Methadone Hydrochloride Sugar Free 1 Mg/Ml Oral Solution
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METHADONE HYDROCHLORIDE^ you are not sure ifany oJThe above SUGAR FREE 1 mg/ml apply to y°u' ^ to your i?*°r ?r
pharmacist before taking Methadone ORAL SOLUTION Hydrochloride 1 mjj/ml O ral Solution.
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 I 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
You should 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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines bought without a prescription, and herbal medicines. This is because Methadone Hydrochloride 1 mg/ml Oral Solution can affect the way some other medicines work. Also some medicines can affect the way it works.
1. What Methadone hydrochloride sugar free 1 mg/ml Oral solution is and what it is used for . Before you take Methadone hydrochloride sugar free 1 mg/ml | Oral solution
3. How to take Methadone
| hydrochloride sugar free 1 mg/ml I Oral solution
4. Possible side effects
5. How to store Methadone hydrochloride sugar free 1 mg/ml
| Oral solution
6. Further information
WHAT METHADONE HYDROCHLORIDE SUGAR FREE 1 mg/ml ORAL SOLUTION IS AND WHAT IT IS USED FOR
This medicine contains methadone hydrochloride, which belongs to a group of medicines called narcotic analgesics. It is used to treat opioid drug addiction.
0 BEFORE YOU TAKE
METHADONE HYDROCHLORIDE SUGAR FREE 1 mg/ml ORAL | SOLUTION
Do NOT take Methadone Hydrochloride 1 mg/ml Oral Solution
Do not take this medicine and tell your doctor 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 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 not dependent on opioid I drugs
• you are in labour.
This medicine is not suitable for children.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor before taking Methadone Hydrochloride 1 mg/ml Oral Solution.
You must not take Methadone Hydrochloride 1 mg/ml 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 suchas ascorblcacidlvitamin 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 Hydrochloride 1 mg/ml Oral Solution.
Take special care with Methadone
Hydrochloride 1 mg/ml Oral Solution
Before you take this medicine, tell your
doctor if you:
• have liver or kidney problems
• have epilepsy
• are addicted to alcohol
• have or have recently had a head injury
• have low thyroid function
I (hypothyroid)
• have problems with your adrenal glands. These are linked to your kidneys
• have an enlarged prostate gland
• have low blood pressure
• are in shock
• have a muscle weakness disease called myasthenia gravis
• have bowel problems
• have a history of irregular heart beat
• have a history of heart disease
• have a family history of people dying suddenly without cause
• have low potassium, sodium or magnesium levels
• are pregnant or breast-feeding
• are extremely ill or an older person. You may be more sensitive to the medicine.
Taking Methadone Hydrochloride 1 mg/ml Oral Solution with food and drink
Do not drink alcohol whilst taking Methadone Hydrochloride 1 mg/ml Oral Solution. This is because Methadone Hydrochloride 1 mg/ml 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 Hydrochloride 1 mg/ml 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.
• Breast-feeding is possible if you are taking 20 mg a day or less of Methadone Hydrochloride 1 mg/ml Oral Solution. Talk to your doctor before starting breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
|Driving and using machines
Methadone Hydrochloride 1 mg/ml Oral Solution will severely affect your ability to drive or use machines, whilst taking it and afterwards. You should only start doing these activities again with the permission of your doctor.
Important information about some of the ingredients of Methadone Hydrochloride 1 mg/ml Oral Solution
his medicine contains:
• Methyl and propyl parahydroxybenzoates, which may cause an allergic reaction. This allergy may happen some time after starting the medicine
• Liquid maltitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
HOW TO TAKE METHADONE HYDROCHLORIDE SUGAR FREE 1 mg/ml ORAL SOLUTION
Always take Methadone Hydrochloride 1 mg/ml Oral Solution exactly as your doctor has told you. You should check with your doctor or pharmacist if you pre not sure.
Take this medicine by mouth.
Adults
The starting dose is 10 mg to 20 mg 1(10 ml to 20 ml) each day.
The doctor can increase this to 60 mg to |100 mg (60 ml to 100 ml) 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
This medicine is not suitable for phildren.
If you take more Methadone Hydrochloride 1 mg/ml Oral Solution than you should
Other possible side effects include:
Very common (these side effects may affect more than 1 user in 10 patients):
• Feeling or being sick.
Common (these side effects may affect 1 to 10 users in 100):
• Weight increase
• Water retention
• Constipation
• Feeling high (euphoria), seeing or hearing things that are not real (hallucinations), feeling sleepy
• Feeling of dizziness or spinning
• Blurred vision, pin point pupils
• Skin rash, sweating
• Feeling tired.
Uncommon (these side effects may
affect 1 to 10 users in 1,000):
• Loss of appetite
• Breathing difficulty (including with cough)
• Dry mouth, inflammation of the tongue
• Feeling down (dysphoria), agitation, confusion, difficulty sleeping
• Reduction of sex drive
• Headache
• Fainting, low blood pressure, swelling of the legs, facial flush
• Itching, hives, rash
• Weakness.
• Urine retention, difficulty in passing urine
• Bile duct spasm (abdominal pain)
• Difficulty achieving or maintaining an erection
• Disturbances of menstruation.
Blood potassium or magnesium deficiency or lower levels of platelets in blood may also occur, although the frequency of these side effects is not known.
If any of the side effects get serious, or ifl you notice any side effects not listed in this leaflet, please tell your doctor.
©HOW TO STORE METHADONE HYDROCHLORIDE SUGAR FREE I 1 mg/ml ORAL SOLUTION
If you take too much Methadone Hydrochloride 1 mg/ml Oral Solution, you can experience the following:
• difficulty breathing
• extreme sleepiness, fainting or coma
• pinpoint 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 from methadone poisoning.
If you forget to take Methadone Hydrochloride 1 mg/ml 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 to make up for a forgotten dose.
If you stop taking Methadone ^Hydrochloride 1 mg/ml 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.
| ^ POSSIBLE SIDE EFFECTS
Like all medicines, Methadone Hydrochloride 1 mg/ml Oral Solution can cause side effects, although not everybody gets them.
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 becomes slow and shallow. These side effects are rare and may affect 1 to 10 users in 10,000.
Keep out of the reach and sight of children.
Do not use Methadone Hydrochloride 1 mg/ml Oral Solution after the expiry date which is stated on the bottle and carton after 'EXP'. The expiry date refers to the last day of that month. Keep the bottle tightly closed.
Use within 50 days after opening.
Do not freeze
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 Hydrochloride 1 mg/ml Oral Solution contains
• The active ingredient is methadone hydrochloride. Each millilitre of solution contains 1 mg methadone hydrochloride.
• The other ingredients are methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), propylene glycol (E1520), maltitol liquid (E965), caramel colour (E150d), patent blue 85 (E131) and purified water.
What Methadone Hydrochloride 1 mg/ml Oral Solution looks like and contents of the pack
• Methadone Hydrochloride 1 mg/ml Oral Solution is a clear green liquid.
• It is available in bottles of 30, 50, 100 and 500 ml. Not all bottle sizes may be marketed.
Marketing Authorisation Holder:
Teva UK Limited, Eastbourne,
BN229AG.
Manufacturer:
TEVA Czech Industries s.r.o, Ostravska, c.p. 305, 747 70 Opava-Komarov.
This leaflet was last revised in May 2011
PL 00289/1343
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