Buprenorphine Hydrochloride (bue-pre-NOR-feen hye-droe-KLOR-ide), Naloxone Hydrochloride (nal-OX-one hye-droe-KLOR-ide)
Treats an addiction to or dependence on narcotic medicine.
There may be other brand names for this medicine.
When This Medicine Should Not Be Used
Do not use this medicine if you have had an allergic reaction to buprenorphine or naloxone.
How to Use This Medicine
Thin Sheet, Tablet
You will have serious side effects if you take too much of this medicine. If you do not understand the directions or warnings, ask your doctor.
- Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
You must let the medicine dissolve under your tongue. Never swallow the film or tablet. Your body may not absorb enough of the medicine if you swallow it.
- Your health caregiver should show you how to use the medicine. If you do not understand, ask for help. It is important to use the medicine correctly. Do not talk while the medicine is in your mouth.
Tablet: Place the tablet under your tongue. If your doctor told you to use more than 1 tablet, place all of the tablets under your tongue together. You can use 2 tablets at a time until you have taken all of the medicine, if that is easier for you. Let the tablets dissolve completely in your mouth.
Film: Place the film under your tongue. If your doctor told you to use more than 1 film, place the second film on the opposite side from the first one. Do not move the film after you place it under your tongue. If you are supposed to use more than 2 films, use them the same way, but do not start until the first 2 films are completely dissolved.
- Do not break, crush, chew, or cut the film or tablet.
- You should always get the same form and strength of medicine every time you fill the prescription, unless your doctor told you that it will change. Tell the pharmacist if your medicine is different than what you expected.
- This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.
If a dose is missed:
- If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.
How to Store and Dispose of This Medicine
- Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
- Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
- Keep all medicine away from children and never share your medicine with anyone. This medicine could cause death in a child.
Drugs and Foods to Avoid
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.
- Make sure your doctor knows if you are using a tranquilizer (benzodiazepine, such as alprazolam, clonazepam, diazepam, lorazepam, or Xanax®). Tell your doctor if you are using any medicines that make you sleepy. These include sleeping pills, cold and allergy medicine, narcotic pain relievers, and sedatives.
- Make sure your doctor knows if you are using an antibiotic (such as erythromycin, Ery-tab®), medicine to treat a fungus infection (such as itraconazole, ketoconazole, Nizoral®), or medicine to treat HIV/AIDS (such as atazanavir, delavirdine, efavirenz, etravirine, nevirapine, Atripla®, Intelence®, Rescriptor®, Reyataz®, Sustiva®, Viramune®).
- Tell your doctor if you are also using carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), or rifampicin (Rifadin®, Rimactane®).
- Do not drink alcohol while you are using this medicine.
Warnings While Using This Medicine
- Make sure your doctor knows if you are pregnant or breastfeeding. This medicine could cause side effects in your baby if you use it while pregnant or breastfeeding.
- Tell your doctor if you have kidney disease, liver disease (including hepatitis), an adrenal problem such as Addison disease, enlarged prostate, gallbladder problems, digestion problems, trouble urinating, or low thyroid levels.
- Make sure your doctor knows if you have any kind of breathing problem, such as chronic obstructive pulmonary disease (COPD) or a curved spine that interferes with breathing. Make sure your doctor knows if you have had a recent head injury, brain tumor, or other problem that could increase the pressure in your head.
An overdose of this medicine can cause death. Symptoms of overdose include trouble breathing, slow or shallow breathing, severe dizziness or weakness, slow heartbeat, fainting, pinpoint pupils, or severe sleepiness.
- Make sure your doctor knows about all drug or alcohol problems you or your family members have. Also tell your doctor about any mental or emotional problems.
- This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
- Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.
- Make sure any doctor or dentist who treats you knows that you are using this medicine.
- Never inject this medicine. It will cause serious health problems if injected.
- It is against the law and dangerous for anyone else to use your medicine. Always keep your medicine in a secure place so no one can steal it.
- This medicine may make you dizzy or drowsy. Avoid driving, using machine, or doing anything else that could be dangerous until you know how this medicine affects you. You may also feel lightheaded when standing up suddenly from a sitting or lying position, so get up slowly.
- Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.
Possible Side Effects While Using This Medicine
Call your doctor right away if you notice any of these side effects:
- Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
- Dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, yellow skin or eyes
- Lightheadedness, dizziness, fainting
- Severe headache
- Sever stomach pain
Trouble breathing, slow or shallow breathing, sighing, or extreme weakness or sleepiness
If you notice these less serious side effects, talk with your doctor:
- Headache, trouble sleeping
- Mild stomach pain, constipation, upset stomach
- Shaking, sweating, feeling hot or cold, runny nose, watery eyes, diarrhea, vomiting, and muscle aches
- Sweating, mild pain
If you notice other side effects that you think are caused by this medicine, tell your doctor
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088
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