TEVETENS PLUS 600 mg/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tevetens plus 600 mg/12.5 mg, film-coated tablets

Eprosartan mesilate and hydrochlorothiazide

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 further questions, ask your doctor or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What is Tevetens plus and what is it used for

Tevetens plus is used to:

? treat high blood pressure.

Tevetens plus contains two active substances, eprosartan and hydrochlorothiazide.

? Eprosartan belongs to a group of medicines called “angiotensin II receptor antagonists”. It blocks the action of a substance in your body called “angiotensin II”. This substance causes your blood vessels to narrow. This makes it more difficult for blood to flow through your blood vessels, which increases your blood pressure. By blocking this substance, your blood vessels relax and your blood pressure decreases.

? Hydrochlorothiazide belongs to a group of medicines called “thiazide diuretics”. It increases the frequency and amount of urine you produce. This decreases your blood pressure.

You will only take Tevetens plus if your blood pressure does not decrease sufficiently with eprosartan alone.

Tevetens plus is used:

for the treatment of non-organic high blood pressure (essential hypertension). This combination product is used in patients whose blood pressure does not decrease sufficiently with eprosartan alone.

2. What you need to know before you start taking Tevetens plus

Do not take Tevetens plus if:

• you are allergic to eprosartan, hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6)
• you are allergic to a group of medicines called “sulfonamides”
• you have severe liver disease
• you have severe kidney problems with a decreased blood flow to your kidneys
• if you have diabetes or kidney problems and are being treated with a blood pressure medicine that contains aliskiren
• you have high levels of calcium or low levels of potassium or sodium in your blood. These levels can be measured in your blood
• you have a problem with your gallbladder or bile ducts (gallstones)
• you have gout or other signs of increased uric acid levels in your blood (hyperuricemia)

if you are more than 3 months pregnant (it is better to avoid taking Tevetens Plus at the start of pregnancy – see the section on pregnancy)

Do not take Tevetens plus if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking this medicine

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tevetens plus if:

• you have any other liver problems
• you have had a kidney transplant
• you have other kidney problems. Your doctor will check how well your kidneys are working before starting your treatment and at intervals during your treatment. Your doctor will also check the levels of potassium, creatinine and uric acid in your blood
• 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 check 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 plus”.

• you have a heart problem such as coronary heart disease, heart failure, narrowing of your blood vessels or heart valves or a problem with your heart muscle
• you have a disease called “Systemic Lupus Erythematosus” (SLE)
• you have diabetes. Your doctor may need to adjust the dose of your diabetes medicines
• you produce too much of a hormone called “aldosterone”
• you have a history of allergies
• you are on a low-salt diet, are taking “water tablets” (diuretics) or are vomiting or have diarrhea. This is because they can cause your blood volume or sodium levels in your blood to decrease. These situations should be corrected before starting treatment with Teveten Plus
• if you are taking any medicine that may increase your potassium levels (see section “Taking Tevetens Plus with other medicines”)
• you think you are pregnant (or plan to be). Tevetens Plus is not recommended at the start of pregnancy and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at this stage (see section on pregnancy).
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, in particular long-term use at high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Tevetens plus.
• If you experience a decrease in vision or eye pain, they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure and can occur within hours to weeks after taking Tevetens plus. This can lead to permanent vision loss if not treated. If you have previously been allergic to penicillin or sulfonamide, you may be at higher risk of developing it.
• If you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Tevetens plus, seek medical attention immediately.
• If you are a black patient, as this medicine may be less effective in reducing blood pressure

If any of the above applies to you (or you are not sure), consult your doctor or pharmacist before taking Tevetens plus.

Treatment with hydrochlorothiazide may cause an electrolyte imbalance in your body. Your doctor should regularly monitor your blood electrolyte levels.

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

Surgery and tests

Consult your doctor or pharmacist before taking this medicine if you are scheduled for:

• surgery or an operation
• a doping test. The hydrochlorothiazide in this medicine may give a positive result
• any other blood test

Taking Tevetens plus with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Tevetens plus may affect the way other medicines work. Also, some other medicines may affect the way Tevetens plus works.

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

? lithium – for mood problems. Your doctor should check your lithium levels in your blood because Tevetens plus may increase the level

? medicines for diabetes such as metformin or insulin. Your doctor may need to adjust the dose of your diabetes medicines

? medicines that may cause potassium loss. These include “water tablets”, laxatives, corticosteroids, amphotericin (an antifungal medicine), carbenoxolone (for the treatment of mouth ulcers) and a hormone produced by the pituitary gland called “ACTH”. Tevetens plus may increase the risk of low potassium levels in the blood when taking these medicines

? medicines that reduce the amount of sodium in the blood. These include medicines for treating depression, psychosis and epilepsy. Tevetens Plus may increase the risk of low sodium levels in the blood when taken with these medicines.

• non-steroidal anti-inflammatory medicines (NSAIDs) e.g. ibuprofen, naproxen, diclofenac, indomethacin, acetylsalicylic acid, celecoxib or etoricoxib - medicines to relieve pain and inflammation

? digitalis glycosides such as digoxin used for heart failure or a fast or slow heartbeat. Tevetens plus may increase its effect and also its side effects, such as an irregular heartbeat

? beta-blockers and diazoxide. When taken with Tevetens plus, blood sugar levels may increase

? medicines for treating cancer, such as "methotrexate" and "cyclophosphamide"

? medicines that narrow your blood vessels or stimulate your heart, such as noradrenaline,

• muscle relaxants, such as "baclofen" and "tubocurarine”

? anesthetics.

• amantadine used for the treatment of Parkinson's disease or viral diseases. Teveten Plus may increase the risk of side effects caused by amantadine.

If any of the above applies to you (or you are not sure), consult your doctor or pharmacist before taking Tevetens Plus.

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 plus” and “Warnings and precautions”

The following medicines may decrease the effect of Tevetens plus

? medicines that lower the fat in your blood, such as "colestipol” and “colestiramine”.

If any of the above applies to you (or you are not sure), consult your doctor or pharmacist before taking Tevetens Plus.

The following medicines may increase the effect of Tevetens plus

? medicines that induce sleep, such as "sedatives" and "narcotics".

• medicines for treating depression

? some medicines for Parkinson's disease, such as “biperiden”

? medicines that lower blood pressure

? “amifostine” a medicine that protects cells from chemotherapy.

If any of the above applies to you (or you are not sure), consult your doctor or pharmacist before taking Tevetens Plus.

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.

? medicines for gout such as “probenecid”, “sulfinpyrazone” and “allopurinol”

? medicines for diabetes such as "metformin" and "insulin"

? medicines to control your heart rate, such as quinidine, disopyramide, amiodarone and sotalol

? some antibiotics, such as “tetracyclines”

? some antipsychotic medicines such as thioridazine, chlorpromazine and levomepromazine

? calcium salts or vitamin D

? steroids.

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

Taking Tevetens plus with food and drinks and alcohol

Drinking alcohol while taking Tevetens plus may lower your blood pressure and make you feel tired or dizzy.

Consult your doctor before taking Tevetens plus if you are on a low-salt diet. Not having enough salt can cause your blood volume or sodium levels in your blood to be lower.

Pregnancy and breastfeeding

? Tell your doctor if you think you are pregnant (or plan to be). Your doctor will normally advise you to stop treatment with Tevetens Plus before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Tevetens Plus.

? Tevetens Plus is not recommended at the start of pregnancy, and should not be taken after the third month of pregnancy. It may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

? Tell your doctor if you are breastfeeding or about to start breastfeeding.

? Tevetens Plus is not recommended for breastfeeding mothers. Your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

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.

Driving and using machines

Tevetens plus is unlikely to affect your ability to drive or use machines. However, occasionally you may feel drowsy or dizzy while taking Tevetens plus. If this happens, do not drive or use tools or machines and consult your doctor.

Tevetens plus contains lactose

This medicine contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Tevetens plus

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.

Taking this medicine

? Take this medicine by mouth.

? You can take the tablets with or without food.

? Swallow the tablet whole with plenty of liquid, such as a glass of water

? Do not chew or crush the tablets.

• Take the tablets in the morning at the same time each day.

How to take it

Adults

The usual dose is one tablet a day.

Use in children and adolescents

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

If you take more Tevetens plus than you should

If you take more Tevetens plus than you should or someone accidentally takes something, consult your doctor or go to a hospital immediately.

Bring the medicine pack with you. The following effects may occur:

• a feeling of slight dizziness and dizziness due to a drop in blood pressure (hypotension)
• a feeling of discomfort (nausea)
• drowsiness
• a feeling of thirst (dehydration).

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone: 91.562.04.20.

If you forget to take Tevetens plus

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, skip the missed dose. Do not take a double dose to make up for the missed doses.

If you stop taking Tevetens plus

Do not stop taking Tevetens plus without consulting your doctor first

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. The following adverse effects may appear with this medicine:

Allergic Reactions

If you have an allergic reaction, stop taking Teveten Plus and see a doctor immediately. The symptoms may include:

? skin reactions such as a rash or hives with swelling (urticaria), (may affect up to 1 in 10 people)

? swelling of the face, swelling of the skin and mucous membranes (angioedema), (may affect up to 1 in 100 people)

Other possible side effects of Teveten Plus include:

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

? headache

Common(may affect up to 1 in 10 people)

? feeling dizzy

? tingling, nerve pain

? feeling nauseous, vomiting or diarrhea

? feeling of weakness (asthenia)

? skin rash

? itching

? nasal congestion (rhinitis)

? low blood pressure, including low blood pressure when standing up. You may feel slightly dizzy or lightheaded.

? changes in blood tests, such as:

• increase in blood glucose level (hyperglycemia)

Uncommon(may affect up to 1 in 100 people)

? sleep problems (insomnia)

? feeling of depression

? feeling of anxiety or nervousness

? sexual dysfunction and/or change in sexual desire

? muscle cramps

? fever

? dizziness (vertigo)

? constipation,

? changes in blood tests, such as:

• increase in uric acid level (gout)
• increase in fat (cholesterol)
• decrease in potassium, sodium, and chloride levels
• decrease in white blood cell count

Rare(may affect up to 1 in 1,000 people)

? water in the lungs

? inflammation of the lungs

? inflammation of the pancreas

Very Rare(may affect less than 1 in 10,000 people)

? hemolytic anemia

? Acute respiratory distress (signs include severe respiratory distress, fever, weakness, and confusion).

Frequency Not Known(frequency that cannot be estimated from available data)

Lack of appetite, jaundice, visual disturbances, feeling of restlessness, changes in blood cell count: decrease in granulocytes and platelets, alterations in red blood cell formation; decrease in magnesium level in the blood, increase in calcium and triglyceride levels in the blood, kidney disorders, kidney inflammation, acute kidney failure, inflammation of the blood vessel wall, formation of bubbles in the skin including dead skin cells (toxic epidermal necrolysis), rash/lesions on the skin usually in sun-exposed areas due to an autoimmune disease (cutaneous lupus erythematosus), systemic lupus erythematosus, arthralgia, severe allergic reactions (anaphylactic reactions), increased sensitivity to sunlight (photosensitivity), skin and lip cancer (non-melanoma skin cancer), decreased vision or eye pain due to high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma]. Intestinal angioedema: inflammation in the intestine has been reported, presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea after using similar products.

Reporting of Adverse Effects:

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

5. Storage of Tevetens plus

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

Do not use this medicine after the expiry date that appears on the box after CAD. or EXP. The expiry date is the last day of the month indicated.

Medicines should not be thrown away via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Tevetens plus

• The active ingredients are 600 mg of eprosartan (in the form of mesylate) and 12.5 mg of hydrochlorothiazide per tablet.
• The other components are:

Core of the tablet: lactose monohydrate, microcrystalline cellulose, pregelatinized starch (from corn), crospovidone, magnesium stearate, and purified water.

Coating: polyvinyl alcohol, talc, titanium dioxide (E 171), macrogol 3350, yellow iron oxide (E 172), and black iron oxide (E 172).

Appearance of the Product and Package Contents

White-yellowish film-coated tablets, capsule-shaped.

The tablets have the inscription “5147” on one side.

Tevetens plus is packaged in blisters containing 28 tablets.

Marketing Authorization Holder and Manufacturer

The marketing authorization holder is:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

The manufacturer of the medicine is:

Mylan Laboratories SAS

Route de Belleville Lieu dit Maillard

F- 01400 Châtillon-sur-Chalaronne, France

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

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this Prospectus:January 2025

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