Temgesic Injection 1ml

If you are allergic (hypersensitive) to buprenorphine, to any of the other i [ingredients of Temgesic Injection see section 6 'Further Information') or | to other opiates (drugs which are morphine - like in their action).

[Take special care with Temgesic

Before starti_np_treatment with Jemgesjc, contact your doctor jf you:____i____

6 Are or have ever been addicted to medicines or substances; j

» Have problems with your liver;

[• Have breathing problems or are taking medicines which may make !

[ your breathing slower or weaker.

Athletes must be aware that this medicine may cause a positive reaction!

[to 'anti-doping' tests j

Taking other medicines [

Temgesic should not be taken with:

• Medicines containing gestodene (a hormone); !

• Antibiotic medicines (troleandomycin, rifampicin);

Medicines to treat fungal Infections (ketoconazole);_____i____

• Medicines for depression (norfluoxetine); [

• Medicines for HIV infection (protease inhibitors:

[ ritonavir, indinavir, saquinavir); [

» Medicines for epilespsy (carbamazepine, phenytoin, phenobarbital); i» Other opioid medicines. I

[in particular, you should also tell your doctor if you are taking: [

[• Medicines used to treat depression known as monoamine oxidase [ i inhibitors (examples include tranylcypromide, phenelzine);

[• Medicines to help you sleep (for example tranquilisers, hypnotics or [

| sedatives).

jYoirshuutd visityourdoctor regut arty whilst you are taking these------¹----

medicines at the same time as Temgesic.

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

Using Temgesic with food and drink

[Do not drink alcohol while you taking this medicine as it may make you [

[feel drowsy.

Pregnancy and breast-feeding

You should tell your doctor or pharmacist if you are pregnant or

[breast-feeding-before-tak'mg-Temgesic.--------------------------!----

Ask your doctor or pharmacist for advice before taking any medicine. [ [Driving and using machines !

[If you feel drowsy while taking this medicine do not drive or use [

[machines.

[The medicine can affect your ability to drive as it may make you sleepy j or dizzy. I

[• Do not drive while taking this medicine until you know how it affects [ i you.

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

• -However-, you-would-not-be committing^ an offenee tft-------------'----

[ o The medicine has been prescribed to treat a medical or dental [ problem and j

i o You have taken it according to the instructions given by the [ prescriber or in the information provided with the medicine and [

¹ 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. IND00229

The new driving offence concerning driving after drugs have been taken i [applies in Great Britain. There is further information for patients who arej intending to drive in Great Britain available at:

[https://www.gov.uk/drug-driving-law I

3. HOW TO USE TEMGESIC INJECTION

Always take Temgesic exactly as your doctor has told you. You should j check with your doctor or pharmacist if you are not sure.

- - Oo-not-injectmore-thanyour-doctor has told ^ou-to----------------1-----

Adults and children over 12 years of age

The usual dose is 300 - 600 micrograms of buprenorphine every six to ¹ieight hours, or as required. Inject Temgesic into a muscle or slowly into ! ja vein, as instructed by your doctor. j

Children between 6 years and 12 years of age The dose depends on their weight and your doctor will tell you the icorrect dose for your child. j

[This product will not be given to infants and children under 6 months of[ age.

ifyou take m o re Te mges icl n jerfio nt ha n .you. shout d_______________i_____

[If you accidentally inject too much Temgesic you must get medical help [ at once. Take any remaining medication, the carton and the leaflet with >

[you when seeking medical attention. [

[If you forget to take Temgesic Injection [

[Ifyou miss an injection, take it as soon as you remember unless it is [time for your next injection. Do not take a double dose to make up for a I [missed dose. [

[4. POSSIBLE SIDE EFFECTS

[Like all medicines, Temgesic can cause side effects, although not [

everybody gets them.

iTell your doctor immediately if you experience any of the following Symptoms after taking this medicine. [

Although they are rare, these symptoms can be serious.

[- if you get any sudden wheeziness, difficulty breathing, swelling of the [

[ eyelids, face or lips, rash or itching especially those covering your i whole body. These may be signs of an allergic reaction.

[- if you start to to: breathe more slowly or weakly than expected j

¹ (respiratory depression)

1- if you start to feel faint, as this may be a sign of low blood pressure. [

[Other side effects that may occur with Temgesic are: [

_ _ • .Effects on_your .stomach _or .intestine: feelingjsick, being, sick_________j_____

i» Effects on your nervous system: dizziness, hallucinations (sensing [ things that are not real), drowsiness, headaches, sweating. [

» Effects on your bladder: difficulty in urinating.

[• Effects on your eyes: blurred vision. [

[Side effects that may occur when buprenorphine is used a^Institution j treatment are fever, diarrhoea, loss of appetite, dark urine, jyellowing of i [the eyes and skin, difficulty with balance and walking, i tremor and impaired speech. [

[If any of the side effects gets serious, or if you notice aiyF j side effects not listed in this leaflet, please tell your do^gor i

- - pr phaFmaeist.-------------------------------

5. HOW TO STORE TEMGESIC INJECTION Keep this medicine out of the sight and reach of children. [

[Store below 30°C

Store in the original package to protect from light.

Do not use Temgesic Injection after the expiry date which is stated on [the pack (EXP month/year). The expiry date refers to the first day of that [month.

Medicine should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required.

~ ~ [These measureswfli helptoprotectthe environment.

6. FURTHER INFORMATION What Temgesic Injection contains

[The active substance is 300 micrograms buprenorphine hydrochloride [The other ingredients are dextrose, hydrochloric acid and water for 'injections.

What Temgesic Injection looks like and contents of the pack

[Temgesic Injection comes as 1 ml ampoules and in cartons containing a plastic tray of five ampoules.

Marketing Authorisation Holder and Manufacturer ~ ~ [Marketing Authorisation^- Holder:

[Indivior UK Limited [103-105 Bath Road [Slough Berkshire [SL1 3UH [Manufacturer:

[Reckitt Benckiser Healthcare (UK) Limited Dansom Lane [Hull, HU8 7DS UK.

[This leaflet waslast revisedln July 2015

3.0J52J1'