ENALAPRIL VIATRIS 20 mg TABLETS

Introduction

Package Leaflet: Information for the User

Enalapril Viatris 20 mg Tablets EFG

enalapril maleate

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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Enalapril Viatris contains the active substance enalapril maleate. It belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors).

Enalapril Viatris is used to:

• Treat high blood pressure (hypertension).
• Treat heart failure (weakening of the heart's function). It may reduce the need for hospitalization and may help some patients to live longer.
• Prevent signs of heart failure. Signs include: difficulty breathing, tiredness after light physical activity such as walking or swelling of the ankles and feet.

This medicine works by widening your blood vessels. This reduces your blood pressure. Normally, the medicine starts to work within an hour and the effect lasts for at least 24 hours. Some people may need several weeks of treatment before the effect on their blood pressure is seen.

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

Do not take Enalapril Viatris:

• If you are allergic to enalapril maleate or any of the other ingredients of this medicine (listed in section 6).
• If you have had an allergic reaction to any other ACE inhibitor medicine.
• If you have ever had swelling of the face, lips, tongue or throat that caused difficulty swallowing or breathing (angioedema), when the cause was unknown or if a family member has a history of angioedema.
• If you are more than 3 months pregnant. (It is also better to avoid the use of enalapril maleate during the first months of pregnancy - see section pregnancy).
• If you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine that contains aliskiren.
• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure, as it increases the risk of angioedema (rapid swelling under the skin in an area such as the throat).

Do not take this medicine if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Enalapril Viatris if:

• You have heart problems.
• You have a disease that affects the blood vessels in the brain.
• You have blood disorders such as low or lack of white blood cells (neutropenia/agranulocytosis), low platelet count (thrombocytopenia), or low red blood cell count (anemia).
• You have liver problems.
• You have any kidney problems (including kidney transplant), follow a low-salt diet, take potassium supplements, salt substitutes that contain potassium, or other medicines that may increase potassium levels in the blood (such as heparin [a medicine used to prevent blood clots], trimethoprim and cotrimoxazole [medicines used to treat bacterial infections], cyclosporin [an immunosuppressive medicine used to prevent organ transplant rejection], and heparin [a medicine used to thin the blood to prevent clots]). These may lead to an increase in potassium levels in the blood, which can be serious. Your doctor may need to adjust the dose of Enalapril Viatris or monitor your potassium levels in the blood. See also the information under "Other medicines and Enalapril Viatris".
• You are undergoing dialysis.
• You have recently had excessive vomiting or diarrhea.
• You have diabetes. You should monitor your blood glucose levels, especially during the first month of treatment. Your potassium levels in the blood may also increase.
• You have had an allergic reaction with swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing. You should be aware that black patients are more sensitive to this type of reaction to ACE inhibitors.
• You have low blood pressure (you may notice it as fainting or dizziness, especially when standing up).
• You have a disease of the collagen vascular system (such as lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with medicines that suppress your immune system, are taking the medicines allopurinol or procainamide, or any combination of these.
• 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 (such as temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine used to treat diabetes.
• If you are taking any of the following medicines used to treat high blood pressure:

• An angiotensin II receptor antagonist (ARA II) or aliskiren (see also the information under "Do not take Enalapril Viatris" and "Warnings and precautions").
• Aliskiren.

Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (such as potassium) at regular intervals.

See also the information under "Do not take Enalapril Viatris".

You must inform your doctor if you think you are pregnant (or might be). This medicine is not recommended at the start of pregnancy and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby when administered from this time on (see section Pregnancy).

You should be aware that this medicine may be less effective in reducing blood pressure in black patients than in other patients.

If you are going to undergo a procedure

If you are going to undergo any of the following procedures, inform your doctor that you are taking enalapril:

• any surgery or if you are going to receive anesthetics (even at the dentist)
• a treatment called LDL apheresis, to remove cholesterol from the blood using a machine
• desensitization treatment, to reduce the effect of an allergy to bee or wasp stings.

If any of the above situations apply to you, consult your doctor or dentist before starting the procedure.

Children and adolescents

Information on the use of enalapril maleate in children around 6 years old with high blood pressure is limited, and there is no information for children with heart problems. Enalapril maleate should not be used in babies or children with reduced kidney function.

Other medicines and Enalapril Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Enalapril Viatris may affect the way other medicines work. Also, other medicines may affect the action of enalapril maleate. Your doctor may need to change your dose and/or take other precautions.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• an angiotensin II receptor antagonist (ARA II) or aliskiren (see also the information under "Do not take Enalapril Viatris" and "Warnings and precautions")
• other medicines to reduce blood pressure, such as beta-blockers or water pills (diuretics)
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (such as trimethoprim and cotrimoxazole, for bacterial infections; cyclosporin, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots). See also the information under "Warnings and precautions"
• medicines for diabetes (including oral antidiabetics and insulin)
• lithium (a medicine used to treat a certain type of depression)
• medicines for depression known as "tricyclic antidepressants"
• medicines used to treat mental problems known as "antipsychotics"
• certain medicines for coughs and colds and weight loss medicines that contain a substance called "sympathomimetic agent"
• certain medicines for pain or arthritis, including gold treatment
• a medicine that contains a neprilysin inhibitor such as sacubitril (available in a fixed-dose combination with valsartan), racecadotril, or vildagliptin. It may increase the risk of angioedema (swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing). See also the information in the sections "Do not take Enalapril Viatris" and "Warnings and precautions"
• non-steroidal anti-inflammatory medicines, including COX-2 inhibitors (medicines that reduce inflammation and may be used to help relieve pain)
• aspirin (acetylsalicylic acid)
• medicines used to dissolve blood clots (thrombolytics).

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking Enalapril Viatris.

Taking Enalapril Viatris with food, drinks, and alcohol

If you drink alcohol while taking enalapril maleate, it may cause your blood pressure to drop too low and you may experience dizziness, drowsiness, or fainting. You should keep your alcohol intake to a minimum.

Enalapril Viatris can be taken with or without food. Most people take enalapril with a little water.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will normally advise you to stop taking enalapril maleate before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of enalapril maleate. This medicine is not recommended during the first few months of pregnancy and should not be taken after the third month of pregnancy, as it may cause serious harm to your baby when administered from this time on.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. The use of this medicine is not recommended during breastfeeding of newborns (first few weeks after birth) and, especially, in premature babies. In the case of an older child, your doctor will advise you on the benefits and risks of taking this medicine while breastfeeding, compared to other treatments.

Driving and using machines

You may feel dizzy or drowsy while taking this medicine. If this happens, do not drive or use tools or machines.

Enalapril Viatris contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Enalapril Viatris contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Enalapril Viatris

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

Taking the medicine

• It is very important that you continue taking this medicine for the time your doctor prescribes it.
• Do not take more tablets than prescribed.
• The score line is only to help you break the tablet if you have difficulty swallowing it whole.

Hypertension

• The recommended initial dose varies from 5 to 20 mg once daily.
• Some patients may need a lower initial dose.
• The recommended maintenance dose is 20 mg daily
• The maximum maintenance dose is 40 mg daily.

Heart Failure

• The recommended initial dose is 2.5 mg once daily.
• Your doctor will gradually increase the dose until the appropriate dose for your case is reached.
• The recommended maintenance dose is 20 mg once daily or divided into two doses. The maximum dose is 40 mg daily taken in two doses.

Patient with kidney problems

Your dose of medicine will change depending on how well your kidneys are working:

• moderate kidney problems – 5 mg to 10 mg a day
• severe kidney problems – 2.5 mg a day
• if you are undergoing dialysis – 2.5 mg a day. On days when you do not have dialysis, your dose may change depending on how low your blood pressure is.

Patient of advanced age

Your doctor will decide what dose you should take and will be based on the functioning of your kidneys.

Use in children

Experience with the use of enalapril maleate in children with high blood pressure is limited. If the child can swallow tablets, the dose will be calculated according to the child's weight and blood pressure. The usual initial doses are:

• between 20 kg and 50 kg – 2.5 mg a day
• more than 50 kg – 5 mg a day.

The dose may be changed according to the child's needs:

• up to 20 mg a day can be used in children who weigh between 20 kg and 50 kg
• up to 40 mg a day can be used in children who weigh more than 50 kg.

This medicine is not recommended in newborn babies (first few weeks after birth) or in children with kidney problems.

Not all the recommended doses are available with this medicine, however, there are other products with lower doses available on the market.

If you take more Enalapril Viatris than you should

If you take more enalapril than you should, consult your doctor or go to the hospital immediately. Take the medicine pack with you. The following effects may occur: feeling of dizziness or vertigo. This is due to a sudden or excessive drop in blood pressure.

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

If you forget to take Enalapril Viatris

If you forget to take a tablet, do not take the forgotten dose.

Take the next dose as usual.

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

If you stop taking Enalapril Viatris

Do not stop taking your medicine unless your doctor tells you to.

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. The reported adverse effects are as follows:

Stop taking enalapril maleate immediately and seek advice from your doctor in any of the following cases:

• swelling of the face, lips, tongue, or throat, making it difficult to breathe or swallow
• swelling of the hands, feet, or ankles
• red rash on the skin with swelling (hives).

You should be aware that black patients have a higher risk of suffering from this type of reaction. If you experience any of the above reactions, stop taking enalapril and talk to your doctor immediately.

When you start taking this medicine, you may feel faint or dizzy. If this happens, lying down may help. This is due to a decrease in your blood pressure. This will improve as you continue taking the medicine. If you are concerned, please talk to your doctor.

Other adverse effects include:

Very Common(may affect more than 1 in 10 people)

• general malaise (nausea), dizziness, weakness
• blurred vision
• cough.

Common(may affect up to 1 in 10 people)

• headache, depression, fainting (syncope), taste disorder
• dizziness due to low blood pressure, changes in heart rhythm, rapid heartbeats, chest pain or angina
• difficulty breathing
• diarrhea, abdominal pain
• fatigue
• rash, allergic reactions with swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing
• high potassium levels in the blood, increased creatinine levels in the blood (both usually detected in blood tests).

Uncommon(may affect up to 1 in 100 people)

• flushing
• sudden drop in blood pressure
• rapid and irregular heartbeats (palpitations)
• myocardial infarction (possibly due to very low blood pressure in certain high-risk patients, even those with altered blood flow to the heart or brain)
• stroke (possibly due to very low blood pressure in high-risk patients)
• anemia (including aplastic and hemolytic anemia)
• confusion, drowsiness, or inability to sleep, nervousness
• tingling or numbness sensation on the skin
• vertigo (dizziness sensation)
• ringing in the ears (tinnitus)
• runny nose, sore throat, or hoarseness
• asthma-associated chest tightness
• slow movement of food through the intestine (ileus), pancreatitis
• vomiting, indigestion, constipation, anorexia
• irritated stomach (gastric irritation), dry mouth, ulcer
• muscle cramps
• reduced kidney function, kidney failure
• increased sweating
• itching or hives
• hair loss
• malaise (general discomfort), elevated temperature (fever)
• impotence
• high protein levels in the urine (determined in a test)
• low blood sugar or sodium levels, high urea levels in the blood (all determined in a blood test).

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

• “Raynaud's phenomenon” in which your hands and feet may become very cold and white due to low blood flow
• changes in blood values such as a lower number of white or red blood cells, lower hemoglobin, lower platelet count in the blood
• bone marrow depression
• inflamed glands in the neck, armpits, or groin
• autoimmune diseases
• sleep disturbances or sleep problems
• fluid or substance accumulation in the lungs (as seen on X-rays)
• nasal inflammation
• lung inflammation causing difficulty breathing (pneumonia)
• inflammation of the cheeks, gums, tongue, lips, or throat
• reduced urine production
• target-shaped rash (erythema multiforme)
• “Stevens-Johnson syndrome” and “toxic epidermal necrolysis” (a severe skin disorder in which you have red and scaly skin, ulcers with blisters or open sores)
• exfoliative dermatitis/erythroderma (severe skin rash with scaling or peeling), pemphigus (small fluid-filled blisters on the skin)
• liver or bile duct problems such as reduced liver function, liver inflammation, jaundice (yellowing of the skin or eyes), elevated liver enzyme or bilirubin levels (determined in a test)
• breast enlargement in men (gynecomastia).

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

• swelling in your intestine (intestinal angioedema).

Frequency Not Known(frequency cannot be estimated from available data)

• overproduction of antidiuretic hormone, leading to fluid retention, causing weakness, fatigue, or confusion
• a symptom complex has been reported that may include all or some of the following symptoms: fever, blood vessel inflammation (serositis, vasculitis), muscle pain (myalgia, myositis), joint pain (arthralgia, arthritis). Rash, photosensitivity, and other skin effects may occur.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. 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 Enalapril Viatris

Keep this medicine out of sight and reach of children.

Do not store above 25°C. Store in the original package.

Do not put the tablets in another container, as they may get mixed up.

Do not use this medicine after the expiration date shown on the blister pack and on the carton 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 in the SIGRE collection point at 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 ofEnalaprilViatris

• The active ingredient is enalapril maleate. Each tablet contains 20 mg of enalapril maleate.
• The other ingredients are: sodium hydrogen carbonate (E-500), pregelatinized corn starch, corn starch, lactose monohydrate (see section 2, “Enalapril Viatris contains lactose”), magnesium stearate (E-572), and iron oxide brown (E-172).

Appearance and Package Contents

Enalapril Viatris is presented in the form of peach-colored, arched triangle-shaped tablets, with the inscription “20” and “G” in relief on one face and a score line on the other, approximately 9 mm in length, 9 mm in width, and 4 mm in thickness.

It is available in the following formats:

Blister packs in cardboard boxes, containing 10, 11, 14, 20, 28, 30, 49, (49 x 1 blister), 50, 56, 60, 84, 90, 98, 100, 250, 500 tablets.

Bottles with desiccant and child-resistant cap containing 10, 11, 14, 20, 28, 30, 50, 56, 60, 84, 90, 100, 250, 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

McDermott Laboratories Ltd. t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road, Dublin 13

Ireland

or

Mylan Hungary Kft.

H-2900 Komárom

Mylan utca 1

Hungary

or

Logiters, Logistica Portugal, S.A.

Estrada dos Arneiros, 4

2050-306 Azambuja

Portugal

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

Spain: Enalapril Viatris 20 mg tablets EFG

Netherlands: Enalapril Maleaat Mylan 20 mg tablets

Portugal: Maleato de Enalapril Mylan 20 mg tablets

Date of the last revision of this prospectus:October 2022

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