Ipam

Leaflet attached to the packaging: patient information

IPAM, 5 mg + 1.25 mg + 5 mg, film-coated tablets

IPAM, 5 mg + 1.25 mg + 10 mg, film-coated tablets

IPAM, 10 mg + 2.5 mg + 5 mg, film-coated tablets

IPAM, 10 mg + 2.5 mg + 10 mg, film-coated tablets

Perindopril arginine + Indapamide + Amlodipine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is IPAM and what is it 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 packaging and other information

1. What is IPAM and what is it used for

IPAM is a combination product containing three active substances: perindopril, indapamide, and amlodipine.
This is a blood pressure lowering medicine used to treat high blood pressure (hypertension).
Patients already taking perindopril and indapamide in one medicine and amlodipine in another can take one IPAM tablet instead, which contains these three active substances in the same doses.
Each active substance lowers blood pressure, and together they help control blood pressure in the patient:

• Perindopril belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors). It works by widening the blood vessels, making it easier for the heart to pump blood.
• Indapamide is a diuretic (a medicine that increases the amount of urine produced by the kidneys). Diuretics increase the amount of urine produced by the kidneys. However, indapamide differs from other diuretics because it only causes a slight increase in urine production.
• Amlodipine is a calcium channel blocker (which belongs to a group of medicines called dihydropyridines). It causes relaxation of the blood vessels, making it easier for blood to flow through them.

2. Important information before taking IPAM

When not to take IPAM:

such symptoms have occurred in the patient or someone in their family under any other circumstances (a condition called angioedema);

• after the third month of pregnancy (it is also recommended to avoid taking IPAM in early pregnancy - see the section on pregnancy);

Warnings and precautions

If any of the following conditions apply to the patient, they should consult a doctor or pharmacist before taking IPAM:

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

The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (such as potassium) in the blood.
See also the subsection "When not to take IPAM".
The doctor may recommend blood tests to check if there has been a decrease in sodium or potassium levels or an increase in calcium levels in the blood.
The patient should tell their doctor if they are pregnant, planning to become pregnant, or suspect they are pregnant. IPAM should not be taken during pregnancy, especially after the third month, as it can seriously harm the baby (see the section on pregnancy and breastfeeding).
When taking IPAM, the patient should inform their doctor or medical staff if:

• they are to undergo anesthesia and/or surgery;
• they have recently had diarrhea or vomiting, or are dehydrated;
• they are to undergo LDL apheresis (mechanical removal of cholesterol from the blood);
• they are to undergo desensitization treatment to reduce allergic reactions to bee or wasp stings;
• they are to undergo a test that requires the use of a contrast agent containing iodine (a substance that allows organs such as the kidney or stomach to be seen on an X-ray).

Athletes should be aware that IPAM contains the active substance indapamide, which can cause a positive doping test result.

Children and adolescents

IPAM should not be given to children and adolescents.

IPAM and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Patients with diabetes or kidney disease should not take aliskiren (used to treat high blood pressure).
IPAM should be avoided when taking:

• lithium (used to treat certain mental illnesses, such as mania, manic-depressive illness, and recurrent depression);
• potassium-sparing medicines (such as triamterene, amiloride), potassium supplements, or salt substitutes containing potassium, other medicines that may increase potassium levels in the body (such as heparin, a medicine used to thin the blood to prevent clotting; trimethoprim and cotrimoxazole, also known as a combination of trimethoprim and sulfamethoxazole, used to treat bacterial infections);
• dantrolene (given by infusion), also used to treat malignant hyperthermia (a condition characterized by very high fever and muscle stiffness) during anesthesia;
• estramustine (used to treat cancer);
• medicines used to treat diarrhea (such as racecadotril) or medicines used to prevent the rejection of a transplanted organ (such as sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of so-called mTOR inhibitors). See the section "Warnings and precautions";
• a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See the sections "When not to take IPAM" and "Warnings and precautions";
• other medicines used to treat high blood pressure: ACE inhibitors and angiotensin II receptor antagonists.

Taking other medicines may affect treatment with IPAM. The doctor may recommend a dose change and/or take other precautions. The patient should tell their doctor if they are taking any of the following medicines, as they may require special precautions:

• other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (AIIRAs), aliskiren (see also the subsections "When not to take IPAM" and "Warnings and precautions"), or diuretics (medicines that increase the amount of urine produced by the kidneys);
• potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone in doses of 12.5 mg to 50 mg per day;
• anesthetics;
• iodine-containing contrast agents;
• bepridil (used to treat angina pectoris);
• methadone (used to treat addiction);
• medicines used to treat irregular heart rhythms (such as dofetilide, ibutilide, bretylium, cyzaprid, difemanil, procainamide, quinidine, hydroquinidine, disopyramide, amiodarone, sotalol);
• verapamil, diltiazem (used to treat heart conditions);
• digoxin or other cardiac glycosides (used to treat heart conditions);
• antibiotics used to treat bacterial infections (such as rifampicin, erythromycin, clarithromycin, sparfloxacin, moxifloxacin);
• antifungal medicines (such as itraconazole, ketoconazole, amphotericin B given by infusion);
• allopurinol (used to treat gout);
• antihistamines used to treat allergic reactions, such as hay fever (such as mizolastine, terfenadine, or astemizole);
• corticosteroids used to treat various diseases, including severe asthma and rheumatoid arthritis, as well as non-steroidal anti-inflammatory drugs (such as ibuprofen) or high doses of salicylates (such as acetylsalicylic acid, a substance found in many medicines, used to relieve pain and reduce fever, as well as to prevent blood clots);
• immunosuppressive medicines (given to control the immune system's response) used to treat autoimmune diseases or after organ transplantation (such as cyclosporine, tacrolimus);
• tetracosactide (used to treat Crohn's disease);
• gold salts, especially when given intravenously (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 used to treat diabetes, such as insulin or metformin;
• calcium, including calcium supplements;
• laxatives with a stimulating effect (such as senna);
• medicines used to treat cancer;
• vinpocetine (used to treat symptomatic cognitive disorders in the elderly, including memory loss);
• medicines used to treat mental disorders, such as depression, anxiety, schizophrenia (such as tricyclic antidepressants, antipsychotic medicines, antidepressant medicines of the imipramine type, 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 infections);
• Hypericum perforatum(St. John's Wort);
• trimethoprim (used to treat infections);
• medicines used to treat low blood pressure, shock, or asthma (such as ephedrine, noradrenaline, or adrenaline);
• nitroglycerin and other nitrates or other vasodilators, as they can further lower blood pressure.

IPAM with food and drink

When taking IPAM, the patient should not consume grapefruits or grapefruit juice, as this can increase the levels of the active substance amlodipine, leading to an unexpected increase in the blood pressure lowering effect of IPAM.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

The patient should tell their doctor about pregnancy, suspected pregnancy, or plans to become pregnant.
Usually, the doctor will advise the patient to stop taking IPAM before planned pregnancy or as soon as pregnancy is confirmed, and will recommend an alternative medicine. IPAM should not be taken during pregnancy, especially after the third month, as it can seriously harm the baby.

Breastfeeding

The patient should tell their doctor if they are breastfeeding or plan to breastfeed. IPAM should not be taken during breastfeeding, especially when breastfeeding a newborn or premature baby. The doctor may recommend an alternative medicine.

Driving and using machines

IPAM may affect the ability to drive or operate machines. If taking the medicine causes nausea, dizziness, fatigue, or headache, the patient should not drive or operate machines and should contact their doctor immediately.

IPAM contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take IPAM

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The tablet should be swallowed with a glass of water, preferably in the morning, before breakfast. The doctor will determine the appropriate dose for the patient. The recommended dose is usually one tablet per day.

Taking a higher dose of IPAM than recommended

Taking too many tablets can cause blood pressure to drop, even to a dangerous level, which may be accompanied by nausea, vomiting, cramps, dizziness, drowsiness, disorientation, oliguria (production of abnormally small amounts of urine), or anuria (inability to produce or pass urine). The patient may feel "empty" in the head, may experience fainting or weakness. If the drop in blood pressure is significant, shock may occur, in which case the skin becomes cool and moist, and the patient may lose consciousness. Even 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulation in the lungs (pulmonary edema) may occur.
In case of taking too many IPAM tablets, the patient should immediately contact their doctor or go to the emergency department of the nearest hospital.

Missing a dose of IPAM

It is essential to take the medicine every day, as regular treatment ensures more effective action. However, if a dose of IPAM is missed, the next dose should be taken at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping IPAM treatment

Treatment of high blood pressure is usually long-term, so before stopping IPAM, the patient should consult their doctor.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, IPAM can cause side effects, although not everybody gets them.

If the patient experiences any of the following severe side effects, they should stop taking IPAM and contact their 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 mucous membrane of the mouth, tongue, or throat, causing 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, 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);
• pancreatitis, which can cause severe abdominal pain, radiating to the back, and very poor general condition (very rare - may affect up to 1 in 10,000 people);
• muscle weakness, cramps, tenderness, or pain, especially if the patient feels unwell or has a high temperature, which may be caused by abnormal muscle breakdown (frequency not known).

Side effects, grouped by frequency of occurrence:

• Very common(affects at least 1 in 10 people): Edema (fluid retention).
• Common(affects up to 1 in 10 people): Low potassium levels in the blood, headache, dizziness of central origin, palpitations (feeling of heartbeat), sudden reddening of the face and neck, dizziness of labyrinthine origin, feeling of tingling or numbness, vision disturbances, double vision, tinnitus (feeling of hearing sounds), feeling of "emptiness" in the head due to low blood pressure, cough, shortness of breath, gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, indigestion or digestive disorders, diarrhea, constipation, changes in bowel movements), allergic reactions (such as rash, itching), muscle cramps, feeling of tiredness, weakness, drowsiness, swelling of the ankles.
• Uncommon(affects up to 1 in 100 people): Mood changes, anxiety, depression, sleep disturbances, tremors, hives, fainting, loss of sensation, irregular or rapid heartbeat, rhinitis (swelling or discharge from the nose), hair loss, purpura (red spots on the skin), skin discoloration, itching, sweating, chest pain, muscle or joint pain, back pain, pain, poor general condition, kidney disorders, urinary disorders, need to urinate at night, increased frequency of urination, impotence (inability to achieve or maintain an erection), fever or elevated body temperature, discomfort or breast enlargement in men, weight gain or loss, increased white blood cell count, hyperglycemia (very high blood sugar levels), low sodium levels in the blood, which can cause dehydration and low blood pressure, vasculitis (inflammation of blood vessels), photosensitivity reaction (skin changes after exposure to sunlight), blistering skin, swelling of hands or feet, increased creatinine and urea levels in the blood, falls, dry mouth.
• Rare(affects up to 1 in 1,000 people): Disorientation, abnormal laboratory test results: low chloride levels in the blood, low magnesium levels in the blood, increased liver enzyme activity, high bilirubin levels in serum; exacerbation of lupus erythematosus (a type of collagenosis). Abnormal electrocardiogram (ECG) recording; in case of systemic lupus erythematosus, symptoms may worsen. Myopia, blurred vision, decreased vision, or eye pain due to high pressure (possible symptoms of choroidal effusion or acute angle-closure glaucoma). Tremors, stiffness, mask-like face, slow movements, and shuffling gait. Cyanosis, numbness, and pain in the fingers of the hands or feet (Raynaud's phenomenon).
• Very rare(affects up to 1 in 10,000 people): Decreased white blood cell count, decreased platelet count (which can cause easy bruising and nosebleeds), anemia (decreased red blood cell count), angina pectoris (chest pain, jaw pain, and back pain caused by heart disease), eosinophilic pneumonia (a rare type of pneumonia), gum hypertrophy, 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 (rash, often starting with red, itchy spots on the face, arms, or legs), bleeding, tender, or swollen gums, liver dysfunction, hepatitis, severe kidney dysfunction, jaundice (yellowing of the skin), abdominal distension (gastritis), nerve disorders that can cause weakness, tingling, or numbness, increased muscle tone, hyperglycemia (very high blood sugar levels), high calcium levels in the blood, stroke, likely due to significant lowering of blood pressure.
• Frequency not known(cannot be estimated from available data): Hepatic encephalopathy (a brain disorder caused by liver disease), abnormal ECG recording; in case of systemic lupus erythematosus, symptoms may worsen. Myopia, blurred vision, decreased vision, or eye pain due to high pressure (possible symptoms of choroidal effusion or acute angle-closure glaucoma). Tremors, stiffness, mask-like face, slow movements, and shuffling gait. Cyanosis, numbness, and pain in the fingers of the hands or feet (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 such symptoms occur, the patient should contact their doctor as soon as possible.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store IPAM

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
There are no special storage instructions for the medicine. Store in the original packaging to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What IPAM contains

• The active substances of IPAM are: perindopril arginine, indapamide, and amlodipine. Each film-coated tablet IPAM, 5 mg+1.25 mg+5 mg 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 IPAM, 5 mg+1.25 mg+10 mg 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 IPAM, 10 mg+2.5 mg+5 mg contains 10 mg of perindopril arginine, equivalent to 6.79 mg of perindopril, 2.5 mg of indapamide, and 5 mg of amlodipine (as amlodipine besylate). Each film-coated tablet IPAM, 10 mg+2.5 mg+10 mg contains 10 mg of perindopril arginine, equivalent to 6.79 mg of perindopril, 2.5 mg of indapamide, and 10 mg of amlodipine (as amlodipine besylate).
• The other ingredients of the tablet are: microcrystalline cellulose, calcium carbonate, pregelatinized starch, sodium croscarmellose, magnesium stearate, and anhydrous colloidal silica. IPAM, 5 mg+1.25 mg+5 mg and IPAM, 10 mg+2.5 mg+10 mg: the coating contains copolymer of methacrylic acid and ethyl acrylate, talc, titanium dioxide (E171), glycerol monocaprylocaprate, and polyvinyl alcohol. IPAM, 5 mg+1.25 mg+10 mg and IPAM, 10 mg+2.5 mg+5 mg: the coating contains copolymer of methacrylic acid and ethyl acrylate, talc, titanium dioxide (E171), glycerol monocaprylocaprate type I, 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, oval, film-coated tablets with "TEV" engraved on one side and "2" on the other. The tablet dimensions are approximately 12.3 mm x 6.5 mm.
IPAM, 5 mg+1.25 mg+10 mg: light beige, round, film-coated tablets with "TEV" engraved on one side and "3" on the other. The tablet diameter is approximately 9.0 mm.
IPAM, 10 mg+2.5 mg+5 mg: light beige, oval, film-coated tablets with "TEV" engraved on one side and "4" on the other. The tablet dimensions are approximately 12.3 mm x 6.5 mm.
IPAM, 10 mg+2.5 mg+10 mg: white, round, film-coated tablets with "TEV" engraved on one side and "5" on the other. The tablet diameter is approximately 9.0 mm.
IPAM is available in blisters of 10, 30, 90, and 100 tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Teva B.V.
Swensweg 5
2031 GA, Haarlem
Netherlands

Manufacturer

Actavis Ltd.
BLB015, BLB016, Bulebel Industrial Estate
Zejtun ZTN3000
Malta
Teva Operations Poland Sp. z.o.o
Mogilska Street 80
31-546 Krakow
To obtain detailed information, please contact the representative of the marketing authorization holder:
Teva Pharmaceuticals Polska Sp. z o.o., Emilii Plater Street 53, 00-113 Warsaw, phone (22) 345 93 00

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium
Perindopril/Indapamide/Amlodipine Teva Generics 5 mg/1.25 mg/5 mg film-coated tablets/comprimés pelliculés/Filmtabletten
Perindopril/Indapamide/Amlodipine Teva Generics 5 mg/1.25 mg/10 mg film-coated tablets/comprimés pelliculés/Filmtabletten
Perindopril/Indapamide/Amlodipine Teva Generics 10 mg/2.5 mg/5 mg film-coated tablets/comprimés pelliculés/Filmtabletten
Perindopril/Indapamide/Amlodipine Teva Generics 10 mg/2.5 mg/10 mg film-coated tablets/comprimés pelliculés/Filmtabletten
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
Croatia
Perindopril arginine/Indapamide/Amlodipine Teva
Articel Trio 5 mg/1.25 mg/5 mg film-coated tablets
Articel Trio 5 mg/1.25 mg/10 mg film-coated tablets
Articel Trio 10 mg/2.5 mg/5 mg film-coated tablets
Articel Trio 10 mg/2.5 mg/10 mg film-coated tablets
Czech Republic
Perindopril arginine/Indapamide/Amlodipine Teva
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
Estonia
Perindopril arginine/Indapamide/Amlodipine Teva
5 mg/1.25 mg/5 mg film-coated tablets
Perindopril arginine/Indapamide/Amlodipine Teva
5 mg/1.25 mg/10 mg film-coated tablets
Perindopril arginine/Indapamide/Amlodipine Teva
10 mg/2.5 mg/5 mg film-coated tablets
Perindopril arginine/Indapamide/Amlodipine Teva
10 mg/2.5 mg/10 mg film-coated tablets
IPAM
Perindopril + Indapamide + Amlodipine
ratiopharm
Perindopril arginină/Indapamidă/Amlodipină Teva
5 mg/1.25 mg/5 mg film-coated tablets
Perindopril arginină/Indapamidă/Amlodipină Teva
5 mg/1.25 mg/10 mg film-coated tablets
Perindopril arginină/Indapamidă/Amlodipină Teva
10 mg/2.5 mg/5 mg film-coated tablets
Perindopril arginină/Indapamidă/Amlodipină Teva
10 mg/2.5 mg/10 mg film-coated tablets
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
PERINDOPRIL/INDAPAMIDE/AMLODIPINA TEVA
Date of last revision of the leaflet:April 2025

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