Enalapril Pensa 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Enalapril Pensa 5 mg tablets EFG

Enalapril maleate

Read the entire leaflet carefully before you start taking this medicine, as 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, since 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.

Contents of the leaflet

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 adverse 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 for:

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

This medicine works by widening your blood vessels, thereby lowering your blood pressure. The medicine usually starts to work within one hour, and the effect lasts for at least 24 hours. Some people may require several weeks of treatment before the full effect on blood pressure is observed.

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 ever been treated for an allergic reaction to a similar medicine called 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 not sure, consult your doctor or pharmacist before starting to take this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take 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 potassium levels 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 had frequent vomiting (excessive vomiting) or recent 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 patients of black race 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 transplanted organs). 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 need to 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”.

Tell your doctor if you think you are pregnant (or might be). This medicine is not recommended during 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 during this period (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 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. This includes herbal medicines. 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.

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 Pensa” and “Warnings and precautions”)
• other medicines to lower 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 certain types of depression)
• antidepressant medicines called "tricyclic antidepressants"
• medicines for mental disorders called "antipsychotics"
• certain cough and cold medicines and weight-reducing medicines containing 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 rejection of transplanted organs). See also information in the section “Warnings and precautions”
• non-steroidal anti-inflammatory medicines, 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 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 recommend an alternative to Enalapril Pensa. This medicine is not recommended during 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 while taking this medicine in newborns (first weeks after birth) and especially in premature infants. For an older infant, your doctor should advise you on the benefits and risks of taking this medicine compared to other treatments while breastfeeding.

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.

This medicine contains lactose and sunset yellow FCF

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

This medicine may cause allergic reactions because it contains sunset yellow FCF (E 110), an azo dye. It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Enalapril Pensa

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, please 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 initial 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 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 per day, taken 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 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. 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 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 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: dizziness or vertigo. 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 as scheduled.
• 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 experiences them.

If you experience any of the following symptoms, stop taking Enalapril Pensa 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 rash on the skin 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 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)

• 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
• elevated levels of potassium in the blood, elevated creatinine levels in your blood (both are 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 your skin
• vertigo (dizziness)
• 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 hives
• hair loss
• malaise (general discomfort), elevated temperature (fever)
• impotence
• elevated levels of protein in your urine (detected in a test)
• low blood sugar or sodium levels, elevated blood urea levels (all determined by 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 pale due to poor blood flow
• changes in blood values such as reduced numbers 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-rays)
• inflammation of the nose
• inflammation of the lungs causing difficulty breathing (pneumonitis)
• swelling 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 you have red, peeling skin, blistering 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 your intestine (intestinal angioedema)

Frequency not known (frequency cannot be estimated from the available data)

• excessive production of antidiuretic hormone, leading to fluid retention and 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 on the 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 container to protect it from moisture.

Medicines must 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 are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Enalapril Pensa

The active substance is enalapril maleate. Each tablet contains 5 mg of enalapril maleate.

The other components are sodium hydrogen carbonate, corn starch, sodium carboxymethyl starch (type A) (from potato), pregelatinized, magnesium stearate (E470b), monohydrate lactose, and orange-yellow S (E 110).

Appearance of the medicine and contents of the pack

This medicine is presented as tablets. The tablets are round, orange in colour, and scored.

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

Each pack contains 10 or 60 tablets.

Only certain pack sizes may be marketed.

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 review 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.