Polpril

Leaflet accompanying the packaging: patient information

Polpril

2.5 mg, 5 mg, 10 mg, hard capsules
Ramiprilum

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 any not listed in this leaflet, they should tell 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 pack 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 that may increase blood pressure in the body
• Reducing tension and dilating blood vessels
• Making it easier for the heart to pump blood throughout the body.

Polpril can be used for:

• Treating high blood pressure (hypertension)
• Reducing the risk of heart attack or stroke
• Reducing the risk of or delaying kidney problems (regardless of whether the patient has diabetes)
• Treating heart failure when the heart is not pumping enough blood to the rest of the body
• Treating 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 face, lips, throat, or tongue.

An allergic reaction (hypersensitivity) may cause: rash, difficulty swallowing or breathing, swelling of the face, lips, throat, or tongue.

• if the patient has ever had a severe allergic reaction called "angioedema". Its 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 blood filtration. Depending on the type of equipment used, Polpril may not be a suitable medicine.
• if the patient has kidney disease related to reduced blood flow to the kidneys (renal artery stenosis).
• if the patient is pregnant after the third month (it is best to avoid taking Polpril in early pregnancy - see "Pregnancy and breastfeeding").
• if blood pressure is very low or unstable. The doctor should assess blood pressure.
• 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 occur, do not take Polpril. In case of doubts about taking the medicine, consult a doctor before starting to take Polpril.

Warnings and precautions

Before starting to take Polpril, discuss it with your doctor or pharmacist:

• if the patient has heart, liver, or kidney disease
• if the patient has recently lost a significant amount of electrolytes or fluids (through vomiting, diarrhea, excessive sweating, a low-salt diet, or prolonged use of diuretics or dialysis)
• if the patient is to undergo desensitization to bee or wasp venom (allergy shots)
• if the patient is to receive anesthesia. They may be used during surgical or dental procedures. It may be necessary to stop taking Polpril the day before the procedure, in case of doubts, consult a doctor.
• if the patient has high potassium levels in the blood (as shown by blood tests).
• if the patient has collagenosis, such as scleroderma or systemic lupus erythematosus.
• if the patient is taking any of the following medicines for high blood pressure:
• angiotensin II receptor antagonist (ARB) (also known as sartans - 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, the risk of angioedema may increase:
• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent transplant rejection and treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• wildagliptin, a medicine used to treat type 2 diabetes.

Women must tell their doctor if they are pregnant or think they may be pregnant. It is not recommended to take Polpril in early pregnancy. Do not take the medicine after the third month of pregnancy, as it may cause serious birth defects.
The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals.
See also the information under the heading "When not to take Polpril" and "Warnings and precautions".

Children and adolescents

Polpril is not recommended for children and adolescents under 18 years of age, as safety and efficacy in children and adolescents have not yet been established.
If any of the above situations occur (or there are doubts), before starting to take Polpril, consult a doctor.

Polpril and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. Polpril may affect the action of other medicines, and other medicines may affect the action of Polpril.
Tell your doctor about taking the following medicines, as they may reduce the effect of Polpril:

• medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and acetylsalicylic acid).
• medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, norepinephrine, or adrenaline. Blood pressure should be checked by a doctor.

Tell your doctor about taking the following medicines, as they may increase the risk of side effects when taken with Polpril:

• sacubitril with valsartan - used to treat chronic heart failure in adults (see section 2 "When not to take Polpril")
• medicines used to relieve pain and inflammation (e.g., NSAIDs, such as ibuprofen or indomethacin and acetylsalicylic acid)
• diuretics (such as furosemide)
• potassium supplements (including salt substitutes), potassium-sparing diuretics (such as 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 immunosuppressant used to prevent transplant rejection, and heparin, a medicine used to thin the blood to prevent clots)
• corticosteroids, such as prednisolone
• allopurinol (used to lower uric acid levels in the blood)
• procainamide (used to treat irregular heart rhythms)
• temsirolimus (used to treat cancer);
• sirolimus, everolimus, and other mTOR inhibitors (used to prevent transplant rejection);
• wildagliptin (used to treat type 2 diabetes);
• racecadotril (used to treat diarrhea).

