Lisihexal 20

Leaflet accompanying the packaging: patient information

LisiHEXAL 5, 5 mg, tablets

LisiHEXAL 10, 10 mg, tablets

LisiHEXAL 20, 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 the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is LisiHEXAL and what is it used for

LisiHEXAL contains the active substance lisinopril, a medicine from the group of so-called angiotensin-converting enzyme inhibitors (ACE), which lowers blood pressure.
The indications for the use of LisiHEXAL are:
essential and renovascular hypertension, regardless of the severity;
congestive heart failure;
acute myocardial infarction in hemodynamically stable patients, without cardiogenic shock,
with blood pressure above 100 mmHg;
microalbuminuria in diabetes.

2. Important information before taking LisiHEXAL

When not to take LisiHEXAL

if the patient is allergic to lisinopril, to another angiotensin-converting enzyme inhibitor, or to
any of the other ingredients of this medicine (listed in section 6);
if the patient has been diagnosed with angioedema: hereditary or idiopathic angioedema, as well as
if angioedema has occurred in the past during treatment with angiotensin-converting enzyme inhibitors;
if the patient is pregnant;
if the patient has diabetes or kidney problems 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 to treat chronic heart failure in adults), as this increases the risk of angioedema
(rapid swelling of the subcutaneous tissue in areas such as the throat).
In case of doubt as to whether any of the above situations apply to the patient, consult a doctor or
pharmacist.

Warnings and precautions

Before starting treatment with LisiHEXAL, discuss it with your doctor.
Tell your doctor if you are taking any of the following medicines, as the risk of angioedema may
increase:
racecadotril, a medicine used to treat diarrhea;
medicines used to prevent transplant rejection and to treat cancer (e.g., temsirolimus, sirolimus,
everolimus);
vildagliptin, a medicine used to treat diabetes.
Tell your doctor 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 the patient has kidney problems related to diabetes, aliskiren.
The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte
levels (e.g., potassium) in the blood.
See also the subsection "When not to take LisiHEXAL".
Angioedema

Inform your doctor immediately if you experience:

skin and (or) mucous membrane swelling; swelling of the face, lips, throat, tongue, or larynx;
difficulty breathing or swallowing; itching or rash.
Swelling of the tongue, throat, or larynx can cause airway obstruction. In such cases, immediate
treatment is necessary.
In patients who have already experienced these symptoms in the past, the risk of their recurrence
is higher.
In black patients, the frequency of angioedema after taking ACE inhibitors is higher than in patients
of other races.
The risk of angioedema is also higher in patients taking mTOR kinase inhibitors, such as sirolimus,
everolimus, temsirolimus (used to prevent transplant rejection or to treat tumors) or tissue plasminogen
activator, see also the section "LisiHEXAL and other medicines".
Hypotension

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

Tell your doctor if:

• the patient has coronary artery disease or cerebrovascular disease;
• the patient is to undergo surgery under general anesthesia.

In case of significant blood pressure reduction, the patient should be placed on their back and the doctor
should be informed about the incident.
Heart disease

• heart failure;
• diagnosed left ventricular outflow tract obstruction or other left ventricular outflow tract obstruction.

Kidney problems
Before starting treatment and during its duration, the doctor will recommend monitoring of kidney
function.
Tell your doctor if:

• the patient has kidney failure;
• the patient has been diagnosed with bilateral renal artery stenosis or stenosis of the artery of a single
  kidney;
• the patient is undergoing hemodialysis;
• the patient is taking diuretics;
• the patient has kidney problems and is taking a blood pressure-lowering medicine containing aliskiren.

Liver problems
If, during treatment with LisiHEXAL, the patient experiences jaundice or an increase in liver enzyme
activity, they should stop taking the medicine and consult a doctor.
Diabetes
During the first month of treatment with LisiHEXAL, the doctor will recommend more frequent monitoring
of blood glucose levels and, if necessary, adjust the doses of antidiabetic medicines.
Severe hypersensitivity reactions (so-called pseudoanaphylactic reactions)
Due to the risk of hypersensitivity reactions, inform your doctor if:

• the patient is allergic to bee or wasp venom;
• the patient is undergoing treatment to remove cholesterol from the blood (so-called LDL apheresis).
  The doctor may recommend stopping LisiHEXAL at the appropriate time.

Changes in blood count
During treatment, neutropenia (decrease in the number of neutrophils) or agranulocytosis (decrease
in the number of or lack of a certain type of white blood cell), thrombocytopenia, and anemia may occur.
The doctor may recommend performing relevant blood tests. If, during treatment with LisiHEXAL, any
infection symptoms occur, contact your doctor immediately.
Cough

A dry, persistent cough may occur during treatment with LisiHEXAL, which disappears after stopping
treatment. Inform your doctor about the cough.
Increased potassium levels in the blood
Due to the possibility of increased potassium levels in the blood, inform your doctor if:

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

The doctor will recommend more frequent blood tests.
Tell your doctor if:

• the patient has collagenosis;
• the patient is taking immunosuppressive medicines (inhibiting the body's immune responses), allopurinol
  (a medicine used to treat gout), or procainamide (a medicine used to treat heart rhythm disorders).

Consult your doctor, even if the above warnings refer to situations that occurred in the past.

LisiHEXAL and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as those you
plan to take.
LisiHEXAL and other medicines taken at the same time may affect each other's action and the occurrence
of side effects. This applies in particular to such medicines as:
diuretics;
indomethacin and other non-steroidal anti-inflammatory medicines (medicines with anti-inflammatory,
analgesic, and antipyretic effects, so-called NSAIDs);
acetylsalicylic acid in doses greater than 3 g/day;
lithium (a medicine used to treat depression);
gold preparations (used to treat, among other things, rheumatic diseases or psoriasis);
medicines used to treat mental disorders (antipsychotic medicines);
certain antidepressants;
anesthetics used during anesthesia;
antidiabetic medicines (insulin and oral antidiabetic medicines);
sympathomimetics (e.g., those found in cold and flu medicines);
other blood pressure-lowering medicines and (or) used to treat heart diseases (e.g., beta-adrenergic
blockers, nitrates, other vasodilators);
allopurinol (a medicine used to treat gout);
certain medicines used to treat heart rhythm disorders (e.g., procainamide);
a medicine from the group of tissue plasminogen activators (medicines used in case of risk of blood clots
that can cause, for example, a stroke or heart attack).
In particular, consult your doctor or pharmacist if you are currently taking, have recently taken, or may
take any of the following medicines:
potassium supplements (including salt substitutes containing potassium), potassium-sparing diuretics,
and other medicines that increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole,
being a combination of trimethoprim and sulfamethoxazole, used in bacterial infections;
cyclosporine, an immunosuppressive medicine used to prevent transplant rejection and hepatitis,
and heparin, a medicine used to thin the blood to prevent clots).
Excessive salt consumption may reduce the blood pressure-lowering effect of LisiHEXAL.
The doctor may recommend changing the dose and (or) taking other precautions:

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

In case of doubt as to whether the patient is taking the mentioned medicines, consult a doctor.

LisiHEXAL with food and drink

The medicine can be taken independently of meals, at the same time every day. The tablets should be
swallowed, washed down with a sufficient amount of liquid.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they
should consult their doctor or pharmacist before taking this medicine.
LisiHEXAL should not be taken during pregnancy.
If the patient becomes pregnant during treatment, they should stop taking the medicine and contact their
doctor immediately. Women planning to become pregnant should discuss alternative treatment with their
doctor.
It is not known whether the active substance of the medicine (lisinopril) passes into breast milk, so LisiHEXAL
should not be taken during breastfeeding.

Driving and using machines

During treatment with LisiHEXAL, dizziness or fatigue may occur, which can impair the ability to drive
vehicles, operate machinery, or work in hazardous conditions. This is especially important at the beginning
of treatment, after increasing the dose, changing the medicine, and concurrent alcohol consumption.

LisiHEXAL contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is
considered "sodium-free".

3. How to take LisiHEXAL

This medicine should be taken as directed by your doctor. In case of doubts, consult your doctor.
Hypertension
Dosing in patients not taking diuretics
The initial dose is 2.5 mg once a day. If, after 2 to 4 weeks, the desired therapeutic effect is not achieved,
the doctor may increase the dose of the medicine. 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, 2 or 3 days before starting LisiHEXAL, the diuretic should be discontinued or its dose reduced.
In patients with hypertension who, before starting lisinopril treatment, cannot discontinue the diuretic,
the doctor will recommend using a smaller initial dose of lisinopril (2.5 mg or 5 mg once a day) and will
closely monitor the patient's condition.
Dosing in children and adolescents aged 6 to 16 years
Recommended initial dose:

• 2.5 mg once a day in patients with a body weight of 20 to <50 kg< li>
• 5 mg once a day in patients with a body weight ≥50 kg.

The doctor will determine the dose individually and may increase it to a maximum daily dose of:

• 20 mg in patients with a body weight of 20 to <50 kg< li>
• 40 mg in patients with a body weight ≥50 kg.

In children with kidney problems, the doctor may use a smaller initial dose or extend the intervals between
doses.
Lisinopril is not recommended for use in children with severe kidney problems.
Chronic heart failure
Initial dosing
The recommended initial dose is 2.5 mg per day and, if necessary, the doctor may increase this dose.
In some patients, the doctor may recommend starting LisiHEXAL in a hospital setting. Before starting treatment
and during its duration, the doctor will recommend monitoring of blood pressure and kidney function.
Maintenance dose
The doctor may gradually increase the initial dose, depending on the patient's response to treatment, to
achieve the most commonly used maintenance dose (from 5 to 20 mg).
Do not increase subsequent doses of LisiHEXAL by more than 10 mg.
Acute myocardial infarction

The doctor may recommend taking LisiHEXAL within the first 24 hours of symptom onset. Initially, 5 mg is
taken, after 24 hours another 5 mg, after 48 hours 10 mg, and then 10 mg once a day. Patients with a systolic
blood pressure of 120 mmHg or less are given a lower dose of lisinopril, i.e., 2.5 mg. If the patient experiences
hypotension (systolic blood pressure <90 mmhg) that persists for more than 1 hour, the medicine should be
discontinued.
Treatment lasts 6 weeks. Longer treatment may be necessary in patients with worsening heart failure
symptoms.
Microalbuminuria in diabetes

The initial dose is 2.5 mg of lisinopril per day.
In patients with normal blood pressure and insulin-dependent diabetes, 10 mg per day is usually used.
The doctor may increase the daily dose to 20 mg (to achieve a diastolic blood pressure <75 mmhg).
In patients with hypertension and non-insulin-dependent diabetes, 10 mg per day is usually used.
If necessary, the doctor may increase the daily dose to 20 mg (to achieve a diastolic blood pressure <90 mmhg).
Use in patients with kidney problems

Patients undergoing dialysis may receive the usual dose of LisiHEXAL on dialysis days. On non-dialysis days,
the doctor will determine the dosing based on the patient's blood pressure.
Use in children and adolescents

Lisinopril is not recommended for use in children for indications other than hypertension. Lisinopril is not
recommended for use in children under 6 years of age or in children with severe kidney problems.
If you feel that the effect of LisiHEXAL is too strong or too weak, consult your doctor.

Taking a higher dose of LisiHEXAL than recommended

In case of taking a higher dose of the medicine than recommended, consult a doctor, pharmacist, or go to
the hospital immediately.
Symptoms of overdose may include: severe hypotension, electrolyte disturbances, and kidney failure.
In case of overdose, the patient should be under close observation. The treatment depends on the type and
severity of the symptoms.

Missing a dose of LisiHEXAL

Do not take a double dose to make up for a missed dose.

Stopping treatment with LisiHEXAL

The doctor will provide information on how long to take LisiHEXAL. In no case should treatment be stopped
too early, as the disorder may recur.
In case of any further doubts related to the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, LisiHEXAL can cause side effects, although not everybody gets them.
Side effects related to the use of lisinopril may occur with the following frequency:
Common (may occur in less than 1 in 10 people):
dizziness, headache, orthostatic hypotension (decrease in blood pressure when standing up), cough,
diarrhea, vomiting, kidney problems.
Uncommon (may occur in less than 1 in 100 people):
mood changes, tingling sensation, dizziness, taste disturbances, sleep disturbances, myocardial infarction
or stroke, palpitations, accelerated heart rate, Raynaud's phenomenon (cooling and blanching of the fingers
of the hands and feet due to constriction of the arteries in the limbs), nasal congestion, nausea, abdominal
pain, indigestion, rash, itching, impotence, feeling of tiredness, weakness, increased urea levels in the blood,
increased creatinine levels in the serum, increased liver enzyme activity, increased potassium levels in the
blood, hallucinations.
Rare (may occur in less than 1 in 1000 people):
decreased hemoglobin levels, decreased hematocrit values, feeling of disorientation, dryness in the mouth,
hypersensitivity/allergic angioedema (angioedema of the face, limbs, lips, tongue, larynx, and (or) throat),
hives, hair loss, psoriasis, gout, acute kidney failure, gynecomastia (breast enlargement in men), increased
bilirubin levels in the serum, decreased sodium levels in the blood, syndrome of inappropriate antidiuretic
hormone secretion, disturbances of smell.
Very rare (may occur in less than 1 in 10,000 people):
bone marrow suppression, anemia, decreased platelet count, decreased white blood cell count, decreased
neutrophil count, agranulocytosis (complete or almost complete lack of granulocytes), hemolytic anemia
(anemia due to the breakdown of red blood cells), lymphadenopathy (a disease affecting the lymph nodes),
autoimmune diseases, decreased glucose levels in the blood (hypoglycemia), bronchospasm, sinusitis, allergic/
eosinophilic pneumonia, pancreatitis, intestinal angioedema, hepatitis (hepatocellular or cholestatic), jaundice
and liver failure, sweating, pemphigus, severe skin reactions (toxic epidermal necrolysis, Stevens-Johnson
syndrome, erythema multiforme), cutaneous pseudolymphoma, decreased or absent urine excretion.
Frequency not known (cannot be estimated from the available data):
anaphylactic or pseudoanaphylactic reactions, symptoms of depression, fainting.
A disease complex has been described that may include all or some of the following symptoms: fever, serositis,
vasculitis, muscle and (or) joint pain, and positive antinuclear antibodies (ANA), accelerated erythrocyte
sedimentation rate (ESR), increased eosinophil count, and leukocytosis (increased white blood cell count).
A rash, hypersensitivity to light, or other skin symptoms may occur.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug 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, website: https://smz.ezdrowie.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 LisiHEXAL

Keep the medicine out of sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging after EXP. 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 LisiHEXAL contains

The active substance is lisinopril. One tablet contains 5 mg, 10 mg, or 20 mg of lisinopril in the form of
lisinopril dihydrate.
Other ingredients are: calcium hydrogen phosphate dihydrate, mannitol, cornstarch, sodium carmellose,
magnesium stearate, red iron oxide (E 172).
Information for diabetic patients
1 tablet contains less than 0.01 WW (carbohydrate exchange units).

What LisiHEXAL looks like and contents of the pack

LisiHEXAL tablets are pink, speckled, round, biconvex, with a dividing line on one side. The medicine is
available in packs containing 30 tablets.

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturer

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek S.A.
Domaniewska 50 C
02-672 Warsaw
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
To obtain more detailed information, please contact:
Sandoz Polska Sp. z o.o.
Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of last revision of the leaflet:04/2022
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