Enalapril Pensa 20 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Enalapril Pensa 20 mg 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 you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Enalapril Pensa is and what it is used for

This medicine contains an active substance called enalapril maleate. It belongs to a group of medicines known as ACE inhibitors (angiotensin-converting enzyme inhibitors).

This medicine is used to:

• treat high blood pressure (hypertension)
• treat heart failure (weakening of the heart's function). It may reduce the need for hospitalisation and may help some patients live longer
• prevent signs of heart failure. 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. The medicine usually starts to work within one hour and its 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 taking Enalapril Pensa

Do not take Enalapril Pensa

• if you are allergic to enalapril maleate or to any of the other ingredients of this medicine (listed in section 6)
• if you have previously 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 this medicine in early pregnancy – see Pregnancy section).

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

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if:

• you have a heart condition
• you have a disease affecting the blood vessels in the brain
• 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)
• you have a liver problem
• you have a kidney problem (including after 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 this medicine or monitor your blood potassium levels
• you are undergoing dialysis
• you have recently experienced excessive vomiting or severe diarrhoea
• you are on a salt-free diet, taking potassium supplements, potassium-sparing medicines, or salt substitutes containing potassium
• you are over 70 years old
• 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
• you have ever had an allergic reaction with swelling of the face, lips, tongue or throat, causing difficulty swallowing or breathing. Please note that black patients have a higher risk of such reactions to ACE inhibitors
• you have low blood pressure (you may feel faint or dizzy, especially when standing up)
• 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, or are taking allopurinol, procainamide, or any combination of these
• 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.
• 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 Pensa”.

Inform your doctor if you think you are pregnant (or could be). This medicine is not recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby (see section Pregnancy).

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

If you are unsure whether any of the above 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 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 Pensa with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including herbal medicines. This is because this medicine may affect how other medicines work, and other medicines may affect how this medicine works. Your doctor may need to adjust 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 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 (“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 medicine”
• certain pain or arthritis medicines, 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 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 unsure whether any of the above apply to you, consult your doctor or pharmacist before starting to take this medicine.

Taking Enalapril Pensa with food and drink

This medicine may be taken with or without food. Most people take this medicine with a glass of 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 recommend an alternative to Enalapril Pensa. This medicine is not recommended in early 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 from the third month of pregnancy onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Breastfeeding is not recommended in newborns (first weeks after birth) and especially in premature infants while taking this medicine. For an older infant, 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.

This medicine contains lactose

This medicine contains lactose, a type of sugar. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Enalapril Pensa

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 once daily.
• The maximum long-term dose is 40 mg once daily.

Heart failure

• The usual initial 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 daily, given in one or two divided doses.
• The maximum long-term dose is 40 mg daily, divided into two doses.

Patients with kidney problems

Your dose will be adjusted depending on how well your kidneys are functioning:

• moderate kidney problems – 5 mg to 10 mg daily
• severe kidney problems – 2.5 mg daily
• if undergoing dialysis – 2.5 mg daily. 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 determine the 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 swallow 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 daily
• over 50 kg – 5 mg daily

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

• a maximum of 20 mg daily may be used in children weighing between 20 kg and 50 kg
• a maximum of 40 mg daily 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 take more Enalapril Pensa than you should

If you take more Enalapril Pensa than you should, consult your doctor or go to hospital immediately. Take the medicine package with you. The following effects may occur: feeling dizzy or lightheaded. 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 Pensa

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

If you stop taking Enalapril Pensa

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

If you have any further questions about 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 everyone gets them.

If you experience any of the following symptoms, stop taking Enalapril Pensa and speak with 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 (wheals).

Please be aware that patients of black race have a higher risk of experiencing these types of reactions. If you experience any of the above reactions, stop taking this medicine and speak with 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 drop in your blood pressure. This will improve as you continue taking the medicine. If you are concerned, please speak with your doctor.

Other adverse effects include:

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

• feeling dizzy, weak, or nauseous
• 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
• high levels of potassium in the blood, elevated creatinine levels in the blood (both usually detected in a blood test).

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, nervousness
• sensation of itching or numbness in the skin
• vertigo (dizziness)
• ringing in the ears (tinnitus)
• runny nose, sore throat, or hoarseness
• asthma-related chest tightness
• slow movement of food through the 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 hives
• hair loss
• malaise (general discomfort), elevated body temperature (fever)
• impotence
• high levels of protein in the urine (detected in a test)
• low blood sugar or sodium levels, elevated blood urea levels (all detected in a blood test).

Rare (may affect up to 1 in 1,000 people)

• “Raynaud’s phenomenon”, in which your hands and feet may become very cold and pale due to poor blood flow
• changes in blood values such as reduced number of white or red blood cells, reduced haemoglobin, reduced platelet count
• 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-ray)
• inflammation of the nose
• lung inflammation 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” (serious skin disorders in which the skin becomes red and peeling, with blisters or open sores), 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, liver inflammation, jaundice (yellowing of the skin or eyes), elevated liver enzymes or bilirubin levels (detected in a blood test)
• breast enlargement in men (gynaecomastia).

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

• swelling in the 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 group of symptoms has been reported which may include one or several 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 effect, talk to your doctor or pharmacist, even if it is a possible adverse effect 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 Pensa

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

Do not use this medicine after the expiry date stated on the blister and outer packaging following EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Enalapril Pensa

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

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

Appearance of the medicine and contents of the pack

This medicine is presented as tablets. The tablets are round, white, and scored.

The score mark is intended only to facilitate breaking the tablet for ease of swallowing and not for dividing into equal doses.

Each pack contains 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer:

Industria Química y Farmacéutica Vir, S.A.

C/ Laguna, 66-68-70

28923 Alcorcón (Madrid)

Date of the most recent revision of this leaflet: October 2016

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