2 mg / 0.5 mg, 8 mg / 2 mg sublingual
buprenorphine / naloxone
Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.
- Save this information, you may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
- If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.
In this leaflet:
1. What Bunalict is and what it is used for
2. What you need to know before you take Bunalict
3. How to take Bunalict
4. Possible side effects
5. How to store Bunalict
6. Contents of the packaging and other information
1. What Bunalict is and what it is used for
Bunalict is used to treat drug addicts, addicted to opiate drugs (narcotics) such as heroin or morphine, who have given their consent to be treated for their addiction. Bunalict treatment is intended for adults and adolescents over the age of 15 who also receive medical, social, and psychological support.
Buprenorphine and naloxone contained in Bunalict may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
2. What you need to know before taking Bunalict
Do not take Bunalict
- if you are allergic to buprenorphine, naloxone, or any of the other ingredients of this medicine (listed in section 6)
- if you have severe breathing problems
- if you have severe liver problems
- if you are under the influence of alcohol or suffer from tremors, sweating, anxiety, confusion, or hallucinations caused by alcohol
- if you are taking naltrexone or nalmefene for the treatment of alcohol or opiate dependence.
Warnings and cautions
Talk to your doctor before taking Bunalict if you have:
- asthma or other respiratory problems
- a liver disease, e.g. hepatitis
- low blood pressure
- a recent head injury or brain disease
- urinary tract problems (mainly associated with an enlarged prostate in men)
- a kidney disease
- thyroid problems
- adrenocortical disorders (eg Addison’s disease ).
Never open the blister in advance.
Contact an emergency department immediately in case of accidental ingestion or suspected ingestion.
Important things to keep in mind:
- Extra follow your doctor can follow you up more closely if you are under 18 or over 65. People under the age of 15 must not take this medicine.
- Misuse and abuse of this medicine may be desirable for people abusing prescription drugs and should be stored in a safe place to protect against theft. Never give the medicine to anyone else, it could lead to death or injury.
The respiratory problem some people have died of respiratory depression (severe difficulty breathing) due to misuse of this drug or that they took it together with drugs that affect the central nervous system such as. alcohol, benzodiazepines (sedatives), or other opioids.
This medicine can cause severe, possibly fatal respiratory paralysis (difficulty breathing) in children and in people who do not have an addiction and who take the medicine intentionally or unintentionally.
- DependentThis medicine may be addictive.
Withdrawal symptoms This medicine may cause withdrawal symptoms if you take it earlier than 6 hours after using a short-acting opioid (eg morphine or heroin) or earlier than 24 hours after using a long-acting opioid such as methadone.
Bunalict can also cause withdrawal symptoms if you stop taking them suddenly.
- Liver damage has been reported with the use of Bunalict, especially if the medicine is used incorrectly. These liver damages can also be due to viral infections (chronic hepatitis C), alcohol abuse, anorexia or the use of other drugs that can damage the liver (listed in section 4). Doctors may perform regular blood tests to monitor the condition of your liver. Tell your doctor if you have liver problems before starting treatment with Bunalict.
- Blood pressure this medicine may cause your blood pressure to drop rapidly, making you feel dizzy if you get up quickly from a sitting or lying position.
- Diagnosis of unrelated medical conditions this medicine can hide pain which is a sign of certain diseases. Remember to tell your doctor that you are taking this medicine.
Other medicines and Bunalict
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines can aggravate the side effects of Bunalict and in some cases can cause very serious reactions. Do not take any other medicines while you are taking Bunalict without talking to a doctor first, especially:
- Concomitant use of Bunalict and sedatives or medicines for insomnia such as benzodiazepines or similar medicines increases the risk of drowsiness, difficulty breathing ( breathing depression ), coma and can be life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible.
If your doctor prescribes Bunalict at the same time as sedatives, the dose and treatment time should be limited by your doctor. Tell your doctor if you are taking any sedatives and carefully follow your doctor’s dose recommendations. It may be helpful to inform friends or relatives about paying attention to the signs and symptoms described above. Contact a doctor if you experience any of these symptoms.
Other medications that can make you feel sleepy are used to treat illnesses such as anxiety, insomnia, seizures, or pain. These types of medications reduce your alertness, which can make driving vehicles and using machines risky. They can also cause depression of the CNS ( central nervous system ), which is very serious. Below is a list of examples of these types of drugs:
- other opioid-containing medications, e.g. methadone, some painkillers, and antitussives
- antidepressants (used to treat depression), e.g. isocarboxazid, phenelzine, selegiline, tranylcypromine, and valproate, may potentiate the effects of this medicine
- sedative H 1 receptor antagonists (used to treat allergic reactions), e.g. diphenhydramine and chlorphenamine
- barbiturates (used to induce sleep or sedation ), e.g. phenobarbital and secobarbital
- sedatives (used to induce sleep or sedation), e.g. chloral hydrate
- Clonidine (used to treat high blood pressure ) may prolong the effects of this medicine
- Antiretroviral agents (used to treat HIV), e.g. ritonavir, nelfinavir, and indinavir, may prolong the effects of this medicine
- Certain antifungals (used to treat fungal infections), e.g. ketoconazole, itraconazole, and certain antibiotics, may prolong the effects of this medicine
- Some medicines may reduce the effect of Bunalict. They include medicines to treat epilepsy (eg carbamazepine and phenytoin ), as well as medicines to treat tuberculosis (rifampicin).
- Naltrexone and nalmefene (medicines used to treat addiction) may counteract the therapeutic effects of Bunalict. They should not be taken with Bunalict treatment because you may then experience a sudden onset of prolonged and intense withdrawal symptoms.
Bunalict with food, drink, and alcohol
Alcohol may increase drowsiness and increase the risk of respiratory depression if taken with Bunalict. Do not take Bunalict with alcoholic beverages. Do not swallow or consume food or drink of any kind until the travel tablet has completely dissolved.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The risks for pregnant women using Bunalict are not known. Tell your doctor if you are pregnant or planning to become pregnant. Your doctor will decide if you should continue treatment with another medicine.
Drugs such as Bunalict can, if taken during – especially advanced – pregnancy cause withdrawal symptoms and also breathing problems in the newborn baby. These problems can occur several days after birth.
Do not breast-feed while taking this medicine as Bunalict passes into breast milk.
Driving and using machines
Bunalict may cause drowsiness. It can happen more often during the first weeks of treatment when the dose is changed, but it can also happen if you drink alcohol or take other sedatives while taking Bunalict. Do not drive, use tools or machines, or perform dangerous activities until you know how this medicine affects you.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist
Bunalict contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Bunalict contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per travel tablet, ie is essential ‘sodium-free’.
3. How to take Bunalict
The treatment is prescribed and monitored by a doctor with experience in the treatment of drug addiction.
Your doctor will decide which dose is best for you. During your treatment, your doctor may adjust your dose depending on how you react.
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended starting dose for adults and adolescents over the age of 15 is 1-2 Bunalict
2 mg / 0.5 mg resoriblets. An additional 1-2 Bunalict 2 mg / 0.5 mg resoriblets may be administered on the first day, depending on your needs.
Clear signs of abstinence should be obvious before taking the first dose of Bunalict. The doctor’s assessment of how ready you are for treatment determines when you should receive the first dose of one with Bunalict.
- Initial treatment with Bunalict during heroin addiction
If you are addicted to heroin or a short-acting opioid, the first dose of one of Bunalict should be taken when signs of abstinence occur, but not earlier than 6 hours before the last time you used opioids.
- Initial treatment with Bunalict during methadone dependence
If you have taken methadone or a long-acting opioid, the methadone dose should preferably be reduced to less than 30 mg/day before starting treatment with Bunalict. The first dose of Bunalict should be taken when signs of abstinence occur, but not earlier than 24 hours after the last use of methadone.
How to take Bunalict
- Take the dose once a day by placing the resoriblets under the tongue.
- Hold the travel tablet under the tongue until it is completely dissolved. This may take 5-10 minutes.
- Do not chew or swallow the resoriblets. The drug will then not work and it can lead to withdrawal symptoms.
- Do not consume food or drink until the resoriblet has completely dissolved.
How to remove the travel tablet from the package
1 – Do not push the tablet through the foil.
2 – Remove a box of the blister pack by dragging along the perforated line.
3 – Start from the edge where the seal is folded up and pull off the foil on the back to remove the travel tray.
If the blister pack is damaged, discard the travel tablet.
Dose adjustment and maintenance treatment:
During the first days after starting treatment, your doctor may increase the dose ofBunalict according to your needs. If you have the impression that the effect of Bunalict is too strong or too weak, talk to your doctor or pharmacist. The maximum daily dose is 24 mg.
After a period of successful treatment, you can agree with your doctor to gradually reduce the dose to a lower maintenance dose.
End of treatment
Depending on your condition, you can continue to reduce the dose of Bunalict under close medical supervision, until it can be completely discontinued.
Do not change the treatment in any way or discontinue it without the consent of the doctor who gives you the treatment.
If you take more Bunalict than you should
If you or anyone else takes too much of this medicine, you must immediately go to an emergency room or hospital for treatment as an overdose of Bunalict may cause serious and life-threatening breathing problems.
Symptoms of overdose may include feelings of drowsiness and incoherence with slow reflexes, blurred vision, and/or slurred speech. You may have difficulty thinking clearly and your breathing may be much slower than normal.
