Package Insert: Information for the User

Navixen 600 mg Film-Coated Tablets

eprosartan, mesylate

Read this package insert carefully before you start taking this medicine because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Navixenis used for:

• Treating high blood pressure.

Navixen contains the active ingredient eprosartán.

• Eprosartánbelongs to a group of medicines known as “angiotensin II receptor inhibitors” and blocks the action of a substance called “angiotensin II”. This substance causes blood vessels to constrict, making it difficult for blood to pass through them, resulting in an increase in blood pressure. By blocking this substance, blood vessels relax and blood pressure decreases.

Do not take Navixen

• if you are allergic to the active ingredient or any of the other components of this medication (listed in section 6)
• if you have a severe liver disease
• if you have severe problems with blood flow to the kidneys
• if you are more than 3 months pregnant (it is also recommended not to take Navixen at the beginning of pregnancy - see the "Pregnancy" section)
• if you have diabetes or kidney insufficiency and are being treated with a blood pressure medication that contains aliskirén.

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Navixen, if:

• you have any other liver problems
• you have any other kidney problems. Your doctor will check the function of your kidneys before starting treatment and periodically once treatment has begun. They will also determine the concentrations of potassium, creatinine, and uric acid in your blood.
• you have a heart problem such as coronary heart disease, heart failure, narrowing of the blood vessels or heart valves, or a problem with the heart muscle.
• you produce too much of a hormone called "aldosterone".
• you are following a low-sodium diet, taking diuretics, or experiencing vomiting or diarrhea. This is because in these cases, a decrease in blood volume or sodium concentration in the blood may occur. These situations must be corrected before taking Navixen.
• you think you are (or may become) pregnant. Navixen is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby. See the "Pregnancy" and "Breastfeeding" sections.
• if you are taking any of the following medications used to treat high blood pressure (hypertension):

- an angiotensin-converting enzyme inhibitor (ACE inhibitor) (such as enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

- aliskirén

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

See also the information under the heading "Do not take Navixen".

• you are taking any medication that may increase your serum potassium levels (see the "Taking Navixen with other medications" section).
• you are a black patient, as this medication may be less effective in reducing blood pressure.

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

Consult 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 medications

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

In particular, inform your doctor or pharmacist if you are taking the following medications:

• lithium, for mood problems. Your doctor must monitor your lithium blood levels because Navixen may increase them.

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

The following medications may increase the effect of Navixen:

• medications that lower your blood pressure.

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

The following medications may reduce the effect of Navixen:

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

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

• medications that contain potassium or potassium-sparing medications.
• medications that increase potassium levels, such as heparin, trimetoprima, and ACE inhibitors.

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

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

if you are taking an ACE inhibitor or aliskirén (see also the information under the headings "Do not take Navixen" and "Warnings and precautions")

Taking Navixen with food, drinks, and alcohol:

• You can take the tablets with or without food.
• Consult your doctor before taking Navixen if you are following a low-sodium diet. Not consuming enough salt may cause a decrease in blood volume or sodium concentration in the blood.

Pregnancy, breastfeeding, and fertility:

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

Pregnancy

Normally, before you become pregnant, your doctor will replace Navixen with another suitable antihypertensive medication. In general, your doctor will advise you to take another medication instead of Navixen, as Navixen is not recommended for use at the beginning of pregnancy (first 3 months) and should not be used in any case during the last 6 months of pregnancy, as it may cause serious harm to your baby.

Breastfeeding

• Inform your doctor if you are breastfeeding or plan to start breastfeeding.
• Navixen is not recommended for mothers who are breastfeeding. Your doctor may choose another treatment if you want to breastfeed, especially if your baby is newborn or premature.

Driving and operating machinery:

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 is your case, do not drive or use tools or machinery and inform your doctor.

Navixen contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How to Take This Medication

• Take this medication orally.
• Swallow the tablet whole with plenty of liquid, for example with 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 per day.

Use in Children and Adolescents

Navixen should not be administered to children and adolescents under 18 years old.

If You Take More Navixen Than You Should

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

• sensation of dizziness due to a drop in blood pressure (hypotension)
• urge to vomit (nausea)
• drowsiness

You can alsoconsult the Toxicological Information Service, phone 91.562.04.20, indicating the medication 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 the next dose is approaching, do not take the missed dose. Do not take a double dose to compensate for the missed doses.

If You Interrupt Treatment with Navixen

Do not stop taking Navixen without consulting your doctor first.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.The following adverse effects may occur with this medication:

Allergic Reactions(may affect fewer than 1 in 100 people)

If you experience an allergic reaction, stop taking the medication and seek medical attention immediately. Symptoms may include:

• 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 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
• eruption 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 when standing. You may feel dizzy.

Unknown Frequency(frequency that cannot be estimated from available data)

• kidney problems, including renal insufficiency.
• joint pain (arthralgia).
• intestinal angioedema: intestinal inflammation has been reported, presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea after use of similar products.

Reporting Adverse Effects

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

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging, after CAD or EXP. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or trash. Deposit empty packaging and unused medications at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Navixen

• The active ingredient is eprosartan. Each coated tablet contains 600 mg of eprosartan (in the form of dihydrous mesilate).
• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch without gluten, crospovidone, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 400, and polisorbate 80.

Appearance of the product and contents of the packaging

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

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing:

Mylan Laboratories SAS

Route de Belleville Lieu dit Maillard

F- 01400 Châtillon-sur-Chalaronne, France

Phone:+33 4 74 45 54 42

Fax:+33 4 74 55 02 83

You can request more information about this medication by contacting the local representative of the marketing authorization holder::

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

Last review date of this leaflet:January 2025

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