Enalapril Cinfa 20 mg tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

enalapril cinfa 20 mg tablets EFG

enalapril maleate

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

Leaflet Contents

1. What enalapril cinfa is and what it is used for
2. What you need to know before taking enalapril cinfa
3. How to take enalapril cinfa
4. Possible side effects
5. How to store enalapril cinfa

Pack contents and additional information

1. What enalapril cinfa is and what it is used for

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

enalapril cinfa is indicated for:

• Treating hypertension (high blood pressure).
• 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: shortness of breath, fatigue after mild physical activity such as walking, or swelling of the ankles and feet.

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

2. What you need to know before taking enalapril cinfa

Do not take enalapril cinfa

• If you are allergic to enalapril maleate or to 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, mouth, tongue, or throat that caused difficulty swallowing or breathing (angioedema) when the cause was unknown or hereditary.
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you are more than 3 months pregnant. (Enalapril should also be avoided early in pregnancy – see Pregnancy section).
• If you are taking sacubitril/valsartan, a medicine for heart failure.

Do not take this medicine if any of the above situations apply to you. If you are unsure, consult your doctor or pharmacist before starting to take this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking enalapril cinfa.

• If you have a heart condition.

• If you have a disease affecting 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 enalapril dose or monitor your blood potassium levels.

• If you are undergoing dialysis.

• If you have had excessive vomiting or severe diarrhea recently.

• If you are on a salt-free diet, taking potassium supplements, potassium-sparing medicines, salt substitutes containing potassium, or other medicines that may increase blood potassium levels, such as heparin (a medicine used to prevent blood clots), medicines containing 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 glucose levels, especially during the first month of treatment. Your blood potassium levels may also be higher.

• If you have ever had an allergic reaction with swelling of the face, lips, tongue, or throat causing difficulty swallowing or breathing. Please note that black patients have a higher risk of such reactions to ACE inhibitors.

• If you have low blood pressure (you may feel faint or dizzy, especially when standing up).

• If you have a vascular collagen disease (e.g. systemic lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with medicines that suppress your immune system, are taking 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 rejection of a transplanted organ), or a medicine containing a neprilysin inhibitor such as sacubitril (available in a fixed-dose combination with valsartan), used in patients with heart failure, or racecadotril, used in patients with acute diarrhea. You may have an increased risk of an allergic reaction called angioedema.

• If you are taking any of the following medicines for high blood pressure (hypertension):

• an angiotensin II receptor antagonist (ARA) (also known as “sartans” – e.g. valsartan, telmisartan, irbesartan, etc.), particularly if you have kidney problems related to diabetes.

• aliskiren.

Your doctor may need to monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.

See also information under the heading “Do not take enalapril cinfa”.

You should be aware that this medicine is less effective in lowering blood pressure in black patients compared to non-black patients.

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

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 (including at the dentist)
• 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 situations apply to you, consult your doctor or dentist before undergoing the procedure.

Other medicines and enalapril cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes herbal remedies. This is because enalapril may affect how other medicines work. Other medicines may also affect how enalapril works.

Your doctor may need to adjust your dose and/or take other precautions.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• An angiotensin II receptor antagonist (ARA) or aliskiren (see also information under the headings “Do not take enalapril cinfa” and “Warnings and precautions”).
• Other medicines to lower blood pressure, such as beta-blockers or diuretics ("water pills").
• Medicines containing potassium (including dietary salt substitutes) or other medicines that may increase blood potassium levels, such as heparin (a medicine used to prevent blood clots), medicines containing 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 health conditions).
• Certain cough and cold medicines and weight-reducing medicines containing a substance called “sympathomimetic agent”.
• 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 rejection of a transplanted organ). See also information in the section “Warnings and precautions”.
• A medicine containing a neprilysin inhibitor such as 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 information in the sections “Do not take enalapril cinfa” and “Warnings and precautions”.
• Non-steroidal anti-inflammatory drugs, 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 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 drink

Enalapril can be taken with or without food. Most people take enalapril with a glass of 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 medicine.

Usually, your doctor will advise you to stop taking enalapril before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Enalapril is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used from the third month onwards.

Breastfeeding:

Inform your doctor if you are breastfeeding or about to start breastfeeding. While taking enalapril, breastfeeding is not recommended in newborns (first weeks after birth), and especially in premature infants. For an older infant, 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 operate tools or machinery.

enalapril cinfa contains lactose

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

enalapril cinfa contains sorbitol

This medicine contains 34.80 mg of sorbitol in each tablet.

enalapril cinfa contains Sunset Yellow FCF (E-110)

May cause allergic reactions.

3. How to take enalapril cinfa

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

It is very important that you continue taking this medicine for as long as your doctor has prescribed it.

The tablet may be divided into equal doses.

Do not take more tablets than those prescribed for you.

High blood pressure

The recommended starting dose ranges from 5 to 20 mg once daily. Some patients may require a lower starting 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 starting 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, taken in one or two doses.

The maximum long-term dose is 40 mg once daily, divided into two doses.

Patients with kidney problems

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

• moderate kidney problems – 5 mg to 10 mg daily.
• severe kidney problems – 2.5 mg daily.
• if undergoing dialysis – 2.5 mg daily. On days when you are not undergoing dialysis, your dose may be adjusted depending on how low your blood pressure is.

Elderly patients

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

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 according to the child's weight and blood pressure. Usual starting doses are:

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

The dose may be adjusted according to the child's needs:

• a maximum of 20 mg daily may be used in children weighing between 20 kg and 50 kg.
• a maximum of 40 mg daily may be used in children weighing over 50 kg.

This medicine is not recommended for newborn infants (first weeks after birth) or for 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 nearest hospital. Take the medicine pack with you.

The following effects may occur: 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 at 91 562 04 20, indicating the medicine 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 make up for forgotten doses.

If you stop taking enalapril cinfa

Do not stop treatment without first consulting your doctor.

If you have any further questions about 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 everyone will experience them.

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

• If your face, lips, tongue or throat swell so much that it becomes difficult for you to breathe or swallow.
• If your hands, feet or ankles swell.
• If you develop a red rash on the skin with swelling (hives).

Please note that black patients have a higher risk of experiencing these types of reactions. If you experience any of the reactions listed above, stop taking enalapril and speak to your doctor immediately.

When you start taking this medicine, you may feel faint or dizzy. If this occurs, lying down may help. This is due to a drop in your blood pressure. This will improve as you continue taking the medicine. If you are concerned, please speak to your doctor.

Other adverse effects include:

Very common (may affect more than 1 in 10 people)

• feeling dizzy, weak or nauseous.
• blurred vision.
• cough.

Common (may affect up to 1 in 10 people)

• dizziness due to low blood pressure, changes in heart rhythm, rapid heartbeat, angina or chest pain
• headache, depression, fainting (syncope), taste disturbances
• difficulty breathing
• diarrhoea, abdominal pain
• tiredness (fatigue)
• rash, allergic reactions with swelling of the face, lips, tongue or throat with difficulty swallowing or breathing
• elevated levels of potassium in the blood, elevated levels of creatinine in the blood (both are usually detected in a blood test).

Uncommon (may affect up to 1 in 100 people)

• flushing
• sudden drop in blood pressure
• rapid and irregular heartbeat (palpitations)
• myocardial infarction (possibly due to very low blood pressure in certain high-risk patients, including those with impaired blood flow to the heart or brain)
• stroke (possibly due to very low blood pressure in high-risk patients)
• anaemia (including aplastic and haemolytic anaemia)
• confusion, drowsiness or inability to sleep, restlessness
• itching or numbness sensation in the skin
• vertigo (dizziness)
• ringing in the ears (tinnitus)
• runny nose, sore throat or hoarseness
• asthma-related chest tightness
• slow movement of food through the intestine (ileus), inflammation of the pancreas
• 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), high temperature (fever)
• impotence
• elevated levels of protein in the urine (detected in a test)
• low blood sugar or sodium levels, elevated blood urea levels (all detected 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 reduced blood flow
• changes in blood values such as reduced numbers of white or red blood cells, reduced haemoglobin levels, reduced platelet count
• bone marrow depression
• swollen glands in the neck, armpits or groin
• autoimmune diseases
• sleep disturbances or sleep problems
• accumulation of fluid or other substances in the lungs (as seen on X-ray)
• inflammation of the nose
• inflammation of the lungs causing difficulty breathing (pneumonitis)
• swelling 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 serious skin disorder in which you have red, peeling skin, blistering ulcers or open sores), exfoliative dermatitis/erythroderma (severe skin rash with peeling or shedding of the skin), pemphigus (small fluid-filled blisters on the skin)
• liver or gallbladder problems such as reduced liver function, liver inflammation, jaundice (yellowing of the skin or eyes), elevated liver enzymes or bilirubin levels (detected in a blood test)
• breast enlargement in men (gynaecomastia).

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, tiredness or confusion
• a group of symptoms has been reported which may include one or more of the following: fever, inflammation of blood vessels (serositis, vasculitis), muscle pain (myalgia, myositis), joint pain (arthralgia/arthritis). Skin rash, photosensitivity or other skin manifestations may also occur.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of enalapril cinfa

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

Nature of the product and pack contents

Enalapril cinfa are orange-colored, cylindrical, biconvex tablets, scored on one side and marked with "E20C" on the other.

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

Only certain pack 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 most recent review of this leaflet: July 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may 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