METHADONE 1 MG / ML ORAL SOLUTION - patient leaflet, side effects, dosage

Patient leaflet - METHADONE 1 MG / ML ORAL SOLUTION

Package leaflet: Information for the patient

Methadone hydrochloride

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.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Methadone Oral Solution is and what is it used for
2. What you need to know before you take Methadone Oral Solution
3. How to take Methadone Oral Solution
4. Possible side effects
5. How to store Methadone Oral Solution
6. Contents of the pack and other information

1. What Methadone Oral Solution is and what is it used for

The name of your medicine is Methadone 1mg/1ml Oral Solution (now called Methadone Oral Solution throughout the leaflet). It contains methadone hydrochloride.

This medicine has been prescribed for you for the treat opioid drug addiction or moderate to severe pain. It contains 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 oral solution

Do not use Methadone Oral Solution and tell your doctor if:

you are allergic to methadone or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can include a rash, itching or shortness of breath
you have severe breathing problems or a history of asthma. You must not use this medicine during an asthma attack. If you give this medicine to yourself (self-administration), wait until the asthma attack has passed and you are fully recovered
you are addicted to alcohol
you have a head injury and the pressure inside your brain is higher than it should be (check this with your doctor). You might be getting bad headaches.
you are taking Monoamine Oxidase Inhibitors (MAOIs) used to treat depression or if you have taken a MAOI medicine in the past two weeks (see ‘Other Medicines and Methadone Oral Solution’)
you are dependent on any other drugs
you are in labour
you have phaeochromocytoma, a tumour of the adrenal glands
you have a bowel disorder known as paralytic ileus
children must not be given this medicine

Do not take this medicine if any of the above points 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 relied if you:

have ever been addicted to opioids, alcohol, prescription medicines or illegal drugs
have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs
feel you need to take more of Methadone Solution to get the same level of pain relief, this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative pain reliever.

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 prescriber before taking Methadone oral solution if:

you have liver or kidney problems
you have problems with your gallbladder and bile duct
you have epilepsy
you have low thyroid function (hypothyroid)
you have problems with your adrenal glands. These are linked to your kidneys
you have an enlarged prostate gland
you have low blood pressure
you are in shock
you have a muscle weakness disease called myasthenia gravis
you have bowel problems
you have a history of irregular heart beat
you have a history of heart disease
you have a family history of people dying suddenly without cause
you have low potassium, sodium or magnesium levels
you are pregnant or breast-feeding
you are extremely ill or an older person. You may be more sensitive to the medicine
you are taking medicines called CNS depressants to treat anxiety, acute stress and panic attacks.
you have weakness, fatigue, lack of appetite, nausea, vomiting or low blood pressure. This may be a symptom of the adrenals producing too little of the hormone cortisol, and you may need to take hormone supplement.

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 Oral Solution

Tell your doctor or pharmacist if you are taking, 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:

mental-status changes (e.g. agitation, hallucinations, coma)
fast heartbeat, unstable blood pressure, fever
exaggeration of reflexes, impaired coordination, muscle stiffness
gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea).

You must not take Methadone Oral Solution

at the same time or within 2 weeks of taking Monoamine Oxidase Inhibitors (MAOIs).

Some medicines can increase the risk of heart problems when used with methadone. Talk to your doctor before taking methadone if you are taking:

medicines for heart problems such as verapamil and enalapril
medicines which affect electrolyte balance such as diuretics (water tablets) or lithium.

Tell your doctor if you are taking any of the following medicines:

medicines that dull your senses such as:

– medicines to help you sleep (including anaesthetics) and medicines to calm you down called tranquillisers

serotonergic medicines used to treat migraine, such as sumatriptan
cimetidine, used to treat stomach ulcers
rifampicin, used to treat tuberculosis (TB)
medicines used to treat epilepsy such as phenytoin, carbamazepine, phenobarbital and primidone.
medicines that make your urine acidic such as ascorbic acid (vitamin C)
narcotic painkillers such as codeine and pentazocine
naloxone used to reverse the effects of opioid drugs
medicines used to stop opioid drugs working such as naltrexone and buprenorphine
medicines used to treat HIV such as nevirapine, abacavir, efavirenz and nelfinavir. The doctor

may have to change the amount of methadone you take whilst on these medicines

antibiotics such as ciprofloxacin or macrolide antibiotics for example erythromycin
medicines used to treat fungal infections such as ketoconazole or fluconazole
St. John’s Wort – a herbal preparation for depression
cyclizine, domperidone and metoclopramide, or serotonergic anti-emetics medicines such as ondansetron, used to treat nausea and vomiting
medicines used to treat Parkinson’s disease and atropine
mexiletine used to treat unusual heart rhythms
lofexidine or clonidine, used to treat withdrawal effects
other opioid type drugs e.g. morphine.
medicines used to treat pain and fever such as metamizole
Concomitant use of Methadone Oral Solution 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 Oral Solution 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.

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 Oral Solution with food and drink

Do not drink alcohol whilst taking Methadone Oral Solution. This is because Methadone Oral 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

take care if you are taking a pregnancy test as the methadone may interfere with the results.
you should not take this medicine whilst you are in labour.
talk to your doctor if you are breastfeeding or thinking of breast-feeding while you are taking Methadone Oral Solution 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.

Driving and using machines

Methadone Oral 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.

Do not drive while taking this medicine until you know how it affects you.
It is an offence to drive if this medicine affects your ability to drive.
However, you would not be committing an offence if:
– The medicine has been prescribed to treat a medical or dental problem and
– You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
– It was not affecting your ability to drive safely.

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Methadone Oral Solution contains sucrose, tartrazine, sunset yellow and sodium benzoate

This product contains sucrose (1.67g per 5ml). You should take this into account if you have diabetes. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this product. It may also be harmful to teeth.
This product also contains Tartrazine (E102) and Sunset Yellow (E110), which may cause allergic reactions.
This medicine contains 40 mg Sodium Benzoate (E211) in each 40mg which is equivalent to

1 mg/ml. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).

This medicine contains less than 1 mmol sodium (23 mg) per 40mg, that is to say essentially ‘sodium-free’.

3. how to take methadone 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

this medicine contains 1mg of methadone in each 1ml
take this medicine by mouth.

Adults

For addiction

the starting dose is 10mg to 20mg (10ml to 20ml) each day
the doctor can increase this to 40mg to 60mg (40ml to 60ml) each day.

For pain

the usual dose is 5mg to 10mg (5ml to 10ml) every 6 to 8 hours
the dose may be changed by your doctor.

Older people and very ill people

if you have to have repeated doses of this medicine, the doctor may want to monitor you more closely.

Use in children

Children must not take this medicine.

If you take more Methadone Oral Solution than you should

if you take more of this medicine than you should, talk to a doctor or go to your nearest hospital

straight away. Take the medicine pack with you.

the signs you may notice are difficulty in breathing; feeling very drowsy which may lead to a stupor or coma; very small pupils; cold and clammy skin; a very slow pulse rate; low blood pressure and muscle weakness. In extreme cases, you may stop breathing, your blood flow may stop, you may have a heart attack which could lead to death
it can result in low blood sugar.

If you forget to take Methadone Oral Solution

if you forget a dose do not take it. Wait until the next dose is due and take only that amount
do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking Methadone Oral 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, this medicine 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 Oral Solution.

An allergic reaction may include:

swelling of your face, lips, tongue or throat or difficulty breathing or swallowing
severe itching of your skin with raised lumps.

Stop taking this medicine and see a doctor straight away if you have any of the following:

heart problems. The signs of this may include changes in the way your heart beats, such as it beating faster or missed heart beats, breathing difficulties and dizziness
if your breathing become slow and shallow
worsening of the pressure inside your head if you already have this condition following an injury to your brain or brain disease.

Keep taking the medicine but tell your doctor straight away if you get any of the following side effects:

if you have asthma and it gets worse.

Tell your doctor if you get any of these side effects:

Very common affects more than 1 in 10 people)

feeling sick (nausea) or being sick (vomiting).

Common (affects less than 1 in 10 people)

feeling weak, tired
weight gain
water retention
constipation
rash, that may appear and disappear
sweating a lot more than usual
blurred vision, small pupils, dry eyes
feeling of dizziness, spinning sensation
changes in your mood, feeling “high” or over excited, feeling drowsy
seeing or hearing things that are not there (hallucinations).

Uncommon (affects less than 1 in 100 people)

feeling dizzy, particularly when standing up. This may be a sign that you have low blood pressure
headache
feeling down (dysphoria), agitation, confusion, difficulty sleeping
itching, rashes
dry mouth or nose, inflammation of the tongue, facial flushing
breast growth and production of breast milk
difficulty in passing water (urine), pain in the lower back and abdomen caused by muscle spasms
low body heat (hypothermia)
lower sexual urge or desire
painful periods or lack of periods
addiction to this medicine
build-up of fluid in the lungs
disorder of the biliary part of the digestive system (bile duct dyskinesis).

Not known (frequency cannot be estimated from the available data)

reduction in blood platelets, which increase the risk of bleeding or bruising
high prolactin levels in the blood
rapid, uncontrollable movements of the eyes
low blood sugar.
dependence and addiction (see section ‚How do I know if I am addicted?‘).

Drug Withdrawal

When you stop taking Methadone Oral 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.

you need to take the medicine for longer than advised by your prescriber
you feel you need to use more than the recommended dose
you are using the medicine for reasons other than prescribed
when you stop taking the medicine you feel unwell, and you feel better once taking the medicine again.

If you notice any of these signs, it is important you talk to your prescriber.

The following side effects have also been reported

loss of appetite
swollen arms and legs. This may be a sign of your body holding onto more water than usual
low potassium and magnesium which will be found by blood tests
eye and eyesight problems in babies and young children born to mothers who used methadone during pregnancy
reduction in the body’s normal production of adrenal and sexual hormones.

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 Oral 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 doctoror 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: 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 oral solution

Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original container. Discard after 4 weeks of first opening.
Do not use this medicine after the expiry date which is stated on the bottle after EXP. The expiry

date refers to the last day 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 to protect the environment.

6. contents of the pack and other information

What Methadone Oral Solution contains

The active substance is methadone hydrochloride. Each 1ml of oral solution contains 1mg of methadone hydrochloride.
The other ingredients are tartrazine (E102), sunset yellow (E110), green S (E142), sucrose, hydrochloric acid, sodium benzoate (E211), glycerol and purified water.

What Methadone Oral Solution looks like and contents of the pack

Methadone 1mg/ml Oral Solution is a clear green solution.

Each bottle contains 500ml of oral solution. A double ended 5ml and 2.5ml polypropylene spoon is also included to help measure the dose.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder:

Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units,

Polhampton Lane, Overton, Hants, RG25 3ED, UK.

Manufacturer:

Percuro Medica Ltd, Unit 5 Powergate Business Park, Volt Avenue, Park Royal, London, NW10 6PW

This leaflet was last revised in 11/2021

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