Buprenorphine Sublingual

Read the Medication Guide provided by your pharmacist before you start using sublingual buprenorphine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Use this medication as directed by your doctor, usually once daily. Place the medication under your tongue for 5 to 10 minutes and let it dissolve completely. If you are prescribed more than one tablet each day, you may place all of the tablets under your tongue at once or place two tablets at a time under your tongue. Do not swallow or chew this medication. It will not work as well.Buprenorphine alone is usually used for the first 2 days after you have stopped all other narcotics. It is usually given in your doctor's office. Your doctor will then switch you to the combination buprenorphine/naloxone medication for maintenance treatment. The combination with naloxone works the same way as buprenorphine alone to prevent withdrawal symptoms. It is combined with naloxone to prevent misuse (injection) of the medication.Buprenorphine works best when the first dose is started after signs of narcotic withdrawal have begun or at least 4 hours after last narcotic use. Buprenorphine can cause withdrawal symptoms if started too soon after your last narcotic use. Follow your doctor's instructions for your treatment plan.The dosage is based on your medical condition and response to treatment. Do not increase your dose, take the medication more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed.Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day.This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, watering eyes, runny nose, nausea, sweating, muscle aches) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.Do not inject ("shoot up") buprenorphine. Injecting it is dangerous and may cause severe withdrawal symptoms (see Side Effects section). Consult your doctor or pharmacist for more details.Tell your doctor immediately if you experience any withdrawal reactions.

Buprenorphine Hydrochloride Sublingual Tablets are available containing buprenorphine hydrochloride, USP equivalent to 2 mg or 8 mg of buprenorphine.

• The 2 mg sublingual tablets are white, round, unscored tablets debossed with M over 923 on one side of the tablet and blank on the other side. • The 8 mg sublingual tablets are white, round, unscored tablets debossed with M over 924 on one side of the tablet and blank on the other side.

Controlled Substance

Buprenorphine is a Schedule III narcotic under the Controlled Substances Act.

Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of this product in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription.

Abuse

Buprenorphine, like morphine and other opioids, has the potential for being abused and is subject to criminal diversion. This should be considered when prescribing or dispensing buprenorphine in situations when the clinician is concerned about an increased risk of misuse, abuse, or diversion. Healthcare professionals should contact their state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.

Patients who continue to misuse, abuse, or divert, buprenorphine products or other opioids should be provided or referred for more intensive and structured treatment.

Abuse of buprenorphine poses a risk of overdose and death. This risk is increased with the abuse of buprenorphine and alcohol and other substances, especially benzodiazepines.

The healthcare provider may be able to more easily detect misuse or diversion by maintaining records of medication prescribed including date, dose, quantity, frequency of refills, and renewal requests of medication prescribed.

Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper handling and storage of the medication are appropriate measures that help to limit abuse of opioid drugs.

Dependence

Buprenorphine is a partial agonist at the mu-opioid receptor and chronic administration produces physical dependence of the opioid type, characterized by moderate withdrawal signs and symptoms upon abrupt discontinuation or rapid taper. The withdrawal syndrome is typically milder than seen with full agonists and may be delayed in onset [see Warnings and Precautions (5.7)].

Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy [see Warnings and Precautions (5.5)].

Buprenorphine hydrochloride sublingual tablets are white, round, unscored tablets, debossed with M over 923 (2 mg) or M over 924 (8 mg) on one side of the tablet and blank on the other side. They contain buprenorphine hydrochloride, a partial agonist at the mu-opioid receptor, and are available in two dosage strengths, 2 mg buprenorphine and 8 mg buprenorphine (as the free base, equivalent to 2.156 mg buprenorphine hydrochloride, USP and 8.624 mg buprenorphine hydrochloride, USP). Each tablet also contains anhydrous citric acid, anhydrous lactose, colloidal silicon dioxide, corn starch, crospovidone, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose and sodium citrate.

Chemically, buprenorphine hydrochloride is 21-Cyclopropyl-7α-[(S)-1-hydroxy-1,2,2-trimethylpropyl]-6,14-endo-ethano-6,7,8,14-tetrahydrooripavine hydrochloride. It has the following chemical structure:

Buprenorphine hydrochloride, USP has the molecular formula C29H41NO4•HCl and the molecular weight is 504.10. It is a white or off-white powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol and practically insoluble in cyclohexane.

Buprenorphine Hydrochloride Sublingual Tablets are available containing buprenorphine hydrochloride, USP equivalent to 2 mg or 8 mg of buprenorphine.

The 2 mg sublingual tablets are white, round, unscored tablets debossed with M over 923 on one side of the tablet and blank on the other side. They are available as follows:

NDC 0378-0923-93
bottles of 30 tablets

The 8 mg sublingual tablets are white, round, unscored tablets debossed with M over 924 on one side of the tablet and blank on the other side. They are available as follows:

NDC 0378-0924-93
bottles of 30 tablets

Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

PHARMACIST: Dispense a Medication Guide with each prescription.

Patients should be advised to store buprenorphine-containing medications safely and out of sight and reach of children. Destroy any unused medication appropriately [see Patient Counseling (17.2)].

Rx only

See FDA-approved patient labeling (Medication Guide)

Safe Use

Before initiating treatment with buprenorphine hydrochloride sublingual tablets, explain the points listed below to caregivers and patients. Instruct patients to read the Medication Guide each time buprenorphine hydrochloride sublingual tablets are dispensed because new information may be available.

• Patients should be warned that it is extremely dangerous to self-administer non-prescribed benzodiazepines or other CNS depressants (including alcohol) while taking buprenorphine hydrochloride sublingual tablets. Patients prescribed benzodiazepines or other CNS depressants should be cautioned to use them only as directed by their healthcare providers [see Warnings and Precautions (5.2), Drug Interactions (7)]. • Patients should be advised that buprenorphine hydrochloride sublingual tablets contain an opioid that can be a target for people who abuse prescription medications or street drugs. Patients should be cautioned to keep their tablets in a safe place, and to protect them from theft. • Patients should be instructed to keep buprenorphine hydrochloride sublingual tablets in a secure place, out of the sight and reach of children. Accidental or deliberate ingestion by a child may cause respiratory depression that can result in death. Patients should be advised that if a child is exposed to buprenorphine hydrochloride sublingual tablets, medical attention should be sought immediately. • Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare providers if they are taking, or plan to take serotonergic medications [see Drug Interactions (7)]. • Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms [see Warnings and Precautions (5.6)]. • Patients should be advised never to give buprenorphine hydrochloride sublingual tablets to anyone else, even if he or she has the same signs and symptoms. It may cause harm or death. • Patients should be advised that selling or giving away this medication is against the law. • Patients should be cautioned that buprenorphine hydrochloride sublingual tablets may impair the mental or physical abilities required for the performance of potentially dangerous tasks such as driving or operating hazardous machinery. Caution should be taken especially during drug induction and dose adjustment and until individuals are reasonably certain that buprenorphine therapy does not adversely affect their ability to engage in such activities [see Warnings and Precautions (5.13)]. • Patients should be advised not to change the dosage of buprenorphine hydrochloride sublingual tablets without consulting their healthcare providers. • Patients should be advised to take buprenorphine hydrochloride sublingual tablets once a day. • Patients should be informed that buprenorphine hydrochloride sublingual tablets can cause drug dependence and that withdrawal signs and symptoms may occur when the medication is discontinued. • Patients seeking to discontinue treatment with buprenorphine for opioid dependence should be advised to work closely with their healthcare providers on a tapering schedule and should be apprised of the potential to relapse to illicit drug use associated with discontinuation of opioid agonist/partial agonist medication-assisted treatment. • Patients should be cautioned that, like other opioids, buprenorphine hydrochloride sublingual tablets may produce orthostatic hypotension in ambulatory individuals [see Warnings and Precautions (5.14)]. • Patients should inform their healthcare providers if any other prescription medications, over-the-counter medications, or herbal preparations are prescribed or currently being used [see Drug Interactions (7)]. • Advise women that if they are pregnant while being treated with buprenorphine hydrochloride sublingual tablets, the baby may have signs of withdrawal at birth and that withdrawal is treatable [see Warnings and Precautions (5.5), Use in Specific Populations (8.1)]. • Patients should be warned that buprenorphine passes into breast milk. Breastfeeding is therefore not advised in mothers treated with buprenorphine products [see Use in Specific Populations (8.2)]. • Patients should inform their family members that, in the event of emergency, the treating healthcare providers or emergency room staff should be informed that the patient is physically dependent on an opioid and that the patient is being treated with buprenorphine hydrochloride sublingual tablets. • Refer to the Medication Guide for additional information regarding the counseling information.

Disposal of Unused Buprenorphine Hydrochloride Sublingual Tablets

Unused buprenorphine hydrochloride sublingual tablets should be disposed of as soon as they are no longer needed. Flush unused tablets down the toilet.

Buprenorphine Hydrochloride Sublingual Tablets
(bue″ pre nor′ feen hye″ droe klor′ ide)

IMPORTANT: Keep buprenorphine hydrochloride sublingual tablets in a secure place away from children. Accidental use by a child is a medical emergency and can result in death. If a child accidentally uses buprenorphine hydrochloride sublingual tablets, get emergency help right away.

Read this Medication Guide that comes with buprenorphine hydrochloride sublingual tablets before you start taking them 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 hydrochloride 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 hydrochloride sublingual tablets?

• Buprenorphine hydrochloride sublingual tablets can cause serious and life-threatening breathing problems. Call your doctor right away or get emergency help if: o You feel faint, dizzy or confused o Your breathing gets much slower than is normal for you    These can be signs of an overdose or other serious problems. • Do not switch from buprenorphine hydrochloride sublingual tablets to other medicines that contain buprenorphine without talking with your doctor. The amount of buprenorphine in a dose of buprenorphine hydrochloride sublingual tablets may not be the same as the amount of buprenorphine in other medicines that contain buprenorphine. Your doctor will prescribe a starting dose of buprenorphine hydrochloride sublingual tablets that may be different than other buprenorphine containing medicines you may have been taking. • Buprenorphine hydrochloride sublingual tablets contain an opioid that can cause physical dependence. o Do not stop taking buprenorphine hydrochloride 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 o Physical dependence is not the same as drug addiction o Buprenorphine hydrochloride sublingual tablets are not for occasional or “as needed” use

 

• An overdose, and even death, can happen if you take benzodiazepines, sedatives, tranquilizers, antidepressants, or alcohol while using buprenorphine hydrochloride 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: o Feel sleepy and uncoordinated o Have blurred vision o Have slurred speech o Cannot think well or clearly o Have slowed reflexes and breathing • Do not inject (“shoot-up”) buprenorphine hydrochloride sublingual tablets. o Injecting buprenorphine hydrochloride sublingual tablets may cause life-threatening infections and other serious health problems. o Injecting buprenorphine hydrochloride 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 hydrochloride sublingual tablets.

What are buprenorphine hydrochloride sublingual tablets?

• Buprenorphine hydrochloride sublingual tablets are a prescription medicine used to begin treatment in adults who are addicted to (dependent on) opioid drugs (either prescription or illegal drugs), as part of a complete treatment program that also includes counseling and behavioral therapy. • Buprenorphine hydrochloride sublingual tablets are most often used for the first 1 or 2 days to help you start with treatment.

Buprenorphine hydrochloride sublingual tablets are a controlled substance (CIII) because they contain buprenorphine, which can be a target for people who abuse prescription medicines or street drugs. Keep your buprenorphine hydrochloride sublingual tablets in a safe place to protect them from theft. Never give your buprenorphine hydrochloride sublingual tablets to anyone else; they can cause death or harm them. Selling or giving away this medicine is against the law.

• It is not known if buprenorphine hydrochloride sublingual tablets are safe or effective in children.

Who should not take buprenorphine hydrochloride sublingual tablets?

Do not take buprenorphine hydrochloride sublingual tablets if you are allergic to buprenorphine.

What should I tell my doctor before taking buprenorphine hydrochloride sublingual tablets?

Buprenorphine hydrochloride sublingual tablets may not be right for you. Before taking buprenorphine hydrochloride sublingual tablets, tell your doctor if you:

• Have liver or kidney problems • 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 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. If you take buprenorphine hydrochloride sublingual tablets while pregnant, your baby may have symptoms of opioid withdrawal or respiratory depression at birth. Talk to your doctor if you are pregnant or plan to become pregnant. • Are breastfeeding or plan to breastfeed. Buprenorphine hydrochloride can pass into your milk and may harm your baby. Talk to your doctor about the best way to feed your baby if you take buprenorphine hydrochloride sublingual tablets. Monitor your baby for increased sleepiness and breathing problems.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Buprenorphine hydrochloride sublingual tablets may affect the way other medicines work, and other medicines may affect how buprenorphine hydrochloride sublingual tablets work. Some medicines may cause serious or life-threatening medical problems when taken with buprenorphine hydrochloride sublingual tablets.

Sometimes the doses of certain medicines and buprenorphine hydrochloride sublingual tablets may need to be changed if used together. Do not take any medicine while using buprenorphine hydrochloride 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 taking buprenorphine hydrochloride sublingual tablets.

Be especially careful about taking other medicines that may make you sleepy, such as pain medicines, tranquilizers, sleeping pills, anxiety medicines or antihistamines.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist each time you get a new medicine.

How should I take buprenorphine hydrochloride sublingual tablets?

• Always take buprenorphine hydrochloride 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 hydrochloride sublingual tablets more often than prescribed by your doctor. • If you are prescribed a dose of 2 or more buprenorphine hydrochloride sublingual tablets at the same time: o Ask your doctor for instructions on the right way to take buprenorphine hydrochloride sublingual tablets o Follow the same instructions every time you take a dose of buprenorphine hydrochloride sublingual tablets • Put the tablets under your tongue. Let them dissolve completely. • While buprenorphine hydrochloride sublingual tablets are 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 hydrochloride sublingual tablets is absorbed. • If you miss a dose of buprenorphine hydrochloride 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 hydrochloride 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 hydrochloride sublingual tablets the right way. • If you take too many buprenorphine hydrochloride sublingual tablets or overdose, call Poison Control or get emergency medical help right away.

What should I avoid while taking buprenorphine hydrochloride sublingual tablets?

• Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how this medication affects you. 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 hydrochloride sublingual tablets. • You should not drink alcohol while using buprenorphine hydrochloride sublingual tablets, as this can lead to loss of consciousness or death.

What are the possible side effects of buprenorphine hydrochloride sublingual tablets?

Buprenorphine hydrochloride sublingual tablets can cause serious side effects including:

• See “What is the most important information I should know about buprenorphine hydrochloride sublingual tablets?” • Respiratory problems. You have a higher risk of death and coma if you take buprenorphine hydrochloride sublingual tablets with other medicines, such as benzodiazepines. • Sleepiness, dizziness, and problems with coordination • Dependency or abuse • Liver problems. 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 hydrochloride sublingual tablets. • Allergic reaction. You may have a rash, hives, swelling of the face, wheezing, or loss of blood pressure and consciousness. Call a doctor or get emergency help right away. • Opioid withdrawal. 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. • Decrease in blood pressure. You may feel dizzy if you get up too fast from sitting or lying down.

Common side effects of buprenorphine hydrochloride sublingual tablets include:

• Nausea • Vomiting • Drug withdrawal syndrome • Headache • Sweating • Numb mouth • Constipation • Swollen and/or painful tongue • The inside of your mouth is more red than normal • Intoxication (feeling lightheaded or drunk) • Disturbance in attention • Irregular heart beat (palpitations) • Decrease in sleep (insomnia) • Blurred vision • Back pain • Fainting • Dizziness • Sleepiness

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 hydrochloride 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 hydrochloride sublingual tablets?

• Store buprenorphine hydrochloride sublingual tablets at room temperature between 20º to 25ºC (68º to 77ºF). • Keep buprenorphine hydrochloride sublingual tablets in a safe place, out of the sight and reach of children.

How should I dispose of unused buprenorphine hydrochloride sublingual tablets?

• Dispose of unused buprenorphine hydrochloride sublingual tablets as soon as you no longer need them. • Unused tablets should be flushed down the toilet.

If you need help with disposal of buprenorphine hydrochloride sublingual tablets, call 1-877-446-3679 (1-877-4-INFO-RX).

General information about the safe and effective use of buprenorphine hydrochloride sublingual tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take buprenorphine hydrochloride sublingual tablets for a condition for which they were not prescribed. Do not give buprenorphine hydrochloride 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 hydrochloride 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 Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX).

What are the ingredients in buprenorphine hydrochloride sublingual tablets?

Active Ingredient: buprenorphine hydrochloride

Inactive Ingredients: anhydrous citric acid, anhydrous lactose, colloidal silicon dioxide, corn starch, crospovidone, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose and sodium citrate

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Mylan Pharmaceuticals Inc.

Morgantown, WV 26505 U.S.A.

Revised: 6/2017
BUPET:R8

Drowsiness, dizziness, constipation, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist right away.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Severe (possibly fatal) breathing problems can occur if this medication is abused, injected, or mixed with other depressants (such as alcohol, benzodiazepines including diazepam, other opioids).

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as agitation, confusion, hallucinations), stomach/abdominal pain, signs of your adrenal glands not working well (such as unusual tiredness, weight loss).

Get medical help right away if any of these rare but seriousfainting, fast/irregular heartbeat, severe dizziness, slow/shallow breathing, unusual drowsiness/difficulty waking up.

Although this medication is used to prevent withdrawal reactions, it may rarely cause opioid withdrawal symptoms, including diarrhea, severe mental/mood changes (such as anxiety, irritability, trouble sleeping), muscle stiffness or shakiness. This is more likely when you first start treatment or if you have been using long-acting opioids such as methadone. If such symptoms occur, notify your doctor or pharmacist right away.

This drug may rarely cause serious liver disease. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting, loss of appetite, yellowing eyes/skin, severe stomach/abdominal pain.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

List Buprenorphine Hcl Tablet, Sublingual side effects by likelihood and severity.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), liver disease, mental/mood disorders (such as confusion, depression), stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), difficulty urinating (such as due to enlarged prostate).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages. Alcohol also increases your risk for breathing problems.

Buprenorphine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using buprenorphine, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using buprenorphine safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, slow/shallow breathing, and QT prolongation (see above).

Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea.

This drug passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor right away if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.