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COVERSYL ARGININE PLUS 5 MG/1.25 MG FILM-COATED TABLETS

Active substance: PERINDOPRIL ARGININE

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Coversyl Arginine Plus
5 mg/1.25 mg film-coated tablets
(perindopril arginine / indapamide)
Your medicine is called by the above name but will be referred to as
Coversyl Arginine Plus 5mg/1.25mg throughout the leaflet.
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 gets 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 Plus 5mg/1.25mg is and what it is used for
2. Before you take Coversyl Arginine Plus 5mg/1.25mg
3. How to take Coversyl Arginine Plus 5mg/1.25mg
4. Possible side effects
5. How to store Coversyl Arginine Plus 5mg/1.25mg
6. Further information

1. WHAT COVERSYL ARGININE PLUS 5mg/1.25mg IS AND
WHAT IT IS USED FOR
What is Coversyl Arginine Plus 5mg/1.25mg?
Coversyl Arginine Plus 5mg/1.25mg is a combination of two active
ingredients, perindopril and indapamide. It is an anti-hypertensive and is
used in the treatment of high blood pressure (hypertension).
What is Coversyl Arginine Plus 5mg/1.25mg used for?
Perindopril belongs to a class of medicines called ACE inhibitors. These
work by widening the blood vessels, which makes it easier for your
heart to pump blood through them. Indapamide is a diuretic. Diuretics
increase the amount of urine produced by the kidneys. However,
indapamide is different from other diuretics, as it only causes a slight
increase in the amount of urine produced. Each of the active ingredients
reduces blood pressure and they work together to control your blood
pressure.

2. BEFORE YOU TAKE COVERSYL ARGININE PLUS
5mg/1.25mg
Do not take Coversyl Arginine Plus 5mg/1.25mg
 if you are allergic to perindopril or any other ACE inhibitor, or to
indapamide or any other sulphonamides or any of the other
ingredients of Coversyl Arginine Plus 5mg/1.25mg,
 if you have experienced symptoms such as wheezing, swelling of
the face or tongue, 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 have severe liver disease or suffer from a condition called
hepatic encephalopathy (degenerative disease of the brain),
 if you have a severe kidney disease or if you are receiving dialysis,
 if you have low or high blood potassium,
 if you are suspected of having untreated decompensated heart
failure (severe water retention, difficulty in breathing),
 if you are more than 3 months pregnant (It is also better to avoid
Coversyl Arginine Plus 5mg/1.25mg in early pregnancy – see
“Pregnancy and Breast-feeding”),
 if you are breast-feeding.
Take special care with Coversyl Arginine Plus 5mg/1.25mg
If any of the following apply to you please talk to your doctor before
taking Coversyl Arginine Plus 5mg/1.25mg:
 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 or problems with your kidneys,
 if you have liver problems,
 if you suffer from a collagen disease (skin disease) such as
systemic lupus erythematosus or scleroderma,
 if you have atherosclerosis (hardening of the arteries),
 if you suffer from hyperparathyroidism (overactive parathyroid
gland),






if you suffer from gout,
if you have diabetes,
if you are on a salt restricted diet or use salt substitutes which
contain potassium,
if you take lithium or potassium-sparing diuretics (spironolactone,
triamterene) as their use with Coversyl Arginine Plus 5mg/1.25mg
should be avoided (see “Taking other medicines”).

You must tell your doctor if you think that you are (or might become)
pregnant. Coversyl Arginine Plus 5mg/1.25mg 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 and Breast-feeding”).
When you are taking Coversyl Arginine Plus 5mg/1.25mg, you should
also inform your doctor or the medical staff:
 if you are to undergo anaesthesia and/or surgery,
 if you have recently suffered from diarrhoea or vomiting, or are
dehydrated,
 if you are to undergo dialysis or 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 are to undergo a medical test that requires injection of an
iodinated contrast agent (a substance that makes organs like
kidney or stomach visible on an X-ray)
Athletes should be aware that Coversyl Arginine Plus 5mg/1.25mg
contains an active ingredient (indapamide) which may give a positive
reaction in drug tests.
Coversyl Arginine Plus 5mg/1.25mg should not be given to children.
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.
You should avoid Coversyl Arginine Plus 5mg/1.25mg with:
 lithium (used to treat depression),
 potassium-sparing diuretics (spironolactone, triamterene), potassium
salts.
Treatment with Coversyl Arginine Plus 5mg/1.25mg can be affected by
other medicines. Make sure to tell your doctor if you are taking any of
the following medicines as special care may be required:
 other medicines for treating high blood pressure,
 procainamide (for the treatment of an irregular heart beat),
 allopurinol (for the treatment of gout),
 terfenadine or astemizole (antihistamines for hay fever or allergies),
 corticosteroids used to treat various conditions including severe
asthma and rheumatoid arthritis,
 immunosuppressants used for the treatment of auto-immune
disorders or following transplant surgery to prevent rejection (e.g.
ciclosporin),
 medicines for the treatment of cancer,
 erythromycin by injection (an antibiotic),
 halofantrine (used to treat certain types of malaria),
 pentamidine (used to treat pneumonia),
 injectable gold (used to treat rheumatoid polyarthritis),
 vincamine (used to treat symptomatic cognitive disorders in elderly
including memory loss),
 bepridil (used to treat angina pectoris),
 sultopride (for the treatment of psychoses),
 medicines used for heart rhythm problems (e.g. quinidine,
hydroquinidine, disopyramide, amiodarone, sotalol),
 digoxin or other cardiac glycosides (for the treatment of heart
problems),
 baclofen (to treat muscle stiffness occurring in diseases such as
multiple sclerosis),
 medicines to treat diabetes such as insulin or metformin,
 calcium including calcium supplements,
 stimulant laxatives (e.g. senna),
 non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or high dose
salicylates (e.g. aspirin),
 amphotericin B by injection (to treat severe fungal disease),
 medicines to treat mental disorders such as depression, anxiety,
schizophrenia (e.g. tricyclic antidepressants, neuroleptics),
 tetracosactide (to treat Crohn’s disease).

Taking Coversyl Arginine Plus 5mg/1.25mg with food and drink
It is preferable to take Coversyl Arginine Plus 5mg/1.25mg before a
meal.
Pregnancy and Breast-feeding
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 Plus 5mg/1.25mg 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 Plus 5mg/1.25mg. Coversyl
Arginine Plus 5mg/1.25mg 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
You must not take Coversyl Arginine Plus 5mg/1.25mg if you are
breast-feeding. Tell your doctor immediately if you are breast-feeding or
about to start breast-feeding.
See your doctor immediately.
Driving and using machines
Coversyl Arginine Plus 5mg/1.25mg usually does not affect alertness
but different reactions such as dizziness or weakness in relation to the
decrease in blood pressure may occur in certain patients. If affected,
your ability to drive or to operate machinery may be impaired.
Important information about some of the ingredients of Coversyl
Arginine Plus 5mg/1.25mg
Coversyl Arginine Plus 5mg/1.25mg 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.

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, feelings of 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, epigastric
pain, anorexia, vomiting, abdominal pain, taste disturbances, dry
mouth, dyspepsia or difficulty of digestion, diarrhoea, constipation),
allergic reactions (such as skin rashes, itching), 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),
angioedema (symptoms such as wheezing, swelling of the face or
tongue), urticaria, purpura (red pinpoints on skin), kidney problems,
impotence, sweating,
 Very rare (occur in fewer than 1 in 10,000 users): confusion,
cardiovascular disorders (irregular heart beat, angina, heart attack),
eosinophilic pneumonia (a rare type of pneumonia), rhinitis (blocked
up or runny nose), severe skin manifestations such as erythema
multiforme. If you suffer from systemic lupus erythematosus (a type
of collagen disease), this might get worse. Cases of photosensitivity
reactions (change in skin appearance) after exposure to the sun or
artificial UVA have also been reported.
 Not known (frequency cannot be estimated from the available data):
fainting, life-threatening irregular beat (Torsade de Pointes),
abnormal ECG heart tracing, increased levels of liver enzymes.
Disorders of the blood, kidney, liver or pancreas and changes in
laboratory parameters (blood tests) can occur. Your doctor may need to
give you blood tests to monitor your condition.
In cases of hepatic insufficiency (liver problems), there is a possibility of
onset of hepatic encephalopathy (degenerative disease in the brain).
If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

3. HOW TO TAKE COVERSYL ARGININE PLUS 5mg/1.25mg
Always take Coversyl Arginine Plus 5mg/1.25mg exactly as your doctor
has told you. You should check with your doctor or pharmacist if you
are not sure. The usual dose is one tablet once a day. Your doctor may
decide to modify the dosage regimen if you suffer from renal
impairment. Take your tablet preferably in the morning and before a
meal. Swallow the tablet with a glass of water.
If you take more Coversyl Arginine Plus 5mg/1.25mg than you
should
If you take too many tablets, contact your doctor or nearest hospital
casualty department immediately. The most likely effect in case of
overdose is low blood pressure. If marked low blood pressure occurs
(symptoms such as dizziness or faintness), lying down with the legs
raised can help.
If you forget to take Coversyl Arginine Plus 5mg/1.25mg
It is important to take your medicine every day as regular treatment is
more effective. However, if you forget to take a dose of Coversyl
Arginine Plus 5mg/1.25mg, 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 Plus 5mg/1.25mg
As the treatment for high blood pressure 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 Plus 5mg/1.25mg 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.

5. HOW TO STORE COVERSYL ARGININE PLUS 5mg/1.25mg
Keep out of the sight and reach of children.
Do not use Coversyl Arginine Plus 5mg/1.25mg after the expiry date
which is stated on the carton and container. The expiry date refers to
the last day of that month.
Keep the container 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.

6. FURTHER INFORMATION
What Coversyl Arginine Plus 5mg/1.25mg contains
 The active substances are perindopril arginine and indapamide.
One film-coated tablet contains 5mg perindopril arginine
(corresponding to 3.395 mg perindopril) and 1.25 mg indapamide.
 The other ingredients in the tablet core are: lactose monohydrate,
magnesium stearate (E470B), maltodextrin, anhydrous colloidal
silica (E551), sodium starch glycolate (type A), and in the tablet
film-coating: glycerol (E422), hypromellose (E464), macrogol 6000,
magnesium stearate (E470B), titanium dioxide (E171).
What Coversyl Arginine Plus 5mg/1.25mg looks like and contents
of the pack
Coversyl Arginine Plus 5mg/1.25mg tablets are white, rod-shaped filmcoated tablets.
The tablets are available in containers of 30 tablets.
Leaflet revision and issue date (Ref.): 09 October 2013
POM

PL No: 20507/0155

Coversyl Arginine Plus 5mg/1.25mg

Coversyl Arginine Plus Tablets are manufactured by Les Laboratoires
Servier Industrie, 905 route de Saran, 45520 Gidy, France and is
procured from within the EU and repackaged on behalf of the Product
Licence Holder: Central Pharmaceuticals UK Limited., Unit 5, Waverley
Industrial Estate, Hailsham Drive, Harrow, HA1 4TR
Coversyl is a registered trademark of Les Laboratoires Servier
CPL/155/3

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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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