COVERSYL ARGININE 5MG TABLETS

Active substance: PERINDOPRIL ARGININE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

COVERSYL® ARGININE 5MG TABLETS
(perindopril arginine)

Your medicine is available using the name Coversyl Arginine 5mg
Tablets but it will be referred to as Coversyl Arginine throughout
this leaflet. Other strengths 2.5mg and 10mg are also available.

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.

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
Contents 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 pregnancy
section).
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 (heart 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 desensitisation treatment to reduce
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 take aliskiren (medicines used to treat hypertension).

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 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).

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.

Children and adolescents

Breast-feeding

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, or 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 potassium-containing salt
substitutes,
potassium-sparing drugs used in the treatment of heart
failure: eplerenone and spironolactone at doses between
12.5mg to 50mg 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),
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Tell your doctor if you are breast-feeding or about to start breastfeeding. 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

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
Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are not
sure.
Swallow your tablet with a glass of water, 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
5mg once daily. After one month, this can be increased to 10mg
once a day if required. 10mg a day is the maximum
recommended dose for high blood pressure.
If you are 65 or older, the usual starting dose is 2.5mg once a
day. After a month this can be increased to 5mg once a day and
then if necessary to 10mg once daily.
Heart failure: the usual starting dose is 2.5mg once daily. After
two weeks, this can be increased to 5mg once a day, which is the
maximum recommended dose for heart failure.
Stable coronary artery disease: the usual starting dose is 5mg
once daily. After two weeks, this can be increased to 10mg once
daily, which is the maximum recommended dose in this indication.
If you are 65 or older, the usual starting dose is 2.5mg once a
day. After a week this can be increased to 5mg once a day and
after a further week to 10mg 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

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 tiredness,

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 1,000 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 or Tel: Freephone
0808 1003352. By reporting side effects you can help provide
more information on the safety of this medicine.

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

5. How to store Coversyl Arginine
Keep out of the sight and reach of children.
Do not use Coversyl Arginine after the expiry date which is
stated on the carton and bottle. The expiry date refers to the
last day of that month.
Keep the container tightly closed.
Protect from moisture.
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.
If your tablets appear discoloured, or show any other signs
of deterioration, take them to your pharmacist who will
advise you.
If your doctor tells you to stop taking the tablets, please
take them back to the pharmacist for safe disposal. Only
keep them if your doctor tells you to.

6. Contents of the pack and other
information
What Coversyl Arginine contains

The active substance is perindopril arginine. One film-coated
tablet contains 3.395mg perindopril corresponding to 5mg
perindopril arginine.
The other ingredients in the tablet core are: lactose monohydrate,
magnesium stearate, maltodextrin, hydrophobic colloidal silica,
sodium starch glycolate, and in the tablet film-coating: glycerol,
hypromellose, magnesium stearate, macrogol,
copper chlorophyllin complex and titanium dioxide (E171).

What Coversyl Arginine looks like and contents of
the pack

Coversyl Arginine are light-green, rod-shaped film-coated tablets
engraved with the company logo on one face and scored on both
edges and plain on the other side.
Coversyl Arginine comes in packs of 30 tablets.

Manufacturer

Manufactured by: ANPHARM Przedsiębiorstwo Farmaceutyczne
S.A., ul. Annopol 6B, 03-236 Warszawa, Poland.
Or
Les Laboratoires Servier Industrie, 905 route de Saran,
45520 Gidy, France.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster,
DN3 1QR, UK.
Product Licence holder: Doncaster Pharmaceuticals Group Ltd.,
Kirk Sandall, Doncaster, DN3 1QR, UK.
PL No: 04423/0610

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

POM

Leaflet issue and revision date (Ref): 07.03.14
COVERSYL® is a registered trademark of Biofarma.

swelling of the face, lips, mouth, tongue or throat, difficulty
in breathing,
severe dizziness or fainting,

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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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