الأدوية والمكملات الغذائية

Precautions

Drug information provided by: Merative, Micromedex®

It is very important that your healthcare provider check your progress while you are using this medicine, especially within the first 24 to 72 hours of treatment. This will allow your provider to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

It is against the law and dangerous for anyone else to use your medicine. Keep your unused tablets and buccal films in a safe and secure place. People who are addicted to drugs might want to steal this medicine.

Do not use this medicine if you have used an MAO inhibitor (MAOI) (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.

Using too much buprenorphine may cause an overdose. Symptoms of overdose include: change in consciousness, chest pain, cold and clammy skin, increased sweating coughing that sometimes produces a pink frothy sputum, difficult or trouble breathing, increased sweating, irregular, fast or slow, or shallow breathing, loss of consciousness, pale or blue lips, fingernails, or skin, sleepiness or unusual drowsiness, or swelling in legs and ankles. Your healthcare provider may give you naloxone to treat an overdose.

This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your healthcare provider may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.

This medicine may cause serious tooth problems. Tell your dentist right away if you have cavities, tooth decay, tooth pain, tooth infection, tooth erosion, tooth fracture, or tooth loss.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the healthcare provider or dentist that you are using this medicine. Serious unwanted effects can occur if certain medicines are given together with buprenorphine.

This medicine will add to the effects of central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, benzodiazepines, tranquilizers, or sleeping medicine, other prescription pain medicine or opioids, medicine for seizures or barbiturates, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. Check with your healthcare provider or dentist before taking any of the medicines listed above while you are using this medicine.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help.

This medicine may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your healthcare provider right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Call your healthcare provider right away if you have worsening of pain, increased sensitivity to pain, or new pain after taking this medicine. These may be symptoms of opioid-induced hyperalgesia and allodynia.

Check with your healthcare provider right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting. These may be symptoms of adrenal gland problem.

Contact your healthcare provider right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your provider knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.

Belbuca® 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 healthcare provider for instructions.

Using opioids for a long time can cause severe constipation. To prevent this, your healthcare provider may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

If you have been using this medicine regularly for several weeks or longer, do not change your dose or suddenly stop using it without checking first with your healthcare provider. Your provider may want you to gradually reduce the amount you are using before stopping it completely. This may help reduce the possibility of withdrawal symptoms, including stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Tell your healthcare provider right away if you think you are pregnant or if you plan to become pregnant while using this medicine. Do not suddenly stop using this medicine without first talking to your provider. This medicine may cause serious unwanted effects in your newborn baby, including neonatal opioid withdrawal syndrome.

For nursing mothers taking Belbuca®:

• Do not suddenly stop using this medicine without first talking to your healthcare provider. Talk to your provider if you have any questions about how this medicine may affect your baby.
• Call your provider if you become extremely tired and have difficulty caring for your baby.
• Your baby should generally nurse every 2 to 3 hours and should not sleep for more than 4 hours at a time.
• Check with your provider or hospital emergency room immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of opioid poisoning and need immediate medical attention.

Using too much of this medicine may cause reduced infertility (unable to have children). Talk with your healthcare provider before using this medicine if you plan to have children.

Check with your healthcare provider right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your healthcare provider right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Do not take other medicines unless they have been discussed with your healthcare provider. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.