Package Leaflet: Information for the User

EnalaprilNormon5 mg Tablets EFG

enalapril maleate

Read this leaflet carefully before you start to take 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 the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist. Even if they do not appear in this leaflet, see section 4.

Enalapril Normon belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors).

Enalapril is indicated for:

• treatment of hypertension (high blood pressure).
• treatment of symptomatic heart failure.

- prevention of symptomatic heart failure.

Do not take Enalapril Normon:

• if you are allergic to enalapril or any of the other ingredients of this medicine (listed in section 6),
• if you have previously been treated with a medicine from the same group of medicines as Enalapril Normon (ACE inhibitors) and have had allergic reactions with swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing,
• if you have been diagnosed with hereditary or unknown cause angioedema (the development of large hives on the surface of the skin, especially around the eyes and lips, which can also affect hands, feet, and throat and can also cause swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing),
• if you have diabetes or kidney failure and are being treated with a medicine to lower blood pressure that contains aliskirén
• if you are more than 3 months pregnant. (It is also recommended to avoid Enalapril Normon at the beginning of pregnancy - see Pregnancy section)

Be careful with Enalapril Normon:

You should inform your doctor if you think you are pregnant (or may be). Enalapril Normon 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)

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Enalapril Normon.

• If you have heart disease.
• If you have a disease that affects the blood vessels of 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 diabetes mellitus or any kidney problem (including kidney transplant), as these may lead to high levels of potassium in the blood that can be serious.
• If you have liver problems.
• If you are undergoing dialysis.
• If you are receiving diuretic treatment (medicines that increase urine elimination).
• If you have recently had excessive vomiting or diarrhea.
• If you are following a low-sodium diet, taking potassium supplements, potassium-sparing medicines, or salt substitutes that contain potassium, or if you have recently had excessive vomiting or diarrhea.
• If you are over 70 years old.
• If you have ever had an allergic reaction with swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing. You should be aware that black patients are more sensitive to this type of reaction to ACE inhibitors.
• If you are about to undergo a treatment called LDL apheresis, or a desensitization treatment to reduce the effect of an allergy to bee or wasp stings.
• If you have low blood pressure (you may feel dizzy or lightheaded, especially at the beginning of treatment and when standing up. In these cases, lying down may help).
• If you have vascular collagen disease (e.g. lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with immunosuppressive medicines, are taking allopurinol or procainamide, or any combination of these.
• 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" - for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
• aliskirén.

Your doctor may need to monitor your kidney function, blood pressure, and electrolyte levels (e.g. potassium) at regular intervals.

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

You should be aware that Enalapril Normon reduces blood pressure in black patients less effectively than in patients who are not black.

In all these cases, inform your doctor as you may need to adjust your dose or stop taking Enalapril Normon or monitor your potassium levels in the blood. If you have diabetes and are taking oral antidiabetic medicines or insulin, you should closely monitor your blood glucose levels, especially during the first month of treatment with Enalapril Normon.Before undergoing surgery or anesthesia (including dental consultation), inform your doctor or dentist that you are taking Enalapril Normon, as there may be a sudden drop in blood pressure associated with anesthesia.

Enalapril Normon with other medicines:

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine. Certain medicines may interact with Enalapril Normon; in these cases, you may need to change your dose or stop taking one of them. Your doctor may need to modify your dose and/or take other precautions.

It is essential to inform your doctor if you are taking or have taken recently any of the following medicines:

• an angiotensin II receptor antagonist (ARA) or aliskirén (see also the information under the headings “Do not take Enalapril Normon” and “Warnings and precautions”).
• antihypertensive medicines (reduce elevated blood pressure).
• diuretics (medicines that increase urine elimination).
• potassium-containing medicines (including salt substitutes).
• lithium (medicine used to treat certain types of depression).
• tricyclic antidepressants.
• antipsychotics.
• anesthetics.
• antidiabetic medicines (including oral antidiabetic medicines and insulin)
• non-steroidal anti-inflammatory drugs (NSAIDs) (medicines for pain or certain inflammation, e.g. acetylsalicylic acid).
• sympathomimetics.
• certain medicines for pain or arthritis, including gold treatment.
• non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (medicines that reduce inflammation and may be used to help you relieve pain)

Enalapril Normon with food, drinks, and alcohol:

Foods do not affect the absorption of Enalapril Normon.

Alcohol potentiates the hypotensive effect (reduction of blood pressure) of enalapril, so inform your doctor if you are taking beverages that contain alcohol while taking this medicine.

Enalapril Normon can be taken with meals or between them along with a glass of water.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medicine.

Pregnancy

You should inform your doctor if you think you are pregnant (or may be). Normally, your doctor will advise you to stop taking Enalapril Normon before becoming pregnant or as soon as you know you are pregnant and will advise you to take a different medicine instead of Enalapril Normon. Enalapril Normon 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 from the third month of pregnancy.

Lactation

Inform your doctor if you are breastfeeding or are about to start breastfeeding. While taking Enalapril Normon, breastfeeding is not recommended in newborns (first 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 Enalapril Normon compared to other treatments while breastfeeding.

Driving and operating machinery:

Individual responses to medication may vary.

Since Enalapril Normon may cause dizziness or fatigue, avoid performing tasks that require special attention (driving vehicles or operating machinery) until you know how you tolerate the medicine.

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 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Use in children and adolescents

There is limited experience in clinical studies on the use of enalapril in pediatric hypertensive patients.

The tablet can be divided into equal doses.

