Do not take Coversyl Arginine

• if you are allergic to perindopril, or any of the other ingredients of this medicine (listed in Section 6), or to any other ACE inhibitor,
• if you have experienced symptoms such as wheezing, swelling of the face, tongue or throat, intense itching or severe skin rashes with previous ACE inhibitor treatment or if you or a member of your family have had these symptoms in any other circumstances (a condition called angioedema),
• if you are more than 3 months pregnant (it is also better to avoid Coversyl Arginine in early pregnancy — see pregnancy section),
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
• if you are having dialysis or any other type of blood filtration. Depending on the machine that is used, Coversyl Arginine may not be suitable for you,
• if you have kidney problems where the blood supply to your kidneys is reduced (renal artery stenosis),
• if you have taken or are currently taking sacubitril/valsartan, a medicine for heart failure, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is increased (see “Warnings and Precautions” and “Other medicines and Coversyl Arginine”).

Warnings and precautions

If any of the following apply to you please talk to your doctor or pharmacist or nurse before taking Coversyl Arginine if you:

• have aortic stenosis (narrowing of the main blood vessel leading from the heart) or hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery supplying the kidney with blood),
• have any other heart problems,
• have liver problems,
• have kidney problems or if you are receiving dialysis,
• have abnormally increased levels of a hormone called aldosterone in your blood (primary aldosteronism),
• suffer from a collagen vascular disease (disease of the connective tissue) such as systemic lupus erythematosus or scleroderma,
• have diabetes,
• are on a salt restricted diet or use salt substitutes which contain potassium,
• are to undergo anaesthesia and/or major surgery,
• are to undergo LDL apheresis (which is removal of cholesterol from your blood by a machine),
• are going to have desensitisation treatment to reduce the effects of an allergy to bee or wasp stings,
• have recently suffered from diarrhoea or vomiting, or are dehydrated,
• have been told by your doctor that you have an intolerance to some sugars,
• are 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 you have diabetes-related kidney problems,
  • aliskiren,

  Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
  See also information under the heading “Do not take Coversyl Arginine”.

• are of black origin since you may have a higher risk of angioedema and this medicine may be less effective in lowering your blood pressure than in non-black patients,
• are taking any of the following medicines, the risk of angioedema is increased:
  • racecadotril (used to treat diarrhoea),
  • sirolimus, everolimus, temsirolimus and other drugs belonging to the class of so-called mTor inhibitors (used to avoid rejection of transplanted organs and for cancer),
  • sacubitril (available as fixed-dose combination with valsartan), used to treat long-term heart failure,
  • linagliptin, saxagliptin, sitagliptin, vildagliptin and other drugs belonging to the class of the also called gliptins (used to treat diabetes).

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 Arginine. This may occur at any time during treatment. If you develop such symptoms, you should stop taking Coversyl arginine and see a doctor immediately. See also section 4.

You must tell your doctor if you think you are (or might become) pregnant. Coversyl Arginine is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

Children and adolescents

The use of perindopril in children and adolescents up to the age of 18 years is not recommended.

Other medicines and Coversyl Arginine

Please tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

Treatment with Coversyl Arginine can be affected by other medicines. Your doctor may need to change your dose and/or to take other precautions. These include:

• other medicines for high blood pressure, including angiotensin II receptor blockers (ARB), aliskiren (see also information under the headings “Do not take Coversyl Arginine” and “Warnings and precautions”) or diuretics (medicines which increase the amount of urine produced by the kidneys),
• potassium-sparing drugs (e.g. triamterene, amiloride), potassium supplements or potassium-containing salt substitutes, other drugs which can increase potassium in your body (such as heparin, a medicine used to thin blood to prevent clots; trimethoprim and co-trimoxazole also known as trimethoprim/sulfamethoxazole for infections caused by bacteria),
• potassium-sparing drugs used in the treatment of heart failure: eplerenone and spironolactone at doses between 12.5 mg to 50 mg per day,
• lithium for mania or depression,
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen) for pain relief or high dose acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever, as well as to prevent blood clotting,
• medicines to treat diabetes (such as insulin or metformin),
• baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis),
• medicines to treat mental disorders such as depression, anxiety, schizophrenia etc (e.g. tricyclic antidepressants, antipsychotics),
• immunosuppressants (medicines which reduce the defence mechanism of the body) used for the treatment of auto-immune disorders or following transplant surgery (e.g. ciclosporin, tacrolimus),
• trimethoprim (for the treatment of infections),
• estramustine (used in cancer therapy),
• medicines, which are most often used to treat diarrhoea (racecadotril) or avoid rejection of transplanted organs (sirolimus, everolimus, temsirolimus and other drugs belonging to the class of so-called mTor inhibitors). See section “Warnings and precautions”,
• sacubitril/valsartan (used to treat long-term heart failure). See sections “Do not take Coversyl Arginine” and “Warnings and precautions”,
• allopurinol (for the treatment of gout),
• procainamide (for the treatment of an irregular heart beat),
• vasodilators including nitrates (products that make the blood vessels become wider),
• medicines used for the treatment of low blood pressure, shock or asthma (e.g. ephedrine, noradrenaline or adrenaline),
• gold salts, especially with intravenous administration (used to treat symptoms of rheumatoid arthritis).

Coversyl Arginine with food and drink

It is preferable to take Coversyl Arginine before a meal.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Coversyl Arginine before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Coversyl Arginine. Coversyl Arginine is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding.

Coversyl Arginine is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines

Coversyl Arginine usually does not affect alertness but dizziness or weakness due to low blood pressure may occur in certain patients. If you are affected in this way, your ability to drive or to operate machinery may be impaired.

Coversyl Arginine contains lactose

Coversyl Arginine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Coversyl Arginine contains sodium

Coversyl Arginine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.