Physeptone Mixture
PACKAGE LEAFLET: INFORMATION FOR THE USER D02773
Physeptone Mixture
Methadone Hydrochloride
(This medicine will be referred to as
Read all this leaflet carefully before you take Physeptone Mixture
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally and you should 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:
1. What Physeptone Mixture is and what it is used for
2. Before you take Physeptone Mixture
3. How to take Physeptone Mixture
4. Possible side effects
5. Storing Physeptone Mixture
6. Further information
This leaflet contains a summary of the information available for this medicine. You should ask your doctor or pharmacist if you are unsure about any aspect of this medicine.
1. What Physeptone Mixture is and what it is used for
The active ingredient of this medicine, Methadone Hydrochloride, is a synthetic opiate (a morphine-like drug) used to treat addiction in order to reduce withdrawal symptoms.
2. Before you take Physeptone Mixture
Do not take Physeptone Mixture if:
• you are allergic (hypersensitive) to methadone or any of the ingredients of this medicine (listed in section 6)
• you have had a head injury and the pressure inside your brain is higher than it should be (check this with your doctor). You might be getting bad headaches
• you are suffering from alcoholism
• you are in labour
• 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 are at risk of developing an obstruction of the intestine
• you have any problems with your breathing or any chronic lung disease
• you are having an asthma attack. Do not take your dose until you have completely recovered.
Physeptone Mixture is not suitable for children.
Take special care with Physeptone Mixture Tell your doctor if:
• you have a history of asthma or breathing difficulties
• you have bowel problems
• you have liver or kidney problems
• you have a history of convulsions, fits or epilepsy
• 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 a condition that causes severe muscle weakness and fatigue (myasthenia gravis)
• you are in shock
• you are diabetic or you have an intolerance to some sugars.
Physeptone Mixture in this leaflet)
Physeptone Mixture 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 pharmacist 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 difficulties with breathing)
• antibiotics (medicines used to treat bacterial infections)
• antifungals (medicines used to treat fungal infections)
• medicines that make urine more acidic e.g. ammonium chloride
• antiviral drugs including some medicines used to treat HIV e.g. nevirapine, zidovudine, efavirenz, nelfinavir, ritonavir and abacavir
• metoclopramide or domperidone (medicines used to stop you feeling and being sick)
• mexiletine (a drug used to treat heart irregularities)
• medicines used to treat depression including fluvoxamine, tricyclic antidepressants such as amitriptyline and imipramine, or MAOIs including moclobemide
• CNS depressants (medicines that act on the brain and cause drowsiness or sleepiness)
• other opioid type drugs e.g. morphine
• pentazocine (a pain killer)
• medicines used to help you relax (tranquillisers)
• medicines used to help you to sleep (sedatives).
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. Taking Physeptone Mixture with food and drink You must not drink alcohol whilst you are taking Physeptone Mixture as this could cause serious side effects.
Pregnancy, breast -feeding and labour Physeptone Mixture should not be taken during labour. If you are pregnant or breast-feeding you should discuss this with your doctor before taking Methadone Mixture.
Contin ued overleaf
If any of the conditions above apply to you, please consult your doctor.
Driving and using machinery
The ability to drive or use 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.
This medicine can affect your ability to drive and operate machinery 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.
Important information about some of the ingredients
Physeptone Mixture contains:
• glycerol which may cause headache, stomach upset and diarrhoea
• Tartrazine (E102) and sunset yellow (E110) which may cause allergic reactions.
• 12g of sucrose per maximum daily dose. This should be taken into account if you suffer from diabetes mellitus. It may also be harmful to your teeth.
3. How to take Physeptone Mixture
You must only take Physeptone Mixture 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.
Your doctor will tell you how much Physeptone Mixture 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. You can become dependant on Physeptone Mixture.
Adults:
The usual initial dose is 10-20mg a day. The dose will be slowly increased until you show no signs of withdrawal or intoxication. The usual dose is 40-60mg/day. Your doctor will decide what dose you need and when to reduce the dose.
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 forget to take Physeptone Mixture During a course of treatment it is important that, should you miss a dose, you take the dose as soon as you remember. However, if it is almost time for you to take your next dose, miss the dose and wait until the next scheduled dose.
DO NOT TAKE A DOUBLE DOSE.
If you take more Physeptone Mixture than you should
If you take too much Physeptone Mixture, 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.
4. Possible side effects
Like all medicines, Physeptone Mixture can cause side effects, although not everybody gets them.
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.
• dependence on Methadone
If any of the side effects get serious or you notice side effects not listed in this leaflet please contact your doctor or pharmacist.
5. Storing Physeptone Mixture
Keep out of the reach and sight of children.
This product has an expiry date on the bottle label. This will have been checked by your pharmacist or doctor. If you have a product that has passed the given expiry date, return it to your pharmacist or doctor for safe disposal.
Store below 25°C and protect from light.
6. Further information
What Physeptone Mixture contains
The active ingredient is Methadone Hydrochloride 1mg in 1ml.
The other ingredients are, syrup (contains sucrose), glycerol (E422), hydrochloric acid (E507), sodium hydroxide (for pH adjustment), sodium benzoate (E211), purified water and colours tartrazine (E102), sunset yellow (E110), green S (E142).
What Physeptone Mixture looks like and the contents of the pack
Physeptone Mixture is a bright green liquid, supplied in amber glass bottles, each containing 500, 100, 50 or 30ml of the liquid, or it is supplied in HDPE plastic bottles, each containing 5l, 2.5l, 1l or 500ml of the liquid.
Marketing Authorisation Holder and Manufacturer
Martindale Pharmaceuticals, Bampton Road, Harold Hill, Essex RM3 8UG, UK
If this leaflet is difficult to see or read, please contact the marketing authorisation holder for help.
Product licence number: PL 01883/0018
This leaflet was last approved in January 2014 © Martindale Pharmaceuticals
MART'NDALE PHARMA
Bampton Road. Harold Hill. Romford. RM3 8UG, UK
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2773-C
Component Code: D02773
Paper size: 170 x 30mm
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