Lisinoratio 20

Leaflet accompanying the packaging: patient information

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

Lisinoratio 20(LISINOPRIL-TEVA 20 mg)

20 mg, tablets

Lisinoprilum
Lisinoratio 20 and LISINOPRIL-TEVA 20 mg are different trade names for the same drug.

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 you need to.
• You should consult a doctor or pharmacist if you have any doubts.
• 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.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Lisinoratio 20 and what is it used for
• 2. Important information before taking Lisinoratio 20
• 3. How to take Lisinoratio 20
• 4. Possible side effects
• 5. How to store Lisinoratio 20
• 6. Contents of the packaging and other information

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

Lisinopril, the active substance of Lisinoratio 20, belongs to a group of medicines called angiotensin-converting enzyme inhibitors (or ACE inhibitors). ACE inhibitors work by reducing the tension of blood vessels, which leads to a decrease in blood pressure. The medicine has a protective effect on the heart and blood vessels.
Lisinoratio 20 is used to:

• treat high blood pressure and renovascular hypertension in monotherapy (as the only medicine) or in combination with other blood pressure-lowering medicines,
• treat heart failure in monotherapy or in combination with diuretics and, in certain cases, with digitalis preparations,
• treat hemodynamically stable patients in the early (24 hours) phase of myocardial infarction to prevent the development of left ventricular dysfunction and heart failure,
• treat patients with high blood pressure and type 2 diabetes and initial nephropathy.

2. Important information before taking Lisinoratio 20

When not to take Lisinoratio 20:

• if you are allergic to lisinopril or any of the other ingredients of this medicine (listed in section 6) or to any other ACE inhibitor,
• if you have ever had a condition called angioedema caused by previous treatment with an ACE inhibitor,
• in case of congenital or idiopathic (primary) angioedema,
• after the 3rd month of pregnancy (you should also avoid taking Lisinoratio 20 in early pregnancy - see "Pregnancy"),
• if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren,
• if you have taken or are taking a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure in adults), as the risk of angioedema (rapid swelling of the subcutaneous tissue, in areas such as the throat) increases.

Warnings and precautions

Before starting treatment with Lisinoratio 20, you should discuss it with your doctor, pharmacist, or nurse:

• if you 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),
• wildagliptin, a medicine used to treat diabetes,
• in case of diuretic use or a low-salt diet,
• in case of gastrointestinal disorders (diarrhea and vomiting),
• if you have ever had an allergic reaction when taking other ACE inhibitors, including angioedema of the face, lips, tongue, and/or throat, with difficulty breathing or swallowing,
• in case of hypersensitivity to wasp venom,
• if you have coronary heart disease or cerebral artery stenosis,
• in case of heart failure,
• in case of kidney or liver problems,
• in case of bilateral renal artery stenosis or stenosis of the artery supplying blood to a single kidney,
• if you are undergoing dialysis (some types of dialysis membranes may be unsuitable),
• if you have collagen vascular disease,
• in case of aortic or mitral stenosis or increased myocardial thickness (hypertrophic cardiomyopathy),
• if you are in the early stages of myocardial infarction,
• if you have high cholesterol levels and are undergoing a procedure called "LDL apheresis",
• in case of surgical procedures before general anesthesia,
• in case of diabetes,
• in case of lithium use,
• if you are of black race, as lisinopril may be less effective in people of this race. Also, in people of black race, angioedema (a severe allergic reaction) is more likely to occur.
• in case of suspected or planned pregnancy. It is not recommended to take Lisinoratio 20 during early pregnancy and it should not be taken after the 3rd month of pregnancy, as it may seriously harm the fetus; see "Pregnancy and breastfeeding",
• if you are taking any of the following blood pressure-lowering medicines:
• angiotensin II receptor antagonist (AIIRA), also known as a sartan - e.g., valsartan, telmisartan, irbesartan, especially if you have kidney problems related to diabetes,
• aliskiren.

Your 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 Lisinoratio 20".

Lisinoratio 20 and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
In particular, you should inform your doctor about taking:

• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole - used to treat bacterial infections; cyclosporine - an immunosuppressive medicine used to prevent transplant rejection and hepatitis; heparin - a medicine used to thin the blood to prevent blood clots),
• other medicines used to treat high blood pressure,
• diuretics,
• non-steroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid in a dose greater than 3 g per day,
• lithium salts,
• medicines used to prevent transplant rejection and to treat cancer (e.g., sirolimus, everolimus, and other mTOR inhibitors); see the subsection "Warnings and precautions",
• immunosuppressive medicines (e.g., cytotoxic medicines, systemic corticosteroids),
• general anesthetics,
• tricyclic antidepressants, antipsychotics, or anesthetics,
• sympathomimetic medicines,
• antidiabetic medicines,
• medicines containing gold, such as sodium aurothiomalate, given by injection,
• racecadotril (an anti-diarrheal medicine),
• wildagliptin (an anti-diabetic medicine).

Your doctor may recommend changing the dose and/or taking other precautions:

• if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also the subsections "When not to take Lisinoratio 20" and "Warnings and precautions").

Lisinoratio 20 with food and drink

Lisinoratio 20 can be taken with food and drink.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to become pregnant, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
You should inform your doctor about suspected or planned pregnancy. Your doctor will usually recommend stopping Lisinoratio 20 before planned pregnancy or immediately after confirming pregnancy and recommend taking another medicine instead of Lisinoratio 20. It is not recommended to take Lisinoratio 20 during early pregnancy and it should not be taken after the 3rd month of pregnancy, as it may seriously harm the fetus.
Breastfeeding
You should inform your doctor about breastfeeding or intending to breastfeed. It is not recommended to take Lisinoratio 20 during breastfeeding, especially in the case of breastfeeding a newborn or premature baby. Your doctor may recommend taking another medicine.

Driving and using machines

Taking Lisinoratio 20 may cause dizziness or fatigue.

3. How to take Lisinoratio 20

This medicine should always be taken exactly as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Lisinoratio 5 (5 mg), Lisinoratio 10 (10 mg), and Lisinoratio 20 (20 mg) are available on the market.
Since food does not affect the absorption of lisinopril from tablets, the medicine can be taken regardless of meals.
Lisinopril should be taken once a day, at the same time every day.

Hypertension in patients not taking diuretics

The recommended initial dose for patients with hypertension is 10 mg. The usual effective maintenance dose is between 20 mg and 40 mg taken once a day at the same time.
The size of the maintenance dose should be adjusted according to the blood pressure value measured just before taking the next dose. The blood pressure-lowering effect may decrease as the time of taking the next dose approaches, regardless of the dose size, but this is most often observed with a dose of 10 mg. In some patients, the expected decrease in blood pressure occurs after 2 to 4 weeks of treatment with maintenance doses.
The maximum dose used in long-term controlled clinical trials was 80 mg per day, but its use did not increase the effectiveness of the treatment.
Treatment should be started with a smaller dose in patients:

• with kidney problems (see the table: Dosing in kidney problems),
• who cannot stop taking diuretics,
• with electrolyte and water balance disorders, regardless of the cause. Before taking the medicine, fluid deficiencies should be supplemented and electrolyte disturbances in the serum should be corrected,
• with renovascular hypertension.

Hypertension in patients taking diuretics

At the beginning of lisinopril treatment, symptomatic hypotension may occur, which occurs more frequently in patients taking diuretics. Lisinoratio 20 should be used with caution, as there is an increased risk of developing electrolyte and water balance disorders or kidney problems. Diuretic treatment should be stopped 2-3 days before starting lisinopril treatment.
If lisinopril monotherapy is ineffective, diuretic treatment (usually hydrochlorothiazide in a single daily dose of 12.5 mg) can be started. In patients with hypertension who cannot stop taking diuretics before starting lisinopril, lisinopril treatment should be started under close medical supervision with a smaller initial daily dose of 5 mg. In such cases, blood pressure should be monitored until the expected decrease in blood pressure occurs and for an additional hour. The size of the maintenance dose should be adjusted according to the blood pressure value.

Renovascular hypertension

In some patients with renovascular hypertension, especially those with bilateral renal artery stenosis or stenosis of the artery supplying a single kidney, excessive blood pressure reduction may occur after taking lisinopril. Kidney dysfunction or failure may occur. Therefore, it is recommended to start with a smaller initial dose of 2.5 mg or 5 mg. Later, the daily dose can be gradually increased, adjusting it to the blood pressure value.

Hypertension in children aged 6 to 16 years

The recommended initial dose for patients weighing between 20 kg and 50 kg is 2.5 mg once a day, and 5 mg once a day for patients weighing 50 kg or more. The dose size should be adjusted individually to a maximum dose of 20 mg for patients weighing between 20 kg and 50 kg, and 40 mg for patients weighing 50 kg or more. In studies with children and adolescents, doses greater than 0.61 mg/kg (or greater than 40 mg) were not administered.
In children with reduced kidney function, the initial dose should be considered to be reduced or the interval between doses extended.

Heart failure

In patients with heart failure, the initial daily dose is 2.5 mg, taken in the morning. Daily maintenance doses usually range from 5 mg to 20 mg taken once a day. In clinical trials, patients who required stronger action of the medicine had their doses increased every 4 weeks. The next doses of lisinopril should not be increased by more than 10 mg. The dose size should be adjusted according to the effectiveness of the medicine, assessing the severity of heart failure symptoms. Lisinopril can be used in combination with diuretics and digitalis preparations.
In patients at increased risk of developing symptomatic hypotension, e.g., those with hyponatremia, hypovolemia, or being treated with high doses of diuretics, fluid and electrolyte disturbances should be corrected before starting lisinopril treatment, and - if possible - the dose of diuretics should be reduced. The effect of the first dose of lisinopril on blood pressure should be monitored. In patients with low systolic blood pressure (<100 mmhg), the initial dose should be administered under close medical supervision. greatest decrease in blood pressure occurs approximately 6-8 hours after taking dose. monitoring of circulatory system, especially pressure, continued until values stabilize.
Dose adjustment in patients with heart failure, kidney problems, or hyponatremia
In patients with heart failure and hyponatremia (sodium level in serum less than 130 mEq/l) or moderate or severe kidney problems (creatinine clearance <30 ml min or serum creatinine>3 mg/dl), a small initial dose of 2.5 mg per day should be used under close medical supervision.

Early phase of myocardial infarction

In hemodynamically stable patients, lisinopril treatment should be started within 24 hours of myocardial infarction. The first single daily dose of lisinopril is 5 mg, taken orally. After another 24 hours from the first dose, 5 mg should be taken, and after 48 hours, a dose of 10 mg. Then, lisinopril should be continued at a dose of 10 mg once a day for 6 weeks. In combination with lisinopril, the following medicines should be taken (if there are no contraindications to their use in the given patient): anticoagulant, antiplatelet, and beta-adrenergic blockers. Patients with low systolic blood pressure (≤120 mmHg) should receive a smaller daily dose of lisinopril, 2.5 mg, at the beginning of treatment or for the first 3 days after myocardial infarction.
In case of hypotension (systolic blood pressure less than or equal to 100 mmHg), the maintenance dose should be reduced to 5 mg or 2.5 mg per day.
If prolonged and severe hypotension (systolic blood pressure less than 90 mmHg lasting more than 1 hour) occurs, Lisinoratio 20 should be discontinued.
Treatment with maintenance doses lasts 6 weeks. In patients who develop symptoms of heart failure, Lisinoratio 20 treatment should be continued using the dosing as for heart failure. Lisinoratio 20 can be used in combination with nitroglycerin administered intravenously or transdermally.
Dose adjustment in patients with acute myocardial infarction and kidney problems
In patients with acute myocardial infarction and kidney problems (serum creatinine greater than 2 mg/dl), lisinopril treatment should be started with great caution.
The dosing rules for lisinopril have not been established in patients with acute myocardial infarction and severe kidney problems.

Nephropathy in diabetes

In patients with high blood pressure and type 2 diabetes and initial nephropathy, the initial dose is 10 mg once a day, and if necessary, it can be increased to 20 mg/day to achieve a diastolic blood pressure less than 90 mmHg measured while sitting. In case of kidney problems (creatinine clearance <80 ml min), the initial dose of lisinoratio 20 should be adjusted according to creatinine clearance value (see table 1).< p>

Dosing in patients with kidney problems

Since lisinopril is excreted in the urine, the daily dose in patients with kidney problems should be adjusted according to the creatinine clearance value (see the table below). The size of the maintenance dose and/or the interval between doses should be adjusted according to the blood pressure value.
Table 1. Dose adjustment in patients with impaired kidney function

* See the section "Warnings and precautions".
The maximum daily maintenance dose of lisinopril in patients with kidney problems is 40 mg.
Lisinopril is eliminated from the blood during hemodialysis. Patients undergoing dialysis should be given the appropriate daily dose of lisinopril after the dialysis procedure.

Dosing in elderly patients

The effect of lisinopril given in the same doses to elderly and younger patients is very similar, but it has been shown that in elderly patients, the maximum concentration of lisinopril in the blood serum was about twice as high as in younger patients.
In elderly patients, lisinopril doses should be increased very cautiously.

Dosing in children

Experience with the efficacy and safety of lisinopril in the treatment of hypertension in children over 6 years of age is limited; there is no experience with the use of lisinopril in other indications than hypertension. It is not recommended to use lisinopril in children for other indications than hypertension.
Lisinopril should not be used in children under 6 years of age or in children with severe kidney problems (GFR <30 ml min 1.73 m2).< p>

Overdose of Lisinoratio 20

In case of overdose, you should contact a doctor or pharmacist or go to the hospital. Symptoms that may occur include: hypotension, shock, electrolyte disturbances, kidney failure, hyperventilation, tachycardia, bradycardia, palpitations, dizziness, anxiety, and cough.

Missed dose of Lisinoratio 20

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

Stopping treatment with Lisinoratio 20

If you have any doubts about taking the medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During treatment with Lisinoratio 20 and other ACE inhibitors, the following side effects have occurred with the following frequency:

Common (occurring in 1 to 10 out of 100 patients)

• headache;
• dizziness or lightheadedness, especially when standing up quickly;
• cough;
• diarrhea;
• nausea;
• kidney problems.

Uncommon (occurring in 1 to 10 out of 1000 patients)

• mood changes;
• changes in the color of fingers and toes (cyanosis, followed by redness) or numbness or tingling of fingers;
• taste disturbances;
• sleep disturbances;
• drowsiness;
• peripheral dizziness;
• difficulty falling asleep;
• stroke;
• palpitations, rapid heartbeat;
• Raynaud's syndrome;
• rhinitis;
• nausea, stomach pain, or indigestion;
• skin rash or itching;
• impotence;
• fatigue or weakness;
• significant decrease in blood pressure may occur in patients with the following conditions: coronary heart disease; aortic stenosis (the artery that carries blood from the heart), renal artery stenosis, or heart valve stenosis; increased myocardial thickness. In case of hypotension, the patient may experience dizziness or lightheadedness, especially when standing up quickly;
• changes in blood test results assessing liver and kidney function;
• myocardial infarction.

Rare (occurring in 1 to 10 out of 10,000 patients)

• disorientation;
• syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• dryness of the mucous membranes of the mouth;
• hypersensitivity and/or angioedema: angioedema of the face, limbs, lips, tongue, glottis, and/or larynx;
• hives;
• hair loss;
• psoriasis (skin disease);
• smell disturbances;
• breast enlargement in men;
• decreased hemoglobin, decreased hematocrit;
• increased bilirubin in the blood, decreased sodium in the blood (hyponatremia);
• uremia, acute kidney failure.

Very rare (occurring in less than 1 in 10,000 patients)

• bone marrow suppression, anemia, thrombocytopenia, leukopenia, neutropenia, agranulocytosis, hemolytic anemia, lymphadenopathy, autoimmune disease;
• bronchospasm, sinusitis, allergic alveolitis/pulmonary eosinophilia;
• hypoglycemia (low blood sugar);
• pneumonia. Symptoms include: cough, shortness of breath, and high fever;
• jaundice (yellowing of the skin or whites of the eyes);
• pancreatitis;
• angioedema of the intestines;
• hepatitis - parenchymal or cholestatic, jaundice;
• liver failure;
• increased sweating;
• pemphigus;
• toxic epidermal necrolysis;
• Stevens-Johnson syndrome;
• erythema multiforme;
• pseudolymphoma of the skin;
• decreased or absent urine output.

Unknown (frequency cannot be estimated from available data)

• symptoms of depression;
• fainting.

The following symptoms have also been reported: anorexia, constipation, bloating, as well as a syndrome of symptoms that occurred singly or together: fever, vasculitis, muscle pain, joint pain and/or arthritis, positive antinuclear antibody titer (ANA), increased erythrocyte sedimentation rate (ESR), eosinophilia, and leukocytosis, rash, photosensitivity, and other skin symptoms.
Data on safety from clinical trials indicate that lisinopril is generally well-tolerated in the treatment of hypertension in children and adolescents. The safety profile in this patient group is comparable to the safety profile in adults.
If you experience any side effects, including any possible side effects not listed in the leaflet, you should consult your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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, you can help gather more information on the safety of this medicine.

5. How to store Lisinoratio 20

The medicine should be stored out of sight and reach of children.
Do not store above 25°C. Store in the original packaging.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Translation of some information on the immediate packaging:

Ch.-B./Verwendbar bis siehe Aufdruck – Batch number and expiry date see imprint

Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Lisinoratio 20 contains

• The active substance of the medicine is lisinopril (in the form of lisinopril dihydrate).
• Other ingredients of the medicine are: mannitol, calcium hydrogen phosphate dihydrate, corn starch, magnesium stearate, corn starch paste.

What Lisinoratio 20 looks like and contents of the packaging

White, oval tablet with the inscription "LSN 20" on one side and a score line on the other side.
Packaging:30 tablets.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Germany, the country of export:

TEVA GmbH
Graf-Arco-Str. 3
89079 Ulm, Germany

Manufacturer:

Pharmachemie B.V.
Swensweg 5, Postbus 552
2003 RN Haarlem
Netherlands
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13
H-4042 Debrecen, Hungary

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:57016.03.00

Parallel import authorization number: 83/23 Date of leaflet approval: 12.05.2023

[Information about the trademark]