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PERINDOPRIL ARGININE / INDAPAMIDE 5 MG/1.25 MG FILM-COATED TABLETS

Active substance(s): INDAPAMIDE / PERINDOPRIL ARGININE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Perindopril arginine / Indapamide 5 mg/1.25 mg film-coated tablets
perindopril arginine and indapamide
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.
What Perindopril arginine / Indapamide is and what it is used for
2.
Before you take Perindopril arginine / Indapamide
3.
How to take Perindopril arginine / Indapamide
4.
Possible side effects
5.
How to store Perindopril arginine / Indapamide
6.
Further information
1.

WHAT PERINDOPRIL ARGININE / INDAPAMIDE IS AND WHAT IT IS USED FOR

Perindopril arginine / Indapamide 5 mg/1.25 mg 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).
Perindopril belongs to a group of medicines known as angiotensin converting enzyme
(ACE) inhibitors, which widen the blood vessels, and therefore it is easier for the heart to pump blood
through them. Indapamide is a diuretic, which is a type of medicine that increases the amount of urine
produced by the kidneys. These two active ingredients work together to reduce and control your blood
pressure.
2.

BEFORE YOU TAKE PERINDOPRIL ARGININE / INDAPAMIDE

Do not take Perindopril arginine / Indapamide










if you are allergic to perindopril or any other ACE inhibitor, indapamide or any other
sulphonamides, or any of the other ingredients of Perindopril arginine / Indapamide 5 mg/1.25
mg (see section 6 – ‘Further Information’)
if you have ever 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 better to avoid Perindopril arginine / Indapamide
5 mg/1.25 mg see ‘Pregnancy and breast-feeding’)
if you are breast-feeding
Page 1 of 6



Perindopril arginine / Indapamide 5 mg/1.25 mg contains soya oil. If you are allergic to
peanut or soya do not use this medicinal product

Take special care with Perindopril arginine / Indapamide
If any of the following apply to you please talk to your doctor before taking Perindopril arginine /
Indapamide 5 mg/1.25 mg:











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
schleroderma
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 Perindopril arginine / Indapamide 5 mg/1.25 mg should be avoided (see ‘Taking other
medicines’)

You must tell your doctor if you think that you are (or might become) pregnant. Perindopril arginine /
Indapamide 5 mg/1.25 mg 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 Perindopril arginine / Indapamide 5 mg/1.25 mg, 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 Perindopril arginine / Indapamide 5 mg/1.25 mg contains an active
ingredient (indapamide) which may give a positive reaction in drug tests.
Perindopril arginine / Indapamide 5 mg/1.25 mg 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.
Do not take Perindopril arginine / Indapamide 5 mg/1.25 mg if you are taking the following:
• lithium (for the treatment of depression)
• potassium-sparing diuretics (e.g. spironolactone or triamterene), or potassium salts.

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Treatment with Perindopril arginine / Indapamide 5 mg/1.25 mg 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 in the treatment of 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, sotolol)
digoxin or other cardiac glycosides (for the treatments 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 or schizophrenia…(e.g.
tricyclic antidepressants or neuroleptics)
tetracosactide (to treat Crohn's disease)

Perindopril arginine / Indapamide with food and drink
It is preferable to take Perindopril arginine / Indapamide 5 mg/1.25 mg 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 Perindopril arginine / Indapamide 5 mg/1.25 mg before you
become pregnant or as soon as you know you are pregnant and will advise you to take another
medicine instead of Perindopril arginine / Indapamide 5 mg/1.25 mg. Perindopril arginine /
Indapamide 5 mg/1.25 mg 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 Perindopril arginine / Indapamide 5 mg/1.25 mg if you are breast-feeding. Tell
your doctor immediately if you are breast-feeding or about to start breast-feeding.
Page 3 of 6

Driving and using machines
Perindopril arginine / Indapamide 5 mg/1.25 mg usually does not affect alertness, but different
reactions such as dizziness or weariness in relation to the decrease in blood pressure may occur in
certain patients. If affected, your ability to drive or operate machinery may be impaired.
Important information about some of the ingredients of Perindopril arginine / Indapamide
This medicine contains soya oil. If you are allergic to peanut or soya do not use this medicinal
product.
This medicine also contains lactose. If you have been told by your doctor that you have an intolerance
to some sugars, such as lactose, contact your doctor before taking this medicinal product.
3.

HOW TO TAKE PERINDOPRIL ARGININE / INDAPAMIDE

Always take Perindopril arginine / Indapamide 5 mg/1.25 mg 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 increase the dose to 2 tablets daily or 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.
Always take Perindopril arginine / Indapamide 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 Perindopril arginine / Indapamide 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 fainting), lying down with the legs raised can help.
If you forget to take Perindopril arginine / Indapamide
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 Perindopril arginine / Indapamide
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, Perindopril arginine / Indapamide 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
• unusually fast or irregular heart beat
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In decreasing order of frequency, side effects can include:
Common: affects 1 to 10 users in 100
• headache, feelings of dizziness, vertigo, light-headedness due to low blood pressure
• vision disturbances
• tinnitus (sensation of noises in the ears)
• 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, pins and needles
• feeling of tiredness
Uncommon: affects 1 to 10 users in 1,000
• mood swings, sleep disturbances
• bronchospasm (tightening of the chest, wheezing and shortness of breath)
• angiodema (symptoms such as wheezing, swelling of the face or tongue)
• purpura (red pinpoints on skin), urticaria
• kidney problems
• impotence
• sweating
Very rare: affects less than 1 user in 10,000
• 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 of 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 PERINDOPRIL ARGININE / INDAPAMIDE

Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
Do not use Perindopril arginine / Indapamide 5 mg/1.25 mg after the expiry date, which is stated on
the bottle, carton or blister after ‘EXP’. The expiry date refers to the last day of that month.
Perindopril arginine / Indapamide 5 mg/1.25 mg supplied in bottles should be used for no longer than
6 months after the bottle has first been opened.
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.
Page 5 of 6

6.

FURTHER INFORMATION

What Perindopril arginine / Indapamide 5 mg/1.25 mg contains
The active substances are perindopril arginine and indapamide. One tablet contains 5 mg of
perindopril arginine and 1.25 mg of indapamide.
The other ingredients are:
Core:
Silica, hydrophobic colloidal , lactose monohydrate, magnesium stearate, maltodextrin, povidone (K
30), sodium starch glycolate (Type A).
Film-coating (Opadry AMB White OY-B-28920):
Lecithin (Soya) (E322), polyvinyl alcohol, talc (E553b), titanium dioxide (E171), xanthan gum
(E415).
What Perindopril arginine / Indapamide looks like and contents of the pack
Perindopril arginine / Indapamide 5 mg/1.25 mg film-coated tablets are white, capsule shaped,
biconvex, film-coated tablets debossed with a ‘PI’ on one side and ‘M2’ on the other side.
Perindopril arginine / Indapamide 5 mg/1.25 mg is available in blisters of 10, 14, 30, 60, 90 and 100
film-coated tablets and in a plastic bottle of 30 film-coated tablets. Not all pack sizes may be
marketed.
Marketing Authorisation Holder
Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Manufacturer
McDermott Laboratories Limited trading as Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.
This leaflet was last approved in 04/2011

Page 6 of 6

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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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