PATIENT INFORMATION
Divalproex sodium is used in the treatment of epilepsy,
mania, and other conditions. Do not use if you are pregnant,
nursing, or have liver disease. Avoid alcohol and other
depressants. Inform your doctor if you are taking any
other medications, including over-the-counter drugs. Divalproex
Sodium may cause drowsiness. Use caution while driving
or operating hazardous machinery. In addition, divalproex
sodium may cause nausea, sleepiness, dizziness, vomiting,
weakness, or stomach pain. Notify your doctor or pharmacist
if these occur.
PATIENT PACKAGE INSERT
Please read this information carefully before you take
divalproex sodium tablets. This section provides a summary
of important information about taking divalproex sodium
for migraine to women who could become pregnant. Divalproex
sodium is also prescribed for uses other than those discussed
here. If you have any questions or concerns, or want more
information about divalproex sodium, contact your doctor
or pharmacist.
Information For Women Who Could Become Pregnant
Divalproex sodium is used to prevent or reduce the number
of migraines you experience. Divalproex sodium can be
obtained only by prescription from your doctor. The decision
to use divalproex sodium for the prevention of migraine
is one that you and your doctor should make together,
taking into account your individual needs and medical
condition.
Before using divalproex sodium, women who can become
pregnant should consider the fact that Divalproex
has been associated with birth defects, in particular,
with spina bifida and other defects related to failure
of the spinal canal to close normally. Although the incidence
is unknown in migraine patients treated with divalproex
sodium, approximately 1 to 2% of children born to women
with epilepsy taking divalproex sodium in the first 12
weeks of pregnancy had these defects (based on data from
the Centers for Disease Control and Prevention, and U.S.
agency based in Atlanta). The incidence in the general
population is 0.1 to 0.2%.
Information For Women Who Are Planning to
Get Pregnant
Women taking divalproex sodium for the prevention of
migraine who are planning to get pregnant should discuss
with their doctor temporarily stopping divalproex sodium,
before and during their pregnancy.
Information For Women Who Become Pregnant
While Taking Divalproex Sodium
If you become pregnant while taking divalproex sodium
for the prevention of migraine, you should contact your
doctor immediately.
Other Important Information About Divalproex
Sodium Tablets
Divalproex sodium tablets should be taken exactly as
it is prescribed by your doctor to get the most benefits
from divalproex sodium and reduce the risk of side effects.
If you have taken more than the prescribed dose of divalproex
sodium, contact your hospital emergency room or local
poison center immediately.
This medication was prescribed for your particular condition.
Do not use it for another condition or give the drug to
others.
Facts About Birth Defects
It is important to know that birth defects may occur
even in children of individuals not taking any medications
or without any additional risk factors.
Facts About Migraine
About 23 million Americans suffer from migraine headaches.
About 75% of migraine sufferers are women. A migraine
is described as a throbbing headache that gets worse with
activity. Migraine may also include nausea and/or vomiting
as well as sensitivity to light and sound. Migraine usually
happens about once a month, but some people may have them
as often as once or twice a week. Often, the symptoms
from a migraine can cause people to miss work or school.
If you have frequent migraines, or if acute treatment
is not working for you, your doctor may prescribe a preventative
therapy. Preventative (prophylactic) treatment is used
to prevent attacks and reduce the frequency and severity
of headache events.
This summary provides important information about the
use of divalproex sodium for migraine to women who could
become pregnant. If you would like more information about
the other potential risks and benefits of divalproex sodium,
ask your doctor or pharmacist to let you read the professional
labeling and then discuss it with them. If you have any
questions or concerns about taking divalproex sodium,
you should discuss them with your doctor.
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