Skip to Content

PHYSEPTONE TABLETS

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

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER

Physeptone Hydrochloride 5mg Tablets
Methadone Hydrochloride
Read all of this leaflet carefully before you start taking
Physeptone Hydrochloride Tablets because it contains
important information for you.
• 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 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. This includes any possible side effects not
listed in this leaflet. See section 4.

What is in this leaflet:
1. What Physeptone Hydrochloride Tablets are and what they
are used for
2. What you need to know before you take Physeptone
Hydrochloride Tablets
3. How to take Physeptone Hydrochloride Tablets
4. Possible side effects
5. How to store Physeptone Hydrochloride Tablets
6. Contents of the pack and other information

1. What Physeptone Hydrochloride 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.
You must talk to a doctor if you do not feel better or if you feel worse.

2. What you need to know before you take Physeptone
Hydrochloride Tablets
Do not take Physeptone Hydrochloride Tablets 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 an acquired or inherited heart condition which is
characterized by irregular heartbeats.
• You have severe liver disease.
• You suffer from sudden involuntary muscle contraction of the bile ducts
and kidney.
Physeptone Hydrochloride Tablets are not suitable for children.
Warnings and precautions
Talk to your doctor or pharmacist before taking Methadone Tablets 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 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 Hydrochloride Tablets 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.
Other medicines and Methadone Tablets
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.
• Medicines used to treat epilepsy such as phenytoin and carbamazepine
• Naloxone (a medicine used to treat an overdose of opioid medicines).
• Antibiotics (medicines used to treat bacterial infections e.g.
ciprofloxacin, erythromycin, telithromycin and clarithromycin).
• Antifungals (medicines used to treat fungal infections) e.g fluconazole,
itranozole, ketoconaloz
• Medicines that make urine more acidic e.g. ammonium chloride and
ascorbic acid.
• Antiviral medicines including some medicines used to treat HIV e.g.
nevirapine, zidovudine, delavirdine, lopinavir, saquinavir, didanosine,
stavudine, efavirenz, nelfinavir, amprenavir and ritonavir.
• Medicines used to treat depression including fluvoxamine, nefazodone,
paroxetine, sertralinie and fluoxetine 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).
• St John’s Wort- a herbal preparation for depression
• Medicines used to treat heart irregularities e.g quinidine, mexiletine,
verapamil, amiodarone, sotalol, flecainide
• Medicines that suppress the immune system e.g ciclosporin,
dexamethasone
• Medicines used to treat certain mental and emotional conditions. (antipsychotics) e.g thioridazine, haloperidol, sertindole, and phenotiazines
• Medicines used to treat high blood pressure e.g spironolactone
• Medicines used to treat diarrhoea e.g Loperamide
• Medicines used to treat allergies e.g diphenhydramine
• Medicines used to treat tuberculosis e.g 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 Hydrochloride Tablets with food and drink
You must not drink alcohol whilst you are taking Physeptone Hydrochloride
Tablets as this could cause serious side effects. You are advised not to drink
grapefruit juice whilst you are being treated with Methadone tablets as it
could cause an overdose
Pregnancy, breast-feeding and fertility
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 Methadone Tablets 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 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:
Continued overleaf

• 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 Hydrochloride 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 Hydrochloride Tablets
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 Hydrochloride Tablets.
Adults:
The recommended 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.
Use in children and adolescents
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 Hydrochloride 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 TO MAKE UP FOR A
FORGOTTEN DOSE.
If you stop taking Methadone Tablets
Do not stop taking your medicine except on medical advice.
If you take more Physeptone Hydrochloride Tablets than you should
If you take too many Physeptone Hydrochloride 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, this medicine can cause side effects, although not
everybody gets them.
Repeated use of methadone can result in tolerance and addiction.
Stop taking this medicine and see a doctor straight away if you get
any of the following side effects:
• 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
• Worsening of the pressure inside your head if you already have this
condition following an injury to your brain or brain disease.
• Severe itching of your skin with raised lumps
• Low blood platelet count. Symptoms include bleeding or bruising
more easily than normal
Other possible side effects
Very common (may affect more than 1 in 10 people):
• Feeling sick (nausea) or being sick (vomiting)
Common (may affect up to 1 in 10 people):
• fluid retention due to slow metabolism
• changes in your mood, feeling ‘high’ or over excited
• seeing or hearing things that are not there (hallucinations)
• low magnesium levels in the blood
• drowsiness or sleepiness ( sedation)
• blurred vision
• small pupils

• dizziness, spinning sensation
• constipation
• rash
• sweating
• tiredness
• weight increase
Uncommon (may affect up to 1 in 100 people):
• feeling tense and restless
• additiction to medicines
• 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
• build-up of fluid in the lungs
• 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
• Unusual weakness ( asthenia)
• Itching
• Hives
• Uncontrollable twitching, jerking or writhing movement of the bile duct
(bile duct dyskinesia)
• Swelling of the hands, ankles or feet
Not known (frequency cannot be estimated from the available data):
• Loss of appetite
• Low potassium and magnesium levels in the blood
• High prolactin levels in the blood Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Hydrochloride Tablets
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.
Do not store above 25°C.

6. Contents of the pack and other information
What Physeptone Hydrochloride Tablets contain:
The active ingredient is Methadone Hydrochloride 5mg per tablet.
The other ingredients are lactose, maize starch, gelatin, glycerol and
magnesium stearate.
What Physeptone Hydrochloride Tablets look like and the contents of
the pack:
Physeptone Hydrochloride Tablets are plain white uncoated tablets with
break line “MART 5” marking, supplied either in amber glass bottles, each
containing 100 tablets or in plastic blister packs, each containing 50 tablets.
Manufacturer:
Marketing Authorisation Holder:
Dales Pharmaceuticals Ltd.,
Macarthys Laboratories Ltd
Snaygill Industrial Estate,
T/A Martindale Pharma,
Keighley Road, Skipton,
Bampton Road, Harold Hill,
North Yorkshire. BD23 2RW,
Essex, RM3 8UG,
United Kingdom
United Kingdom
Product licence number: PL 01883/0062
This leaflet was last revised in: January 2017
If this leaflet is difficult to see or read, please contact the marketing
authorisation holder for help.

F1080

100mm Measurement Verification Bar

D0339700000

3397-C

DEVELOPMENT ARTWORK
D03397
PIL Physeptone 5mg Tablets

185 x 255mm

01/06/16

BM

21/11/16

BM

14/02/16

SM

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.

Hide