Package Insert: Information for the User

Lisinopril Viatris 5 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Lisinopril Viatris and how is it used

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

3. How to take Lisinopril Viatris

4. Possible adverse effects

5. Storage of Lisinopril Viatris

6. Contents of the package and additional information

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

Lisinopril Viatris is indicated for:

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

Do not take Lisinopril Viatris:

• If you are allergic to lisinopril, other medications in the same group (ACE inhibitors) or any of the other components of this medication (listed in section 6).
• If you have previously received a medication in the same group of drugs as lisinopril (ACE inhibitors) and have had an allergic reaction that caused swelling of hands, feet, or ankles, face, lips, tongue, and/or throat with difficulty swallowing or breathing, or if you or a family member has had a similar reaction (angioedema).
• If you are pregnant more than 3 months (It is also best to avoid lisinopril at the beginning of pregnancy (see section "Pregnancy and breastfeeding").
• If you have diabetes or kidney failure 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, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is high.
• If you are taking any of the following medications, the risk of angioedema may increase:
• Racecadotril, a medication used to treat diarrhea.
• Medications used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medication used to treat diabetes.

Warnings and precautions:

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

Inform your doctor if you are in any of the following situations, as you may need to adjust the dose or discontinue lisinopril treatment:

• 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 assistance immediately.
• If you are taking any of the following medications, the risk of angioedema (rapid swelling under the skin in areas such as the throat) increases:

• Temsirólimus, sirólimus, everólimus, and other medications in the class of mTOR inhibitors (used to prevent organ transplant rejection).

• If you have recently had vomiting or excessive diarrhea.
• If you have a narrowing of the aorta (aortic stenosis), the arteries of the kidneys (renal artery stenosis), or the heart valves (mitral valve stenosis), or an increase in the thickness of the heart muscle (hypertrophic cardiomyopathy).
• If you have had a recent heart attack.
• If you have kidney function impairment or are on dialysis.
• If you have liver disease (liver function impairment).
• If you have a vascular disease (collagen vascular disease) and/or are being treated with allopurinol (for gout treatment), procainamide (for heart rhythm disorders), immunosuppressants (medications that suppress the body's immune response)because you may be at risk of severe infections. In these cases, inform your doctor of any signs of infection.
• If you have diabetesand are taking oral antidiabetic medications or insulin. Lisinopril may increase the risk of hypoglycemia (low blood sugar levels), so you will need to have better control of your blood glucose levels, especially during the first month of treatment with Lisinopril.
• If you are on a low-sodium diet, taking potassium supplements or salt substitutes containing potassium, taking potassium-sparing diuretics (medications that increase urine production), have diabetes or any kidney problems, as they may cause high potassium levels in the blood that can be severe. In these cases, your doctor may need to adjust the dose of Lisinopril or monitor your potassium levels in the blood.
• If you have a cough,as it may be caused by the treatment.
• If you are about to undergo a treatment called LDL apheresis.
• If you are about to undergo a desensitization treatment to reduce the effect of an allergy to bee or wasp stings.
• If you have low blood pressureas the use of Lisinopril, especially in the first doses, may cause a sudden drop in blood pressure(you may notice it as dizziness or lightheadedness when standing up. In these cases, lying down may help).
• 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 "sartans" - for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
  • Aliskirén.

• If you are taking a medication that contains a neprilysin inhibitor (for example, sacubitril). Do not administer Lisinopril within 36 hours before or after taking sacubitril/valsartán.

Your doctor may need to monitor your kidney function, blood pressure, and electrolyte levels in the blood (such as potassium) at regular intervals.

See also the information under the heading “Do not take Lisinopril Viatris”.

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

You should inform your doctor if you think you are pregnant (or may be). Lisinopril is not recommended at the beginning of pregnancy and should not be used if you are more than 3 months pregnant, as it may cause serious damage to your baby if used from the third month of pregnancy.

Children and adolescents:

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

Other medications and Lisinopril Viatris:

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

Be aware that these instructions may also apply to medications that have been used before or may be used later.

The use of some medications with Lisinopril may modify the effect (interaction) of both lisinopril and the mentioned medications, so, in these cases, you may need to change the dose or discontinue treatment with one of them.Your doctor may need to adjust your dose and/or take other precautions.

Particularly, talk to your doctor or pharmacist if you are taking or have taken recentlyor may need to take any of the following medications:

• Diuretics (medications that increase urine production).
• Potassium supplements (including salt substitutes), diuretics that spare potassium ("urine tablets") and other medications that may increase potassium levels in the blood (for example, trimethoprim and cotrimoxazole for bacterial infections; ciclosporin, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medication used to dilute the blood to prevent clots).
• Angiotensin II receptor antagonists (ARAs) or aliskirén (see also the information under the headings “Do not take Lisinopril Viatris” and “Warnings and precautions”.
• Medications for mental disorders such as lithium, antipsychotics, or tricyclic antidepressants.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) such as indomethacin and high doses of aspirin (more than 3 grams per day) and gold treatment, used to treat arthritis or muscle pain.
• Anti-hypertensive medications (medications that reduce high blood pressure).
• Sympathomimetic medications (stimulate the central nervous system).
• Medications used to treat diabetes, such as insulin or oral antidiabetic medications.
• Thrombolytic medications (prevent blood clots).
• Medications used more frequently to prevent organ transplant rejection (temsirolimus, sirolimus, everolimus, and other mTOR inhibitors). See the section “Warnings and precautions”.
• Medications that contain a neprilysin inhibitor (for example, sacubitril).

Taking Lisinopril with food and drinks:

This medication can be taken before or after meals

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medication.

Pregnancy:

You should inform your doctor if you think you are pregnant (or may be). Normally, your doctor will advise you to stop taking Lisinopril before becoming pregnant or as soon as you know you are pregnant and will advise you to take a different medication instead of Lisinopril. Lisinopril is not recommended at the beginning of pregnancy and should not be used if you are more than 3 months pregnant, as it may cause serious damage to your baby if used from the third month of pregnancy.

Breastfeeding:

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

Driving and operating machines:

It is unlikely that lisinopril tablets will affect your ability to drive vehicles or operate machines; 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.

Remember to take your medication.

Your doctor will indicate how many tablets you should take each day and the duration of your treatment with lisinopril. Do not discontinue treatment before.

Adults

• Hypertension

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

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

• Symptomatic heart failure

The usual initial recommended dose is 2.50 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 initial recommended dose is 5 mg on the first and second day after the infarction, followed by 10 mg once a day.

• Diabetic renal complications

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

Patients with renal function impairment

Your doctor will adjust the dose.

Administration form

• Swallow the tablet with water.
• Try to take your tablets at the same time every 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 decrease in blood pressure than what will be seen when continuing treatment. This effect may be felt as dizziness, in which case lying down will help.

If you estimate that the action of lisinopril is too strong or too weak, consult your doctor or pharmacist.

If you take more Lisinopril Viatris than you should

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

The most frequent symptoms in case of overdose are: hypotension (low blood pressure), shock, renal insufficiency (kidney function impairment), hyperventilation (very rapid breathing), tachycardia (increased heart rate), palpitations (rapid and irregular heartbeat sensation), bradycardia (decreased heart rate), dizziness, anxiety, and cough.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service (Telephone 91 562 04 20), indicating the medication and the amount ingested.

If you forgot to take Lisinopril Viatris

Do not take a double dose to compensate for the missed dose and wait for the next administration.

If you interrupt treatment with Lisinopril Viatris

Your doctor will indicate the duration of your treatment with lisinopril. Do not discontinue treatment before, even if you feel better.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

Medication side effects are classified as follows:

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

Common (may affect up to 1 in 10 people)

Uncommon (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)

Common(may affect up to 1 in 10 people)

• Renal function impairment.
• Cough.
• Dizziness or lightheadedness, especially when standing up quickly.
• Dizziness,
• Headache.
• Diarrhea.

Uncommon(may affect up to 1 in 100 people)

• Myocardial infarction or stroke, possibly secondary to excessive blood pressure reduction in high-risk patients
• Irregular heart palpitations
• Abnormal heart rhythms
• Raynaud's phenomenon, characterized by numbness and spasms in the fingers of the hands, followed by heat and pain
• Numbness in certain limbs
• Inability to achieve an erection
• Skin rash
• Itching.
• Liver enzyme increase
• Increased blood urea
• Increased creatinine in the blood
• Increased potassium in the blood
• Mood changes
• Nausea
• Stomach pain
• Fatigue
• Tiredness.

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

• Cardiac arrest
• Renal function impairment
• Allergic reaction (angioedema), characterized by swelling of the face, extremities, lips, tongue, and/or larynx
• Chronic bronchitis inflammation
• Skin rash with blisters or hives
• Poriasis
• Hair loss
• Increased urea in the blood
• Increased bilirubin in the blood
• Decreased hemoglobin (a blood protein)
• Decreased hematocrit (ratio of red blood cells in the blood)
• Decreased sodium in the blood
• Male breast enlargement
• Confusion
• Dry mouth
• Tongue disorders
• Visual field defect (area of vision)

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

• Contraction of the bronchial muscle and difficulty breathing (bronchospasm)
• Lung inflammation (allergic alveolitis/ eosinophilic pneumonia)
• Decreased ability of the body to form blood cells
• Decreased number of red blood cells and/or hemoglobin in the blood
• Decreased number of platelets in the blood
• Low white blood cell count
• Decreased number of a certain type of white blood cell (neutrophils)
• Absence of a certain type of white blood cell (agranulocytosis)
• Lymph node alterations
• Autoimmune disease
• Decreased blood glucose
• Liver inflammation
• Pancreatitis,
• Yellow skin and/or eyes color.
• Excessive release of antidiuretic hormone (SIADH)
• Decreased urine output or inability to urinate.
• Intestinal inflammation
• Intense sweating

Side effects observed in people treated with Lisinopril, of unknown causal relationship:

Common: may affect up to 1 in 10 people

- Vomiting.

Uncommon: may affect up to 1 in 100 people

- Sleep disorders (insomnia and somnolence)

- Dizziness

- 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.

- Rapid destruction of red blood cells, resulting in decreased red blood cell count.

- Sinusitis (sensation of pain and pressure behind the cheeks and eyes).

Frequency not known(cannot be estimated from available data)

- Stroke (cerebral accident)

- Angina pectoris and heart rhythm alterations

- Liver function impairment

- Urinary tract infection

- Difficulty breathing (dyspnea)

- Bronchitis inflammation

- Chest pain

- Back pain

- Shoulder pain

- Joint pain

- Muscle cramps

- Depression

- Decreased libido

- Gout

- Syncope

- Loss of appetite

- Constipation

- Gas

- Nasal congestion

- Throat pain

- Upper respiratory tract symptoms

- Redness

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: https://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.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the box after CAD or EXP. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Lisinopril Viatris Composition

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

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

Holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Responsible for manufacturing:

McDermott Laboratories Ltd t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road

Dublín 13

Ireland

or

Mylan Hungary Kft

H-2900 Komárom

Mylan utca 1

Hungary

Last review date of this leaflet:December 2022

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