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

Active substance(s): INDAPAMIDE / PERINDOPRIL ARGININE

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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 this medicine
because it contains important information for you.
• 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 only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See section
4.
What is in this leaflet:
1) What Coversyl Arginine Plus is and what it is used for
2) What you need to know 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) Contents of the pack and other information

1) What Coversyl Arginine Plus is and what it is used for
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) in adults.
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) What you need to know 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 sulfonamides or any of the other ingredients
of this medicine (listed in section 6),
• 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 diabetes or impaired kidney function and you are treated
with a blood pressure lowering medicine containing aliskiren,
• 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 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.
Warnings and precautions
Talk to your doctor or pharmacist 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 heart failure or any other heart problems,
• if you have kidney problems,
• 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 drugs (spironolactone,
triamterene) or potassium supplements as their use with Coversyl
Arginine Plus should be avoided (see “Taking other medicines”).
• if you are elderly,
• if you have had photosensitivity reactions,
• if you have a severe allergic reaction with swelling of the face, lips,
mouth, tongue or throat which may cause difficulty in swallowing or
breathing (angioedema). This may occur at any time during treatment.
If you develop such symptoms, you should stop taking the treatment
and see a doctor immediately.
• if you are taking any of the following medicines used to treat high blood
pressure:
− an “angiotensin II receptor blocker” (ARBs) (also known as
sartans – for example valsartan, telmisartan, irbesartan), in
particular if you have diabetes-related kidney problems.
− aliskiren,
Your doctor may check your kidney function, blood pressure, and the
amount of electrolytes (e.g. potassium) in your blood at regular intervals.
See also information under the heading “Do not take Coversyl Arginine
Plus”.
• if you are of black origin since you may have a higher risk of
angioedema and this medicine may be less effective in lowering your
blood pressure than in non-black patients,
• if you are a haemodialysis patient dialysed with high-flux membranes,
• if you are taking any of the following medicines, the risk of angioedema
is increased:
− racecadotril (used to treat diarrhoea),
− sirolimus, everolimus, temsirolimus and other drugs belonging to
the class of so-called mTor inhibitors (used to avoid rejection of
transplanted organs).
Angioedema
Angioedema (a severe allergic reaction with swelling of the face, lips,
tongue or throat with difficulty in swallowing or breathing) has been
reported in patients treated with ACE inhibitors, including Coversyl Arginine
Plus. This may occur at any time during treatment. If you develop such
symptoms, you should stop taking Coversyl Arginine Plus and see a doctor
immediately. See also section 4.

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),
• if you have changes in your vision or pain in one or both of your eyes
while taking Coversyl Arginine Plus. This could be a sign that you are
developing glaucoma, increased pressure in your eye(s). You should
discontinue Coversyl Arginine Plus treatment and seek medical
attention.
Athletes should be aware that Coversyl Arginine Plus contains an active
ingredient (indapamide) which may give a positive reaction in drug tests.
Children and adolescents
Coversyl Arginine Plus should not be given to children and adolescents.
Other medicines and Coversyl Arginine Plus
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
You should avoid Coversyl Arginine Plus with:
• lithium (used to treat mania or depression),
• aliskiren (medicine used to treat hypertension) if you have no diabetes
mellitus or kidney problems,
• potassium-sparing diuretics (e.g. triamterene, amiloride), potassium
salts,
• estramustine (used in cancer therapy),
• medicines, which are most often used to treat diarrhoea (racecadotril)
or avoid rejection of transplanted organs (sirolimus, everolimus,
temsirolimus and other drugs belonging to the class of so-called mTor
inhibitors). See section "Warnings and precautions",
• other medicines used to treat high blood pressure: angiotensinconverting-enzyme inhibitors and angiotensin receptor blockers.
Treatment with Coversyl Arginine Plus can be affected by other medicines.
Your doctor may need to change your dose and/or to take other
precautions. 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 including angiotensin
II receptor blocker (ARB) or aliskiren (see also information under the
headings “Do not take Coversyl Arginine Plus and “Warnings and
precautions”) or diuretics (medicines which increase the amount of
urine produced by the kidneys),
• potassium-sparing drugs used in the treatment of heart failure:
eplerenone and spironolactone at doses between 12.5 mg to 50 mg
per day,
• anaesthetic medicines,
• iodinated contrast agent,
• moxifloxacin, sparfloxacin (antibiotic: medicine used to treat infection),
• methadone (used to treat addiction),
• procainamide (for the treatment of an irregular heart beat),
• allopurinol (for the treatment of gout),
• mizolastine, 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,
tacrolimus),
• 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),
• cisapride, diphemanil (used to treat gastric and digestive problems),
• 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, metformin or gliptins,
• 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 (such as
amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol)),
• tetracosactide (to treat Crohn’s disease),
• trimethoprim (for the treatment of infections),
• 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).
Coversyl Arginine Plus with food and drink
It is preferable to take Coversyl Arginine Plus before a meal.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this 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
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 breast-feeding. Tell
your doctor immediately if you are breast-feeding or about to start breastfeeding.
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.
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 this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure. The
recommended 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
(associated with nausea, vomiting, cramps, dizziness, sleepiness, mental
confusion, changes in the amount of urine produced by kidneys), 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 medicine, ask your
doctor or pharmacist.

4) Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Stop taking the medicinal product and see a doctor immediately, if
you experience any of the following side effects that can be serious:
• Severe dizziness or fainting due to low blood pressure (Common - may
affect up to 1 in 10 people),
• Bronchospasm (tightening of the chest, wheezing and shortness of
breath (Uncommon) (may affect up to 1 in 100 people),
• Swelling of the face, lips, mouth, tongue or throat, difficulty in breathing
(angioedema) (See section 2 "Warnings and precautions"),
(Uncommon) (may affect up to 1 in 100 people),
• Severe skin reactions including erythema multiforme (a skin rash which
often starts with red itchy patches on your face, arms or legs) or
intense skin rash, hives, reddening of the skin over your whole body,
severe itching, blistering, peeling and swelling of the skin, inflammation
of mucous membranes (Stevens Johnson Syndrome) or other allergic
reactions (Very rare) (may affect up to 1 in 10,000 people),
• Cardiovascular disorders (irregular heart beat, angina pectoris (pains
to the chest, jaw and back, brought on by physical effort), heart attack)
(Very rare) (may affect up to 1 in 10,000 people),
• Weakness of arms or legs, or problems speaking which could be a sign
of a possible stroke (Very rare) (may affect up to 1 in 10,000 people),
• Inflamed pancreas which may cause severe abdominal and back pain
accompanied with feeling very unwell (Very rare) (may affect up to 1 in
10,000 people),
• Yellowing of the skin or eyes (jaundice) which could be a sign of
hepatitis (Very rare) (may affect up to 1 in 10,000 people),
• Life-threatening irregular beat (Not known),
• Disease of the brain caused by liver illness (Hepatic encephalopathy)
(Not known).
In decreasing order of frequency, side effects can include:
• Common (may affect up to 1 in 10 people):
Skin reactions in subjects predisposed to allergic and asthmatic
reactions, headache, dizziness, vertigo, pins and needles, vision
disturbances, tinnitus (sensation of noises in the ears), cough,
shortness of breath (dyspnoea), gastro-intestinal disorders (nausea,
vomiting, abdominal pain, taste disturbances, dyspepsia or difficulty of
digestion, diarrhoea, constipation), allergic reactions (such as skin
rashes, itching), cramps, feeling of tiredness.
• Uncommon (may affect up to 1 in 100 people):
Mood swings, sleep disturbances, urticaria, purpura (red pinpoints on
skin), blister cluster, kidney problems, impotence, sweating, an excess
of eosinophils (a type of white blood cells), change in laboratory
parameters: high blood level of potassium reversible on
discontinuation, low blood level of sodium, somnolence, fainting,
palpitations (awareness of your heartbeat), tachycardia (fast
heartbeat), hypoglycaemia (very low blood sugar level) in case of
diabetic patients, vasculitis (inflammation of blood vessels), dry mouth,
photosensitivity reactions (increased sensitivity of the skin to sun),
arthralgia (joint pain), myalgia (muscle pain), chest pain, malaise,
oedema peripheral, fever, increased blood urea, increased blood
creatinine, fall.
• Rare (may affect up to 1 in 1000 people):
Psoriasis worsening, changes in laboratory parameters: increased
level of liver enzymes, high level of serum bilirubin, fatigue.
• Very rare (may affect up to 1 in 10,000 people):
Confusion, eosinophilic pneumonia (a rare type of pneumonia), rhinitis
(blocked up or runny nose), severe kidney problems, changes in blood
values such as a lower number of white and red blood cells, lower
haemoglobin, lower number of blood platelets, high level of calcium in
the blood, abnormal hepatic function.



Not known (frequency cannot be estimated from the available data):
Abnormal ECG heart tracing, changes in laboratory parameters: low
potassium levels, high uric acid levels and high sugar levels in the
blood, short sightedness (myopia), vision blurred, visual impairment. If
you suffer from systemic lupus erythematosus (a type of collagen
disease), this might get worse.

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.
Reporting of suspected adverse reactions
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the
Google Play or Apple App Store. By reporting side effects, you can help
provide more information on the safety of this medicine.

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) Contents of the pack and other 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, 4/5 Northolt
Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 25.01.2018
Coversyl is a registered trademark of Biofarma, France.

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