LISINOPRIL VIATRIS 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Lisinopril Viatris 5 mg Tablets EFG

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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Lisinopril Viatris belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors).

Lisinopril Viatris is indicated for:

• Treatment of high blood pressure (hypertension).
• Treatment of symptomatic heart failure.
• Short-term treatment of acute myocardial infarction.
• Treatment of kidney problems in patients with type 2 diabetes and high blood pressure.

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

Do not take Lisinopril Viatris:

• If you are allergic to lisinopril, to other ACE inhibitors or to any of the other ingredients of this medicine (listed in section 6).
• If you have ever had a severe allergic reaction to ACE inhibitors, which caused swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing.
• If you are more than 3 months pregnant (also, it is better to avoid lisinopril at the start of pregnancy; see section "Pregnancy and breast-feeding").
• If you have diabetes or kidney problems and are taking a blood pressure medicine that contains aliskiren.
• If you are taking or have recently taken sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in areas such as the throat) is increased.
• If you are taking any of the following medicines, the risk of angioedema may be increased:
• Racecadotril, a medicine used to treat diarrhea.
• Medicines used to prevent organ transplant rejection and to treat cancer (e.g. temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine used to treat diabetes.

Warnings and precautions

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

Tell your doctor if you are in any of the following situations, as you may need a dose adjustment or to stop treatment with lisinopril:

• If you have difficulty breathing or swallowing with or without swelling of the face, lips, tongue and/or throat, stop taking Lisinopril and seek medical help immediately.
• If you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) is increased:

• Temsirolimus, sirolimus, everolimus and other medicines of the class of mTOR inhibitors (used to prevent organ transplant rejection).

• If you have recently had excessive vomiting or diarrhea.
• If you have a narrowing of the aorta (aortic stenosis), of the kidney arteries (renal artery stenosis), or of the heart valves (mitral valve stenosis), or an increase in the thickness of the heart muscle (hypertrophic cardiomyopathy).
• If you have had a recent acute myocardial infarction.
• If you have kidney problems or are on dialysis.
• If you have liver problems (liver dysfunction).
• If you have a disease of the blood vessels (collagen vascular disease) and/or are being treated with allopurinol (for gout), procainamide (for heart rhythm disorders), or immunosuppressants (medicines that suppress the body's immune response), as you may be at risk of serious infections. In these cases, inform your doctor of any signs of infection.
• If you have diabetes and are taking oral antidiabetics or insulin. Lisinopril may increase the risk of hypoglycemia (low blood sugar levels), so you will need to have closer monitoring of your glucose levels, especially during the first month of treatment with Lisinopril.
• If you are on a low-salt diet, take potassium supplements or salt substitutes that contain potassium, take potassium-sparing diuretics (medicines that increase urine production), have diabetes or kidney problems, as these may cause increases in blood potassium levels that can be serious. In these cases, your doctor may need to adjust the dose of Lisinopril or monitor your potassium levels.
• If you have a cough, as it may be due to treatment.
• If you are going to undergo a treatment called low-density lipoprotein (LDL) apheresis.
• If you are going to undergo desensitization treatment to reduce the effect of an allergy to bee or wasp stings.
• If you have low blood pressure, as the use of Lisinopril, especially in the first doses, may cause a sudden drop in blood pressure (which you may notice as dizziness or fainting when standing up; in these cases, lying down may help).
• If you are taking any of the following medicines used to treat high blood pressure:
• • 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.

• If you are taking a medicine that contains a neprilysin inhibitor (e.g. sacubitril or sacubitril/valsartan). Do not take Lisinopril in the 36 hours before or after taking sacubitril/valsartan.

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 Viatris".

Before undergoing surgery with general or local anesthesia (even at the dentist), inform your doctor or dentist that you are taking Lisinopril, as it may cause a sudden drop in blood pressure associated with anesthesia.

You must inform your doctor if you think you are pregnant (or might be). Lisinopril is not recommended at the start 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.

Children and adolescents

Lisinopril has been studied in children. For more information, talk to your doctor.

Other medicines and Lisinopril Viatris

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

Note that these instructions may also apply to medicines that you have taken before or may take after.

The use of some medicines with Lisinopril may affect the action of lisinopril and/or the other medicine. In these cases, it may be necessary to change the dose or stop treatment with one of them. Your doctor may need to adjust your dose and/or take other precautions.

In particular, talk to your doctor or pharmacist if you are taking or have recently taken or might take any of the following medicines:

• Diuretics (medicines that increase urine production).
• Potassium supplements (including salt substitutes), potassium-sparing diuretics ("water pills") 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).
• If you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings "Do not take Lisinopril Viatris" and "Warnings and precautions").
• Medicines for mental disorders such as lithium, antipsychotics or tricyclic antidepressants.
• Non-steroidal anti-inflammatory medicines (NSAIDs) such as indometacin and high doses of aspirin (more than 3 grams per day) and gold treatment used for arthritis or muscle pain.
• Antihypertensives (medicines that lower high blood pressure).
• Sympathomimetic medicines (stimulate the central nervous system).
• Medicines for diabetes, such as insulin or oral antidiabetics.
• Thrombolytic medicines (prevent blood clots).
• Medicines used more frequently to prevent organ transplant rejection (temsirolimus, sirolimus, everolimus and other medicines of the mTOR inhibitor type). See section "Warnings and precautions".
• Medicines that contain a neprilysin inhibitor (e.g. sacubitril).

Taking Lisinopril Viatris with food and drink

This medicine can be taken before or after meals

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

You must inform your doctor if you think you are pregnant (or might be). 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 a different medicine instead of Lisinopril. Lisinopril is not recommended at the start 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 if you want to breast-feed, your doctor may choose a different treatment, especially if your baby is newborn or premature.

Driving and using machines

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

3. How to take Lisinopril Viatris

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Remember to take your medicine.

Your doctor will tell you how many tablets to take each day and how long to take lisinopril. Do not stop treatment before.

Adults

• High blood pressure

The usual recommended initial dose is 10 mg once a day.

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

• Symptomatic heart failure

The usual recommended initial dose is 2.5 mg once a day.

The usual long-term dose is 5 mg up to a maximum of 35 mg once a day.

• Acute myocardial infarction

The usual recommended initial dose is 5 mg on the first and second day after the infarction, followed by 10 mg once a day.

• Kidney problems in diabetes

The usual dose is 10 mg or 20 mg once a day.

Patients with kidney problems

Your doctor will adjust the dose.

Method of administration

• Swallow the tablet with water.
• Try to take your tablets at the same time each day. It does not matter if you take Lisinopril Viatris before or after meals.
• The tablet can be divided into equal doses.
• Do not stop taking your tablets if you feel well, unless your doctor tells you to.
• Remember, the first dose of lisinopril may cause a greater drop in blood pressure than will occur with continued treatment. This effect may be noticed as dizziness; in this case, lying down may help.

If you think the action of lisinopril is too strong or too weak, talk to your doctor or pharmacist.

If you take more Lisinopril Viatris than you should

If you take more lisinopril than you should, talk to your doctor or pharmacist immediately.

The most common symptoms in case of overdose are: low blood pressure, shock, kidney problems, rapid breathing, fast heart rate, palpitations, slow heart rate, dizziness, anxiety, and cough.

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicology Information Service (Telephone 91 562 04 20), indicating the medicine and the amount taken.

If you forget to take Lisinopril Viatris

Do not take a double dose to make up for a forgotten dose. Wait for the next dose.

If you stop taking Lisinopril Viatris

Your doctor will tell you how long to take lisinopril. Do not stop treatment before, 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, this medicine can cause adverse effects, although not all people suffer from them.

Adverse effects of medicines are classified as follows:

Very frequent: (may affect more than 1 in 10 people)

Frequent (may affect up to 1 in 10 people)

Infrequent (may affect up to 1 in 100 people)

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

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

Frequency not known (cannot be estimated from available data)

Frequent(may affect up to 1 in 10 people)

• Alteration in kidney function.
• Cough.
• Feeling of dizziness or lightheadedness, especially when standing up quickly.
• Dizziness,
• Headache.
• Diarrhea.

Infrequent(may affect up to 1 in 100 people)

• Myocardial infarction or stroke, possibly secondary to excessive decrease in blood pressure in high-risk patients
• Rapid and irregular heartbeat
• Rapid and unusual heartbeats
• Numbness and spasms in the fingers, followed by heat and pain (Raynaud's phenomenon)
• Feeling of tingling in certain limbs
• Inability to obtain an erection
• Rash.
• Itching.
• Increased liver enzymes
• Increased urea in blood
• Increased creatinine in blood
• Increased potassium in blood
• Mood alterations
• Nausea
• Stomach pain
• Fatigue
• Tiredness.

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

• Cardiac arrest
• Alteration of kidney function
• Allergic reaction (angioedema), characterized by swelling of the face, limbs, lips, tongue, and/or larynx
• Inflammation of the bronchi that can be chronic
• Rash with hives or welts
• Psoriasis
• Hair loss
• Increased urea in the blood
• Increased bilirubin in blood
• Decrease in hemoglobin (a blood protein)
• Decrease in hematocrit (proportion of red blood cells in the blood)
• Decrease in sodium in blood
• Increased breast size in men
• Mental confusion
• Dry mouth
• Tongue disorders
• Visual field defect (area of vision)

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

• Contraction of bronchial muscles and difficulty breathing (bronchospasm)
• Inflammation of the lungs (allergic alveolitis/eosinophilic pneumonia)
• Decrease in the body's ability to form blood cells
• Decrease in the amount of red blood cells and/or hemoglobin in the blood
• Decrease in the number of platelets in the blood
• Low levels of white blood cells
• Decrease in the amount of a certain type of white blood cell (neutrophils)
• Absence of a certain type of white blood cell (agranulocytosis)
• Alterations of lymph nodes
• Autoimmune disease
• Decrease in blood glucose
• Inflammation of the liver
• Inflammation of the pancreas,
• Yellowish color of skin and/or eyes.
• Excessive release of antidiuretic hormone (SIADH)
• Decrease in urine output or inability to urinate.
• Inflammation of the intestine
• Excessive sweating

Adverse Effects Observed in People Treated with Lisinopril, of Unknown Causal Relationship:

Frequent: may affect up to 1 in 10 people

• Vomiting.

Infrequent: may affect up to 1 in 100 people

• Sleep disorders (insomnia and somnolence)
• Feeling of vertigo
• Rhinitis
• Indigestion
• Taste alterations.

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

• Blurred vision

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

• Severe skin disorders (pemphigus, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, cutaneous pseudolymphoma). Symptoms include redness, blistering, and peeling.
• Decrease in the amount of red blood cells due to rapid destruction.
• Sinusitis (feeling of pain and pressure behind the cheeks and eyes).

Frequency not known(cannot be estimated from available data)

• Stroke (cerebrovascular accident)
• Chest pain and heart rhythm disorders
• Liver function alteration
• Urinary tract infection
• Difficulty breathing (dyspnea)
• Bronchitis
• Chest pain
• Back pain
• Shoulder pain
• Joint pain
• Muscle cramps
• Depression
• Decreased sexual desire
• Gout
• Fainting
• Lack of appetite
• Constipation
• Gas
• Nasal congestion
• Sore throat
• Upper respiratory symptoms
• Redness

Reporting of Adverse Effects

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

5. Storage of Lisinopril Viatris

Keep this medicine out of sight and reach of children.

This medicine does not require special storage conditions

Do not use this medicine after the expiration date shown on the box after CAD or EXP. 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 collection point in your pharmacy. If in 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 Viatris

• The active ingredient is lisinopril (as dihydrate). Each tablet contains 5 mg of lisinopril
• The other ingredients (excipients) are: magnesium stearate (E-572), talc (E-553B), mannitol (E-421), cornstarch, calcium hydrogen phosphate dihydrate.

Appearance of the Product and Package Contents

Lisinopril Viatris is presented in the form of white tablets. Each package contains 60 tablets.

Marketing Authorization Holder and Manufacturer

Holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer:

Mylan Hungary Kft

H-2900 Komárom

Mylan utca 1

Hungary

Date of the Last Revision of this Leaflet:December 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