Package Insert: Information for the Patient

Enalapril Alter 5 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

Enalapril Alter is used for:

This medicine works by widening blood vessels. This reduces your blood pressure. Normally, the medicine starts to work within an 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 takeEnalapril Alter

Especially, talk to your doctor or pharmacist if you are taking, have taken recently, or may need to take any of the following medications:

Warnings and precautions

Consult your doctor before starting to take Enalapril Alter:

Your doctor may need to monitor your kidney 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 Alter".

You should inform your doctor if you think you may be pregnant. Enalapril 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 during this period (see Pregnancy section).

You should be aware that enalapril is less effective in lowering blood pressure in patients of black race than in patients who are not of black race.

If you are unsure whether any of these 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:

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

Taking Enalapril Alter with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This is because enalapril may affect how other medications work. Other medications may also affect how enalapril works. Your doctor may need to adjust your dose and/or take other precautions.

Especially, inform your doctor if you are taking any of the following medications:

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

Taking Enalapril Alter with food and drinks

Enalapril Alter can be taken with or without food. Most people take this medication with a little 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 medication.

Pregnancy

You should inform your doctor if you think you may be pregnant (or may be). Normally, your doctor will advise you to stop taking this medication before becoming pregnant or as soon as you know you are pregnant and will advise you to take a different medication instead of enalapril. Enalapril 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 during this period.

Breastfeeding

Inform your doctor if you are breastfeeding or are about to start breastfeeding. While taking enalapril, it is not recommended to breastfeed newborns (first weeks after birth), and especially premature babies. In the case of an older baby, your doctor should advise you on the benefits and risks of taking this medication 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 Alter contains lactose.If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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 prescribed.

Hypertension

• The usual initial dose varies between 5 and 20 mg once a day.
• Some patients may need a lower initial dose. The usual long-term dose is 20 mg administered once a day.
• The maximum long-term dose is 40 mg administered once a day.

Heart failure

• The usual initial dose is 2.5 mg administered once a day.
• Your doctor will gradually increase this amount until the appropriate dose for you is reached.
• The usual long-term dose is 20 mg per day administered in one or two doses.
• The maximum long-term dose is 40 mg per day, divided into two doses.

Patients with kidney problems

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

Older patients

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

Children and adolescents

The experience with the use of enalapril in children with hypertension 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:

The dose may be adjusted as needed:

This medication is not recommended for newborns (first weeks after birth) or children with kidney problems.

If you take moreEnalapril Alterthan you should

If you take more enalapril than you should, consult your doctor or pharmacist immediately or go to the hospital immediately. Bring the medication 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeEnalapril Alter

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

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 your 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 this medicine and talk to 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 talk to your doctor.

Other side 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, chest pain, or chest discomfort
• headache, depression, fainting (syncope), taste disorder
• difficulty breathing
• diarrhea, abdominal pain
• fatigue (tiredness)
• 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 (usually both are detected in a blood test).

Rare (may affect up to 1 in 100 people)

• rubefaction
• sudden drop in blood pressure
• rapid and irregular heartbeat (palpitations)
• heart attack (possibly due to very low blood pressure in certain high-risk patients, even those with alterations in blood flow to the heart or brain)
• 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
• sensation of itching or numbness in your skin
• dizziness (sensation of spinning)
• ringing in the ears (tinnitus)
• runny nose, sore throat, or hoarseness
• asthma-associated chest tightness
• slow movement of food through your intestine (ileus), pancreatitis
• vomiting, indigestion, constipation, anorexia
• irritated stomach (gastritis), dry mouth, ulcers
• muscle cramps
• reduced kidney function, kidney failure
• increased sweating
• itching or urticaria
• hair loss
• general feeling of being unwell, elevated temperature (fever)
• impotence
• elevated levels of proteins in your urine (determined in a blood test)
• low levels of sugar or sodium in the blood, elevated 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 blood cells or red blood cells, lower hemoglobin levels, lower platelet count 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 in X-rays)
• inflamed nose
• inflamed lungs causing difficulty breathing (pneumonia)
• inflamed cheeks, gums, tongue, lips, throat
• reduced urine production
• target-shaped rash (erythema multiforme)
• Stevens-Johnson syndrome and toxic epidermal necrolysis (a severe skin disorder in which you have red, peeling skin, blisters, or open sores), dermatitis exfoliativa/erythroderma (severe skin rash with peeling or shedding of the skin), pemphigus (small fluid-filled blisters on the skin)
• liver or bile duct problems such as reduced liver function, liver inflammation, jaundice (yellow discoloration of the skin or eyes), elevated levels of liver enzymes or bilirubin (determined in a blood test)
• enlarged breasts in men (gynecomastia).

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

• swelling in your intestine (intestinal angioedema)

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

• overproduction of the antidiuretic hormone, which causes fluid retention, leading to weakness, fatigue, or confusion
• a set of symptoms that may include some or all of the following: fever, inflammation of blood vessels (serositis, vasculitis), muscle pain (myalgia, myositis), joint pain (arthralgia/arthritis). It may cause a rash, photosensitivity, or other skin manifestations.

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 does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse 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 use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

Store in the original packaging to protect it from moisture.

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 ofEnalapril Alter

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

Appearance of the product and content of the container

Enalapril Alter is presented in containers of 10 and 60 tablets. The tablets are white, round, flat, and scored on one side.

Holder of the marketing authorization

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Responsible for manufacturing

Farmalider, S.A.

C/ Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

or

Toll Manufacturing Services, S.L.

C/ Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Last review date of this leaflet:March 2019.

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