Poltriq

Leaflet accompanying the packaging: patient information

POLTRIQ, 5 mg + 1.25 mg + 5 mg, film-coated tablets

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

POLTRIQ, 10 mg + 2.5 mg + 5 mg, film-coated tablets

POLTRIQ, 10 mg + 2.5 mg + 10 mg, film-coated tablets

Perindopril arginine + Indapamide + Amlodipine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Poltriq and what is it used for
• 2. Important information before taking Poltriq
• 3. How to take Poltriq
• 4. Possible side effects
• 5. How to store Poltriq
• 6. Contents of the pack and other information

1. What is Poltriq and what is it used for

Poltriq 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 Poltriq 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 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 type of medicine that increases urine production) that belongs 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 channel blocker (a type of medicine called dihydropyridines). It causes the blood vessels to relax, making it easier for blood to flow through them.

2. Important information before taking Poltriq

When not to take Poltriq:

• 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 medicine (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 a family member in 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, 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 methods. Depending on the device used, Poltriq may not be suitable for the patient.
• if the patient has moderate kidney impairment (applies to Poltriq 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 Poltriq during early pregnancy - see the section on pregnancy);
• if the patient has diabetes or kidney disease and is being treated with a blood pressure-lowering medicine containing aliskiren;
• if the patient has taken or is currently taking a combination medicine containing sacubitril and valsartan, used to treat chronic heart failure, as the risk of angioedema (rapid swelling of tissues under the skin in the throat area) increases (see "Warnings and precautions" and "Poltriq and other medicines").

Warnings and precautions

Before starting to take Poltriq, the patient should discuss it with their doctor or pharmacist:

• if the patient has hypertrophic cardiomyopathy (a heart muscle disease) or renal artery stenosis (narrowing of the artery that supplies blood to the kidney);
• if the patient has heart failure or any other heart disease;
• if the patient has a significant increase in blood pressure (hypertensive crisis);
• if the patient has liver disease;
• if the patient has collagenosis (a disease of the connective tissue), such as systemic lupus erythematosus or scleroderma;
• if the patient has atherosclerosis (hardening of the arteries);
• if the patient is to undergo 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 that contain 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 when taking Poltriq (see "Poltriq and other medicines");
• 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 medicine may be less effective in lowering blood pressure;
• if the patient is undergoing dialysis using high-flux membranes;
• if the patient has kidney disease or is on dialysis;
• if the patient experiences vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which can occur within hours or weeks of taking Poltriq. 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 excessive 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 medicine and consult a doctor immediately;
• if the patient is taking any of the following medicines, as the risk of angioedema increases:
• racecadotril (used to treat diarrhea);
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of so-called mTOR inhibitors (used to prevent organ rejection and treat cancer);
• sacubitril (available in a combination medicine containing sacubitril and valsartan), used to treat chronic heart failure;
• gliptins (used to treat diabetes), such as linagliptin, saxagliptin, sitagliptin, and vildagliptin.
• if the patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonist (AIIRA), also known as a sartan (e.g., valsartan, telmisartan, irbesartan), especially if the patient has kidney disease 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 Poltriq".

The doctor may recommend blood tests to check if the levels of sodium or potassium have decreased or if the level of calcium has increased. The patient should tell their doctor if they are pregnant (or think they may be pregnant). It is not recommended to take Poltriq during early pregnancy, and it should not be taken after the third month of pregnancy, as it may seriously harm the baby (see the section on pregnancy and breastfeeding). When taking Poltriq, the patient should also inform their doctor or healthcare professional if:

• they are to undergo anesthesia and/or surgery;
• they have recently had diarrhea or vomiting, or are dehydrated;
• they are to undergo dialysis or LDL apheresis (mechanical removal of cholesterol from the blood);
• they are to undergo desensitization treatment to reduce allergic reactions after a bee or wasp sting;
• they are to undergo a test that requires the use of a contrast agent containing iodine (a substance that allows organs such as the kidney or stomach to be seen on an X-ray).

Athletes should be aware that Poltriq contains the active substance indapamide, which may cause a positive result in a doping test.

Children and adolescents

Poltriq should not be given to children and adolescents.

Poltriq and other medicines

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. Patients with diabetes or kidney disease should not take aliskiren (used to treat high blood pressure). The patient should avoid taking Poltriq 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 that contain potassium, and other medicines that may increase potassium levels in the body (such as heparin - a medicine used to thin the blood and 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 that occurs during anesthesia);
• estramustine (used to treat cancer);
• medicines used to treat diarrhea (racecadotril) or medicines used to prevent organ rejection (sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of so-called mTOR inhibitors). See 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 Poltriq" and "Warnings and precautions".
• other medicines used to treat high blood pressure: ACE inhibitors and angiotensin II receptor antagonists.

