LISINOPRIL TEVA 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Lisinopril Teva 5 mg Tablets EFG

Contents of the Package Leaflet

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

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

Lisinopril is an antihypertensive that belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors).

Lisinopril Teva is indicated for:

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

Use of lisinopril in children (over 6 years) is only recommended for the treatment of high blood pressure (hypertension).

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

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

Do not take Lisinopril Teva

• if you are allergic to lisinopril dihydrate, to any other ACE inhibitor, or to any of the other ingredients of this medicine (listed in section 6).
• if you have ever had a serious allergic reaction to any other ACE inhibitor, such as captopril, enalapril, which caused swelling of the face, lips, tongue and/or throat.
• if you or a member of your family has a history of swelling of the face or body (angioedema) that may be related to the use of ACE inhibitors.
• if you are more than 3 months pregnant. (It is also better to avoid the use of Lisinopril Teva in the first months of pregnancy – see section 2: Pregnancy and breast-feeding).
• if you have diabetes or kidney problems and are treated with a blood pressure-lowering medicine containing aliskiren.
• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (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 supply the kidneys, any other kidney problem, or are on dialysis.
• if you have recently suffered from diarrhea or vomiting.
• if you are on a low-salt diet.
• if you have low blood pressure (you may notice this as dizziness, or lightheadedness especially when standing up).
• if you suffer from liver disease.
• if the blood supply to your heart is reduced (ischemic heart disease).
• if the blood supply to your brain is reduced (cerebrovascular disease).
• if you have aortic stenosis or hypertrophic cardiomyopathy.
• if you suffer from collagen vascular disease, such as systemic lupus erythematosus, an allergic disease that causes joint pain, itching, and fever.
• if you are going to undergo desensitization treatment (e.g., to reduce the effects of an allergy to wasp or bee stings).

• if you are going to undergo a treatment called apheresis (removing cholesterol from the blood using a machine).
• if you have recently suffered a heart attack and have low blood pressure or kidney problems.
• if you have been informed that you have severe congestive heart failure.
• if you are black, as Lisinopril Teva may be less effective. You are also more likely to 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 medicines used to treat high blood pressure (hypertension):

• an angiotensin II receptor antagonist (ARA) (also known as “sartans”, e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals. See also the information under the heading “Do not take Lisinopril Teva”.

• If you are taking any of the following medicines, the risk of angioedema may increase:

• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes.

You should inform your doctor if you think you are (or might become) pregnant. Lisinopril is not recommended in the first months of pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy (see section 2: Pregnancy and breast-feeding).

Tell your doctor or dentist that you are taking Lisinopril Teva tablets if you are going to have an operation that requires anesthesia (including dental procedures).

If you develop a dry cough that persists for a long time 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 medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines:

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

• Medicines to reduce blood pressure, such as diuretics (e.g., amiloride), as your blood pressure may become too low.
• Beta-blockers (e.g., atenolol, propranolol).
• Nitrate-based medicines (for heart problems).
• Antipsychotics (e.g., chlorpromazine) or tricyclic antidepressants (e.g., amitriptiline), which may cause a drop in blood pressure.
• Lithium, as lithium levels may increase.
• Insulin or oral antidiabetics, as the risk of hypoglycemia (low blood sugar) may increase.
• 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 transplant rejection; and heparin, a medicine used to thin the blood to prevent clots).
• Medicines containing gold, such as sodium aurothiomalate, which may be given as an injection.

Your doctor may need to change 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 medicines, as they may reduce the effectiveness of Lisinopril Teva:

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

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

• procainamide (for irregular heart rhythms).
• allopurinol (for gout).
• immunosuppressant medicines (used in organ transplantation).

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

• medicines to dissolve blood clots (tissue plasminogen activator) that are usually given in the hospital.
• medicines used more often to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus, and other medicines belonging to the class of mTOR inhibitors). See section “Warnings and precautions”.
• racecadotril, used to treat diarrhea.
• vildagliptin, a medicine used to treat diabetes.
• sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure (see section “Do not take Lisinopril Teva”).

Pregnancy and breast-feeding

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

Pregnancy

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

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Lisinopril is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you want to breast-feed your baby, especially if your baby is newborn or was born prematurely.

Driving and using machines

Lisinopril Teva tablets are unlikely to affect your ability to drive or use machines; however, if you experience dizziness or fatigue, do not perform tasks that require special attention until you know how the medicine affects you.

3. How to take Lisinopril Teva

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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

The recommended dose is:

Adults and elderly patients

• Hypertension

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

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

• Heart failure

Treatment usually starts in the hospital with a dose of 2.5 mg once a day. The dose will then be gradually increased until your symptoms are controlled.

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

• After a heart attack

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

• Diabetic nephropathy and high blood pressure

Treatment usually starts with a dose of 10 mg once a day. The dose will then be gradually adjusted according to your needs. The usual long-term dose is 10-20 mg once a day.

Some black patients may require higher doses of Lisinopril Teva to achieve adequate control of symptoms.

Children under 6 years

The use of lisinopril is not recommended.

Children and adolescents from 6 to 16 years

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

If you take more Lisinopril Teva than you should

If you (or someone else) swallow a lot of tablets or think that a child has swallowed some, contact the nearest hospital or your doctor immediately. An overdose may cause a severe drop in blood pressure, changes in heart rhythm, dizziness, anxiety, cough, disturbances in salt balance, kidney failure, whose symptoms are drowsiness, nausea, vomiting, difficulty breathing, and fainting. Please bring this leaflet, the remaining tablets, and the packaging to the hospital or doctor so they know which tablets have been taken.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 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 nearly time for your next dose.

Do not take a double dose to make up for forgotten doses.

If you stop taking Lisinopril Teva

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

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

4. Possible Adverse Effects

Like all medicines, Lisinopril Teva can cause adverse effects, although not all people suffer from them.

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

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

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

• Severe skin disorders, such as an unexpected and sudden rash, redness, or peeling of the skin (very rare, may affect up to 1 in 10,000 people).
• An infection with symptoms such as fever and severe deterioration of your general condition, or fever with symptoms of local infection such as throat/pharynx/mouth irritation or urinary 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. This is unlikely to happen if you take the tablets regularly. Consult your doctor if you are concerned.

The following adverse 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 standing up
• vomiting, diarrhea
• cough
• kidney function problems.

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

• palpitations (awareness of heart hyperactivity), rapid heartbeat
• myocardial infarction or stroke in susceptible patients (possibly due to excessive blood pressure drop)
• poor circulation that causes fingers and toes to be pale, cold, and numb
• numb limbs
• vertigo (a feeling that everything around you is spinning, up and down or from side to side)
• mood changes, changes in taste
• seeing and/or hearing hallucinations.
• feeling of numbness or other problems such as inability to sleep
• nasal congestion
• abdominal pain, indigestion, nausea
• rash, itching
• fatigue, loss of muscle strength (asthenia)
• high potassium levels in the blood
• increased urea in blood, serum creatinine, or liver enzyme levels in the blood
• impotence (inability to achieve or maintain an erection).

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

• a decrease in red blood cells (anemia), symptoms that may include fatigue, pale skin
• syndrome of inappropriate antidiuretic hormone secretion (condition where the body produces too much antidiuretic hormone).
• confusion
• changes in the smell of things
• dry mouth
• skin rash with red, itchy bumps (urticaria)
• hair loss
• psoriasis (condition that causes red, scaly patches on the skin)
• severe allergic reactions
• uremia (retention in the bloodstream of waste products that are normally excreted in the urine)
• acute kidney failure that causes nausea, vomiting, lethargy, drowsiness
• breast development in men
• high bilirubin levels in the blood (a breakdown product of red blood cells, which can cause yellowing of the skin and eyes), low sodium levels in the blood.

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

• bone marrow depression, excessive breakdown of red blood cells that causes fatigue and pale skin, low platelet count (thrombocytopenia), reduced white blood cell count (neutropenia, leucopenia, agranulocytosis) which makes infection more likely, lymph node disorder, autoimmune disease in which the body attacks itself
• low blood sugar levels (hypoglycemia)
• urinating less than usual or not at all
• wheezing, bronchitis, sinus problems, lung inflammation
• jaundice (symptoms that include yellowing of the skin and the whites of the eyes), liver inflammation (symptoms that may include fatigue, loss of appetite, fever, jaundice)
• pancreatitis (symptoms that may include nausea, abdominal pain or severe back pain)
• allergic reaction in the small intestine (intestinal angioedema)
• sweating
• blisters that can burst easily, leaving raw, painful skin, or can bleed, red, itchy bumps, or skin that peels, leaving red, raw patches on the body
• temporary enlargement of the lymph nodes in the skin
• a combination of symptoms including fever, blood disorders, or muscle and joint pain, sensitivity to sunlight, and a severe reduction in white blood cells, making infections more likely.

Unknown(cannot be estimated from available data):

• severe allergic reactions (anaphylactic)
• symptoms of depression
• fainting.

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

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

Reporting of Adverse Effects:

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

5. Storage of Lisinopril Teva

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

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

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Lisinopril Teva 5 mg Tablets

• The active substance is lisinopril (as dihydrate)

Each tablet contains 5 mg of lisinopril in the form of lisinopril dihydrate.

• The other ingredients (excipients) are: hydrogenated calcium phosphate, magnesium stearate, pregelatinized corn starch, mannitol, and corn starch.

Appearance of the Product and Package Contents

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

The medicine is presented in blisters of 14, 28, 30, 50, 60, 100, and 500 tablets, and in a clinical package of 50 and 100 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1ª planta.

28108 Alcobendas. Madrid.

Manufacturer:

Pharmachemie BV

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

Netherlands

TEVA Pharmaceutical Works Private Limited Company

Pallagi str. 13

H-4042 Debrecen

Hungary

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

Germany: Lisinopril-TEVA® 5 mg Tabletten

Belgium: Lisinophar 5 mg Tablets

Spain: Lisinopril Teva 5 mg comprimidos EFG

Date of the Last Revision of this Leaflet: April 2022

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