Enalapril Cinfa 10 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

enalapril cinfa 10 mg tablets

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 adverse effects
5. How to store enalapril cinfa
6. 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 the 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, 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 maximum effect on blood pressure is observed.

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 previously been treated with a medicine from the same drug class as enalapril (ACE inhibitors) and experienced allergic reactions with swelling of the face, lips, tongue, and/or throat, causing difficulty swallowing or breathing.
• If you have been diagnosed with hereditary or idiopathic angioedema (development of large hives on the skin surface, especially around the eyes and lips, which may also affect hands, feet, and throat, and may cause swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing).
• If you have diabetes or renal impairment and are being treated with an antihypertensive medicine containing aliskiren.
• If you are more than 3 months pregnant. (Enalapril should also be avoided in early 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 this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking enalapril cinfa:

• If you have heart disease.

• If you have a disease affecting the blood vessels of 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 are undergoing dialysis.

• If you have recently experienced excessive vomiting or diarrhea.

• If you are on a salt-free diet, take 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 mellitus, hypoaldosteronism, or any kidney problems (including kidney transplant), as these may lead to high potassium levels in the blood, which can be serious.

• 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 are more susceptible to this type of reaction to ACE inhibitors.

• If you have low blood pressure (you may experience fainting or dizziness, especially when standing up).

• If you have vascular collagen disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with immunosuppressive medicines, or are taking allopurinol, 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 developing 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 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”.

Please note that enalapril cinfa is less effective in lowering blood pressure in black patients compared to 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 (including at the dentist's office).
• A treatment to remove cholesterol from your blood called "LDL apheresis".
• 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 starting the procedure.

You must inform your doctor if you think you are pregnant (or could be). Enalapril is not recommended during early pregnancy and should 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

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes herbal remedies.

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

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 adjust your dose and/or take other precautions:

• An angiotensin II receptor antagonist (ARA) or aliskiren (see also information under the headings “Do not take enalapril cinfa” and “Warnings and precautions”).
• Antihypertensive medicines (reduce high blood pressure).
• Diuretics (medicines that increase urine elimination).
• Potassium-containing medicines (including dietary salt substitutes) or other medicines that may increase potassium levels in blood, 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).
• Lithium (a medicine used to treat certain types of depression).
• Tricyclic antidepressants (a type of antidepressant).
• Antipsychotics (medicines used in the treatment of mental disorders).
• Anesthetics.
• Antidiabetic medicines (medicines that lower blood glucose levels, including oral antidiabetics and insulin).
• Aspirin (acetylsalicylic acid).
• Certain cough and cold medicines and weight-reducing medicines containing a substance called "sympathomimetic agent".
• Certain pain or arthritis medicines, including gold therapy.
• Non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (medicines that reduce inflammation and may 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 information under the heading “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 sections “Do not take enalapril cinfa” and “Warnings and precautions”.
• Medicines used to dissolve blood clots (thrombolytics).
• Alcohol.

Taking enalapril cinfa with food and drink

Enalapril may 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.

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 another medicine instead of enalapril. Enalapril is not recommended during early pregnancy and should 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. While taking enalapril, breastfeeding is not recommended in newborns (first weeks after birth), and especially in premature infants. In the case of 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 occurs, do not drive or operate tools or machinery.

enalapril cinfa contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

enalapril cinfa contains sorbitol

This medicine contains 34.80 mg of sorbitol in each tablet.

enalapril cinfa contains Ponceau 4R (E-124)

May produce allergic reactions.

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.
• Do not take more tablets than those prescribed for you.
• The tablet can be divided into equal doses.

The recommended dose is:

High blood pressure

For most patients, the recommended initial dose is 5 mg to 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 recommended initial dose is usually 2.5 mg once daily. Your doctor will gradually increase the dose until the appropriate dose for your case is reached. The recommended long-term dose is 20 mg daily, taken either once or twice daily.

The maximum long-term dose is 40 mg, 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 undergo dialysis, your dose may be adjusted depending on how low your blood pressure is.

Elderly patients

Your doctor will determine the dose based on kidney function.

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 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 in newborn infants (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, contact your doctor or pharmacist immediately.

In case of overdose, the most likely symptom is dizziness or vertigo 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 your doctor's instruction.

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 in any of the following cases:

• 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 (wheals).

Please note that black patients have a higher risk of experiencing these types of reactions. If any of the above reactions occur, 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 with your doctor.

Other adverse 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 heartbeat, angina, or chest pain
• headache, depression, fainting (syncope), taste disturbances
• difficulty breathing
• diarrhea, 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 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)
• anemia (including aplastic and hemolytic anemia)
• confusion, drowsiness, or inability to sleep, nervousness
• sensation of itching or numbness in the skin
• vertigo (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), 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), elevated 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 lower numbers of white or red blood cells, lower hemoglobin levels, 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
• inflammation of the lungs causing difficulty breathing (pneumonitis)
• swelling of the cheeks, gums, tongue, lips, or 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 (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 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 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 effects, talk to your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly via the Spanish System for Pharmacovigilance of 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 30°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 should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. 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 10 mg of enalapril maleate.
• The other components (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 (E-124).

Appearance of the product and contents of the pack

enalapril cinfa is presented as rose-coloured, cylindrical, biconvex, and scored tablets on one side. Each pack contains 10, 28, 56, 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 - Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Date of the most recent review of this leaflet: September 2018

Detailed 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 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/73300/P_73300.html

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