Lisinoratio 5

Leaflet attached to the packaging: patient information

Lisinoratio 5, 5 mg, tablets

Lisinoratio 10, 10 mg, tablets

Lisinoratio 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.
• 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, tell your doctor or pharmacist. See section 4.

DO NOT USE IN PREGNANT WOMEN

Table of contents of the leaflet

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

1. What is Lisinoratio and what is it used for

Lisinoratio contains lisinopril (an angiotensin-converting enzyme inhibitor - ACE), which inhibits the activity of the enzyme that converts angiotensin I into angiotensin II, a vasoconstrictor that increases blood pressure. Inhibiting angiotensin-converting enzyme reduces the concentration of angiotensin II in the blood, reduces aldosterone secretion, lowers blood pressure in patients with hypertension, and reduces symptoms of heart failure. Lisinopril is absorbed orally at about 25%, and the presence of food does not affect the absorption of the medicine. The maximum concentration in serum occurs after 6-8 hours. The half-life of the medicine is about 12 hours. Long-term administration of therapeutic doses of Lisinoratio does not lead to its accumulation in the blood. In the body, it does not undergo metabolic transformations and is excreted in the urine in its unchanged form. Lisinoratio is used to:

• treat essential and renovascular hypertension as monotherapy (as the only medicine) or in combination with other antihypertensive medicines
• treat heart failure as monotherapy or in combination with diuretics and, in certain cases, with digitalis preparations
• treat hemodynamically stable patients in the early (24-hour) phase of myocardial infarction to prevent the development of left ventricular dysfunction and heart failure
• treat patients with hypertension and type 2 diabetes with concomitant renal impairment and microalbuminuria.

2. Important information before taking Lisinoratio

When not to use Lisinoratio:

• if the patient is allergic to lisinopril or any of the other ingredients of this medicine (listed in section 6),

(see section 6),

• if the patient has ever had a condition called angioedema caused by previous treatment with an ACE inhibitor, characterized by swelling of the face, lips, tongue, and/or throat, difficulty swallowing, and breathing difficulties (feeling of shortness of breath);
• in cases of hereditary or idiopathic (spontaneous) angioedema;
• in pregnant or breastfeeding women;
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren;
• if the patient is taking a medicine containing a neprilysin inhibitor (e.g., sacubitril). Do not use Lisinoratio within 36 hours before or after taking sacubitril + valsartan, which contains a neprilysin inhibitor.

Warnings and precautions

Before starting treatment with Lisinoratio, discuss it with your doctor or pharmacist. Lisinoratio should be taken in the prescribed doses by the doctor for the entire treatment period, even if it is very long. Do not change the dose or method of taking the medicine on your own without consulting your doctor, especially in cases of increased risk of kidney function disorders or in patients with heart failure. Tell your doctor if you 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 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 "When not to use Lisinoratio" section. Inform your doctor about taking other medicines, including those available without a prescription. Inform your doctor, among other things, about taking antidiabetic medicines - oral or insulin, lithium salts (used, among other things, to treat depression), gold salts (used to treat a specific type of pain or arthritis). Due to the increased risk of hypotension, characterized by dizziness, vision disturbances, fainting, inform your doctor about taking diuretics before using Lisinoratio. Also, inform your doctor about any complaints or disorders, especially those related to the kidneys, vomiting, and diarrhea, dialysis, or a salt-free diet, or other medicines that may increase potassium levels in the blood (e.g., trimethoprim-containing medicines). Inform your doctor about any hypersensitivity reactions (allergic reactions) that have occurred, especially if they were characterized by swelling of the face, lips, tongue, and/or throat, difficulty breathing or swallowing. If hypotension occurs, characterized by vision disturbances, dizziness, fainting, lie down with your legs raised. If the symptoms do not subside after a few minutes, contact your doctor. Be cautious when taking potassium-containing preparations (including dietary supplements) and potassium-sparing diuretics during therapy with Lisinoratio. In patients with coronary artery disease or significant narrowing of the arteries supplying the brain, excessive lowering of blood pressure may cause myocardial infarction or cerebral hypoperfusion. During treatment with Lisinoratio or another ACE inhibitor, angioedema may occur [swelling of the face, limbs, lips, tongue, larynx, and/or throat]. In such a case, discontinue the medicine and consult a doctor immediately. In patients using ACE inhibitors and undergoing dialysis using high-flux dialysis membranes, a pseudo-anaphylactic reaction may occur. Before dialysis, inform your doctor about taking lisinopril. Similar reactions have occurred during low-density lipoprotein apheresis using dextran sulfate. This method should not be used in patients taking ACE inhibitors. In patients taking lisinopril and desensitized to hymenoptera venom, a life-threatening pseudo-anaphylactic reaction may occur. The doctor will recommend discontinuing the medicine during desensitization or abandoning the desensitization procedure. Inform your doctor about taking Lisinoratio before undergoing general anesthesia for surgical procedures. At the beginning of treatment with Lisinoratio, a transient decrease in blood pressure may occur, characterized by a feeling of excessive fatigue and dizziness. If such symptoms occur, lie down with your legs raised, and if the symptoms do not subside after a few minutes, contact your doctor. To assess the effectiveness of treatment and determine the smallest effective dose, your doctor may recommend frequent blood pressure measurements, especially at the beginning of treatment and after changing the dose of the medicine. Your doctor may also recommend frequent monitoring of electrolyte levels in the blood, especially in patients with increased risk of kidney failure or those taking potassium-sparing diuretics. If symptoms such as fever, lymph node enlargement, pharyngitis, nosebleeds, gingival bleeding, or excessive bruising of the skin occur, contact your doctor as soon as possible, as they may be related to an excessive decrease in the number of white blood cells or platelets. Inform your doctor about taking a medicine containing a neprilysin inhibitor (e.g., sacubitril). Inform your doctor about taking a medicine containing wildagliptin.

Children and adolescents

Experience with the effectiveness and safety of lisinopril in the treatment of hypertension in children over 6 years of age is limited, and there is no experience with the use of lisinopril in other indications than hypertension. The use of lisinopril is not recommended in children for other indications than hypertension. The use of lisinopril is not recommended in children under 6 years of age or in children with severe kidney function disorders.

Lisinoratio and other medicines

Generally, Lisinoratio can be taken with other medicines. However, you should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take, as some medicines may affect the action of others. 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 "When not to use Lisinoratio" and "When to exercise caution when taking Lisinoratio" sections).

For the prescription of the correct dose of Lisinoratio, it is particularly important for the doctor to know about the use of: other blood pressure-lowering medicines, diuretics (diuretic medicines), potassium-containing preparations (including dietary supplements), or other medicines that may increase potassium levels in the blood (e.g., trimethoprim-containing medicines), medicines used to treat diabetes (including oral antidiabetic medicines or insulin), lithium (a medicine used to treat certain types of depression), and some medicines used to treat pain and joint diseases. Tell your doctor about taking a medicine containing a neprilysin inhibitor (e.g., sacubitril) or wildagliptin (an antidiabetic medicine), as concomitant use with Lisinoratio may increase the risk of angioedema. Lisinoratio used with diuretics may enhance the blood pressure-lowering effect. Indomethacin and other non-steroidal anti-inflammatory medicines (e.g., acetylsalicylic acid) may weaken the antihypertensive effect of Lisinoratio. Concomitant administration of Lisinoratio and lithium may lead to decreased lithium excretion. Your doctor will recommend regular monitoring of lithium levels in the blood and, if necessary, recommend lower doses of lithium. Concomitant use of potassium supplements, potassium-containing salt substitutes, or potassium-sparing diuretics (spironolactone, eplerenone, amiloride, triamterene) may lead to hyperkalemia (increased potassium levels in the blood).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. PregnancyDo not use Lisinoratio in pregnant women. ACE inhibitors, including lisinopril, may cause fetal harm or death when administered in the second or third trimester of pregnancy (i.e., from the fourth month of pregnancy to birth). If it is discovered during treatment that the woman is pregnant, discontinue the medicine, contact your doctor, and, according to the doctor's recommendation, change the treatment method. A pregnant woman or a woman planning to become pregnant should inform her doctor before starting treatment with Lisinoratio. Women of childbearing age taking lisinopril should use effective contraception. BreastfeedingIt is not known whether lisinopril passes into human milk. If you are breastfeeding or plan to breastfeed, discuss this with your doctor.

Driving and using machines

Individual reactions to the medicine may vary. Some side effects reported during treatment with lisinopril may affect the ability to drive or operate machines (see section 4).

Lisinoratio contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Lisinoratio

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Since food does not affect the absorption of lisinopril, the medicine can be taken with or without food. Lisinopril should be taken once a day, at the same time every day. Essential hypertension The recommended initial dose for patients with essential hypertension is 10 mg per day. The usual effective maintenance dose is 20 mg per day. The maximum single daily dose is 80 mg. In patients treated with diuretics, the doctor usually recommends discontinuing or reducing the dose of the diuretic 2-3 days before starting treatment with Lisinoratio. The recommended initial dose is 5 mg. Renovascular hypertension In some patients with renovascular hypertension, especially those with bilateral renal artery stenosis or stenosis of the artery supplying a single kidney, the initial dose is 2.5 mg or 5 mg per day. The doctor may then recommend a higher dose of the medicine. Heart failure In patients with heart failure, the initial single daily dose is 2.5 mg. Daily maintenance doses usually range from 5 mg to 20 mg. If diuretics cannot be discontinued, in dehydrated patients, with sodium deficiency, in patients with renal failure, the doctor should recommend a lower dose of lisinopril, adjusting it according to the severity of renal impairment (creatinine clearance). Acute phase of myocardial infarction In the acute phase of myocardial infarction, in hemodynamically stable patients (who have not had cardiogenic shock), within 24 hours of the onset of myocardial infarction, the doctor should recommend an initial dose of 5 mg. After another 24 hours, take the same dose (5 mg), and after 48 hours from the onset of myocardial infarction, take a dose of 10 mg of lisinopril. Then, continue taking the medicine in a single daily dose of 10 mg for 6 weeks. If there are no contraindications, the doctor will also recommend taking other medicines usually used to treat myocardial infarction (anticoagulants, antiplatelet agents, and beta-blockers). Patients with low systolic blood pressure (≤ 120 mmHg) at the beginning of treatment and for the next three days should take a lower dose - 2.5 mg of lisinopril per day. In case of hypotension (systolic blood pressure below 100 mmHg), the doctor may recommend reducing the maintenance dose to 5 mg or 2.5 mg. If prolonged hypotension occurs (systolic blood pressure below 90 mmHg lasting longer than 1 hour), the doctor should recommend discontinuing Lisinoratio. Diabetic nephropathy In patients with hypertension and type 2 diabetes, the usual initial dose of Lisinoratio is 10 mg, while the daily maintenance dose should be adjusted to lower diastolic blood pressure to the currently recommended values for these patients. Renal impairment In patients with renal impairment, the dosage should be adjusted according to the severity of the impairment based on creatinine clearance using the following table. Then, the doctor usually recommends gradually increasing the dose. The maximum single daily dose of lisinopril is 40 mg. Use in children aged 6 to 16 years with hypertension The doctor will determine the dose suitable for the child, which depends on the child's body weight. For children with a body weight of 20 to <50 kg, the recommended initial dose is 2.5 mg once daily. for children with a body weight ≥ 50 5 daily.< p>

Using a higher than recommended dose of Lisinoratio

If you have taken too much Lisinoratio, contact your doctor immediately. Medical supervision is necessary. The most likely symptom of overdose is excessive lowering of blood pressure and associated dizziness.

Missing a dose of Lisinoratio

Take the medicine in the dose prescribed by your doctor. If you miss a dose at the usual time, do not take an extra dose. The next day, return to the regular use of the medicine in the dose prescribed by your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Lisinopril is generally well-tolerated. Common side effects include dizziness, headache, diarrhea, vomiting, kidney function disorders, cough, and dizziness associated with a sudden drop in blood pressure when standing up quickly (orthostatic symptoms). Other side effects that occur not very often include myocardial infarction or stroke, probably secondary to excessive blood pressure lowering in high-risk patients, palpitations (feeling of strong heartbeat), tachycardia (fast heartbeat), decreased blood flow to the fingers and toes, characterized by a change in their color, accompanied by a feeling of cold or numbness (Raynaud's phenomenon), rhinitis, abdominal pain, nausea, rash, itching, weakness (fatigue), mood disorders, sleep disorders, paresthesia (tingling, prickling, or burning sensation), impotence, fatigue, dizziness, taste disturbances, increased urea levels in the blood, increased creatinine levels in the serum, increased liver enzyme activity, and hyperkalemia (elevated potassium levels in the blood). Other side effects that occur rarely include decreased hemoglobin levels, decreased red blood cell count (decreased hematocrit value), disorientation, dryness of the mucous membranes, hypersensitivity/angioedema (swelling of the face, limbs, lips, tongue, larynx, and/or throat), hives, hair loss (alopecia), elevated urea, creatinine, and other nitrogenous end-products of protein metabolism in the blood (uremia), acute renal failure, gynecomastia, increased bilirubin levels in the serum, and hyponatremia (low sodium levels in the blood). Other side effects may occur very rarely, and some of them may be serious. Examples of such side effects include jaundice (yellowing of the skin and/or eyes) and severe abdominal pain. Other side effects that occur very rarely include bone marrow suppression, anemia, thrombocytopenia (low platelet count), leukopenia (decreased total white blood cell count), neutropenia (decreased neutrophil count), agranulocytosis (significant decrease in granulocyte count), hemolytic anemia, lymphadenopathy (enlarged lymph nodes), autoimmune disease, hypoglycemia (low blood sugar), bronchospasm (bronchial constriction), sinusitis, pancreatitis, intestinal angioedema (intestinal wall edema), hepatitis (hepatocellular or cholestatic), liver failure, excessive sweating, blistering of the skin and mucous membranes (pemphigus), and toxic epidermal necrolysis (toxic skin necrosis). The following side effects have also been reported, but their frequency cannot be determined from the available data (frequency unknown): gout, decreased libido, depression, somnolence, stroke, fainting, angina pectoris, arrhythmias, shortness of breath, pulmonary infiltrates, laryngitis, bronchitis, nasal congestion, sore throat, anorexia, constipation, bloating, photosensitivity, pseudolymphoma, urinary tract infections, chest pain, flushing, SIADH (syndrome of inappropriate antidiuretic hormone secretion), blurred vision, back pain, joint pain, muscle cramps, and shoulder pain. A syndrome has been reported that includes one or more of the following symptoms: fever, vasculitis, muscle pain, joint pain or inflammation, positive antinuclear antibody titer (ANA), elevated erythrocyte sedimentation rate (ESR), eosinophilia, and leukocytosis, rash, photosensitivity, or other skin symptoms. For more information on side effects, consult your doctor or pharmacist. If you experience any side effects or worrying symptoms, tell your doctor or pharmacist. You should discontinue Lisinoratio and contact your doctor immediately in any of the following cases:

• if swelling of the face, lips, tongue, larynx, and/or throat occurs, which may cause difficulty breathing or swallowing
• if swelling of the hands, ankles, or feet occurs
• if hives occur

After taking the first dose of the medicine, a greater decrease in blood pressure may occur than after subsequent doses. This may be manifested by fainting or dizziness. If this happens, lie down. In case of doubt, contact your doctor.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. 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, Tel: +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, you can help gather more information on the safety of the medicine.

5. How to store Lisinoratio

Keep the medicine out of the sight and reach of children. Lisinoratio 5: There are no special storage instructions. Lisinoratio 10, Lisinoratio 20: Do not store above 25°C. Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Lisinoratio contains

• The active substance of the medicine is lisinopril.
• The other ingredients of the medicine are: mannitol, calcium hydrogen phosphate dihydrate, cornstarch, sodium croscarmellose, magnesium stearate. Lisinoratio 10 mg tablets also contain the dye PB-24823 Pink [cornstarch, iron(III) oxide, iron(II, III) oxide, iron(III) hydroxide]. Lisinoratio 20 mg tablets also contain the dye PB-24824 Pink [cornstarch, iron(III) oxide, iron(II, III) oxide, iron(III) hydroxide].

What Lisinoratio looks like and what the package contains

Lisinoratio 5: white, round, biconvex tablets with a dividing line on one side. Lisinoratio 10: light pink, round, biconvex tablets with a dividing line on one side. Lisinoratio 20: pink, round, biconvex tablets with a dividing line on one side.

Packaging:

30 tablets

Marketing authorization holder:

ratiopharm GmbH, Graf-Arco-Strasse 3, 89079 Ulm, Germany

Manufacturer:

Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143 Blaubeuren, Germany Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków For more detailed information about the medicine, please contact the local representative of the marketing authorization holder. Teva Pharmaceuticals Polska Sp. z o.o., tel. +48 22 345 93 00

Date of last revision of the leaflet: