Lisihexal 10

Leaflet attached to 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 as yours.
• 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 (ACE) inhibitors, 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, another ACE inhibitor, or 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 ACE 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).

Warnings and precautions

Before starting treatment with LisiHEXAL, the patient should discuss it with their doctor.
The patient should tell their doctor if they 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);
saxagliptin, a medicine used to treat diabetes.
The patient should tell their doctor if they 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

The patient should immediately inform their doctor if they experience:

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 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 (e.g., sirolimus, everolimus, temsirolimus) or tissue plasminogen activator, see also the section "LisiHEXAL and other medicines".
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 coronary heart disease or cerebrovascular disease;
• they are to undergo surgery under general anesthesia.

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

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

Liver problems
If the patient experiences jaundice or an increase in liver enzyme activity while taking LisiHEXAL, they should stop taking the medicine and consult their doctor.
Diabetes
During the first month of taking LisiHEXAL, the doctor will recommend more frequent monitoring of blood glucose levels and, if necessary, adjust the doses of antidiabetic medicines.
Anaphylactic reactions (so-called pseudoanaphylactic 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 (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 or absence of a certain type of white blood cell), thrombocytopenia, and anemia may occur. The doctor may recommend performing relevant blood tests. If the patient experiences any symptoms of infection while taking LisiHEXAL, they should immediately contact their doctor.
Cough

A dry, persistent cough may occur during treatment with LisiHEXAL, 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 kidney problems;
• they have diabetes;
• they are taking potassium-sparing diuretics or medicines 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 collagenosis;
• they are taking immunosuppressive medicines (inhibiting the body's immune response), allopurinol (a medicine used to treat gout), or procainamide (a medicine 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 and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they 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:

• 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 antidepressant medicines;
• anesthetics used during anesthesia;
• antidiabetic medicines (insulin and oral antidiabetic medicines);
• sympathomimetics (e.g., those found in cold and flu medicines);
• other medicines that lower blood pressure and (or) are 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 a risk of blood clots that can cause, for example, a 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 medicines:

• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines 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 medicine used to prevent transplant rejection, and heparin, a medicine used to thin the blood to prevent clots).

Excessive consumption of table salt may weaken 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").

If the patient is in doubt about whether they are taking any of the mentioned medicines, they should consult their 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 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 immediately contact their doctor. Women planning a pregnancy should discuss an 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, or concurrent consumption of alcohol.

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 the doctor. In case of doubts, the patient should consult their doctor.
Hypertension
Dosing in patients who are 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 cannot discontinue the diuretic before starting lisinopril, 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
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 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 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 of LisiHEXAL, depending on the patient's response to treatment, to the most commonly used maintenance dose (from 5 to 20 mg).
The dose of LisiHEXAL should not be increased by more than 10 mg at a time.
Acute myocardial infarction

The doctor may recommend taking LisiHEXAL within the first 24 hours of the onset of symptoms. 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 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 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. 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, the usual dose is 10 mg per day. 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 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 children in other indications than hypertension. Lisinopril is not recommended for children under 6 years of age or for children with severe kidney problems.
If the patient feels that the effect of LisiHEXAL is too strong or too weak, they should consult their doctor.

Taking a higher dose of LisiHEXAL than recommended

In case of taking a higher dose of the medicine 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

The patient should 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 the treatment be stopped too early, as the disorders may recur.
If the patient has any further doubts about taking this medicine, they should consult their 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, feeling of tingling, dizziness, taste disturbances, sleep disturbances, myocardial infarction or stroke, palpitations, accelerated heart rate, Raynaud's phenomenon (cooling and discoloration of the fingers and toes due to constriction of blood vessels), 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):
decreased hemoglobin levels, decreased hematocrit values, 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, decreased platelet count, decreased white blood cell count, decreased neutrophil count, agranulocytosis (complete or almost complete absence 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, angioedema of the intestines, 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 the available data):
anaphylactic or pseudoanaphylactic reactions, symptoms of depression, fainting.
A disease syndrome has been described that may include all or some of the following symptoms: fever, serositis, vasculitis, muscle and (or) joint pain, 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 the patient experiences any side effects, including those not listed in this leaflet, they should inform 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, 02-222 Warsaw
phone: +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, more information can be collected on the safety of the medicine.

5. How to store LisiHEXAL

The medicine should be stored out of sight and reach of children.
Store at 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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. 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.
The 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 WW (carbohydrate exchange units).

What LisiHEXAL looks like and what the pack contains

LisiHEXAL tablets are pink, speckled, round, biconvex, with a score 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
phone: 22 209 70 00
Date of last revision of the leaflet:04/2022
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