ENALAPRIL BELMAC 20 mg TABLETS

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

Do not take Enalapril Belmac

• If you are allergic to enalapril maleate or any of the other ingredients of this medicine (listed in section 6)
• If you have ever been treated for an allergic reaction to a medicine similar to this one, called an ACE inhibitor
• If you have ever had swelling of the face, lips, tongue or throat that caused difficulty in swallowing or breathing (angioedema) when the cause was hereditary or unknown
• 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 (also, it is better to avoid this medicine at the start of pregnancy - see section Pregnancy)
• If you have taken or are 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

Do not take this medicine if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking this medicine

Warnings and precautions

Consult your doctor or pharmacist before taking Enalapril Belmac

• If you have heart disease
• If you have a disease that affects the blood vessels in the brain
• If you have blood disorders such as low or lack of white blood cells (neutropenia/agranulocytosis), low platelet count (thrombocytopenia) or low red blood cell count (anaemia)
• If you have liver problems
• If you have kidney problems (including kidney transplant), follow a low salt diet, are taking potassium supplements, potassium-sparing diuretics, salt substitutes that contain potassium or other medicines that may increase potassium levels in the blood (such as heparin, a medicine used to prevent blood clots; trimethoprim and cotrimoxazole for bacterial infections; ciclosporin, an immunosuppressant medicine used to prevent organ transplant rejection). This may cause high levels of potassium in the blood, which can be serious. Your doctor may need to adjust your dose of enalapril or monitor your potassium levels in the blood. See also the information under the heading “Taking Enalapril Belmac with other medicines”
• If you are having dialysis
• If you have recently had severe vomiting (excessive vomiting) or severe diarrhoea

• If you have diabetes, you should 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 black patients are more sensitive to this type of reaction to ACE inhibitors

• If you have low blood pressure (you may notice this as dizziness or fainting, especially with the initial doses and when standing up)
• If you have collagen vascular disease (e.g. lupus erythematosus, rheumatoid arthritis or scleroderma), are being treated with medicines that suppress your immune system, are taking the medicines allopurinol or procainamide or any combination of these
• If you are taking any of the following medicines, the risk of angioedema may increase:

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

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

• an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not take Enalapril Belmac” and “Warnings and precautions”
• aliskiren

Your doctor may monitor your kidney function, blood pressure and blood electrolyte levels (such as 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 are pregnant (or might be). Your doctor will normally advise you to stop taking enalapril 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 Belmac. Enalapril Belmac 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 after the third month of pregnancy

You should be aware that this medicine is less effective at lowering blood pressure in black patients than in non-black patients

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking 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 anaesthetics (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 undergoing the procedure

Taking Enalapril Belmac with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This is because enalapril may affect the way other medicines work and some medicines may affect the way 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 Belmac” and “Warnings and precautions”
• Other medicines to lower blood pressure, such as beta blockers or diuretics
• Potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that may increase potassium levels in the blood (such as trimethoprim and cotrimoxazole for bacterial infections; ciclosporin, an immunosuppressant medicine used to prevent organ transplant rejection; and heparin, a medicine used to prevent blood clots). See also the information in the section “Warnings and precautions”
• Medicines for diabetes (including oral antidiabetics and insulin)
• Lithium (a medicine used to treat certain types of depression)
• Medicines for depression “tricyclic antidepressants”
• Medicines for mental problems “antipsychotics”
• Certain cough and cold medicines and weight loss medicines that contain a substance called “sympathomimetic medicines”
• Certain medicines for pain or arthritis, including gold treatment
• An mTOR inhibitor (e.g. temsirolimus, sirolimus, everolimus; medicines used to treat certain types of cancer or to prevent the immune system from rejecting a transplanted organ). See also the information in the section “Warnings and precautions”
• A medicine that contains sacubitril/valsartán, 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”
• 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 taking 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, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine

Pregnancy

You should inform your doctor if you think you are pregnant (or might be). Your doctor will normally advise you to stop taking enalapril 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 Belmac. Enalapril Belmac 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 after the third month of pregnancy

Breast-feeding

Inform your doctor if you are breast-feeding or about to start breast-feeding. While taking enalapril, 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, 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 Belmac contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially “sodium-free”

3. How to take Enalapril Belmac

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist

It is very important that you continue to take this medicine for as long as your doctor prescribes it

Do not take more tablets than your doctor has told you to

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 initial recommended dose is normally 2.5 mg once a day

Your doctor will gradually increase the dose until the suitable dose for you is reached

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

Patients with kidney problems

Your dose of medicine will depend on how well your kidneys are working:

• mild kidney problems - 5 mg to 10 mg per day
• severe kidney problems - 2.5 mg per day
• if you are having dialysis - 2.5 mg per day. On the days when you are not having dialysis, your dose may need to be changed depending on how low your blood pressure is

Elderly patients

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

Use in children

Experience with 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 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 over 50 kg

This medicine is not recommended in newborn babies (first few weeks after birth) or in paediatric 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

Take the medicine pack with you

In the event of an overdose, the most likely symptom is dizziness or fainting 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, stating the medicine and the amount taken

If you forget to take Enalapril Belmac

You should continue to take this medicine as prescribed by your doctor. Do not take a double dose to make up for forgotten doses

If you stop taking Enalapril Belmac

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 this medicine and consult your doctor immediately:

• swelling of the face, lips, tongue, or throat that can 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 black patients have a higher risk of suffering from this type of reaction. If you experience any of the above reactions, stop taking it and talk to your doctor immediately.

When you start taking this medicine, you may feel loss of consciousness or dizziness. 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 talk to your doctor.

Other adverse effects include:

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

• feeling of dizziness, 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 pectoris, rapid heartbeats
• difficulty breathing,
• fatigue (fatigue)
• diarrhea, abdominal pain
• rash, allergic reactions with swelling of the face, limbs, 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):

• flushing
• sudden drop in blood pressure
• anemia (including aplastic and hemolytic anemia)
• confusion, drowsiness, or inability to sleep, nervousness
• feeling of itching or numbness in your skin
• vertigo (feeling of dizziness)
• rapid and arrhythmic heartbeats (palpitations)
• myocardial infarction or stroke (possibly due to excessively low blood pressure in high-risk patients, even in those with alterations in heart and/or brain blood flow)
• runny nose, sore throat, or hoarseness
• asthma-associated chest tightness
• slow movement of food through the intestine (ileus), pancreatitis
• vomiting, indigestion, constipation, anorexia
• gastric irritation (irritated stomach), dry mouth, peptic ulcer
• increased sweating

• itching or hives
• hair loss
• reduced kidney function, kidney failure
• high levels of protein in the urine (determined in an analysis)
• impotence
• muscle cramps
• ringing in the ears (tinnitus)
• malaise (general discomfort), elevated temperature (fever)
• 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 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, lower number of platelets in the blood
• bone marrow depression
• inflamed glands in the neck, armpits, or groin
• autoimmune diseases
• sleep disturbances or sleep problems
• fluid accumulation or other substances in the lungs (as seen on X-rays),
• inflammation of the nose
• inflammation of the lungs causing difficulty breathing (pneumonia)
• inflammation of the cheeks, gums, tongue, lips, throat
• target-shaped rash (erythema multiforme)
• “Stevens-Johnson syndrome” and “toxic epidermal necrolysis” (a severe skin disorder in which you have red and scaly skin, ulcers with blisters or open sores), exfoliative dermatitis/erythroderma (severe skin rash with scaling or peeling of the skin), pemphigus (small blisters filled with fluid on the skin)
• reduction in the amount of urine produced per day
• enlargement of the breasts in men (gynecomastia)
• liver or bile duct problems such as decreased liver function, liver inflammation, jaundice (yellowish color of the skin or eyes), elevated levels of liver enzymes or bilirubin (determined in an analysis).

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

• Intestinal angioedema (swelling in the intestine)

Frequency Not Known(frequency cannot be estimated from available data)

• overproduction of antidiuretic hormone, leading to fluid retention, causing weakness, fatigue, or confusion

A symptomatic complex has been observed that may include all or some of the following symptoms: fever, inflammation of the blood vessels (serositis, vasculitis), muscle pain (myalgia, myositis), joint pain (arthralgia/arthritis). A rash, photosensitivity, or other skin manifestations may occur.

Reporting of Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, 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: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Enalapril Belmac

Keep this medicine out of sight and reach of children.

Do not store above 30°C. Store in the original package.

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

Medicines should not be thrown away through 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 will help protect the environment.

6. Package Contents and Additional Information

Composition of Enalapril Belmac 20 mg tablets

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

The other components are sodium croscarmellose, lactose, magnesium stearate, pregelatinized corn starch (derived from corn), sodium bicarbonate, red iron oxide (E-172), yellow iron oxide (E-172), and corn starch.

Appearance of the Product and Package Contents

Enalapril Belmac 20 mg are circular, flat, scored* tablets, light orange in color. They are presented in packages of 28 tablets.

*The score line is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1ª planta.

Alcobendas, 28108 Madrid (Spain)

Manufacturer:

Teva Pharma, S.L.U.

Polígono Malpica c/C nº 4

50016 Zaragoza. Spain.

Date of the Last Revision of this Prospectus: February 2022

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/