Ipam

Poland
Brand name Ipam
Form tablets, film-coated
Active substance / Dosage
perindopril arginine · 5 mg
indapamide · 1.25 mg
amlodipine · 10 mg
Prescription type Prescription only
ATC code
C09BX01
Registration number 100457471
Manufacturer Actavis Ltd. Teva Operations Poland Sp. z o.o.

Table of Contents

Package leaflet: information for the patient

IPAM, 5 mg + 1.25 mg + 5 mg, coated tablets
IPAM, 5 mg + 1.25 mg + 10 mg, coated tablets
IPAM, 10 mg + 2.5 mg + 5 mg, coated tablets
IPAM, 10 mg + 2.5 mg + 10 mg, coated tablets
Perindoprilum argininum + Indapamidum + Amlodipinum
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

  • Keep this leaflet, as you may need to read it again.
  • If you have any further questions, please consult your doctor or pharmacist.
  • This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
  • If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

  1. What IPAM is and what it is used for
  2. Important information before taking IPAM
  3. How to take IPAM
  4. Possible side effects
  5. How to store IPAM
  6. Contents of the pack and other information

1. What IPAM is and what it is used for

IPAM is a fixed combination medicine containing three active substances: perindopril, indapamide, and amlodipine.
It is an antihypertensive medicine used for the treatment of high blood pressure (arterial hypertension).
Patients already taking perindopril and indapamide in one medicine and amlodipine in another may instead take a single tablet of IPAM, which contains these three active substances at the same doses.
Each of the active substances helps lower blood pressure, and together they enable control of the patient's blood pressure:

  • Perindopril belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors. It works by dilating blood vessels, making it easier for the heart to pump blood through them.
  • Indapamide is a diuretic (belonging to a group of medicines called sulfonamide derivatives with an indole 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 urine production.
  • Amlodipine is a calcium channel blocker (belonging to a group of medicines called dihydropyridines). It causes relaxation of blood vessels, facilitating blood flow through them.

2. Important information before using IPAM

When not to use IPAM:

  • if the patient is allergic to perindopril or other ACE inhibitors, indapamide or other sulphonamides, amlodipine or other dihydropyridines, or to any of the other components of this medicine (listed in section 6);

  • if the patient previously experienced symptoms such as wheezing, facial or tongue swelling, intense itching, or severe rashes while being treated with an ACE inhibitor, or if such symptoms occurred in the patient or a family member under any circumstances (a condition known as angioedema);

  • if the patient has severe liver disease or a condition called hepatic encephalopathy (a brain dysfunction caused by liver disease);

  • if untreated, decompensated heart failure is suspected in the patient (severe fluid retention, breathing difficulties);

  • if the patient is taking non-antiarrhythmic medicines that may cause life-threatening irregular heartbeat ( torsades de pointes );

  • if the patient has aortic valve stenosis (narrowing of the aorta) or cardiogenic shock (a condition in which the heart cannot supply sufficient blood to the body);

  • if the patient has heart failure following a heart attack;

  • if the patient has very low blood pressure (hypotension);

  • if the patient has low potassium levels in the blood;

  • if the patient has severe kidney disease causing reduced blood supply to the kidneys (renal artery stenosis);

  • if the patient is undergoing dialysis or another form of blood filtration. Depending on the device used, IPAM may not be suitable for the patient;

  • if the patient has moderately severe kidney disease (applies to IPAM 10 mg + 2.5 mg + 5 mg and 10 mg + 2.5 mg + 10 mg);

  • after the 3rd month of pregnancy (it is also advisable to avoid using IPAM in early pregnancy - see the section on pregnancy);

  • if the patient has diabetes or kidney dysfunction and is being treated with a blood pressure-lowering medicine containing aliskiren;

  • if the patient has taken or is currently taking a combination medicine containing sacubitril and valsartan, used in treating heart failure, as this increases the risk of angioedema (rapid swelling of tissues under the skin, particularly in the throat area) (see "Warnings and precautions" and "IPAM with other medicines").

