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 01883/0058.
Physeptone 10mg/ml Injection Solution for Injection
PACKAGE LEAFLET: INFORMATION FOR THE USER
Physeptone 10mg/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
This medicine contains methadone, which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.
1. What Physeptone Solution for Injection is and what it is used for
This medicine has been prescribed for you for the treatment of addiction in order to reduce withdrawal symptoms.
It contains the methadone which belongs to a class of medicines called opioids.
This medicine has been prescribed to you and should not be given to anyone else.
Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.
This medicine may also be used as a painkiller if you are unable to take morphine.
2. What you need to know before Physeptone Solution for Injection is given
You should not be given Physeptone Solution for Injection if:
You are allergic to methadone hydrochloride or any of the ingredients of this medicine ( listed in section 6).
Physeptone Solution for 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:
These types of heart disorder are usually confirmed after an electrocardiogram (ECG) has been performed and may be more likely to occur with the following:
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.
Taking this medicine regularly, particularly for a long time, can lead to addiction.
Addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms.
Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of opioid, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.
Long-term use may cause decreased sex hormone levels and increased levels of the hormone prolactin. Contact your doctor if you experience symptoms such as decreased libido, impotence or absence of menstruation (amenorrhea).
Talk to your doctor or pharmacist if you experience any of the following symptoms while taking Physeptone Solution for Injection:
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.
The risk of side effects increases, if you use methadone concomitantly with antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, amitriptyline, clomipramine, imipramine, nortriptyline). Contact your doctor if you experience symptoms such as:
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, 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.
Talk to your doctor if you are breastfeeding or thinking of breast-feeding while you are taking methadone as it may affect your baby. Monitor your baby for abnormal signs and symptoms such as increased drowsiness (more than usual), breathing difficulties or limpness. Consult your doctor immediately if you notice any of these symptoms.
Pregnancy
Do not take Physeptone Solution for Injection if you are pregnant or think you might be pregnant unless you have discussed this with your prescriber and the benefits of treatment are considered to outweigh the potential harm to the baby.
If you use Physeptone Solution for Injection during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.
Breast-feeding
Do not take Physeptone Solution for Injection while you are breastfeeding as methadone passes into breast milk and will affect your baby.
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 machines 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.
Your prescriber should discuss your treatment and whether you need to continue taking Physeptone Solution for Injection at regular intervals. If you and your prescriber decide to stop treatment a plan will be put in place to gradually reduce the dose and stop taking the medicine to minimise the risk of withdrawal effects.
Adults:
For the treatment of drug addiction:
The recommended initial dose is 10-20 mg a day. The dose will be slowly increased until you show no signs of withdrawal or intoxication. 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 recommended dose is 5-10mg every 6 to 8 hours although your doctor may decide to give you a different dose. You may be prescribed a different dose if you are elderly, have liver disease or are ill.
The elderly or ill:
If you are elderly or ill, your doctor will only prescribe repeated doses with caution.
Use in Children and adolescents:
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
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.
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 Solution for Injection
In the case of serious side effects, patients should be kept conscious wherever possible and an airway established; artificial respiration may be necessary.
Drug Withdrawal
When you stop taking Physeptone Solution for Injection, 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.
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 ampoule. 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.
Protect from light.
6. Contents of the pack and other information
What Physeptone Solution for Injection contains:
The active ingredient is Methadone Hydrochloride 10 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 1, 2, 3.5 or 5 ml 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:
Manufacturer:
Product licenced number: PL 01883/0058
This leaflet was last revised in May 2020
D05326
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