Summary of Product Characteristics: Information for the User

Enalapril Cinfa 5 mg Tablets EFG

Enalapril Maleate

Read this 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, do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack and additional information

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

enalapril cinfa is indicated for:

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 cinfa

• If you are allergic to enalapril maleate or any of the other components of this medication (listed in section 6).
• If you have ever been treated for an allergic reaction to a similar medication 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 insufficiency 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 enalapril at the beginning of pregnancy – see Pregnancy section).
• If you are being treated with sacubitrilo/valsartan, a medication for heart failure.

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 cinfa.

• If you have a heart problem.
• If you have a disease 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 kidney problems (including kidney transplant). This may cause high levels of potassium in your blood that can be serious. Your doctor may need to adjust your enalapril dose or monitor your potassium levels in the blood.
• If you are undergoing dialysis.
• If you have had excessive vomiting (excessive vomiting) or intense diarrhea recently.
• If you are following a low-sodium diet, taking potassium supplements, taking 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).
• If you are over 70 years old.
• If you have diabetes. You should monitor your blood sugar levels to see if you have low blood sugar 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 have a higher risk of suffering this type of reaction to ACE inhibitors.
• If you have low blood pressure (you may feel dizzy or lightheaded, especially when standing up).
• If you have collagen vascular disease (e.g. lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with immunosuppressive medications, are taking allopurinol or procainamide, or any combination of these.
• If you are taking an mTOR inhibitor (e.g. temsirolimus, sirolimus, everolimus: medications used to treat certain types of cancer or to prevent the immune system from rejecting a transplanted organ) or a medication containing a neprilysin inhibitor such as sacubitrilo (available in a fixed-dose combination with valsartan), used in patients with heart failure, and racecadotrilo, used in patients with acute diarrhea. You may have a higher risk of suffering an allergic reaction called angioedema.
• If you are taking any of the following medications used to treat high blood pressure (hypertension):
• • An angiotensin II receptor antagonist (ARA) (also known as "sartanes" – for example valsartan, telmisartan, irbesartan, etc.), particularly if you have kidney problems related to diabetes.
  • Aliskiren.

Your doctor may 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 cinfa".

You should inform your doctor if you think you may be pregnant (or could be). This medication 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 damage to your baby if used during this period (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 office)
• A treatment to remove cholesterol from your blood called "apheresis of LDL"
• 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.

Other medications and enalapril cinfa

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. Other 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 cinfa" and "Warnings and precautions").
• Other medications to reduce blood pressure, such as beta-blockers or diuretics.
• Medications with potassium (including salt substitutes) 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).
• Medications for diabetes (including oral antidiabetic medications and insulin).
• Lithium (a medication used to treat certain types of depression).
• Tricyclic antidepressants (a type of antidepressant).
• Antipsychotics (medications used in the treatment of mental health problems).
• 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 the immune system from rejecting a transplanted organ). See also the information in the "Warnings and precautions" section.
• A medication containing a neprilysin inhibitor such as sacubitrilo (available in a fixed-dose combination with valsartan) and racecadotrilo. You may have a higher 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 cinfa" and "Warnings and precautions".
• Nonsteroidal anti-inflammatory medications, including COX-2 inhibitors (medications that reduce inflammation and may be used to help you alleviate 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 cinfa with food and drinks

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

Pregnancy and breastfeeding

Pregnancy:

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

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. 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 damage to your baby if used during this period.

Lactation:

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 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 cinfa contains lactose

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

Enalapril cinfa contains sorbitol

This medication contains 34.80 mg of sorbitol in each tablet.

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

The tablet can be divided into equal doses.

Do not take more tablets than those prescribed to you.

Hypertension

The recommended initial dose varies between 5 and 20 mg once a day.Some patients may need a lower initial dose.

The recommended 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 dose is 2.5 mg once a day. The doctor will gradually increase the dose until the appropriate dose is reached in 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
• Those undergoing dialysis - 2.5 mg per day. In the days when you are not undergoing dialysis, your dose may change depending on how low your blood pressure is.

Older patients

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

Use in children

The experience on 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:

• Between 20 kg and 50 kg - 2.5 mg per day
• More than 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 more than 50 kg.

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

If you take more enalapril cinfa than 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. This is 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take enalapril cinfa

If you forget to take a tablet, do not take the missed dose. Take the next dose at your usual time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with enalapril cinfa

Do not stop treatment without your doctor's indication. If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, althoughnot everyone will experience them.

If you experience any of the following symptoms, stop taking enalapril and consult your doctor immediately in any of thefollowing cases:

• If your face, lips, tongue, or throat become swollen, making it difficult tobreathe or swallow.
• If your hands, feet, or ankles become swollen.
• If you develop a red rash on your skin with swelling (hives).

You should be aware that black patients have a higher risk of experiencing this type of reaction. If you experience any of the previous reactions, stop taking enalapril 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. 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)

• dizziness, weakness, or 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 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, making it difficult to breathe or swallow
• elevated potassium levels in the blood, elevated creatinine levels in the blood (usually both are 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)
• myocardial infarction (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 the skin
• vertigo (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 (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 protein levels in the urine (determined in a blood test)
• low blood sugar or sodium levels, elevated urea levels 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 skin or eyes), elevated liver enzymes or bilirubin levels (determined in a blood test)
• enlarged breasts in men (gynecomastia).

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

• swelling in the intestine (intestinal angioedema).

Frequency not known(cannot be estimated from available data)

• excessive production of antidiuretic hormone, leading to fluid retention, causing 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 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 25°C.

Do not use this medication after the expiration date that appears on the packaging afterCAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging andmedicines that you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. Bydoing so, you will help protect the environment.

Composition of enalapril cinfa

• The active ingredient is enalapril maleate. Each tablet contains 5 mg of enalapril maleate.
• The other components (excipients) are: magnesium carbonate (E-504), pregelatinized cornstarch, lactose monohydrate, sorbitol (E-420), hydroxypropylcellulose (E-463), magnesium stearate (E-470b), and hydrogenated ricin oil.

Appearance of the product and content of the packaging

Enalapril cinfa tablets are white, cylindrical, biconvex, scored on one face and with the code “E5C” on the other.

They are presented in Aluminio/Aluminio blisters. Each package contains 10, 60, or 500 (clinical package) tablets.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Last review date of this leaflet:July 2021

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/

You can access detailed and updated information on this medicine by scanning with your smartphone the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/63377/P_63377.html

QR code to:https://cima.aemps.es/cima/dochtml/p/63377/P_63377.html