METHADONE 5 MG/ML ORAL SOLUTION

Active substance: METHADONE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Methadone 5 mg/ml Oral Solution
Methadone hydrochloride
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:
1.
What Methadone 5 mg/ml Oral Solution is and what it is used for
2.
Before you take Methadone 5 mg/ml Oral Solution
3.
How to take Methadone 5 mg/ml Oral Solution
4.
Possible side effects
5.
How to store Methadone 5 mg/ml Oral Solution
6.
Further information
1.

WHAT METHADONE 5 MG/ML ORAL SOLUTION IS AND WHAT IT IS
USED FOR

Methadone 5 mg/ml Oral Solution 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.
2.

BEFORE YOU TAKE METHADONE 5 MG/ML ORAL SOLUTION

Do not take Methadone 5 mg/ml Oral Solution 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, have a history of asthma 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 dependant on any other drugs or are addicted to alcohol
• are in labour
• have bowel problems
Methadone 5 mg/ml Oral Solution is not recommended for use in children.

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Take special care with Methadone 5 mg/ml Oral Solution
You must tell your doctor or pharmacist and take special care 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 5 mg/ml Oral Solution )
• recognised risk factors for the heart condition ‘QT prolongation’
• blood salt imbalance
• inflammation, infection of the brain or its lining, head injury
• an under-active thyroid gland
• a family history of sudden death
• an enlarged prostate
• a convulsive disorder
• problems with your adrenal glands
• muscle weakness
• taken other opioid type (painkiller) drugs such as morphine and pentazocine
or are
• pregnant or breast-feeding
• elderly or ill
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 and especially if you are
taking any of the following, since interactions between these and Methadone 5 mg/ml
Oral Solution can be hazardous.
Tell your doctor if you are taking any of the following:
• other opiate analgesics
• any medicines that have an effect on your mental state (e.g. thioridazine,
phenothiazines, haloperidol and sertindole)
• medicines used to treat heart diseases (e.g. verapamil, quinidine)
• medicines used to treat depression known as monoamine oxidase inhibitors (MAOIs),
particularly if you have taken them within the last two weeks. Also tell your doctor if
you use other medicines to treat depression (e.g. imipramine, desipramine,
nefazodone, fluoxetine, fluvoxamine, paroxetine and sertraline).
• anti-inflammatory and immunosuppressants (e.g. dexamethasone and cyclosporine)
• antiviral drugs including some medicines used to treat HIV (e.g. nevirapine,
zidovudine, efavirenz, nelfinavir, ritonavir, abacavir, didanosine and stavudine)
• macrolide antibiotics (medicines used to treat bacterial infections) such as
clarithromycin, telithromycin and erythromycin
• cimetidine (a medicine used to treat stomach ulcers)
• antifungals (medicines used to treat fungal infections) such as ketoconazole,

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itraconazole and fluconazole
naloxone (a medicine used to treat difficulties with breathing)
medicines used to treat addiction (e.g. naltrexone and buprenorphine)
rifampicin (a medicine used to treat tuberculosis or ‘TB’)
drugs used to treat epilepsy (e.g. phenytoin, phenobarbital and carbamazepine)
vitamin tablets containing vitamin C
medicines used to treat diarrhoea (e.g. loperamide, diphenoxylate)
medicines that make urine more acidic (e.g. ammonium chloride)
diuretic medicines (e.g. spironolactone)
medicines that make you feel sleepy
herbal medicines containing St John’s Wort

Other medicines you may be taking can also affect the heart (e.g. sotalol, amiodarone and
flecainide).
You must tell your doctor about any other medicines that you are taking as they may be
dangerous if they are taken with methadone. In these situations your doctor may decide
that it is necessary to monitor your heart with an electrocardiogram (ECG) at the start of
treatment to ensure that these effects do not occur. Methadone can also affect some blood
and urine tests. Please tell your doctor if you are taking methadone before any test is
performed.
Taking Methadone 5 mg/ml Oral Solution with food and drink
Do not drink alcohol while you are taking this product. This medicine and alcohol can
react with each other and this can increase their effects. Do not drink grapefruit juice
while you are taking Methadone, as it may alter the effect of the medicinal product.
Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine.
This medicine is not recommended for use if you are pregnant, in labour or breastfeeding. 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 this medicine, small amounts can pass to the baby in the breast milk.
Driving and using machines
Methadone 5 mg/ml Oral Solution is likely to cause drowsiness, blurred vision, dizziness
or nausea. Do not drive or operate machinery while taking this medicinal product.
Important information about some of the ingredients of Methadone 5 mg/ml Oral
Solution this medicine
Methadone 5 mg/ml Oral Solution also contains:



Liquid Maltitol (E965): If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor before taking this
medicinal product
Sunset Yellow (E110): which may cause allergic reactions.

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3.

