ENALAPRIL NORMON 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

EnalaprilNormon5 mg EFG Tablets

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 and other information

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

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

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

Enalapril is used to:

• treat high blood pressure (hypertension).
• treat symptomatic heart failure.

• prevent symptomatic heart failure.

2. What you need to know before you take Enalapril Normon

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 been treated with a medicine of the same group 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 idiopathic angioedema (development of large hives on the skin surface, 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 problems and are being treated with a blood pressure-lowering medicine that contains aliskiren
• if you are more than 3 months pregnant. (It is also recommended to avoid Enalapril Normon at the beginning of pregnancy - see section Pregnancy)

Be especially careful with Enalapril Normon

You should inform your doctor if you think you are pregnant (or might 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 section Pregnancy)

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 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 diabetes mellitus or any kidney problems (including kidney transplant), as these can lead to high levels of potassium in the blood, which can be serious.
• If you have liver problems.
• If you are undergoing dialysis.
• If you are receiving treatment with diuretics (medicines that increase urine production).
• If you have recently had excessive vomiting or diarrhea.
• If you are on a salt-free diet, taking potassium supplements, potassium-sparing medicines, or salt substitutes that contain potassium, or medicines associated with increased potassium levels in the blood (e.g., anticoagulants such as heparin), 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 desensitization treatment to reduce the effect of an allergy to bee or wasp stings.
• If you have low blood pressure (you may notice dizziness or fainting, especially in the initial doses 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 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 used to treat high blood pressure (hypertension):
• an angiotensin II receptor antagonist (ARA) (also known as "sartans" - e.g., valsartan, telmisartan, irbesartan), especially 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 Normon"

You should be aware that Enalapril Normon lowers blood pressure in black patients less effectively than in non-black patients.

In all these cases, inform your doctor as you may need a dose adjustment or discontinuation of medication with Enalapril Normon or monitoring of your potassium blood level. If you have diabetes and are taking oral antidiabetics 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 (even at the dentist), inform your doctor or dentist that you are taking Enalapril Normon, as there may be a sudden drop in blood pressure associated with anesthesia.

Taking Enalapril Normon with other medicines:

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. Certain medicines may interact with Enalapril Normon; in these cases, it may be necessary to change the dose or interrupt treatment with one of them. Your doctor may need to adjust your dose and/or take other precautions.

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

• An angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings "Do not take Enalapril Normon" and "Warnings and precautions").
• Blood pressure-lowering medicines (antihypertensives).
• Diuretics (medicines that increase urine production).
• Potassium-containing medicines (including dietary salt substitutes).
• Lithium (a medicine used to treat certain types of depression).
• Tricyclic antidepressants.
• Antipsychotics.
• Anesthetics.
• Antidiabetics (including oral antidiabetics and insulin)
• Non-steroidal anti-inflammatory medicines (NSAIDs) (medicines to treat pain or certain inflammations, e.g., acetylsalicylic acid).
• Sympathomimetics.
• Certain medicines for pain or arthritis, including gold treatment.
• Non-steroidal anti-inflammatory medicines (NSAIDs), including COX-2 inhibitors (medicines that reduce inflammation and can be used to help relieve pain)

Taking Enalapril Normon with food, drinks, and alcohol:

Food does not affect the absorption of Enalapril Normon.

Alcohol enhances the blood pressure-lowering effect of enalapril, so inform your doctor if you are taking alcoholic beverages while being treated with this medicine.

Enalapril Normon can be taken with or without food, 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 might 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.

Breastfeeding

Inform your doctor if you are breastfeeding or 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 using machines

Individual responses to the medicine may vary.

Since Enalapril Normon can 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 some sugars, consult with them before taking this medicine.

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

3. How to take Enalapril Normon

Follow exactly the administration instructions of this medicine given 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 patients with hypertension

The tablet can be divided into equal doses.

Hypertension:

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

The usual long-term dose is 20 mg once daily.

Heart failure:

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

At the start of treatment, precautions should be taken due to the possibility of dizziness or vertigo.

Inform your doctor immediately if you experience these symptoms.

If you think the effect of Enalapril NORMON is too strong or too weak, tell 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 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 Toxicology Information Service. Phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Enalapril Normon

You should continue taking Enalapril Normon as prescribed. Do not take a double dose to make up for forgotten doses.

If you stop taking Enalapril Normon

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Enalapril Normon can cause side effects, although not everybody gets them.

If you experience any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

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

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

Eye disorders:Very common:blurred vision.

Cardiac and vascular disorders:Very common:dizziness. Common:low blood pressure (including orthostatic hypotension), fainting, chest pain, heart rhythm disturbances, angina pectoris, rapid heartbeat. Uncommon:orthostatic hypotension (decrease in blood pressure when sitting or standing up), rapid and strong heartbeat, myocardial infarction or stroke possibly due to excessively low blood pressure in high-risk patients (patients with coronary or cerebrovascular disorders). Rare:small arteries, usually in the fingers or toes, that produce spasms that make the skin turn pale or unevenly red to blue (Raynaud's phenomenon).

Respiratory, thoracic, and mediastinal disorders:Very common:cough. Common:difficulty breathing. Uncommon:runny nose, sore throat and hoarseness, asthma. Rare:fluid in the lungs, inflammation of the nasal mucosa, 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, ulcerative stomatitis. Rare:mouth ulcers, tongue inflammation. Very rare: intestinal angioedema (intestinal swelling)

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

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

A symptom complex has been observed that may include some of the following reactions: fever, inflammation of blood vessels, pain and inflammation of muscles and joints, blood disorders that affect blood components and are usually detected in a blood test, rash, hypersensitivity to sunlight, and other skin effects.

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

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

General disorders and administration site conditions:Very common:weakness. Common:fatigue. Uncommon:muscle cramps, flushing, ringing in the ears, general malaise, fever.

Clinical laboratory tests:Common:high potassium levels in the blood, increased creatinine levels in the blood. Uncommon:increased urea levels in the blood, decreased sodium levels in the blood. Rare:increased liver enzymes, increased bilirubin levels 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 swell, making it difficult to breathe or swallow.

• If your hands, feet, or ankles swell.

• If you experience hives (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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Enalapril Normon

Keep this medicine out of sight and reach of children.

Store below 25°C.

Store in the original packaging to protect it from moisture.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medicines at the SIGRE collection point in your 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 ofEnalapril Normon 5 mg EFG Tablets:

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

Appearance of the Product and Package Contents

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.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the Last Revision of this Leaflet: September 2017

Detailed and updated information on 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/63598/P_63598.html