COVERSYL ARGININE 10 MG ORODISPERSIBLE TABLETS

Active substance: PERINDOPRIL ARGININE

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Package leaflet: Information for the patient
Coversyl Arginine 2.5 mg orodispersible tablets
Coversyl Arginine 5 mg orodispersible tablets
Coversyl Arginine 10 mg 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.
2.
3.
4.
5.
6.

1.

What Coversyl Arginine is and what it is used for
What you need to know before you take Coversyl Arginine
How to take Coversyl Arginine
Possible side effects
How to store Coversyl Arginine
Content of the pack and other information

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 mellitus or kidney problems and you are treated with 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),
• if you have any other heart problems,
• if you have liver problems,
• if you have kidney problems or if you are receiving dialysis,
• if you suffer from a collagen vascular disease (disease of the connective tissue) such as systemic
lupus erythematosus or scleroderma,
• if you have diabetes,
• if you are on a salt restricted diet or use salt substitutes which contain potassium,
• if you are to undergo anaesthesia and/or major surgery,
• if you are to undergo LDL apheresis (which is removal of cholesterol from your blood by a
machine),
• if you are going to have treatment to make you less sensitive to the effects of an allergy to bee or
wasp stings,
• if you have recently suffered from diarrhoea or vomiting, or are dehydrated,
• if you have been told by your doctor that you have an intolerance to some sugars,
• if you have been told by your doctor that you have phenylketonuria,
• if you take aliskiren (medicines used to treat hypertension).
You must tell your doctor if you think that 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 this stage (see pregnancy section).
Children and adolescents
Coversyl Arginine is not recommended for use in children and adolescents.
Other medicines and Coversyl Arginine
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Treatment with Coversyl Arginine can be affected by other medicines. These include:
• other medicines for high blood pressure, including aliskiren, diuretics (medicines which increase
the amount of urine produced by the kidneys),
• potassium-sparing drugs (e.g. triamterene, amiloride), potassium supplements or potassiumcontaining salt substitutes,
• 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),
allopurinol (for the treatment of gout),
procainamide (for the treatment of an irregular heartbeat),
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 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 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 or pharmacist 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 failure: 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:
• swelling of the face, lips, mouth, tongue or throat, difficulty in breathing,
• severe dizziness or fainting,
• unusual fast or irregular heart beat or chest pain,
• severe abdominal pain.
In decreasing order of frequency, side effects can include:


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

Headache, 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, 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, bronchospasm (tightening of the chest, wheezing and shortness
of breath), dry mouth, angioedema (symptoms such as wheezing, swelling of the face, tongue or
throat), intense itching or severe skin rashes, formation of blister clusters over the skin, kidney
problems, impotence, sweating, an 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):
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, cardiovascular disorders (irregular heartbeat, heart attack and stroke), eosinophilic
pneumonia (a rare type of pneumonia), rhinitis (blocked up or runny nose), erythema multiforme,
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, inflammation of the pancreas (which causes
severe pain in the abdomen and the back), hepatitis.

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 Tel: Freephone 0808 100 3352. 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

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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).

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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
50 rue Carnot
92284 Suresnes cedex – France
Manufacturer
Servier (Ireland) Industries Ltd
Gorey Road
Arklow - Co. Wicklow – Ireland

This leaflet was last revised in 08/2013

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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