Methadone 1 mg / ml oral solution sugar free – patient leaflet, side effects, dosage

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

This medicine has been prescribed for you to treat opioid drug addiction. 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

• If you are allergic to methadone or any of the other ingredients of this medicine (listed in section 6)
• If 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
• If 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’)
• If you are dependent on any other drugs
• If you are in labour
• children must not be given this medicine
• If you have liver or kidney problems
• If you have a bowel problem called ulcerative colitis
• If you are addicted to alcohol
• If you have recently had a head injury.

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 Oral Solution.

Warnings and precautions

Talk to your doctor before taking Methadone Oral Solution:

• If you have low thyroid function (hypothyroid)
• If you have problems with your adrenal glands, kidneys or liver. If you have an enlarged prostate gland
• If you have low blood pressure
• If you are in shock
• If you have a muscle weakness disease called myasthenia gravis
• If you have bowel problems
• If you have a history of irregular heart beat
• If you have a history of heart disease
• If you have a family history of people dying suddenly without cause
• If you have low potassium, sodium or magnesium levels
• If you are pregnant or breast-feeding
• If you are extremely ill or an older person. You may be more sensitive to the medicine.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Methadone Oral Solution.

Talk to your doctor or pharmacist if you experience any of the following symptoms while taking Methadone Oral Solution: 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).

Tolerance, dependence, and addiction

This medicine contains methadone which is an opioid medicine. Repeated use of opioids can result in the drug being less effective (you become accustomed to it, known as tolerance). Repeated use of Methadone Oral Solution can also lead to dependence, abuse, and addiction, which may result in life-threatening overdose.

Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it.

The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent or addicted on Methadone Oral Solution if:

• You or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”).
• You are a smoker.
• You have ever had problems with your mood (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following signs whilst taking Methadone Oral Solution, it could be a sign that you have become dependent or addicted:

• You need to take the medicine for longer than advised by your doctor
• You need to take more than the recommended dose
• You are using the medicine for reasons other than prescribed, for instance, ‘to stay calm’ or ‘help you sleep’
• You have made repeated, unsuccessful attempts to quit or control the use of the medicine
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again (‘withdrawal effects’).

If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (See section 3, If you stop taking Methadone Oral Solution).

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.

Sleep-related breathing disorders

Methadone Oral Solution can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.

Children

Children must not take this medicine.

Other medicines and Methadone Oral Solution

Tell your doctor or pharmacist if you are taking, have recently taken or might take 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).

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.

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 medicine for depression (for example, fluvoxamine, fluoxetine), medicines to help you sleep (including anaesthetics) and medicines to calm you down called tranquillisers
• 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
• metamizole, a medicine used to treat pain and fever
• 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, 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
• cannabidiol (a medicine used to treat seizures)
• gabapentin and pregabalin (medicines used to treat epilepsy, nerve pain or anxiety), can increase the risk of opioid overdose, respiratory depression (breathing difficulties) and may be life-threatening.

If any of the above apply to you, talk to your doctor before taking Methadone Solution.

Taking Methadone Oral Solution with alcohol

• 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.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take Methadone Oral 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.

Take care if you are taking a pregnancy test as the methadone may interfere with the results.

If you use Methadone Oral Solution during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

You should not take this medicine whilst you are in labour.

Breast-feeding

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.

Driving and using machines

Methadone Oral Solution will severely affect your ability to drive or use machines, whilst taking it and afterwards. You should only start doing these activities again with the permission of your doctor.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

• 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 tartrazine (E102) and sunset yellow (E110) which may cause allergic reactions.

Information on sodium content

This medicine contains less than 1 mmol sodium (23 mg) per 60mg dose, that is to say essentially ‘sodium-free’.

Methadone Oral Solution contains 1mg of sodium benzoate (E211) in each ml. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).

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 discuss your treatment and whether you need to continue taking Methadone Oral Solution 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.

i

Taking this medicine

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

Adults

• 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.

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.

If you take more Methadone Oral Solution than you should

If you accidentally take an overdose of your medicine, either call your doctor straight away, or go to your nearest hospital casualty department. Do not drive yourself there as you may begin to feel sleepy. Always take any remaining medicine, the container and the label with you, so that the medicine can be identified.

You may experience the following symptoms if you take too much of this medicine:

• Difficulty in breathing
• Extreme drowsiness, being unaware (stupor) or loss of consciousness (coma)
• Very small pupils
• Cold and clammy skin
• A very slow pulse rate
• Muscle weakness
• Low blood sugar
• A brain disorder (known as toxic leukoencephalopathy).

In extreme cases, heart and blood pressure can be affected, leading to heart attack and death.

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 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.

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.

Symptoms 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 serious side effects (not known, frequency cannot be estimated from the available data):

• 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.

Keep taking the medicine but tell your doctor straight away if you get any of the following serious side effects (not known, frequency cannot be estimated from the available data):

• if you have asthma and it gets worse
• worsening of the pressure inside your head if you already have this condition following an injury to your brain or brain disease.

Other side effects:

Uncommon (may affect up to 1 in 10 people):

• withdrawal symptoms (see section ‘Drug withdrawal’).

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

• feeling sick (nausea) or being sick (vomiting)
• constipation
• sweating a lot more than usual
• feeling dizzy, particularly when standing up. This may be a sign that you have low blood pressure
• small pupils
• breast growth and production of breast milk
• difficulty in passing water (urine), pain in the lower back and abdomen caused by muscle spasms
• dry mouth, eyes or nose, facial flushing
• spinning or swaying sensation (vertigo)
• feeling drowsy, confused or restless
• changes in your mood, feeling “high” or over excited
• seeing or hearing things that are not there (hallucinations)
• headache, rashes
• low body heat (hypothermia)
• lower sexual urge or desire
• painful periods or lack of periods
• you can become dependent on Methadone Oral Solution (for more information see section 2 Warnings and Precautions)
• sleep apnoea (breathing pauses during sleep)
• low blood sugar
• eye and eyesight problems in babies and young children born to mothers who used methadone during pregnancy. This may mean your child needs more frequent eye-tests.

You may notice that some of the side effects become less severe with time as you get used to the methadone.

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.

When taken for a long period of time, it is possible that you may become dependent on Methadone Oral Solution.

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 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 Oral Solution

• Keep this medicine out of the sight and reach of children.

• Store this medicine in a safe and secure storage space, where other people cannot access it.

  It can cause serious harm and be fatal to people when it has not been prescribed for them.

• Do not store above 25˚C. Store in the original package to protect from light. Keep the bottle in the outer carton. 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 protect the environment.

6. Contents of the pack and other information

What Methadone contains

• The active substance is methadone hydrochloride. Each 1 ml of oral solution contains 1 mg of methadone hydrochloride.
• The other ingredients are: Tartrazine (E102), Sunset yellow (E110), Green S (E142), sodium saccharin, hydrochloric acid, sodium benzoate (E211), glycerol and purified water.

What Methadone looks like and contents of the pack

Methadone 1 mg/ml oral solution is a clear green solution.

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

Marketing Authorisation Holder

Accord-UK Ltd

Barnstaple, Devon, EX32 8NS

Manufacturer

Percuro Medica Ltd.

Unit 5, Powergate Business Park,

Volt Avenue,

London

NW10 6PW

This leaflet was updated in November 2024.