Lisinopril grindeks

Patient Information Leaflet

Lisinopril Grindeks, 5 mg, tablets
Lisinopril Grindeks, 10 mg, tablets
Lisinopril Grindeks, 20 mg, tablets
Lisinoprilum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Lisinopril Grindeks is and what it is used for
2. What you need to know before taking Lisinopril Grindeks
3. How to take Lisinopril Grindeks
4. Possible side effects
5. How to store Lisinopril Grindeks
6. Contents of the pack and other information

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

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

• For the treatment of high blood pressure (hypertension) in adults, adolescents, and children aged 6 years and older.
• For the treatment of heart failure in adults.
• If a heart attack (myocardial infarction) has recently occurred in an adult patient.
• For the treatment of kidney dysfunction caused by type 2 diabetes in adult patients with high blood pressure.

Lisinopril Grindeks works by dilating blood vessels. This helps reduce arterial 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 while taking another ACE inhibitor. An allergic reaction may cause swelling of the hands, feet, ankles, face, lips, tongue or throat. It may also cause difficulty swallowing or breathing (angioedema).
• if the patient has taken or is currently taking a combination medicine containing sacubitril and valsartan, used to treat certain types of chronic (long-term) heart failure in adults, as this increases the risk of angioedema (sudden swelling under the skin, e.g. in the throat).
• if a close relative of the patient has had severe allergic reactions (angioedema) while taking any ACE inhibitor, or if the patient has had severe allergic reactions (angioed游戏副本) of unknown cause.
• if the patient is more than 3 months pregnant (use of Lisinopril Grindeks should also be avoided in early pregnancy – see section "Pregnancy").
• if the patient has diabetes or kidney function disorders and is being treated with a blood pressure-lowering medicine containing aliskiren.

If in doubt whether any of the above conditions apply, contact a doctor or pharmacist before taking Lisinopril Grindeks.
If the patient develops a persistent dry cough after starting treatment with Lisinopril Grindeks, inform the doctor.

Warnings and precautions

Before starting Lisinopril Grindeks, discuss with a doctor or pharmacist:

• if the patient has narrowing (stenosis) of the aorta (the main artery carrying blood from the heart) or narrowing of a heart valve (mitral valve).
• if the patient has narrowing (stenosis) of a renal artery.
• if the patient has thickening of the heart muscle (known as hypertrophic cardiomyopathy).
• if the patient has blood vessel disorders (collagenoses).
• if the patient has low blood pressure. This may be experienced as dizziness or lightheadedness, especially when standing up.
• if the patient has kidney problems or is undergoing dialysis.
• if the patient has liver function disorders.
• if the patient has diabetes.
• if the patient is taking any of the following medicines, as the risk of angioedema (sudden swelling under the skin, e.g. in the throat) is increased:
  • Temsirolimus, sirolimus, everolimus and other medicines belonging to the mTOR inhibitor class (used to prevent organ transplant rejection and in cancer treatment).
  • Racecadotril, a medicine used to treat diarrhoea.
  • Vildagliptin, a medicine used to treat diabetes.
• if the patient is taking any of the following medicines used to treat high blood pressure:
  • an angiotensin II receptor antagonist (ARB), also known as a 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 blood electrolyte levels (e.g. potassium). See also section "When not to take Lisinopril Grindeks".

• if the patient has recently had diarrhoea or vomiting.
• if the doctor has advised limiting salt intake.
• if the patient has high cholesterol and is undergoing a procedure called "LDL apheresis".
• inform the doctor if the patient thinks she is (or might be) pregnant. Use of Lisinopril Grindeks is not recommended in early pregnancy and must not be taken after 3 months of pregnancy, as it may seriously harm the unborn child if used at this stage (see section "Pregnancy").
• if the patient is of Black race, as Lisinopril Grindeks may be less effective. In addition, the patient may be more likely to experience the adverse effect "angioedema" (severe allergic reaction).

If in doubt whether any of the above conditions apply, contact a doctor or pharmacist before taking Lisinopril Grindeks.

Treatment of allergies, such as insect venom allergy

Inform the doctor if desensitisation treatment (allergy immunotherapy) for insect venom allergy is being or will be performed. Taking Lisinopril Grindeks during such treatment may cause severe allergic reactions.

Surgical procedures

Inform the doctor or dentist about taking Lisinopril Grindeks if a surgical procedure (including dental surgery) is planned. Low blood pressure (hypotension) may occur during local or general anaesthesia when taking Lisinopril Grindeks.

Children and adolescents

The use of Lisinopril Grindeks in children has been studied. Contact a doctor for further information. Lisinopril Grindeks is not recommended for children under 6 years of age or for children with severe kidney function disorders.

Lisinopril Grindeks and other medicines

Tell the doctor or pharmacist about all medicines currently taken, recently taken or planned to be taken. This is because Lisinopril Grindeks may affect the action of certain medicines, and some medicines may affect Lisinopril Grindeks. The doctor may recommend a dose adjustment and/or additional precautions.

In particular, inform the doctor or pharmacist if the patient is taking any of the following medicines:

• other medicines that lower blood pressure.
• angiotensin II receptor antagonists (ARBs) or aliskiren (see also information under the headings "When not to take Lisinopril Grindeks" and "Warnings and precautions").
• diuretics (water tablets).
• nitrates (used to treat heart conditions).
• non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain and joint inflammation.
• aspirin (acetylsalicylic acid) at doses above 3 g per day.
• medicines used to treat depression and psychiatric disorders, including lithium.
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (e.g. trimethoprim and co-trimoxazole for bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots).
• medicines used to treat nasal or sinus congestion or other cold remedies (including those available without prescription).
• medicines that suppress the body's immune response (immunosuppressants).
• allopurinol (used to treat gout).
• procainamide (used for heart rhythm disorders).
• gold-containing medicines such as sodium aurothiomalate, administered 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 administered in hospital.
• Medicines most commonly used to prevent organ transplant rejection (temsirolimus, sirolimus, everolimus and other mTOR inhibitors). See section 2 "Warnings and precautions".
• Racecadotril used to treat diarrhoea.
• Vildagliptin, a medicine used to treat diabetes.

Pregnancy, breastfeeding and fertility

Pregnancy

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before taking this medicine.
The doctor will usually advise stopping Lisinopril Grindeks before planning pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine.
Use of Lisinopril Grindeks is not recommended during early pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child if used at this stage.

Breastfeeding

Inform the doctor if the patient is breastfeeding or intends to breastfeed. Lisinopril Grindeks is not recommended for breastfeeding mothers. 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 experience dizziness or fatigue while taking this medicine. If such symptoms occur, do not drive, use tools or operate machinery.
• Before engaging in these activities, the patient should assess their individual response 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 your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
After starting treatment with Lisinopril Grindeks, your doctor may recommend a blood test.
Your doctor may then adjust the dose to suit your individual needs.

How to take the medicine

• Swallow the tablet with water.
• Try to take the medicine at the same time each day. It does not matter whether Lisinopril Grindeks is taken before or after food.
• Lisinopril Grindeks should be taken for as long as your doctor recommends. Treatment is usually long-term. It is important to take the medicine every day.

Taking the first dose

• Exercise particular caution when taking the first dose or when the dose is increased. A greater drop in blood pressure may occur compared to subsequent doses.
• Dizziness or lightheadedness may occur. If such symptoms occur, lying down may help. In case of any doubts, contact your doctor as soon as possible.

Adults
The dose depends on the patient's medical condition and other medicines being taken. Your doctor will inform you how many tablets to take daily. If in doubt, consult your doctor or pharmacist.

High blood pressure

• The recommended starting dose is 10 mg once daily.
• The usual maintenance dose is 20 mg once daily.

Heart failure

• The recommended starting dose is 2.5 mg once daily.
• The maintenance dose is 5 mg to 35 mg once daily.

After a heart attack

• The recommended starting dose is 5 mg within 24 hours after the heart attack, followed by 5 mg during the next 24 hours.
• The usual maintenance dose is 10 mg once daily.

Kidney disease due to diabetes

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

In elderly patients, patients with impaired kidney function, or those taking diuretics, your doctor may recommend a lower than usual dose.

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

• Lisinopril Grindeks is not recommended for children under 6 years of age or for children with severe kidney problems.
• Your doctor will determine the appropriate dose for the child, based on body weight.
• For children weighing between 20 and 50 kg, the recommended starting dose is 2.5 mg once daily.
• For children weighing more than 50 kg, the recommended starting dose is 5 mg once daily.

If you take more Lisinopril Grindeks than you should
If you take more Lisinopril Grindeks than prescribed, contact your doctor immediately or go to hospital. The most likely symptoms include dizziness and palpitations.

If you forget to take Lisinopril Grindeks

• If you miss a dose of Lisinopril Grindeks, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten tablet.

Stopping Lisinopril Grindeks
Do not stop taking the tablets, even if you feel well, unless your doctor advises otherwise.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following reactions occur, you must stop taking Lisinopril Grindeks immediately
and contact your doctor without delay:

• Severe allergic reactions (rare: occurring in 1 to 10 out of 10,000 people). Symptoms may include sudden onset of:
  • swelling of the face, lips, tongue or throat. This may cause difficulty in swallowing;
  • severe swelling of hands, feet and ankles;
  • difficulty breathing;
  • intense itching of the skin (with formation of lumps).
• Severe skin disorders, such as sudden, unexpected rash or burning sensation, redness or peeling of the skin (very rare: occurring in fewer than 1 out of 10,000 people).
• Infection with symptoms such as fever and severe deterioration in general condition, or fever with local signs of infection such as sore throat or mouth, or urinary tract disturbances (very rare: occurring in fewer than 1 out of 10,000 people).

Other possible adverse reactions:
Common (occurring in 1 to 10 out of 100 people):

• headache;
• dizziness or lightheadedness, especially when standing up quickly;
• diarrhoea;
• dry, persistent cough;
• malaise (nausea, vomiting);
• kidney-related disorders (detected in blood tests).

Uncommon (occurring in 1 to 10 out of 1,000 people):

• mood changes;
• changes in colour of fingers or toes (bluish discoloration followed by redness), or numbness or tingling in fingers;
• changes in taste perception;
• drowsiness;
• vertigo (peripheral dizziness);
• difficulty falling asleep;
• stroke;
• rapid heartbeat;
• nasal inflammation (rhinitis);
• nausea;
• stomach pain or indigestion;
• skin rash or itching;
• inability to achieve erection (impotence);
• fatigue or weakness (loss of strength);
• significant drop in blood pressure may occur in patients with the following conditions: coronary artery disease; aortic stenosis (narrowing of the artery carrying blood from the heart), renal artery stenosis, or heart valve disorders; thickening of the heart muscle. In case of hypotension, the patient may experience dizziness or lightheadedness, especially when standing up quickly;
• changes in blood test results assessing liver and kidney function;
• heart attack;
• visual and/or auditory hallucinations.

Rare (occurring in 1 to 10 out of 10,000 people):

• feeling of disorientation;

• nodular rash (urticaria);

• dryness of the oral mucosa;

• hair loss;

• psoriasis (skin disorder);

• changes in smell perception;

• breast enlargement in males;

• changes in certain blood cells or other blood components. Your doctor may periodically recommend blood tests to monitor the effect of Lisinopril Grindeks on blood parameters. Possible symptoms include:

  • fatigue, pale skin, sore throat, high temperature (fever), joint and muscle pain, swelling of joints or lymph nodes, or increased sensitivity to sunlight;

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

• acute kidney failure.

Very rare (occurring in fewer than 1 out of 10,000 people):

• sinusitis (pain and pressure around cheeks and eyes);
• wheezing;
• low blood sugar (hypoglycaemia). Symptoms may include: feeling hungry or weak, sweating, rapid heartbeat;
• pneumonia. Symptoms include: cough, shortness of breath, high temperature (fever);
• yellowing of the skin or eyes (jaundice);
• hepatitis. This may cause loss of appetite, yellowing of the skin and eyes, and dark urine;
• pancreatitis. This causes moderate to severe pain in the upper abdomen;
• severe skin diseases, with symptoms such as redness, blistering and peeling of the skin;
• sweating;
• reduced or absent urine output;
• liver failure;
• nodules;
• enteritis (inflammation of the intestine).

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

• symptoms of depression;
• fainting.

Adverse reactions in children appear to be similar to those observed in adults.
Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Lisinopril Grindeks

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: "Expiry date (EXP)". The expiry date refers to the last day of the stated month.

Lisinopril Grindeks 5 mg tablets:
Store below 30°C.

Lisinopril Grindeks 10 mg and Lisinopril Grindeks 20 mg tablets:
No special storage instructions for this medicine.

Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack 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 (as 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 bevelled edges. Tablet dimensions: 6 mm in diameter.
Lisinopril Grindeks 10 mg tablets: white, round, smooth, uncoated tablets with bevelled edges and a double break line on one side. Tablet dimensions: 8 mm in diameter. The break line is intended only to facilitate tablet division for easier swallowing and does not ensure equal dose division.
Lisinopril Grindeks 10 mg tablets: white, round, smooth, uncoated tablets with bevelled edges and a single break line on one side. Tablet dimensions: 10 mm in diameter. The break line is intended only to facilitate tablet division for easier swallowing and does not ensure equal dose division.
Lisinopril Grindeks tablets are available in cardboard boxes containing blisters made of Aluminium/PVC/PVDC foil with 14, 28, 30, 56, 60, 84 or 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
AS GRINDEKS
Krustpils iela 53, Rīga, LV-1057, Latvia
Tel.: +371 67083205
Fax: +371 67083505
E-mail: [email protected]

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Lisinopril Grindeks 5 mg, 10 mg, 20 mg Tabletten
Belgium Lisinopril Grindeks 5 mg, 10 mg, 20 mg comprimés
Bulgaria Лизиноприл Гриндекс 5 mg, 10 mg, 20 mg таблетки
Lisinopril Grindeks 5 mg, 10 mg, 20 mg tablets
Estonia Lisinopril Grindeks
Finland Lisinopril Grindeks 5 mg, 10 mg, 20 mg tabletit
France Lisinopril Grindeks 5 mg comprimé
Lisinopril Grindeks 10 mg comprimé
Lisinopril Grindeks 20 mg comprimé
Greece Lisinopril Grindeks 5 mg, 10 mg, 20 mg δισκία
Spain Lisinopril Grindeks 5 mg, 10 mg, 20 mg comprimidos
Ireland Lisinopril Grindeks 5 mg, 10 mg, 20 mg tablets
Poland Lisinopril Grindeks
Portugal Lisinopril Grindeks 5 mg, 10 mg, 20 mg comprimidos
Romania Lisinopril Grindeks 5 mg, 10 mg, 20 mg comprimate
Slovakia Lisinopril Grindeks 5 mg, 10 mg, 20 mg tablety
Hungary Lisinopril Grindeks 5 mg, 10 mg, 20 mg tabletta
Italy Lisinopril Grindeks