NAPRILENE 20 mg TABLETS

Introduction

Package Leaflet: Information for the User

NAPRILENE 20 mg 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What NAPRILENE 20 mg tablets are and what they are used for
2. What you need to know before you take NAPRILENE 20 mg tablets
3. How to take NAPRILENE 20 mg tablets
4. Possible side effects
5. Storing NAPRILENE 20 mg tablets
6. Contents of the pack and other information

1. What NAPRILENE 20 mg tablets are and what they are used for

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

NAPRILENE is indicated for:

• Treating high blood pressure (hypertension).
• Treating symptomatic heart failure.
• Preventing symptomatic heart failure.

2. What you need to know before you take NAPRILENE 20 mg tablets

Do not take NAPRILENE

• 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 NAPRILENE (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 (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 better to avoid NAPRILENE at the start of pregnancy – see section Pregnancy.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take NAPRILENE

• If you have heart disease.
• If you have blood disorders.
• If you have diabetes.
• If you have liver problems.
• If you have kidney problems (including kidney transplant).
• If you are undergoing dialysis.
• If you are receiving treatment with diuretics (medicines that increase urine production).
• If you are on a low-salt diet, taking potassium supplements, potassium-sparing medicines, or salt substitutes that contain potassium, or if you have recently had excessive vomiting or diarrhea.
• If an allergic reaction with swelling of the face, lips, tongue and/or throat with difficulty swallowing or breathing occurs during treatment.
• 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 it as fainting or dizziness, especially in the initial doses and when standing up. In these cases, lying down may help).
• If you are taking any of the following medicines used to treat high blood pressure (hypertension):
• • an angiotensin II receptor antagonist (ARA II) (also known as "sartans" – e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes
  • aliskiren
• If you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) increases:
• • Sirolimus, everolimus, and other mTOR inhibitor medicines (used to prevent organ transplant rejection).

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 NAPRILENE".

You must inform your doctor if you think you are pregnant (or might be). NAPRILENE is not recommended at the start 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 at this stage (see section Pregnancy).

In all these cases, inform your doctor, as you may need a dose adjustment or discontinuation of medication with NAPRILENE.

Before undergoing surgery or anesthesia (even at the dentist's office), inform your doctor or dentist that you are taking NAPRILENE, as there may be a sudden drop in blood pressure associated with anesthesia.

Other medicines and NAPRILENE

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Certain medicines may interact with NAPRILENE; in these cases, your doctor may need to modify your dose and/or take other precautions or interrupt treatment with some of them.

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

• If you are taking an angiotensin II receptor antagonist (ARA II) or aliskiren (see also the information under the headings "Do not take NAPRILENE" and "Warnings and precautions").
• Blood pressure-lowering medicines (to reduce high blood pressure)
• Diuretics (medicines that increase urine production).
• Lithium (medicines used to treat certain types of depression).
• Tricyclic antidepressants.
• Antipsychotics.
• Anesthetics.
• Anti-diabetic medicines.
• Non-steroidal anti-inflammatory medicines (NSAIDs) (medicines to treat pain or certain inflammations, e.g., acetylsalicylic acid).
• Sympathomimetics.

This applies especially if you are also taking:

• Medicines commonly used to prevent organ transplant rejection (sirolimus, everolimus, and other mTOR inhibitor medicines). See section "Warnings and precautions".
• Potassium supplements or salt substitutes that contain potassium, diuretics (especially potassium-sparing ones), or other medicines that may increase potassium levels in the body (such as heparin and cotrimoxazole, also known as trimethoprim/sulfamethoxazole).

Taking NAPRILENE with food, drinks, and alcohol

Food does not affect the absorption of NAPRILENE.

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.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You must inform your doctor if you think you are pregnant or might be. Normally, your doctor will advise you to stop taking NAPRILENE before becoming pregnant or as soon as you know you are pregnant and advise you to take a different medicine instead of NAPRILENE. NAPRILENE is not recommended at the start 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 from the third month of pregnancy onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. While taking NAPRILENE, breastfeeding is not recommended in newborns (first few weeks after birth), especially in premature babies. In the case of an older baby, your doctor should advise you on the benefits and risks of taking NAPRILENE compared to other treatments while breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Individual responses to the medicine may vary.

Since NAPRILENE 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.

Naprilene 20 mg tablets contain lactose and sodium

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

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

3. How to take NAPRILENE 20 mg tablets

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor. In case of doubt, ask your doctor or pharmacist.

NAPRILENE tablets are administered orally.

Remember to take your medicine.

Your doctor will indicate the duration of your treatment with NAPRILENE. Do not stop treatment before.

NAPRILENE can be taken with or without food, with a glass of water.

Your doctor will decide the appropriate dose of NAPRILENE that you should take, depending on your condition and whether you are taking other medicines.

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 in your case. The usual long-term dose is 20 mg per day in one or two doses.

If you take more NAPRILENE than you should

If you take more NAPRILENE 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 the Toxicology Information Service. Telephone 915 620 420.

If you forget to take NAPRILENE

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• swelling of the 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 these types of reactions. If you experience any of the above reactions, stop taking this medicine 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 side effects include:

Very common(may affect more than 1 in 10 people)

• blurred vision
• dizziness
• nausea
• cough
• weakness.

Common(may affect up to 1 in 10 people)

• angioedema (allergic reaction that can cause swelling of limbs, lips, tongue, and/or throat), hypersensitivity (allergic reaction)
• increased potassium levels in the blood
• depression
• headache, altered sense of taste
• chest pain, changes in heart rhythm, angina pectoris, rapid heartbeat
• low blood pressure (including orthostatic hypotension), fainting
• difficulty breathing
• diarrhea, abdominal pain
• skin rash
• fatigue
• increased creatinine levels in the blood.

Uncommon(may affect up to 1 in 100 people)

• anemia (including aplastic anemia and hemolytic anemia)
• low blood sugar levels, decreased appetite, low sodium levels in the blood
• confusion, insomnia, nervousness
• drowsiness, feeling of tingling or numbness
• vertigo, ringing in the ears
• rapid and strong heartbeat, myocardial infarction, or stroke
• orthostatic hypotension, flushing
• runny nose, sore throat, and hoarseness, asthma
• intestinal obstruction, pancreatitis, vomiting, indigestion, constipation, gastric irritation, dry mouth, peptic ulcer
• sweating, itching, urticaria, hair loss
• muscle cramps
• reduced kidney function or kidney failure, presence of protein in the urine
• impotence
• general malaise, fever
• increased urea levels in the blood.

Rare(may affect up to 1 in 1,000 people)

• blood disorders, such as abnormally low neutrophil count, reduction or complete absence of granulocytes, deficiency of all blood cell components, bone marrow depression, lymph node disease
• autoimmune diseases
• sleep disorders, sleep problems
• small arteries, usually in the fingers of the hands or feet, that produce spasms that make the skin turn pale or unevenly red to blue (Raynaud's phenomenon)
• fluid in the lungs, inflammation of the mucous membrane of the nose, allergic inflammation of the lungs
• inflammation and ulcers of the mouth, inflammation of the tongue
• severe skin reaction, including excessive redness of the skin, blisters, peeling of the skin
• liver failure, liver inflammation, reduction or obstruction of bile flow from the bile duct to the liver (cholestasis, including jaundice)
• breast enlargement in men
• reduced urine output per day
• increased liver enzymes, increased bilirubin levels in the blood, decreased hemoglobin in the blood, and decreased blood cells.

Very rare(may affect up to 1 in 10,000 people)

• intestinal swelling.

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

• confusion, nausea, and irritability due to a syndrome known as the syndrome of inadequate secretion of antidiuretic hormone
• a complex of symptoms 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, skin rash, hypersensitivity to sunlight, and other skin effects.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report them 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. Storing NAPRILENE 20 mg tablets

No special storage conditions are required.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging, after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Angileptol mint flavor

Each tablet contains:

• The active ingredients:

Chlorhexidine dihydrochloride, 5 mg

Benzocaine, 4 mg

Enoxolone, 3 mg

• The other ingredients (excipients) are: sorbitol (E420), acesulfame potassium (E950), magnesium stearate, and mint flavor

Appearance of the product and packaging contents

Angileptol is a mint-flavored tablet for sucking, white, round, and with the Greek letter σ on one side.

It is available in packs containing 15 and 30 tablets for sucking.

Other presentations

Angileptol Mint-Eucalyptus Flavor

Angileptol Honey-Lemon Flavor

Marketing authorization holder

Alfasigma España S.L.

C/ Aribau 195, 4º

08021 Barcelona, Spain

Manufacturer

Pharmaloop, S.L.

Polígono Industrial Azque C/Bolivia, 15

28806 Alcalá de Henares (Madrid), Spain

or

Alfasigma, S.p.A.

Via Pontina, Km 30,400

00071 Pomezia (Rome), Italy

Date of the last revision of this leaflet:September 2021

Other sources of information

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