Poltriq

Package Leaflet: Information for the Patient

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 all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Poltriq is and what it is used for
• 2. What you need to know before you take 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 Poltriq is and what it is used for

Poltriq is a combination of three active substances: perindopril, indapamide, and amlodipine. It is used to treat high blood pressure (hypertension).

• 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 the amount of urine produced by the kidneys). However, indapamide is different from other diuretics because it only slightly increases urine production.
• Amlodipine is a calcium channel blocker (a type of medicine that relaxes blood vessels, making it easier for blood to flow through them).

2. What you need to know before you take Poltriq

Do not take Poltriq:

• if you are 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 you have ever had symptoms such as wheezing, swelling of the face, lips, tongue, or throat, intense itching, or severe skin rashes after taking an ACE inhibitor (a condition called angioedema);
• if you have severe liver disease or a condition called hepatic encephalopathy (a brain disorder caused by liver disease);
• if you have suspected or diagnosed untreated or uncontrolled heart failure (fluid buildup in the body, difficulty breathing);
• if you have a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition where the heart is unable to pump enough blood to the body);
• if you have heart failure after a heart attack;
• if you have very low blood pressure (hypotension);
• if you have low potassium levels in the blood;
• if you have severe kidney disease that reduces blood flow to the kidneys (renal artery stenosis);
• if you are undergoing dialysis or other blood filtration methods. Depending on the equipment used, Poltriq may not be suitable for you.
• if you have moderate kidney problems (for 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 section on pregnancy);
• if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren;
• if you are 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 area of the face, lips, tongue, or throat, which can cause difficulty swallowing or breathing) is increased (see "Warnings and precautions" and "Poltriq with other medicines").

Warnings and precautions

Before taking Poltriq, tell your doctor or pharmacist:

• if you have hypertrophic cardiomyopathy (a heart muscle disease) or renal artery stenosis (narrowing of the artery that supplies blood to the kidney);
• if you have heart failure or any other heart disease;
• if you have a significant increase in blood pressure (hypertensive crisis);
• if you have liver disease;
• if you have collagen disease (a disease that affects connective tissue), such as systemic lupus erythematosus or scleroderma;
• if you have atherosclerosis (hardening of the arteries);
• if you are going to have parathyroid function tests;
• if you have gout;
• if you have diabetes;
• if you are on a low-salt diet or taking potassium-sparing diuretics (e.g., spironolactone, triamterene), as it is essential to maintain proper potassium levels in the blood;
• if you are taking lithium or potassium-sparing diuretics (spironolactone, triamterene), as you should avoid taking them with Poltriq (see "Poltriq with other medicines");
• if you are elderly and need to increase the dose;
• if you have had allergic reactions to sunlight;
• in black patients, angioedema (swelling of the face, lips, tongue, or throat) may occur more frequently, and the medicine may be less effective in lowering blood pressure;
• if you are undergoing dialysis using high-flux membranes;
• if you have kidney disease or are on dialysis;
• if you experience vision changes or eye pain. These may be symptoms of fluid buildup in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, which can occur within hours or weeks of taking Poltriq. Untreated symptoms can lead to permanent vision loss. If you have previously been allergic to penicillin or sulfonamides, you are at higher risk for these disorders.
• if you have muscle disorders, including pain, tenderness, weakness, or cramps;
• if you have an excessive level of a hormone called aldosterone in the blood (primary aldosteronism);
• if you have an excessive level of acid in the blood, which can cause rapid breathing;
• if you have cerebral hypoperfusion (low blood pressure in the brain);
• if you experience swelling of the face, lips, tongue, or throat, which can cause difficulty swallowing or breathing (angioedema), which can occur at any time during treatment. You should stop taking the medicine and consult a doctor immediately;
• if you are taking any of the following medicines, as the risk of angioedema is increased:
• 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, vildagliptin, and others.
• if you are 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 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). See also "Do not take Poltriq" and "Warnings and precautions".

Your doctor may recommend blood tests to check if you have low sodium or potassium levels or high calcium levels in the blood.

Tell your doctor if you are pregnant or think you may be pregnant. Do not take Poltriq during early pregnancy and do not take it after the third month of pregnancy, as it may harm the baby (see "Pregnancy and breastfeeding").

