How to take it

Physeptone 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 Tablets. Your prescriber should have discussed with you, how long the course of tablets will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine. 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 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 Physeptone Tablets Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine. If you take more Physeptone Tablets than you should If you take too many Physeptone 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
• low blood sugar. 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 Physeptone tablets 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

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Possible side effects

directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

100mm Measurement Verification Bar

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How to store it

Physeptone 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.

Contents of the pack and other information

What Physeptone 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 Tablets look like and the contents of the pack: Physeptone 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. Marketing Authorisation Holder: Macarthys Laboratories Ltd T/A Martindale Pharma, Bampton Road, Harold Hill, Essex, RM3 8UG, United Kingdom Manufacturer: Dales Pharmaceuticals Ltd., Snaygill Industrial Estate, Skipton, North Yorkshire, BD23 2RW Macarthys Laboratories Ltd T/A Martindale Pharma, Bampton Road, Harold Hill, Essex, RM3 8UG, United Kingdom Product licence number: PL 01883/0062 This leaflet was last revised in: May 2020 If this leaflet is difficult to see or read, please contact the marketing authorisation holder for help.

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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.

• 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
• Dependence and addiction (see section "How do I know if I am addicted?")
• low blood sugar Drug Withdrawal When you stop taking Physeptone Tablets, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating. How do I know if I am addicted? If you notice any of the following signs whilst taking physeptone tablets, it could be a sign that you have become addicted.
• You need to take the medicine for longer than advised by your prescriber
• You feel you need to use more than the recommended dose
• You are using the medicine for reasons other than prescribed
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again If you notice any of these signs, it is important you talk to your prescriber 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