What is Buprenorphine/Naloxone Sublingual tablet?
Buprenorphine/Naloxone Sublingual Tablet _Manufactured by Faran Shimi Pharmaceutical Company_ is available in two dosage strengths, 2/0.5mg and 8/2mg. 10 tablets are packed in a blister and 10 blisters are packaged in one box with a leaflet.


What is Buprenorphine/Naloxone Sublingual tablet used for?
Buprenorphine/Naloxone is indicated for maintenance 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/Naloxone?
• Always take it exactly as your doctor tells you. Your doctor may change your dose after seeing how it affects you. Do not take it more often than prescribed by your doctor.
• Tablet should be placed under the tongue until dissolved completely. It usually dissolves in your mouth within 5 minutes. If your mouth is dry, take a sip of water to moisten it. Spit out or swallow the water and dry your hands if they are wet before you place tablet(s) under your tongue.
• Do not drink while this drug is dissolving. Talking while the tablet is dissolving can affect how well the medicine in Buprenorphine/Naloxone is absorbed.
• Do not chew or swallow tablet because the medicine will not work as well.
• If more than 1 tablet is required, place the tablets in different places under your tongue at the same time.
• Do not stop taking it suddenly. To have fewer withdrawal symptoms, ask your doctor how to stop using Buprenorphine/Naloxone the right way.
What other drugs could affect Buprenorphine/Naloxone?
Tell your doctor about all the medicines you take, including prescription and over‐the‐counter medicines, vitamins, and herbal supplements.
Buprenorphine/Naloxone 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/Naloxone safe during pregnancy and breastfeeding?
If you are pregnant (or breastfeeding), talk to your doctor or pharmacist before taking Buprenorphine/Naloxone.
What to do if you miss a dose?
If you miss a dose of Buprenorphine/Naloxone, 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.
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/Naloxone?
Do not use if you are allergic to Buprenorphine, Naloxone or any of the other ingredients of this medicine.
Who should use with caution?
• Before taking Buprenorphine/Naloxone, 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/Naloxone while pregnant, your baby may have symptoms of opioid withdrawal 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/Naloxone, 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.
• Do not switch from Buprenorphine/Naloxone to other medicines that contain buprenorphine without talking with your doctor. The amount of buprenorphine in a dose of Buprenorphine/Naloxone is not the same as the amount of buprenorphine in other medicines that contain buprenorphine.

Side Effects

What are some side effects of Buprenorphine/Naloxone?
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. You have a higher risk of death and coma if you take Buprenorphine/Naloxone with other medicines, such as benzodiazepines.
• 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)


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