Enalapril Normon 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

EnalaprilNormon 5 mg Tablets EFG

enalapril maleate

Read the entire leaflet carefully before you start taking 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions 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 adverse 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 belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors).

Enalapril is indicated for:

• treating hypertension (high blood pressure).

• treating symptomatic heart failure.

• preventing symptomatic heart failure.

2. What you need to know before taking Enalapril Normon

Do not take Enalapril Normon:

• if you are allergic to enalapril or to any of the other components of this medicine (listed in section 6),
• if you have previously been treated with a medicine from the same group of drugs as Enalapril Normon (ACE inhibitors) and experienced allergic reactions with swelling of the face, lips, tongue, and/or throat, causing difficulty in swallowing or breathing,
• if you have been diagnosed with angioedema (large hives on the skin surface, especially around the eyes and lips, which may also affect hands, feet, and throat, and may cause swelling of the face, lips, tongue, and/or throat with difficulty in swallowing or breathing), whether hereditary or of unknown cause,
• 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 Normon in early pregnancy—see Pregnancy section)

Take special care with Enalapril Normon

You should inform your doctor if you think you may be pregnant (or could become pregnant). Enalapril Normon is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause severe harm to your baby if used at this stage (see Pregnancy section).

Warnings and precautions

Talk to your doctor or pharmacist before starting Enalapril Normon.

• If you have heart disease.
• If you have a condition affecting the blood vessels in the brain.
• If you have blood disorders such as low or absent 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 may lead to high potassium levels 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 output).
• If you have recently experienced excessive vomiting or diarrhea.
• If you are on a salt-free diet, take potassium supplements, potassium-sparing medicines, salt substitutes containing potassium, or medicines known to increase blood potassium levels (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, causing difficulty in swallowing or breathing. Note that patients of Black race are more prone to this type of reaction to ACE inhibitors.
• If you are about to undergo LDL apheresis treatment or desensitization therapy to reduce the effects of an allergy to bee or wasp stings.
• If you have low blood pressure (you may feel faint or dizzy, especially with initial doses and when standing up. In such cases, lying down may help).
• If you have a vascular collagen disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma), are taking medicines that suppress your immune system, or are taking allopurinol, 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), 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 the information under the heading “Do not take Enalapril Normon.”

Please note that Enalapril Normon is less effective in lowering blood pressure in Black patients compared to non-Black patients.

In all these cases, inform your doctor, as you may require a dose adjustment, discontinuation of Enalapril Normon, or monitoring of your blood potassium levels. 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 at the dentist), inform the doctor or dentist that you are taking Enalapril Normon, as a sudden drop in blood pressure may occur in association with anesthesia.

Taking Enalapril Normon with other medicines:

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicine. Certain medicines may interact with Enalapril Normon; in such cases, it may be necessary to adjust the dose or discontinue one of the treatments. Your doctor may need to modify your dose and/or take additional 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 information under the headings “Do not take Enalapril Normon” and “Warnings and precautions”).
• Antihypertensive medicines (reduce high blood pressure).
• Diuretics (medicines that increase urine output).
• Potassium-containing medicines (including dietary salt substitutes).
• Lithium (a medicine used to treat certain types of depression).
• Tricyclic antidepressants.
• Antipsychotics.
• Anesthetics.
• Antidiabetic medicines (including oral antidiabetics and insulin).
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to treat pain or certain inflammations, e.g., acetylsalicylic acid).
• Sympathomimetics.
• Certain medicines for pain or arthritis, including gold therapy.
• Non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (medicines that reduce inflammation and may help relieve pain).

Taking Enalapril Normon with food, drinks, and alcohol:

Food does not affect the absorption of Enalapril Normon.

Alcohol enhances the hypotensive effect (blood pressure-lowering effect) of enalapril. Therefore, inform your doctor if you are consuming alcoholic beverages while taking this medicine.

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

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medicine.

Pregnancy

Inform your doctor if you think you are pregnant (or could be). Your doctor will usually advise you to stop taking Enalapril Normon before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Enalapril Normon is not recommended in early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onward.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Breastfeeding is not recommended in newborns (first weeks after birth) while taking Enalapril Normon, especially in premature infants. For older infants, your doctor should advise you on the benefits and risks of taking Enalapril Normon compared to other treatments during breastfeeding.

Driving and using machines

Individual responses to medication may vary.

Since Enalapril Normon may cause dizziness or fatigue, avoid performing tasks requiring special attention (such as driving or operating machinery) until you know how you react to the medicine.

Enalapril Normon contains lactose and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Enalapril Normon

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Use in children and adolescents

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

The tablet can be divided into equal doses.

Hypertension:

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

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

Heart failure:

The recommended starting dose is usually 2.5 mg once daily. Your doctor will gradually increase the dose until the appropriate dose for your condition is reached. The usual long-term dose is 20 mg daily, taken in one or two doses.

Extreme caution should be exercised at the beginning of treatment due to the possibility of dizziness or vertigo.

Inform your doctor immediately if you experience these symptoms.

If you think that 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 prescribed, contact your doctor or pharmacist immediately.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Enalapril Normon

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 about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Enalapril Normon may produce adverse effects, although not everyone will experience them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, consult your doctor or pharmacist.

Blood and lymphatic system disorders:
Uncommon: Anaemia (including aplastic and haemolytic anaemia). Rare: Blood disorders such as abnormally low neutrophil count, low haemoglobin levels, reduced 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 glucose levels (hypoglycaemia).

Nervous system and psychiatric disorders:
Frequent: Headache, depression. Uncommon: Confusion, drowsiness or inability to sleep, nervousness, tingling or numbness sensation, dizziness. Rare: Sleep disturbances, sleep problems.

Eye disorders:
Very frequent: Blurred vision.

Cardiac and vascular disorders:
Very frequent: Dizziness. Frequent: Drop in 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 impaired blood flow to the heart and/or brain). Rare: Small arteries, usually in the fingers of the hands or feet, that produce spasms causing the skin to become pale or mottled blue-red (Raynaud's phenomenon).

Respiratory, thoracic and mediastinal disorders:
Very frequent: Cough. Frequent: Difficulty breathing. Uncommon: Runny nose, throat irritation and hoarseness, asthma. Rare: Fluid in the lungs, inflammation of the nasal mucosa, allergic inflammation of the lungs.

Gastrointestinal disorders:
Very frequent: Nausea. Frequent: Diarrhoea, abdominal pain, taste disturbances. Uncommon: Intestinal obstruction, pancreatitis, vomiting, indigestion, constipation, anorexia, gastric irritation, dry mouth, peptic ulcer. Rare: Mouth inflammation and ulcers, tongue inflammation. Very rare: Intestinal angioedema (intestinal swelling).

Hepatobiliary disorders:
Rare: Liver failure, liver inflammation (hepatitis), reduced or obstructed bile flow from the bile duct to the liver (cholestasis including jaundice).

Skin and subcutaneous tissue disorders:
Frequent: Skin rash, hypersensitivity or allergic reaction causing swelling of the face, limbs, lips, tongue, glottis and larynx. Uncommon: Sweating, pruritus (itching sensation), urticaria (red, itchy swellings), hair loss. Rare: Severe skin reactions, including excessive skin redness, blistering, peeling of the skin.

A symptomatic complex has been observed which may include some of the following reactions: fever, blood vessel inflammation, muscle and joint pain and swelling, blood disorders affecting blood components and usually detected in a blood test, skin rash, photosensitivity and other skin effects.

Kidney and urinary excretion disorders:
Uncommon: Reduced kidney function or renal failure, presence of protein in urine. Rare: Decreased daily urine output.

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

General disorders and administration site conditions:
Very frequent: Weakness. Frequent: Fatigue. Uncommon: Muscle cramps, tinnitus, general malaise, fever.

Clinical laboratory findings:
Frequent: High blood potassium levels, increased creatinine levels in blood. Uncommon: Increased blood urea levels, decreased blood sodium levels. Rare: Increased liver enzymes, increased blood bilirubin levels.

Stop taking Enalapril NORMON and consult your doctor immediately if any of the following occur:

• If your face, lips, tongue and/or throat swell so much that you have difficulty breathing or swallowing.

• If your hands, feet or ankles swell.

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

Please note that black patients are more susceptible to these types of adverse reactions.

If you consider any of the adverse effects you experience to be severe, or if you notice any other reactions not described in this leaflet, consult your doctor or pharmacist.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects 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

Keep this medicine out of sight and reach of children.

Store below 25°C.

Keep in the original packaging to protect from moisture.

Do not use this medicine after the expiry date which is stated on the blister and on the outer packaging after {CAD}. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Enalapril Normon 5 mg Tablets EFG:

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

Appearance of the product and pack contents

Enalapril Normon is presented in the form of tablets. Each pack contains 10 or 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 most recent review of this leaflet: September 2017

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (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 may also access this information at the following internet address:

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