PATIENT INFORMATION LEAFLET

Enalapril BD-MABO 20 mg buccal tablets EFG

Enalapril maleate

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.This includes information about why you are taking this medicine and what it is for.

• 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Enalapril BD-MABO 20 mg buccal tabletscontain an active ingredient called enalapril maleate. Pertains to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors.

Enalapril BD-MABO 20 mg buccal tablets are used for:

• To treat high blood pressure (hypertension)
• To treat heart failure. (Weakening of the heart function). It may reduce the need for hospital visits and may help some patients live longer
• To prevent signs of heart failure. The signs include: difficulty breathing, fatigue 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 to work within an hour and the effect lasts for at least 24 hours. Some people may need several weeks of treatment before they notice the greatest effect on their blood pressure.

Do not take Enalapril BD-MABO20 mg buccal tablets

• if you are allergic to enalapril maleate or any of the other components of Enalapril BD-MABO 20 mg buccal tablets (listed in section 6)

• if you have ever been treated for an allergic reaction to a similar medicine, known as 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 medicine that contains aliskiren

• if you are more than 3 months pregnant. (It is also best to avoid Enalapril BD-MABO 20 mg buccal tablets at the beginning of pregnancy – see Pregnancy section).

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

Consult your doctor or pharmacist before starting to take Enalapril BD-MABO 20 mg buccal tablets:

• if you have a heart problem
• if you have a disease that affects the blood vessels in your brain
• if you have blood disorders such as low white blood cell count (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 that can be serious. Your doctor may need to adjust your dose of Enalapril BD-MABO 20 mg buccal tablets or monitor your potassium levels in your blood
• if you are undergoing dialysis
• if you have had many vomiting episodes (excessive vomiting) or have had intense diarrhea recently

• if you are following a low-sodium diet, taking potassium supplements, potassium-sparing medicines, or salt substitutes that contain potassium
• if you are over 70 years old
• if you have diabetes. You should monitor your blood for low blood glucose levels, especially during the first month of treatment. Your potassium levels in your blood may also be higher

• if you have ever had an allergic reaction with swelling of the face, lips, tongue, or throat that caused difficulty swallowing or breathing. You should be aware that patients of black race have a higher risk of experiencing this type of reaction to ACE inhibitors

• if you have low blood pressure (you may notice it as dizziness or lightheadedness, especially when standing up)
• if you have vascular collagen disease (e.g., lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with immunosuppressive medicines, 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 the immune system from rejecting a transplanted organ). You may be at higher risk of experiencing an allergic reaction called angioedema

• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
• an angiotensin II receptor antagonist (ARA) (also known as “sartanes” – for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes
• aliskiren

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

See also the information under the heading “Do not take Enalapril BD-MABO 20 mg buccal tablets”.

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

You should be aware that this medicine reduces blood pressure in black patients less effectively than in patients who are not black.

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

Before undergoing a procedure

If you are about to undergo any of the following procedures, inform your doctor that you are taking Enalapril BD-MABO 20 mg buccal tablets:

• any surgery or if you are to receive anesthetics (including dental consultations)
• 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 starting the procedure.

Taking Enalapril BD-MABO 20 mg buccal tablets with other medicines

Inform your doctor or pharmacist if you are taking or have recently taken or may need to take any other medicine. This includes herbal remedies. This is because Enalapril BD-MABO 20 mg buccal tablets may affect how other medicines work. Other medicines may also affect how Enalapril BD-MABO 20 mg buccal tablets works. Your doctor may need to adjust your dose and/or take other precautions.

Especially, inform your doctor or pharmacist if you are taking:

• an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not take Enalapril BD-MABO 20 mg buccal tablets” and “Warnings and precautions”)
• other medicines to reduce blood pressure such as beta-blockers or diuretics

• potassium medicines (including salt substitutes)
• diabetes medicines (including oral antidiabetic medicines and insulin)
• lithium (a medicine used to treat certain types of depression)
• tricyclic antidepressants
• antipsychotics
• certain medicines for coughs and colds and weight loss medicines that contain a substance called “sympathomimetic”.
• certain medicines for pain or arthritis, including gold treatment
• mTOR inhibitors (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 “Warnings and precautions” section
• non-steroidal anti-inflammatory medicines, including COX-2 inhibitors (medicines that reduce inflammation and may be used to help you relieve pain)
• aspirin (acetylsalicylic acid)
• blood thinners (thrombolytics)
• alcohol

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

Taking Enalapril BD-MABO 20 mg buccal tablets with food and drinks

Enalapril BD-MABO 20 mg buccal tablets can be taken with or without food. Most people take it with a little water.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before using this medicine. Normally, your doctor will advise you to stop taking Enalapril BD-MABO before becoming pregnant or as soon as you know you are pregnant and will advise you to take a different medicine instead of Enalapril BD-MABO. This medicine is not recommended at the beginning of 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 during this period.

Breastfeeding

Inform your doctor if you are breastfeeding or are about to start breastfeeding. While taking this medicine, breastfeeding is not recommended in newborns (first 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 operating machines

You may feel dizzy or drowsy while taking this medicine. If this happens, do not drive or use tools or machines.

Enalapril BD-MABO contains aspartame

This medicine contains 2.70 mg of aspartame in each tablet.

Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Enalapril BD-MABO contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• It is very important that you continue taking this medication for the time your doctor prescribes.
• Do not take more tablets than those prescribed to you.

Hypertension

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

Heart failure

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

Patients with kidney problems

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

• Moderate kidney problems - 5 mg to 10 mg per day
• Severe kidney problems - 2.5 mg per day
• 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.

Older adults

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

Children

The experience with the use of this medication in children with hypertension is limited. If the child can take 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 per day
• More than 50 kg - 5 mg per day

The dose may be adjusted as needed:

• A maximum of 20 mg per day may be used in children weighing between 20 kg and 50 kg
• A maximum of 40 mg per day may be used in children weighing more than 50 kg

This medication is not recommended for newborns (first weeks after birth) or children with kidney problems.

If you estimate that the action of Enalapril BD-MABO 20 mg tablets is too strong or too weak, inform your doctor or pharmacist.

If you take more Enalapril BD-MABO than you should

Ifyoutake more Enalapril BD-MABO than you should, consult your doctor or pharmacistor go to the hospital immediately. Bring the medication packaging with you. The following effects may occur: dizziness or vertigo.This is dueto a sudden or excessive drop in blood pressure.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 91 562 04 20.

If you forgot to take Enalapril BD-MABO

• 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 compensate for the missed doses.

If you interrupt treatment with Enalapril BD-MABO

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following symptoms, stop taking Enalapril BD-MABO 20 mg tablets and talk to your doctor immediately:

• swelling of the face, lips, tongue, or throat that may cause difficulty swallowing or breathing

• swelling of your hands, feet, or ankles

• if you develop a red rash on your skin with swelling (hives)

You should be aware that patients of black race have a higher risk of experiencing this type of reaction. If you experience any of the reactions mentioned above, stop taking Enalapril BD-MABO and talk to your doctor immediately.

When you start taking this medicine, you may feel a loss of consciousness or feel dizzy. If this happens, lying down may help. This is due to a decrease in your blood pressure. This will improve as you continue to take the medicine. If you are concerned, please talk to your doctor.

Other side effects include:

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

• sensation 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)
• eruption, allergic reactions with swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing
• elevated potassium levels in the blood, elevated creatinine levels in the blood (usually both are detected in a blood test)

Rare(may affect up to 1 in 100 people)

• rubor
• sudden drop in blood pressure
• rapid and arrhythmic heartbeats (palpitations)
• myocardial infarction (possibly due to very low blood pressure in certain high-risk patients, even those with alterations in 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 (sensation 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 (gastritis), dry mouth, ulcers
• muscle cramps
• reduced kidney function, renal failure
• increased sweating
• itching or urticaria
• hair loss
• general feeling of illness, elevated temperature (fever)
• impotence
• elevated protein levels in the urine (determined in a blood test)
• low blood sugar or sodium levels, elevated urea levels in the blood (all determined in blood tests)

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 blood cells or red blood cells, lower hemoglobin levels, 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 accumulation or other substances in the lungs (as seen in X-rays)
• inflamed nose
• inflamed lungs causing difficulty breathing (pneumonia)
• inflamed cheeks, gums, tongue, lips, throat
• reduced urine production
• eruption in the shape of a target (erythema multiforme)
• Stevens-Johnson syndrome and toxic epidermal necrolysis (a severe skin disorder in which you have red skin, peeling skin, ulcers with vesicles, or open ulcers), dermatitis exfoliativa/erythroderma (severe skin eruption with peeling or skin shedding), pemphigus (small blisters filled with fluid on the skin)
• liver or bile duct problems such as reduced liver function, liver inflammation, jaundice (yellow skin or eyes), elevated liver enzymes or bilirubin levels (determined in a blood test)
• enlarged breasts in men (gynecomastia).

Very rare(may affect up to 1 in 10,000 people)

• swelling in your intestine (intestinal angioedema)

Frequency unknown(the frequency cannot be estimated from the available data)

• excessive production of the antidiuretic hormone, which causes fluid retention, leading to weakness, fatigue, or confusion
• a set of symptoms that may include one or more of the following: fever, inflammation of blood vessels (serositis, vasculitis), muscle pain (myalgia, myositis), joint pain (arthralgia/arthritis). It may cause a rash, photosensitivity, or other skin manifestations.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

Do not use Enalapril BD-MABO 20 mg buccal tablets after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

Store below25 °C

Composition of Enalapril BD-MABO20 mg buccal dispersible tablets

-The active ingredient is enalapril (maleate). Each Enalapril BD-MABO 20 mg buccal dispersible tablet contains 20 mg of enalapril (maleate)

-The other components are D-mannitol, microcrystalline cellulose, ascorbic acid, aspartame, lemon essence, magnesium stearate, sodium stearyl fumarate.

Appearance of the product and contents of the packaging

Enalapril BD-MABO 20 mg is presented in the form of buccal dispersible tablets in packaging of28tablets. The tablets are white, round, and flat.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

MABO- FARMA S.A.

Calle Rejas 2, planta 1

28821 (Coslada) Madrid

Responsible for manufacturing

MEIJI PHARMA SPAIN, S.A.

Avda. de Madrid, 94,

28802, Alcala de Henares, Madrid

Spain

or

MEDREICH PLC

Warwick House, Plane Tree Crescent,

Feltham, TW13 7HF, United Kingdom.

Last review date of this leaflet: May 2018

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/