PERINDOPRIL 5 mg /1.25 Mg/5 Mg Tabletki Powlekane

Treść ulotki

1. Perindopril, Indapamide and Amlodipine EG 5 mg/1.25 mg/5 mg film-coated tablets, 5 mg/1.25 mg/10 mg film-coated tablets, 10 mg/2.5 mg/5 mg film-coated tablets, 10 mg/2.5 mg/10 mg film-coated tablets
   1. What Perindopril, indapamide and amlodipine EG is and what it is used for
   2. What you need to know before taking Perindopril, indapamide and amlodipine EG
   3. How to take Perindopril, indapamide and amlodipine EG
   4. Possible side effects
   5. How to store Perindopril, indapamide and amlodipine EG
   6. Package contents and other information

Perindopril, Indapamide and Amlodipine EG 5 mg/1.25 mg/5 mg film-coated tablets, 5 mg/1.25 mg/10 mg film-coated tablets, 10 mg/2.5 mg/5 mg film-coated tablets, 10 mg/2.5 mg/10 mg film-coated tablets

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

1. What Perindopril, indapamide and amlodipine EG is and what it is used for

Perindopril, indapamide and amlodipine EG is a combination of 3 active ingredients: perindopril, indapamide and
amlodipina. It is an antihypertensive medicine used in the treatment of high blood pressure
(hypertension).
Patients who are already taking the fixed combination of perindopril/indapamide and amlodipine in separate tablets
can instead take a tablet of Perindopril, indapamide and amlodipine EG, which contains the three
active ingredients at the same dosage.
Each active ingredient lowers blood pressure and, together, they work to control it:

• Perindopril belongs to a class of medicines called Angiotensin Converting Enzyme (ACE) inhibitors. It works by relaxing the blood vessels, making it easier for the heart to pump blood through them.
• Indapamide is a diuretic (which belongs to a class of medicines called sulfonamide derivatives with an indolic ring). 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.
• Amlodipina is a calcium channel blocker (which belongs to the class of medicines called dihydropyridines). It works by relaxing the blood vessels so that it is easier for blood to pass through them.

2. What you need to know before taking Perindopril, indapamide and amlodipine EG

Do not take Perindopril, indapamide and amlodipine EG

• if you are allergic to perindopril or other ACE inhibitors, to indapamide or other sulfonamides, to amlodipine or other dihydropyridines, or to 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 related to a previous treatment with ACE inhibitors or if you or a family member has experienced such symptoms in any other circumstance (a condition called angioedema);
• if you have a severe liver disease or if you suffer from a condition called hepatic encephalopathy (a brain disease caused by a liver disease);
• if you suspect you have decompensated heart failure (severe fluid retention, difficulty breathing);
• if you have a narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to provide enough blood to the body);
• if you have heart failure following a heart attack;
• if your blood pressure is severely low (hypotension);
• if your potassium levels in the blood are low;
• if you have severe kidney problems caused by reduced blood flow to the kidneys (renal artery stenosis);
• if you are undergoing dialysis or any type of blood filtration. Depending on the machinery used, therapy with Perindopril, indapamide and amlodipine EG may not be suitable for you;
• if you have moderate kidney problems (for dosages of Perindopril, indapamide and amlodipine EG containing 10 mg/2.5 mg/5 mg and 10 mg/2.5 mg/10 mg);
• if you are pregnant for more than three months (it is also better to avoid Perindopril, indapamide and amlodipine EG even in the early stages of pregnancy - see section on pregnancy);
• 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 taken or are taking sacubitril/valsartan, a medicine for the treatment of heart failure, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is increased (see "Warnings and precautions" and "Other medicines and Perindopril, indapamide and amlodipine EG").

Warnings and precautions
Talk to your doctor or pharmacist before taking Perindopril, indapamide and amlodipine EG:

• if you have hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery supplying blood to the kidneys);
• if you suffer from heart failure or any other heart problem;
• if you suffer from a severe increase in blood pressure (hypertensive crisis);
• if you have liver problems;
• if you suffer from a connective tissue disease (skin disease) such as systemic lupus erythematosus or scleroderma;
• if you suffer from atherosclerosis (hardening of the arteries);
• if you are going to undergo a test to check the functioning of the parathyroid gland;
• if you suffer from gout;
• if you have diabetes;
• if you are following a diet that restricts salt intake or use salt substitutes containing potassium (it is essential to maintain a balanced potassium level in the blood);
• if you are taking lithium or potassium-sparing diuretics (spironolactone, triamterene) as their use with Perindopril, indapamide and amlodipine EG should be avoided (see "Other medicines and Perindopril, indapamide and amlodipine EG");
• if you are elderly and your dosage needs to be increased;
• if you have had photosensitivity reactions;
• if you are of black ethnicity you may have a higher incidence of angioedema (swelling of the face, lips, mouth, tongue or throat that can cause difficulty swallowing or breathing) and a lesser effect in lowering blood pressure;
• if you are a hemodialysis patient using high-flux membranes;
• if you have kidney problems or are undergoing dialysis;
• if you experience decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and may occur within hours or weeks of taking Perindopril, indapamide and amlodipine EG. If left untreated, this condition can lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this condition;

