Triplixam

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Triplixam, 5 mg + 1.25 mg + 10 mg, Film-Coated Tablets

Perindopril Arginine + Indapamide + Amlodipine

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. 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 medication containing three active substances: perindopril, indapamide, and amlodipine. It is an antihypertensive medication used to treat high blood pressure (hypertension). Patients already taking perindopril and indapamide in one medication and amlodipine in another can use one Triplixam tablet, 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 medications called angiotensin-converting enzyme inhibitors (ACE inhibitors). It works by dilating blood vessels, making it easier for the heart to pump blood through them;
• Indapamide is a diuretic (a medication that increases urine production in the kidneys). However, indapamide differs from other diuretics because it only slightly increases urine production;
• Amlodipine is a calcium antagonist (belonging to a group of medications called dihydropyridines). It causes blood vessels to relax, making it easier for blood to flow through them.

2. Important information before taking Triplixam

When not to take Triplixam:

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

Warnings and precautions

If any of the following conditions apply to you, consult your 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 medication may be less effective in lowering blood pressure;
• racecadotril (used to treat diarrhea);
• sirolimus, everolimus, temsirolimus, and other medications belonging to the group of so-called mTOR inhibitors (used to prevent organ rejection and treat cancer);
• sacubitril (available in a combination medication containing sacubitril and valsartan), used to treat chronic heart failure;
• linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medications belonging to the group of medications called gliptins (used to treat diabetes);
• angiotensin II receptor antagonist (AIIRA), also known as a sartan - for example, valsartan, telmisartan, irbesartan, especially if you have kidney problems related to diabetes,
• aliskiren. Your 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".

Your doctor may recommend blood tests to check if your sodium or potassium levels have decreased or if your calcium levels have increased. You should tell your doctor if you are pregnant, planning to become pregnant, or suspect you are pregnant. It is not recommended to take Triplixam during early pregnancy, and it should not be taken after the third month of pregnancy, as it can seriously harm the fetus (see the section on "Pregnancy and breastfeeding"). When taking Triplixam, you should inform your doctor or medical staff if:

• you are to be anesthetized and/or undergo surgery;
• you have recently experienced diarrhea or vomiting, or you are dehydrated;
• you are to undergo LDL apheresis (mechanical removal of cholesterol from the blood);
• you are to undergo desensitization treatment to reduce allergic reactions to bee or wasp stings;
• you are to undergo a test that requires the administration 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 may cause a positive result in a doping test.

Children and Adolescents

Triplixam should not be given to children and adolescents.

Triplixam and other medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take. Patients with diabetes or kidney disease should not take aliskiren (used to treat high blood pressure). You should avoid taking Triplixam with:

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

Taking other medications may affect treatment with Triplixam. Your doctor may recommend changing the dose and/or taking other precautions. You should tell your doctor if you are taking any of the following medications, as it may require special caution:

• other medications used to treat high blood pressure, including angiotensin II receptor antagonists (AIIRA), aliskiren (see also the subsections "When not to take Triplixam" and "Warnings and precautions"), or diuretics (medications that increase urine production in the kidneys);
• potassium-sparing medications 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);
• medications used to treat heart rhythm disorders (e.g., dofetilide, ibutilide, bretylium, cisapride, difemanil, procainamide, quinidine, hydroquinidine, disopyramide, 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 (e.g., rifampicin, erythromycin injection, clarithromycin, sparfloxacin, moxifloxacin);
• antifungal medications (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, as well as non-steroidal anti-inflammatory medications (e.g., ibuprofen) or high doses of salicylates (e.g., acetylsalicylic acid, a substance found in many medications, used as a pain reliever and antipyretic, as well as to prevent blood clotting);
• immunosuppressive medications (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;
• medications used to treat diabetes, such as insulin or metformin;
• calcium, including calcium supplements;
• laxatives with a stimulating effect (e.g., senna);
• medications used to treat cancer;
• vincamine (used to treat symptomatic cognitive disorders in the elderly, including memory loss);
• medications used to treat mental disorders, such as depression, anxiety, schizophrenia (e.g., 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);
• medications used to treat low blood pressure, shock, or asthma (e.g., ephedrine, noradrenaline, or adrenaline);
• nitroglycerin and other nitrates or other medications that dilate blood vessels, as they can further lower blood pressure.

Triplixam with food and drink

Do not consume grapefruits or grapefruit juice while taking Triplixam, 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 you are pregnant, breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medication. Pregnancy Tell your doctor if you are pregnant, suspect you are pregnant, or are planning to become pregnant. Your doctor will normally advise you to stop taking Triplixam before you become pregnant or as soon as you know you are pregnant, and will advise you to take a different medication instead. You should not take Triplixam during early pregnancy, and you must not take it after the third month of pregnancy, as it can seriously harm your baby. Breastfeeding Tell your doctor if you are breastfeeding or plan to breastfeed. You should not take Triplixam while breastfeeding, especially if you are breastfeeding a newborn or premature baby. Your doctor may recommend a different medication.

Driving and using machines

Triplixam may affect your ability to drive or operate machines. If you experience nausea, dizziness, fatigue, or headache while taking the medication, do not drive or operate machines, and contact your doctor immediately.

Triplixam contains sodium

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

3. How to take Triplixam

Always take this medication exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist. Swallow the tablet with a glass of water, preferably in the morning, before breakfast. Your doctor will determine the correct dose for you. The recommended dose is usually one tablet per day. 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.

If you take more Triplixam than you should

Taking too many tablets can cause your blood pressure to drop, even to a dangerous level, which may be accompanied by nausea, vomiting, cramps, dizziness, sleepiness, disorientation, decreased urine production, or anuria (lack of urine production). You may feel "empty" in your head, or you may experience fainting or weakness. If your blood pressure drops significantly, you may experience shock, where your skin becomes cool and moist, and you may lose consciousness. Even up to 24-48 hours after taking the medication, you may experience shortness of breath due to excess fluid accumulation in the lungs (pulmonary edema). If you take too many Triplixam tablets, contact your doctor or go to the emergency department of the nearest hospital immediately.

If you forget to take Triplixam

It is essential to take the medication every day, as regular use ensures more effective treatment. However, if you miss a dose, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

If you stop taking Triplixam

Treatment of high blood pressure is usually long-term, so before stopping Triplixam, consult your doctor. If you have any further questions about taking this medication, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following serious side effects, stop taking Triplixam and contact your 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 membranes of the mouth, tongue, or throat, causing significant difficulty breathing (uncommon - may affect up to 1 in 100 people);
• severe skin reactions, including severe rash, hives, redness of the skin, 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 heart rhythm disorders (frequency not known);
• pancreatitis, which can cause severe abdominal pain and very poor general condition (very rare - may affect up to 1 in 10,000 people);
• muscle weakness, cramps, tenderness, or pain, especially if you feel unwell or have a high fever, which can be caused by abnormal muscle breakdown (frequency not known).

Side effects, grouped by decreasing frequency:

• very common (affects more than 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 fatigue, 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 and/or rapid heart rate, nasal congestion (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, 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), photosensitivity reaction (changes in skin appearance) after exposure to sunlight or artificial UVA radiation, 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, 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).
• 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 and/or jaw 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, severe itching, blistering, peeling, and swelling of the skin, erythema multiforme (rash, often starting with red, itchy patches on the face, arms, or legs), bleeding, tender, or swollen gums, liver dysfunction, hepatitis, severe kidney dysfunction, jaundice (yellowing of the skin), abdominal distension (stomach swelling), 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 blood pressure lowering.
• frequency not known (cannot be estimated from the available data): hepatic encephalopathy (a brain disorder caused by liver disease), abnormal ECG (electrocardiogram); in patients with systemic lupus erythematosus, symptoms may worsen. Myopia, blurred 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 may occur. Your doctor may recommend blood tests to monitor your health. If you experience any of these symptoms, contact your doctor as soon as possible.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can report side effects directly to the Department of Drug Safety Monitoring, 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. By reporting side effects, you can help provide more information on the safety of this medication.

5. How to store Triplixam

Keep this medication out of the sight and reach of children. Do not use this medication 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 precautions. The shelf life after opening the container with 30 film-coated tablets is 30 days. Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications 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. One film-coated tablet contains 3.395 mg of perindopril (in the form of 5 mg of perindopril arginine), 1.25 mg of indapamide, and 13.870 mg of amlodipine besylate (equivalent to 10 mg of amlodipine).
• The other ingredients of the tablet are:
• tablet core: calcium carbonate with cornstarch composition: calcium carbonate (90%), cornstarch (10%), microcrystalline cellulose, sodium croscarmellose, magnesium stearate, colloidal anhydrous 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 + 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 number embossed on the other.

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. The cap of the container with tablets contains a desiccant.

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 Przedsiebiorstwo Farmaceutyczne S.A. ul. Annopol 6b, 03-236 Warsaw, Poland

Parallel importer:

InPharm Sp. z o.o. ul. Strumykowa 28/11 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k. ul. Chełmżyńska 249 04-458 Warsaw Marketing authorization number in Latvia, the country of export:14-0058

Parallel import authorization number: 137/24

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, филмирани таблетки Croatia TRIPLIXAM, filmom obložene tablete Cyprus TRIPLIXAM, επικαλυμμένα με λεπτό υμένιο δισκία Czech Republic TRIPLIXAM Estonia TRIPLIXAM Finland TRIPLIXAM, kalvopäällysteinen tabletti France TRIPLIXAM, comprimé pelliculé Greece TRIPLIXAM, επικαλυμμένα με λεπτό υμένιο δισκία Ireland COVERDINE film-coated tablets Italy TRIPLIAM, compresse rivestite con film Latvia TRIPLIXAM, apvalkotās tabletes Lithuania TRIPLIXAM, plėvele dengtos tabletės Luxembourg TRIPLIXAM, comprimé pelliculé Malta TRIPLIXAM film-coated tablets Netherlands TRIPLIXAM, filmomhulde tabletten Poland TRIPLIXAM Portugal TRIPLIXAM Romania TRIPLIXAM comprimate filmate Slovakia TRIPLIXAM, filmom obalené tablety Slovenia TRIPLIXAM filmsko obložene tablete

Date of approval of the leaflet: 28.03.2024

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