Lisinopril Grindeks

Leaflet accompanying the packaging: patient information

Lisinopril Grindeks, 5 mg, tablets

Lisinopril Grindeks, 10 mg, tablets

Lisinopril Grindeks, 20 mg, tablets

Lisinopril

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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 or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Lisinopril Grindeks contains the active substance lisinopril. It belongs to a group of medicines called ACE inhibitors.
Lisinopril Grindeks can be used in the following cases:

• Treatment of high blood pressure (hypertension) in adults, adolescents, and children aged 6 and over.
• Treatment of heart failure in adults.
• If the adult patient has recently had a heart attack (myocardial infarction).
• Treatment of kidney problems caused by type 2 diabetes in adult patients with high blood pressure.

The action of Lisinopril Grindeks is based on the dilation of blood vessels. This helps to reduce blood pressure. It also makes it easier for the heart to pump blood to all parts of the body.

2. Important information before taking Lisinopril Grindeks

When not to take Lisinopril Grindeks

if a relative of the patient has had severe allergic reactions (angioedema) when taking any ACE inhibitor or if the patient has had severe allergic reactions (angioedema) of unknown cause.

In case of doubts about any of the above conditions, the patient should consult a doctor or pharmacist before taking Lisinopril Grindeks.
If the patient experiences a persistent dry cough after starting Lisinopril Grindeks, they should tell their doctor.

Warnings and precautions

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

• Temsirolimus, sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors (used to avoid rejection of transplanted organs and in the case of tumors).
• Racecadotril, a medicine used to treat diarrhea.
• Wildagliptin, a medicine used to treat diabetes.
• angiotensin receptor antagonist (ARB) (also known as sartan - e.g., valsartan, telmisartan, irbesartan), especially if the patient has kidney problems associated with diabetes.
• aliskiren.

The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also "When not to take Lisinopril Grindeks".

• the patient should inform their doctor if they think they are (or may be) pregnant. It is not recommended to take Lisinopril Grindeks in early pregnancy, and it must not be taken if the patient is pregnant for more than 3 months, as it may seriously harm the baby if taken at this stage (see "Pregnancy").

In case of doubts about any of the above conditions, the patient should consult a doctor or pharmacist before taking Lisinopril Grindeks.

Allergy treatment, such as bee sting allergy

The patient should inform their doctor if they are undergoing or planning to undergo desensitization treatment to reduce allergic reactions to bee stings. Taking Lisinopril Grindeks during such treatment may cause severe allergic reactions.

Surgical procedures

The patient should inform their doctor or dentist that they are taking Lisinopril Grindeks if a surgical procedure is planned (including dental surgery). During local or general anesthesia, low blood pressure (hypotension) may occur when taking Lisinopril Grindeks.

Children and adolescents

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

Lisinopril Grindeks 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. This is because Lisinopril Grindeks may affect the action of some medicines, and some medicines may affect Lisinopril Grindeks. 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 receptor antagonists (ARB) or aliskiren (see also "When not to take Lisinopril Grindeks" and "Warnings and precautions").
• diuretics.
• nitrates (used to treat heart diseases).
• non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain and inflammation of 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 for bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ rejection; and heparin, a medicine used to thin the blood to prevent clots).
• medicines used to treat nasal congestion or sinusitis or other cold remedies (including those available without a prescription).
• medicines that suppress the immune system (immunosuppressants).
• allopurinol (used to treat gout).
• procainamide (used to treat irregular heart rhythms).
• medicines containing gold salts, such as aurothioglucose, 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 that are most commonly used to avoid rejection of transplanted organs (temsirolimus, sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors). See "Warnings and precautions" in section 2.
• Racecadotril used to treat diarrhea.
• Wildagliptin, a medicine used to treat diabetes.

Pregnancy, breastfeeding, and fertility

Pregnancy

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult a doctor or pharmacist before taking this medicine.
Normally, the doctor will advise stopping Lisinopril Grindeks before planned pregnancy or as soon as pregnancy is confirmed and recommend an alternative medicine instead of Lisinopril Grindeks.
Lisinopril Grindeks should not be taken in early pregnancy and must not be taken after the 3rd month of pregnancy, as it may seriously harm the baby if taken at this stage.

Breastfeeding

The patient should inform their doctor if they are breastfeeding or plan to breastfeed.
Lisinopril Grindeks is not recommended for mothers who are breastfeeding. The doctor may recommend an 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 Grindeks

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should consult a doctor or pharmacist.
After starting to take Lisinopril Grindeks, the doctor may recommend a blood test.
Then, the doctor may adjust the dose to be suitable for the 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 Grindeks is taken before or after food.
• Lisinopril Grindeks should be taken for as long as the doctor recommends, as the treatment is long-term. It is essential to take the medicine every day.

First dose

• The patient should be particularly careful when taking the first dose or increasing the dose. A greater decrease in blood pressure may occur than after subsequent doses.
• Dizziness or fainting may occur. If these symptoms occur, it may be helpful to lie down. In case of doubts, the patient should consult a doctor as soon as possible.

Adults

The dose of Lisinopril Grindeks depends on the patient's condition and other medicines they are taking. The doctor will inform the patient how many tablets to take daily. In case of doubts, the patient should consult a doctor or pharmacist.

High blood pressure

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

Heart failure

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

Post-myocardial infarction

• The recommended initial dose is 5 mg within 24 hours of myocardial infarction and 5 mg the next day.
• The usual dose for long-term treatment is 10 mg once daily.

Diabetic nephropathy

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

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

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

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

Taking a higher dose of Lisinopril Grindeks than recommended

If the patient takes more Lisinopril Grindeks than recommended by the doctor, they should talk to a doctor or go to a hospital immediately. The most likely symptoms that may occur are dizziness and rapid heartbeat.

Missing a dose of Lisinopril Grindeks

• If the patient misses a dose of Lisinopril Grindeks, they should take it as soon as they remember. However, if it is almost time for the next dose, they should skip the missed dose.
• The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Lisinopril Grindeks

The patient should not stop taking the tablets, even if they feel well, unless their doctor tells them to.
In case of further doubts about taking this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

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

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

Other possible side effects:

Common (occur in 1 to 10 people per 100):

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

Uncommon (occur in 1 to 10 people per 1,000):

• mood changes;
• changes in the color of the fingers or toes (cyanosis, followed by redness) or numbness or tingling of the fingers;
• changes in taste;
• drowsiness;
• feeling of spinning (vertigo of peripheral origin);
• difficulty sleeping;
• stroke;
• rapid heartbeat;
• runny nose;
• nausea;
• stomach pain or indigestion;
• skin rash or itching;
• impotence;
• fatigue or weakness (loss of strength);
• significant decrease in blood pressure may occur in people with the following conditions: coronary artery disease; aortic stenosis (the artery carrying 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 liver and kidney function test results;
• heart attack;
• visual and/or auditory hallucinations.

Rare (occur in 1 to 10 people per 10,000):

• disorientation;
• hives;
• dryness of the mucous membranes;
• hair loss;
• psoriasis (skin disorder);
• changes in smell perception;
• 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 Grindeks on blood parameters. Possible symptoms are fatigue, pale skin, sore throat, high temperature (fever), joint or muscle pain, swelling of joints or lymph nodes, or increased sensitivity to sunlight;

low sodium levels in the blood (symptoms may include: fatigue, headache, nausea, vomiting);

• acute kidney failure.

Very rare (occur in less than 1 person per 10,000):

• sinusitis (pain and pressure in the cheek and eye area);
• wheezing;
• low blood sugar (hypoglycemia). Symptoms may include: feeling hungry or weak, sweating, and rapid heartbeat;
• pneumonia. Symptoms include: cough, shortness of breath, and high temperature (fever);
• jaundice (yellowing of the skin and eyes);
• liver inflammation. This can cause loss of appetite, yellowing of the skin and eyes, and dark urine;
• pancreatitis. This causes moderate to severe abdominal pain;
• severe skin diseases, with symptoms such as redness, blistering, and peeling of the skin;
• sweating;
• reduced or absent urine production;
• liver failure;
• hives;
• enteritis.

Frequency not known (frequency cannot be estimated from 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 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Lisinopril Grindeks

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month.
Lisinopril Grindeks, 5 mg, tablets:
Store in a temperature below 30°C.
Lisinopril Grindeks, 10 mg and Lisinopril Grindeks, 20 mg, tablets:
There are no special storage precautions for this medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Package contents and other information

What Lisinopril Grindeks contains

• The active substance is lisinopril (in the form of dihydrate). Each tablet contains 5 mg, 10 mg, or 20 mg of lisinopril (in the form of dihydrate).
• The other ingredients are: calcium hydrogen phosphate (E341); cornstarch; mannitol (E421); crospovidone (E1202); colloidal anhydrous silica (E551); magnesium stearate (E572).

What Lisinopril Grindeks looks like and contents of the pack

Lisinopril Grindeks, 5 mg, tablets: white, round, smooth, uncoated tablets with beveled edges. Tablet size: diameter 6 mm.
Lisinopril Grindeks, 10 mg, tablets: white, round, smooth, uncoated tablets with beveled edges and a double dividing line on one side. Tablet size: diameter 8 mm. The dividing line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses.
Lisinopril Grindeks, 10 mg, tablets: white, round, smooth, uncoated tablets with beveled edges and a dividing line on one side. Tablet size: diameter 10 mm. The dividing line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses.
Lisinopril Grindeks tablets are available in cardboard boxes containing blisters of aluminum/PVC/PVDC foil with 14, 28, 30, 56, 60, 84, or 98 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

AS GRINDEKS.
Krustpils iela 53, Rīga, LV-1057, Latvia
tel.: +371 67083205
fax: +371 67083505
email: grindeks@grindeks.lv

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

Austria
Lisinopril Grindeks 5 mg, 10 mg, 20 mg Tablets
Belgium
Lisinopril Grindeks 5 mg, 10 mg, 20 mg tablets
Bulgaria
Лизиноприл Гриндекс 5 mg, 10 mg, 20 mg tablets
Lisinopril Grindeks 5 mg, 10 mg, 20 mg tablets
Estonia
Lisinopril Grindeks
Finland
Lisinopril Grindeks 5 mg, 10 mg, 20 mg tablets
France
Lisinopril Grindeks 5 mg tablet
Lisinopril Grindeks 10 mg tablet
Lisinopril Grindeks 20 mg tablet
Greece
Lisinopril Grindeks 5 mg, 10 mg, 20 mg tablets
Spain
Lisinopril Grindeks 5 mg, 10 mg, 20 mg tablets
Ireland
Lisinopril Grindeks 5 mg, 10 mg, 20 mg tablets
Poland
Lisinopril Grindeks
Portugal
Lisinopril Grindeks 5 mg, 10 mg, 20 mg tablets
Romania
Lisinopril Grindeks 5 mg, 10 mg, 20 mg tablets
Slovakia
Lisinopril Grindeks 5 mg, 10 mg, 20 mg tablets
Hungary
Lisinopril Grindeks 5 mg, 10 mg, 20 mg tablets
Italy
Lisinopril Grindeks

Date of last revision of the leaflet: