NAVIXEN 600 mg FILM-COATED TABLETS

2. What you need to know before you take Navixen

Do not take Navixen

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6)
• if you have severe liver disease
• if you have severe kidney problems
• if you are pregnant for more than 3 months (it is also better not to take Navixen at the beginning of pregnancy - see the section “Pregnancy”)
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.

If you are in any of these situations, 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 your kidney function before starting treatment and periodically once treatment has started. They will also determine the levels 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 follow a low-salt diet, take diuretics, or suffer from vomiting or diarrhea. This is because these situations can cause a decrease in blood volume or blood sodium levels. These situations should be corrected before taking Navixen.
• you think you are (or may be) pregnant. Navixen is not recommended at the start of pregnancy, and you should not take this medicine if you are pregnant for more than 3 months, as it can cause serious harm to your baby. See section Pregnancy and breastfeeding.
• if you are taking any of the following medicines used to treat high blood pressure:

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially 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 potassium levels (see section “Taking Navixen with other medicines”).
• you are a black patient, as this medicine may be less effective in reducing blood pressure.

If you are in any of these situations (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 medicines

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

In particular, tell your doctor or pharmacist if you are taking the following medicines:

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

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

The following medicines may reduce the effect of Navixen:

• indomethacin - for pain, stiffness, and swelling, and to lower fever.

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 medicines, your doctor may perform blood tests:

• medicines that contain 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. Based on the results of your blood test, 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 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 follow a low-salt diet. Not consuming enough salt can cause a decrease in blood volume or blood sodium levels.

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Normally, before you become pregnant, your doctor will switch you to another blood pressure medicine. Usually, your doctor will advise you to take another medicine instead of Navixen, as Navixen is not recommended at the start of pregnancy (first 3 months) and should not be used in the last 6 months of pregnancy, as it can cause serious harm to your baby.

Breastfeeding

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

Driving and using machines

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

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

3. How to take Navixen

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, 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, 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 given to children and adolescents under 18 years.

If you take more Navixen than you should

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

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

You can also contact the Toxicology Information Service, phone 91.562.04.20, indicating the medicine and the amount taken.

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 doses.

If you stop taking Navixen

Do not stop taking Navixen without consulting your doctor first.

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

4. Possible side effects

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

Allergic reactions(may affect up to 1 in 100 people)

If you have an allergic reaction, stop taking the medicine and see a doctor immediately. The signs 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 side 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 when standing up. You may feel dizzy.

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

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

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 side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) https://www.notificaram.es. By reporting side 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 which is stated on the carton, after EXP. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Navixen

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

Appearance and packaging

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

You can obtain further information on this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

Date of last revision of this leaflet:January 2025

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