Buvidal 128 mg prolonged-release solution for injection

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Buvidal is and what it is used for
2. What you need to know before you receive Buvidal
3. How Buvidal is given
4. Possible side effects
5. How to store Buvidal
6. Contents of the pack and other information

• if you are allergic to buprenorphine or any of the other ingredients of this medicine (listed in section 6)
• if you have serious breathing problems
• if you have serious liver problems
• if you are intoxicated with alcohol or have trembling, sweating, anxiety, confusion or hallucinations caused by alcohol

Talk to your doctor before receiving Buvidal if you have:

• seizures, fits or convulsions
• asthma or other breathing problems
• any liver disease such as hepatitis
• severe kidney impairment
• certain heart rhythm conditions (long QT syndrome or prolonged QT interval)
• low blood pressure
• recently suffered a head injury or brain disease
• a urinary disorder (especially linked to enlarged prostate in men)
• thyroid problems
• an adrenocortical disorder (e.g. Addison’s disease)
• gall bladder problems
• depression or other conditions that are treated with antidepressants.
  The use of these medicines together with Buvidal can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Buvidal”).
• if you have ever had an allergic reaction to latex.

Important things to be aware of

• Breathing problems: Some people have died from very slow or shallow breathing caused by taking buprenorphine with other central nervous system depressants (substances that slow down some brain activity) such as benzodiazepines, alcohol or other opioids.
• Drowsiness: This medicine may cause drowsiness especially when used with alcohol or other central nervous system depressants (substances that slow down some brain activity) such as benzodiazepines, other medicines that reduce anxiety or cause sleepiness, pregabalin or gabapentin.
• Dependence: This medicine can cause dependence.
• Liver damage: Liver damage can occur with buprenorphine, especially when it is misused. It can also occur because of viral infections (chronic hepatitis C), alcohol abuse, anorexia (eating disorder) or use of other medicines which harm your liver. Your doctor may ask you to have regular blood tests to check your liver. Tell your doctor if you have any liver problems before you start treatment with Buvidal.
• Withdrawal symptoms: This medicine can cause withdrawal symptoms if you take it less than 6 hours after you use a short-acting opioid (e.g. morphine, heroin) or less than 24 hours after you use a long-acting opioid such as methadone.
• Blood pressure: This medicine may cause your blood pressure to drop suddenly, causing you to feel dizzy if you get up too quickly from sitting or lying down.
• Diagnosis of unrelated medical conditions: This medicine may mask pain and make it difficult to diagnose some diseases. Do not forget to tell your doctor that you are being treated with this medicine.
• Sleep-related breathing disorders: Buvidal can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.

Buvidal is not for use in children below 16 years of age. You will be more closely monitored by your doctor if you are an adolescent (16-17 years old).

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Some medicines may increase the side effects of Buvidal and may cause very serious reactions.

It is especially important to tell your doctor if you are taking:

• benzodiazepines (used to treat anxiety or sleep disorders). Taking too much of a benzodiazepine together with Buvidal may lead to death because both medicines can cause very slow and shallow breathing (respiratory depression). If you need a benzodiazepine, your doctor will prescribe the correct dose.
• gabapentinoids (gabapentin or pregabalin) (used to treat epilepsy or neuropathic pain). Taking too much of a gabapentinoid may lead to death because both medicines can cause very slow and shallow breathing (respiratory depression). You must use the dose that your doctor has prescribed for you.
• alcohol or medicines containing alcohol. Alcohol can worsen the sedative effect of this medicine.
• other medicines that may make you feel sleepy which are used to treat illnesses such as anxiety, sleeplessness, convulsions (fits) and pain. These medicines when taken together with Buvidal can slow down some brain activity and reduce alertness and how well you will drive and use machines.
  Examples of medicines that can make you feel sleepy or less alert include:
  • other opioids such as methadone, certain painkillers and cough medicines. These medicines may also increase the risk of opioid overdose
  • antidepressants (used to treat depression)
  • sedative antihistamines (used to treat allergic reactions)
  • barbiturates (used to cause sleep or sedation)
  • certain anxiolytics (used to treat anxiety disorders)
  • antipsychotics (used to treat psychiatric disorders such as schizophrenia)
  • clonidine (used to treat high blood pressure)
• opioid painkillers. These medicines may not work properly when taken together with Buvidal and they may increase the risk of overdose.
• naltrexone and nalmefene (used to treat addiction disorders) as they can stop Buvidal from working properly. You should not take them at the same time as this medicine.
• certain antiretrovirals (used to treat HIV infection) such as ritonavir, nelfinavir or indinavir as they may increase the effects of this medicine.
• certain antifungal medicines (used to treat fungal infections) such as ketoconazole, itraconazole as they may increase the effects of this medicine.
• macrolide antibiotics (used to treat bacterial infections) such as clarithromycin and erythromycin as they may increase the effects of this medicine.
• certain antiepileptic medicines (used to treat epilepsy) such as phenobarbital, carbamazepine and phenytoin as they may decrease the effect of Buvidal.
• rifampicin (used to treat tuberculosis). Rifampicin may decrease the effect of Buvidal.
• monoamine oxidase inhibitors (used to treat depression) such as phenelzine, isocarboxazid, iponiazid and tranylcypromine as they may increase the effects of this medicine.
• anti-depressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepine, or trimipramine. These medicines may interact with Buvidal and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms.

