Lisinopril Aurovitas

Leaflet accompanying the packaging: patient information

Lisinopril Aurovitas, 10 mg, tablets

Lisinopril Aurovitas, 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.
• If you have any doubts, consult your 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 as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Lisinopril Aurovitas and what is it used for

Lisinopril Aurovitas contains the active substance lisinopril. It belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).
Lisinopril Aurovitas can be used for the following diseases:

• Treatment of high blood pressure (hypertension).
• Treatment of heart failure.
• Treatment after a recent heart attack.
• Treatment of kidney problems caused by type 2 diabetes in patients with high blood pressure. The action of Lisinopril Aurovitas is to dilate blood vessels. This helps to lower blood pressure and make it easier for the heart to pump blood to all parts of the body.

2. Important information before taking Lisinopril Aurovitas

When not to take Lisinopril Aurovitas:

• after the 3rd month of pregnancy (it is also recommended to avoid taking Lisinopril Aurovitas in early pregnancy - see "Pregnancy");

In case of doubt about any of the above conditions, the patient should consult their doctor or pharmacist before taking Lisinopril Aurovitas.
If the patient experiences a dry cough that persists for a long time after starting Lisinopril Aurovitas, they should tell their doctor.

Warnings and precautions

Before starting to take Lisinopril Aurovitas, the patient should discuss it with their doctor or pharmacist:

• angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections "When not to take Lisinopril Aurovitas" and "Warnings and precautions");
• for example, valsartan, telmisartan, irbesartan, especially if the patient has kidney problems related to diabetes;
• aliskiren;
• racecadotril, used to treat diarrhea;
• medicines used to prevent rejection of a transplanted organ and to treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• wildagliptin, a medicine used to treat diabetes.

The doctor may periodically check kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also section "When not to take Lisinopril Aurovitas"

• the patient should inform their doctor if they suspect or plan to become pregnant. It is not recommended to take Lisinopril Aurovitas in early pregnancy and it should not be taken after the 3rd month of pregnancy, as it may seriously harm the baby (see "Pregnancy and breastfeeding");

In case of doubt about any of the above conditions, the patient should consult their doctor or pharmacist before taking Lisinopril Aurovitas.

Allergy treatment, such as bee sting allergy

The patient should inform their doctor if they are undergoing or planning to undergo desensitization treatment for allergies (e.g., bee stings). Taking Lisinopril Aurovitas during such treatment may cause severe allergic reactions.

Surgical procedures

The patient should inform their doctor or dentist that they are taking Lisinopril Aurovitas if they are scheduled for surgery (including dental surgery). Low blood pressure (hypotension) may occur during anesthesia.

Children and adolescents

Lisinopril Aurovitas has been studied in children. The patient should consult their doctor for more information. It is not recommended to take Lisinopril Aurovitas in children under 6 years of age and in children with severe kidney problems.

Lisinopril Aurovitas and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Lisinopril Aurovitas may affect the action of other medicines, and other medicines may affect the action of Lisinopril Aurovitas. The doctor may recommend a dose change and/or other precautions.
In particular, the patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• other blood pressure-lowering medicines;
• angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections "When not to take Lisinopril Aurovitas" and "Warnings and precautions");
• diuretics;
• beta-blockers, such as atenolol and propranolol;
• nitrates (used to treat heart disease);
• non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain and inflammation of the joints;
• aspirin (acetylsalicylic acid) in doses greater than 3 g per day;
• medicines used to treat depression and mental disorders, including lithium;
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressant used to prevent rejection of a transplanted organ; and heparin, a medicine used to thin the blood to prevent clots);
• insulin or oral antidiabetic medicines;
• asthma medicines;
• medicines used to treat nasal congestion or sinusitis, or other medicines used to treat colds (including over-the-counter medicines);
• immunosuppressants;
• allopurinol (used to treat gout);
• procainamide (used to treat heart rhythm disorders);
• medicines containing gold compounds, such as sodium aurothiomalate, given by injection.

The following medicines may increase the risk of angioedema (symptoms of angioedema include swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing):

• medicines that dissolve blood clots (tissue plasminogen activator), usually given in a hospital;
• medicines used to prevent rejection of a transplanted organ and to treat cancer (e.g., sirolimus, everolimus) and other medicines belonging to the group of so-called mTOR inhibitors - see section "Warnings and precautions";
• racecadotril, used to treat diarrhea.

Pregnancy and breastfeeding

Pregnancy
The patient should inform their doctor if they suspect or plan to become pregnant. The doctor will usually recommend stopping Lisinopril Aurovitas before planned pregnancy or as soon as pregnancy is confirmed, and recommend an alternative treatment. It is not recommended to take Lisinopril Aurovitas in early pregnancy and it should not be taken after the 3rd month of pregnancy, as it may seriously harm the baby.
Breastfeeding
The patient should inform their doctor if they are breastfeeding or plan to breastfeed. It is not recommended to take Lisinopril Aurovitas in breastfeeding women. The doctor may recommend alternative treatment if the patient wishes to breastfeed, especially if the baby is a newborn or premature.

Driving and using machines

• Some people may feel dizzy or tired when taking this medicine. If these symptoms occur, the patient should not drive, use tools, or operate machinery.
• Before performing these activities, the patient should know how they react to the medicine.

3. How to take Lisinopril Aurovitas

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
If the patient has already started taking Lisinopril Aurovitas, their doctor may perform blood tests. The doctor may then adjust the dose accordingly for the individual patient.

Taking the medicine

• The tablet should be swallowed with water.
• The patient should try to take the medicine at the same time every day. It does not matter whether Lisinopril Aurovitas is taken before or after food.
• Lisinopril Aurovitas should be taken for as long as the doctor recommends. The treatment is long-term. It is important to take the medicine every day.

First dose

• The patient should be careful when taking the first dose or increasing the dose. A greater decrease in blood pressure may occur than with subsequent doses.
• Dizziness or fainting may occur. If these symptoms occur, it may be helpful to lie down. If the patient has any doubts, they should contact their doctor as soon as possible.

The patient should contact their doctor as soon as possible.

Adults

The dose of the medicine depends on the patient's health and other medicines they are taking. The doctor will inform the patient how many tablets to take daily. If the patient has any doubts, they should consult their doctor or pharmacist.

High blood pressure

• The usual initial dose is 10 mg once daily.
• The usual dose for long-term treatment is 20 mg once daily.

Heart failure

• The usual initial dose is 2.5 mg once daily.
• The dose for long-term treatment is 5 mg to 35 mg once daily.

Post-heart attack

• The usual initial dose is 5 mg within 24 hours after the heart attack and 5 mg the next day.
• The usual dose for long-term treatment is 10 mg once daily.

Kidney problems caused by diabetes

• The usual dose is 10 mg or 20 mg once daily.

In elderly patients, patients with kidney problems, or patients taking diuretics, the doctor may recommend a lower dose than usual.

Use in children and adolescents (aged 6 to 16) with high blood pressure

• It is not recommended to take Lisinopril Aurovitas in children under 6 years of age or in children with severe kidney problems.
• The doctor will determine the appropriate dose of the medicine, which depends on the child's body weight.
• In children with a body weight of 20 to 50 kg, the usual initial dose is 2.5 mg once daily.
• In children with a body weight over 50 kg, the usual initial dose is 5 mg once daily.

Overdose of Lisinopril Aurovitas

If the patient takes more of the medicine than prescribed by their doctor, they should contact their doctor or go to the hospital immediately. The most likely symptoms that may occur are dizziness and rapid heartbeat.

Missed dose of Lisinopril Aurovitas

• If the patient misses a dose of Lisinopril Aurovitas, they should take it as soon as possible, unless it is almost time for the next dose, in which case they should skip the missed dose.
• The patient should not take a double dose to make up for the missed dose.

Stopping Lisinopril Aurovitas

The patient should not stop taking Lisinopril Aurovitas, even if they feel well, and should take it for as long as their doctor recommends.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Lisinopril Aurovitas can cause side effects, although not everybody gets them.
If the patient experiences any of the following reactions, they should stop taking Lisinopril Aurovitas and contact their doctor immediately.

Aurovitas and contact their doctor immediately.

• Severe allergic reactions (rare, may occur less frequently than 1 in 1,000 people). Symptoms may have a sudden onset:
• swelling of the face, lips, tongue, or throat, which may cause difficulty swallowing;
• severe or sudden swelling of the hands, feet, and ankles;
• difficulty breathing;
• severe itching of the skin (with rash formation).
• Severe skin disorders, such as sudden, unexpected rash or burning, redness, and peeling of the skin (very rare, may occur less frequently than 1 in 10,000 people).
• Infection with symptoms such as fever and severe deterioration of general condition or fever with local symptoms of infection, such as sore throat or mouth and throat problems, or urinary tract problems (very rare, may occur less frequently than 1 in 10,000 people).

Other possible side effects:

Common (may occur less frequently than 1 in 10 people):

• headache;
• dizziness or fainting, especially when standing up quickly;
• diarrhea;
• dry cough that does not go away;
• vomiting;
• kidney problems (detected in blood test results).

Uncommon (may occur less frequently than 1 in 100 people):

• mood changes;
• changes in skin color of the fingers or toes (cyanosis, followed by redness) or numbness or tingling of the fingers;
• changes in taste;
• drowsiness;
• dizziness;
• difficulty sleeping;
• stroke;
• rapid heartbeat;
• runny nose;
• nausea;
• abdominal pain or indigestion;
• skin rash or itching;
• impotence;
• feeling tired or weak;
• significant decrease in blood pressure may occur in people with the following conditions: coronary artery disease; aortic stenosis (the artery that carries blood from the heart); renal artery stenosis; or heart valve problems. In case of hypotension, the patient may feel dizzy or faint, especially when standing up quickly;
• changes in blood test results evaluating liver and kidney function;
• heart attack;
• visual and/or auditory hallucinations.

Rare (may occur less frequently than 1 in 1,000 people):

• feeling disoriented;
• hives;
• dryness of the mucous membranes of the mouth;
• hair loss;
• psoriasis (a skin disorder);
• changes in sense of smell;
• breast enlargement in men;
• changes in certain blood cells or other blood components. The doctor may periodically recommend blood tests to check the effect of Lisinopril Aurovitas on blood parameters. Possible symptoms include feeling tired, pale skin, sore throat, high temperature (fever), joint or muscle pain, swelling of the joints or lymph nodes, or increased sensitivity to sunlight;
• low sodium levels in the blood (symptoms may include: feeling tired, headache, nausea, vomiting);
• sudden kidney failure.

Very rare (may occur less frequently than 1 in 10,000 people):

• sinusitis (pain and pressure in the area of the cheeks and eyes);
• wheezing;
• low blood sugar (hypoglycemia). Symptoms include: feeling hungry or weak, sweating, and rapid heartbeat;
• pneumonia. Symptoms include: cough, shortness of breath, and high temperature (fever);
• yellowing of the skin or whites of the eyes (jaundice);
• hepatitis. This can cause loss of appetite, yellowing of the skin and eyes, and dark urine;
• pancreatitis, causing moderate to severe abdominal pain;
• severe skin diseases. Symptoms include: redness, blistering, and peeling;
• sweating;
• decreased or absent urine production;
• liver failure;
• hives;
• inflammation of the intestines.

Frequency not known (frequency cannot be estimated from the available data):

• symptoms of depression;
• fainting.

Side effects in children appear to be similar to those in adults.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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, more information can be collected on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Lisinopril Aurovitas

This medicine should be stored out of sight and reach of children.
There are no special storage instructions for the medicine.
The medicine should not be taken after the expiration date stated on the carton after "EXP". The expiration date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Lisinopril Aurovitas contains

• The active substance of the medicine is lisinopril in the form of lisinopril dihydrate.

Each tablet of Lisinopril Aurovitas contains 10 mg of lisinopril (in the form of lisinopril dihydrate).
Each tablet of Lisinopril Aurovitas contains 20 mg of lisinopril (in the form of lisinopril dihydrate).

• The other ingredients are: calcium hydrogen phosphate, cornstarch, mannitol, cornstarch, magnesium stearate, and yellow iron oxide (E 172).

What Lisinopril Aurovitas looks like and contents of the pack

Tablets.
Lisinopril Aurovitas, 10 mg, tablets
Lisinopril Aurovitas, 10 mg are light yellow, round (6 mm in diameter), biconvex, uncoated tablets, with the letter "L" embossed on one side and the number "10" on the other side.
Lisinopril Aurovitas, 20 mg, tablets
Lisinopril Aurovitas, 20 mg are light yellow, capsule-shaped, biconvex, uncoated tablets, with the letter "L" embossed on one side and the number "20" on the other side. The tablet size is 10 mm x 5 mm.
Lisinopril Aurovitas tablets are available in blisters.
Package sizes:14, 28, 56, and 84 tablets.
Not all package sizes may be available in the market.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal
Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France

This medicine is authorized in the Member States of the European Economic Area under the following names:

France:
Lisinopril Arrow Lab 20 mg, tablet
Malta:
Lisinopril Aurobindo 10 mg/20 mg tablets
Poland:
Lisinopril Aurovitas
Portugal:
Lisinopril Generis Phar
Spain:
Lisinopril Aurovitas 20 mg tablets EFG

Date of last revision of the leaflet: