Lisiprol

Package leaflet: Information for the patient

LISIPROL, 5 mg, tablets
LISIPROL, 10 mg, tablets
LISIPROL, 20 mg, tablets
(Lisinoprilum)
Please read this leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Lisiprol is and what it is 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 Lisiprol is and what it is used for

Lisiprol contains the active substance called lisinopril. It belongs to a group of medicines known as
ACE inhibitors (angiotensin-converting enzyme inhibitors).
Lisiprol may be used in the following conditions:

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

Lisiprol works by relaxing blood vessels. This helps lower blood pressure and makes it easier for the heart to pump blood to all parts of the body.

2. Important information before using Lisiprol

When not to use Lisiprol:

• if the patient is allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has ever had an allergic reaction while taking another ACE inhibitor. An allergic reaction may cause swelling of the hands, feet, ankles, face, lips, tongue or throat. It may also cause difficulty swallowing or breathing (angioedema);
• if a family member has had severe allergic reactions (angioedema) while taking any ACE inhibitor or if the patient has had severe allergic reactions (angioedema) of unknown cause;
• after the 3rd month of pregnancy (Lisiprol should also be avoided during early pregnancy – see section "Pregnancy"); if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren;
• if the patient is taking or has taken a combination medicine containing sacubitril and valsartan (used to treat certain types of chronic (long-term) heart failure in adults), because the risk of angioedema (rapid swelling of the subcutaneous tissue, e.g. in the throat) is increased.

If in doubt whether any of the above conditions apply to the patient, contact a doctor or pharmacist before using Lisiprol.
If the patient develops a dry cough that persists for a long time after starting Lisiprol, inform the doctor.

Warnings and precautions

Before starting Lisiprol, discuss with your doctor or pharmacist:

• if the patient has narrowing (stenosis) of the aorta (the main artery carrying blood from the heart) or narrowing of heart valves (mitral valve);
• if the patient has narrowing (stenosis) of the renal artery;
• if the patient has thickening of the heart muscle (hypertrophic cardiomyopathy);
• if the patient has blood vessel disorders (vascular diseases such as collagenoses);
• if the patient has low blood pressure, experienced as dizziness or lightheadedness, especially when standing up;
• if the patient has kidney problems or is undergoing dialysis;
• if the patient has liver problems;
• if the patient has diabetes;
• if the patient is taking any of the following medicines, because the risk of angioedema (sudden swelling of tissue, e.g. in the throat) is increased:
  • racecadotril, used to treat diarrhoea,
  • medicines used to prevent organ transplant rejection and in cancer treatment (e.g. temsirolimus, sirolimus, everolimus);
  • vildagliptin, used to treat diabetes;
  • tissue plasminogen activator (a medicine dissolving blood clots), usually administered in hospital;
• if the patient is taking any of the following medicines used to treat high blood pressure:
  • an angiotensin II receptor antagonist (AIIRA), also known as a sartan – for example valsartan, telmisartan, irbesartan, especially if the patient has kidney problems related to diabetes,
  • aliskiren. The doctor may regularly monitor kidney function, blood pressure and blood electrolyte levels (e.g. potassium). See also section "When not to use Lisiprol".
• if the patient has recently had diarrhoea or vomiting;
• if the patient has been advised by a doctor to restrict salt intake;
• if the patient has high cholesterol and is undergoing a procedure called "LDL apheresis" (a treatment used to reduce very high blood cholesterol levels);
• inform the doctor if pregnancy is suspected or planned. Lisiprol is not recommended during early pregnancy and must not be taken after the 3rd month of pregnancy, as it may seriously harm the unborn child (see section "Pregnancy and breastfeeding");
• if the patient is of Black race, as lisinopril may be less effective in people of this race. Also, in people of Black race, the adverse reaction called "angioedema" (severe allergic reaction) may occur more frequently.

If in doubt whether any of the above conditions apply to the patient, contact a doctor or pharmacist before using Lisiprol.

Treatment of allergies, such as insect venom allergy

Inform the doctor if desensitisation treatment (allergy shots) for insect venom allergy is being or is planned to be administered. Taking Lisiprol during such treatment may cause severe allergic reactions.

