Leaflet: information for the user

enalapril cinfa 10 mg tablets

enalapril maleate

Read this leaflet carefully before you start taking this medicine, as 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.

1.What isenalapril cinfaand what it is used for

2.What you need to know before starting to takeenalapril cinfa

3.How to takeenalapril cinfa

4.Possible side effects

5.Storage ofenalapril cinfa

6.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 an angiotensin-converting enzyme inhibitor (ACE inhibitor).

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 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 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 previously been treated with a medication from the same group of drugs as enalapril (ACE inhibitors) and have had allergic reactions with swelling of the face, lips, tongue, and/or throat, difficulty swallowing or breathing.
• If you have been diagnosed with hereditary or unknown cause angioedema (development of large hives on the surface of the skin, especially around the eyes and lips, which can also affect hands, feet, and throat, and can cause swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing).
• If you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskirén.
• If you are more than 3 months pregnant. (It is also recommended to avoid enalapril at the beginning of pregnancy – see Pregnancy section).
• If you are being treated with sacubitrilo/valsartán, 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 disease.
• 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 are undergoing dialysis.
• If you have recently had excessive vomiting or diarrhea.
• If you are following a low-sodium diet, taking potassium supplements, medications that save potassium, salt substitutes that contain potassium, or other medications that can increase potassium levels in the blood, such as heparin (a medication used to prevent blood clots), medications with trimetoprima or cotrimoxazol, also known as trimetoprima/sulfametoxazol (medications used to treat infections).
• If you are over 70 years old.
• If you have diabetes mellitus, hypoadrenocorticism, or any kidney problem (including kidney transplant), as these can lead to high potassium levels in the blood that can be serious.
• 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 are more sensitive to 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 vascular collagen disease (e.g. lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with immunosuppressive medications, are taking alopurinol 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 that contains a neprilisina inhibitor such as sacubitrilo (available in a fixed-dose combination with valsartán), used in patients with heart failure, and racecadotrilo, used in patients with acute diarrhea. You may be at higher risk of having 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 valsartán, telmisartán, irbesartán, etc.), particularly if you have kidney problems related to diabetes.
  • Aliskirén.

Your doctor may monitor your renal 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 be aware that enalapril cinfa reduces blood pressure in black patients less effectively than in patients who are not black.

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.

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 can cause serious damage to your baby if used in this stage (see Pregnancy section).

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.

Certain medications may interact with enalapril. In these cases, your doctor may need to modify your dose and/or take other precautions, such as stopping treatment with one of them.

It is especially important to inform your doctor if you are taking or have taken recently any of the following medications, your doctor may need to modify your dose and/or take other precautions:

• An angiotensin II receptor antagonist (ARA) or aliskirén (see also the information under the headings “Do not take enalapril cinfa” and “Warnings and precautions”).
• Antihypertensive medications (reduce elevated blood pressure).
• Diuretics (medications that increase urine elimination).
• Medications with potassium (including salt substitutes) or other medications that can increase potassium levels in the blood, such as heparin (a medication used to prevent blood clots), medications with trimetoprima or cotrimoxazol, also known as trimetoprima/sulfametoxazol (medications used to treat infections).
• Lithium (a medication used to treat certain types of depression).
• Tricyclic antidepressants (a type of antidepressant).
• Antipsychotics (medications used in the treatment of mental disorders).
• Anesthetics.
• Antidiabetic medications (medications that decrease blood glucose levels, including oral antidiabetic medications and insulin).
• Aspirin (acetylsalicylic acid).
• Certain medications for cough and cold and weight loss medications that contain a substance called “sympathomimetic agent”.
• Certain medications for pain or arthritis, including gold treatment.
• Nonsteroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (medications that reduce inflammation and can be used to help you relieve pain).
• 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 under the heading “Warnings and precautions”.
• A medication that contains a neprilisina inhibitor such as sacubitrilo (available in a fixed-dose combination with valsartán) and racecadotrilo. You may be at 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”.
• Thrombolytic medications (medications used to dissolve blood clots).
• Alcohol.

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 plan 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 can cause serious damage to your baby if used in this stage.

Lactation:

Inform your doctor if you are breastfeeding or plan 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

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.

Enalapril cinfa contains Red Ponceau 4R (E-124)

It may cause allergic reactions.

.

Follow exactly the administration instructions of this medication as 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.
• Do not take more tablets than those prescribed to you.
• The tablet can be divided into equal doses.

The recommended dose is:

Hypertension

For most patients, the initial recommended dose is 5 mg to 20 mg once a day.Some patients may need a lower initial dose.

The long-term recommended dose is 20 mg once a day.

The maximum long-term dose is 40 mg once a day.

Heart failure

The initial recommended dose is usually 2.5 mg once a day. The doctor will gradually increase the dose until the appropriate dose is reached in your case. The long-term recommended dose is 20 mg per day in one or two doses.

The maximum long-term dose is 40 mg, 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.

- If undergoing dialysis - 2.5 mg per day. On the days you undergo 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 the functioning of your kidneys.

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 according to the child's needs:

• 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 pediatric patients 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.

In case of overdose, the most likely symptom is a feeling of 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 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, although not everyone will experience 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 up, making it difficult to breathe or swallow.
• If your hands, feet, or ankles swell up.
• 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 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
• Cough
• Blurred vision

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).

Rare(may affect up to 1 in 100 people):

• Redness
• 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)
• Cerebrovascular accident (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
• Dizziness (sensation of spinning)
• Ear ringing (tinnitus)
• Coughing, sore throat, or hoarseness
• Asthma associated with 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 illness, 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
• Depression of the bone marrow
• Swollen glands in the neck, armpits, or groin
• Autoimmune diseases
• Changes in sleep or sleep problems
• Accumulation of fluids or other substances in the lungs (as seen in X-rays)
• Inflammation of the nose
• Pneumonia caused by inflammation of the lungs, making it difficult to breathe
• Inflammation of the cheeks, gums, tongue, lips, throat
• Reduced urine production
• Rash in the shape of a target (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 blisters filled with fluid on the skin)
• Problems with the liver or bile ducts such as reduced liver function, inflammation of the liver, jaundice (yellowish color of the skin or eyes), elevated liver enzymes or bilirubin levels (determined in a blood test)
• Enlargement of the breasts in men (gynecomastia).

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

• Swelling in the intestine (intestinal angioedema).

Frequency unknown(cannot be estimated from available data):

• Overproduction of the antidiuretic hormone, causing fluid retention, leading to weakness, fatigue, or confusion.
• A set of symptoms that may include one or more 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 30°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 SIGREpoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging andmedicines that you no longer need. By doing so, you will help protect the environment.

Composition of enalapril cinfa

• The active ingredient is enalapril maleate. Each tablet contains 10 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), hydrogenated ricin oil, and Red Ponceau 4R (E-124).

Appearance of the product and contents of the packaging

Enalapril cinfa is presented in the form of pinkish-colored, cylindrical, biconvex, and scored tablets on one face. Each package contains 10, 28, 56, or 500 (clinical package) tablets.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10 - Industrial Park Areta.

31620 Huarte (Navarra) - Spain

Last review date of this leaflet : September 2018

Detailed information about this medication 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 about this medication 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/73300/P_73300.html

QR code to: https://cima.aemps.es/cima/dochtml/p/73300/P_73300.html