ENALAPRIL ALTER 5 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

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

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

Enalapril Alter contains the active substance enalapril maleate. It belongs to a group of medicines called angiotensin-converting enzyme inhibitors (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 to go to the hospital and may help some patients to live longer,
• prevent signs of heart failure. The signs include: difficulty breathing, tiredness after light physical activity such as walking or swelling of ankles and feet.

This medicine works by widening the 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 the full effect on their blood pressure is seen.

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

Do not takeEnalapril Alter

• if you are allergic to the active substance 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 swallowing or breathing (angioedema) when the cause was unknown or hereditary,
• 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 better to avoid enalapril 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 the area of the throat) is increased.

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 before taking Enalapril Alter:

• if you have a heart problem,
• if you have a disease that affects the blood vessels of 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 (anemia),
• if you have liver problems,
• if you have kidney problems (including kidney transplant), are on a low-salt diet, are taking potassium supplements, potassium-sparing medicines, salt substitutes that contain potassium, or other medicines that may increase potassium levels in your blood (such as heparin, a medicine used to prevent blood clots, trimetoprima and cotrimoxazol for bacterial infections; ciclosporina, an immunosuppressive medicine used to prevent organ transplant rejection; and heparina, a medicine used to thin the blood to prevent clots). 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. See also the information under the heading “Other medicines and Enalapril Alter”.
• if you are undergoing dialysis,
• if you have recently had severe vomiting (excessive vomiting) or severe diarrhea,
• 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 have low blood pressure (you may notice this as fainting or dizziness, especially when standing),
• if you have a disease of the collagen vascular system (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 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 are taking any of the following medicines used to treat high blood pressure (hypertension):
• an angiotensin II receptor antagonist (ARA) (also known as “sartans” - e.g. valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• 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 Alter”.

You should inform your doctor if you think you are pregnant (or might be). Normally, your doctor will advise you to stop taking this medicine 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. Enalapril is not recommended at the start 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 enalapril lowers 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 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 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.

Other medicines and Enalapril Alter

Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because enalapril may affect the way other medicines work. Other medicines may also affect the way enalapril works. Your doctor may need to change 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 the 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 medicines (including dietary salt substitutes), potassium-sparing diuretics and other medicines that may increase potassium levels in your blood (such as trimetoprima and cotrimoxazol for bacterial infections; ciclosporina, an immunosuppressive medicine used to prevent organ transplant rejection; and heparina, a medicine used to thin the blood to prevent clots). See also the information in the section “Warnings and precautions”.
• 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 problems called “antipsychotics”,
• certain medicines for cough and cold 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 body's immune system from rejecting a transplanted organ). See also the information under the heading “Warnings and precautions”.
• a medicine that contains a neprilysin inhibitor such as sacubitril (available in a fixed-dose combination with 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 the information in the 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 not sure if any of the above applies to you, consult your doctor or pharmacist before taking this medicine.

Taking Enalapril Alter with food and drink

Enalapril can be taken with or without food. Most people take this medicine 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). Normally, your doctor will advise you to stop taking this medicine 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. Enalapril is not recommended at the start 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 this medicine, 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 Alter contains lactose and sodium.

If your doctor has told you that you have an intolerance to some sugars, consult them 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

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 keep taking this medicine for as long as your doctor prescribes it.
• Do not take more tablets than your doctor has told you to.
• The tablet can be divided into equal doses.

High blood pressure

• The recommended starting dose is between 5 and 20 mg once daily.
• Some patients may need 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 right dose for you is reached.
• The recommended long-term dose is 20 mg daily, taken in one or two doses.
• The maximum long-term dose is 40 mg daily, 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 daily
• severe kidney problems – 2.5 mg daily
• if you are undergoing dialysis – 2.5 mg daily. On days when you are not undergoing 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 based on how well your kidneys are working.

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 based 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 can be changed according to the child's needs:

• a maximum of 20 mg daily can be used in children who weigh between 20 kg and 50 kg.
• a maximum of 40 mg daily can be used in children who weigh over 50 kg.

This medicine is not recommended for newborn babies (first few weeks after birth) or for children with kidney problems.

If you take more Enalapril Alter than you should

If you take more enalapril than you should, consult your doctor or pharmacist immediately or go to the hospital immediately. Take the medicine pack with you. The following effects may happen:

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

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 stop taking Enalapril Alter

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 talk to your doctor immediately:

• swelling of the face, lips, tongue, or throat that 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).

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 this medicine and talk to your doctor immediately.

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

Other adverse effects include:

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

• feeling of 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 heartbeats, chest pain or chest tightness
• headache, depression, fainting (syncope), taste disorder
• difficulty breathing
• diarrhea, abdominal pain
• fatigue (fatigue)
• rash, 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 (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 heartbeats (palpitations)
• heart attack (possibly due to very low blood pressure in certain high-risk patients, even those with alterations in heart or brain blood flow)
• stroke (possibly due to very low blood pressure in high-risk patients)
• anemia (including aplastic and hemolytic anemia)
• confusion, drowsiness, or inability to sleep, nervousness
• feeling of itching or numbness on the skin
• vertigo (feeling of dizziness)
• ringing in the ears (tinnitus)
• runny nose, sore throat, or hoarseness
• asthma-associated chest tightness
• slow movement of food through the intestine (ileus), pancreatitis
• 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 temperature (fever)
• impotence
• high levels of protein in the urine (determined in a urine test)
• 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 amount of hemoglobin, lower number of platelets in the blood
• bone marrow depression
• inflamed glands in the neck, armpits, or groin
• autoimmune diseases
• sleep disorders or sleep problems
• fluid or substance accumulation in the lungs (as seen on X-rays)
• nasal inflammation
• lung inflammation causing difficulty breathing (pneumonia)
• inflammation of the cheeks, gums, tongue, lips, throat
• reduced amount of urine produced
• 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 fluid-filled blisters on the skin)
• liver or bile duct problems such as reduced liver function, liver inflammation, jaundice (yellowish color of the skin or eyes), high levels of liver enzymes or bilirubin (determined in a blood test)
• breast enlargement in men (gynecomastia).

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, fatigue, or confusion
• a set of symptoms has been reported that may include one or more of the following: fever, blood vessel inflammation (serositis, vasculitis), muscle pain (myalgia, myositis), joint pain (arthralgia/arthritis). Rash, photosensitivity, or other skin manifestations may occur.

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 leaflet. 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 Alter

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

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

Do not store above 30°C.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofEnalapril Alter

• The active ingredient is enalapril maleate. Each tablet contains 5 mg of enalapril.
• The other ingredients are: sodium bicarbonate, lactose monohydrate, pregelatinized corn starch, corn starch, and magnesium stearate (E572).

Appearance of the Product and Package Contents

It is presented in packages of 10 and 60 tablets. The tablets are white, 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 Last Revision of this Leaflet:August 2025

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