0.7 mg/0.18 mg, 1.4 mg/0.36 mg, 2.9 mg/0.71 mg, 5.7 mg/1.4 mg, 8.6 mg/2.1 mg and 11.4 mg/2.9 mg sublingual resorbable tablets
buprenorphine/naloxone
What Zubsolv is and what it is used for
Zubsolv contains the active substances buprenorphine and naloxone. Zubsolv is used to treat drug addicts who are dependent on opioid drugs (narcotics), such as heroin or morphine, who have consented to treatment for their addiction. Treatment with Zubsolv is intended for adults and adolescents over 15 years of age, who also receive medical, social, and psychological support.
How Zubsolv works
The resoriblet contains buprenorphine which provides the therapeutic effect of opioid (narcotic) addiction. It also contains naloxone, which is used to prevent intravenous abuse of the product.
What you need to know before taking Zubsolv
Do not take Zubsolv if you:
- are allergic to buprenorphine, naloxone, or any of the other ingredients of this medicine (listed in section 6)
- have serious breathing problems
- have serious liver problems
- is intoxicated by alcohol or has tremors, sweating, anxiety, confusion, or hallucinations caused by alcohol
- taking naltrexone or nalmefene to treat alcohol or opioid dependence.
Warnings and precautions
- Abuse and misuse
If Zubsolv is used incorrectly, e.g. by injection into a vein ( intravenous use), serious cases of infection with a potentially fatal outcome can occur.
This drug may be desirable for people who abuse prescription drugs and should be kept in a safe place to protect it from theft. Do not give this medicine to anyone else. It can cause death or otherwise injure them.
- Breathing problems (see also “Do not take Zubsolv” above)
Some people have died from respiratory depression (severe difficulty breathing) due to misuse of this drug or taking it in combination with other agents that cause central nervous system depression, such as alcohol, benzodiazepines (tranquilizers), or other opioids.
This medicine should be used with caution in patients who have breathing problems.
This medicine can cause serious, possibly life-threatening, respiratory paralysis (impaired ability to breathe) in children and people who do not have an opioid addiction.
- Drowsiness
This medicine may cause drowsiness, especially when taken with alcohol or other medicines that cause depression of the central nervous system (such as sedatives, or sleeping pills).
- Dependent
This medicine can be addictive.
- Liver damage
Liver damage has been reported in connection with the use of buprenorphine/naloxone, especially when the drug has been 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. Regular blood tests may be performed by your doctor to monitor your liver condition. Tell your doctor if you have any liver problems before starting treatment with Zubsolv.
- Withdrawal symptoms
This medicine may cause withdrawal symptoms if you take it sooner than six hours after using a short-acting opioid (eg, morphine, or heroin) or sooner than 24 hours after using a long-acting opioid such as methadone.
Zubsolv can also cause withdrawal symptoms if you suddenly stop taking it.
- Blood pressure
This medicine can cause your blood pressure to drop suddenly, causing you to feel dizzy if you get up quickly from a sitting or lying position.
- Sleep-related breathing problems
Zubsolv can cause sleep-related breathing problems such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxia (low oxygen levels in the blood). Symptoms may include breathing pauses during sleep, waking up at night due to shortness of breath, difficulty staying asleep, or excessive fatigue during the day. Contact your doctor if you or anyone else observes these symptoms. Your doctor may consider reducing the dose.
- Children and young people
The doctor may monitor you more closely if you are under 18 years of age. This medicine must not be taken by people under 15 years of age.
- Diagnosis of unrelated medical conditions
This medicine can mask pain symptoms that are signs of certain diseases. Remember to inform the doctor that you are taking this medicine.
Talk to your doctor before taking Zubsolv if you:
- have depression or other conditions treated with antidepressants. If these medicines are used together with Zubsolv, this can lead to serotonin syndrome, a condition that can be life-threatening (see “Other medicines and Zubsolv”).
- have kidney problems
- have recently suffered a head injury or brain disease
- have low blood pressure, an enlarged prostate gland, or difficulty urinating due to a narrowing of the urethra
- have an underactive thyroid which can cause fatigue or weight gain
- have impaired adrenal function (e.g. Addison’s disease )
- have problems with the bile ducts (e.g. gallbladder, bile duct)
- are older
- have a physical or mental weakness.
Other medicines and Zubsolv
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Certain medicines can increase the side effects of Zubsolv and in some cases can cause very serious reactions. Do not take other medicines while taking Zubsolv without first talking to your doctor, especially:
- antidepressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin, or trimipramine. These medicines can affect or be affected by Zubsolv and you may have symptoms such as involuntary rhythmic muscle twitching, including in the muscles that control eye movements, agitation, hallucinations, coma, profuse sweating, tremors, increased reflexes, tense muscles and body temperature above 38°C. Contact the doctor if you experience such symptoms.
- Naltrexone and nalmefene (drugs for the treatment of addiction), as may counteract the therapeutic effects of Zubsolv. They must not be taken together with Zubsolv treatment as you may experience a sudden onset of prolonged and intense withdrawal symptoms.
- Benzodiazepines (used to treat anxiety or sleep disorders) such as diazepam, temazepam, and alprazolam. If you use Zubsolv at the same time as sedatives such as benzodiazepines or similar medicines, it can increase the risk of drowsiness, difficulty breathing ( respiratory depression ), and coma, and it can be life-threatening. Concurrent treatment should therefore only be considered if there are no other treatment options. However, if the doctor prescribes Zubsolv together with sedative drugs, the doctor must limit the dose of one and the duration of treatment of the other drug. Inform the doctor about all sedatives you are taking and follow the doctor’s prescription very carefully. It may be helpful to inform family and friends that they should be aware of the signs and symptoms described above. Contact the doctor if you experience any such symptoms.
- Other medicines that can make you feel sleepy are used to treat conditions such as anxiety, insomnia, seizures/fits, pain, and other mental health conditions. These types of drugs reduce your level of alertness, which can make driving and operating machinery risky. They can also cause impairment of the central nervous system, which is very serious. Below is a list of examples of these types of drugs:
- other medicines that contain opioids, such as methadone, some painkillers, or cough suppressants
- certain antidepressants (used to treat depression) such as isocarboxazid, phenelzine, selegiline, tranylcypromine, valproate and monoamine oxidase inhibitors ( MAOIs ) may increase the effect of this medicine
- sedative HI receptor antagonists (used to treat allergic reactions) such as diphenhydramine and chlorphenamine
- barbiturates (used to induce sleep or provide a sedative effect) such as phenobarbital and secobarbital
- sedative medicines (used to induce sleep or have a sedative effect) such as chloral hydrate
- clonidine (used to treat high blood pressure ) and related medicines may prolong the effects of this medicine
- antiretroviral medicines (used to treat HIV ) such as ritonavir, nelfinavir, and indinavir, may prolong the effect of this medicine
- certain antifungal medicines (used to treat fungal infections) such as ketoconazole, itraconazole and some antibiotics may prolong the effects of this medicine
- some medicines can reduce the effect of Zubsolv. These include drugs for the treatment of epilepsy (e.g. carbamazepine and phenytoin ), and drugs for the treatment of tuberculosis (rifampicin).
Zubsolv with food, drink, and alcohol
Alcohol can increase drowsiness and increase the risk of respiratory depression if used together with Zubsolv. Do not take Zubsolv with alcohol. Do not swallow or consume food or drink of any kind until the resorbable has completely dissolved.
Pregnancy and breastfeeding
The risks for pregnant women using Zubsolv are not known. Inform the doctor if you are pregnant or plan to become pregnant. The doctor will decide if your treatment should be continued with another medicine.
If medicines such as Zubsolv are taken during pregnancy, especially during advanced pregnancy, they can cause withdrawal symptoms and also breathing problems in the newborn baby. These problems can occur several days after birth.
Do not breastfeed while taking this medicine, as Zubsolv passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving ability and use of machinery
Zubsolv may cause drowsiness. It may happen more often in the first few weeks of treatment when your dose is changed, but it can also happen if you drink alcohol or take other sedatives while taking Zubsolv. Do not drive, use tools or machines, or do dangerous activities until you know how this medicine affects you.
Zubsolv contains Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is almost “sodium-free”.
How to take Zubsolv
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Your treatment is prescribed and supervised by doctors experienced in drug addiction treatment.
The doctor will decide which dose is best for you. During your treatment, the doctor may adjust the dose depending on how you react.
Initial treatment
The recommended starting dose for adults and adolescents over 15 years of age is:
- one recordable tablet of Zubsolv 1.4 mg/0.36 mg every day or
- one recordable tablet of Zubsolv 2.9 mg/0.71 mg every day.
An additional resotriplet of Zubsolv 1.4 mg/0.36 mg or 2.9 mg/0.71 mg may be given on day 1, depending on your need.
There are other strengths available for use. The doctor will decide which treatment is best for you. This may mean that you may take a combination of different strengths, but your daily dose should not exceed 17.2 mg of buprenorphine.
Clear signs of withdrawal should be evident before taking the first dose of Zubsolv. The doctor’s assessment of how ready you are for treatment determines when you should receive the first dose of Zubsolv.
- Initial treatment with Zubsolv during heroin addiction:
If you are addicted to heroin or a short-acting opioid, your first dose of Zubsolv should be taken when signs of withdrawal appear, but no earlier than 6 hours after you last used the opioid. - Initial treatment with Zubsolv during methadone dependence:
If you have taken methadone or a long-acting opioid, the dose of methadone should preferably be reduced to below 30 mg/day before starting treatment with Zubsolv. The first dose of Zubsolv is taken when signs of withdrawal appear, but no earlier than 24 hours after you last used methadone.
How to take Zubsolv
- Take one dose once a day or as recommended by your doctor.
- Remove the travel tickets from the blister as described below. Only open the blister just before you are about to take dose one. Never open the blister in advance because the resorbable is sensitive to moisture.
- Place the resoriblets under the tongue.
- Keep the recordable tablets in place under the tongue until they are completely dissolved.
- You must not chew or swallow the travel tickets. The medicine will then not work, and this can lead to withdrawal symptoms.
- You may not eat or drink anything until the resoriblets have completely dissolved. Although you may notice that most of the resorbable tablet dissolves within 40 seconds, it may take 5 to 10 minutes for the entire resorbable tablet to disappear from your mouth.
Do this to remove the travel ticket from the blister card
Dose adjustment and maintenance treatment
The doctor may increase the dose of Zubsolv according to your needs. Talk to the doctor or pharmacist if you think the effect of Zubsolv is too strong or too weak. The maximum daily dose is 17.2 mg.
After a period of successful treatment, you can agree with the doctor to gradually reduce the dose to a lower maintenance dose.
End of treatment
Do not change the treatment in any way, and do not stop the treatment without the consent of the doctor treating you.
Beroende på ditt tillstånd, kan man fortsätta att minska dosen av Zubsolv under noggrann medicinsk övervakning, tills den eventuellt kan avslutas helt.
Om du har tagit för stor mängd av Zubsolv
Om du eller någon annan tar för stor mängd av detta läkemedel, måste du omedelbart ta dig till eller tas till en akutmottagning eller sjukhus för behandling, eftersom överdosering med Zubsolv kan orsaka allvarliga och livshotande andningsproblem.
Symptom på överdosering kan inkludera långsammare och svagare andning än normalt, att du känner dig mer sömnig än normalt, minskning av pupillernas storlek, lågt blodtryck, sjukdomskänsla, kräkningar och/eller sluddrigt tal.
Om du har glömt att ta Zubsolv
Berätta för läkaren så snart som möjligt om du missar en dos.
Om du slutar att ta Zubsolv
Ändra inte behandlingen på något sätt och avbryt inte behandlingen utan samtycke från den läkare som behandlar dig. Plötsligt avbrytande av behandlingen kan leda till abstinenssymptom.
Om du har ytterligare frågor om detta läkemedel, kontakta läkare eller apotekspersonal.
Eventuella biverkningar
Liksom alla läkemedel kan detta läkemedel orsaka biverkningar, men alla användare behöver inte få dem.
Meddela genast läkare eller sök akutvård om du upplever biverkningar såsom:
- uppsvällt ansikte, läppar, tunga eller hals, som kan göra det svårt att svälja eller andas, allvarliga utslag/nässelutslag. Dessa kan vara tecken på en livshotande allergisk reaktion
- känsla av sömnighet och klumpighet, dimsyn, sluddrigt tal, svårigheter att tänka klart eller att andningen blir mycket långsammare än vad som är normalt för dig
- svår trötthet, klåda med gulfärgning av hud eller ögon. Dessa kan vara symptom på leverskada.
- att man ser eller hör saker som inte finns (hallucinationer).
Andra biverkningar
Mycket vanliga (kan förekomma hos fler än 1 av 10 användare):
- sömnlöshet (oförmåga att sova)
- huvudvärk
- förstoppning, illamående
- kraftig svettning
- drogabstinenssyndrom.
