Lisiprol

Package Leaflet: Information for the Patient

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

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package 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 pack 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 conditions:

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

The action of Lisiprol is to widen the blood vessels. This helps to lower blood pressure and makes 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:

while taking any ACE inhibitor or if you have had a severe allergic reaction (angioedema) of unknown cause;

• after the 3rd month of pregnancy (you should also avoid taking Lisiprol during early pregnancy - see section "Pregnancy"); if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren;

If you are unsure 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 taking Lisiprol, discuss with your doctor or pharmacist:

• racecadotril, used to treat diarrhea,
• medicines used to prevent transplant rejection 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;
• 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 blood electrolyte levels (e.g., potassium). See also section "When not to take Lisiprol".
• if you suspect or plan to become pregnant. It is not recommended to take Lisiprol during early pregnancy and it should not be taken after the 3rd month of pregnancy, as it may seriously harm the baby (see section "Pregnancy and breastfeeding");

If you are unsure whether any of the above conditions apply to you, consult your doctor or pharmacist before taking Lisiprol.
Allergy treatment, such as desensitization to insect venom
Tell your doctor if you are undergoing or planning to undergo desensitization treatment to reduce allergic reactions to insect venom. 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 or 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 might take.
Lisiprol may affect the way other medicines work, and other medicines may affect the way Lisiprol works. Your doctor may need to change your dose and/or take 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 sections "When not to take Lisiprol" and "Warnings and precautions");
• diuretics (water tablets);
• beta-blockers, such as atenolol and propranolol;
• nitrates (used to treat heart conditions);
• non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain and inflammation of the joints;
• aspirin (acetylsalicylic acid) in doses 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; cyclosporin, an immunosuppressant used to prevent transplant rejection; and heparin, a medicine used to thin the blood to prevent clots);
• insulin or oral antidiabetic medicines;
• asthma medicines;
• medicines used to treat nasal congestion or sinusitis, or other medicines used to treat colds (including over-the-counter medicines);
• immunosuppressants;
• allopurinol (used to treat gout);
• procainamide (used to treat irregular heartbeat);
• 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 transplant rejection and to treat cancer (e.g., sirolimus, everolimus) and other medicines belonging to the group of mTOR inhibitors - see section "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 are pregnant or think you may be pregnant. Your doctor will usually advise you to stop taking Lisiprol before you become pregnant or as soon as you find out you are pregnant, and will advise you to take a different medicine instead of Lisiprol. It is not recommended to take Lisiprol during 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 advise you to take a different 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 while taking this medicine. If you experience these 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 exactly as your doctor or pharmacist has told you.
If you are unsure, ask your doctor or pharmacist.
If you have already started taking Lisiprol, your doctor may perform blood tests. Your doctor may then adjust your dose accordingly.
Taking the medicine

• Swallow the tablet with water.
• Try to take the medicine at the same time each day. It does not matter whether you take Lisiprol before or after food.
• Take Lisiprol for as long as your doctor tells you to. 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. There may be a greater decrease in blood pressure than with subsequent doses.
• You may feel dizzy or faint. If you experience these symptoms, it may help to lie down. If you have any doubts, contact your doctor as soon as possible.

Adults
The dose of Lisiprol depends on your condition and other medicines you are taking. Your doctor will tell you how many tablets to take each day. If you are unsure, ask your doctor or pharmacist.
High blood pressure

• The usual starting dose is 10 mg once a day.
• The usual long-term dose is 20 mg once a day.

Heart failure

• The usual starting dose is 2.5 mg once a day.
• The long-term dose is 5 mg to 35 mg once a day.

Post-myocardial infarction

• The usual starting dose is 5 mg within 24 hours of myocardial infarction and 5 mg the next day.
• The usual long-term dose is 10 mg once a day.

Kidney problems caused by diabetes

• The usual dose is 10 mg or 20 mg once a day.

In elderly patients, with kidney problems, or taking diuretics, your doctor may advise 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 weight.
• In children weighing between 20 and 50 kg, the usual starting dose is 2.5 mg once a day.
• In children weighing more than 50 kg, the usual starting dose is 5 mg once a day.

Overdose

If you take more Lisiprol than you should, contact your doctor or go to the hospital immediately. The most likely symptoms are dizziness and rapid heartbeat.

Missed dose

If you forget to take a dose of Lisiprol, take it as soon as you remember, unless it is almost time for your next dose. In this case, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.

Stopping treatment

Do not stop taking Lisiprol, even if you feel better, and take it for as long as your doctor tells you to.
If you have any further questions on the use of this product, ask 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, stop taking Lisiprol and contact your doctor immediately.

• Severe allergic reactions (rare, may affect up to 1 in 1,000 people). Symptoms may start suddenly:
• swelling of the face, lips, tongue, or throat, which may cause difficulty swallowing;
• severe or sudden swelling of the hands, feet, or 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 affect up to 1 in 10,000 people).
• 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 ulcers, or urinary tract disorders (very rare, may affect up to 1 in 10,000 people).

Other possible side effects:
Common(may affect up to 1 in 10 people):

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

Uncommon(may affect up to 1 in 100 people):

• mood changes;
• changes in the color of the fingers or toes (pale, then red) or numbness or tingling of the fingers;
• changes in taste;
• drowsiness;
• 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 (narrowing of the artery that carries blood from the heart), renal artery stenosis, or heart valve problems. If you experience low blood pressure, you may feel dizzy or faint, especially when standing up;
• changes in blood test results for liver and kidney function;
• heart attack;
• visual and/or auditory hallucinations.

Rare(may affect up to 1 in 1,000 people):

• disorientation;
• hives;
• dryness of the mucous membranes;
• hair loss;
• psoriasis (skin disorder);
• changes in sense of smell;
• breast enlargement in men;
• changes in certain blood cells or other blood components. Your doctor may periodically recommend blood tests to check the effect of Lisiprol on your blood. Possible symptoms include feeling tired, pale skin, sore throat, high temperature (fever), joint or muscle pain, swollen 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 affect up to 1 in 10,000 people):

• sinusitis (pain and pressure in 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);
• yellowing of the skin or whites of the eyes (jaundice);
• hepatitis. This may 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 depression, anemia, low platelet count (thrombocytopenia), low white blood cell count (neutropenia, leucopenia), low 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 disease) 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 appear to be similar to those in adults.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist, or nurse.
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, 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

Keep this medicine out of the sight and reach of children.
Store in the original package.
Do not use this medicine after the expiry date which is stated on the packaging after "Expiry date". The expiry date refers to the last day of that 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 pack and other information

What Lisiprol contains

The active substance 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, maize starch, 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 side. 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 side. 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 side. The tablet can be divided into equal doses.
Pack sizes: 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
For more 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: