Enalapril Normon 10 mg tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Enalapril Normon 10 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, because it may harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Enalapril Normon contains an active substance called enalapril maleate. It belongs to a group of medicines known as 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. 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, 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 seen.

2. What you need to know before taking Enalapril Normon

Do not take Enalapril Normon

• 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 enalapril in early pregnancy – see Pregnancy section).
• If you have taken or are currently 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, such as in the throat) is high.

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

Talk to your doctor or pharmacist before taking Enalapril Normon:

• 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 after a kidney transplant), follow a salt-free diet, take potassium supplements, potassium-sparing medicines, salt substitutes containing potassium, or other medicines that may increase blood potassium levels, such as heparin (a medicine used to prevent blood clots), medicines containing trimethoprim or cotrimoxazole, also known as trimethoprim/sulfamethoxazole (medicines used to treat infections). This may lead to high levels of potassium in your blood, which can be serious. Your doctor may need to adjust your enalapril dose or monitor your blood potassium levels. See also information under the heading “Other medicines and Enalapril Normon”.

• If you undergo dialysis.

• If you have experienced repeated vomiting (excessive vomiting) or have recently had severe diarrhea.

• 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 level 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 black patients have a higher risk of this type of reaction to ACE inhibitors.

• If you have low blood pressure (you may feel faint or dizzy, 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, or are taking allopurinol or procainamide, or any combination of these.

• If you are taking any of the following medicines, your risk of developing angioedema may increase:

• racecadotril, a medicine used to treat diarrhea.

• medicines used to prevent rejection of organ transplants and for cancer (e.g., temsirolimus, sirolimus, everolimus).

• vildagliptin, a medicine used to treat diabetes.

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

• an angiotensin II receptor antagonist (ARA) (also known as “sartans” – for example, 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 information under the heading “Do not take Enalapril Normon”.

You should inform your doctor if you think you are pregnant (or could be). This medicine is not recommended in early 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 during this period (see Pregnancy section).

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

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 enalapril:

• Any surgery or if you are to receive anesthetics (including 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 bee or wasp stings.

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

Other medicines and Enalapril Normon

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes herbal remedies. This is because enalapril may affect how other medicines work. Other medicines may also affect how enalapril 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 Normon” and “Warnings and precautions”).
• Other medicines to lower blood pressure, such as beta-blockers or diuretics (“water pills”).
• Medicines containing potassium (including dietary salt substitutes) or other medicines that may increase blood potassium levels, such as heparin (a medicine used to prevent blood clots), medicines containing 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 certain types of depression).
• Medicines for depression called “tricyclic antidepressants”.
• Medicines for mental disorders called “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 the immune system from rejecting a transplanted organ). See also information under the heading “Warnings and precautions”.
• A medicine containing a neprilysin inhibitor such as sacubitril (available in a fixed-dose combination with valsartan) and racecadotril or vildagliptin. This may increase the risk of angioedema (swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing). See also information in 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 help relieve pain).
• Aspirin (acetylsalicylic acid).
• Medicines used to dissolve blood clots (thrombolytics).
• Alcohol.

If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before starting to take enalapril.

Taking Enalapril Normon with food and drinks

Enalapril can be taken with or without food. Most people take enalapril 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 enalapril before becoming pregnant or as soon as you know you are pregnant and will recommend an alternative medicine to enalapril. This medicine is not recommended during early pregnancy and must not be taken after 3 months 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 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.

Enalapril Normon contains lactose and sodium

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

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

3. How to take Enalapril Normon

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. 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.
• The tablet may be divided into equal doses.

High blood pressure

• The usual initial dose ranges between 5 mg 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 medicine dose will change depending 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 change depending on how low your blood pressure is.

Elderly patients

Your doctor will decide the dose based on how well your kidneys are functioning.

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. 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 Normon than you should

If you take more enalapril than prescribed, consult your doctor or go to hospital immediately. Take the medicine packaging 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, call the Toxicology Information Service at telephone number 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 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 and speak to your doctor immediately:

• Swelling of your 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 note that patients of black race have a higher risk of experiencing these types of reactions. If you experience any of the reactions listed above, stop taking enalapril 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.
• High 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 or irregular heartbeat (palpitations).

• Myocardial infarction (possibly due to very low blood pressure in certain high-risk patients, even 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.

• Itching or numbness sensation in the skin.

• Dizziness (feeling of spinning).

• Ringing in the ears (tinnitus).

• Runny nose, sore throat or hoarseness.

• Asthma – associated with chest tightness.

• Slowed 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), high temperature (fever).

• Impotence.

• High 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 white due to reduced 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 difficulty sleeping.

• Accumulation of fluid or other substances in the lungs (as seen on X-rays).

• Inflammation of the nose.

• Lung inflammation causing difficulty breathing (pneumonitis).

• Inflammation of the cheeks, gums, tongue, lips, throat.

• Decreased amount of urine produced.

• Rash with target-like appearance (erythema multiforme).

• “Stevens-Johnson syndrome” and “toxic epidermal necrolysis” (serious skin disorders in which you have red, peeling skin, 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 your intestine (intestinal angioedema).

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

• Excessive production of antidiuretic hormone, causing fluid retention, leading to 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 effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Normon

Do not use this medicine after the expiry date stated on the blister and carton following EXP. The expiry date refers to 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. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Enalapril Normon

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

Appearance of the medicine and contents of the pack

Red, round, biconvex tablets, with a score line on one side and printed on the other side with "10", 8.1 mm ± 10% in diameter. 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 clinical packaging).

Pack sizes:

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent revision of this leaflet: May 2022

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

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

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