Prospect: Information for the user

Enalapril Belmac 20 mg tablets EFG

enalapril maleate

6. Contents of the pack and additional information

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

Enalapril Belmac is indicated for:

• Treating high blood pressure (hypertension).
• Treating symptomatic heart failure.
• Preventing symptomatic heart failure.

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 take Enalapril Belmac

• If you are allergic to enalapril maleate or any of the other components of this medication (including those listed in section 6).
• If you have ever been treated for an allergic reaction to a similar medication to this one, known as an ACE inhibitor.
• 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 hereditary or unknown.
• If you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskiren.
• If you are more than 3 months pregnant. (It is also best to avoid this medication at the beginning of pregnancy - see Pregnancy section).
• If you have taken or are currently taking sacubitril/valsartan, a medication used to treat a type of chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is high.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Enalapril Belmac

• If you have a heart condition.
• If you have a condition 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 liver problems.
• If you have a kidney problem (including kidney transplant), follow a low-sodium diet, are taking potassium supplements, potassium-sparing medications, salt substitutes containing potassium, or other medications that may increase potassium levels in the blood such as heparin (a medication used to prevent blood clots), trimethoprim, or cotrimoxazole (medications used to treat infections). This may cause high potassium levels in the blood that can be serious. Your doctor may need to adjust your enalapril dose or monitor your potassium levels in the blood. See also the information under the heading "Taking Enalapril Belmac with other medications".
• If you are undergoing dialysis.
• If you have had many vomiting episodes (excessive vomiting) or have had intense diarrhea recently.

• If you have diabetes.You must closely monitor your 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 are more sensitive to this type of reaction to ACE inhibitors.
• If you have low blood pressure (you may notice it as dizziness or lightheadedness, especially in the initial doses and when standing).
• If you have collagen vascular disease (e.g. lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with immunosuppressive medications, are taking alopurinol or procainamide, or any combination of these.
• If you are taking any of the following medications, the risk of angioedema may increase:

• racecadotril, a medication used to treat diarrhea.
• medications used to prevent organ transplant rejection and for cancer (e.g., sirolimus, everolimus, temsirolimus)
• vildagliptin, a medication used to treat diabetes.

• If you are taking any of the following medications used to treat high blood pressure:

- 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 renal 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 Belmac".

You should inform your doctor if you think you may be pregnant (or could be). Enalapril Belmac 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 in this stage (see Pregnancy section).

You should be aware that this medication 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 medication.

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 consultation),
• 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 Belmac with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.This includes herbal remedies. This is because enalapril may affect how other medications work and certain medications may also affect how enalapril works. 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 medications:

• An angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings "Do not take Enalapril Belmac" and "Warnings and precautions").
• Other medications to reduce blood pressuresuch as blockers or diuretics.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medications that may increase potassium levels in the blood (e.g. trimethoprim and cotrimoxazole for bacterial infections; ciclosporin, an immunosuppressive medication used to prevent organ transplant rejection; and heparin, a medication used to prevent blood clots). See also the information in the "Warnings and precautions" section.
• Medications for diabetes (including oral antidiabetic medications and insulin).
• Lithium (a medication used to treat certain types of depression).
• Tricyclic antidepressants.
• Antipsychotics.
• Certain medications for coughs and colds and weight loss medications that contain a substance called "sympathomimetic".
• Certain medications for pain or arthritis, including gold treatment.
• An mTOR inhibitor (e.g. temsirolimus, sirolimus, everolimus; medications used to treat certain types of cancer or to prevent organ transplant rejection). See also the information in the "Warnings and precautions" section.
• A medication containing sacubitril/valsartan, racecadotril, or vildagliptin. This may increase the risk of angioedema (swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing). See also "Do not take Enalapril Belmac" and "Warnings and precautions".
• Nonsteroidal anti-inflammatory drugs, including COX-2 inhibitors (medications that reduce inflammation and may be used to help you relieve pain).
• Aspirin (acetylsalicylic acid).
• Medications 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 Belmac with food, drinks, and alcohol

Enalapril can be taken with or without food. Most people take enalapril with a little water.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant (or could be, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

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 before becoming pregnant or as soon as you know you are pregnant and advise you to take a different medication instead of Enalapril Belmac. Enalapril Belmac 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.

Breastfeeding

Inform your doctor if you are breastfeeding or are about to start breastfeeding. While taking enalapril, breastfeeding is not recommended 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 compared to other treatments while breastfeeding.

Driving and operating machinery

You may feel dizzy or drowsy while taking this medication. If this happens, do not drive or use tools or machinery.

Enalapril Belmac contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Follow exactly the administration instructions of this medication as indicated by your doctor. 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.

The recommended dose is:

Hypertension

The initial recommended dose is 5 to 20 mg once a day.

Some patients may need a lower initial dose.

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

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

Heart failure

The usual initial recommended dose is 2.5 mg once a day.

Your doctor will gradually increase the dose until the appropriate dose is reached for your case.

The usual long-term dose is 20 mg per day in one or two doses.The maximum long-term dose is 40 mg once a 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
• 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.

Older patients

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

Use in children

The experience with the use of enalapril 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 pediatric patients with kidney problems.

If you take more Enalapril Belmac than you should

If you take more enalapril than you should, consult your doctor or pharmacist immediately.

Bring the medication packaging with you.

In case of overdose, the most likely symptom is a feeling of dizziness or vertigo 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 20indicating the medication and the amount taken.

If you forget to take Enalapril Belmac

You should continue taking this medication as prescribed. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Enalapril Belmac

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 medicines, this medicine may cause side effects, although not everyone will experience them.

If you experience any of the following symptoms, stop taking this medicine and consult your doctor immediately:

• swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing,
• swelling of the hands, feet, or ankles,
• if you develop a red rash on the skin with swelling (hives).

You should be aware that patients of black race have a higher risk of suffering from this type of reaction. If you experience any of the previous reactions, stop taking it and speak with 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 speak with your doctor.

Other side effects include:

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

• feeling dizzy, weakness, or vomiting
• cough
• blurred vision

Common(may affect up to 1 in 10 people):

• headache, depression, fainting (syncope), alteration of taste
• dizziness due to low blood pressure, chest pain, changes in heart rhythm, angina, rapid heartbeat
• difficulty breathing,
• fatigue (tiredness)
• diarrhea, abdominal pain
• eruption, allergic reactions with swelling of the face, extremities, 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 an analysis).

Uncommon(may affect up to 1 in 100 people):

• rubefaction
• sudden drop in blood pressure
• anemia (including aplastic and hemolytic anemia)
• confusion, drowsiness, or inability to sleep, nervousness
• feeling of itching or numbness on your skin
• dizziness (feeling of dizziness)
• rapid and arrhythmic heartbeat (palpitations)
• heart attack or stroke (possibly due to excessively low blood pressure in high-risk patients,even in thosepatients with alterations in blood flow to the heart and/or brain)
• sneezing, sore throat, or hoarseness
• asthma-associated chest tightness
• slow movement of food through yourintestine (ileus), inflammation of the pancreas
• vomiting, indigestion, constipation, anorexia
• irritated stomach (gastritis), dry mouth, peptic ulcer
• increased sweating

• itching or urticaria
• hair loss
• reduced kidney function, kidney failure
• elevated protein levels in the urine(determined in an analysis)
• impotence
• muscle cramps
• ringing in the ears (tinnitus)
• general feeling of illness, elevated temperature (fever)
• low levels of sugar or sodium in the blood, elevatedurea levels in the blood(all determined in a blood analysis)

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 or red blood cells, lower hemoglobin levels,lower platelet countin the blood
• bone marrow depression
• inflamed glands in the neck, armpits, or groin
• autoimmune diseases
• sleep disturbances or sleep problems
• fluid or other substance accumulationin the lungs(as seen in X-rays),
• inflammation of the nose
• inflammation of the lungs causing difficulty breathing (pneumonia)
• inflammation of the cheeks, gums, tongue, lips, throat
• eruption in the shape of a target (erythema multiforme)
• “Stevens-Johnson syndrome” and “toxic epidermal necrolysis” (a severe skin disorder in which you have red, peeling skin, ulcers with vesicles, or open ulcers), dermatitis exfoliativa/erythroderma (severe skin eruption with peeling or shedding of the skin), pemphigus (small blisters filled with fluid on the skin)
• reduced urine production per day
• enlargement of the breasts in men (gynecomastia)
• liver or bile duct problems such as reduced liver function, inflammation of the liver, jaundice (yellowish color of the skin or eyes), elevated liver enzymes or bilirubin levels (determined in an analysis).

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

• intestinal angioedema (swelling in the intestine)

Frequency unknown(the frequency cannot be estimated from the available data):

• excessive production of the antidiuretic hormone, causing fluid retention, resulting in weakness, fatigue, or confusion

a complex symptom syndrome has been observed that may include any or all of the following symptoms: fever, inflammation of the blood vessels(serositis, vasculitis),muscle pain(myalgia, myositis), joint pain(arthralgia/arthritis). It may causeeruption,photosensitivity, or other skin manifestations.

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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 30 °C. Store in the original packaging.

Do not use this medication after the expiration date indicated on the packaging after CAD. 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 packaging and medications you no longer need 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 of Enalapril Belmac 20 mg tablets

The active ingredient of this medication is enalapril maleate 20 mg. Each tablet contains 20 mg of enalapril maleate as the active ingredient.

The other components arecroscarmelosa sodium, lactose, magnesium stearate, pregelatinized cornstarch (from corn), sodium bicarbonate,red iron oxide (E-172), yellow iron oxide (E-172)and cornstarch.

Appearance of the product and contents of the packaging

Enalapril Belmac 20 mg areround, flat, scored*, light orange tablets. They are presented in packs of 28 tablets.

*The score serves only to break and facilitate swallowing, but not to divide into equal doses.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor.

Alcobendas, 28108 Madrid (Spain)

Responsible for manufacturing:

Teva Pharma, S.L.U.

Malpica Industrial Estate c/C nº 4

50016 Zaragoza. Spain.

Date of the last review of this leaflet: February 2022

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