Synastone 50mg/Ml Solution For Injection
Do not use Synastone Injection after the expiry date which is stated on the ampoule and carton after Exp:. The expiry date refers to the last day of that month.
Medicines should not be disposed via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Synastone Injection is a sterile solution for injection containing Methadone Hydrochloride.
It also contains Sodium Chloride and water.
Synastone 50mg/ml Solution for Injection is available as a 1ml ampoule (Methadone Hydrochloride 50mg in 1ml);
Synastone 25mg/ml Solution for Injection is available as a 2ml ampoule (Methadone Hydrochloride 50mg in 2ml). Ampoules come in packs of 10.
The Marketing Authorisation for Synastone Injection is held by Auden Mckenzie (Pharma Division) Ltd., Mckenzie House, Bury Street, Ruislip, Middlesex, HA4 7TL, UK.
Synastone Injection is manufactured by SNS Pharmaceuticals Ltd., Mckenzie House, Bury Street, Ruislip, Middlesex, HA4 7TL, UK.
This leaflet was updated in May 2015.
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PATIENT INFORMATION LEAFLET
Synastone® 50mg in 1ml and 25mg in 1ml Solution for injection
Methadone Hydrochloride 50mg in 1ml and 50mg in 2ml
This leaflet contains important information about Synastone Injection.
Read all of this leaflet carefully before you start your treatment with this medicine.
1. Keep this leaflet. You may need to read it again.
2. If you have further questions, please ask your doctor.
3. 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.
In this leaflet
1. What is Synastone Injection and what is it for
2. Before you are given Synastone Injection
3. How Synastone Injection is used
4. Possible side effects
5. How Synastone Injection is stored
6. Further information
Synastone belongs to a group of medicines called opiates. It is used as part of the treatment of addiction to opium-related drugs.
Synastone Injection should not be used if you:
are not already using Methadone think you are allergic (hypersensitive) to
Methadone or any of the other ingredients of Synastone injection (see section 6: Further Information). Signs of an allergic reaction include: a rash, itching, swallowing or breathing problems, swelling of your lips, face, throat or tongue. suffer from any illness which causes severe breathing difficulties for example severe asthma. have been told you have a tumour of the adrenal gland near your kidney called phaeochromocytoma are taking, or have taken in the last two weeks, any of the antidepressant medicines called monoamine oxidase inhibitors (MAOIs), including moclobemide loss of consciousness.
have a risk of paralysis of the intestine, perhaps after abdominal surgery.
Always tell your doctor or nurse about any of these before having your injection.
Take special care with Synastone Injection:
because it can be addictive.
only use the dose prescribed for you by your
doctor because higher doses could be fatal.
Without you knowing, the levels of the drug can build up in your body and affect your breathing, causing drowsiness and possible loss of consciousness.
if you have increased pressure on the brain or have
just had a head injury.
if you are suffering from acute alcoholism.
if you are suffering from mental illness brought on
by an infection
if you have liver problems
if you have kidney problems
if you have problems with your bile duct
if you suffer from an enlarged prostate gland
(in men) or have difficulty passing urine
if you have an under-active thyroid or adrenal
gland
if you have low blood pressure
if you are in a state of severe shock
if you are very run down and feeling weak
if you have bowel disease, such as Crohn’s
disease or ulcerative colitis
if you suffer from convulsions (fits)
if you are a child. Even at low doses methadone
is a special hazard to children if taken accidentally.
Children under 6 months, particularly newborns,
may be more sensitive to breathing difficulties
than adults
if you are elderly
if you have myasthenia gravis (a disorder that causes extreme muscle fatigue). if you suffer from certain types of heart disorders. These types of heart disorder are usually confirmed after an electrocardiogram (ECG) has been performed and may be more likely to occur with the following:
if you have, or have had in the past any heart disorder or disease.
- if you have liver disease
- if other members of your family have died
suddenly from unexplained causes.
- if you have reduced blood levels of potassium
or magnesium continued... please turn over
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- if you take particular medicines while you are taking Synastone; please read the section ‘Taking/using other medicines’.
- if you are taking high doses of Synastone (e.g. more than 100 mg per day).
Your doctor may wish to monitor you by doing an ECG either before you start taking Synastone and/or during treatment.
Injections may be painful; check the site of injection regularly for swelling, reddening or itching.
Always tell your doctor or nurse about any of these conditions or medicines before having your treatment.
Taking other medicines
Tell your doctor if you are taking or have recently taken any medicines including medicines obtained without a prescription. Synastone can interfere with the action of some other drugs and some drugs can have an effect on Synastone. The following drugs can cause some problems when taken together with Synastone Injection:
• Strong pain killers such as pethidine or codeine
• Antidepressants (fluoxetine, fluvoxamine, and other SSRIs, tricyclic antidepressants), sedatives and hypnotics (sleeping pills e.g. benzodiazepines, chloral hydrate).
• Barbiturates
• some medicines used for heart disease or medicines that can change your blood levels of potassium or magnesium (e.g. diuretics), there may be a greater risk of heart problems
• Antibiotics such as rifampicin, ciprofloxacin, erythromycin or rifabutin
• antifungal drugs such as fluconazole, ketoconazole or voriconazole
• medicines to treat epilepsy (e.g. phenytoin or carbamazepine)
• certain medicines for reducing stomach acid (e.g. cimetidine)
• drugs which affect gastric emptying (domperidone, metoclopramide)
• antihistamines
• naltrexone or naloxone blockade; buprenorphine or pentazocine
• medicines to change the acidity of your urine such as vitamin C or sodium bicarbonate
• drugs used to treat the AIDS virus
• atropine and other muscle relaxants.
Taking Synastone injection with drink and food
• Alcohol may interfere with the metabolism of methadone and should be avoided.
• Grapefruit juice may also interfere with methadone metabolism; it is best not to consume grapefruits or grapefruit juice.
Pregnancy and breast-feeding
• Always tell your doctor if you are pregnant, think you might be pregnant or are trying to
become pregnant.
There is not enough evidence of safety of methadone in pregnancy; for the benefit of both you and your baby, you should seek the advice of a doctor with appropriate experience so specialized care can be arranged. Babies born to mothers taking methadone may suffer withdrawal symptoms.
• Methadone gets into breast milk; breast-fed infants may develop their own physical dependence on it. If breast feeding is considered, your dose of Synastone should be as low as possible and you should watch your baby closely for any signs of excessive sleepiness. Remember your baby could suffer withdrawal symptoms if you either stop taking methadone or stop breast feeding suddenly. Talk to your doctor so you
and your baby get the care required where necessary.
Driving and using machines
Synastone may make you feel sleepy. Do not drive or operate any tools or machines as you may not be safe.
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 Synastone Injection is used
Synastone will be given to you as an injection under the skin, into a muscle or into a vein.
Repeated injections should preferably be given either into a vein or into a muscle. Volumes greater than 2ml (20mg) may need to be injected in divided doses at different sites.
For drug addiction:
You will probably be started on 10-20mg per day increasing by 10-20mg per day until your symptoms are controlled. The usual dose of injectable methadone in a stabilised patient may exceed 100mg daily.
You may be prescribed a different dose if you are elderly, have liver disease or are ill.
Dosing must be managed by physicians with suitable experience. Your initial dose, safe dosage increases and maintenance dose to prevent symptoms of opiate withdrawal should be tailored just for you, taking into consideration any additional consumption of oral methadone and your general health. The aim of treatment is to allow you to reduce any criminality and improve your health and social productivity.
Children:
As methadone has not been studied in children, it should not be used in children under the age of 16 years.
If more Synastone is used than should be:
Contact your nearest hospital, doctor or pharmacist immediately.
You may feel sleepy, have problems breathing, feel floppy and have cold, clammy skin and very small pupils.
It can also affect your heart and blood pressure.
It is important that you get to your nearest hospital casualty department immediately.
If you miss a dose of Synastone
Do not take a double dose if you have missed one. Take the missed dose as soon as you remember and then ask your doctor or pharmacist when to take the next dose.
If you are thinking about stopping or have recently been told to stop Synastone
Do not suddenly stop taking it as you may get unpleasant withdrawal symptoms. Your doctor will tell you how long your treatment will last and how to gradually stop taking it.
If you have any further questions on the use of this product, ask your doctor or pharmacist
4. Possible side effects
Like all medicines, Synastone can have side effects although not everyone gets them.
One of the most serious and common side effect
(at higher doses) is slower breathing and can be serious in that you may be unaware or too drowsy to notice.
Other common side effects are:
■ feeling or being sick
■ constipation
■ sleepiness
■ gallbladder disorder
■ feeling confused
■ small pupils
■ dry mouth, eyes and nose.
Less common side effects are:
■ headache
■ problems with passing water
■ sweating
■ flushing
■ dizziness
■ changes in your heart beat
■ low blood pressure or body temperature
■ lower sex drive and function
■ changes in menstruation
■ rashes
■ restlessness
■ changes of mood and
■ hallucinations
■ high blood levels of the hormone prolactin
■ tense muscles
■ fluid retention
■ sleep disturbances
■ visual disturbances.
You can become dependent on methadone.
In the case of serious side effects, patients should be kept conscious wherever possible and an airway established; artificial respiration may be necessary.
Repeated intravenous administration of appropriate antidote medication (nalorphine or levallorphine) may be required if there is evidence of significant breathing difficulty. Oxygen, intravenous fluids, drugs to increase blood pressure and other supportive measures should be employed as necessary according to the severity of the side effects.
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 or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (Website: www. mhra.gov.uk/yellowcard). By reporting side effects, you can help provide more information on the safety of this medicine.
5. How Synastone Injection is stored
■ Keep out of the reach and sight of children.
■ Do not store above 25°C.
■ Store in the outer carton and protect from light.
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