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

Active substance: PERINDOPRIL ARGININE

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MOCK UP

Assessed against UK PIL dated February 2009
By Pratyush Bhartiya at 3:50 pm, Jan 31, 2011

®

Coversyl Arginine Plus 5mg/1.25mg Film-coated Tablets
(perindopril arginine/indapamide)
Your medicine is known by the above name, but will be referred to as
Coversyl Arginine Plus throughout this:
Patient Information Leaflet
Read all of this leaflet carefully before you start taking Coversyl
Arginine Plus.
 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 is Coversyl Arginine Plus and what is it used for?
2) Before you take Coversyl Arginine Plus
3) How to take Coversyl Arginine Plus
4) Possible side effects
5) How to store Coversyl Arginine Plus
6) Further information

1) What is Coversyl Arginine Plus and what is it used for?
What is Coversyl Arginine Plus?
Coversyl Arginine Plus 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 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
Do not take Coversyl Arginine Plus:
 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,
 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 in early pregnancy – see pregnancy section.)
 if you are breastfeeding.
Take special care with Coversyl Arginine Plus:
If any of the following apply to you please talk to your doctor before taking
Coversyl Arginine Plus:
 if you have aortic stenosis (narrowing of the main blood vessel leading
from the heart) or hypertrophic cardiomyopathy (cardiac 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 should be avoided
(see “Taking other medicines”).

You must tell your doctor if you think you are (or might become) pregnant.
Coversyl Arginine Plus 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).
When you are taking Coversyl Arginine Plus, 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,
 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 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 contains an active
ingredient (indapamide) which may give a positive reaction in drug tests.
Coversyl Arginine Plus 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 with:
 lithium (used to treat depression),
 potassium-sparing diuretics (spironolactone, triamterene), potassium
salts.
Treatment with Coversyl Arginine Plus 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 rhumatoid polyarthritis)
 vincamine (used to treat symptomatic cognitive disorders in elderly
including memory loss),
 bepridil (used to treat angina pectoris),
 sultopride (antipsychotic treatment),
 medicines used for heart rhythm problems (e.g. quinidine,
hydroquinidine, disopyramide, amiodarone, sotalol),
 digoxin (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 with food and drink
It is preferable to take Coversyl Arginine Plus 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 you are (or might become) pregnant.
Your doctor will normally advise you to stop taking Coversyl Arginine Plus
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.
Coversyl Arginine Plus 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.
Breastfeeding
Tell your doctor if you are breast-feeding or about to start breast feeding.
Coversyl Arginine Plus 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.
See your doctor immediately.
Driving and using machines
Coversyl Arginine Plus 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
Coversyl Arginine Plus 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 Plus
Always take Coversyl Arginine Plus 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 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
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, 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
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 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, 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.
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.

5) How to store Coversyl Arginine Plus
 Keep all medicines out of the reach and sight of children.
 Do not use Coversyl Arginine Plus 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.
 If the tablets become discoloured or show any other signs of deterioration,
you should seek the advice of your 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) Further information
What Coversyl Arginine Plus contains
 The active substances are perindopril arginine and indapamide. One
film-coated tablet contains 5mg perindopril arginine (corresponding to
3.395mg perindopril) and 1.25 mg indapamide.
 The other ingredients in the tablet core are: lactose monohydrate,
magnesium stearate (E470B), maltodextrin, colloidal anhydrous silica
dioxide, 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 looks like and contents of the pack
Coversyl Arginine Plus tablets are white, rod-shaped film-coated tablets.
Tablets are blank on both sides.
One film-coated tablet contains 5 mg perindopril arginine and 1.25 mg
indapamide.
The tablets are available in a container of 30 tablets.
PL 10383/1935 Coversyl Arginine Plus 5mg/1.25mg Film-coated Tablets
POM
Who makes and repackages your medicine?
Your medicine is manufactured by Les Laboratoires Servier Industrie, 905
route de Saran, 45520 Gidy, France. Procured from within the EU and
repackaged by Product Licence Holder: Primecrown Ltd, 28 Sarum
Complex, Uxbridge, Middlesex UB8 2RZ.
Leaflet date: 27.01.2011
Coversyl Arginine Plus® is a trademark of Biofarma, Neuilly-sur-Seine,
France.

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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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