If you forget to take Bunalict
Tell your doctor as soon as possible if you miss a dose.
If you stop taking Bunalict
Do not change the treatment in any way or discontinue it without the consent of the doctor who gives you the treatment. Sudden discontinuation of treatment may lead to withdrawal symptoms.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately or seek emergency care if you experience side effects, such as:
- swollen face, lips, tongue, or throat that may make it difficult to swallow or breathe, severe hives/rash. This may be a sign of a life-threatening allergic reaction.
- the feeling of drowsiness and clumsiness, foggy vision, slurred speech, difficulty clear thinking, or that breathing becomes much slower than normal.
Also tell your doctor immediately if you experience side effects, such as:
- severe fatigue, or itching with yellowing skin or eyes. It may be a sign of liver damage.
- see or hear things that do not exist (hallucinations).
|Side effects reported for Bunalict|
|Very common (may affect more than 1 user in 10):|
|insomnia (inability to sleep)constipationnauseaheavy sweatingheadachedrug withdrawal syndrome.|
|Common (may affect up to 1 in 10 people):|
|weight lossswelling (hands and feet)drowsinessanxietynervousnessknittingDepressiondecreased sex drivemuscle twitchingabnormal thoughtsincreased tear flow (watery eyes) or other disturbance of tear flowdimsynhot flasheshigh blood pressuremigraineRunny nose sore throat and pain when swallowingincreased coughupset stomach or other stomach upsetdiarrheahepatic impairmentgas formationvomitingrashitchinghivespainjoint painmuscle achesleg crampsimpotenceurinary incontinenceabdominal painback painweaknessinfectionoverindulgechest painfeverflu-like symptomsgeneral malaiseinjury in the event of an accident caused by a reduced level of consciousness or coordinationdullness and dizziness.|
|Uncommon (may affect up to 1 in 100 people):|
|swollen glands ( lymph nodes )agitation, tremorsabnormal dreamsexcessive muscle activitypersonality change (not feeling like yourself)drug dependence, memory lossinterestexcessive sense of well-beingseizuresspeech difficultiessmall pupilsproblems urinatingconjunctivitis of the eyefast or slow heartbeatlow blood pressurepalpitationmyocardial infarctionpressure over the chestshortness of breathasthmayawningpain and sores in the mouthdiscoloration of the tongueacneskin noduleshair lossdry or scaly skinarthritisurinary tract infectionabnormal blood test resultsblood in the urineabnormal ejaculationmenstrual or vaginal problemskidney stoneprotein in the urinepain when urinating or difficulty urinatingsensitivity to heat or coldheatstrokeloss of appetite feelings of hostility.|
|Has been reported (occurs in the unknown number of users):|
|Sudden withdrawal syndrome caused by the Bunalict taken too soon after use of illicit opioid you, drug withdrawal syndrome in newborn.Slow breathing or difficulty breathing, liver problems with or without jaundice, hallucinations, swelling of the face and throat or life-threatening allergic reactions, drop in blood pressure when changing position from sitting or lying to standing.Misuse of the drug by injection may cause withdrawal symptoms, infections , other skin reactions and potentially serious liver problems (see “Warnings and Precautions”).|
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Bunalict
Keep this medicine out of the reach and sight of children and other members of the household.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C. Store in the original package. Sensitive to light. However, Bunalict may be desirable for people who abuse prescription drugs. Store this medicine in a safe place to protect it from theft.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
- The active substances are buprenorphine and naloxone.
Each 2 mg / 0.5 mg sublingual resoriblett contains 2 mg buprenorphine (as hydrochloride) and 0.5 mg naloxone (as hydrochloride dihydrate).
Each 8 mg / 2 mg sublingual resorblett contains 8 mg buprenorphine (as hydrochloride) and 2 mg naloxone (as hydrochloride dihydrate).
- The other ingredients are lactose monohydrate, maize starch, mannitol (E421), povidone K30, anhydrous citric acid, sodium citrate, flavors (lemon and lime), acesulfame potassium, and sodium stearyl fumarate.
What the medicine looks like and the contents of the pack
Bunalict 2 mg / 0.5 mg sublingual resoriblet tablets are white to off-white, round, biconvex uncoated tablets, 6.5 mm in diameter, marked with “N2” on one side and the symbol “↑” on the other side.
Bunalict 8 mg / 2 mg sublingual resoriblet tablets are white to off-white, round, biconvex uncoated tablets, 10.5 mm in diameter, marked with “N8” on one side and the symbol “↑” on the other side.
Packed in child-resistant, removable single-dose blisters of 7×1, 28×1, and 49×1 resoriblet.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
Ethypharm 194, Bureaux de la Colline, Building D, 92213 Saint-Cloud, France
Ethypharm, Chemin de la Poudrière, 76120 Grand Quevilly, France