Each film coated tablet of Tripcar® 600  contains:

• Oxcarbazepine           600 mg   

Each film coated tablet of Tripcar® 300 contains:

• Oxcarbazepine           300 mg

Each 1 ml of Tripcar® For oral suspension contains:

• Oxcarbazepine           60 mg   

• Tripcar® is used to treat partial seizures with or without secondarily generalized tonic-clonic seizures.
• Tripcar® can be used alone or in combination with other antiepileptic medicine.

¤ Tripcar® is used in Pediatrics:

• Monotherapy in the treatment of partial seizures in children 4-6 years.
• Adjunctive therapy in the treatment of partial seizures in children 2-16 years.

• Tripcar® should not be administered to patients who have shown hypersensitivity to Oxcarbazepine or any of the ingredients of the Tripcar® or if you are allergic to eslicarbazepine.

¤ Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines and this applies especially to:

• Hormonal contraceptives, such as oral contraceptives. 
• Other antiepileptic and enzyme inducing medicines, such as carbamazepine, phenobarbital, phenytoin or lamotrigine and rifampicin.
• Medicines that reduce the level of sodium in your blood, such as diuretics (used to help the kidneys get rid of salt and water by increasing the amount of urine produced), desmopressin and nonsteroidal anti-inflammatory medicines, such as indometacin and ibuprofen.
• Lithium and monoamine oxidase inhibitors (medicines used to treat mood swings and some types of depression).
• Medicines that control the body’s immune system, such as ciclosporin and tacrolimus.

• Contact your doctor if you become pregnant, think you may be pregnant or are planning to become pregnant while taking Tripcar®.
• It is important that seizures during pregnancy are controlled but Tripcar® may affect the growth of your unborn baby.
• Your doctor will discuss the benefits and possible risks of the use Tripcar® during pregnancy.
• Tripcar® should not be used during breast feeding. 

Very common:

• tiredness; headache; dizziness; drowsiness; feeling sick (nausea); being sick (vomiting); double vision.

Common:

• weakness; memory disturbances; impaired concentration; apathy; agitation; confusion; blurred vision; visual disturbance; constipation; diarrhoea; stomach (abdominal) pain; acne; hair loss;balance disturbances; weight increased.
• This includes any possible side effects not listed in this leaflet.

Overdosage:

• If you or anyone take too many Tripcar® you should contact you doctor directly or go to the nearest hospital even if there are no signs of discomfort. Symptoms of overdose are drowsiness, dizziness, nausea, vomiting, an abnormal degree of muscular or bodily activity, lack of co-ordination of movements and uncontrolled eye movements.

• Tripcar® can be used either as a monotherapy or in combination with other anti-epileptic drugs. In both monotherapy and combination therapy,Tripcar® should be started with a clinically effective dose given in two doses per day. The dose may be increased according to the patient's clinical response. In the case of co-treatment, it may be necessary to reduce the dosage of the other anti-epileptic or increase the dose of Tripcar® more slowly.
• Tripcar® can be taken with or without food.
• The oral suspension is available for use in younger children who are unable to swallow tablets.
• Before using a Tripcar® suspension, the bottle should be carefully cooled and the dose should be immediately withdrawn from the bottle.The suspension can be swallowed directly from a dose-measuring syringe or can be diluted in a small glass of water before directly manipulating.
• When the oral suspension of Tripcar® is prescribed, the dose should be 
  determined in milliliters.
• In case of monotherapy or joint treatment in adults: The treatment can be started with a daily dose of 600mg, divided into two doses. the daily dose can be increased at weekly intervals, in increments not exceeding 1200 mg.

Children:

• In monotherapy and joint therapy,starting dose therapy (8-10 mg / kg / day) is divided into two doses. The best results are usually with a dose of (30mg/kg/day). The maximum dose for child is 46mg/kg/day.
• If the clinical condition is called, the daily dose may be increased at weekly intervals in increments not exceeding 10 mg / kg / day, up to a maximum dose of 60 mg / kg / day.

Elderly patients:

• It is recommended to adjust the dose in elderly patients with renal impairment who may be at risk of low blood sodium.

Patients with renal impairment:

• In patients with renal impairment (creatine clearance less than 30 ml / min), treatment is started at the usual half-dose (300mg / day) and the dose is increased at intervals of not less than one week until the desired clinical response is achieved. They should be monitored well during dose calibration.

• Your doctor may increase the dose gradually to find the best dose for you.
• The best results are usually with doses between 600 and 2,400 mg per day.

¤ If you forget to take Tripcar®

• If you have forgotten one dose, take it as soon as you remember. However, if it is time for your next dose, do not take the missed dose. Go back to yourregular dosing timetable. Do not take a double dose to make up for a forgotten dose.
• Treatment may be needed for many years to control the seizures. Do not change the dose or stop treatment without talking to your doctor.

Tell your doctor or pharmacist before taking Tripcar® :

• if you have ever shown unusual sensitivity,
• if you have kidney disease,
• if you have serious liver disease,
• if you are taking diuretics,
• if you have heart disease, shortness of breath and/or swelling of the feet or legs due to fluid build-up,
• if your blood level of sodium is low,
• if you are a woman taking a hormonal contraceptive.

Tell your doctor if you develop any of the following symptoms after talking Tripcar® :

• if you experience an allergic reaction,
• if you notice symptoms of hepatitis such as jaundice,
• if you notice possible symptoms of blood disorders such as tiredness, being short of breath when exercising, looking pale, headache, chills, dizziness, frequent infections leading to fever, sore throat, mouth ulcers, bleeding or bruising more easily than normal, nose bleeds, reddish or purplish patches, or unexplained blotches on the skin,
• if you have a fast or unusually slow heart beat.
• Tripcar® can lower the sodium levels in your blood further which may lead to symptoms of sodium shortage,
• If you have a renal disease your doctor may examine your blood before and at regular intervals after starting treatment with Oxcarbazepine.
• if you have heart problems such as heart failure, (breathlessness and swollen ankles).
• if you have a heart rhythm disorder.
• if you are planning to become pregnant.

• Tripcar® 600 tablet : Blister of 10 tablets pack of 3 blisters.
• Tripcar® 300 tablet : Blister of 10 tablets pack of 3 blisters.
• Tripcar® suspension 60mg / 1 ml :Bottle of 100 ml.

• Tablets: Store at a temperature below 25ºC, protect from light.
• Syrup for suspension: Store at a temperature below 25ºC, keep away from light.