PACKAGE LEAFLET: INFORMATION FOR THE USER

COVERSYL® ARGININE PLUS 5MG/1.25MG TABLETS

(perindopril arginine / indapamide)

Your medicine is available using the name Coversyl Arginine Plus 5mg/1.25mg Tablets but will be referred to as Coversyl Arginine Plus throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine.

■    Keep this leaflet. You may need to read it again.

■    If you have any further questions, ask your doctor or pharmacist.

■    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

■    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Coversyl Arginine Plus is and what it is used for

2.    Before you take Coversyl Arginine Plus

3.    How to take Coversyl Arginine Plus

4.    Possible side effects

5.    How to store Coversyl Arginine Plus

6.    Further information

1.    What Coversyl Arginine Plus is and what it is used for

What is Coversyl Arginine Plus?

Coversyl Arginine Plus is a combination of two active ingredients, perindopril arginine and indapamide. It is an anti-hypertensive and is used in the treatment of high blood pressure (hypertension).

What is Coversyl Arginine Plus used for?

Perindopril arginine belongs to a class of medicines called ACE inhibitors. These work by widening the blood vessels, which makes it easier for your heart to pump blood through them. Indapamide is a diuretic. Diuretics increase the amount of urine produced by the kidneys. However, indapamide is different from other diuretics, as it only causes a slight increase in the amount of urine produced. Each of the active ingredients reduces blood pressure and they work together to control your blood pressure.

2.    Before you take Coversyl Arginine Plus

Do not take Coversyl Arginine Plus

■    if you are allergic to perindopril arginine or any other ACE inhibitor, or to indapamide or any other sulphonamides or any of the other ingredients of Coversyl Arginine Plus,

■    if you have experienced symptoms such as wheezing, swelling of the face or tongue, 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 have severe liver disease or suffer from a condition called hepatic encephalopathy (degenerative disease of the brain),

■    if you have a severe kidney disease or if you are receiving dialysis,

■    if you have low or high blood potassium,

■    if you are suspected of having untreated decompensated heart failure (severe water retention, difficulty in breathing),

■    if you are more than 3 months pregnant (It is also better to avoid Coversyl Arginine Plus in early pregnancy - see "Pregnancy and Breast-feeding"),

■    if you are breast-feeding.

Take special care with Coversyl Arginine Plus

If any of the following apply to you please talk to your doctor before taking Coversyl Arginine Plus:

■    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),

■    if you have any other heart problems or problems with your kidneys,

■    if you have liver problems,

■    if you suffer from a collagen disease (skin disease) such as systemic lupus erythematosus or scleroderma,

■    if you have atherosclerosis (hardening of the arteries),

■    if you suffer from hyperparathyroidism (overactive parathyroid gland),

■    if you suffer from gout,

■    if you have diabetes,

■    if you are on a salt restricted diet or use salt substitutes which contain potassium,

■    if you take lithium or potassium-sparing diuretics (spironolactone, triamterene) as their use with Coversyl Arginine Plus should be avoided (see "Taking other medicines").

You must tell your doctor if you think that you are (or might become) pregnant. Coversyl Arginine Plus 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 and Breast-feeding").

When you are taking Coversyl Arginine Plus, you should also inform your doctor or the medical staff:

■    if you are to undergo anaesthesia and/or surgery,

■    if you have recently suffered from diarrhoea or vomiting, or are dehydrated,

■    if you are to undergo dialysis or LDL apheresis (which is removal of cholesterol from your blood by a machine),

■    if you are going to have desensitisation treatment to reduce the effects of an allergy to bee or wasp stings,

■    if you are to undergo a medical test that requires injection of an iodinated contrast agent (a substance that makes organs like kidney or stomach visible on an X-ray).

Athletes should be aware that Coversyl Arginine Plus contains an active ingredient (indapamide) which may give a positive reaction in drug tests.

Coversyl Arginine Plus should not be given to children.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

You should avoid Coversyl Arginine Plus with:

■    lithium (used to treat depression),

■    potassium-sparing diuretics (spironolactone, triamterene), potassium salts.

Treatment with Coversyl Arginine Plus can be affected by other medicines. Make sure to tell your doctor if you are taking any of the following medicines as special care may be required:

■    other medicines for treating high blood pressure,

■    procainamide (for the treatment of an irregular heart beat),

■    allopurinol (for the treatment of gout),

■    terfenadine or astemizole (antihistamines for hay fever or allergies),

■    corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis,

■    immunosuppressants used for the treatment of autoimmune disorders or following transplant surgery to prevent rejection (e.g. ciclosporin),

■    medicines for the treatment of cancer,

■    erythromycin by injection (an antibiotic),

■    halofantrine (used to treat certain types of malaria),

■    pentamidine (used to treat pneumonia),

■    injectable gold (used to treat rheumatoid polyarthritis),

■    vincamine (used to treat symptomatic cognitive disorders in elderly including memory loss),

■    bepridil (used to treat angina pectoris),

■    sultopride (for the treatment of psychoses),

■    medicines used for heart rhythm problems (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol),

■    digoxin or other cardiac glycosides (for the treatment of heart problems),

■    baclofen (to treat muscle stiffness occurring in diseases such as multiple sclerosis),

■    medicines to treat diabetes such as insulin or metformin,

■    calcium including calcium supplements,

■    stimulant laxatives (e.g. senna),

■    non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or high dose salicylates (e.g. aspirin),

■    amphotericin B by injection (to treat severe fungal disease),

■    medicines to treat mental disorders such as depression, anxiety, schizophrenia...(e.g. tricyclic antidepressants, neuroleptics),

■    tetracosactide (to treat Crohn's disease).

