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PHYSEPTONE SF MIXTURE

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

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PACKAGE LEAFLET

Package leaflet: Information for the patient
Physeptone Mixture SF
(Methadone Hydrochloride)
This medicine will be referred to as Physeptone Mixture (Sugar Free) in this leaflet)
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
If you get any of the side effects talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.

What is in this leaflet
1.
What Physeptone Mixture (Sugar Free) is and what it is used for
2.
What you need to know before you take Physeptone Mixture (Sugar Free)
3.
How to take Physeptone Mixture (Sugar Free)
4.
Possible side effects
5.
How to store Physeptone Mixture (Sugar Free)
6.
Contents of the pack and other information
1.

What Physeptone Mixture (Sugar Free) is and what it is used for

Physeptone is a synthetic opiate (a morphine-like drug) used in the treatment of addiction in order to
reduce withdrawal symptoms
2.

What you need to know before you take Physeptone Mixture (Sugar Free)

Do not take Physeptone Mixture (Sugar Free):













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 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 have a bowel problem called ulcerative colitis.
You are dependent on other non-opioid drugs.
You have severe liver disease.
You suffer from sudden involuntary muscle contraction of the bile ducts and kidney.

Physeptone Mixture (Sugar Free) is not suitable for children.
Warnings and precautions
Talk to your doctor or pharmacist before taking Physeptone Mixture (Sugar Free)













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.

If any of the conditions above apply to you, please consult your doctor.
Physeptone 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 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

During treatment, this medicine should not be stopped suddenly, but gradually, as sudden
stoppage could lead to withdrawal symptoms.
Children and adolescents
Physeptone Mixture (Sugar Free) is not suitable for children.
Other medicines and Physeptone Mixture (Sugar Free)

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).
medicines used to treat epilepsy such as phenytoin, carbamazepine, phenobarbital and
primidone.
naloxone ( a medicine used to treat an overdose of opioid medicines).
antibiotics ( medicines used to treat bacterial infections e.g. ciprofloxacin.
antifungals ( medicines used to treat fungal infections).
medicines that make urine more acidic e.g. ammonium chloride.










antiviral medicines including some medicines used to treat HIV e.g. nevirapine,
zidovudine, efavirenz, nelfinavir and ritonavir.
Medicines used to treat depression including fluvoxamine and fluoxetine, tricyclic
antidepressants such as amitriptyline and imipramine, or MAOIs including
moclobemide, must not be taken at the same time or within 2 weeks of taking MAOIs.
CNS depressants ( medicines that act on the brain and cause drowsiness or sleepiness).
Pentazocine ( a pain killer).
Medicines used to help you relax (tranquillisers)
Medicines used to help you to sleep ( sedatives).
Herbal medicines including St John’s Wort.
medicines used to treat tuberculosis ( rifampicin).

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 isnecessary to monitor
your heart with an electrocardiogram (ECG) at the start of treatment to ensure that these
effects do not occur.
Physeptone Mixture (Sugar Free) with food and drink

You must not drink alcohol whilst you are taking Physeptone Mixture (Sugar Free) as this
could cause serious side effects. You are advised not to drink grapefruit juice whilst you are
being treated with Physeptone Mixture (Sugar Free) as it could cause an overdose.
Pregnancy, breastfeeding and labour

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 physeptone 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 (Sugar Free) whilst you are in labour.
Driving and using machinery
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 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 (Sugar Free) contains:
 Colouring agent E110 (sunset yellow) which may cause an allergic reaction.
 Liquid manitol : 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 (Sugar Free)

You must only take Physeptone Mixture (Sugar Free) 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 dependent on
Physeptone Mixture (Sugar Free).
Adults:
The recommended initial dose is 10-20mg a day. The dose will be slowly increased to 40mg60mg each day until you show no signs of withdrawal or intoxication.
Elderly or ill:
If you are elderly or ill, your doctor will only prescribe repeated doses with caution.
Use in Children:

Not recommended. There is a serious risk of poisoning. Remember to keep your medicine
safely where children cannot get it.
If you forget to take Physeptone Mixture (Sugar Free)
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 (Sugar Free)
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 (Sugar Free) than you should
If you take too much Physeptone Mixture (Sugar Free), 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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking this medicine and see a doctor straight away 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 the medicine but tell your doctor straight away if you get any of the
following side effects:
• if you have asthma and it gets worse
• 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



















feeling sick (nausea) or being sick (vomiting)
constipation
sweating a lot more than usual
feeling dizzy, particularly when standing up. This may be a sign
that you have low blood pressure
small pupils
breast growth and production of breast milk
difficulty in passing water (urine), pain in the lower back and
abdomen caused by muscle spasms
dry mouth, eyes or nose, facial flushing
feeling drowsy, confused or restless
changes in your mood, feeling “high” or over excited
seeing or hearing things that are not there (hallucinations)
headache, rashes
low body heat (hypothermia)
painful periods or lack of periods.
High prolactin level in the blood.

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 (Sugar Free).This product contains sunset yellow which
may cause allergic reaction.
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 (Sugar Free)

Keep this medicine out of the sight and reach of children.

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 that has passed the given expiry date, return it to
your pharmacist or doctor for safe disposal. Once you have opened the bottle you are advised
to dispose of it after 4 weeks. Do not store above 25°C.
6.

Contents of the pack and other information

What Physeptone Mixture (Sugar Free) contains
The active ingredient is Methadone Hydrochloride 1mg/1ml.

The other ingredients are Maltitol liquid, Hydrochloric acid, Potassium Sorbate (E202),
purified water and colours E110 (sunset yellow FCF), E142 (green S) and quinoline yellow
(E104).
What Physeptone Mixture (Sugar Free) looks like and the contents of
the pack:
Physeptone Mixture (Sugar Free) is a bright green liquid, supplied in amber glass bottles,
each containing 500, 100, 50 or 30ml of the solution fitted with child resistant closures.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Martindale Pharmaceuticals Ltd, Bampton
Road, Harold Hill, Essex RM3 8UG, U.K
Manufacturers
Macarthys Laboratories Limited
T/A Martindale Pharma
Bampton Road
Romford
Essex
RM3 8UG
United Kingdom
Product license number: PL 00156/0030
This leaflet was last revised in March 2017

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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