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. This treatment must be supervised by specialist services.

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 alter heart rhythm (e.g. sotalol, amiodarone and flecainide)
• 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 ciclosporin)
• antiviral drugs including some medicines used to treat HIV (e.g. nevirapine, zidovudine, efavirenz, nelfinavir, ritonavir, lopinavir, saquinavir, amprenavir, delaviridine,
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, itraconazole and fluconazole
• naloxone (a medicine used to treat difficulties with breathing which may occur after taking opioid drugs)
• 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 and ascorbic acid)
• diuretic medicines (e.g. spironolactone)
• medicines that make you feel sleepy
• herbal medicines containing St John’s Wort
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 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 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
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.
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.

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2.
BEFORE YOU TAKE METHADONE 5 MG/ML ORAL SOLUTION
Do not take Methadone 5 mg/ml Oral Solution if you:
• are in labour
• have raised pressure in the brain or a head injury
• are dependant on any other drugs or are addicted to alcohol
• have severe breathing problems, have a history of asthma or are having an acute asthma attack
• are taking monoamine oxidase inhibitors (MAOIs) or other CNS depressants, or have taken them in the past 2 weeks
• are allergic (hypersensitive) to Methadone hydrochloride, or any of the other ingredients listed (see Section 6 and end of Section 2).
• have bowel problems or severe liver problems. Methadone may cause constipation which can be dangerous for this group of patients.
Methadone 5 mg/ml Oral Solution is not recommended for use in children.
Take special care with Methadone 5 mg/ml Oral Solution
You must tell your doctor or pharmacist and take special care if you have:
• kidney disease
• low blood pressure
• an enlarged prostate
• a convulsive disorder
• problems with your adrenal glands
• inflammation, infection of the brain or its lining, head injury
• asthma or difficulty breathing
• muscle weakness associated with myasthenia gravis
• an under-active thyroid gland
• taken other opioid type (painkiller) drugs such as morphine and pentazocine
• recognised risk factors for the heart condition ‘QT prolongation’ which include heart disease, liver disease, a family history of sudden death or low levels of magnesium in
the blood. Your doctor may recommend electrocardiogram (ECG) monitoring before and during treatment with methadone if you are at risk of developing QT prolongation.
You must tell your doctor or pharmacist and take special care if you are:
• pregnant or breast-feeding
• elderly or ill

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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:
• pin point pupils
• muscle weakness
• difficulty breathing
• extreme sleepiness, fainting or coma
• 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.
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.
Serious side effects
Serious side effects are rare, however, if you have difficulty in breathing or experience any change in heart rate or rhythm you may need urgent medical attention. Stop taking
methadone immediately and contact a doctor or go to your nearest hospital emergency department.
Side effects which may occur include:
Very common side effects: These may affect more than 1 in 10 people treated with Methadone
• feeling sick or being sick

Uncommon side effects: These may affect up to 1 in 1000 people treated with Methadone
• loss of appetite
• facial flush
• dry mouth
• inflammation of tongue
• 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)
• feeling down (dysphoria)
• breathing difficulty (including with cough)
• disturbances in menstruation
• difficulty in passing urine
• difficulty achieving or maintaining an erection
Rare side effects: These may affect up to 1 in 10,000 people treated with Methadone
• heart problems
• slower heart beat
• feeling your heart beat (palpitations)
Unknown side effects: Frequency of these side effects is not known yet.
• deficiency of potassium or magnesium in blood
• lower levels of platelets in blood
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.
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 medicine.
5.
HOW TO STORE METHADONE 5 MG/ML ORAL SOLUTION
Keep out of the sight and reach of children. Store below 25˚C. 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: 100 ml, 200 ml, 300 ml, 500 ml or 1 litre.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 08/2013.
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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Common side effects: These may affect up to 1 in 100 people treated with Methadone
• weight increase
• water retention
• constipation
• feeling high (euphoria)
• blurred vision
• pin point pupils
• feeling sleepy
• skin rash
• sweating
• feeling tired
• feeling of dizziness or spinning
• seeing or hearing things that are not real (hallucinations)

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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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