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Belbuca is a strong pain medicine that contains an opioid that is used to manage severe pain that requires daily, around-the-clock, long-term treatment, when other pain treatments have not worked well enough or cannot be tolerated. Belbuca is available as a film that is dissolved on the inside of your cheek.
Belbuca is a federally controlled substance because it has abuse potential.
How does this medication work?
Belbuca works in your central nervous system (the brain and spinal cord) and affects the way your body responds to pain.
Belbuca is not used to treat pain that you only have now and then ("as needed").
What are the beneficial effects of this medication and when should I begin to have results?
What: Belbuca has been shown to help relieve pain.
When: Everyone responds differently to treatment, so try to be patient and follow your healthcare provider's instructions. It is important that you use Belbuca exactly as your healthcare provider has prescribed.
How do I know it is working?
You may feel an improvement in your pain. This is a good indicator that the medicine is working. Your healthcare provider may also ask you questions from time to time to assess how well your symptoms are controlled with treatment.
The following is not a full list of side effects. Side effects cannot be anticipated. If any develop or change in intensity, tell your healthcare provider as soon as possible. Only your healthcare provider can determine if it is safe for you to continue taking this medication.
Belbuca has addiction, abuse, and misuse potential. If you have concerns, talk to your healthcare provider for more information about abuse and addiction. Do not share Belbuca with others. Take steps to protect Belbuca from theft or misuse.
Serious, life-threatening breathing problems may occur when using Belbuca.
Keep Belbuca in a safe place, away from children. Accidental use may result in serious harm and may be life-threatening.
Long-term use of Belbuca during pregnancy can cause withdrawal symptoms (such as poor feeding, diarrhea, irritability, shaking, rigidity, and seizures) in your newborn baby that may be life-threatening if not recognized and treated. Tell your healthcare provider if you are pregnant or plan to become pregnant.
More common side effects may include: nausea, constipation, headache, vomiting, dizziness, sleepiness.
Less common side effects may include:
Liver problems, with symptoms such as stomach pain, itching, unusual tiredness, loss of appetite, light-color bowel movements, dark-colored urine, or yellowing of your skin or the whites of your eyes.
Serious allergic reactions, with symptoms such as hives; rash; trouble breathing or swallowing; swelling of the face, lips, tongue, or throat; rapid heartbeat; or fainting.
Changes in the electrical activity of your heart, with symptoms such as fainting.
Sudden fall in your blood pressure with symptoms such as dizziness, lightheadedness, or fainting when rising too quickly from a sitting or lying position.
Do not use Belbuca if you are allergic to it or any of its ingredients.
Do not use Belbuca if you have severe asthma, trouble breathing, or other lung problems.
Do not use Belbuca if you have a blockage or narrowing of the stomach or intestines.
Tell your healthcare provider about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Belbuca. Also, talk to your healthcare provider about your complete medical history, especially if you have a history of head injury, seizures, heart rhythm problems (long QT syndrome), liver problems, kidney problems, thyroid problems, pancreas or gallbladder problems, problems urinating, abuse of street or prescription drugs, alcohol addiction, or mental health problems; or if you are pregnant, plan to become pregnant, or are breastfeeding.
The information below is based on the dosage guidelines your healthcare provider uses. Depending on your condition and medical history, your healthcare provider may prescribe a different regimen. Do not change the dosage or stop taking your medication without your healthcare provider's approval.
Adults: Your healthcare provider will prescribe the appropriate dose for you, based on your previous pain medicine or the type and severity of your pain.
If you take certain other medicines or have liver impairment, your healthcare provider may adjust your dose appropriately.
It is important that you do not stop using this medication abruptly. If you need to change or stop using this medication, it is important that you only do this with the guidance of your healthcare provider.
Use Belbuca exactly as prescribed by your healthcare provider. Do not use it more often or stop using it without first talking to your healthcare provider.
Wet the inside of your cheek using your tongue, or rinse your mouth with water to wet the area for placement of Belbuca. Apply immediately after removal from the package.
Place the yellow side of the film against the inside of your cheek, and hold in place with clean, dry fingers for 5 seconds. Leave in place on the inside of your cheek until fully dissolved (usually within 30 minutes).
Throw away any unused Belbuca films if no longer needed. Remove any unused films from the packaging, and flush them down the toilet. Discard foil packaging in trash.
Please review the instructions that come with your prescription on how to properly use Belbuca.
Do not use Belbuca if the package seal is broken or if the film is cut, damaged, or changed in any way.
Do not eat food or drink any liquids until the film has completely dissolved.
Do not touch or move the film with your tongue or fingers.
Do not apply Belbuca to areas of the mouth with any open sores or lesions.
Do not drive, operate heavy machinery, or do other dangerous activities until you know how Belbuca affects you.
Do not drink alcohol or use prescription or over-the-counter medicines containing alcohol.
If Belbuca is used with certain other drugs, the effects of either could be increased, decreased, or altered. Belbuca may interact with numerous medications. Therefore, it is very important that you tell your healthcare provider about any other medications you are taking.
Belbuca may harm your newborn baby if you use it during pregnancy. Long-term use of Belbuca during pregnancy can cause withdrawal symptoms in your newborn baby that may be life-threatening if not recognized and treated. Belbuca can be found in your breast milk if you use it while breastfeeding. Do not breastfeed while you are using Belbuca. Tell your healthcare provider immediately if you are pregnant, plan to become pregnant, or are breastfeeding.
If you miss a dose of Belbuca, use it as soon as you remember. However, if it is almost time for your next dose, skip the one you missed and return to your regular dosing schedule. Do not use two doses at once.
Store at room temperature.
In the event of a medical emergency call your doctor or 9-1-1 immediately. In the event of overdose, call your doctor or poison control for further instructions.
National Poison Control#: Call 1-800-222-1222
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