LISINOPRIL GRINDEKS 10 mg TABLETS

Introduction

Patient Information Leaflet

Lisinopril Grindeks 5mg tablets EFG

Lisinopril Grindeks 10mg tablets EFG

Lisinopril Grindeks 20mg tablets EFG

lisinopril

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, do not pass it on to others, it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack:

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

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

Lisinopril Grindeks contains a medicine called lisinopril, which belongs to a group of medicines called angiotensin-converting enzyme inhibitors(ACE inhibitors).

Lisinopril Grindeks can be used for the following diseases:

• To treat high blood pressure (hypertension) in adults, adolescents, and children from 6 years of age.
• To treat heart failure in adults.
• After a heart attack (myocardial infarction) in adults.
• To treat kidney problems caused by type 2 diabetes in adults who also have high blood pressure.

Lisinopril works by widening the blood vessels, which reduces blood pressure. This effect also helps the heart to pump blood to the whole body.

2. What you need to know before you take Lisinopril Grindeks

Do not take Lisinopril Grindeks

• if you are allergic to lisinopril or any of the other ingredients of this medicine (listed in section 6).
• if you have ever had an allergic reaction to another ACE inhibitor. The allergic reaction can cause swelling of the hands, feet, ankles, face, lips, tongue, or throat. It can also cause problems with swallowing or breathing (angioedema).
• if you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure, as it increases the risk of angioedema (rapid swelling of the deeper layers of the skin in areas such as the throat).
• if a family member has had a severe allergic reaction (angioedema) to an ACE inhibitor or you have had a severe allergic reaction (angioedema) without a known cause.
• if you are more than 3 months pregnant (in any case, it is also best to avoid taking Lisinopril at the start of pregnancy; see the section on Pregnancy).
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine that contains aliskiren.

If you are not sure if you meet any of the above points, consult your doctor or pharmacist before taking this medicine.

If, after a long period of time after starting treatment with Lisinopril, you experience a dry cough, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lisinopril Grindeks:

• If you have a narrowing (stenosis) of the aorta (a heart artery) or of the heart valves (mitral valves).
• If you have a narrowing (stenosis) of the kidney artery.
• If you have an increase in the thickness of the heart muscle (a condition known as hypertrophic cardiomyopathy).
• If you have a disorder of the blood vessels (collagen vascular disease).
• If you have low blood pressure (hypotension). The symptoms of hypotension that you may experience are dizziness or a feeling of faintness, especially when standing up.
• If you have kidney problems or are undergoing hemodialysis.
• If you have liver problems.
• If you have diabetes.
• If you are taking any of the following medicines, which increase the risk of angioedema (a rapid swelling of the deeper layers of the skin in areas such as the throat):

• temsirolimus, sirolimus, everolimus, and other medicines that belong to the class of medicines called mTOR inhibitors(used to prevent rejection in organ transplantation and in cancer).
• Racecadotril, a medicine used to treat diarrhea.
• Vildagliptin, a medicine used to treat diabetes.

• If you are taking any of the following medicines used to treat high blood pressure:

• an angiotensin II receptor antagonist (ARA) (also known as a "sartan" - e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• Aliskiren.

It is possible that your doctor will check your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) periodically. Also, see the information in the section Do not take Lisinopril Grindeks.

• If you have recently had diarrhea or vomiting (nausea).
• If your doctor has told you to control the amount of salt in your diet.
• If you have high cholesterol and are receiving a treatment called low-density lipoprotein (LDL) apheresis.
• If you think you may be pregnant or are planning to become pregnant, inform your doctor. It is not recommended to use Lisinopril at the start of pregnancy or in any case, it should not be administered from the third month of pregnancy, as it may cause serious harm to the fetus at this stage (see the section on Pregnancy).
• If you are of African American origin, as Lisinopril may be less effective. You may also experience angioedema (a severe allergic reaction) more quickly.

If you are not sure if you meet any of the above points, consult your doctor or pharmacist before taking Lisinopril.

Allergy treatment, such as insect bites

If you are receiving treatment or are about to receive treatment to reduce the effects of an allergy, such as an insect bite allergy (desensitization treatment). If you take Lisinopril while receiving this treatment, you may experience a severe allergic reaction.

Surgery

If you are going to undergo surgery (including dental surgery), inform your doctor or dentist that you are taking Lisinopril. If you are given certain local or general anesthetics while taking Lisinopril, you may experience low blood pressure (hypotension).

Children and adolescents

Lisinopril has been studied in the pediatric population. If you want more information, consult your doctor. This medicine is not indicated in children under 6 years of age or in children with severe kidney problems.

Other medicines and Lisinopril Grindeks

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Lisinopril may affect the way some medicines work, and some medicines may have an effect on Lisinopril. Your doctor may need to change the dose or take other precautions.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• Other medicines to lower blood pressure.
• An angiotensin II receptor antagonist (ARA) or aliskiren (see also the information in the sections Do not take Lisinopril Grindeksand Warnings and precautions).
• Diuretics (medicines that increase urine production).
• Betablockers, such as atenolol and propranolol.
• Nitrates (for heart problems).
• Non-steroidal anti-inflammatory medicines (NSAIDs) used to treat pain and arthritis.
• Aspirin, if you are taking more than 3 grams per day.
• Medicines for depression and mental problems, 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 and prevent blood clots).
• Insulin or oral medicines (taken by mouth) for diabetes.
• Medicines for asthma.
• Medicines for nasal or sinus congestion or other cold remedies (including those available at the pharmacy).
• Medicines that suppress the body's immune response (immunosuppressants).
• Allopurinol (for gout).
• Procainamide (for heart problems).
• Medicines that contain gold, such as sodium aurothiomalate, which are given by injection.

The following medicines may increase the risk of angioedema (signs of angioedema include swelling of the face, lips, tongue, or throat, accompanied by difficulty swallowing or breathing):

• Medicines to dissolve blood clots (tissue plasminogen activator), which are usually given in the hospital.
• Medicines used more frequently to prevent organ rejection (temsirolimus, sirolimus, everolimus, and other medicines that belong to the class of medicines called mTOR inhibitors). See the section on Warnings and precautionsin section 2.
• Racecadotril, used to treat diarrhea.
• Vildagliptin, a medicine used to treat diabetes.

Pregnancy, breastfeeding, and fertility

Pregnancy:

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Normally, your doctor will advise you to stop taking Lisinopril before you become pregnant or as soon as you find out you are pregnant, and will recommend that you take another blood pressure-lowering medicine instead. It is not recommended to use Lisinopril at the start of pregnancy or in any case, it should not be administered from the third month of pregnancy, as it may cause serious harm to the fetus at this stage.

Breastfeeding:

Tell your doctor if you are breastfeeding or about to start breastfeeding. The use of Lisinopril is not recommended in breastfeeding women, and your doctor may decide on a different treatment that is more suitable for you if you want to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

• Some people may experience dizziness or fatigue when taking this medicine. If you experience these effects, avoid driving vehicles or using tools or machines.
• You should wait until you see how the medicine affects you before performing these activities.

3. How to take Lisinopril Grindeks

Follow exactly the instructions for taking this medicine as stated in this leaflet or as directed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.

Once you start taking Lisinopril, your doctor may perform blood tests and, from then on, may adjust the dose so that you take the right amount of the medicine.

Taking the medicine

• Swallow the tablet with a glass of water.
• Try to take the tablets at the same time every day. You can take this medicine before or after food.
• Keep taking Lisinopril for as long as your doctor has told you, as it is a long-term treatment. It is important that you keep taking Lisinopril every day.

Taking the first dose

• Be careful when taking the first dose of Lisinopril or if your dose is increased, as it may cause a greater decrease in blood pressure than with subsequent doses.
• This may make you feel dizzy or faint. In that case, lying down may help. If you have any concerns about these symptoms, consult your doctor as soon as possible.

Adults

The dose you receive depends on your disease and whether you are already taking other medicines. Your doctor will tell you how many tablets to take each day. If you are not sure, consult your doctor or pharmacist again.

Hypertension

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

Heart failure

• The recommended starting dose is 2.5 mg once a day.
• The usual dose in long-term treatment is 5-35 mg once a day.

After a heart attack

• The recommended starting dose is 5 mg in the 24 hours following the heart attack and, one day later, 5 mg.
• The usual dose in 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.

If you are elderly, have kidney problems, or are taking diuretics, your doctor will prescribe a lower dose than usual.

Use in children and adolescents (6-16 years) with high blood pressure

• Lisinopril is not recommended for children under 6 years of age or for children with severe kidney problems.
• Your doctor will determine the correct dose for your child. The dose depends on the child's weight.
• For children weighing 20-50 kg, the recommended starting dose is 2.5 mg per day.
• For children weighing more than 50 kg, the recommended starting dose is 5 mg per day.

If you take more Lisinopril Grindeks than you should

If you take more Lisinopril than your doctor has prescribed, talk to your doctor or go to the hospital immediately. You may experience dizziness and palpitations.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service. Phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Lisinopril Grindeks

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.
• Do not take a double dose to make up for the missed doses.

If you stop taking Lisinopril Grindeks

Even if you feel better, do not stop taking the tablets unless your doctor tells you to.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you experience any of the following reactions, stop taking Lisinopril Grindeks and consult your doctor immediately:

• Severe allergic reactions (rare; affect between 1 and 10 out of 10,000 people). The signs of this reaction may include the sudden appearance of:

• Swelling of the face, lips, tongue, or throat, which can cause difficulty swallowing.
• Sudden swelling of the hands, feet, and ankles.
• Difficulty breathing.
• Acute skin itching (accompanied by nodules).
• • Severe skin disorders, such as a rash or skin burning, redness, or peeling of unknown origin and sudden onset (very rare; affects less than 1 in 10,000 people).
  • An infection accompanied by symptoms such as fever and severe deterioration of general condition or fever with symptoms of local infection, such as sore throat, pharynx, or mouth, or urinary problems (very rare; affects less than 1 in 10,000 people).

Other possible adverse effects:

Frequent (affect between 1 and 10 out of 100 people)

• Headache.
• Feeling of dizziness or lightheadedness, especially when standing up too quickly.
• Diarrhea.
• Dry cough that does not go away.
• Nausea (vomiting).
• Kidney problems (observed in blood tests).

Infrequent (affect between 1 and 10 out of 1,000 people)

• Mood changes.
• Change in the color of the fingers of the hands or feet (light blue, followed by redness) or numbness or tingling in the fingers of the hands or feet.
• Changes in taste.
• Somnolence (feeling of sleep).
• Vertigo (feeling that everything is spinning).
• Difficulty sleeping.
• Stroke.
• Rapid heartbeat.
• Rhinitis.
• Feeling of nausea (nausea).
• Stomach pain or indigestion.
• Skin rash or itching.
• Inability to have an erection (impotence).
• Feeling of fatigue or weakness (loss of strength).
• In people who suffer from the following disorders, a very large drop in blood pressure may occur: coronary heart disease; narrowing of the aorta (a heart artery), renal artery, or heart valves; an increase in the thickness of the heart muscle. If you suffer from any of these disorders, you may feel dizzy or lightheaded, especially when standing up too quickly.
• Changes in blood test results that indicate the proper functioning of the liver and kidneys.
• Heart attack.
• Seeing or hearing hallucinations.

Rare (affect between 1 and 10 out of 10,000 people)

• Feeling of confusion.
• Pruritic papules (hives).
• Dry mouth.
• Hair loss.
• Psoriasis (a skin problem).
• Changes in smell.
• Enlargement of the breast in men.
• Changes in some blood cells or other blood components. Your doctor may perform periodic blood tests to check if Lisinopril Grindeks has had any effect on the blood. The signs may include feeling of fatigue, paleness, sore throat, elevated temperature (fever), joint and muscle pain, swelling of the joints or glands, or sensitivity to sunlight.
• Low sodium levels in the blood (symptoms may be fatigue, headache, nausea, and vomiting).
• Acute kidney failure.

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

• Sinusitis (feeling of pain and fullness behind the cheeks and eyes).
• Wheezing (breathing noises).
• Low blood sugar levels (hypoglycemia). The signs may include feeling of hunger or weakness, sweating, and rapid heartbeat.
• Lung inflammation. The signs include cough, feeling of shortness of breath, and elevated temperature (fever).
• Yellowing of the skin or the whites of the eyes (jaundice).
• Liver inflammation. This can cause loss of appetite, yellowing of the skin and eyes, and dark urine color.
• Pancreas inflammation. This causes moderate to severe stomach pain.
• Severe skin disorders. The symptoms include redness, blistering, and peeling of the skin.
• Sweating.
• Reduced urine volume or absence of it.
• Liver failure.
• Nodules.
• Intestinal inflammation.

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

• Depression symptoms.
• Fainting.

Adverse effects in the pediatric population are comparable to those observed in adults.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Lisinopril Grindeks

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the box and blister after CAD. The expiration date is the last day of the month indicated.

Lisinopril Grindeks 5 mg EFG tablets:

Store below 30°C.

Lisinopril Grindeks 10 mg and Lisinopril Grindeks 20 mg EFG tablets:

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the containers and medicines that you no longer need in the SIGRE collection point at the pharmacy or in any other Medicine Waste Collection System. In case of doubt, ask your pharmacist how to dispose of the containers and medicines that you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Lisinopril Grindeks

• The active ingredient 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 components are calcium hydrogen phosphate (E-341), cornstarch, mannitol (E-421), crospovidone (E-1202), colloidal anhydrous silica (E-551), magnesium stearate (E-572).

Appearance of the product and package contents

Lisinopril Grindeks 5 mg EFG tablets: smooth, uncoated, white, round tablets with beveled edges and 6 mm in diameter.

Lisinopril Grindeks 10 mg EFG tablets: smooth, uncoated, white, round tablets with beveled edges, 8 mm in diameter, and scored on one side. The score line is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Lisinopril Grindeks 20 mg EFG tablets: smooth, uncoated, white, round tablets with beveled edges, 10 mm in diameter, and scored on one side. The score line is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Lisinopril Grindeks is available in cardboard boxes with Aluminio/PVC/PVDC blisters of 14, 28, 30, 56, 60, 84, or 98 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

AS GRINDEKS

Krustpils iela 53, Riga, LV-1057, Latvia

Phone: (+371) 67083205

Fax: (+371) 67083505

Email: [email protected]

You can request more information about this medicine by contacting the local representative of the marketing authorization holder

Grindeks Kalceks España, S.L.

C/ José Abascal, 58 – 2º Dcha.

28003, Madrid, Spain

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 Tabletten

Belgium Lisinopril Grindeks 5 mg, 10 mg, 20 mg comprimés

Bulgaria ?????????? ???????? 5 mg, 10 mg, 20 mg ????????

Lisinopril Grindeks 5 mg, 10 mg, 20 mg tablets

Slovakia Lisinopril Grindeks 5 mg, 10 mg, 20 mg tablety

Spain Lisinopril Grindeks 5 mg, 10 mg, 20 mg comprimidos

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 δισκ?α

Hungary Lisinopril Grindeks 5 mg, 10 mg, 20 mg tabletta

Ireland Lisinopril Grindeks 5 mg, 10 mg, 20 mg tablets

Italy Lisinopril Grindeks

Poland Lisinopril Grindeks

Portugal Lisinopril Grindeks 5 mg, 10 mg, 20 mg comprimidos

Romania Lisinopril Grindeks 5 mg, 10 mg, 20 mg comprimate

Date of the last revision of this prospectus:January 2023.

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.