Medication Guide
KLONOPIN®
(KLON-oh-pin)
(clonazepam)
Tablets and Wafers
CIV
Read this Medication Guide before you start taking KLONOPIN and each time you
get a refill. There may be new information. This information does not take the
place of talking to your healthcare provider about your medical condition or
treatment.
KLONOPIN can cause serious side effects. Because stopping KLONOPIN suddenly
can also cause serious problems, do not stop taking KLONOPIN without talking to
your healthcare provider first.
What is the most important information
I should know about KLONOPIN?
Do not stop taking KLONOPIN without first talking to your
healthcare provider. Stopping KLONOPIN suddenly can cause serious
problems.
KLONOPIN can cause serious side effects, including:
1.
KLONOPIN can slow your thinking and motor skills
- Do not drive, operate heavy machinery, or do other dangerous activities
until you know how KLONOPIN affects you.
- Do not drink alcohol or take other drugs that may make you sleepy or dizzy
while taking KLONOPIN until you talk to your healthcare provider. When taken
with alcohol or drugs that cause sleepiness or dizziness, KLONOPIN may make your
sleepiness or dizziness worse.
2.
Like other antiepileptic drugs, KLONOPIN may cause suicidal
thoughts or actions in a very small number of people, about 1 in
500.
Call a healthcare provider right away if you have any of these
symptoms, especially if they are new, worse, or worry you:
- thoughts about suicide or dying
- attempt to commit suicide
- new or worse depression
- new or worse anxiety
- feeling agitated or restless
- panic attacks
- trouble sleeping (insomnia)
- new or worse irritability
- acting aggressive, being angry, or violent
- acting on dangerous impulses
- an extreme increase in activity and talking (mania)
- other unusual changes in behavior or mood
How can I
watch for early symptoms of suicidal thoughts and actions?
- Pay attention to any changes, especially sudden changes, in mood, behaviors,
thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as
scheduled.
Call your healthcare provider between visits as needed, especially
if you are worried about symptoms.
Suicidal thoughts or actions can be
caused by things other than medicines. If you have suicidal thoughts or actions,
your healthcare provider may check for other causes.
Do
not stop KLONOPIN without first talking to a healthcare provider.
Stopping KLONOPIN suddenly can cause serious problems. Stopping KLONOPIN
suddenly can cause seizures that will not stop (status epilepticus).
3.
KLONOPIN may harm your unborn or developing baby.
- If you take KLONOPIN during pregnancy, your baby is at risk for serious
birth defects. These defects can happen as early as in the first month of
pregnancy, even before you know you are pregnant. Birth defects may occur even
in children born to women who are not taking any medicines and do not have other
risk factors.
- Children born to mothers receiving benzodiazepine medications (including
KLONOPIN) late in pregnancy may be at some risk of experiencing breathing
problems, feeding problems, hypothermia, and withdrawal symptoms.
- Tell your healthcare provider right away if you become pregnant while taking
KLONOPIN. You and your healthcare provider should decide if you will take
KLONOPIN while you are pregnant.
- If you become pregnant while taking KLONOPIN, talk to your healthcare
provider about registering with the North American Antiepileptic Drug Pregnancy
Registry. You can register by calling 1-888-233-2334. The purpose of this
registry is to collect information about the safety of antiepileptic drugs
during pregnancy.
- KLONOPIN can pass into breast milk. Talk to your healthcare provider about
the best way to feed your baby if you take KLONOPIN. You and your healthcare
provider should decide if you will take KLONOPIN or breast feed. You should not
do both.
4.
KLONOPIN can cause abuse and dependence.
- Do not stop taking KLONOPIN all of a sudden. Stopping KLONOPIN suddenly can
cause seizures that do not stop, hearing or seeing things that are not there
(hallucinations), shaking, and stomach and muscle cramps.
- Talk to your doctor about slowly stopping KLONOPIN to avoid getting sick
with withdrawal symptoms.
- Physical dependence is not the same as drug addiction. Your healthcare
provider can tell you more about the differences between physical dependence and
drug addiction.
KLONOPIN is a federally controlled substance (C-IV) because
it can be abused or lead to dependence. Keep KLONOPIN in a safe place to prevent
misuse and abuse. Selling or giving away KLONOPIN may harm others, and is
against the law. Tell your doctor if you have ever abused or been dependent on
alcohol, prescription medicines or street drugs.
What is KLONOPIN?
KLONOPIN is a prescription medicine used alone or with other medicines to
treat:
- certain types of seizure disorders (epilepsy) in adults and children
- panic disorder with or without fear of open spaces (agoraphobia) in adults
It is not known if KLONOPIN is safe or effective in treating panic disorder
in children younger than 18 years old.
Who should not take KLONOPIN?
Do not take KLONOPIN if you:
- are allergic to benzodiazepines
- have significant liver disease
- have an eye disease called acute narrow angle glaucoma
Ask your healthcare provider if you are not sure if you have
any of the problems listed above.
What should I tell my healthcare provider before taking
KLONOPIN?
Before you take KLONOPIN, tell your healthcare provider if you:
- have liver or kidney problems
- have lung problems (respiratory disease)
- have or have had depression, mood problems, or suicidal thoughts or behavior
- have any other medical conditions
Tell your healthcare provider about all the medicines you
take, including prescription and non-prescription medicines, vitamins,
and herbal supplements. Taking KLONOPIN with certain other medicines can cause
side effects or affect how well they work. Do not start or stop other medicines
without talking to your healthcare provider.
Know the medicines you take. Keep a list of them and show it to your
healthcare provider and pharmacist when you get a new medicine.
How should I take KLONOPIN?
- Take KLONOPIN exactly as your healthcare provider tells you. KLONOPIN is
available as a tablet or as an orally disintegrating tablet (wafer).
- Do not stop taking KLONOPIN without first talking to your healthcare
provider. Stopping KLONOPIN suddenly can cause serious problems.
-
KLONOPIN tablets should be taken with water and
swallowed whole.
-
KLONOPIN wafers can be taken with or without water.
- Do not open the pouch until you are ready to take KLONOPIN.
- After opening the pouch, peel back the foil on the blister pack.
- Do not push the wafer through the foil.
- After opening the blister pack, with dry hands, take the wafer and place it
in your mouth.
- The wafer will melt quickly.
- If you take too much KLONOPIN, call your healthcare provider or local Poison
Control Center right away.
What should I avoid while taking KLONOPIN?
- KLONOPIN can slow your thinking and motor skills. Do not drive, operate
heavy machinery, or do other dangerous activities until you know how KLONOPIN
affects you.
- Do not drink alcohol or take other drugs that may make you sleepy or dizzy
while taking KLONOPIN until you talk to your healthcare provider. When taken
with alcohol or drugs that cause sleepiness or dizziness, KLONOPIN may make your
sleepiness or dizziness worse.
What are the possible side effects of KLONOPIN?
See " What is the most important
information I should know about KLONOPIN?"
KLONOPIN can also make your seizures happen more often or make them worse.
Call your healthcare provider right away if your seizures get worse while taking
KLONOPIN.
The most common side effects of KLONOPIN include:
- Drowsiness
- Problems with walking and coordination
- Dizziness
- Depression
- Fatigue
- Problems with memory
These are not all the possible side effects of KLONOPIN. For more
information, ask your healthcare provider or pharmacist.
Tell your healthcare provider if you have any side effect that bothers you or
that does not go away.
Call your doctor for medical advice about side effects. You may report side
effects to FDA at 1-800-FDA-1088 or Genentech at 1-888-835-2555.
How should I store KLONOPIN?
- Store KLONOPIN between 59°F to 86°F (15°C to 30°C)
Keep KLONOPIN and all medicines out of the reach of
children.
General Information about KLONOPIN
Medicines are sometimes prescribed for purposes other than those listed in a
Medication Guide. Do not use KLONOPIN for a condition for which it was not
prescribed. Do not give KLONOPIN to other people, even if they have the same
symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about
KLONOPIN. If you would like more information, talk with your healthcare
provider. You can ask your pharmacist or healthcare provider for information
about KLONOPIN that is written for health professionals.
For more information, go to www.gene.com/gene/products/information/klonopin
or call 1-888-835-2555.
What are the ingredients in KLONOPIN?
Active ingredient: clonazepam
Inactive ingredients:
- Tablets:
- 0.5 mg tablets contain lactose, magnesium stearate, microcrystalline
cellulose, corn starch, FDandC Yellow No. 6 Lake
- 1 mg tablets contain lactose, magnesium stearate, microcrystalline
cellulose, corn starch, FDandC Blue No. 1 Lake and FDandC Blue No. 2 Lake
- 2 mg tablets contain lactose, magnesium stearate, microcrystalline
cellulose, corn starch
- Wafers: gelatin, mannitol, methylparaben sodium, propylparaben sodium and
xanthan gum
MG Issued: August 2010
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Disbributed by:
Genentech USA, Inc.
A Member of the Roche
Group
1 DNA Way
South San Francisco, CA 94080-4990
KNTW_54023_MG_062010_K
© 2010 Genentech, Inc. All rights reserved.
For additional copies of this Medication Guide, please call 1-877-436-3683 or
visit www.gene.com/gene/products/information/klonopin.
ATTENTION PHARMACIST: Dispense the accompanying
Medication
Guide to each patient. For additional
Medication Guides call 1-877-436-3683
or visit
www.gene.com/gene/products/information/klonopin.