if you suffer from muscle disorders including muscle pain, sensitivity, weakness or cramps;

• if you have an abnormal increase in the levels in the blood of a hormone called aldosterone (primary aldosteronism);
• if you have too much acid in the blood, which can cause rapid breathing;
• if you have cerebral circulatory insufficiency (low blood pressure in the brain);
• if you have swelling of the face, lips, mouth, tongue or throat that can cause difficulty swallowing or breathing (angioedema), which can occur at any time during treatment, immediately stop treatment and contact your doctor directly;
• if you are taking any of the following medicines, there may be an increased risk of angioedema:
• racecadotril (used to treat diarrhea),
• sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors (used in the prevention of organ rejection following transplantation and for cancer),
• sacubitril (available as a fixed-dose combination with valsartan), used for the long-term treatment of heart failure;
• linagliptin, saxagliptin, sitagliptin, vildagliptin and other drugs belonging to the class of so-called gliptins (used to treat diabetes)
• 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 - e.g. valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• 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 what is reported in the section “Do not take Perindopril, indapamide and amlodipine EG”.

Your doctor may prescribe blood tests to check for low levels of sodium or potassium or high levels of calcium.
You should inform your doctor if you suspect (or are planning) a pregnancy. Perindopril, indapamide and amlodipine 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 (see "Pregnancy and breastfeeding").
If you are taking Perindopril, indapamide and amlodipine EG, also inform your doctor or medical staff:

• if you are going to have anesthesia and/or surgery,
• if you have recently had diarrhea or vomiting or are dehydrated,
• if you are going to undergo dialysis or LDL apheresis (blood purification from cholesterol by means of a machine),
• if you are going to undergo a desensitization treatment to reduce the effects of allergy to bee or wasp stings,
• if you are going to undergo a medical examination that requires the injection of an iodinated contrast agent (a substance that makes organs such as kidneys or stomach visible on X-rays).

Athletes should be informed that Perindopril, indapamide and amlodipine EG contains an active ingredient (indapamide) that can result in a positive doping test.

Children and adolescents
Perindopril, indapamide and amlodipine EG should not be given to children and adolescents.

Other medicines and Perindopril, indapamide and amlodipine EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take aliskiren (used to treat high blood pressure) if you have diabetes or kidney problems.
Avoid concomitant use of Perindopril, indapamide and amlodipine EG with:

• lithium (used to treat some mental health disorders such as mania, manic depression and recurrent depression),
• potassium-sparing diuretics (e.g. triamterene, amiloride), potassium supplements or salt substitutes containing potassium, other drugs that can increase potassium levels in the body (such as heparin, a medicine used to thin the blood and prevent blood clots); trimethoprim and co-trimoxazole, also known as trimethoprim/sulfamethoxazole for the treatment of infections caused by bacteria),
• dantrolene (for infusion) also used for the treatment of malignant hyperthermia during anesthesia (symptoms include very high fever and muscle stiffness),
• estramustine (used in cancer therapy),
• medicines used mainly to treat diarrhea (racecadotril) or to prevent organ rejection after transplantation (sirolimus, everolimus, temsirolimus and other drugs belonging to the class of so-called mTOR inhibitors). See section “Warnings and precautions”,
• sacubitril/valsartan (used for the long-term treatment of heart failure). See sections “Do not take Perindopril, indapamide and amlodipine EG” and “Warnings and precautions”,
• other medicines used to treat high blood pressure: angiotensin-converting enzyme inhibitors and angiotensin receptor blockers.

The treatment with Perindopril, indapamide and amlodipine EG may be affected by other medicines. Your doctor may need to adjust the 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 the treatment of hypertension, including an angiotensin II receptor blocker (AIIRA), aliskiren (see also what is reported in the section "Do not take Perindopril, indapamide and amlodipine 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,
• anesthetics,
• iodinated contrast agents,
• bepridil (used in the treatment of angina pectoris),
• methadone (used for the treatment of addictions),
• medicines used to treat heart rhythm problems (e.g. dofetilide, ibutilide, bretylium, cisapride, difemil, procainamide, quinidine, hydroquinidine, disopyramide, amiodarone, sotalol),
• verapamil, diltiazem (heart medicines),
• digoxin or other digitalis (for the treatment of heart problems),
• antibiotics used to treat bacterial infections (e.g. rifampicin, erythromycin, clarithromycin, sparfloxacin, moxifloxacin),
• antifungal medicines (e.g. itraconazole, ketoconazole, amphotericin B injection)
• 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, and non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or salicylates at high doses (e.g. acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever and to prevent blood clotting),
• immunosuppressants (medicines used to control the body's immune response) for the treatment of autoimmune diseases or after an organ transplant (e.g. cyclosporine, tacrolimus),
• tetracosactide (for the treatment of Crohn's disease),
• gold salts, especially for intravenous administration (used to treat the symptoms of rheumatoid arthritis),
• alofantrine (used to treat some types of malaria),
• baclofen used to treat muscle stiffness in diseases such as multiple sclerosis,
• medicines for the treatment of diabetes such as insulin or metformin,
• calcium including calcium supplements,
• stimulant laxatives (e.g. senna),
• medicines for the treatment of cancer,
• vincamine (used to treat symptomatic cognitive disorders in the elderly including memory loss),
• medicines used to treat mental health disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, antipsychotics, imipramine-like antidepressants, neuroleptics (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol),
• pentamidine (used to treat pneumonia),
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors, used to treat HIV),
• Hypericum perforatum (St. John's Wort),
• trimethoprim (for the treatment of infections),
• medicines used to treat low blood pressure, shock or asthma (e.g. ephedrine, norepinephrine or adrenaline),
• nitroglycerin and other nitrates or other vasodilators that can further reduce blood pressure.

Perindopril, indapamide and amlodipine EG with food and drink
People taking Perindopril, indapamide and amlodipine EG should not consume grapefruit or grapefruit juice, as grapefruit and its juice can increase the levels of the active ingredient amlodipine in the blood, and this may lead to an unpredictable increase in the hypotensive effect of Perindopril, indapamide and amlodipine EG.

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

Pregnancy
You must inform your doctor if you suspect (or are planning) a pregnancy.
Normally, your doctor will advise you to stop treatment with Perindopril, indapamide and amlodipine EG before starting a pregnancy or as soon as pregnancy is confirmed and will prescribe another medicine to use instead of Perindopril, indapamide and amlodipine EG.
Perindopril, indapamide and amlodipine EG is not recommended in early pregnancy and must not be taken if you are more than 3 months pregnant as, if taken after the third month of pregnancy, it can cause serious harm to the baby.

Breastfeeding
Ask your doctor for advice if you are breastfeeding or intend to breastfeed your baby.
Perindopril, indapamide and amlodipine EG is not recommended for women who are breastfeeding and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and using machines
Perindopril, indapamide and amlodipine EG may impair your ability to drive and operate machinery.
If the tablets cause you to feel unwell, dizzy, tired or give you a headache, do not drive vehicles or use machinery and contact your doctor immediately.

Perindopril, indapamide and amlodipina EG contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e.
essentially ‘sodium-free’.

3. How to take Perindopril, indapamide and amlodipine EG

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
Swallow the tablet with a glass of water, preferably in the morning and before a meal. The doctor
will decide the correct dose for you. Usually, it will be one tablet once a day.

If you take more Perindopril, indapamide and amlodipine EG than you should
If you take an excessive number of tablets, your blood pressure may drop, even excessively, and this
may be dangerous, sometimes associated with nausea, vomiting, cramps, dizziness, drowsiness, confusion
mental, oliguria (less urine output than normal), anuria (no urine production or passage of
urine). You may feel faint, weak or pass out. If the blood pressure drop is severe enough, it may
cause you to go into shock. Your skin may become cold and clammy and you may lose consciousness.
Excess fluid may accumulate in the lungs (pulmonary edema) causing shortness of breath which may
manifest up to 24-48 hours after taking it.
If you have taken an excessive number of tablets of Perindopril, indapamide and amlodipine EG,
contact your doctor immediately.

If you forget to take Perindopril, indapamide and amlodipine 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, indapamide and amlodipine EG, 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, indapamide and amlodipine EG
As treatment for hypertension is usually lifelong, you should talk to your doctor before stopping
taking this medicine.
If you have any questions about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
manifest.

