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PERINDOPRIL ARGININE 10MG TABLETS

Active substance(s): PERINDOPRIL ARGININE

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Coversyl®
arginine
Tablets

Coversyl®
5mg

(perindopril arginine)

arginine
Tablets

10mg
(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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
See section 4.
The name of your medicine is Coversyl arginine 5mg Tablets or
Coversyl arginine 10mg Tablets but will be referred to as
Coversyl arginine throughout this leaflet. Please note that this
leaflet also contains information about the other strength:
Coversyl arginine 2.5mg Tablets.

What is in this leaflet:
1. What Coversyl 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 ‘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:
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),
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 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:
an ‘angiotensin ll 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.
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 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 ll 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
12.5mg 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),
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,
anti-psychotics),
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 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 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
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
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 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 (jaundice) 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),
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):
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 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 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.
By reporting side effects, you can help provide more information
on the safety of this medicine.

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 container after ‘Exp’. 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 the tablets become discoloured or show any signs of
deterioration, you should seek the advice of your pharmacist.

6. Content of the pack and other information
What Coversyl arginine contains
The active substance is perindopril arginine. Each
film-coated tablet contains either 5mg or 10mg perindopril
arginine.
The other ingredients in the tablet core are: lactose
monohydrate, magnesium stearate (E470B), maltodextrin,
hydrophobic colloidal silica, sodium starch glycolate (type A),
and in the tablet film-coating: glycerol (E422), hypromellose
(E464), macrogol, magnesium stearate (E470B), titanium
dioxide (E171) and copper chlorophyllin (E141 (ii)).

What Coversyl arginine looks like and contents of
the pack
Coversyl arginine 5mg tablets are light-green, rod-shaped filmcoated tablets engraved with
on one face, plain on the
reverse and scored on both edges.
Coversyl arginine 10mg tablets are green, round, biconvex, filmcoated tablets engraved with
on one face and
on the
other face.
Each strength of Coversyl arginine is available in containers of
30 tablets.
Manufacturer: Anpharm Przedsiebiorstwo Farmaceutyczne
S.A., ul. Annopol 6B, 03-236 Warsaw, Poland.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road,
Ruislip, Middlesex, HA4 0NU, UK.
POM
Coversyl arginine 5mg Tablets, PL 18799/1993
Coversyl arginine 10mg Tablets, PL 18799/1994
Leaflet date: 25.04.2016
Coversyl is a registered trademark of Biofarma.

Perindopril
arginine
Tablets

5mg
(perindopril arginine)

Perindopril
arginine
Tablets

10mg
(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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
See section 4.
The name of your medicine is Perindopril arginine 5mg Tablets
or Perindopril arginine 10mg Tablets but will be referred to as
Perindopril arginine throughout this leaflet. Please note that this
leaflet also contains information about the other strength:
Perindopril arginine 2.5mg Tablets.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

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

1. What Perindopril arginine is and what it is
used for
Perindopril 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.
Perindopril 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
Perindopril arginine
Do not take Perindopril 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 Perindopril 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 Perindopril 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),
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 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:
an ‘angiotensin ll 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
Perindopril 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.

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 Perindopril arginine. This may occur at any time during
treatment. If you develop such symptoms, you should stop taking
Perindopril arginine and see a doctor immediately. See also
section 4.
You must tell your doctor if you think you are (or might become)
pregnant. Perindopril 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 perindopril in children and adolescents up to the age
of 18 years is not recommended.

Other medicines and Perindopril arginine
Please tell your doctor or pharmacist if you are taking or have
recently taken or might take any other medicines.
Treatment with Perindopril 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 ll receptor blockers (ARB), aliskiren (see also
information under the headings ‘Do not take Perindopril
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
12.5mg 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),
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,
anti-psychotics),
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 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).

Perindopril arginine with food and drink
It is preferable to take Perindopril 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
Perindopril arginine before you become pregnant or as soon as
you know you are pregnant and will advise you to take another
medicine instead of Perindopril arginine. Perindopril
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 breastfeeding. Perindopril 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
Perindopril 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.

Perindopril arginine contains lactose
Perindopril 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 Perindopril 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 Perindopril 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 Perindopril arginine
It is important to take your medicine every day as regular
treatment works better. However, if you forget to take a dose of
Perindopril 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 Perindopril arginine
As the treatment with Perindopril 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 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 (jaundice) 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),

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

5. How to store Perindopril arginine
Keep out of the sight and reach of children.
Do not use Perindopril arginine after the expiry date which is
stated on the carton and container after ‘Exp’. 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 the tablets become discoloured or show any signs of
deterioration, you should seek the advice of your pharmacist.

6. Content of the pack and other information
What Perindopril arginine contains
The active substance is perindopril arginine. Each
film-coated tablet contains either 5mg or 10mg perindopril
arginine.
The other ingredients in the tablet core are: lactose
monohydrate, magnesium stearate (E470B), maltodextrin,
hydrophobic colloidal silica, sodium starch glycolate (type A),
and in the tablet film-coating: glycerol (E422), hypromellose
(E464), macrogol, magnesium stearate (E470B), titanium
dioxide (E171) and copper chlorophyllin (E141 (ii)).

What Perindopril arginine looks like and contents
of the pack
Perindopril arginine 5mg tablets are light-green, rod-shaped filmcoated tablets engraved with
on one face, plain on the
reverse and scored on both edges.
Perindopril arginine 10mg tablets are green, round, biconvex,
film-coated tablets engraved with
on one face and
on
the other face.
Each strength of Perindopril arginine is available in containers of
30 tablets.
Manufacturer: Anpharm Przedsiebiorstwo Farmaceutyczne
S.A., ul. Annopol 6B, 03-236 Warsaw, Poland.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road,
Ruislip, Middlesex, HA4 0NU, UK.
POM
Perindopril arginine 5mg Tablets, PL 18799/1993
Perindopril arginine 10mg Tablets, PL 18799/1994
Leaflet date: 25.04.2016

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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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