Prospect: information for the user

Enalapril Vir 5 mg tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribedonlyto you,and you must not give it to others even iftheyhavethe same symptomsas you, as it may harm them.

• Ifyou experienceadverse effects, consult your doctor or pharmacist, eveniftheyare not listed in this prospect. See section 4.

Enalapril Virbelongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors).

Enalapril Viris indicated for:

• Treating high blood pressure (hypertension).
• Treating heart failure(weakening of the heart function). It may reduce the need for hospitalization and may help some patients live longer.
• Preventing signs of heart failure. The signs include: difficulty breathing, fatigue after light physical activity such as walking, and 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 greatest effect on their blood pressure.

Do not takeEnalapril Vir:

• If you are allergic to enalapril or any of the other ingredients in this medicine (see section 6).
• If you have had a reaction to a similar medicine (ACE inhibitors) in the past and have had swelling of the face, lips, tongue, or throat, difficulty swallowing or breathing.
• If you have ever had swelling of the face, lips, mouth, tongue, or throat that caused difficulty swallowing or breathing, and the cause was unknown or hereditary.

• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (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 have diabetes or kidney failure and are being treated with a medicine to lower blood pressure that contains aliskiren.
• If you are more than 3 months pregnant. (It is also best to avoid Enalapril Vir at the beginning of pregnancy - see Pregnancy section).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Enalapril Vir

• If you have a heart problem.
• If you have a disease that affects the blood vessels in the brain.
• If you have blood disorders such as low white blood cell count (neutropenia/agranulocytosis), low platelet count (thrombocytopenia), or low red blood cell count (anemia).
• If you have a liver problem.
• If you have a kidney problem (including kidney transplant). This may cause high levels of potassium in your blood that can be serious. Your doctor may need to adjust your Enalapril dose or monitor your potassium levels in the blood.
• If you are undergoing dialysis.
• If you have had many vomiting episodes (excessive vomiting) or have had intense diarrhea recently
• If you are following a low-sodium diet, taking potassium supplements, potassium-sparing medicines, or salt substitutes that contain potassium.
• If you are over 70 years old.
• If you have diabetes. You should monitor your blood for low blood glucose levels, especially during the first month of treatment. Your potassium levels in the blood may also be higher.
• If you have ever had an allergic reaction with swelling of the face, lips, tongue, or throat, with difficulty swallowing or breathing. You should be aware that patients of black race have a higher risk of suffering this type of reaction to ACE inhibitors.
• If you are taking any of the following medicines, the risk of angioedema may increase (rapid swelling under the skin in areas such as the throat):

− Racecadotril (a medicine used to treat diarrhea),

• Medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus)

− Vildagliptin (a medicine used to treat diabetes).

• If you have low blood pressure (you may notice it as dizziness or lightheadedness, especially when standing up).
• If you have a disease that affects the blood vessels (e.g., 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.
• If you are taking any of the following medicines used to treat high blood pressure (hypertension):

• An angiotensin II receptor antagonist (ARA) (also known as "sartanes" - for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
• Aliskiren.

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

See also the information under the heading “Do not take Enalapril Vir”.

You should inform your doctor if you think you may be pregnant (or could be). Enalapril Vir is not recommended at the beginning of pregnancy and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at this stage (see Pregnancy section).

You should be aware that this medicine reduces blood pressure in black patients less effectively than in patients who are not black.

If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before starting to take this medicine.

If you are about to undergo a procedure

If you are about 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's office).
• A treatment to remove cholesterol from your blood called “LDL apheresis”.
• A desensitization treatment to reduce the effect of an allergy to a bee or wasp sting.

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

Taking Enalapril Vir with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. This includes herbal remedies. This is because Enalapril may affect how other medicines work. Other medicines may also affect how Enalapril works. Your doctor may need to adjust your dose and/or take other precautions.

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

• An angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not take Enalapril Vir” and “Warnings and precautions”).
• Other medicines to lower blood pressure, such as beta-blockers, angiotensin receptor antagonists, diuretics.
• Potassium supplements (including salt substitutes), diuretics that spare potassium, and other medicines that may increase the amount of potassium in the blood (e.g., trimethoprim and co-trimoxazole for bacterial infections; ciclosporin, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots).
• Diabetes medicines (including oral antidiabetic medicines and insulin).
• Lithium (a medicine used to treat a certain type of depression).
• Tricyclic antidepressants.
• Antipsychotic medicines.
• Certain medicines for coughs and colds and weight loss medicines that contain a substance called “sympathomimetic”.
• Certain medicines for pain or arthritis, including gold treatment
• Nonsteroidal anti-inflammatory drugs, including COX-2 inhibitors (medicines that reduce inflammation and may be used to help you relieve pain).
• Aspirin (acetylsalicylic acid).
• Medicines used to dissolve blood clots (thrombolytics).
• Alcohol.

If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before starting to take Enalapril.

Taking Enalapril Vir with food and drink:

Foods do not affect the absorption of Enalapril Vir.

Alcohol potentiates the hypotensive effect (reduction of blood pressure) of enalapril, so inform your doctor if you are taking beverages that contain alcohol while you are being treated with this medicine.

Pregnancy, breastfeeding, and fertility:

Consult your doctor or pharmacist before using a medicine.

You should inform your doctor if you think you may be pregnant (or could be). Normally, your doctor will advise you to stop taking Enalapril Vir before becoming pregnant or as soon as you know you are pregnant and will advise you to take a different medicine instead of Enalapril Vir. Enalapril Vir is not recommended at the beginning of pregnancy and should 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.

Inform your doctor if you are breastfeeding or are about to start breastfeeding. While taking Enalapril Vir, it is not recommended to breastfeed in newborns (first weeks after birth), and especially in premature babies. In the case of an older baby, your doctor should advise you on the benefits and risks of taking Enalapril Vir, compared to other treatments, while breastfeeding.

Driving and operating machinery:

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

use tools or machines.

Enalapril Vir contains lactose.If your doctor has told you that you have a intolerance to certain sugars, consult with him before taking this medicine.

Enalapril Vir contains Yellow Iron Oxide (E-110).

This medicine may cause allergic reactions because it contains Yellow Iron Oxide (E-110).

It may cause asthma, especially in patients allergic to acetylsalicylic acid.

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

• 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.

Hypertension

• The usual initial dose varies between 5 and 20 mg, administered once a day.

• Some patients may need a lower initial dose.

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

• The maximum long-term dose is 40 mg administered once a day.

Heart failure

• The usual initial dose is 2.5 mg, administered once a day.

• Your doctor will gradually increase this amount until the appropriate dose for you is reached.

• The usual long-term dose is 20 mg per day, administered in one or two doses.

• The maximum long-term dose is 40 mg per day, divided into two 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 per day.

• Severe kidney problems - 2.5 mg per day.

• If you are undergoing dialysis - 2.5 mg per day. On the days you are not undergoing dialysis, your dose may change depending on how low your blood pressure is.

Older patients

Your doctor will decide the dose and will base it on how well your kidneys are functioning.

Children

The experience with the use of Enalapril Vir in children with hypertension 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.

• More than 50 kg - 5 mg per day.

The dose may be adjusted as needed:

• A maximum of 20 mg per day may be used in children weighing between 20 kg and 50 kg.

• A maximum of 40 mg per day may be used in children weighing more than 50 kg.

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

If you take more Enalapril Vir than you should

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

If you forget to take Enalapril Vir

• 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 make up for the missed doses.

If you interrupt treatment with Enalapril Vir

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following symptoms, stop taking Enalapril Vir and talk to your doctor immediately:

• Swelling of the face, lips, tongue, or throat that may cause difficulty swallowing or breathing.

• Swelling of your hands, feet, or ankles.

• If you develop a red rash on your skin with swelling (hives).

You should be aware that patients of black race have a higher risk of experiencing this type of reaction. If you experience any of the previous reactions, stop taking Enalapril Vir and talk to your doctor immediately.

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

Other side effects include:

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

• Dizziness, weakness, or vomiting.

• Blurred vision.

• Cough.

Common(may affect up to 1 in 10 people)

• Low blood pressure, changes in heart rhythm, rapid heartbeats, chest pain, or chest discomfort.

• Headache, fainting (syncope).

• Taste disturbance, difficulty breathing.

• Diarrhea or abdominal pain, rash.

• Fatigue, depression.

• Allergic reactions with swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing.

• Elevated potassium levels in the blood, elevated creatinine levels in the blood (usually both are detected in a blood test).

Uncommon(may affect up to 1 in 100 people)

• 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 alterations in blood flow to the heart or brain).

• Anemia (including aplastic and hemolytic anemia).

• Cerebrovascular accident (possibly due to very low blood pressure in high-risk patients).

• Confusion, drowsiness, or inability to sleep, nervousness.

• Sensation of itching or numbness in your skin.

• Dizziness.

• Ringing in the ears (tinnitus).

• Runny nose, sore throat, or hoarseness.

• Asthma.

• Slow movement of food through your intestine, pancreatitis.

• Vomiting, indigestion, constipation, anorexia.

• Irritated stomach (gastritis), dry mouth, ulcers, reduced kidney function, renal failure

• Increased sweating.

• Itching or urticaria.

• Hair loss.

• Muscle cramps, redness, general malaise, elevated temperature (fever), impotence.

• Elevated protein levels in your urine (determined in a blood test).

• Low blood sugar or sodium levels, elevated 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 blood cells or red blood cells, lower hemoglobin levels, lower platelet count in the blood.

• Bone marrow depression.

• Autoimmune diseases.

• Sleep disturbances or sleep problems.

• Pulmonary infiltrates.

• Nasal inflammation.

• Pneumonia.

• Inflammation of the cheeks, gums, tongue, lips, throat.

• Reduced urine production.

• Erythema multiforme.

• “Stevens-Johnson syndrome”, a severe skin disorder in which you have red skin, peeling skin, ulcers with vesicles, or open ulcers or shedding of the top layer of the skin from the lower layers.

• Liver problems such as reduced liver function, liver inflammation, jaundice (yellow skin or eyes), elevated liver enzymes or bilirubin levels (determined in a blood test).

• Enlarged breasts in men.

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

• Swelling in your intestine (intestinal angioedema).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano. Website:www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Store in the original packaging. Store protected from moisture.

Expiration Date:

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

Medications should not be disposed of through drains or trash.Deposit empty containers and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.

Composition of Enalapril Vir

The active ingredient is enalapril in the form of maleate. Each tablet contains 5 mg of enalapril.

The other components (excipients): are bicarbonate of soda (sodium hydrogen carbonate), lactose, cornstarch, carboxymethylstarch sodium (type A) (derived from potato starch), magnesium stearate, yellow orange S (E-110).

Appearance of the product and content of the packaging

Enalapril Vir 5 mg is presented in the form of tablets. Each package contains 10 and 60 tablets. The tablets are round, orange, and scored.

Holder of the marketing authorization and responsible for manufacturing

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Last review date of this leaflet: October 2019

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