Temgesic Sublingual Tablets

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

Buprenorphine (as hydrochloride)
Consumer Medicine Information
WARNINGS
Limitations of use
TEMGESIC should only be used when your doctor decides that other treatment options are not able to effectively manage your pain or you cannot tolerate them.
Hazardous and harmful use
TEMGESIC poses risks of abuse, misuse and addiction which can lead to overdose and death. Your doctor will monitor you regularly during treatment.
Life threatening respiratory depression
TEMGESIC can cause life-threatening or fatal breathing problems (slow, shallow, unusual or no breathing) even when used as recommended. These problems can occur at any time during use, but the risk is higher when first starting TEMGESIC and after a dose increase, if you are older, or have an existing problem with your lungs. Your doctor will monitor you and change the dose as appropriate.
Use of other medicines while using TEMGESIC
Using TEMGESIC with other medicines that make you feel drowsy such as sleeping tablets (e.g. benzodiazepines), other pain relievers, antihistamines, antidepressants, antipsychotics, gabapentinoids (e.g. gabapentin and pregabalin), cannabis and alcohol may result in severe drowsiness, decreased awareness, breathing problems, coma and death. Your doctor will minimise the dose and duration of use; and monitor you for signs and symptoms of breathing difficulties and sedation. You must not drink alcohol while using TEMGESIC.

What is in this leaflet

This leaflet answers some common questions about TEMGESIC. It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking TEMGESIC against the benefits they expect it will have for you.
If you have any concerns about taking TEMGESIC, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.

What TEMGESIC is used for

TEMGESIC is a "pain killer". It is used for the short term relief of severe pain.
TEMGESIC belongs to a group of medicines called opioid (narcotic) analgesics.
Opioid analgesics act directly on the brain and spinal cord to block the sensation of pain.
Your doctor may have prescribed TEMGESIC for another reason.
Ask your doctor if you have any questions about why TEMGESIC has been prescribed for you.
 
TEMGESIC contains the active ingredient, buprenorphine (as hydrochloride). People who take buprenorphine to relieve short term pain do not usually become addicted to it.
It is important that you discuss this issue with your doctor.

Before you are given TEMGESIC.

When you must not use it

You should not take TEMGESIC if you are:
allergic to buprenorphine or to any of the other ingredients in this medicine (see Product Description at the end of this leaflet).
allergic to opioid (narcotic) medicines.
pregnant.
breast-feeding.
a child
suffering from severe or acute respiratory disease
Do not take TEMGESIC after the Expiry Date printed on the pack.
If you take this medicine after the Expiry Date has passed it may not work as well.
Do not take TEMGESIC if the package is torn, shows signs of tampering or the tablets do not look quite right.

Before you are given TEMGESIC

You must tell your doctor if:

1. you have been given TEMGESIC (buprenorphine) before and had any problems with it

2. you have any allergies to

any ingredients in this medicine (see Product Description at the end of this leaflet).
other strong analgesics (pain killers) eg. morphine
any other substances such as foods, preservatives, or dyes.

3. you have any of these medical conditions:

asthma or other breathing problems
thyroid problems
prostate problems
problems with excess alcohol use
Addison's disease
Kyphoscoliosis (hunchback disease)
Low blood pressure problems
liver problems
kidney problems
if you are pregnant
biliary tract problems
head injuries or a condition where you have increased pressure within your head
stomach (abdominal) pains
severe mental problems or hallucinations (seeing or hearing things that are not really there)
It may not be safe for you to be given TEMGESIC if you have any of these conditions.
Tell your doctor if you are currently taking or have been taking other opioid medicines or drugs.
Some people who are taking or using opioid medicines or drugs may experience opioid withdrawal effects when they are given TEMGESIC.

Taking Other Medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop, before you begin treatment with TEMGESIC.
You should not use benzodiazepines (medicines used to treat anxiety or sleeping problems) whilst you are taking TEMGESIC tablets unless they are prescribed by your doctor.
A number of medicines may change the effects of TEMGESIC. These include:
other strong pain killers (eg morphine)
cough medicines containing opioid-related substances
certain medicines for treating HIV/AIDS
certain medicines for treating fungal and bacterial infections
certain drugs for treating high blood pressure
certain antidepressants including monoamine oxidase inhibitors
certain medicines for treating epilepsy (fits)
sedatives
sedating anti-histamines
certain anti-anxiety/anti-psychotic medicines
certain medicines for treating nerve and muscle pain, including fibromyalgia
certain medicines for treating nausea/vomiting
general anaesthetics
naltrexone
cannabis
The above medicines may be affected by TEMGESIC, or may affect how well it works.
Do not drink alcohol or take medicines that contain alcohol while you are being treated with TEMGESIC.
Alcohol and certain other medicines (as listed above) may increase the sedative effects of TEMGESIC, which can make driving and operating machinery hazardous.
Your doctor or pharmacist has more information on medicines to be careful with or to avoid while taking TEMGESIC.

How to take TEMGESIC

TEMGESIC tablets must be placed under the tongue (sublingually). The tablets should be kept under the tongue for about 10 minutes.
The tablets will not work if you chew or swallow them whole, or are split or broken before you take them.
The usual recommended dose is 1 to 2 tablets dissolved under the tongue every 6 to 8 hours, or as required.
If you have any questions about the dose given to you, ask your doctor.

How long to take it

When used for the relief of pain, TEMGESIC tablets are usually taken for short periods of time.

If you forget to take it

If you forget to take a dose of TEMGESIC take it as soon as you remember.
If it is almost time for your next dose, skip the dose you have missed and take your next dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you are not sure, ask your doctor or pharmacist.

Overdose

If you or someone else receive too much TEMGESIC (overdose), call triple zero (000) for an ambulance. Keep the person awake by talking to them or gently shaking them every now and then. You should follow the above steps even if someone other than you have accidentally used TEMGESIC that was prescribed for you. If someone takes an overdose they may experience one or more of the following symptoms:
slow, unusual or difficult breathing
drowsiness, dizziness or unconsciousness
slow or weak heartbeat
nausea or vomiting
convulsions or fits.
If you think you or someone else may have used too much TEMGESIC, you should immediately:
phone the Poisons Information Centre (in Australia telephone 13 11 26 or in New Zealand telephone 0800 POISON or 0800 764 766), or
contact your doctor or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
When seeking medical attention, take this leaflet and remaining medicine with you to show the doctor. Also tell them about any other medicines or alcohol which have been taken.

While you are taking TEMGESIC

Things to be careful of

Athletes should be aware that this medicine may cause a positive reaction to "anti-doping" tests.
You should not drive or operate machinery until you know how TEMGESIC affects you.
TEMGESIC can cause drowsiness, which may be made worse if you also drink alcohol or take certain other medicines. If you are drowsy, do not drive or operate machinery.
TEMGESIC may cause your blood pressure to drop suddenly, causing you to feel dizzy if you get up too quickly from sitting or lying down.
If you feel lightheaded or dizzy or faint, get up slowly when getting out of bed or standing up.

Things you must not do

Do not take TEMGESIC to treat any condition other than the one prescribed for by your doctor.
Do not give TEMGESIC to anyone else, even if their symptoms seem the same as yours.
It may harm them.

Addiction

You can become addicted to TEMGESIC even if you take it exactly as prescribed. TEMGESIC may become habit forming causing mental and physical dependence. If abused it may become less able to reduce pain.

Dependence

As with all other opioid containing products, your body may become used to you taking TEMGESIC. Taking it may result in physical dependence. Physical dependence means that you may experience withdrawal symptoms if you stop taking TEMGESIC suddenly, so it important to take it exactly as directed by your doctor.

Tolerance

Tolerance to TEMGESIC may develop, which means that the effect of the medicine may decrease. If this happens, more may be needed to maintain the same effect.

Withdrawal

Continue taking you medicine for as long your doctor tells you. If you stop having this medicine suddenly, your pain may worsen and you may experience some or all of the following withdrawal symptoms:
nervousness, restlessness, agitation, trouble sleeping or anxiety
body aches, weakness or stomach cramps
loss of appetite, nausea, vomiting or diarrhoea
increased heart rate, breathing rate or pupil size
watery eyes, runny nose, chills or yawning
increased sweating
TEMGESIC given to the mother during labour can cause breathing problems and signs of withdrawal in the newborn.

Side effects.

TEMGESIC, like all medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Drowsiness or sleep from which you can be easily awoken is very common, particularly if TEMGESIC is used to relieve pain following surgery. Other very common side effects include vertigo, dizziness and nausea.
Less common side effects include:
vomiting
sweating
blood pressure changes causing dizziness or fainting
blurred vision
headache
difficulty breathing or slowed breathing
Uncommon side effects include:
changes in heart rate or blood pressure
difficulty urinating
dry mouth
weakness/fatigue
malaise
mood changes
slurred speech
tremor
paleness of skin
feeling of "pins and needles"
confusion
nervousness or uneasiness
depression
hallucinating
dreaming
skin rash/itchiness
flushing/warmth
chills/cold
tinnitus (ringing in the ears)
constipation
heartburn
flatulence
conjunctivitis
coma
Rare side effects include:
loss of appetite
diarrhoea
hives
convulsions (fits)
lack of body co-ordination
agitation
Cases of hypersensitivity reactions have been reported. Signs and symptoms include, rashes, hives, and skin itchiness. Serious, life threatening allergic reactions have occurred, including, difficulty breathing, swelling, and anaphylactic shock.
Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on the list.
Other side effects not listed above may also occur in some patients.

After taking TEMGESIC.

Safe Storage

Keep your tablets in the original pack (blister) until it is time to take them.
If you take the tablets out of the box or the blister pack they may not keep well.
Keep it in a cool, dark and dry place where the temperature stays below 30°C.
Keep medicines where children cannot reach them. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.
Do not use the medicine after the expiry date.

Product Description

TEMGESIC Sublingual Tablets are available in blister packs of 20 tablets and 50 tablets.
Each tablet contains 216 micrograms of buprenorphine hydrochloride (equivalent to 200 micrograms of buprenorphine) as the active ingredient. The other ingredients in the tablet are: lactose monohydrate, mannitol, maize starch, povidone, magnesium stearate, citric acid and sodium citrate dihydrate.
Each blister pack of TEMGESIC Sublingual Tablets is marked with Australian Registration Number AUST R 34091.

Sponsor

Indivior Pty Ltd
78 Waterloo Road
Macquarie Park NSW 2113
Australia
For adverse event reporting please contact:
Indivior Pty Ltd
+800-270-81901
 
Date of most recent amendment:
8 May 2020