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Meda Pharmaceuticals
About Felbatol
CAN FELBATOL HELP REFRACTORY EPILEPSY?
FELBATOL is an effective medication for the treatment of severe refractory epilepsy. The medicine can have serious side effects. This means that doctors will prescribe FELBATOL only if the risks from seizures are greater than the possible side effects of the medication. You must understand these risks and provide written informed consent before taking FELBATOL. In adults, FELBATOL may help control partial seizures. This type of seizure starts with a "stray spark" in one area of the brain. The seizure affects the part of the body that the area of the brain controls. Partial seizures can sometimes become generalized (spreading to both sides of the brain). In children, FELBATOL may help control seizures associated with Lennox-Gastaut syndrome. This kind of refractory epilepsy is characterized by different types of seizures, including, among others:
  • Tonic-clonic (grand mal) seizures - the child may pass out, fall down, and the whole body can become stiff and spasm
  • Atonic seizures (drop attacks) - the child suddenly loses muscle tone, and the head may drop forward; the arms and legs can get weak and the child may fall over
Common side effects
More common side effects of FELBATOL include weight loss, problems sleeping, headache, and nausea. If these side effects occur, tell your doctor right away. You should also tell your doctor about all other medications you or your child are taking because FELBATOL might interact with these drugs.

WHAT ARE THE SERIOUS SIDE EFFECTS?
FELBATOL has been associated with serious side effects. One of them is called aplastic anemia. This happens when the marrow (tissue inside the bones) is damaged and cannot make as many blood cells. Aplastic anemia can be fatal.

Symptoms include:
  • Fever/chills
  • Fatigue
  • Bleeding
  • Easy bruising
  • Signs of infection
Liver failure is a serious side effect that can be fatal. Symptoms may include:
  • Dark urine along with nausea/vomiting
  • Yellowing of the skin and eyes (jaundice) along with nausea/vomiting If you experience any of the above symptoms, contact your doctor immediately.
How to recognize serious side effects
Have regular blood tests
  • Your doctor will order routine blood tests
  • It is your responsibility to make sure that the doctor has received the lab results
See the warning signs
  • Watch for symptoms listed in the section on the left page
  • If you see or experience any of these symptoms, contact your doctor right away
  • Do not stop taking the medication without first talking with your doctor
Talk with your doctor
  • Check back with your doctor on a regular basis
  • Report progress, setbacks, side effects, and other observations related to treatment
  • Request regular checkups if your doctor has not set them up
IS FELBATOL RIGHT FOR ME?
Doctors offer FELBATOL as an option when patients face the serious risks of severe refractory epilepsy. Only you and your doctor can decide if FELBATOL is right for you or your child.

As previously outlined, FELBATOL has been associated with serious side effects. Patients with a history of blood disorders or liver problems should not take FELBATOL. Your doctor, who is familiar with your epilepsy and your medical history, can explain the possible risks and the potential benefits of treatment with FELBATOL.

Consider these facts when you talk with your doctor:
  • Refractory epilepsy may pose significant health risks
  • Quality of life should be improved when uncontrolled seizures are effectively treated
  • Some patients with refractory epilepsy can benefit from trying new medication
  • FELBATOL has been effective in treating refractory epilepsy in some patients



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Indications & Usage
Indications
  • FELBATOL (felbamate) should not be used as initial therapy in epilepsy (see Warnings in full Prescribing Information)
  • FELBATOL is recommended for use only in those patients who do not respond well to other treatments and whose epilepsy is so severe that the potential risk of developing aplastic anemia (a severe blood disorder) or liver failure is outweighed by the potential benefit of felbamate treatment.
  • After the patient or their caregiver has discussed the potential risks of Felbatol treatment with their doctor and have provided written consent, FELBATOL treatment can be considered. FELBATOL, by itself or in combination with other drugs is approved for the treatment of partial seizures, with or without generalization, in adults with epilepsy, and as combination therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.
Additional Safety Information
  • FELBATOL should not be used in patients with a history of any blood or liver problems
  • Routine blood tests should be performed that can help identify potential blood or liver problems.
  • FELBATOL should be discontinued if there is evidence that blood or liver problems have occurred Adverse Events
  • The most common adverse experiences observed in clinical studies are loss of appetite, vomiting, insomnia, nausea, headache, and sleepiness