Perindopril and indapamide EG: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

PERINDOPRIL AND INDAPAMIDE EG 2 mg/0.625 mg tablets, 4 mg/1.25 mg tablets

perindopril tert-butylamine/indapamide
Equivalent medicine
Please read this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What PERINDOPRIL AND INDAPAMIDE EG is and what it is used for
What you need to know before taking PERINDOPRIL AND INDAPAMIDE EG
How to take PERINDOPRIL AND INDAPAMIDE EG
Possible side effects
How to store PERINDOPRIL AND INDAPAMIDE EG
Contents of the pack and other information

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

PERINDOPRIL AND INDAPAMIDE EG is a combination of two active substances, perindopril and indapamide.
It is an antihypertensive medicine used for 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, thereby making it easier for the heart to pump blood through them.
Indapamide is a diuretic. Diuretics increase the amount of urine produced by the kidneys. However, indapamide differs from other diuretics in that it causes only a slight increase in the amount of urine produced.
Both active substances 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 AND INDAPAMIDE EG

if you are allergic to perindopril or any other ACE inhibitor, or to indapamide or any other sulfonamide, or to any of the other ingredients of this medicine (listed in section 6);
if during previous treatment with ACE inhibitors you experienced symptoms such as shortness of breath, facial swelling, tongue swelling, severe itching or severe skin rash, or if you or a family member has had these symptoms under other circumstances (a condition called angioedema);
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren;
if you have severe liver disease or suffer from a condition called hepatic encephalopathy (a degenerative brain disorder);
if you have severe kidney disease, particularly when 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 equipment used, PERINDOPRIL AND INDAPAMIDE EG may not be suitable for you;
if you have low levels of potassium in your blood;
if you suspect you have untreated decompensated heart failure (severe fluid retention, difficulty breathing);
if you are more than three months pregnant. (It is best to avoid PERINDOPRIL AND INDAPAMIDE EG even in early pregnancy – see “Pregnancy and breastfeeding”);
if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat heart failure, as this increases the risk of angioedema (rapid swelling under the skin, e.g. in the throat) (see “Warnings and precautions” and “Other medicines and PERINDOPRIL AND INDAPAMIDE EG”).

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

if you have aortic stenosis (narrowing of the main blood vessel from the heart) or hypertrophic cardiomyopathy (a heart muscle disease) or renal artery stenosis (narrowing of the artery supplying blood to the kidney);
if you have heart failure or other heart problems;
if you have kidney problems or are undergoing dialysis;
if you experience vision changes or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, which may occur from a few hours to several weeks after taking PERINDOPRIL AND INDAPAMIDE EG. This may lead to permanent vision loss if not treated. If you have recently had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this symptom;
if you have muscle disorders including muscle pain, tenderness, weakness or cramps;
if you have excessively high levels of a hormone called aldosterone in your blood (primary aldosteronism);
if you have liver problems;
if you suffer from a collagen disease (skin disorder) such as systemic lupus erythematosus or scleroderma;
if you suffer from atherosclerosis (hardening of the arteries);
if you have hyperparathyroidism (overactive parathyroid gland);
if you suffer from gout;
if you have diabetes;
if you are on a low-salt diet or use salt substitutes containing potassium;
if you are taking lithium or potassium-sparing medicines (spironolactone, triamterene) or potassium supplements, as their use with PERINDOPRIL AND INDAPAMIDE EG should be avoided (see “Other medicines and PERINDOPRIL AND 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 may cause difficulty swallowing or breathing (angioedema). This may occur at any time during treatment. If such symptoms develop, stop treatment immediately and contact a doctor without delay;
if you are taking any of the following medicines used to treat high blood pressure:
- an "angiotensin II receptor antagonist" (AIIRA) (also known as sartans – for example valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.

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aliskiren. Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also the section "Do not take PERINDOPRIL AND 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 lowering your blood pressure compared to non-Black patients;
- if you are a patient undergoing hemodialysis with high-flux dialysis membranes;
- if you are taking any of the following medicines, the risk of angioedema may be increased:
- racecadotril (used to treat diarrhoea);
- sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors (used to prevent organ transplant rejection and in cancer treatment);
- 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 (a severe allergic reaction with swelling of the face, lips, tongue or throat, causing difficulty in swallowing or breathing) has been reported. This may occur at any time during treatment. If you develop such symptoms, you must stop taking PERINDOPRIL AND 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 becoming pregnant). PERINDOPRIL AND INDAPAMIDE EG is not recommended during early pregnancy, and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn baby if taken during this period (see “Pregnancy and breastfeeding”).
While taking PERINDOPRIL AND INDAPAMIDE EG, you should also inform your doctor or healthcare professional

if you are scheduled for anaesthesia and/or surgery;
if you have recently experienced diarrhoea or vomiting, or are dehydrated;
if you are scheduled for dialysis or LDL apheresis (a procedure involving removal of cholesterol from the blood using a machine);
if you are scheduled for desensitisation treatment to reduce the effects of an allergy to bee or wasp stings;
if you are scheduled for medical tests requiring injection of an iodinated contrast agent (a substance that makes organs such as kidneys or stomach visible on X-rays);
if you experience vision disturbances or pain in one or both eyes while taking PERINDOPRIL AND INDAPAMIDE EG. This could be a sign of developing glaucoma, increased pressure in one or both eyes. Stop treatment with PERINDOPRIL AND INDAPAMIDE EG and consult a doctor.