Tell your doctor about taking the following medicines, as their action may be altered when taken with Polpril:

• medicines used to treat diabetes, such as oral hypoglycemic agents and insulin. Polpril may lower blood sugar levels. Blood sugar levels should be regularly monitored while taking Polpril.
• lithium (used to treat mental illnesses). Polpril may increase lithium levels in the blood. Lithium levels in the blood should be closely monitored.

The doctor may need to change the dose and/or take other precautions:
If the patient is taking an angiotensin II receptor antagonist (ARB) or aliskiren (see also the information under the heading "When not to take Polpril" and "Warnings and precautions").

Polpril with food and drink

• Drinking alcohol while taking Polpril may cause dizziness and fainting. In case of doubts about the amount of alcohol allowed while taking Polpril, consult a doctor about the potential interaction between blood pressure-lowering medicines and alcohol.
• Polpril can be taken with or without food.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult a doctor or pharmacist before taking this medicine.
Pregnancy
Women must tell their doctor if they are pregnant or think they may be pregnant. The doctor will advise stopping Polpril before becoming pregnant or as soon as possible after becoming pregnant and will recommend an alternative medicine. It is not recommended to take Polpril in early pregnancy. Do not take the medicine after the third month of pregnancy, as it may cause serious birth defects.
Breastfeeding
Tell your doctor if you are breastfeeding or plan to breastfeed. It is not recommended to take Polpril while breastfeeding. The doctor may recommend other blood pressure-lowering medicines if the patient decides 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 increasing the dose. If dizziness occurs, do not drive vehicles or operate machinery.

3. How to take Polpril

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

Taking the medicine

• Take the medicine orally, once a day, at the same time.
• Swallow the capsules whole with a drink of water.
• Do not crush or chew the capsules.

Dosage

Treating high blood pressure

• The initial dose is usually 1.25 mg or 2.5 mg once a day.
• Based on blood pressure control, the doctor may adjust the dosage of Polpril.
• The maximum dose is 10 mg once a day.
• In case of diuretic use, the doctor may discontinue or reduce the dose of the diuretic before starting Polpril treatment.

Preventing heart attack or stroke

• The initial dose is usually 2.5 mg once a day.
• The doctor may decide to increase the dose.
• The usual dose is 10 mg once a day.

Reducing or delaying kidney problems

• The initial dose is usually 1.25 mg or 2.5 mg once a day.
• The doctor may adjust the dosage of Polpril.
• The usual dose is 5 mg or 10 mg once a day.

Treating heart failure

• The initial dose is usually 1.25 mg once a day.
• The doctor may adjust the dosage of Polpril.
• The maximum dose is 10 mg per day. It is preferred to take the medicine in two divided doses.

Treating heart attack

• The initial dose is usually 1.25 mg to 2.5 mg once a day.
• The doctor may adjust the dosage of Polpril.
• The usual dose is 10 mg per day. It is preferred to take the medicine in two divided doses.

Elderly patients
The initial dose should be lower, and the dose increase should be more gradual.

Taking a higher dose of Polpril than recommended

Consult a doctor or go to the nearest hospital emergency department immediately. Do not drive yourself, ask someone to drive you to the hospital or call an ambulance. Take the medicine packaging with you so the doctor knows what medicine was taken.

Missing a dose of Polpril

• If a dose is missed, take the next planned dose.
• Do not take a double dose to make up for the missed dose.

In case of further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

If you notice any of the following serious side effects, stop taking Polpril and contact your doctor immediately - prompt treatment may be necessary:

• swelling of the face, lips, or throat, making it difficult to swallow or breathe, as well as itching and rash. They may be symptoms of a severe allergic reaction to Polpril.
• severe skin reactions, including rash, ulcers in the mouth, worsening of existing skin conditions, redness, blisters, or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

If you experience any of the following, tell your doctor promptly:

• 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. They may indicate 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. They may indicate blood or bone marrow disorders.
• severe abdominal pain, which may radiate to the back. It may be a symptom of pancreatitis.
• fever, chills, weakness, loss of appetite, abdominal pain, nausea, vomiting, yellowing of the skin or whites of the eyes (jaundice). They may be symptoms of liver disease, such as inflammation or liver damage.

