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 00427/0086.
Methadone Hydrochloride DTF 1mg/1ml Oral Solution (Glass Packs)
Patient Information Leaflet
Methadone Hydrochloride DTF 1mg/1ml Oral Solution
This medicine contains methadone, which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Methadone Hydrochloride DTF 1mg/1ml Oral Solution is and what it is used for
2. What you need to know before you take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
3. How to take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
4. Possible side effects
5. How to store Methadone Hydrochloride DTF 1mg/1ml Oral Solution
6. Contents of the pack and other information
1. What Methadone Hydrochloride DTF 1mg/1ml Oral Solution is and what it is used for
The name of your medicine is Methadone Hydrochloride DTF 1mg/1ml Oral Solution (referred to as Methadone Solution in this leaflet). It contains methadone hydrochloride.
This medicine has been prescribed for you to treat opioid drug addiction or moderate to severe pain. 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 discussed 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 Hydrochloride DTF 1mg/1ml Oral Solution
Do not take Methadone Solution and tell your doctor if:
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor before taking methadone.
Warnings and precautions
Talk to your prescriber before taking this medicine for pain relief if you:
Taking this medicine regularly, particularly for a long time, can lead to addiction. 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.
Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your prescriber about your treatment.
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.
Talk to your doctor before taking Methadone Solution if:
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).
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking methadone.
Other medicines and Methadone Solution
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines bought without a prescription, including herbal medicines. This is because methadone can affect the way some other medicines work. Also some medicines can affect the way methadone works.
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:
You must not take Methadone Solution:
Some medicines can increase the risk of heart problems when used with methadone. Talk to your doctor before taking methadone if you are taking:
Tell your doctor if you are taking any of the following 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 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.
If any of the above apply to you, talk to your doctor before taking Methadone Solution.
Methadone Solution with food and drink
Do not drink alcohol whilst taking Methadone Solution. This is because Methadone Solution can make you feel sleepy and drinking alcohol will make you even more sleepy.
Grapefruit juice may effect how your methadone works.
Pregnancy and Breast-feeding
Driving and using machines
Methadone solution can severely affect your ability to drive or use machines as it may make you sleepy or dizzy. You should only start doing these activities again with the permission of your doctor.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Methadone Solution contains methyl and propyl parahydroxybenzoates, sucrose, liquid maltitol, propylene glycol, tartrazine and sunset yellow:
3. How to take Methadone Hydrochloride DTF 1mg/1ml Oral Solution
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your prescriber should have discussed with you, how long the course of this medicine will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.
Taking this medicine
Adults
For addiction
For pain
Older people and very ill people
Use in children
Children must not take this medicine.
If you take more Methadone Solution than you should
If you forget to take Methadone Solution
If you stop taking Methadone Solution
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.
Pregnancy
Do not take Methadone Solution 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 Solution during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Methadone can cause side effects although not everybody gets them.
Stop taking this medicine and see a doctor straight away if you have an allergic reaction to Methadone Solution.
An allergic reaction may include:
Stop taking this medicine and see a doctor straight away if you have any of the following:
Keep taking the medicine but tell your doctor straight away if you get any of the following side effects:
Tell your doctor if you get any of these side effects:
Very common (affects more than 1 in 10 people)
Common (affects less than 1 in 10 people)
Uncommon (affects less than 1 in 100 people)
Not known (frequency cannot be estimated from the available data)
Drug Withdrawal
When you stop taking Methadone Solution, 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 Methadone Solution, it could be a sign that you have become addicted.
If you notice any of these signs, it is important you talk to your prescriber.
The following side effects have also been reported
You may notice that some of the side effects become less severe with time as you get used to the methadone.
When taken for a long period of time, it is possible that you may become dependent on methadone solution.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at 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 Hydrochloride DTF 1mg/1ml Oral Solution
6. Contents of the pack and other information
What Methadone Solution contains
What Methadone Solution looks like and contents of the pack
It comes in a brown glass bottle holding 100ml or 500ml of solution.
Marketing Authorisation Holder and Manufacturer
This leaflet was last revised in 06/2020.
E8T98RBJ4
Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE
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