Triplixam

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Triplixam (Covercard Plus), 5 mg + 1.25 mg + 5 mg, film-coated tablets

Perindopril arginine + Indapamide + Amlodipine
Triplixam and Covercard Plus are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should 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 illness symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is Triplixam and what is it used for

Triplixam is a combination preparation containing three active substances: perindopril, indapamide, and amlodipine. It is an antihypertensive medicine used to treat high blood pressure (hypertension).
Patient already taking perindopril and indapamide in one medicine and amlodipine in another can use one Triplixam tablet instead, which contains these three active substances in the same doses.
Each of the active substances lowers blood pressure, and together they allow for better control of blood pressure in the patient:

• perindopril belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE). It works by widening the blood vessels, making it easier for the heart to pump blood through them.
• indapamide is a diuretic (which belongs 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 because it only causes a slight increase in urine production.
• amlodipine is a calcium antagonist (which belongs to a group of medicines called dihydropyridines). It causes the blood vessels to relax, making it easier for blood to flow through them.

2. Important information before taking Triplixam

When not to take Triplixam:

• if the patient is allergic to perindopril or other ACE inhibitors, indapamide or other sulfonamides, amlodipine or other dihydropyridines, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has experienced symptoms such as wheezing, swelling of the face or tongue, intense itching, or severe rash during previous treatment with an ACE inhibitor,

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

• if the patient has severe liver disease or a condition called hepatic encephalopathy (a brain function disorder caused by liver disease);
• if the patient is suspected of having untreated, uncontrolled heart failure (severe fluid retention in the body, difficulty breathing);
• if the patient has a narrowing of the aortic valve in the heart (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to supply enough blood to the body);
• if the patient has heart failure after 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, which reduces blood flow to the kidneys (renal artery stenosis);
• if the patient is undergoing dialysis or blood filtration by another method. Depending on the device used, Triplixam may not be suitable for the patient;
• after 3 months of pregnancy (it is also recommended to avoid taking Triplixam in early pregnancy
• see the section on pregnancy);
• if the patient has diabetes or kidney problems 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 to treat chronic heart failure, as the risk of angioedema (rapid swelling of tissues under the skin in the throat area) increases (see "Warnings and precautions" and "Triplixam and other medicines").

Warnings and precautions

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

• 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 a significant increase in blood pressure (hypertensive crisis);
• if the patient has liver disease;
• if the patient has collagenosis (a connective tissue disease), such as systemic lupus erythematosus or scleroderma;
• if the patient has atherosclerosis (hardening of the arteries);
• if the patient is undergoing parathyroid function tests;
• if the patient has gout;
• if the patient has diabetes;
• if the patient is on a low-salt diet or uses salt substitutes containing potassium (it is essential to have the right potassium levels in the blood);
• if the patient is taking lithium or potassium-sparing diuretics (spironolactone, triamterene), as they should be avoided when taking Triplixam (see "Triplixam and other medicines");
• if the patient is elderly and the dose needs to be increased;
• if the patient has had allergic reactions to light;
• in black patients, angioedema (swelling of the face, lips, mouth, tongue, or throat, which can 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 on dialysis;
• if the patient experiences vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which can occur within a few hours or weeks of taking Triplixam. Untreated symptoms can lead to permanent vision loss. If the patient has previously been allergic to penicillin or sulfonamides, there is a higher risk of these disorders.
• if the patient has muscle disorders, including pain, tenderness, weakness, or muscle cramps;

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• if the patient has an excessively high level of a hormone called aldosterone in the blood (primary aldosteronism);
• if the patient has an excessively high level of acid in the blood, which can cause rapid breathing;
• if the patient has cerebral hypoperfusion (low blood pressure in the brain);
• if the patient experiences swelling of the face, lips, mouth, tongue, or throat, which can cause difficulty swallowing or breathing (angioedema), which can occur at any time during treatment. The patient should stop taking the medicine and consult a doctor immediately.
• if the patient is taking any of the following medicines, as the risk of angioedema increases:
• racecadotril (used to treat diarrhea);
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of so-called mTOR inhibitors (used to prevent transplant rejection and treat cancer);
• sacubitril (available in a combination medicine containing sacubitril and valsartan), used to treat chronic heart failure;
• linagliptin, saxagliptin, sitagliptin, wildagliptin, and other medicines belonging to the group of medicines called gliptins (used to treat diabetes);
• if the patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonist (AIIRA), also known as a sartan - for example, valsartan, telmisartan, irbesartan, especially if the patient has kidney problems related to diabetes,
• aliskiren. 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 Triplixam".

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. It is not recommended to take Triplixam during early pregnancy, and it should not be taken after 3 months of pregnancy, as it can seriously harm the fetus (see the section on "Pregnancy and breastfeeding").
When taking Triplixam, the patient should inform their doctor or medical staff if:

• they are going to have anesthesia and/or surgery;
• they have recently had diarrhea or vomiting, or are dehydrated;
• they are going to have LDL apheresis (mechanical removal of cholesterol from the blood);
• they are going to have desensitization treatment to reduce allergic reactions to bee or wasp stings;
• they are going to have 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 Triplixam contains an active substance (indapamide) that may cause a positive result in a doping test.

Children and adolescents

Triplixam should not be given to children and adolescents.

Triplixam 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.
Patient with diabetes or kidney disease should not take aliskiren (used to treat high blood pressure).
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The patient should avoid taking Triplixam with:

• lithium (used to treat certain mental illnesses, such as mania, manic-depressive illness, and recurrent depression);
• potassium-sparing medicines, such as triamterene, amiloride, or potassium supplements, 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 a combination medicine containing trimethoprim and sulfamethoxazole, used to treat bacterial infections);
• dantrolene (used to treat malignant hyperthermia during anesthesia);
• estramustine (used to treat cancer);
• medicines used to treat diarrhea (racecadotril) or medicines used to prevent transplant rejection (sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of so-called mTOR inhibitors). See the section on "Warnings and precautions";
• a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See the sections on "When not to take Triplixam" and "Warnings and precautions";
• other medicines used to treat high blood pressure: ACE inhibitors and angiotensin II receptor antagonists.

Taking other medicines may affect the treatment with Triplixam. The doctor may recommend changing the dose and/or taking other precautions. The patient should tell their doctor if they are taking any of the following medicines, as special precautions may be necessary:

• other medicines used to treat high blood pressure, including angiotensin II receptor antagonist (AIIRA), aliskiren (see also the subsections "When not to take Triplixam" and "Warnings and precautions"), or diuretics (medicines that increase urine production);
• potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone in doses of 12.5 mg to 50 mg per day;
• anesthetics;
• contrast agents containing iodine;
• bepridil (used to treat angina pectoris);
• methadone (used to treat addiction);
• medicines used to treat heart rhythm disorders (such as dofetilide, ibutilide, bretylium, cyzaprid, difemanil, procainamide, quinidine, hydroquinidine, dyzopyramide, amiodarone, sotalol);
• verapamil, diltiazem (used to treat heart disease);
• digoxin or other cardiac glycosides (used to treat heart disease);
• antibiotics used to treat bacterial infections (such as rifampicin, erythromycin injection, clarithromycin, sparfloxacin, moxifloxacin);
• antifungal medicines (such as itraconazole, ketoconazole, amphotericin B injection);
• allopurinol (used to treat gout);
• antihistamines used to treat allergic reactions, such as hay fever (such as mizolastine, terfenadine, 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 as a pain reliever and antipyretic, as well as to prevent blood clot formation);
• immunosuppressive medicines (used 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 those given intravenously (used to treat symptoms of rheumatoid arthritis);
• halofantrine (used to treat certain types of malaria);

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• 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, antipsychotics, antidepressants 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 may further lower blood pressure.

Triplixam with food and drink

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

Pregnancy and breastfeeding

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

Pregnancy

The patient should tell their doctor if they are pregnant, suspect they are pregnant, or plan to become pregnant. The doctor will usually recommend stopping Triplixam before planned pregnancy or as soon as pregnancy is confirmed and recommend an alternative medicine instead of Triplixam. It is not recommended to take Triplixam during early pregnancy, and it should not be taken after 3 months of pregnancy, as it can seriously harm the fetus.

Breastfeeding

The patient should tell their doctor if they are breastfeeding or plan to breastfeed. It is not recommended to take Triplixam while breastfeeding, especially when breastfeeding a newborn or premature baby. The doctor may recommend an alternative medicine.

Driving and using machines

Triplixam may affect the patient's 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.

Triplixam contains sodium

Triplixam contains less than 1 mmol of sodium (23 mg) per tablet, which means that the medicine is considered "sodium-free".

3. How to take Triplixam

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult a doctor or pharmacist.
Triplixam is available in the following strengths:
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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.
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 Triplixam than recommended

Taking too many tablets may cause blood pressure to drop, even to a dangerous level, which may be accompanied by nausea, vomiting, cramps, dizziness, drowsiness, disorientation, and decreased urine production or absence of urine production. 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 cold 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.
If the patient has taken too many Triplixam tablets, they should contact their doctor or go to the emergency department of the nearest hospital immediately.

Missing a dose of Triplixam

It is essential to take the medicine every day, as regular treatment ensures more effective action. However, if a dose of Triplixam 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 Triplixam treatment

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

4. Possible side effects

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

If the patient experiences any of the following severe side effects, they should stop taking the medicine and contact their doctor immediately:

• sudden onset of wheezing, chest pain, shortness of breath, or difficulty breathing (uncommon - may occur in less than 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 membrane of the mouth, tongue, or throat, causing significant difficulty breathing (uncommon - may occur in less than 1 in 100 patients);
• 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 occur in less than 1 in 10,000 patients);
• severe dizziness or fainting (common - may occur in less than 1 in 10 patients);
• heart attack (very rare - may occur in less than 1 in 10,000 patients), life-threatening heart rhythm disorders (frequency not known);
• pancreatitis, which can cause severe abdominal pain radiating to the back and very poor general condition (very rare - may occur in less than 1 in 10,000 patients);
• 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:
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• very common (occurring in at least 1 in 10 patients): edema (fluid retention).
• common (occurring in less than 1 in 10 patients): 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/numbness, visual 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 (occurring in less than 1 in 100 patients): mood changes, anxiety, depression, sleep disturbances, tremors, hives, fainting, loss of pain sensation, irregular and/or rapid heart rate, inflammation of the nasal mucosa (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 enlargement of the breasts in men, weight gain or loss, increased white blood cell count, high potassium levels in the blood, hypoglycemia (very low blood sugar levels), low sodium levels in the blood, which can cause dehydration and low blood pressure, vasculitis (inflammation of blood vessels), photosensitivity reaction (changes in skin appearance) after exposure to sunlight or artificial UVA radiation, blistering skin lesions, swelling of the hands or feet, increased creatinine and urea levels in the blood, falls, dryness of the mucous membrane of the mouth.
• rare (occurring in less than 1 in 1,000 patients): 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). Reduced urine production or absence of urine production, dark urine, nausea, or vomiting, muscle cramps, disorientation, and seizures. These may be symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion).
• very rare (occurring in less than 1 in 10,000 patients): 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 exertion and related to 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, or other allergic reactions, bleeding, sensitive, or swollen gums, liver function disorders, liver inflammation, severe kidney function disorders, jaundice (yellowing of the skin), abdominal distension (gastritis), nerve disorders, which can cause weakness, tingling, or numbness, increased muscle tone, hyperglycemia (very high blood sugar levels), high calcium levels in the blood, stroke, possibly secondary to significant blood pressure lowering, hepatic encephalopathy (a brain disease caused by liver disease); abnormal ECG results; in case of systemic lupus erythematosus, exacerbation of symptoms may occur. Myopia, blurred vision, or eye pain due to high pressure (possible symptoms of choroidal effusion or acute angle-closure glaucoma). Page 7 9

Tremors, stiffness, mask-like face, slow movements, and shuffling gait. Cyanosis, numbness, and pain in the 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 such symptoms occur, the patient should contact their doctor as soon as possible.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. 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
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Triplixam

The medicine should be stored in a place that is out of sight and reach of children.
The medicine should not be used after the expiration date stated on the packaging. The expiration date refers to the last day of the month stated.
There are no special storage precautions.
The shelf life after opening the container with 30 film-coated tablets: 30 days.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Triplixam contains

• The active substances of Triplixam are perindopril arginine, indapamide, and amlodipine. One film-coated tablet of Triplixam contains 3.395 mg of perindopril (which corresponds to 5 mg of perindopril arginine), 1.25 mg of indapamide, and 6.935 mg of amlodipine besylate (which corresponds to 5 mg of amlodipine).
• The other ingredients of the tablet are:
• tablet core: calcium carbonate with cornstarch [composition: calcium carbonate (90%), cornstarch (10%)], microcrystalline cellulose, croscarmellose sodium, magnesium stearate, colloidal silica, cornstarch.
• tablet coating: glycerol, hypromellose 6 mPas, macrogol 6000, magnesium stearate, titanium dioxide (E 171).

What Triplixam looks like and contents of the pack

Triplixam, 5 mg + 1.25 mg + 5 mg: white, elongated, film-coated tablet, 9.75 mm long and 5.16 mm wide, with a logo embossed on one side and a logo embossed on the other side.

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The tablets are available in cardboard boxes containing 30, 60 (2 containers of 30 tablets each), or 90 (3 containers of 30 tablets each) film-coated tablets.
A desiccant is placed in the cap of the container with the tablets.
To obtain more detailed information, the patient should contact the marketing authorization holder or the parallel importer:

Marketing authorization holder in Hungary, the country of export:

Proterapia Hungary Kft., 1134 Budapest, Lehel utca 11., Hungary

Manufacturer:

Servier (Ireland) Industries Ltd, Gorey Road, Arklow - Co. Wicklow, Ireland
Les Laboratoires Servier Industrie, 905 route de Saran, 45520 Gidy, France
Anpharm Pharmaceutical Company S.A., ul. Annopol 6B, 03-236 Warsaw, Poland
EGIS Pharmaceutical Plant Zrt., 9900 Körmend, Mátyás király u. 65., Hungary

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Hungarian marketing authorization number: OGYI-T-22626/02

Parallel import authorization number: 228/25

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

Belgium
TRIPLIXAM, film-coated tablet
Bulgaria
TRIPLIXAM, film-coated tablets
Croatia
TRIPLIXAM, film-coated tablets
Cyprus
TRIPLIXAM, film-coated tablets
Czech Republic
TRIPLIXAM
Estonia
TRIPLIXAM
Finland
TRIPLIXAM, film-coated tablet
France
TRIPLIXAM, film-coated tablet
Greece
TRIPLIXAM, film-coated tablets
Ireland
COVERDINE film-coated tablets
Italy
TRIPLIAM, film-coated tablets
Latvia
TRIPLIXAM, film-coated tablets
Lithuania
TRIPLIXAM, film-coated tablets
Luxembourg
TRIPLIXAM, film-coated tablet
Malta
TRIPLIXAM film-coated tablets
Netherlands
TRIPLIXAM, film-coated tablets
Poland
TRIPLIXAM
Portugal
TRIPLIXAM
Romania
TRIPLIXAM, film-coated tablets
Slovakia
TRIPLIXAM, film-coated tablets
Slovenia
TRIPLIXAM, film-coated tablets

Date of approval of the leaflet: 01.07.2025

[Information about the trademark]
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