Lisihexal 10

Package leaflet: Information for the patient

Warning! Keep this 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.
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.

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

Contents of the leaflet:

1. What LisiHEXAL 10 is and what it is 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 pack and other information

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

LisiHEXAL 10 contains lisinopril as the active substance – a medicine belonging to the group of so-called angiotensin-converting enzyme (ACE) inhibitors, which lowers arterial blood pressure.
Indications for the use of LisiHEXAL 10 include:

• essential and renovascular hypertension, regardless 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 using LisiHEXAL 10

When not to use LisiHEXAL 10

• 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 impairment and is taking an antihypertensive medicine containing aliskiren;
• if the patient has taken or is currently taking a combination medicine containing sacubitril and valsartan (used in the treatment of long-term (chronic) heart failure in adults), because

the risk of angioedema (rapid swelling of the subcutaneous tissue, for example in the throat) 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 10, discuss this with your doctor.
Tell your doctor if the patient is taking any of the following medicines, because
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:

• angiotensin II receptor antagonist (AIIRA), so-called "sartans" – for example valsartan, telmisartan, irbesartan, especially if the patient has kidney impairment related to diabetes,
• aliskiren.

Your 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 10".
Angioedema
Seek immediate medical advice 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 required.
Patients who have previously experienced such symptoms are at higher risk
of recurrence.
In black patients, the incidence of angioedema after using ACE inhibitors
is higher than in patients of other races.
The risk of angioedema is also higher in patients taking concomitantly
medicines from the group of so-called mTOR kinase inhibitors, such as sirolimus, everolimus, temsirolimus
(used to prevent organ transplant rejection or in cancer treatment) or
tissue plasminogen activator – see also section "LisiHEXAL 10 with other medicines".
Hypotension
Excessive reduction in blood pressure may occur in the following patients:

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

Inform your doctor if:

• the patient has ischaemic heart disease or cerebrovascular disease;
• the patient is undergoing 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 your 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 impairment
Before starting and during ongoing treatment, your doctor will recommend monitoring kidney function.
Inform your doctor if:

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

Liver function impairment
If jaundice or increased liver enzyme activity occurs during treatment with LisiHEXAL 10, discontinue the medicine and consult your doctor.
Diabetes
During the first month of treatment with LisiHEXAL 10, your doctor will recommend more frequent monitoring of blood glucose levels and, if necessary, adjustment of antidiabetic medication doses.
Severe hypersensitivity reactions (so-called pseudoanaphylactic reactions)
Due to the risk of hypersensitivity reactions, inform your doctor if:

• the patient is undergoing desensitisation treatment against bee or wasp venom;
• the patient is undergoing treatment to remove cholesterol from the blood (so-called LDL apheresis). Your doctor may recommend temporarily discontinuing LisiHEXAL 10 at an appropriate time.

Changes in blood tests
During treatment, neutropenia (reduced number of neutrophil granulocytes)
or agranulocytosis (reduced number or absence of certain white blood cells), thrombocytopenia
and anaemia may occur. Your doctor may recommend appropriate blood tests.
If any signs of infection occur during treatment with LisiHEXAL 10, contact your doctor immediately.
Cough
During treatment with LisiHEXAL 10, a dry, persistent cough may occur, which resolves
after stopping treatment. Inform your doctor if cough develops.
Increased blood potassium levels
Due to the possibility of increased blood potassium levels, inform your doctor if:

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

Your doctor may recommend more frequent blood tests.
Inform your doctor if:

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

Consult your doctor even if the above warnings refer to conditions that occurred
in the past.
LisiHEXAL 10 with other medicines
Tell your doctor about all medicines the patient is currently taking or
has recently taken, as well as any medicines the patient plans to take.
LisiHEXAL 10 and other concomitantly used medicines may interact and affect each other's actions and
the occurrence of adverse effects. This particularly applies to the following medicines:

• diuretics;
• indomethacin and other non-steroidal anti-inflammatory drugs (medicines with anti-inflammatory, analgesic and antipyretic effects, so-called NSAIDs);
• acetylsalicylic acid at doses exceeding 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);
• certain 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);
• certain 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 that may lead, for example, to stroke or myocardial infarction).

In particular, talk to your 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 blood potassium levels (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 10.
Your doctor may recommend adjusting the dose and/or taking additional precautions:

• if the patient is taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections "When not to use LisiHEXAL 10" and "Warnings and precautions").

If in doubt whether the patient is taking any of the listed medicines, consult your doctor.
LisiHEXAL 10 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 become
pregnant, she should consult her doctor or pharmacist before using this medicine.
LisiHEXAL 10 must not be used during pregnancy.
If the patient becomes pregnant during treatment, she must stop taking the medicine and contact her
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 10 should not be used during breastfeeding.
Driving and operating machinery
While taking LisiHEXAL 10, 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
concomitant alcohol intake.
LisiHEXAL 10 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 10

This medicine should be used according to the doctor's instructions. In case of doubt, consult your
doctor.
LisiHEXAL 5 (5 mg), LisiHEXAL 10 (10 mg), and LisiHEXAL 20 (20 mg) are available on the market.
Arterial hypertension
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, the 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 receiving diuretics
If possible, discontinue or reduce the dose of the diuretic 2 or 3 days before starting treatment with LisiHEXAL 10.
In patients with arterial hypertension who cannot discontinue diuretic therapy before starting lisinopril, the doctor will recommend a lower initial dose of lisinopril (2.5 mg or 5 mg once daily) 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 daily in patients with body weight from 20 to <50 kg
• 5 mg once daily in patients with body weight ≥50 kg.

The 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 renal function, the doctor may use a lower initial dose or extend the dosing intervals.
Lisinopril is not recommended in children with severe renal impairment.
Congestive heart failure
Initial dosing
The recommended initial dose is 2.5 mg daily, which the doctor may increase if necessary. In some patients, the doctor may recommend initiating treatment with LisiHEXAL 10 in a hospital setting. Before starting and during treatment, the doctor will recommend monitoring blood pressure and renal function.
Maintenance dose
The doctor may gradually increase the initial dose depending on the patient's response to treatment, up to the most commonly used maintenance dose (from 5 to 20 mg).
Subsequent doses of LisiHEXAL 10 should not be increased by more than 10 mg.
Acute myocardial infarction
The doctor may recommend taking LisiHEXAL 10 within the first 24 hours after the onset of infarction symptoms. Initially, 5 mg is administered, followed by another 5 mg after 24 hours, 10 mg after 48 hours, and then 10 mg once daily. In patients with systolic blood pressure of 120 mmHg or lower, a lower dose of lisinopril (2.5 mg) should be given. If arterial hypotension (systolic pressure <90 mmHg) occurs and persists for more than 1 hour, the medicine should be discontinued.
Treatment lasts for 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 up to 20 mg (to achieve a diastolic 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 up to 20 mg (to achieve a diastolic pressure <90 mmHg).
Use in patients with renal impairment
Patients undergoing dialysis may receive the usual dose of LisiHEXAL 10 on dialysis days. On non-dialysis days, the 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 arterial hypertension. Lisinopril is not recommended in children under 6 years of age or in children with severe renal impairment.
If you feel that the effect of LisiHEXAL 10 is too strong or too weak, consult your doctor.
Taking more LisiHEXAL 10 than recommended
If you take more medicine than recommended, contact your doctor, pharmacist, or go immediately to a hospital.
Symptoms of overdose may include: severe hypotension, electrolyte disturbances, and renal 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 10
Do not take a double dose to make up for a missed dose.
Stopping LisiHEXAL 10 treatment
Your doctor will advise how long you should take LisiHEXAL 10. Do not stop treatment prematurely, as symptoms may return.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Adverse reactions 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 function disorders.

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

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

Very rare (may affect fewer than 1 in 10,000 people):
bone marrow suppression, anaemia, decreased platelet count, decreased white blood cell count, decreased neutrophil count, agranulocytosis (complete or near-complete absence of neutrophils), haemolytic anaemia (anaemia due to destruction of red blood cells), lymphadenopathy (disease involving lymph nodes), autoimmune diseases, decreased blood glucose concentration (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, decreased or absent urine output.

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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 reactions helps provide more information on the safety of this medicine.

5. How to store LisiHEXAL 10

• 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 specified 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 in use. This will help protect the environment.

6. Contents of the pack 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.
Other ingredients: calcium hydrogen phosphate dihydrate, mannitol, maize starch, sodium croscarmellose,
magnesium stearate, iron oxide red (E 172).
Information for diabetic patients
1 tablet contains less than 0.01 carbohydrate exchange unit (CEU).
What LisiHEXAL 10 looks like and contents of the pack
LisiHEXAL 10 tablets are light red, mottled, round, biconvex, with a dividing score line on one side.
The medicine is available in packs containing 25 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
Marketing authorisation number in Germany, the country of export: 45584.02.00
Parallel import authorisation number: 116/22