PACKAGE LEAFLET: INFORMATION FOR THE USER

Physeptone 10mg/ml Injection

Methadone

(This medicine will be referred to a

Hydrochloride

f hyseptone Injection in this leaflet)

Read all of this leaflet carefully before you are given

Physeptone Injection

•    Keep this leaflet. You may need to read it again

•    If you have any further questions, please ask your doctor or nurse

•    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 nurse

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In this leaflet:

1.    What Physeptone Injection is and what it is used for

2.    Before Physeptone Injection is given

3.    How Physeptone Injection is given

4.    Possible side effects

5.    Storing Physeptone Injection 5. Further information

This leaflet contains a summary of the information available for this medicine. You should ask your doctor or nurse if you are unsure about any aspect of this medicine.

1.    What Physeptone Injection 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.

This medicine may also be used as a painkiller if you are unable to take morphine.

2.    Before Physeptone Injection is given

You should not be given Physeptone Injection if:

you are allergic (hypersensitive) to methadone or any of the ingredients of this medicine (listed in section 6) you are suffering from alcoholism you are in labour

you are taking, or have stopped taking within the last two weeks, a type of medicine known as monoamine oxidase inhibitors (MAOIs) which are used to treat depression 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

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 have been told you are at risk of developing an

obstruction of the intestine

Physeptone Injection is not suitable for children.

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

Take special care with Physeptone Injection

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 problems with your adrenal glands or

an underactive thyroid gland

you have an enlarged prostate gland

you have a condition that causes severe muscle weakness

and fatigue known as myasthenia gravis

you think you may be in shock

Physeptone Injection may affect the electrical signals which control your heart contractions, particularly at high doses.

Tell your doctor 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.

Taking other medicines

Please tell your doctor or nurse 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:

medicines used to treat addiction e.g. naltrexone and buprenorphine

cimetidine (a medicine used to treat stomach ulcers)

metoclopramide or domperidone (medicines used to stop

you feeling or being sick)

drugs used to treat epilepsy (e.g. phenytoin)

naloxone (a medicine used to treat difficulties with

breathing)

mexiletine, a drug used to treat heart irregularities antibiotics (medicines used to treat bacterial infections e.g. ciprofloxacin, rifampicin)

antifungals (medicines used to treat fungal infections) medicines that make urine more acidic such as ammonium chloride

antiviral drugs including some medicines used to treat HIV e.g. nevirapine, zidovudine, efavirenz, nelfinavir, ritonavir and abacavir

medicines used to treat depression known as tricyclic antidepressants, such as amitriptyline, and selective serotonin re-uptake inhibitors, such as fluvoxamine medicines used to treat severe depression known as monoamine oxidase inhibitors (MAOIs)

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 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.

Receiving Physeptone Injection with food and drink

You must not drink alcohol whilst you are being treated with Physeptone Injection as this could cause serious side effects.

Pregnancy, breast-feeding and labour

Physeptone Injection should not be taken during labour. If you are pregnant or breast-feeding you should discuss this with your doctor before being given Physeptone Injection.

Continued overleaf

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.

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:

•    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.

3. How Physeptone Injection is given

Physeptone Injection will be given to you by a doctor in a hospital. It will be given under the skin or into a muscle

Adults:

For the treatment of drug addiction:

The usual initial dose is 10-20mg a day. The dose will be slowly increased until you show no signs of withdrawal or ntoxication. The usual dose is 40-60mg/day. Your doctor will decide what dose you need and when to reduce the dose.

For the treatment of pain:

The usual dose is 5-10mg every 6 to 8 hours for as long as needed. If you are being given Physeptone Injection for a arolonged period you should be given a maximum of two doses daily.

The elderly or ill:

f you are elderly or ill, your doctor will only prescribe repeated doses with caution.

Children:

Not recommended. There is a serious risk of poisoning.

If you think you have been given too much Physeptone Injection

This medicine will be given to you by your doctor so it is unlikely you will receive too much. If you are concerned about your treatment, please talk to your doctor. If you are given too much Physeptone Injection, 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.

n the event of overdose you should seek medical assistance mmediately even if you feel well as you may be suffering methadone poisoning.

If you stop having Physeptone Injection

f you stop having Physeptone Injection suddenly you may experience withdrawal symptoms.

f you need to stop having Physeptone Injection your doctor will gradually reduce the dose.

4.    Possible side effects

Like all medicines, Physeptone Injection can cause side effects, although not everybody gets them.

Repeated use of methadone can result in tolerance and addiction.

Side effects which may occur include:

•    dizziness

•    nausea (feeling sick) or vomiting (being sick)

•    headaches, raised pressure in the brain

•    pain and skin irritation at the site of injection

•    rashes or itching

•    sweating

•    reduced blood pressure (you may feel dizzy on standing up)

•    pin point pupils

•    confusion, mood changes

•    fast or slow beating of the heart, a feeling of trembling in the heart

•    facial flushing

•    spasms in the lower abdomen

•    difficulty passing urine

•    a reduction in sex drive

•    feeling cold

If any of the side effects get serious or you notice side effects not listed in this leaflet please contact your doctor or nurse.

5.    Storing Physeptone Injection

Keep out of the reach and sight of children.

This product has an expiry date on the ampoule label and carton. Your doctor or nurse will check that this medicine has not passed the expiry date before it is given to you.

Protect from light.

6.    Further information

What Physeptone Injection contains:

The active ingredient is Methadone Hydrochloride 10mg in 1ml.

The other ingredient is water for injections.

What Physeptone Injection looks like and the contents of the pack:

Physeptone Injection is a clear colourless solution supplied in clear glass ampoules, each containing 1,2, 3.5 or 5ml of the solution. The 2, 3.5 and 5ml ampoules are supplied in packs of 10. The 1ml ampoules are supplied in packs of both 10 and 100 ampoules.

Marketing Authorisation Holder and Manufacturer:

Martindale Pharmaceuticals, Bampton Road, Harold Hill, Essex RM3 8UG, UK

Product licence number: Date of Revision:

PL 01883/0058 January 2014

If this leaflet is difficult to see or read, please contact the marketing authorisation holder for help.

M

Martindale

Pharmaceuticals

Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom

100mm Measurement Verification Bar

2742-B

D02742

Component Code: D02742

Paper size: 170 x 296mm mm