Enalapril Cinfa 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

enalapril cinfa 5 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 other people, even if they have the same symptoms as you, because it may 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

Contents of the pack and other 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 symptoms of heart failure. Symptoms include: shortness of breath, fatigue after mild physical activity such as walking, and swelling of the ankles and feet.

This medicine works by widening your blood vessels, thereby lowering your blood pressure. The medicine usually starts to work within one hour, and the effect lasts for at least 24 hours. Some people may require several weeks of treatment before the full effect on blood pressure is achieved.

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 similar medicine called an ACE inhibitor.
• If you have ever had swelling of the face, lips, mouth, tongue, or throat causing 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 at the beginning of pregnancy – see Pregnancy section).
• If you are being treated with 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 levels or absence of 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 lead to high potassium levels 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 recently experienced excessive vomiting or severe diarrhea.
• 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 blood sugar 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 this type of reaction 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, or 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 the information under the heading “Do not take enalapril cinfa”.

You should inform your doctor if you think you are pregnant (or could be). This medicine is not recommended at the beginning 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 during this stage (see Pregnancy section).

Please note 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 anaesthetics (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 apply to you, consult your doctor or dentist before starting 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, inform 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 tablets”).
• 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 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 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 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 unsure whether any of the above 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Your doctor will usually 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 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:

Inform your doctor if you are breastfeeding or about to start breastfeeding. Breastfeeding is not recommended in newborns (first weeks after birth) while taking enalapril, especially in premature babies. For older infants, your doctor should advise you on the benefits and risks of taking enalapril compared to other treatments while breastfeeding.

Driving and using machines

This medicine may cause dizziness or drowsiness. If this occurs, 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, talk to your doctor before taking this medicine.

enalapril cinfa contains sorbitol

This medicine contains 34.80 mg of sorbitol in each tablet.

3. How to take enalapril cinfa

Follow exactly the instructions for use of 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 prescribed.

High blood pressure

The recommended initial dose ranges between 5 and 20 mg once daily. Some patients may require 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 your condition 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 daily, divided into two doses.

Patients with kidney problems

Your dose will depend 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 determine the dose based on how well your kidneys are functioning.

Use in children

Experience with enalapril use 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. Usual initial 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 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 straight away. Take the medicine pack 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, 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 a missed dose.

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 gets 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 happens, 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)

• 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 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
• high levels of potassium in the blood, elevated creatinine levels in your 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, nervousness
• itching or numbness sensation in your skin
• dizziness (feeling of spinning)
• ringing in the ears (tinnitus)
• runny nose, sore throat or hoarseness
• asthma-related chest tightness
• slow movement of food through your 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), high temperature (fever)
• impotence
• high levels of protein in your urine (detected in a test)
• low blood sugar or sodium levels, high 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 poor blood flow
• changes in blood values such as lower numbers of white or red blood cells, reduced haemoglobin, lower 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-rays)
• inflammation of the nose
• lung inflammation causing difficulty breathing (pneumonitis)
• 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 serious skin disorder where you have red, peeling skin, blisters 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, causing fluid retention, leading to weakness, fatigue or confusion
• a group of symptoms has been reported which may include one or several 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 Medicines: 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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. 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 5 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), and hydrogenated castor oil.

Appearance of the medicinal product and contents of the container

enalapril cinfa are white, cylindrical, biconvex tablets, scored on one side and marked with the code "E5C" on the other.

They are presented in aluminum/aluminum blisters. Each pack contains 10, 60 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 Medical Devices (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 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