PERINDOPRIL 5 mg /1.25 Mg/5 Mg Tabletki Powlekane

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1. Perindopril/Indapamide/Amlodipina Teva 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 is Perindopril/Indapamide/Amlodipina Teva and what is it used for
   2. What you need to know before taking Perindopril/Indapamide/Amlodipine Teva
   3. How to take Perindopril/Indapamide/Amlodipina Teva
   4. Possible side effects
   5. How to store Perindopril/Indapamide/Amlodipina Teva
   6. Package Contents and Other Information

Perindopril/Indapamide/Amlodipina Teva 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

perindopril arginine/indapamide/amlodipine

Read this leaflet carefully before 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/Amlodipina Teva is and what it is used for
• 2. What you need to know before you take Perindopril/Indapamide/Amlodipina Teva
• 3. How to take Perindopril/Indapamide/Amlodipina Teva
• 4. Possible side effects
• 5. How to store Perindopril/Indapamide/Amlodipina Teva
• 6. Contents of the pack and other information

1. What is Perindopril/Indapamide/Amlodipina Teva and what is it used for

Perindopril/Indapamide/Amlodipina Teva is a combination of three active ingredients: perindopril,
indapamide and amlodipine. It is an antihypertensive medicine used in the treatment of high blood
pressure (hypertension).
Patients already treated with the fixed-dose combination of perindopril/indapamide and amlodipine in the
form of separate tablets may alternatively take a tablet of
Perindopril/Indapamide/Amlodipina Teva, which contains the three active ingredients at the same dosage.
Each active ingredient lowers blood pressure and, together, the three ingredients exert a combined action to
control it:

• Perindopril belongs to a class of medicines called angiotensin converting enzyme (ACE) inhibitors. These drugs work by widening 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 indolic sulfonamide derivatives). 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 antagonist (which belongs to a class of medicines called dihydropyridines). It works by relaxing the blood vessels, making it easier for blood to flow through them.

2. What you need to know before taking Perindopril/Indapamide/Amlodipine Teva

Do not take Perindopril/Indapamide/Amlodipine Teva

• 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 with a previous treatment based on 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 are taking non-antiarrhythmic medicines that cause a potentially fatal irregular heartbeat (torsade de pointes);
• 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 suffer from heart failure following a heart attack;
• if you suffer from severe low blood pressure (hypotension);
• if you have low levels of potassium in your blood;
• if you have severe kidney problems where blood flow 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/Indapamide/Amlodipine Teva may not be suitable for you;
• if you suffer from moderate kidney problems (for doses of Perindopril/Indapamide/Amlodipine Teva containing 10 mg/2.5 mg/5 mg and 10 mg/2.5 mg/10 mg);
• if you are pregnant for more than 3 months (it is best to avoid Perindopril/Indapamide/Amlodipine Teva even in the early stages of pregnancy; see the section on pregnancy);
• if you have diabetes or your kidney function is impaired and are being treated with a medicine that lowers blood pressure containing aliskiren;
• if you are being treated with sacubitril/valsartan, a medicine for heart failure, as the risk of angioedema (rapid development of swelling under the skin in areas such as the throat) is increased (see “Warnings and precautions” and “Other medicines and Perindopril/Indapamide/Amlodipine Teva”).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking
Perindopril/Indapamide/Amlodipine Teva:

• if you suffer from hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery that supplies blood to the kidneys);
• if you suffer from heart failure or other heart problems;
• if you experience a severe increase in blood pressure (hypertensive crisis);
• if you suffer from liver problems;
• if you have a collagen 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 an examination to check the functioning of the parathyroid gland;
• if you suffer from gout;
• if you have diabetes;
• if you are following a low-salt diet or using potassium-containing salt substitutes (balanced levels of potassium in the blood are essential);
• if you are taking lithium or potassium-sparing diuretics (spironolactone, triamterene), as their use with Perindopril/Indapamide/Amlodipine Teva should be avoided (see “Other medicines and Perindopril/Indapamide/Amlodipine Teva”);
• if you are elderly and your dose needs to be increased;
• if you have experienced 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 reduced effect in lowering blood pressure;
• if you are a patient undergoing hemodialysis with high-flux membranes;
• if you have kidney problems or are undergoing dialysis;
• if you experience decreased vision or eye pain. These effects may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure and can occur within hours or weeks of taking Perindopril/Indapamide/Amlodipine Teva. If left untreated, they can lead to permanent vision loss. If you have a history of allergy to penicillin or sulfonamides, you may be more likely to develop this condition;
• if you suffer from muscle disorders, including pain, tenderness, weakness or cramps;
• if you have an abnormally high level of a hormone called aldosterone in your blood (primary aldosteronism);
• if you have an excessive amount of acid in your blood, which can cause an increased breathing rate;
• if you suffer from cerebral circulatory insufficiency (low blood pressure in the brain);
• if you experience swelling of the face, lips, mouth, tongue or throat that can cause difficulty swallowing or breathing (angioedema), which can occur at any time during therapy, stop treatment immediately and contact your doctor directly;
• if you are taking any of the following medicines, there is a greater risk of angioedema:
• racecadotril (used to treat diarrhea);
• sirolimus, everolimus, temsirolimus and other drugs belonging to the class of so-called mTOR inhibitors (used to prevent transplant rejection 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 called 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 the information under “Do not take Perindopril/Indapamide/Amlodipine Teva”.
Your doctor may prescribe blood tests to check for low levels of sodium or potassium or high levels of calcium.
You must tell your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Perindopril/Indapamide/Amlodipine Teva is not recommended in the early stages of pregnancy and should not be taken if you are pregnant for more than 3 months, as it can cause serious harm to the baby (see “Pregnancy and breastfeeding”).
If you are taking Perindopril/Indapamide/Amlodipine Teva, also inform your doctor or medical staff:

• if you are going to have an anaesthetic and/or surgery;
• if you have recently suffered from diarrhoea or vomiting, or if you are dehydrated;
• if you are going to undergo dialysis or LDL apheresis (blood purification from cholesterol using a machine);
• if you are going to undergo desensitization therapy to reduce the effects of an allergy to bee or wasp stings;
• if you are going to undergo a medical examination that requires the injection of an iodine-containing contrast agent (a substance that makes organs such as the kidneys or stomach visible on X-rays).

Athletes should be aware that Perindopril/Indapamide/Amlodipine Teva contains an active ingredient (indapamide) that may result in a positive doping test.
For athletes:the use of the drug without therapeutic need constitutes doping and may still result in a positive anti-doping test.

Children and adolescents
Perindopril/Indapamide/Amlodipine Teva should not be given to children and adolescents.

Other medicines and Perindopril/Indapamide/Amlodipine Teva
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.
You should avoid taking Perindopril/Indapamide/Amlodipine Teva with:

• lithium (used to treat some mental disorders, such as mania, manic depression and recurrent depression);
• potassium-sparing diuretics (e.g. triamterene, amiloride), potassium supplements or salt substitutes containing potassium, other medicines 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 infections caused by bacteria);
• dantrolene (infusion), also used to treat malignant hyperthermia during anaesthesia (symptoms include very high fever and muscle stiffness);
• estramustine (used in the treatment of cancer);
• medicines used mainly to treat diarrhoea (racecadotril) or to prevent transplant rejection (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 also sections “Do not take Perindopril/Indapamide/Amlodipine Teva” and “Warnings and precautions”;
• other medicines used to treat high blood pressure: angiotensin-converting enzyme inhibitors and angiotensin receptor blockers.

Treatment with Perindopril/Indapamide/Amlodipine Teva 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 angiotensin II receptor blockers (AIIRAs), aliskiren (see also the information under “Do not take Perindopril/Indapamide/Amlodipine Teva” 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;
• anaesthetics;
• iodine-containing contrast agents;
• bepridil (used to treat angina pectoris);
• methadone (used to treat dependencies);
• medicines used for heart rhythm problems (e.g. dofetilide, ibutilide, bretylium, cisapride, difemanil, procainamide, quinidine, hydroquinidine, disopyramide, amiodarone, sotalol);
• verapamil, diltiazem (heart medicines);
• digoxin and other cardiac glycosides (for the treatment of heart problems);
• antibiotics used to treat bacterial infections (e.g. rifampicin, erythromycin, clarithromycin, sparfloxacin, moxifloxacin);
• antifungals (e.g. itraconazole, ketoconazole, amphotericin B by injection);
• allopurinol (for the treatment of gout);
• antihistamines used to treat allergic reactions, such as hay fever (e.g. mizolastine, terfenadine or 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, as well as to prevent blood clotting);
• immunosuppressants (medicines used to control the body's immune response) for the treatment of autoimmune diseases or after a transplant (e.g. cyclosporine, tacrolimus);
• tetracosactide (for treating Crohn's disease);
• gold salts, especially for intravenous administration (used to treat the symptoms of rheumatoid arthritis);
• aloferine (used to treat certain 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 for the treatment of mental 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);
• 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 lower blood pressure.

Perindopril/Indapamide/Amlodipina Teva with food and beverages
People treated with Perindopril/Indapamide/Amlodipina Teva should not drink grapefruit juice or eat grapefruit.
Grapefruit and grapefruit juice can in fact induce an increase in the levels of the active substance amlodipine in the blood, which may determine an unpredictable increase in the hypotensive effect of Perindopril/Indapamide/Amlodipina Teva.

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

Pregnancy
Tell 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 treatment with Perindopril/Indapamide/Amlodipina Teva before starting a pregnancy or as soon as you become aware of being pregnant and will advise you to take another medicine instead of Perindopril/Indapamide/Amlodipina Teva. Perindopril/Indapamide/Amlodipina Teva is not recommended in the early stages of pregnancy and should not be taken if you are pregnant for more than 3 months, as it can cause serious harm to the baby if used after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or if you are about to start breastfeeding. Perindopril/Indapamide/Amlodipina Teva is not recommended for mothers who are breastfeeding and your doctor may choose another treatment if you wish to breastfeed, especially if the baby is newly born or was born prematurely.

Driving and operating machinery
Perindopril/Indapamide/Amlodipina Teva may affect your ability to drive vehicles or operate machinery. If the tablets cause you to feel unwell, dizzy or tired, or give you a headache, do not drive vehicles or operate machinery and contact your doctor immediately.

Perindopril/Indapamide/Amlodipina Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. it is essentially “sodium-free”.

3. How to take Perindopril/Indapamide/Amlodipina Teva

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult 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. The usual dose is one tablet a day.

If you take more Perindopril/Indapamide/Amlodipina Teva than you should
Taking an excessive number of tablets may cause a lowering, even
dangerous, of blood pressure, sometimes associated with nausea, vomiting, cramps, dizziness,
drowsiness, mental confusion, oliguria (emission of urine lower than normal), anuria (no
production or emission of urine). You may experience lightheadedness, fainting or weakness. In case of very severe blood pressure drop, shock may occur. The skin may feel cold and clammy and you
may lose consciousness.
Excess fluid may accumulate in the lungs (pulmonary edema), resulting in
shortness of breath, which can develop up to 24-48 hours after taking the medicine.
If you take an excessive number of tablets of Perindopril/Indapamide/Amlodipina Teva, contact
your doctor immediately.

If you forget to take Perindopril/Indapamide/Amlodipina TevaIt 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/Amlodipina Teva, take the next dose at the usual
time. Do not take a double dose to compensate for the missed dose.

If you stop taking Perindopril/Indapamide/Amlodipina Teva
Because treatment for high blood pressure usually continues for life, you
should talk to 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 everyone gets them.

If any of the following side effects occur, stop treatment with the medicine and contact your doctor immediately:

• sudden onset of 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 breathing (uncommon; may affect up to 1 in 100 people);
• severe skin reactions, including severe rash, hives, redness of the skin all over the body, severe itching, blistering, 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 people);
• 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 people), life-threatening irregular heartbeat (frequency not known);
• inflammation of the pancreas, which can cause severe abdominal and back pain associated with a feeling of severe discomfort (very rare; may affect up to 1 in 10,000 people);
• weakness, cramps, soreness or muscle pain; in particular, if at the same time you do not feel well or have a high fever, these effects may be caused by abnormal muscle breakdown (frequency not known).

In order of decreasing 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 (awareness of your heartbeat), flushing, vertigo, tingling, impaired vision, double vision, tinnitus (sensation of noises in the ears), lightheadedness due to low blood pressure, cough, shortness of breath, gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbance, dyspepsia or indigestion, diarrhea, constipation, change in bowel habits), allergic reactions (such as skin rashes, itching), muscle spasms, feeling tired, weakness, drowsiness, swelling of the ankles.
• Uncommon(may affect up to 1 in 100 people): mood swings, anxiety, depression, sleep disorders, tremor, 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), changes in skin color, skin itching, sweating, chest pain, joint or muscle pain, back pain, pain, feeling unwell, kidney problems, problems with urination, 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 gain or loss, increased number of white blood cells, high levels of potassium in the blood, hypoglycemia (very low blood sugar levels), low levels of sodium in the blood, which can cause dehydration and low blood pressure, vasculitis (inflammation of blood vessels), photosensitivity reaction (change in the appearance of the skin) after exposure to sunlight or artificial UVA rays, groups of blisters on the skin, swelling of the hands or feet, increased creatinine in the blood and increased urea in the blood, falls, dry mouth.
• Rare(may affect up to 1 in 1,000 people): confused state, changes in laboratory parameters: low levels of chloride in the blood, low levels of magnesium in the blood, increased levels of liver enzymes, high levels of serum bilirubin and worsening of psoriasis. Reduced or absent urine output, flushing, acute kidney failure. Dark urine, nausea or vomiting, muscle cramps, confusion and convulsions. These effects may be symptoms of a condition called SIADH (inappropriate secretion of antidiuretic hormone). If you experience these symptoms, contact your doctor as soon as possible.
• Very rare(may affect up to 1 in 10,000 people):

decrease in the number of white blood cells, decrease in the number of platelets (which determines a tendency to bruise and nosebleeds), anemia (decrease in red blood cells), angina pectoris (chest pain, jaw/jaw pain and back pain, caused by physical exertion and due to problems with blood flow to the heart), eosinophilic pneumonia (a rare type of pneumonia), swelling of the gums, severe skin reactions, including severe rash, redness of the skin all over the body, severe itching, blistering, peeling and swelling of the skin, erythema multiforme (a rash that often starts with itchy red patches on the face, arms or legs), bleeding, tenderness or enlargement of the gums, 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 levels), high levels of calcium in the blood, stroke potentially secondary to excessively low blood pressure.

• Frequency not known(the frequency cannot be estimated from the available data): hepatic encephalopathy (brain disease caused by liver disease), abnormal ECG heart tracing, low levels of potassium in the blood; if you suffer from systemic lupus erythematosus (a 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). Tremor, postural rigidity, mask-like face, slow movements, unbalanced and shuffling gait. Change in color, 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 need to prescribe blood tests to monitor your condition.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at: 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/Amlodipina Teva

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 after EXP and on the package
after Scad. The expiry date refers to the last day of that month.
This medicine does not require special storage temperature conditions.
Store in the original package protected 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/Amlodipina Teva 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 silicon dioxide. [5 mg/1.25 mg/5 mg and 10mg/2.5 mg/10 mg:]The film coating contains macrogol copolymer grafted with polyvinyl alcohol, talc, titanium dioxide (E171), glycerol monocaprylocaprate and polyvinyl alcohol. [5mg/1.25 mg/10 mg and 10 mg/2.5 mg/5 mg:]The film coating contains macrogol copolymer grafted with polyvinyl alcohol, talc, titanium dioxide (E171), glycerol monocaprylocaprate, polyvinyl alcohol, yellow iron oxide (E172), black iron oxide (E172) and red iron oxide (E172).

Description of the appearance of Perindopril/Indapamide/Amlodipina Teva and package contents

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

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

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

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Teva B.V.
Swensweg 5
2031GA Haarlem
Netherlands

Manufacturer:
Actavis Ltd.
BLB015, BLB016
Bulebel Industrial Estate
ZTN3000 Zejtun
Malta
Teva Operations Poland Sp. z.o.o.
ul. Mogilska 80
31-546 Kraków
Poland