Tevetens Plus 600 mg/12.5 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Tevetens plus 600 mg/12.5 mg, film-coated tablets
Eprosartan mesilate and hydrochlorothiazide
Read the entire 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 or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
- If you consider any of the side effects you experience to be severe or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist, even if they are side effects not mentioned in this leaflet. See section 4.
Contents of the leaflet:
- What Tevetens plus is and what it is used for
- What you need to know before taking Tevetens plus
- How to take Tevetens plus
- Possible side effects
- How to store Tevetens plus
- Contents of the pack and other information
1. What Tevetens plus is and what it is 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 harder for blood to flow through the blood vessels, resulting in increased blood pressure. By blocking this substance, the blood vessels relax and your blood pressure decreases.
• Hydrochlorothiazide belongs to a group of medicines called “thiazide diuretics”. It increases how often and how much urine you pass. This lowers 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 fixed combination product is used in patients whose blood pressure is not sufficiently controlled with eprosartan alone.
2. What you need to know before 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 serious problems with blood flow to your kidneys
- you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing 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 best to avoid taking Tevetens Plus in early pregnancy – see the pregnancy section)
Do not take Tevetens Plus if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking 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 treatment and at regular intervals during treatment. Your doctor will also monitor levels of potassium, creatinine, and "uric acid" in your blood
-
you are taking any of the following medicines for 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 Plus”.
- you have a heart condition 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 medication
- you produce too much of a hormone called "aldosterone"
- you have a history of allergies
- you are on a low-salt diet, taking "water tablets" (diuretics), or experiencing vomiting or diarrhea. This is because these conditions can reduce your blood volume or blood sodium levels. These situations should be corrected before starting treatment with Tevetens Plus
- you are taking any medicine that may increase your blood potassium levels (see section “Taking Tevetens Plus with other medicines”)
- you think you are pregnant (or plan to become pregnant). Tevetens Plus is not recommended in early pregnancy and must not be taken after 3 months of pregnancy, as it may cause serious harm to the unborn baby (see pregnancy section)
- you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from sun exposure and UV rays while taking Tevetens Plus.
- If you experience vision changes or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours to weeks of taking Tevetens Plus. This may lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk.
- If you have had breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop shortness of breath or severe difficulty breathing after taking Tevetens Plus, seek medical attention immediately.
- If you are of Black African or Afro-Caribbean origin, as this medicine may be less effective in lowering blood pressure
If any of the above apply to you (or you are unsure), consult your doctor or pharmacist before taking Tevetens Plus.
Treatment with hydrochlorothiazide may cause an electrolyte imbalance in your body. Your doctor should monitor your blood electrolytes regularly.
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
Talk to 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 cause 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 need to use any other medicines. This includes medicines obtained without prescription, including herbal medicines. This is because Tevetens Plus may affect how other medicines work. Also, some other medicines may affect how Tevetens Plus works.
In particular, consult your doctor or pharmacist if you are taking the following:
? lithium – for mood disorders. Your doctor must monitor your blood lithium levels, as Tevetens Plus may increase them
? diabetes medicines 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 (used to treat mouth ulcers), and a hormone produced by the pituitary gland called "ACTH". Tevetens Plus may increase the risk of low blood potassium levels when taken with these medicines
? medicines that reduce sodium levels in the blood. These include medicines used to treat depression, psychosis, and epilepsy. Tevetens Plus may increase the risk of low blood sodium levels when taken with these medicines.
- non-steroidal anti-inflammatory drugs (NSAIDs), for example, ibuprofen, naproxen, diclofenac, indomethacin, acetylsalicylic acid, celecoxib, or etoricoxib – medicines used to relieve pain and inflammation
? digitalis glycosides such as digoxin, used for heart failure or fast or slow heartbeats. Tevetens Plus may increase its effect and also its side effects, such as irregular heartbeat
? beta-blockers and diazoxide. When taken with Tevetens Plus, blood sugar levels may increase
? cancer treatments such as "methotrexate" and "cyclophosphamide"
? medicines that constrict your blood vessels or stimulate your heart, such as noradrenaline
- muscle-relaxing medicines such as "baclofen" and "tubocurarine"
? anaesthetics
? amantadine, used to treat Parkinson's disease or viral infections. Tevetens Plus may increase the risk of side effects caused by amantadine.
If any of the above apply 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 information under the headings “Do not take Tevetens Plus” and “Warnings and precautions”)
The following medicines may reduce the effect of Tevetens Plus
? medicines that lower blood fats, such as "cholestyramine" and "colestipol".
If any of the above apply to you (or you are unsure), consult your doctor or pharmacist before taking Tevetens Plus.
The following medicines may increase the effect of Tevetens Plus
? medicines that cause drowsiness, such as "sedatives" and "narcotics"
? medicines used to treat 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 apply to you (or you are unsure), consult your doctor or pharmacist before taking Tevetens Plus.
If you are taking any of the following medicines, your doctor may perform blood tests:
? potassium-containing medicines or potassium-sparing medicines
? medicines that increase potassium levels such as heparin, trimethoprim, and ACE inhibitors
? gout medicines such as "probenecid", "sulfinpyrazone", and "allopurinol"
? diabetes medicines such as "metformin" and "insulin"
? medicines to control your heart rhythm, 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 your blood test results, your doctor may decide to change your treatment with these medicines or with Tevetens Plus.
Taking Tevetens Plus with food and drink and alcohol
Drinking alcohol while taking Tevetens Plus may lower your blood pressure further and make you feel tired or dizzy.
Consult your doctor before taking Tevetens Plus if you are on a low-salt diet. Having too little salt may cause your blood volume or blood sodium levels to become too low.
Pregnancy and breastfeeding
? Inform your doctor if you think you are pregnant (or plan to become pregnant). 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 recommend an alternative medicine.
? Tevetens Plus is not recommended during early pregnancy and must not be taken after 3 months of pregnancy. It may cause serious harm to your unborn baby if used after the third month of pregnancy.
Breastfeeding
? Inform your doctor if you are breastfeeding or about to start breastfeeding.
? Tevetens Plus is not recommended for breastfeeding mothers. Your doctor may choose a different 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
Tevetens Plus is unlikely to affect your ability to drive or use machines. However, you may occasionally feel drowsy or dizzy while taking Tevetens Plus. If this happens, do not drive or operate tools or machinery 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 certain sugars, consult with him before taking this medicine.
3. How to take Tevetens plus
Follow exactly the instructions for taking this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Taking this medicine
? Take this medicine by mouth.
? You may 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 per day.
Use in children and adolescents
Tevetens plus must not be given to children and adolescents under 18 years of age.
If you take more Tevetens plus than you should
If you take more Tevetens plus than you should, or if someone accidentally ingests it, contact your doctor or go to a hospital immediately.
Take the medicine packaging with you. The following effects may occur:
- feeling slightly dizzy and dizziness due to a drop in blood pressure (hypotension)
- feeling unwell (nausea)
- drowsiness
- feeling thirsty (dehydration).
In case of overdose or accidental ingestion, contact 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 forgotten dose.
If you stop taking Tevetens plus
Do not stop taking Tevetens plus without first consulting your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them. The following adverse effects may occur with this medicine:
Allergic reactions
If you have an allergic reaction, stop taking Teveten Plus and see a doctor immediately. Symptoms may include:
? skin reactions such as 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
? nausea, vomiting or diarrhoea
? feeling of weakness (asthenia)
? skin rash
? itching
? nasal congestion (rhinitis)
? low blood pressure, including low blood pressure upon standing (orthostatic hypotension). You may feel slightly lightheaded or dizzy.
? changes in blood tests, such as:
- increase in blood glucose levels (hyperglycaemia)
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 tests, such as:
- increase in uric acid levels (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)
? fluid in the lungs
? inflammation of the lungs
? inflammation of the pancreas
Very rare (may affect less than 1 in 10,000 people)
? haemolytic anaemia
? Acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness and confusion).
Frequency not known (frequency cannot be estimated from the available data)
Loss of appetite, jaundice, visual disturbances, feeling of restlessness, changes in blood cell counts: decrease in granulocytes and platelets, disturbances in red blood cell formation; decrease in blood magnesium levels, increase in blood calcium and triglyceride levels, kidney disorders, inflammation of the kidney, acute renal failure, inflammation of blood vessel walls, blistering of the skin including skin cell death (toxic epidermal necrolysis), skin rash/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 and lip cancer (non-melanoma skin cancer), decreased vision or eye pain due to elevated pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma]. Intestinal angioedema: intestinal inflammation has been reported with similar products, presenting symptoms such as abdominal pain, nausea, vomiting and diarrhoea.
Reporting of adverse effects:
If you experience any type of 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 stated on the carton after CAD. or EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Tevetens plus
- The active substances are 600 mg of eprosartan (as mesilate) and 12.5 mg of hydrochlorothiazide per tablet.
- The other components are:
Tablet core: 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 contents of the pack
Yellowish-white, capsule-shaped coated tablets.
The tablets are marked with the code "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 responsible for the production 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 under the following names:
Germany, Greece, Ireland, Luxembourg, Portugal: | Teveten Plus HCT 600 mg/12.5 mg Teveten Plus, 600 mg/12.5 mg |
Finland, Norway: | Teveten Comp, 600 mg/12.5 mg |
Spain: Austria: | Tevetens Plus 600 mg/12.5 mg Tevetens Plus |
Date of the most recent review of this leaflet: January 2025
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): https://www.aemps.gob.es