COVERSYL ARGININE PLUS 5 MG/1.25MG TABLETS

Active substance: INDAPAMIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

COVERSYL® ARGININE PLUS
5MG/1.25MG TABLETS
(perindopril arginine / indapamide)

Your medicine is available using the name Coversyl Arginine Plus
5mg/1.25mg Tablets but will be referred to as Coversyl Arginine
Plus throughout this 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.
2.
3.
4.
5.
6.

What Coversyl Arginine Plus is and what it is used for
Before you take Coversyl Arginine Plus
How to take Coversyl Arginine Plus
Possible side effects
How to store Coversyl Arginine Plus
Further information

1. What Coversyl Arginine Plus is and what it
is used for
What is Coversyl Arginine Plus?

Coversyl Arginine Plus is a combination of two active ingredients,
perindopril arginine 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 arginine 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 arginine 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 and Breast-feeding”),
if you are breast-feeding.

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 (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 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 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, 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 contains an
active ingredient (indapamide) which may give a positive reaction
in drug tests.
Coversyl Arginine Plus should not be given to children.

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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 autoimmune 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 with food and drink
It is preferable to take Coversyl Arginine Plus before a meal.

Pregnancy and breast-feeding

4. Possible side effects

Pregnancy

Like all medicines, Coversyl Arginine Plus can cause side effects,
although not everybody gets them.

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 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.

Breast-feeding

You must not take Coversyl Arginine Plus if you are breastfeeding. 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 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

Coversyl Arginine Plus 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 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 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.
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.

5. How to store Coversyl Arginine Plus
Keep container tightly closed in order to protect form
moisture.
Keep out of the sight and reach of children.
Do not use Coversyl Arginine Plus after the expiry date
which is clearly marked on the outside of the box. The
expiry date refers to the last day of that month.
If your doctor decides to stop your treatment, return any
tablets left over to the pharmacist. Only keep them if your
doctor tells you to.
If your tablets appear discoloured, or show any other signs
of deterioration, take them to your pharmacist who will
advise you.
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

Each film-coated tablet contains 5mg perindopril arginine
and 1.25mg indapamide as the active ingredients.
The other inactive ingredients are: lactose monohydrate,
magnesium stearate, maltodextrin,
silica colloidal anhydrous, sodium starch glycollate (type A),
glycerol, hypromellose, macrogol 6000 and
titanium dioxide (E171).

What Coversyl Arginine Plus looks like and contents
of the pack
Coversyl Arginine Plus are white, rod-shaped, film-coated tablets
which are plain on both sides.
Coversyl Arginine Plus tablets come in a tablet container
containing 30 tablets.

Manufacturer

Manufactured by: Les Laboratoires Servier Industrie,
905 route de Saran, 45520 Gidy, France.
Or
Servier (Ireland) Industries Ltd, Gorey Road, Arklow, Co. Wicklow,
Ireland.
Or
ANPHARM Przedsiebiorstwo Farmaceutyczne S.A.,
ul. Annopol 6B, 03-236 Warsaw, Poland.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0369

POM

Leaflet revision and issue date (Ref): 23.07.13

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.

COVERSYL® is a registered trademark of Biofarma.

If you have any further questions on the use of this product, ask
your doctor or pharmacist.
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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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