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PERINDOPRIL ARGININE 5 MG TABLETS

Active substance(s): PERINDOPRIL ARGININE

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2108/2109
Coversyl® Arginine 5 mg Tablets / 04.07.16[11]
Perindopril Arginine 5 mg Tablets
Coversyl® Arginine 10 mg Tablets /
Perindopril Arginine 10 mg Tablets

(perindopril arginine)
PATIENT INFORMATION LEAFLET
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.
Your medicine is known by one of the above names but will be referred to
as Coversyl Arginine throughout this leaflet. Your medicine is also available
in other strengths.
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 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.
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 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 12.5 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 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 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
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 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 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 heartbeat, 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).

MANUFACTURER AND PRODUCT LICENCE HOLDER
Coversyl Arginine is manufactured by Les Laboratoires Servier Industrie,
905 route de Saran, Gidy, F-45520, France and is procured from within the
EU by Product Licence holder Tenolol Ltd. 5, Sandridge Close, Harrow, HA1
1XD. Repackaged by Servipharm Ltd.

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.

Coversyl is a registered trademark of Biofarma.

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 bottle. The expiry date refers to the last day of that month.
Store in the original package. Keep container tightly closed. Protect from
moisture.
If your tablets become discoloured or show any other signs of deterioration,
consult your doctor or pharmacist who will tell you what to do.
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.
6. CONTENT OF THE PACK AND OTHER INFORMATION
What Coversyl Arginine contains
- Coversyl Arginine 5mg Tablet - each film-coated tablet contains 5mg of
perindopril arginine as the active ingredient.
Coversyl Arginine 10mg Tablet - each film-coated tablet contains 10mg of
perindopril arginine as the active ingredient.
- 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 complex (E141).
What Coversyl Arginine looks like and contents of the pack
Coversyl Arginine 5 mg tablets are light-green, rod-shaped film-coated
tablets engraved with servier logo on one face and scored on both edges.
Coversyl Arginine 10 mg tablets are green, round, biconvex, film-coated
tablets engraved with servier logo on one face and a heart shape on the
other face.
Each strength of Coversyl Arginine is available in tablet containers of
30 tablets.

POM

Coversyl Arginine 5mg Tablets / Perindopril Arginine 5mg
Tablets - PL 30900/2108
Coversyl Arginine 10mg Tablets / Perindopril Arginine 10mg
Tablets - PL 30900/2109

Leaflet revision and issue date (Ref) 04.07.16[11]

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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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