Taking Coversyl Arginine Plus with food and drink

It is preferable to take Coversyl Arginine Plus before a meal.

Pregnancy and breast-feeding Pregnancy

You must tell your doctor if you think that you are (or might become) pregnant. Your doctor will normally advise you to stop taking Coversyl Arginine Plus 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 Plus. Coversyl Arginine Plus 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

You must not take Coversyl Arginine Plus if you are breastfeeding. Tell your doctor immediately if you are breast-feeding or about to start breast-feeding.

See your doctor immediately.

Driving and using machines

Coversyl Arginine Plus usually does not affect alertness but different reactions such as dizziness or weakness in relation to the decrease in blood pressure may occur in certain patients. If affected, your ability to drive or to operate machinery may be impaired.

Important information about some of the ingredients of Coversyl Arginine Plus

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

3. How to take Coversyl Arginine Plus

Always take Coversyl Arginine Plus exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is one tablet once a day. Your doctor may decide to modify the dosage regimen if you suffer from renal impairment. Take your tablet preferably in the morning and before a meal. Swallow the tablet with a glass of water.

If you take more Coversyl Arginine Plus than you should

If you take too many tablets, contact your doctor or nearest hospital casualty department immediately. The most likely effect in case of overdose is low blood pressure. If marked low blood pressure occurs (symptoms such as dizziness or faintness), lying down with the legs raised can help.

If you forget to take Coversyl Arginine Plus

It is important to take your medicine every day as regular treatment is more effective. However, if you forget to take a dose of Coversyl Arginine Plus, 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 Plus

As the treatment for high blood pressure is usually life-long, you should discuss with your doctor before stopping this medicinal product.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Coversyl Arginine Plus can cause side effects, although not everybody gets them.

If you experience any of the following, stop taking the medicinal product at once and tell your doctor immediately:

■    swelling of the face, lips, mouth, tongue or throat, difficulty in breathing,

■    severe dizziness or fainting,

■    unusual fast or irregular heart beat.

In decreasing order of frequency, side effects can include:

■    Common (occur in fewer than 1 in 10 users but in more than 1 in 100 users): headache, feelings of dizziness, vertigo, pins and needles, vision disturbances, tinnitus (sensation of noises in the ears), light-headedness due to low blood pressure, cough, shortness of breath, gastro-intestinal disorders (nausea, epigastric pain, anorexia, vomiting, abdominal pain, taste disturbances, dry mouth, dyspepsia or difficulty of digestion, diarrhoea, constipation), allergic reactions (such as skin rashes, itching), cramps, feeling of tiredness,

■    Uncommon (occur in fewer than 1 in 100 users but in more than 1 in 1000 users): mood swings, sleep disturbances, bronchospasm (tightening of the chest, wheezing and shortness of breath), angioedema (symptoms such as wheezing, swelling of the face or tongue), urticaria, purpura (red pinpoints on skin), kidney problems, impotence, sweating,

■    Very rare (occur in fewer than 1 in 10,000 users): confusion, cardiovascular disorders (irregular heart beat, angina, heart attack), eosinophilic pneumonia (a rare type of pneumonia), rhinitis (blocked up or runny nose), severe skin manifestations such as erythema multiforme. If you suffer from systemic lupus erythematosus (a type of collagen disease), this might get worse. Cases of photosensitivity reactions (change in skin appearance) after exposure to the sun or artificial UVA have also been reported.

■    Not known (frequency cannot be estimated from the available data): fainting, life-threatening irregular beat (Torsade de Pointes), abnormal ECG heart tracing, increased levels of liver enzymes.

Disorders of the blood, kidney, liver or pancreas and changes in laboratory parameters (blood tests) can occur. Your doctor may need to give you blood tests to monitor your condition.

In cases of hepatic insufficiency (liver problems), there is a possibility of onset of hepatic encephalopathy (degenerative disease in the brain).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    How to store Coversyl Arginine Plus

■    Keep container tightly closed in order to protect form moisture.

■    Keep out of the sight and reach of children.

■    Do not use Coversyl Arginine Plus after the expiry date which is clearly marked on the outside of the box. The expiry date refers to the last day of that month.

■    If your doctor decides to stop your treatment, return any tablets left over to the pharmacist. Only keep them if your doctor tells you to.

■    If your tablets appear discoloured, or show any other signs of deterioration, take them to your pharmacist who will advise you.

■    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    Further information

What Coversyl Arginine Plus contains

■    Each film-coated tablet contains 5mg perindopril arginine and 1.25mg indapamide as the active ingredients.

■    The other inactive ingredients are: lactose monohydrate, magnesium stearate, maltodextrin,

silica colloidal anhydrous, sodium starch glycollate (type A), glycerol, hypromellose, macrogol 6000 and titanium dioxide (E171).

What Coversyl Arginine Plus looks like and contents of the pack

Coversyl Arginine Plus are white, rod-shaped, film-coated tablets which are plain on both sides.

Coversyl Arginine Plus tablets come in a tablet container containing 30 tablets.

Manufacturer

Manufactured by: Les Laboratoires Servier Industrie,

905 route de Saran, 45520 Gidy, France.

Or

Servier (Ireland) Industries Ltd, Gorey Road, Arklow, Co. Wicklow, Ireland.

Or

ANPHARM Przedsiebiorstwo Farmaceutyczne S.A., u l. Ann o pol 6 B, 03-236 Wa rsaw, Poland.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.

PL No: 21828/0369    | POM |

Leaflet revision and issue date (Ref): 23.07.13

COVERSYL® is a registered trademark of Biofarma.

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