Taking other medicines may affect the treatment with Poltriq. The doctor may recommend changing the dose and/or taking other precautions. The patient should tell their doctor if they are taking any of the following medicines, as they may require special precautions:

• other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (AIIRAs), aliskiren (see also the subsections "When not to take Poltriq" and "Warnings and precautions"), or diuretics (medicines that increase urine production);
• potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone at 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, cyzapride, 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, clarithromycin, sparfloxacin, moxifloxacin);
• antifungal medicines (e.g., itraconazole, ketoconazole, amphotericin B given by injection);
• allopurinol (used to treat gout);
• antihistamines used to treat allergic reactions and 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);
• immunosuppressants (given to control the immune system's response, used to treat autoimmune diseases or after organ transplantation, e.g., cyclosporine, tacrolimus);
• tetracosactide (used to treat Crohn's disease);
• gold salts, especially those given intravenously (used to treat symptoms of rheumatoid arthritis);
• halofantrine (used to treat certain types of malaria);
• baclofen used to treat muscle stiffness that occurs in diseases such as multiple sclerosis;
• medicines used to treat diabetes, such as insulin or metformin;
• calcium, including calcium supplements;
• laxatives with a stimulating effect (e.g., senna);
• medicines used to treat cancer;
• vinpocetine (used to treat symptomatic cognitive disorders in the elderly, including memory loss);
• medicines used to treat mental disorders, such as depression, anxiety, schizophrenia (e.g., tricyclic antidepressants, antipsychotics, 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);
• medicines used to treat low blood pressure, shock, or asthma (e.g., ephedrine, noradrenaline, or adrenaline);
• nitroglycerin and other nitrates or other vasodilators, as they may further lower blood pressure.

Poltriq with food and drink

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. Pregnancy The patient should tell their doctor if they are pregnant or think they may be pregnant. The doctor will usually recommend stopping Poltriq before a planned pregnancy or as soon as possible after confirmation of pregnancy and will recommend taking a different medicine instead of Poltriq. It is not recommended to take Poltriq during early pregnancy, and it should not be taken after the third month of pregnancy, as it may seriously harm the baby. Breastfeeding The patient should tell their doctor if they are breastfeeding or plan to breastfeed. It is not recommended to take Poltriq while breastfeeding, especially when breastfeeding a newborn or premature baby. The doctor may recommend taking a different medicine.

Driving and using machines

Poltriq may affect the ability to drive or use machines. If the medicine causes nausea, dizziness, fatigue, or headache, the patient should not drive or use machines and should contact their doctor immediately.

Poltriq contains sodium

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

3. How to take Poltriq

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

Taking a higher dose of Poltriq than recommended

Taking too many tablets may 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 lack 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 may lead to shock, in which case the skin becomes cold and wet, 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 takes too many Poltriq tablets, they should seek medical attention immediately.

Missing a dose of Poltriq

It is essential to take the medicine every day, as regular use ensures more effective treatment. However, if a dose of Poltriq 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 Poltriq

Treatment of high blood pressure is usually long-term, so before stopping treatment with this medicine, the patient should consult their doctor. If the patient has any further doubts about the use of this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Poltriq can cause side effects, although not everybody gets them.

If the patient experiences any of the following severe side effects, they should stop taking the medicine and contact their doctor immediately:

• sudden onset of wheezing, chest pain, shortness of breath, or difficulty breathing (uncommon - occurs in less than 1 in 100 patients);
• swelling of the eyelids, face, or lips (uncommon - occurs in less than 1 in 100 patients);
• swelling of the mucous membranes of the mouth, tongue, or throat, causing severe breathing difficulties (uncommon - occurs 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, or other allergic reactions (very rare - occurs in less than 1 in 10,000 patients);
• severe dizziness or fainting (common - occurs in less than 1 in 10 patients);
• heart attack (very rare - occurs in less than 1 in 10,000 patients), life-threatening heart rhythm disorders (frequency not known);
• pancreatitis, which can cause severe abdominal pain and very poor health (very rare - occurs in less than 1 in 10,000 patients).
• muscle weakness, cramps, tenderness, or pain, especially if the patient feels unwell or has a high temperature, which may be caused by abnormal muscle breakdown (frequency not known).

