Skip to Content

METHADONE MIXTURE 1MG/1ML DTF

Active substance(s): METHADONE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Physeptone Mixture
Methadone Hydrochloride

(This medicine will be referred to as Physeptone Mixture in this leaflet)
Physeptone Mixture may affect the electrical signals which control
Read all this leaflet carefully before you take Physeptone
your heart contractions, particularly at high doses.
Mixture
• 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 Mixture is and what it is used for
2. Before you take Physeptone Mixture
3. How to take Physeptone Mixture
4. Possible side effects
5. Storing Physeptone Mixture
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 Mixture 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.

2. Before you take Physeptone Mixture
Do not take Physeptone Mixture if:
• you are allergic (hypersensitive) to methadone or any of the
ingredients of this medicine (listed in section 6)
• 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 are suffering from alcoholism
• you are in labour
• you are taking, or have recently stopped taking, a type of
medicine known as Monoamine Oxidase Inhibitors (MAOIs)
which are used to treat depression
• you are at risk of developing an obstruction of the intestine
• 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.
Physeptone Mixture is not suitable for children.
Take special care with Physeptone Mixture
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 are diabetic or you have an intolerance to some sugars.
If any of the conditions above apply to you, please consult your
doctor.

Tell your doctor if:
• you have 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 difficulties with breathing)
• 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 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
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.
Taking Physeptone Mixture with food and drink
You must not drink alcohol whilst you are taking Physeptone
Mixture as this could cause serious side effects.
Pregnancy, breast -feeding and labour
Physeptone Mixture should not be taken during labour. If you
are pregnant or breast-feeding you should discuss this with your
doctor before taking Methadone Mixture.
Continued overleaf

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.

4. Possible side effects
Like all medicines, Physeptone Mixture can cause side effects,
although not everybody gets them.

This medicine can affect your ability to drive and operate machinery Side effects which may occur include:
as it may make you sleepy or dizzy.
• dizziness (including vertigo), drowsiness, hallucinations
• Do not drive while taking this medicine until you know how it
• nausea (feeling sick) or vomiting (being sick), constipation, a dry
affects you.
mouth
• It is an offence to drive if this medicine affects your ability to
• headaches, raised pressure in the brain
drive.
• rashes or itching
• However, you would not be committing an offence if:
• sweating
• The medicine has been prescribed to treat a medical or
• reduced blood pressure (you may feel dizzy on standing up)
dental problem and
• pin point pupils
• You have taken it according to the instructions given by the
• confusion, mood changes
prescriber or in the information provided with the medicine
• fast or slow beating of the heart, a feeling of trembling in the
and
heart
• It was not affecting your ability to drive safely
• facial flushing
• spasms of the tubes from the gall bladder or urinary bladder
Talk to your doctor or pharmacist if you are not sure whether it is
• difficulty in passing water
safe for you to drive while taking this medicine.
• a reduction in sex drive
• a reduction in body temperature.
Important information about some of the ingredients
• dependence on Methadone
Physeptone Mixture contains:
• glycerol which may cause headache, stomach upset and
If any of the side effects get serious or you notice side effects not
diarrhoea
listed in this leaflet please contact your doctor or pharmacist.
• Tartrazine (E102) and sunset yellow (E110) which may cause
allergic reactions.
5. Storing Physeptone Mixture
• 12g of sucrose per maximum daily dose. This should be taken
Keep out of the reach and sight of children.
into account if you suffer from diabetes mellitus. It may also be
harmful to your teeth.
This product has an expiry date on the bottle label. This will have
been checked by your pharmacist or doctor. If you have a product
3. How to take Physeptone Mixture
that has passed the given expiry date, return it to your pharmacist
You must only take Physeptone Mixture by mouth. Under no
or doctor for safe disposal.
circumstances should you inject this product as injection may
cause serious and permanent damage to your body with possibly Store below 25°C and protect from light.
fatal consequences.
Your doctor will tell you how much Physeptone Mixture you need 6. Further information
to take, and how often you need to take it. It is important that you What Physeptone Mixture contains
do not take more than the dose agreed with your doctor. You can The active ingredient is Methadone Hydrochloride 1mg in 1ml.
become dependant on Physeptone Mixture.
The other ingredients are, syrup (contains sucrose), glycerol
Adults:
(E422), hydrochloric acid (E507), sodium hydroxide (for pH
The usual initial dose is 10-20mg a day. The dose will be slowly
adjustment), sodium benzoate (E211), purified water and colours
increased until you show no signs of withdrawal or intoxication.
The usual dose is 40-60mg/day. Your doctor will decide what dose tartrazine (E102), sunset yellow (E110), green S (E142).
you need and when to reduce the dose.
What Physeptone Mixture looks like and the contents of the
pack
Elderly or ill:
Physeptone Mixture is a bright green liquid, supplied in amber
If you are elderly or ill, your doctor will only prescribe repeated
glass bottles, each containing 500, 100, 50 or 30ml of the liquid, or
doses with caution.
it is supplied in HDPE plastic bottles, each containing 5l, 2.5l, 1l or
Children:
500ml of the liquid.
Not recommended. There is a serious risk of poisoning. Remember
Marketing Authorisation Holder and Manufacturer
to keep your medicine safely where children can not get it.
Martindale Pharmaceuticals, Bampton Road, Harold Hill, Essex
If you forget to take Physeptone Mixture
RM3 8UG, UK
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 If this leaflet is difficult to see or read, please contact the
marketing authorisation holder for help.
is almost time for you to take your next dose, miss the dose and
Product licence number:
PL 01883/0018
wait until the next scheduled dose.
This leaflet was last approved in January 2014
DO NOT TAKE A DOUBLE DOSE.
© Martindale Pharmaceuticals
If you take more Physeptone Mixture than you should
If you take too much Physeptone Mixture, 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.

D02773

PACKAGE LEAFLET: INFORMATION FOR THE USER D02773

2773-C

100mm Measurement Verification Bar

DEVELOPMENT ARTWORK
Component Code: D02773
Paper size: 170 x 30mm
Version Control Date

By

Version A Created 30/01/14 AC
Version B

11/02/14 AC

Version C

20/02/14 AC

Version D
Version E
Version F
Version G
Version H
Version I
Version J
Version K
Version L
Version M
Version N
Grand Fromage Creative Ltd
Amherst House, 22 London Road
Sevenoaks, Kent TN13 2BT
t:+44 (0)1732 456 187
e:alan@grand-fromage.co.uk
www.grand-fromage.co.uk

Expand view ⇕

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.

Hide