HOW TO TAKE METHADONE 5 MG/ML ORAL SOLUTION

Always take your medicine exactly as your doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
You must only take Methadone by mouth. Under no circumstances should you inject this
product as injection may cause serious and permanent damage to your body with possibly
fatal consequences. This product is not intended to be diluted.
Your doctor will tell you how much Methadone you need to take, and how often you
need to take it. It is important that you do not take more than the dose agreed with your
doctor.
Adults
The usual initial dose is 10-30 mg a day. The dose will be slowly increased until you
show no signs of withdrawal or intoxication. The usual dose is 60-120 mg/day. Your
doctor will decide what dose you need and when to reduce the dose.
Elderly or ill:
Caution must be exercised if you are elderly, ill or have liver or kidney problems.
Methadone 5 mg/ml Oral Solution is not recommended for use by children.
If you take more Methadone 5 mg/ml Oral Solution than you should
Overdose can cause coma and in severe cases death. If you take too much Methadone, you can
experience the following:
• difficulty breathing
• extreme sleepiness, fainting or coma
• pin point pupils
• muscle weakness
• cold and clammy skin
• slow heartbeat, low blood pressure, heart attack or shock
Medical attention is required urgently and you should go to the nearest hospital casualty
department and take the medicine pack with you if possible.
If you forget to take Methadone 5 mg/ml Oral Solution
If you forget to take a dose of your medicine, tell your healthcare worker or doctor.
DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR A FORGOTTEN DOSE.

If you stop taking Methadone 5 mg/ml Oral Solution
Do not stop taking your medicine except on medical advice, because your withdrawal
symptoms may come back.

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If you have any further questions on the use of this product, ask your doctor, pharmacist
or healthcare worker.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, this product can cause side effects, although not everybody gets them.
Side effects which may occur include:
Very common side effects:

These may affect more than 1 in 10 people
treated with Methadone

Common side effects:


These may affect up to 1 in 100 people treated •
with Methadone









Uncommon side effects:


These may affect up to 1 in 1000 people •
treated with Methadone




















feeling sick or being sick

weight increase
water retention
constipation
feeling high (euphoria)
seeing or hearing things that are not real
(hallucinations)
feeling of dizziness or spinning
blurred vision
pin point pupils
feeling sleepy
skin rash
sweating
feeling tired
loss of appetite
breathing difficulty (including with cough)
dry mouth
inflammation of tongue
feeling down (dysphoria)
agitation
difficulty sleeping
confusion
reduction of sex drive
headache
fainting
low blood pressure
itching
hives
rash
swelling of legs
weakness
water retention
bile duct spasm (abdominal pain)
facial flush
difficulty in passing urine
difficulty achieving or maintaining an erection
disturbances in menstruation

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• heart problems
• slower heart beat
These may affect up to 1 in 10,000 people • feeling your heart beat (palpitations)
treated with Methadone
Rare side effects:

• deficiency of potassium or magnesium in
blood
Frequency of these side effects is not known • lower levels of platelets in blood
yet.
Unknown side effects:

If any of these side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE METHADONE 5 MG/ML ORAL SOLUTION
Keep out of the reach and sight of children. Store below 25oC. Store the bottle in an
upright position.
This medicine should be used within 60 days of first opening
Do not use this product after the expiry date which is stated on the bottle. The expiry date
refers to the last day of that month. Keep the bottle in the outer carton in order to protect
from light.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.
6. FURTHER INFORMATION
What Methadone 5 mg/ml Oral Solution contains
- The active ingredient is: methadone hydrochloride, 5mg in each ml.
- The other ingredients are: Hydroxyethylcellulose, Propylene glycol, Liquid maltitol
(E965), Sodium hydroxide, Benzoic acid (E210), Sunset yellow (E110) and purified
water. (see end of Section 2 for further information)
What Methadone 5 mg/ml Oral Solution looks like and contents of the pack
Methadone 5 mg/ml Oral Solution is a clear light amber solution, which is available in
the following pack sizes:
HDPE bottles: 14 ml, 16 ml, 18 ml, 20 ml, 22 ml, 24 ml, 26 ml, 28 ml, 30 ml, 32 ml, 34
ml, 36 ml, 38 ml, 40 ml, 42 ml, 44 ml, 46 ml, 48 ml or 50 ml.
Amber glass and PET bottles: 100ml, 200ml, 300ml, 500ml or 1 litre.
In Sweden, the larger pack sizes (>30 ml) should be handled by healthcare professionals only

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Your physician will advise you on the correct amount to take each day. Not all pack sizes
may be marketed.
Manufacturer / Marketing Authorisation Holder
Pinewood Laboratories Ltd.,
Ballymacarbry,
Clonmel,
Co. Tipperary, Ireland
MA number: PL 04917/0111
This leaflet was last updated in 07/2011.
Product name in Sweden : Metadon Evolan 5 mg/ml oral lösning
Product name in Denmark : Metadon Evolan 5 mg/ml oral opløsning

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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.

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