Leaflet: information for the user

NAPRILENE 20 mg TABLETS

enalapril maleate

Read this 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; do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

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

3. How to take NAPRILENE 20 mg tablets

4. Possible side effects

5. Storage of NAPRILENE 20 mg tablets

6. Contents of the pack and additional information

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

NAPRILENE is indicated for:

- Treating high blood pressure (high blood pressure).

- Treating symptomatic heart failure.

- Preventing symptomatic heart failure.

Do not take NAPRILENE

• If you are allergic to enalapril or any of the other components of this medication (including those listed in section 6).
• If you have been previously treated with a medication from the same group of drugs as NAPRILENE (angiotensin-converting enzyme 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 cause swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing).
• If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén.
• If you are more than 3 months pregnant. It is also best to avoid Naprilene at the beginning of pregnancy – see Pregnancy section.

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 (medications that increase urine elimination).
• If you are following a low-sodium diet, taking potassium supplements, potassium-sparing medications, or salt substitutes containing potassium, or if you have recently had excessive vomiting or diarrhea.
• If during treatment, an allergic reaction occurs with swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing.
• 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 in the initial doses and when standing up. In these cases, lying down may help).
• If you are taking any of the following medications used to treat high blood pressure (hypertension):
• • An angiotensin II receptor antagonist (ARA II) (also known as “sartanes” – for example, valsartán, telmisartán, irbesartán), particularly if you have kidney problems related to diabetes
  • Aliskirén
• If you are using any of the following medications, the risk of angioedema (rapid swelling under the skin in areas such as the throat) increases:
• • Sirolimus, everolimus, and other mTOR inhibitors (used to prevent organ transplant rejection).

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels in the blood (such as potassium) at regular intervals.

See also the information under the heading “Do not take NAPRILENE”.

You should inform your doctor if you think you may be pregnant (or could be). Naprilene is not recommended at the beginning of pregnancy and should not be taken if you are more than 3 months pregnant, as it can cause serious harm to your baby if used during that stage (see Pregnancy section).

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

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 medications and NAPRILENE

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Certain medications may interact with NAPRILENE; in these cases, your doctor may need to adjust your dose and/or take other precautions, or discontinue some of them.

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

• If you are taking an angiotensin II receptor antagonist (ARA II) or aliskirén (See also the information under the headings “Do not take NAPRILENE” and “Warnings and precautions”).
• Antihypertensive medications (reduce elevated blood pressure)
• Diuretics (medications that increase urine elimination)
• Lithium (medications used to treat certain types of depression)
• Tricyclic antidepressants
• Antipsychotics
• Anesthetics
• Antidiabetic medications
• Nonsteroidal anti-inflammatory drugs (NSAIDs) (medications for pain or certain inflammation, e.g., acetylsalicylic acid)
• Sympathomimetics

This applies especially if you are also taking:

• Medications used more frequently to prevent organ transplant rejection (sirolimus, everolimus, and other mTOR inhibitors). See section “Warnings and precautions”.
• Potassium supplements or salt substitutes containing potassium, diuretics (especially those called potassium-sparing), or other medications that can increase potassium levels in the body (such as heparin and cotrimoxazol, also known as trimetoprima/sulfametoxazol).

Taking NAPRILENE with food, drinks, and alcohol

Foods do not affect the absorption of NAPRILENE.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You should inform your doctor if you think you may be pregnant or could 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 another medication different from Naprilene. Naprilene is not recommended at the beginning of pregnancy and should not be taken if you are more than 3 months pregnant, as it can cause serious harm to your baby if used during that stage.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. While taking Naprilene, it is not recommended to breastfeed newborns (first weeks after birth), and especially 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 medication.

Driving and operating machinery

Individual responses to medication can 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 medication.

Naprilene 20 mg tablets contain lactose and sodium

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor. If in doubt, ask your doctor or pharmacist.

NAPRILENE tablets are administered orally.

Remember to take your medication.

Your doctor will inform you of the duration of your treatment with NAPRILENE. Do not discontinue treatment before.

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

Your doctor will decide on the appropriate dose of NAPRILENE for you, depending on your condition and if you are taking other medications.

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.

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

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 915 620 420.

If you forgot to take NAPRILENE

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

Like all medicines, this medicine may cause side effects, although not everyone will experience 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 may cause difficulty swallowing or breathing
• swelling of your hands, feet, or ankles
• if you develop a red rash on your skin with swelling (hives).

You should be aware that patients of black race have a higher risk of suffering from this type of reaction. 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 a loss of consciousness or feel dizzy. If this happens, lying down may help. This is due to a decrease in your blood pressure. This will improve as you continue to take 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 may be accompanied by swelling of extremities, lips, tongue, and/or throat), hypersensitivity (allergic reaction)
• increased potassium in the blood
• depression
• headache, alteration of taste
• chest pain, alterations of heart rhythm, angina pectoris, rapid heartbeats
• low blood pressure (including orthostatic hypotension), fainting
• difficulty breathing
• diarrhea, abdominal pain
• skin rash
• fatigue
• increased creatinine in the blood.

Uncommon(may affect up to 1 in 100 people)

• anemia (including aplastic and hemolytic anemia)
• low blood glucose, decreased appetite, decreased sodium in the blood
• confusion, insomnia, nervousness
• drowsiness, sensation of tingling or numbness
• dizziness, ear noises
• rapid and strong heartbeats, myocardial infarction or stroke
• orthostatic hypotension, flushing
• runny nose, tickling of the 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 renal insufficiency, presence of proteins in the urine
• impotence
• general discomfort, fever
• increased urea in the blood.

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

• blood disorders, such as an abnormally low number of neutrophils, reduction or complete absence of granulocytes, deficiency of all blood cells, bone marrow depression, lymph node disease
• autoimmune diseases
• sleep disorders, difficulty sleeping
• small arteries, usually in the fingers of the hands or feet, that produce spasms that make the skin turn pale or become red and blue (Raynaud's phenomenon)
• fluid in the lungs, inflammation of the nasal mucosa membrane, 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, skin peeling
• liver insufficiency, inflammation of the liver, 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 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(the frequency cannot be estimated from the available data)

• confusion, nausea, and irritability due to a syndrome known as Syndrome of Inadequate Secretion of Antidiuretic Hormone
• a complex of symptoms 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 normally detected in a blood test, skin rash, hypersensitivity to sunlight, and other skin effects.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use (https://www.notificaram.es). By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

No special storage conditions are required.

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

Do not use this medication after the expiration date that appears 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 the packaging and medications you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of NAPRILENE 20 mg tablets

• The active ingredient is enalapril maleate. Each tablet contains 20 mg of enalapril maleate.
• The other components (excipients) are: sodium bicarbonate, lactose, cornstarch, pregelatinized cornstarch, magnesium stearate, red iron oxide (E-172), and yellow iron oxide (E-172).

Appearance of the product and contents of the packaging

NAPRILENE is presented in the form of tablets.

Each package contains 30 tablets. The tablets are round, salmon-colored, biconvex, with a groove on one face and the letter σ on the other.

Holder of the marketing authorization

Alfasigma España S.L.

Av. Diagonal, 490

08006 Barcelona. SPAIN

Responsible for manufacturing

Pharmaloop, S.L

C/ Bolivia, 15 –Industrial Estate Azque

28806 Alcalá de Henares (Madrid). SPAIN

or

Alfasigma, S.p.A.

Via Pontina km 30,400

00071 Pomezia (Rome). ITALY

Date of the last review of this leaflet: February 2021

Other sources of information

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