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PHYSEPTONE 25MG/ML INJECTION

Active substance(s): METHADONE HYDROCHLORIDE / METHADONE HYDROCHLORIDE / METHADONE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Physeptone 25mg/ml Solution for Injection
Methadone Hydrochloride

D037280000

(This medicine will be referred to as Physeptone Solution for Injection in this leaflet)
extreme muscle fatigue)
Read all of this leaflet carefully before you are given
• if you suffer from certain types of heart disorders. These
Physeptone Solution for Injection because it contains
types of heart disorder are usually confirmed after an
important information for you.
electrocardiogram (ECG) has been performed and may be
• Keep this leaflet. You may need to read it again
more likely to occur with the following:
• If you have any further questions, ask your doctor or nurse
– if you have, or have had in the past any heart disorder or
• If you get any side effects, talk to your doctor or nurse.
disease.
This includes any possible side effects not listed in this
– if you have liver disease
leaflet. See section 4.
– if other members of your family have died suddenly from
unexplained causes.
What is in this leaflet
– if you have reduced blood levels of potassium or
1. What Physeptone Solution for Injection is and what
magnesium
it is used for
– if you take particular medicines while you are taking
2. What you need to know before Physeptone Solution for
Physeptone; please read the section ‘Taking/using other
Injection is given
medicines’.
3. How Physeptone Solution for Injection is given
– if you are taking high doses of Physeptone (e.g. more than
4. Possible side effects
100 mg per day).
5. How to store Physeptone Solution for Injection
Your doctor may wish to monitor you by doing an ECG either
6. Contents of the pack and other information
before you start taking Physeptone and/or during treatment.
may be painful; check the site of injection regularly
1. What Physeptone Solution for Injection is and Injections
for swelling, reddening or itching.
what it is used for
Always tell your doctor or nurse about any of these conditions
or medicines before having your treatment
The active ingredient of this medicine, Methadone
Hydrochloride, is a synthetic opiate (a morphine- like drug) used Other medicines and Physeptone Solution for Injection
in the treatment of addiction in order to reduce withdrawal
Tell your doctor or pharmacist, if you are taking, have recently
symptoms.
taken, or might take any other medicines.
• Medicines used to treat addiction e.g. naltrexone, naloxone
2. What you need to know before Physeptone
and buprenorphine
Solution for Injection is given
• Cimetidine (a medicine used to treat stomach ulcers)
• Metoclopramide or domperidone (medicines used to stop
You should not be given Physeptone Solution for Injection if:
you feeling or being sick)
• You are allergic to methadone hydrochloride or any of the
• Drugs used to treat epilepsy (e.g. phenytoin)
ingredients of this medicine ( listed in section 6).
• Mexiletine, a drug used to treat heart irregularities
• You are not already receiving physeptone. This is a high
• Antibiotics (medicines used to treat bacterial infections e.g.
concentration and is not suitable for people who have not
ciprofloxacin, rifampicin,erythromycin and rifabutin)
taken physeptone before.
• Antifungals (medicines used to treat fungal infections) e.g
• You have any problem with your breathing or any chronic
itraconazole and fluconazole
lung disease such as chronic obstructive pulmonary disease

Medicines that makes urine more acidic such as ammonium
• You are having an asthma attack. Do not take your dose
chloride
until you have completely recovered.
• Antiviral drugs including some medicines used to treat HIV
• You are taking, or have stopped taking within the last two
e.g. nevirapine, zidovudine, efavirenz, nelfinavir, ritonavir
weeks, a type of medicine known as monoamine oxidase
and abacavir
inhibitors (MAOIs) which are used to treat depression
• Medicines used to treat depression known as tricyclic
• You have pheochromocytoma, a tumour of the adrenal
antidepressants, such as amitriptyline, and selective
glands.
serotonin re-uptake inhibitors, such as fluvoxamine
• You have a bowel disorder known as paralytic ileus

Medicines used to treat severe depression known as
• You have loss of consciousness
monoamine oxidase inhibitors (MAOIs)
Physeptone Injection is not suitable for children under the
• CNS depressants (medicines that act on the brain and cause
age of 16 years.
drowsiness or sleepiness) e.g benzodiazepines, chloral
hydrate and chlormethiazole
If any of the conditions above apply to you, please consult
• Other opioid type drugs e.g. morphine
your doctor.
• Medicines used to treat sleep disorders e.g. sodium oxybate
Warnings and precautions
• Pentazocine (a pain killer)
Talk to your doctor or pharmacist before taking Physeptone
• Medicines used to help you relax (tranquillisers)
Solution for Injection
• Cyclizine (an antihistamine used to treat nausea, vomiting
• because it can be addictive.
and dizziness)
• only use the dose prescribed for you by your doctor because
Other
medicines you may be taking can also affect the heart.
higher doses could be fatal. Without you knowing, the
You must tell your doctor about any other medicines that you
levels of the drug can build up in your body and affect
are taking as they may be dangerous if they are taken with
your breathing, causing drowsiness and possible loss of
Physeptone. In these situations your doctor may decide that it
consciousness.
is necessary to monitor your heart with an electrocardiogram
• if you have increased pressure on the brain or have just had
(ECG) at the start of treatment to ensure that these effects do
a head injury.
not occur.
• if you are suffering from acute alcoholism.
Physeptone Solution for Injection with food, drink and
• if you are suffering from mental illness brought on by an
alcohol
infection
You must not drink alcohol whilst you are being treated with
• if you have liver problems
Physeptone Solution for Injection as this could cause serious
·if you have kidney problems
side effects.
• if you have problems with your bile duct
You are advised not to drink grapefruit juice whilst you are being
• if you suffer from an enlarged prostate gland (in men) or
treated with Physeptone Solution for Injection as it could cause
have difficulty passing urine
an overdose.
• if you have an under-active thyroid or adrenal gland.
• if you have low blood pressure
Pregnancy
• if you are in a state of severe shock
There is not enough evidence of safety of physeptone
• if you are very run down and feeling weak
in pregnancy; for the benefit of both you and your baby,
• if you have bowel disease, such as Crohn’s disease or
you should seek the advice of a doctor with appropriate
ulcerative colitis
experience so specialized care can be arranged. Babies born to
• if you suffer from convulsions (fits)
mothers taking physeptone may suffer withdrawal symptoms.
• if you are a child. Even at low doses Physeptone is a special
Breast-feeding
hazard to children if taken accidentally. Children under 6
Physeptone gets into breast milk; breast-fed infants may
months, particularly newborns, may be more sensitive to
develop their own physical dependence on it. If breast feeding
breathing difficulties than adults
is considered, your dose of Physeptone Solution for Injection
• if you are elderly
• if you have myasthenia gravis (a disorder that causes

Continued overleaf

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
necessary.
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
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 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 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 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:
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
disease.
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 up)
• Small pupils
• Confusion, mood changes
• Fast, slow beating of the heart, a feeling of trembling in the
heart
• Facial flushing
• Spasms of the tubes from the gall bladder or urinary
bladder
• 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
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 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 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 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 protect from light.

6. Contents of the pack and other information
What Physeptone Solution for Injection contains:
The active ingredient is Methadone Hydrochloride 25 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 2ml 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
Romford
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 01883/0063
This leaflet was last revised in: April 2017

D03728

3728-B

100mm Measurement Verification Bar

DEVELOPMENT ARTWORK
D03728
25mg/ml PIL Physeptone UK PL
01883/0063
170 x 220mm

03/04/17

NF

07/04/17

NF

Expand Transcript

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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