PERINDOPRIL 2 mg /0,625 Mg Coated Tablet

Зміст інструкції

1. PERINDOPRIL E INDAPAMIDE EG 2 mg/0,625 mg tablets, 4 mg/1,25 mg tablets
   1. What is Perindopril and Indapamide EG and what it is used for
   2. What you need to know before taking Perindopril and Indapamide EG
   3. How to take Perindopril and Indapamide EG
   4. Possible side effects
   5. How to store Perindopril and Indapamide EG
   6. Package contents and other information

PERINDOPRIL E INDAPAMIDE EG 2 mg/0,625 mg tablets, 4 mg/1,25 mg tablets

perindopril tert-butylamine/indapamide

Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What PERINDOPRIL E INDAPAMIDE EG is and what it is used for
• 2. What you need to know before you take PERINDOPRIL E INDAPAMIDE EG
• 3. How to take PERINDOPRIL E INDAPAMIDE EG
• 4. Possible side effects
• 5. How to store PERINDOPRIL E INDAPAMIDE EG
• 6. Contents of the pack and other information

1. What is Perindopril and Indapamide EG and what it is used for

PERINDOPRIL E INDAPAMIDE EG 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) in adults.
Perindopril belongs to a class of medicines called ACE inhibitors. These work by widening the
blood vessels, making it easier for the heart to pump through them.
Indapamide is a diuretic. Diuretics increase the amount of urine produced by the kidneys. However,
indapamide is different from other diuretics in that it causes only a slight increase in the amount of urine
produced.
Both active ingredients reduce blood pressure and work together to control blood
pressure.

2. What you need to know before taking Perindopril and Indapamide EG

Do not take PERINDOPRIL E INDAPAMIDE EG

• if you are allergic to perindopril or to any other ACE inhibitor, or to indapamide or to any other sulfonamide or to any of the other ingredients of this medicine (listed in section 6);
• if you have previously experienced symptoms such as wheezing, swelling of the face, tongue or throat, severe itching or skin rashes with a previous ACE inhibitor treatment, or if a member of your family has experienced these symptoms in other circumstances (a condition called angioedema);

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• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren;
• if you have a severe liver disease or suffer from a condition called hepatic encephalopathy (degenerative brain disease);
• if you have a severe kidney disease, where the blood supply to the kidneys is reduced (renal artery stenosis);
• if you are undergoing dialysis, or any other type of blood filtration. Depending on the machinery used, PERINDOPRIL E INDAPAMIDE EG may not be suitable for you;
• if you have low levels of potassium;
• if you suspect you have decompensated heart failure (severe fluid retention, difficulty breathing);
• if you are pregnant for more than three months. (It is best to avoid PERINDOPRIL E INDAPAMIDE EG even in the early stages of pregnancy - see “Pregnancy and breastfeeding”);
• if you have taken or are taking sacubitril/valsartan, a medicine to treat heart failure, as this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat) (see “Warnings and precautions” and “Other medicines and PERINDOPRIL E INDAPAMIDE EG”).

Warnings and precautions
Talk to your doctor or pharmacist before taking PERINDOPRIL E INDAPAMIDE EG:

• if you have aortic stenosis (narrowing of the main blood vessel from the heart) or hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery that carries blood to the kidney);
• if you suffer from heart failure or have other heart problems;
• if you have kidney problems, or are undergoing dialysis;
• if you have impaired vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and can occur within a period ranging from a few hours to weeks after taking PERINDOPRIL E INDAPAMIDE EG. This can lead to permanent vision loss if not treated. If you have recently had an allergy to penicillin or sulfonamides, you may be at high risk of developing this symptom;
• if you have muscle disorders including muscle pain, tenderness, weakness or cramps;
• if you have excessively increased levels of a hormone called aldosterone in the blood (primary aldosteronism);
• if you have liver problems;
• if you suffer from a collagen disease (skin disease) such as systemic lupus erythematosus or scleroderma;
• if you suffer from 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 following a diet with a limited salt content or if you use salt substitutes that contain potassium;
• if you are taking lithium or potassium-sparing medicines (spironolactone, triamterene) or potassium supplements because their use with PERINDOPRIL E INDAPAMIDE EG must be avoided (see “Other medicines and PERINDOPRIL E INDAPAMIDE EG”);
• if you are elderly;
• if you have experienced photosensitivity reactions;
• if you have a severe allergic reaction with swelling of the face, lips, mouth, tongue or throat that can cause difficulty swallowing or breathing (angioedema). This can occur at any time during treatment. If you develop such symptoms, stop treatment and call a doctor immediately;
• if you are taking any of the following medicines used to treat high blood pressure:
• an "angiotensin II receptor blocker" (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you suffer from kidney problems related to diabetes.

