ENALAPRIL NORMON 10 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Enalapril Normon 10 mg 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 is Enalapril Normon and what is it used for
2. What you need to know before you take Enalapril Normon
3. How to take Enalapril Normon
4. Possible side effects
5. Storage of Enalapril Normon
6. Contents of the pack and other information

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

Enalapril Normon contains the active substance enalapril maleate. It belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).

Enalapril is 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. 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. Normally, the medicine 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 Normon

Do not take Enalapril Normon

• 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 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 best to avoid enalapril at the start of pregnancy - see section Pregnancy).
• If you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is high.

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 Normon:

• 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), are on a low-salt diet, are taking potassium supplements, potassium-sparing medicines, salt substitutes that contain potassium, or other medicines that may increase potassium levels in the blood, such as heparin (a medicine used to prevent blood clots), trimethoprim or cotrimoxazole, also known as trimethoprim/sulfamethoxazole (medicines used to treat infections). This may cause high levels of potassium in your blood, which can be serious. Your doctor may need to adjust your dose of enalapril or monitor your potassium levels in the blood. See also the information under the heading "Other medicines and Enalapril Normon".
• If you are undergoing dialysis.
• If you have recently had severe vomiting or intense diarrhea.
• 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 level 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 these 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 any of the following medicines, the risk of angioedema may increase:

• Racecadotril, a medicine used to treat diarrhea.
• Medicines used to prevent organ rejection and cancer (e.g., temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine used to treat diabetes.

• If you are taking any of the following medicines used to treat high blood pressure (hypertension):

• An angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings "Do not take Enalapril Normon" and "Warnings and Precautions").
• Other medicines to reduce blood pressure, such as beta-blockers or water pills (diuretics).
• Medicines with potassium (including dietary salt substitutes) or other medicines that may increase potassium levels in the blood, such as heparin (a medicine used to prevent blood clots), trimethoprim or cotrimoxazole, also known as trimethoprim/sulfamethoxazole (medicines used to treat infections).
• 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 agent".
• 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 the immune system from rejecting a transplanted organ). See also the information under the heading "Warnings and Precautions".
• A medicine that contains a neprilysin inhibitor such as sacubitril (available in a fixed-dose combination with valsartan) and racecadotril or vildagliptin. It may increase the risk of angioedema (swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing). See also the information in the sections "Do not take Enalapril Normon" and "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 enalapril.

Taking Enalapril Normon with food and drinks

Enalapril can be taken with or without food. Most people take enalapril 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 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. This medicine is not recommended during the first trimester of 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 after the third month of pregnancy.

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 Normon contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

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

3. How to take Enalapril Normon

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 as long as your doctor prescribes it.
• Do not take more tablets than your doctor has prescribed.
• The tablet can be divided into equal doses.

High blood pressure

• The usual initial dose is between 5 mg 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.

Patients 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 undergoing dialysis - 2.5 mg per day. On days when you are not undergoing 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.

Use in children

Experience with the use of enalapril 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.
• More than 50 kg - 5 mg per day.

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

• A maximum of 20 mg per day can be used in children who weigh between 20 kg and 50 kg.
• A maximum of 40 mg per day can be used in children who weigh more than 50 kg.

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

If you take more Enalapril Normon than you should

If you take more enalapril than you should, consult your doctor or go to the hospital immediately. Take the medicine pack with you. The following effects may happen: feeling dizzy or lightheaded. This is due to a sudden or excessive drop in blood pressure.

In case of overdose or accidental ingestion, call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Enalapril Normon

• 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 forgotten doses.

If you stop taking Enalapril Normon

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

If you have any further questions on 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 all people suffer from them.

If you experience any of the following symptoms, stop taking enalapril and talk to your doctor immediately:

• Swelling of your 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 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 chest tightness.
• Headache, depression, fainting (syncope), taste disorder.
• Difficulty breathing.
• Diarrhea, abdominal pain.
• Fatigue (tiredness).
• 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)

• Flush.
• Sudden drop in blood pressure.
• Rapid or irregular heartbeats (palpitations).
• Myocardial infarction (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.
• Feeling of itching or numbness in your skin.
• Vertigo (feeling of dizziness).
• Tinnitus (ringing in the ears).
• Rhinitis, sore throat, or hoarseness.
• Asthma - associated with 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 a blood test).

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 problems sleeping.
• 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.
• Rash with a target-like shape (erythema multiforme).

• "Stevens-Johnson syndrome" and "toxic epidermal necrolysis" (a severe skin disorder in which you have red and scaly skin, with blisters or open sores), exfoliative dermatitis/erythroderma (severe skin rash with scaling or peeling of the skin), pemphigus (small blisters filled with fluid on the skin).

• Liver or bile duct problems such as decreased liver function, liver inflammation, jaundice (yellowing of the skin or eyes), elevated liver enzymes or bilirubin levels (determined in a blood test).
• Increased breast size 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). Rash, photosensitivity, or other skin manifestations may occur.

Reporting Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects that do not appear in this leaflet. 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 Normon

Do not use this medicine after the expiration date stated on the blister pack and carton after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Keep in the outer packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Enalapril Normon

• The active ingredient is enalapril maleate. Each tablet contains 10 mg of enalapril maleate.
• The other ingredients are: lactose monohydrate, pregelatinized corn starch, corn starch, sodium hydrogen carbonate, red iron oxide (E172), magnesium stearate.

Appearance of the Product and Package Contents

Red, round, biconvex tablets with a score line on one side and engraved with "10" on the other side, with a diameter of 8.1 mm ± 10%. The tablet can be divided into equal doses.

Enalapril Normon is available in aluminum/polyamide-aluminum-PVC blisters (single-dose blister only in the case of the clinical package).

Package sizes:

10 mg: 10, 28, 56, 60 tablets, and 500 tablets (as a clinical package).

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of Last Revision of this Leaflet:May 2022

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/87272/P_87272.html