(flew-raz-e-pam) HCl Capsules, 15 mg and 30 mg, are a Sedative-Hypnotic
indicated for Insomnia
Read this Medication Guide carefully before you start
taking your medicine and each time you get more, since there may be new
information. It does not contain all the information about your medicine that
you may need to know, so please ask your doctor, nurse or pharmacist if you
have any questions.
YOUR DOCTOR HAS PRESCRIBED THIS DRUG FOR YOUR USE ONLY.
DO NOT LET ANYONE ELSE USE IT. KEEP THIS MEDICINE OUT OF THE REACH OF CHILDREN
AND PETS. If a child puts a Flurazepam Hydrochloride Capsule in his or her
mouth or swallows it, call your local Poison Control Center or go immediately
to the nearest emergency room.
What is the most important information I should know
about sedative-hypnotic drugs ?
After taking a sedative-hypnotic drug, you may get up
out of bed while not being fully awake and do an activity that you do not know
you are doing. The next morning, you may not remember that you did anything
during the night. You have a higher chance for doing these activities if
you drink alcohol or take other medications that make you sleepy with a
sedative-hypnotic drug. Reported activities include:
- driving a car (“sleep-driving”)
- making and eating food
- talking on the phone
- having sex
1. Take a sedative-hypnotic drug exactly as prescribed:
- Do not take more sedative-hypnotic drugs than prescribed.
- Take the sedative-hypnotic drug right before you get in
bed, not sooner.
2. Do not take a sedative-hypnotic drug if you:
- drink alcohol
- take other medicines that can make you sleepy. Talk to
your doctor about all of your medicines. Your doctor will tell you if you can take
a sedative-hypnotic drug with your other medicines
- cannot get a full night sleep
3. Call your doctor right away if you find out that
you have done any of the above activities after taking a sedative-hypnotic
What are Flurazepam Hydrochloride Capsules ?
Flurazepam Hydrochloride Capsules are a sedative-hypnotic
agent used to treat insomnia (difficulty falling asleep and staying asleep).
Who should not take Flurazepam Hydrochloride Capsules?
Do not use Flurazepam Hydrochloride Capsules if
- allergic to anything in Flurazepam Hydrochloride
Capsules. (Being allergic may include having a rash, itching, swelling or
breathing difficulties.) See the end of this Medication Guide for a complete
list of ingredients in Flurazepam Hydrochloride Capsules. In rare cases
patients have had additional symptoms such as shortness of breath, throat
closing, or nausea and vomiting that suggest an allergic reaction. Some
patients have required medical therapy in the emergency department as these
rare complications could be fatal. Patients who experience these symptoms
should seek medical attention and discontinue taking the sedative-hypnotic
- pregnant or intending to become pregnant. If a woman
becomes pregnant while taking Flurazepam Hydrochloride Capsules, she should
discontinue use immediately.
- under 15 years of age. Flurazepam Hydrochloride Capsules
have not been studied in children.
How should I take Flurazepam Hydrochloride Capsules ?
Flurazepam Hydrochloride comes as a capsule to take by
mouth. You should take Flurazepam Hydrochloride Capsules, or other
sedative-hypnotic medications, exactly as directed by your doctor. It usually
is taken right before you get in bed, not sooner. If you forget to take
Flurazepam Hydrochloride Capsules at bedtime, you are unable to fall asleep,
and you will still be able to stay in bed for a full night's sleep, you may
take Flurazepam Hydrochloride Capsules at that time. Do not take a double dose of
Flurazepam Hydrochloride Capsules to make up for a missed dose.
The smallest possible effective dose is suggested for
elderly patients due to the risk of the development of oversedation, dizziness,
confusion and/or loss of coordination.
Sleep problems are often temporary, requiring treatment
for a very short time. You should not use Flurazepam Hydrochloride Capsules, or
any other sedative-hypnotic medications, for long periods of time without
talking to your doctor about the risks and benefits of prolonged use.
In the case of a suspected overdose, you should contact
your local poison control center immediately.
What should I avoid while taking Flurazepam
Hydrochloride Capsules ?
Do not drink alcohol or take other medications that
depress the central nervous system.
While taking Flurazepam Hydrochloride Capsules, do not
engage in any hazardous occupations requiring complete mental alertness such as
operating machinery or driving a car.
What are the possible or reasonably likely side
effects of Flurazepam Hydrochloride Capsules ?
Dizziness, drowsiness, light-headedness, staggering, loss
of coordination and falling have occurred, particularly in elderly or
debilitated persons. Severe sedation, lethargy, disorientation and coma, probably
indicative of drug intolerance or overdosage, have been reported. Also reported
are headache, heartburn, upset stomach, nausea, vomiting, diarrhea,
constipation, nervousness, talking more than usual, anxiety, irritability,
weakness, pounding heartbeat, chest pain, body and joint pains and difficulty
Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use
of Flurazepam Hydrochloride Capsules
Medicines are sometimes prescribed for purposes other
than those listed in a Medication Guide. If you have any concerns about taking
this, or any sedative-hypnotic medication, please ask your doctor. For detailed
information regarding Flurazepam Hydrochloride Capsules please consult the
physician's package insert. Do not use for conditions for which this medication
was not prescribed. Do not give this medication to others.
What are the ingredients of Flurazepam Hydrochloride
Active Ingredient: flurazepam hydrochloride
(15 mg or 30 mg)
Inactive Ingredients : Each capsule contains
lactose monohydrate, magnesium stearate, pregelatinized starch and sodium
starch glycolate. Capsule shells may contain: colloidal silicon dioxide,
FD&C Blue No. 1, FD&C Red No. 3, gelatin, silicon dioxide, sodium
lauryl sulfate, and titanium dioxide.
How should I store Flurazepam Hydrochloride Capsules ?
- Store Flurazepam Hydrochloride Capsules at 20-25°C
(68-77°F) [See USP Controlled Room Temperature]. Protect from light and
- KEEP THIS MEDICINE OUT OF THE REACH OF CHILDREN. If
a child accidentally takes Flurazepam Hydrochloride Capsules, call your local
Poison Control Center or go immediately to the nearest emergency room.
If you would like more information, contact West-ward
Pharmaceutical Corp. at 1-877-233-2001.
This Medication Guide has been approved by the U.S. Food
and Drug Administration.