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• aliskiren The doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g., potassium) in your blood at regular intervals. See also what is stated under "Do not take PERINDOPRIL E INDAPAMIDE EG".
• if you are of Black origin as you may have a higher risk of developing angioedema and this medicine may be less effective in reducing your blood pressure compared to non-Black patients;
• if you are a patient undergoing haemodialysis with high-flux membranes;
• if you are taking any of the following drugs, the risk of angioedema may be increased:
• racecadotril (used for the treatment of diarrhoea);
• sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors (used in the prevention of organ rejection following organ transplantation and cancer);
• sacubitril (available as a fixed-dose combination with valsartan), used to treat long-term heart failure;
• linagliptin, saxagliptin, sitagliptin, vildagliptin and other medicines belonging to the class of gliptins;

Angioedema
In patients treated with ACE inhibitors, including perindopril, angioedema has been reported (a serious
allergic reaction with swelling of the face, lips, tongue or throat with difficulty swallowing or breathing).
This can occur at any time during treatment. If you develop such symptoms, you should stop
taking PERINDOPRIL E INDAPAMIDE EG and consult a doctor immediately. See also
section 4.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy). PERINDOPRIL E INDAPAMIDE EG is not recommended in the early stages of pregnancy, and
should not be taken if you are pregnant for more than three months, as it can cause serious harm
to the baby if taken during this period (see “Pregnancy and breastfeeding”).
When you are taking PERINDOPRIL E INDAPAMIDE EG, you should also inform your doctor or
healthcare professional

• 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 consists of removing cholesterol from the blood using a machine);
• if you are to undergo a desensitization treatment to reduce the effects of an allergy to bee or wasp stings;
• if you are to undergo medical examinations that require the injection of an iodine-containing contrast agent (a substance that makes organs such as the kidneys or stomach visible on X-rays);
• if you have had changes in vision or eye pain during the intake of PERINDOPRIL E INDAPAMIDE EG. This could be a sign that glaucoma, increased pressure in an eye(s) is developing. Stop taking PERINDOPRIL E INDAPAMIDE EG and consult a doctor.

Athletes must be informed that PERINDOPRIL E INDAPAMIDE EG contains an
active ingredient (indapamide) that can induce a positive reaction to doping control tests.

Children and adolescents
PERINDOPRIL E INDAPAMIDE EG should not be given to children and adolescents.

Other medicines and PERINDOPRIL and INDAPAMIDE EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
You must avoid PERINDOPRIL E INDAPAMIDE EG with:
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• lithium (used for the treatment of manic disorder or depression);
• aliskiren (a medicine used to treat hypertension) if you do not have diabetes mellitus or kidney problems;
• potassium-sparing diuretics (such as triamterene, amiloride), potassium salts, or other medicines that can increase potassium levels in the body (including heparin, a medicine used to thin the blood to prevent clots; trimethoprim and co-trimoxazole also known as trimethoprim/sulfamethoxazole for infections caused by bacteria);
• estramustine (used in cancer therapy);
• other medicines used to treat high blood pressure: angiotensin-converting enzyme inhibitors and angiotensin receptor blockers.

