Navixen 600 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Navixen 600 mg film-coated tablets

eprosartan, mesilate

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

Leaflet contents

1. What Navixen is and what it is used for
2. What you need to know before taking Navixen
3. How to take Navixen
4. Possible adverse effects
5. How to store Navixen
6. Contents of the pack and other information

1. What Navixen is and what it is used for

Navixen is used to:

• treat hypertension.

Navixen contains the active substance eprosartan.

• Eprosartan belongs to a group of medicines known as “angiotensin II receptor blockers” and blocks the action of a substance called “angiotensin II”. This substance causes blood vessels to narrow, making it harder for blood to flow through them, which leads to increased blood pressure. By blocking this substance, blood vessels relax and blood pressure decreases.

2. What you need to know before starting to take Navixen

Do not take Navixen

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
• you have severe liver disease
• you have serious problems with blood flow to the kidneys
• you are more than 3 months pregnant (it is also advisable not to take Navixen during early pregnancy – see section “Pregnancy”)
• you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are in any of these situations, it is important to inform your doctor before starting treatment.

Warnings and precautions

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

• you have any other liver problems

• you have any other kidney problems. Your doctor will check your kidney function before starting treatment and periodically thereafter. Your doctor will also measure blood levels of potassium, creatinine, and uric acid.

• you have a heart condition such as coronary heart disease, heart failure, narrowing of blood vessels or heart valves, or a problem with the heart muscle.

• you produce too much of a hormone called "aldosterone".

• you are on a low-salt diet, take diuretics, or have vomiting or diarrhea. This is because these conditions may lead to reduced blood volume or low blood sodium concentration. These conditions should be corrected before taking Navixen.

• you think you are (or might become) pregnant. The use of Navixen is not recommended in early pregnancy, and you must not take this medicine if you are more than 3 months pregnant, as it may cause serious harm to your baby. See section “Pregnancy and breastfeeding”.

• you are taking any of the following medicines used to treat high blood pressure (hypertension):

  • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), 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 Navixen”.

• you are taking any medicine that may increase your serum potassium levels (see section “Taking Navixen with other medicines”).
• you are a Black patient, as this medicine may be less effective in lowering blood pressure.

If you are in any of these situations (or are unsure), consult your doctor or pharmacist before taking Navixen.

Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Navixen. Your doctor will decide whether to continue treatment. Do not stop taking Navixen on your own.

Taking Navixen with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. This includes herbal medicines. This is because Navixen may affect how other medicines work, and other medicines may affect how Navixen works.

Specifically, inform your doctor or pharmacist if you are taking the following medicines:

• lithium, used for mood disorders. Your doctor must monitor blood lithium levels, as Navixen may increase them.

If this applies to you (or you are unsure), consult your doctor or pharmacist before taking Navixen.

The following medicines may increase the effect of Navixen:

• medicines that lower your blood pressure.

If this applies to you (or you are unsure), consult your doctor or pharmacist before taking Navixen.

The following medicines may reduce the effect of Navixen:

• indometacin – used for pain, stiffness, swelling, and to reduce fever.

If this applies to you (or you are unsure), consult your doctor or pharmacist before taking Navixen.

If you are taking any of the following medicines, your doctor may perform blood tests:

• medicines containing potassium or potassium-sparing medicines.
• medicines that increase potassium levels, such as heparin, trimethoprim, and ACE inhibitors.

Consult your doctor or pharmacist before taking Navixen. Depending on the results of your blood tests, your doctor may decide to change your treatment with these medicines or with Navixen.

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Navixen” and “Warnings and precautions”)

Taking Navixen with food, drinks, and alcohol:

• You may take the tablets with or without food.
• Consult your doctor before taking Navixen if you are on a low-salt diet. Not consuming enough salt may lead to reduced blood volume or low blood sodium concentration.

Pregnancy, breastfeeding, and fertility:

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

Normally, before you become pregnant, your doctor will switch you from Navixen to another appropriate antihypertensive medicine. Your doctor will generally advise you to take a different medicine instead of Navixen, as the use of Navixen is not recommended during early pregnancy (first 3 months), and it must in no case be used during the last 6 months of pregnancy because it may cause serious harm to your baby.

Breastfeeding

• Inform your doctor if you are breastfeeding or plan to start breastfeeding your child
• Navixen is not recommended for breastfeeding mothers. Your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is newborn or was born prematurely

Driving and use of machines

It is unlikely that Navixen will affect your ability to drive or operate machinery. However, you may feel drowsy or dizzy while taking Navixen. If this occurs, do not drive or use tools or machines, and inform your doctor.

Navixen contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Navixen

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How to take this medicine

• Take this medicine by mouth.
• Swallow the tablet whole with plenty of liquid, for example, a glass of water.
• Do not crush or chew the tablets.
• Take the tablets in the morning, approximately at the same time each day.

Adults

The recommended dose is one tablet daily.

Use in children and adolescents

Navixen must not be given to children and adolescents under 18 years of age.

If you take more Navixen than you should

If you take more Navixen than you should, or if someone accidentally ingests it, consult your doctor or go to a hospital immediately. Take the medicine's packaging and leaflet with you. The following effects may occur:

• dizziness due to low blood pressure (hypotension)
• nausea
• drowsiness

You may also contact the Toxicology Information Service at telephone number 91.562.04.20, stating the name of the medicine and the amount ingested.

If you forget to take Navixen

• If you forget to take a dose, take it as soon as you remember.
• If you forget to take a dose and it is almost time for your next dose, do not take the missed dose. Do not take a double dose to make up for the missed dose.

If you stop taking Navixen

Do not stop taking Navixen without first consulting your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody gets them. The following adverse effects may occur with this medicine:

Allergic reactions (may affect less than 1 in 100 people)

If you experience an allergic reaction, stop taking the medicine and contact your doctor immediately. Signs may include the following:

• skin reactions such as rash or hives with swelling (urticaria)
• swelling of the lips, face, throat, or tongue
• difficulty breathing
• swelling of the face or of the skin and mucous membranes (angioedema).

Other possible adverse effects of Navixen include the following:

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

• headache.

Common (may affect up to 1 in 10 people)

• dizziness
• rash or itching (pruritus)
• nausea, vomiting, diarrhea
• weakness (asthenia)
• stuffy nose (rhinitis).

Uncommon (may affect up to 1 in 100 people)

• low blood pressure, including low blood pressure upon standing. You may feel dizzy.

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

• kidney problems, including renal failure.
• joint pain (arthralgia).
• intestinal angioedema: inflammation in the intestine has been reported with similar products, presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Navixen

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the container, following CAD or 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 containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Navixen

• The active substance is eprosartan. Each coated tablet contains 600 mg of eprosartan (as eprosartan mesilate dihydrate).
• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch (gluten-free), crospovidone, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 400, and polysorbate 80.

Appearance of the product and contents of the pack

White, oval-shaped tablets with the inscription 5046 on one side.

Navixen is packaged in opaque PVC/PCTFE blisters, in cartons containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer:

Mylan Laboratories SAS
Route de Belleville, Lieu dit Maillard
F-01400 Châtillon-sur-Chalaronne, France
Tel.: +33 4 74 45 54 42
Fax: +33 4 74 55 02 83

For further information about this medicine, contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 Madrid
Spain

Date of the most recent revision of this leaflet: January 2025

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/