Polpril

Leaflet attached to the packaging: patient information

Polpril

2.5 mg, 5 mg, 10 mg, hard capsules
Ramipril

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should 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 as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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. Package contents 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 to:

• Treat high blood pressure (hypertension)
• Reduce the risk of heart attack or stroke
• Reduce the risk of or delay kidney problems (regardless of whether the patient has diabetes)
• Treat heart failure when the heart is not pumping enough blood to the rest of the body
• Treat heart failure after a heart attack.

2. Important information before taking Polpril

When not to take Polpril:

• if you are 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 you have 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 you have undergone dialysis or other blood filtration. Depending on the type of equipment used, Polpril may not be a suitable medicine.
• if you have kidney disease related to reduced blood flow to the kidneys (renal artery stenosis).
• if you are pregnant over three months (it is best to avoid taking Polpril in early pregnancy - see "Pregnancy and breastfeeding").
• if your blood pressure is very low or unstable. Your doctor should assess your blood pressure.
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren.
• if you have taken or are 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) may increase.

If any of the above situations occur, you should not take Polpril. In case of doubts about taking the medicine, you should consult a doctor before starting to take Polpril.

Warnings and precautions

Before taking Polpril, you should discuss it with your doctor or pharmacist:

• if you have heart, liver, or kidney disease
• if you have 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 you are to undergo desensitization to bee or wasp stings (allergy shots)
• if you are 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 you have high levels of potassium in the blood (as shown by blood tests).
• if you have collagen diseases such as scleroderma or systemic lupus erythematosus.
• if you are taking any of the following medicines used to treat high blood pressure:
• angiotensin receptor antagonist (ARB) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes;
• aliskiren;
• you are taking any of the following medicines, the risk of angioedema may increase:
• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent organ 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 suspect they are (or may be) pregnant. It is not recommended to take Polpril in early pregnancy. You must not take Polpril after the third month of pregnancy, as it may cause serious birth defects.
Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood at regular intervals.
See also the information under the heading "When not to take Polpril" and "Warnings and precautions".

Children and adolescents

Polpril should not be used in 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 about them), before taking Polpril, you should consult a doctor.

Polpril and other medicines

You should 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.
You should inform 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. Your doctor will need to check your blood pressure.

You should inform 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., non-steroidal anti-inflammatory drugs (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; cyclosporin, an immunosuppressant used to prevent organ 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 organ rejection);
• wildagliptin (used to treat type 2 diabetes);
• racecadotril (used to treat diarrhea).

You should inform 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. You should regularly check your blood sugar levels while taking Polpril.
• lithium (used to treat mental illnesses). Polpril may increase lithium levels in the blood. You should closely monitor your lithium levels in the blood. If any of the above situations occur (or there are doubts about them), before taking Polpril, you should consult a doctor.

Your doctor may need to change the dose and/or take other precautions:
If you are taking an angiotensin 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 drowsiness. If you have doubts about the amount of alcohol allowed while taking Polpril, you should discuss it with your doctor regarding the potential additive effect of blood pressure-lowering medicines and alcohol.
• Polpril can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult a doctor or pharmacist before taking this medicine.
Pregnancy
Women must tell their doctor if they suspect they are (or may be) pregnant. The doctor will advise stopping Polpril before becoming pregnant or as soon as possible after becoming pregnant and will recommend using another medicine instead. It is not recommended to take Polpril in early pregnancy. You must not take Polpril after the third month of pregnancy, as it may cause serious birth defects.
Breastfeeding
You should inform your doctor if you are breastfeeding or start breastfeeding. It is not recommended to take Polpril while breastfeeding. Your doctor may recommend using other blood pressure-lowering medicines if you decide to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

While taking Polpril, you may experience dizziness. The risk of dizziness is higher when you start taking Polpril and after increasing the dose. If you experience dizziness, you should not drive vehicles or use machines.

3. How to take Polpril

This medicine should always be taken exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist.

Taking the medicine

• The medicine should be taken orally, once a day, at the same time.
• You should swallow the capsules whole with a drink of water.
• You should 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, your doctor may adjust the dosage of the medicine.
• The maximum dose is 10 mg once a day.
• If you are taking diuretics (water pills), your doctor may stop or reduce the dose of the diuretic before starting Polpril.

Preventing heart attack or stroke

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

Treating after a heart attack

• The initial dose is usually 1.25 mg to 2.5 mg once a day.
• Your doctor may adjust the dosage of the medicine.
• 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

You should contact your doctor or have someone take you to the nearest hospital emergency department immediately. You should not drive yourself, you should ask someone to take you to the hospital or call an ambulance. You should take the packaging of the medicine with you, so the doctor knows what medicine was taken.

Missing a dose of Polpril

• If you miss a dose, you should take the next planned dose.
• You should not take a double dose to make up for a missed dose.

If you have any further doubts about taking this medicine, you should 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 changes, you should inform 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

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

• headache or feeling tired
• dizziness. The risk of dizziness is higher when you start taking 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, nausea, or vomiting
• rash with or without raised patches
• chest pain
• muscle cramps or pain
• high levels of potassium in the blood, as shown by laboratory tests.

Uncommon(occurring in less than 1 in 100 patients)

• 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 angioedema, which can cause abdominal pain, vomiting, and diarrhea
• heartburn, constipation, or dry mouth
• increased urine production 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 retaining more fluid than usual.
• hot flashes
• blurred vision
• joint pain
• fever
• impotence, decreased libido in men and women
• increased levels of certain white blood cells (eosinophilia) in blood tests
• blood test results indicating changes in the liver, pancreas, or kidneys.

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

• feeling uncertain, confused, or disoriented
• 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 count, white blood cell count, or platelet count, or hemoglobin levels in blood tests.

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

• sensitivity to sunlight.

Other reported side effects:

You should inform your doctor if any of the following symptoms worsen significantly 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
• dark-colored urine, nausea, or vomiting, muscle cramps, confusion, and seizures, which may be due to abnormal antidiuretic hormone (ADH, vasopressin) secretion. If you experience any of these symptoms, you should see 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 those not listed in this leaflet, you should tell your doctor or pharmacist. You can 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
Phone: +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 Polpril

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 carton and blister. The expiry date refers to the last day of the month stated.
The notation 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. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Polpril contains

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

What Polpril looks like and what the pack contains

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