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METHADONE 10MG/ML INJECTION

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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

D0334800000

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, please 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
Physeptone 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 Physeptone
Solution for Injection is given
You should not be given Physeptone 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
Physeptone Solution for 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Physeptone 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 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
medicines’.
· 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 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
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
alcohol
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.
Pregnancy
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. Babies born to
mothers taking physeptone may suffer withdrawal symptoms.
Continued overleaf

Breast-feeding
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 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 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 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 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:
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
• 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
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 ampoule. 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.
Protect from light.

6. Contents of the pack and other information
What Physeptone Solution for Injection contains:
The active ingredient is Methadone Hydrochloride
10 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 1, 2, 3.5 or
5 ml 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:
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 01883/0058
This leaflet was last revised in April 2017

100mm Measurement Verification Bar

D0334800000

3348-E

DEVELOPMENT ARTWORK
D03348
PIL PHYSEPTONE 10MG/ML
SOL INJ
170 x 296 mm

12/05/16

BM

29/09/16

BM

02/03/17

SM

29/03/17

NF

11/05/17

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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