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

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Assessed against UK PIL dated February 2009

PACKAGE LEAFLET: INFORMATION FOR THE
USER

COVERSYL ARGININE
PLUS 5 mg / 1.25 mg
Film-coated tablets
perindopril arginine / indapamide
This medicine is called COVERSYL ARGININE PLUS 5 mg /
1.25 mg Film-coated tablets but will be referred to as
COVERSYL ARGININE PLUS 5mg/1.25mg through the
remainder of 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 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.
2.
3.
4.
5.
6.

What COVERSYL ARGININE PLUS 5mg/1.25mg is and
what it is used for
Before you take COVERSYL ARGININE PLUS
5mg/1.25mg
How to take COVERSYL ARGININE PLUS 5mg/1.25mg
Possible side effects
How to store COVERSYL ARGININE PLUS 5mg/1.25mg
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 antihypertensive 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),
By hyperparathyroidism (overactive
if you suffer from whitneya at 11:36 am, Nov 28, 2011
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 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 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

-

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 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
Tell your doctor if you are breast-feeding or about to start
breast-feeding. COVERSYL ARGININE PLUS 5mg/1.25mg is
contra-indicated 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 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.

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.
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, gastrointestinal 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
5mg/1.25mg
Keep out of the reach and sight 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 (551), 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,
oblong shaped film-coated tablets.
One film-coated tablet contains 5 mg perindopril arginine and
1.25 mg indapamide.
The tablets are available in containers of 30 tablets.
Manufacturers:
Les Laboratoires Servier Industrie
905 route de Saran
45520 Gidy
France
and
Servier (Ireland) Industries Ltd
Gorey Road
Arklow - Co. Wicklow
Ireland
Or
EGIS Pharmaceuticals Plc
H-1106 Budapest, Kereszt ri t 30-38
Hungary
This product is procured within the EU and repackaged by
Mediwin Limited Product Licence Holder Mediport Limited
13 Martello Enterprise Centre, Courtwick Lane, Littlehampton,
West Sussex, BN17 7PA, United Kingdom.
POM

PL: 18980/0821

Coversyl is a registered Trademark of BIOFARMA

Date of leaflet preparation 23/11/2011.

Lot:
MCP-0821v1

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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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