Lisihexal 10

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

LisiHEXAL 10(Lisinopril 10 - 1 A Pharma)

10 mg, tablets

Lisinoprilum
LisiHEXAL 10 and Lisinopril 10 - 1 A Pharma are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, 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 medicine has been prescribed specifically for you. Do not pass it on to others. The medicine 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 or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is LisiHEXAL 10 and what is it used for
• 2. Important information before taking LisiHEXAL 10
• 3. How to take LisiHEXAL 10
• 4. Possible side effects
• 5. How to store LisiHEXAL 10
• 6. Contents of the packaging and other information

1. What is LisiHEXAL 10 and what is it used for

LisiHEXAL 10 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 10 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 10

When not to take LisiHEXAL 10

• 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, they should consult a doctor or pharmacist.

Warnings and precautions

Before starting treatment with LisiHEXAL 10, 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);
• vildagliptin, 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 associated with diabetes,
• aliskiren.

The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium).
See also the subsection "When not to take LisiHEXAL 10".
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 10 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 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 medicine containing aliskiren.

Liver problems

If, during treatment with LisiHEXAL 10, the patient experiences jaundice or an increase in liver enzyme activity, they should stop taking the medicine and consult their doctor.
Diabetes

During the first month of treatment with LisiHEXAL 10, the doctor will recommend more frequent monitoring of blood glucose levels and, if necessary, adjust the doses of antidiabetic medicines.
Pseudoallergic reactions (so-called pseudoallergic reactions)

Due to the risk of pseudoallergic 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 10 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) may occur, as well as thrombocytopenia and anemia. The doctor may recommend performing appropriate blood tests.
If, during treatment with LisiHEXAL 10, the patient experiences any symptoms of infection, they should immediately contact their doctor.
Cough

During treatment with LisiHEXAL 10, 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 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 (which suppress the body's immune response), allopurinol (a medicine used to treat gout), or procainamide (a medicine used to treat arrhythmias).

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

LisiHEXAL 10 and other medicines

The patient should tell their doctor about all medicines they are currently taking, have recently taken, or plan to take.
LisiHEXAL 10 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 medicines that lower blood pressure and/or are used to treat heart diseases (e.g., beta-blockers, nitrates, other vasodilators);
• allopurinol (a medicine used to treat gout);
• certain medicines used to treat arrhythmias (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, 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, 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 blood clots).

Excessive consumption of table salt may reduce the antihypertensive effect of LisiHEXAL 10.
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 10" and "Warnings and precautions").

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

LisiHEXAL 10 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 10 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 alternative treatment with their doctor.
It is not known whether the active substance of the medicine (lisinopril) passes into breast milk, so LisiHEXAL 10 should not be taken during breastfeeding.

Driving and using machines

During treatment with LisiHEXAL 10, 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 consumption of alcohol.

LisiHEXAL 10 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 10

This medicine should be taken as recommended by the doctor. In case of doubt, the patient should consult their doctor.
LisiHEXAL 5 (5 mg), LisiHEXAL 10 (10 mg), and LisiHEXAL 20 (20 mg) are available on the market.
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 who are taking diuretics
If possible, 2 or 3 days before starting LisiHEXAL 10, 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 lower 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 lower initial dose or extend the intervals between doses.
Lisinopril is not recommended for use in children with severe kidney problems.
Congestive 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 10 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).
The dose of LisiHEXAL 10 should not be increased by more than 10 mg at a time.
Acute myocardial infarction

The doctor may recommend taking LisiHEXAL 10 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 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, 10 mg per day is usually used. The doctor may increase the daily dose to 20 mg (to achieve a diastolic blood pressure of <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 of <90 mmhg).
Use in patients with kidney problems

Patients undergoing dialysis may receive the usual dose of LisiHEXAL 10 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 10 is too strong or too weak, they should consult their doctor.

Taking a higher dose of LisiHEXAL 10 than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult a 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 10

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

Stopping treatment with LisiHEXAL 10

The doctor will provide information on how long to take LisiHEXAL 10. 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 medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, LisiHEXAL 10 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 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, dry 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, olfactory disturbances.
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 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 side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products 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.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store LisiHEXAL 10

• The medicine should be stored out of sight and reach of children.
• Store at a temperature below 25°C.
• This medicine should not be taken after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
• Translation of some information on the immediate packaging: Ch.-B./verwendbar bis: see embossing - batch number/expiry date: see embossing
• 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 10 contains

The active substance is lisinopril. One tablet contains 10 mg of lisinopril in the form of lisinopril dihydrate.
The other ingredients are: calcium hydrogen phosphate dihydrate, mannitol, corn starch, 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 10 looks like and what the packaging contains

LisiHEXAL 10 tablets are pink, speckled, round, biconvex, with a dividing line on one side.
The medicine is available in packaging containing 25 tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization 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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Germany, the country of export:45584.02.00

Parallel import authorization number: 116/22 Date of leaflet approval: 01.03.2022

[Information about the trademark]