Suboxone 2 mg/0.5 mg sublingual resorbable tablet, 8 mg/2 mg sublingual resorbable tablet, Suboxone 16 mg/4 mg sublingual resorbable tablet
buprenorphine/naloxone
What Suboxone is and what it is used for
Suboxone is used to treat drug addicts who are addicted to opioids (narcotics) such as heroin or morphine, and who have consented to treatment for their addiction.
Suboxone is used for adults and young people over the age of 15 who also receive medical, social, and psychological support.
What you need to know before taking Suboxone
Do not take Suboxone
- 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 to treat alcohol or opiate addiction.
Warnings and precautions
Talk to your doctor before taking Suboxone if you have:
- asthma or other respiratory problems
- problems with the liver, e.g. hepatitis
- low blood pressure
- a recent head injury or brain disease
- problems in the urinary tract (mainly linked to an enlarged prostate in men)
- any kidney disease
- problems with the thyroid gland
- problems with the adrenal glands (eg Addison’s disease )
- depression or other conditions treated with antidepressants. If these medicines are used together with Suboxone, this can lead to serotonin syndrome, a condition that can be life-threatening (see “Other medicines and Suboxone”).
Important to remember:
- Contact the emergency department immediately in case of accidental ingestion or suspected ingestion.
- Extra follow-your doctor may want to monitor you more closely if you are over 65.
- Misuse and abuse this medicine may be desirable for people who abuse prescription medicines and should be kept in a safe place to protect them from theft (see section 5). Do not give this medicine to anyone else. This can lead to death or injury.
- Breathing problems some people have died from respiratory failure (inability to breathe) after misusing buprenorphine or taking it with other substances that affect the central nervous system, such as alcohol, and benzodiazepines (sedatives), or other opioids.
This medicine can cause severe, possibly fatal, respiratory depression (impaired ability to breathe) in children and non-addicted people who accidentally or intentionally take the medicine.
- Sleep-related breathing problems
Suboxone can cause sleep-related breathing problems such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). The symptoms can be breathing pauses during sleep, waking up at night due to shortness of breath, difficulty staying asleep, or pronounced fatigue during the day. Contact the doctor if you or anyone else observes these symptoms. The doctor may consider reducing the dose.
- DependentThis medicine can be addictive.
- Withdrawal symptoms this medicine can cause opioid withdrawal symptoms if you take it too soon after taking your opioid. It must be at least 6 hours after using a short-acting opioid (eg, morphine or heroin) or at least 24 hours after using a long-acting opioid such as methadone.
This medicine can also cause withdrawal symptoms if you suddenly stop taking it. See section 3 “If you stop taking Suboxone”. - Liver damage liver damage has been reported after using Suboxone, especially if the drug is used incorrectly. Liver damage can also be caused by viral infections (eg chronic hepatitis C), alcohol abuse, anorexia, or the use of other drugs that can damage the liver (see section 4). Doctors may take blood tests regularly to check your liver. Tell your doctor if you have any liver problems before starting Suboxone.
- Blood pressure this medicine can cause your blood pressure to drop suddenly, which may make you feel dizzy if you get up quickly from sitting or lying down.
- Diagnosis of unrelated medical conditions this medicine can mask pain symptoms that could facilitate the diagnosis of certain diseases. You must tell the doctor that you are taking this medicine.
Children and young people
Do not give this medicine to children under 15 years of age. If you are between 15 and 18 years old, your doctor may want to monitor you extra closely during treatment as there is no data on this age group.
Other drugs and Suboxone
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Some medications can increase the side effects of Suboxone. These can become serious. Do not take any other medications while taking Suboxone without first talking to your doctor. This applies in particular to:
- Benzodiazepines (used to treat anxiety or sleep disorders), eg diazepam, temazepam, or alprazolam. Using Suboxone at the same time as sedatives such as benzodiazepines or similar drugs can increase the risk of drowsiness, difficulty breathing, and coma, and it can be life-threatening. Concomitant treatment should therefore only be considered if there are no other treatment options. However, if the doctor prescribes Suboxone together with sedative drugs, the doctor should 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, convulsions/seizures, or pain. These types of drugs reduce your alertness and make it more difficult to drive and use machines. They can also lead to central nervous system depression, which is very serious. Below is a list of examples of these types of drugs:
- Other opioid-containing medicines, e.g. methadone, some pain relievers, and cough suppressants.
- Antidepressants (used to treat depression), eg isocarboxazid, phenelzine, selegiline, tranylcypromine, and valproate, may enhance the effects of this drug.
- Attenuating H 1 -receptor antagonists (used to treat allergic reactions), e.g. diphenhydramine and chlorphenamine.
- Barbiturates (used to induce sleep or for sedative effect), e.g. phenobarbital and secobarbital.
- Sedatives (used to induce sleep or for sedative effect), e.g. chloral hydrate.
- 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 Suboxone 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.
