Triplixam

Package Leaflet: Information for the Patient

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

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

Triplixam, 10 mg + 2.5 mg + 5 mg, Film-Coated Tablets

Triplixam, 10 mg + 2.5 mg + 10 mg, Film-Coated Tablets

Perindopril Arginine + Indapamide + Amlodipine

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed 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, please inform 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.
• Indapamide is a diuretic (a medication that increases urine production) belonging to a group of medications 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 causes only a slight increase in urine production.
• Amlodipine is a calcium antagonist (belonging to a group of medications called dihydropyridines). 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 ingredients of this medication (listed in section 6);
• 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 under any other circumstances (a condition called angioedema);

• If the patient has severe liver disease or a condition called hepatic encephalopathy (a brain disorder caused by liver disease);
• If the patient is suspected of having untreated or uncontrolled heart failure (severe water retention, breathing difficulties);
• If the patient has a narrowing of the aortic valve in the heart (aortic stenosis) or cardiogenic shock (a condition where 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 other means. Depending on the device used, Triplixam may not be suitable for the patient;
• If the patient has moderate kidney disease (applies to Triplixam 10 mg + 2.5 mg + 5 mg and 10 mg + 2.5 mg + 10 mg);
• After the third month of pregnancy (it is also recommended to avoid taking Triplixam during early pregnancy); see the section on pregnancy;
• If the patient has diabetes or kidney problems and is taking a blood pressure-lowering medication containing aliskiren;
• If the patient has taken or is taking a combination medication 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 Medications").

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 conditions;
• If the patient has a significant increase in blood pressure (hypertensive crisis);
• If the patient has liver disease;
• If the patient has collagenosis (a disease of connective tissue), 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 level in the blood);
• If the patient is taking lithium or potassium-sparing diuretics (spironolactone, triamterene), as they should be avoided with Triplixam (see "Triplixam and Other Medications");
• If the patient is elderly and the dose needs to be increased;
• If the patient has had allergic reactions to sunlight;
• 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;
• 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 can 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.

If the patient has muscle disorders, including pain, tenderness, weakness, or muscle cramps;

• If the patient has an abnormally high level of a hormone called aldosterone in the blood (primary aldosteronism);
• If the patient has too much acid in the blood, which can cause rapid breathing;
• If the patient has cerebral circulatory failure (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, and the patient should stop taking the medication and consult their doctor immediately.
• If the patient is taking any of the following medications, as the risk of angioedema increases:
• Racecadotril (used to treat diarrhea);
• Sirolimus, everolimus, temsirolimus, and other medications belonging to the group of mTOR inhibitors (used to prevent organ rejection and treat cancer); see the section on "Warnings and Precautions";
• Sacubitril (available in a combination medication containing sacubitril and valsartan), used to treat chronic heart failure; see the sections on "When Not to Take Triplixam" and "Warnings and Precautions";
• Linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medications belonging to the group of gliptins (used to treat diabetes);
• If the patient is taking any of the following medications used to treat high blood pressure:
• An angiotensin II receptor antagonist (AIIRA), also known as a sartan, such as 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 section on "When Not to Take Triplixam" and "Warnings and Precautions".

The doctor may recommend blood tests to check if there is a decrease in sodium or potassium levels or an increase in calcium levels in the blood.

The patient should inform 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 the third month of pregnancy, as it can seriously harm the baby (see the section on "Pregnancy and Breastfeeding").

• If the patient is to undergo anesthesia and/or surgery;
• If the patient has recently experienced diarrhea or vomiting or is dehydrated;
• If the patient is to undergo LDL apheresis (mechanical removal of cholesterol from the blood);
• If the patient is to undergo desensitization treatment to reduce allergic reactions after a bee or wasp sting;
• If the patient is 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

Triplixam should not be given to children and adolescents.

Triplixam and Other Medications

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.

Patients 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, bipolar disorder, and recurrent depression);
• Potassium-sparing medications (triamterene, amiloride), potassium supplements, or salt substitutes containing potassium, other medications that can 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 mTOR inhibitors); see the section on "Warnings and Precautions";
• A combination medication containing sacubitril and valsartan (used to treat chronic heart failure); see the sections on "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 can affect 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 medications, as they may require special precautions:

• Other medications used to treat high blood pressure, including angiotensin II receptor antagonists (AIIRAs), aliskiren (see also the sections on "When Not to Take Triplixam" and "Warnings and Precautions"), or diuretics (medications that increase urine production);
• Potassium-sparing medications 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);
• Medications used to treat arrhythmias (such as dofetilide, ibutilide, bretylium, cyzaprid, difemanil, procainamide, quinidine, hydroquinidine, disopyramide, amiodarone, sotalol);
• Verapamil, diltiazem (used to treat heart conditions);
• Digoxin or other cardiac glycosides (used to treat heart conditions);
• Antibiotics used to treat bacterial infections (such as rifampicin, erythromycin injection, clarithromycin, sparfloxacin, moxifloxacin);
• Antifungal medications (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 conditions, including severe asthma and rheumatoid arthritis, as well as non-steroidal anti-inflammatory medications (such as ibuprofen) or high doses of salicylates (such as acetylsalicylic acid, a substance found in many medications, used as a pain reliever and antipyretic, as well as to prevent blood clotting);
• Immunosuppressive medications (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);
• Baclofen (used to treat muscle stiffness in conditions such as multiple sclerosis);
• Medications used to treat diabetes, such as insulin or metformin;
• Calcium, including calcium supplements;
• Laxatives with a stimulating effect (such as senna);
• Medications used to treat cancer;
• Vincamine (used to treat cognitive disorders in the elderly, including memory loss);
• Medications 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 (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 (such as ephedrine, noradrenaline, or adrenaline);
• Nitroglycerin and other nitrates or 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 this can increase the levels of the active substance amlodipine, leading to an unpredictable 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 their doctor or pharmacist before taking this medication.

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 prescribe a different medication instead of Triplixam. 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 baby.

Breastfeeding

The patient should inform 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 a different medication.

Driving and Using Machines

Triplixam can affect the ability to drive or operate machinery. If the patient experiences nausea, dizziness, fatigue, or headache while taking the medication, they should not drive or operate machinery and should consult their doctor immediately.

Triplixam Contains Sodium

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

3. How to Take Triplixam

This medication should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

The tablet should be swallowed with a glass of water, preferably in the morning, before breakfast. The doctor will determine the appropriate dose for the patient. The recommended dose is usually one tablet per day.

Overdose of Triplixam

Taking too many tablets can cause a significant drop in blood pressure, potentially leading to dizziness, nausea, vomiting, cramps, dizziness, sleepiness, disorientation, decreased urine production, or anuria (lack of urine production or excretion). The patient may feel lightheaded or weak. If the drop in blood pressure is severe, it can lead to shock, characterized by cool and moist skin, and the patient may lose consciousness. Even 24-48 hours after taking the medication, shortness of breath due to excess fluid accumulation in the lungs (pulmonary edema) may occur. If the patient takes too many Triplixam tablets, they should immediately consult their doctor or go to the emergency department of the nearest hospital.

Missed Dose of Triplixam

It is essential to take the medication every day, as regular treatment ensures better effectiveness. If a dose 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 for high blood pressure is usually long-term, so the patient should consult their doctor before stopping the medication. If the patient has any further doubts about taking this medication, they should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medications, Triplixam can cause side effects, although not everyone will experience them.

If the Patient Experiences Any of the Following Serious Side Effects, They Should Stop Taking the Medication and Immediately Consult Their Doctor:

• 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, 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);
• Myocardial infarction (very rare - may occur in less than 1 in 10,000 patients), life-threatening arrhythmias (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 fever, which can 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 heartbeat), sudden flushing of the face and neck, dizziness of labyrinthine origin, feeling of tingling or numbness, vision disturbances, double vision, tinnitus (ringing in the ears), 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 sensation, irregular or rapid heart rate, nasal congestion (swelling or runny 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), hyponatremia (low sodium levels in the blood), which can cause dehydration and low blood pressure, vasculitis (inflammation of blood vessels), photosensitivity reaction (skin changes after sun exposure), blistering skin disorders, swelling of the hands or feet, increased creatinine and urea levels in the blood, falls, dry 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 the blood; exacerbation of lupus erythematosus (a type of collagenosis). Short-sightedness, blurred vision, worsening vision, or eye pain due to high pressure (possible symptoms of 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).
• 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 bleeding from the nose), anemia (decreased red blood cell count), angina pectoris (chest pain due to heart disease), eosinophilic pneumonia (a rare type of pneumonia), gingival hyperplasia (gum overgrowth), severe skin reactions, including severe rash, redness of the skin, severe itching, blistering, peeling, and swelling of the skin, or other allergic reactions, erythema multiforme (a rash that often starts with red, itchy patches on the face, arms, or legs), bleeding, tender, or enlarged gums, liver dysfunction, hepatitis, severe kidney dysfunction, jaundice (yellowing of the skin), abdominal distension (stomach inflammation), neurological disorders that can cause weakness, numbness, or tingling, increased muscle tone, hyperglycemia (very high blood sugar), hypercalcemia (high calcium levels in the blood), stroke, possibly due to a significant drop in blood pressure, hepatic encephalopathy (a brain disorder caused by liver disease); abnormal electrocardiogram (ECG) readings; in the case of systemic lupus erythematosus, symptoms may worsen. Short-sightedness, blurred vision, worsening vision, or eye pain due to high pressure (possible symptoms of 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).
• Frequency not known (cannot be estimated from available data): hepatic encephalopathy (a brain disorder caused by liver disease); abnormal ECG readings; in the case of systemic lupus erythematosus, symptoms may worsen.

Changes in laboratory test results (blood tests) may occur. The doctor may recommend blood tests to monitor the patient's health. If any of these symptoms occur, the patient should consult their doctor as soon as possible.

Reporting Side Effects

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

5. How to Store Triplixam

The medication should be stored out of sight and reach of children. Do not use this medication after the expiry date stated on the packaging after the words "EXP" (abbreviation for expiry date). The expiry date refers to the last day of the month stated. The "Lot" number on the packaging refers to the batch number of the medication. There are no special storage instructions for the product. The shelf life after opening the container with 30 film-coated tablets is 30 days. Medications should not be disposed of in wastewater or household waste. The patient should ask their 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 of Triplixam 5 mg + 1.25 mg + 5 mg contains 3.395 mg of perindopril (equivalent to 5 mg of perindopril arginine), 1.25 mg of indapamide, and 6.935 mg of amlodipine besylate (equivalent to 5 mg of amlodipine). One film-coated tablet of Triplixam 5 mg + 1.25 mg + 10 mg contains 3.395 mg of perindopril (equivalent to 5 mg of perindopril arginine), 1.25 mg of indapamide, and 13.870 mg of amlodipine besylate (equivalent to 10 mg of amlodipine).

One film-coated tablet of Triplixam 10 mg + 2.5 mg + 5 mg contains 6.790 mg of perindopril (equivalent to 10 mg of perindopril arginine), 2.5 mg of indapamide, and 6.935 mg of amlodipine besylate (equivalent to 5 mg of amlodipine). One film-coated tablet of Triplixam 10 mg + 2.5 mg + 10 mg contains 6.790 mg of perindopril (equivalent to 10 mg of perindopril arginine), 2.5 mg of indapamide, and 13.870 mg of amlodipine besylate (equivalent to 10 mg of amlodipine).

• Other ingredients of the tablet are:
• Core of the tablet: calcium carbonate with maize starch composition: calcium carbonate (90%), maize starch (10%), microcrystalline cellulose, sodium croscarmellose, magnesium stearate, silicon dioxide, maize starch.
• Coating of the tablet: 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 with a length of 9.75 mm and a width of 5.16 mm, with a marking on one side.

Triplixam 5 mg + 1.25 mg + 10 mg: white, elongated, film-coated tablet with a length of 10.7 mm and a width of 5.66 mm, with a marking on one side and a marking on the other side.

Triplixam 10 mg + 2.5 mg + 5 mg: white, elongated, film-coated tablet with a length of 11.5 mm and a width of 6.09 mm, with a marking on one side and a marking on the other side.

Triplixam 10 mg + 2.5 mg + 10 mg: white, elongated, film-coated tablet with a length of 12.2 mm and a width of 6.46 mm, with a marking on one side and a marking 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) film-coated tablets. The cap of the container has a desiccant. Not all pack sizes may be marketed.

Marketing Authorization Holder

Servier Laboratories, 50, rue Carnot, 92284 Suresnes cedex, France

Manufacturer

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

For further information, the patient should contact the representative of the marketing authorization holder: Servier Polska Sp. z o.o., phone number: (22) 594 90 00

This Medication 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 Last Revision of the Leaflet: 07/2022