Perindopril/indapamide/amlodipine Teva

Patient Information Leaflet

Perindopril/Indapamide/Amlodipine 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
Please read all of 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Perindopril/Indapamide/Amlodipine Teva is and what it is used for
2. What you need to know before taking Perindopril/Indapamide/Amlodipine Teva
3. How to take Perindopril/Indapamide/Amlodipine Teva
4. Possible side effects
5. How to store Perindopril/Indapamide/Amlodipine Teva
6. Contents of the pack and other information

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

Perindopril/Indapamide/Amlodipine Teva is a combination of three active substances: perindopril,
indapamide, and amlodipine. It is an antihypertensive medicine used to treat high blood pressure (hypertension).
Patients already being treated with the fixed-dose combination of perindopril/indapamide and amlodipine as separate tablets may alternatively take one tablet of Perindopril/Indapamide/Amlodipine Teva, which contains the three active substances at the same dosage.
Each active substance reduces blood pressure, and together the three exert a combined effect in controlling it:

• Perindopril belongs to a class of medicines known as angiotensin-converting enzyme (ACE) inhibitors. These medicines work by dilating blood vessels, thereby making it easier for the heart to pump blood through them.
• Indapamide is a diuretic (belonging to a class of medicines called indoline-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.
• Amlodipine is a calcium antagonist (belonging to a class of medicines called dihydropyridines). It works by relaxing blood vessels, thus making it easier for blood to flow through them.

2. What you should 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 previously experienced symptoms such as shortness of breath, swelling of the face or tongue, intense itching, or severe skin rashes during prior treatment with ACE inhibitors, or if you or a family member has ever had such symptoms under any circumstances (a condition called angioedema);
• if you have severe liver disease or suffer from a condition known as hepatic encephalopathy (a brain disorder caused by liver disease);
• if you suspect you have untreated decompensated heart failure (severe fluid retention, difficulty breathing);
• if you are taking non-antiarrhythmic medicines that may cause a potentially life-threatening irregular heartbeat (torsades de pointes);
• if you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to supply sufficient blood to the body);
• if you have heart failure following a heart attack;
• if you have severely low blood pressure (hypotension);
• if you have low levels of potassium in your blood;
• if you have severe kidney problems due to reduced blood flow to the kidneys (renal artery stenosis);
• if you are undergoing dialysis or any other type of blood filtration. Depending on the equipment used, Perindopril/Indapamide/Amlodipine Teva may not be suitable for you;
• if you have moderate kidney problems (for Perindopril/Indapamide/Amlodipine Teva doses containing 10 mg/2.5 mg/5 mg and 10 mg/2.5 mg/10 mg);
• if you are more than 3 months pregnant (Perindopril/Indapamide/Amlodipine Teva should also be avoided in early pregnancy; see the section on pregnancy);
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren;
• if you are being treated with sacubitril/valsartan, a medicine for heart failure, as the risk of angioedema (rapid swelling under the skin, for example in the throat) is higher (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 have hypertrophic cardiomyopathy (a heart muscle disease) or renal artery stenosis (narrowing of the artery supplying blood to the kidneys);
• if you have heart failure or other heart problems;
• if you experience a severe increase in blood pressure (hypertensive crisis);
• if you have liver problems;
• if you have a collagen disease (skin disease), such as systemic lupus erythematosus or scleroderma;
• if you have atherosclerosis (hardening of the arteries);
• if you are scheduled for a test to check parathyroid gland function;
• if you suffer from gout;
• if you have diabetes;
• if you are on a low-salt diet or use potassium-containing salt substitutes (balanced potassium levels 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 may cause difficulty swallowing or breathing) and may experience a reduced effect in lowering blood pressure;
• if you are a dialysis patient undergoing hemodialysis with high-flux membranes;
• if you have kidney problems or are undergoing dialysis;
• if you experience a decrease in vision or eye pain. These effects could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure and may occur within hours or weeks of taking Perindopril/Indapamide/Amlodipine Teva. If untreated, this may lead to permanent vision loss. If you have a history of allergy to penicillin or sulfonamides, you may be at higher risk of developing this condition;
• if you have muscle disorders, including muscle pain, tenderness, weakness, or cramps;
• if you have abnormally high levels of a hormone called aldosterone in your blood (primary hyperaldosteronism);
• if you have excessive acid in your blood, which may cause increased respiratory rate;
• if you have cerebral circulatory insufficiency (low blood pressure in the brain);
• if you develop swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema), which may occur at any time during therapy, stop treatment immediately and contact your doctor without delay;
• if you are taking any of the following medicines, your risk of angioedema is increased:
• racecadotril (used to treat diarrhoea);
• 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 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 antagonist" (AIIRA), also known as sartans (e.g. valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes;
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals.
See also the information under the heading “Do not take Perindopril/Indapamide/Amlodipine Teva”.
Your doctor may order blood tests to check for low levels of sodium or potassium or high levels of calcium.
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Perindopril/Indapamide/Amlodipine Teva is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if used during this period (see “Pregnancy and breastfeeding”).
If you are taking Perindopril/Indapamide/Amlodipine Teva, inform your doctor or medical staff also:

• if you are scheduled for anaesthesia and/or surgery;
• if you have recently had diarrhoea or vomiting, or if you are dehydrated;
• if you are scheduled for dialysis or LDL apheresis (blood purification to remove cholesterol using a machine);
• if you are scheduled for desensitisation therapy to reduce the effects of an allergy to bee or wasp stings;
• if you are scheduled for a medical examination requiring injection of an iodinated contrast agent (a substance that makes organs such as kidneys or stomach visible on X-rays).

Athletes should be aware that Perindopril/Indapamide/Amlodipine Teva contains an active substance (indapamide) that may lead to positive results in doping control tests.
For those engaged in sports: using the medicine without therapeutic need constitutes doping and may result in positive anti-doping tests.

Children and adolescents
Perindopril/Indapamide/Amlodipine Teva must not be administered to children and adolescents.

Other medicines and Perindopril/Indapamide/Amlodipine Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take aliskiren (used to treat high blood pressure) if you have diabetes or kidney problems.
You must avoid taking Perindopril/Indapamide/Amlodipine Teva with:

• lithium (used to treat certain mental disorders such as mania, manic depression, and recurrent depression);
• potassium-sparing diuretics (e.g. triamterene, amiloride), potassium supplements, or potassium-containing salt substitutes, or other medicines that may increase potassium levels in the body (such as heparin, a medicine used to thin the blood and prevent clot formation, trimethoprim, and cotrimoxazole, also known as trimethoprim/sulfamethoxazole, for bacterial infections);
• dantrolene (infusion), also used to treat malignant hyperthermia during anaesthesia (symptoms include high fever and muscle rigidity);
• estramustine (used in cancer treatment);
• medicines used primarily 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 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 (ACE) inhibitors and angiotensin receptor antagonists.

Treatment with Perindopril/Indapamide/Amlodipine Teva 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 angiotensin II receptor antagonists (AIIRAs), aliskiren (see also 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 heart failure treatment: eplerenone and spironolactone at doses between 12.5 mg and 50 mg per day;
• anaesthetics;
• iodinated contrast agents;
• bepridil (used to treat angina pectoris);
• methadone (used to treat addictions);
• medicines used for heart rhythm disorders (e.g. dofetilide, ibutilide, bretylium, cisapride, difemanyl, procainamide, quinidine, hydroquinidine, disopyramide, amiodarone, sotalol);
• verapamil, diltiazem (heart medicines);
• digoxin and other cardiac glycosides (for treating 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 treating 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 high-dose salicylates (e.g. acetylsalicylic acid, a substance present in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting);
• immunosuppressants (medicines used to control the body's immune response) for treating autoimmune diseases or after organ transplantation (e.g. cyclosporine, tacrolimus);
• tetracosactide (to treat Crohn's disease);
• gold salts, especially for intravenous administration (used to treat symptoms of rheumatoid arthritis);
• halofantrine (used to treat certain types of malaria);
• baclofen, used to treat muscle stiffness in diseases such as multiple sclerosis;
• medicines for treating diabetes, such as insulin or metformin;
• calcium, including calcium supplements;
• stimulant laxatives (e.g. senna);
• medicines for treating cancer;
• vincamine (used to treat symptomatic cognitive disorders in the elderly, including memory loss);
• medicines for treating 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 (Hypericum perforatum);
• trimethoprim (for treating infections);
• medicines used to treat low blood pressure, shock, or asthma (e.g. ephedrine, noradrenaline, or adrenaline);
• nitroglycerin and other nitrates, or other vasodilators that may further lower blood pressure.