Vanliga (kan förekomma hos upp till 1 av 10 användare):
- influensaliknande symptom, infektion, halsont och ont att svälja, rinnande näsa
- ångest, depression, minskad sexlust, nervositet, onormala tankar
- migrän, yrsel, svimning, ökade muskelspänningar, stickande känsla i huden, dåsighet
- ökat tårflöde (rinnande ögon) eller annan rubbning i tårflödet, dimsyn
- förhöjt blodtryck, värmevallningar
- ökad hosta
- magsmärta, orolig mage eller andra magbesvär, diarré, gaser, kräkningar.
- utslag, klåda, nässelutslag
- ryggvärk, ledvärk, muskelsmärta, benkramper (muskelspasmer)
- urinbesvär
- svårigheter att få eller behålla en erektion
- svaghet, bröstsmärta, frossa, feber, känsla av allmänt obehag, smärta, svullnad (händer och fötter)
- onormal leverfunktion, viktminskning
- skada vid olycksfall på grund av sänkt medvetandegrad eller koordination.
Mindre vanliga (kan förekomma hos upp till 1 av 100 användare):
- avvikande blodprover, svullna körtlar (lymfknutor)
- onormala drömmar, upprördhet (agitation), ointresse, personlighetsförändring (inte känna sig som sig själv), läkemedelsberoende, överdriven känsla av välbefinnande, känslor av fientlighet
- minnesförlust(minnesstörning), krampanfall, talsvårigheter, darrningar
- ögoninflammation eller ögoninfektion, liten pupillstorlek
- fast or slow heartbeats, myocardial infarction (heart attack), palpitations, tightness in the chest
- low blood pressure
- asthma , shortness of breath, yawning
- pain and sores in the mouth, discoloration of the tongue
- acne , hair loss, dry or scaly skin, skin lump
- arthritis
- protein in the urine, urinary tract infection, difficulty urinating, pain when you urinate, blood in the urine, kidney stones
- menstrual or vaginal problems, abnormal ejaculation (semen depletion)
- sensitivity to heat or cold
- heatstroke.
Has been reported (occurring in an unknown number of users):
- deterioration of brain function, which is a serious complication of liver disease
- feeling that everything is spinning
- drop in blood pressure when changing position from sitting or lying to standing
- sudden withdrawal syndrome caused by taking the medicine too soon after using illicit opioids, and drug withdrawal syndrome in newborns.
Misuse of this medicine by injection can cause withdrawal symptoms, infection, other skin reactions, and potentially serious liver problems (see section 2, Warnings and precautions).
How to store Zubsolv
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and blister after “EXP”. The expiration date is the last day of the specified month.
Store at a maximum of 25°C.
Store in the original packaging. Moisture sensitive.
Zubsolv can be demanding for people who abuse prescription drugs. Keep this medicine in a safe place to protect it from theft.
Keep the blister safe.
Never open the blister beforehand.
Do not take this medicine in front of children.
In case of accidental ingestion or suspected ingestion, an emergency department must be contacted immediately.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substances are buprenorphine and naloxone.
One 0.7 mg/0.18 mg sublingual resorbable tablet contains 0.7 mg buprenorphine (as hydrochloride) and 0.18 mg naloxone (as hydrochloride dihydrate).
One 1.4 mg/0.36 mg sublingual resorbable tablet contains 1.4 mg buprenorphine (as hydrochloride) and 0.36 mg naloxone (as hydrochloride dihydrate).
One 2.9 mg/0.71 mg sublingual resorbable tablet contains 2.9 mg buprenorphine (as hydrochloride) and 0.71 mg naloxone (as hydrochloride dihydrate).
One 5.7 mg/1.4 mg sublingual resorbable tablet contains 5.7 mg buprenorphine (as hydrochloride) and 1.4 mg naloxone (as hydrochloride dihydrate).
One 8.6 mg/2.1 mg sublingual resorbable tablet contains 8.6 mg buprenorphine (as hydrochloride) and 2.1 mg naloxone (as hydrochloride dihydrate).
One 11.4 mg/2.9 mg sublingual resorbable tablet contains 11.4 mg buprenorphine (as hydrochloride) and 2.9 mg naloxone (as hydrochloride dihydrate).
Other ingredients are mannitol, citric acid, sodium citrate, microcrystalline cellulose, croscarmellose sodium, sucralose, levomenthol, colloidal anhydrous silica, and sodium stearyl fumarate (see section 2 “Zubsolv contains sodium”).
Appearance and package sizes of the medicine
Zubsolv is available in six different strengths, distinguished by its shape and embossing:
Zubsolv is available in blisters with 7, 28, or 30 resorbable tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare SLU
World Trade Center, Moll de Barcelona, s/n
Edifici Est 6ª planta
08039 Barcelona
Spain