5mm 80mm 10mm 75mm 5mm 5mm 75mm 10mm 80mm 5mm

flOWTO^TORESUBUTEJC

As with all medicines, keep out of the isight and reach of children. iThe tablets should be stored below 30°C in the original package.

,Do not use after the date which is ptamped on the pack.

6. FURTHER INFORMATION -What Subutex contains

The active substance is buprenorphine '(as buprenorphine hydrochloride).

'Each sublingual tablet contains 0.4mg, '2mg or 8mg of buprenorphine.

The other ingredients are monohydrated ilactose, mannitol, maize starch, ipovidone K30, citric acid, magnesium stearate and sodium citrate.

What Subutex looks like and contents of the pack

iSubutex 0.4mg sublingual tablets are luncoated oval white tablets of 8 mm x 4 mm, debossed with "04" on one side. 'Subutex 2mg sublingual tablets are 'uncoated oval white tablets of 10 mm x '5 mm, debossed with "B2" on one side. 'Subutex 8mg sublingual tablets are Xi rrcoated oval white tabtet5T>f14mmx“ 7 mm, debossed with "B8" on one side. The sublingual tablets come in blister 'packs containing either 7 or 28 tablets. Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Indivior UK Limited 103-105 Bath Road

plough---------------

Berkshire SL1 3UH UK

Manufacturer:

Reckitt Benckiser Healthcare (UK)

Limited 'Dansom Lane 'Hull, HU8 7DS

UK_________________

For any information about this medicine, 'please contact the Marketing 'Authorisation Holder:

Telephone +800 270 81 901

'PatientSafetyRoW@indivior.com

this leaflet was last revised in July 2015.

PACKAGE LEAFLET: INFORMATION FORTHE USER Subutex 0.4 mg, 2 mg and 8 mg sublingual tablets

buprenorphine

Read aN of this leaflet carefully before

confusion or hallucinations caused by alcohol.

If you are breastfeeding a baby.

Take special care with Subutex

Tell your doctor before you start taking [Subutex if you have:

[• asthma or other breathing problems H any liver disease such as hepatitis !• low blood pressure

recently suffered hoad4njury-or-bram -disease

a urinary disorder (especially linked to enlarged prostate in men) any kidney disease thyroid problems

adrenocortical disorder (e.g. Addison's disease)

"3D2JJ17Z

Some medicines may increaseThe side^-[effects of Subutex and may sometimes pause very serious reactions. Do not ;take any other medicines whilst taking ;Subutex without first talking to your ;doctor, especially:

Benzodiazepines (used to treat anxiety or sleep disorders) such as diazepam, temazepam, alprazolam. Your doctor wiM prescribe the cojrectdose for:you.

sleeplessness, convulsions / seizures, pain.These types of medicines will reduce your alertness levels making it difficult for you to drive and use machines.They may also cause central nervous system depression, which is very serious. Below is a list of _examples of these types of medicines: ⁺ - other opioid containing medicines such as methadone, certain pain killers and cough suppressants.

-    antidepressants (used to treat depression) such as isocarboxazide, phenelzine, selegiline, tranylcypromine, and valproate may increase the effects of this medicine.

-    sedative Hi receptor antagonists

_ Jused lolreataller gic_re_a ct ions)__

such as diphenhydramine and chlorphenamine.

-    barbiturates (used to cause sleep or sedation) such as phenobarbital, secobarbital.

-    tranquilisers (used to cause sleep or sedation) such as chloral hydrate.

Naltrexone may prevent Subutex from working. If you take naltrexone whilst

+ -you-are taking Subutexyou may---

experience a sudden onset of prolonged and intense withdrawal symptoms.

Clonidine (used to treat high blood pressure) may extend the effects of this medicine. j» Anti-retrovirals (used to treat AIDS) such as ritonavir, nelfinavir, indinavir _± may increase the effects of this “medicine. “

Some antifungal agents (used to treat fungal infections) such as ketoconazole and itraconazole and certain antibiotics (macrolide) may extend the effects of this medicine. Some medicines may decrease the effect of Subutex.These include medicines used to treat epilepsy (such -as-carbamazepine and phenytoin) and medicines used to treat tuberculosis (rifampicin).

To get the greatest benefit from taking Subutex, 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 ithat has not been prescribed for you by

nyou+doetor.-------------

Taking Subutex with food and drink 'Alcohol may increase drowsiness and 'may increase the risk of respiratory failure (inability to breathe) if taken with Subutex. Do not take Subutex together iwith alcohol. Do not swallow or consume food or drink until the tablet is completely dissolved.

Pregnancy and breast-feeding_____

Tell your doctor if you are pregnant or lintend to become pregnant.

When taken during pregnancy, 'particularly late pregnancy, medicines 'like Subutex may cause drug withdrawal isymptoms including problems with 'breathing in your new born baby.

^IFTese symptoms may occur several [days after birth.

;Do not breast feed your baby whilst taking this medicine as Subutex passes into breast milk.

|Ask your doctor or pharmacist for advice before taking any medicine.

Driving -and using machines-------

[If you feel drowsy or dizzy while taking [these tablets do not use machinery.

The medicine can affect your ability to [drive as it may make you sleepy or dizzy. Do not drive while taking this medicine until you know how it affects you.

It is an offence to drive if this medicine affects your ability to drive.

However, you wautdmot ber committing an offence if: o The medicine has been prescribed to treat a medical or dental problem and

o You have taken it according to the instructions given by the prescriber or in the information jarovidedwith “tReTriedicine aTicf “ o It was not affecting your ability to drive safely Talk to your doctor or pharmacist if you [are not sure whether it is safe for you to [drive while taking this medicine. [Important information about some of [the ingredients of Subutex [Subutex contains lactose. If you have been told fay-your doeter that -you -have-;an intolerance to some sugars, contact your doctor before taking this medicine.

3. HOWTOTAKE SUBUTEX

l

[You must place the tablet under your [tongue (sublingual) and allow it to [dissolve, which will take 5 to 10 minutes, [This is the only way to take the tablets. Do not chew or swallow them whole, as

hey will rrotrwork.----------

[Your doctor will tell you how many [tablets to take and you should always [follow this advice.

To avoid sudden withdrawal symptoms, [treatment with Subutex should be given [when there are already clear signs of [withdrawal symptoms.

Adults and children over the age of 16 years: when-beginning-treatmentlhe [dose is between 0.8 to 4mg, taken once [a day.

For drug addicts who have not had any Withdrawal treatment: one dose of ISubutex should be taken at least 6 hours [after the last use of the opioid (narcotic [such as morphine or heroin), or when the first signs of craving appear. If you take it less than six hours after you use a narcolic you may gerwlthdrawat “ [symptoms.

[For patients taking methadone: before beginning treatment, your doctor should reduce your dose of methadone to not more than 30mg a day. Subutex may [cause withdrawal symptoms in patients

who are dependent on methadone if jused within 24 hours of the last dose of methadone.

[During your treatment, your doctor may [increase your dose of Subutex, to a [maximum single daily dose of 32mg, depending upon your response. Once |you have_been stable for_a while,your. _ doctor will gradually reduce your dose |and it may be possible to stop it altogether. Do not suddenly stop taking !the tablets, as this may cause Withdrawal symptoms.

|lf you take more Subutex than you should

[If you or someone else takes too much ;of this medicine, you must go or be

follow his-ox hen instructions- -Do not take a double dose to make up [for the forgotten dose.

[If you stop taking Subutex !Do not change the treatment in any way lor stop treatment without the agreement lof the doctor who is treating you. Stopping treatment suddenly may cause Withdrawal symptoms.

Iltyou-have .any further_questions-on-tbe-l luse of this product, ask your doctor or Ipharmacist.

[How to remove the tablet from the blister pack

1 - Remove just one section from the blister pack, tearing it along the perforated line.

2 - Starting from the edge where the seal is lifted, pull back the foil on the back to remove the tablet.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Subutex can cause Iside effects, although not everybody Igets them.

Tell your doctor immediately or seek urgent medical attention if you

experience side effects such as:

sudden wheezing, d iff icujty breath ing_L swelling of the eyelids, face, tongue, lips, throat or hands; rash or itching especially those covering your whole body.These may be signs of a life-threatening allergic reaction, if you start to breathe more slowly or weakly than expected (respiratory depression!

if you start to Teel Taint, as this may lae a sign of low blood pressure.

Also tell your doctor immediately if you [experience side effects such as:

• severe fatigue (tiredness), have no appetite or if your skin or eyes look yellow.These may be symptoms of

live rda mage,____________

The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10)

common (affects 1 to 10 users in 100) not known (frequency cannot be estimated from the available data).

Side effects reported with Subutex

Very common side effects:

Drug withdrawal syndrome, headache, hyperhidrosis (sweating), insomnia (inability to sleep), nausea (feeling sick), pain_

Common side effects:

Abdominal pain, agitation, anxiety, joint pain, weakness, back pain, bone pain, bronchitis, chest pain, chills,

constipation,-cough; decreased----

appetite, depression, diarrhoea, dizziness, dry mouth, painful period, indigestion, shortness of breath, flatulence, gastrointestinal disorder, hostility, increase in muscle tension, infection, influenza, nervousness, tearing (watery eyes) disorder, swollen glands (lymph nodes), malaise, migraine, muscje spasrns^rnusc|e pahv dilation of the pupil, neck pain, palpitations, paranoia, burning or tingling in hands and feet, swelling (hands and feet), sore throat and painful swallowing, fever, rash, somnolence, syncope (fainting), thinking abnormal, tooth disorder, tremor; flushing, vomiting (being sick), yawning.

~Frequency~not know nr

Drug dependence, drug withdrawal syndrome in newborn, hallucinations (sensing things that are not real), drop in blood pressure on changing position from sitting or lying down to standing, difficulty in urinating.

Misusing this medicine by injecting it can cause withdrawal symptoms,

infections,.other skin reactions_and___

potentially serious liver problems.

f 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.

[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 via theYellow Card [Scheme at:

www.mhra.gov.uk/yellowcard [By reporting side effects you can help [provide more information on the safety [of this medicine.

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