COVERSYL ARGININE PLUS 5MG / 1.25MG TABLETS

Active substance: INDAPAMIDE

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ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

In this leaflet:
1. What Coversyl Arginine Plus is and what it is 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 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 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.

PROOF HISTORY:
v.1 - waymade -19/12/13

Leaflet Flat Size = 148 x 432

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 get serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

DATE:
DATE:

DT

19/12/13
DATE OF PROOF:

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 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)

TVT CHECKED

CUSTOMER
APPROVED:
Q.A.
APPROVED:
04-1957

ARTWORKER:

UK PIL DATED MAY 2012
REPORTING OF SIDE EFFECTS

MANUFACTURER:

6464/2703B

Athletes should be aware that Coversyl Arginine Plus contains an active ingredient (indapamide) which may
give a positive reaction in drug tests.

CODE:

Coversyl arginine plus
PRODUCT:

CUSTOMER:

Waymade

PRE-PRESS NO.:

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 and Breast-feeding"),
• if you are breast-feeding.

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 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.

WARNING!

This product is known as the above name but will be referred to as Coversyl Arginine Plus throughout this
leaflet.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

27mm

WARNING!

(perindopril arginine/indapamide)
Patient Information Leaflet

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

COVERSYL® ARGININE PLUS 5mg/1.25mg TABLETS

Leaflet Flat Size = 148 x 432

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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.

PROOF HISTORY:
v.1 - waymade -19/12/13

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.

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,

DATE:

CUSTOMER
APPROVED:

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.

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.

19/12/13
DATE OF PROOF:

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).

TVT CHECKED

DT

DATE:

04-1957

ARTWORKER:

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.

UK PIL DATED MAY 2012
REPORTING OF SIDE EFFECTS

MANUFACTURER:

6464/2703B

Reporting of side effects
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.

CODE:

Coversyl arginine plus
PRODUCT:

PRE-PRESS NO.:
Waymade
CUSTOMER:

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,

•
Q.A.
APPROVED:

•

By reporting side effects you can help provide more information on the safety of this medicine.
•
•
•
•
•

5. How to store Coversyl Arginine Plus
Keep out of the sight and reach 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.
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.
If the tablets become discoloured or show any other signs of deterioration, you should consult your
pharmacist who will advise you what to do.

6. Further Information
What Coversyl Arginine Plus contains
• The active substances are perindopril arginine and indapamide. One film-coated tablet contains
5mg perindopril arginine and 1.25 mg indapamide.
• The other ingredients in the tablet core are: lactose monohydrate, magnesium stearate (E470B),
maltodextrin (contains glucose), 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 looks like and contents of the pack
Coversyl Arginine Plus 5mg/1.25mg tablets are white, rod-shaped film-coated tablets with no markings.
The tablets are available in containers of 30 tablets
Product Licence Holder and Manufacturer
POM

PL No: 6464/2703

This product is manufactured by Les Laboratoires Servier Industrie, 905 route de Saran, 45520 Gidy,
France, and/or, ANPHARM Przedsiębiorstwo Farmaceutyczne SA. ul. Annopol 6B 03-236 Warsaw, Poland
and procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR.
Leaflet Reference (revision and issue date) 19.12.2013
Coversyl is a registered trademark of BIOFARMA

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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.

WARNING!

See your doctor immediately.

WARNING!

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 breast-feeding.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Pregnancy and Breast-feeding
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.

Expand view ⇕

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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