Coversyl Arginine 5 mg Film-coated Tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Coversyl Arginine is and what it is used for
2. What you need to know before you take Coversyl Arginine
3. How to take Coversyl Arginine
4. Possible side effects
5. How to store Coversyl Arginine
6. Content of the pack and other information

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 are being treated with sacubitril/valsartan, a medicine for heart failure (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).
  • sacubitril (available as fixed-dose combination with valsartan), used to treat long-term heart failure.

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 and co-trimoxazole also known as trimethoprim/sulfamethoxazole),
• 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 aspirin,
• 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.

Use in children and adolescents

Use in children and adolescents is not recommended.

If you take more Coversyl Arginine than you should

If you take too many tablets, contact your nearest accident and emergency department or tell your doctor immediately. The most likely effect in case of overdose is low blood pressure which can make you feel dizzy or faint. If this happens, lying down with the legs raised can help.

If you forget to take Coversyl Arginine

It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of Coversyl arginine, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Coversyl Arginine

As the treatment with Coversyl Arginine is usually life-long, you should discuss with your doctor before stopping this medicinal product.

Tell your doctor if you notice any of the following side effects:

Common (may affect up to 1 in 10 people):

• headache,
• dizziness,
• vertigo,
• pins and needles,
• vision disturbances,
• tinnitus (sensation of noises in the ears),
• cough,
• shortness of breath (dyspnoea),
• gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, dyspepsia or difficulty of digestion, diarrhoea, constipation),
• allergic reactions (such as skin rashes, itching),
• muscle cramps,
• feeling of weakness.

Uncommon (may affect up to 1 in 100 people):

• mood swings,
• sleep disturbances,
• dry mouth,
• intense itching or severe skin rashes,
• formation of blister clusters over the skin,
• kidney problems,
• impotence,
• sweating,
• excess of eosinophils (a type of white blood cells),
• somnolence,
• fainting,
• palpitations,
• tachycardia,
• vasculitis (inflammation of blood vessels),
• photosensitivity reaction (increased sensitivity of the skin to sun),
• arthralgia (joint pain),
• myalgia (muscle pain),
• chest pain,
• malaise,
• oedema peripheral,
• fever,
• fall,
• change in laboratory parameters: high blood level of potassium reversible on discontinuation, low level of sodium, hypoglycaemia (very low blood sugar level) in case of diabetic patients, increased blood urea, and increased blood creatinine.

Rare (may affect up to 1 in 1000 people):

• psoriasis worsening,
• changes in laboratory parameters: Increased level of liver enzymes, high level of serum bilirubin

Very rare (may affect up to 1 in 10,000 people):

• confusion,
• eosinophilic pneumonia (a rare type of pneumonia),
• rhinitis (blocked up or runny nose),
• acute renal failure,
• changes in blood values such as a lower number of white and red blood cells, lower haemoglobin, lower number of blood platelets.

Concentrated urine (dark in colour), feel or are sick, have muscle cramps, confusion and fits which may be due to inappropriate ADH (anti-diuretic hormone) secretion can occur with ACE inhibitors.

If you have these symptoms contact your doctor as soon as possible.

Frequency not known (cannot be estimated from available data):

Discoloration, numbness and pain in fingers or toes (Raynaud‘s phenomenon).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

What Coversyl Arginine contains

• The active substance is perindopril arginine. One film-coated tablet contains 1.6975 mg perindopril (corresponding to 2.5 mg perindopril arginine), or 3.395 mg perindopril (corresponding to 5 mg perindopril arginine), or 6.790 mg perindopril (corresponding to 10 mg perindopril arginine).
• The other ingredients in the tablet core are: lactose monohydrate, magnesium stearate, maltodextrin, hydrophobic colloidal silica, sodium starch glycolate (type A), and in the tablet film-coating: glycerol, hypromellose, macrogol 6000, magnesium stearate, titanium dioxide and for the 5 mg and 10 mg tablets copper chlorophyllin.

What Coversyl arginine looks like and contents of the pack

Coversyl arginine 2.5 mg tablets are white, round, convex, film coated tablets.

Coversyl arginine 5 mg tablets are light-green, rod-shaped film-coated tablets engraved with the Servier logo on one face and scored on both edges. The tablet can be divided into equal halves.

Coversyl arginine 10 mg tablets are green, round, biconvex, film-coated tablets engraved with a heart on one face and the Servier logo on the other face.

The tablets are available in box of 5, 10, 14, 20, 28, 30, 50, 60 (60 or 2 containers of 30), 84 (84 or 3 containers of 28), 90 (90 or 3 containers of 30), 100 (100 or 2 containers of 50), 120 (120 or 4 containers of 30) or 500 tablets (500 or 10 containers of 50).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Manufacturer