Stop taking the medicine and consult your doctor immediately if you experience any of the
following side effects which may be serious:

• Sudden wheezing, chest pain, shortness of breath or difficulty breathing (uncommon - may affect up to 1 in 100 people);
• swelling of the eyelids, face or lips (uncommon - may affect up to 1 in 100 people);
• swelling of the mouth, tongue and throat which can cause severe difficulty in breathing (uncommon - may affect up to 1 in 100 people);
• severe skin reactions including intense skin rash, hives, redness of the skin all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens Johnson Syndrome, Toxic Epidermal Necrolysis) or other allergic reactions (very rare - may affect up to 1 in 10,000);
• severe dizziness or fainting (common - may affect up to 1 in 10 people)
• heart attack (very rare - may affect up to 1 in 10,000), irregular heartbeat that can be life-threatening (frequency not known);
• inflammation of the pancreas which can cause severe abdominal and back pain accompanied by a feeling of unwellness (very rare - may affect up to 1 in 10,000);
• muscle weakness, cramps, soreness or pain and, in particular, if at the same time you do not feel well and have a high fever, this may be caused by abnormal muscle breakdown (frequency not known).

In decreasing order of frequency, side effects may include:

• Very common(may affect more than 1 in 10 people): Edema (fluid retention).
• Common(may affect up to 1 in 10 people):

Low levels of potassium in the blood, headache, dizziness, palpitations (feeling your own heartbeat
cardiac), hot flushes, vertigo, pins and needles sensation, vision disorders, double vision,
tinnitus (sensation of noises in the ears), lightheadedness due to a drop in
blood pressure, cough, shortness of breath, gastrointestinal disorders (nausea, vomiting, abdominal pain,
taste disturbances, indigestion or difficulty digesting, diarrhea, constipation, change in bowel
regularity), allergic reactions (such as skin rashes, itching), muscle spasms, feeling of
tiredness, weakness, drowsiness, swelling of the ankles.

• Uncommon(may affect up to 1 in 100 people): Mood swings, anxiety, depression, sleep disorders, tremors, hives, fainting, loss of sensation of pain, irregular and/or fast heartbeat, rhinitis (blocked or runny nose), hair loss, purpura (small red spots on the skin), skin discoloration, itchy skin, sweating, chest pain, joint or muscle pain, back pain, pain, feeling unwell (malaise), kidney disorders, problems passing urine, increased need to urinate during the night, increased number of times you urinate, impotence (inability to get or maintain an erection), fever or high temperature, discomfort or enlargement of the breasts in men, weight increase or decrease, increased number of certain white blood cells, high levels of potassium in the blood, hypoglycemia (very low blood sugar level), low levels of sodium in the blood which can lead to dehydration and low blood pressure, vasculitis (inflammation of blood vessels), photosensitivity reaction (change in skin appearance) following exposure to the sun or artificial UVA rays, clusters of blisters on the skin, swelling of hands or feet, increased creatinine in the blood and increased urea in the blood, falls, dry mouth.
• Rare(may affect up to 1 in 1000 people): Confusional state, changes in laboratory parameters: low chloride content in the blood, low level of magnesium in the blood, increased levels of liver enzymes, high level of serum bilirubin and worsening of psoriasis. Reduced or absent urination, acute kidney failure. Dark urine, feeling unwell (nausea) or feeling sick (vomiting), muscle cramps, confusion and seizures. These may be symptoms of a condition called SIADH (inappropriate secretion of antidiuretic hormone).
• Very rare(may affect up to 1 in 10,000 people): Decreased number of white blood cells, decreased number of platelets (which causes bruising and nosebleeds), anemia (decreased red blood cells), angina pectoris (chest, jaw and back pain, caused by exertion, and due to problems with blood supply to the heart), eosinophilic pneumonia (a rare type of pneumonia), swelling of the gums, severe skin reactions including intense skin rash, redness of the skin all over the body, severe itching, blisters, peeling and swelling of the skin, erythema multiforme (a skin rash that often starts with red, itchy patches on the face, arms or legs), painful or swollen gums, bleeding, abnormal liver function, inflammation of the liver (hepatitis), severe kidney problems, yellowing of the skin (jaundice), abdominal swelling (gastritis), nerve disorder that can cause weakness, tingling or numbness, increased muscle tension, hyperglycemia (very high blood sugar level), high level of calcium in the blood, stroke possibly secondary to excessive lowering of blood pressure.
• Not known(frequency cannot be estimated from the available data): Hepatic encephalopathy (brain disease caused by a liver disease), abnormal ECG tracing, if you suffer from systemic lupus erythematosus (a type of connective tissue disease), this may worsen. Myopia, blurred 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). Tremors, postural rigidity, mask-like face, slow movements and unbalanced gait. Discoloration, numbness and pain in the fingers of the hands or feet (Raynaud's phenomenon).

