Methadone Injection Bp 10mg/Ml 1ml 2ml 5ml And 10ml
Package leaflet: Information for the patient Methadone injection BP Methadone Hydrochloride 10mg/ml
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you
-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 signs of illness are the same as yours.
-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is In this leaflet:
1. What Methadone Injection is and what it is used for
2. What you need to know before you are given Methadone Injection
3. How Methadone Injection is given to you
4. Possible side effects
5. How to store Methadone Injection
6. Contents of the pack and other information
1.What Methadone Injection is and what it is used for
Methadone is a type of medicine called an opioid analgesic. The word opioid means a substance similar to opium, for instance strong pain relievers such as morphine or codeine.
An analgesic is a medicine that can be used to relieve pain.
Methadone Injection is used to relieve moderate to severe pain, or in the treatment of addiction to opioid drugs (e.g. morphine and heroin) when it can control the withdrawal symptoms that occur when these drugs are stopped.
Methadone injection is used in adults and children over 16 years.
2. What you need to know before you are given methadone injection You should not be given this medicine if:
• You know that you are allergic to methadone or one of the other ingredients in this product (listed in section 6).
• You have any lungs problems that affect your breathing including chronic bronchitis or emphysema( lung disorder).
• You have had a head injury.
• You suffer from alcoholism.
• You have a problem of paralysis of the gut.
• You suffer from tumour of the adrenal gland (situated near the kidney).
• You are taking monoamine oxidase inhibitors (MAOIs) or have been taking them within the last two weeks. MAOIs (eg. phenelzine or isocarboxazid) are medicines used to treat depression.
• You are a child under 16 years of age.
Speak to your doctor if one of these applies to you before you are given this medicine.
Warnings and precautions Talk to your doctor if:
• You had an asthma attack just before you are given this medicine.
• Your blood pressure is abnormally low, or you have an underactive thyroid gland (which may cause tiredness, intolerance to cold, constipation, and puffiness of the face).
• You have an enlarged prostate gland causing difficulty in passing water.
• You have a condition that makes you have fits, eg. epilepsy.
• You have a problem with your liver or kidneys or adrenal gland.
• You suffer from obstructive bowel disorders (blockage of intestine ) or biliary tract disorders (digestive tract disorder).
• You suffer from myasthenia gravis (muscle weakness).
• You are in shock (life-threatening condition that occurs when the body is not getting enough blood flow)
• You are pregnant or breast-feeding.
• You are an elderly patient.
• You have any kind of heart disease (eg. abnormalities of heart rate or rhythm, heart blocks, inadequate blood supply to heart).
• You have a blood relative who has died suddenly.
• You have been told that you have low levels of potassium or magnesium in your blood.
In certain cases, your doctor may need to monitor your heart with an electrocardiogram (ECG) before starting or during treatment with methadone.
Speak to your doctor if one of these applies to you before you are given this medicine.
Other medicines and methadone injection
Tell your doctor before you are given this medicine if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
A large number of drugs can interact with Methadone which can significantly alter their effects. These drugs include:
• Medicines for depression (eg tricyclic antidepressants such as amitriptyline, desipramine, fluvoxamine, fluoxetine) and medicines for anxiety (eg benzodiazepines such as diazepam)
• Medicines for schizophrenia or other serious mental illness, such as phenothiazines (which may be present in various medicines including some for treating allergic disorders, nausea (feeling sick) and vomiting (being sick))
• Sedatives, sleeping tablets or barbiturates (eg. phenobarbital for epilepsy)
• Phenytoin, carbamazepine and primidone (for epilepsy)
• Antibiotics for infection (eg. erythromycin, rifampicin and ciprofloxacin), and certain antifungal medicines (eg. ketoconazole and similar drugs)
• Drugs used to treat HIV infection such as ritonavir, nevirapine or zidovudine
• Cimetidine (for heartburn or peptic ulcer)
• Naloxone (which reverses the effects of methadone and other opioid medicines)
• Pethidine (used for pain relief)
• St. John's wort (herbal preparation)
• Drugs which are likely to effect conduction of impulses to the heart (eg. drugs for irregular heartbeats) or salts and chemicals (electrolytes) in your blood (eg. Water tablets).
If you are already taking one of these medicines, speak to your doctor before you receive Methadone Injection.
Methadone Injection with food drink and alcohol
You must tell your doctor if you drank a lot of alcohol within 24 hours before you are given Methadone Injection, or are planning to drink a lot of alcohol after you have been given this injection. You must avoid drinking alcohol whilst taking Methadone Injection as it may increase the risk of developing breathing problems and low blood pressure.
Pregnancy, breast-feeding and fertility
Tell your doctor before you are given this medicine if you are pregnant, think you may be pregnant or are planning to become pregnant, or are breast-feeding.
There is no evidence of harmful effects in pregnancy. You should not be given Methadone Injection if you are in labour or if you are breast-feeding.
Driving and using machines
Methadone can cause drowsiness and clouding of consciousness which could interfere with your ability to use machines. Do not operate machinery whilst you are taking this medicine. When your methadone treatment has stopped, ask your doctor when it will be safe for you to drive or use machines.
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.
Tolerance and dependence
Methadone can become less effective with repeated use. This is called tolerance and it means that the dose may have to be increased for methadone to remain effective. If methadone is used repeatedly, it becomes habit-forming. This is called dependence and if methadone treatment is suddenly stopped, unpleasant withdrawal symptoms may occur.
Methadone Injection contain sodium
This medicine contains less than 1mmol sodium (23mg) per dose, i.e. is essentially 'sodium-free'.
3. How methadone injection given to you
Methadone Injection may be administered by injection into a muscle (Intramuscular injection ) or into the tissue beneath the skin ( subcutaneous injection).
• Adults
Use as an analgesic to relieve moderate to severe pain:
The usual single dose is 5 to 10mg. This may be repeated every 6 to 8 hours as required.
Your doctor will adjust the dose to meet your need for pain relief. The dosage and frequency of repeated doses may be reduced if you are very ill.
Use to treat addiction to opioid drugs:
The usual starting dose is 10 to 20mg per day. This may be increased until there are no signs of withdrawal and no signs of unwanted effects of the methadone. After this, your doctor will aim to gradually reduce the dosage.
• Children:
This medicine is not for use in children under 16 years.
• Elderly:
If you are elderly, your doctor may decide to reduce any repeated doses, or to give them less frequently.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you think you have been given more Methadone Injection
Overdoasge is characterized by problem in breathing, feeling of about to faint or fits, pupil size become small, muscles becomes stiff, abnormal heart beat, heart pain, hearing loss, brain damage (symptoms of brain damage are difficult in speaking , partially blind, feel difficulity to handle the easy things.
If you think you have missed a dose Tell your doctor, nurse or pharmacist immediately.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Methadone Injection can sometimes cause side-effects, although not everyone gets them. All medicines can cause allergic reactions although serious allergic reactions are rare.
Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately.
Other side effects associated with frequency (Not known - frequency can not be estimated from available data) may include:
• dizziness
• nausea (feeling sick)
• vomiting (being sick)
• constipation
• headache
• feeling faint especially after standing up
• pain
• irritation (such as redness or pain) hardening of the tissue in and around the site of your injection
• menstrual irregularities
• drowsiness, confusion,
• restlessness
• eye disorders
• dry eyes and nose
• fall in body temperature
• difficulty in passing water
• dry mouth,
• sweating
• a very slow or rapid or irregular heartbeat
• abnormal/ irregular heartbeat which may progress to cause death
• mood changes
• hallucinations (seeing or hearing things that are not there)
• decreased sex drive
• a skin rash
• respiratory depression (decrease in respiratory rate)
• galactorrhea (spontaneous flow of milk from the breast)
• flushing
Reporting of side effects
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.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE METHADONE INJECTION
Keep this medicine out of the sight and reach of children.
The product should not be used after the expiry date printed on the ampoule or carton.
Methadone Injection should be protected from light and stored below 25°C.
If only part of the contents of an ampoule is used, the remaining solution should be discarded.
6. Contents of the pack and other information
The active substance is Methadone hydrochloride BP.
The other ingredients are sodium chloride BP and sodium hydroxide BP (as a 10% w/v solution) or dilute hydrochloric acid BP in water for injections BP.
What Methadone Injection looks like and contents of pack
Methadone Injection is a clear, colourless, sterile solution. Each 1ml of solution contains 10mg of Methadone hydrochloride.
The solution is presented in clear glass ampoules (bottles), containing either 1ml, 2ml, 5ml or 10ml. The ampoules are then packed in cardboard cartons with either 5 or 10 ampoules per box.
Marketing authorization holder
Mercury Pharma International Ltd., 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland Manufacturer
Mercury Pharma International Ltd., 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland