Medication
Guide
HYSINGLA® ER (hye-SING-luh)
(hydrocodone bitartrate) extended-release tablets, CII |
HYSINGLA ER
is:
- A strong prescription pain medicine that contains an opioid
(narcotic) that is used to manage severe and persistent pain that
requires an extended treatment period with a daily opioid pain medicine,
when other non-opioid pain medicines do not treat your pain well enough
or you cannot tolerate them.
- A long-acting (extended-release) opioid pain medicine that
can put you at risk for overdose and death. Even if you take your
dose correctly as prescribed you are at risk for opioid addiction,
abuse, and misuse that can lead to death.
- Not to be taken on an “as needed” basis.
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Important
information about HYSINGLA ER:
-
Get emergency help or call 911 right away if you take
too much HYSINGLA ER (overdose). When you first start taking
HYSINGLA ER, when your dose is changed, or if you take too much (overdose),
serious or life-threatening breathing problems that can lead to death
may occur. Talk to your healthcare provider about naloxone, a medicine
for the emergency treatment of an opioid overdose.
- Taking HYSINGLA ER with other opioid medicines, benzodiazepines,
alcohol, or other central nervous system depressants (including street
drugs) can cause severe drowsiness, decreased awareness, breathing
problems, coma, and death.
- Never give anyone else your HYSINGLA ER. They could die
from taking it. Selling or giving away HYSINGLA ER is against the
law.
- Store HYSINGLA ER securely, out of sight and reach of children,
and in a location not accessible by others, including visitors to
the home.
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Do not take HYSINGLA
ER if you have:
- severe asthma, trouble breathing, or other lung problems.
- a bowel blockage or have narrowing of the stomach or intestines.
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Before taking HYSINGLA ER, tell
your healthcare provider if you have a history of:
- head injury, seizures
- liver, kidney, thyroid problems
- problems urinating
- abuse of street or prescription drugs, alcohol addiction,
opioid overdose, or mental health problems
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- pancreas or gallbladder problems
- heart rhythm problems (long QT syndrome)
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Tell your
healthcare provider if you are:
- noticing your pain getting worse. If your pain gets worse
after you take HYSINGLA ER, do not take more of HYSINGLA ER without
first talking to your healthcare provider. Talk to your healthcare
provider if the pain that you have increases, if you feel more sensitive
to pian, or if you have new pain after taking HYSINGLA ER.
-
pregnant or planning to become pregnant. Use
of HYSINGLA ER for an extended period of time during pregnancy can
cause withdrawal symptoms in your newborn baby that could be life-threatening
if not recognized and treated.
-
breastfeeding. Not recommended during treatment
with HYSINGLA ER. It may harm your baby.
- living in a household where there are small children or
someone who has abused street or prescription drugs.
- taking prescription or over-the-counter medicines, vitamins,
or herbal supplements. Taking HYSINGLA ER with certain other medicines
can cause serious side effects and could lead to death.
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When taking
HYSINGLA ER:
- Do not change your dose. Take HYSINGLA ER exactly as prescribed
by your healthcare provider. Use the lowest dose possible for the
shortest time needed.
- Take your prescribed dose every 24 hours, at the same time
every day. Do not take more than your prescribed dose in 24 hours.
If you miss a dose, take your next dose at your usual time the next
day.
- Swallow HYSINGLA ER whole. Do not cut, break, chew, crush,
dissolve, snort, or inject HYSINGLA ER because this may cause you
to overdose and die.
- HYSINGLA ER should be taken 1 tablet at a time. Do not
pre-soak, lick, or wet the tablet before placing it in your mouth
to avoid choking on the tablet.
Call your healthcare provider if the dose you are taking
does not control your pain.
-
Do not stop taking HYSINGLA ER without talking to
your healthcare provider.
-
Dispose of expired, unwanted, or unused HYSINGLA ER,
by promptly flushing down the toilet, if a drug take-back option is
not readily available. Visit www.fda.gov/drugdisposal for additional
information on disposal of unused medicines.
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While taking
HYSINGLA ER, DO NOT:
- Drive or operate heavy machinery until you know how HYSINGLA
ER affects you. HYSINGLA ER can make you sleepy, dizzy, or lightheaded.
- Drink alcohol or use prescription or over-the-counter medicines
that contain alcohol. Using products containing alcohol during treatment
with HYSINGLA ER may cause you to overdose and die.
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The possible
side effects of HYSINGLA ER are:
- constipation, nausea, sleepiness, vomiting, tiredness, headache,
dizziness, abdominal pain. Call your healthcare provider if you have
any of these symptoms and they are severe.
Get emergency medical help or call 911 right away if
you have:
- trouble breathing, shortness of breath, fast heartbeat,
chest pain, swelling of your face, tongue or throat, extreme drowsiness,
light-headedness when changing positions, feeling faint, agitation,
high body temperature, trouble walking, stiff muscles, or mental changes
such as confusion.
These are not all the possible side effects of
HYSINGLA ER. Call your healthcare provider for medical advice about
side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.
Manufactured by: Purdue Pharma L.P., Stamford, CT 06901-3431, www.purduepharma.com or call 1-888-726-7535
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