (see "Contraindications"). Sacubitril/valsartan must not be initiated until 36 hours after taking the last dose of perindopril therapy. If treatment with sacubitril/valsartan is stopped, perindopril therapy must not be initiated until 36 hours after the last dose of sacubitril/valsartan (see "Contraindications" and "Interactions"). Concomitant use of other NEP inhibitors (e.g. racecadotril) and ACE inhibitors may also increase the risk of angioedema (see "Interactions"). Hence, a careful benefit-risk assessment is needed before initiating treatment with NEP inhibitors (e.g. racecadotril) in patients on perindopril.
Renovascular hypertension: There is an increased risk of hypotension and renal insufficiency when patient with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with ACE inhibitors (see "Contraindications"). Treatment with diuretics may be a contributory factor. Loss of renal function may occur with only minor changes in serum creatinine even in patients with unilateral renal artery stenosis.
Primary aldosteronism: Patients with primary hyperaldosteronism generally will not respond to anti-hypertensive drugs acting through inhibition of the renin-angiotensin system. Therefore, the use of this product is not recommended.
Drivers and machinery operators: Special care should be taken by drivers and machine operators due to the risk of dizziness.
Use in Pregnancy: The patient must tell the doctor if the patient thinks that she (or might become) pregnant. Coversyl is not recommended in early pregnancy, and must not be taken if the patient is more than 3 months pregnant, as it may cause serious harm to the baby if used at this stage (see "Use in Pregnancy & Lactation").
Use in Children: The use of perindopril in children and adolescents up to the age of 18 years is not recommended.
