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 01883/0062 .
Methadone 5mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Methadone 5mg Tablets
Methadone Hydrochloride
Read all of this leaflet carefully before you start taking Methadone Hydrochloride Tablets because it contains important information for you.
What is in this leaflet
1. What Methadone Tablets are and what they are used for
2. What you need to know before you take Methadone Tablets
3. How to take Methadone Tablets
4. Possible side effects
5. How to store Methadone Tablets
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 Tablets are and what they are used for
This medicine has been prescribed for you for treatment of moderate to severe pain.
It contains methadone which belongs to a class of medicines called opioids, which are ‘pain relievers’. 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 Tablets
Do not take Methadone Tablets if:
Methadone Tablets are not suitable for children.
Warnings and precautions
Talk to your doctor or pharmacist before taking Methadone Tablets if:
You should be aware that prolonged use of Methadone tablets can result in tolerance of the drug and both physical and psychological addiction to Methadone tablets. If you have any concerns speak to your doctor before you are given this medicine.
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.
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).
Methadone Tablets 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
Talk to your doctor or pharmacist if you experience any of the following symptoms while taking Methadone tablets:
Other medicines and Methadone Tablets
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 tablets. 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 tablets 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 tablets 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 Tablets with food and drink
You must not drink alcohol whilst you are taking Methadone Tablets as this could cause serious side effects. You are advised not to drink grapefruit juice whilst you are being treated with Methadone tablets 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.
Pregnancy
Do not take Methadone Tablets 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 Tablets during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.
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.
Breast-feeding:
Do not take Methadone Tablets while you are breastfeeding as methadone passes into breast milk and will affect your baby.
Labour:
You should not take Methadone Tablets 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.
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.
Important information about some of the ingredients
Methadone Tablets contain:
3. How to take Methadone 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 Methadone 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 Methadone 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 Methadone 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 Methadone Tablets than you should
If you take too many Methadone Tablets, 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. Repeated use of Methadone 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:
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 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 Methadone tablets, 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
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 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.
5. How to store Methadone 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.
6. Contents of the pack and other information
What Methadone Tablets contain:
The active ingredient is Methadone Hydrochloride 5mg per tablet.
The other ingredients are lactose, maize starch, gelatin, glycerol and magnesium stearate.
What Methadone Tablets look like and the contents of the pack:
Methadone 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:
Manufacturer:
Product licence number: PL 01883/0062
This leaflet was last revised in: September 2020
If this leaflet is difficult to see or read, please contact the marketing authorisation holder for help.
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