Polpril Plus

Leaflet accompanying the packaging: patient information

Polpril Plus, 5 mg + 1.25 mg, hard capsules
Polpril Plus, 5 mg + 2.5 mg, hard capsules
Polpril Plus, 10 mg + 1.25 mg, hard capsules
Polpril Plus, 10 mg + 2.5 mg, hard capsules
Ramipril+ Indapamide

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 those not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Polpril Plus and what is it used for

Polpril Plus contains two active substances called ramipril and indapamide. Ramipril belongs to
a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors). They work
by reducing the production of substances that may increase blood pressure in the body and
expanding blood vessels, making it easier for the heart to pump blood through them.
Indapamide belongs to a class of medicines called "diuretics". Diuretics increase the amount of
urine produced by the kidneys. However, indapamide differs from other diuretics because it only
causes a slight increase in the amount of urine produced.
Each of these active substances lowers blood pressure and they work together to control blood
pressure.
This medicine is used to treat high blood pressure (hypertension) as a replacement therapy in adult
patients whose blood pressure is adequately controlled with ramipril and indapamide, in the same
dose as in combination therapy, but as separate medicines.

2. Important information before taking Polpril Plus

When not to take Polpril Plus

• if the patient is allergic to ramipril or indapamide, other ACE inhibitors or other sulfonamides or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may include: rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue.
• if the patient has ever had a severe allergic reaction called "angioedema". Symptoms include: itching, hives, red spots on the palms, soles and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.
• if the patient has undergone dialysis or other type of blood filtration. Depending on the type of equipment used, Polpril Plus may not be a suitable medicine;
• if the patient has kidney disease related to reduced blood flow to the kidneys (renal artery stenosis);
• within the last 6 months of pregnancy (see below under "Pregnancy and breastfeeding");
• if the patient is breastfeeding;
• if blood pressure is very low or unstable. The doctor should assess blood pressure.
• if the patient has diabetes or kidney function disorders and is being treated with a blood pressure-lowering medicine containing aliskiren;
• if the patient has taken or is taking sacubitril + valsartan, a medicine used to treat chronic heart failure in adults, as the risk of angioedema (rapid, usually painful, severe swelling under the skin in an area such as the throat) increases;
• if the patient has severe liver function disorders or a condition called hepatic encephalopathy (liver damage affecting the nervous system);
• if the patient has severe kidney failure;
• if the patient has low potassium levels in the blood (hypokalemia);
• if the patient has uncontrolled heart failure (especially untreated).

If any of the above situations apply to the patient (or there are doubts about it), before starting to take Polpril Plus, they should contact their doctor.

Warnings and precautions

Before starting to take Polpril Plus, the patient should discuss it with their doctor or pharmacist.
Special caution should be exercised when taking Polpril Plus:

• if the patient has lost a significant amount of salt or fluids (due to vomiting, diarrhea, excessive sweating, a low-salt diet, or long-term use of diuretics or dialysis therapy);
• if the patient is to receive anesthesia. It may be given in connection with a surgical or dental procedure. It may be necessary to discontinue treatment with Polpril Plus on the day before the procedure, in case of doubts, consult a doctor;
• if the patient is scheduled to undergo desensitization treatment (e.g., for bee or wasp venom allergy);
• if the patient's blood tests have shown high potassium levels or low sodium levels;
• if the patient has a collagen vascular disease (when immune system problems affect collagen in the body), such as scleroderma (a chronic disease that mainly affects the skin) or systemic lupus erythematosus (a long-term inflammatory disease in which the immune system attacks healthy tissues);
• if the patient is of black race. There is a higher risk of sudden, usually painful, severe angioedema, mainly of the face and reduced effectiveness of ramipril;
• if the patient has a cough. They should consult a doctor if it worsens;
• 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 function disorders related to diabetes;
• aliskiren;
• if the patient is taking any of the following medicines, the risk of angioedema may increase:
• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent rejection of a transplanted organ and to treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat type 2 diabetes;
• if the patient has heart, liver, or kidney disease;
• if the patient has diabetes (they should regularly check their blood sugar levels);
• if the patient has gout;
• if the patient is sensitive to light (immune system reactions to sunlight);
• if the patient experiences vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (choroidal effusion) or increased pressure inside the eye - they may occur within a few hours to weeks after taking Polpril Plus. Without treatment, these symptoms may lead to permanent vision loss. If the patient has previously been allergic to penicillin or sulfonamides, they may be at increased risk of developing these symptoms;
• if the patient has electrolyte imbalance or dehydration;
• if the patient is to undergo a test to assess parathyroid function.