Changes in laboratory parameters (blood tests) may occur. Your doctor may consider
it necessary to prescribe blood tests to monitor your condition.
If you experience these symptoms, contact your doctor as soon as possible.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. 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, indapamide and amlodipine EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister or the packaging after
“Exp.” The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature.
Store in the original packaging to protect the medicine from light and moisture.
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, indapamide and amlodipine EG contains

• The active ingredients are perindopril arginine, indapamide and amlodipine. Each film-coated tablet contains 5 mg of perindopril arginine equivalent to 3.395 mg of perindopril, 1.25 mg of indapamide and 5 mg of amlodipine (as amlodipine besilate). Each film-coated tablet contains 5 mg of perindopril arginine equivalent to 3.395 mg of perindopril, 1.25 mg of indapamide and 10 mg of amlodipine (as amlodipine besilate). Each film-coated tablet contains 10 mg of perindopril arginine equivalent to 6.790 mg of perindopril, 2.5 mg of indapamide and 5 mg of amlodipine (as amlodipine besilate). Each film-coated tablet contains 10 mg of perindopril arginine equivalent to 6.790 mg of perindopril, 2.5 mg of indapamide and 10 mg of amlodipine (as amlodipine besilate).

The other ingredients are: microcrystalline cellulose, calcium carbonate, pregelatinized starch,
sodium croscarmellose, magnesium stearate and anhydrous colloidal silica.

[5 mg/1.25 mg/5 mg and 10 mg/2.5 mg/10 mg:]
The tablet coating contains macrogol copolymer grafted with poly(vinyl alcohol),talc, titanium
dioxide (E171), glycerol monocaprylocaprate and poly(vinyl alcohol).

[5 mg/1.25 mg/10 mg and 10 mg/2.5 mg/5 mg:]
The tablet coating contains macrogol copolymer grafted with poly(vinyl alcohol),talc, titanium
dioxide (E171), glycerol monocaprylocaprate, poly(vinyl alcohol), yellow iron oxide (E172), iron
oxide black (E172) and red iron oxide (E172).

Description of the appearance of Perindopril, indapamide and amlodipine EG and package contents

[5 mg/1.25 mg/5 mg:]The film-coated tablets are white, oblong, with “TEV” imprinted on one
side and “2” on the other. The tablet has a size of approximately 12.3 mm x 6.5 mm.

[5 mg/1.25 mg/10 mg:]The film-coated tablets are light beige, round, with “TEV” imprinted on
one side and “3” on the other. The tablet has a diameter of approximately 9.0 mm.

[10 mg/2.5 mg/5 mg:]The film-coated tablets are light beige, oblong, with “TEV” imprinted on
one side and “4” on the other. The tablet has a size of approximately 12.3 mm x 6.5 mm.

[10 mg/2.5 mg/10 mg:]The film-coated tablets are white, round, with “TEV” imprinted on
one side and “5” on the other. The tablet has a diameter of approximately 9.0 mm.
Perindopril, indapamide and amlodipine EG is available in blisters containing 10, 30, 90 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., via Pavia 6, 20136 Milan, Italy

Manufacturers
Actavis Ltd, BLB015, BLB016, Bulebel Industrial Estate, Zejtun ZTN3000 - Malta
STADA Arzneimittel AG, Stadastrasse 2 – 18 Bad Vilbel, 61118 –Germany

This medicinal product is authorised in the Member States of the European Economic Area (EEA) under the
following denominations:
BE Perindopril/Indapamide/Amlodipine EG 5 mg/1.25 mg/5 mg - 5 mg/1.25 mg/10 mg - 10 mg/2.5
mg/5 mg - 10 mg/2.5 mg/10 mg - filmomhulde tabletten, comprimés pelliculés, Filmtabletten
CZ Ridupresa
LU Perindopril/Indapamid/Amlodipin EG 5 mg - 1.25 mg - 5 mg / 5 mg - 1.25 mg - 10 mg /10 mg - 2.5
mg - 5 mg /10 mg - 2.5 mg - 10 mg comprimés pelliculés
IT Perindopril, indapamide e amlodipina EG
SK Perindopril-Indapamid-Amlodipín STADA 5 mg/1.25 mg/5 mg - 5 mg/1.25 mg/10mg - 10 mg/2.5
mg/5 mg - 10 mg/2.5 mg/10 mg