Athletes should be informed that PERINDOPRIL AND INDAPAMIDE EG contains an active substance (indapamide) that may lead to a positive result in anti-doping tests.
Children and adolescents
PERINDOPRIL AND INDAPAMIDE EG must not be given to children and adolescents.
Other medicines and PERINDOPRIL AND INDAPAMIDE EG
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
You must avoid PERINDOPRIL AND INDAPAMIDE EG with:

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lithium (used to treat 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 may increase potassium levels in the body (including heparin, a medicine used to thin the blood to prevent clots; trimethoprim and cotrimoxazole, also known as trimethoprim/sulfamethoxazole, for bacterial infections);
estramustine (used in cancer therapy);
other medicines used to treat high blood pressure: angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers.

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

other medicines for treating high blood pressure, including an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also “Do not take PERINDOPRIL AND INDAPAMIDE EG” and “Warnings and precautions”) or diuretics (medicines that increase urine production 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 primarily for treating diarrhoea (racecadotril) or for preventing organ transplant rejection (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 AND INDAPAMIDE EG” and “Warnings and precautions”;
anaesthetics;
iodinated contrast agents;
antibiotics used to treat bacterial infections (e.g. moxifloxacin, sparfloxacin, injectable erythromycin);
methadone (used to treat addiction);
procainamide (for treating irregular heartbeat);
allopurinol (for treating 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);
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 the elderly, including memory loss);
bepridil (used to treat angina pectoris);
medicines used for heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis, bretylium);
cisapride, difenamizine (used to treat gastric and digestive problems);
digoxin or other cardiac glycosides (for treating heart problems);
baclofen (to treat muscle stiffness occurring in diseases such as multiple sclerosis);
medicines for treating 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 found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clots));
injectable amphotericin B (for treating serious fungal infections); Page 4 of 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 treating Crohn's disease);
trimethoprim (for treating infections);
vasodilators including nitrates (substances that widen blood vessels);
medicines used to treat low blood pressure, shock or asthma (e.g. ephedrine, noradrenaline or adrenaline).

PERINDOPRIL AND INDAPAMIDE EG with food and drink
It is preferable to take PERINDOPRIL AND INDAPAMIDE EG before a meal.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant).
Your doctor will usually advise you to stop taking PERINDOPRIL AND INDAPAMIDE EG before becoming pregnant or as soon as you find out you are pregnant, and will recommend an alternative medicine instead.
PERINDOPRIL AND INDAPAMIDE EG is not recommended during early pregnancy, and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.
Breastfeeding
PERINDOPRIL AND INDAPAMIDE EG is not recommended if you are breastfeeding. Inform your doctor if you are breastfeeding or planning to start breastfeeding.
Contact your doctor immediately.
Driving and using machines
PERINDOPRIL AND INDAPAMIDE EG usually does not affect alertness, but in some patients low blood pressure-related reactions such as dizziness or weakness may occur. If this happens, your ability to drive or operate machinery may be impaired.
PERINDOPRIL AND INDAPAMIDE EG contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Perindopril and Indapamide EG

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one tablet once daily. Your doctor may decide to adjust the dosage regimen if you have renal impairment. Take the tablet preferably in the morning and before a meal. Swallow the tablet with a glass of water.
If you take more Perindopril and Indapamide EG than you should
If you take too many tablets, contact your doctor or the nearest emergency department immediately. The most common effect of overdose is low blood pressure. If you experience low blood pressure (associated with nausea, vomiting, cramps, dizziness, drowsiness, 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 and Indapamide EG
It is important to take the medicine every day, as regular treatment is more effective. However, if you forget to take a dose of Perindopril and Indapamide EG, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you stop taking Perindopril and Indapamide EG
Since treatment for high blood pressure usually lasts a lifetime, inform your doctor before stopping this medicine.
If you have any doubts about how to use this medicine, consult 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 medicine and inform 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) (may affect up to 1 in 10 people);
bronchospasm (tightness of the chest, wheezing and breathlessness) (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 such as erythema multiforme (a skin rash often starting with itchy red spots on the face, arms or legs) or severe rash, hives, redness of the skin all over the body, intense itching, blisters, 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 heartbeat, angina pectoris (chest, jaw and back pain caused by physical exertion), heart attack) (Very rare) (may affect up to 1 in 10,000 people);
weakness in arms or legs, or speech problems which could be signs of a possible stroke (Very rare) (may affect up to 1 in 10,000 people);
inflammation of the pancreas which may cause severe abdominal pain and backache accompanied by malaise (Very rare) (may affect up to 1 in 10,000 people);
yellowing of the skin or eyes (jaundice), which may be a sign of hepatitis (Very rare) (may affect up to 1 in 10,000 people);
life-threatening irregular heartbeat (Not known);
brain disease caused by liver disease (hepatic encephalopathy) (Not known);
muscle weakness, cramps, tenderness or pain, particularly if you also feel unwell or have a high fever, which could be due to abnormal muscle breakdown (Not known).

