Lisinopril Grindeks

Leaflet attached to 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 to a specific person. 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. Contents of the packaging 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 to widen the blood vessels. This helps to lower 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 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 an allergic reaction when taking another ACE inhibitor. An allergic reaction can cause swelling of the hands, feet, ankles, face, lips, tongue, or throat. It can also cause difficulty swallowing or breathing (angioedema).
• if the patient is taking or has taken a medicine containing sacubitril and valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure in adults, as the risk of angioedema (sudden swelling under the skin, e.g. around the throat) is increased.

if a family member of the patient has had severe allergic reactions (angioedema) when taking an 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 dry cough that persists for a long time after starting to take Lisinopril Grindeks, they should tell their doctor.

Warnings and precautions

Before taking Lisinopril Grindeks, the patient should discuss the following with their doctor or pharmacist:

• if the patient has narrowing (stenosis) of the aorta (main artery carrying blood from the heart) or narrowing of the heart valve (mitral valve).
• if the patient has narrowing (stenosis) of the renal artery.
• if the patient has increased thickness of the heart muscle (known as hypertrophic cardiomyopathy).
• if the patient has blood vessel disorders (collagenosis).
• if the patient has low blood pressure. This can be felt as dizziness or fainting, especially when standing up.
• if the patient has kidney problems or is undergoing dialysis.
• if the patient has liver problems.
• if the patient has diabetes.
• if the patient is taking any of the following medicines, the risk of angioedema (sudden swelling under the skin, e.g. around the throat) is increased:
• Temsirolimus, sirolimus, everolimus, and other mTOR inhibitors (used to prevent rejection of transplanted organs and in the case of tumors).
• Racecadotril, a medicine used to treat diarrhea.
• Wildagliptin, a medicine used to treat diabetes.
• if the patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin receptor blocker (ARB) (also known as sartan - e.g. valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to 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".

• if the patient has recently had diarrhea or vomiting.
• if the doctor has recommended a low-salt diet.
• if the patient has high cholesterol levels and is undergoing a procedure called "LDL apheresis".
• the patient should inform their doctor if they think they are (or may be) pregnant. It is not recommended to take Lisinopril Grindeks during early pregnancy and it should 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").
• if the patient is black, as Lisinopril Grindeks may be less effective. Additionally, the patient may be more likely to experience angioedema (a severe allergic reaction).

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 plan to undergo desensitization treatment for allergies (e.g. 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 they are scheduled to undergo surgery (including dental surgery). Low blood pressure (hypotension) may occur during anesthesia, especially if the patient is 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 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 change in dose 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 blockers (ARBs) or aliskiren (see also "When not to take Lisinopril Grindeks" and "Warnings and precautions").
• diuretics.
• nitrates (used to treat heart conditions).
• 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 for bacterial infections; cyclosporin, an immunosuppressant 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).
• immunosuppressant medicines.
• allopurinol (used to treat gout).
• procainamide (used to treat irregular heart rhythms).
• 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 hospital.
• medicines used to prevent rejection of transplanted organs (temsirolimus, sirolimus, everolimus, and other mTOR inhibitors). See "Warnings and precautions" above.
• Racecadotril, used to treat diarrhea.
• Wildagliptin, 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 during early pregnancy and should 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 during breastfeeding. The doctor may recommend an alternative treatment if the patient wants to breastfeed, especially if the baby is a newborn or premature.

Driving and using machines

• Some people may feel dizzy or tired while taking this medicine. If these symptoms occur, the patient should not drive, use tools, or operate machinery.
• Before performing these activities, the patient should be aware of their individual reaction to the medicine.

3. How to take Lisinopril Grindeks

This medicine should always be taken exactly as described in this patient information 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 important 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 with 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 each day. In case of doubts, the patient should consult a doctor or pharmacist.

High blood pressure

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

Heart failure

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

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 a day.

Kidney problems caused by diabetes

• The recommended dose is 10 mg or 20 mg once a day.

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 Lisinopril Grindeks for the child. The dose depends on the child's weight.
• For children weighing between 20 and 50 kg, the recommended initial dose is 2.5 mg once a day.
• For children weighing more than 50 kg, the recommended initial dose is 5 mg once a day.

Overdose of Lisinopril Grindeks

If the patient takes more Lisinopril Grindeks than their doctor recommended, they should talk to a doctor or go to a hospital immediately. The most likely symptoms to occur are dizziness and a fast heart rate.

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 better, 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: may affect up to 1 in 10,000 people). Symptoms may include:
• swelling of the face, lips, tongue, or throat. This 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, or peeling of the skin (very rare: may affect less than 1 in 10,000 people).
• 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: may affect less than 1 in 10,000 people).

Other possible side effects:

Common (may affect up to 1 in 100 people):

• 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 (may affect up to 1 in 1,000 people):

• 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;
• fast heart rate;
• runny nose;
• nausea;
• stomach pain or indigestion;
• skin rash or itching;
• impotence (inability to get an erection);
• 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 or kidney function tests;
• heart attack;
• visual or auditory hallucinations.

Rare (may affect up to 1 in 10,000 people):

• disorientation;
• hives;
• dryness of the mucous membranes;
• hair loss;
• psoriasis (skin disorder);
• changes in 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 Grindeks on blood parameters. Possible symptoms are fatigue, 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: fatigue, headache, nausea, vomiting);

• acute kidney failure.

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

• sinusitis (pain and pressure in the area of the cheeks and eyes);
• wheezing;
• low blood sugar (hypoglycemia). Symptoms may include: feeling hungry or weak, sweating, and fast heart rate;
• 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, or peeling of the skin;
• sweating;
• decreased or absent urine production;
• liver failure;
• hives;
• inflammation of the intestines.

Frequency not known (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 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
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:
No special storage precautions are required.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging 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); maize starch; 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 score line on one side. Tablet size: diameter 8 mm. The score 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 score line on one side. Tablet size: diameter 10 mm. The score 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 film, each blister containing 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: [email protected]

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: