Polpril

Package leaflet: Information for the patient

Polpril
2.5 mg, 5 mg, 10 mg, hard capsules
Ramiprilum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Polpril is and what it is used for
2. What you need to know 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 Polpril is and what it is 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 a substance that can raise blood pressure in the body
• Reducing tension and widening blood vessels
• Helping the heart pump blood more easily around the body.

Polpril may be used to:

• Treat high blood pressure (hypertension)
• Reduce the risk of heart attack or stroke
• Reduce the risk of or delay worsening kidney problems (regardless of whether the patient has diabetes)
• Treat heart failure, when the heart does not pump enough blood to the rest of the body
• Treat patients after a heart attack complicated by heart failure.

2. Information before using Polpril

When not to use Polpril:

• if the patient is allergic to ramipril, any other medicine in the class of ACE inhibitors, 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.
• if the patient has ever experienced a severe allergic reaction called "angioedema". Symptoms include: itching, hives, red patches 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 has undergone dialysis or another type of blood filtration. Depending on the type of equipment used, Polpril may not be an appropriate medicine.
• if the patient has kidney diseases related to reduced blood flow to the kidneys (renal artery stenosis).
• if the patient is more than three months pregnant (it is best to avoid using Polpril in early pregnancy - see section "Pregnancy and 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 currently taking sacubitril with valsartan, a medicine used to treat certain types of chronic heart failure in adults, because the risk of angioedema (rapid swelling of tissues under the skin, such as in the throat) increases.

If any of the above situations apply, Polpril should not be used. In case of doubt about using this medicine, contact your doctor before starting treatment with Polpril.

Warnings and precautions

Before starting treatment with Polpril, discuss the following with your doctor or pharmacist:

• if the patient has heart, liver, or kidney diseases
• if the patient has recently lost a significant amount of electrolytes or fluids (due to vomiting, diarrhea, excessive sweating, a low-salt diet, long-term use of diuretics, or dialysis)
• if the patient is scheduled for allergen immunotherapy (desensitization) to bee or wasp venom
• if the patient is to receive medicines used for anesthesia. These may be used during surgical or dental procedures. It may be necessary to discontinue Polpril one day before the procedure. In case of doubt, contact your doctor.
• if the patient has high blood potassium levels (as shown in 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:
  • an angiotensin II receptor antagonist (ARB) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if the patient has kidney 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 organ transplant rejection and to treat cancer (e.g., temsirolimus, sirolimus, everolimus)
  • vildagliptin, a medicine used to treat diabetes

Women must inform their doctor if they suspect they are (or might be) pregnant. Use of Polpril is not recommended during early pregnancy. Polpril must not be used after the third month of pregnancy, as use during this period may cause serious fetal abnormalities (see section "Pregnancy and breastfeeding").

The treating doctor may monitor kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also information under the heading "When not to use Polpril".

Children and adolescents

Polpril is not recommended for use in children and adolescents under 18 years of age, as safety and efficacy have not yet been established.

If any of the above situations apply (or if there is any doubt), contact your doctor before starting treatment with Polpril.

Polpril and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. Polpril may affect the action of other medicines, and other medicines may affect the action of Polpril.

Inform your doctor if the patient is taking any of the following medicines. These may reduce the effectiveness of Polpril:

• pain-relieving and anti-inflammatory medicines (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, noradrenaline, or adrenaline. The doctor should check blood pressure.

Inform your doctor if the patient is taking any of the following medicines. These may increase the risk of adverse effects when used together with Polpril:

• sacubitril in combination with valsartan – used to treat chronic heart failure in adults (see section 2 "When not to use Polpril")
• pain-relieving and anti-inflammatory medicines (e.g., NSAIDs such as ibuprofen or indomethacin, and acetylsalicylic acid)
• diuretics (water tablets), such as furosemide
• potassium supplements (including salt substitutes), potassium-sparing diuretics (such as spironolactone, triamterene, amiloride), and other medicines that increase blood potassium levels (e.g., trimethoprim and co-trimoxazole, used for bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots)
• corticosteroid anti-inflammatory medicines, such as prednisolone
• allopurinol (used to lower blood uric acid levels)
• propranolol (used for heart rhythm disorders)
• temsirolimus (used to treat cancer)
• sirolimus, everolimus, and other mTOR inhibitors (used to prevent transplant rejection)
• vildagliptin (used to treat type 2 diabetes)
• racecadotril (used to treat diarrhea)

