Tevetens 600 mg film-coated tablets

Package leaflet: Information for the user

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 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 you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Tevetens is and what it is used for

Tevetens is a medicine that belongs to a group of medicines called angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that causes blood vessels to tighten. Tevetens works by blocking angiotensin II and relaxing blood vessels, which lowers blood pressure. Tevetens contains the active substance telmisartan.

Tevetens is used to treat:

• High blood pressure (hypertension) in adults.
• Reduced blood supply to the heart (ischaemic heart disease) or stroke in adults aged 55 years and over who are at high risk of these conditions, even if their blood pressure is normal.

Tevetens is used for:

• treating hypertension

Tevetens contains the active substance eprosartan.

Eprosartan belongs 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 flow through them, resulting in increased blood pressure. By blocking this substance, blood vessels relax and blood pressure decreases.

2. What you need to know before taking Tevetens

Do not take Tevetens:

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

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 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 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. These conditions may lead to reduced blood volume or low blood sodium levels. These situations should be corrected before taking Tevetens,

• you are taking any of the following medicines for 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 Tevetens”.

• you think you are (or might become) pregnant. Use of Tevetens is not recommended during 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 medicine that may increase your serum potassium levels (see section “Taking Tevetens 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 Tevetens.

Contact 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 need to take any other medicines, including those obtained without a prescription. These include herbal medicines. This is because Tevetens may affect how other medicines work, and other medicines may affect how Tevetens works.

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

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

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

The following medicines may reduce the effect of Tevetens:

• 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 Tevetens.

If you are taking any of the following medicines, your doctor may need to 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 Tevetens. Depending on your blood test results, 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 angiotensin-converting enzyme inhibitor (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 may 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 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 replace Tevetens with another appropriate antihypertensive medicine. Your doctor will generally advise you to take a different medicine instead of Tevetens, as Tevetens is not recommended during pregnancy (first 3 months), and 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.
• Tevetens is not recommended for breastfeeding mothers. Your doctor may choose a different 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 Tevetens will affect your ability to drive or operate machinery. However, you may feel drowsy or dizzy while taking Tevetens. If this occurs, do not drive or use tools or machines, and inform your doctor.

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

3. How to take Tevetens

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

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

If you take more Tevetens than you should

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

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

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

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 the next dose, skip the missed dose.

If you stop taking Tevetens:

Do not stop taking Tevetens 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 can cause adverse effects, although not everyone experiences 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 membrane (angioedema).

Other possible adverse 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 upon standing. You may feel dizzy.

Frequency not known (frequency cannot be estimated from 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 may also report them directly via 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 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 stated on the packaging, after 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 unused medicines and their packaging at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tevetens

• The active substance is eprosartan. Each coated tablet contains 600 mg of eprosartan (as mesilate dihydrate).
• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch (gluten-free), 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 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

Further information on this medicinal product is available by contacting the local representative of the Marketing Authorization Holder:

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

Date of latest revision of this leaflet: January 2025

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