Do not take alcohol while using Buvidal (see section 2 warnings and precautions). Taking alcohol with this medicine may increase drowsiness and may increase the risk of breathing problems.

If you are pregnant or breast-feeding, think you may become pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine. The risks of using Buvidal in pregnant women are not known. Your doctor will help you decide if you should continue taking the medicine during pregnancy.

Using this medicine during late pregnancy may cause drug withdrawal symptoms including breathing problems in your new-born baby. This may happen from several hours to several days after birth.

Check with your doctor before using Buvidal during breastfeeding as this medicine passes into breast milk.

The medicine can affect your ability to drive as it may make you sleepy or dizzy. This is more likely at the start of treatment and when your dose is being changed. These effects can be worse if you drink alcohol or take other sedative medicines.

• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
  • the medicine has been prescribed to treat a medical or dental problem and
  • you have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
  • it was not affecting your ability to drive safely.

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Buvidal 8 mg, 16 mg, 24 mg and 32 mg contain 95.7 mg of alcohol (ethanol) in each mL (10% w/w). The amount in 1 dose of this medicine is equivalent to less than 2 mL beer or 1 mL wine. The small amount of alcohol in this medicine will not have any noticeable effects.

If you have received more buprenorphine than you should you need to contact your doctor immediately since this can cause very slow and shallow breathing which can lead to death.

If you use too much buprenorphine, you must immediately seek medical attention as overdose may cause serious and life-threatening breathing problems. Symptoms of overdose may include breathing more slowly and weakly, feeling more sleepy than normal, feeling sick, vomiting and/or having slurred speech or difficulty talking. You may also have smaller pupils. If you start to feel faint, this may be a sign of low blood pressure.

It is very important to keep all your appointments to receive Buvidal. If you miss an appointment, ask your doctor when to schedule your next dose.

Do not stop treatment without checking with the doctor who is treating you. Stopping treatment may cause withdrawal symptoms.

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

or search MHRA Yellow Card in the Google Play or Apple App Store

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is buprenorphine
• The other ingredients are soybean phosphatidylcholine, glycerol dioleate, ethanol anhydrous (see section 2 Buvidal contains alcohol) (only in weekly formulation) and N-methylpyrrolidone (only in monthly formulation).

The following syringes are available:

Weekly injection:

8 mg: Pre-filled syringe containing 8 mg buprenorphine in 0.16 mL solution

16 mg: Pre-filled syringe containing 16 mg buprenorphine in 0.32 mL solution

24 mg: Pre-filled syringe containing 24 mg buprenorphine in 0.48 mL solution

32 mg: Pre-filled syringe containing 32 mg buprenorphine in 0.64 mL solution

Monthly injection:

64 mg: Pre-filled syringe containing 64 mg buprenorphine in 0.18 mL solution

96 mg: Pre-filled syringe containing 96 mg buprenorphine in 0.27 mL solution

128 mg: Pre-filled syringe containing 128 mg buprenorphine in 0.36 mL solution

160 mg: Pre-filled syringe containing 160 mg buprenorphine in 0.45 mL solution

Buvidal is a prolonged-release solution for injection. Each pre-filled syringe contains a yellowish to yellow clear liquid.

The following pack sizes are available:

Pre-filled syringes containing 8 mg, 16 mg, 24 mg, 32 mg, 64 mg, 96 mg, 128 mg and 160 mg solution for injection.

Each pack contains 1 pre-filled syringe with stopper, needle, needle shield, safety device and 1 plunger rod.