Polpril

Leaflet accompanying the packaging: patient information

Polpril, 2.5 mg, tablets

Polpril, 5 mg, tablets

Polpril, 10 mg, tablets

Ramipril

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

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Polpril and what is it used for

Polpril contains ramipril. It belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).
Polpril works by:

• reducing the production of substances in the body that can increase blood pressure,
• reducing tension and widening blood vessels,
• making it easier for the heart to pump blood throughout the body.

Polpril can be used:

• to treat high blood pressure (hypertension),
• to reduce the risk of heart attack or stroke,
• to reduce the risk of or delay kidney function deterioration (in both diabetic and non-diabetic patients),
• to treat heart failure, where the heart is not able to pump enough blood to meet the body's needs,
• after a heart attack complicated by heart failure.

2. Important information before taking Polpril

When not to take Polpril:

• if the patient is allergic to ramipril, another ACE inhibitor, or any of the other ingredients of this medicine (listed in section 6) - symptoms of an allergic reaction may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue,

an allergic reaction may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue,

• if the patient has ever had a severe allergic reaction called angioedema - its symptoms include: itching, hives, red spots on the hands, feet, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing,
• if the patient is undergoing dialysis or other type of blood filtration - depending on the type of device used, Polpril may not be suitable for the patient,
• if the patient has kidney disease with reduced blood flow to the kidney (renal artery stenosis),
• if the patient is pregnant after the third month (it is also recommended to avoid taking Polpril in early pregnancy - see the "Pregnancy and breastfeeding" section),
• if blood pressure is very low or unstable - the doctor will recommend the necessary tests,
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren,
• if the patient has taken or is currently taking sacubitril with valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin, such as the throat) increases.

If any of the above situations apply to the patient, they should not take Polpril. In case of doubts, the doctor should be consulted before starting to take Polpril.

Warnings and precautions

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

• the patient has heart, liver, or kidney disease;
• the patient has lost a significant amount of salt or fluids (due to vomiting, diarrhea, excessive sweating, a low-salt diet, taking diuretics for a long time, or dialysis);
• the patient is scheduled to undergo desensitization treatment for bee or wasp stings;
• the patient is scheduled to receive anesthetics during surgical or dental procedures - it may be necessary to stop taking Polpril the day before the procedure, in case of doubts, the doctor should be consulted;
• blood tests have shown high potassium levels or low sodium levels;
• the patient has collagenosis, such as scleroderma or systemic lupus erythematosus;
• the patient is pregnant, planning to become pregnant, or suspects they may be pregnant - it is not recommended to take Polpril in early pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the baby (see the "Pregnancy and breastfeeding" section);
• 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 problems related to diabetes;
• aliskiren;
• the patient is taking any of the following medicines, which may increase the risk of angioedema:
• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent transplant rejection and to treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes.

The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium or sodium) in the blood.
See also the "When not to take Polpril" section.

Children and adolescents

Polpril should not be used in children and adolescents under 18 years of age, as the safety and efficacy of ramipril in children have not been established yet.
If any of the above situations apply to the patient (or there are doubts), before starting to take Polpril, the doctor should be consulted.

Polpril and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take (including herbal medicines). Polpril may affect the way other medicines work, and other medicines may affect the way Polpril works.
The patient should inform their doctor about taking any of the following medicines, as they may weaken the effect of Polpril:

• pain and anti-inflammatory medicines (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indomethacin, or acetylsalicylic acid);
• medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, noradrenaline, or adrenaline - the doctor will recommend blood pressure monitoring.

The patient should inform their doctor about taking any of the following medicines, as they may increase the risk of side effects when taken with Polpril:

• pain and anti-inflammatory medicines (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indomethacin, or acetylsalicylic acid);
• medicines used to treat cancer (e.g., chemotherapy), such as temsirolimus;
• diuretics, such as furosemide;
• potassium supplements (including salt substitutes), potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), and other medicines that increase potassium levels in the blood (e.g., trimethoprim and co-trimoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent transplant rejection, and heparin, a medicine used to thin the blood to prevent clots);
• corticosteroids, such as prednisolone;
• allopurinol (used to reduce uric acid levels in the blood);
• procainamide (used to treat irregular heart rhythms);
• medicines that are commonly used to prevent transplant rejection (e.g., sirolimus, everolimus, and other medicines belonging to the mTOR inhibitor class). See the "Warnings and precautions" section.

