COVERSYL ARGININE 5MG TABLETS

Active substance: PERINDOPRIL ARGININE

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COVERSYL® ARGININE 5mg TABLETS
COVERSYL® ARGININE 10mg TABLETS
(perindopril arginine)
27mm

Patient Information Leaflet

This product is known as either of the above names but will be referred to as Coversyl Arginine
throughout this leaflet. Please note the leaflet also contains information about another strength of the
medicine, Coversyl Arginine 2.5mg tablets.

PROOF HISTORY:
v.3 - waymade - 29/01/13

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet:
1. What Coversyl Arginine is and what it is used for
2. Before you take Coversyl Arginine
3. How to take Coversyl Arginine
4. Possible side effects
5. How to store Coversyl Arginine
6. Further 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. Before you take Coversyl Arginine
Do not take Coversyl Arginine

if you are allergic (hypersensitive) to perindopril, to any other ACE inhibitor or to any of the other
ingredients of Coversyl Arginine,

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 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).
Take special care with Coversyl Arginine
If any of the following apply to you please talk to your doctor 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.
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 that stage (see pregnancy section).
Coversyl Arginine is not recommended for use in children and adolescents.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Treatment with Coversyl Arginine can be affected by other medicines. These include:

other medicines for high blood pressure, including diuretics (medicines which increase the
amount of urine produced by the kidneys),

potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium supplements or
potassium-containing salt substitutes,

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),

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),

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).
Taking Coversyl Arginine with food and drink
It is preferable to take Coversyl Arginine before a meal.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any 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.

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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.
Important information about some of the ingredients of Coversyl Arginine
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 Coversyl Arginine exactly as your doctor has told you. You should 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 usual 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.

Notes:

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.
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 product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Coversyl Arginine can cause side effects, although not everybody gets them.
If you experience any of the following, stop taking the medicinal product at once and tell your doctor
immediately:

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

severe dizziness or fainting,

unusual fast or irregular heart beat.
In decreasing order of frequency, side effects can include:

Common (occur in fewer than 1 in 10 users but in more than 1 in 100 users): 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 (occur in fewer than 1 in 100 users but in more than 1 in 1000 users): 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), kidney problems, impotence, sweating,

Very rare (occur in fewer than 1 in 10,000 users): confusion, cardiovascular disorders (irregular
heart beat, angina, heart attack and stroke), eosinophilic pneumonia (a rare type of pneumonia),
rhinitis (blocked up or runny nose), erythema multiforme, disorders of the blood, pancreas or
liver.

In case of diabetic patients, hypoglycaemia (very low blood sugar level) can occur,

Vasculitis (inflammation of blood vessels) have been reported.

6464/2662 2663D
CODE:

Coversyl 5mg 10mg tabs
PRODUCT:

CUSTOMER: Waymade

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
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 bottle tightly closed in order to 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 other signs of deterioration, you should consult your
pharmacist who will advise you what to do.
6. Further Information
What Coversyl Arginine contains

The active substance is perindopril arginine. Each film-coated tablet contains either 5 mg or
10 mg of 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 (E422a), hypromellose (E464), macrogol, magnesium stearate
(E470B), titanium dioxide (E171) and copper chlorophyllin complex (E141ii).

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
face and scored on both edges.
Coversyl Arginine 10 mg tablets are green, round, biconvex, film-coated tablets engraved with
face and on the other face.

on one
on one

Each strength of Coversyl Arginine is available in bottles of 30 tablets.

Colour
Swatch

Marketing Authorisation Holder and Manufacturer
POM

PL No: 6464/2662 Coversyl Arginine 5mg tablets
PL No: 6464/2663 Coversyl Arginine 10mg tablets

These products are manufactured by ANPHARM Przedsiebiorstwo Farmaceutyczne S.A., ul. Annopol 6B,
03-236, Warsaw, Poland and procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR.
Leaflet Reference (revision and issue date) 29.01.2013
Coversyl is a registered trademark of BIOFARMA

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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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