Warnings and precautions
If any of the following conditions apply to the patient, consult a doctor or pharmacist before using IPAM:

  • if the patient has hypertrophic cardiomyopathy (a heart muscle disease) or renal artery stenosis (narrowing of the blood vessel supplying blood to the kidney);

  • if the patient has heart failure or any other heart disease;

  • if the patient has significantly elevated blood pressure (hypertensive crisis);

  • if the patient has liver disease;

  • if the patient has collagenosis (connective tissue disease), such as systemic lupus erythematosus or scleroderma;

  • if the patient has atherosclerosis (hardening of the arteries);

  • if tests on parathyroid function are being performed;

  • if the patient has gout;

  • if the patient has diabetes;

  • if the patient is on a low-salt diet or uses potassium-containing salt substitutes (maintaining appropriate blood potassium levels is important);

  • if the patient is taking lithium or potassium-sparing diuretics (spironolactone, triamterene), as their use with IPAM should be avoided (see "IPAM with other medicines");

  • if the patient is elderly and the dose needs to be increased;

  • if the patient has previously experienced light allergies;

  • in black patients, angioedema (swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing) may occur more frequently, and the medicine may be less effective in lowering blood pressure;

  • if the patient is undergoing dialysis using high-flux membranes;

  • if the patient has kidney disease or is undergoing dialysis;

  • if the patient experiences worsening vision or eye pain. These may be symptoms of fluid accumulation in the choroid layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur within hours or weeks of taking IPAM. Untreated symptoms may lead to permanent vision loss. If the patient previously had an allergy to penicillin or sulphonamides, the risk of these disorders is higher.

  • if the patient has muscle disorders, including pain, tenderness, weakness, or cramps;

  • if the patient has abnormally high levels of a hormone called aldosterone in the blood (primary hyperaldosteronism);

  • if there is excessive acid in the blood, which may cause rapid breathing;

  • if the patient has cerebral circulatory insufficiency (low blood pressure in the brain);

  • if the patient develops swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing (angioedema), which can occur at any time during treatment; treatment must be stopped immediately and medical advice sought.

  • if the patient is taking any of the following medicines, as this increases the risk of angioedema:

  • racecadotril (used to treat diarrhoea);

  • sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of so-called mTOR inhibitors (used to prevent organ transplant rejection and in cancer treatment);

  • sacubitril (available in a combination medicine containing sacubitril and valsartan), used in treating chronic heart failure;

  • if the patient is taking any of the following medicines used to treat high blood pressure:

  • an angiotensin II receptor antagonist (AIIRA) (also known as a sartan - e.g. valsartan, telmisartan, irbesartan), especially if the patient has kidney dysfunction related to diabetes,

  • aliskiren;

  • linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medicines belonging to the group of drugs called gliptins (used to treat diabetes).

The doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium).
See also the section "When not to use IPAM".
The doctor may recommend blood tests to assess whether sodium or potassium levels have decreased or calcium levels have increased.
Inform the doctor if you are pregnant, planning pregnancy, or suspect pregnancy. Use of IPAM is not recommended in early pregnancy and must not be taken after the 3rd month of pregnancy, as it may seriously harm the unborn child (see section "Pregnancy and breastfeeding").
When using IPAM, inform your doctor or medical staff if:

  • the patient is to undergo anaesthesia and/or surgery;
  • the patient has recently experienced diarrhoea or vomiting, or is dehydrated;
  • LDL apheresis (mechanical removal of cholesterol from the blood) is to be performed;
  • desensitisation treatment is planned to reduce allergic reactions after bee or wasp stings;
  • a test requiring administration of an iodine-containing contrast agent (a substance allowing visualisation of organs such as the kidney or stomach in X-ray imaging) is to be performed.

Athletes should be aware that IPAM contains an active substance (indapamide) that may lead to a positive result in doping tests.
Children and adolescents
IPAM should not be given to children and adolescents.
IPAM with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
Patients with diabetes or kidney disease must not take aliskiren (used to treat high blood pressure).
Avoid taking IPAM with:

  • lithium (used to treat certain mental disorders such as mania, bipolar disorder, and recurrent depression);
  • potassium-sparing medicines (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 to prevent clots; trimethoprim and co-trimoxazole, also known as a combination medicine containing trimethoprim and sulfamethoxazole, used to treat bacterial infections);
  • dantrolene (intravenous), also used to treat malignant hyperthermia occurring during anaesthesia (symptoms include very high fever and muscle rigidity);
  • estramustine (used to treat cancer);
  • medicines used to treat diarrhoea (racecadotril) or medicines used to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of so-called mTOR inhibitors). See section "Warnings and precautions".
  • a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See sections "When not to use IPAM" and "Warnings and precautions".
  • other medicines used to treat high blood pressure: angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists.

Other medicines may affect treatment with IPAM. The doctor may recommend a dose adjustment and/or additional precautions. Inform the doctor if the patient is taking any of the following medicines, as this may require special caution:

  • other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (AIIRA), aliskiren (see also sections "When not to use IPAM" and "Warnings and precautions") or diuretics (medicines that increase urine production by the kidneys);
  • potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone at doses from 12.5 mg to 50 mg per day;
  • anaesthetics;
  • iodine-containing contrast agents;
  • bepridil (used to treat angina pectoris);
  • methadone (used to treat addiction);
  • medicines used to treat heart rhythm disorders (e.g. dofetilide, ibutilide, bretylium, cizapride, difemanil, procainamide, quinidine, hydroquinidine, disopyramide, amiodarone, sotalol);
  • verapamil, diltiazem (used in heart diseases);
  • digoxin or other cardiac glycosides (used in heart diseases);
  • antibiotics used to treat bacterial infections (e.g. rifampicin, erythromycin, clarithromycin, sparfloxacin, moxifloxacin);
  • antifungal medicines (e.g. itraconazole, ketoconazole, intravenous amphotericin B);
  • allopurinol (used to treat gout);
  • antihistamines used to treat allergic reactions such as hay fever (e.g. mizolastine, terfenadine, or astemizole);
  • corticosteroids used to treat various diseases, including severe asthma and rheumatoid arthritis, and non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or high doses of salicylates (e.g. acetylsalicylic acid, a substance found in many medicines used for pain relief, fever reduction, and prevention of blood clots);
  • immunosuppressive medicines (given to control immune system reactions) used to treat autoimmune diseases or after organ transplantation (e.g. cyclosporine, tacrolimus);
  • tetracosactide (used to treat Crohn's disease);
  • gold salts, especially when administered intravenously (used to treat symptoms of rheumatoid arthritis);
  • halofantrine (used to treat certain types of malaria);
  • baclofen used to treat muscle stiffness occurring in diseases such as multiple sclerosis;
  • medicines used to treat diabetes, such as insulin or metformin;
  • calcium, including calcium supplements;
  • stimulant laxatives (e.g. senna);
  • medicines used to treat cancer;
  • vinpocetine (used to treat symptomatic cognitive disorders in elderly patients, including memory loss);
  • medicines used to treat mental disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, antipsychotics, imipramine-type 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 infection);
  • Hypericum perforatum (St. John's wort);
  • trimethoprim (used to treat infections);
  • medicines used to treat low blood pressure, shock, or asthma (e.g. ephedrine, noradrenaline, or adrenaline);
  • nitroglycerin and other nitrates or other vasodilating medicines, as they may further lower blood pressure.

IPAM with food and drink
While taking IPAM, do not consume grapefruit or grapefruit juice, as this may increase the concentration of the active substance - amlodipine - potentially causing an unexpected intensification of the blood pressure-lowering effect of IPAM.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Inform the doctor about pregnancy, suspected pregnancy, or planned pregnancy.
Usually, the doctor will recommend stopping IPAM before planned pregnancy or immediately after pregnancy is confirmed and will advise using another medicine instead of IPAM. Use of IPAM is not recommended in early pregnancy and must not be taken after the 3rd month of pregnancy, as it may seriously harm the unborn child.
Breastfeeding
Inform the doctor if the patient is breastfeeding or plans to breastfeed. Use of IPAM is not recommended during breastfeeding, especially when nursing a newborn or premature infant. The doctor may recommend using another medicine.
Driving and operating machinery
IPAM may affect the ability to drive or operate machinery. If taking the medicine causes nausea, dizziness, fatigue, or headache, do not drive or operate machinery and contact a doctor immediately.
IPAM contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to use IPAM

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The tablet should be swallowed with a glass of water, preferably in the morning, before a meal. The appropriate dose will be determined by the doctor. The usual recommended dose is one tablet once daily.