The patient should inform their doctor about taking any of the following medicines, as their effect may be altered when taken with Polpril:

• medicines used to treat diabetes, such as oral glucose-lowering medicines and insulin - Polpril may lower blood glucose levels, so blood glucose levels should be regularly monitored during its use;
• lithium (used to treat mental disorders) - Polpril may increase lithium levels in the blood, so the doctor will recommend regular monitoring of lithium levels in the blood.

If any of the above situations apply to the patient (or there are doubts), before starting to take Polpril, the doctor should be consulted.
The doctor may recommend a dose change and/or take other precautions:

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

Polpril with food and alcohol

• Consuming alcohol while taking Polpril may cause dizziness and drowsiness. If there are doubts about the amount of alcohol allowed while taking Polpril, the doctor should be consulted, as the effects of alcohol and blood pressure-lowering medicines may be additive.
• Polpril can be taken with or without food.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. The doctor will usually recommend stopping Polpril before becoming pregnant or as soon as pregnancy is confirmed and recommend a different medicine. Polpril should not be taken during the first trimester of pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the baby.
Breastfeeding
The patient should inform their doctor if they are breastfeeding or plan to breastfeed. It is not recommended to take Polpril during breastfeeding. The doctor may recommend a different medicine if the patient wants to breastfeed, especially if the baby is a newborn or premature.

Driving and using machines

While taking Polpril, dizziness may occur. The risk of dizziness is higher at the beginning of treatment with Polpril and after dose increase. If dizziness occurs, the patient should not drive, use tools, or operate machines.

Important information about some ingredients of Polpril

The medicine contains lactose. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Polpril

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.

Method of administration

• The medicine should be taken orally, once a day, at the same time.
• The tablets should be swallowed with a drink of water.
• The tablets should not be chewed or crushed.

Dosage

Treatment of high blood pressure

• The usual starting dose is 1.25 mg or 2.5 mg once a day.
• The doctor will adjust the dose until blood pressure is controlled.
• The maximum dose is 10 mg once a day.
• If the patient is taking diuretics, the doctor may recommend stopping them or reducing the dose before starting Polpril.

Treatment to reduce the risk of heart attack or stroke

• The usual starting dose is 2.5 mg once a day.
• The doctor may then recommend increasing the dose.
• The usual dose is 10 mg once a day.

Treatment to reduce the risk of or delay kidney function deterioration

• The usual starting dose is 1.25 mg or 2.5 mg once a day.
• The doctor may adjust the dose.
• The usual dose is 5 mg or 10 mg once a day.

Treatment of heart failure

• The usual starting dose is 1.25 mg once a day.
• The doctor may adjust the dose.
• The maximum dose is 10 mg per day. It is recommended to take the medicine in two divided doses.

Treatment after a heart attack

• The usual starting dose is 1.25 mg once a day to 2.5 mg twice a day.
• The doctor may adjust the dose.
• The usual dose is 10 mg per day. It is recommended to take the medicine in two divided doses.

Elderly patients
The doctor will use a lower starting dose and will increase it more slowly.

Taking a higher dose of Polpril than recommended

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 packaging of the medicine with them, so the doctor knows what medicine was taken.

Missing a dose of Polpril

• If a dose is missed, the next dose should be taken at the usual time.
• A double dose should not be taken to make up for a missed dose.

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

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

• Swelling of the face, lips, or throat, which may cause difficulty swallowing or breathing, as well as itching and rash. These may be symptoms of a severe allergic reaction to Polpril.
• Severe skin reactions, including rash, ulcers of the mucous membranes, 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, longer than usual bleeding time, 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, or vomiting, yellowing of the skin or eyes (jaundice), which may be symptoms of liver disease, such as inflammation or liver damage.

