SYNASTONE METHADONE DTF 1MG/ML ORAL SOLUTION SUGAR FREE
Active substance(s): METHADONE HYDROCHLORIDE / METHADONE HYDROCHLORIDE / METHADONE HYDROCHLORIDE
Methadone DTF 1mg/ml Oral Solution Sugar Free
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
In this leaflet:
What Methadone is and what it is used for
Before you take Methadone
How to take Methadone
Possible side effects
How to store Methadone
WHAT METHADONE IS AND WHAT IT IS USED FOR
Methadone DTF 1mg/ml Oral Solution Sugar Free contains the active ingredient methadone
hydrochloride. It has been given to you to help in treating an opioid-related drug dependency
by suppressing the symptoms of withdrawal.
BEFORE YOU TAKE METHADONE
Do not take Methadone if you:
are allergic (hypersensitive) to methadone hydrochloride, or any of the other
ingredients listed (see Section 6 and end of Section 2)
have severe breathing problems, or are having an acute asthma attack
have raised pressure in the brain, or a head injury
are taking monoamine oxidase inhibitors (MAOIs) or have taken them in the past 2 weeks
are addicted to alcohol
have bowel problems
Methadone is not recommended for use in children.
Take special care with Methadone
You must tell your doctor or pharmacist and take special care if you are:
pregnant or breast-feeding
taking ciprofloxacin (an antibiotic)
elderly or ill
or if you have:
asthma, or difficulty breathing
low blood pressure
liver or kidney disease
heart disease (your doctor may recommend electrocardiogram (ECG) monitoring before
and during treatment with Methadone)
recognised risk factors for the heart condition ‘QT prolongation’
blood salt imbalance
inflammation, infection of the brain or its lining
an under-active thyroid gland
a family history of sudden death
an enlarged prostate gland
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other
medicines, including medicines obtained without a prescription. Especially if you are taking
any of the following, since interactions between these and Methadone can be hazardous:
Medicines used to treat bacterial (e.g. rifampicin), viral (e.g. zidovudine) and fungal
infections (e.g. ketoconazole).
Medicines to treat depression or anxiety problems (MAOIs including moclobemide and
SSRIs e.g. fluoxetine).
Anti-psychotics used to treat mental illness.
Hypnotics (to help you sleep, including anaesthetics).
Cisapride for serious heartburn.
Sodium Oxybate for the treatment of cataplexy (episodes of weak muscles) in patients
with narcolepsy (a condition that causes excessive sleepiness).
Medicines that make your urine acidic such as ascorbic acid (vitamin C).
Drugs affecting electrolyte balance (blood salt levels) such as diuretics (water tablets)
Opioid antagonists (naloxone, naltrexone, buprenorphine) used to reverse the effects of
Opioid drugs (codeine, co-proxamol, morphine, diamorphine, pentazocine, pethidine
which are strong painkillers).
Domperidone and metoclopramide for nausea and sickness.
Dopaminergics (e.g. selegiline used to treat Parkinson’s disease).
Drugs used to treat epilepsy (e.g. phenytoin and carbamazepine).
Ulcer healing drugs (cimetidine).
Medicines to treat heart problems (e.g. verapamil, enalapril and mexiletine).
Nevirapine (used to treat HIV) may affect blood concentration of Methadone and your
doctor may consider dosage adjustments.
Atomoxetine used to treat Attention-deficit hyperactivity disorder (ADHD).
Taking Methadone with food and drink Do not drink alcohol while you are taking your
medicine. Methadone and alcohol can react with each other and this can increase their
Pregnancy and breast-feeding
Talk to your doctor before using any medicine.
Methadone is not recommended for use if you are pregnant, in labour or breast-feeding.
If used during pregnancy, your baby
may suffer withdrawal effects after birth. Problems for you or your baby may result if
you use it during labour. If you
breast-feed whilst taking Methadone, small amounts can pass to the baby in the breast
Driving and using machines
Methadone may cause drowsiness, blurred vision, dizziness or nausea. If you are
affected in this way, do not drive or operate machinery.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
Do not drive while taking this medicine until you know how it affects you.
It is an offence to drive if this medicine affects your ability to drive.
However, you would not be committing an offence if:
o The medicine has been prescribed to treat a medical or dental problem
o You have taken it according to the instructions given by the prescriber or
in the information provided with the medicine and
o It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive
while taking this medicine.
Important information about some of the ingredients of Methadone
Your medicine also contains:
- Maltitol solution (E965): If you have an intolerance to some sugars, contact
your doctor before taking Methadone. Methadone contains 2.75g maltitol/5ml,
and may have mild laxative effect. Maltitol has a calorific value of 2.3kcal/g.
- the colour Sunset Yellow FCF (E110) which may cause allergic reactions.
HOW TO TAKE METHADONE
Always take your medicine exactly as your doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
Methadone is usually taken in a single daily dose, and is only to be taken by mouth.
The dose will be adjusted personally for you, with a usual starting dose of between 10
20 mg (two to four 5ml spoonfuls) daily. Your dose will be increased by 10-20 mg
daily, until the level that stops your withdrawal symptoms is reached.
Commonly, you will be given 40-60mg (40 to 60 mls) daily, with the aim of gradual
reduction until you have withdrawn completely from your drug dependency.
Your healthcare worker, doctor or pharmacist will give you the correct amount of
Methadone to take each day. At the weekend, you will be given the correct amounts to
take on each day of the weekend. Methadone is not recommended for use in children.
If you take more Methadone than you should
Overdose can cause coma. Seek medical attention immediately and you should go the
the nearest hospital casualty department.
If you forget to take Methadone
If you forget to take a dose of Methadone, tell your healthcare worker or doctor. Do
not take a double dose to make up for a forgotten dose.
If you stop taking Methadone
Do not stop taking Methadone except on medical advice, because your withdrawal
symptoms may come back. If you have any further questions on the use of this product, ask
your doctor, pharmacist or healthcare worker.
POSSIBLE SIDE EFFECTS
Like all medicines, Methadone can cause side effects, although not everybody gets
them. If you notice any of the following, tell your doctor immediately or go to the
nearest hospital casualty department:
- slow, faster or irregular heartbeat
low body temperature (hypothermia)
low blood pressure or a fall in blood pressure (signs of this may be dizziness,
feeling faint and blurred vision when you stand up)
- difficulty breathing
Tell your doctor if any of the following become troublesome:
- dry mouth
• difficulty urinating
- facial flushing
• itching or skin rash (urticaria)
• mood changes
- pupil constriction
• muscle stiffness
- lower sexual urge or desire • dizziness or vertigo (feeling of spinning around)
- bile duct spasm (pain in the right-hand side of your stomach
Common side effects are: constipation, drowsiness and feeling or being sick.
When taken for a long period of time, it is possible that you may become
dependant on Methadone.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly
via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this
HOW TO STORE METHADONE
Keep out of the sight and reach of children. Store below 25˚C.
Do not use Methadone after the expiry date which is stated on the label. The expiry date
refers to the last day of that month.
6. FURTHER INFORMATION
What Methadone contains
The active ingredient is methadone hydrochloride, 1mg in each ml.
The other ingredients are maltitol solution (E965), propylene glycol, benzoic
acid (E210), sodium hydroxide, purified water and colours Sunset yellow
(E110) and Green S (E142).
What Methadone looks like and contents of the pack
Methadone is a clear green solution, which is available in 30ml, 50ml, 100ml,
200ml, 300ml, 500ml, 1 litre, 2 litre, 2.5 litre and 5 litre pack sizes, although your
healthcare worker or pharmacist will give you the correct amount to take each day.
Marketing Authorisation Holder and Manufacturer
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
This leaflet was last updated in 07/2014
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.