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TE MGESIC INJECTION 1ML - patient leaflet, side effects, dosage

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Patient leaflet - TE MGESIC INJECTION 1ML

(1. WHAT TEMGESIC INJECTION IS AND WHAT IT IS USED FOR                             

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(This medicine has been prescribed for you and is a strong pain killer that helps lessen moderate onsevqre plain.

It contains buprenorphine which belongs to a class of medicines called opioids, which are ‚pain re I i^ver.s‘. This medicine has been prescribed to you and should not be given to anyone else. Opioids can pause addiction and you may get withdrawal symptoms if you stop using it suddenly. Your prescriber shoulld have explained how long you will be using it for and when it is appropriate to stop, howto do (this safely. I 1 (

£ BEFORE Y01HJSE TEMGESIC4NJECTI0N---------------- I- L f-----------------------------

[If you are allergic to buprenorphine, to any of the other ingredients of this medicine (listed in sectio(n 6) lor to other opiates (drugs which are morphine – like in their action).

without first talking to your doctor, especially: [

  • ( Medicines used to_treat depressionknown as_monoamjne_o­xidas_e inhibitors (examples include trajiylcypromin^ phenelzine);

AnWepressanTs, sucTf as moclobemide, tranylcypromine, citalopram, escitalopram.Tru­oxefmeTfluvoj­ramjihe, paroxetine, sertraline,"du­loxetine, venlafaxine, । amitriptyline, doxepine, or trimipramine. These medicines may interact with Temgesic and you rr|ay experience symptoms such as involuntary, rhythmic ( contractions of muscles, including the muscles, that control movement of the eye, agitation, hallucinations, coma, excessiv 1 temperature above 38°C. Contact your doctor when experiencing such symptoms. ( । 1

|» Medicines to help you sleep (for example tranquilisers, hypnotics or sedatives). 1 I |


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excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body


* Sedative medicines such as benzodiazepines or related drugs: । ।

। Concomitant use of Temgesic and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be [ life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However if your doctor does prescribe Temgesic together with sedative । medicines the dose and duration of concomitant treatment should be limited by your doctor. Please till your doctor about all sedative medicines you are taking, and follow your doctor's dose ! recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

(You should visit your doctor regularly whilst you are taking these medicines at the same time as Te(ngebic.(

Temgesic with alcohol [ I !

(DoTOt-driftkatohof-whtteyou-are-ustncrthis-medieine-as-tt may-make^yotrfeel drowsy;----1— ।–[----------------------------


(Pregnancy and breast-feeding । । [

i|f you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

(Do not use this medicine if you are pregnant or think you might be pregnant unless you have discussed this with your[prescriber and the benefits of treatment are considered to outweigh the potential harm to the baby. i|f you use this medicine during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

(Do not use this medicine while you are breastfeeding as buprenorphine passes into breast milk and will affect yog r bajoy.


(—o—The med-ieine-h-as been-presc-ribed totreat-a medieal-er-derrtal-problem and— — — — — —' — l–r — — — — — — — — — — — — — — — — — — — — — — — — — — — — — 1 [ o You have used it according to the instructions given by the prescriber or in the information provided with the medicine and

(____________­________________________­_______________________' ' (____________­________________________­__________________SM011J2


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  • 3. HOWTO”USFTEM­GESrciNJECirohT

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Do not use more than your doctor has told you to.

Your prescriber should have discussed with you, how long the course of injectionswill last. They will arrange a plan for stopping treatment. This will outline howto gradually reduce the dose and stop using ihe medicine. |

[The usual dose is 300 – 600 micrograms of buprenorphine every six to eight hours, or as required. Inject Temgesic into a muscle or slowly into a vein, as instructed by your doctor.

hyoiuisamoreJem­gesicJnjection­lhan you should__________­_____ I__। _)___________­___________________

)lf 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.

po not suddenly stop using this medicine. If you want to stop using this medicine, discuss this with) yodr prescriber first. They will tell you howto do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, diffipult^j sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly)' stop using this medicine.

Tell your doctor immediately if you experience any of the following symptoms after using this medicine. Although they are rare, these symptomscan be serious

r if you get any sudden wheeziness, difficulty breathing, swelling of the eyelids, face or lips, rash or itchingospecially those covering your whole body. These may be signs of an allergic reaction.

j- jf you starLto_breat­h_mQre_slojtfly_or­jtfeaklyJhan expected (respiratory_de­pression)_____)__I _ I____________­__________________

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

  • * Dependence and addiction: frequency not known (cannot be estimated from the available data, s£e section „How do I know if I am addicted?“)

  • * Drug Withdrawal: When you stop using Temgesic you may experience drug withdrawal symptoms, Which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat । (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweatipg. )

Side effects that may occur when buprenorphine is used as substitution treatment are fever, diarrhoea, |loss)of appetite, dark urine, yellowing of the eyes and skin, difficulty with balance and walking, tremor (and impaired speech. ) ! ।

)lf-any-ofJthe-side effects gets-serious; or if-you-notice-any side-effects-not-listed-tn thisHeafletTpleas^-teUjyourdoetor-or-pharmacist. — — — — — — — — — — — — — — — — — — — — — — — plow do I know if I am addicted? )

If vou notice any of the following signs whilst using Temgesic, it could be a sign that you have become addicted.

  • * When you stop using the medicine you feel unwell, and you feel better once using the medicine again )

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effectsmotjlistejd in this leaflet. You can also report side effects directly via the Yellow Card Scheme website: or search for MHRA Yellow Card in the Google Play or Apple App Stcjre. By reporting side effects you can help provide more information on the safety of this medicine.