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METHADONE 10MG/ML SOLUTION FOR INJECTION

Active substance(s): METHADONE HYDROCHLORIDE

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Package leaflet: Information for the patients
Methadone 10mg/ml Solution For Injection
(methadone hydrochloride)
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
-

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.

What is in this leaflet
1.
2.
3.
4.
5.
6.

What Methadone Solution for Injection is and what it is used for
What you need to know before you use Methadone Solution for Injection
How to use Methadone Solution for Injection
Possible side effects
How to store Methadone Solution for Injection
Contents of the pack and other information

1. What Methadone Solution for Injection is and what it is used for?
Methadone Solution for Injection is a synthetic opiate (a morphine-like drug) used to treat addiction in
order to reduce withdrawal symptoms.
This medicine may also be used as a painkiller if you are unable to take morphine.

2. What you need to know before you use Methadone solution for injection?
Do not use Methadone Solution for Injection if :
 You are allergic to methadone hydrochloride or any of the ingredients of this medicine
(listed in section 6)
 You have any problem with your breathing or any chronic lung disease such as chronic
obstructive pulmonary disease
 You are having an asthma attack. Do not take your dose until you have completely
recovered.
 You are taking, or have stopped taking within the last two weeks, a type of medicine
known as monoamine oxidase inhibitors(MAOIs) which are used to treat depression
 You have pheochromocytoma, a tumour of the adrenal glands.
 You have a bowel disorder known as paralytic ileus
 You have loss of consciousness
If any of the conditions above apply to you, please consult your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before using Methadone Solution for Injection:
 because it can be addictive.





















only use the dose prescribed for you by your doctor because higher doses could be
fatal. Without you knowing, the
levels of the drug can build up in your body and affect your breathing, causing
drowsiness and possible loss of consciousness.
if you have increased pressure on the brain or have just had a head injury.
if you are suffering from acute alcoholism.
if you are suffering from mental illness brought on by an infection
if you have liver problems
if you have kidney problems
if you have problems with your bile duct
if you suffer from an enlarged prostate gland (in men) or have difficulty passing urine
if you have an under-active thyroid or adrenal gland.
if you have low blood pressure
if you are in a state of severe shock
if you are very run down and feeling weak
· if you have bowel disease, such as Crohn’s disease or ulcerative colitis
if you suffer from convulsions (fits)
if you are a child. Even at low doses methadone is a special hazard to children if taken
accidentally. Children under 6 months, particularly newborns, may be more sensitive
to breathing difficulties than adults
if you are elderly
if you have myasthenia gravis (a disorder that causes extreme muscle fatigue)
if you suffer from certain types of heart disorders.

These types of heart disorder are usually confirmed after an electrocardiogram (ECG) has
been performed and may be more likely to occur with the following:
 if you have, or have had in the past any heart disorder or disease.
 if you have liver disease
 if other members of your family have died suddenly from unexplained causes.
 if you have reduced blood levels of potassium or magnesium
 if you take particular medicines while you are taking Methadone; please read the
section ‘Taking/using other medicines’.
 if you are taking high doses of Methadone (e.g. more than 100 mg per day).
Your doctor may wish to monitor you by doing an ECG either before you start taking
Methadone and/or during treatment. Injections may be painful; check the site of injection
regularly for swelling, reddening or itching.
Always tell your doctor or nurse about any of these conditions or medicines before having
your treatment
Children
Methadone Solution for Injection is not suitable for children under the age of 16 years.
Other medicines and Methadone Solution for Injection
Tell your doctor or pharmacist, if you are taking, have recently taken, or might take any other
medicines, including:
• Medicines used to treat addiction e.g. naltrexone and buprenorphine
• Cimetidine (a medicine used to treat stomach ulcers)
• Metoclopramide or domperidone (medicines used to stop you feeling or being sick)
• Drugs used to treat epilepsy (e.g. phenytoin)

• Mexiletine, a drug used to treat heart irregularities
• Antibiotics (medicines used to treat bacterial infections e.g. ciprofloxacine, rifampicin,
erythromycin and rifabutin)
• Antifungals (medicines used to treat fungal infections e.g. itraconazole and fluconazole)
• Medicines that makes urine more acidic such as ammonium chloride
• Antiviral drugs including some medicines used to treat HIV e.g. nevirapine, zidovudine,
efavirenz, nelfinavir, ritonavir and abacavir
• Medicines used to treat depression known as tricyclic antidepressants, such as amitriptyline,
and selective serotonin re-uptake inhibitors, such as fluvoxamine
• Medicines used to treat severe depression known as monoamine oxidase inhibitors
(MAOIs)
• CNS depressants (medicines that act on the brain and cause drowsiness or sleepiness) e.g
benzodiazepines, chloral hydrate and chlormethiazole
• Other opioid type drugs e.g. morphine
• Medicines used to treat sleep disorders e.g.. sodium oxybate
• Pentazocine (a pain killer)
• Medicines used to help you relax (tranquillisers)
• Cyclizine (an antihistamine used to treat nausea, vomiting and dizziness)
Other medicines you may be taking can also affect the heart. 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 Solution for Injection with food drink and alcohol
You must not drink alcohol whilst you are being treated with Methadone Solution for Injection as this
could cause serious side effects.
You are advised not to drink grapefruit juice whilst you are being treated with Methadone Solution for
Injection as it could cause an overdose.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist before taking this medicine.
Pregnancy
There is not enough evidence of safety of methadone in pregnancy; for the benefit of both you and
your baby, you should seek the advice of a doctor with appropriate experience so specialized care can
be arranged. Babies born to mothers taking methadone may suffer withdrawal symptoms.
Breast-feeding
Methadone gets into breast milk; breast-fed infants may develop their own physical dependence on it.
If breast feeding is considered, your dose of Methadone Solution for Injection should be as low as
possible and you should watch your baby closely for any signs of excessive sleepiness. Remember
your baby could suffer withdrawal symptoms if you either stop taking methadone or stop breast
feeding suddenly. Talk to your doctor so you and your baby get the care required where necessary.
Driving and using machines

The ability to drive or use machines may be severely affected during and after treatment with
Methadone. You must not drive or use machines until you are told that you can do so by your doctor.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
 Do not drive while using 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 and
o You have used it according to the instructions given by the prescriber or in the
information provided with the machines 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 using
this medicine.
3. How to use Methadone Solution for Injection
Methadone Solution for Injection will be given to you by a doctor in a hospital. It will be given under
the skin or into a muscle.
Adults:
For the treatment of drug addiction:
The recommended initial dose is 10-20 mg a day. The dose will be slowly increased until you show
no signs of withdrawal or intoxication. The usual dose is 40-60mg/day. Your doctor will decide what
dose you need and when to reduce the dose.
For the treatment of pain:
The recommended dose is 5-10mg every 6 to 8 hours although your doctor may decide to give you a
different dose. You may be prescribed a different dose if you are elderly, have liver disease or are ill.
The elderly or ill:
If you are elderly or ill, your doctor will only prescribe repeated doses with caution.
Use in Children and adolescents:
Methadone Solution for Injection should not be used in children under the age of 16 years.
If you think you have been given too much Methadone Solution for Injection
The medicine will be given to you by your doctor so it is unlikely you will receive too much. If you
are concerned about your treatment, please talk to your doctor. If you are given too much Methadone
Solution for Injection, you can experience the following:
• Difficulty in breathing
• Extreme sleepiness, fainting or coma
• Small pupils
• Muscle weakness
• Cold and clammy skin
• Slow heartbeat, low blood pressure, heart attack or shock. In severe cases death may occur.
In the event of overdose you should seek medical assistance immediately even if you feel well as you
may be suffering Methadone poisoning.
If you stop having Methadone Solution for Injection
If you stop having Methadone Solution for Injection suddenly you may experience withdrawal
symptoms. If you need to stop having Methadone Solution for Injection your doctor will gradually
reduce the dose.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Stop taking this medicine and see a doctor straightaway if you have any of the following:
• Heart problems. The signs of this may include changes in the way your heart beats, such as it
beating faster or missed heart beats, breathing difficulties and dizziness
• If your breathing become slow and shallow.
Keep taking this medicine but tell your doctor straightaway if you get the following side effect:
• Worsening of the pressure inside your head if you already have this condition following an injury to
your brain or brain disease.
Other side effects
Not known: frequency cannot be estimated from the available data
• Dizziness drowsiness, vertigo
• Restlessness
• Sleep disturbances
• Nausea (feeling sick) or vomiting (being sick)
• Headaches
• Pain and skin irritation at the site of injection
• Rashes or itching
• Sweating
• Reduced blood pressure (you may feel dizzy on standing up)
• Small pupils
• Dry eyes
• Dry nose
• Confusion, mood changes
• • Facial flushing
• Spasms of the tubes from the gall bladder or urinary bladder
• Difficulty passing urine
• Muscles stiffness
• A reduction in sex drive
• Feeling cold (fall in body temperature)
• Redness, swelling and hardening of the skin at the site of injection
• Painful menstruation cramps or absence of period
• Constipation
• High blood levels of the hormone prolactin
• Hearing or seeing things that are not there (hallucinations)
You can become dependent on methadone.
In the case of serious side effects, patients should be kept conscious wherever possible and an airway
established; artificial respiration may be necessary.
Repeated intravenous administration or appropriate antidote medication (nalorphine or levallorphine)
may be required if there is evidence of significant breathing difficulty. Oxygen, intravenous fluids,
drugs to increase blood pressure and other supportive measures should be employed as necessary
according to the severity of the side effect.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 or search for MHRA Yellow Card in the Google Play or Apple App

Store. By reporting side effects, you can help provide more information on the safety of this medicine.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Methadone Solution for Injection
This medicine should not be used if the expiry date on the ampoule has passed or if it shows signs of
deterioration such as discoloration. Do not store above 25°C.
Store in the original packaging in order to protect from light and moisture.
Keep out of the sight and reach of children.
Methadone can be extremely dangerous to children.
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information:
Product Name
Methadone 10mg/ml Solution for Injection

Reference Number
PL 29831/0135

This is a service provided by the Royal National Institute of the Blind.
6.

Contents of the pack and other information

What Methadone Solution for Injection contains:
The active ingredient is Methadone Hydrochloride 10 mg / 1 ml. The other ingredient is water for
injection.
What Methadone Solution for Injection looks like and the content of the pack:
Pack of 10 neutral glass ampoules. Each ampoule contains 1, 2, 3.5, 5, 7.5 or 10ml of solution.
Marketing Authorisation Holder:
Wockhardt UK Ltd
Ash Road North
Wrexham
LL13 9UF
UK
Manufacturer:
CP Pharmaceuticals Ltd
Ash Road North
Wrexham
LL13 9UF
UK
Product licence number: PL 29831 0135
This leaflet was last revised in 09 /2017

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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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