Other side effects

Tell your doctor if any of the following symptoms worsen or persist for more than a few days.
Common(affecting less than 1 in 10 people)

• headache or feeling tired
• dizziness. The risk of dizziness is higher at the beginning of treatment with Polpril and after increasing the dose.
• fainting, hypotension (abnormally low blood pressure), especially when standing up or changing position quickly from lying down to sitting or standing
• dry, persistent cough, sinusitis, or bronchitis, shortness of breath
• abdominal pain, diarrhea, indigestion, nausea, or vomiting
• rash with or without itching
• chest pain
• muscle cramps or pain
• high potassium levels in the blood, as shown by laboratory tests.

Uncommon(affecting less than 1 in 100 people)

• balance disorders (dizziness)
• itching of the skin and sensory disturbances such as numbness, tingling, prickling, or burning sensations (paresthesia)
• loss or disturbance of taste
• sleep disorders
• depression, anxiety, nervousness, or restlessness
• stuffy nose, difficulty breathing, or worsening of asthma
• intestinal edema, called "angioedema of the intestine", whose symptoms are abdominal pain, vomiting, and diarrhea
• heartburn, constipation, or dry mouth
• increased urination during the day
• excessive sweating
• loss or decreased appetite (anorexia)
• rapid or irregular heartbeat
• swelling of the hands and feet. They may be a sign of water retention.
• hot flashes
• blurred vision
• joint pain
• fever
• impotence, decreased libido in men and women
• increased white blood cell count (eosinophilia) in blood tests
• blood test results indicating changes in the liver, pancreas, or kidneys.

Rare(affecting less than 1 in 1,000 people)

• feeling of uncertainty, confusion, disorientation
• red, swollen tongue
• severe skin peeling, itchy papular rash
• nail disorders (e.g., loosening or separation of the nail from the nail bed)
• rash or bruising of the skin
• spots on the skin and cold extremities
• redness, itching, swelling, and tearing of the eyes
• hearing disorders and ringing in the ears
• weakness
• decreased red blood cell, white blood cell, or platelet count, or hemoglobin level in blood tests.

Very rare(affecting less than 1 in 10,000 people)

• sensitivity to sunlight.

Other reported side effects:

Tell your doctor if any of the following symptoms worsen or persist for more than a few days.

• difficulty concentrating
• swelling of the lips
• low blood cell count, as shown by blood tests
• low sodium levels in the blood, as shown by 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 the above symptoms occur, consult a doctor immediately.
• change in finger color upon cooling and sensation of tingling or pain upon warming (Raynaud's phenomenon)
• breast enlargement in men
• slowed or impaired reactions
• burning sensation
• smell disorders
• hair loss.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Polpril

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
The inscription on the blister after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
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 Polpril contains

• The active substance is ramipril. Each capsule contains 2.5 mg, 5 mg, or 10 mg of ramipril.
• The other ingredient inside the capsule is cornstarch.
• The capsule is made of gelatin and water. It also contains: black iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), and indigo carmine (E132). The ink contains: shellac, black iron oxide (E172), propylene glycol, ammonium hydroxide.

What Polpril looks like and contents of the pack

Polpril is packaged in blisters containing 28 capsules.
2.5 mg: Capsules are light green-gray (marked 'R') - light gray (marked '2.5'). The capsules contain white or off-white powder.
5 mg: Capsules are green - light gray (marked '5'). The capsules contain white or off-white powder.
10 mg: Capsules are dark green - light gray (marked '10').
The capsules contain white or off-white powder.

Marketing authorization holder and manufacturer

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

Date of last revision of the leaflet: