COVERSYL ARGININE 5MG TABLETS

PACKAGE LEAFLET: INFORMATION FOR THE USER

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COVERSYL® ARGININE 5MG TABLETS

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(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.

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

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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:

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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
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:
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to treat high blood pressure (hypertension),
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to treat heart failure (a condition where the heart is
unable to pump enough blood to meet the body's
needs),
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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
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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.

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:
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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),
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have any other heart problems,
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have liver problems,
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have kidney problems or if you are receiving dialysis,
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suffer from a collagen vascular disease (disease of the
connective tissue) such as systemic lupus
erythematosus or scleroderma,
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have diabetes,
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are on a salt restricted diet or use salt substitutes which
contain potassium,

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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:
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an “angiotensin II receptor blocker” (ARBs) (also
known as sartans - for example valsartan,
telmisartan, irbesartan), in particular if you have
diabetes-related kidney problems,
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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:
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racecadotril (used to treat diarrhoea),
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sirolimus, everolimus, temsirolimus and other
drugs belonging to the class of so-called mTor
inhibitors (used to avoid rejection of transplanted
organs).

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 Coversyl Arginine 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:
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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),
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potassium-sparing drugs (e.g. triamterene, amiloride),
potassium supplements or potassium-containing salt
substitutes,
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potassium-sparing drugs used in the treatment of heart
failure: eplerenone and spironolactone at doses between
12.5mg to 50mg per day,
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lithium for mania or depression,
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non-steroidal anti-inflammatory drugs (e.g. ibuprofen)
for pain relief or high dose aspirin,
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medicines to treat diabetes (such as insulin or
metformin),
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baclofen (used to treat muscle stiffness in diseases such
as multiple sclerosis),
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medicines to treat mental disorders such as depression,
anxiety, schizophrenia etc. (e.g. tricyclic
antidepressants, antipsychotics),
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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),
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trimethoprim (for the treatment of infections),
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estramustine (used in cancer therapy),
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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",
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allopurinol (for the treatment of gout),
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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. 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 monohydrate

Coversyl Arginine 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
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.

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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:
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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),
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severe dizziness or fainting due to low blood pressure
(Common – may affect up to 1 in 10 people),
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unusual fast or irregular heartbeat, chest pain (angina)
or heart attack (Very rare – may affect up to 1 in 10,000
people),
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weakness of arms or legs, or problems speaking which
could be sign of a possible stroke (Very rare – may
affect up to 1 in 10,000 people),
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sudden wheeziness, chest pain, shortness of breath, or
difficulty in breathing (bronchospasm) (Uncommon –
may affect up to 1 in 100 people),
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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),
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yellowing of the skin or eyes (jaundice) which could be a
sign of hepatitis (Very rare – may affect up to 1 in
10,000 people),
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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):

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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):

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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 1,000 people):
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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):

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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 or pharmacist.
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.

5. How to store Coversyl Arginine
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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. Content 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

POM
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Leaflet issue and revision date (Ref): 24.11.17
COVERSYL® is a registered trademark of Biofarma.

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Product name: COVERSYL
ARGININE 5mg Tablets
Reference No: 04423/0610