Prinivil

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

PRINIVIL, 5 mg, tablets

Lisinopril

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.
• In case of any doubts, you should consult a doctor or pharmacist.
• 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

DO NOT USE IN PREGNANT WOMEN

Table of contents of the leaflet

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

1. What is PRINIVIL and what is it used for

PRINIVIL contains lisinopril (an angiotensin-converting enzyme inhibitor, or ACE inhibitor), which inhibits the activity of the enzyme that converts angiotensin I into angiotensin II, a potent vasoconstrictor that increases blood pressure. Inhibiting the conversion of angiotensin results in decreased levels of angiotensin II in the blood, decreased aldosterone secretion, and lowered blood pressure in patients with hypertension, as well as reduced symptoms of heart failure. Lisinopril is absorbed orally at about 25%, and the presence of food does not affect its absorption. Maximum serum levels occur after 6-8 hours. The half-life of the drug is approximately 12 hours. Long-term administration of therapeutic doses of PRINIVIL does not result in its accumulation in the blood. In the body, it does not undergo metabolic transformations and is excreted in the urine unchanged. PRINIVIL is indicated for the treatment of:

• essential and renovascular hypertension, both as monotherapy and in combination with other antihypertensive agents;
• heart failure, as monotherapy or in combination with diuretics and digitalis glycosides;
• hemodynamically stable patients in the early (24-hour) phase of myocardial infarction to prevent the development of left ventricular dysfunction and heart failure;
• patients with diabetes and hypertension, as well as concomitant kidney damage with microalbuminuria.

2. Important information before taking PRINIVIL

When not to use PRINIVIL:

• if the patient is hypersensitive to lisinopril or any other component of the drug (listed in section 6);
• if the patient has ever experienced angioedema while taking ACE inhibitors, characterized by swelling of the face, lips, tongue, and/or throat, difficulty swallowing, and shortness of breath;
• if the patient has hereditary or idiopathic 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). PRINIVIL should not be used within 36 hours before or after taking sacubitril/valsartan, which contains a neprilysin inhibitor.

Warnings and precautions

Before starting treatment with PRINIVIL, you should discuss it with your doctor or pharmacist. PRINIVIL should be taken in the doses prescribed by your doctor for the entire treatment period, even if it is very long. You should not change the dose or the way you take the medicine without consulting your doctor, especially if you have an increased risk of kidney problems or 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, such as valsartan, telmisartan, or 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 your blood. See also the section "When not to use PRINIVIL". You should inform your doctor about taking other medicines, including those available without a prescription. You should inform your doctor about taking antidiabetic medicines (oral or insulin), lithium (used to treat certain types of depression), or certain medicines used to treat pain and joint diseases. Due to the increased risk of hypotension, characterized by dizziness, blurred vision, fainting, you should inform your doctor about taking diuretics before taking PRINIVIL. You should also inform your doctor about any conditions or disorders, especially those related to the kidneys, vomiting, diarrhea, dialysis, or a salt-free diet, or other medicines that may increase potassium levels in the blood (e.g., trimethoprim-containing medicines). You should inform your doctor about any allergic reactions, especially those characterized by swelling of the face, lips, tongue, and/or throat, difficulty breathing or swallowing. If hypotension occurs, characterized by blurred vision, dizziness, fainting, you should lie down with your legs elevated. If the symptoms do not disappear after a few minutes, you should contact your doctor. You should be cautious when taking potassium-containing preparations (including dietary supplements) and potassium-sparing diuretics during PRINIVIL therapy. 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 PRINIVIL or another ACE inhibitor, angioedema may occur [swelling of the face, limbs, lips, tongue, larynx, and/or throat]. In such cases, the medicine should be discontinued immediately, and you should 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 discontinuing the medicine during desensitization or avoiding the desensitization procedure. You should inform your doctor about taking PRINIVIL before undergoing general anesthesia for surgical procedures. At the beginning of treatment with PRINIVIL, transient hypotension may occur, characterized by excessive fatigue and dizziness. If such symptoms occur, you should lie down with your legs elevated, 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. Your doctor may recommend regular 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, or easy bruising occur, you should contact your doctor immediately, as they may be related to an excessive decrease in white blood cell or platelet count. You should inform your doctor about taking a medicine containing a neprilysin inhibitor (e.g., sacubitril) or wildagliptin (an antidiabetic medicine).

Children and adolescents

PRINIVIL has been studied in children. For more information, you should consult your doctor. It is not recommended to use lisinopril in children under 6 years of age or in children with severe kidney problems.

PRINIVIL and other medicines

Generally, PRINIVIL 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 those 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 sections "When not to use PRINIVIL" and "Warnings and precautions").

For the prescription of the correct dose of PRINIVIL, it is particularly important for your doctor to know 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., trimethoprim-containing medicines), antidiabetic medicines (including oral or insulin), lithium (used to treat certain types of depression), and certain medicines used to treat pain and joint diseases. 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 PRINIVIL may increase the risk of angioedema. PRINIVIL used with diuretics may enhance the blood pressure-lowering effect. Indomethacin and other nonsteroidal anti-inflammatory drugs (e.g., acetylsalicylic acid) may reduce the antihypertensive effect of PRINIVIL. Concomitant administration of PRINIVIL and lithium may result in decreased lithium excretion. Your doctor will recommend regular monitoring of lithium levels in the blood and, if necessary, prescribe 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 (elevated 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. PregnancyPRINIVIL should not be used in pregnant women. ACE inhibitors, including PRINIVIL, may cause fetal harm or death when administered during the second or third trimester of pregnancy (from the fourth month of pregnancy to birth). If you become pregnant during treatment, you should stop taking the medicine, contact your doctor, and follow their recommendations for changing the treatment. 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, you should discuss this with your doctor.

Driving and using machines

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

3. How to take PRINIVIL

This medicine should always be taken as directed by your doctor. If you have any doubts, you should consult your doctor or pharmacist. The medicine is available in the following strengths: 5 mg, 10 mg, 20 mg. PRINIVIL should be taken once a day, at the same time every day. The tablets can be taken before meals, during meals, or after meals. Food does not affect the action of the medicine. Essential hypertension In essential hypertension, the usual initial dose is 10 mg per day, and the 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 PRINIVIL. The recommended initial dose is 5 mg. Renovascular hypertension In patients with renovascular hypertension, patients with bilateral renal artery stenosis or stenosis of a single kidney artery, the initial dose is 2.5-5 mg per day. The doctor may then recommend a higher dose of the medicine. Heart failure In heart failure, the initial dose is 2.5 mg per day, and the maintenance dose is 5-20 mg per day. If diuretics cannot be stopped, in dehydrated patients, with sodium deficiency, or in patients with kidney failure, the doctor should recommend a lower dose of lisinopril, adjusting it according to the severity of kidney problems (creatinine clearance). Acute phase of myocardial infarction In the acute phase of myocardial infarction, in hemodynamically stable patients (without 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, the dose of 10 mg of lisinopril should be taken. 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 (systolic blood pressure below 90 mmHg lasting more than 1 hour) occurs, the doctor should recommend stopping PRINIVIL. Diabetic nephropathy In patients with hypertension and type 2 diabetes, the usual initial dose of PRINIVIL is 10 mg, and the maintenance dose should be adjusted to lower diastolic blood pressure to the currently recommended values in these patients. Kidney problems In patients with kidney problems, the dosage should be adjusted according to the severity of the problems based on creatinine clearance using the following table. Creatinine clearance [ml/min] Initial dose [mg/day] ≤ 70 > 30 ml/min 5-10 mg/day ≤ 30 ≥ 10 ml/min 2.5-5 mg/day <10 ml min 2.5 mg day then, the doctor usually recommends gradually increasing dose. maximum single daily dose of lisinopril is 40 mg. use in children aged 6-16 years with hypertension will determine suitable for child, which depends on child's weight. a body weight 20-<50 kg, recommended initial once day. ≥ 50 5 day.< p>

Overdose of PRINIVIL

In case of overdose, the patient should immediately consult a doctor. Medical supervision is necessary. The most likely symptom of overdose is excessive lowering of blood pressure, which may be accompanied by dizziness.

Missed dose of PRINIVIL

The medicine should be taken in the dose prescribed by the doctor. If a dose is missed, 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 the doctor.

4. Possible side effects

Like all medicines, PRINIVIL can cause side effects, although not everybody gets them. PRINIVIL 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 high-risk patients, palpitations (feeling of strong heartbeat), rapid heartbeat (tachycardia), decreased blood flow to the fingers and toes, which may cause a change in their color, accompanied by a feeling of cold or numbness (Raynaud's phenomenon), nasal congestion, abdominal pain, nausea, rash, itching, weakness (fatigue), mood changes, sleep disturbances, tingling, numbness, or burning sensation (paresthesia), impotence, fatigue, dizziness, taste disturbances, increased urea levels in the blood, increased creatinine levels in the blood, increased liver enzyme activity, and elevated 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/allergic edema (swelling of the face, limbs, lips, tongue, larynx, and/or throat), hives, hair loss (alopecia), excessive levels of urea, creatinine, and other nitrogenous end products of protein and amino acid metabolism in the blood (uremia), acute kidney failure, gynecomastia, elevated 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), oliguria or anuria, 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 levels of a type of white blood cell called neutrophils (neutropenia), significant decrease in the count of a type of white blood cell called granulocytes (agranulocytosis), hemolytic anemia, lymphadenopathy, autoimmune disease, low blood sugar levels (hypoglycemia), bronchospasm, sinusitis, pancreatitis, intestinal angioedema, hepatitis (hepatocellular or cholestatic), liver failure, excessive sweating, blistering of the skin and mucous membranes, and toxic epidermal necrolysis. 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, 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 PRINIVIL and immediately consult your doctor in 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, you should lie down. In case of doubts, you should consult your doctor.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. 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 By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store PRINIVIL

The medicine should be stored out of sight and reach of children. Store at a temperature below 30°C. Do not use this medicine after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month. 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 PRINIVIL contains

• The active substance of the medicine is lisinopril (in the form of lisinopril dihydrate). Each tablet contains 5 mg of lisinopril.
• The other ingredients are: mannitol, calcium hydrogen phosphate dihydrate, cornstarch, pregelatinized cornstarch, magnesium stearate.

What PRINIVIL looks like and contents of the pack

Available packs: PRINIVIL is available in packs containing 30 tablets. For more detailed information, you should consult the marketing authorization holder or parallel importer:

Marketing authorization holder in Spain, the country of export:

ROVI Pharma Industrial Services, S.A. Vía Complutense 140 28805 Alcalá de Henares (Madrid) Spain

Manufacturer:

ROVI Pharma Industrial Services, S.A. Vía Complutense 140 28805 Alcalá de Henares (Madrid) Spain

Parallel importer:

Delfarma Sp. z o.o. ul. Św. Teresy od Dzieciątka Jezus 111 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o. ul. Św. Teresy od Dzieciątka Jezus 111 91-222 Łódź Spanish authorization number: 673131.4

Parallel import authorization number: 567/13

Date of leaflet approval: 20.12.2023

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