Physeptone 25mg/Ml Injection
PACKAGE LEAFLET: INFORMATION FOR THE USER
Physeptone Injection 25mg/ml
loiszzoa
Read all this leaflet carefully before you are given Physeptone Injection
• Keep this leaflet. You may need to read it again
• If you have any further questions, please askyour doctor or nurse
• 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 nurse
Methadone Hydrochloride
In this leaflet:
1. What Physeptone Injection is and what it is used for
2. Before Physeptone Injection is given
3. How Physeptone Injection is given
4. Possible side effects
5. Storing Physeptone Injection
6. Further information
This leaflet contains a summary of the information available for this medicine. You should askyour doctor or nurse if you are unsure about any aspect of this medicine.
1. What Physeptone Injection is and what it is used for
The active ingredient Methadone Hydrochloride is a synthetic opiatefa morphine-like drug) used in the treatment of addiction in order to reduce withdrawal symptoms.
2. Before you are given Physeptone Injection
You should not be given Physeptone Injection if:
• you are allergic (hypersensitive) to methadone or any of the ingredients of this medicine (listed in section 6)
• you are taking or have recently stopped taking a type of medicine known as Monoamine Oxidase Inhibitors (MAOIs) which are used to treat depression
• you have any problems with your breathing or any chronic lung disease such as chronic obstructive pulmonary disease
• you are having an asthma attack. Do not take your dose until you have completely recovered
• you are not already receiving methadone.This is a high concentration and is not suitable for people who have not taken methadone before
• you are suffering from a problem that could cause paralysis of the small intestine (paralytic ileus)
• you are suffering from problems with your bowel, such as an inflammatory bowel disorder
Physeptone Injection is not suitable for children.
Take special care with Physeptone Injection 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 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
• you are at risk of developing an obstruction of the intestine
• you are suffering from alcoholism
• you are pregnant, trying for a baby, breast-feeding or are in labour
• you have a type of cancer of the adrenal glands known as phaeochromocytoma.
If you are elderly your doctor will give Physeptone Injection to you with special care. If any of the conditions above apply to you, please consult your doctor.
You should be aware that prolonged use of methadone can result in tolerance of the drug and both physical and psychological addiction to methadone. If you have any concerns speak to your doctor before you are given this medicine. Physeptone Injection may affect the electrical signals which control your heart contractions, particularly at high doses.
Tell your doctor if:
• you have 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 nurse 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 e.g. rifampicin, ciprofloxacin, erythromycin and rifabutin)
• antifungals (medicines used to treat fungal infections e.g. fluconazole and ketoconazole)
• medicines that make urine more acidic or alkaline e.g. ascorbic acid and sodium bicarbonate
• antiviral drugs including some medicines used to treat HIV e.g. nevirapine, zidovudine, efavirenz, nelfinavir, ritonavir and abacavir
• metoclopramide or domperidone (medicines used to treat nausea and vomiting)
• mexiletine (a drug used to treat heart irregularities)
• medicines used to treat depression including fluvoxamine, fluoxetine and tricyclic antidepressants or MAOIs
• CNS depressants (medicines that act on the brain and cause drowsiness or sleepiness e.g. barbiturates, benzodiazopines, chloral hydrate and chlormethiazole)
• other opioid type drugs e.g. pethidine
• pentazocine (a pain killer)
• atropine (a medicine used to treat heart problems)
• cyclizine (an antihistamine used to treat nausea, vomiting and dizziness)
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.
Continued overleaf
Receiving Physeptone Injection with food and drink
You must not drink alcohol whilst you are being treated with Physeptone Injection as this could cause serious side effects.
You are advised not to drink grapefruit juice whilst you are being treated with Physeptone Injection as it could cause an overdose. Pregnancy, breast-feeding and labour
Physeptone Injection should not be given during labour. If you are pregnant or breast-feeding you should discuss this with your doctor before being given Physeptone Injection.
Driving and using machinery
The ability to drive or operate 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.
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:
• 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.
3. How Physeptone Injection is given
Physeptone Injection will be given to you by a doctor in a hospital. It will be given under the skin, into the vein or into a muscle.
Adults
The usual initial dose is 10-20mg a day. The dose will be slowly increased by 10-20mg until you show no signs of withdrawal or intoxication. The dose may need to be over lOOmg daily (depending of the level of tolerance you have to Physeptone) in order to prevent withdrawal symptoms.
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 thinkyou have been given too much Physeptone Injection
This medicine will be given to you by your doctor so it is unlikely you will receive too much. If you are concerned about your treatment, please talk to your doctor. If you are given too much Physeptone Injection, 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.
Like all medicines, Physeptone Injection can cause side effects, although not everybody gets them.
Repeated use of methadone can result in tolerance and addiction.
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
• redness, swelling and hardening of the skin at the site of the injection
• painful menstrual cramps or absence of period.
If any of the side effects becomes serious or you notice side effects not listed in this leaflet please contact your doctor or pharmacist.
5. Storing Physeptone Injection
Keep out of the reach and sight of children.
This medicine has an expiry date on the ampoule label and carton. Your doctor or nurse will check that this medicine has not passed the expiry date before it is given to you.
Store below 25°C and protect from light.
6. Further Information
What Physeptone Injection contains:
The active ingredient is Methadone Hydrochloride 25mg in 1 ml. The other ingredient is water for injections.
What Physeptone Injection looks like and the contents of the pack:
Physeptone Injection is a clear colourless solution supplied in clear glass ampoules, each containing 2ml of solution packed into a cardboard carton. Each pack contains 10 ampoules. Marketing Authorisation Holder and Manufacturer:
Martindale Pharmaceuticals, Bampton Road, Harold Hill, Essex RM3 8UG, UK
Product licence number: PL 01883/0063 Date of Revision: January 2014
If this leaflet is difficult to see or read, please contact the marketing authorisation holder for help.
D02751 ____________!
2751-A
MARTjNDALE PHARMA
DEVELOPMENT ARTWORK
Component Code: D02751
Paper size: 170 x 220mm
|
Version Control |
Date |
By |
|
Version A Created |
21/01/14 |
HM |
|
Version B | ||
|
Version C | ||
|
Version D | ||
|
Version E | ||
|
Version F | ||
|
Version G | ||
|
Version H | ||
|
Version I | ||
|
Version J | ||
|
Version K | ||
|
Version L | ||
|
Version M | ||
|
Version N |
Grand Fromage Creative Limited
Amherst House, 22 London Road Riverhead, Sevenoaks, Kent, TN13 2BT, UK t: 01732 456 187 e: alan@grand-fromage.co.uk www.grand-fromage.co.uk