Lisihexal 5

Package leaflet: Information for the user

LisiHEXAL 5, 5 mg, tablets
LisiHEXAL 10, 10 mg, tablets
LisiHEXAL 20, 20 mg, tablets
Lisinopril
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

1. What LisiHEXAL is and what it is used for

LisiHEXAL contains lisinopril as the active substance—a drug belonging to the group of angiotensin-converting enzyme (ACE) inhibitors, which reduce arterial blood pressure.
Indications for the use of LisiHEXAL 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

When not to use LisiHEXAL
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 in the past during treatment
with ACE inhibitors;
if the patient is pregnant;
if the patient has diabetes or kidney dysfunction 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 long-term (chronic) heart failure in adults), because the risk of angioedema (rapid swelling of the subcutaneous tissue, e.g. in the throat area) increases.
If in doubt whether any of the above situations applies to the patient, consult a doctor or pharmacist.
Warnings and precautions
Before starting treatment with LisiHEXAL, discuss this with your doctor.
Tell your doctor if the patient is taking any of the following medicines, as 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 dysfunction related to diabetes,
aliskiren.
The doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium).
See also the section "When not to use LisiHEXAL".
Angioedema
Inform your doctor immediately 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 the symptoms described above have a higher risk of recurrence.
In black patients, the incidence of angioedema after administration of ACE inhibitors is higher than in patients of other races.
The risk of angioedema is also increased in patients taking concomitant 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 with other medicines".
Hypotension
Excessive reduction in blood pressure may occur in the following patients:

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

Inform your doctor if:

• the patient has ischaemic heart disease or cerebrovascular disease;
• the patient is scheduled for surgery under general anaesthesia.

If the patient's blood pressure drops significantly, lay them 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 dysfunction
Before starting and during treatment, the 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 kidney dysfunction and is receiving an antihypertensive medicine containing aliskiren.

Liver dysfunction
If jaundice or increased liver enzyme activity occurs during treatment with LisiHEXAL, discontinue the medicine and consult your doctor.
Diabetes
During the first month of treatment with LisiHEXAL, the doctor will recommend more frequent monitoring of blood glucose levels and, if necessary, adjustment of antidiabetic medicine doses.
Severe hypersensitivity reactions (so-called pseudoallergic 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). The doctor may recommend temporarily discontinuing LisiHEXAL at an appropriate time.

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

• the patient has kidney dysfunction;
• 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.

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

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

Consult your doctor, even if the above warnings relate to conditions that occurred in the past.
LisiHEXAL 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 and other concomitant medicines may interact and affect each other's actions and the occurrence of adverse effects. This especially 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 for psychiatric disorders (antipsychotics);
some antidepressants;
anaesthetic medicines used during anaesthesia;
antidiabetic medicines (insulin and oral antidiabetic medicines);
sympathomimetics (e.g. ingredients of cold and flu medicines);
other medicines reducing blood pressure and/or used in heart diseases (e.g. beta-blockers, nitrates, other vasodilators);
allopurinol (a medicine used to treat gout);
some medicines used for cardiac arrhythmias (e.g. procainamide);
a medicine from the group of tissue plasminogen activators (medicines used in case of risk of thrombus formation, which may lead, e.g., 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 weaken the antihypertensive effect of LisiHEXAL.
The doctor may recommend a dose adjustment and/or additional precautions:

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

If in doubt whether the patient is taking the medicines listed, consult your doctor.
LisiHEXAL with food and drink
The medicine can be taken independently of meals, at the same time each day. Swallow the tablets with an adequate amount of liquid.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
LisiHEXAL 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 an alternative treatment method with their doctor.
It is not known whether the active substance of the medicine (lisinopril) passes into breast milk; therefore, LisiHEXAL should not be used during breastfeeding.
Driving and using machines
During treatment with LisiHEXAL, 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 when alcohol is consumed concurrently.
LisiHEXAL 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

This medicine should be used as directed by the doctor. If in doubt, consult your
doctor.
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
daily dose is 40 mg.
Dosing in patients taking diuretics
If possible, discontinue or reduce the dose of the diuretic 2 or 3 days before starting treatment with
LisiHEXAL.
In patients with arterial hypertension who cannot discontinue diuretic therapy before starting lisinopril,
the doctor may prescribe 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, and the doctor may increase this dose if necessary.
In some patients, the doctor may recommend initiating LisiHEXAL treatment in a hospital setting.
Before starting treatment and during its course, 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 dose increases of LisiHEXAL should not exceed 10 mg.
Acute myocardial infarction
The doctor may recommend starting LisiHEXAL within the first 24 hours after the onset of infarction
symptoms. Initially, 5 mg is administered, followed by another 5 mg after 24 hours, then 10 mg after 48 hours,
and subsequently 10 mg once daily. Patients with systolic blood pressure of 120 mmHg or lower should
receive a lower dose of lisinopril, i.e. 2.5 mg. If the patient develops hypotension (systolic blood pressure
<90 mmHg) lasting 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 daily.
In patients with normal blood pressure and insulin-dependent diabetes, the usual dose is 10 mg daily.
The doctor may increase the daily dose up to 20 mg (to achieve a diastolic blood pressure <75 mmHg).
In patients with hypertension and non-insulin-dependent diabetes, the usual dose is 10 mg daily.
If necessary, the doctor may increase the daily dose up to 20 mg (to achieve a diastolic blood pressure
<90 mmHg).
Use in patients with renal impairment
Patients undergoing dialysis may receive the usual dose of LisiHEXAL on dialysis days. On non-dialysis
days, the doctor will determine the dosing according to 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 is too strong or too weak, consult your doctor.
Taking more LisiHEXAL than recommended
If you take more than the recommended dose of this medicine, contact your doctor, pharmacist, or go
immediately to the nearest 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
Do not take a double dose to make up for a missed dose.
Stopping LisiHEXAL treatment
Your doctor will advise you on how long to take LisiHEXAL. Do not stop treatment prematurely under
any circumstances, as symptoms may recur.
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 paleness of fingers and toes due to arterial spasm in the extremities), nasal mucosal inflammation, nausea, abdominal pain, indigestion, rash, itching, impotence, feeling of fatigue, weakness, increased blood urea levels, increased serum creatinine levels, increased liver enzyme activity, increased blood potassium levels, hallucinations.

Rare (may affect fewer than 1 in 1,000 people):
decreased haemoglobin concentration, decreased haematocrit values, feeling of disorientation, dry mouth, hypersensitivity/angioedema (vascular swelling of the face, limbs, lips, tongue, larynx and/or pharynx), urticaria, alopecia, psoriasis, uraemia, acute renal failure, gynaecomastia (enlargement of breasts in males), increased serum bilirubin levels, decreased blood sodium levels, 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 granulocytes), haemolytic anaemia (anaemia due to destruction of red blood cells), lymphadenopathy (disease involving lymph nodes), autoimmune diseases, decreased blood glucose levels (hypoglycaemia), bronchospasm, sinusitis, allergic/eosinophilic pneumonia, pancreatitis, intestinal angioedema, hepatitis (hepatocellular or cholestatic), jaundice and liver failure, sweating, bullae, severe skin reactions (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme), pseudolymphoma of the skin, reduced or absent urine output.

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

A syndrome has been reported 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), increased erythrocyte sedimentation rate (ESR), increased eosinophil count and leukocytosis (increased white blood cell count). Skin 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, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring 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.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store LisiHEXAL

Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging following EXP. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What LisiHEXAL contains
The active substance is lisinopril. Each 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, 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 looks like and contents of the pack
LisiHEXAL tablets are light red, speckled, round, biconvex tablets with a break line on one side.
The medicine is available in packs containing 30 tablets.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia

For further information, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
tel. 22 209 70 00