The patient must tell their doctor if they are (or may be) pregnant. It is not recommended to take Polpril Plus during the first 3 months of pregnancy and it must not be taken after 3 months of pregnancy, as it may seriously harm the baby (see "Pregnancy and breastfeeding").
If any of the above situations apply to the patient (or there are doubts about it), before starting to take Polpril Plus, they should contact their doctor.
The doctor may recommend monitoring the white blood cell count. More frequent monitoring is recommended:

• at the beginning of treatment
• in patients with kidney function disorders or collagen vascular diseases or
• when medicines that affect blood cell count are used.

The doctor may recommend regular tests to assess kidney function, blood pressure, and electrolyte levels (such as sodium, potassium) in the blood.
Athletes should be informed that Polpril Plus contains an active substance (indapamide) that may cause a positive result in a doping test.
See also the information under "When not to take Polpril Plus".

Children and adolescents

Polpril Plus is not recommended for use in children and adolescents.

Polpril Plus 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.
Polpril Plus must not be taken:

• with lithium (used to treat depression).

The effect of Polpril Plus may be altered by other medicines. The patient should inform their doctor if they are taking any of the following medicines, as special caution may be necessary:

• sacubitril in combination with valsartan - used to treat chronic heart failure in adults (see section 2 under "When not to take Polpril Plus");
• medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, indomethacin, or acetylsalicylic acid);
• potassium supplements (including salt substitutes), potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) and other medicines that may increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent rejection of a transplanted organ, and heparin, a medicine used to thin the blood to prevent clots);
• diuretics (tablets that help produce urine), such as furosemide;
• blood pressure-lowering medicines;
• medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, noradrenaline, or adrenaline, as well as dopamine, dobutamine, epinephrine, isoprenaline;
• corticosteroids used to treat inflammatory conditions, such as prednisolone;
• allopurinol (used to lower uric acid levels in the blood);
• procainamide (used to treat heart rhythm disorders);
• temsirolimus (used to treat cancer);
• sirolimus, everolimus, and other mTOR inhibitors (used to prevent rejection of a transplanted organ);
• vildagliptin (used to treat type 2 diabetes);
• racecadotril (used to treat diarrhea);
• medicines that may alter blood cell count;
• erythromycin injections (an antibiotic used to treat infections);
• medicines used to treat heart rhythm disorders (quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide, digitalis preparations);
• medicines used to treat mental disorders, such as depression, anxiety, schizophrenia (e.g., tricyclic antidepressants, antipsychotics, neuroleptics);
• bepridil (used to treat angina pectoris, a condition that causes chest pain);
• cisapride (used to treat limited mobility of the esophagus and stomach);
• difemanil (used to treat stomach problems, such as ulcers, excessive acid, overactive digestive system);
• sparfloxacin, moxifloxacin (antibiotics used to treat infections);
• vinpocetine injections (used to treat symptomatic cognitive disorders in the elderly, including memory loss);
• halofantrine (an antiparasitic medicine used to treat certain types of malaria);
• pentamidine (used to treat certain types of pneumonia);
• mizolastine (used to treat allergic reactions, such as high fever);
• amphotericin B injections (an antifungal medicine);
• oral corticosteroids used to treat various conditions, including severe asthma and rheumatoid arthritis;
• laxatives that stimulate bowel movements;
• baclofen (used to treat muscle stiffness in conditions such as multiple sclerosis);
• diabetes medicines (e.g., metformin) and insulin;
• iodine-containing contrast agents (used during diagnostic tests using X-rays);
• medicines containing calcium or other calcium supplements;
• tetracosactide (used to treat Crohn's disease).

The doctor may recommend changing the dose and (or) taking other precautions:

• if the patient is taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections "When not to take Polpril Plus" and "Warnings and precautions").

Polpril Plus with food and alcohol

Drinking alcohol while taking Polpril Plus may cause dizziness and drowsiness. In case of doubts about the amount of alcohol allowed while taking Polpril Plus, the patient should consult their doctor, as the effect of alcohol and blood pressure-lowering medicines may be cumulative.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, 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 must tell their doctor if they are (or may be) pregnant. The doctor will recommend stopping Polpril Plus before becoming pregnant or as soon as pregnancy is confirmed and will recommend using another medicine instead. It is not recommended to take Polpril Plus during the first trimester of pregnancy and it must not be taken after 3 months of pregnancy, as it may seriously harm the baby.
Breastfeeding
Polpril Plus must not be taken during breastfeeding. The patient should inform their doctor if they are breastfeeding or plan to breastfeed.

Driving and using machines

Polpril Plus has a minor or moderate effect on the ability to drive and use machines. While taking Polpril Plus, the patient may experience dizziness, headache, fatigue, weakness, or nausea. This is more likely to occur at the beginning of treatment.
If this happens, the patient should not drive, use tools, or operate machines.

3. How to take Polpril Plus

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.

