Triplixam

Package Leaflet: Information for the Patient

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

Triplixam, 10 mg + 2.5 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 given 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 pack and other information

1. What is Triplixam and what is it used for

Triplixam is a combination medicine that contains three active substances: perindopril, indapamide, and amlodipine. It is an antihypertensive medicine used to treat high blood pressure (hypertension). Patients already taking perindopril and indapamide in one medicine and amlodipine in another can use one Triplixam tablet, which contains these three active substances in the same doses. Each of the active substances 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 slightly increases the amount of urine produced.
• 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:

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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);

• after 3 months of pregnancy (it is also recommended to avoid taking Triplixam during early pregnancy
• see section on pregnancy);

Warnings and precautions

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

• 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;

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• 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, vildagliptin, and other medicines belonging to the group of medicines called gliptins (used to treat diabetes);
• 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 (e.g., 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.

The patient should tell their doctor about pregnancy, planned pregnancy, or suspected pregnancy. 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 "Pregnancy and breastfeeding").

Athletes should be aware that Triplixam contains an active substance (indapamide) that can cause a positive doping test result.

Children and adolescents

Triplixam should not be given to children and adolescents.

Triplixam and other medicines

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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).
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 (triamterene, amiloride), potassium supplements, or salt substitutes containing potassium, or other medicines that can increase potassium levels in the body (such as heparin, a medicine used to thin the blood to prevent blood clots; 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 "Warnings and precautions";
• a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See the sections "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 treatment with Triplixam. The doctor may recommend a change in dose and/or take 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 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;
• contrast agents containing iodine;
• bepridil (used to treat angina pectoris);
• methadone (used to treat addiction);
• medicines used to treat heart rhythm disorders (e.g., dofetilide, ibutilide, bretylium, cyzaprid, difemanil, procainamide, quinidine, hydroquinidine, dyzopiramid, amiodarone, sotalol);
• verapamil, diltiazem (used to treat heart diseases);
• digoxin or other cardiac glycosides (used to treat heart diseases);
• antibiotics used to treat bacterial infections (e.g., rifampicin, erythromycin injection, clarithromycin, sparfloxacin, moxifloxacin);
• antifungal medicines (e.g., itraconazole, ketoconazole, amphotericin B injection);
• allopurinol (used to treat gout);
• antihistamines used to treat allergic reactions, such as hay fever (e.g., mizolastine, terfenadine, astemizole);
• corticosteroids used to treat various diseases, including severe asthma and rheumatoid arthritis, and non-steroidal anti-inflammatory medicines (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 clots);

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• immunosuppressive medicines (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 those 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;
• vincamine (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, 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 (e.g., ephedrine, noradrenaline, or adrenaline);
• nitroglycerin and other nitrates or other vasodilators, as they can further lower blood pressure.

Triplixam with food and drink

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or are planning 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 planned pregnancy. The doctor will usually recommend stopping Triplixam before planned pregnancy or as soon as possible after confirming pregnancy and will 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

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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. In case of doubts, 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 a meal. 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 can cause a significant drop in blood pressure, which can be dangerous, and 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, it can lead to shock, 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 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 treatment with Triplixam

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 serious 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 membranes 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);

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severe dizziness or fainting (common - may occur in less than 1 in 10 patients);

Side effects, grouped by frequency of occurrence:

• 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 or 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), low sodium levels in the blood, which can cause dehydration and low blood pressure, vasculitis (inflammation of blood vessels), sensitivity to light (changes in skin appearance) after exposure to sun or artificial UVA radiation, blistering skin lesions, swelling of hands or feet, increased creatinine and urea levels in the blood, falls, dryness 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). Angioedema (swelling of the face, lips, mouth, tongue, or throat) can occur. Dark urine, nausea, or vomiting, muscle cramps, disorientation, and seizures may occur. These can 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 coronary artery disease), eosinophilic pneumonia (a rare type of pneumonia), gingival hyperplasia (gum overgrowth), 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, itchy spots on the face, arms, or legs), bleeding, sensitive, or swollen gums, liver dysfunction, hepatitis, severe kidney dysfunction, 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), high calcium levels in the blood, stroke, probably secondary to significant lowering of blood pressure.

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unknown frequency (cannot be estimated from available data): hepatic encephalopathy (a brain disease caused by liver disease); abnormal ECG (electrocardiogram); in patients with 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 choroidal effusion or acute angle-closure glaucoma). Tremors, rigidity, 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 the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Triplixam

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
There are no special storage requirements.
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 pack and other information

What Triplixam contains

• The active substances of Triplixam are: perindopril arginine, indapamide, and amlodipine.

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One film-coated tablet of Triplixam contains 6.790 mg of perindopril (which corresponds to 10 mg of perindopril arginine), 2.5 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, silicon dioxide, 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, 10 mg + 2.5 mg + 10 mg: white, elongated, film-coated tablet, 12.2 mm long and 6.46 mm wide, with a logo embossed on one side and a logo embossed on the other side.

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 tablets.
To obtain more detailed information, the patient should contact the marketing authorization holder or the 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., ul. 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: 14-0060

Parallel import authorization number: 48/25

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
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: 04.02.2025

[Information about the trademark]
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