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PHYSEPTONE 1MG/ML ORAL SOLUTION SUGAR-FREE

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

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Package leaflet: Information for the user

D03391

You must only take Physeptone Oral Solution 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.

Physeptone 1mg/1ml Oral Solution sugar-free
Methadone Hydrochloride

(This medicine will be referred to as Physeptone Oral Solution in this leaflet)
Read all of this leaflet carefully before you start taking
Physeptone Oral Solution 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 side effects, talk to your doctor, or pharmacist
or nurse. This includes any possible side effects not listed in
this leaflet. See section 4.

What is in this leaflet
1. What Physeptone Oral Solution is and what it is used for
2. What you need to know before you take Physeptone Oral
Solution
3. How to take Physeptone Oral Solution
4. Possible side effects
5. How to store Physeptone Oral Solution
6. Contents of the pack and other 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 Oral Solution is and what it is
used for
Methadone 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 Oral Solution
Do not take Physeptone Oral Solution 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 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 Oral Solution is not suitable for children.
Warnings and precautions
Talk to your doctor or pharmacist before taking Physeptone
Oral Solution 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.
Methadone 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.

3. How to take Physeptone Oral Solution

Children and adolescents
Physeptone Oral Solution is not suitable for children.
Other medicines and Physeptone Oral Solution
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).
• 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
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.
Physeptone Oral Solution with food and drink
You must not drink alcohol whilst you are taking Physeptone Oral
Solution as this could cause serious side effects.
You are advised not to drink grapefruit juice whilst you are being
treated with this medicine as it could cause an overdose
Pregnancy, breast-feeding and labour
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:
If used during pregnancy, your baby may suffer from withdrawal
syndromes. Take care if you are taking a pregnancy test as
methadone 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 Oral Solution 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 methadone. 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 Oral Solution contains:
• Colouring agent E110 (sunset yellow) which may cause an
allergic reaction.
• liquid maltitol - If you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor before
taking this medicinal product.

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 an allergic reaction to Physeptone Oral Solution.
An allergic reaction may include:
• swelling of your face, lips, tongue or throat or difficulty
breathing or swallowing
• severe itching of your skin with raised lumps.
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 excessive 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

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 Oral Solution
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.
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 Oral Solution contains:
The active ingredient is Methadone Hydrochloride 1mg/1ml.
The other ingredients are Maltitol liquid, Hydrochloric acid,
sodium benzoate (E211), purified water and colours E110 (sunset
yellow FCF), E142 (green S) and quinoline yellow (E104).
What Physeptone Oral Solution looks like and the contents of
the pack:
Physeptone Oral Solution is a bright green liquid, supplied in
amber glass bottles, each containing 500, 100, 50 or 30ml of the
solution, or it is supplied in HDPE plastic bottles, each containing
5L, 2.5L, 1L or 500ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Martindale Pharmaceuticals Ltd, T/A Martindale Pharma, Bampton
Road, Harold Hill, Essex RM3 8UG, UK
Manufacturers
Macarthys Laboratories Limited
T/A Martindale Pharma
Bampton Road
Romford
Essex
RM3 8UG
United Kingdom
Or
Dales Pharmaceuticals Limited
Snaygill Industrial Estate
Keighley Road
Skipton
North Yorkshire
BD23 2RW
United Kingdom
Product licence number: PL 00156/0320
This leaflet was last revised in: February 2017
If this leaflet is difficult to see or read, please contact the
marketing authorisation holder for help.

You may notice that some of the side effects become less severe
with time as you get used to the methadone.
D03391

During treatment, this medicine should not be stopped suddenly,
but gradually, as sudden stoppage could lead to withdrawal
symptoms.

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 Oral Solution.
Adults:
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 per day.
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 can not get it.
If you forget to take Physeptone Oral Solution
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 TO MAKE UP FOR A
FORGOTTEN DOSE.
If you stop taking Physeptone Oral Solution
Do not stop taking your medicine except on medical advice,
because your withdrawal symptoms may come back.
If you take more Physeptone Oral Solution than you should
If you take too much Physeptone Oral Solution, 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.

When taken for a long period of time, it is possible that you may
become dependent on Physeptone Oral Solution.

Continued overleaf

100mm Measurement Verification Bar

3391-E

DEVELOPMENT ARTWORK
D03391
PIL PHYSEPTONE S/F (0320)

292 x 170mm

31/05/16

BM

26/09/16

BM

06/02/17

SM

23/02/17

SM

15/03/17

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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