Enalapril Alter 20 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Enalapril Alter 20 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Enalapril Alter contains an active substance called enalapril maleate. It belongs to a group of medicines known as angiotensin-converting enzyme (ACE) inhibitors.

Enalapril is used to:

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

This medicine works by widening the blood vessels. This lowers your blood pressure. The medicine usually starts to work within one 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 taking Enalapril Alter

Do not take Enalapril Alter

• if you are allergic to the active substance or to 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, mouth, tongue or throat that caused difficulty swallowing or breathing (angioedema) when the cause was unknown or hereditary,
• 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. (It is also advisable to avoid enalapril early in pregnancy – see Pregnancy section),
• 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, including in the throat area) is high.

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 before taking Enalapril Alter:

• if you have a heart condition,

• if you have a disease affecting 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 after a kidney transplant), are on a salt-free diet, are taking potassium supplements, potassium-sparing medicines, salt substitutes containing potassium, or other medicines that may increase potassium levels in the blood, such as heparin (a medicine used to prevent blood clots), medicines containing trimethoprim or cotrimoxazole, also known as trimethoprim/sulfamethoxazole (medicines used to treat infections). This may cause high potassium levels in your blood, which can be serious. Your doctor may need to adjust your enalapril dose or monitor your blood potassium levels. See also information under the heading “Other medicines and Enalapril Alter”,

• if you are undergoing dialysis,

• if you have had excessive vomiting or severe diarrhoea recently,

• 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 blood potassium levels may also be higher,

• if 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 this type of reaction to ACE inhibitors,

• if you have low blood pressure (you may feel faint or dizzy, especially when standing up),

• if you have vascular collagen disease (e.g. systemic 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, the risk of developing angioedema may increase:

• racecadotril, a medicine used to treat diarrhoea,

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

• vildagliptin, a medicine used to treat diabetes.

• 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 “sartans” – for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes,

• aliskiren.

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

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

You should inform your doctor if you think you are pregnant (or could be). Enalapril is not recommended during early 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 at this stage (see Pregnancy section).

Please note that enalapril 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 anaesthetics (including at the dentist),
• a treatment to remove cholesterol from your blood called “LDL apheresis”,
• a desensitisation treatment to reduce the effect of an allergy to bee or wasp stings.

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

Other medicines and Enalapril Alter

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. 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 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 Alter” and “Warnings and precautions”),
• other medicines to lower blood pressure, such as beta-blockers or water tablets (diuretics),
• potassium-containing medicines (including dietary 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). See also information in the section “Warnings and precautions”,
• 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 disorders called “antipsychotics”,
• certain cough and cold medicines and weight-reducing medicines containing a substance called “sympathomimetic medicines”,
• certain medicines for pain or arthritis, including gold therapy,
• an mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus, medicines used to treat certain types of cancer or to prevent the body’s immune system from rejecting a transplanted organ). See also information under the heading “Warnings and precautions”,
• a medicine containing a neprilysin inhibitor such as sacubitril (available in a fixed-dose combination with valsartan), racecadotril, or vildagliptina. This may increase the risk of angioedema (swelling of the face, lips, tongue or throat with difficulty swallowing or breathing). See also information in sections “Do not take Enalapril Alter” 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 unsure whether any of the above situations apply to you, consult your doctor or pharmacist before starting this medicine.

Taking Enalapril Alter with food and drink

Enalapril can be taken with or without food. Most people take this medicine with a glass of water.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Inform your doctor if you think you are pregnant (or could be). Your doctor will usually advise you to stop taking this medicine before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative to enalapril. Enalapril is not recommended during early 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.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start. Breastfeeding is not recommended in newborns (first weeks after birth) while taking enalapril, and especially in premature infants. For an older infant, your doctor should advise you on the benefits and risks of taking this medicine compared to other treatments during breastfeeding.

Driving and using machines

You may feel dizzy or drowsy while taking this medicine. If this occurs, do not drive or operate tools or machinery.

Enalapril Alter contains lactose and sodium.

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

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

3. How to take Enalapril Alter

Follow exactly the instructions for using this medicine as given by your doctor. 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.
• The tablet can be divided into equal doses.

High blood pressure

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

Heart failure

• The recommended starting dose is 2.5 mg once daily.
• Your doctor will gradually increase this amount until the appropriate dose for you is reached.
• The recommended long-term dose is 20 mg daily, given in one or two doses.
• The maximum long-term dose is 40 mg daily, divided into two doses.

Patients with kidney problems

Your medicine dose will change depending on how well your kidneys are functioning:

• moderate kidney problems – 5 mg to 10 mg daily
• severe kidney problems – 2.5 mg daily
• if undergoing dialysis – 5.5 mg daily. On days when you are not undergoing dialysis, your dose may change depending on how low your blood pressure is.

Elderly patients

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

Children and adolescents

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 depending on the child's weight and blood pressure. The recommended starting doses are:

• between 20 kg and 50 kg – 2.5 mg daily
• over 50 kg – 5 mg daily.

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

• a maximum of 20 mg daily may be used in children weighing between 20 kg and 50 kg.
• a maximum of 40 mg daily may be used in children weighing over 50 kg.

This medicine is not recommended in newborn infants (first weeks after birth) or in children with kidney problems.

If you take more Enalapril Alter than you should

If you take more enalapril than you should, contact your doctor or pharmacist immediately or go to hospital straight away. Take the medicine packaging with you. The following effects may occur:

dizziness or vertigo due to a sudden or excessive drop in blood pressure.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Enalapril Alter

• 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 forgotten doses.

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

If you stop treatment with Enalapril Alter

Do not stop taking your medicine unless your doctor tells you to do so.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you experience any of the following symptoms, stop taking this medicine 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 (hives).

Please be aware that black patients have a higher risk of experiencing these types of reactions. If you experience any of the above reactions, stop taking this medicine and speak to your doctor immediately.

When you start taking this medicine, you may feel faint or dizzy. If this occurs, lying down may help. This is due to a drop 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)

• dizziness, weakness, vomiting
• blurred vision
• cough

Common (may affect up to 1 in 10 people)

• dizziness due to low blood pressure, changes in heart rhythm, rapid heartbeat, angina or chest pain
• headache, depression, fainting (syncope), taste disturbances
• difficulty breathing
• diarrhoea, abdominal pain
• tiredness (fatigue)
• rash, allergic reactions with swelling of the face, lips, tongue or throat causing difficulty swallowing or breathing
• elevated potassium levels in blood, elevated creatinine levels in blood (both usually detected in a blood test).

Uncommon (may affect up to 1 in 100 people)

• flushing
• 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)
• stroke (possibly due to very low blood pressure in high-risk patients)
• anaemia (including aplastic and haemolytic anaemia)
• confusion, drowsiness or inability to sleep, restlessness
• tingling or numbness sensation in your skin
• vertigo (sensation of dizziness)
• ringing in the ears (tinnitus)
• runny nose, sore throat or hoarseness
• asthma-related chest tightness
• slow movement of food through your intestine (ileus), inflammation of the pancreas
• vomiting, indigestion, constipation, anorexia
• irritated stomach (gastric irritation), dry mouth, ulcer
• muscle cramps
• reduced kidney function, kidney failure
• increased sweating
• itching or hives
• hair loss
• malaise (general discomfort), elevated body temperature (fever)
• impotence
• elevated protein levels in urine (detected in a test)
• low blood sugar or sodium levels, elevated 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 reduced blood flow
• changes in blood values such as reduced number of white or red blood cells, reduced haemoglobin, reduced platelet count
• bone marrow depression
• swollen glands in the neck, armpits or groin
• autoimmune diseases
• sleep disturbances or sleep problems
• accumulation of fluid or other substances in the lungs (as seen on X-rays)
• inflammation of the nose
• lung inflammation causing difficulty breathing (pneumonitis)
• inflammation of cheeks, gums, tongue, lips, throat
• reduced amount of urine produced
• target-shaped rash (erythema multiforme)
• “Stevens-Johnson syndrome” and “toxic epidermal necrolysis” (a serious skin disorder in which you have red, peeling skin, blisters or open sores), exfoliative dermatitis/erythroderma (severe skin rash with peeling or shedding of the skin), pemphigus (small fluid-filled blisters on the skin)
• liver or gallbladder 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 (gynaecomastia).

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

• swelling in your intestine (intestinal angioedema)

Frequency not known (frequency cannot be estimated from available data)

• overproduction of antidiuretic hormone, leading to fluid retention, causing weakness, tiredness or confusion
• a group of symptoms has been reported which may include one or more of the following: fever, inflammation of blood vessels (serositis, vasculitis), muscle pain (myalgia, myositis), joint pain (arthralgia/arthritis). Skin rash, photosensitivity or other skin manifestations may also occur.

Reporting of adverse effects:

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

5. Storage of Enalapril Alter

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

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

Do not store above 30°C.

Keep in the original packaging to protect it from moisture.

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 in doubt, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Enalapril Alter

• The active substance is enalapril maleate. Each tablet contains 20 mg of enalapril.
• The other components are: sodium bicarbonate, monohydrate lactose, pregelatinized corn starch, corn starch, magnesium stearate (E572), and red and yellow iron oxides (E172).

Appearance of the medicine and contents of the pack

It is presented in packs containing 28 tablets. The tablets are peach-colored, round, flat, and scored on one side.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

Manufacturer

Farmalider, S.A.

C/ Aragoneses, 2

28108 Alcobendas, Madrid

Spain

or

Toll Manufacturing Services, S.L.

C/ Aragoneses, 2

28108 Alcobendas, Madrid

Spain

Date of the most recent revision of this leaflet: August 2025

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