When taking Poltriq, also inform your doctor or medical staff if:

• you are going to have anesthesia and/or surgery;
• you have recently had diarrhea or vomiting, or are dehydrated;
• you are going to have dialysis or LDL apheresis (mechanical removal of cholesterol from the blood);
• you are going to have desensitization treatment to reduce allergic reactions after a bee or wasp sting;
• you are going to have 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 note that Poltriq contains the active substance indapamide, which may cause a positive result in anti-doping tests.

Children and adolescents

Do not give Poltriq to children and adolescents.

Poltriq with other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

• lithium (used to treat certain mental illnesses, such as mania, manic-depressive illness, and recurring depression);
• potassium-sparing diuretics (triamterene, amiloride), potassium supplements, or salt substitutes containing 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 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 "Warnings and precautions".
• a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See "Do not 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 your treatment with Poltriq. Your doctor may recommend changing the dose and/or taking other precautions. Tell your doctor if you are taking any of the following medicines, as special caution may be required:

• other medicines used to treat high blood pressure, including angiotensin II receptor antagonist (AIIRA), aliskiren (see also "Do not take Poltriq" and "Warnings and precautions"), or diuretics (medicines that increase urine production);
• potassium-sparing diuretics 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);
• 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 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 drugs (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 when given intravenously (used to treat symptoms of rheumatoid arthritis);
• halofantrine (used to treat certain types of malaria);
• baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis);
• medicines used to treat diabetes, such as insulin or metformin;
• calcium, including calcium supplements;
• laxatives with a stimulating effect (e.g., senna);
• medicines used to treat cancer;
• vincamine (used to treat cognitive disorders in the elderly, including memory loss);
• medicines used to treat mental 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 vasodilators, as they may further lower blood pressure.

Poltriq with food and drink

Do not eat grapefruits or drink grapefruit juice while taking Poltriq, as the level of the active substance amlodipine may increase, which may cause an unexpected increase in the blood pressure-lowering effect of Poltriq.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Tell your doctor if you are pregnant or think you may be pregnant. Your doctor will normally advise you to stop taking Poltriq before you become pregnant or as soon as you know you are pregnant, and will advise you to take a different medicine instead of Poltriq. Do not take Poltriq during early pregnancy and do not take it after the third month of pregnancy, as it may harm the baby (see "Pregnancy and breastfeeding").

Breastfeeding

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not recommended to take Poltriq while breastfeeding, especially if you are breastfeeding a newborn or premature baby. Your doctor may recommend a different medicine.

Driving and using machines

Poltriq may affect your ability to drive or use machines. If the medicine causes dizziness, drowsiness, fatigue, or headache, do not drive or use machines, and consult your doctor immediately.

Poltriq contains sodium

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

3. How to take Poltriq

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Swallow the tablet with a glass of water, preferably in the morning, before breakfast. Your doctor will determine the appropriate dose for you. The recommended dose is one tablet per day.

If you take more Poltriq than you should

Taking too many tablets may cause your blood pressure to drop, even to a dangerous level, which may be accompanied by nausea, vomiting, cramps, dizziness, drowsiness, disorientation, decreased urine production, or anuria (lack of urine production or excretion). You may feel "empty" in your head, or you may experience fainting or weakness. If your blood pressure drops significantly, you may experience shock, in which case your skin becomes cool and moist, and you may lose consciousness.

Even 24-48 hours after taking the medicine, you may experience shortness of breath due to excess fluid buildup in the lungs (pulmonary edema).

If you take too many Poltriq tablets, seek medical attention immediately.

If you forget to take Poltriq

It is important to take the medicine 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 Poltriq

Treatment of high blood pressure is usually long-term, so before stopping the medicine, consult your doctor.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

If you experience any of the following serious side effects, stop taking the medicine and consult your 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 significant difficulty breathing (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 radiating to the back and very poor general condition (very rare - occurs in less than 1 in 10,000 patients).
• muscle weakness, cramps, tenderness, or pain, especially if you feel unwell or have a high temperature, which may be caused by abnormal muscle breakdown (frequency not known).

Side effects, grouped by frequency of occurrence:

• 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, palpitations (feeling of heartbeat), flushing, dizziness, 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(occurs in less than 1 in 100 patients): mood changes, anxiety, depression, sleep disturbances, tremors, hives, fainting, loss of sensation, irregular or rapid heartbeat, 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, 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, dry 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 erythematosus (a type of collagen disease); 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, jaw pain, and back pain 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 (a rash that can occur after a viral infection or as an allergic reaction), bleeding, sensitive, or swollen gums, liver dysfunction, hepatitis, severe kidney dysfunction, jaundice (yellowing of the skin), abdominal distension (stomach swelling), neurological disorders that can cause weakness, numbness, or tingling, increased muscle tone, hyperglycemia (very high blood sugar), high calcium levels in the blood, stroke, possibly due to significant lowering of blood pressure.
• frequency not known(cannot be estimated from the available data): hepatic encephalopathy (a brain disorder caused by liver disease), abnormal electrocardiogram (ECG) results; in patients with systemic lupus erythematosus, symptoms may worsen. Myopia, blurred vision, or eye pain may occur due to high pressure (possible symptoms of choroidal effusion or acute angle-closure glaucoma). Tremors, stiffness, mask-like face, slow movements, and shuffling gait. Changes in skin color, numbness, pain in fingers or toes (Raynaud's phenomenon).

Changes in laboratory test results may occur (blood tests). Your doctor may recommend blood tests to monitor your health.

If you experience any of these symptoms, consult 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, pharmacist, or nurse.

Side effects can be reported directly to the Department of Drug Safety, Ministry of Health, via the online reporting system at [insert website URL]. You can also report side effects to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Poltriq

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

The packaging is marked with the expiry date and batch number after EXP and Lot, respectively.

There are no special storage instructions for this medicine. Store in the original packaging to protect from light and moisture.

Medicines should 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 Poltriq contains

• The active substances 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 (equivalent to 3.395 mg of perindopril), 1.25 mg of indapamide, and 5 mg of amlodipine (as amlodipine besylate).

Each film-coated tablet of Poltriq 5 mg + 1.25 mg + 10 mg contains 5 mg of perindopril arginine (equivalent to 3.395 mg of perindopril), 1.25 mg of indapamide, and 10 mg of amlodipine (as amlodipine besylate).

Each film-coated tablet of Poltriq 10 mg + 2.5 mg + 5 mg contains 10 mg of perindopril arginine (equivalent to 6.790 mg of perindopril), 2.5 mg of indapamide, and 5 mg of amlodipine (as amlodipine besylate).

Each film-coated tablet of Poltriq 10 mg + 2.5 mg + 10 mg contains 10 mg of perindopril arginine (equivalent to 6.790 mg of perindopril), 2.5 mg of indapamide, and 10 mg of amlodipine (as amlodipine besylate).

• The other ingredients are: tablet core: microcrystalline cellulose type 102, calcium carbonate, pregelatinized starch, sodium croscarmellose, magnesium stearate, colloidal anhydrous silica. film coating of Poltriq 5 mg + 1.25 mg + 5 mg and Poltriq 10 mg + 2.5 mg + 10 mg: macrogol/polyvinyl alcohol copolymer, talc, titanium dioxide (E171), glycerol monocaprylocaprate type I, and polyvinyl alcohol. film coating of Poltriq 5 mg + 1.25 mg + 10 mg and Poltriq 10 mg + 2.5 mg + 5 mg: macrogol/polyvinyl alcohol copolymer, 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 "TEV" engraved on one side and "2" on the other, approximately 12.3 mm x 6.5 mm in size.
• Poltriq 5 mg + 1.25 mg + 10 mg: light beige, round, film-coated tablets with "TEV" engraved on one side and "3" on the other, approximately 9.0 mm in diameter.
• Poltriq 10 mg + 2.5 mg + 5 mg: light beige, oval, film-coated tablets with "TEV" engraved on one side and "4" on the other, approximately 12.3 mm x 6.5 mm in size.
• Poltriq 10 mg + 2.5 mg + 10 mg: white, round, film-coated tablets with "TEV" engraved on one side and "5" on the other, approximately 9.0 mm in diameter.

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: