Lisihexal 20

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

LisiHEXAL 20 (Lisinopril Sandoz 20 mg)

20 mg, tablets
Lisinopril
LisiHEXAL 20 and Lisinopril Sandoz 20 mg are different trade names for the same drug.

You should carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This drug has been prescribed to a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is LisiHEXAL 20 and what is it 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. Package contents and other information

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

LisiHEXAL 20 contains the active substance lisinopril, a drug from the group of so-called angiotensin-converting enzyme (ACE) inhibitors, which lowers blood pressure.
Indications for the use of LisiHEXAL 20 are:

• essential and renovascular hypertension, regardless of the degree of 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 20

When not to take LisiHEXAL 20

• if the patient is allergic to lisinopril, another ACE inhibitor, or any of the other ingredients of this drug (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 ACE inhibitors;
• if the patient is pregnant;
• if the patient has diabetes or kidney problems and is taking a blood pressure-lowering drug containing aliskiren;
• if the patient has taken or is currently taking a combination drug containing sacubitril and valsartan (used to treat chronic heart failure in adults), because

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the risk of angioedema (rapid swelling of the subcutaneous tissue in the area, such as the throat) increases.
In case of doubts, whether any of the listed situations apply to the patient, they should consult a doctor or pharmacist.

Warnings and precautions

Before starting treatment with LisiHEXAL 20, the patient should discuss it with their doctor.
The patient should tell their doctor if they are taking any of the following drugs, as the risk of angioedema may increase:

• racecadotril, a drug used to treat diarrhea;
• drugs used to prevent transplant rejection and to treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• vildagliptin, a drug used to treat diabetes.

The patient should tell their doctor if they are taking any of the following drugs used to treat high blood pressure:

• angiotensin II receptor antagonist (AIIRA), also known as 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).
See also the section "When not to take LisiHEXAL 20".
Angioedema

The patient should immediately inform their doctor if they experience:

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

Tongue, throat, or larynx swelling 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 20 and other drugs".
Hypotension

Excessive lowering of blood pressure may occur in the following patients:

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

The patient should inform their doctor if:

• they have been diagnosed with coronary heart disease or cerebrovascular disease;
• they are going to undergo surgery under general anesthesia.

In case of significant lowering of blood pressure, the patient should be placed on their back and inform their doctor about the incident.
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Heart diseases

The patient should inform their doctor about:

• heart failure;
• diagnosed left ventricular or other outflow obstruction from the left ventricle.

Kidney problems

Before starting treatment and during its duration, the doctor will recommend monitoring of kidney function.
The patient should inform their doctor if:

• they have been diagnosed with kidney failure;
• they have been diagnosed with bilateral renal artery stenosis or stenosis of the artery of a single kidney;
• they are undergoing hemodialysis;
• they are taking diuretics;
• they have kidney problems and are taking a blood pressure-lowering drug containing aliskiren.

Liver problems

If, during treatment with LisiHEXAL 20, the patient experiences jaundice or an increase in liver enzyme activity, they should stop taking the drug and consult their 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 doses of antidiabetic drugs.
Pseudo-anaphylactic reactions (anaphylactoid reactions)

Due to the risk of anaphylactic reactions, the patient should inform their doctor if:

• they are desensitized to bee or wasp venom;
• they are undergoing treatment to remove cholesterol from the blood (LDL apheresis). The doctor may recommend stopping LisiHEXAL 20 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) may occur, as well as thrombocytopenia and anemia. The doctor may recommend performing relevant blood tests. If, during treatment with LisiHEXAL 20, the patient experiences any symptoms of infection, they should immediately contact their doctor.
Cough

During treatment with LisiHEXAL 20, a dry, persistent cough may occur, which disappears after stopping the treatment. The patient should inform their doctor about the cough.
Increased potassium levels in the blood

Due to the possibility of increased potassium levels in the blood, the patient should inform their doctor if:

• they have been diagnosed with kidney problems;
• they have diabetes;
• they are taking potassium-sparing diuretics or drugs that increase potassium levels in the blood;
• they are taking potassium supplements or potassium-containing salt substitutes.

The doctor will recommend more frequent blood tests.
The patient should inform their doctor if:

• they have been diagnosed with collagenosis;

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• the patient is taking immunosuppressive drugs (inhibiting the body's immune responses), allopurinol (a drug used to treat gout), or procainamide (a drug used to treat heart rhythm disorders).

The patient should consult their doctor, even if the above warnings refer to situations that occurred in the past.

LisiHEXAL 20 and other drugs

The patient should tell their doctor about all the drugs they are currently taking or have recently taken, as well as any drugs they plan to take.
LisiHEXAL 20 and other drugs taken at the same time may affect each other's action and the occurrence of side effects. This applies in particular to such drugs as:
diuretics;
indomethacin and other non-steroidal anti-inflammatory drugs (drugs with anti-inflammatory, analgesic, and antipyretic effects, so-called NSAIDs);
acetylsalicylic acid in doses greater than 3 g/day;
lithium (a drug used to treat depression);
gold preparations (used to treat, among other things, rheumatic diseases or psoriasis);
drugs used to treat mental disorders (antipsychotic drugs);
certain antidepressants;
anesthetics used during anesthesia;
antidiabetic drugs (insulin and oral antidiabetic drugs);
sympathomimetics (e.g., those found in cold and flu medications);
other drugs that lower blood pressure and/or are used to treat heart diseases (e.g., beta-adrenergic blockers, nitrates, other vasodilators);
allopurinol (a drug used to treat gout);
certain drugs used to treat heart rhythm disorders (e.g., procainamide);
a drug from the group of tissue plasminogen activators (drugs used in case of risk of blood clots that can cause, for example, stroke or heart attack).
In particular, the patient should discuss with their doctor or pharmacist if they are currently taking, have recently taken, or may take any of the following drugs:
potassium supplements (including salt substitutes), potassium-sparing diuretics, and other drugs that increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole, a combination of trimethoprim and sulfamethoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressive drug used to prevent transplant rejection and to treat certain diseases; heparin, a drug used to thin the blood to prevent blood clots).
Excessive salt consumption may reduce the antihypertensive effect of LisiHEXAL 20.
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 sections "When not to take LisiHEXAL 20" and "Warnings and precautions").

In case of doubts about whether the patient is taking the listed drugs, they should consult their doctor.

LisiHEXAL 20 with food and drink

The drug can be taken regardless 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 drug.
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LisiHEXAL 20 should not be used during pregnancy.
If the patient becomes pregnant during treatment, they should stop taking the drug and immediately contact their doctor. Women planning to become pregnant should discuss alternative treatment with their doctor.
It is not known whether the active substance of the drug (lisinopril) passes into breast milk, so LisiHEXAL 20 should not be used during breastfeeding.

Driving and operating machinery

During treatment with LisiHEXAL 20, 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 drug, and concurrent consumption of alcohol.

LisiHEXAL 20 contains sodium

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

3. How to take LisiHEXAL 20

This drug should be taken as directed by the doctor. In case of doubts, the patient should consult their doctor.
Available are: LisiHEXAL 5 (5 mg), LisiHEXAL 10 (10 mg), LisiHEXAL 20 (20 mg).
Hypertension

Dosing in patients who do not take 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 drug. 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 20, the diuretic should be discontinued or its dose reduced.
In patients with hypertension who, before starting treatment with lisinopril, 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
The recommended initial dose is:

• 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 the maximum daily dose, which is:

• 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.
LisiHEXAL 20 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 treatment with LisiHEXAL 20 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 the most commonly used maintenance dose (from 5 to 20 mg).
The dose of LisiHEXAL 20 should not be increased by more than 10 mg at a time.
Acute myocardial infarction

The doctor may recommend taking LisiHEXAL 20 within the first 24 hours of the onset of symptoms of myocardial infarction. 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 systolic blood pressure of 120 mmHg or lower 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 drug should be discontinued.
Treatment lasts 6 weeks. Longer 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, 10 mg per day is usually used. The doctor may increase the daily dose to 20 mg (to achieve 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 diastolic blood pressure <90 mmhg).
Use in patients with kidney problems

Patients undergoing dialysis may receive the usual dose of LisiHEXAL 20 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 the patient feels that the effect of LisiHEXAL 20 is too strong or too weak, they should consult their doctor.

Taking a higher dose of LisiHEXAL 20 than recommended

In case of taking a higher dose of the drug than recommended, the patient should immediately consult their doctor, pharmacist, or go directly 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. The treatment depends on the type and severity of the symptoms.

Missing a dose of LisiHEXAL 20

The patient should not take a double dose to make up for the missed dose.

Stopping treatment with LisiHEXAL 20

The doctor will provide information on how long to take LisiHEXAL 20. In no case should the treatment be stopped too early, as the disorders may recur.
In case of any further doubts related to the use of this drug, the patient should consult their doctor or pharmacist.
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4. Possible side effects

Like all drugs, LisiHEXAL 20 can cause side effects, although not everyone will experience them.
Side effects related to the use of lisinopril may occur with the following frequency:
Frequent (may occur in less than 1 in 10 people):
dizziness, headaches, 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, rapid heart rate, Raynaud's phenomenon (cooling and discoloration of fingers and toes due to constriction of blood vessels in the limbs), nasal congestion, nausea, abdominal pain, indigestion, rash, itching, impotence, feeling of fatigue, weakness, increased urea levels in the blood, increased creatinine levels in serum, increased liver enzyme activity, increased potassium levels in the blood, hallucinations.
Rare (may occur in less than 1 in 1000 people):
decrease in hemoglobin levels, decrease in hematocrit value, feeling of disorientation, dryness in the mouth, hypersensitivity/angioedema (angioedema of the face, limbs, lips, tongue, larynx, and/or throat), urticaria, hair loss, psoriasis, gout, acute kidney failure, gynecomastia (breast enlargement in men), increased bilirubin levels in 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, decrease in platelet count, decrease in white blood cell count, decrease in neutrophil count, agranulocytosis (complete or almost complete lack of granulocytes), hemolytic anemia (anemia due to red blood cell destruction), lymphadenopathy (disease affecting 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), pseudolymphoma of the skin, decreased or absent urine output.
Frequency not known (cannot be estimated from available data):
anaphylactic or pseudo-anaphylactic 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, arthralgia and/or arthritis, 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 side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor, 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
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02-222 Warsaw
phone: +48 (22) 49 21 301
fax: +48 (22) 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the drug.

5. How to store LisiHEXAL 20

• The drug should be stored out of sight and reach of children.
• Store at a temperature below 25°C.
• This drug should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
• Drugs should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Package contents 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 ingredients are: calcium hydrogen phosphate dihydrate, mannitol, cornstarch, sodium croscarmellose, magnesium stearate, red iron oxide (E 172).
Information for diabetic patients
1 tablet contains less than 0.01 BU (carbohydrate units).

What LisiHEXAL 20 looks like and what the package contains

LisiHEXAL 20 tablets are light red, speckled, round, biconvex, with a dividing groove on one side.
The drug is available in packages containing 30 tablets.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in the Netherlands, the country of export:

Sandoz B.V.
Veluwezoom 22
1327 AH Almere, Netherlands

Manufacturer:

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Rowa Pharmaceuticals Ltd.
Newtown, Bantry, Co. Cork, Ireland
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
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Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Netherlands marketing authorization number: RVG 28426

Parallel import authorization number: 415/17

Date of leaflet approval:16.11.2022
[Information about the trademark]
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