ABECOR 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

ABECOR 10 mg tablets EFG

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 ABECOR and what is it used for
2. What you need to know before you take ABECOR
3. How to take ABECOR
4. Possible side effects
5. Storing ABECOR
6. Contents of the pack and other information

1. What is ABECOR and what is it used for

ABECOR contains the active substance enalapril maleate. It belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors). ABECOR is used to:

• Treat high blood pressure (hypertension)
• Treat heart failure (weakening of the heart's function). It may reduce the need to go to the hospital and may help some patients live longer
• Prevent signs of heart failure. The 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. The medicine usually 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 ABECOR

Do not takeABECOR

• if you are allergic to enalapril maleate or any of the other ingredients of this medicine (listed in section 6)
• if you have ever had an allergic reaction to a medicine similar to this one, called an ACE inhibitor
• If you have ever had swelling of the face, lips, tongue, or throat that caused difficulty swallowing or breathing (angioedema) when the cause was unknown or hereditary
• if you have diabetes or kidney problems and are being treated with a blood pressure medicine that contains aliskiren
• if you are more than 3 months pregnant. (It is also best to avoid ABECOR at the start of pregnancy - see section Pregnancy)
• if you are being treated with sacubitril/valsartan, a medicine for the treatment of a type of long-term (chronic) heart failure in adults, as the risk of angioedema (sudden swelling under the skin in areas such as the throat) increases.

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 ABECOR:

• if you have a heart problem
• 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 a liver problem
• if you have a kidney problem (including kidney transplant). This may cause high levels of potassium in your blood, which can be serious. Your doctor may need to adjust your dose of ABECOR or monitor your potassium levels in your blood
• if you are on dialysis
• if you have recently had severe vomiting or severe diarrhea
• if you are on a low-salt diet, are taking potassium supplements, or are taking potassium-sparing diuretics or salt substitutes that contain potassium
• if you have diabetes. You should monitor your blood for low blood sugar levels, especially during the first month of treatment. Your potassium level in your blood may also be higher
• 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 have a higher risk of these reactions 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, or are taking the medicines allopurinol or procainamide, or any combination of these.
• if you have had a persistent dry cough while using an ACE inhibitor (see section 4 Possible side effects)
• if you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor antagonist (ARA) (also known as a “sartan” - e.g., valsartan, telmisartan, irbesartan, etc.), especially if you have kidney problems related to diabetes.
• aliskiren

If you are taking any of the following medicines, the risk of angioedema may increase:

• Racecadotril, a medicine used to treat diarrhea.
• Medicines used to prevent organ rejection and cancer (e.g., temsirolimus, sirolimus, everolimus)
• Vildagliptin, a medicine used to treat diabetes.

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 ABECOR”.

You must inform your doctor if you think you are pregnant (or might be). This medicine 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).

You should be aware that this medicine reduces blood pressure in black patients less effectively than in non-black patients.

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking 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 ABECOR:

• any surgery or if you are going to receive anesthetics (even 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 applies to you, consult your doctor or dentist before starting the procedure.

Taking ABECOR with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes herbal treatments. This is because ABECOR may affect the way other medicines work. Other medicines may also affect how ABECOR works. Your doctor may need to change 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 the information under the headings “Do not take ABECOR” and “Warnings and precautions”)
• other medicines to reduce blood pressure, such as beta-blockers or water tablets (diuretics)
• potassium supplements (including dietary salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium in your blood (e.g., trimethoprim or cotrimoxazole for the treatment of bacterial infections; cyclosporin, an immunosuppressant used to prevent organ rejection; and heparin, a medicine used to prevent blood clots)
• medicines for diabetes (including oral antidiabetic medicines and insulin)
• lithium (a medicine used to treat a certain type of depression)
• medicines for depression called “tricyclic antidepressants”
• medicines for mental problems called “antipsychotics”
• certain cough and cold medicines and weight loss medicines that contain a substance called a “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 the immune system from rejecting a transplanted organ). See also the information in the section “Warnings and precautions”
• a medicine that contains 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 the information in the sections “Do not take ABECOR” 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 not sure if any of the above applies to you, consult your doctor or pharmacist before taking ABECOR.

Taking ABECOR with food and drink

The absorption of ABECOR is not affected by food intake.

Alcohol and ABECOR may have additive effects and may cause dizziness or fainting. Your doctor will have told you to always drink as little alcohol as possible. If you are concerned about the amount of alcohol you can drink while taking ABECOR, consult your doctor.

If you are on a low-salt diet (sometimes called a low-sodium diet), inform your doctor before taking these tablets.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

You must inform your doctor if you think you are pregnant or might be. Your doctor will normally advise you to stop taking ABECOR before you become pregnant or as soon as you know you are pregnant and will advise you to take a different medicine instead of ABECOR. This medicine 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.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. While taking this medicine, 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 this medicine, compared to other treatments, while breastfeeding.

Driving and using machines

ABECOR may cause side effects such as dizziness, fainting, headache, tiredness, confusion, and blurred vision. If this happens, do not drive or use tools or machines.

Important information about some of the ingredients of ABECOR

ABECOR contains lactose, which is a type of sugar. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take ABECOR

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist again.

High blood pressure

• The usual starting dose is between 5 and 20 mg, taken once a day.
• Some patients may need a lower starting dose.
• The usual long-term dose is 20 mg taken once a day.
• The maximum long-term dose is 40 mg taken once a day.

Heart failure

• The usual starting dose is 2.5 mg, taken once a day.
• Your doctor will gradually increase this amount until the right dose for you is reached.
• The usual long-term dose is 20 mg per day, taken in one or two doses.
• The maximum long-term dose is 40 mg per day, divided into two doses.

Patient 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 per day
• severe kidney problems - 2.5 mg per day
• if you are on dialysis - 2.5 mg per day. On days when you are not on dialysis, your dose may change depending on how low your blood pressure is.

Elderly patients

Your doctor will decide the dose and will be based on how well your kidneys are working.

Use in children

Experience with the use of ABECOR 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 starting doses are:

• between 20 kg and 50 kg - 2.5 mg per day
• over 50 kg - 5 mg per day.

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

• a maximum of 20 mg per day can be used in children who weigh between 20 kg and 50 kg
• a maximum of 40 mg per day 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 children with kidney problems.

If you take more ABECOR than you should

If you take more ABECOR than you should, consult your doctor, go to the hospital immediately, or call the Poison Information Service, phone 91 562 04 20. Take the medicine pack with you and tell them the amount you have taken. The following effects may occur: feeling dizzy or faint. This is due to a sudden or excessive drop in blood pressure.

If you forget to take ABECOR

If you forget to take a tablet, do not take the missed dose.

Take the next dose as usual.

Do not take a double dose to make up for forgotten doses.

If you stop taking ABECOR

Do not stop taking your medicine unless your doctor tells you to.

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 ABECOR and talk to your doctor immediately:

• swelling of the face, lips, tongue, or throat that can cause difficulty swallowing or breathing
• swelling of your hands, feet, or ankles
• 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 ABECOR and talk to your doctor immediately.

When you start taking this medicine, you may feel faint or dizzy. If this happens, lying down can 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 talk to your doctor.

Other adverse effects include:

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

• feeling of 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 heartbeats, chest pain, or chest tightness
• 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 with difficulty swallowing or breathing
• high levels of potassium in the blood, high levels of creatinine in the blood (usually both are 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)
• heart attack (possibly due to very low blood pressure in certain high-risk patients)
• stroke (possibly due to very low blood pressure in high-risk patients)
• anemia (including aplastic anemia and hemolytic anemia)
• confusion, drowsiness, or inability to sleep, nervousness
• feeling of itching or numbness in your skin
• vertigo (feeling of dizziness)
• ringing in the ears (tinnitus)
• runny nose, sore throat, or hoarseness
• asthma-associated 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 can 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 hemoglobin, lower platelet count in the blood
• bone marrow depression
• inflamed glands in the neck, armpits, or groin
• autoimmune diseases
• sleep disturbances or sleep problems
• fluid or other 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, throat
• reduced amount of urine produced
• target-shaped rash (erythema multiforme)
• “Stevens-Johnson syndrome” and “toxic epidermal necrolysis” (a severe skin disorder in which you have red and scaly skin, ulcers with blisters or open sores), exfoliative dermatitis/erythroderma (severe skin rash with scaling or peeling of the skin), pemphigus (small fluid-filled blisters on the skin)
• liver or bile duct problems such as reduced liver function, liver inflammation, jaundice (yellowing 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 your intestine (intestinal angioedema)

Frequency Not Known(frequency cannot be estimated from available data)

• overproduction of antidiuretic hormone, leading to fluid retention, causing weakness, fatigue, or confusion
• a symptomatic complex has been reported that may include all or some of the following symptoms: fever, blood vessel inflammation (serositis, vasculitis), muscle pain (myalgia, myositis), joint pain (arthralgia/arthritis). 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 prospectus. 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 ABECOR

PVC/Aluminum Blister Packs

Store at a temperature below 30°C. Keep in the original package to protect it from moisture.

HDPE Bottle

This medicine does not require any special storage temperature. Keep the bottle tightly closed to protect it from moisture.

Do not store in another container as it may mix. Keep in the original package.

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

Do not use this medicine after the expiration date that appears on the package after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packages and medicines you no longer need at the pharmacy's SIGRE Point. Ask your pharmacist how to dispose of the packages and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of ABECOR

• The active ingredient is enalapril maleate (10 mg)
• The other components are: Maleic Acid, Lactose (58.875 mg), Hypromellose E 464, Croscarmellose Sodium, Stearate and Sodium, Purified Water.

Appearance of the Product and Package Contents

Each tablet is presented in the form of white or off-white, round, flat-faced, beveled, and scored on one side and marked with “10” on the other.

ABECOR 10 mg tablets EFG are available in opaque PVC/Aluminum blister packs of 10, 28, 56, 60, and 500 tablets and HDPE bottles of 10, 28, 56, 60, and 500 tablets.

Marketing Authorization Holder and Manufacturer

UXA farma, S.A.

Avda. San Francisco Javier 24

41018 Sevilla, Spain

Date of the Last Revision of this Prospectus:May 2020

Other Sources of Information

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)