Physeptone 25mg/Ml Injection
PACKAGE LEAFLET: INFORMATION FOR THE USER
Methadone 25mg/ml Injection
Methadone Hydrochloride
(This medicine will be referred to as Methadone Injection in this leaflet)
Read all this leaflet carefully before you are given Methadone Injection
• Keep this leaflet. You may need to read it again
• If you have any further questions, please ask your doctor or nurse
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse
In this leaflet:
1. What Methadone Injection is and what it is used for
2. Before Methadone Injection is given
3. How Methadone Injection is given
4. Possible side effects
5. Storing Methadone Injection
6. Further information
This leaflet contains a summary of the information available for this medicine. You should ask your doctor or nurse if you are unsure about any aspect of this medicine.
1. What Methadone Injection is and what it is used for
The active ingredient of this medicine, Methadone Hydrochloride, is a synthetic opiate (a morphinelike drug) used in the treatment of addiction in order to reduce withdrawal symptoms.
This medicine may also be used as a painkiller if you are unable to take morphine.
2. Before Methadone Injection is given
You should not be given Methadone Injection if:
• You are allergic (hypersensitive) to methadone or any of the ingredients of this medicine (listed in section 6)
• 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 any problems 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 not already receiving methadone. This is a high concentration and is not suitable for people who have not taken methadone before
• You are suffering problem that could cause paralysis of the small intestine (paralytic ileus)
• You are suffering from problems with your bowel, such as inflammatory bowel disorders
Methadone Injection is not suitable for children.
Take special care with Methadone Injection
Tell your doctor if:
• You have a history of asthma or breathing difficulties
• You have bowel problems
• You have liver or kidney problems
• You have a history of low blood pressure
• You have a history of underactive thyroid gland, or problems with your adrenal glands
• You have a history of enlarged prostate gland
• You have a condition that causes severe muscle weakness and fatigue known as myasthenia gravis
• You are in shock
• You are at risk of developing an obstruction of the intestine
• You are suffering from alcoholism
• You are pregnant, trying for a baby, breast-feeding or are in labour
• You have a type of cancer of the adrenal glands known as phaeochromocytoma
If you are elderly your doctor will give Methadone injection to you with special care. If any of the conditions above apply to you, please consult your doctor.
You should be aware that prolonged use of methadone can result in tolerance of the drug and both physical and psychological addiction to methadone. If you have any concerns speak to your doctor before you are given this medicines.
Methadone Injection may affect the electrical signals which controls your heart contractions, particularly at high doses.
Tell your doctor if:
• You have a history of heart problems
• You have liver disease
• You have any blood abnormalities such as low levels of potassium or magnesium
• You have a history of sudden death in the family
Taking other medicines
Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Tell your doctor if you are taking any of the following medicines:
• Medicines used to treat addiction e.g. naltrexone and buprenorphine
• Cimetidine (a medicine used to treat stomach ulcers)
• Drugs used to treat epilepsy (e.g. phenytoin)
• Naloxone (a medicine used to treat difficulties with breathing)
• Antibiotics (medicines used to treat bacterial infections e.g. ciprofloxacine, rifampicin)
• Antifungals (medicines used to treat fungal infections)
• Medicines that makes urine more acidic or alkaline e.g. ascorbic acid and sodium bicarbonate
• Antiviral drugs including some medicines used to treat HIV e.g. nevirapine, zidovudine, efavirenz, nelfinavir, ritonavir and abacavir
• Metoclopramide or domperidone (medicines used to stop you feeling or being sick)
• Mexiletine (a drug used to treat heart irregularities)
• Medicines used to treat depression including fluvoxamine, fluoxetine and tricyclic antidepressants or MAOIs
• CNS depressants (medicines that act on the brain and cause drowiness or sleepiness e.g. barbiturates, benzodiazepines, chloral hydrate and chlormethiazole)
• Other opioid type drugs e.g. pethidine
• Pentazocine (a pain killer)
• Atropine (a medicine used to treat heart problems)
• 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.
Receiving Methadone Injection with food and drink
You must not drink alcohol whilst you are being treated with Methadone Injection as this could cause serious side effects.
You are advised not to drink grapefruit juice whilst you are being treated with Methadone Injection as it could cause an overdose.
Pregnancy, breast-feeding and labour
Methadone Injection should not be taken during labour. If you are pregnant or breast-feeding you should discuss this with your doctor before being given Methadone Injection.
Driving and using machinery
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.
• 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 :
o The medicine has been prescribed to treat a medical or dental problem and o You have taken 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 taking this medicine.
3. How Methadone Injection is given
Methadone 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 usual initial dose is 10-20 mg a day. The dose will be slowly increased by 10-20mg until you show no signs of withdrawal or intoxication. The dose may need to be over 100mg daily (depending of the level of tolerance you have to Methadone) in order to prevent withdrawal symptoms.
The elderly or ill:
If you are elderly or ill, your doctor will only prescribe repeated doses with caution.
Children:
Not recommended. There is a serious risk of poisoning.
Remember to keep your medicine safely where children can not get it.
If you think you have been given too much Methadone 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 Injection, you can experience the following:
• Difficulty in breathing
• Extreme sleepiness, fainting or coma
• Pin point 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 Injection
If you stop having Methadone Injection suddenly you may experience withdrawal symptoms.
If you need to stop having Methadone Injection your doctor will gradually reduce the dose.
4. Possibly side effects
Like all medicines, Methadone Injection can cause side effects, although not everybody gets them.
Repeated use of methadone can result in tolerance and addiction.
Side effects which may occur include:
• Dizziness (including vertigo), drowsiness, hallucinations
• Nausea (feeling sick) or vomiting (being sick), constipation, a dry mouth
• Headaches, raised pressure in the brain
• Rashes or itching
• Sweating
• Reduced blood pressure (you may feel dizzy on standing up)
• Pin point pupils
• Confusion, mood changes
• Fast or slow beating of the heart, a feeling of trembling in the heart
• Facial flushing
• Spasms of the tubes from the gall bladder or urinary bladder
• Difficulty passing water
• A reduction in sex drive
• A reduction in body temperature
• Redness, swelling and hardening of the skin at the site of the injection
• Painful menstrual cramps or absence of period
If any of the side effects get serious or you notice side effects not listed in this leaflet please contact your doctor or pharmacist.
5. Storing Methadone Injection
Keep out of the reach and sight of children.
This product has an expiry date on the ampoule label and carton. Your doctor or nurse will check that this medicine has not passed the expiry date before it is given to you.
Store below 25°C and protect from light.
6. Further information
What Methadone Injection contains:
The active ingredient is Methadone Hydrochloride 25 mg in 1 ml.
The other ingredient is water for injections.
What Methadone Injection looks like and the content of the pack:
Methadone Injection is a clear colourless solution supplied in clear glass ampoules, each containing 2ml of solution packed into a cardboard carton. Each pack contains 10 ampoules.
Marketing Authorisation Holder and Manufacturer:
Martindale Pharmaceuticals, Bampton Road, Harold Hill, Essex RM3 8UG, UK