Adult administration

The recommended dose is one capsule once a day, preferably in the morning with a sufficient amount of liquid (e.g., a glass of water).

Pediatric administration

Polpril Plus is not recommended for use in children and adolescents due to lack of data on safety and efficacy.

Overdose of Polpril Plus

The patient should immediately contact their doctor or go to the emergency department of the nearest hospital. They should not drive themselves, but ask someone to drive them to the hospital or call an ambulance. They should take the medicine packaging with them so that the doctor knows what medicine was taken.

Missed dose of Polpril Plus

If a dose of the medicine is missed, the patient should take the next dose at the usual time. They should not take a double dose to make up for the missed capsule.

Stopping treatment with Polpril Plus

The patient should not suddenly stop taking the medicine or change the prescribed dose without consulting their doctor, as the disease may worsen.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

If any of the following serious side effects occur, the patient should stop taking Polpril Plus and immediately contact their doctor – urgent medical attention may be necessary:

• swelling of the face, lips, or throat that makes swallowing or breathing difficult, as well as itching and rash. These may be symptoms of a severe allergic reaction to Polpril Plus.
• severe skin changes, including rash, ulcers of the mucous membrane of the mouth, worsening of existing skin conditions, redness, blistering, or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

The patient should immediately contact their doctor if they experience:

• rapid heartbeat, irregular or stronger heartbeat (palpitations), chest pain, tightness in the chest, or more serious conditions, including heart attack or stroke;
• shortness of breath or cough, which may be symptoms of lung disease;
• easy bruising, prolonged bleeding, any signs of bleeding (e.g., bleeding from the gums), purple spots on the skin, or more frequent infections, sore throat, and fever, fatigue, weakness, dizziness, or paleness of the skin, which may be symptoms of blood or bone marrow disorders;
• severe abdominal pain radiating to the back, which may be a symptom of pancreatitis;
• fever, chills, fatigue, loss of appetite, stomach pain, nausea, yellowing of the skin or eyes (jaundice), or liver damage;
• concentrated urine (dark color), nausea, muscle cramps, confusion, and seizures, which may be caused by abnormal secretion of antidiuretic hormone (ADH).

Other side effects

The patient should inform their doctor if any of the following symptoms worsen or persist for more than a few days.
Frequent(occurring in less than 1 in 10 patients)

• increased potassium levels in the blood, low potassium levels in the blood shown in blood tests;
• headache and dizziness;
• fainting, low blood pressure (abnormally low blood pressure), especially when standing up or sitting down quickly;
• dry, irritating cough, sinusitis, or bronchitis, shortness of breath;
• gastritis and/or enteritis, stomach or intestinal pain, diarrhea, indigestion, nausea, or vomiting;
• allergic reaction (especially in people who tend to have allergic or asthmatic reactions) leading to skin rash with spots and nodules;
• muscle cramps or pain;
• chest pain or feeling of tiredness.

Uncommon(occurring in less than 1 in 100 patients)

• increased number of certain white blood cells (eosinophilia) detected in blood tests;
• loss or decreased appetite (anorexia), low sodium levels in the blood, which may lead to dehydration and low blood pressure;
• depression, anxiety, increased nervousness than usual or restlessness, sleep problems, including drowsiness;
• balance problems (dizziness), itching, and abnormal skin sensations, such as numbness, tingling, burning, or prickling of the skin (paresthesia), loss or change of taste;
• vision disturbances (including blurred vision);
• myocardial ischemia, including angina pectoris or myocardial infarction, rapid or irregular heartbeat, palpitations, swelling of the ankles, feet, or toes;
• flushing;
• stuffy nose, difficulty breathing, or worsening of asthma;
• pancreatitis, intestinal edema called "angioedema of the intestine" characterized by abdominal pain, vomiting, and diarrhea;
• heartburn, constipation, or dry mouth;
• blood tests showing changes in liver, pancreas, or kidney function;
• swelling of the face, lips, or throat. See the first dash at the beginning of section 4.
• excessive sweating;
• rash, purple spots on the skin (purpura), skin discoloration;
• joint pain;
• kidney function disorders, including acute kidney failure, increased need to urinate;
• decreased sex drive in men or women, impotence (inability to achieve or maintain an erection);
• fever.

Rare(occurring in less than 1 in 1,000 patients)

• decreased number of red blood cells, white blood cells, or platelets, or hemoglobin levels detected in blood tests;
• low chloride levels in the blood, low magnesium levels in the blood;
• feeling of shaking or disorientation;
• tremors, balance problems;
• fatigue (weakness);
• conjunctivitis ("pink eye");
• hearing impairment, tinnitus (ringing in the ears);
• vasoconstriction, hypoperfusion (decreased blood flow), vasculitis;
• tongue swelling (tongue edema);
• jaundice (yellowing of the skin and eyes), liver cell damage;
• severe skin peeling or exfoliation, hives, nail problems (e.g., loosening or separation of the nail from the nail bed);
• weakness (asthenia).