Treatment with PERINDOPRIL E INDAPAMIDE EG may be affected by other medicines. Your
doctor may need to adjust the dose and/or take other precautions. Make sure to
tell your doctor if you are taking any of the following medicines as special attention may be required:

• other medicines for the treatment of high blood pressure including an angiotensin II receptor blocker (AIIRA) or aliskiren (see also what is stated under “Do not take PERINDOPRIL E INDAPAMIDE EG” and “Warnings and precautions”) or diuretics (medicines that increase the amount of urine produced by the kidneys);
• potassium-sparing diuretics used in the treatment of heart failure: eplerenone and spironolactone, at doses between 12.5 mg and 50 mg per day;
• medicines used mainly for the treatment of diarrhoea (racecadotril) or for the prevention of rejection following organ transplantation (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors). See section “Warnings and precautions”;
• sacubitril/valsartan (used to treat long-term heart failure). See sections “Do not take PERINDOPRIL E INDAPAMIDE EG” and “Warnings and precautions”;
• anaesthetics;
• iodine-containing contrast agents;
• antibiotics used to treat bacterial infections (e.g. moxifloxacin, sparfloxacin, injectable erythromycin);
• methadone (used for the treatment of addictions);
• procainamide (for the treatment of irregular heartbeat);
• allopurinol (for the treatment of gout);
• antihistamines used to treat allergic reactions, such as hay fever (e.g. mizolastine, terfenadine, astemizole;
• corticosteroids used to treat various conditions, including severe asthma and rheumatoid arthritis;
• immunosuppressants used to treat autoimmune disorders or after transplant surgery to prevent rejection (e.g. cyclosporine, tacrolimus);
• alofantrine (used to treat certain types of malaria);
• pentamidine (used to treat pneumonia);
• injectable gold (used for the treatment of rheumatoid polyarthritis);
• vincamine (used to treat symptomatic cognitive disorders in the elderly including memory loss);
• bepridil (used for the treatment of angina pectoris);
• medicines used for heart rhythm problems (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis, bretylium);
• cisapride, difemanil (used to treat stomach and digestive problems);
• digoxin or other cardiac glycosides (for the treatment of heart problems);
• baclofen (for the treatment of muscle stiffness that occurs in diseases such as multiple sclerosis);
• medicines for the treatment of 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. acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever, as well as to prevent blood clots));
• amphotericin B for injection (for the treatment of severe fungal diseases); Page 4of 9
• medicines used to treat mental disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, neuroleptics (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol));
• tetracosactide (for the treatment of Crohn's disease);
• trimethoprim (for the treatment of infections);
• vasodilators including nitrates (products that make blood vessels wider);
• medicines used to treat low blood pressure, shock or asthma (e.g. ephedrine, norepinephrine or adrenaline).

PERINDOPRIL E INDAPAMIDE EGwith food and drink
It is preferable to take PERINDOPRIL E INDAPAMIDE EG before a meal.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy).
As a rule, your doctor will advise you to stop taking PERINDOPRIL E INDAPAMIDE EG
before starting a pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of PERINDOPRIL E INDAPAMIDE EG.
PERINDOPRIL E INDAPAMIDE EG is not recommended in the early stages of pregnancy, and should not
be taken if you are pregnant for more than three months, as it can cause serious harm to the baby if
taken after the third month of pregnancy.

Breastfeeding
PERINDOPRIL E INDAPAMIDE EG is not recommended if you are breastfeeding. Inform your doctor if you are
breastfeeding or are about to start breastfeeding.
Consult your doctor immediately.

Driving and operating machinery
PERINDOPRIL E INDAPAMIDE EG usually does not affect alertness, but in some patients
various reactions related to low blood pressure such as dizziness or weakness may occur. If this happens to you,
your ability to drive or operate machinery may decrease.

PERINDOPRIL E INDAPAMIDE EG contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking this
medicine.

3. How to take Perindopril and Indapamide EG

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet once a day. Your doctor may decide to modify the
dosage regimen if you suffer from renal insufficiency. Take the tablet preferably in the morning and
before a meal. Swallow the tablet with a glass of water.

If you take more PERINDOPRIL E INDAPAMIDE EGthan you should
If you take too many tablets, contact your doctor or the nearest emergency room immediately. The most
common effect in case of overdose is low blood pressure. If you experience low blood pressure (associated with nausea,
vomiting, cramps, dizziness, drowsiness, mental confusion, changes in the amount of urine produced by the
kidneys), it may be helpful to lie down with your legs raised.
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If you forget to take PERINDOPRIL E INDAPAMIDE EG
It is important to take the medicine every day because regular treatment is more effective. However, if
you forget to take a dose of PERINDOPRIL E INDAPAMIDE EG, take the next dose
at the usual time. Do not take a double dose to compensate for forgetting the dose.

