Suboxone 2 mg/0.5 mg sublingual tablets

 

What is it and how is it used?

Medicinal product used in opioid dependence.

Suboxone is part of a medical, social and psychological treatment programme for patients addicted to opiate (narcotic) drugs. Treatment is prescribed and monitored by physicians who are specialists in the treatment of drug dependence.

Treatment with Suboxone sublingual tablets is intended for use in adults and adolescents over 15 years of age.

What do you have to consider before using it?

Do not take Suboxone

  • if you are allergic (hypersensitive) to buprenorphine, naloxone or any of the other ingredients of Suboxone,
  • if you have serious breathing problems,
  • if you have serious problems with your liver,
  • if you are intoxicated due to alcohol or have delirium tremens.

Take special care with Suboxone Misuse and abuse
Some people have died from respiratory failure (inability to breathe) because they misused buprenorphine or took it in combination with other Central Nervous System depressants, such as alcohol, benzodiazepines (tranquilisers), or other opioids.

Cases of acute hepatic injury (liver problems) have been reported in a context of misuse, especially by intravenous route and at a high dose. These injuries could be due to special conditions as viral infections (chronic C hepatitis), alcohol abuse, anorexia, or medicines association (for example: antiretroviral nucleoside analogues, acetylsalicylic acid (aspirin), amiodarone, isoniazid, valproate). If you have symptoms of severe fatigue, itching, or if your skin or eyes look yellow, tell your doctor immediately, so that you can receive the proper treatment.

This product can cause withdrawal symptoms if you take it less than six hours after you use a narcotic (e.g. morphine, heroin) or less than 24 hours after you use methadone.

This product can cause sleepiness which may be increased by alcohol or anti-anxiety medicines.

Advise your physician in case of:

  • recent head injury or brain disease,
  • decrease of blood pressure,
  • in men: urinary disorders (especially linked to enlarged prostate).

This medicinal product may mask pain reflecting some diseases. Do not forget to advise your physician if you take this medicine.

This product may cause your blood pressure to drop suddenly, causing you to feel dizzy if you get up too quickly from sitting or lying down.

This product can cause dependence.

Athletes should be aware that this medicine, due to its active substance, may cause a positive reaction to “anti-doping tests”.

Advise your physician in case of:

  • asthma or other breathing problems,
  • kidney disease,
  • liver disease.

Using other medicines
Using other medicines may increase the undesirable effects of buprenorphine and use of these medicines must be carefully monitored:

  • tranquilizers
  • anti-anxiety medicines
  • anti-depressants
  • benzodiazepines
  • some medicines used to treat high blood pressure.

If your physician prescribes benzodiazepines, you must not take more than the prescribed dose. Taking this product with benzodiazepines (medicines used to treat anxiety or sleep disorders) may cause death due to respiratory failure.

The following medicines may increase the buprenorphine blood concentrations, so concomitant use of these medicines together with Suboxone should be closely monitored and could require in some cases a dose reduction by your doctor:

  • anti-retrovirals (ritonavir, nelfinavir, indinavir)
  • ketoconazole
  • itraconazole

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Using Suboxone with food and drink
Do not take Suboxone together with alcoholic beverages as alcohol may possibly increase drowsiness induced by Suboxone.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.

You should not use Suboxone during pregnancy. Tell your doctor if you are pregnant or intend to become pregnant. He will decide if your treatment should be continued with an alternative medication.

Since this product will pass into your milk and may adversely affect the breast-fed child, you should discontinue breast-feeding while taking Suboxone.

Driving and using machines
Suboxone may cause drowsiness. If you feel tired, do not drive a motor vehicle or operate machinery.

Important information about some of the ingredients of Suboxone
Suboxone contains lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

How is it used?

Sublingual route is the only efficacious administration route for this product. Do not swallow the tablets.

Keep the tablet dose under your tongue until it dissolves. This may take 5-10 minutes.

Take the dose once a day.

Your doctor will determine the best dose for you. During your treatment, the doctor may adjust the dose, depending upon your response. To get the greatest benefit from taking Suboxone, you must tell your doctor about all the medicines you are taking, including alcohol, medicines containing alcohol, street drugs, and any prescription medicine you are taking that have not been prescribed to you by your doctor.

After the first dose of Suboxone, it is possible that you may have some opiate withdrawal symptoms, see section 4 ‘POSSIBLE SIDE EFFECTS’.

Treatment duration The length of treatment will be determined individually by your doctor.
After a time of successful treatment, the doctor may reduce the dose gradually to a lower maintenance dose. Depending on your condition, the Suboxone dose may continue to be reduced under careful medical supervision, until eventually it may be stopped.
Do not change the treatment in any way or stop treatment without the agreement of the doctor who is treating you.

The effectiveness of this treatment depends:

  • on the dose,
  • in combination with the associated medical, psychological and social treatment.

If you have the impression that the effect of Suboxone is too strong or too weak, talk to your doctor or pharmacist.

If you use more Suboxone than you should
In case of overdose of buprenorphine, you must go or be taken immediately to an emergency centre or hospital for treatment.
Advise immediately your doctor or your pharmacist.

If you forget to use Suboxone
Contact your doctor.

If you stop using Suboxone

Stopping treatment suddenly may cause withdrawal symptoms.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

What are possible side effects?

Like all medicines, Suboxone can cause side effects, although not everybody gets them.

After the first dose of Suboxone, you may have some opiate withdrawal symptoms, see section 3 ‘HOW TO TAKE SUBOXONE’.

Very common side effects (occurring in at least 1 in 10 patients) that may occur with Suboxone are: insomnia, constipation, nausea, sweating, headache, withdrawal syndrome.

Common side effects (occurring in at least 1 in 100 patients) that may occur during treatment with Suboxone are: weight loss, swelling (hands and feet), tiredness, drowsiness, anxiety, nervousness, tingling, depression, decreased sexual drive, muscle spasms, abnormal thinking, tearing disorder, blurred vision, flushing, increased blood pressure, migraines, runny nose, sore throat and painful swallowing, increased cough, upset stomach, diarrhoea, abnormal liver function, loss of appetite, flatulence, vomiting, rash, itching, hives, pain, joint pain, muscle pain, leg cramps, impotence, urine abnormality, abdominal pain, back pain, weakness, infection, chills, chest pain, fever, flu syndrome, feeling of general discomfort, accidental injury, faintness and dizziness, drop in blood pressure on changing position from sitting or lying down to standing.

Uncommon side effects (occurring in at least 1 in 1,000 patients) with Suboxone are: swollen glands (lymph nodes), agitation, tremor, abnormal dream, excessive muscle activity, depersonalization (not feeling like yourself), medicine dependence, amnesia (memory disturbance), loss of interest, exaggerated feeling of well being, convulsion (fits), speech disorder, small pupil size, problems with urination, conjunctivitis, rapid or slow heart beat, low blood pressure, palpitations, myocardial infarction (heart attack), shortness of breath, asthma, yawning, pain and sores in mouth, tongue discolouration, acne, skin nodule, hair loss, dry or scaling skin, inflammation of joints, urinary tract infection, blood in urine, abnormal ejaculation, menstrual or vaginal problems, kidney stone, sensitivity to heat or cold, allergic reaction, feelings of hostility.

Rarely (occurring in at least 1 in 10,000 patients), the following have occurred with buprenorphine alone:

  • respiratory depression (severe difficulty in breathing) - see “Take special care with Suboxone”,
  • liver problems with or without jaundice- see “Take special care with Suboxone”,
  • hallucinations.

Misusing this medicine by injecting it can cause withdrawal symptoms, infections, other skin reactions and potentially serious liver problems - see “Take special care with Suboxone”.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

Do not use Suboxone after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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.

What is it?

Suboxone is a medicine that contains two active substances, buprenorphine and naloxone. It is available aswhite, hexagonal, sublingual tabletscontainingeither 2mg buprenorphine and 0.5mg naloxone, or 8mg buprenorphine and 2mg naloxone.‘Sublingual’means that the tablet isplaced under the tongue where itdissolves.

What is it used for?

Suboxone is used to treat dependenceon opioid(narcotic) drugssuch as heroin or morphineindrug addicts who have agreed to be treated for their addiction.Suboxone is used in adults and children over 15years of age, who are also receiving medical, social and psychological support.

The medicine can only be obtained by‘special’prescription.This means that because the medicine can be misused or cause addiction, it is used under stricter conditions than normal.

How is it used?

Suboxone must be used under the supervision of a doctor who has experience in the management of opioid addiction. It is recommended that the patient’s liver be checked before starting treatment withSuboxoneandshould also be monitoredregularly during treatment. The way Suboxone is used depends on the patient’s status: type of addiction, state of withdrawal, and whether the patient is already using another substitution treatment such as methadone before starting Suboxone.

The tablets must never be swallowed but shouldbe placed under the tongue and allowed to dissolve, whichusuallytakesfiveto 10 minutes.The recommended starting dose is one or two tablets of Suboxone 2mg/0.5mg. The doctor may increasethe dose depending on the patient’s responsebut thedaily dose should not be higher than 24mg buprenorphine. Once the patient has been stabilised, themaintenancedose may be reduced gradually and eventually treatment may be stopped.

The effectiveness of Suboxonetreatment depends on the patientalso receiving other medical, social and psychological support. For full details, see the summary of product characteristics (also part of the EPAR).

How does it work?

Suboxone contains two active substances:buprenorphine, a partial opioid agonist (it acts like an opioid drug), and naloxone, an opioid antagonists (it counteracts the effects of opioid drugs).

Sublingual tabletscontaining Buprenorphinealonehavebeen available in the EUsince the mid-1990’s for thetreatment ofopioid addiction. However, Buprenorphine tablets have beenmisusedby drug addicts whodissolvethe tabletsandinjectthemselves withthe resulting solution. The addition of naloxone helps prevent the misuse of the medicine. This is because, when injected, naloxone counteracts the effects of opioids,causingthe patient to experience acute withdrawal symptoms.

How has it been studied?

Onemain study compared Suboxone withbuprenorphine on its own or withplacebo (a dummy treatment) in 326 heroin-dependent patientsfor fourweeks, and measured the percentage of patients who had no trace of opioids in their urine at the end of the study. Patients also used a specially designed questionnaire to record their cravings, and the change in the questionnaire score before and at the end ofthe study was measured.

What benefits has it shown during the studies?

Suboxone was as effective as buprenorphine on its own and more effective than placebo: 17.8% of the patients who received Suboxone had a urine sample that tested negative at the end of the study, compared with5.8% of thepatients receiving placebo. The craving score, which was between 62.4 and 65.6 before treatment, decreasedat the end of the study to 29.8 with Suboxone,compared with 55.1 with placebo.

What is the risk associated?

The most common sideeffects with Suboxone (seen in more than 1 patient in 10) are insomnia (difficulty sleeping), constipation, nausea (feeling sick), sweating, headache and withdrawal syndrome. For the full list of all side effects reported with Suboxone, see the package leaflet.

Suboxone should not be used in people who may be hypersensitive (allergic) to buprenorphine or naloxone, or to any of the other ingredients. It mustnot be used in patients with severe respiratoryinsufficiency(difficulty breathing) orsevere liverproblems. It must also not be used in patients with acute alcohol intoxication (excessive alcohol consumption)or delirium tremens(a condition causedby alcohol withdrawal).

Why has it been approved?

The CHMP notedthat the combination of an opioid analogue with an opioid antagonist is an established strategy for reducing the potential misuseof the medicine. The Committee decided that Suboxone’s benefits are greater than its risks and recommended that itbe given marketing authorisation.

How has it been studied?

The company that makesSuboxone will providedoctors and pharmacistswith educational materials informing them of the risk of misuse, and reminding them to report specific side effectssuch as liver problemsand effectson newborns.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Suboxone on 26 September 2006.The marketing authorisation holder is RB Pharmaceuticals Limited.The marketing authorisation is valid for five years, after which it can be renewed. europa.eu/Find medicine/Human medicines/European Public Assessment ReportsFor more information about treatmentwith Suboxone, read the package leaflet (also part of the EPAR)or contact your doctor or pharmacist.

This summary was last updated in 09-2010.