Very rare(occurring in less than 1 in 10,000 patients)

• increased calcium levels in the blood;
• decreased number of certain blood cells, which may cause weakness, bruising, or increased risk of infection (hemolytic anemia); aplastic anemia (bone marrow suppression);
• irregular heartbeat;
• pancreatitis;
• abnormal liver function;
• reactions to sunlight (changes in skin appearance) after exposure to sunlight or artificial UV light;
• severe skin reactions. See the second dash at the beginning of section 4.

Frequency not known(frequency cannot be estimated from the available data)

• bone marrow failure, pancytopenia (low number of red blood cells, white blood cells, and platelets), hemolytic anemia;
• severe allergic reactions;
• syndrome of inappropriate antidiuretic hormone secretion;
• concentration problems;
• cerebrovascular disorders, including stroke, feeling of burning, change in smell;
• worsening of vision or eye pain due to high pressure [possible symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma];
• life-threatening irregular heartbeat (torsades de pointes);
• change in finger or toe color when cold, followed by tingling or pain when warmed up (Raynaud's phenomenon);
• mouth ulcers (ulcers of the mucous membrane lining the mouth) with small ulcers;
• acute liver failure, hepatitis. If the patient has liver problems, taking Polpril Plus may cause a condition called hepatic encephalopathy (liver damage affecting the brain and nerves);
• hair loss;
• breast enlargement in men (gynecomastia);
• abnormal ECG (electrocardiogram);
• changes in blood tests and the doctor may order blood tests to check the patient's condition. The following changes in blood test results may occur:
• increased blood sugar levels in patients with diabetes;
• increased uric acid levels, a substance that can cause or worsen gout (joint pain, especially in the feet);
• increased liver enzyme activity.

Reporting side effects

If the patient experiences any side effects, including those 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
Phone: +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Polpril Plus

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging. 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.
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 packaging and other information

What Polpril Plus contains

• The active substances of the medicine are ramipril and indapamide. Each 5 mg + 1.25 mg capsule contains 5 mg of ramipril and 1.25 mg of indapamide. Each 5 mg + 2.5 mg capsule contains 5 mg of ramipril and 2.5 mg of indapamide. Each 10 mg + 1.25 mg capsule contains 10 mg of ramipril and 1.25 mg of indapamide. Each 10 mg + 2.5 mg capsule contains 10 mg of ramipril and 2.5 mg of indapamide.
• The other ingredients of the medicine are: capsule contents: microcrystalline cellulose, mannitol, magnesium stearate; capsule shell: gelatin (bovine); 5 mg + 2.5 mg; 10 mg + 1.25 mg; 10 mg + 2.5 mg capsules contain: red iron oxide (E 172); 5 mg + 1.25 mg; 5 mg + 2.5 mg; 10 mg + 1.25 mg capsules contain: yellow iron oxide (E 172).

What Polpril Plus looks like and contents of the pack

Polpril Plus, 5 mg + 1.25 mg: Hard yellow gelatin capsules with the inscription on the body 5+1.25;
capsule size - No. 3 (length approximately 16 mm), containing a filling in the form of a white or almost white powder or slightly compressed larger agglomerates.
Polpril Plus, 5 mg + 2.5 mg: Hard gelatin capsules with a yellow body and orange cap,
with the inscription on the body 5 mg+2.5 mg; capsule size - No. 1 (length approximately 19.5 mm),
containing a filling in the form of a white or almost white powder or slightly compressed larger agglomerates.
Polpril Plus, 10 mg + 1.25 mg: Hard orange gelatin capsules with a red cap,
with the inscription on the body 10 mg+1.25 mg; capsule size - No. 1 (length approximately 19.5 mm),
containing a filling in the form of a white or almost white powder or slightly compressed larger agglomerates.
Polpril Plus, 10 mg + 2.5 mg: Hard red gelatin capsules with the inscription on the body 10 mg+2.5 mg;
capsule size - No. 1 (length approximately 19.5 mm), containing a filling in the form of a white or almost white powder or slightly compressed larger agglomerates.
The medicine is packaged in aluminum/OPA/aluminum/PVC blisters in a cardboard box containing 28 or 84 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Metalowca 2, 39-460 Nowa Dęba

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

Bulgaria
ПОЛПРИЛ ПЛЮС 5 mg/1,25 mg твърди капсули, ПОЛПРИЛ ПЛЮС 5 mg/2,5 mg
твърди капсули, ПОЛПРИЛ ПЛЮС 10 mg/1,25 mg твърди капсули, ПОЛПРИЛ
ПЛЮС 10 mg/2,5 mg твърди капсули

Date of last revision of the leaflet: