TEVALEPTIN table. 600 mg

TEVALEPTIN table. 600 mg
€ 53.00
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Oxcarbazepine belongs to a group of medicines called anticonvulsants used to treat epilepsy. Designed to help control seizures or seizures in patients who have epilepsy. Oxcarbazepine is used for treating certain types of epilepsy in adults and children 6 years of age.

TEVALEPTIN table. 600 mg
 

WHAT TEVALEPTIN tablets AND WHAT IT IS USED FOR? 

 Oxcarbazepine belongs to a group of medicines called anticonvulsants used to treat epilepsy. Designed to help control seizures or seizures in patients who have epilepsy.
 Oxcarbazepine is used for treating certain types of epilepsy in adults and children 6 years of age.
 Your doctor may prescribe oxcarbazepine alone or in combination with other anti-epileptic drugs.
 

 BEFORE YOU TAKE TEVALEPTIN tablets

 
Do not take tablets TEVALEPTIN
 If you are allergic (hypersensitive) to oxcarbazepine or to any other ingredients of this medicine.
 
Take special care with TEVALEPTIN tablets
 
Tell your doctor if any of the following applies to you:
 If you are allergic (ie you get a rash or other signs of allergy) to carbamazepine like anticonvulsant medication or other drugs. If you are allergic to carbamazepine, there is approximately V * (25%) risk of allergic to oxcarbazepine
 If you have or have ever had liver disease or severe skin reaction "Possible Side Effects")
 If you have or have ever had kidney disease associated with low sodium
Blood. Oxcarbazepine can reduce your blood levels of sodium deficiency (see section 4 "Possible side effects").
 
If you have kidney disease, your doctor may require blood tests before and periodically during treatment with oxcarbazepine
 If you are taking drugs that lower sodium levels (eg, diuretics ("water pills") or painkillers (NSAIDs such as indomethacin or ibuprofen)): see "Taking! Other medicines"
 If you have heart problems or heart failure (shortness of breath and swollen ankles). Your doctor will monitor your weight to make sure your body does not hold water
 If you have an irregular heart beat
 If you are on hormonal contraceptives ("the pill"), see "Taking other medicines".
 If you are pregnant (see "Pregnancy and lactation").
A small number of people being treated with antiepileptic drugs such as oxcarbazepine had
thoughts about suicide or hurting. If at any time such thoughts occur, immediately
call your doctor.
 
Taking other medicines
 
Tell your doctor if you are taking any of the following medicines as they may interfere with oxcarbazepine:
 Other anticonvulsants (eg phenobarbital, phenytoin, carbamazepine, lamotrigine, or valproic acid). You may need your doctor to adjust the dose of these medicines if you are taking oxcarbazepine at the same time. With lamotrigine risk of side effects such as nausea, drowsiness, dizziness and headache may be increased.
 Hormonal contraceptives ("the pill") since oxcarbazepine may reduce their effectiveness. To prevent pregnancy, you should take more effective measures.
 medicines for mental illnesses such as lithium and MAO (monoamine oxidase) inhibitors (phenelzine, moclobemide). Combination with lithium may increase the potential for adverse reactions.
 Drugs that reduce your sodium level as diuretics ("water pills") or painkillers (NSAIDs such as indomethacin or ibuprofen). Oxcarbazepine can lower your blood sodium levels further, which can lead to symptoms of sodium deficiency (see 4 "Possible side effects"). Your doctor will check the levels of sodium in your blood before and periodically during your treatment with oxcarbazepine.
 Drugs that block the body's natural defenses you (immunosuppressants such as cyclosporine and tacrolimus).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
 
Taking TEVALEPTIN tablets with food and drink
 
Your tablets may be taken with or without food.
You should be cautious if you drink alcohol while taking oxcarbazepine, as this could make you drowsy.
 
Pregnancy and lactation
 
Please consult your doctor if you are pregnant, think you are pregnant or plan to become pregnant while being treated with oxcarbazepine. It is important to control your epileptic seizures during pregnancy, but oxcarbazepine may affect the growth of your unborn child.
You should not breastfeed while being treated with oxcarbazepine.
 
Ask your doctor or pharmacist before taking any medicine
 
Driving and operating machinery
 
TEVALEPTIN can cause side effects such as dizziness and drowsiness, which can affect your ability to drive or operate machinery.
 
Important information about some of the ingredients of the tablets TEVALEPTIN
 
Patients who are intolerant to lactose should know that TEVALEPTIN tablets contain a small amount of lactose. You should tell your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
This product contains sunset yellow (E110) and may cause allergic reactions.
 

 HOW TO TAKE TEVALEPTIN tablets?

 
Always TEVALEPTIN tablets exactly as your doctor tells you. If you're not sure, ask your doctor or pharmacist.
For doses that are not practical for this concentration, additional formulations and concentrations.
Your doctor will probably start with a low dose and if necessary will increase slowly until the best dose. The usual dose is:
 
Adults:
 
The usual starting dose is 300 mg twice daily. If necessary, your doctor may increase your dose weekly stages of maximum 600 mg daily. The usual maintenance dose is in the range of 600 to 2400 mg daily.
If also taking other anticonvulsant medicines, your doctor may reduce their dose or increasing the dose of oxcarbazepine slower.
If other drugs are being replaced by oxcarbazepine dose of these drugs should be reduced slowly.
 
Children over 6 years:
 
The usual starting dose is 8-10 mg / kg body weight per day, divided into two doses. If necessary, your doctor may increase the dose every week with no more than 10 mg / kg per day to a maximum dose of 46 mg / kg body weight per day. The usual maintenance dose in combination with other anticonvulsants is 30 mg / kg body weight per day.
 
Children under 6 years:
 
Oxcarbazepine is not recommended for children younger than 6 years of age, as its safety and efficacy have not been established for this age group.
 
  
For patients who can not swallow tablets or required dose can these tablets are offered other formulations of oxcarbazepine.
Patents with renal disease:
 
If you have kidney problems (decreased kidney function), your doctor will be half the normal dose (see above) and increasing the dose more slowly.
 
Patients with severe liver disease:
 
If you have severe liver problems, you should follow your doctor's advice.
For doses that are not practical with this concentration, additional drug concentrations and
forms.
 
Method of application:
 
Take the tablets with a glass of water. Do not crushing or chewing. Tablets may be broken in half for ease of swallowing.
 
If you take an overdose of tablets TEVALEPTIN
 
If you (or someone else) swallow many tablets at once, or you think a child has swallowed some tablets, call immediately to the nearest hospital or doctor. Please bring this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
Overdose may cause drowsiness, dizziness, nausea, vomiting, unusual muscle or bodily activity, uncoordinated movements and involuntary movements of the eyes.
 
If you forget to take oxcarbazepine
 
If you miss a dose, take it as soon as you remember unless it is almost time for your next dose. Take your next dose as usual. Do not take a double dose to make up for a forgotten tablet.
 
If you stop taking oxcarbazepine
 
Do not stop taking oxcarbazepine, unless your doctor has advised you to do so because its suspension can cause sudden worsening of your fits. Your doctor will decide when and how to stop your treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
 

 POSSIBLE SIDE EFFECTS

 
Like all medicines, TEVALEPTIN tablets can cause side effects, although not everybody gets them.
If you experience any of these reactions. Immediately contact your doctor or nearest hospital:
 
 Severe skin reactions such as:
 Severe allergic reaction (high) fever, red spots on the skin, pain in the limbs and / or eyes
 Sudden severe allergic reaction with fever and blisters on the skin and flakes
Red (wet) plates of irregular shape.
This side effect is very rare and occurs in less than 1 in 10,000 patients, but may require medical attention. If such reactions occur while treatment with oxcarbazepine should never use this drug again.
 Signs of liver inflammation (such as yellow skin or eyes eclairs). This side effect is very rare and occurs in less than 1 in 10,000 patients, but requires monitoring function of your liver.
 Swelling of the face, tongue or throat, difficulty swallowing or hives to difficulty breathing, or other symptoms of allergic reactions such as skin rash, fever or joint pain.
 
 If you notice that your heart is beating irregularly
This side effect is very rare and occurs in less than 1 in 10,000 patients, but may require medical attention.
 If you feel confused or ill, if you are poor, if you get a reduced level of consciousness, blurred vision, or have more frequent seizures (these are symptoms of low blood sodium).
This side effect is very rare and occurs in less than 1 in 10,000 patients, but may require medical attention.
 If symptoms suggestive of blood disorders such as fatigue, shortness of breath during physical exertion, pallor, headache, chills, dizziness, frequent infections leading to fever, sore throat, mouth ulcers, bleeding or bruising more easily than normal Bleeding from the nose, reddish or purplish patches or unexplained blotches on the skin.
This side effect is very rare and occurs in less than 1 in 10,000 patients, but may require medical attention.
 
Other side effects may occur:
 
Very common (affects more than 1 patient in 10):
 Dizziness, fatigue or drowsiness, headache
 Double vision
 Feeling sick or vomiting.
Common (affecting one in 10 patients in 100):
 Low levels of sodium (salt) in the blood
 Confusion, depression, apathy, anxiety or other mood changes
 Blurred vision, uncontrollable eye movements or other visual disturbances
 Loss of coordination, tremors, inability to concentrate, memory impairment
 Diarrhea or constipation, abdominal pain
 Rash, acne
 Hair Loss
 Feeling weak.
Uncommon (affecting one in 10 patients in 1000):
 Itching
 Changes in the blood, low white blood cell count and elevated liver enzymes.
Very rare (affecting less than one in 10,000 patients):
 Changes in the blood as a reduced number of cells involved in clotting (platelets), inflammation of the pancreas and the immune system may occur with limb pain, fever and changes in liver function.
Not known (frequency can not be estimated from available data):
 High blood pressure.

 ADDITIONAL INFORMATION

 

What TEVALEPTIN tablets?

 
 The active substance is oxcarbazepine (oxcarbazepim). Each tablet contains 150, 300,600 mg oxcarbazepine.
 The other ingredients are:
Tablet core: lactose monohydrate, corn starch, crospovidone, povidone (K-30), sodium starch glycolate (type A), silica colloidal anhydrous and magnesium stearate.
Film coating: hypromellose, macrogol 6000, macrogol 400, titanium dioxide (E171), iron oxide yellow (E172), sunset yellow aluminum lake (E110).
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