ENALAPRIL BD- MABO 20 mg ORALLY DISINTEGRATING TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Enalapril BD-MABO 20 mg buccal dispersible 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 Enalapril BD-MABO 20 mg buccal dispersible tablets are and what they are used for
2. What you need to know before you take Enalapril BD-MABO 20 mg buccal dispersible tablets
3. How to take Enalapril BD-MABO 20 mg buccal dispersible tablets
4. Possible side effects
5. Storage of Enalapril BD-MABO 20 mg buccal dispersible tablets
6. Contents of the pack and other information

1. What Enalapril BD-MABO 20 mg buccal dispersible tablets are and what they are used for

Enalapril BD-MABO 20 mg buccal dispersible tablets contain the active substance enalapril maleate. It belongs to a group of medicines called ACE inhibitors (angiotensin converting enzyme inhibitors).

Enalapril BD-MABO 20 mg buccal dispersible tablets are 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 to work 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 Enalapril BD-MABO 20 mg buccal dispersible tablets

Do not take Enalapril BD-MABO 20 mg buccal dispersible tablets

• if you are allergic to enalapril maleate or any of the other ingredients of Enalapril BD-MABO 20 mg buccal dispersible tablets (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, 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 better to avoid Enalapril BD-MABO 20 mg buccal dispersible tablets at the start of pregnancy – see section Pregnancy).

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 Enalapril BD-MABO 20 mg buccal dispersible tablets:

• 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 Enalapril BD-MABO 20 mg buccal dispersible tablets or monitor your potassium levels in the blood
• if you are on dialysis
• if you have recently had severe vomiting or diarrhea

• if you are on a low-salt 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 sugar levels, especially during the first month of treatment. Your potassium levels in the 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 having these types of 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, are taking the medicines 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 your immune system from rejecting a transplanted organ). You may have a higher risk of having 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 "sartans" - e.g. valsartan, telmisartan, irbesartan), especially 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 BD-MABO 20 mg buccal dispersible tablets".

You should inform your doctor if you think you are pregnant (or might be). This medicine is not recommended during the first trimester 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 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 Enalapril BD-MABO 20 mg buccal dispersible tablets:

• 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 Enalapril BD-MABO 20 mg buccal dispersible tablets with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. This includes herbal treatments. This is because Enalapril BD-MABO 20 mg buccal dispersible tablets may affect the way other medicines work. Other medicines may also affect the way Enalapril BD-MABO 20 mg buccal dispersible tablets work. Your doctor may need to change 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 the information under the headings "Do not take Enalapril BD-MABO 20 mg buccal dispersible tablets" and "Warnings and precautions")
• other medicines to reduce blood pressure such as beta-blockers or water tablets (diuretics)

• potassium-containing medicines (including dietary salt substitutes)
• 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 medicines for cough and cold and weight loss medicines that contain 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 your immune system from rejecting a transplanted organ). See also the information in the section "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 this medicine.

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

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

Pregnancy and breast-feeding

Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Normally your doctor will advise you to stop taking Enalapril BD-MABO before you become 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 during the first trimester 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.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. While taking this medicine, breast-feeding 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 breast-feeding.

Driving and using 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 is a source of phenylalanine that may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to remove it properly.

Enalapril BD-MABO contains sodium

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

3. How to take Enalapril BD-MABO 20 mg buccal dispersible tablets

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

• It is very important that you keep taking this medicine for the time your doctor has prescribed it.
• Do not take more tablets than you have been prescribed

High blood pressure

• The usual initial dose is between 5 and 20 mg, taken once a day.
• Some patients may need a lower initial 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 initial 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 the days you are not on dialysis, your dose may change depending on how low your blood pressure is.

Elderly patients

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

Children

Experience with the use of this medicine in children with high blood pressure 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
• over 50 kg - 5 mg per day

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

• up to 20 mg per day can be used in children who weigh between 20 kg and 50 kg
• up to 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 think the action of Enalapril BD-MABO 20 mg buccal dispersible tablets is too strong or too weak, tell your doctor or pharmacist.

If you take more Enalapril BD-MABO than you should

If you take more Enalapril BD-MABO than you should, talk to your doctor or pharmacist or go to the hospital immediately. Take the medicine pack with you. The following effects may happen: feeling dizzy or faint. This is due to a sudden or excessive drop in blood pressure.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20.

If you forget to take Enalapril BD-MABO

• If you forget to take a tablet, do not take the forgotten dose.
• Take the next dose as usual.
• Do not take a double dose to make up for forgotten doses.

If you stop taking Enalapril BD-MABO

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

If you have any further questions on the use of this product, 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 Enalapril BD-MABO 20 mg tablets 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 Enalapril BD-MABO and talk 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 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 angina
• headache, depression, fainting (syncope), taste disorder
• difficulty breathing
• diarrhea, abdominal pain
• fatigue (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, high levels of creatinine in the blood (usually both are detected in an analysis)

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, even those with alterations in heart or brain blood flow)
• 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
• tingling or numbness sensation 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 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), elevated temperature (fever)
• impotence
• high levels of protein in your urine (determined in an analysis), low levels of sugar or sodium in the blood, high levels of urea 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 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 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), pemphigus (small blisters filled with fluid on the skin)
• liver or bile duct problems such as reduced liver function, liver inflammation, jaundice (yellowish color of the skin or eyes), elevated liver enzyme or bilirubin levels (determined in an analysis)
• 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 set of symptoms has been reported that may include one or more of the following: fever, blood vessel inflammation (serositis, vasculitis), muscle pain (myalgia, myositis), joint pain (arthralgia/arthritis). A rash, photosensitivity, or other skin manifestations may occur.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 ENALAPRIL BD-MABO 20 mg Oral Disintegrating Tablets

Keep out of sight and reach of children.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

Store below 25 ºC

6. Package Contents and ADDITIONAL INFORMATION

Composition of Enalapril BD-MABO 20 mg Oral Disintegrating Tablets

• The active ingredient is enalapril (maleate). Each Enalapril BD-MABO 20 mg oral disintegrating tablet contains 20 mg of enalapril (maleate)
• The other ingredients are D-mannitol, microcrystalline cellulose, ascorbic acid, aspartame, lemon flavor, magnesium stearate, sodium stearyl fumarate.

Appearance of the Product and Package Contents

Enalapril BD-MABO 20 mg is presented in the form of oral disintegrating tablets in packages of 28 tablets. The tablets are white, round, and flat.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

MABO-FARMA S.A.

Vía de los Poblados 3,

Edificio 6, 28033, Madrid,

Spain.

Manufacturer

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.

Date of the Last Revision of this Prospectus: May 2018

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/