Prospecto: information for the user

Lisinopril Teva 5 mg tablets EFG

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

2. What you need to know before starting to take Lisinopril Teva

3. How to take Lisinopril Teva

4. Possible adverse effects

5. Storage of Lisinopril Teva

6. Contents of the package and additional information

Lisinopril is an antihypertensive that belongs to the group of medications known as angiotensin-converting enzyme inhibitors (ACE inhibitors).

Lisinopril Teva is indicated for:

• Treatment of hypertension (elevated blood pressure).
• Treatment of symptomatic heart failure.
• Short-term treatment of acute myocardial infarction.
• Treatment of diabetic nephropathy complications in hypertensive patients.

Lisinopril is recommended for use in children (over 6 years old) only for the treatment of elevated blood pressure (hypertension).

Lisinopril should not be used in children with severe renal insufficiency.

Do not take Lisinopril Teva

• if you are allergic to lisinopril dihydrate, any other angiotensin-converting enzyme (ACE) inhibitor, or any of the components of this medication (including those listed in section 6).
• if you have had an allergic reaction to any other ACE inhibitor, for example, captopril, enalapril, which causes swelling of the face, lips, tongue, and/or throat.
• if you or a family member has a history of facial or body swelling (angioneurotic edema) that may be related to the use of medications.
• if you are more than 3 months pregnant. (It is also recommended to avoid the use of Lisinopril Teva in the early months of pregnancy – see section 2: Pregnancy and breastfeeding).
• if you have diabetes or kidney disease and are being treated with a medication to lower blood pressure that contains aliskiren.
• if you have taken or are currently taking sacubitril/valsartan, a medication used to treat a type of chronic heart failure in adults, the risk of angioedema (rapid swelling under the skin in an area such as the throat) is increased.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lisinopril:

• if you have narrowing of the arteries that lead to the kidneys, any other kidney problem, or are on dialysis.
• if you have recently had diarrhea or vomiting.
• if you are on a low-sodium diet.
• if you have low blood pressure (you may notice it as dizziness, or lightheadedness especially when standing).
• if you have liver disease.
• if the blood supply to your heart is insufficient (ischemic heart disease).
• if the blood supply to your brain is insufficient (cerebrovascular disease).
• if you have aortic stenosis or obstruction of the outflow (a narrowing of the main artery that leads from your heart), a narrowing of the heart valves (mitral valve stenosis), or an increase in the thickness of the heart muscle (hypertrophic cardiomyopathy).
• if you have vascular disease of the collagen, for example, systemic lupus erythematosus, an allergic disease that causes joint pain, itching, and fever.
• if you are undergoing desensitization treatment (for example, to reduce the effects of an allergy to a bee or wasp sting).

• if you are undergoing a treatment called apheresis (removing cholesterol from the blood using a machine).
• if you have recently had a heart attack and have low blood pressure or kidney problems.
• if you have been told that you have severe congestive heart failure.
• if you are of black race, as Lisinopril Teva may be less effective. It is also more likely that you will develop the adverse effect "angioedema" (a severe allergic reaction).
• if you are taking lithium, used to treat mania or depression.

• if you are taking any of the following medications used to treat high blood pressure (hypertension):

• an angiotensin II receptor antagonist (ARA) (also known as "sartanes", for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may need to monitor your kidney function, blood pressure, and electrolyte levels in the blood (for example, potassium) at regular intervals. See also the information under the heading "Do not take Lisinopril Teva".

• if you are taking any of the following medications, the risk of angioedema may increase:

• racecadotrilo, a medication used to treat diarrhea;
• medications used to prevent organ transplant rejection and for cancer (for example, temsirolimus, sirolimus, everolimus);
• vildagliptina, a medication used to treat diabetes.

You must inform your doctor if you think you are (or may become) pregnant. Lisinopril is not recommended in the early months of pregnancy, and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to the baby if used in this period (see section 2: Pregnancy and breastfeeding).

Inform your doctor or dentist that you are taking Lisinopril Teva tablets if you are to undergo an operation that requires anesthesia (including dental treatments).

If you develop persistent dry cough after starting treatment with Lisinopril Teva, consult your doctor.

Pediatric population

Lisinopril has been studied in children. For more information, consult your doctor. Lisinopril Teva is not recommended in children under 6 years or in children with severe kidney problems.

Taking Lisinopril Teva with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication:

Consult your doctor if you are taking any of the following medications:

• Medications to reduce blood pressure such as diuretics, for example, amiloride, as your blood pressure may become very low.
• beta-blockers, such as atenolol and propranolol.
• nitrate-derived medications (for heart problems).
• antipsychotics, for example, chlorpromazine (to treat mental disorders) or tricyclic antidepressants, for example, amitriptyline, which may cause a drop in blood pressure.
• lithium, as lithium levels may increase.
• insulin or oral antidiabetic medications, as the risk of hypoglycemia (low blood sugar) may increase.
• potassium supplements (including salt substitutes) and other medications that may increase the amount of potassium in the blood (for example, trimethoprim and co-trimoxazole for bacterial infections; cyclosporine, an immunosuppressive medication used to prevent organ transplant rejection; and heparin, a medication used to thin the blood to prevent clots.
• medications containing gold, such as sodium aurothiomalate, which may be administered as an injection.

Your doctor may need to modify your dose and/or take other precautions:

• if you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings "Do not take Lisinopril Teva" and "Warnings and precautions").

Consult your doctor before taking Lisinopril Teva in combination with any of the following medications, as they may reduce the effectiveness of Lisinopril Teva:

• nonsteroidal anti-inflammatory drugs (NSAIDs) (a type of pain reliever, for example, indomethacin); kidney function may also be affected.
• aspirin (acetylsalicylic acid), if you are taking more than 3 grams per day.
• sympathomimetic medications, for example, ephedrine, adrenaline, or isoprenaline. Ephedrine may be present in medications to treat colds and nasal congestion.
• medications used to treat asthma.

Consult your doctor before taking Lisinopril Teva in combination with any of the following medications, as they may increase the risk of developing leukopenia (a reduction in the number of white blood cells):

• procainamide (to treat abnormal heart rhythms).
• allopurinol (to treat gout).
• immunosuppressive medications (used in organ transplant rejection).

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

• medications used to dissolve blood clots (tissue plasminogen activator) that are normally administered in the hospital.
• medications used more often to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus, and other medications belonging to the class of mTOR inhibitors). See section "Warnings and precautions".
• racecadotrilo, used to treat diarrhea.
• vildagliptina, a medication used to treat diabetes.
• sacubitril/valsartan, a medication used to treat a type of chronic heart failure (see section "Do not take Lisinopril Teva").

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You must inform your doctor if you think you are (or may become) pregnant. Normally, your doctor will advise you to stop taking lisinopril before becoming pregnant or as soon as you know you are pregnant and recommend that you take another medication instead of lisinopril. Lisinopril is not recommended in the early months of pregnancy, and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to the baby if used after the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Lisinopril is not recommended in breastfeeding mothers, and your doctor may choose another treatment for you if you wish to breastfeed your baby, especially if it is a newborn or premature.

Driving and operating machinery

It is unlikely that Lisinopril Teva tablets will affect your ability to drive vehicles or operate machinery; however, if you notice symptoms of dizziness or fatigue, avoid performing tasks that require special attention until you know how you tolerate the medication.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The tablets should be swallowed preferably with a glass of water approximately at the same time of day. Lisinopril Teva can be taken with or without food.

The recommended dose is:

Adults and elderly patients

• Hypertension

The treatment usually starts with 10mg once a day. Some patients, such as those with kidney problems, may start with a lower dose. Then, the dose will be increased gradually every 2-4 weeks until blood pressure is controlled.

The usual long-term dose is 20mg once a day.

• Heart failure

The treatment usually starts in the hospital with a dose of 2.5mg once a day. Then, the dose will be increased gradually until symptoms are controlled.

The usual long-term dose is 5-35mg once a day. The dose of any diuretic being taken may be reduced before starting treatment with Lisinopril Teva.

• After a myocardial infarction

The usual dose is 5mg on the first and second day, then 10mg once a day, which is usually continued for 6weeks. Patients with low blood pressure (hypotension) are usually given a lower dose of 2.5mg with a maintenance dose of 5mg with temporary reductions to 2.5mg as needed. If low blood pressure persists, your doctor may withdraw you from Lisinopril Teva treatment.

• Renal complications resulting from diabetes and high blood pressure

The treatment usually starts with a dose of 10mg once a day. Then, the dose will be adjusted gradually according to needs. The usual long-term dose is 10-20mg once a day.

Some Afro-Caribbean patients may require higher doses of Lisinopril Teva to achieve adequate symptom control.

Children under 6 years

Lisinopril is not recommended for use.

Children and adolescents aged 6 to 16 years

The dose depends on your weight. The usual initial dose is between 2.5mg and 5mg once a day, which may be increased up to a maximum of 20mg to 40mg once a day. Patients with kidney problems should take lower doses. Your doctor will decide on the correct dose for you.

If you take more Lisinopril Teva than you should

If you (or someone) ingest a large amount of tablets or think a child has swallowed some tablets, contact the nearest hospital or your doctor immediately. An overdose may cause severe blood pressure drop, cardiac rhythm disturbances, dizziness, anxiety, cough, electrolyte imbalances, kidney insufficiency, whose symptoms are drowsiness, nausea, vomiting, difficulty breathing, and fainting. Please bring this leaflet, remaining tablets, and the packaging to the hospital or your doctor so they know how many tablets you have taken.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone 91 562 04 20.

If you forget to take Lisinopril Teva

If you forget to take a tablet, take it as soon as you remember, unless it is almost time for the next tablet.

Do not take a double dose to compensate for missed doses.

If you interrupt treatment with Lisinopril Teva

Do not stop treatment without consulting your doctor first, even if you feel better.

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

Like all medicines, Lisinopril Teva can cause side effects, although not everyone will experience them.

If you experience any of the following reactions, stop taking Lisinopril Teva and seek medical attention immediately.

• Severe allergic reactions (rare, may affect up to 1 in 1,000 people). The signs may include sudden appearance of:

• Swelling of the face, lips, tongue, or throat. This may make it difficult to swallow.
• Severe or sudden swelling of the hands, feet, or ankles.
• Difficulty breathing.
• Severe skin itching (with hives)

• Severe skin disorders, such as sudden and unexpected rash, redness, or peeling of the skin (very rare, may affect up to 1 in 10,000 people).
• Infection with symptoms such as fever and severe deterioration of your general condition, or fever with local infection symptoms such as throat, pharynx, or mouth irritation, or urinary tract disorders (very rare, may affect up to 1 in 10,000 people).

If you take Lisinopril Teva for the first time, you may feel dizzy or lightheaded for a short period of time. This is unlikely to occur if you take the tablets regularly. Consult your doctor if you are concerned.

The following side effects have been described according to the following frequency categories:

Frequent(may affect up to 1 in 10 people):

• Headache
• Dizziness or lightheadedness, especially when getting up
• Vomiting, diarrhea
• Cough
• Problems with kidney function.

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

• Palpitations (awareness of rapid heart activity), rapid heartbeat
• Myocardial infarction or stroke in susceptible patients (possibly due to excessive blood pressure drop)
• Poor circulation that makes the hands and feet pale, cold, and numb
• Limbs numbness
• Dizziness (a sensation that everything around you is spinning, up and down, or from side to side)
• Mood changes, changes in the taste of things
• Seeing and/or hearing hallucinations.
• Sensation of numbness or other problems such as inability to sleep
• Runny nose
• Abdominal pain, indigestion, nausea
• Rash, itching
• Fatigue, muscle weakness (asthenia)
• High levels of potassium in the blood
• Increased urea in the blood, creatinine in serum, or levels of liver enzymes in the blood
• Impotence (inability to achieve or maintain an erection).

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

• Reduction in red blood cells (anemia), symptoms that may include fatigue, pale skin
• Syndrome of inappropriate antidiuretic hormone secretion (condition where the body produces excessive antidiuretic hormone)
• Confusion
• Changes in the smell of things
• Dry mouth
• Rash with protuberances (urticaria) of dark red color that itches
• Hair loss
• Poriasis (condition that causes red patches on the skin, peeling)
• Severe allergic reactions
• Uremia (retention in the bloodstream of waste products that are normally excreted in the urine)
• Acute renal insufficiency that causes nausea, vomiting, lethargy, somnolence
• Development of breasts in men
• Elevated levels of bilirubin in the blood (a product of red blood cell breakdown, which can cause yellow discoloration of the skin and eyes), low levels of sodium in the blood.

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

• Depressionof the bone marrow, excessive breakdown of red blood cells that causes fatigue and pale skin, low platelet count (thrombocytopenia), reduction in white blood cell count (neutropenia, leucopenia, agranulocytosis) making infection more likely, lymph node disorder, autoimmune disease in which the body attacks itself
• Low blood sugar (hypoglycemia)
• Urinating less than normal or not at all
• Wheezing, bronchitis, breast problems, lung inflammation
• Icterus (symptoms in which there is yellow discoloration of the skin and the white of the eyes), liver inflammation (symptoms that may include fatigue, loss of appetite, fever, icterus)
• Pancreatitis (symptoms that may include nausea, severe abdominal or back pain)
• Intestinal allergic reaction (angioedema intestinal)
• Sweating
• Blisters that can easily burst, leaving raw, painful skin or can bleed, red, itchy papules, or skin that peels, leaving red patches on the body
• Transient enlargement of skin lymph nodes
• A combination of symptoms including fever, blood disorders, or muscle and joint pain, sensitivity to sunlight, and severe reduction in white blood cells making infections more likely.

Unknown(cannot be estimated from available data):

• Severe allergic reactions (anaphylactic)
• Mood depression symptoms
• Fainting.

A high incidence of angioedema (facial or body swelling) has been reported in the Afro-Caribbean population.

While taking Lisinopril Teva, changes in blood and urine tests may occur. Therefore, your treatment should be regularly monitored by performing blood and urine tests.

Reporting of side effects:

If you experience any type of side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use, Website:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 25°C. Store in the original packaging. Do not transfer to another container.

Do not use Lisinopril Teva after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE point of the pharmacy.If in doubt, please ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Lisinopril Teva 5 mg Tablet Composition

- The active substance is lisinopril (as dihydrate)

Cada comprimido contains 5 mg of lisinopril in the form of lisinopril dihydrate.

- The other components (excipients) are: calcium hydrogen phosphate, magnesium stearate, pregelatinized cornstarch, mannitol, and cornstarch.

Product appearance and container content

Lisinopril Teva 5 mg is presented in the form of oral tablets, white, oval, marked “LSN 5” on one side and with a groove on the other side.

The medication is presented in blister packs of 14, 28, 30, 50, 60, 100, and 500 tablets and in clinical packaging of 50 and 100 tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor.

28108 Alcobendas. Madrid.

Responsible manufacturer:

Pharmachemie BV

Swensweg 5, P.O.Box 552, 2003 RN Haarlem

Holland

TEVA Pharmaceutical Works Private Limited Company

Pallagi str. 13

H-4042 Debrecen

Hungary

This medication is authorized in the Member States of the European Economic Area with the following names:

Germany: Lisinopril-TEVA 5 mg Tabletten

Belgium: Lisinophar 5 mg Tablets

Spain: Lisinopril Teva 5 mg tablets EFG

Last review date of this leaflet: April 2022

The detailed and updated information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/