600 mg/12.5 mg film-coHydrochlorothiazideated tablet
eprosartan and hydrochlorothiazide
What Teveten Comp is and what it is used for
Teveten Comp is used:
- to treat high blood pressure.
Teveten Comp contains two active substances, eprosartan and hydrochlorothiazide .
- Eprosartan belongs to a group of medicines called ‘angiotensin II inhibitors. Angiotensin II causes constriction of blood vessels a. This means that the blood has more difficulty passing through vessels and that blood pressure increases. Eprosartan blocks the effect of angiotensin II so that blood vessels dilate and blood pressure drops.
- Hydrochlorothiazide belongs to the group “thiazide diuretics”. Hydrochlorothiazide increases the amount of urine and how often you need to urinate and thus lowers blood pressure etc.
You will only be treated with Teveten Comp when eprosartan alone does not lower blood pressure sufficiently.
2. What you need to know before taking Teveten Comp
Do not take Teveten Comp:
- if you are allergic to eprosartan, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to a group of medicines called sulphonamides
- if you have severe liver disease
- if you have severe kidney disease
- if you have serious problems with the blood flow in your kidneys
- if you have diabetes or impaired kidney function and are being treated with an antihypertensive medicine containing aliskiren
- if you have high levels of calcium or low levels of potassium or sodium. The levels of these substances are measured in the blood
- if you have problems with the gallbladder or bile ducts ( gallstones )
- if you have gout or other symptoms of the increased uric acid level in the blood (hyperuricemia)
- during the last 6 months of pregnancy. (Even earlier in pregnancy it is good to avoid Teveten Comp, see Pregnancy and breastfeeding).
Do not take Teveten Comp if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Teveten Comp if:
- Do you have any other liver disease
- you have undergone a kidney transplant
- Do you have any other kidney diseases? Your doctor will check your kidney function before treatment and regularly during treatment. Your doctor will check the levels of potassium, creatinine, and uric acid in your blood
- you are taking any of the following medicines used to treat high blood pressure:
- an ACE inhibitor (for example enalapril, lisinopril, ramipril), especially if you have diabetes-related kidney problems
- aliskiren
Your doctor may need to check your kidney function, blood pressure, and the number of electrolytes (eg potassium ) in your blood at regular intervals. See also the information under the heading “Do not take Teveten Comp”
- you have a heart condition, e.g. coronary artery disease, heart failure, narrow blood vessels, narrow heart valves, or heart muscle disease
- you have a disease called systemic lupus erythematosus ( SLE )
- you have diabetes. Your doctor may need to change the dose of one of your diabetes medications
- you have increased production of a hormone called aldosterone
- you have a history of allergies
- you are on a low-salt diet, take diuretics, have diarrhea, or are vomiting. The reason is that blood volume or sodium levels in the blood may decrease. This should be addressed before starting treatment with Teveten Comp
- you are taking other medicines that can increase the potassium level in the blood (see section “Other medicines and Teveten Comp”)
- you think you are pregnant (or may become pregnant). Teveten Comp is not recommended during pregnancy and should not be used during the last 6 months of pregnancy as it can then cause birth defects, see Pregnancy and breastfeeding.
- you have had skin cancer or if you get an unexpected skin change during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to sunlight and UV rays while taking Teveten Comp.
- you experience impaired vision or eye pain. These may be symptoms of fluid accumulation in the eye (between the choroid and sclera) or an increase in pressure in the eye and may occur within hours to weeks of taking Teveten Comp. This can lead to permanent vision loss if left untreated. If you have previously had a penicillin or sulfonamide allergy, you may have a higher risk of developing this.
- you have previously had breathing or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you experience severe shortness of breath or severe breathing problems after taking Teveten Comp, seek medical attention immediately.
If any of the above apply to you (or if you are not sure), talk to your doctor or pharmacist before taking Teveten Comp.
Treatment with hydrochlorothiazide can cause disturbances in the electrolyte balance in your body. Your doctor may need to do regular checks of the electrolytes in your blood.
Operations and tests
Talk to your doctor or pharmacist before taking this medicine if you have any of the following:
- an operation
- other blood tests.
Other medicines and Teveten Comp
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to non-prescription drugs and herbal remedies. The reason is that Teveten Comp can affect how certain other medicines work. Some medicines can also affect how Teveten Comp works.
You must tell your doctor or pharmacist if you are taking any of the following:
- lithium for mental disorders. Your doctor must monitor the level of lithium in your blood as Teveten Comp may increase its level
- medicines for diabetes, e.g. metformin or insulin. Your doctor may need to change the dose of one of your diabetes medications
- medicines that can cause potassium deficiency, e.g. diuretics, laxatives (medicines against constipation), corticosteroids, amphotericin (medicines against fungi), carbenoxolone (medicines against mouth ulcers) and the hormone ACTH, which is produced in the pituitary gland. Teveten Comp may increase the risk of low levels of potassium in the blood when used simultaneously
- with medicines that can reduce sodium levels in the blood, such as medicines to treat depression, psychosis, and epilepsy. Teveten Comp may increase the risk of low sodium levels in the blood when used together with these medicines
- non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen, naproxen, diclofenac, indomethacin, aspirin, celecoxib or etoricoxib – medicines to relieve pain and inflammation
- digitalis glycosides e.g. digoxin used for heart failure or a fast or irregular heartbeat. Teveten Comp can increase the risk of organ-related heart rhythm
- beta blockers or diazoxide. Simultaneous use of Teveten Comp may increase blood sugar levels.
- medicines against cancer, e.g. methotrexate and cyclophosphamide
- medicines that constrict the blood vessels or that stimulate the heart, e.g. norepinephrine
- muscle relaxant drugs, e.g. baclofen and tubocurarine
- narcotics
- amantadine for Parkinson’s disease or viral infections. Teveten Comp can increase the risk of getting side effects from amantadine.
If any of the above apply to you (or if you are not sure), talk to your doctor or pharmacist before taking Teveten Comp.
Your doctor may need to change 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 Teveten Comp” and “Warnings and precautions”.
The following medicines can reduce the effect of Teveten Comp
- medicines that reduce blood fats, e.g. colestipol and cholestyramine.
If any of the above apply to you (or if you are not sure), talk to your doctor or pharmacist before taking Teveten Comp.
The following medicines can increase the effect of Teveten Comp
- sleep medicines such as sedatives and narcotics
- medication for depression
- certain medicines for Parkinson’s disease, e.g. the biperiden
- antihypertensive drugs
- amifostine, a drug that protects the cells against chemotherapy.
If any of the above apply to you (or if you are not sure), talk to your doctor or pharmacist before taking Teveten Comp.
If you are taking any of the following medicines, your doctor may need to take a blood sample from you:
- medicines containing potassium or potassium-sparing medicines
- medicines that increase potassium levels e.g. heparin, trimethoprim, and ACE inhibitors
- medicines for gout, e.g. probenecid, sulfinpyrazone, and allopurinol
- medicines for diabetes, e.g. metformin and insulin
- medicines that control your heart rhythm e.g. quinidine, disopyramide, amiodarone, and sotalol
- certain antibiotics e.g. tetracycline er
- certain medicines for mental disorders, e.g. thioridazine, chlorpromazine or levopromazine
- calcium salts or vitamin D
- steroid er.
Talk to your doctor or pharmacist before taking Teveten Comp. Depending on the results of your blood tests, your doctor may decide to change your treatment with these medicines or Teveten Comp.
Teveten Comp with food, drink, and alcohol
- Consuming alcohol during treatment with Teveten Comp can lower your blood pressure and make you feel tired or dizzy.
- Talk to your doctor before taking Teveten Comp if you are on a low-salt diet. Not getting enough salt can cause your blood volume or blood sodium levels to drop.
Pregnancy and breastfeeding
Pregnancy
- You must tell your doctor if you think you are pregnant or become pregnant during treatment. Usually, your doctor will suggest that you stop taking Teveten Comp before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you.
- Teveten Comp should not be used at the beginning of pregnancy and should not be used during the last 6 months of pregnancy as it can then cause birth defects.
Breast-feeding
- Tell your doctor if you are breastfeeding or intend to start breastfeeding.
- Teveten Comp is not recommended during breastfeeding and your doctor may choose another treatment for you if you wish to breastfeed your baby, especially if your baby is a newborn or was born prematurely.
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 using this medicine.
Driving ability and use of machinery
Teveten Comp is less likely to affect the ability to drive or use machines. However, you may experience dizziness and fatigue during treatment with Teveten Comp. If you experience such symptoms, you should consult a doctor before driving or using machinery.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects.
A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Teveten Comp contains lactose
Teveten Comp contains lactose. If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
How to take Teveten Comp
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Use
- This medicine should be swallowed
- You can take tablets with or without food.
- Swallow the tablet whole with plenty of liquid, e.g. a glass of water.
- You should not crush or chew the tablets.
- Take the tablets in the morning at about the same time each day.
Dosage
Adults
The usual dose is one tablet per day.
Use for children and adolescents
Teveten Comp should not be given to children and adolescents under 18 years of age.
If you have taken too much Teveten Comp
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice. Take the medicine package with you.
The following effects may occur:
- you feel dizzy and dizzy because your blood pressure drops
- nausea
- you feel sleepy
- the feeling of thirst.
If you forget to take Teveten Comp
If you forget to take your medicine, take a tablet 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. Do not take a double dose to make up for a missed dose.
If you stop taking Teveten Comp
Do not stop taking Teveten Comp without talking to your doctor first.
If you have any further questions about this medicine, ask your doctor or pharmacist.
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
If you have an allergic reaction, stop taking Teveten Comp and see a doctor immediately. The signs can be:
- skin reactions such as rash or hives with swelling ( urticaria ) (affects more than 1 in 100 users)
- 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 Compare:
Very common (may affect more than 1 in 10 users)
- headache
Common (may affect up to 1 in 10 users)
- dizziness
- tingling, nerve pain
- nausea, vomiting, or diarrhea
- weakness
- rash
- itching
- nasal congestion
- low blood pressure including low blood pressure when standing up. You may feel dizzy and dizzy
- changes in blood values e.g. increase in blood glucose.
Uncommon (may affect up to 1 in 100 users)
- sleeping problems
- Depression
- worry or nervousness
- changes in sexual function and/or change in sexual desire
- muscle cramps
- fever
- dizziness
- constipation
- changes in blood values e.g. increase in uric acid ( gout ), increase in fat values ( cholesterol ), decrease in potassium, sodium, and chloride, and decrease in the number of white blood cells.
Rare (may affect up to 1 in 1,000 users)
- water in the lungs
- pneumonia
- inflammation of the pancreas.
Very rare (may affect up to 1 in 10,000 users)
- increased breakdown of the red blood cells ( hemolytic anemia ).
- acute respiratory distress syndrome (signs of this are severe shortness of breath, fever, weakness, and confusion).
Has been reported (occurring in an unknown number of users)
Decreased appetite, jaundice, visual disturbances or pain in the eyes due to high pressure (possible sign of fluid accumulation in the eye (between the choroid and the sclera) or acute narrow-angle glaucoma ), restlessness, changes in the number of blood cells: decrease in granulocytes and platelets, disorders in the formation of red blood cells, decrease in magnesium content in the blood, increase in the content of calcium and triglycerides in the blood, kidney function problems, kidney inflammation, acute kidney failure, inflammation of the blood vessel wall, blistering of the skin including dead skin cells ( toxic epidermal necrolysis), skin rash/skin lesions, usually on areas exposed to the sun, due to an autoimmune disease ( cutaneous lupus erythematosus), systemic lupus erythematosus, joint pain ( arthralgia ), severe allergic reactions (anaphylactic reactions), increased sensitivity to (sun)light ( photosensitivity ), skin and lip cancer (non-melanoma skin cancer).
How to store Teveten Comp
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton and printed packaging. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medications that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substances are 600 mg eprosartan (as mesylate) and 12.5 mg hydrochlorothiazide per tablet.
Other ingredients are:
- Tablet core: lactose monohydrate, microcrystalline cellulose, pregelatinized starch (from corn), crospovidone, magnesium stearate, and purified water.
- Film coating: polyvinyl alcohol, talc, titanium dioxide (E171), macrogol 3350, iron oxide yellow (E172), and iron oxide black (E172).
Appearance and package sizes of the medicine
Light brown, capsule-shaped, film-coated tablet.
The tablet is marked with 5147 on one side.
Teveten Comp is supplied in pressure packs of 14, 28, 56, 98, or 280 (10×28) tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Viatris AB
Box 23033
104 35 Stockholm
Manufacturer
Mylan Laboratories SAS
Route de Belleville
Lieu dit Maillard
01400 Châtillon-sur-Chalaronne
France
| This medicine is approved in the European Economic Area under the names: | |
|---|---|
| Germany | Teveten Plus HTC 600 mg/12.5 mg |
| Belgium, Greece, Ireland, Luxembourg, Portugal | Teveten Plus, 600 mg/12.5 mg |
| Finland, Norway, Sweden | Teveten Comp, 600 mg/12.5 mg |
| Italy | The tiara |
| Spain | Tevetens Plus, 600 mg/12.5 mg |
| Austria | Teveten Plus |