Taking more IPAM than recommended
Taking too many tablets may cause blood pressure to drop, even to a dangerous extent, which may sometimes be accompanied by nausea, vomiting, cramps, dizziness, drowsiness, disorientation, oliguria (passing less urine than usual), anuria (lack of urine production or excretion). The patient may feel a "void" in the head, experience faintness or weakness. If the drop in blood pressure is significant, shock may occur, in which the skin becomes cold and clammy, and the patient may lose consciousness. Breathlessness due to fluid accumulation in the lungs (pulmonary edema) may occur even up to 24–48 hours after taking the medicine.
If too many tablets of IPAM have been taken, seek immediate medical attention by contacting a doctor or going to the nearest hospital emergency department.

Missing a dose of IPAM
It is important to take the medicine every day, as regular use ensures more effective treatment. However, if a dose of IPAM is missed, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping IPAM treatment
Treatment of high blood pressure is usually long-term; therefore, consult your doctor before stopping this medicine.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
If the patient experiences any of the following serious adverse symptoms, the medicine must be discontinued
and medical advice must be sought immediately:

  • sudden onset of wheezing, chest pain, shortness of breath or difficulty breathing (uncommon – may occur in up to 1 in 100 patients);
  • swelling of the eyelids, face or lips (uncommon – may occur in less than 1 in 100 patients);
  • swelling of the mucous membranes of the mouth, tongue or throat, causing significant breathing difficulties (uncommon – may occur in up to 1 in 100 patients);
  • severe skin reactions, including severe rash, urticaria, redness of the entire skin surface, intense itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions (very rare – may occur in up to 1 in 10,000 patients);
  • severe dizziness or fainting (common – may occur in up to 1 in 10 patients);
  • myocardial infarction (very rare – may occur in up to 1 in 10,000 patients), life-threatening cardiac arrhythmias (frequency unknown);
  • pancreatitis, which may cause severe abdominal pain radiating to the back and severe malaise (very rare – may occur in less than 1 in 10,000 patients);
  • muscle weakness, cramps, tenderness or muscle pain, especially when the patient also feels unwell or has a high temperature, which may be due to abnormal muscle breakdown (frequency unknown).

Adverse effects, grouped by decreasing frequency of occurrence:

  • Very common (affects at least 1 in 10 patients): Oedema (fluid retention).
  • Common (affects less than 1 in 10 patients): Low blood potassium levels, headache, central dizziness, palpitations (awareness of heartbeat), sudden flushing of the face and neck, labyrinthine dizziness, tingling/numbness, visual disturbance, double vision, tinnitus (sensation of hearing sounds), feeling of "emptiness" in the head due to low blood pressure, cough, shortness of breath, gastrointestinal disturbances (nausea, vomiting, abdominal pain, taste disturbances, indigestion or digestive discomfort, diarrhoea, constipation, changes in defecation rhythm), allergic reactions (such as rashes, itching), muscle cramps, fatigue, weakness, drowsiness, swelling of the ankle area.
  • Uncommon (affects less than 1 in 100 patients): Mood swings, anxiety, depression, sleep disturbances, tremor, urticaria, fainting, pain insensitivity, irregular and/or rapid heartbeat, nasal mucositis (nasal swelling or discharge), hair loss, purpura (red spots on the skin), skin depigmentation, itching, sweating, chest pain, muscle or joint pain, back pain, pain, malaise, kidney disorders, urinary disorders, nocturia (need to urinate at night), increased frequency of urination, impotence (inability to achieve or maintain erection), fever or elevated body temperature, discomfort or enlargement of the breasts in men, weight gain or weight loss, increased number of a certain type of white blood cells, high blood potassium levels, hypoglycaemia (very low blood sugar levels), low blood sodium levels, which may lead to dehydration and lowered blood pressure, vasculitis, photosensitivity reaction (skin changes) after exposure to sunlight or artificial UVA radiation, clusters of blisters on the skin, swelling of hands or feet, increased blood creatinine and urea levels, falls, dryness of the oral mucosa.
  • Rare (affects less than 1 in 1,000 patients): Disorientation, abnormal laboratory test results: low blood chloride levels, low blood magnesium levels, increased liver enzyme activity, high serum bilirubin levels; exacerbation of psoriasis, reduced or absent urine output, acute kidney failure. Dark-coloured urine, nausea or vomiting, muscle cramps, disorientation and seizures. These may be symptoms of a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion).
  • Very rare (affects less than 1 in 10,000 patients): Decreased number of white blood cells, decreased platelet count (leading to easy bruising and nosebleeds), anaemia (reduced number of red blood cells), angina pectoris (chest pain, jaw and back pain, triggered by physical exertion and caused by impaired cardiac blood flow), eosinophilic pneumonia (a rare type of lung inflammation), gum swelling, severe skin reactions, including severe rash, redness of the entire skin surface, intense itching, blistering, peeling and swelling of the skin, erythema multiforme (rash, often beginning with red, itchy spots on the face, arms or legs), bleeding, tender or enlarged gums, liver dysfunction, hepatitis, severe kidney dysfunction, yellowing of the skin (jaundice), abdominal distension (gastritis), nerve disorders causing weakness, tingling or numbness, increased muscle tone, hyperglycaemia (very high blood sugar levels), high blood calcium levels, stroke, possibly secondary to significant drop in blood pressure.
  • Frequency not known (cannot be estimated from available data): Hepatic encephalopathy (brain disorder caused by liver disease), abnormal ECG (electrocardiogram) findings; in patients with systemic lupus erythematosus (a type of collagenosis), symptoms may worsen. Myopia, blurred vision, worsening of vision or eye pain due to high pressure (possible symptoms of fluid accumulation in the choroidal layer of the eye (choroidal effusion) or acute angle-closure glaucoma). Tremor, postural rigidity, facial masking, bradykinesia and shuffling gait, unsteady gait. Cyanosis, numbness and pain in fingers or toes (Raynaud's phenomenon).