- Clonidine (used to treat high blood pressure ) may prolong the effects of this medicine.
- Antiretrovirals (used to treat HIV ), e.g. ritonavir, nelfinavir, and indinavir, may increase the effects of this medicine.
- Some antifungals (used to treat fungal infections), e.g. ketoconazole, itraconazole, and certain antibiotics, may prolong the effects of this drug.
- Some medicines can reduce the effectiveness of Suboxone. These include medicines for the treatment of epilepsy (e.g. carbamazepine and phenytoin ) and medicines for the treatment of tuberculosis (rifampicin).
- Naltrexone and nalmefene (drugs to treat addiction) can counteract the therapeutic effect of Suboxone. They should not be taken at the same time as you are being treated with Suboxone because then you may suddenly suffer long-term and severe withdrawal symptoms.
Suboxone with food, drink, and alcohol
Do not use alcohol while being treated with this medicine. Alcohol can increase drowsiness and increase the risk of respiratory failure if used at the same time as Suboxone. Do not swallow or consume food or drink of any kind until the tablet has completely dissolved.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before taking this medicine. The risks of using Suboxone during pregnancy are not known. The doctor will decide whether the treatment should be continued with another medicine.
If drugs such as Suboxone are taken during pregnancy, especially during the latter part of pregnancy, they can cause withdrawal symptoms and breathing problems in the newborn baby. These problems can occur several days after birth.
Do not breastfeed while taking this medicine because buprenorphine passes into breast milk.
Driving ability and use of machinery
You should not drive, ride a bicycle, use any tools or machinery, or perform dangerous activities until you know how this medicine affects you. Suboxone can cause drowsiness, dizziness, or impaired thinking. This may happen more often during the first few weeks of treatment when the dose is changed, but may also occur if you drink alcohol or take other sedative drugs while taking Suboxone.
Suboxone contains lactose and sodium.
This medicine contains lactose. If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost ‘sodium-free’.
How to take Suboxone
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The treatment is prescribed and supervised by doctors with experience in the treatment of drug addiction.
The doctor will decide which dose is best for you. During your treatment, the doctor may adjust your dose depending on how you respond to the treatment.
Start of treatment
The recommended starting dose for adults and adolescents over 15 years of age is two Suboxone 2 mg/0.5 mg sublingual resorbable tablets.
Dose one can be taken up to three times on day 1, depending on your needs.
You should feel clear signs of withdrawal before taking the first dose of Suboxone. The doctor tells you when it is time to take the first dose.
- Starting Suboxone for heroin addiction
If you are addicted to heroin or a short-acting opioid, take the first dose when you experience withdrawal symptoms, but at least 6 hours must have passed since you last used an opioid.
- Starting Suboxone for methadone addiction
If you have been taking methadone or a long-acting opioid, the methadone dose should preferably be reduced to less than 30 mg/day before Suboxone treatment begins. The first dose of Suboxone should be taken when you experience withdrawal symptoms, but it must have been at least 24 hours since you last used methadone.
How to take Suboxone
- Take one dose once daily by placing the tablets under the tongue.
- Keep the tablets in place under the tongue until they have completely dissolved. This may take 5-10 minutes.
- You must not chew or swallow the tablets. The medicine will then not work and you may experience withdrawal symptoms.
Do not eat or drink anything until the tablets are completely dissolved.
This is how you take the tablet out of the blister pack
1 – Do not push the tablet through the foil.
2 – Simply remove a portion from the blister pack by tearing along the perforation line.
3 – Starting from the edge where the seal lifts, pull the foil back on the back to remove the tablet.
Discard the tablet if the blister pack is damaged.
Dose adjustment and maintenance treatment: During the first days after starting treatment, the doctor may increase the dose of Suboxone to adapt it to your needs. Talk to your doctor or pharmacist if you think the effect of Suboxone is too strong or too weak. The highest daily dose is 24 mg of buprenorphine.
After a period of successful treatment, you can agree with the doctor to gradually reduce the dose to a lower maintenance dose.
If you stop treatment
Depending on your condition, the Suboxone dose may continue to be reduced under close medical supervision, until treatment can be stopped completely.
Do not change the treatment in any way and do not stop it without the consent of the doctor responsible for your treatment.
If you have taken too much Suboxone
If you or someone else takes too much of this medicine, you must see or be taken to an emergency room or hospital for treatment as an overdose of Suboxone can cause serious and life-threatening breathing problems.
Symptoms of overdose may include drowsiness and uncoordinated movements with slow reflexes, blurred vision, and/or slurred speech. You may have difficulty thinking clearly and your breathing may become much slower than normal.
If you forget to take Suboxone
Inform the doctor as soon as possible if you have forgotten a dose.
If you stop taking Suboxone
Do not change the treatment in any way and do not stop it without the consent of the doctor responsible for your treatment. If you stop treatment suddenly, you may experience withdrawal symptoms.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor or seek medical attention right away if you experience side effects, such as:
- swelling of the face, lips, tongue, or throat which may make it difficult to swallow or breathe, or cause severe hives. This could be a sign of a life-threatening allergic reaction.
- sleepiness and uncoordinated movements, blurred vision, slurred speech, difficulty thinking clearly, or breathing much slower than normal.
Also inform your doctor immediately if you experience side effects, such as:
- severe fatigue, or itching with yellowing of the skin or eyes. It could be a sign of liver damage.
- seeing or hearing things that are not there (hallucinations).
| Very common side effects (may affect more than 1 in 10 users): |
| insomnia, constipation, nausea, profuse sweating, headache, and drug withdrawal syndrome. |
| Common side effects (may affect up to 1 in 10 users): |
| weight loss, swollen hands, and feet, drowsiness, worry/anxiety, nervousness, tingling, depression, decreased sex drive, increased muscle tension, abnormal thoughts, increased tear flow (watery eyes) or other disturbance in tear production, blurred vision, flushing, increased blood pressure, migraine, running nose, sore throat and pain when swallowing, increased cough, upset stomach or other stomach problems, diarrhea, abnormal liver function, flatulence, vomiting, skin rash, itching, hives, pain, joint pain, muscle pain, leg cramps, difficulty getting or maintaining an erection, abnormal urine, stomach pain, back pain, weakness, infection, chills, chest pain, fever, flu-like symptoms, general malaise, accidental injury caused by reduced attention or impaired coordination, fainting and dizziness. |
| Uncommon (may affect up to 1 in 100 users): |
| swollen lymph nodes, agitation, tremors, abnormal dreams, excessive muscle activity, depersonalization (not feeling like yourself), drug addiction, memory loss, lack of interest, an exaggerated sense of well-being, seizures, speech problems, small pupils, difficulty urinating, eye inflammation or – infection, fast or slow heartbeat, low blood pressure, heart palpitations, heart attack, chest tightness, shortness of breath, asthma, yawning, mouth problems (sores, blisters, numbness, tingling, swelling or pain), tongue discoloration or pain, acne, lumps in the skin, hair loss, dry or scaly skin, joint inflammation, urinary tract infection, abnormal blood tests, blood in the urine, abnormal ejaculation, menstrual or vaginal problems, kidney stones, protein in the urine, pain when urinating or difficulty urinating, sensitivity to heat or cold, heat stroke, loss of appetite, feeling hostile. |
| Has been reported (occurring in an unknown number of users): |
| sudden withdrawal syndrome caused by taking Suboxone too soon after using illicit opioids, drug withdrawal syndrome in newborns, slow breathing or difficulty breathing, liver damage with or without jaundice, hallucinations, swelling of the face or throat, or life-threatening allergic reactions, drops in blood pressure that causes dizziness when changed position from sitting or lying down to standing. |
Misuse by injection of the drug can cause withdrawal symptoms, infection, other skin reactions, and potentially serious liver problems (see “Warnings and precautions”).
How to store Suboxone
Keep this medicine out of the sight and reach of children and other members of the household.
Use before the expiry date stated on the carton. The expiration date is the last day of the specified month.
No special storage instructions. However, Suboxone may be desirable for people who abuse prescription drugs. Keep this medicine in a safe place to protect it from theft.
Keep the blister pack in a safe place.
Never open the blister pack in advance.
Do not take the medicine in front of children.
Contact the emergency department immediately in case of accidental ingestion or suspected ingestion.
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. Each 2 mg/0.5 mg sublingual resorbable tablet contains 2 mg buprenorphine (as hydrochloride) and 0.5 mg naloxone (as hydrochloride dihydrate). Each 8 mg/2 mg sublingual resorbable tablet contains 8 mg buprenorphine (as hydrochloride) and 2 mg naloxone (as hydrochloride dihydrate). Each 16 mg/4 mg sublingual resorbable tablet contains 16 mg buprenorphine (as hydrochloride) and 4 mg naloxone (as hydrochloride dihydrate).
- Other ingredients are lactose monohydrate, mannitol, corn starch, povidone K 30, anhydrous citric acid, sodium citrate, magnesium stearate, acesulfame potassium, and natural flavoring from lemon and lime.
Appearance and package sizes of the medicine
Suboxone 2 mg/0.5 mg sublingual resorbable tablet is a white hexagonal biconvex tablet of 6.5 mm marked with “N2” on one side.
Suboxone 8 mg/2 mg sublingual resorbable is a white hexagonal biconvex tablet of 11 mm marked with “N8” on one side.
Suboxone 16 mg/4 mg sublingual resorbable tablet is a white round biconvex tablet of 10.5 mm marked with “N16” on one side.
Packaged in packs of 7 and 28 packs.
Not all pack sizes may be marketed.
Indivior Europe Limited
27 Windsor Place
Dublin 2
D02 DK44
Ireland
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