Methadone 1mg/Ml Oral Solution
I
In this leaflet
1. What is Metahdone Oral Solution and what is it for
2. Before taking Methadone Oral Solution
3. How to take Methadone Oral Solution
4. Possible side effects
5. Storing Methadone Oral Solution
6. Further information
1. What is Methadone Oral Solution and what is it for
The name of your medicine is Methadone 1mg/1ml Oral Solution (now called Methadone Oral Solution throughout the leaflet). It contains methadone hydrochloride as an active ingredient. This belongs to a group of medicines called Narcotic Analgesics.
Methadone is used to treat opioid drug addiction.
2. Before taking Methadone Oral Solution
X Do not use this medicine if.....
• you are allergic (hypersensitive) to methadone or any other ingredients in this liquid (see section 6 below). An allergic reaction can include a rash, itching or shortness of breath.
• 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.
• 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’)
• you are dependent on any other drugs
• you are in labour
• children must not be given this medicine.
• you have liver or kidney problems
• you have a bowel problem called ulcerative colitis.
• you are addicted to alcohol
• 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.
r^Take special care with Methadone Oral Solution:
Before you take this medicine, tell your doctor if:
• you have epilepsy
• 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.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking methadone.
^Making other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includs 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.
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.
• 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.
If any of the above apply to you, talk to your doctor before taking Methadone Solution.
Taking Methadone Oral Solution with food and drink
• 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
• talk to your doctor before taking Methadone Oral Solution if you are pregnant or likely to become pregnant
• 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
• do not breast-feed if you are taking Methadone Oral Solution.
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 using machines 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:
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 medicine 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.
Important information about what is in Methadone Oral Solution:
• This product contains sucrose (1.67 g per 5 ml).
You should take this into account if you have diabetes. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this product.
It may also be harmful to teeth.
• This product also contains Tartrazine (E102) and Sunset Yellow (E110), which may cause allergic reactions.
Take this medicine as your doctor or pharmacist has told you. Look on the label and ask your doctor or pharmacist if you are not sure.
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.
Children
• Children must not take this medicine.
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.
In extreme cases, heart and blood pressure can be affected, leading to heart attack and death.
i^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 (two doses at the same time) to make up for a forgotten dose.
If you stop taking Methadone Oral Solution:
• do not stop taking this medicine unless your doctor tells you to as you may suffer withdrawal effects.
• your doctor will tell you how to lower the dose gradually.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Methadone Oral Solution can cause side effects although not everyone gets them.
Stop taking this medicine and see a doctor straight away if you have an allergic reaction to Methadone Oral 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.
Stop taking this medicine and see a doctor straight away 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 the medicine but tell your doctor
straight away if you get any of the following
side effects:
• 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.
Tell your doctor if you get any of these side
effects:
• 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 Oral Solution.
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. u k/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
• Keep out of the reach and sight of children
• Do not store above 25°C. Store in the original container. Discard after 4 weeks of first opening.
• Do not use Methadone Oral Solution after the expiry date which is stated on the bottle after Exp:. The expiry date refers to the last day of that month.
• Medicines should not be disposed via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Methadone 1 mg/ml Oral Solution is a clear green solution.
Each 1 ml of oral solution contains 1 mg of methadone hydrochloride.
It also contains:
Tartrazine (E102), Sunset yellow (E110),
Green S (E142), sucrose, hydrochloric acid, sodium benzoate (E211), glycerol and purified water.
Each bottle contains 500ml of oral solution.
A double ended 5ml and 2.5ml polypropylene spoon is also included to help measure the dose.
Marketing Authorisation holder and manufacturer:
Percuro Medica Ltd
Unit 5 Powergate Business Park
Volt Avenue
Park Royal
London
NW10 6PW
For information in large print, tape, CD or Braille, telephone 0208 963 0938
PL 35517/0001
This leaflet was updated in July 2014
3009/2/AM