Naprilene 20 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

NAPRILENE 20 mg TABLETS

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, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if these effects are not listed in this leaflet. See section 4.

Leaflet contents

1. What NAPRILENE 20 mg tablets are and what they are used for
2. What you need to know before taking NAPRILENE 20 mg tablets
3. How to take NAPRILENE 20 mg tablets
4. Possible side effects
5. How to store 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 known as angiotensin-converting enzyme inhibitors (ACE inhibitors).

NAPRILENE is indicated for:

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

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

Do not take NAPRILENE

• 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 drug class as NAPRILENE (ACE inhibitors) and experienced allergic reactions with swelling of the face, lips, tongue, and/or throat, accompanied by difficulty swallowing or breathing.
• If you have been diagnosed with hereditary or idiopathic angioedema (a condition characterized by the development of large welts on the skin surface, especially around the eyes and lips, which may also affect the 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 renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you are more than 3 months pregnant. Naprilene is also best avoided at the beginning of pregnancy – see Pregnancy section.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Naprilene if:

• You have heart disease.
• You have blood disorders.
• You have diabetes.
• You have liver problems.
• You have kidney problems (including kidney transplant).
• You are undergoing dialysis.
• You are receiving treatment with diuretics (medicines that increase urine elimination).
• You are on a salt-free diet, take potassium supplements, potassium-sparing medicines, or salt substitutes containing potassium, or if you have recently experienced excessive vomiting or diarrhea.
• You develop an allergic reaction during treatment, with swelling of the face, lips, tongue, and/or throat, accompanied by difficulty swallowing or breathing.
• You are about to undergo a treatment called LDL apheresis, or desensitization therapy to reduce the effect of an allergy to bee or wasp stings.
• You have low blood pressure (you may experience fainting or dizziness, especially with initial doses and when standing up. In such cases, lying down may help).
• 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.
• You are using any of the following medicines, which increase the risk of angioedema (rapid swelling under the skin, such as in the throat):
  • Sirolimus, everolimus, and other medicines of the mTOR inhibitor class (used to prevent rejection of transplanted organs).

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

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

Inform your doctor if you think you may be pregnant (or could become pregnant). Naprilene is not recommended during early 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 Pregnancy section).

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

Before undergoing surgery or anesthesia (including at the dentist), inform the 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 taking, have recently taken, or might need to take any other medicines.

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

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

• An angiotensin II receptor antagonist (ARA II) or aliskiren (see also information under the headings “Do not take NAPRILENE” and “Warnings and precautions”).
• Antihypertensive medicines (reduce high blood pressure).
• Diuretics (medicines that increase urine elimination).
• Lithium (medicines used to treat certain types of depression).
• Tricyclic antidepressants.
• Antipsychotics.
• Anesthetics.
• Antidiabetic medicines.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to treat pain or certain inflammations, e.g., acetylsalicylic acid).
• Sympathomimetics.

This is especially important if you are also taking:

• Medicines more commonly used to prevent rejection of transplanted organs (sirolimus, everolimus, and other medicines of the mTOR inhibitor class). See section “Warnings and precautions”.
• Potassium supplements or potassium-containing salt substitutes, diuretics (urine tablets, especially potassium-sparing types), or other drugs 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 hypotensive effect (blood pressure lowering) of enalapril; therefore, inform your doctor if you are consuming alcoholic beverages while taking this medicine.

Pregnancy and breastfeeding

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

Pregnancy

Inform your doctor if you think you may be pregnant or could be pregnant. Your doctor will usually advise you to stop taking Naprilene before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Naprilene is not recommended during early 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 onward.

Breastfeeding

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

Consult your doctor or pharmacist before using any medicine.

Driving and use of machinery

Individual responses to medication may vary.

Since NAPRILENE may cause dizziness or fatigue, avoid tasks requiring special attention (such as driving 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 informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take NAPRILENE 20 mg tablets

Follow exactly the instructions for use provided in this leaflet or those given by your doctor. If in doubt, ask your doctor or pharmacist.

NAPRILENE tablets are administered orally.

Remember to take your medicine.

Your doctor will determine how long you should take NAPRILENE. Do not stop treatment prematurely.

NAPRILENE may be taken with meals or between meals, together with a glass of water.

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

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 case is reached. The usual long-term dose is 20 mg daily, given in one or two doses.

If you take more NAPRILENE than you should

If you take more NAPRILENE than prescribed, consult 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 the Toxicology Information Service. Telephone: 915 620 420.

If you forget to take NAPRILENE

Continue taking NAPRILENE as prescribed. Do not take a double dose to make up for missed doses.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

• swelling of the face, lips, tongue or throat which may cause difficulty swallowing or breathing
• swelling of your hands, feet or ankles
• if you develop a red skin rash with swelling (hives).

Please note that patients of black race have a higher risk of experiencing these types of reactions. If you experience any of the above reactions, stop taking this medicine and speak to your doctor immediately.

When you start taking this medicine, you may feel faint or dizzy. If this occurs, lying down may help. This is due to a drop in your blood pressure. This will improve as you continue taking the medicine. If you are concerned, please speak to your doctor.

Other adverse 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 which may include swelling of limbs, lips, tongue and/or throat), hypersensitivity (allergic reaction)
• increased potassium in blood
• depression
• headache, altered taste sensation
• chest pain, irregular heart rhythm, angina pectoris, rapid heartbeat
• drop in blood pressure (including orthostatic hypotension), fainting
• difficulty breathing
• diarrhoea, abdominal pain
• skin rash
• fatigue
• increases in blood creatinine.

Uncommon (may affect up to 1 in 100 people)

• anaemia (including aplastic and haemolytic anaemia)
• low blood glucose, decreased appetite, decreased sodium in blood
• confusion, insomnia, nervousness
• drowsiness, tingling or numbness sensation
• dizziness, 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, pruritus, urticaria, hair loss
• muscle cramps
• reduced kidney function or renal failure, presence of protein in urine
• impotence
• general malaise, fever
• increases in blood urea.

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

• blood disorders, such as abnormally low neutrophil count, reduced or complete absence of granulocytes, deficiency of all blood cell elements, bone marrow depression, lymph node disease
• autoimmune diseases
• sleep disorders, difficulty sleeping
• small arteries, usually in the fingers of the hands or feet, causing spasms that make the skin become pale or mottled red to blue (Raynaud's phenomenon)
• fluid in the lungs, inflammation of the nasal mucosa, allergic inflammation of the lungs
• inflammation and ulcers in the mouth, inflammation of the tongue
• severe skin reaction, including excessive redness of the skin, blisters, skin peeling
• liver failure, inflammation of the liver, reduced or obstructed flow of bile from the bile duct to the liver (cholestasis including jaundice)
• breast enlargement in men
• reduced daily urine output
• increases in liver enzymes, increases in blood bilirubin, decreased blood haemoglobin 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 available data)

• confusion, nausea, and irritability due to a condition known as Syndrome of Inappropriate Secretion of Antidiuretic Hormone
• a symptomatic complex has been observed which may include some of the following reactions: fever, inflammation of blood vessels, 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.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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 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 expiry date stated on the container, after EXP. 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 the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of NAPRILENE 20 mg tablets

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

Appearance of the product and contents of the pack

NAPRILENE is presented as tablets.

Each pack contains 30 tablets. The tablets are round, salmon-coloured, biconvex, with a score on one side and the letter σ on the other.

Marketing Authorization Holder

Alfasigma España S.L.

C/ Aribau 195, 4º

08021 Barcelona. Spain

Manufacturer

Pharmaloop, S.L

C/ Bolivia, 15 – Polígono Industrial Azque

28806 Alcalá de Henares (Madrid). SPAIN

or

Alfasigma, S.p.A.

Via Pontina km 30,400

00071 Pomezia (Rome). ITALY

Date of the most recent revision of this leaflet: February 2021

Other sources of information

“Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/”