In decreasing order of frequency, the side effects may include:
Common (may affect up to 1 in 10 people):
Skin reactions in individuals predisposed to allergies and asthmatic reactions, headache, dizziness, vertigo,
tingling, visual disturbances, tinnitus (ringing or noise in the ears), cough, shortness of breath (dyspnea),
gastrointestinal disturbances (nausea, vomiting, abdominal pain, taste disturbances, indigestion or
difficulty in digestion, diarrhoea, constipation), allergic reactions (such as skin rashes, itching), cramps,
feeling of fatigue, low blood potassium levels.
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Uncommon (may affect up to 1 in 100 people):
Mood swings, sleep disorders, urticaria, purpura (red spots on the skin), blistering rash, kidney problems,
impotence (inability to achieve or maintain an erection), sweating, increased eosinophils (a type of white
blood cells), changes in laboratory parameters: high blood potassium levels reversible upon discontinuation,
low blood sodium levels which may lead to dehydration and low blood pressure, drowsiness, fainting,
palpitations (awareness of heartbeat), tachycardia (rapid heartbeat), hypoglycaemia (very low blood sugar
levels) in diabetic patients, vasculitis (inflammation of blood vessels), dry mouth, photosensitivity reactions
(increased skin sensitivity to sunlight), arthralgia (joint pain), myalgia (muscle pain), chest pain, malaise,
peripheral oedema, fever, increased blood urea, increased blood creatinine, falls, depression.
Rare (may affect up to 1 in 1,000 people):
Worsening of psoriasis, changes in laboratory parameters: increased liver enzymes, elevated serum bilirubin
levels, fatigue, low blood chloride levels, low blood magnesium levels, dark-coloured urine, feeling of
malaise (nausea) or state of malaise (vomiting), muscle cramps, confusion and seizures. These symptoms may
be related to a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion).
Reduced or absent urine output. Flushing. Acute kidney failure.
Very rare (may affect up to 1 in 10,000 people):
Confusion, eosinophilic pneumonia (a rare type of pneumonia), rhinitis (stuffy or runny nose), severe kidney
problems, changes in blood parameters such as decreased numbers of white and red blood cells, lower
haemoglobin, reduced platelet count, high blood calcium levels, abnormal liver function.
Not known (frequency cannot be estimated from the available data):
Abnormal ECG pattern, changes in laboratory parameters: high levels of uric acid and high blood sugar
levels, decreased vision (myopia), blurred vision, visual impairment, reduced 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 skin colour, numbness and pain in fingers or toes (Raynaud's phenomenon).
If you suffer from systemic lupus erythematosus (a collagen disease), this may worsen.
Blood, kidney, liver or pancreas disorders may occur, as well as changes in laboratory parameters (blood
tests). Your doctor may need to prescribe blood tests to monitor your condition.
If you experience any of these symptoms, contact your doctor as soon as possible.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or
nurse. You can also report side effects directly via 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 packaging to protect the medicine from moisture.
When unopened, this medicine does not require any special storage conditions.
Once the laminated carton has been opened, the blisters must be stored in the outer packaging at a temperature below 30°C.
Unused tablets should be discarded after two months from opening the carton.
For 4 mg: Aluminum–Aluminum blisters:
Store in the original packaging to protect the medicine from moisture. Store below 30°C.
Do not use this medicine after the expiry date which is stated on the label, on the blister, on the carton, and on the box after "Exp." The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What PERINDOPRIL E INDAPAMIDE EG contains

The active substances 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.
The other components are: monohydrate lactose, magnesium stearate, hydrophobic colloidal anhydrous silica, microcrystalline cellulose.

Description of the appearance of PERINDOPRIL E INDAPAMIDE EG and contents of the package
PERINDOPRIL E INDAPAMIDE EG 2 mg/0.625 mg Tablets
White, capsule-shaped tablets, marked with "P" and "I" on both sides of the break line on one side, and a score line on the other side. The tablet can be divided into two equal parts.
PERINDOPRIL E INDAPAMIDE EG 4 mg/1.25 mg Tablets
White, capsule-shaped tablets, embossed with "PI" on one side and plain on the other.
For 2 mg and 4 mg: PVC/PVdC–Aluminum blisters:
Tablets are packaged in PVC/PVdC–Aluminum blisters, inside an aluminum protective container containing a desiccant to protect the tablets from moisture. The desiccant must not be ingested.
For 4 mg: Aluminum–Aluminum blisters:
Tablets are packaged in Aluminum–Aluminum blisters in a cardboard carton.
Pack sizes
30, 90 and 100 tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
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EG S.p.A., Via Pavia, 6 - 20136 Milan, Italy

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, WD18 8YA, United Kingdom

This medicinal product is authorized 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 Tablets
Spain: Perindopril/Indapamide Viso Farmacéutica 2/0.625mg and 4/1.25mg tablets
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