Changes in laboratory test results (blood tests) may occur. The doctor may recommend blood tests
to monitor the patient's health.
If any of these symptoms occur, contact a doctor as soon as possible.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine IPAM

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP. The expiry date refers to the last day of the stated month.
There are no special storage temperature requirements for this medicine. Store in the original packaging to protect from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What IPAM contains

  • The active substances are: perindopril with arginine, indapamide and amlodipine. Each IPAM coated tablet, 5 mg+1.25 mg+5 mg contains 5 mg of perindopril with arginine equivalent to 3.395 mg of perindopril, 1.25 mg of indapamide and 5 mg of amlodipine (as amlodipine besilate). Each IPAM coated tablet, 5 mg+1.25 mg+10 mg contains 5 mg of perindopril with arginine equivalent to 3.395 mg of perindopril, 1.25 mg of indapamide and 10 mg of amlodipine (as amlodipine besilate). Each IPAM coated tablet, 10 mg+2.5 mg+5 mg contains 10 mg of perindopril with arginine equivalent to 6.790 mg of perindopril, 2.5 mg of indapamide and 5 mg of amlodipine (as amlodipine besilate). Each IPAM coated tablet, 10 mg+2.5 mg+10 mg contains 10 mg of perindopril with arginine equivalent to 6.790 mg of perindopril, 2.5 mg of indapamide and 10 mg of amlodipine (as amlodipine besilate).
  • The other ingredients in the tablet are: microcrystalline cellulose, calcium carbonate, pregelatinized starch, sodium croscarmellose, magnesium stearate and anhydrous colloidal silicon dioxide.
    IPAM, 5 mg+1.25 mg+5 mg and IPAM, 10 mg+2.5 mg+10 mg: the coating contains polyethylene glycol-grafted polyvinyl alcohol copolymer, talc, titanium dioxide (E171), glycerol monokaprylokaprynan and poly(vinyl) alcohol.
    IPAM, 5 mg+1.25 mg+10 mg and IPAM, 10 mg+2.5 mg+5 mg: the coating contains polyethylene glycol-grafted polyvinyl alcohol copolymer, talc, titanium dioxide (E171), glycerol monokaprylokaproate (type 1), polyvinyl alcohol, yellow iron oxide (E172), black iron oxide (E172) and red iron oxide (E172).

What IPAM looks like and contents of the pack
IPAM, 5 mg+1.25 mg+5 mg: white, elongated coated tablets, embossed with the code "TEV" on one side and "2" on the other side. The tablet dimensions are approximately 12.3 mm x 6.5 mm.
IPAM, 5 mg+1.25 mg+10 mg: light beige, round coated tablets, embossed with the code "TEV" on one side and "3" on the other side. The tablet diameter is approximately 9.0 mm.
IPAM, 10 mg+2.5 mg+5 mg: light beige, elongated coated tablets, embossed with the code "TEV" on one side and "4" on the other side. The tablet dimensions are approximately 12.3 mm x 6.5 mm.
IPAM, 10 mg+2.5 mg+10 mg: white, round coated tablets, embossed with the code "TEV" on one side and "5" on the other side. The tablet diameter is approximately 9.0 mm.
IPAM is available in blister packs of 10, 30, 90 and 100 tablets, packed in a cardboard box.
Not all pack sizes may be marketed.

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

Manufacturer
Actavis Ltd.
BLB015, BLB016, Bulebel Industrial Estate
Zejtun ZTN3000
Malta
Teva Operations Poland Sp. z o.o
ul. Mogilska 80
31-546 Kraków
For further information, please contact the representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00

This medicinal product is authorised in the European Economic Area countries under the following names:

Belgium
Perindopril/Indapamide/Amlodipine Teva Generics 5 mg/1.25 mg/5 mg film-coated tablets
Perindopril/Indapamide/Amlodipine Teva Generics 5 mg/1.25 mg/10 mg film-coated tablets
Perindopril/Indapamide/Amlodipine Teva Generics 10 mg/2.5 mg/5 mg film-coated tablets
Perindopril/Indapamide/Amlodipine Teva Generics 10 mg/2.5 mg/10 mg film-coated tablets

Bulgaria
Залпам Плюс 5 mg/1.25 mg/5 mg филмирани таблетки
Zalpam Plus 5 mg/1.25 mg/5 mg film-coated tablets
Залпам Плюс 5 mg/1.25 mg/10 mg филмирани таблетки
Zalpam Plus 5 mg/1.25 mg/10 mg film-coated tablets
Залпам Плюс 10 mg/2.5 mg/5 mg филмирани таблетки
Zalpam Plus 10 mg/2.5 mg/5 mg film-coated tablets
Залпам Плюс 10 mg/2.5 mg/10 mg филмирани таблетки
Zalpam Plus 10 mg/2.5 mg/10 mg film-coated tablets

Czech Republic
Perindopril arginin/Indapamid/Amlodipin Teva

Croatia
Articel Trio 5 mg/1.25 mg/5 mg filmom obložene tablete
Articel Trio 5 mg/1.25 mg/10 mg filmom obložene tablete
Articel Trio 10 mg/2.5 mg/5 mg filmom obložene tablete
Articel Trio 10 mg/2.5 mg/10 mg filmom obložene tablete

Estonia
Perindopril arginine/Indapamide/Amlodipine Teva

Ireland
Triperindam 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 film-coated tablets

Latvia
Perindopril arginine/Indapamide/Amlodipine Teva 5 mg/1.25 mg/5 mg apvalkotas tabletes
Perindopril arginine/Indapamide/Amlodipine Teva 5 mg/1.25 mg/10 mg apvalkotas tabletes
Perindopril arginine/Indapamide/Amlodipine Teva 10 mg/2.5 mg/5 mg apvalkotas tabletes
Perindopril arginine/Indapamide/Amlodipine Teva 10 mg/2.5 mg/10 mg apvalkotas tabletes

Poland
IPAM

Portugal
Perindopril + Indapamide + Amlodipine ratiopharm

Romania
Perindopril arginină/Indapamidă/Amlodipină Teva 5 mg/1.25 mg/5 mg comprimate filmate
Perindopril arginină/Indapamidă/Amlodipină Teva 5 mg/1.25 mg/10 mg comprimate filmate
Perindopril arginină/Indapamidă/Amlodipină Teva 10 mg/2.5 mg/5 mg comprimate filmate
Perindopril arginină/Indapamidă/Amlodipină Teva 10 mg/2.5 mg/10 mg comprimate filmate

Slovakia
Perindopril arginín/indapamid/amlodipín Teva 5 mg/1.25 mg/5 mg
Perindopril arginín/indapamid/amlodipín Teva 5 mg/1.25 mg/10 mg
Perindopril arginín/indapamid/amlodipín Teva 10 mg/2.5 mg/5 mg
Perindopril arginín/indapamid/amlodipín Teva 10 mg/2.5 mg/10 mg

Italy
PERINDOPRIL/INDAPAMIDE/AMLODIPINA TEVA