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Temgesic Sublingual Tablets

Buprenorphine hydrochloride
Consumer Medicine Information
 

 

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 strong "pain killer". It is used for the short term relief of moderate to 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 hydrochloride (or buprenorphine). 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.
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
general anaesthetics
naltrexone
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 think that you or anyone else may have taken too much TEMGESIC, immediately telephone your doctor or National Poison Centre (in Australia telephone 13 11 26 or in New Zealand telephone 0800 POISON or 0800 764 766), or go to accident and emergency at your nearest hospital. Do this even if there are no signs of discomfort or poisoning.

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

Will I become addicted to TEMGESIC

Opioid analgesics such as TEMGESIC are used to relieve moderate to severe pain. In most cases, when used as directed by your doctor, addiction does not occur. However, your body may become used to taking the TEMGESIC, so if the TEMGESIC tablets are stopped suddenly you may experience some symptoms of withdrawal.
It is important that you discuss this issue with your doctor.

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.

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.
TEMGESIC should be kept out of the reach of children.

Disposal

If your doctor tells you to stop taking the tablets or the tablets have passed their Expiry Date, ask your pharmacist what to do with any that are left over.

Product Description

TEMGESIC Sublingual Tablets are available in blister packs of 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, mannitol, maize starch, povidone, magnesium stearate, citric acid - anhydrous and sodium citrate.
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
[email protected]
Date of most recent amendment:
August 2016.