Active ingredient
- methadone hydrochloride
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 01883/0063.
Physeptone 25mg/ml Solution for Injection
PACKAGE LEAFLET: INFORMATION FOR THE USER
Physeptone 25mg/ml Solution for Injection
Methadone Hydrochloride
(This medicine will be referred to as Physeptone Solution for Injection in this leaflet)
Read all of this leaflet carefully before you are given Physeptone Solution for Injection because it contains important information for you.
What is in this leaflet
1. What Physeptone Solution for Injection is and what it is used for
2. What you need to know before Physeptone Solution for Injection is given
3. How Physeptone Solution for Injection is given
4. Possible side effects
5. How to store Physeptone Solution for Injection
6. Contents of the pack and other information
1. What Physeptone Solution for 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 in the treatment of addiction in order to reduce withdrawal symptoms.
2. What you need to know before Physeptone Solution for Injection is given
You should not be given Physeptone Solution for Injection if:
Physeptone Injection is not suitable for children under the age of 16 years.
If any of the conditions above apply to you, please consult your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Physeptone Solution for Injection
Your doctor may wish to monitor you by doing an ECG either before you start taking Physeptone and/or during treatment.
Injections may be painful; check the site of injection regularly for swelling, reddening or itching.
Always tell your doctor or nurse about any of these conditions or medicines before having your treatment
Other medicines and Physeptone Solution for Injection
Tell your doctor or pharmacist, if you are taking, have recently taken, or might take any other medicines.
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.
Concomitant use of Physeptone Solution for Injection and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
However if your doctor does prescribe Physeptone Solution for Injection together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.
Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
Physeptone Solution for Injection with food, drink and alcohol
You must not drink alcohol whilst you are being treated with Physeptone Solution for Injection as this could cause serious side effects.
You are advised not to drink grapefruit juice whilst you are being treated with Physeptone Solution for Injection as it could cause an overdose.
Pregnancy
There is not enough evidence of safety of physeptone in pregnancy; for the benefit of both you and your baby, you should seek the advice of a doctor with appropriate experience so specialized care can be arranged. Babies born to mothers taking physeptone may suffer withdrawal symptoms.
Breast-feeding
Physeptone gets into breast milk; breast-fed infants may develop their own physical dependence on it. If breast feeding is considered, your dose of Physeptone Solution for Injection should be as low as possible and you should watch your baby closely for any signs of excessive sleepiness. Remember your baby could suffer withdrawal symptoms if you either stop taking physeptone or stop breast feeding suddenly. Talk to your doctor so you and your baby get the care required where necessary.
Driving and using machines
The ability to drive or use machines 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.
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 Solution for Injection is given
Physeptone Solution for 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 recommended initial dose is 10-20 mg a day. The dose will be slowly increased by 10-20mg until you show no signs of withdrawal or intoxication. The dose may need to be over 100mg daily (depending of the level of tolerance you have to Physeptone) in order to prevent withdrawal symptoms.
The elderly or ill:
If you are elderly or ill, your doctor will only prescribe repeated doses with caution.
Use in children:
Physeptone Solution for Injection should not be used in children under the age of 16 years.
If you think you have been given too much Physeptone Solution for Injection
The 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 Solution for Injection, you can experience the following:
In the event of overdose you should seek medical assistance immediately even if you feel well as you may be suffering physeptone poisoning.
If you stop having Physeptone Solution for Injection
If you stop having Physeptone Solution for Injection suddenly you may experience withdrawal symptoms. If you need to stop having Physeptone Solution for Injection your doctor will gradually reduce the dose.
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 straightaway if you have any of the following:
Keep taking this medicine but tell your doctor straightaway if you get the following side effect:
Other side effects:
You can become dependent on physeptone.
In the case of serious side effects, patients should be kept conscious wherever possible and an airway established; artificial respiration may be necessary.
Repeated intravenous administration or appropriate antidote medication (nalorphine or levallorphine) may be required if there is evidence of significant breathing difficulty. Oxygen, intravenous fluids, drugs to increase blood pressure and other supportive measures should be employed as necessary according to the severity of the side effect.
Reporting of side effects
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. You can also report side effects directly via 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.
5. How to store Physeptone Solution for Injection
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 ampoules. 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 and protect from light.
6. Contents of the pack and other information
What Physeptone Solution for Injection contains:
The active ingredient is Methadone Hydrochloride 25 mg / 1 ml. The other ingredient is water for injection.
What Physeptone Solution for Injection looks like and the content of the pack:
Physeptone Solution for Injection is a clear colourless solution supplied in clear glass ampoules, each containing 2ml of solution packed into a cardboard carton. Each pack contains 10 ampoules.
Marketing Authorisation Holder:
Manufacturer:
Product licenced number: PL 01883/0063
This leaflet was last revised in: August 2019
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