600 mg film-coated tablet
eprosartan
What Teveten is and what it is used for
Tevet is used for:
- to treat high blood pressure.
Teveten contains the active substance eprosartan.
- eprosartan belongs to a group of medicines called ‘angiotensin II antagonists. It blocks the effect of a substance in the body called “angiotensin II”. This substance causes the blood vessels to constrict. This makes it more difficult for the blood to flow through the vessels and therefore increases blood pressure et. By blocking this substance, the blood vessels dilate and blood pressure drops.
What you need to know before using Teveten.
Do not use the Teveten
- if you are allergic (hypersensitive) to eprosartan or any of the other ingredients in Teveten (listed in section 6)
- if you have severe liver disease
- you have serious problems with blood flow in the kidneys
- if you have diabetes or impaired kidney function and are being treated with an antihypertensive medicine containing aliskiren
- during the last 6 months of pregnancy (even earlier during pregnancy it is good to avoid Teveten, see Pregnancy and breastfeeding).
Ask your doctor if you are unsure about any of the above points.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if:
- Do you have any other liver problems
- Do you have any other kidney problems? Your doctor will then check how well your kidneys are working before you start your treatment and at regular intervals during treatment. Your doctor will check the potassium, “creatinine” and “uric acid” levels in the blood
- if you are taking any of the following medicines used to treat high blood pressure:
- an ACE inhibitor (eg enalapril, lisinopril, ramipril), especially if you have diabetes-related kidney problems.
- the 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 use the Teveten”.
- you have heart problems such as coronary artery disease, heart failure, narrowing of your blood vessels or heart valves, or problems with your heart muscle
- you have excessive production of the hormone et alaldosterone
- you are on a low-salt diet, take diuretic tablets or are vomiting or have diarrhea. This is because they can cause your blood volume or blood salt level to decrease. This should be corrected before starting treatment with Teveten
- you are taking other medicines that can increase the potassium level in the blood (see section “Other medicines and Teveten”).
- If you think you are pregnant or become pregnant during treatment, contact your doctor. Teveten 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.
If any of the above apply to you (or if you are not sure), talk to your doctor or pharmacist before taking Teveten.
Teveten may be less effective in lowering blood pressure et in black patients.
Other medicines and Teveten
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes over-the-counter medicines, including herbal remedies. This is because Teveten can affect how other medicines work. Some other medicines can also affect how Teveten works.
In particular, tell your doctor or pharmacist if you are taking any of the following:
- lithium – for mood problems. Your doctor must monitor lithium in your blood because Teveten can increase the level.
- non-steroidal anti-inflammatory drugs ( NSAIDs ), e.g. ibuprofen, naproxen, diclofenac, indomethacin, aspirin, celecoxib, or etoricoxib – medicines to relieve pain and inflammation.
If the above applies to you (or if you are not sure), talk to your doctor or pharmacist before taking Teveten.
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 use Teveten” and “Warnings and precautions”).
The following medicines can increase the effect of Teveten:
- drugs that lower blood pressure, etc.
If the above applies to you (or if you are not sure), talk to your doctor or pharmacist before taking Teveten.
If you are taking any of the following medicines, your doctor may perform blood tests:
- medicines containing potassium or potassium-sparing medicines
- medicines that increase potassium levels such as “heparin”, “trimethoprim” and “ACE inhibitors”.
Talk to your doctor or pharmacist before taking Teveten. Depending on the results of your blood tests, your doctor may decide to change your treatment with these medicines or Teveten.
The TV with food, drink, and alcohol
The Tevet can be taken with or without food.
Talk to your doctor before taking Teveten 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
If you think you are pregnant or become pregnant during treatment, contact your doctor. Usually, your doctor will suggest that you stop taking Teveten before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Teveten 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 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.
Ask your doctor or pharmacist before taking any medicine if you are pregnant, may become pregnant, or are breastfeeding.
Driving ability and use of machinery
It is less likely that Teveten affects the ability to drive or use machines. However, you may feel sleepy or dizzy while taking Teveten. If this happens, do not drive, do not use tools or machines, and talk to your doctor
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 a doctor or pharmacist if you are unsure.
The TV contains
lactose (a type of sugar). If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
How to use the Teveten
Always use Teveten according to your doctor’s instructions. Ask your doctor or pharmacist if you are unsure.
Take this medicine
- Take this medicine by mouth.
- Swallow the tablet whole with plenty of liquid, e.g. a glass of water.
- Do not crush or chew the tablets.
- Take the tablets in the morning at about the same time each day.
How much to take
Adults
The usual dose is one tablet per day.
Children and young people
Teveten should not be given to children and young people under 18 years of age.
If you have taken too much Teveten
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poisons Information Center (tel. 112) 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 ( hypotension ).
- nausea.
- you feel sleepy.
If you forget to take Teveten
- If you forget 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. Do not take a double dose to make up for the missed dose.
If you stop taking Teveten
Do not stop taking Teveten without talking to your doctor first.
Possible side effects
Like all medicines, Teveten can cause side effects, but not everybody needs them. The following side effects may occur with this medicine
Allergic reactions (may affect up to 1 in 100 users)
If you get an allergic reaction, stop taking Teveten and see a doctor immediately. The signs can be:
- skin reactions such as rash or hives with swelling ( urticaria ).
- swelling of the lips, face, throat, or tongue.
- respiratory distress.
- swelling of the face, swelling of the skin, and mucous membranes ( angioedema ).
Other possible side effects of Teveten include:
Very common (may affect up to 1 in 10 people)
- headache.
Common (may affect up to 1 in 10 users)
- dizziness
- skin rash or itching ( pruritus )
- nausea, vomiting, diarrhea
- the feeling of weakness ( asthenia )
- stuffy nose ( rhinitis ).
Uncommon (may affect up to 1 in 100 users)
- low blood pressure, including low blood pressure when standing up. You may feel dizzy or dizzy.
Has been reported (occurring in an unknown number of users)
- kidney problems, including kidney failure.
- joint pain ( arthralgia ).
If any side effects get worse or if you notice any side effects not mentioned in this information, contact your doctor or pharmacist.
How to store the Tevet
Store out of sight and reach of children.
Store at a maximum of 25 °C.
Use before the expiry date stated on the carton and blister. The expiration date is the last day of the specified month.
The medicine must not be thrown into the drain or among the household waste. Ask the pharmacist how to deal with drugs that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is eprosartan mesylate, corresponding to 600 mg of eprosartan per tablet.
Other ingredients are:
Tablet core:
Lactose monohydrate, microcrystalline cellulose, pregelatinized starch (from corn), crospovidone, magnesium stearate, and purified water.
Film coating:
Hypromellose (E464), titanium dioxide (E 171), macrogol 400, and polysorbate 80 (E433).
Appearance and package sizes of the medicine
Teveten 600 mg:
Capsule-shaped, white film-coated tablet marked “5046” on one side.
Teveten is supplied in pressure packs containing 14, 28, 56, or 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
BGP Products AB
Box 23033
104 35 Stockholm
Manufacturer
Mylan Laboratories SAS
Route de Belleville, Lieu dit Maillard
F-01400 Châtillon-sur-Chalaronne
France
| This medicine is approved in the European Economic Area under the names: | |
|---|---|
| Austria, Belgium, Finland, Greece, Ireland, Luxembourg, Portugal, Sweden | Teveten 600 mg |
| Germany | Teveten Mono 600 mg |
| Italy | TevetenZ 600 mg |