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Babies born to mothers taking physeptone may suffer
withdrawal symptoms.


Physeptone 50mg/ml Solution for Injection
Methadone Hydrochloride
(This medicine will be referred to as Physeptone Solution for Injection in this leaflet)


Read all of this leaflet carefully before you are given
Physeptone Solution for Injection 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 nurse
• If you get any side effects, talk to your doctor or nurse.
This includes any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet:
1. What Physeptone Solution for Injection is and what it is
used for
2. What you need to know before Physeptone Solution for
Injection is given
3. How Physeptone Solution for Injection is given
4. Possible side effects
5. How to store Physeptone Solution for Injection
6. Contents of the pack and other information
1. What Physeptone Solution for Injection is and what it is
used for
The active ingredient of this medicine, Methadone
Hydrochloride, is a synthetic opiate (a morphine- like
drug) used in the treatment of addiction in order to reduce
withdrawal symptoms.
2. What you need to know before Physeptone Solution for
Injection is given
You should not be given Physeptone Solution for Injection
• You are allergic to methadone or any of the ingredients of
this medicine ( listed in section 6).
• You are not already receiving physeptone. This is a high
concentration and is not suitable for people who have not
taken physeptone before.
• 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
• You have a bowel disorder known as paralytic ileus
• You have loss of consciousness
Physeptone Injection is not suitable for children under the
age of 16 years.
If any of the conditions above apply to you, please consult
your doctor.
Warning and precautions
Talk to your doctor before taking because it can be
• 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
• 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
• 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
• Iif you suffer from convulsions (fits)
• If you are a child. Even at low doses Physeptone 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
Physeptone; please read the section ‘Taking/using other
• If you are taking high doses of Physeptone (e.g. more than
100 mg per day).
Your doctor may wish to monitor you by doing an ECG either
before you start taking Physeptone 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
Other medicines and Physeptone Solution for Injection
Tell your doctor or pharmacist, if you are taking, have recently
taken, or might take any other medicines.
• Medicines used to treat addiction e.g. naltrexone, naloxone
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. ciprofloxacin, 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
• 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
Physeptone. 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.
Physeptone solution for Injection with food, drink and
You must not drink alcohol whilst you are being treated with
Physeptone solution for Injection as this could cause serious
side effects.
You are advised not to drink grapefruit juice whilst you are
being treated with Physeptone solution for Injection as it
could cause an overdose.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast feeding, think you maybe
pregnant or are planning to have a baby, ask your doctor or
pharmacist before taking this medicine.
There is not enough evidence of safety of physeptone
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.

Physeptone gets into breast milk; breast-fed infants may
develop their own physical dependence on it. If breast feeding
is considered, your dose of Physeptone 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 physeptone or stop breast feeding suddenly. Talk to
your doctor so you and your baby get the care required where
Driving and using machines
The ability to drive or use machines may be severely affected
during and after treatment with physeptone. You must not
drive or use machinery 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 taking this medicine until you know how
it affects you
• It is an offence to drive if this medicine affects your ability to
• 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 taken 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 taking this medicine.
3. How Physeptone Solution for Injection is given
Physeptone Solution for Injection will be given to you by a
doctor in a hospital. It may be given as an injection into a vein,
under the skin or into a muscle.
For the treatment of drug addiction:
The recommended initial dose is 10-20 mg a day. The dose
will be slowly increased by 10-20mg until you show no signs
of withdrawal or intoxication. The dose may need to be over
100mg daily (depending of the level of tolerance you have to
Physeptone) in order to prevent withdrawal symptoms.
The elderly or ill:
If you are elderly or ill, your doctor will only prescribe repeated
doses with caution.
Use in Children and adolescents
Physeptone Solution for Injection should not be used in
children under the age of 16 years.
If you think you have been given too much Physeptone
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 Physeptone Solution for Injection, you can experience
the following:
• Difficulty in breathing
• Extreme sleepiness, fainting or coma
• Pin point 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
Physeptone poisoning.
If you stop having Physeptone Solution for Injection
If you stop having Physeptone Solution for Injection suddenly
you may experience withdrawal symptoms. If you need to
stop having Physeptone 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.
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
Other side effects
• Dizziness
• 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
• small pupils
• Confusion, mood changes
• Fast, slow beating of the heart, a feeling of trembling in
• Facial flushing
• Spasms of the tubes from the gall bladder or urinary
• Difficulty passing urine
• A reduction in sex drive
• Feeling cold (fall in body temperature)
• Redness, swelling and hardening of the skin at the site of
• 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 physeptone.
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 By reporting side
effects, you can help provide more information on the safety
of this medicine.
5. How to store Physeptone Solution for Injection
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated
on the ampoules. The expiry date refers to the last date of that
month. Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help protect
the environment.
Do not store above 25°C and Keep container in the outer
6. Contents of the pack and other information
What Physeptone Solution for Injection contains:
The active ingredient is Methadone Hydrochloride 50 mg / 1
ml. The other ingredient is water for injection.
What Physeptone Solution for Injection looks like and the
content of the pack:
Physeptone Solution for Injection is a clear colourless solution
supplied in clear glass ampoules, each containing 1ml of
solution packed into a cardboard carton. Each pack contains
10 ampoules.
Marketing Authorisation Holder:
Macarthys Laboratories Ltd
T/A Martindale Pharma
Bampton Road
Harold Hill
Essex, RM3 8UG
United kingdom
Manufacturer: Macarthys Laboratories Limited T/A
Martindale Pharma, Bampton Road, Harold Hill, Romford,
Essex, RM3 8UG, UK
Product licenced number: PL 01883/0064
This leaflet was last revised in: April 2017

Continued overleaf

100mm Measurement Verification Bar

296 x 170mm





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