TEVETENS 600 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tevetens 600 mg Film-Coated Tablets

eprosartan, mesilate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

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

1. What is Tevetens and what is it used for

Tevetens is used to

• treat high blood pressure

Tevetens contains the active substance eprosartan.

Eprosartanbelongs to a group of medicines known as “angiotensin II receptor antagonists” and blocks the action of a substance called “angiotensin II”. This substance causes blood vessels to narrow, making it harder for blood to pass through them, which leads to an increase in blood pressure. By blocking this substance, blood vessels relax and blood pressure decreases.

2. What you need to know before you take Tevetens

Do not take Tevetens:

• 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 have diabetes or kidney problems and are being treated with a medicine to lower blood pressure that contains aliskiren
• if you are pregnant for more than 3 months (it is also better not to take Tevetens at the beginning of pregnancy - see the section “Pregnancy”).

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 Tevetens 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 are on a low-salt diet, taking diuretics, or suffering 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 Tevetens
• 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 Tevetens”.

• you think you are (or may be) pregnant. Tevetens 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 may cause serious harm to your baby. See section Pregnancy and breastfeeding.
• you are taking any medicine that may increase your potassium levels (see section “Taking Tevetens 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 Tevetens.

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

Taking Tevetens 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 Tevetens may affect the way other medicines work, and they may affect the way Tevetens 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 Tevetens may increase them.

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

The following medicines may increase the effect of Tevetens:

• medicines that lower your blood pressure.

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

The following medicines may reduce the effect of Tevetens:

• 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 Tevetens.

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 Tevetens. Based on the results of your blood tests, your doctor may decide to change your treatment with these medicines or with Tevetens.

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

If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Tevetens” and “Warnings and precautions”

Taking Tevetens with food, drinks, and alcohol:

• You can take the tablets with or without food.
• Consult your doctor before taking Tevetens if you are on 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 anti-hypertensive medicine. Usually, your doctor will advise you to take another medicine instead of Tevetens, as it is not recommended to take Tevetens at the start of pregnancy (first 3 months) and should not be used in the last 6 months of pregnancy, as it may cause serious harm to your baby.

Breastfeeding

• Tell your doctor if you are breastfeeding or planning to breastfeed.
• Tevetens 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 Tevetens will affect your ability to drive or use machines. However, you may feel drowsy or dizzy while taking Tevetens. If this is the case, do not drive or use tools or machines and inform your doctor.

Tevetens 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 Tevetens

Follow exactly the instructions of administration of this medicine given to you by your doctor or pharmacist. In case of 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, 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

Tevetens should not be given to children and adolescents under 18 years.

If you Take More Tevetens than You Should

If you take more Tevetens than you should or someone else takes your medicine by mistake, contact your doctor or go to the hospital immediately. Take the package and this leaflet with you. The following effects may occur:

• dizziness due to low blood pressure (hypotension)
• feeling sick (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 Tevetens

• Do not take a double dose to make up for forgotten doses.

• 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.

If you Stop Taking Tevetens:

Do not stop taking Tevetens 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 Tevetens 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 with symptoms such as abdominal pain, nausea, vomiting, and diarrhea has been reported with similar products.

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) through the website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tevetens

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 Tevetens

• 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 (E 171), 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

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 request more information about this medicine from the local representative of the marketing authorisation 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/