Read this Medication Guide before you start taking
Buprenorphine HCl sublingual tablets and each time you get a
refill. There may be new information. This Medication Guide does
not take the place of talking to your doctor. Talk to your
doctor or pharmacist if you have questions about Buprenorphine
HCl sublingual tablets.
Share the important information in this Medication Guide
with members of your household.
What is the most important information
I should know about Buprenorphine HCl sublingual tablets?
- Buprenorphine HCl sublingual tablets can cause serious and
life-threatening breathing problems. Call your doctor right
away or get emergency help if:
- You feel faint, dizzy or confused
- Your breathing gets much slower than is normal for
you
These can be signs of an overdose or other serious
problems.
- Buprenorphine HCl sublingual tablets contains an opioid
that can cause physical dependence
- Do not stop taking Buprenorphine HCl sublingual
tablets without talking to your doctor. You could
become sick with uncomfortable withdrawal signs and
symptoms because your body has become used to this
medicine
- Physical dependence is not the same as drug
addictio
- Buprenorphine HCl sublingual tablets is not for
occasional or "as needed"
use
- An overdose, and even death, can happen if you take
benzodiazepines, sedatives, tranquilizers, or alcohol while
using Buprenorphine HCl sublingual tablets. Ask your doctor
what you should do if you are taking one of these.
- Call a doctor or get emergency help right away if
you:
- Feel sleepy and uncoordinated
- Have blurred vision
- Have slurred speech
- Cannot think well or clearly
- Have slowed reflexes and breathing
- Do not inject ("shoot-up") Buprenorphine
HCl sublingual tablets.
- Injecting this medicine may cause life-threatening
infections and other serious health problems.
- Injecting Buprenorphine HCl sublingual tablets may
cause serious withdrawal symptoms such as pain,
cramps, vomiting, diarrhea, anxiety, sleep problems
and cravings
- In an emergency, have family members tell the emergency
department staff that you are physically dependent on an
opioid and are being treated with Buprenorphine HCl
sublingual tablets .
What is Buprenorphine HCl sublingual
tablets?
- Buprenorphine HCl sublingual tablets is a prescription
medicine used to begin treatment in adults who are addicted
to (dependent on) opioid drugs (either prescription or
illegal), as part of a complete treatment program that also
includes counseling and behavioral therapy.
- Buprenorphine HCl sublingual tablets is most often used
for the first 1 or 2 days to help you start with
treatment.
- It is not known if Buprenorphine HCl sublingual tablets is
safe or effective in children.
Who should not take Buprenorphine HCl
sublingual tablets?
Do not take Buprenorphine HCl sublingual tablets if you
are allergic to buprenorphine.
What should I tell my doctor before
taking Buprenorphine HCl sublingual tablets?
Buprenorphine HCl sublingual tablets
may not be right for you. Before taking Buprenorphine HCl
sublingual tablets, tell your doctor if you:
- Have trouble breathing or lung problems
- Have an enlarged prostate gland (men)
- Have a head injury or brain problem
- Have problems urinating
- Have a curve in your spine that affects your breathing
- Have liver or kidney problems
- Have gallbladder problems
- Have adrenal gland problems
- Have Addison's disease
- Have low thyroid (hypothyroidism)
- Have a history of alcoholism
- Have mental problems such as hallucinations (seeing or
hearing things that are not there)
- Have any other medical condition
- Are pregnant or plan to become pregnant. It is not known
if Buprenorphine HCl sublingual tablets will harm your
unborn baby. If you take Buprenorphine HCl sublingual
tablets while pregnant, your baby may have symptoms of
withdrawal at birth. Talk to your doctor if you are pregnant
or plan to become pregnant.
- Are breast feeding or plan to breast feed. Buprenorphine
HCl can pass into your milk and may harm the baby. Talk to
your doctor about the best way to feed your baby if you take
Buprenorphine HCl sublingual tablets. Breast feeding is not
recommended while taking Buprenorphine HCl sublingual
tablets.
including prescription and
nonprescription medicines, vitamins and herbal supplements.
Buprenorphine HCl sublingual tablets may affect the way other
medicines work, and other medicines may affect how Buprenorphine
HCl sublingual tablets works. Some medicines may cause serious
or life-threatening medical problems when taken with
Buprenorphine HCl sublingual tablets.
Tell your doctor about all the
medicines you take,
Sometimes the doses of certain medicines and
Buprenorphine HCl sublingual tablets may need to be changed if
used together. Do not take any medicine while using
Buprenorphine HCl sublingual tablets until you have talked with
your doctor. Your doctor will tell you if it is safe to take
other medicines while you are using Buprenorphine HCl sublingual
tablets.
such as pain medicines, tranquilizers, sleeping pills,
anxiety medicines or antihistamines.
Be especially careful about
taking other medicines that may make you sleepy,
Know the medicines you take. Keep a list of them to show
your doctor or pharmacist each time you get a new medicine.
How should I take Buprenorphine HCl
sublingual tablets?
- Always take Buprenorphine HCl sublingual tablets exactly
as your doctor tells you Your doctor may change your dose after seeing
how it affects you. Do not change your dose unless your
doctor tells you to change it.
.
- Do not take Buprenorphine HCl sublingual tablets more
often than prescribed by your doctor.
- If you are prescribed a dose of 2 or more Buprenorphine
HCl sublingual tablets at the same time:
- Ask your doctor for instructions on the right way
to take Buprenorphine HCl sublingual tablets
- Follow the same instructions every time you take a
dose of Buprenorphine HCl sublingual tablets
- Put the tablets under your tongue. Let them dissolve
completely.
- While Buprenorphine HCl sublingual tablets is
dissolving, do not chew or swallow the tablet
because the medicine will not work as well.
- Talking while the tablet is dissolving can affect
how well the medicine in Buprenorphine HCl
sublingual tablets is absorbed.
- If you miss a dose of Buprenorphine HCl sublingual
tablets, take your medicine when you remember. If it
is almost time for your next dose, skip the missed
dose and take the next dose at your regular time. Do
not take 2 doses at the same time unless your doctor
tells you to. If you are not sure about your dosing,
call your doctor.
- Do not stop taking Buprenorphine HCl sublingual
tablets suddenly. You could become sick and have
withdrawal symptoms because your body has become
used to the medicine. Physical dependence is not the
same as drug addiction. Your doctor can tell you
more about the differences between physical
dependence and drug addiction. To have fewer
withdrawal symptoms, ask your doctor how to stop
using Buprenorphine HCl sublingual tablets the right
way.
-
If you take too much
Buprenorphine HCl sublingual tablets or
overdose, call Poison Control or get emergency
medical help right away.
What should I avoid while taking
Buprenorphine HCl sublingual tablets?
- Buprenorphine can cause drowsiness and slow
reaction times. This may happen more often in the first few
weeks of treatment when your dose is being changed, but can
also happen if you drink alcohol or take other sedative
drugs when you take Buprenorphine HCl sublingual tablets.
Do not drive, operate heavy
machinery, or perform any other dangerous activities
until you know how this medication affects you.
- while using Buprenorphine HCl sublingual tablets,
as this can lead to loss of consciousness or death.
You should not drink alcohol
What are the possible side effects of
Buprenorphine HCl sublingual tablets?
Buprenorphine HCl sublingual tablets
can cause serious side effects including:
-
See "What is the most
important information I should know about Buprenorphine
HCl sublingual tablets?"
- You have a higher risk of death and coma if you
take Buprenorphine HCl sublingual tablets with other
medicines, such as benzodiazepines.
Respiratory problems.
-
Sleepiness, dizziness, and
problems with coordination
-
Dependency or abuse
- Call
your doctor right away if you notice any of these signs of
liver problems: Your skin or the white part of your eyes
turning yellow (jaundice), urine turning dark, stools
turning light in color, you have less of an appetite, or you
have stomach (abdominal) pain or nausea. Your doctor should
do tests before you start taking and while you take
Buprenorphine HCl sublingual tablets.
Liver problems.
- You
may have a rash, hives, swelling of your face, wheezing, or
loss of blood pressure and consciousness. Call a doctor or
get emergency help right away.
Allergic reaction.
- This can include: shaking, sweating more than normal,
feeling hot or cold more than normal, runny nose, watery
eyes, goose bumps, diarrhea, vomiting and muscle aches. Tell
your doctor if you develop any of these symptoms.
Opioid withdrawal.
- . You may feel dizzy if you get up too
fast from sitting or lying down.
Decrease in blood
pressure
Common side effects of Buprenorphine
HCl sublingual tablets include:
- Headache
- Nausea
- Vomiting
- Increased sweating
- Constipation
- Drug withdrawal syndrome
- Decrease in sleep (insomnia)
- Pain
Tell your doctor about any side effect that bothers you
or that does not go away.
These are not all the possible side effects of
Buprenorphine HCl sublingual tablets. For more information, ask
your doctor or pharmacist.
Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.
How should I store Buprenorphine HCl
sublingual tablets?
- Store Buprenorphine HCl sublingual tablets at room
temperature.
-
Keep Buprenorphine HCl sublingual
tablets in a safe place, out of the sight and reach of
children
How should I dispose of unused
Buprenorphine HCl sublingual tablets?
- Dispose of unused Buprenorphine HCl sublingual tablets as
soon as you no longer need them.
- Flush unused tablets down the toilet.
General information about the safe and
effective use of Buprenorphine HCl sublingual tablets
Medicines are sometimes prescribed for purposes other
than those listed in a Medication Guide. Do not use
Buprenorphine HCl sublingual tablets for a condition for which
it was not prescribed. Do not give Buprenorphine HCl sublingual
tablets to other people, even if they have the same symptoms you
have. It may harm them and it is against the law.
This Medication Guide summarizes the most important
information about Buprenorphine HCl sublingual tablets. If you
would like more information, talk to your doctor or pharmacist.
You can ask your doctor or pharmacist for information that is
written for healthcare professionals.
For more information call 1-888-775-1770.
Rev. 924/930:00 2/13
Manufactured by: Ethypharm S.A. 76121 Le Grand
Quevilly cedex France
Distributed by: Hi-Tech Pharmacal Co.,
Inc. Amityville, NY 11701 Tel:
1-888-775-1770 www.hitechpharm.com/drugsafety
This Medication Guide has been approved by the U.S. Food
and Drug Administration.
Revised: February 2013.