Package Insert: Information for the User

Enalapril Viatris 5 mg Tablets EFG

enalapril maleate

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 refer to 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 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.

Enalapril Viatriscontains an active ingredient called enalapril maleate. It belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors).

Enalapril Viatris is used for:

• To lower high blood pressure (hypertension).
• To treat heart failure (weakening of the heart function). It may reduce the need for hospital visits and may help some patients live longer.
• To prevent signs of heart failure. The signs include: difficulty breathing, fatigue 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 one hour and the effect lasts for at least 24 hours. Some people may need several weeks of treatment before they notice the effect on their blood pressure.

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 medicines as enalapril (ACE inhibitors).
• If you have ever had swelling of the face, lips, mouth, tongue or throat that caused difficulty swallowing or breathing (angioedema), even if 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 best to avoid taking enalapril maleate during the first months of pregnancy - see the pregnancy section).
• If you have diabetes or kidney problems and are being treated with a blood pressure medicine that contains aliskirén.
• If you have taken or are currently taking sacubitril/valsartán, 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 circumstances apply to you. If you are unsure, 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 white blood cell count (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 low-salt diet, take potassium supplements, salt substitutes that contain potassium, or other medicines that may increase blood potassium levels (for example, heparin [a medicine used to prevent blood clots], medicines with trimetoprima such as cotrimoxazol [medicines used to treat infections]). These may lead to high blood potassium levels, which can be serious. Your doctor may need to adjust the dose of Enalapril Viatris or monitor your blood potassium levels. 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 blood potassium levels may also increase.
• You have had an allergic reaction with swelling in the face, lips, tongue, or throat that caused 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 dizziness or lightheadedness, especially when standing up).
• You have a disease called vascular collagen disease (for example, lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with medicines that suppress your immune system, are taking alopurinol 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 (for example, temsirolimus, sirolimus, everolimus).
• Vildagliptina, 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) (also known as “sartanes” - for example, valsartán, telmisartán, irbesartán, etc.), particularly if you have kidney problems related to diabetes.
• Aliskirén.

Your doctor may need to monitor 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 should inform your doctor if you think you may be pregnant (or are going to be). This medicine is not recommended at the start of pregnancy and should not be administered if you are more than 3 months pregnant, as it may cause serious harm to your baby when administered from that point onwards (see the pregnancy section).

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

If you are to undergo a procedure

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

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

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

Children and adolescents

The 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 infants or children with reduced kidney function.

Other medicines and Enalapril Viatris

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. This includes medicines made from plants. This is because Enalapril Viatris may affect how other medicines work. In addition, other medicines may also affect the action of enalapril maleate. Your doctor may need to modify your dose and/or take other precautions.

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

• A receptor antagonist of angiotensin II (ARA II) or aliskirén (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 diuretics
• Potassium supplements (including salt substitutes), diuretics that spare potassium, and other medicines that may increase blood potassium levels (for example, trimetoprim and cotrimoxazol, for bacterial infections; ciclosporina, an immunosuppressant medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent blood clots). See also the information under “Warnings and precautions”
• Medicines for diabetes (including oral antidiabetic medicines and insulin)
• Lithium (a medicine used to treat certain types of depression)
• Tricyclic antidepressants
• Antipsychotic medicines
• 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
• An mTOR inhibitor (for example, temsirolimus, sirolimus, everolimus; medicines used to treat certain types of cancer or to prevent organ transplant rejection). See also the information under “Warnings and precautions”
• A medicine that contains a neprilysin inhibitor such as sacubitril (available in a fixed-dose combination with valsartán), racecadotril, or vildagliptina. It may increase the risk of angioedema (swelling of the face, lips, tongue, or throat that causes difficulty swallowing or breathing). See also the information in the sections “Do not take Enalapril Viatris” and “Warnings and precautions”
• Nonsteroidal 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 unsure whether any of the above circumstances apply to you, consult your doctor or pharmacist before taking Enalapril Viatris.

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 consumption 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, or think you may be pregnant (or are going to be), consult your doctor or pharmacist before taking this medicine. Your doctor will usually recommend that you stop taking enalapril maleate before becoming pregnant, or as soon as you know you are pregnant, and recommend that you take another medicine instead of enalapril maleate. This medicine is not recommended at the start of pregnancy and should not be administered if you are more than 3 months pregnant, as it may cause serious harm to your baby when administered from that point onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or are going to start breastfeeding. This medicine is not recommended for newborns (first weeks after birth) and, especially, for 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 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; it is essentially “sodium-free”.

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

Medication intake

• It is very important that you continue taking this medication for the time your doctor prescribes.
• Do not take more tablets than those prescribed to you.
• The groove is only for breaking the tablet if it is difficult for you to swallow it whole.

Hypertension

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

Heart failure

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

Patients with kidney problems

Yourmedicationdose will changedependingon how well your kidneys are functioning:

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

Older patients

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

Use in children

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

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

The dose can be changed as needed:

• a maximum of 20 mg per day can be used in children weighing between 20 kg and 50 kg
• a maximum of 40 mg per day can be used in children weighing over 50 kg.

This medication is not recommended for newborns (first weeks after birth) or children with kidney problems.

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

If you take more Enalapril Viatristhan you should

If you take more enalapril than you should, consult your doctor or go to the hospital immediately. Bring the medication packaging with you. The following effects may occur: a 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 Toxicological Information Service. Phone: 91 562 04 20.

If you forgot to take EnalaprilViatris

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

Take the next dose as usual.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Enalapril Viatris

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

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. The reported side effects are as follows:

Stop taking enalapril maleate immediately and consult your doctor in any of the following cases:

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

It is essential to note that patients of black race have a higher risk of experiencing this type of reaction. If you experience any of the above reactions, stop taking enalapril and speak with your doctor immediately.

When you start taking this medication, you may feel a loss of consciousness or feel 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 medication. If you are concerned, please speak with your doctor.

Other side effects include:

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

Common(may affect up to 1 in 10 people)

Rare(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)

Unknown frequency(the frequency cannot be estimated from available data)

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 Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

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

Do not store at a temperature above 25°C. Store in the original packaging.

Do not place the tablets in another container, as they may become mixed.

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

Medications should not be disposed of through drains or in the trash. Dispose of the 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.

Composition ofEnalaprilViatris

• The active ingredient is enalapril maleate. Each tablet contains 5 mg of enalapril maleate.
• The other components are: sodium hydrogen carbonate (E-500), pregelatinized cornstarch, cornstarch, lactose monohydrate (see section 2, “Enalapril Viatris contains lactose”) and magnesium stearate (E-572).

Appearance of the product and contents of the package

Enalapril Viatris is presented in the form of white, triangular-arched tablets, with the inscription in relief “5” and “G” on one face and a groove 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 pack), 50, 56, 60, 84, 90, 98, 100, 250, 500 tablets.

Flasks with desiccant and safety-capped stoppers containing 10, 11, 14, 20, 28, 30, 50, 56, 60, 84, 90, 100, 250, 500 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible 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

Further information about this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

SpainEnalapril Viatris 5 mg tablets EFG

NetherlandsEnalapril Maleaat Mylan 5 mg tablets

PortugalMaleato de Enalapril Mylan 5 mg tablets

Last review date of this leaflet:October 2022

For detailed and updated information about this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/