Methadone 5 Mg/Ml Oral Solution
210mm
PACKAGE LEAFLET: INFORMATION FOR THE USER Methadone 5 mg/ml Oral Solution
Methadone hydrochloride
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
[n this leaflet:
1. What Methadone 5 mg/ml Oral Solution is and what it is used for l. Before you take Methadone 5 mg/ml Oral Solution 3. How to take Methadone 5 mg/ml Oral Solution \. Possible side effects
5. How to store Methadone 5 mg/ml Oral Solution 5. Further information
1. WHAT METHADONE 5 MG/ML ORAL SOLUTION IS AND WHAT IT IS USED FOR
VIethadone 5 mg/ml Oral Solution contains the active ingredient Methadone hydrochloride. It has been given to you to help in treating an opioid-related drug dependency by suppressing the symptoms of withdrawal. This treatment must be supervised by specialist services.
BEFORE YOU TAKE METHADONE 5 MG/ML ORAL SOLUTION
Do not take Methadone 5 mg/ml Oral Solution if you: are in labour
have raised pressure in the brain or a head injury are dependant on any other drugs or are addicted to alcohol
have severe breathing problems, have a history of asthma or are having an acute asthma attack
are taking monoamine oxidase inhibitors (MAOIs) or other CNS depressants, or have taken them in the past 2 weeks are allergic (hypersensitive) to Methadone hydrochloride, or any of the other ingredients listed (see Section 6 and end of Section 2). have bowel problems or severe liver problems. Methadone may cause constipation which can be dangerous for this group of patients.
VIethadone 5 mg/ml Oral Solution is not recommended for use in children.
Take special care with Methadone 5 mg/ml Oral Solution
You must tell your doctor or pharmacist and take special care if you have: kidney disease an enlarged prostate problems with your adrenal glands asthma or difficulty breathing an under-active thyroid gland
low blood pressure a convulsive disorder
inflammation, infection of the brain or its lining, head injury muscle weakness associated with myasthenia gravis
taken other opioid type (painkiller) drugs such as morphine and pentazocine
recognised risk factors for the heart condition £QT prolongation’ which include heart disease, liver disease, a family history of sudden death or low levels of magnesium in the blood. Your doctor may recommend electrocardiogram (ECG) monitoring before and during treatment with methadone if you are at risk of developing QT prolongation. You must tell your doctor or pharmacist and take special care if you are: pregnant or breast-feeding elderly or ill
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 and especially if you are aking any of the following, since interactions between these and Methadone 5 mg/ml Oral Solution can be hazardous.
Tell your doctor if you are taking any of the following: other opiate analgesics
any medicines that have an effect on your mental state (e.g. thioridazine, phenothiazines, haloperidol and sertindole)
medicines used to treat heart diseases (e.g. verapamil, quinidine)
medicines used to alter heart rhythm (e.g. sotalol, amiodarone and flecainide)
medicines used to treat depression known as monoamine oxidase inhibitors (MAOIs), particularly if you have taken them within the last two weeks. Also tell your doctor if you use other medicines to treat depression (e.g. imipramine, desipramine, nefazodone, fluoxetine, fluvoxamine, paroxetine and sertraline), anti-inflammatory and immunosuppressants (e.g. dexamethasone and ciclosporin)
antiviral drugs including some medicines used to treat HIV (e.g. nevirapine, zidovudine, efavirenz, nelfmavir, ritonavir, lopinavir, saquinavir, amprenavir, delaviridine, didanosine and stavudine)
macrolide antibiotics (medicines used to treat bacterial infections) such as clarithromycin, telithromycin and erythromycin cimetidine (a medicine used to treat stomach ulcers)
antifungals (medicines used to treat fungal infections) such as ketoconazole, itraconazole and fluconazole
naloxone (a medicine used to treat difficulties with breathing which may occur after taking opioid drugs)
medicines used to treat addiction (e.g. naltrexone and buprenorphine)
rifampicin (a medicine used to treat tuberculosis or £TB’)
drugs used to treat epilepsy (e.g. phenytoin, phenobarbital and carbamazepine)
vitamin tablets containing vitamin C
medicines used to treat diarrhoea (e.g. loperamide, diphenoxylate)
medicines that make urine more acidic (e.g. ammonium chloride and ascorbic acid)
diuretic medicines (e.g. spironolactone)
medicines that make you feel sleepy
herbal medicines containing St John’s Wort
^bu 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 hat 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 can also affect some 3lood and urine tests. Please tell your doctor if you are taking Methadone before any test is performed.
Taking Methadone 5 mg/ml Oral Solution with food and drink
Do not drink alcohol while you are taking this product. This medicine and alcohol can react with each other and this can increase their effects. Do not drink grapefruit juice while you are taking Methadone, as it may alter the effect of the medicinal product.
Pregnancy and breast-feeding
A.sk your doctor for advice before taking any medicine. This medicine is not recommended for use if you are pregnant, in labour or breast-feeding. If used during pregnancy, yrour baby may suffer withdrawal effects after birth. Problems for you or your baby may result if you use it during labour. If you breast-feed whilst taking this medicine, small miounts can pass to the baby in the breast milk.
Driving and using machines
VIethadone 5 mg/ml Oral Solution is likely to cause drowsiness, blurred vision, dizziness or nausea. Do not drive or operate machinery while taking this medicinal product.
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 abiltiy 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 of you are not sure whether it is safe for you to drive while taking this medicine.
Important informatii : VIethadone 5 mg/ml C r« Liquid Malritol (E Sunset Yellow (EL ‘
n about some of the ingredients of Methadone 5 mg/ml Oral Solution
al Solution also contains:
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Always take your medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. You must only take Methadone 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. This product is not intended to be diluted. Your doctor wifi tell you how much Methadone 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.
Adults
The usual initial dose is 10-30 mg a day. The dose will be slowly increased until you show no signs of withdrawal or intoxication. The usual dose is 60-120 mg/day. Your doctor will decide what dose you need and when to reduce the dose.
Elderly or ill:
Caution must be exercised if you are elderly, ill or have liver or kidney problems.
Methadone 5 mg/ml Oral Solution is not recommended for use by children.
[f you take more Methadone 5 mg/ml Oral Solution than you should
Overdose can cause coma and in severe cases death. If you take too much Methadone, you can experience the following: pin point pupils • muscle weakness
difficulty breathing • extreme sleepiness, fainting or coma
cold and clammy skin • slow heartbeat, low blood pressure, heart attack or shock
Medical attention is required urgently and you should go to the nearest hospital casualty department and take the medicine pack with you if possible.
If you forget to take Methadone 5 mg/ml Oral Solution
[f you forget to take a dose of your medicine, tell your healthcare worker or doctor. DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR A FORGOTTEN DOSE.
If ou stop taking Methadone 5 mg/ml Oral Solution
Do not stop taking your medicine except on medical advice, because your withdrawal symptoms may come back.
[f you have any further questions on the use of this product, ask your doctor, pharmacist or healthcare worker.
POSSIBLE SIDE EFFECTS
Like all medicines, this product can cause side effects, although not everybody gets them.
Serious side effects
Serious side effects are rare, however, if you have difficulty in breathing or experience any change in heart rate or rhythm you may need urgent medical attention. Stop taking methadone immediately and contact a doctor or go to your nearest hospital emergency department.
Side effects which may occur include:
Vrery common side effects: These may affect more than 1 in 10 people treated with Methadone feeling sick or being sick
Common side effects: These may affect up to 1 in 100 people treated with Methadone weight increase • water retention
constipation • feeling high (euphoria)
blurred vision • pin point pupils
feeling sleepy • skin rash
sweating • feeling tired
feeling of dizziness or spinning • seeing or hearing things that are not real (hallucinations)
Uncommon side effects: These may affect up to 1 in 1000 people treated with Methadone
loss of appetite dry mouth agitation confusion headache
low blood pressure hives
swelling of legs
water retention
feeling down (dysphoria)
disturbances in menstruation
difficulty achieving or maintaining an erection
facial flush inflammation of tongue difficulty sleeping reduction of sex drive fainting itching rash
weakness
bile duct spasm (abdominal pain) breathing difficulty (including with cough) difficulty in passing urine
Rare side effects: These may affect up to 1 in 10,000 people treated with Methadone heart problems slower heart beat
feeling your heart beat (palpitations)
Unknown side effects: Frequency of these side effects is not known yet. deficiency of potassium or magnesium in blood lower levels of platelets in blood
Reporting of side effects
[f 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.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
HOW TO STORE METHADONE 5 MG/ML ORAL SOLUTION
Keep out of the sight and reach of children. Store below 25°C. Store the bottle in an upright position. This medicine should be used within 60 days of first opening. Do not use this product after the expiry date which is stated on the bottle. The expiry date refers to the last day of that month. Keep the bottle in the outer carton in order to protect from light. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
FURTHER INFORMATION What Methadone 5 mg/ml Oral Solution contains
The active ingredient is: Methadone hydrochloride, 5mg in each ml.
The other ingredients are: Hydroxyethylcellulose, Propylene glycol, Liquid maltitol (E965), Sodium hydroxide, Benzoic acid (E210), Sunset yellow (El 10) and purified water, (see end of Section 2 for fiirther infoimation)
What Methadone 5 mg/ml Oral Solution looks like and contents of the pack
Methadone 5 mg/ml Oral Solution is a clear light amber solution, which is available in the following pack sizes:
HDPE bottles: 14 ml, 16 ml, 18 ml, 20 ml, 22 ml, 24 ml, 26 ml, 28 ml, 30 ml, 32 ml, 34 ml, 36 ml, 38 ml, 40 ml, 42 ml, 44 ml, 46 ml, 48 ml or 50 ml.
Amber glass and PET bottles: 100 ml, 200 ml, 300 ml, 500 ml or 1 litre.Your physician will advise you on the correct amount to take each day. Not all pack sizes may be marketed.
Manufacturer / Marketing Authorisation Holder
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland MA number: PL 04917/0111
This leaflet was last updated in 02/2015.
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