Enalapril Viatris 20 mg tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Enalapril Viatris 20 mg Tablets EFG

enalapril maleate

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, consult 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, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Enalapril Viatris contains an active substance called enalapril maleate. It belongs to a group of medicines known as angiotensin-converting enzyme (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 live longer.
• Prevent signs of heart failure. These signs include: shortness of breath, fatigue after mild physical activity such as walking, and swelling of the ankles and feet.

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

2. What you need to know before taking Enalapril Viatris

Do not take Enalapril Viatris:

• If you are allergic to enalapril maleate or to any of the other ingredients of this medicine (listed in section 6).
• If you have had an allergic reaction to any medicine in the same group of drugs as enalapril (ACE inhibitors).
• If you have ever had swelling of the face, lips, mouth, tongue, or throat causing difficulty swallowing or breathing (angioedema), whether 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 advisable to avoid the use of enalapril maleate during the first months of pregnancy – see Pregnancy section.)
• 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 a type of long-term (chronic) heart failure, as this increases the risk of angioedema (rapid swelling beneath the skin, such as in the throat).

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Enalapril Viatris if:

• You have heart problems.
• You have a disease affecting the blood vessels in the brain.
• You have blood disorders such as low or absent 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 a kidney transplant), follow a salt-free diet, take potassium supplements, potassium-containing salt substitutes, or other medicines that may increase blood potassium levels (for example, heparin [a medicine used to prevent blood clots], or trimethoprim-containing medicines such as cotrimoxazole [medicines used to treat infections]). These may lead to increased blood potassium levels, which can be serious. Your doctor may need to adjust your dose of Enalapril Viatris or monitor your blood potassium levels. See also information under “Other medicines and Enalapril Viatris”.
• You are undergoing dialysis.
• You have recently had excessive vomiting or diarrhoea.
• You have diabetes. You should monitor your blood glucose levels, especially during the first month of treatment. Your blood potassium levels may also increase.
• You have had an allergic reaction with swelling of the face, lips, tongue, or throat causing difficulty swallowing or breathing. Please note that black patients are more likely to experience this type of reaction to ACE inhibitors.
• You have low blood pressure (you may experience fainting or dizziness, especially when standing up).
• You have a vascular collagen disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with medicines that suppress your immune system, are taking allopurinol or procainamide, or any combination of these.
• You are taking any of the following medicines, as the risk of angioedema may increase:
  • Racecadotril, a medicine used to treat diarrhoea.
  • Medicines used to prevent rejection of organ transplants and for cancer (e.g., temsirolimus, sirolimus, everolimus).
  • Vildagliptin, a medicine used to treat diabetes.
• You are taking any of the following medicines used to treat high blood pressure:
  • An angiotensin II receptor antagonist (ARA-II) (also known as "sartans" – e.g., valsartan, telmisartan, irbesartan, etc.), particularly 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 “Do not take Enalapril Viatris”.

You should inform your doctor if you think you are pregnant (or plan to become pregnant). This medicine is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may cause serious harm to your baby when used from that stage onward (see Pregnancy section).

Please be aware that this medicine may be less effective in lowering blood pressure in black patients compared to other patients.

If you are undergoing a procedure

If you are scheduled for any of the following procedures, inform your doctor that you are taking enalapril:

• Any surgery or if you are to receive anaesthetics (including at the dentist)
• LDL apheresis treatment, to remove cholesterol from the blood using a machine
• Desensitisation treatment, to reduce the effect of an allergy to bee or wasp stings.

If any of the above 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 of age with high blood pressure is limited, and there is no information for children with heart problems. Enalapril maleate should not be used in infants or children with impaired kidney function.

Other medicines and Enalapril Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes herbal medicines. Enalapril Viatris may affect how other medicines work. In addition, other medicines may affect the action of enalapril maleate. Your doctor may need to adjust your dose and/or take other precautions.

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

• An angiotensin II receptor antagonist (ARA-II) or aliskiren (see also information under “Do not take Enalapril Viatris” and “Warnings and precautions”)
• Other medicines to lower blood pressure, such as beta-blockers or diuretic tablets ("water pills")
• Potassium supplements (including potassium-containing salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (e.g., trimethoprim and cotrimoxazole, used for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots). See also information under “Warnings and precautions”
• Medicines for diabetes (including oral antidiabetics and insulin)
• Lithium (a medicine used to treat certain types of depression)
• Medicines for depression known as "tricyclic antidepressants"
• Medicines used to treat mental disorders known as "antipsychotics"
• Certain cough and cold medicines and weight-loss medicines containing a substance called a "sympathomimetic agent"
• Certain medicines for pain or arthritis, including gold therapy
• An mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus; medicines used to treat certain types of cancer or to prevent the immune system from rejecting a transplanted organ). See also information under “Warnings and precautions”
• A medicine containing a neprilysin inhibitor such as sacubitril (available in a fixed-dose combination with valsartan), racecadotril, or vildagliptin. These may increase the risk of angioedema (swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing). See also information in sections “Do not take Enalapril Viatris” and “Warnings and precautions”
• Non-steroidal anti-inflammatory drugs, 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 unsure whether any of the above apply to you, consult your doctor or pharmacist before taking Enalapril Viatris.

Taking Enalapril Viatris with food, drinks, and alcohol

Drinking alcohol while taking enalapril maleate may cause your blood pressure to drop too much, leading to dizziness, lightheadedness, or fainting. You should keep your alcohol consumption to a minimum.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine. Your doctor will usually advise you to stop taking enalapril maleate before becoming pregnant, or as soon as you know you are pregnant, and will recommend an alternative medicine. This medicine is not recommended during early pregnancy and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby when used from that stage.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. The use of this medicine is not recommended during breastfeeding of newborns (first weeks after birth), and especially in premature infants. For older children, 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 occurs, do not drive or operate tools or machinery.

Enalapril Viatris contains lactose

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

Enalapril Viatris contains sodium

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

3. How to take Enalapril Viatris

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

Taking the medicine

• It is very important that you continue taking this medicine for as long as your doctor has prescribed it.
• Do not take more tablets than those prescribed for you.
• The score line is intended only for breaking the tablet if you find it difficult to swallow whole.

Hypertension

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

Heart failure

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

Patients with kidney problems

Your medication dose will change depending on how well your kidneys are functioning:

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

Elderly patients

Your doctor will decide the appropriate dose based on kidney function.

Use in children

Experience with 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. Usual initial doses are:

• between 20 kg and 50 kg – 2.5 mg daily
• over 50 kg – 5 mg daily.

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

• a maximum of 20 mg daily may be used in children weighing between 20 kg and 50 kg
• a maximum of 40 mg daily may be used in children weighing over 50 kg.

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

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

If you take more Enalapril Viatris than you should

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

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

If you forget to take Enalapril Viatris

If you forget to take a dose, do not take the missed 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 this medicine unless your doctor tells you to.

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 everybody will experience them. The reported adverse effects are as follows:

Stop taking enalapril maleate immediately and seek advice from your doctor if you experience any of the following:

• swelling of the face, lips, tongue or throat causing difficulty breathing or swallowing
• swelling of the hands, feet or ankles
• red rash on the skin with swelling (hives).

Please note that patients of black African or Caribbean origin have a higher risk of experiencing these types of reactions. If you experience any of the above reactions, stop taking enalapril and speak 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 drop in your blood pressure. These symptoms usually improve as you continue taking the medicine. If you are concerned, please speak to your doctor.

Other adverse effects include:

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

• feeling unwell (nausea), dizziness, weakness
• blurred vision
• cough.

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• flushing
• sudden drop in blood pressure
• rapid and irregular heartbeat (palpitations)
• myocardial infarction (possibly due to very low blood pressure in certain high-risk patients, including those with impaired blood flow to the heart or brain)
• stroke (possibly due to very low blood pressure in high-risk patients)
• anaemia (including aplastic and haemolytic anaemia)
• confusion, drowsiness or inability to sleep, restlessness
• itching or numbness of the skin
• vertigo (dizziness)
• ringing in the ears (tinnitus)
• runny nose, sore throat or hoarseness
• asthma-related chest tightness
• slow movement of food through the intestine (ileus), inflammation of the pancreas
• 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
• elevated levels of protein in the urine (detected in urine tests)
• low blood sugar or sodium levels, elevated blood urea levels (all detected in blood tests).

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 reduced blood flow
• changes in blood values such as reduced numbers of white or red blood cells, reduced haemoglobin levels, reduced platelet count
• bone marrow depression
• swollen glands in the neck, armpits or groin
• autoimmune diseases
• sleep disturbances or insomnia
• accumulation of fluid or other substances in the lungs (as seen on X-rays)
• inflammation of the nose
• inflammation of the lungs causing breathing difficulties (pneumonitis)
• inflammation of the cheeks, gums, tongue, lips, throat
• reduced urine output
• target-shaped rash (erythema multiforme)
• “Stevens-Johnson syndrome” and “toxic epidermal necrolysis” (serious skin disorders in which you develop red, peeling skin, blisters or open sores)
• exfoliative dermatitis/erythroderma (severe skin rash with peeling or shedding of the skin), pemphigus (small fluid-filled blisters on the skin)
• liver or gallbladder problems such as reduced liver function, liver inflammation, jaundice (yellowing of the skin or eyes), elevated liver enzymes or bilirubin levels (detected in blood tests)
• breast enlargement in men (gynaecomastia).

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

• swelling in the intestine (intestinal angioedema).

Frequency not known (frequency cannot be estimated from available data)

• excessive production of antidiuretic hormone, leading to fluid retention and causing weakness, tiredness or confusion
• a symptomatic complex has been reported which may include all or some of the following symptoms: fever, inflammation of blood vessels (serositis, vasculitis), muscle pain (myalgia, myositis), joint pain (arthralgia, arthritis). Skin rash, photosensitivity and other skin effects may also occur.
• Psoriasis or worsening of psoriasis (a skin disease causing red, scaly lesions, typically on elbows, knees, trunk and scalp).

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish System for Pharmacovigilance of 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 Enalapril Viatris

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 the tablets to another container, as they may become mixed up.

Do not use this medicine after the expiry date stated on the blister and outer packaging following 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 containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to 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 Enalapril Viatris

• The active substance is enalapril maleate. Each tablet contains 20 mg of enalapril maleate.
• The other components 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 brown iron oxide (E-172).

Appearance of the medicinal product and contents of the pack

Enalapril Viatris is presented as peach-colored, arched triangular tablets, with the embossed inscription “20” and “G” on one side 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 pack sizes:

Blister packs contained in cardboard cartons 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 safety cap containing 10, 11, 14, 20, 28, 30, 50, 56, 60, 84, 90, 100, 250, 500 tablets.

Only certain 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product 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 Viatris 20 mg tabletten
Portugal: Maleato de Enalapril Mylan 20 mg tablets

Date of the most recent review of this leaflet: February 2026

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