Enalapril BD- Mabo 20 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Enalapril BD-MABO 20 mg orodispersible 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What ENALAPRIL BD-MABO 20 mg orodispersible tablets is and what it is used for

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

Enalapril BD-MABO 20 mg orodispersible tablets are used to:

• treat high blood pressure (hypertension)
• treat heart failure (weakening of the heart's function). It may reduce the need for hospitalization and may help some patients live longer
• prevent signs of heart failure. These signs include: shortness of breath, tiredness after mild physical activity such as walking, or swelling of the ankles and feet.

This medicine works by widening your blood vessels. This lowers your blood pressure. Normally, the medicine starts to work within one hour and the effect lasts for at least 24 hours. Some people may need several weeks of treatment before the maximum effect on blood pressure is observed.

2. What you need to know before taking Enalapril BD-MABO 20 mg orodispersible tablets

Do not take Enalapril BD-MABO 20 mg orodispersible tablets

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

• if you have ever been treated for an allergic reaction to a medicine similar to this one, known as 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. (It is also advisable to avoid Enalapril BD-MABO 20 mg orodispersible tablets in early pregnancy – see Pregnancy section.)

Do not take this medicine if any of the above situations apply to you. If you are not sure, consult your doctor or pharmacist before starting to take this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Enalapril BD-MABO 20 mg orodispersible tablets:

• 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 levels of potassium in your blood, which can be serious. Your doctor may need to adjust your dose of Enalapril BD-MABO 20 mg orodispersible tablets or monitor your blood potassium levels

• if you are undergoing dialysis

• if you have recently experienced excessive vomiting or severe diarrhoea

• if you are on a salt-free diet, taking potassium supplements, potassium-sparing medicines, or salt substitutes containing 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 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 patients of Black African descent have a higher risk of such reactions to ACE inhibitors

• if you have low blood pressure (you may experience fainting or dizziness, 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, 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). 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), 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 BD-MABO 20 mg orodispersible tablets”.

You should inform your doctor if you think you are pregnant (or could be). This medicine is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby (see Pregnancy section).

Please note that this medicine is less effective in lowering blood pressure in Black patients than in non-Black patients.

If you are not sure whether any of the above situations apply 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 orodispersible tablets:

• 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 desensitisation 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.

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

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes herbal medicines. This is because Enalapril BD-MABO 20 mg orodispersible tablets may affect how other medicines work. Other medicines may also affect how Enalapril BD-MABO 20 mg orodispersible tablets works. Your doctor may need to adjust 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 information under the headings “Do not take Enalapril BD-MABO 20 mg orodispersible tablets” and “Warnings and precautions”)
• other blood pressure-lowering medicines such as beta-blockers or diuretics (“water tablets”)
• potassium-containing medicines (including dietary salt substitutes)
• medicines for diabetes (including oral antidiabetic medicines and insulin)
• lithium (a medicine used to treat certain types of depression)
• antidepressant medicines known as “tricyclic antidepressants”
• medicines for mental disorders known as “antipsychotics”
• certain cough and cold medicines and weight-reducing medicines containing a substance called “sympathomimetic agent”
• certain medicines for pain or arthritis, including gold therapy
• 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 “Warnings and precautions” section
• non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (medicines that reduce inflammation and may help relieve pain)
• aspirin (acetylsalicylic acid)
• medicines used to dissolve blood clots (thrombolytics)
• alcohol

If you are not sure whether any of the above situations apply to you, consult your doctor or pharmacist before taking this medicine.

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

Enalapril BD-MABO 20 mg orodispersible tablets can be taken with or without food. Most people take them with a little 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 before using this medicine. Your doctor will usually advise you to stop taking Enalapril BD-MABO before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative to Enalapril BD-MABO. This medicine is not recommended during early pregnancy and must not be taken after the third month of pregnancy, 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 while taking this medicine in newborns (first weeks after birth) and especially in premature infants. For older infants, your doctor should advise you on the benefits and risks of taking this medicine compared to other treatments during 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 BD-MABO contains aspartame

This medicine contains 2.70 mg of aspartame per tablet.

Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

Enalapril BD-MABO contains sodium

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

3. How to take ENALAPRIL BD-MABO 20 mg orodispersible tablets

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. 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 prescribed.

High blood pressure

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

Heart failure

• The usual starting dose is 2.5 mg, taken once daily.
• Your doctor will gradually increase this dose until the appropriate dose for you is reached.
• The usual long-term dose is 20 mg per day, given in one or two doses.
• The maximum long-term dose is 40 mg per day, 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 per day
• severe kidney problems - 2.5 mg per day
• if undergoing dialysis - 2.5 mg per day. 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 decide your dose based on how well your kidneys are functioning.

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. Usual initial doses are:

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

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

• 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 over 50 kg

This medicine is not recommended in newborn infants (first weeks after birth) or in children with kidney problems.

If you think that the effect of Enalapril BD-MABO 20 mg orodispersible 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 prescribed, contact your doctor or pharmacist or go to hospital immediately. Take the medicine pack with you. The following effects may occur: dizziness or vertigo. These are 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 missed dose.
• Take the next dose at your usual time.
• Do not take a double dose to make up for forgotten doses.

If you stop taking Enalapril BD-MABO

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

If you have any further questions about using 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 BD-MABO 20 mg tablets and speak to your doctor immediately:

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

• swelling of your hands, feet or ankles

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

Please note that black patients have a higher risk of experiencing these types of reactions. If you experience any of the above reactions, stop taking Enalapril BD-MABO and speak to your doctor immediately.

When you start taking this medicine, you may feel faint or dizzy. If this occurs, 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
• elevated potassium levels in blood, elevated creatinine levels in blood (both are usually detected by blood tests)

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, restlessness
• sensation of itching or numbness in your skin
• vertigo (dizzy sensation)
• ringing in the ears (tinnitus)
• runny nose, sore throat or hoarseness
• asthma-related chest tightness
• slow movement of food through your 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 urticaria
• hair loss
• malaise (general discomfort), elevated body temperature (fever)
• impotence
• elevated protein levels in your urine (detected in a test)
• low blood sugar or sodium levels, elevated blood urea levels (all detected 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 poor blood flow
• changes in blood values such as reduced number of white or red blood cells, reduced haemoglobin, reduced number of platelets in blood
• 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)
• 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 in which you have red, peeling skin, blistering sores or open ulcers), 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, inflammation of the liver, jaundice (yellowing of the skin or eyes), elevated liver enzymes or bilirubin levels (detected in blood tests)
• breast enlargement in men (gynaecomastia)

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)

• 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 more 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, consult your doctor, pharmacist or nurse, even if they are possible adverse effects 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 BD-MABO 20 mg orodispersible tablets

Keep out of the sight and reach of children.

Do not use Enalapril BD-MABO 20 mg orodispersible tablets 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.

Store below 25 °C.

6. Contents of the pack and ADDITIONAL INFORMATION

Composition of Enalapril BD-MABO 20 mg orodispersible tablets

• The active substance is enalapril (maleate). Each Enalapril BD-MABO 20 mg orodispersible tablet contains 20 mg of enalapril (maleate).
• The other components are D-mannitol, microcrystalline cellulose, ascorbic acid, aspartame, lemon flavour, magnesium stearate, sodium stearyl fumarate.

Appearance of the medicinal product and contents of the pack

Enalapril BD-MABO 20 mg is presented as orodispersible tablets in packs of 28 tablets. The tablets are white, round and flat.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

MABO-FARMA S.A.

Calle Vía de los Poblados 3,

Edificio 6, 28033, Madrid,

Spain.

Manufacturer

MEIJI PHARMA SPAIN, S.A.

Avda. de Madrid, 94,

28802, Alcalá de Henares, Madrid

Spain

or

MEDREICH PLC

Warwick House, Plane Tree Crescent,

Feltham, TW13 7HF, United Kingdom.

Date of the most recent revision of this leaflet: May 2018

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/