METHADONE HYDROCHLORIDE DTF (SUGAR FREE) 1 MG / 1ML ORAL SOLUTION - patient leaflet, side effects, dosage

Patient leaflet - METHADONE HYDROCHLORIDE DTF (SUGAR FREE) 1 MG / 1ML ORAL SOLUTION

1. what methadone solution is and what it is used for

The name of your medicine is Methadone Hydrochloride DTF (sugar free) 1mg/1ml Oral Solution (referred to as Methadone Solution in this leaflet).

This medicine has been prescribed for you for opioid drug addiction and to treat 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 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 solutiondo not take methadone solution if you are allergic (hypersensitive) to methadone or any other ingredients in this liquid (see section

6 for all of the ingredients). An allergic reaction can include a rash, itching or shortness of breath

if you are having 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 ‘Taking other medicines’)
if you are dependent on any other drugs including alcohol
if you are in labour.
if you are at risk of developing an obstruction of the intestine.
if you have a head injury and the pressure inside your brain is higher than it should be. You may be getting bad headaches.

Warnings and Precautions

Talk to your prescriber before taking this medicine for pain relief if you:

are or 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.

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

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.

Children must not be given this medicine.

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.

Take special care with Methadone Solution

Before you take this medicine, tell your doctor if:

you have a history of asthma or breathing difficulties
you have liver or kidney problems
you have epilepsy
you have or have recently had a head injury
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.

Pregnancy and breast-feeding

If you are pregnant, think you might be pregnant or intend to become pregnant, speak with your doctor before using this medicine.
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 breast-feeding 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 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.

Methadone Solution contains quinoline yellow (E104) and sunset yellow (E110).

These may cause allergic reactions.

3. how to take methadone solution

Always take Methadone Solution exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

Under no circumstances should you inject this medicine as injecting it may cause serious and permanent damage to your body with possibly fatal consequences.

Your prescriber should have discussed with you how long the course of solution will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.

Using this medicine

This medicine contains 1mg of methadone in each 1ml and should be taken 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 until you show no signs of withdrawal or intoxication.
the usual dose is 5mg to 10mg (5ml to 10ml) every 6 to 8 hours
the dose may be changed by your doctor.
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.

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.

Do not take Methadone Solution while you are breastfeeding as methadone passes into breast milk and will affect your baby.

If you take more Methadone Solution than you should

it can result in low blood sugar
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 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.

If you forget to take Methadone Solution

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 using 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.

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 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.
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 becomes slow and shallow.
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.
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
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 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.

Unknown frequency:

-dependence and addiction (see section “How do I know if I am addicted?”).

-low blood sugar

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.

– 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

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: 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 solutionkeep this medicine out of the sight and reach of childrendo not use methadone solution after the expiry date which is stated on the label. the expiry date refers to the last day of that month. once you have opened the bottle you are advised to dispose of it after 4 weeks.

Store in an upright position.
Store below 25°C
Do not refrigerate
Protect from light

6. contents of the pack and other informationwhat methadone solution containsthe active ingredient is methadone hydrochloride.

Each 1ml of solution contains 1mg of methadone hydrochloride.

The other ingredients are lycasin, potassium sorbate, hydrochloric acid, quinoline yellow (E104), sunset yellow (E110), green s (E142) and purified water.

What Methadone Solution looks like and contents of the pack

The appearance of the product is a green solution supplied in an amber glass bottle containing 500ml of solution.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation is held by:

Ayrton Saunders Ltd,

9 Arkwright Road,

Astmoor Industrial Estate,

Runcorn,

Cheshire,

WA7 1NU,

The medicine is made by

Pharmasol Ltd,

North Way,

Walworth Industrial Estate,

Andover,

PL 16431-0183

Hampshire,

SP10 5AZ, UK

This leaflet was revised May 2020.

Pg. 8