Hypertension:

For most patients, the recommended initial dose is usually 5 to 20 mg once a day. Some patients may need a lower initial dose.

The usual long-term dose is 20 mg once a day.

Heart failure:

The recommended initial dose is usually 2.5 mg once a day. Your doctor will gradually increase the dose until the appropriate dose is reached for your case. The usual long-term dose is 20 mg per day in one or two doses.

Be cautious at the beginning of treatment, as there is a possibility of dizziness or vertigo appearing.

Inform your doctor immediately if you experience these symptoms.

If you estimate that the action of Enalapril NORMON is too strong or too weak, inform your doctor or pharmacist.

If you take more Enalapril NORMON than you should

If you take more Enalapril Normon than you should, consult your doctor or pharmacist immediately.

In case of an overdose, the most likely symptom is a feeling of dizziness or vertigo due to a sudden or excessive drop in blood pressure.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take EnalaprilNormon

You should continue taking Enalapril Normon as prescribed. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with EnalaprilNormon

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Enalapril Normon can cause side effects, although not everyone will experience them.

If you consider that any of the side effects you are experiencing are severe or if you notice any other side effect not mentioned in this leaflet, consult your doctor or pharmacist.

Blood and lymphatic system disorders:Uncommon:anemia (including aplastic and hemolytic anemia).Rare:blood disorders, such as an abnormally low number of neutrophils, low hemoglobin levels, reduction or complete absence of granulocytes, deficiency of all blood cells, bone marrow depression, lymph node disease or abnormal immune response.

Metabolism and nutrition disorders:Uncommon:low blood sugar (hypoglycemia).

Nervous system and mental disorders:Common:headache, depression.Uncommon:confusion, drowsiness or inability to sleep, nervousness, tingling or numbness, dizziness.Rare:sleep disturbances, sleep problems.

Eye disorders:Very common:blurred vision.

Cardiac and vascular disorders:Very common:dizziness.Common:fall in blood pressure (including orthostatic hypotension), fainting, chest pain, heart rhythm disturbances, angina pectoris, rapid heartbeats.Uncommon:orthostatic hypotension (decrease in blood pressure when sitting or standing up),rapid and strong heartbeats, myocardial infarction or possible stroke in high-risk patients (patients with heart or brain blood flow abnormalities).Rare:small arteries, usually in the hands or feet, that produce spasms causing the skin to become pale or red and blue (Raynaud's phenomenon).

Respiratory, thoracic and mediastinal disorders:Very common:cough.Common:difficulty breathing.Uncommon:nasal mucus discharge, sore throat and hoarseness, asthma.Rare:fluid in the lungs, inflammation of the nasal mucosa membrane, allergic inflammation of the lungs.

Gastrointestinal disorders:Very common:nausea.Common:diarrhea, abdominal pain, altered taste.Uncommon:intestinal obstruction, pancreatitis, vomiting, indigestion, constipation, anorexia, gastric irritation, dry mouth, peptic ulcer.Rare:inflammation and ulcers of the mouth, inflammation of the tongue. Very rare: intestinal angioedema (intestinal swelling)

Hepatobiliary disorders:Rare:hepatic insufficiency, hepatitis, reduction or obstruction of bile flow from the bile duct to the liver (cholestasis including jaundice).

Skin and subcutaneous tissue disorders:Common:skin rash, hypersensitivity or allergic reaction causing swelling of the face, limbs, lips, tongue, glottis and larynx.Uncommon:sweating, pruritus (itching), urticaria (hives), hair loss.Rare:severe skin reaction, including excessive redness of the skin, blisters, skin peeling.

A complex of symptoms has been observed that may include some of the following reactions: fever, inflammation of blood vessels, muscle and joint pain, blood disorders affecting blood components and normally detected in a blood test, skin rash, hypersensitivity to sunlight and other skin effects.

Renal and urinary disorders:Uncommon:reduced renal function or renal insufficiency, presence of proteins in the urine.Rare:reduction in the amount of urine produced per day.

Reproductive and mammary system disorders:Uncommon:impotence.Rare:breast enlargement in men.

General disorders and administration site conditions:Very common:weakness.Common:fatigue.Uncommon:muscle cramps, flushing, ear noises, general malaise, fever.

Investigations:Common:high potassium levels in the blood, increases in creatinine in the blood.Uncommon:increases in urea in the blood, decreases in sodium levels in the blood.Rare:increases in liver enzymes, increases in bilirubin in the blood.

Stop taking Enalapril NORMON and consult your doctor immediately in any of the following cases:

• If your face, lips, tongue and/or throat become swollen, making it difficult to breathe or swallow.

• If your hands, feet or ankles become swollen.

• If you develop urticaria (itching and redness in some areas of the body).

You should be aware that black patients are more sensitive to this type of adverse reaction.

If you consider that any of the side effects you are experiencing are severe or if you notice any other reaction not described in this leaflet, consult your doctor or pharmacist.

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 not mentioned in this leaflet. You can also report them directly through the Spanish System for 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.

Store below25°C.

Store in the original packaging to protect it from moisture.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofEnalapril Normon 5 mg Tablets EFG:

• The active ingredient is enalapril maleate.
• The other components are: sodium hydrogen carbonate, lactose monohydrate, pregelatinized cornstarch and magnesium stearate.

Appearance of the product and contents of the packaging

Enalapril Normon is presented in the form of tablets. Each package contains 10 and 60 tablets. The tablets are white or almost white, round, biconvex, and scored on one side.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Date of the last review of this leaflet: September 2017

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

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

https://cima.aemps.es/cima/dochtml/p/63598/P_63598.html