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 "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

Echo Therapeutics Pty Ltd
Sydney, Australia
www.echotherapeutics.com.au

Date of last amendment:
January 2023

Published by MIMS March 2023

Boxed Warnings

Warnings. Limitations of use. Because of the risks associated with the use of opioids, Temgesic should only be used in patients for whom other treatment options, including non-opioid analgesics, are ineffective, not tolerated or otherwise inadequate to provide appropriate management of pain (see Section 4.4 Special Warnings and Precautions for Use).
Hazardous and harmful use. Temgesic poses risks of hazardous and harmful use which can lead to overdose and death. Assess the patient's risk of hazardous and harmful use before prescribing and monitor the patient regularly during treatment (see Section 4.4 Special Warnings and Precautions for Use).
Life threatening respiratory depression. Serious, life-threatening or fatal respiratory depression may occur with the use of Temgesic. Be aware of situations which increase the risk of respiratory depression, modify dosing in patients at risk and monitor patients closely, especially on initiation or following a dose increase (see Section 4.4 Special Warnings and Precautions for Use).
Concomitant use of benzodiazepines and other central nervous system (CNS) depressants, including alcohol. Concomitant use of opioids with benzodiazepines, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, cannabis or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Limit dosages and durations to the minimum required; and monitor patients for signs and symptoms of respiratory depression and sedation. Caution patients not to drink alcohol while taking Temgesic.

1 Name of Medicine

Temgesic injection and Temgesic sublingual tablets contain buprenorphine (as hydrochloride).

2 Qualitative and Quantitative Composition

Each 1 mL of Temgesic injection contains 300 micrograms of buprenorphine (as hydrochloride).
Each Temgesic sublingual tablet contains 200 micrograms of buprenorphine (as hydrochloride).
Excipients with known effect. Temgesic sublingual tablets contain sugars as lactose.
Chemically, buprenorphine is 21-cyclopropyl -7α-[(S)-1-hydroxy -1,2,2-trimethylpropyl] -6,14-endo-ethano -6,7,8,14-tetrahydrooripavine hydrochloride. Buprenorphine hydrochloride has the molecular formula C₂₉H₄₁NO₄.HCl and the molecular weight is 504.09.
Buprenorphine hydrochloride is a white powder, weakly acidic with limited solubility in water (19.5 mg/mL at 37°C, pH 4.1).
For the full list of excipients, see Section 6.1.

3 Pharmaceutical Form

Temgesic injection. Colourless liquid in clear glass snap-ampoules.
Temgesic sublingual tablets. White, circular, biconvex tablets debossed with a "L".

4 Clinical Particulars

4.9 Overdose

Symptoms. Manifestations of acute overdose include miosis, sedation, hypotension, respiratory depression and death. Nausea and vomiting may be observed.
The major symptom requiring intervention is respiratory depression, which could lead to respiratory arrest and death.
Treatment. In the event of overdose, general supportive measures should be instituted, including close monitoring of respiratory and cardiac status of the patient. Symptomatic treatment of respiratory depression, following standard intensive care measures, should be performed. In the event of depression of respiratory or cardiac function, primary attention should be given to the re-establishment of adequate respiratory exchange through the provision of a patent airway and institution of assisted or controlled ventilation following standard intensive care measures. The patient should be transferred to an environment within which full resuscitation facilities are available.
If the patient vomits, care must be taken to prevent aspiration of the vomitus.
Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated. Use of an opioid antagonist (i.e. naloxone) is recommended, despite the modest effect it may have in reversing the respiratory symptoms of buprenorphine compared with its effects on full agonist opioid agents. High doses of naloxone hydrochloride 10-35 mg/70 kg may be of limited value in the management of buprenorphine overdose. If naloxone is used the long duration of action of buprenorphine should be taken into consideration when determining the length of treatment needed to reverse the effects of an overdose. Naloxone can be cleared more rapidly than buprenorphine, allowing for a return of previously controlled buprenorphine overdose symptoms, so a continuing infusion may be necessary. Ongoing IV infusion rates should be titrated to patient response. If infusion is not possible, repeated dosing with naloxone may be required.
For further information on the management of overdose, contact the Poison Information Centre on 131 126 (Australia) or the National Poisons Centre on 0800 764 766 (New Zealand).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. There was no evidence of genotoxicity for buprenorphine in bacterial gene mutation assays, chromosomal aberration studies and a mouse lymphoma assay.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. The chemical structure of buprenorphine is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSBUPREO.gif CAS number. The CAS number is 53152-21-9.

7 Medicine Schedule (Poisons Standard)

Schedule 8 - Controlled Drug.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/TEMGESST.gif