Perindopril/Indapamide/Amlodipine Teva with food and drink
People being treated with Perindopril/Indapamide/Amlodipine Teva must not drink grapefruit juice or eat grapefruit.
Grapefruit and grapefruit juice may increase blood levels of the active substance amlodipine, which could lead to an unpredictable increase in the blood pressure-lowering effect of Perindopril/Indapamide/Amlodipine Teva.

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
Inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop treatment with Perindopril/Indapamide/Amlodipine Teva before starting a pregnancy or as soon as you find out you are pregnant, and will recommend an alternative medicine. Perindopril/Indapamide/Amlodipine Teva is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if used after the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed.
Perindopril/Indapamide/Amlodipine Teva is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if the baby is newborn or was born prematurely.

Driving and using machines
Perindopril/Indapamide/Amlodipine Teva may affect your ability to drive or use machines. If the tablets make you feel unwell, dizzy, or tired, or cause headaches, do not drive or use machines and contact your doctor immediately.

Perindopril/Indapamide/Amlodipine 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/Amlodipine Teva

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Swallow the tablet with a glass of water, preferably in the morning and before a meal. Your doctor will determine the correct dose for you. The usual dose is one tablet daily.
If you take more Perindopril/Indapamide/Amlodipine Teva than you should
Taking too many tablets may cause a drop in blood pressure, which can be dangerous, sometimes associated with nausea, vomiting, cramps, dizziness, drowsiness, confusion, oliguria (passing less urine than normal), anuria (no urine production or passage). You may experience dizziness, fainting, or weakness. In case of severe drop in blood pressure, shock may occur. The skin may feel cold and clammy and you may lose consciousness.
Excess fluid may accumulate in the lungs (pulmonary edema), causing breathlessness, which may develop up to 24–48 hours after ingestion.
If you have taken too many Perindopril/Indapamide/Amlodipine Teva tablets, contact a doctor immediately.
If you forget to take Perindopril/Indapamide/Amlodipine Teva
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/Amlodipine Teva, take the next dose at your usual time. Do not take a double dose to make up for the missed dose.
If you stop taking Perindopril/Indapamide/Amlodipine Teva
Since treatment for high blood pressure usually continues for life, you must speak to your doctor before stopping this medicine.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you experience any of the following side effects, stop taking the medicine and contact a 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 may cause severe breathing difficulties (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 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), potentially life-threatening irregular heartbeat (frequency not known);
• inflammation of the pancreas, which may cause severe abdominal and back pain associated with a strong feeling of illness (very rare; may affect up to 1 in 10,000 people);
• muscle weakness, cramps, soreness, or pain; particularly if you also feel unwell or have a high fever, these effects may be due to abnormal muscle breakdown (frequency not known).