Surgical procedures

Inform the doctor or dentist about taking Lisiprol if a surgical procedure (including dental surgery) is planned. Low blood pressure (hypotension) may occur during local or general anaesthesia when the patient is taking Lisiprol.

Children and adolescents

The use of Lisiprol in children has been studied. Contact a doctor for further information. Lisiprol is not recommended for children under 6 years of age and for children with severe kidney problems.

Lisiprol and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Lisiprol may affect the action of other medicines, and other medicines may affect the action of Lisiprol. The doctor may recommend changing the dose and/or taking other precautions.

In particular, inform the doctor or pharmacist if the patient is taking any of the following medicines:

• other medicines that lower blood pressure;
• an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections "When not to use 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 joint inflammation;
• aspirin (acetylsalicylic acid) at doses higher than 3 g per day;
• medicines used to treat depression and psychiatric disorders, including lithium; potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (e.g. trimethoprim and co-trimoxazole, used in bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots);
• insulin or oral antidiabetic medicines;
• anti-asthma medicines;
• medicines used for nasal or sinus congestion, or other cold remedies (including over-the-counter medicines);
• medicines that suppress the immune response (immunosuppressants);
• allopurinol (used to treat gout);
• procainamide (used for heart rhythm disorders);
• gold-containing medicines, such as sodium aurothiomalate, administered 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):

• clot-dissolving medicines (tissue plasminogen activator), usually administered in hospital;
• medicines most commonly used to prevent organ transplant rejection (sirolimus, everolimus) and in cancer treatment (temsirolimus), and other medicines belonging to the group of so-called mTOR inhibitors – see section "Warnings and precautions";
• vildagliptin, used to treat diabetes;
• racecadotril, used to treat diarrhoea.

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 a doctor or pharmacist before using this medicine.

Pregnancy

Inform the doctor if pregnancy is suspected or planned. Usually, the doctor will advise stopping Lisiprol before a planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine. Lisiprol is not recommended during early pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child if used during this period.

Breastfeeding

Inform the doctor if the patient is breastfeeding or intends to breastfeed. Lisiprol is not recommended for breastfeeding mothers. The doctor may recommend alternative treatment if the patient wishes to breastfeed, especially if the baby is a newborn or premature.

Driving and operating machinery

• Some people may experience dizziness or fatigue while taking this medicine. If such symptoms occur, do not drive, use tools or operate machinery.
• Before engaging in these activities, the patient should assess their individual response to the medicine.

3. How to take Lisiprol

This medicine should always be taken exactly 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 carry out blood tests. Your doctor may
then adjust the dose according to your individual needs.

Taking the medicine

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

Taking the first dose

• Be cautious when taking the first dose or when the dose is increased, as a greater drop in blood pressure may occur compared to subsequent doses.
• Dizziness or lightheadedness may occur. If such symptoms occur, lying down may help. In case of any concerns, contact your doctor as soon as possible.

Adults
The dose of the medicine depends on the patient's health condition and other medicines being taken. Your doctor will advise how many tablets to take each day. If in doubt, consult your doctor or pharmacist.

High blood pressure

• The usual recommended starting dose is 10 mg once daily.
• The usual maintenance dose is 20 mg once daily.

Heart failure

• The usual recommended starting dose is 2.5 mg once daily.
• The usual maintenance dose ranges from 5 mg to 35 mg once daily.

After a heart attack

• The usual recommended starting dose is 5 mg within 24 hours after the heart attack, followed by 5 mg the next day.
• The usual maintenance dose is 10 mg once daily.

Diabetic kidney disease

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

For elderly patients, patients with impaired kidney function, or those taking diuretics, your doctor may recommend a lower than usual dose.

Use in children and adolescents
Children and adolescents (aged 6 to 16 years) with high blood pressure

• Lisiprol is not recommended for children under 6 years of age or for children with severe kidney problems.
• Your doctor will determine the appropriate dose based on the child's body weight.
• For children weighing between 20 and 50 kg, the usual recommended starting dose is 2.5 mg once daily.
• For children weighing more than 50 kg, the usual recommended starting dose is 5 mg once daily.

Taking more Lisiprol than recommended
If you take more Lisiprol than prescribed, contact your doctor immediately or go to the nearest hospital. The most likely symptoms include dizziness and palpitations.

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

Stopping Lisiprol
Do not stop taking Lisiprol, even if you feel well, and continue taking it for as long as your doctor recommends.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following reactions occur, the medicine Lisiprol must be discontinued
and you should contact your doctor immediately.

• Severe allergic reactions (rare, may occur in up to 1 in 1,000 patients). Symptoms may begin suddenly:
• swelling of the face, lips, tongue or throat, which may cause difficulty in swallowing;
• severe or sudden swelling of the hands, feet and ankles;
• difficulty breathing;
• severe skin itching (with skin rash).
• Severe skin disorders, such as sudden, unexpected rash or burning sensation, 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 worsening of general condition or fever with local signs of infection such as sore throat or mouth, or urinary tract disturbances (very rare, may occur in up to 1 in 10,000 patients).

Other possible adverse reactions:
Common (may occur in up to 1 in 10 patients):

• headache;
• dizziness or lightheadedness, especially when standing up quickly;
• diarrhoea;
• dry cough that does not go away;
• vomiting;
• kidney-related disorders (detected in blood test results).

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

• mood changes;
• changes in the colour of fingers or toes (bluish discoloration followed by redness) or numbness or tingling in the fingers;
• changes in taste sensation;
• drowsiness;
• peripheral dizziness;
• difficulty falling asleep;
• stroke;
• rapid heartbeat;
• nasal inflammation;
• nausea;
• abdominal pain or indigestion;
• skin rash or itching;
• inability to achieve erection (impotence);
• fatigue or weakness;
• significant drop in blood pressure may occur in patients with the following conditions: ischaemic heart disease; aortic stenosis (the artery carrying blood from the heart), renal artery sten0sis or heart valve stenosis; hypertrophy of the heart muscle. In case of hypotension, patients may experience dizziness or lightheadedness, especially when standing up quickly;
• changes in blood test results assessing liver and kidney function;
• myocardial infarction;
• visual and (or) auditory hallucinations.

Rare (may occur in up to 1 in 1,000 patients):

• feeling of disorientation;
• nodular rash (urticaria);
• dryness of the oral mucosa;
• hair loss;
• psoriasis (a skin disorder);
• changes in smell perception;
• breast enlargement in men;
• changes in certain blood cells or other blood components. Your doctor may periodically recommend blood tests to monitor the effect of Lisiprol on blood parameters. Possible symptoms include feeling tired, pale skin, sore throat, high temperature (fever), joint and muscle pain, swelling of joints or lymph nodes, or photosensitivity;
• low blood sodium levels (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 cheek and eye area);
• wheezing;
• low blood sugar levels (hypoglycaemia). 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 upper abdominal pain;
• severe skin diseases. Symptoms include redness, blistering and peeling;
• sweating;
• reduced urine output or absence of urine;
• liver failure;
• nodules;
• intestinal inflammation;
• bone marrow suppression, anaemia, reduced platelet count (thrombocytopenia), reduced white blood cell count (neutropenia, leukopenia), reduced number of white blood cells (agranulocytosis), increasing the risk of infection, lymph node disease;
• a condition in which the immune system (which protects the body from disease) fails to recognize healthy cells and attacks them. This disorder is known as autoimmune disease.

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

• symptoms of depression;
• fainting.

Adverse reactions in children appear to be similar to those in adults.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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: [email protected]
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Lisiprol

This medicine should be stored out of the sight and reach of children.
Keep 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 stated month.
Medicines must 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, respectively.
The other ingredients are: mannitol, calcium hydrogen phosphate dihydrate, corn starch, magnesium stearate, talc.

What Lisiprol looks like and contents of the pack
Lisiprol 5 mg
White or almost white, round, flat tablets with bevelled edges, approximately 6 mm in diameter, marked with "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, marked with "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, marked with "20" on one side and a score line on the other. The tablet can be divided into equal doses.

Available pack sizes: 28 or 56 tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation 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 further 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
[email protected]
fax: +48 (22) 755 96 24