ENALAPRIL VIR 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Enalapril Vir 5 mg Tablets EFG

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

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

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

Enalapril Vir is used for:

• Treating high blood pressure (hypertension).
• Treating heart failure (weakening of the heart's function). It can reduce the need for hospitalization and may help some patients live longer.
• Preventing signs of heart failure. These 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. The medicine usually 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 full effect on blood pressure is seen.

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

Do not takeEnalapril Vir:

• If you are allergic to enalapril or any of the other ingredients of this medicine (listed in section 6).
• If you have previously been treated with a medicine from the same group of medicines as enalapril (ACE inhibitors) and have had allergic reactions with swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing.
• If you have ever had swelling of the face, lips, mouth, tongue, or throat that caused difficulty swallowing or breathing (angioedema) for unknown reasons or due to heredity.

• 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 areas such as the throat) is high.
• If you have diabetes or kidney problems and are being treated with a blood pressure medicine that contains aliskiren.
• If you are more than 3 months pregnant. (It is also best to avoid Enalapril Vir at the start of pregnancy - see section Pregnancy).

Do not take this medicine if any of the above applies to you. If you are not sure, 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 or absent white blood cells (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, which can be serious. Your doctor may need to adjust your dose of Enalapril or monitor your potassium levels in your blood.
• If you are on dialysis.
• If you have recently had severe vomiting (excessive vomiting) or severe diarrhea.
• If you are on a low-salt diet, taking potassium supplements, potassium-sparing diuretics, 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 sugar levels, especially during the first month of treatment. Your potassium level in your 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 black patients have a higher risk of these reactions to ACE inhibitors.
• If you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) may increase:

• 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 this as dizziness or lightheadedness, especially when standing up).
• If you have a disease of the blood vessels in the skin (e.g., lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with medicines that suppress your immune system, or are taking the medicines 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) or aliskiren (see also the information under the headings “Do not take Enalapril Vir” and “Warnings and precautions”).
• Other medicines to reduce blood pressure, such as beta-blockers, angiotensin receptor antagonists, water pills (diuretics).

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 Enalapril Vir”.

You should inform your doctor if you think you are pregnant (or might be). This medicine is not recommended during the first trimester of 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 during this stage (see section Pregnancy).

You should be aware that this medicine reduces blood pressure in black patients less effectively than in non-black patients.

If you are not sure if any of the above applies 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 going to receive anesthetics (even at the dentist).
• A treatment to remove cholesterol from your blood called “LDL apheresis”.
• A desensitization treatment to reduce the effect of an allergy to bee or wasp stings.

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

Taking Enalapril Vir with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes herbal treatments. This is because Enalapril may affect the way other medicines work. Other medicines may also affect how Enalapril works. Your doctor may need to change 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) or aliskiren (see also the information under the headings “Do not take Enalapril Vir” and “Warnings and precautions”).
• Other medicines to reduce blood pressure, such as beta-blockers, angiotensin receptor antagonists, water pills (diuretics).
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in your blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporin, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots).
• Medicines for diabetes (including oral antidiabetic medicines and insulin).
• Lithium (a medicine used to treat certain types of depression).
• Medicines for depression called “tricyclic antidepressants”.
• Medicines for mental problems called “antipsychotics”.
• Certain medicines for coughs and colds and weight loss medicines that contain a substance called “sympathomimetic medicine”.
• Certain medicines for pain or arthritis, including gold treatment.
• 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).
• Alcohol.

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

Taking Enalapril Vir with food and drinks:

Food does not affect the absorption of Enalapril Vir.

Alcohol enhances the blood-pressure-lowering effect of enalapril, therefore, inform your doctor if you are taking alcoholic beverages while being treated with this medicine.

Pregnancy, breast-feeding, and fertility:

Consult your doctor or pharmacist before using a medicine.

You should inform your doctor if you think you are pregnant (or might be). Normally, your doctor will advise you to stop taking Enalapril Vir before you become 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 during the first trimester of 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.

Inform your doctor if you are breast-feeding or about to start breast-feeding. While taking Enalapril Vir, breast-feeding is not recommended in newborns (first few 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 breast-feeding.

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

Enalapril Vir contains Orange Yellow S (E-110).

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

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

3. How to take Enalapril Vir

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

• It is very important that you keep taking this medicine for the time your doctor has prescribed it.
• Do not take more tablets than you have been prescribed.

High blood pressure

• The usual initial dose is between 5 and 20 mg, taken once a day.
• Some patients may need a lower initial dose.
• The usual long-term dose is 20 mg taken once a day.
• The maximum long-term dose is 40 mg taken once a day.

Heart failure

• The usual initial dose is 2.5 mg, taken once a day.
• Your doctor will gradually increase this amount until the suitable dose for you is reached.
• The usual long-term dose is 20 mg per day, taken in one or two doses.
• The maximum long-term dose is 40 mg per day, divided into two doses.

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

Patients over 70 years old

Your doctor will decide on the dose and will be based on how well your kidneys are working.

Children

Experience with the use of Enalapril Vir 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.
• More than 50 kg - 5 mg per day.

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

• A maximum of 20 mg per day can be used in children who weigh between 20 kg and 50 kg.
• A maximum of 40 mg per 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.

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. 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, consult the Toxicology Information Service. Telephone: 91 562 04 20.

If you forget to take Enalapril Vir

• 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 Vir

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.

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 can cause difficulty swallowing or breathing.
• Swelling of your hands, feet, or ankles.
• If you develop a 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 Vir and talk to your doctor immediately.

When you start taking this medicine, you may feel faint or dizzy. If this happens, lying down can 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)

• Feeling of 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 angina.
• Headache, fainting (syncope).
• Taste disorder, 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.
• High levels of potassium in the blood, high levels of creatinine in the blood (usually both are detected in an analysis).

Uncommon(may affect up to 1 in 100 people)

• Sudden drop in blood pressure.
• Rapid and arrhythmic heartbeats (palpitations).
• Myocardial infarction (possibly due to very low blood pressure in certain high-risk patients, even those with alterations in heart or brain blood flow).
• Anemia (including aplastic and hemolytic anemia).
• Stroke (possibly due to very low blood pressure in high-risk patients).
• Confusion, drowsiness, or inability to sleep, nervousness.
• Feeling of itching or numbness in the skin.
• Dizziness.
• Noises in the ears (tinnitus).
• Rhinitis, sore throat, or hoarseness.
• Asthma.
• Slow movement of food through the intestine, pancreatitis.
• Vomiting, indigestion, constipation, anorexia.
• Irritated stomach (gastric irritation), dry mouth, ulcer, reduced kidney function, kidney failure.
• Increased sweating.
• Itching or hives.
• Hair loss.
• Muscle cramps, flushing, indisposition (general malaise), elevated temperature (fever), impotence.
• High levels of protein in the urine (determined in an analysis).
• Low levels of sugar or sodium in the blood, high levels of urea 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 can 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.
• Autoimmune diseases.
• Sleep disorders or sleep problems.
• Pulmonary infiltrates.
• Nasal inflammation.
• Pneumonia.
• Inflammation of the cheeks, gums, tongue, lips, throat.
• Reduced amount of urine produced.
• Erythema multiforme.
• "Stevens-Johnson syndrome", a severe skin disorder in which you have red and scaly skin, ulcers with blisters or open sores, or peeling of the top layer of skin from the underlying layers.
• Liver problems such as reduced liver function, liver inflammation, jaundice (yellowing of the skin or eyes), elevated liver enzymes or bilirubin levels (determined in an analysis).
• Enlargement of the breasts in men.

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

• Swelling in the intestine (intestinal angioedema).

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines. Website: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Enalapril Vir

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

Store in the original package. Store protected from moisture.

Expiry Date:

Do not use this medicine after the expiry date stated on the package. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packages and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

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 sodium bicarbonate (sodium hydrogen carbonate), lactose, cornstarch, sodium carboxymethylcellulose (type A) (derived from potato starch), magnesium stearate, orange yellow S (E-110).

Appearance of the Product and Package Contents

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.

Marketing Authorization Holder and Manufacturer

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Date of the Last Revision of this Prospectus: October 2019

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