Patient Information for Buprenorphine 0.4, 2, 8mg

Introduction

What is Buprenorphine Sublingual tablet used for?
Buprenorphine is indicated for the treatment of opioid dependence. It should be used as part of a complete treatment plan to include counseling and psychosocial support.

Important Information

How to use Buprenorphine?
• Use this drug as ordered by your doctor. Avoid taking more than the prescribed amount.
• Place under tongue and let dissolve all the way. Do not drink while this drug is dissolving.
• For doses requiring the use of more than two tablets, patients are advised to either place all the tablets at once or alternatively (if they cannot fit in more than two tablets comfortably), place two tablets at a time under the tongue.
• Do not chew or swallow tablet. swallowing the tablets reduces the bioavailability of the drug.
• Do not stop taking Buprenorphine without talking to your doctor. You could become sick with uncomfortable withdrawal signs and symptoms.
What other drugs could affect Buprenorphine?
Tell your doctor about all the medicines you take, including prescription and over‐the‐counter medicines, vitamins, and herbal supplements.
Buprenorphine may interfere with other medications you are taking. Be especially careful about taking other medicines that may make you sleepy, such as pain medicines, tranquilizers, sleeping pills, anxiety medicines or antihistamines.
Is Buprenorphine safe during pregnancy and breastfeeding?
If you are pregnant (or breastfeeding), talk to your doctor or pharmacist before taking buprenorphine.
What to do if you miss a dose?
Take a missed dose as soon as you think about it. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. Do not take 2 doses at the same time or extra doses.
What to do if you overdose?
If you think there has been an overdose, call your doctor, pharmacist, or other health care provider right away.

Contraindications & Cautions

Who should not use Buprenorphine?
Do not use if you are allergic to Buprenorphine or any of the other ingredients of this medicine.
Who should use with caution?
• Before taking Buprenorphine, tell your doctor if you Have a/an: liver or kidney problems, trouble breathing or lung problems, low thyroid (hypothyroidism), enlarged prostate gland, head injury or brain problem, mental problems such as hallucinations (seeing or hearing things that are not there), Addison’s disease, gallbladder or adrenal gland problems.
• Talk to your doctor If you are pregnant or plan to become pregnant. If you take Buprenorphine while pregnant, your baby may have symptoms of opioid withdrawal or respiratory depression at birth.
• Talk to your doctor If you are breastfeeding or plan to breastfeed. Buprenorphine can pass into your milk and may harm your baby. Monitor your baby for increased sleepiness and breathing problems.
• You should not drink alcohol while using Buprenorphine, as this can lead to loss of consciousness or death.
• 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.

Side Effects

What are some side effects of Buprenorphine?
All drugs may cause side effect. However, many people have no side effects or only have minor side effects. Call your doctor or pharmacist if any of these side effects or any other side effects bother you or do not go away.
-Side effects require medical attention as soon as possible:
• Allergic reactions (rash, hives, swelling of the face, wheezing, or loss of blood pressure and consciousness).
• Respiratory problems.
• Decrease in blood pressure. You may feel dizzy if you get up too fast from sitting or lying down.
• Liver problems (yellowing of the skin or white part of the eye, urine turning dark, loss of appetite, abdominal pain)
• Opioid withdrawal (shaking, sweating more than normal, feeling hot or cold more than normal, muscle aches)


-Side effects require medical attention if it persists or worsens:
Nausea/Vomiting, Headache, Sweating, Constipation, Swollen and/or painful tongue, Disturbance in attention, Blurred vision, Irregular heart beat (palpitations), Back pain, Dizziness and Sleepiness.

Storage

How to store Buprenorphine?
• Store below 30°C and keep away from light and moisture.
• Keep out of the reach and sight of children.
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