Suboxone 8 mg/2 mg sublingual tablets

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.

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 SuboxoneMisuse 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.

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.

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.

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 Suboxone contains

• The active substance is buprenorphine and naloxone. Each tablet contains 8 mg buprenorphine as buprenorphine hydrochloride and 2 mg naloxone as naloxone hydrochloride dihydrate.
• The other ingredients are lactose monohydrate, mannitol, maize starch, povidone K30, citric acid anhydrous, sodium citrate, magnesium stearate, acesulfame potassium and natural lemon and lime flavour.

What Suboxone looks like and contents of the pack

Sublingual tablets, white hexagonal biconvex tablets, embossed with a sword logo on one side and ?N8? on the reverse side, packed in packs of 7 and 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
RB Pharmaceuticals Limited
103-105 Bath Road
Slough
Berkshire SL1 3UH
United Kingdom
Tel. + 800 270 81 901

Manufacturer:
Reckitt Benckiser Healthcare (UK) Ltd,
Dansom Lane,
Hull,
East Yorkshire HU8 7DS,
United Kingdom.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien , -------- , -eská republika , Danmark , Deutschland , Eesti , ???-?? , España , France , Ireland , Ísland , Italia , ?-???? , Latvija , Lietuva , Luxembourg/Luxemburg , Magyarország , Malta , Nederland , Norge , Österreich , Polska , Portugal , România , Slovenija , Slovenská republika, Suomi/Finland , Sverige , United Kingdom: Tel. + 800 270 81 901

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