Triplixam

Leaflet attached to the packaging: patient information

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

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

Perindopril arginine + Indapamide + Amlodipine

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

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for one person. It should not be passed on to others. The medicine may harm another person, even if the symptoms of their illness 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 tablet of Triplixam 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 dilating blood vessels, making it easier for the heart to pump blood through them.
• indapamide is a diuretic (a type of sulfonamide derivative 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 antagonist (a type of dihydropyridine). It causes relaxation of blood vessels, 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 components of this medicine (listed in section 6);

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• if the patient has experienced symptoms such as wheezing, facial or tongue swelling, intense itching, or severe rash during previous treatment with an ACE inhibitor, 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, breathing difficulties);
• 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 that 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 their 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 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 correct potassium level 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 (facial, lip, mouth, tongue, or throat swelling) 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 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.

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The doctor may recommend blood tests to check if the patient's sodium or potassium levels have decreased or if their calcium levels have increased.
The patient should inform their doctor if they are pregnant, planning to become pregnant, or suspect they are pregnant. Triplixam should not be taken during pregnancy, especially after the third month, as it can seriously harm the fetus (see "Pregnancy and breastfeeding").
When taking Triplixam, the patient should inform their doctor or medical staff if:

• they are to be anesthetized and/or undergo 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 Triplixam contains the active substance indapamide, which can cause a positive result in a doping test.

Children and adolescents

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Triplixam should not be given to children and adolescents.

Triplixam and other medicines

The patient should inform 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).
The patient should avoid taking Triplixam with:

• lithium (used to treat certain mental illnesses, such as mania, manic-depressive illness, and recurring depression);
• potassium-sparing diuretics (triamterene, amiloride), potassium supplements, or salt substitutes containing potassium, and 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 (given by infusion), also used to treat malignant hyperthermia during anesthesia (symptoms include very high fever and muscle stiffness);
• estramustine (used to treat cancer);
• medicines used to treat diarrhea (racecadotril) or medicines used to prevent organ rejection (sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of so-called mTOR inhibitors). See "Warnings and precautions".
• a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See "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 inform their doctor if they are taking any of the following medicines, as it may require special precautions:

• other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (AIIRA), aliskiren (see also "When not to take Triplixam" and "Warnings and precautions"), or diuretics (medicines that increase urine production);
• potassium-sparing diuretics 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 heart rhythm disorders (e.g., dofetilide, ibutilide, bretylium, cyzapride, 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 (e.g., rifampicin, erythromycin given by injection, clarithromycin, sparfloxacin, moxifloxacin);
• antifungal medicines (e.g., itraconazole, ketoconazole, amphotericin B given by injection);
• allopurinol (used to treat gout);
• antihistamines used to treat allergic reactions, such as hay fever (e.g., mizolastine, terfenadine, astemizole);

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• 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 as a pain reliever and antipyretic, as well as to prevent blood clot formation);
• immunosuppressants (given to control the immune system's response) used to treat autoimmune diseases or after organ transplantation (e.g., cyclosporine, tacrolimus);
• tetracosactide (used to treat Crohn's disease);
• gold salts, especially 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 (e.g., 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 (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 infections);
• 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 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 unpredictable intensification of 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 their doctor or pharmacist before taking this medicine.

Pregnancy

The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. The doctor will usually recommend stopping Triplixam before planned pregnancy or as soon as pregnancy is confirmed and recommend taking a different medicine instead of Triplixam. Triplixam should not be taken during pregnancy, especially after the third month, as it can seriously harm the fetus.

Breastfeeding

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

Driving and using machines

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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 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. In case of doubt, the patient should consult their doctor or pharmacist.
Triplixam is available in the following strengths:
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 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.
If the patient has taken too many Triplixam tablets, they should immediately contact their doctor or go to the emergency department of the nearest hospital.

Missing a dose of Triplixam

It is essential to take the medicine every day, as regular use 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 their 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);

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• 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, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) 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 decreasing frequency:

• 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 heartbeats), sudden reddening of the face and neck, dizziness of labyrinthine origin, feeling of tingling/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 rashes, 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 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 breast enlargement in men, weight gain or loss, increased white blood cell count, hyperkalemia (high potassium levels in the blood), hypoglycemia (very low blood sugar levels), hyponatremia (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 sun or artificial UVA radiation, blistering skin, swelling of 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 psoriasis, decreased or absent urine production, acute kidney failure. Dark urine, nausea, or vomiting, muscle cramps, disorientation, and seizures. These may be symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion).

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• 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 coronary artery 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 the appearance of red, itching spots on the face, arms, or legs), bleeding, sensitive, or swollen gums, liver function disorders, hepatitis, 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.
• frequency not known (cannot be estimated from the available data): hepatic encephalopathy (a brain disease caused by liver disease), abnormal ECG results; in case of systemic lupus erythematosus (a type of collagenosis), symptoms may worsen. Myopia, blurred vision, decreased vision, or eye pain due to high pressure (possible symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute 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 any side effects not listed in this leaflet, they should inform 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
Jerozolimskie Avenue 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 out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
There are no special precautions for storage.
The shelf life after opening the container with 30 film-coated tablets: 30 days.
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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 13.870 mg of amlodipine besylate (which corresponds to 10 mg of amlodipine).
• Other ingredients of the tablet are:
• tablet core: calcium carbonate with starch [composition: calcium carbonate (90%), corn starch (10%)], microcrystalline cellulose, sodium croscarmellose, magnesium stearate, colloidal silica, corn starch;
• 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 + 10 mg: white, elongated, film-coated tablet, 10.7 mm long and 5.66 mm wide, with a logo embossed on one side and a logo embossed on the other side.
The tablets are available in cardboard boxes containing 30, 60 (2 containers of 30 tablets each), or 90 (3 containers of 30 tablets each) tablets.
A desiccant is placed in the cap of the tablet container.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer:

Marketing authorization holder in Latvia, the country of export:

Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex, France

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., Annopol 6b, 03-236 Warsaw, Poland

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
Marketing authorization number in Latvia, the country of export: 14-0058

Parallel import authorization number: 90/25

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

Belgium
TRIPLIXAM, film-coated tablets
Bulgaria
TRIPLIXAM, film-coated tablets
Croatia
TRIPLIXAM, film-coated tablets

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Cyprus
TRIPLIXAM, film-coated tablets
Czech Republic
TRIPLIXAM
Estonia
TRIPLIXAM
Finland
TRIPLIXAM, film-coated tablet
France
TRIPLIXAM, film-coated tablets
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 tablets
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: 07.03.2025

[Information about the trademark]
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