METHADONE 10 MG / ML SOLUTION FOR INJECTION - patient leaflet, side effects, dosage

Patient leaflet - METHADONE 10 MG / ML SOLUTION FOR INJECTION

Read all of this leaflet carefully before you start using 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.
– If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

This medicine contains methadone hydrochloride which is an opioid which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.

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

This medicine has been prescribed for you for the treatment of addiction in order to reduce withdrawal symptoms. It contains methadone hydrochloride 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.

This medicine may also be used as a painkiller if you are unable to take morphine.

2.

Do not use Methadone Solution for Injection if :

You are allergic to methadone hydrochloride or any of the ingredients of this medicine (listed in section 6)
You have any problem with your breathing or any chronic lung disease such as chronic obstructive pulmonary disease
You are having an asthma attack. Do not take your dose until you have completely recovered.
You are taking, or have stopped taking within the last two weeks, a type of medicine known as monoamine oxidase inhibitors(MAOIs) which are used to treat depression
You have pheochromocytoma, a tumour of the adrenal glands.
You have a bowel disorder known as paralytic ileus
You have loss of consciousness

If any of the conditions above apply to you, please consult your doctor.

Warnings and precautions

Talk to your prescriber before taking this medicine if you:

– Are or have ever been addicted to opioids, alcohol, precription 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 Methadone Solution for Injection 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 addiciton. Overuse and misuse can lead to overdose and/or death.

Talk to your doctor or pharmacist before using Methadone Solution for Injection:

because it can be addictive.
only use the dose prescribed for you by your doctor because higher doses could be fatal. Without you knowing, the
levels of the drug can build up in your body and affect your breathing, causing drowsiness and possible loss of consciousness.
if you have increased pressure on the brain or have just had a head injury.
if you are suffering from acute alcoholism.
if you are suffering from mental illness brought on by an infection
if you have liver problems
if you have kidney problems
if you have problems with your bile duct
if you suffer from an enlarged prostate gland (in men) or have difficulty passing urine if you have an under-active thyroid or adrenal gland.
if you have low blood pressure
if you are in a state of severe shock
if you are very run down and feeling weak
if you have bowel disease, such as Crohn’s disease or ulcerative colitis
if you suffer from convulsions (fits)
if you are a child. Even at low doses methadone is a special hazard to children if taken accidentally. Children under 6 months, particularly newborns, may be more sensitive to breathing difficulties than adults
if you are elderly
if you have myasthenia gravis (a disorder that causes extreme muscle fatigue)
if you suffer from certain types of heart disorders.

These types of heart disorder are usually confirmed after an electrocardiogram (ECG) has been performed and may be more likely to occur with the following:

if you have, or have had in the past any heart disorder or disease.
if you have liver disease
if other members of your family have died suddenly from unexplained causes.
if you have reduced blood levels of potassium or magnesium
if you take particular medicines while you are taking Methadone; please read the section ‘Taking/using other medicines’.
if you are taking high doses of Methadone (e.g. more than 100 mg per day). Your doctor may wish to monitor you by doing an ECG either before you start taking Methadone and/or during treatment. Injections may be painful; check the site of injection regularly for swelling, reddening or itching.

Always tell your doctor or nurse about any of these conditions or medicines before having your treatment

Children

Methadone Solution for Injection is not suitable for children under the age of 16 years.

Other medicines and Methadone Solution for Injection

Tell your doctor or pharmacist, if you are taking, have recently taken, or might take any other medicines, including:

Medicines used to treat addiction e.g. naltrexone and buprenorphine
Cimetidine (a medicine used to treat stomach ulcers)
Metoclopramide or domperidone (medicines used to stop you feeling or being sick)
Drugs used to treat epilepsy (e.g. phenytoin)
Mexiletine, a drug used to treat heart irregularities
Antibiotics (medicines used to treat bacterial infections e.g. ciprofloxacine, rifampicin, erythromycin and rifabutin)
Antifungals (medicines used to treat fungal infections e.g. itraconazole and fluconazole)
Medicines that makes urine more acidic such as ammonium chloride
Antiviral drugs including some medicines used to treat HIV e.g. nevirapine, zidovudine, efavirenz, nelfinavir, ritonavir and abacavir
Medicines used to treat depression known as tricyclic antidepressants, such as amitriptyline, and selective serotonin re-uptake inhibitors, such as fluvoxamine
Medicines used to treat severe depression known as monoamine oxidase inhibitors (MAOIs)
CNS depressants (medicines that act on the brain and cause drowsiness or sleepiness) e.g benzodiazepines, chloral hydrate and chlormethiazole
Other opioid type drugs e.g. morphine
Medicines used to treat sleep disorders e.g.. sodium oxybate
Pentazocine (a pain killer)
Medicines used to help you relax (tranquillisers)
Cyclizine (an antihistamine used to treat nausea, vomiting and dizziness)

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.

Methadone Solution for Injection with food drink and alcohol

You must not drink alcohol whilst you are being treated with Methadone Solution for Injection as this could cause serious side effects.

You are advised not to drink grapefruit juice whilst you are being treated with Methadone Solution for Injection as it could cause an overdose.

Pregnancy, breast-feeding and fertility

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

Pregnancy

There is not enough evidence of safety of methadone in pregnancy; for the benefit of both you and your baby, you should seek the advice of a doctor with appropriate experience so specialized care can be arranged. Babies born to mothers taking methadone may suffer withdrawal symptoms.

Breast-feeding

Methadone gets into breast milk; breast-fed infants may develop their own physical dependence on it. If breast feeding is considered, your dose of Methadone Solution for Injection should be as low as possible and you should watch your baby closely for any signs of excessive sleepiness. Remember your baby could suffer withdrawal symptoms if you either stop taking methadone or stop breast feeding suddenly. Talk to your doctor so you and your baby get the care required where necessary.

Driving and using machines

The ability to drive or use machines may be severely affected during and after treatment with Methadone. You must not drive or use machines 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.

Do not drive while using 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 :

o The medicine has been prescribed to treat a medical or dental problem and o You have used it according to the instructions given by the prescriber or in the information provided with the machines and

o 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 using this medicine.

3. how to use methadone solution for injection

Methadone Solution for Injection will be given to you by a doctor in a hospital. It will be given under the skin or into a muscle.

Adults:

For the treatment of drug addiction:

The recommended initial dose is 10–20 mg a day. The dose will be slowly increased until you show no signs of withdrawal or intoxication. The usual dose is 40–60mg/day. Your doctor will decide what dose you need and when to reduce the dose.

For the treatment of pain:

The recommended dose is 5–10mg every 6 to 8 hours although your doctor may decide to give you a different dose. You may be prescribed a different dose if you are elderly, have liver disease or are ill.

The elderly or ill:

If you are elderly or ill, your doctor will only prescribe repeated doses with caution.

Use in Children and adolescents:

Methadone Solution for Injection should not be used in children under the age of 16 years.

If you think you have been given too much Methadone Solution for Injection

The medicine will be given to you by your doctor so it is unlikely you will receive too much. If you are concerned about your treatment, please talk to your doctor. If you are given too much Methadone Solution for Injection, you can experience the following:

Difficulty in breathing
Extreme sleepiness, fainting or coma
Small pupils
Muscle weakness
Cold and clammy skin
Slow heartbeat, low blood pressure, heart attack or shock. In severe cases death may occur. In the event of overdose you should seek medical assistance immediately even if you feel well as you may be suffering Methadone poisoning.

If you stop having Methadone Solution for Injection

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 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 (paliptations), 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 for Injection if you are pregnant or think you might be pregnant unless you have discussed this with your presiber and the benefits of treatment are considered to outweigh the potential harm to the baby.

If you use Methadone Solution for Injection 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 for Injection while you are breastfeeding as methadone hydrochloride passes into breast milk and will affect your baby.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Drug withdrawal

When you stop taking Methadone Solution for Injection, 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 addicated?

If you notice any of the following signs whilst taking Methadone Solution for Injection, 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.

Serious side effects

Stop taking this medicine and see a doctor straightaway 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.

Keep taking this medicine but tell your doctor straightaway if you get the following side effect:

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

Dizziness drowsiness, vertigo

Restlessness
Sleep disturbances
Nausea (feeling sick) or vomiting (being sick)
Headaches
Pain and skin irritation at the site of injection
Rashes or itching
Sweating
Reduced blood pressure (you may feel dizzy on standing up)
Small pupils
Dry eyes
Dry nose
Confusion, mood changes
Facial flushing
Spasms of the tubes from the gall bladder or urinary bladder
Difficulty passing urine
Muscles stiffness
A reduction in sex drive
Feeling cold (fall in body temperature)
Redness, swelling and hardening of the skin at the site of injection
Painful menstruation cramps or absence of period
Constipation
High blood levels of the hormone prolactin
Hearing or seeing things that are not there (hallucinations)

You can become dependent on methadone.

In the case of serious side effects, patients should be kept conscious wherever possible and an airway established; artificial respiration may be necessary.

Repeated intravenous administration or appropriate antidote medication (nalorphine or levallorphine) may be required if there is evidence of significant breathing difficulty. Oxygen, intravenous fluids, drugs to increase blood pressure and other supportive measures should be employed as necessary according to the severity of the side effect.

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 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store methadone solution for injection

This medicine should not be used if the expiry date on the ampoule has passed or if it shows signs of deterioration such as discoloration. Do not store above 25°C.

Store in the original packaging in order to protect from light and moisture.

Keep out of the sight and reach of children.

Methadone can be extremely dangerous to children.

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only)

Please be ready to give the following information:

Product Name	Reference Number
Methadone 10mg/ml Solution for Injection	PL 44853/0025

This is a service provided by the Royal National Institute of the Blind.

6. contents of the pack and other informationthe active ingredient is methadone hydrochloride 10 mg / 1 ml. the other ingredient is water for injection.

What Methadone Solution for Injection looks like and the content of the pack

Pack of 10 neutral glass ampoules. Each ampoule contains 1, 2, 3.5, 5, 7.5 or 10ml of solution.

Marketing Authorisation Holder:

Kensington Pharma Ltd.,

60 Chain House Lane,

Manufacturer:

CP Pharmaceuticals Ltd

Ash Road North

Wrexham

LL13 9UF

Product licence number: PL 44853/0025

This leaflet was last revised in March 2020