Package leaflet: information for the patient

POLTRIQ, 5 mg + 1,25 mg + 5 mg, coated tablets
POLTRIQ, 5 mg + 1,25 mg + 10 mg, coated tablets
POLTRIQ, 10 mg + 2,5 mg + 5 mg, coated tablets
POLTRIQ, 10 mg + 2,5 mg + 10 mg, coated tablets
Perindoprilum argininum + Indapamidum + Amlodipinum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

What Poltriq is and what it is used for
Important information before taking Poltriq
How to take Poltriq
Possible side effects
How to store Poltriq
Package contents and other information

1. What Poltriq is and what it is used for

Poltriq is a combination medicine containing three active substances: perindopril, indapamide, and amlodipine. It is an antihypertensive medicine used to treat high blood pressure (arterial hypertension).
Patients already taking perindopril and indapamide in one medicine and amlodipine in another may instead use a single Poltriq tablet containing these three active substances at the same doses.
Each of the active substances helps lower blood pressure, and together they enable control of the patient's blood pressure:

Perindopril belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors. It works by dilating 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 causes only a slight increase in urine production.
Amlodipine is a calcium channel antagonist (belonging to a group of medicines called dihydropyridines). It causes relaxation of blood vessels, facilitating blood 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 to any of the other ingredients of this medicine (listed in section 6);
if the patient previously experienced symptoms during treatment with an ACE inhibitor such as wheezing, facial or tongue swelling, intense itching or severe skin rash, or if such symptoms occurred in the patient or a family member under any circumstances (a condition known as angioedema);
if the patient has severe liver disease or a condition called hepatic encephalopathy (a brain disorder caused by liver disease);
if untreated, uncontrolled heart failure is suspected in the patient (severe fluid retention, breathing difficulties);
if the patient has aortic valve stenosis (narrowing of the aortic valve) or cardiogenic shock (a condition in which the heart cannot deliver enough blood to the body);
if the patient has heart failure following a myocardial infarction;
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 blood filtration by another method. Depending on the device used, Poltriq may not be suitable for the patient;
if the patient has moderate kidney dysfunction (applies to Poltriq 10 mg + 2.5 mg + 5 mg and 10 mg + 2.5 mg + 10 mg formulations);
after the third month of pregnancy (it is also advisable to avoid using Poltriq in early pregnancy - see the 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, because this increases the risk of angioedema (rapid swelling of tissues under the skin around the throat) (see "Warnings and precautions" and "Poltriq with other medicines").

Warnings and precautions
Before starting Poltriq, discuss this with your doctor or pharmacist:

if the patient has hypertrophic cardiomyopathy (a heart muscle disease) or renal artery stenosis (narrowing of the artery supplying blood to the kidney);
if the patient has heart failure or any other heart disease;
if the patient has significant high blood pressure (hypertensive crisis);
if the patient has liver disease;
if the patient has collagenosis (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 (maintaining appropriate potassium levels in the blood is important);
if the patient is taking lithium or potassium-sparing diuretics (spironolactone, triamterene), as their use with Poltriq should be avoided (see "Poltriq with other medicines");
if the patient is elderly and the dose needs to be increased;
if the patient has experienced photosensitivity reactions;
angioedema (swelling of the face, lips, mouth, tongue or throat, which may cause difficulty swallowing or breathing) occurs more frequently in black patients, and the medicine may be less effective in lowering blood pressure;
if the patient is undergoing dialysis using high-permeability 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 Poltriq. Untreated, these 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, causing 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 they increase the risk of angioedema:
racecadotril (used to treat diarrhoea);
sirolimus, everolimus, temsirolimus and other medicines belonging to the 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:
angiotensin II receptor antagonists (AIIRAs) (also known as sartans—e.g. valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes;
aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure and blood electrolyte levels (e.g. potassium). See also the section "When not to take Poltriq".