Side effects, grouped by decreasing frequency:

• very common(occurs in more than 1 in 10 patients): edema (fluid retention).
• common(occurs in less than 1 in 10 patients): 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/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 tiredness, weakness, drowsiness, swelling of the ankles.
• uncommon(occurs 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, nasal congestion or runny nose (nasal swelling), hair loss, purpura (red spots on the skin), skin discoloration, itching, sweating, chest pain, muscle or joint pain, back pain, pain, poor health, 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 (skin changes after sun exposure), blistering skin, swelling of hands or feet, increased creatinine and urea levels in the blood, falls, dryness of the mouth.
• rare(occurs 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, 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(occurs 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 and/or pain in the jaw and back, caused by heart disease), eosinophilic pneumonia (a rare type of pneumonia), gum hypertrophy (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, or other allergic reactions, erythema multiforme (rash, often starting with red, itching spots on the face, arms, or legs), bleeding, tender, or swollen gums, liver function disorders, hepatitis, severe kidney function disorders, jaundice (yellowing of the skin), abdominal distension (gastritis), nerve disorders that 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.

There may be changes in laboratory test results (blood tests). The doctor may recommend blood tests to monitor the patient's health. If the patient experiences any of these symptoms, they should contact their doctor as soon as possible.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, 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 medicine.

5. How to store Poltriq

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month stated. The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number. There are no special storage instructions for the medicine. Store in the original packaging to protect from light and moisture. 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 Poltriq contains

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

Each film-coated tablet of Poltriq 5 mg + 1.25 mg + 5 mg contains 5 mg of perindopril arginine (which corresponds to 3.395 mg of perindopril), 1.25 mg of indapamide, and 5 mg of amlodipine (in the form of amlodipine besylate). Each film-coated tablet of Poltriq 5 mg + 1.25 mg + 10 mg contains 5 mg of perindopril arginine (which corresponds to 3.395 mg of perindopril), 1.25 mg of indapamide, and 10 mg of amlodipine (in the form of amlodipine besylate). Each film-coated tablet of Poltriq 10 mg + 2.5 mg + 5 mg contains 10 mg of perindopril arginine (which corresponds to 6.790 mg of perindopril), 2.5 mg of indapamide, and 5 mg of amlodipine (in the form of amlodipine besylate). Each film-coated tablet of Poltriq 10 mg + 2.5 mg + 10 mg contains 10 mg of perindopril arginine (which corresponds to 6.790 mg of perindopril), 2.5 mg of indapamide, and 10 mg of amlodipine (in the form of amlodipine besylate).

• The other ingredients are: tablet core: microcrystalline cellulose type 102, calcium carbonate, pregelatinized starch, sodium croscarmellose, magnesium stearate, colloidal anhydrous silica. Poltriq 5 mg + 1.25 mg + 5 mg and Poltriq 10 mg + 2.5 mg + 10 mg film-coated tablet: copolymer of methacrylic acid and ethyl acrylate, talc, titanium dioxide (E171), glycerol monocaprylocaprate type I, and polyvinyl alcohol. Poltriq 5 mg + 1.25 mg + 10 mg and Poltriq 10 mg + 2.5 mg + 5 mg film-coated tablet: copolymer of methacrylic acid and ethyl acrylate, talc, titanium dioxide (E171), glycerol monocaprylocaprate type I, polyvinyl alcohol, yellow iron oxide (E172), black iron oxide (E172), red iron oxide (E172).

What Poltriq looks like and contents of the pack

• Poltriq 5 mg + 1.25 mg + 5 mg: white, oval, film-coated tablets, with the inscription "TEV" on one side and "2" on the other side, measuring approximately 12.3 mm x 6.5 mm.
• Poltriq 5 mg + 1.25 mg + 10 mg: light beige, round, film-coated tablets, with the inscription "TEV" on one side and "3" on the other side, with a diameter of approximately 9.0 mm.
• Poltriq 10 mg + 2.5 mg + 5 mg: light beige, oval, film-coated tablets, with the inscription "TEV" on one side and "4" on the other side, measuring approximately 12.3 mm x 6.5 mm.
• Poltriq 10 mg + 2.5 mg + 10 mg: white, round, film-coated tablets, with the inscription "TEV" on one side and "5" on the other side, with a diameter of approximately 9.0 mm.

Poltriq is available in blisters in cartons of 10, 30, or 90 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 364 61 01

Manufacturer

Actavis Ltd., BLB015, BLB016, Bulebel Industrial Estate, ZTN3000 Zejtun, Malta

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

Czech Republic, Slovakia: PROXIMIC

Date of last revision of the leaflet: