Lisinopril Viatris 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Lisinopril Viatris 5 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Lisinopril Viatris belongs to a group of medicines known as 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 in type II diabetes in patients with hypertension.

2. What you need to know before taking Lisinopril Viatris

Do not take Lisinopril Viatris:

• If you are allergic to lisinopril, to other medicines of the same group (ACE inhibitors), or to any of the other ingredients of this medicine (listed in section 6).
• If you have previously received a medicine from the same class as lisinopril (ACE inhibitors) and experienced an allergic reaction causing swelling of the hands, feet or ankles, face, lips, tongue and/or throat, with difficulty swallowing or breathing, or if you or a family member has ever had a similar reaction (angioedema).
• If you are more than 3 months pregnant. (It is also advisable to avoid lisinopril in early pregnancy. (See section "Pregnancy and breastfeeding").
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as the risk of angioedema (rapid swelling beneath the skin, such as in the throat) is high.
• If you are taking any of the following medicines, the risk of developing angioedema may increase:
• Racecadotril, a medicine used to treat diarrhoea.
• Medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine used to treat diabetes.

Warnings and precautions

Talk to your doctor or pharmacist before starting Lisinopril Viatris:

Inform your doctor if you are in any of the following situations, as you may require a dose adjustment or discontinuation of lisinopril treatment:

• If you experience difficulty breathing or swallowing, with or without swelling of the face, lips, tongue and/or throat, stop taking Lisinopril and seek immediate medical attention.

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

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

• If you have recently had excessive vomiting or diarrhoea.

• If you have narrowing of the aorta (aortic stenosis), narrowing of the renal arteries (renal artery stenosis), narrowing of heart valves (mitral valve stenosis), or thickening of the heart muscle (hypertrophic cardiomyopathy).

• If you have recently had an acute myocardial infarction (heart attack).

• If you have impaired kidney function or are on dialysis.

• If you have liver impairment (impaired liver function).

• If you have a blood vessel disease (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 develop serious infections. In such cases, inform your doctor immediately if you notice any signs of infection.

• If you have diabetes and are taking oral antidiabetic medicines or insulin. Lisinopril may increase the risk of hypoglycaemia (low blood sugar levels), so you should monitor your blood glucose levels more closely, especially during the first month of treatment with Lisinopril.

• If you are on a salt-free diet, take potassium supplements or salt substitutes containing potassium, take potassium-sparing diuretics (medicines that increase urine output), have diabetes, or any kidney problems, as these may lead to elevated potassium levels in the blood, which can be serious. In such cases, your doctor may need to adjust your dose of Lisinopril or monitor your blood potassium levels.

• If you have a cough, as this may be due to the treatment.

• If you are scheduled to undergo low-density lipoprotein (LDL) apheresis treatment.

• If you are scheduled to undergo desensitisation treatment to reduce the effects of an allergy to bee or wasp stings.

• If you have low blood pressure, as the use of Lisinopril, especially during the initial doses, may cause a sudden drop in blood pressure (you may experience fainting or dizziness upon standing. In such cases, lying down may help).

• If you are taking any of the following medicines for high blood pressure (hypertension):

  • An angiotensin II receptor antagonist (ARA) (also known as "sartans" – e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
  • Aliskiren.

• If you are taking a medicine containing a neprilysin inhibitor (e.g., sacubitril or sacubitril/valsartan). Lisinopril must not be administered within 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 any surgical procedure with general or local anaesthesia (including at the dentist), inform the doctor or dentist that you are taking Lisinopril, as it may cause a sudden drop in blood pressure associated with anaesthesia.

Inform your doctor if you think you are pregnant (or could be). Lisinopril is not recommended in early pregnancy and must not be used if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this stage (see section on Pregnancy).

Children and adolescents

Lisinopril has been studied in children. For further information, speak with your doctor.

Other medicines and Lisinopril Viatris

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

Note that these instructions may also apply to medicines you have taken previously or may take in the future.

Taking certain medicines together with Lisinopril may alter the effect (interaction) of lisinopril and/or the other medicines, so in such cases it may be necessary to adjust the dose or discontinue 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 need to take, any of the following medicines:

• Diuretics (medicines that increase urine output).
• Potassium supplements (including salt substitutes), potassium-sparing diuretics ("water tablets"), and other medicines that may increase blood potassium levels (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, 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 drugs (NSAIDs) such as indomethacin and high-dose aspirin (more than 3 grams per day), and gold therapy, used to treat 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 more commonly used to prevent organ transplant rejection (temsirolimus, sirolimus, everolimus, and other mTOR inhibitors). See section “Warnings and precautions”.
• Medicines containing a neprilysin inhibitor (e.g., sacubitril).

Taking Lisinopril with food and drink

This medicine can be taken with or without food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy

Inform your doctor if you think you are pregnant (or could be). Your doctor will usually advise you to stop taking Lisinopril before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Lisinopril is not recommended in early 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 from the third month of pregnancy onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Lisinopril is not recommended for breastfeeding mothers. If you wish to breastfeed, your doctor may choose an alternative treatment, especially if your baby is a newborn or was born prematurely.

Driving and using machines

Lisinopril tablets are unlikely to affect your ability to drive or operate machinery; however, if you experience symptoms such as dizziness or fatigue, avoid tasks requiring special attention until you know how you tolerate the medicine.

3. How to take Lisinopril Viatris

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will tell you how many tablets to take each day and how long your treatment with lisinril will last. Do not stop treatment early.

Adults

• High blood pressure

The usual recommended starting dose is 10 mg once daily.

The usual long-term dose is 20 mg once daily.

• Symptomatic heart failure

The usual recommended starting dose is 2.50 mg once daily.

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

• Acute myocardial infarction

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

• Diabetic kidney complications

The usual dose is 10 mg or 20 mg once daily.

Patients with impaired renal function

Your doctor will adjust your dose.

Method of administration

• Swallow the tablet with water.
• Try to take your tablets at the same time every day. It does not matter whether 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 occurs during continued treatment. This effect may be noticed as dizziness; in such a case, lying down will help.

If you think that the effect 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, contact your doctor or pharmacist immediately.

The most common symptoms in case of overdose are: hypotension (low blood pressure), shock, renal failure (impaired kidney function), hyperventilation (very rapid breathing), tachycardia (increased heart rate), palpitations (rapid or irregular heartbeat), bradycardia (slowed heart rate), dizziness, anxiety, and cough.

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

If you forget to take Lisinopril Viatris

Do not take a double dose to make up for the forgotten dose; wait until the next scheduled dose.

If you stop taking Lisinopril Viatris

Your doctor will tell you how long your treatment with lisinopril should last. Do not stop treatment early, even if you feel better.

If you have any further 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 everyone experiences them.

Adverse effects of medicines 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)

• Impaired kidney function
• 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 reduction in blood pressure in high-risk patients
• Sensation of rapid and irregular heartbeat
• Rapid and unusual heartbeats
• Numbness and spasms in fingers, followed by warmth and pain (Raynaud's phenomenon)
• Tingling sensation in certain limbs
• Inability to achieve an erection
• Skin rash
• Itching
• Increased liver enzymes
• Increased blood urea
• Increased blood creatinine
• Increased blood potassium
• Mood disturbances
• Nausea
• Stomach pain
• Fatigue
• Tiredness

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

• Cardiac arrest
• Impaired kidney function
• Allergic reaction (angioedema), characterized by swelling of the face, limbs, lips, tongue, and/or larynx
• Inflammation of the bronchi, which may be chronic
• Skin rash with hives or wheals
• Psoriasis
• Hair loss
• Increased blood urea levels
• Increased blood bilirubin
• Decreased hemoglobin (a blood protein)
• Decreased hematocrit (proportion of red blood cells in the blood)
• Decreased blood sodium
• Breast enlargement in men
• Mental confusion
• Dry mouth
• Tongue disorders
• Visual field defects (area of vision)

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

• Contraction of bronchial muscles and difficulty breathing (bronchospasm)
• Lung inflammation (allergic alveolitis/eosinophilic pneumonia)
• Reduced ability of the body to produce 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 levels
• Decreased levels of certain types of white blood cells (neutrophils)
• Absence of certain types of white blood cells (agranulocytosis)
• Lymph node disorders
• Autoimmune disease
• Decreased blood glucose
• Liver inflammation
• Pancreatitis
• Yellowing of the skin and/or eyes (jaundice)
• Excessive release of antidiuretic hormone (SIADH)
• Decreased urine output or inability to urinate
• Intestinal inflammation
• Excessive sweating

Adverse effects observed in patients treated with Lisinopril, with 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 disturbances

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.
• Decreased number of red blood cells due to their rapid destruction
• Sinusitis (sensation of pain and pressure behind the cheeks and eyes)

Frequency not known (cannot be estimated from available data)

• Stroke (cerebrovascular accident)
• Angina and heart rhythm disturbances
• Impaired liver function
• Urinary tract infection
• Difficulty breathing (dyspnea)
• Bronchitis
• Chest pain
• Back pain
• Shoulder pain
• Joint pain
• Muscle cramps
• Depression
• Decreased libido
• Gout
• Fainting
• Loss of appetite
• Constipation
• Flatulence
• Nasal congestion
• Sore throat
• Upper respiratory tract symptoms
• Redness

Reporting of adverse effects

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

5. Storage of Lisinopril Viatris

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after CAD or EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lisinopril Viatris

• The active substance 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), corn starch, calcium hydrogen phosphate dihydrate.

Appearance of the product and contents of the pack

Lisinopril Viatris is presented as white tablets. Each pack contains 60 tablets.

Marketing Authorization Holder and Manufacturer

Holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer:

Mylan Hungary Kft

H-2900 Komárom

Mylan utca 1

Hungary

Date of the most recent review of this leaflet: December 2022

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