The side effects, listed in order of decreasing frequency, may include:

• Very common (may affect more than 1 in 10 people): oedema (fluid retention).
• Common (may affect up to 1 in 10 people): low blood potassium levels, headache, dizziness, palpitations (awareness of heartbeat), flushing, vertigo, tingling, visual disturbances, double vision, tinnitus (sensation of ringing in the ears), drowsiness due to low blood pressure, cough, shortness of breath, gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, dyspepsia or indigestion, diarrhoea, constipation, changes in bowel habits), allergic reactions (such as skin rashes, itching), muscle spasms, feeling of fatigue, weakness, somnolence, swelling of the ankles.
• Uncommon (may affect up to 1 in 100 people): mood swings, anxiety, depression, sleep disorders, tremor, urticaria, fainting, loss of pain sensation, irregular and/or rapid heartbeat, rhinitis (stuffy or runny nose), hair loss, purpura (small red spots on the skin), skin colour changes, skin itching, sweating, chest pain, joint or muscle pain, back pain, pain, feeling unwell, kidney problems, problems with urination, increased need to urinate at night, increased frequency of urination, impotence (inability to achieve or maintain erection), fever or high temperature, discomfort or enlargement of the breasts in men, weight gain or loss, increase in certain white blood cells, high blood potassium levels, hypoglycaemia (very low blood sugar levels), low blood sodium levels, which may cause dehydration and low blood pressure, vasculitis (inflammation of blood vessels), photosensitivity reaction (skin changes) after exposure to sunlight or artificial UVA rays, clusters of blisters on the skin, swelling of hands or feet, increased creatinine in blood and increased urea in blood, falls, dry mouth.
• Rare (may affect up to 1 in 1,000 people): confusion, changes in laboratory parameters: low blood chloride levels, low blood magnesium levels, increased liver enzyme levels, high serum bilirubin levels, and worsening of psoriasis. Reduced or absent urine output, flushing, acute renal failure. Dark urine, nausea or vomiting, muscle cramps, confusion, and seizures. These effects may be symptoms of a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion). 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 (leading to increased tendency to bruise and nosebleeds), anaemia (reduction in red blood cells), angina pectoris (chest, jaw/mouth, and back pain caused by physical exertion due to problems with blood flow to the heart), eosinophilic pneumonia (a rare type of pneumonia), gum swelling, 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 skin rash that often begins 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 disorders causing weakness, tingling or numbness, increased muscle tension, hyperglycaemia (very high blood sugar levels), high blood calcium levels, stroke potentially secondary to excessively low blood pressure.

• Not known (frequency cannot be estimated from available data): hepatic encephalopathy (brain disorder caused by liver disease), abnormal ECG heart tracing, low blood potassium levels; if you have systemic lupus erythematosus (a collagen disease), this may worsen. Myopia, blurred vision, vision loss, 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. Changes in colour, numbness, and pain in 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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/Amlodipine Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister after EXP and on the carton after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions regarding temperature.
Store in the original packaging, protected from light and moisture.
Do not dispose of medicines via 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/Amlodipine Teva contains

• The active substances 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 besylate).
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 besylate).
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 besylate).
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 besylate).

• The other components 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 coating contains poly(vinyl alcohol) graft copolymer, 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 coating contains poly(vinyl alcohol) graft copolymer, talc, titanium dioxide (E171), glycerol monocaprylocaprate, poly(vinyl alcohol), yellow iron oxide (E172), black iron oxide (E172) and red iron oxide (E172).

Description of the appearance of Perindopril/Indapamide/Amlodipine Teva and contents of the
pack

[5 mg/1.25 mg/5 mg:] The tablets are oblong, film-coated tablets, white in colour, marked with “TEV” on one side and “2” on the other side. The tablet dimensions 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, marked with “TEV” on one side and “3” on the other side. The tablet diameter is approximately 9.0 mm.
[10 mg/2.5 mg/5 mg:] The tablets are oblong, film-coated tablets, light beige in colour, marked with “TEV” on one side and “4” on the other side. The tablet dimensions 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, marked with “TEV” on one side and “5” on the other side. The tablet diameter is approximately 9.0 mm.

Perindopril/Indapamide/Amlodipine Teva is available in blister packs containing 10, 30, 90 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Teva B.V.
Swensweg 5
2031GA Haarlem
The 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