ENALAPRIL CINFA 20 mg TABLETS

Introduction

Package Leaflet: Information for the User

Enalapril Cinfa 20 mg Tablets EFG

Enalapril Maleate

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 and other information

1. What is Enalapril Cinfa and what is it used for
2. What you need to know before you take Enalapril Cinfa
3. How to take Enalapril Cinfa
4. Possible side effects
5. Storage of Enalapril Cinfa

Contents of the pack and further information

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

Enalapril Cinfa contains the active substance enalapril maleate. It belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors).

Enalapril Cinfa is indicated for:

• Treating high blood pressure (hypertension).
• Treating heart failure (weakening of the heart's function). It may reduce the need for hospitalization and may help some patients live longer.
• Preventing signs of heart failure. Signs include: difficulty breathing, tiredness after light physical activity such as walking, or swelling of the ankles and feet.

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

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

Do not take Enalapril Cinfa

• 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 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 are being treated with sacubitril/valsartan, a medicine for heart failure.

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 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 or absent 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). 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 the blood.
• If you are having dialysis.
• If you have recently had severe vomiting or severe diarrhea.
• If you are on a low-salt diet, taking potassium supplements, potassium-sparing medicines, 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 or cotrimoxazole, also known as trimethoprim/sulfamethoxazole (medicines used to treat infections).
• 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 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 have a higher risk of these reactions to ACE inhibitors.
• If you have low blood pressure (you may feel faint or dizzy, especially when standing up).
• If you have a disease of the blood vessels in the skin (e.g., lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with medicines that suppress your immune system, or are taking the medicines allopurinol or procainamide, or any combination of these.
• If you are taking 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 "Warnings and precautions" section.
• If you are taking a medicine that contains a neprilysin inhibitor like sacubitril (available in a fixed-dose combination with valsartan) and racecadotril. You may have a higher risk of an allergic reaction called 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".
• If you are taking any of the following medicines used to treat high blood pressure (hypertension):

• 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 medicines to reduce blood pressure, such as beta-blockers or water tablets (diuretics).
• Medicines that contain potassium (including dietary salt substitutes) or other medicines that may increase potassium levels in the blood, such as heparin (a medicine used to prevent blood clots), trimethoprim or cotrimoxazole, also known as trimethoprim/sulfamethoxazole (medicines used to treat infections).
• Medicines for diabetes (including oral antidiabetic medicines and insulin).
• Lithium (a medicine used to treat certain types of depression).
• Tricyclic antidepressants (a type of antidepressant).
• Antipsychotics (medicines used to treat mental problems).
• Certain cough and cold medicines and weight loss medicines that contain a substance called "sympathomimetic medicine".
• 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 "Warnings and precautions" section.
• A medicine that contains a neprilysin inhibitor like sacubitril (available in a fixed-dose combination with valsartan) and racecadotril. 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".
• 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 Cinfa with food and drink

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

Pregnancy and breast-feeding

Pregnancy:

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.

Normally, your doctor will 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. Enalapril 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:

Tell 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 Cinfa contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Enalapril Cinfa contains sorbitol

This medicine contains 34.80 mg of sorbitol in each tablet.

Enalapril Cinfa contains Orange Yellow S (E-110)

May produce allergic reactions.

3. How to take Enalapril Cinfa

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

It is very important that you keep taking this medicine for as long as your doctor prescribes it.

The tablet can be divided into equal doses.

Do not take more tablets than your doctor has prescribed.

High blood pressure

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

The recommended long-term dose is 20 mg once daily.

The maximum long-term dose is 40 mg once daily.

Heart failure

The usual initial dose is 2.5 mg once daily. Your doctor will gradually increase the dose until the appropriate dose for you is reached. The usual long-term dose is 20 mg daily in one or two divided doses.

The maximum long-term dose is 40 mg once daily, 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 daily.
• severe kidney problems - 2.5 mg daily.
• if you are having dialysis - 2.5 mg daily. On 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 your dose based on how well your kidneys are working.

Use in children

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 usual initial doses are:

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

The dose can be adjusted 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 in newborn babies (first few 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, contact your doctor or pharmacist immediately, or go to the hospital immediately. Take the medicine pack with you.

The following effects may happen: feeling dizzy or lightheaded. This is 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, telephone 91 562 04 20, indicating the medicine and the amount taken.

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 the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Enalapril Cinfa

Do not stop treatment without consulting your doctor.

If you have any further questions on the use of this product, 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 enalapril and consult your doctor immediately in any of the following cases:

• If your face, lips, tongue, or throat swell in such a way that it becomes difficult to breathe or swallow.
• If your hands, feet, or ankles swell.
• 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 enalapril and talk to your doctor immediately.

When you start taking this medicine, you may feel faint or 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, 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 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 in 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 disturbances or sleep problems
• fluid or substance accumulation 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
• 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), pemphigus (small fluid-filled blisters on the skin)
• liver or bile duct problems such as reduced liver function, liver inflammation, jaundice (yellowing 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 the intestine (intestinal angioedema).

Frequency Not Known(cannot be estimated from the 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). 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 does not appear 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 Cinfa

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

Do not store above 25°C.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE point. In case of 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 of Enalapril Cinfa

• The active ingredient is enalapril maleate. Each tablet contains 20 mg of enalapril maleate.
• The other ingredients (excipients) are: magnesium carbonate (E-504), pregelatinized corn starch, lactose monohydrate, sorbitol (E-420), hydroxypropylcellulose (E-463), magnesium stearate (E-470b), hydrogenated castor oil, and Orange Yellow S (E-110).

Appearance of the Product and Package Contents

Enalapril Cinfa are orange, cylindrical, biconvex tablets, scored on one side and with the code “E20C” on the other.

They are presented in aluminum/aluminum blisters. Each package contains 28, 30, or 500 (clinical package) tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) – Spain

Date of the Last Revision of this Leaflet:July 2021

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/

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/63355/P_63355.html

QR code to: https://cima.aemps.es/cima/dochtml/p/63355/P_63355.html