Methadone 1mg/Ml Oral Solution
PACKAGE LEAFLET: INFORMATION FOR THE USER D02775
Methadone 1mg in 1ml Oral Solution sugar-free
Methadone Hydrochloride
(This medicine will be referred to as Methadone oral solution in this leaflet)
Read all this leaflet carefully before you take Methadone oral solution
• Keep this leaflet. You may need to read it again
• If you have any further questions, please ask your doctor or pharmacist
• This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours
• 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 pharmacist
In this leaflet:
1. What Methadone oral solution is and what it is used for
2. Before you take Methadone oral solution
3. How to take Methadone oral solution
4. Possible side effects
5. Storing Methadone oral solution
6. Further information
This leaflet contains a summary of the information available for this medicine. You should ask your doctor or pharmacist if you are unsure about any aspect of this medicine.
1. What Methadone oral solution is and what it is used for
Methadone is a synthetic opiate (a morphine-like drug) used in the treatment of addiction in order to reduce withdrawal symptoms.
2. Before you take Methadone oral solution
Do not take Methadone oral solution if:
• you are allergic (hypersensitive) to methadone or any of the ingredients of this medicine (listed in section 6)
• 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 suffering from alcoholism
• you are in labour
• you are taking, or have recently stopped taking, a type of medicine called Monoamine Oxidase Inhibitors (MAOIs) which are used to treat depression
• you are at risk of developing an obstruction of the intestine
• you have any problems with your breathing or any chronic lung disease
• you are having an asthma attack. Do not take your dose until you have completely recovered.
• you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product
Methadone oral solution is not suitable for children.
If any of the conditions above apply to you, please consult your doctor.
Methadone may affect the electrical signals which control 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 pharmacist 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 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 and carbamazepine)
• naloxone (a medicine used to treat an overdose of opioid medicines)
• antibiotics (medicines used to treat bacterial infections)
• antifungals (medicines used to treat fungal infections)
• medicines that make urine more acidic e.g. ammonium chloride
• 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 and being sick)
• mexiletine (a drug used to treat heart irregularities)
• medicines used to treat depression including fluvoxamine, tricyclic antidepressants such as amitriptyline and imipramine, or MAOIs including moclobemide
• CNS depressants (medicines that act on the brain and cause drowsiness or sleepiness)
• other opioid type drugs e.g. morphine
• pentazocine (a pain killer)
• medicines used to help you relax (tranquillisers)
• medicines used to help you to sleep (sedatives).
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. Taking Methadone oral solution with food and drink You must not drink alcohol whilst you are taking Methadone oral solution as this could cause serious side effects.
Take special care with Methadone oral solution Tell your doctor if:
• you have history of asthma or breathing difficulties
• you have bowel problems
• you have liver or kidney problems
• you have a history of convulsions, fits or epilepsy
• you have a history of low blood pressure
• you have a history of under-active thyroid gland, or problems with your adrenal glands
• you have a history of enlarged prostate gland
• you have condition that causes severe muscle weakness and fatigue (myasthenia gravis)
• you are in shock.
Pregnancy, breast-feeding and labour
Methadone oral solution should not be taken during labour. If you are pregnant or breast-feeding you should discuss this with your doctor before taking Methadone oral solution.
Contin ued overleaf
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.
This 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.
Important information about some of the ingredients Methadone oral solution contains:
• Colouring agent E110 which may cause an allergic reaction.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Methadone oral solution
You must only take Methadone oral solution by mouth. Under no circumstances should you inject this product as injection may cause serious and permanent damage to your body with possibly fatal consequences.
Your doctor will tell you how much Methadone oral solution you need to take, and how often you need to take it. It is important that you do not take more than the dose agreed with your doctor. You can become dependant on Methadone oral solution.
Adults:
The usual initial dose is 10-20mg a day. The dose will be slowly increased until you show no signs of withdrawal or intoxication. 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 forget to take Methadone oral solution During a course of treatment it is important that, should you miss a dose, you take the dose as soon as you remember. However, if it is almost time for you to take your next dose, miss the dose and wait until the next scheduled dose.
DO NOT TAKE A DOUBLE DOSE.
If you take more Methadone oral solution than you should
If you take too much Methadone oral solution, 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.
4. Possible side effects
Like all medicines, Methadone oral solution can cause side effects, though not everybody gets them.
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 in passing water
• a reduction in sex drive
• a reduction in body temperature
• dependence on methadone.
This product contains sunset yellow which may cause allergic reaction
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 oral solution
Keep out of the reach and sight of children.
This product has an expiry date on the bottle label. This will have been checked by your pharmacist or doctor. If you have a product that has passed the given expiry date, return it to your pharmacist or doctor for safe disposal. Once you have opened the bottle you are advised to dispose of it after 4 weeks.
Store below 25°C.
6. Further information
What Methadone oral solution contains:
The active ingredient is Methadone Hydrochloride 1mg in 1ml. The other ingredients are Maltitol liquid, Hydrochloric acid, sodium benzoate (E211), purified water and colours E110 (sunset yellow FCF), E142 (green S) and quinoline yellow (E104).
What Methadone oral solution looks like and the contents of the pack:
Methadone oral solution is a bright green liquid, supplied in amber glass bottles, each containing 500, 100, 50 or 30ml of the solution, or it is supplied in HDPE plastic bottles, each containing 5L, 2.5L, 1L or 500ml.
Marketing Authorisation Holder and Manufacturer:
Martindale Pharma, Bampton Road, Harold Hill, Essex RM3 8UG, UK
Product licence number: PL 00156/0321 Date of Revision: January 2014
If this leaflet is difficult to see or read, please contact the marketing authorisation holder for help.
MARTINDALE PHARMA
Bampton Road. Harold Hill, Romford. RM3 8UG, UK
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Component Code: D02775
Paper size: 170 x 30mm
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