Other side effects

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

• headache or feeling tired;
• dizziness (the risk is higher at the beginning of treatment with Polpril and after dose increase);
• fainting, low blood pressure (abnormally low blood pressure), especially when standing up or sitting down quickly;
• dry, persistent cough, sinusitis, or bronchitis, shortness of breath;
• stomach pain or abdominal pain, diarrhea, nausea, or vomiting;
• skin rash with raised patches or without;
• chest pain;
• muscle cramps or muscle pain;
• increased potassium levels in the blood, found in blood tests.

Uncommon(occurring in less than 1 in 100 patients)

• balance disorders (vestibular disorders);
• itching of the skin and abnormal sensations on the skin, such as numbness, tingling, prickling, burning, or tingling (paresthesia);
• loss of or altered taste;
• sleep disorders;
• depression, anxiety, nervousness, or restlessness;
• nasal congestion, difficulty breathing, or worsening of asthma;
• intestinal angioedema, which may cause abdominal pain, vomiting, and diarrhea;
• heartburn, constipation, or dryness of the mouth;
• increased urination during the day;
• excessive sweating;
• loss of or decreased appetite (anorexia);
• rapid or irregular heartbeat;
• swelling of the hands and feet (which may be a sign of excess fluid in the body);
• sudden flushing, especially of the face;
• blurred vision;
• joint pain;
• fever;
• impotence, decreased libido in men and women;
• increased levels of a certain type of white blood cell (eosinophilia), found in blood tests;
• liver, pancreas, or kidney function disorders, found in blood tests.

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

• feeling of uncertainty or disorientation;
• redness and swelling of the tongue;
• increased peeling of the skin, itchy papular rash;
• nail disorders (e.g., loosening or separation of the nail from the nail bed);
• skin rash or bruising;
• spots on the skin and discoloration of the extremities;
• redness, itching, swelling, or tearing of the eyes;
• hearing disorders and tinnitus;
• weakness;
• decreased levels of red blood cells, white blood cells, or platelets, or hemoglobin levels, found in blood tests.

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

• sensitivity to sunlight.

Other reported side effects:

The patient should inform their doctor if any of the following symptoms worsen or persist for more than a few days:

• difficulty concentrating;
• swelling of the mouth mucosa;
• decreased blood cell count, found in blood tests;
• concentrated urine (dark in color), nausea, or vomiting, muscle cramps, confusion, and seizures, which may be due to abnormal antidiuretic hormone (ADH, vasopressin) secretion - if such symptoms occur, the patient should immediately consult their doctor;
• decreased sodium levels in the blood;
• change in finger and toe color in response to cold and tingling or pain when they warm up (Raynaud's phenomenon);
• breast enlargement in men;
• slowed or impaired reactions;
• burning sensation;
• disorders of smell;
• hair loss.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. 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.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Polpril

The medicine should be stored out of sight and reach of children.
It should be stored at a temperature below 25°C.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
The packaging is marked with the expiry date and 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 contains

• The active substance of the medicine is ramipril. Each tablet contains 2.5 mg, 5 mg, or 10 mg of ramipril.
• The other ingredients are: sodium bicarbonate, lactose monohydrate, croscarmellose sodium, maize starch, sodium stearyl fumarate, yellow iron oxide (E172) (only 2.5 mg and 5 mg tablets), red iron oxide (E172) (only 5 mg tablets).

What Polpril looks like and contents of the pack

Polpril 2.5 mg: Yellow, uncoated, flat tablets in the shape of a capsule, 10.0 x 5.0 mm in size, with a dividing line on one side and lateral edges, marked with R2. The tablets can be divided into two halves.
Polpril 5 mg: Pink, uncoated, flat tablets in the shape of a capsule, 8.8 x 4.4 mm in size, with a dividing line on one side and lateral edges, marked with R3. The tablets can be divided into two halves.
Polpril 10 mg: White or almost white, uncoated, flat tablets in the shape of a capsule, 11.0 x 5.5 mm in size, with a dividing line on one side and lateral edges, marked with R4. The tablets can be divided into two halves.
Polpril is packaged in blisters or containers containing 10, 14, 20, 28, 30, 42, 50, 84, 98, and 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański, Poland
Phone: +48 22 364 61 01

Manufacturer

Actavis Ltd.
BLB016, Bulebel Industrial Estate Zejtun ZTN 3000, Malta
Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański, Poland
Balkanpharma Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
Date of last revision of the leaflet:September 2023