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 01883/0018 .
Methadone Mixture DTF 1mg/1ml (T&R)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Methadone Mixture DTF 1mg/1ml
Methadone Hydrochloride
(This medicine will be referred to as Methadone Mixture in this leaflet)
Read all of this leaflet carefully before you take Methadone Mixture because it contains important information for you.
What is in this leaflet
1. What Methadone Mixture is and what it is used for
2. What you need to know before you take Methadone Mixture
3. How to take Methadone Mixture
4. Possible side effects
5. How to store Methadone Mixture
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 Methadone Mixture 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.
2. What you need to know before you take Methadone Mixture
Do not take Methadone Mixture if:
Warnings and precautions
Talk to your doctor or pharmacist before taking Methadone Mixture if:
You are extremely ill or an older person. You may be more sensitive to the medicine.
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 Methadone Mixture:
During treatment, this medicine should not be stopped suddenly, but gradually, as sudden stoppage could lead to withdrawal symptoms.
Methadone Mixture may affect the electrical signals which control your heart contractions, particularly at high doses.
Tell your doctor you have recognised risk factors for the heart condition ‘QT prolongation’ that include if:
Other medicines and Methadone Mixture
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 methadone. 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 Methadone Mixture 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 Methadone Mixture 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.
Methadone Mixture with food, drink and alcohol
You must not drink alcohol whilst you are taking Methadone Mixture as this could cause serious side effects.
You are advised not to drink grapefruit juice whilst you are being treated with Methadone Mixture 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 Methadone Mixture 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 Methadone Mixture 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 Methadone Mixture while you are breastfeeding as methadone passes into breast milk and will affect your baby.
Labour:
You should not take Methadone Mixture whilst you are in labour.
Driving and using machines
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.
This 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.
Important information about some of the ingredients Methadone Mixture contains:
3. How to take Methadone Mixture
You must only take Methadone Mixture by mouth. Under no circumstances should you inject this product as injection may cause serious and permanent damage to your body with possibly fatal consequences.
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 Methadone Mixture.
Your prescriber should discuss your treatment and whether you need to continue taking Methadone Mixture 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.
Elderly or ill:
If 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 Methadone Mixture
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.
If you stop taking Methadone Mixture
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.
DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR A FORGOTTEN DOSE.
If you take more Methadone Mixture than you should
If you take too much Methadone Mixture, 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 methadone poisoning.
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 straight away if you get any of the following side effects:
Stop taking this medicine and see a doctor straightaway if you have any of the following:
Other possible side effects
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Not known (frequency cannot be estimated from the available data):
Drug Withdrawal
When you stop taking Methadone Mixture, 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.
You may notice that some of the side effects become less severe with time as you get used to this medicine.
When taken for a long period of time, it is possible that you may become dependent on Methadone Mixture.
This product contains sunset yellow which may cause allergic reaction.
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 Methadone Mixture
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.
Store below 25°C and protect from light.
6. Contents of the pack and other information
What Methadone Mixture contains
The active ingredient is Methadone Hydrochloride 1mg in 1ml.
The other ingredients are demineralised liquid sucrose, glycerol (E422), hydrochloric acid (E507), sodium hydroxide (for pH adjustment), sodium benzoate (E211), purified water and colours tartrazine (E102), sunset yellow (E110), green S (E142).
What Methadone Mixture looks like and the contents of the pack
Methadone Mixture is a bright green liquid, supplied in amber glass bottles, each containing 500, 100, 50 or 30ml of the liquid, or it is supplied in HDPE plastic bottles, each containing 5l, 2.5l, 1l or 500ml of the liquid.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer:
If this leaflet is difficult to see or read, please contact the marketing authorisation holder for help.
Product licence number: PL 01883/0018
This leaflet was last revised in: May 2020
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