Inform your doctor if the patient is taking any of the following medicines. Their effects may be altered when taking Polpril:

• antidiabetic medicines, such as oral glucose-lowering agents and insulin. Polpril may lower blood glucose levels. Blood glucose levels should be monitored regularly during treatment with Polpril.
• lithium (used for psychiatric disorders). Polpril may increase blood lithium levels. Blood lithium levels should be closely monitored. If any of the above situations apply (or if there is any doubt), contact your doctor before starting treatment with Polpril.

The treating doctor may need to adjust the dose and/or take additional precautions:

If the patient is taking an angiotensin II receptor antagonist (ARB) or aliskiren (see also information under "When not to use Polpril" and "Warnings and precautions").

Polpril with food and alcohol

• Drinking alcohol while taking Polpril may cause dizziness and a feeling of faintness. If in doubt about how much alcohol is safe while taking Polpril, consult your doctor about the possible additive effects of blood pressure-lowering medicines and alcohol.
• Polpril may be taken during or independently of meals.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy

Women must inform their doctor if they suspect they are (or might be) pregnant. The doctor will advise discontinuing Polpril before becoming pregnant or as soon as possible after conception, and will recommend an alternative medicine. Use of Polpril is not recommended during early pregnancy. Polpril must not be used after the third month of pregnancy, as use during this period may cause serious fetal abnormalities.

Breastfeeding

Inform your doctor if the patient is breastfeeding or plans to start breastfeeding. Use of Polpril is not recommended during breastfeeding. The doctor may recommend alternative antihypertensive medicines if the patient decides to breastfeed, especially if the baby is a newborn or premature.

Driving and operating machinery

Dizziness may occur while taking Polpril. The risk of dizziness is higher at the beginning of treatment with Polpril and after dose increases. If dizziness occurs, do not drive vehicles or operate tools or machinery.

3. How to take Polpril

This medicine should always be taken as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Taking the medicine

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

Dosage

Treatment of high blood pressure

• The usual starting dose is 1.25 mg or 2.5 mg once daily.
• Based on blood pressure monitoring, your doctor may adjust the dosage.
• The maximum dose is 10 mg once daily.
• If you are taking diuretics (water pills), your doctor may discontinue or reduce the dose of your diuretic before starting Polpril.

Prevention of heart attack or stroke

• The usual starting dose is 2.5 mg once daily.
• Your doctor may decide to increase the dose.
• The usual dose is 10 mg once daily.

Slowing or delaying worsening of kidney function

• The usual starting dose is 1.25 mg or 2.5 mg once daily.
• Your doctor may adjust the dosage.
• The usual dose is 5 mg or 10 mg once daily.

Treatment of heart failure

• The usual starting dose is 1.25 mg once daily.
• Your doctor may adjust the dosage.
• The maximum dose is 10 mg per day. It is preferable to divide the daily dose into two administrations.

Treatment after heart attack

• The usual starting dose is 1.25 mg to 2.5 mg once daily.
• Your doctor may adjust the dosage.
• The usual dose is 10 mg per day. It is preferable to divide the daily dose into two administrations.

Elderly patients
The starting dose should be lower, and dose escalation should be more gradual.

Taking more Polpril than prescribed
Contact your doctor immediately or go to the nearest hospital emergency department. Do not drive yourself; ask someone to take you to the hospital or call an ambulance. Bring the medicine packaging with you so the doctor knows which medicine was taken.

If you miss a dose of Polpril

• If you miss a dose, take the next scheduled dose as planned.
• Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following serious adverse effects occur, treatment with Polpril must be stopped
and medical advice must be sought immediately – prompt treatment may be necessary:

• swelling of the face, lips or throat causing difficulty in swallowing or breathing, together with itching and rash. These may be symptoms of a severe allergic reaction to Polpril.
• severe skin reactions, including rashes, oral mucosal ulcers, worsening of pre-existing skin disorders, redness, blisters or skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

If any of the following symptoms occur, contact your doctor promptly:

• increased heart rate, irregular or forceful heartbeat (palpitations), chest pain, chest tightness or more serious conditions, including heart attack or stroke.
• shortness of breath or cough. These may indicate lung disorders.
• easy bruising, prolonged bleeding time, any signs of bleeding (e.g. bleeding gums), purpuric skin spots, or increased frequency of infections, sore throat, fever, fatigue, weakness, dizziness or pale skin. These may indicate blood or bone marrow disorders.
• severe abdominal pain which may radiate to the back. This may be a symptom of pancreatitis.
• fever, chills, weakness, loss of appetite, abdominal pain, nausea, yellowing of the skin or whites of the eyes (jaundice). These may be symptoms of liver disorders such as hepatitis or liver damage.

Other adverse effects
Inform your doctor if any of the following symptoms become severe or persist for more than a few days.
Common (occur in less than 1 in 10 patients)

• headache or feeling of fatigue
• dizziness. The risk is higher at the beginning of Polpril treatment and after dose increase.
• fainting, hypotension (abnormally low blood pressure), especially when standing up or after a rapid change from lying to sitting or standing position.
• dry, persistent cough, sinusitis or bronchitis, shortness of breath
• abdominal pain, diarrhoea, indigestion, nausea or vomiting
• rash with or without raised lesions
• chest pain
• muscle cramps or pain
• elevated blood potassium levels detected in laboratory tests.

Uncommon (occur in less than 1 in 100 patients)

• balance disorders (dizziness)
• itching and sensory disturbances such as numbness, tingling, pricking, burning or crawling sensations on the skin (paresthesia)
• loss or disturbance of taste sensation
• sleep disturbances
• depression, anxiety, nervousness or restlessness
• nasal congestion, breathing difficulties or worsening of asthma
• intestinal swelling known as "intestinal angioedema", presenting with abdominal pain, vomiting and diarrhoea
• heartburn, constipation or dry mouth
• increased frequency of urination during the day
• excessive sweating
• loss or decrease in appetite (anorexia)
• rapid or irregular heartbeat
• swelling of hands and feet. These may be symptoms of increased fluid retention.
• hot flushes
• blurred vision
• joint pain
• fever
• impotence, decreased libido in men and women
• increased number of certain white blood cells (eosinophilia) in blood tests
• blood test results indicating changes in liver, pancreas or kidney function.

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

• feelings of uneasiness, disorientation, confusion
• red, swollen tongue
• severe skin peeling, itchy nodular rash
• nail disorders (e.g. loosening or separation of the nail from the nail bed)
• skin rash or purpura
• skin spots and cold extremities
• redness, itching, swelling and tearing of the eyes
• hearing disturbances and tinnitus
• weakness
• decreased number of red blood cells, white blood cells or platelets, or decreased haemoglobin levels in blood tests.

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

• photosensitivity (increased sensitivity to sunlight).

Other reported adverse effects:
Inform your doctor if any of the following symptoms become severe or persist for more than a few days.

• difficulty concentrating
• swelling of the lips
• detection of abnormally low blood cell counts in blood tests
• detection of abnormally low sodium levels in blood tests
• concentrated urine (dark-coloured), nausea or vomiting, muscle cramps, confusion and seizures, which may result from inappropriate antidiuretic hormone (ADH, vasopressin) secretion. If any of these symptoms occur, seek medical advice immediately.
• colour change in fingers upon cold exposure, accompanied by tingling or pain upon warming (Raynaud's phenomenon)
• breast enlargement in men
• slowed or impaired reactions
• burning sensation
• disturbances of smell
• hair loss.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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://s.mz.ezdrowie.gov.pl
Adverse effects can also be reported to the Marketing Authorisation Holder.
Reporting adverse effects helps to provide 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 stated month. The marking on the blister labeled EXP indicates the expiry date, and LOT/LOT indicates the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This practice helps protect the environment.

6. Contents of the pack and other information

What Polpril contains

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

What Polpril looks like and contents of the pack
Polpril is packed in blisters containing 28 capsules.
2.5 mg: Capsules with a light green cap (marked 'R') and light grey body (marked '2.5'). The capsules contain a white or almost white powder.
5 mg: Capsules with a green cap (marked 'R') and light grey body (marked '5'). The capsules contain a white or almost white powder.
10 mg: Capsules with a dark green cap (marked 'R') and light grey body (marked '10'). The capsules contain a white or almost white powder.

Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA SA
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01