If you stop taking PERINDOPRIL E INDAPAMIDE EG
Since treatment for high blood pressure usually lasts a lifetime, inform your doctor before
stopping taking this medicine.
If you have any doubts about 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.
manifest.

Stop taking the medicine and tell your doctor immediately if you experience any of the following
adverse reactions which may be serious:

• severe dizziness or fainting due to low blood pressure (Common) (can affect up to 1 in 10 people);
• bronchospasm (tightness in the chest, wheezing and shortness of breath) (Uncommon) (can affect up to 1 in 100 people);
• swelling of the face, lips, mouth, tongue or throat, difficulty breathing, (angioedema) (see section 2 “Warnings and precautions”) (Uncommon) (can affect up to 1 in 100 people);
• severe skin reactions such as erythema multiforme (a skin rash that often starts with red, itchy patches on the face, arms or legs) or intense skin rash, hives, redness all over the skin, severe itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome) or other allergic reactions (Very rare) (can affect up to 1 in 10,000);
• cardiovascular disorders (irregular heartbeat, angina pectoris (chest, jaw and back pain caused by physical exertion), heart attack) (Very rare) (can affect up to 1 in 10,000);
• weakness of arms or legs, or speech problems which could be a sign of a possible stroke (Very rare) (can affect up to 1 in 10,000);
• inflammation of the pancreas which can cause severe abdominal and back pain accompanied by a feeling of unwellness (Very rare) (can affect up to 1 in 10,000);
• yellowing of the skin or eyes (jaundice) which can be a sign of hepatitis (Very rare) (can affect up to 1 in 10,000);
• life-threatening irregular heartbeat (Not known);
• brain disease caused by liver disease (hepatic encephalopathy) (Not known);
• muscle weakness, cramps, tenderness or pain and in particular, if at the same time you do not feel well or have a high fever, this may be caused by abnormal muscle breakdown (Not known).

In decreasing order of frequency, side effects may include:

Common(can affect up to 1 in 10 people):
Skin reactions in subjects predisposed to allergy and asthmatic reactions, headache, dizziness, vertigo,
tingling, visual disturbances, tinnitus (sensation of noises in the ears), cough, shortness of breath (dyspnea),
gastrointestinal disorders (nausea, vomiting, abdominal pain, taste alteration, dyspepsia or difficulty of
digestion, diarrhoea, constipation), allergic reactions (such as skin rashes, itching), cramps, feeling of
tiredness, low levels of potassium in the blood.
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Uncommon(can affect up to 1 in 100 people):
Mood swings, sleep disorders, hives, purpura (red spots on the skin), clustered blisters, kidney problems, impotence (inability to get or maintain an erection), sweating, excess of eosinophils (a
type of white blood cells), alteration of laboratory parameters: high level in the blood of potassium
reversible with discontinuation, low levels of sodium in the blood that can lead to dehydration and
lowering of blood pressure, drowsiness, fainting, palpitations (awareness of heartbeat), tachycardia (fast heartbeat), hypoglycemia (very low blood sugar
level) in diabetic patients, vasculitis (inflammation of blood vessels), dry mouth, photosensitivity reactions (increased sensitivity of the skin to the sun), arthralgia (joint pain), myalgia (muscle pain), chest pain, malaise, peripheral edema, fever, increased urea in the blood, increased
creatinine in the blood, falls, depression.

Rare(can affect up to 1 in 1000):
Worsening of psoriasis, change of laboratory parameters: increase of liver enzymes levels, high levels of serum bilirubin, fatigue, low levels of chlorine in the blood, low levels of magnesium
in the blood, dark urine, feeling unwell (nausea) or feeling sick (vomiting), muscle cramps, confusion and convulsions. These symptoms may be attributable to a condition
called SIADH (syndrome of inappropriate secretion of the antidiuretic hormone). Reduction or absence of
urine. Flushing. Acute renal failure.

Very rare(can affect up to 1 in 10,000):
Confusion, eosinophilic pneumonia (a rare type of pneumonia), rhinitis (blocked or runny nose), severe
kidney problems, change of blood parameters such as lowering of white blood cells and
red blood cells, lower hemoglobin, lower number of platelets in the blood, high blood levels of calcium,
abnormal liver function.

Not known(frequency cannot be estimated from available data):
Abnormal ECG tracing, change of laboratory parameters: high levels of uric acid and high
levels of sugar in the blood, worsening of vision (myopia), blurred vision, impaired
vision, decreased vision or eye pain due to high pressure (possible signs
of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma), abnormal color vision, numbness and pain in the fingers of the hands or feet (Raynaud's phenomenon). If you suffer from systemic lupus erythematosus (a connective tissue disease), this may worsen.
Blood, kidney, liver or pancreas disorders and changes in laboratory parameters (blood tests) may occur. Your doctor may need to prescribe blood tests to
monitor your condition.
If you have these symptoms, contact your doctor as soon as possible.

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 through
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse. By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Perindopril and Indapamide EG

Keep out of the sight and reach of children.
For 2 mg and 4 mg: PVC/PVdC–Aluminum blisters:
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Store in the original package to protect the medicine from moisture.
When unopened, this medicine does not require special storage conditions.
Once the laminated package has been opened, the blisters must be stored in the outer packaging at
a temperature below 30˚C.
Unused tablets must be discarded after two months of opening the package.
For 4 mg: Aluminum–Aluminum blisters:
Store in the original package to protect the medicine from moisture. Store at a temperature
below 30˚C.
Do not use this medicine after the expiry date which is stated on the label, on the blister, on the package and
on the carton after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What PERINDOPRIL E INDAPAMIDE EG contains

• The active ingredients are perindopril tert-butylamine and indapamide.
• Each tablet contains 2 mg of perindopril tert-butylamine equivalent to 1.669 mg of perindopril and 0.625 mg of indapamide.
• Each tablet contains 4 mg of perindopril tert-butylamine equivalent to 3.338 mg of perindopril and 1.25 mg of indapamide.
• Other ingredients are: Lactose monohydrate Magnesium stearate Colloidal anhydrous silica Microcrystalline cellulose

Description of the appearance of PERINDOPRIL E INDAPAMIDE EGand package contents
PERINDOPRIL E INDAPAMIDE EG 2 mg/0.625 mg Tablets
White capsule-shaped tablets with "P" and "I" printed on both sides of the score line on one
side, and with a score line on the other side. The tablet can be broken into two equal halves.
PERINDOPRIL E INDAPAMIDE EG 4 mg/1.25 mg Tablets
White capsule-shaped tablets with "PI" embossed on one side and smooth on the other side.
For 2 mg and 4 mg: PVC/PVdC–Aluminum blisters:
The tablets are packaged in PVC/PVdC-Aluminum blisters, inside a protective aluminum
pack, which contains a desiccant that protects the tablets from moisture. The desiccant must not
be ingested.
For 4 mg: Aluminum–Aluminum blisters:
The tablets are packaged in Aluminum–Aluminum blisters in a cardboard box.

Package contents
30, 90 and 100
Not all pack sizes may be marketed.

Marketing Authorisation Holder
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EG S.p.A., Via Pavia, 6 - 20136 Milano

Manufacturer
Glenmark Pharmaceuticals s.r.o., Fibìchova 143, 56617 Vysoké, Czech Republic
Glenmark Pharmaceuticals Europe Limited, Building 2, Croxley Green Business Park, Croxley Green,
Hertfordshire, WD188YA, United Kingdom

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Italy PERINDOPRIL E INDAPAMIDE EG 2 mg/0.625 mg and 4 mg/1.25 mg
Netherlands Perindopril tert-butylamine /Indapamide Glenmark 2/0.625mg and 4/1.25mg
Tabletten
Spain Perindopril/Indapamide Viso Farmacéutica 2/0.625mg and 4/1.25mg comprimidos
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