Enalapril Vir 5 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Enalapril Vir 5 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 you should not give it to others, 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 effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

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

Enalapril Vir is indicated for:

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

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

2. What you need to know before taking Enalapril Vir

Do not take Enalapril Vir:

• If you are allergic to enalapril or to any of the other components of this medicine (listed in section 6).

• If you have previously been treated with a medicine from the same group as enalapril (ACE inhibitors) and experienced allergic reactions with swelling of the face, lips, tongue, and/or throat, causing 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), when 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 beneath the skin, such as in the throat) is high.

• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

• If you are more than 3 months pregnant. (Enalapril Vir should also be avoided in early 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 this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting Enalapril Vir if:

• You have a heart condition.

• You have a disease affecting the blood vessels in the brain.

• You have blood disorders such as low levels or absence of white blood cells (neutropenia/agranulocytosis), low platelet count (thrombocytopenia), or low red blood cell count (anemia).

• You have a liver problem.

• You have a kidney problem (including after kidney transplant). This may lead to high levels of potassium in your blood, which can be serious. Your doctor may need to adjust your dose of Enalapril or monitor your blood potassium levels.

• You are undergoing dialysis.

• You have recently experienced excessive vomiting or severe diarrhea.

• You are on a salt-free diet, taking potassium supplements, potassium-sparing medicines, or salt substitutes containing potassium.

• You are over 70 years old.

• You have diabetes. You should monitor your blood for low blood glucose levels, especially during the first month of treatment. Your blood potassium levels may also be higher.

• You have ever had an allergic reaction with swelling of the face, lips, tongue, or throat causing difficulty swallowing or breathing. Please note that black patients have a higher risk of such reactions to ACE inhibitors.

• You are taking any of the following medicines, as the risk of angioedema (rapid swelling beneath the skin, such as in 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 feel faint or dizzy, especially when standing up).
  • If you have a vascular collagen disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with immunosuppressive medicines, or are taking allopurinol, procainamide, or any combination of these.
  • If you are taking any of the following medicines for high blood pressure (hypertension):

• An angiotensin II receptor antagonist (ARA) (also known as "sartans" – e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.

• Aliskiren.

Your doctor may regularly monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium).

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

You should inform your doctor if you think you are pregnant (or could be). This medicine is not recommended during early pregnancy and must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used at this stage (see section Pregnancy).

Please note that this medicine is less effective in lowering blood pressure in black patients compared to non-black patients.

If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before starting 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 (including 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 apply 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 need to take any other medicines. This includes herbal treatments. 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.

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 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 blockers, or diuretics ("water pills").
• Potassium supplements (including potassium-containing salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, 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 a certain type of depression).
• Medicines for depression called “tricyclic antidepressants”.
• Medicines for mental disorders called “antipsychotics”.
• Certain cough and cold medicines and weight-reduction medicines containing a substance called “sympathomimetic medicine”.
• Certain pain or arthritis medicines, including gold therapy.
• Non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (medicines that reduce inflammation and may help relieve pain).
• Aspirin (acetylsalicylic acid).
• Medicines used to dissolve blood clots (thrombolytics).
• Alcohol.

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

Taking Enalapril Vir with food and drink:

Food does not affect the absorption of Enalapril Vir.

Alcohol enhances the blood pressure-lowering effect (hypotensive effect) of enalapril. Therefore, inform your doctor if you are consuming alcoholic beverages while taking this medicine.

Pregnancy, breastfeeding, and fertility:

Consult your doctor or pharmacist before using any medicine.

Inform your doctor if you think you are pregnant (or could be). Your doctor will usually advise you to stop taking Enalapril Vir before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Enalapril Vir is not recommended in early pregnancy and must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onwards.

Inform your doctor if you are breastfeeding or planning to breastfeed. Breastfeeding is not recommended in newborns (first weeks after birth) while taking Enalapril Vir, and especially in premature infants. For older infants, your doctor should advise you on the benefits and risks of taking Enalapril Vir compared to other treatments while breastfeeding.

Driving and using machines:

This medicine may cause dizziness or drowsiness. If this occurs, do not drive or

use tools or machinery.

Enalapril Vir contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

Enalapril Vir contains Sunset Yellow FCF (E-110).

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

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

3. How to take Enalapril Vir

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

• 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 prescribed.

High blood pressure

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

Heart failure

• The usual initial dose is 2.5 mg, taken once daily.
• Your doctor will gradually increase this dose until the appropriate dose for you is reached.
• The usual long-term dose is 20 mg per day, given 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 will depend 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 undergoing dialysis – 2.5 mg per day. On days when dialysis is not performed, your dose may be adjusted depending on how low your blood pressure is.

Elderly patients

Your doctor will determine the dose based on how well your kidneys are functioning.

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. Usual initial doses are:

• Between 20 kg and 50 kg – 2.5 mg per day.
• Over 50 kg – 5 mg per day.

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

• 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 over 50 kg.

This medicine is not recommended for newborn infants (first 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 hospital immediately. Take the medicine 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, contact 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 missed dose.
• Take the next dose at the usual time.
• Do not take a double dose to make up for forgotten doses.

If you stop taking Enalapril Vir

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 everyone will experience them.

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

• Swelling of the face, lips, tongue or throat which may cause difficulty swallowing or breathing.
• Swelling of your hands, feet or ankles.
• If you develop a red rash on the skin with swelling (wheals).

Please be aware that patients of black race have a higher risk of experiencing these types of reactions. If you experience any of the above reactions, stop taking Enalapril Vir 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 decrease in your blood pressure. This will 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 dizzy, weak, or nauseous.
• Blurred vision.
• Cough.

Common (may affect up to 1 in 10 people)

• Low blood pressure, changes in heart rate, rapid heartbeat, angina or chest pain.
• Headache, fainting (syncope).
• Taste disturbances, difficulty breathing.
• Diarrhea or abdominal pain, rash.
• Tiredness (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 your blood (both are usually detected in a blood test).

Uncommon (may affect up to 1 in 100 people)

• 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).
• Anaemia (including aplastic and haemolytic anaemia).
• Stroke (possibly due to very low blood pressure in high-risk patients).
• Confusion, drowsiness or inability to sleep, nervousness.
• Itching or numbness sensation in your skin.
• Dizziness.
• Ringing in the ears (tinnitus).
• Runny nose, sore throat or hoarseness.
• Asthma.
• Slow movement of food through your intestine, inflammation of the pancreas.
• 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, malaise (general discomfort), high temperature (fever), impotence.
• High levels of protein in your urine (detected in a test).
• Low blood sugar or sodium levels, high blood urea levels (all detected 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 poor blood flow.
• Changes in blood values such as reduced numbers of white or red blood cells, reduced haemoglobin levels, reduced number of platelets in the blood.
• Bone marrow depression.
• Autoimmune diseases.
• Sleep disturbances or sleep problems.
• Pulmonary infiltrates.
• Inflammation of the nose.
• Pneumonia.
• Inflammation of the cheeks, gums, tongue, lips, throat.
• Reduced amount of urine produced.
• Erythema multiforme.
• "Stevens-Johnson syndrome", a serious skin disorder in which you have red, peeling skin, blistering ulcers or open sores, or separation 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 (detected in a blood test).
• Breast enlargement in men.

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

• Swelling in your intestine (intestinal angioedema).

Reporting of adverse effects

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

5. Storage of Enalapril Vir

Keep this medicine out of sight and reach of children.

Store in the original container. Keep protected from moisture.

Expiry:

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Enalapril Vir

The active substance 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, corn starch, sodium carboxymethyl starch (type A) (derived from potato starch), magnesium stearate, sunset yellow S (E-110).

Appearance of the product and contents of the pack

Enalapril Vir 5 mg is presented as tablets. Each pack contains 10 or 60 tablets. The tablets are round, orange-colored 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 most recent review of this leaflet: October 2019

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