The doctor may recommend blood tests to assess whether sodium or potassium levels have decreased or calcium levels have increased.
Inform your doctor if you are pregnant (or suspect pregnancy). Use of Poltriq is not recommended in early pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm the unborn child (see section "Pregnancy and breastfeeding").
When taking Poltriq, you should also inform your doctor or healthcare provider if:

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

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

lithium (used to treat certain mental disorders 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 cotrimoxazole, 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 take Poltriq" 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 Poltriq. The doctor may recommend changing the dose and/or taking additional precautions. Inform your doctor if the patient is taking any of the following medicines, as special caution may be required:

other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (AIIRAs), aliskiren (see also sections "When not to take Poltriq" 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 for heart diseases);
digoxin or other cardiac glycosides (used for heart diseases);
antibiotics used to treat bacterial infections (e.g. rifampicin, erythromycin, clarithromycin, sparfloxacin, moxifloxacin);
antifungal medicines (e.g. itraconazole, ketoconazole, intravenous amphotericin B);
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 contained in many medicines used for pain relief, fever reduction and prevention of blood clots);
immunosuppressive medicines (given to control immune system responses, used in 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 in conditions such as multiple sclerosis;
medicines used to treat diabetes, such as insulin or metformin;
calcium, including supplements to correct calcium deficiency;
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 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 vasodilating medicines, as they may further lower blood pressure.

Poltriq with food and drink
While taking Poltriq, do not consume grapefruit or grapefruit juice, as this may increase blood levels of the active substance—amlodipine—and lead to an unexpected intensification of Poltriq's blood pressure-lowering effect.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Inform your doctor if you are pregnant or suspect pregnancy. The doctor will usually recommend discontinuing Poltriq before a planned pregnancy or immediately after pregnancy is confirmed, and will advise taking an alternative medicine. Use of Poltriq is not recommended in early pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm the unborn child.
Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed. Use of Poltriq is not recommended during breastfeeding, especially when nursing a newborn or premature infant. The doctor may recommend an alternative medicine.
Driving and operating machinery
Poltriq may affect the ability to drive or operate machinery. If the medicine causes nausea, dizziness, fatigue or headache, do not drive or operate machinery and contact your doctor immediately.
Poltriq contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to take Poltriq

This medicine should always be taken as directed by a doctor or pharmacist. If in
doubt, consult a doctor or pharmacist.
The tablet should be swallowed with a glass of water, preferably in the morning, before a meal. The doctor will determine
the appropriate dose for the patient. Usually, the recommended dose is one tablet once daily.
Taking more Poltriq than recommended
Taking too many tablets may cause blood pressure to drop, even to a dangerous extent, which may sometimes be accompanied by nausea, vomiting, cramps, dizziness, drowsiness, disorientation, oliguria (passing less urine than usual), anuria
(absence of urine production or excretion). The patient may feel a "void" in the head, and may experience faintness or weakness. If the drop in blood pressure is severe, shock may occur, in which the skin becomes cold and clammy, and the patient may lose consciousness.
Breathlessness due to excess fluid accumulating in the lungs (pulmonary edema) may occur up to 24–48 hours after taking the medicine.
If too many Poltriq tablets have been taken, seek immediate medical help.
Missing a dose of Poltriq
It is important to take the medicine every day, as regular use ensures more effective action. However, if a dose of Poltriq is missed, the next dose should be taken at the usual time. Do not take a double dose to make up for a missed dose.
Stopping Poltriq treatment
Treatment of high blood pressure is usually long-term; therefore, contact a doctor before stopping this medicine.
If there are any further doubts regarding the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the following serious adverse symptoms, the medicine must be
discontinued immediately and medical advice must be sought without delay:

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 breathing difficulties (uncommon – occurs in less than 1 in 100 patients);
severe skin reactions, including severe rash, urticaria, redness of the entire skin surface, intense itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) 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);
myocardial infarction (very rare – occurs in less than 1 in 10,000 patients), life-threatening cardiac arrhythmias (frequency unknown);
pancreatitis, which may cause severe upper abdominal pain radiating to the back and general malaise (very rare – occurs in less than 1 in 10,000 patients);
muscle weakness, cramps, tenderness or pain, especially if the patient also feels unwell or has a high temperature, which may be due to abnormal muscle breakdown (frequency unknown).

Adverse reactions grouped by decreasing frequency of occurrence:

Very common (affects more than 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, vestibular dizziness, tingling/numbness, visual disturbances, double vision, tinnitus (sensation of hearing sounds), sensation of "emptiness" in the head due to low blood pressure, cough, dyspnoea, gastrointestinal disturbances (nausea, vomiting, abdominal pain, taste disturbances, dyspepsia or digestive disorders, 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 heartbeat, rhinitis (nasal mucosa inflammation – nasal swelling or discharge), hair loss, purpura (small red spots on the skin), skin discolouration, 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 number 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, clusters of blisters on the skin, 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 levels; 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).
Very rare (affects less than 1 in 10,000 patients): decreased number of white blood cells, decreased platelet count (leading to easy bruising and nosebleeds), anaemia (reduced number of red blood cells), angina pectoris (chest pain, jaw and back pain triggered by physical exertion and caused by impaired cardiac blood flow), eosinophilic pneumonia (a rare type of lung inflammation), gum swelling, severe skin reactions including severe rash, redness of the entire skin surface, 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, yellowing of the skin (jaundice), 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 lowering of blood pressure.
Frequency not known (cannot be estimated from available data): hepatic encephalopathy (brain disorder caused by liver disease), abnormal 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, postural rigidity, facial masking, bradykinesia and shuffling gait. Change in skin colour, numbness, pain in fingers or toes (Raynaud's phenomenon).

Changes in laboratory test results (blood tests) may occur. The doctor may recommend blood tests to monitor the patient's health.
If the patient experiences any of these symptoms, medical advice should be sought 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store POLTRIQ

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the carton following: EXP.
The expiry date refers to the last day of the stated month.
The marking on the packaging following EXP indicates the expiry date, and following Lot indicates the batch number.
No special temperature storage requirements apply. Store in the original packaging to protect from light and moisture.
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 packaging and other information

What Poltriq contains

The active substances in Poltriq are perindopril with arginine, indapamide, and amlodipine.

Each coated tablet of Poltriq 5 mg + 1.25 mg + 5 mg contains 5 mg of perindopril with arginine (equivalent to 3.395 mg of perindopril), 1.25 mg of indapamide, and 5 mg of amlodipine (as amlodipine besylate).
Each coated tablet of Poltriq 5 mg + 1.25 mg + 10 mg contains 5 mg of perindopril with arginine (equivalent to 3.395 mg of perindopril), 1.25 mg of indapamide, and 10 mg of amlodipine (as amlodipine besylate).
Each coated tablet of Poltriq 10 mg + 2.5 mg + 5 mg contains 10 mg of perindopril with arginine (equivalent to 6.790 mg of perindopril), 2.5 mg of indapamide, and 5 mg of amlodipine (as amlodipine besylate).
Each coated tablet of Poltriq 10 mg + 2.5 mg + 10 mg contains 10 mg of perindopril with arginine (equivalent to 6.790 mg of perindopril), 2.5 mg of indapamide, and 10 mg of amlodipine (as amlodipine besylate).

Other components are:
Tablet core: microcrystalline cellulose type 102, calcium carbonate, pregelatinized starch, sodium croscarmellose, magnesium stearate, anhydrous colloidal silica.
Coating of Poltriq 5 mg + 1.25 mg + 5 mg and Poltriq 10 mg + 2.5 mg + 10 mg tablets: polyethylene glycol grafted copolymer and polyvinyl alcohol, talc, titanium dioxide (E171), glycerol monocaprylocapronate type I, and polyvinyl alcohol.
Coating of Poltriq 5 mg + 1.25 mg + 10 mg and Poltriq 10 mg + 2.5 mg + 5 mg tablets: polyethylene glycol grafted copolymer and polyvinyl alcohol, talc, titanium dioxide (E171), glycerol monocaprylocapronate 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, oblong, coated tablets, engraved with the code "TEV" 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, coated tablets, engraved with the code "TEV" on one side and "3" on the other, approximately 9.0 mm in diameter.
Poltriq 10 mg + 2.5 mg + 5 mg: light beige, oblong, coated tablets, engraved with the code "TEV" 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, coated tablets, engraved with the code "TEV" on one side and "5" on the other, approximately 9.0 mm in diameter.

Poltriq is available in blister packs contained in cardboard cartons of 10, 30, or 90 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 medicinal product is authorised in the Member States of the European Economic Area under the following names:
Czech Republic, Slovakia: PROXIMIC