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PHYSEPTONE 10MG/ML INJECTION

Active substance(s): METHADONE HYDROCHLORIDE

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Driving and using machinery
The ability to drive or use machinery 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.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Physeptone 10mg/ml Injection
Methadone Hydrochloride
(This medicine will be referred to as Physeptone Injection in this leaflet)

D0274200000

Read all of this leaflet carefully before you are given
Physeptone Injection
• Keep this leaflet. You may need to read it again
• If you have any further questions, please ask your doctor
or nurse
• If any of the side effects get serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or nurse
In this leaflet:
1. What Physeptone Injection is and what it is used for
2. Before Physeptone Injection is given
3. How Physeptone Injection is given
4. Possible side effects
5. Storing Physeptone Injection
6. Further information
This leaflet contains a summary of the information available
for this medicine. You should ask your doctor or nurse if you
are unsure about any aspect of this medicine.

1. What Physeptone 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 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. Before Physeptone Injection is given
You should not be given Physeptone Injection if:
• you are allergic (hypersensitive) to methadone or any of the
ingredients of this medicine (listed in section 6)
• you are suffering from alcoholism
• you are in labour
• 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 any problems with your breathing or any chronic
lung disease
• you are having an asthma attack. Do not take your dose
until you have completely recovered
• you have had a head injury and the pressure inside your
brain is higher than it should be (check this with your
doctor). You might be getting bad headaches
• you have been told you are at risk of developing an
obstruction of the intestine
Physeptone Injection is not suitable for children.
If any of the conditions above apply to you, please consult
your doctor.
Take special care with Physeptone Injection
Tell your doctor if:
• you have a history of asthma or breathing difficulties
• you have bowel problems
• you have liver or kidney problems
• you have a history of convulsions, fits or epilepsy
• you have a history of low blood pressure
• you have a history of problems with your adrenal glands or
an underactive thyroid gland
• you have an enlarged prostate gland
• you have a condition that causes severe muscle weakness
and fatigue known as myasthenia gravis
• you think you may be in shock

Physeptone Injection may affect the electrical signals which
control your heart contractions, particularly at high doses.
Tell your doctor if:
• you have a history of heart problems
• you have liver disease
• you have any blood abnormalities such as low levels of
potassium or magnesium
• you have a history of sudden death in the family.
Taking other medicines
Please tell your doctor or nurse if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.
Tell your doctor if you are taking any of the following
medicines:
• 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)
• naloxone (a medicine used to treat difficulties with
breathing)
• mexiletine, a drug used to treat heart irregularities
• antibiotics (medicines used to treat bacterial infections e.g.
ciprofloxacin, rifampicin)
• antifungals (medicines used to treat fungal infections)
• medicines that make 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)
• other opioid type drugs e.g. morphine
• pentazocine (a pain killer)
• medicines used to help you relax (tranquillisers)
• medicines used to help you to sleep (sedatives).
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.
Receiving Physeptone Injection with food and drink
You must not drink alcohol whilst you are being treated with
Physeptone Injection as this could cause serious side effects.
Pregnancy, breast-feeding and labour
Physeptone Injection should not be taken during labour. If you
are pregnant or breast-feeding you should discuss this with
your doctor before being given Physeptone Injection.

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:
• The medicine has been prescribed to treat a medical or
dental problem and
• You have taken it according to the instructions given by
the prescriber or in the information provided with the
medicine and
• 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 Injection is given
Physeptone 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 usual initial dose is 10-20mg 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 usual dose is 5-10mg every 6 to 8 hours for as long as
needed. If you are being given Physeptone Injection for a
prolonged period you should be given a maximum of two
doses daily.
The elderly or ill:
If you are elderly or ill, your doctor will only prescribe repeated
doses with caution.
Children:
Not recommended. There is a serious risk of poisoning.
If you think you have been given too much Physeptone
Injection
This 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 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
methadone poisoning.

4. Possible side effects
Like all medicines, Physeptone Injection can cause side effects,
although not everybody gets them.
Repeated use of methadone can result in tolerance and
addiction.
Side effects which may occur include:
• dizziness
• nausea (feeling sick) or vomiting (being sick)
• headaches, raised pressure in the brain
• pain and skin irritation at the site of injection
• rashes or itching
• sweating
• reduced blood pressure (you may feel dizzy on standing up)
• pin point pupils
• confusion, mood changes
• fast or slow beating of the heart, a feeling of trembling in
the heart
• facial flushing
• spasms in the lower abdomen
• difficulty passing urine
• a reduction in sex drive
• feeling cold
If any of the side effects get serious or you notice side effects
not listed in this leaflet please contact your doctor or nurse.

5. Storing Physeptone Injection
Keep out of the reach and sight of children.
This product has an expiry date on the ampoule label and
carton. Your doctor or nurse will check that this medicine has
not passed the expiry date before it is given to you.
Protect from light.

6. Further information
What Physeptone Injection contains:
The active ingredient is Methadone Hydrochloride 10mg in
1ml.
The other ingredient is water for injections.
What Physeptone Injection looks like and the contents of
the pack:
Physeptone Injection is a clear colourless solution supplied in
clear glass ampoules, each containing 1, 2, 3.5 or 5ml of the
solution. The 2, 3.5 and 5ml ampoules are supplied in packs
of 10. The 1ml ampoules are supplied in packs of both 10 and
100 ampoules.
Marketing Authorisation Holder and Manufacturer:
Martindale Pharmaceuticals, Bampton Road, Harold Hill, Essex
RM3 8UG, UK
Product licence number:
Date of Revision:


PL 01883/0058
January 2014

If this leaflet is difficult to see or read, please
contact the marketing authorisation holder for
help.

If you stop having Physeptone Injection
If you stop having Physeptone Injection suddenly you may
experience withdrawal symptoms.

Continued overleaf
If you need to stop having Physeptone Injection your doctor
will gradually reduce the dose.

100mm Measurement Verification Bar

D0274200000

2742-B

DEVELOPMENT ARTWORK
Component Code: D02742
Paper size: 170 x 296mm mm
Version Control Date

By

Version A Created 21/01/14 HM
Version B

14/05/14 AC

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Grand Fromage Creative Limited
Amherst House, 22 London Road
Riverhead, Sevenoaks, Kent, TN13 2BT, UK
t: 01732 456 187
e: alan@grand-fromage.co.uk
www.grand-fromage.co.uk

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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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