Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about ASPEN METHADONE SYRUP. It does not contain all of 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 this medicine against the benefits they expect it will have for you.

Ask your doctor or pharmacist if you have any concerns about taking this medicine.

Keep this leaflet with the medicine. You may need to read it again.

What it is used for

ASPEN METHADONE SYRUP contains the active ingredient, methadone hydrochloride. It belongs to a group of medicines called opioid analgesics.

It is used for the treatment of severe pain and for the treatment of dependence on opioid drugs.

Addiction

You can become addicted to ASPEN METHADONE SYRUP even if you take it exactly as prescribed. ASPEN METHADONE SYRUP 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 this medicine. Taking it may result in physical dependence. Physical dependence means that you may experience withdrawal symptoms if you stop taking ASPEN METHADONE SYRUP suddenly, so it is important to take it exactly as directed by your doctor.

Tolerance

Tolerance to ASPEN METHADONE SYRUP 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 your medicine for as long as 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.

ASPEN METHADONE SYRUP given to the mother during labour can cause breathing problems and signs of withdrawal in the newborn.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

ASPEN METHADONE SYRUP is only available with a doctor’s prescription.

Before you take it

When you must not take it

Do not take ASPEN METHADONE SYRUP if:

• you have ever had an allergic reaction to methadone hydrochloride, any other opioid drug or any of the ingredients listed toward the end of this leaflet.
  Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue or any other parts of the body; rash, itching or hives on the skin.
• you have any other medical condition including:
  - suffering from a lung disorder such as asthma, or any illness causing difficulty in breathing, especially if there is excessive phlegm or skin is bluish in colour
  - a recent head injury or increased pressure in the head
  - a bowel condition known as ulcerative colitis
  - certain liver or kidney conditions
  - certain heart conditions
  - alcoholism.
• you are taking or have recently taken antidepressants of the type called monoamine oxidase inhibitors (MAOIs) or selective serotonin re-uptake inhibitors (SSRIs).
• you suffer from biliary and renal tract spasm
• the expiry date (EXP) printed on the pack has passed
• the packaging is torn or shows signs of tampering.

Before you start to take it

Tell your doctor if:

• you are under 18 years of age
• you are allergic to foods, dyes, preservatives or any other medicines
• you are pregnant or become pregnant while taking it are about to give birth or are breastfeeding
• you have any other medical condition including:
  - hormone problems
  - an underactive thyroid gland
  - diabetes
  - prostate disease
  - phaeochromocytoma (a rare tumour of the adrenal gland).
  Symptoms include bouts of anxiety and headaches. There may be palpitations (banging of the heart felt in the chest), dizziness, weakness, nausea, vomiting, diarrhoea, dilated pupils, blurry vision, stomach pains and raised blood pressure.
• you intend to drink alcohol, particularly large amounts, while you are taking ASPEN METHADONE SYRUP

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some of the medicines that may interfere with this medicine include:

• St John's wort
• rifampicin, an antibiotic
• medicines to treat epilepsy
• medicines to treat HIV infections
• fluconazole, an antifungal
• selective serotonin re-uptake inhibitors (SSRIs) which are medicines to treat depression or obsessive compulsive disorders e.g. fluvoxamine
• any other medicines to treat depression
• medicines to treat mental illness
• medicines to treat heart conditions
• other pain relievers, muscle relaxants or tranquilisers
• fluid or water tablets
• laxatives
• fludrocortisone, a medicine used in certain hormone conditions.

You may need to take different amounts of your medicine or you may need to take different medicines. Your doctor or pharmacist has a more complete list of medicines to avoid while taking this medicine.

Use in children and elderly patients

ASPEN METHADONE SYRUP is not recommended for use in children under 18 years of age.

The doctor may prescribe a smaller dose in elderly patients.

How to take it

How much to take

Take this medicine as directed by your doctor or pharmacist.

The usual dosage for adults is 1 to 2 mL, taken 3 to 4 times a day, but this dosage may be adjusted by your doctor.

Do not take more than the recommended dose. It can result in low blood sugar.

How to take it

ASPEN METHADONE SYRUP is designed specifically to be taken by mouth only.

It is NOT SUITABLE for injection. Injecting this medicine can be extremely hazardous.

How long to take it for

Do not stop taking this medicine or change the dose without first checking with your doctor. Your doctor may want to gradually reduce the amount you are taking before stopping completely in order to lessen the chance of possible withdrawal side effects.

If you take too much (overdose)

If you or someone else receive too much (overdose) and experience one or more of the symptoms below, immediately 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 ASPEN METHADONE SYRUP 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 ASPEN METHADONE SYRUP, you should immediately:

• phone the Poisons Information Centre (by calling 13 11 26), 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 information 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 it

Things you must do

Tell your doctor if, for any reason, you have not taken your medicine exactly as directed. Otherwise your doctor may think that it was not working as it should and change your treatment unnecessarily.

If you forget to take a dose, take it as soon as you remember and then go on as before, but remember not to take the medicine more often than recommended by your doctor.

Things you must not do

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Seek medical help immediately if ASPEN METHADONE SYRUP is accidentally taken by a child.

Do not use it to treat any other complaints unless your doctor says to.

Things to be careful of

This medicine may cause drowsiness. It is recommended that you don't drive, use machinery or undertake any activities where alertness is required.

Do not drink alcohol while taking ASPEN METHADONE SYRUP.

Particular care should be taken when starting this medicine or increasing the dose. Methadone can decrease heart and breathing rates, which if severe, may lead to death.

Speak to your doctor immediately if you have any concerns.

Side effects

Tell your doctor as soon as possible if you do not feel well while you are taking ASPEN METHADONE SYRUP.

All medicines 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.

Common side-effects are:

• drowsiness
• dizziness
• light-headedness
• nausea
• vomiting
• dry mouth
• sweating
• confusion
• constipation
• problems with urine flow
• tolerance and dependence.

With prolonged use, the dose may have to be increased to achieve the same benefit, whilst a sudden decrease in dose or interruption of therapy may give rise to possible withdrawal symptoms.

Tell your doctor immediately if you notice any of the following:

• wheezing
• swelling of the lips/mouth
• difficulty in breathing
• hayfever
• lumpy rash (hives)
• fainting.

These could be a symptom of an allergic reaction.

Tell your doctor if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur is some patients.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After taking it

Storage

Keep ASPEN METHADONE SYRUP in a cool, dry place where it stays below 25°C. Protect from light.

Keep this medicine where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Do not leave in a car, on a window sill or in the bathroom.

Disposal

Return any unused or expired medicine to your pharmacist.

Product description

What it looks like

ASPEN METHADONE SYRUP is a bright, amber-coloured syrup, with an aromatic odour. It is available in 200 mL or 1 L brown HDPE bottles with a child-resistant cap.

Ingredients

ASPEN METHADONE SYRUP contains methadone hydrochloride 5 mg/mL as the active ingredient.

It also contains the following inactive ingredients:

• sodium benzoate
• ethanol
• sorbitol solution 70% (non-crystallising)
• glycerol
• sunset yellow FCF
• anise spice SC491233
• purified water.

ASPEN METHADONE SYRUP is lactose, sucrose and gluten free.

Sponsor

Aspen Pharma Pty Ltd
34-36 Chandos Street
St Leonards NSW 2065
Australia

Australia Registration Number: AUST R 49372

This leaflet was revised in May 2022.

Published by MIMS June 2022

Boxed Warnings

Limitations of use. Because of the risks associated with the use of opioids, Aspen Methadone Syrup 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. Aspen Methadone Syrup 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 Aspen Methadone Syrup. 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 Aspen Methadone Syrup.

1 Name of Medicine

Methadone hydrochloride.

2 Qualitative and Quantitative Composition

Aspen Methadone Syrup is an oral solution of 5 mg/mL methadone hydrochloride.
List of excipients with known effect: sodium benzoate, ethanol and sorbitol solution (70%) (non-crystallising). For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

A bright amber coloured syrup with an aromatic odour.

4 Clinical Particulars

4.9 Overdose

Symptoms and signs. The symptoms and signs of overdosage with methadone parallel those for other opioids, namely profound respiratory depression, pinpoint pupils, hypotension, circulatory failure and pulmonary oedema, coma and death. Hypoglycaemia has been reported.
Mydriasis may replace miosis as asphyxia intervenes. Drowsiness, floppiness, pinpoint pupils and apnoea have been reported in children.
Treatment. General supportive measures, including ECG monitoring, should be employed as required. Lavage, dialysis and CNS stimulation are contraindicated. The specific opioid antagonist naloxone can be used for the reversal of coma and the restoration of spontaneous respiration. Intravenous infusion is the preferred route of administration in the management of methadone overdose because of the short half-life of naloxone relative to the long half-life of methadone, continuous infusion reduces the possibility of prolonged respiratory depression and the risk of relapse, which can occur suddenly. It should be noted that QT prolongation will not be reversed by naloxone.
In opioid dependent patients the administration of the usual dose of an opioid antagonist will precipitate an acute withdrawal syndrome. The severity of this syndrome will depend on the degree of physical dependence and the dose of the antagonist administered. The use of an opioid antagonist in such a person should be avoided if possible. If it must be used to treat serious respiratory depression in the physically dependent person the antagonist should be administered with extreme care and by titration with smaller than usual doses of the antagonist.
Patients should be monitored closely for at least 48 hours after apparent recovery in case of relapse, since the duration of action of the antagonist may be substantially shorter than that of methadone.
The use of other respiratory or central stimulants is not recommended.
Acidification of the urine will enhance urinary excretion of methadone.
Methadone is not dialysable by either peritoneal or haemodialysis.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Mutagenic potential. Methadone did not exhibit demonstrable mutagenic activity in a wide range of standard in vitro and in vivo mutagenicity assays. However, in a Dominant Lethal assay in mice, treatment with methadone at doses between 1 and 6 mg/kg was associated with increased preimplantation deaths and chromosomal aberrations of sperm cells when compared with controls.
Teratogenic potential. No teratogenic effects have been observed in standard teratogenicity studies in rats and rabbits given methadone at doses from ten to fifty times the average daily human maintenance dose. Developmental abnormalities of the central nervous system have been reported in hamsters and mice given high doses in early pregnancy.
Carcinogenicity. Long-term carcinogenicity tests in rodents did not reveal any evidence of methadone related neoplasia.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Methadone hydrochloride is a synthetic opioid analgesic with the general properties of morphine. Methadone is a racemic mixture and levo-methadone is the active isomer. It occurs as odourless, colourless crystals or white crystalline powder. It is soluble in water, freely soluble in alcohol and chloroform; practically insoluble in ether and in glycerol.
Molecular formula: C₂₁H₂₇NO.HCl, relative molecular mass: 345.9. The chemical name for methadone hydrochloride is (6RS)6-(dimethylamino)-4,4-diphenylheptan-3-one hydrochloride.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSMETHYD.gif CAS number. 1095-90-5.

7 Medicine Schedule (Poisons Standard)

S8 - Controlled Drug.

Summary Table of Changes

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