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In this leaflet:

1.    What Physeptone Tablets are and what they are used for

2.    Before you take Physeptone Tablets

3.    How to take Physeptone Tablets t. Possible side effects

5. Storing Physeptone Tablets 5. Further 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 Tablets are and what they are used for

The active ingredient of this medicine, Methadone Hydrochloride, s a synthetic opiate (a morphine-like drug) used in the treatment of moderate to severe pain.

2.    Before you take Physeptone Tablets

Do not take Physeptone Tablets if: you are allergic (hypersensitive) to methadone or any of the ingredients of this medicine (listed in section 6) you have a head injury and the pressure inside your brain is higher than it should be (check this with your doctor). You might begetting bad headaches you are suffering from alcoholism you are in labour

you are taking or have recently stopped taking a type of medicine called Monoamine Oxidase Inhibitors (MAOIs) which are used to treat depression

you are at risk of developing an obstruction of the intestine (paralytic ileus)

you have any problems with your breathing or any chronic lung disease such as chronic obstructive pulmonary disease you are having an asthma attack. Do not take your dose until you have completely recovered

you are suffering from problems with your bowel, such as an inflammatory bowel disorder Physeptone Tablets are not suitable for children.

Take special care with Physeptone Tablets 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 under-active thyroid gland, or problems with your adrenal glands you have a history of enlarged prostate gland

raking Physeptone Tablets with food and drink

you must not drink alcohol whilst you are taking Physeptone Tablets as this could cause serious side effects.

Pregnancy, breast-feeding and labour

³hyseptone Tablets should not betaken during labour. If you are pregnant or breast-feeding you should discuss this with your doctor before taking Physeptone Tablets.

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. 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.

Important information about some of the ingredients

³hyseptone 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 Tablets

Your doctor will tell you how many Physeptone Tablets you need to take, and how often you need to take them. It is important that /ou do not take more than the dose agreed with your doctor. You can become dependant on PhyseptoneTablets.

Adults:

The usual initial dose is 5-1 Omg (1 to 2 tablets) every 6 to 8 hours. The dose may be adjusted depending on the level of pain relief /ou need.

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.

Remember to keep your medicine safely where children can not get it.

If you forget to take PhyseptoneTablets

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.

If you take more PhyseptoneTablets than you should

fyou take too many PhyseptoneTablets, 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.

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

k Possible side effects

_ike all medicines, PhyseptoneTablets 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 (including vertigo), drowsiness, hallucinations

•    nausea (feeling sick) or vomiting (being sick), constipation, a dry mouth

•    headaches

•    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 of the tubes from the gall bladder or urinary bladder

•    difficulty in passing water

•    a reduction in sex drive

•    a reduction in body temperature

•    dependence on methadone.

f any of the side effects get serious or you notice side effects not isted in this leaflet please contact your doctor or pharmacist.

5.    Storing PhyseptoneTablets

<eep out of the reach and sight of children.

Phis product has an expiry date on the bottle label or carton.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 oharmacist or doctor for safe disposal.

Store below 25°C.

6.    Further information

What PhyseptoneTablets contain:

The active ingredient is Methadone Hydrochloride 5mg per tablet.

The other ingredients are lactose, maize starch, gelatine, glycerol and magnesium stearate.

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

PhyseptoneTablets are plain white tablets supplied either in amber glass bottles, each containing 100 tablets or in plastic blister oacks, each containing 50 tablets.

Marketing Authorisation Holder:

Martindale Pharmaceuticals, Bampton Road, Harold Hill, Essex RM3

BUG, UK

Manufacturer:

Dales Pharmaceuticals Ltd., Snaygill Industrial Estate,

<eighley Road, Skipton, North Yorkshire. BD23 2RW Product licence number: PL 01883/0062 Date of Revision: January 2014

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

Martindale AJL Pharmaceuticals fVi

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

D 0 2 7 5 7 __________|

100mm Measurement Verification Bar

2757-B

MARTJNDALE PHARMA

DEVELOPMENT ARTWORK

Component Code: D02757

Paper size: 180 x 255mm

Grand Fromage Creative Ltd

Amherst House, 22 London Road Sevenoaks, Kent TN13 2BT t:+44 (0)1732 456 187 e:alan@grand-fromage.co.uk www.grand-fromage.co.uk