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 this leaflet carefully before taking this medicine, as 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 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.

Contents of the pack

• 1. What Poltriq is and what it is 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 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). Patients already taking perindopril and indapamide in one tablet and amlodipine in another can take 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 blood vessels, making it easier for the heart to pump blood.
• Indapamide is a diuretic (a type of sulfonamide derivative with an indole ring). Diuretics increase the amount of urine produced by the kidneys. However, indapamide differs from other diuretics because it only slightly increases urine production.
• Amlodipine is a calcium channel blocker (a type of dihydropyridine). It causes blood vessels to relax, making it easier for blood to flow through them.

2. Important information before taking Poltriq

When not to take Poltriq:

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

Warnings and precautions

Before taking Poltriq, discuss with your doctor or pharmacist:

• in black patients, angioedema (swelling of the face, lips, mouth, tongue, or throat, which can cause difficulty swallowing or breathing) is more common, and the medicine may be less effective in lowering blood pressure;
• 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.
• angiotensin II receptor antagonist (AIIRA), also known as a sartan (e.g., valsartan, telmisartan, irbesartan), especially if you have diabetic kidney disease;
• aliskiren. Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also the section "When not to take Poltriq".

Your doctor may recommend blood tests to check if your potassium or sodium levels have decreased or if your calcium levels have increased. You should tell your doctor if you are pregnant or think you 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 harm the baby (see section on pregnancy and breastfeeding). When taking Poltriq, you should also inform your doctor or healthcare professional 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 be aware that Poltriq contains the active substance indapamide, which may cause a positive doping test result.

Children and adolescents

Poltriq should not be given to children and adolescents.

Poltriq with other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those you have bought without a prescription. Patients with diabetes or kidney disease should not take aliskiren (used to treat high blood pressure). You 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 containing potassium, or other medicines that may increase potassium levels in the body (such as heparin, a medicine used to thin the blood and prevent clotting);
• 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 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 your treatment with Poltriq. Your doctor may recommend changing the dose and/or taking other precautions. You should tell your doctor if you are taking any of the following 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 sections "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;
• 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, 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 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 clotting);
• immunosuppressive medicines (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;
• vinpocetine (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 grapefruit or drink grapefruit juice while taking Poltriq, as the level of the active substance amlodipine may increase, which can cause unexpected intensification of 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 You should 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. You should not take Poltriq during early pregnancy and you must not take it after the third month of pregnancy, as it may harm the baby (see section on pregnancy and breastfeeding). Breastfeeding You should 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. The tablet should be swallowed 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 dizziness, 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 cold and sweaty, and you may lose consciousness. Even 24-48 hours after taking the medicine, you may experience shortness of breath due to excess fluid accumulation 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 of Poltriq, 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 this medicine, consult your doctor. If you have any further questions on the use of this product, 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 severe difficulty breathing (uncommon - occurs in less than 1 in 100 patients);
• severe skin reactions, including intense rash, hives, redness of the skin all over the body, intense 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 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 can 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), sudden reddening of the face and neck, dizziness, tingling or numbness, vision disturbances, double vision, ringing in the ears (tinnitus), 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 (changes in skin appearance after sun exposure), blistering skin, swelling of hands or feet, increased levels of creatinine and urea 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 intense rash, redness of the skin all over the body, intense itching, blistering, peeling, and swelling of the skin, or other allergic reactions, erythema multiforme (a rash that often starts with a red patch on the face, arms, or legs), bleeding, tender, or swollen gums, liver dysfunction, hepatitis, severe kidney dysfunction, jaundice (yellowing of the skin), abdominal bloating (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.

Changes in laboratory test results may occur. Your doctor may recommend blood tests to monitor your health. If you experience any of these symptoms, you should contact your doctor as soon as possible.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. 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 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 indicates the expiry date, and after the abbreviation Lot indicates the batch number. 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. 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 (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: