ENALAPRIL CINFA 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

enalapril cinfa 10 mg tablets

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

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. Storing enalapril cinfa
6. Contents of the pack and other 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 working 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 been previously treated with a medicine 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 with difficulty swallowing or breathing.
• If you have been diagnosed with angioedema (development of large hives on the skin surface, especially around the eyes and lips, which can also affect hands, feet, and throat, and can also cause swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing) of hereditary or unknown origin.
• If you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine that contains aliskiren.
• If you are more than 3 months pregnant. (It is also best 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 heart disease.
• If you have a disease that affects the blood vessels in 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 are undergoing dialysis.
• If you have recently had excessive vomiting or diarrhea.
• If you are on a low-salt diet, take 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 mellitus, hypoaldosteronism, or any kidney problem (including kidney transplant), as these can lead to high levels of potassium in the blood, which 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 black patients are more sensitive to this type of reaction to ACE inhibitors.
• If you have low blood pressure (you may notice this as fainting or dizziness, especially when standing up).
• 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 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 under the heading "Warnings and precautions".
• 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 be at increased 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").
  • Aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (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 lowers blood pressure in black patients less effectively than in non-black patients.

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 "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.

You must inform your doctor if you think you are pregnant (or might be). 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 at this stage (see section Pregnancy).

Other medicines and enalapril cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes herbal treatments.

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

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

• An angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings "Do not take enalapril cinfa" and "Warnings and precautions").
• Blood pressure-lowering medicines (antihypertensives).
• Diuretics (medicines that increase urine production).
• Potassium-containing medicines (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).
• Lithium (a medicine used to treat certain types of depression).
• Tricyclic antidepressants (a type of antidepressant).
• Antipsychotics (medicines used to treat mental problems).
• Anesthetics.
• Antidiabetics (medicines that lower blood sugar levels, including oral antidiabetics and insulin).
• Aspirin (acetylsalicylic acid).
• Certain cough and cold medicines and weight-reducing medicines that contain a substance called "sympathomimetic agent".
• Certain medicines for pain or arthritis, including gold treatment.
• Non-steroidal anti-inflammatory medicines (NSAIDs), including COX-2 inhibitors (medicines that reduce inflammation and can be used to help relieve pain).
• 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 under the heading "Warnings and precautions".
• A medicine that contains a neprilysin inhibitor like sacubitril (available in a fixed-dose combination with valsartan) and racecadotril. 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 cinfa" and "Warnings and precautions".
• Medicines used to dissolve blood clots (thrombolytics).
• 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 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 find out 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 from the third month of pregnancy onwards.

Breastfeeding:

Tell your doctor if you are breastfeeding or about to start breastfeeding. While taking enalapril, breastfeeding 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 breastfeeding.

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

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

enalapril cinfa contains sorbitol

This medicine contains 34.80 mg of sorbitol in each tablet.

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

May cause allergic reactions.

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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.
• Do not take more tablets than your doctor has prescribed.
• The tablet can be divided into equal doses.

The recommended dose is:

High blood pressure

For most patients, the initial recommended dose is 5 mg to 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 initial recommended dose is normally 2.5 mg once daily. Your doctor will gradually increase the dose until the suitable dose for you is reached. The recommended long-term dose is 20 mg daily in one or two divided doses.

The maximum long-term dose is 40 mg, 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 the days you undergo 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 and will base it 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 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 in newborn babies (first few 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, contact your doctor or pharmacist immediately.

In case of an overdose, the most likely symptom is a feeling of dizziness or lightheadedness 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, phone 91 562 04 20, stating the medicine and the amount taken.

If you forget to take enalapril cinfa

If you forget to take a tablet, do not take the forgotten 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 your doctor's advice.

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 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 speak with your doctor immediately.

When you start taking this medicine, you may feel loss of consciousness or dizziness. If this occurs, 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 speak with your doctor.

Other adverse effects include:

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

• feeling of 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, angina pectoris, or chest pain
• headache, depression, fainting (syncope), taste disorder
• difficulty breathing
• diarrhea, abdominal pain
• 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)
• myocardial infarction (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 with 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, or throat
• reduced amount of urine produced
• rash with a target-like shape (erythema multiforme)
• “Stevens-Johnson syndrome” and “toxic epidermal necrolysis” (a severe skin disorder in which you have red and peeling skin, ulcers with blisters or open sores), exfoliative dermatitis/erythroderma (severe skin rash with peeling or shedding of the skin), pemphigus (small blisters filled with fluid 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 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 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 Cinfa

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

Do not store above 30°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 SIGRE collection point at the pharmacy. 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 10 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 Ponceau 4R Red (E-124).

Appearance of the Product and Package Contents

Enalapril Cinfa is presented in the form of pink, cylindrical, biconvex, and scored tablets on one face. Each package contains 10, 28, 56, 60, or 500 (clinical package) tablets.

Some package sizes may only 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: September 2018

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/)

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (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