Package Leaflet: Information for the User

Enalapril pensa 20 mg tablets EFG

Enalapril maleate

Read this 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. Do not give it to others even if they have similar symptoms to 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 section4

This medication contains an active ingredient called enalapril maleate. It belongs to a group of medications called angiotensin-converting enzyme (ACE) inhibitors.

This medication is used for:

• treating high blood pressure (hypertension)
• treating heart failure (weakening of the heart function). It may reduce the need for hospital visits and may help some patients live longer
• preventing 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 medication works by widening your blood vessels. This reduces your blood pressure. Normally, the medication starts to work within one 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 Pensa

• if you are allergic to enalapril maleate or any of the other ingredients of this medicine (listed in section 6)
• if you have ever been treated for an allergic reaction to a similar medicine to this one, called 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 medicine to lower blood pressure that contains aliskiren
• if you are more than 3 months pregnant. (It is also best to avoid this medicine 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 this medicine.

• 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 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 this medicine or monitor your potassium levels in the 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 the 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 black patients 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 alopurinol 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" - e.g. 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 the blood (e.g. potassium), at regular intervals.

See also the information under the heading “Do not take Enalapril Pensa”.

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 at this stage (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.

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 this medicine:

• any surgery or if you are to receive anesthetics (even at the dentist's office)
• a treatment to remove cholesterol from your blood called “LDL apheresis”
• a desensitization treatment to reduce the effect of an allergy to a bee or wasp sting

If any of the above situations apply to you, consult your doctor or dentist before starting the procedure.

Taking Enalapril Pensa with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. This includes herbal remedies. This is because this medicine may affect how other medicines work. Other medicines may also affect how this medicine works. Your doctor may need to adjust your dose and/or take other precautions.

Especially, 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 Enalapril Pensa” and “Warnings and precautions”)
• other medicines to lower blood pressure, such as beta-blockers or diuretics
• potassium-containing medicines (including salt substitutes)
• diabetes medicines (including oral antidiabetic medicines and insulin)
• lithium (a medicine used to treat a certain type 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 clot-dissolving medicines (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 Pensa with food and drink

This medicine can be taken with or without food. Most people take this medicine 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 this medicine before becoming pregnant or as soon as you know you are pregnant and will advise you to take a different medicine instead of Enalapril Pensa. 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 at this stage.

Breastfeeding

Inform your doctor if you are breastfeeding or are about to start breastfeeding. While taking this medicine, it is not recommended to breastfeed newborns (first weeks after birth) and especially 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 machinery

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

This medicine contains lactose

This medicine contains lactose, a type of sugar. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

Follow exactly the administration instructions of this medication as 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 increase this amount gradually 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:

• mild 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 the days you are not undergoing dialysis, your dose may change depending on how low your blood pressure is.

Older patients

Your doctor will decide the dose and will base it 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 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 per day
• over 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 over 50 kg.

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

If you take more Enalapril Pensa than you should

If you take more Enalapril Pensa than you should, consult your doctor or go to the hospital immediately. Bring the medication packaging with you. The following effects may occur: dizziness or vertigo. This is due to a sudden or excessive drop in blood pressure.

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

If you forget to take Enalapril Pensa

• 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 the missed doses.

If you interrupt treatment with Enalapril Pensa

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

If you have any other questions 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 Pensa 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 this medicine 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 10people)

• feeling dizzy, weakness, or vomiting
• blurred vision
• cough.

Common(may affect up to 1 in 10people)

• 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
• high levels of potassium in the blood, high levels of creatinine in the blood (usually both are detected in a blood test).

Rare(may affect up to 1 in 100people)

• rubor
• sudden drop in blood pressure
• rapid and arrhythmic heartbeats (palpitations)
• heart attack (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 your skin
• dizziness (feeling of dizziness)
• ringing in the ears (tinnitus)
• runny nose, sore throat, or hoarseness
• asthma-related chest tightness
• slow movement of food through your intestine (ileus), pancreatitis
• vomiting, indigestion, constipation, anorexia
• irritated stomach (gastritis), dry mouth, ulcers
• muscle cramps
• reduced kidney function, kidney failure
• increased sweating
• itching or urticaria
• hair loss
• general feeling of being unwell, elevated temperature (fever)
• impotence
• high levels of proteins in your urine (determined in a blood 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 1,000people)

• “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 shedding of the skin), 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 10,000people)

• swelling in your intestine (intestinal angioedema)

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

• overproduction of the antidiuretic hormone, which causes fluid retention, leading to weakness, fatigue, or confusion
• a set of symptoms that may include some or all 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 or pharmacist, even if it is a possible side effect that does not appear in this prospectus. 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 this medication out of the sight and reach of children.

Do not use this medication afterthe expiration date that appears on the blister and on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required. Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition ofEnalapril Pensa

The active ingredient is enalapril maleate. Each tablet contains 20 mg of enalapril maleate.

The other components are sodium hydrogen carbonate, cornstarch, pregelatinized sodium carboxymethyl starch (type A) (from potato), magnesium stearate (E470b), and lactose monohydrate.

Appearance of the product and contents of the packaging

This medication is presented in the form of tablets. The tablets are round, white, and scored.

The score is only for splitting and facilitating swallowing but not for dividing into equal doses.

Each package contains 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing:

Industria Química y Farmacéutica Vir, S.A.

C/ Laguna, 66-68-70

28923 Alcorcón (Madrid)

Date of the last review of this leaflet: October 2016

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