Lisiprol

Leaflet accompanying the packaging: patient information

LISIPROL, 5 mg, tablets
LISIPROL, 10 mg, tablets
LISIPROL, 20 mg, tablets
(Lisinopril)

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Lisiprol and what is it used for

Lisiprol contains the active substance lisinopril. It belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).
Lisiprol can be used for the following diseases:

• treatment of high blood pressure (hypertension);
• treatment of heart failure;
• treatment after a recent heart attack;
• treatment of kidney problems caused by type 2 diabetes in patients with high blood pressure.

The action of Lisiprol is based on the dilation of blood vessels. This helps to reduce blood pressure and make it easier for the heart to pump blood to all parts of the body.

2. Important information before taking Lisiprol

When not to take Lisiprol:

• if you are allergic (hypersensitive) to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if you have ever had an allergic reaction when taking another ACE inhibitor. An allergic reaction can cause swelling of the hands, feet, ankles, face, lips, tongue, or throat. It can also cause difficulty swallowing or breathing (angioedema);
• if a family member has had severe allergic reactions (angioedema)

when taking any ACE inhibitor or if you have had severe allergic reactions (angioedema) of unknown cause;

• after the 3rd month of pregnancy (you should also avoid taking Lisiprol in early pregnancy - see "Pregnancy"); if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren;
• if you are taking a combination of sacubitril and valsartan (used to treat a certain type of long-term (chronic) heart failure in adults), as the risk of angioedema (rapid swelling of the subcutaneous tissue in areas such as the throat) increases.

In case of doubt, whether any of the above conditions apply to you, consult your doctor or pharmacist before taking Lisiprol.
If you experience a dry cough that persists for a long time after starting Lisiprol, tell your doctor.

Warnings and precautions

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

• if you have narrowing (stenosis) of the aorta (the main artery that carries blood from the heart) or narrowing of the heart valves (mitral valve);
• if you have narrowing (stenosis) of the renal artery;
• if you have increased thickness of the heart muscle (hypertrophic cardiomyopathy);
• if you have vascular disorders (collagen disease);
• if you have low blood pressure, felt as dizziness or fainting, especially when standing up;
• if you have kidney problems or are undergoing dialysis;
• if you have liver problems;
• if you have diabetes;
• if you are taking any of the following medicines, as there is an increased risk of angioedema (sudden swelling of the tissue in areas such as the throat):
• racecadotril, used to treat diarrhea,
• medicines used to prevent the rejection of a transplanted organ and to treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• wildagliptin, used to treat diabetes;
• tissue plasminogen activator (a medicine that dissolves blood clots), usually given in a hospital;
• if you are 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 you have kidney problems related to diabetes,
• aliskiren. Your doctor may regularly check your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood. See also "When not to take Lisiprol".
• if you have recently had diarrhea or vomiting;
• if you have been advised by your doctor to reduce your salt intake;
• if you have high cholesterol levels and are undergoing a procedure called "LDL apheresis" (a treatment used to lower very high cholesterol levels in the blood);
• if you suspect or plan to become pregnant. It is not recommended to take Lisiprol in early pregnancy and it should not be taken after the 3rd month of pregnancy, as it may seriously harm the baby (see "Pregnancy and breastfeeding");
• if you are black, as lisinopril may be less effective in people of this race. Also, in people of black race, angioedema (a severe allergic reaction) may occur more frequently.

In case of doubt, whether any of the above conditions apply to you, consult your doctor or pharmacist before taking Lisiprol.
Allergy treatment, such as bee sting allergy
Tell your doctor if you are undergoing or planning to undergo desensitization treatment for allergies (e.g., bee stings). Taking Lisiprol during such treatment may cause severe allergic reactions.
Surgical procedures
Tell your doctor or dentist that you are taking Lisiprol if you are planning to have surgery (including dental surgery). Low blood pressure (hypotension) may occur during anesthesia.

Children and adolescents

Lisiprol has been studied in children. Consult your doctor for more information. It is not recommended to take Lisiprol in children under 6 years of age and in children with severe kidney problems.

Lisiprol and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take.
Lisiprol may affect the action of other medicines, and other medicines may affect the action of Lisiprol. Your doctor may recommend a dose change and/or other precautions.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• other blood pressure-lowering medicines;
• angiotensin II receptor antagonist (AIIRA) or aliskiren (see also "When not to take Lisiprol" and "Warnings and precautions");
• diuretics;
• beta-blockers, such as atenolol and propranolol;
• nitrates (used to treat heart disease);
• non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain and inflammation of the joints;
• aspirin (acetylsalicylic acid) in a dose greater than 3 g per day;
• medicines used to treat depression and mental disorders, including lithium; potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ rejection; and heparin, a medicine used to thin the blood to prevent clots);
• insulin or oral antidiabetic medicines;
• anti-asthmatic medicines;
• medicines used to treat nasal congestion or sinusitis, or other medicines used to treat colds (including over-the-counter medicines);
• immunosuppressive medicines;
• allopurinol (used to treat gout);
• procainamide (used to treat heart rhythm disorders);
• medicines containing gold compounds, such as aurothioglucose, given by injection.

The following medicines may increase the risk of angioedema (symptoms of angioedema include swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing):

• medicines that dissolve blood clots (tissue plasminogen activator), usually given in a hospital;
• medicines used to prevent the rejection of a transplanted organ and to treat cancer (e.g., sirolimus, everolimus) and other medicines belonging to the group of so-called mTOR inhibitors - see "Warnings and precautions";
• wildagliptin, used to treat diabetes;
• racecadotril, used to treat diarrhea.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Tell your doctor if you suspect or plan to become pregnant. Your doctor will usually recommend stopping Lisiprol before planned pregnancy or as soon as possible after becoming pregnant, and will recommend an alternative treatment instead of Lisiprol. It is not recommended to take Lisiprol in early pregnancy and it should not be taken after the 3rd month of pregnancy, as it may seriously harm the baby if taken during this period.
Breastfeeding
Tell your doctor if you are breastfeeding or plan to breastfeed. It is not recommended to take Lisiprol while breastfeeding, as your doctor may recommend an alternative treatment if you want to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

• Some people may feel dizzy or tired when taking this medicine. If you experience such symptoms, do not drive, use tools, or operate machinery.
• Before performing these activities, you should know how you react to the medicine.

3. How to take Lisiprol

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
If you have already started taking Lisiprol, your doctor may perform blood tests. Your doctor may then adjust the dose accordingly for you.
Taking the medicine

• Swallow the tablet with water.
• Try to take the medicine at the same time every day. It does not matter whether you take Lisiprol before or after food.
• Take Lisiprol for as long as your doctor recommends. The treatment is long-term. It is important to take the medicine every day.

First dose

• Be careful when taking the first dose or increasing the dose. A greater decrease in blood pressure may occur than with subsequent doses.
• Dizziness or fainting may occur. If you experience such symptoms, it may be helpful to lie down. If you have any doubts, consult your doctor as soon as possible.

Adults
The dose of Lisiprol depends on your health and other medicines you are taking. Your doctor will tell you how many tablets to take daily. If you have any doubts, consult your doctor or pharmacist.
High blood pressure

• The usual initial dose is 10 mg once daily.
• The usual dose for long-term treatment is 20 mg once daily.

Heart failure

• The usual initial dose is 2.5 mg once daily.
• The dose for long-term treatment is 5 mg to 35 mg once daily.

Post-heart attack

• The usual initial dose is 5 mg within 24 hours after the heart attack and 5 mg the next day.
• The usual dose for long-term treatment is 10 mg once daily.

Kidney problems caused by diabetes

• The usual dose is 10 mg or 20 mg once daily.

In elderly patients, with kidney problems, or taking diuretics, your doctor may recommend a lower dose than usual.

Use in children and adolescents

Children and adolescents (aged 6 to 16) with high blood pressure

• It is not recommended to take Lisiprol in children under 6 years of age or in children with severe kidney problems.
• Your doctor will determine the appropriate dose of Lisiprol, which depends on the child's body weight.
• In children with a body weight of 20 to 50 kg, the usual initial dose is 2.5 mg once daily.
• In children with a body weight over 50 kg, the usual initial dose is 5 mg once daily.

Taking a higher dose of Lisiprol than recommended

If you take more Lisiprol than recommended by your doctor, contact your doctor or go to the hospital immediately. The most likely symptoms that may occur are dizziness and palpitations.

Missing a dose of Lisiprol

If you miss a dose of Lisiprol, take it as soon as possible, unless it is almost time for the next dose, in which case skip the missed dose.
Do not take a double dose to make up for the missed dose.

Stopping Lisiprol

Do not stop taking Lisiprol, even if you feel well, and take it for as long as your doctor recommends.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following reactions, stop taking Lisiproland contact your doctor immediately.

• Severe allergic reactions (rare, may occur in up to 1 in 1000 patients). Symptoms may have a sudden onset:
• swelling of the face, lips, tongue, or throat, which may cause difficulty swallowing;
• severe or sudden swelling of the hands, feet, and ankles;
• difficulty breathing;
• severe itching of the skin (with hives).
• Severe skin disorders, such as sudden, unexpected rash or burning, redness, or peeling of the skin (very rare, may occur in up to 1 in 10,000 patients).
• Infection with symptoms such as fever and severe deterioration of general condition or fever with local symptoms of infection, such as sore throat or mouth, or urinary tract disorders (very rare, may occur in up to 1 in 10,000 patients).

Other possible side effects:
Common(may occur in up to 1 in 10 patients):

• headache;
• dizziness or fainting, especially when standing up;
• diarrhea;
• dry cough that does not go away;
• vomiting;
• kidney problems (detected in blood tests).

Uncommon(may occur in up to 1 in 100 patients):

• mood changes;
• changes in the color of the fingers or toes (cyanosis, followed by redness) or numbness or tingling of the fingers;
• changes in taste;
• feeling sleepy;
• peripheral dizziness;
• difficulty sleeping;
• stroke;
• rapid heartbeat;
• nasal congestion;
• nausea;
• abdominal pain or indigestion;
• skin rash or itching;
• impotence;
• fatigue or weakness;
• significant decrease in blood pressure may occur in people with the following conditions: coronary artery disease; aortic stenosis (the artery that carries blood from the heart), renal artery stenosis, or heart valve stenosis. In case of hypotension, you may feel dizzy or faint, especially when standing up;
• changes in blood test results evaluating liver and kidney function;
• heart attack;
• visual and/or auditory hallucinations.

Rare(may occur in up to 1 in 1000 patients):

• feeling disoriented;
• hives;
• dryness of the mucous membranes of the mouth;
• hair loss;
• psoriasis (skin disorder);
• changes in the sense of smell;
• breast enlargement in men;
• changes in some blood cells or other blood components. Your doctor may periodically recommend blood tests to check the effect of Lisiprol on your blood parameters. Possible symptoms include feeling tired, pale skin, sore throat, high temperature (fever), joint or muscle pain, swelling of the joints or lymph nodes, or increased sensitivity to sunlight;
• low sodium levels in the blood (symptoms may include: feeling tired, headache, nausea, vomiting);
• syndrome of inappropriate antidiuretic hormone secretion (SIADH);
• sudden kidney failure.

Very rare(may occur in up to 1 in 10,000 patients):

• sinusitis (pain and pressure in the area of the cheeks and eyes);
• wheezing;
• low blood sugar (hypoglycemia). Symptoms may include: feeling hungry or weak, sweating, and rapid heartbeat;
• pneumonia. Symptoms include: cough, shortness of breath, and high temperature (fever);
• jaundice (yellowing of the skin or whites of the eyes);
• hepatitis. This can cause loss of appetite, yellowing of the skin and eyes, and dark urine;
• pancreatitis, causing moderate to severe abdominal pain;
• severe skin diseases. Symptoms include: redness, blistering, and peeling;
• sweating;
• reduced or absent urine production;
• liver failure;
• hives;
• gastroenteritis;
• bone marrow suppression, anemia, decreased platelet count (thrombocytopenia), decreased white blood cell count (neutropenia, leukopenia), decreased white blood cell count (agranulocytosis), which increases the risk of infection, lymph node disease;
• a disease in which the immune system (which protects the body against diseases) does not recognize healthy cells and attacks them. This condition is called an autoimmune disease.

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

• symptoms of depression;
• fainting.

Side effects in children seem to be similar to those in adults.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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,
e-mail: ndl@urpl.gov.pl
Side effects can also be reported 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 Lisiprol

This medicine should be stored out of the sight and reach of children.
Store in the original packaging.
Do not use this medicine after the expiry date stated on the packaging after "Expiry date". The expiry date refers to the last day of the month.
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 packaging and other information

What Lisiprol contains

The active substance of Lisiprol is lisinopril in the form of lisinopril dihydrate.
Each tablet contains 5 mg, 10 mg, or 20 mg of lisinopril.
The other ingredients are: mannitol, calcium hydrogen phosphate dihydrate, cornstarch, magnesium stearate, talc.

What Lisiprol looks like and contents of the pack

Lisiprol 5 mg
White or almost white, round, flat, tablets with beveled edges, approximately 6 mm in diameter, with the marking "5" on one side and a score line on the other. The tablet can be divided into equal doses.
Lisiprol 10 mg
White or almost white, square, biconvex tablets, approximately 7 mm in diameter, with the marking "10" on one side and a score line on the other. The tablet can be divided into equal doses.
Lisiprol 20 mg
White or almost white, pentagonal, biconvex tablets, approximately 8.5 mm in diameter, with the marking "20" on one side and a score line on the other. The tablet can be divided into equal doses.
Packaging available: 28 or 56 tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki, Poland
tel.: (22) 755 50 81

Manufacturer

GEDEON RICHTER Plc.
Gyömrői út 19-21,
1103 Budapest, Hungary
To obtain more detailed information, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22)755 96 48
lekalert@grodzisk.rgnet.org
fax: +48 (22) 755 96 24

Date of last revision of the leaflet: