Lisinoratio 20

Leaflet attached to the packaging: patient information

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

Lisinoratio 20 (Lisinopril-ratiopharm 20 mg Tablets)

20 mg, tablets

Lisinopril
Lisinoratio 20 and Lisinopril-ratiopharm 20 mg Tablets 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.
• 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

Lisinoratio 20 contains lisinopril (also known as an angiotensin-converting enzyme inhibitor - ACE), which inhibits the activity of the enzyme that converts angiotensin I into angiotensin II, which has a vasoconstrictive effect and increases blood pressure.
Inhibiting the conversion of angiotensin results in a decrease in the concentration of angiotensin II in the blood, a decrease in aldosterone secretion, a decrease in blood pressure in patients with hypertension, and a reduction in 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 20 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 an unchanged form.
Lisinoratio 20 is used for:

DO NOT USE IN PREGNANT WOMEN

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

2. Important information before taking Lisinoratio 20

When not to use Lisinoratio 20:

• if the patient is allergic to lisinopril or any of the other ingredients of this medicine (listed in 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 (feeling of shortness of breath);
• in the case 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 20 within 36 hours before or after taking sacubitril + valsartan, which contains a neprilysin inhibitor.

Warnings and precautions

Before starting treatment with Lisinoratio 20, you should discuss it with your doctor or pharmacist.
Lisinoratio 20 should be taken in the doses prescribed by your doctor throughout the entire treatment period, even if it is very long.
You should not change the dose or the way you take the medicine on your own without your doctor's recommendation, especially if you have an increased risk of kidney problems or if you have heart failure.
You should tell your doctor if you are taking any of the following medicines used to treat high blood pressure:

• an 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 use Lisinoratio 20".
You should inform your doctor about taking other medicines, including those available without a prescription.
You should inform your doctor about taking, among others, antidiabetic medicines - oral or insulin, lithium salts (used, among others, in the treatment of depression), gold salts (used in the treatment of a specific type of pain or arthritis).
Due to the increased risk of hypotension, which may manifest as dizziness, vision disturbances, fainting, you should inform your doctor about taking diuretics before taking Lisinoratio 20.
You should 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., trimetoprim-containing medicines).
You should inform your doctor about any allergic reactions that have occurred, especially if they manifested as swelling of the face, lips, tongue, and/or throat, difficulty breathing or swallowing.
In case of hypotension, which may manifest as vision disturbances, dizziness, fainting, you should lie down with your legs raised. If the symptoms do not disappear after a few minutes, you should contact your doctor.
You should be careful when taking potassium-containing preparations (including dietary supplements) and potassium-sparing diuretics during therapy with Lisinoratio 20.
In patients with coronary heart disease or significant narrowing of the arteries supplying the brain, excessive lowering of blood pressure may cause myocardial infarction or cerebral hypoxia.
During treatment with Lisinoratio 20 or another ACE inhibitor, angioedema may occur [swelling of the face, limbs, lips, tongue, larynx, and/or throat]. In such a case, you should stop taking the medicine immediately and consult your doctor.
In patients taking ACE inhibitors and undergoing dialysis using high-flux dialysis membranes, a pseudo-anaphylactic reaction may occur. Before dialysis, you should 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. Your doctor will recommend stopping the medicine during desensitization or resigning from the desensitization procedure.
You should inform your doctor about taking Lisinoratio 20 before general anesthesia for surgical procedures.
At the beginning of treatment with Lisinoratio 20, transient hypotension may occur, which may manifest as excessive fatigue and dizziness. If such symptoms occur, you should lie down with your legs raised, and if the symptoms do not disappear after a few minutes, you should 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 recommend frequent monitoring of electrolyte levels in the blood, especially in patients with an increased risk of kidney failure or those taking potassium-sparing diuretics.
In case of symptoms such as fever, lymph node enlargement, pharyngitis, nosebleeds, gum bleeding, or excessive bruising, you should 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.
You should inform your doctor about taking a medicine containing a neprilysin inhibitor (e.g., sacubitril).
You should 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. It is not recommended to use lisinopril in children for other indications than hypertension.
It is not recommended to use lisinopril in children under 6 years of age or in children with severe kidney problems.

Lisinoratio 20 and other medicines

Generally, Lisinoratio 20 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 the 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 subsections "When not to use Lisinoratio 20" and "When to exercise special caution when taking Lisinoratio 20").

For the prescription of the correct dose of Lisinoratio 20, it is particularly important that your doctor knows about the use of: other blood pressure-lowering medicines, diuretics, potassium-containing preparations (including dietary supplements), or other medicines that may increase potassium levels in the blood (e.g., trimetoprim-containing medicines), antidiabetic medicines (including oral or insulin), lithium (a medicine used to treat certain types of depression), and some medicines used to treat pain and arthritis. You should tell your doctor about taking an mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) or a medicine containing a neprilysin inhibitor (e.g., sacubitril) or wildagliptin (an antidiabetic medicine), as concomitant use with Lisinoratio 20 may increase the risk of angioedema.
Lisinoratio 20 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 20.
Concomitant administration of Lisinoratio 20 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, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
Lisinoratio 20 should not be used in pregnant women.
ACE inhibitors, including lisinopril, may cause harm or death to the fetus if taken during the second or third trimester of pregnancy (i.e., from the fourth month of pregnancy to birth). If it is discovered that you are pregnant during treatment, you should stop taking the medicine, contact your doctor, and, according to your 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 20.
Women of childbearing age taking lisinopril should use effective contraception.
Breastfeeding
It is not known whether lisinopril passes into breast milk. If you are breastfeeding or plan to breastfeed, you should discuss this with your doctor.

Driving and using machines

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

Lisinoratio 20 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 Lisinoratio 20

This medicine should always be taken as directed by your doctor. If you have any doubts, you should consult your doctor or pharmacist.
Since food does not affect the absorption of lisinopril, the medicine can be taken regardless of meals.
Lisinopril should be taken once a day, every day at the same time.
Essential hypertension
The recommended initial dose for patients with essential hypertension is 10 mg per day.
Usually, the 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 stopping or reducing the dose of the diuretic 2-3 days before starting treatment with Lisinoratio 20. The recommended initial dose is 5 mg.
Reno-vascular 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 taken in the morning is 2.5 mg. Daily maintenance doses usually range from 5 mg to 20 mg.
In cases where diuretics cannot be stopped, 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, the same dose (5 mg) should be taken, and after 48 hours from the onset of myocardial infarction, a dose of 10 mg of lisinopril. Then, the medicine should be continued at 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 stopping Lisinoratio 20.
Nephropathy in diabetes
In patients with hypertension and type 2 diabetes, the usual initial dose of Lisinoratio 20 is 10 mg, while the maintenance dose should be adjusted to reduce diastolic blood pressure to the currently recommended values in these patients.
Renal impairment
In patients with impaired renal function, 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 a day.
For children with a body weight ≥ 50 kg, the recommended initial dose is 5 mg once a day.

Using a higher than recommended dose of Lisinoratio 20

In case of taking too much Lisinoratio 20, you should immediately consult a doctor. Medical supervision is necessary. The most likely symptom of overdose is excessive lowering of blood pressure and related dizziness.

Missing a dose of Lisinoratio 20

The medicine should be taken in the dose prescribed by your doctor.
In case of missing a dose at the usual time, you should not take an additional dose.
The next day, you should 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 problems, cough, and dizziness related to 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 patients at high risk, palpitations (feeling of strong heartbeat), rapid heartbeat (tachycardia), decreased blood flow to the fingers and toes, which may manifest as a change in their color, accompanied by a feeling of cold or numbness (Raynaud's phenomenon), rhinitis, abdominal pain, nausea, rash, itching, weakness, mood disorders, sleep disturbances, tingling, feeling of prickling, or burning (paresthesia), impotence, fatigue, dizziness, taste disturbances, increased urea levels in the blood, increased creatinine levels in the blood, increased liver enzyme activity, and increased potassium levels in the blood (hyperkalemia).
Other side effects that occur rarely include decreased hemoglobin levels, decreased red blood cell count (decreased hematocrit), disorientation, dryness of the mucous membranes, hypersensitivity/angioedema (swelling of the face, limbs, lips, tongue, larynx, and/or throat), hives, hair loss (alopecia), excessive urea levels, and creatinine levels in the blood, acute renal failure, gynecomastia, increased bilirubin levels in the blood, low sodium levels in the blood (hyponatremia).
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, low platelet count (thrombocytopenia), decreased total white blood cell count (leukopenia), low neutrophil count (neutropenia), severe decrease in granulocyte count (agranulocytosis), hemolytic anemia, lymphadenopathy, autoimmune disease, low blood sugar levels (hypoglycemia), bronchospasm, sinusitis, pancreatitis, intestinal angioedema, liver disease (hepatocellular or cholestatic), liver failure, excessive sweating, blistering of the skin and mucous membranes, and toxic epidermal necrolysis.
Other side effects have been reported, but their frequency cannot be determined based on available data (frequency unknown): gout, decreased libido, depression, drowsiness, 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, syndrome of inappropriate antidiuretic hormone secretion (SIADH), blurred vision, back pain, joint pain, muscle cramps, and shoulder pain.
There have been reports of a syndrome that includes one or more of the following symptoms: fever, vasculitis, muscle pain, joint pain or arthritis, positive antinuclear antibody titer (ANA), increased erythrocyte sedimentation rate (ESR), eosinophilia, and leukocytosis, rash, photosensitivity, or other skin symptoms.
For additional information on side effects, you should consult your doctor or pharmacist.
If you experience any side effects or worrying symptoms, you should tell your doctor or pharmacist.
You should stop taking Lisinoratio 20 and immediately consult your doctor in any of the following cases:

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

After taking the first dose of the medicine, a greater decrease in blood pressure may occur than after subsequent doses. This may manifest as fainting or dizziness. If this happens, you should lie down. In case of doubts, you should contact your doctor.

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 Drug Safety Monitoring, 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 the 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.
Do not use this medicine 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. und verwendbar bis: siehe Prägung – 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 does Lisinoratio 20 contain

• The active substance of the medicine is lisinopril (in the form of lisinopril dihydrate). Each tablet contains 20 mg of lisinopril.
• Other ingredients of the medicine are: mannitol, calcium hydrogen phosphate dihydrate, cornstarch, croscarmellose sodium, magnesium stearate, iron(III) oxide, iron(II, III) oxide, iron(III) hydroxide.

What does Lisinoratio 20 look like and what does the packaging contain

Pink, round, biconvex tablets with a notch on one 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:

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

Manufacturer:

Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren, 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:43687.03.00
Parallel import authorization number:100/20

Date of leaflet approval: 13.03.2025

[Information about the trademark]