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PHYSEPTONE TABLETS

Active substance(s): METHADONE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Physeptone 5mg Tablets
Methadone Hydrochloride

D0275700000

Read all this leaflet carefully before you take Physeptone
Tablets
• Keep this leaflet. You may need to read it again
• If you have any further questions, please ask your doctor or
pharmacist
• This medicine has been prescribed for you personally and you
should not pass it on to others. It may harm them, even if their
symptoms are the same as yours
• 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
pharmacist

In this leaflet:
1. What Physeptone Tablets are and what they are used for
2. Before you take Physeptone Tablets
3. How to take Physeptone Tablets
4. Possible side effects
5. Storing Physeptone Tablets
6. Further information
This leaflet contains a summary of the information available for
this medicine. You should ask your doctor or pharmacist if you are
unsure about any aspect of this medicine.

1. What Physeptone Tablets are and what they are
used for
The active ingredient of this medicine, Methadone Hydrochloride,
is a synthetic opiate (a morphine-like drug) used in the treatment
of moderate to severe pain.

2. Before you take Physeptone Tablets
Do not take Physeptone Tablets if:
• you are allergic (hypersensitive) to methadone or any of the
ingredients of this medicine (listed in section 6)
• you have 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 are suffering from alcoholism
• you are in labour
• you are taking or have recently stopped taking a type of
medicine called Monoamine Oxidase Inhibitors (MAOIs) which
are used to treat depression
• you are at risk of developing an obstruction of the intestine
(paralytic ileus)
• you have any problems 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 suffering from problems with your bowel, such as an
inflammatory bowel disorder
Physeptone Tablets are not suitable for children.
Take special care with Physeptone Tablets
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 under-active thyroid gland, or problems
with your adrenal glands
• you have a history of enlarged prostate gland

• you have a condition that causes severe muscle weakness and
fatigue (myasthenia gravis)
• you are in shock
• you have an intolerance to some sugars
• you have a type of cancer of the adrenal glands known as
phaeochromocytoma.
If you are elderly your doctor will give Physeptone Tablets to you
with special care. If any of the conditions above apply to you,
please consult your doctor.
You should be aware that prolonged use of methadone can result
in tolerance of the drug and both physical and psychological
addiction to methadone. If you have any concerns speak to your
doctor before you are given this medicine.
Physeptone Tablets 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 pharmacist 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 used to treat addiction e.g. naltrexone and
buprenorphine
• cimetidine (a medicine used to treat stomach ulcers)
• drugs used to treat epilepsy (e.g. phenytoin and carbamazepine)
• naloxone (a medicine used to treat an overdose of opioid
medicines)
• antibiotics (medicines used to treat bacterial infections)
• antifungals (medicines used to treat fungal infections)
• medicines that make urine more acidic e.g. ammonium chloride
• antiviral drugs including some medicines used to treat HIV
e.g. nevirapine, zidovudine, efavirenz, nelfinavir, ritonavir and
abacavir
• metoclopramide or domperidone (medicines used to stop you
feeling and being sick)
• mexiletine (a drug used to treat heart irregularities)
• medicines used to treat depression including fluvoxamine,
tricyclic antidepressants such as amitriptyline and imipramine,
or MAOIs including moclobemide
• CNS depressants (medicines that act on the brain and can cause
drowsiness or sleepiness)
• other opioid type drugs e.g. morphine
• pentazocine (a pain killer)
• medicines used to help you relax (tranquilisers)
• medicines used to help you 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
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.
Continued overleaf

Taking Physeptone Tablets with food and drink
You must not drink alcohol whilst you are taking Physeptone
Tablets as this could cause serious side effects.
Pregnancy, breast-feeding and labour
Physeptone Tablets should not be taken during labour. If you
are pregnant or breast-feeding you should discuss this with your
doctor before taking Physeptone Tablets.
Driving and using machinery
The ability to drive or use machinery may be severely affected
during and after treatment with methadone. 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:
• 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.
Important information about some of the ingredients
Physeptone Tablets contain:
• glycerol: which may cause headache, stomach upset and
diarrhoea
• lactose: if you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking
this medicinal product.

3. How to take Physeptone Tablets
Your doctor will tell you how many Physeptone Tablets you need
to take, and how often you need to take them. It is important that
you do not take more than the dose agreed with your doctor. You
can become dependant on Physeptone Tablets.
Adults:
The usual initial dose is 5-10mg (1 to 2 tablets) every 6 to 8 hours.
The dose may be adjusted depending on the level of pain relief
you need.
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.
Remember to keep your medicine safely where children can not
get it.
If you forget to take Physeptone Tablets
During a course of treatment it is important that, should you miss a
dose, you take the dose as soon as you remember. However, if it is
almost time for you to take your next dose, miss the dose and wait
until the next scheduled dose.
DO NOT TAKE A DOUBLE DOSE.
If you take more Physeptone Tablets than you should
If you take too many Physeptone Tablets, you can experience the
following:
• difficulty in breathing
• extreme sleepiness, fainting or coma
• pin point pupils
• swelling and/or fluid accumulation in the lungs
• low blood pressure.
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 Tablets 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 (including vertigo), drowsiness, hallucinations
• nausea (feeling sick) or vomiting (being sick), constipation, a dry
mouth
• headaches
• 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 of the tubes from the gall bladder or urinary bladder
• difficulty in passing water
• a reduction in sex drive
• a reduction in body temperature
• dependence on methadone.
If any of the side effects get serious or you notice side effects not
listed in this leaflet please contact your doctor or pharmacist.

5. Storing Physeptone Tablets
Keep out of the reach and sight of children.
This product has an expiry date on the bottle label or carton. This
will have been checked by your pharmacist or doctor. If you have
a product that has passed the given expiry date, return it to your
pharmacist or doctor for safe disposal.
Store below 25°C.

6. Further information
What Physeptone Tablets contain:
The active ingredient is Methadone Hydrochloride 5mg per tablet.
The other ingredients are lactose, maize starch, gelatine, glycerol
and magnesium stearate.
What Physeptone Tablets looks like and the contents of the
pack:
Physeptone Tablets are plain white tablets supplied either in
amber glass bottles, each containing 100 tablets or in plastic blister
packs, each containing 50 tablets.
Marketing Authorisation Holder:
Martindale Pharmaceuticals, Bampton Road, Harold Hill, Essex RM3
8UG, UK
Manufacturer:
Dales Pharmaceuticals Ltd., Snaygill Industrial Estate,
Keighley Road, Skipton, North Yorkshire. BD23 2RW
Product licence number: PL 01883/0062
Date of Revision: January 2014
If this leaflet is difficult to see or read, please contact the
marketing authorisation holder for help.

D0275700000

100mm Measurement Verification Bar

2757-B

DEVELOPMENT ARTWORK
Component Code: D02757
Paper size: 180 x 255mm
Version Control Date

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Version A Created 21/01/14 HM
Version B

02/04/14 HM

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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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