IMPORTANT: PLEASE READ
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Stevens-Johnson Syndrome (SJS), have been
reported with TEGRETOL
®
. Other serious skin
reactions such as Drug Rash with Eosinophilia and
Systemic Symptoms (DRESS), Acute Generalized
Exanthematous Pustulosis (AGEP) and
Maculopapular Rash have also been reported.
Although very rare, serious forms of DRESS and
AGEP may also lead to death. Some cases of these
skin reactions have been genetically linked. Your
doctor may recommend a blood test to determine if
you belong to an at-risk population.
Contact your doctor immediately if you are
developing any combination of:
- a rash or any serious skin reactions such as red
skin, blistering of the lips, eyes or mouth, and skin
peeling accompanied by fever
- swollen lymph nodes
- joint pain
- enlargement of the liver and/or the spleen
- problems related to the lungs, kidneys, pancreas,
heart, bone marrow, thymus, and colon
Your doctor will determine if it is indeed drug-
related, and discontinue TEGRETOL
®
in this case.
Cancer: Long-term toxicity studies in rats have
indicated a possible cancer risk associated with
carbamazepine. Before taking TEGRETOL
®
,
discuss with your doctor the potential benefits and
possible risks of this treatment for you.
BEFORE you use TEGRETOL
®
talk to your doctor or
pharmacist:
About your medical conditions, especially if you have or have
had any liver, kidney, heart or thyroid disease or blood
disorders (including those caused by other drugs).
If you have a history, or family history, of bone disease or
have taken antiepileptics (such as phenobarbital, phenytoin,
primidone, oxcarbazepine, lamotrignine, sodium valproate
and/or carbamezepine) for a prolonged period of time.
If you are taking delavirdine, a medicine used to treat HIV-1
infection.
About any allergies you may have, especially if you have ever
shown any unusual sensitivity (rash or other signs of allergy)
to oxcarbazepine or other drugs used to treat your condition. It
is important to note that if you are allergic to TEGRETOL
®
(carbamazepine), there is an approximately 1 in 4 (25%)
chance that you could also have an allergic reaction to
oxcarbazepine (TRILEPTAL
®
).
If you are pregnant. Your doctor may recommend that you
take folic acid before and during your pregnancy and vitamin
K during the last weeks of pregnancy. Your doctor may also
recommend that the newborn receive vitamin K and be
observed for liver and gall bladder problems.
If you are planning on becoming pregnant to discuss the
potential benefits against any potential hazards of
TEGRETOL
®
.
If you are a women taking hormonal contraceptive (birth
control medicine). TEGRETOL
®
may render this
contraceptive ineffective. Therefore, you should use a
different or additional non-hormonal method of contraception
while you are taking TEGRETOL
®
. This should help to
prevent an unwanted pregnancy.
If you get irregular vaginal bleeding or spotting.
If you are breast-feeding. TEGRETOL
®
is known to pass into
breast milk. You must discuss with your doctor the benefits
of breastfeeding against any possible risks to the infant. If
you decide to breastfeed, the baby must be observed for liver
and gall bladder problems, drowsiness, and allergic skin
reactions.
About any other medicines (prescription and non-
prescription) you are taking.
About your usual alcohol consumption.
If you have increased pressure in the eye (glaucoma).
If you have difficulty passing urine (urinary retention).
If you were told by your physician that you suffer from
mental problems, a mental disorder called psychosis that may
be accompanied by confusion or agitation, or have thoughts
about suicide.
If any of the following apply to you, tell your doctor.
If an allergic reaction happens such as fever with lymph
nodes swelling, rash or skin blistering, tell your doctor
immediately or go to the emergency department at your
nearest hospital. (see Side effects and what to do about
them).
If you experience an increase in the number of seizures, tell
your doctor immediately.
If you experience any side effects such as drowsiness,
headache, unsteadiness on the feet, double vision, dizziness,
nausea or vomiting, consult your doctor.
If, at any time, you have thoughts of harming or killing
yourself. A small number of people being treated with
antiepileptic drugs have reported having such thoughts or
behavior. Should this happen to you, or to those in your care
if you are a caregiver or guardian, talk to your doctor
immediately. Close observation by a doctor is necessary in
this situation. Do not discontinue your medication on your
own.
If you have kidney problems associated with low sodium
blood level or if you have kidney problems and you are also
taking certain medicines that lower sodium blood level
(diuretics such as hydrochlorothiazide, furosemide).
TEGRETOL
®
may affect male fertility or cause abnormal sperm.
Periodic eye examinations are recommended while taking
TEGRETOL
®
.
Do not drive a car or operate dangerous machinery until you are
sure that TEGRETOL
®
does not cause dizziness, drowsiness,
sleepiness, blurred or double vision, affect your muscular
coordination or affect your alertness.
INTERACTIONS WITH THIS MEDICATION