Package leaflet: Information for the patient

COVERSYL® ARGININE 2.5mg

Orodispersible Tablets perindopril arginine

COVERSYL

ARGININE 5mg

Orodispersible Tablets perindopril arginine

COVERSYL® ARGININE 10mg

Orodispersible Tablets perindopril arginine

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 Goversyl 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

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

Coversyl Arginine is an angiotensin

converting enzyme (ACE) inhibitor.

These work by widening the blood

vessels, which makes it easier for your

heart to pump blood through them.

Coversyl Arginine is used:

•    to treat high blood pressure (hypertension),

•    to treat heart failure (a condition where the heart is unable to pump enough blood to meet the body's needs),

•    to reduce the risk of cardiac events, such as heart attack, in patients with stable coronary artery disease (a condition where the blood supply to the heart is reduced or blocked) and who have already had a heart attack and/or an operation to improve the blood supply to the heart by widening the vessels that supply it.

2. What you need to know before you take Coversyl Arginine

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 section “Pregnancy and breast-feeding”),

•if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

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 (cardiac 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,

•    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 treatment to make you less sensitive to 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,

•    have been told by your doctor that you have phenylketonuria,

•    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.

Anaioedema

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 that you are for 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 this 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,

•    potassium-sparing drugs used in the treatment of heart failure: eplerenone and spironolactone at doses between 12.5mgto50mg 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 autoimmune disorders or following transplant surgery (e.g. ciclosporin, tacrolimus),

•    trimethoprim (for the treatment of infections),

•    estramustine (used in cancer therapy),

•    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),

•    heparin (medicines used to thin blood),

•    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 that 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 breastfeeding 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 breastfeed, 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 and aspartame

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

Since Coversyl Arginine Orodispersible Tablets also contain a source of phenylalanine (aspartame), it may be harmful for people with phenylketonuria.

3. How to take Coversyl Arginine

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Place the tablet on your tongue for disintegration and swallow with saliva, preferably at the same time each day, in the morning, before a meal.

Your doctor will decide on the correct dose for you.

The recommended dosages are as follows: High blood pressure: the usual starting and maintenance dose is 5 mg once daily. After one month, this can be increased to 10 mg once a day if required. 10 mg a day is the maximum recommended dose for high blood pressure.

If you are 65 or older, the usual starting dose is 2.5 mg once a day. After a month this can be increased to 5 mg once a day and then if necessary to 10 mg once daily.

Heart Mure: the usual starting dose is 2.5 mg once daily. After two weeks, this can be increased to 5 mg once a day, which is the maximum recommended dose for heart failure.

Stable coronary artery disease: the usual starting dose is 5 mg once daily. After two weeks, this can be increased to 10 mg once daily, which is the maximum recommended dose in this indication.

If you are 65 or older, the usual starting dose is 2.5 mg once a day. After a week this can be increased to 5 mg once a day and after a further week to 10 mg once daily.

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.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking the medicinal product and see a doctor immediately, if you experience any of the following side effects that can be serious:

• swelling of the face, lips, mouth, tongue or throat, difficulty in breathing (angioedema) (See section 2 “Warnings and precautions’) (Uncommon - may affect up to 1 in 100 people),

•    severe dizziness or fainting due to low blood pressure (Common - may affect up to 1 in 10 people),

•    unusual fast or irregular heart beat, chest pain (angina) or heart attack (Very rare - may affect up to 1 in

10.000    people),

•    weakness of arms or legs, or problems speaking which could be a sign of a possible stroke (Very rare - may affect up to 1 in 10,000 people),

•    sudden wheeziness, chest pain, shortness of breath, or difficulty in breathing (bronchospasm) (Uncommon

-    may affect up to 1 in 100 people),

•    inflamed pancreas which may cause severe abdominal and back pain accompanied with feeling very unwell (Very rare - may affect up to 1 in

10.000    people),

•    yellowing of the skin or eyes Qaundice) which could be a sign of hepatitis (Very rare - may affect up to 1 in 10,000 people),

•    skin rash which often starts with red itchy patches on your face, arms or legs (erythema multiforme) (Very rare

-    may affect up to 1 in 10,000 people).

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),

•    gastro-intestinal 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 cell),

•    somnolence,

•    fainting,

•    palpitations,

•    tachycardia,

•    vasculitis (inflammation of blood vessels),

•    photosensitivity reaction (increased sensitivity of the skin to sun),

•    arthralgia Qoint pain),

•    myalgia (muscle 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):

•    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.

Reporting of side effects

If you get any side effects, talk to your doctor, 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.aov.uk/vellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Coversyl Arginine

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and container. The expiry date refers to the last day of that month.

Keep the container tightly closed in order to protect from moisture.

Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Content of the pack and other information

What Coversyl Arginine contains

•    The active substance is perindopril arginine. One orodispersible tablet contains 1.698 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 orodispersible tablet are: Magnesium stearate (E470B), silica colloidal anhydrous (E551), spray dried lactose starch compound (lactose monohydrate 85%, maize starch 15%), aspartame (E951) and acesulfame potassium (E950).

What Coversyl Arginine looks like and contents of the pack

Coversyl Arginine Orodispersible Tablets are white, round tablets.

The tablets are available in containers of 5, 10, 14, 20, 30, 50, 60, 90,100, 120 or 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

^ ^ Les Laboratoires Servier ^=-soiv7eh 50, rue Carnot

92284 Suresnes cedex France

Manufacturer

Servier (Ireland) Industries Ltd Gorey Road

Arklow - Co. Wicklow - Ireland

This leaflet was last revised in 02/2015.

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