Package Insert: Information for the User

Tevetens plus 600 mg/12.5 mg, Film-Coated Tablets

Eprosartan mesylate and Hydrochlorothiazide

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 or pharmacist.
• 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 consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package insert, inform your doctor or pharmacisteven if it is a side effect not listed in this package insert. See section 4.

Tevetens plus is used for :

?to treat high blood pressure.

Tevetens plus contains two active ingredients, 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 constrict. This makes it harder for blood to flow through your blood vessels, resulting in increased 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 eliminate. 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.

Do not take Tevetens plus if:

• You are allergic to eprosartan, hydrochlorothiazide, or any of the other components of this medication (listed in section 6)
• You are allergic to a group of medications called “sulfonamides”
• You have severe liver disease
• You have severe problems with blood flow in your kidneys
• You have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskiren
• You have high levels of calcium or low levels of potassium or sodium. These levels can be measured in your blood
• You have a problem with your gallbladder or bile ducts (biliary calculi)
• You have gout or other signs of an increase in the level of “uric acid” in your blood (hyperuricemia)

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

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

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 examine how your kidneys are functioning before starting your treatment and at intervals during your treatment. Your doctor will also monitor the levels of potassium, creatinine, and “uric acid” in your blood
• If you are taking any of the following medications used to treat high blood pressure:

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

- aliskiren

Your doctor may monitor your renal function, blood pressure, and electrolyte levels in your blood (such as 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, a 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 medications
• You produce too much of a hormone called “aldosterone”
• You have a history of allergies
• You have a low-sodium diet, are taking “diuretics” (diuretics), or are vomiting or have diarrhea. This is because they can cause a decrease in your blood volume or sodium levels in your blood. These situations should be corrected before starting treatment with Tevetens Plus
• If you are taking any medication that may increase your serum potassium levels (see section “Taking Tevetens Plus with other medications”)
• You think you may be pregnant (or plan to be). Tevetens Plus is not recommended at the beginning of pregnancy and should not be taken if you are more than 3 months pregnant, as it may cause severe damage to the baby if used during this phase (see the pregnancy section).
• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, particularly its long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Tevetens Plus.
• If you experience a decrease in vision or eye pain, they may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure, which can occur within a few hours to several weeks after taking Tevetens Plus. This can lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may be at a higher risk of developing it.
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Tevetens Plus, seek medical attention immediately.
• If you are a black patient, as this medication may be less effective in reducing blood pressure

If any of the above applies to you (or you are unsure), consult your doctor or pharmacist before taking Tevetens Plus.

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

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

Surgery and tests

Consult your doctor or pharmacist before taking this medication if you have planned the following:

• Surgery or operation
• Drug test. Hydrochlorothiazide in this medication may give a positive result
• Any other blood test

Taking Tevetens plus with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This includes medications obtained without a prescription, including herbal medications. This is because Tevetens Plus may affect how other medications work. Also, some other medications may affect how Tevetens Plus works.

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

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

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

?Medications that may cause a loss of potassium. These include “diuretics”, “laxatives”, “corticosteroids”, amphotericin (an antifungal medication), carbenoxolone (for mouth ulcer treatment), and a hormone produced by the pituitary gland called “ACTH”. Tevetens Plus may increase the risk of low potassium levels in your blood when taken with these medications

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

• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, indomethacin, aspirin, celecoxib, or etoricoxib – medications for pain relief and inflammation

?Digitoxin, a medication used for heart failure or a rapid or slow heart rate. 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, your blood sugar levels may increase

?Cancer medications such as “methotrexate” and “cyclophosphamide”

?Medications that constrict your blood vessels or stimulate your heart, such as norepinephrine,

• Medications that relax your muscles, such as “baclofen” and “tubocurarine”

?Anesthetics.

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

If any of the above applies to you (or you are unsure), 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 medications may reduce the effect of Tevetens plus

?Medications that reduce fat in your blood, such as “cholestyramine” and “colestipol”.

If any of the above applies to you (or you are unsure), consult your doctor or pharmacist before taking Tevetens Plus.

The following medications may increase the effect of Tevetens plus

?Medications that induce sleep, such as “sedatives” and “narcotics”.

• Medications for depression

?Some medications for Parkinson's disease, such as “biperiden”

?Medications that lower blood pressure

?“Amifostine”, a medication that protects cells from chemotherapy.

If any of the above applies to you (or you are unsure), consult your doctor or pharmacist before taking Tevetens Plus.

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, trimethoprim, and ACE inhibitors

?Medications for gout such as “probencid”, “sulfinpyrazone”, and “allopurinol”

?Medications for diabetes such as “metformin” and “insulin”

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

?Some antibiotics, such as “tetracyclines”

?Some antipsychotic medications, such as thioridazine, chlorpromazine, and levopromazine

?Calcium salts or vitamin D

?Glucocorticoids.

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 medications or Tevetens plus.

Taking Tevetens plus with food and drinks and alcohol

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

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

Pregnancy and breastfeeding

?Inform your doctor if you think you may be pregnant (or plan to be). Your doctor will usually advise you to stop taking Tevetens Plus before becoming pregnant or as soon as you know you are pregnant and will advise you to take another medication instead of Tevetens Plus.

?Tevetens Plus is not recommended at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause severe damage to your baby if used during this phase (see the pregnancy section).

Breastfeeding

?Inform your doctor if you are breastfeeding or plan to start breastfeeding.

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

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.

Driving and using machines

Tevetens plus is unlikely to affect your ability to drive or use machines. However, 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 medication contains lactose (a type of sugar). If your doctor has told you that you have a lactose intolerance, consult him before taking this medication.

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

Taking this medication

?Take this medication 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 every day.

How to take it

Adults

The usual dose is one tablet a day.

Use in children and adolescents

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

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 the hospital immediately.

Bring the medication packaging with you. The following effects may appear:

• 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 Toxicological Information Service. Phone: 91.562.04.20.

If you forgot 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 the next dose is near, omit the missed dose. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Tevetens plus

Do not stop taking Tevetens plus without consulting your doctor first

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.This medicine may cause the following side effects:

Allergic reactions

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

?skin reactions such as hives or rashes 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 weak (asthenia)

?skin rash

?itching

?congested nose (rhinitis)

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

?changes in blood test results, such as:

- increased blood glucose levels (hyperglycemia)

Uncommon(may affect up to 1 in 100 people)

?sleep problems (insomnia)

?feeling depressed

?feeling anxious or nervous

?sexual dysfunction and/or change in sexual desire

?muscle cramps

?fever

?dizziness (vertigo)

?constipation,

?changes in blood test results, such as:

- increased uric acid levels (gout)

- increased cholesterol levels

- decreased levels of potassium, sodium, and chloride

- decreased white blood cell count

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

?fluid in the lungs

?inflammation of the lungs

?inflammation of the pancreas

Very rare(may affect fewer than 1 in 10,000 people)

?hemolytic anemia

?acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

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

Loss of appetite, jaundice, , visual disturbances, feeling restless, changes in blood cell count: decreased granulocytes and platelets, alterations in red blood cell formation; decreased magnesium levels in the blood, increased levels of calcium and triglycerides in the blood, renal disorders, inflammation of the kidney, acute renal failure, inflammation of the blood vessel wall, formation of bubbles in the skin including dead skin cells (toxic epidermal necrolysis),skin eruption/lesions 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 cancer and lip cancer (non-melanoma skin cancer), decreased vision or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma].Intestinal angioedema: intestinal inflammation has been reported, presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea after use of similar products.

Reporting of side effects:

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

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

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

Medications should not be disposed of through drains or in the trash.Deposit the containers and medications you no longer need at the SIGRE collection point of the pharmacy.Ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Tevetens Plus Composition

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

Tablet core: lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, 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).

Product Appearance and Packaging Contents

White-yellow coated tablets, in capsule shape.

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

Tevetens Plus is packaged in blisters containing 28 tablets.

Marketing Authorization Holder and Responsible Manufacturer

The marketing authorization holder is:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

The manufacturer of the medicinal product is:

Mylan Laboratories SAS

Route de Belleville Lieu dit Maillard

F- 01400 Châtillon-sur-Chalaronne, France

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last reviewed date of this leaflet:January 2025

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