TRIPLIXAM

Patient Information Leaflet

Caution! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Triplixam, 5 mg + 1.25 mg + 5 mg, film-coated tablets
Perindoprilum argininum + Indapamidum + Amlodipinum
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

1. What Triplixam is and what it is used for
2. What you need to know 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 Triplixam is and what it is used for

Triplixam is a combination medicine containing 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 may
instead take a single Triplixam tablet containing these three active substances in the
same doses.
Each of the active substances lowers blood pressure, and together they help control
the patient's blood pressure:

• perindopril belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors. It works by widening blood vessels, making it easier for the heart to pump blood through them.
• indapamide is a diuretic (belonging to a group of medicines called sulfonamide derivatives with an indole ring). Diuretics increase the amount of urine produced by the kidneys. However, indapamide differs from other diuretics in that it only slightly increases urine production.
• amlodipine is a calcium antagonist (belonging to a group of medicines called dihydropyridines). It relaxes blood vessels, making it easier for blood to flow through them.

2. Important information before using Triplixam

When not to use Triplixam:

• if the patient is allergic to perindopril or other ACE inhibitors, indapamide or other sulfonamides, amlodipine or other dihydropyridines, or to any of the other ingredients of this medicine (listed in section 6);

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• if the patient has previously experienced symptoms during treatment with an ACE inhibitor such as wheezing, facial or tongue swelling, intense itching or severe rashes, or if such symptoms occurred in the patient or a family member under any other circumstances (a condition known as angioedema);
• if the patient has severe liver disease or a condition called hepatic encephalopathy (a brain dysfunction caused by liver disease);
• if untreated, decompensated heart failure is suspected in the patient (severe fluid retention, difficulty breathing);
• if the patient has aortic valve stenosis (narrowing of the aorta) or cardiogenic shock (a condition in which the heart cannot deliver sufficient blood to the body);
• if the patient has heart failure following 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 causing reduced blood supply to the kidneys (renal artery stenosis);
• if the patient is undergoing dialysis or another form of blood filtration. Depending on the equipment used, Triplixam may not be suitable for the patient;
• after the 3rd month of pregnancy (it is also advisable to avoid using Triplixam early in pregnancy – see section on pregnancy);
• if the patient has diabetes or kidney dysfunction 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 heart failure, as this increases the risk of angioedema (rapid swelling of tissues under the skin, particularly in the throat) (see "Warnings and precautions" and "Triplixam with other medicines").

Warnings and precautions
If any of the following conditions apply to the patient, consult a doctor or
pharmacist before using Triplixam:

• if the patient has hypertrophic cardiomyopathy (a heart muscle disease) or renal artery stenosis (narrowing of the blood vessel supplying blood to the kidney);

• if the patient has heart failure or any other heart disease;

• if the patient has severe high blood pressure (hypertensive crisis);

• if the patient has liver disease;

• if the patient has a collagen disease (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 potassium-containing salt substitutes (adequate blood potassium levels are important);

• if the patient is taking lithium or potassium-sparing diuretics (spironolactone, triamterene), as these should not be used with Triplixam (see "Triplixam with other medicines");

• if the patient is elderly and the dose needs to be increased;

• if the patient has previously experienced photosensitivity reactions;

• angioedema (swelling of the face, lips, mouth, tongue or throat, which may cause difficulty swallowing or breathing) may occur more frequently in black patients, and the medicine may be less effective in lowering blood pressure;

• if the patient is undergoing dialysis with high-flux membranes;

• if the patient has kidney disease or is on dialysis;

• if the patient experiences worsening vision or eye pain. These may be symptoms of fluid accumulation in the choroid layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur within hours or weeks of taking Triplixam. Untreated symptoms may lead to permanent vision loss. If the patient previously had an allergy to penicillin or sulfonamides, the risk of these disorders is higher.

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

• if the patient has abnormally high levels of a hormone called aldosterone in the blood (primary hyperaldosteronism);

• if there is excessive acid in the blood, which may cause rapid breathing;

• if the patient has cerebral circulatory insufficiency (low blood pressure in the brain);

• if the patient develops swelling of the face, lips, mouth, tongue or throat, which may cause difficulty swallowing or breathing (angioedema), which may occur at any time during treatment, treatment must be stopped immediately and medical advice sought.

• if the patient is taking any of the following medicines, as this increases the risk of angioedema:

• racecadotril (used to treat diarrhoea);

• sirolimus, everolimus, temsirolimus and other medicines belonging to the group of so-called mTOR inhibitors (used to prevent organ transplant rejection and in cancer treatment);

• 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 drugs called gliptins (used to treat diabetes);

• if the patient is taking any of the following medicines used to treat high blood pressure:

• an angiotensin II receptor antagonist (AIIRA), also known as a sartan – for example valsartan, telmisartan, irbesartan, especially if the patient has kidney dysfunction related to diabetes,

• aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure and blood electrolyte levels (e.g. potassium). See also the section "When not to use Triplixam".

The doctor may recommend blood tests to assess whether sodium or potassium levels have decreased or calcium levels have increased.
Inform the doctor if the patient is pregnant, planning pregnancy or suspects pregnancy. Use of Triplixam is not recommended early in pregnancy and must not be taken after the 3rd month of pregnancy, as it may seriously harm the unborn child (see section "Pregnancy and breastfeeding").
When using Triplixam, inform the doctor or medical staff if:

• the patient is to undergo anaesthesia and/or surgery;
• the patient has recently experienced diarrhoea or vomiting, or is dehydrated;
• an LDL apheresis procedure (mechanical removal of cholesterol from the blood) is to be performed;
• desensitisation treatment to reduce allergic reactions after bee or wasp stings is planned;
• an imaging test requiring iodine-containing contrast agent (a substance allowing organs such as the kidney or stomach to be visualised in X-ray examinations) is to be performed.

Athletes should be aware that Triplixam contains an active substance (indapamide) that
may lead to a positive result in anti-doping tests.
Children and adolescents
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Triplixam must not be given to children or adolescents.
Triplixam with other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Patients with diabetes or kidney disease must not take aliskiren (used to treat high blood pressure).
Avoid taking Triplixam with:

• lithium (used to treat certain psychiatric conditions such as mania, bipolar disorder and recurrent depression);
• potassium-sparing medicines (triamterene, amiloride), potassium supplements or potassium-containing salt substitutes, and other medicines that may increase potassium levels in the body (such as heparin, a medicine used to thin the blood to prevent clots; trimethoprim and co-trimoxazole, also known as a combination medicine containing trimethoprim and sulfamethoxazole, used to treat bacterial infections);
• dantrolene (intravenous), also used to treat malignant hyperthermia occurring during anaesthesia (symptoms include very high fever and muscle rigidity);
• estramustine (used to treat cancer);
• medicines used to treat diarrhoea (racecadotril) or medicines used to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus and other medicines belonging to the group of so-called mTOR inhibitors). See section "Warnings and precautions".
• a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See sections "When not to use Triplixam" and "Warnings and precautions".
• other medicines used to treat high blood pressure: angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor antagonists.

Other medicines may affect treatment with Triplixam. The doctor may recommend dose adjustment and/or additional precautions. Inform the doctor if the patient is taking any of the following medicines, as special precautions may be required:

• other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (AIIRA), aliskiren (see also sections "When not to use Triplixam" and "Warnings and precautions") or diuretics (medicines that increase urine production by the kidneys);
• potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone at doses of 12.5 mg to 50 mg per day;
• anaesthetics;
• 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, cisapride, difemanyl, procainamide, quinidine, hydroquinidine, disopyramide, amiodarone, sotalol);
• verapamil, diltiazem (used in heart diseases);
• digoxin or other cardiac glycosides (used in heart diseases);
• antibiotics used to treat bacterial infections (e.g. rifampicin, intravenous erythromycin, clarithromycin, sparfloxacin, moxifloxacin);
• antifungal medicines (e.g. itraconazole, ketoconazole, intravenous amphotericin B);
• 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 for pain relief, fever reduction and prevention of blood clots);
• immunosuppressive medicines (given to control immune system responses) used to treat autoimmune diseases or after organ transplantation (e.g. cyclosporine, tacrolimus);
• tetracosactide (used to treat Crohn's disease);
• gold salts, especially when administered intravenously (used to treat symptoms of rheumatoid arthritis);
• halofantrine (used to treat certain types of malaria);
• baclofen used to treat muscle stiffness occurring in diseases such as multiple sclerosis;
• medicines used to treat diabetes, such as insulin or metformin;
• calcium, including calcium supplements;
• stimulant laxatives (e.g. senna);
• medicines used to treat cancer;
• vinpocetine (used to treat symptomatic cognitive disorders in elderly patients, including memory loss);
• medicines used to treat psychiatric 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 vasodilating medicines, as they may additionally lower blood pressure.

Triplixam with food and drink
While taking Triplixam, do not consume grapefruit or grapefruit juice,
as this may increase the concentration of the active substance – amlodipine – which may cause an unexpected intensification of the blood pressure-lowering effect of Triplixam.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Inform the doctor about pregnancy, suspected or planned pregnancy. Usually, the doctor will recommend discontinuing Triplixam before planned pregnancy or immediately after pregnancy is confirmed and will recommend an alternative medicine. Use of Triplixam is not recommended early in pregnancy and must not be taken after the 3rd month of pregnancy, as it may seriously harm the unborn child.
Breastfeeding
Inform the doctor if the patient is breastfeeding or intends to breastfeed. Use of Triplixam is not recommended during breastfeeding, especially when feeding a newborn or premature infant. The doctor may recommend an alternative medicine.
Driving and using machines
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Triplixam may affect the ability to drive or operate machinery. If taking the medicine causes nausea, dizziness, fatigue or headache, do not drive or operate machinery and contact the doctor immediately.
Triplixam contains sodium
Triplixam contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to use Triplixam

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
please consult your 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. Your doctor will determine
the appropriate dose for the patient. The usual recommended dose is one tablet once daily.

Taking more Triplixam than prescribed
Taking too many tablets may cause blood pressure to drop, even to dangerous levels, which may sometimes be accompanied by nausea, vomiting, cramps, dizziness, drowsiness, disorientation, oliguria (passing less urine than usual), anuria (lack of urine production or excretion). The patient may feel a "void" in the head, experience faintness or weakness. If the drop in blood pressure is significant, shock may occur, characterized by cold and clammy skin, and the patient may lose consciousness.
Breathing difficulties due to fluid accumulation in the lungs (pulmonary oedema) may occur even 24–48 hours after taking the medicine.
If an overdose of Triplixam is taken, seek immediate medical attention by contacting your doctor or going to the nearest hospital emergency department.

Missing a dose of Triplixam
It is important to take the medicine every day, as regular use ensures more effective treatment. However, if a dose of Triplixam is missed, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping Triplixam treatment
Treatment for high blood pressure is usually long-term; therefore, do not stop taking this medicine without first consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
If the patient experiences any of the following serious adverse reactions, the medicine must be discontinued
and medical advice must be sought 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 membranes of the mouth, tongue or throat, causing significant breathing difficulties (uncommon – may occur in less than 1 in 100 patients);
• severe skin reactions, including severe rash, urticaria, generalized redness of the skin, intense itching, blistering, skin peeling and swelling, mucosal inflammation (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);
• myocardial infarction (very rare – may occur in less than 1 in 10,000 patients), life-threatening cardiac arrhythmias (frequency not known);
• pancreatitis, which may cause severe upper abdominal pain radiating to the back and general malaise (very rare – may occur in less than 1 in 10,000 patients);
• muscle weakness, cramps, tenderness or pain, particularly when accompanied by feeling unwell or fever, which may be due to abnormal muscle breakdown (frequency not known).

Adverse reactions grouped by decreasing frequency of occurrence:

• very common (affects at least 1 in 10 patients): oedema (fluid retention).
• common (affects less than 1 in 10 patients): low blood potassium levels, headache, central dizziness, palpitations (awareness of heartbeat), sudden flushing of the face and neck, labyrinthine dizziness, tingling/numbness, visual disturbances, double vision, tinnitus (sensation of hearing sounds), sensation of "emptiness" in the head due to low blood pressure, cough, shortness of breath, gastrointestinal disturbances (nausea, vomiting, abdominal pain, taste disturbances, dyspepsia or digestive disturbances, diarrhoea, constipation, changes in bowel rhythm), allergic reactions (such as rashes, itching), muscle cramps, fatigue, weakness, somnolence, swelling of the ankle area.
• uncommon (affects less than 1 in 100 patients): mood swings, anxiety, depression, sleep disorders, tremor, urticaria, fainting, pain insensitivity, irregular and/or rapid heart rate, nasal mucosal inflammation (nasal congestion or discharge), hair loss, purpura (small red spots on the skin), skin depigmentation, itching, sweating, chest pain, muscle or joint pain, back pain, pain, malaise, kidney disorders, urinary disorders, nocturia (need to urinate at night), increased frequency of urination, impotence (inability to achieve or maintain erection), fever or elevated body temperature, discomfort or enlargement of the breasts in men, weight gain or weight loss, increased count of a certain type of white blood cells, high blood potassium levels, hypoglycaemia (very low blood sugar levels), low blood sodium levels, which may lead to dehydration and lowered blood pressure, vasculitis, photosensitivity reaction (skin changes) after exposure to sunlight or artificial UVA radiation, skin blister clusters, swelling of hands or feet, increased blood creatinine and urea levels, falls, dryness of the oral mucosa.
• rare (affects less than 1 in 1,000 patients): disorientation, abnormal laboratory test results: low blood chloride levels, low blood magnesium levels, increased liver enzyme activity, elevated serum bilirubin; exacerbation of psoriasis, reduced or absent urine output, acute kidney failure. Dark-coloured urine, nausea or vomiting, muscle cramps, disorientation and seizures may be symptoms of a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion).

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• very rare (affects less than 1 in 10,000 patients): decreased white blood cell count, decreased platelet count (leading to easy bruising and nosebleeds), anaemia (reduced red blood cell count), angina pectoris (chest pain, jaw and back pain triggered by physical exertion and caused by impaired blood supply to the heart), eosinophilic pneumonia (a rare type of lung inflammation), gingival enlargement, severe skin reactions including severe rash, generalized redness of the skin, intense itching, blistering, peeling and swelling of the skin, erythema multiforme (rash often starting with red, itchy spots on the face, arms or legs), bleeding, tender or enlarged gums, liver function disorders, hepatitis, severe kidney function impairment, jaundice (yellowing of the skin), abdominal distension (gastritis), nerve disorders causing weakness, tingling or numbness, increased muscle tone, hyperglycaemia (very high blood sugar levels), high blood calcium levels, stroke, possibly secondary to marked drop in blood pressure.
• frequency not known (cannot be estimated from available data): hepatic encephalopathy (brain disorder caused by liver disease), abnormal electrocardiogram (ECG) findings; in patients with systemic lupus erythematosus (a type of collagenosis), symptoms may worsen. Myopia, blurred vision, worsening of vision or eye pain due to high pressure (possible symptoms of fluid accumulation in the choroidal layer of the eye (choroidal effusion) or acute angle-closure glaucoma). Tremor, rigidity, facial masking, bradykinesia and shuffling gait. Cyanosis, numbness and pain in fingers or toes (Raynaud's phenomenon).

Changes in laboratory test results (blood tests) may occur. Your doctor may recommend
blood tests to monitor your health.
If any of these symptoms occur, contact your doctor as soon as possible.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Triplixam

Keep this medicine 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 stated month.
No special storage conditions are required.
Shelf-life after first opening of the container containing 30 film-coated tablets: 30 days.
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Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Triplixam contains

• The active substances are: perindopril with arginine, indapamide and amlodipine. One Triplixam film-coated tablet 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).
• Other components of the tablet:
• tablet core: calcium carbonate with starch [composition: calcium carbonate (90%), pregelatinized starch, maize (10%)], microcrystalline cellulose, sodium croscarmellose, magnesium stearate, colloidal anhydrous silica, pregelatinized starch, maize.
• tablet coating: glycerol, hypromellose 6 mPa·s, macrogol 6000, magnesium stearate, titanium dioxide (E 171).

What Triplixam looks like and contents of the pack
Triplixam 5 mg + 1.25 mg + 5 mg: white, elongated film-coated tablet, 9.75 mm in length and

5.16 mm in width, with an engraved mark on one side and an engraved mark
on the other side.
Tablets are available in cardboard boxes containing 30, 60 (2 containers with 30 tablets each) or 90 (3 containers with 30 tablets each) tablets.
The container cap contains a moisture-absorbing agent.

For further information, please contact the Marketing Authorisation Holder or Parallel Importer:
Marketing Authorisation Holder in Lithuania, 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 Warszawa, Poland
EGIS Pharmaceuticals Private Limited Company, H–9900 Körmend, Mátyás király u.65, Hungary
Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation Number in Lithuania, country of export: LT/1/14/3522/006
LT/1/14/3522/008
LT/1/14/3522/009
LT/1/14/3522/039
Parallel Import Authorisation Number: 320/25
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This medicinal product is authorised for marketing in the European Economic Area under the following names:
Belgium TRIPLIXAM, comprimé pelliculé
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
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