Lisihexal 20

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
LisiHEXAL 20 (Lisinopril 20 - 1 A Pharma), 20 mg, tablets
Lisinoprilum
LisiHEXAL 20 and Lisinopril 20 - 1 A Pharma are different brand names of the same medicine.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What LisiHEXAL 20 is and what it is used for
2. Important information before taking LisiHEXAL 20
3. How to take LisiHEXAL 20
4. Possible side effects
5. How to store LisiHEXAL 20
6. Contents of the pack and other information

1. What LisiHEXAL 20 is and what it is used for

LisiHEXAL 20 contains as the active substance lisinopril – a medicine belonging to the group of so-called angiotensin-converting enzyme (ACE) inhibitors, which reduce arterial blood pressure.
Indications for the use of LisiHEXAL 20 are:

• essential and renovascular hypertension, regardless of severity;
• congestive heart failure;
• acute myocardial infarction in hemodynamically stable patients without cardiogenic shock, with arterial blood pressure above 100 mmHg;
• microalbuminuria in diabetes.

2. Important information before using LisiHEXAL 20

When not to use LisiHEXAL 20

• if the patient is allergic to lisinopril, to another angiotensin-converting enzyme (ACE) inhibitor, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has angioedema: hereditary or idiopathic angioedema, or if angioedema occurred previously during treatment with ACE inhibitors;
• if the patient is pregnant;
• if the patient has diabetes or kidney function disorders and is taking a blood pressure-lowering medicine containing aliskiren;
• if the patient has taken or is currently taking a combination medicine containing sacubitril and valsartan (used in the treatment of chronic (long-term) heart failure in adults), because the risk of angioedema (rapid swelling of the subcutaneous tissue, e.g. in the throat area) increases.

If in doubt whether any of the above situations apply to the patient, consult a
doctor or pharmacist.
Warnings and precautions
Before starting treatment with LisiHEXAL 20, discuss this with your doctor.
Tell your doctor if the patient is taking any of the following medicines, as
the risk of angioedema may increase:

• racecadotril, a medicine used to treat diarrhoea;
• medicines used to prevent organ transplant rejection and in cancer treatment (e.g. temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes.

Tell your doctor if the patient is taking any of the following medicines used
to treat high blood pressure:

• an angiotensin II receptor antagonist (AIIRA), so-called sartan – for example valsartan, telmisartan, irbesartan, especially if the patient has kidney function disorders associated with diabetes,
• aliskiren.

The doctor may recommend regular monitoring of kidney function, blood pressure, and blood levels of
electrolytes (e.g. potassium).
See also the section "When not to use LisiHEXAL 20".
Angioedema
Immediately inform the doctor if the patient experiences:

• swelling of the skin and (or) mucous membranes; swelling of the face, lips, throat, tongue or larynx; difficulty breathing or swallowing; itching or rash.

Swelling of the tongue, throat or larynx may cause airway obstruction. In such
a case, immediate treatment is necessary.
Patients who have previously experienced the symptoms described above have a higher risk of recurrence.
The incidence of angioedema after using ACE inhibitors is higher in black patients than in patients of other races.
The risk of angioedema is also higher in patients taking concomitant medicines such as mTOR kinase inhibitors (e.g. sirolimus, everolimus, temsirolimus – used to prevent organ transplant rejection or in cancer treatment) or
tissue plasminogen activator – see also section "LisiHEXAL 20 with other medicines".

Hypotension
Excessive reduction in blood pressure may occur in the following patients:

• on a low-salt diet;
• undergoing dialysis;
• with diarrhoea or vomiting;
• taking diuretics;
• with heart failure and kidney failure (or without kidney failure).

Inform the doctor if:

• the patient has ischaemic heart disease or cerebrovascular disease;
• the patient is to undergo surgery under general anaesthesia.

If the patient's blood pressure drops significantly, lay the patient down on their back and inform the doctor immediately.
Heart conditions
Inform the doctor about:

• heart failure;
• diagnosed stenosis of the heart valves in the left ventricle or other obstruction of blood outflow from the left ventricle.

Kidney function disorders
Before starting treatment and during its course, the doctor will recommend monitoring kidney function.
Inform the doctor if:

• the patient has kidney failure;
• bilateral renal artery stenosis or stenosis of the renal artery of a single kidney has been diagnosed;
• the patient is undergoing haemodialysis;
• the patient is taking diuretics;
• the patient has kidney function disorders and is receiving an antihypertensive medicine containing aliskiren.

Liver function disorders
If jaundice or increased liver enzyme activity occurs during treatment with LisiHEXAL 20, discontinue the medicine and consult the doctor.
Diabetes
During the first month of treatment with LisiHEXAL 20, the doctor will recommend more frequent monitoring of blood glucose levels and, if necessary, adjust the dose of antidiabetic medicines.
Severe hypersensitivity reactions (so-called pseudoanaphylactic reactions)
Due to the risk of hypersensitivity reactions, inform the doctor if:

• the patient is undergoing desensitisation therapy against bee or wasp venom;
• the patient is undergoing treatment to remove cholesterol from the blood (so-called LDL apheresis). The doctor may recommend temporarily discontinuing LisiHEXAL 20 at an appropriate time.

Changes in blood picture
During treatment, neutropenia (reduced number of neutrophil granulocytes) or agranulocytosis (reduced number or absence of certain types of white blood cells), thrombocytopenia, and anaemia may occur. The doctor may recommend appropriate blood tests.
If any signs of infection occur during treatment with LisiHEXAL 20, contact the doctor immediately.
Cough
A dry, persistent cough may occur during treatment with LisiHEXAL 20, which resolves after discontinuation of treatment. Inform the doctor if cough occurs.
Increased potassium levels in blood
Due to the possibility of increased potassium levels in blood, inform the doctor if:

• the patient has kidney function disorders;
• the patient has diabetes;
• the patient is taking potassium-sparing diuretics or medicines that increase potassium levels in blood;
• the patient is taking potassium supplements or salt substitutes containing potassium.

The doctor will recommend more frequent blood tests.
Inform the doctor if:

• the patient has collagenosis;
• the patient is receiving immunosuppressive medicines (suppressing the body's immune responses), allopurinol (a medicine used to treat gout), or propranolol (a medicine used to treat cardiac arrhythmias).

Consult the doctor, even if the above warnings refer to conditions that occurred in the past.
LisiHEXAL 20 with other medicines
Tell the doctor about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to take.
LisiHEXAL 20 and other concomitant medicines may interact and affect each other's actions and the occurrence of adverse effects. This especially applies to:

• diuretics;
• indomethacin and other non-steroidal anti-inflammatory drugs (medicines with anti-inflammatory, analgesic and antipyretic effects, so-called NSAIDs);
• acetylsalicylic acid at doses greater than 3 g/day;
• lithium (a medicine used to treat depression);
• gold preparations (used to treat, among others, rheumatic diseases or psoriasis);
• medicines used in psychiatric disorders (antipsychotics);
• some antidepressants;
• anaesthetic medicines used during general anaesthesia;
• antidiabetic medicines (insulin and oral antidiabetic medicines);
• sympathomimetics (e.g. ingredients of cold and flu medicines);
• other medicines lowering blood pressure and (or) used in heart diseases (e.g. beta-blockers, nitrates, other vasodilators);
• allopurinol (a medicine used to treat gout);
• some medicines used in cardiac arrhythmias (e.g. procainamide);
• medicines from the group of tissue plasminogen activators (medicines used in cases of risk of clot formation, which may lead to, e.g., stroke or myocardial infarction).

In particular, talk to the doctor or pharmacist if the patient is currently taking, has recently taken, or may take any of the following medicines:

• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines increasing potassium levels in blood (e.g. trimethoprim and co-trimoxazole, a combination of trimethoprim and sulfamethoxazole, 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).

Excessive intake of table salt may reduce the antihypertensive effect of
LisiHEXAL 20.
The doctor may recommend a change in dose and (or) additional precautions:

• if the patient is taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections "When not to use LisiHEXAL 20" and "Warnings and precautions").

If in doubt whether the patient is taking the listed medicines, consult the doctor.
LisiHEXAL 20 with food and drink
The medicine can be taken independently of meals, at the same time each day. Tablets should be swallowed with sufficient liquid.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
LisiHEXAL 20 must not be used during pregnancy.
If the patient becomes pregnant during treatment, she must stop taking the medicine and contact the doctor immediately. Women planning pregnancy should discuss alternative treatment options with their doctor.
It is not known whether the active substance of the medicine (lisinopril) passes into breast milk; therefore, LisiHEXAL 20 should not be used during breastfeeding.
Driving and operating machinery
During treatment with LisiHEXAL 20, dizziness or fatigue may occur, which may impair the ability to drive, operate machinery or work under hazardous conditions. This is particularly important at the beginning of treatment, after increasing the dose, changing the medicine, or when alcohol is consumed concomitantly.
LisiHEXAL 20 contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use LisiHEXAL 20

This medicine should be used as directed by your doctor. If you have any doubts, consult your
doctor.
LisiHEXAL 5 (5 mg), LisiHEXAL 10 (10 mg), and LisiHEXAL 20 (20 mg) are available on the market.

High blood pressure
Dosing in patients not taking diuretics
The initial dose is 2.5 mg once daily. If the desired therapeutic effect is not achieved after 2 to 4 weeks, your doctor may increase the dose. The effective daily dose is usually between 10 and 20 mg. The maximum dose is 40 mg per day.

Dosing in patients taking diuretics
If possible, discontinue or reduce the dose of the diuretic 2 or 3 days before starting treatment with LisiHEXAL 20.
In patients with high blood pressure who cannot discontinue diuretic therapy before starting lisinopril, your doctor will recommend a lower starting dose of lisinopril (2.5 mg or 5 mg once daily) and will closely monitor your condition.

Dosing in children and adolescents aged 6 to 16 years
Recommended initial dose:

• 2.5 mg once daily in patients with body weight from 20 to <50 kg
• 5 mg once daily in patients with body weight ≥50 kg

Your doctor will determine the dose individually and may increase it up to the maximum daily dose, which is:

• 20 mg in patients with body weight from 20 to <50 kg
• 40 mg in patients with body weight ≥50 kg

In children with impaired kidney function, your doctor may prescribe a lower initial dose or extend the dosing intervals.
Lisinopril is not recommended in children with severe kidney impairment.

Heart failure
Initial dosing
The recommended initial dose is 2.5 mg per day. Your doctor may increase the dose if necessary. In some patients, your doctor may recommend starting treatment with LisiHEXAL 20 in a hospital setting. Before starting treatment and during therapy, your doctor will recommend monitoring of blood pressure and kidney function.

Maintenance dose
Your doctor may gradually increase the initial dose according to the patient's response to treatment, up to the commonly used maintenance dose (5 to 20 mg).
Dose increases of LisiHEXAL 20 should not exceed 10 mg at a time.

Acute myocardial infarction
Your doctor may recommend taking LisiHEXAL 20 within the first 24 hours after the onset of heart attack symptoms. Initially, 5 mg is administered, followed by another 5 mg after 24 hours, then 10 mg after 48 hours, and subsequently 10 mg once daily. Patients with systolic blood pressure of 120 mmHg or lower should receive a lower dose of lisinopril, i.e., 2.5 mg. If a patient develops persistent hypotension (systolic blood pressure <90 mmHg) lasting more than 1 hour, the drug should be discontinued.
Treatment lasts for 6 weeks. Prolonged treatment may be necessary in patients with worsening symptoms of heart failure.

Microalbuminuria in diabetes
The initial dose is 2.5 mg of lisinopril per day.
In patients with normal blood pressure and insulin-dependent diabetes, the usual dose is 10 mg per day. Your doctor may increase the daily dose up to 20 mg (to achieve a diastolic blood pressure <75 mmHg).
In patients with high blood pressure and non-insulin-dependent diabetes, the usual dose is 10 mg per day. If necessary, your doctor may increase the daily dose up to 20 mg (to achieve a diastolic blood pressure <90 mmHg).

Use in patients with renal impairment
Patients undergoing dialysis may receive the usual dose of LisiHEXAL 20 on dialysis days. On non-dialysis days, your doctor will determine the dosing regimen based on the patient's blood pressure.

Use in children and adolescents
Lisinopril is not recommended for use in children for indications other than high blood pressure. Lisinopril is not recommended in children under 6 years of age or in children with severe kidney impairment.

If you feel that the effect of LisiHEXAL 20 is too strong or too weak, consult your doctor.

Taking more LisiHEXAL 20 than prescribed
If you take more than the prescribed dose of this medicine, contact your doctor, pharmacist, or go immediately to the hospital.
Symptoms of overdose may include: severe hypotension, electrolyte disturbances, and kidney failure. In case of overdose, the patient should be under close observation. Treatment depends on the type and severity of symptoms.

Missing a dose of LisiHEXAL 20
Do not take a double dose to make up for a missed dose.

Stopping LisiHEXAL 20 treatment
Your doctor will advise you on how long to take LisiHEXAL 20. Do not stop treatment prematurely under any circumstances, as symptoms may return.

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.
Adverse effects associated with the use of lisinopril may occur with the following frequency:

Common (may affect fewer than 1 in 10 people):
dizziness, headache, orthostatic hypotension (reduction in blood pressure upon standing), cough, diarrhoea, vomiting, renal dysfunction.

Uncommon (may affect fewer than 1 in 100 people):
mood changes, tingling sensation, dizziness, taste disturbances, sleep disorders, heart attack or stroke, palpitations, tachycardia (increased heart rate), Raynaud's phenomenon (coldness and paleness of fingers and toes due to constriction of arteries in the extremities), rhinitis (inflammation of the nasal mucosa), nausea, abdominal pain, dyspepsia, rash, pruritus (itching), impotence, fatigue, weakness, increased blood urea levels, increased serum creatinine levels, increased liver enzyme activity, increased blood potassium levels, hallucinations.

Rare (may affect fewer than 1 in 1,000 people):
decreased haemoglobin concentration, decreased haematocrit value, disorientation, dry mouth, hypersensitivity/angioedema (vascular angioedema of the face, extremities, lips, tongue, glottis and/or larynx), urticaria, alopecia, psoriasis, uraemia, acute renal failure, gynaecomastia (enlargement of the breasts in males), increased serum bilirubin levels, decreased blood sodium levels, syndrome of inappropriate antidiuretic hormone secretion (SIADH), disturbances of smell.

Very rare (may affect fewer than 1 in 10,000 people):
bone marrow suppression, anaemia, thrombocytopenia (decreased platelet count), leucopenia (decreased white blood cell count), neutropenia (decreased neutrophil count), agranulocytosis (complete or near-complete absence of granulocytes), haemolytic anaemia (anaemia due to destruction of red blood cells), lymphadenopathy (disease involving lymph nodes), autoimmune disorders, decreased blood glucose levels (hypoglycaemia), bronchospasm, sinusitis, allergic/eosinophilic pneumonia, pancreatitis, intestinal angioedema, hepatitis (hepatocellular or cholestatic), jaundice and liver failure, sweating, bullous eruption, severe skin reactions (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme), pseudolymphoma of the skin, reduced or absent urine output.

Frequency not known (cannot be estimated from available data):
anaphylactic or anaphylactoid reactions, symptoms of depression, fainting.

A syndrome has been described which may include all or some of the following symptoms: fever, serositis (inflammation of serous membranes), vasculitis (inflammation of blood vessels), myalgia (muscle pain) and/or myositis (muscle inflammation), arthralgia (joint pain) and/or arthritis (joint inflammation), positive antinuclear antibodies (ANA), increased erythrocyte sedimentation rate (ESR), eosinophilia (increased eosinophils) and leucocytosis (increased white blood cell count). Skin manifestations such as rash, photosensitivity or other skin symptoms may also occur.

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 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, website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store LisiHEXAL 20

• Keep this medicine out of the sight and reach of children.
• Store below 25°C.
• Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
• Translation of some information on the immediate packaging: Ch.-B./verwendbar bis: siehe Prägung – batch number/expiry date: see embossing.
• 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 LisiHEXAL 20 contains
The active substance is lisinopril. One tablet contains 20 mg of lisinopril in the form of lisinopril dihydrate.
Other components are: calcium hydrogen phosphate dihydrate, mannitol, corn starch, sodium croscarmellose, magnesium stearate, iron oxide red (E 172).
Information for diabetic patients
One tablet contains less than 0.01 carbohydrate exchange unit (WW).

What LisiHEXAL 20 looks like and contents of the pack
LisiHEXAL 20 tablets are light red, mottled, round, biconvex, with a dividing score on one side. The medicine is available in packs containing 30 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Germany, the country of export:
1 A Pharma GmbH
Keltenring 1 + 3
82041 Oberhaching
Germany

Manufacturer:
Lek Pharmaceuticals d.d.
Verovskova 57
1526 Ljubljana
Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

German marketing authorisation number (country of export): 45584.03.00
Parallel import authorisation number: 117/22