PATIENT INFORMATION/CONSENT

FELBATOL® (felbamate) SHOULD NOT BE USED BY PATIENTS UNTIL THERE HAS BEEN A COMPLETE DISCUSSION OF THE RISKS AND WRITTEN INFORMED CONSENT HAS BEEN OBTAINED.

IMPORTANT INFORMATION AND WARNING:

Felbatol®, taken by itself or with other prescription and/or non-prescription drugs, can result in severe, potentially fatal blood abnormality (“aplastic anemia”) and/or severe, potentially fatal liver damage.

PATIENT CONSENT:

My [My son, daughter, ward, ____________________________________________'s] treatment with Felbatol® has been personally explained to me by Dr.___________________________________ .

The following points of information, among others, have been specifically discussed and made clear and I have had the opportunity to ask any questions concerning this information:

1. I, _______________________________________________________________ (Patient's Name), understand that Felbatol® is used to treat certain types of seizures and my physician has told me that I have this type(s) of seizures; INITIALS: __________________________
2. I understand that Felbatol® is being used since my seizures have not been satisfactorily treated with other antiepileptic drugs; INITIALS: __________________________
3. I understand that there is a serious risk that I could develop aplastic anemia and/or liver failure, both of which are potentially fatal, by using Felbatol®; INITIALS: __________________________
4. I understand that there are no laboratory tests which will predict if I am at an increased risk for one of the potentially fatal conditions; INITIALS: __________________________
5. I understand that I should have the recommended blood work before my treatment with Felbatol® is begun (baseline) and periodically thereafter as clinical judgement warrants. I understand that although this blood work may help detect if I develop one of these conditions, it may do so only after significant, irreversible and potentially fatal damage has already occurred; INITIALS: __________________________
6. If I am currently taking another antiepileptic drug, I understand that the manufacturer of Felbatol® recommends that the dosage of these other drugs be decreased by a certain amount when Felbatol® is started; if my physician determines that this should not be done in my case, he/she has explained the reason(s) for this decision; INITIALS: __________________________
7. I understand that I must immediately report any unusual symptoms to Dr. __________________________ and be especially aware of any rashes, easy bruising, bleeding, sore throats, fever, and/or dark urine; INITIALS: __________________________

I now authorize Dr. _____________________________________________ to begin my treatment with Felbatol®; OR, if my treatment has already begun with Felbatol®, to continue such treatment.

_____________________________________________
                                            Patient, Parent, or Guardian

_____________________________________________
                                                                             Address

_____________________________________________
                                                                         Telephone

PHYSICIAN STATEMENT:

I have fully explained to the patient, __________________________________________, the nature and purpose of the treatment with Felbatol® (felbamate) and the potential risks associated with that treatment. I have asked the patient if he/she has any questions regarding this treatment or the risks and have answered those questions to the best of my ability. I also acknowledge that I have read and understand the prescribing information listed above.

_________________________________________________
Physician                                                                              Date

NOTE TO PHYSICIAN: It is strongly recommended that you retain a signed copy of the informed consent with the patient's medical records.

SUPPLY OF PATIENT INFORMATION/CONSENT FORMS:

A supply of “Patient Information/Consent” forms as printed above is available, free of charge, from your local Wallace representative, or may be obtained by calling 1-800-526-3840. Permission to use the above Patient I nformation/Consent by photocopy reproduction is also hereby granted by MedPointe Healthcare Inc.

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