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METHADONE MIXTURE 1MG/1ML DTF

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

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D03676

Physeptone Mixture
Methadone Hydrochloride

(This medicine will be referred to as Physeptone Mixture in this leaflet)
• cimetidine (a medicine used to treat stomach ulcers)
Read all this leaflet carefully before you take Physeptone
• drugs used to treat epilepsy (e.g. phenytoin, phenobarbital,
Mixture because it contains important information for you.
primidone and carbamazepine)
• Keep this leaflet. You may need to read it again.
• naloxone (a medicine used to treat difficulties with breathing)
• If you have any further questions, ask your doctor or
• antibiotics (medicines used to treat bacterial infections)
pharmacist.
• antifungals (medicines used to treat fungal infections)
• This medicine has been prescribed for you only. Do not pass
• medicines that make urine more acidic e.g. ammonium chloride
it on to others. It may harm them, even if their signs of illness
• antiviral drugs including some medicines used to treat HIV
are the same as yours.
e.g. nevirapine, zidovudine, efavirenz, nelfinavir, ritonavir and
• If you get any side effects, talk to your doctor, or pharmacist
abacavir
or nurse. This includes any possible side effects not listed in

metoclopramide or domperidone (medicines used to stop you
this leaflet. See section 4.
feeling and being sick)
• mexiletine (a drug used to treat heart irregularities)
What is in this leaflet
• medicines used to treat depression including fluvoxamine,
1. What Physeptone Mixture is and what it is used for
tricyclic antidepressants such as amitriptyline and imipramine,
2. What you need to know before you take Physeptone Mixture
or MAOIs including moclobemide, must not be taken at the
3. How to take Physeptone Mixture
same time or within 2 weeks of taking MAOIs,
4. Possible side effects
• CNS depressants (medicines that act on the brain and cause
5. How to store Physeptone Mixture
drowsiness or sleepiness)
6. Contents of the pack and other information
• other opioid type drugs e.g. morphine
(a pain killer)
1. What Physeptone Mixture is and what it is used •• pentazocine
medicines used to help you relax (tranquillisers)
for
• medicines used to help you to sleep (sedatives).
• herbal medicines including St John’s Wort
Physeptone is a synthetic opiate (a morphine-like drug) used
• medicines used to treat diarrhoea (loperamide)
in the treatment of addiction in order to reduce withdrawal
• medicines used to treat tuberculosis (rifampicin)
symptoms.
• medicines used to treat certain mental and emotional
2. What you need to know before you take
conditions (anti-psychotics)

Physeptone Mixture

Do not take Physeptone Mixture if:
• You are allergic to methadone or any of the ingredients of this
medicine ( listed in section 6).
• You have any problem with your breathing, any chronic lung
disease or have an asthma attack.
• You are addicted to alcohol.
• 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 have a bowel disorder known as paralytic ileus.
• You are taking, or have recently stopped taking , a type of
medicine called Monoamine Oxidase Inhibitors (MAOIs)
,including moclobemide which are used to treat depression,
within the past two weeks.
• You are in labour.
• You are a child.
• You are dependent on other non-opioid drugs.
• You have phaeochromocytoma, a tumour of the adrenal glands.
Warnings and precautions
Talk to your doctor or pharmacist before taking Physeptone
Mixture if:
• You are extremely ill or an older person. You may be more
sensitive to the medicine.
• You have 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 taking medicines called CNS depressants to treat
anxiety, acute stress and panic attacks.
During treatment, this medicine should not be stopped suddenly,
but gradually, as sudden stoppage could lead to withdrawal
symptoms.
Physeptone Mixture may affect the electrical signals which control
your heart contractions, particularly at high doses.
Tell your doctor you have recognised risk factors for the heart
condition ‘QT prolongation’ that include 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.
Other medicines and Physeptone Mixture
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

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 Mixture with food, drink and alcohol
You must not drink alcohol whilst you are taking Physeptone
Mixture as this could cause serious side effects.
You are advised not to drink grapefruit juice whilst you are being
treated with Physeptone Mixture as it could cause an overdose.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist
before taking this medicine.
Pregnancy:
If used during pregnancy, your baby may suffer from withdrawal
syndromes. Take care if you are taking a pregnancy test as the
medicine may interfere with the results.
Breast-feeding:
If you breast-feed whilst taking this medicine, small amounts can
pass to the baby in the breast milk.
Labour:
You should not take Physeptone Mixture whilst you are in labour.
Driving and using machines
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.
This medicine can affect your ability to drive and operate
machinery 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 Mixture contains:
• glycerol which may cause headache, stomach upset and diarrhoea
• Tartrazine (E102) and sunset yellow (E110) which may cause
allergic reactions.
• 26.49g of demineralised liquid sucrose per maximum daily
dose. This should be taken into account if you suffer from
diabetes mellitus. It may also be harmful to your teeth.
Continued overleaf

3. How to take Physeptone Mixture
You must only take Physeptone Mixture by mouth. Under no
circumstances should you inject this product as injection may
cause serious and permanent damage to your body with possibly
fatal consequences.
Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are
not sure. It is important that you do not take more than the
dose agreed with your doctor. You can become dependant on
Physeptone Mixture.
Adults:
For the treatment of drug addiction:
The recommended 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.
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 Mixture
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.
If you stop taking Physeptone Mixture
Do not stop taking your medicine except on medical advice,
because your withdrawal symptoms may come back.
DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR A
FORGOTTEN DOSE.
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.

4. Possible side effects

• build-up of fluid in the lungs
• dry nose
• dry mouth
• swollen, red, sore tongue
• swelling of the hip, knee, feet and ankle joints
• difficulty in passing water(urine), pain in the lower back and
abdomen caused by muscle spasms
• lower sexual urge or desire
• painful periods or lack of periods
• low body heat(hypothermia)
• unusual weakness (asthenia)
• disorder of the biliary part of the digestive system (bile duct
dyskinesia)
Not known (frequency cannot be estimated from the available
data):
• High prolactin levels in the blood
• Rapid, uncontrollable movements of the eyes
You may notice that some of the side effects become less severe
with time as you get used to this medicine. When taken for a long
period of time, it is possible that you may become dependent on
Physeptone Mixture.
This product contains sunset yellow which may cause allergic
reaction.
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 Mixture
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 bottle. 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.
Store below 25°C and protect from light.

6. Contents of the pack and other information
What Physeptone Mixture contains
The active ingredient is Methadone Hydrochloride 1mg in 1ml.
The other ingredients are, demineralised liquid sucrose, glycerol
(E422), hydrochloric acid (E507), sodium hydroxide (for pH
adjustment), sodium benzoate (E211), purified water and colours
tartrazine (E102), sunset yellow (E110), green S (E142).

What Physeptone Mixture looks like and the contents of the
pack
Physeptone Mixture is a bright green liquid, supplied in amber
Stop taking this medicine and see a doctor straightaway if you glass bottles, each containing 500, 100, 50 or 30ml of the liquid, or
it is supplied in HDPE plastic bottles, each containing 5l, 2.5l, 1l or
have any of the following:
500ml of the liquid.
• If you have asthma and it gets worse
• Worsening of the pressure inside your head if you already have
Not all pack sizes may be marketed.
this condition following an injury to your brain or brain disease.
• Severe itching of your skin with raised lumps
Marketing Authorisation Holder and Manufacturer
Macarthys Laboratories Ltd T/A Martindale Pharma, Bampton
Other possible side effects
Road, Harold Hill, Romford, Essex, RM3 8UG, United kingdom
Very common (may affect more than 1 in 10 people):
Manufacturers:
• Feeling sick (nausea) or being sick (vomiting)
Macarthys Laboratories Limited T/A Martindale Pharma,
Common (may affect up to 1 in 10 people):
Bampton Road, Romford, Essex, RM3 8UG, United Kingdom
• changes in your mood, feeling ‘high’ or over excited
Or
• seeing or hearing things that are not there (hallucinations)
Dales Pharmaceuticals Limited, Snaygill Industrial Estate, Keighley
• drowsiness or sleepiness ( sedation)
Road, Skipton, North Yorkshire, BD23 2RW, United Kingdom
• blurred vision
• dry eyes
If this leaflet is difficult to see or read, please contact the
• small pupils
marketing authorisation holder for help.
• dizziness, spinning sensation
Product licence number:
PL 01883/0018
• constipation
This leaflet was last approved in May 2017
• rash
© Martindale Pharmaceuticals
• sweating
• tiredness
• drowsiness
• weight increase
Like all medicines, Physeptone Mixture can cause side effects,
although not everybody gets them.

Uncommon (may affect up to 1 in 100 people):
• feeling tense and restless
• addiction to this medicine
• agitation
• inability to sleep
• reduced sexual drive
• disorientation
• facial flushing
• feeling dizzy, particularly when standing up. This may be a sign
that you have low blood pressure
• headache
• fainting

D03676

PACKAGE LEAFLET: INFORMATION FOR THE USER

3676-C

100mm Measurement Verification Bar

DEVELOPMENT ARTWORK
D03676
Methadone PIL Physeptone UK PL
01883/0118 Mixture
170 x 285mm

02/03/17

MA

15/03/17

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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