tramadol hydrochloride modified release tablets
CONSUMER MEDICINE INFORMATION
Limitations for use
Tramadol Mylan SR should only be used when your doctor decides that other treatment
options are not able to effectively manage your pain or you cannot tolerate them.
Hazardous and harmful use
Tramadol Mylan SR poses risks of abuse, misuse and addiction which can lead to overdose
and death. Your doctor will monitor you regularly during treatment.
Life threatening respiratory depression
Tramadol Mylan SR can cause life-threatening or fatal breathing problems (slow, shallow,
unusual or no breathing), even when used as recommended. These problems can occur
at any time during use, but the risk is higher when first starting Tramadol Mylan
SR and after a dose increase, if you are older, or have an existing problem with your
lungs. Your doctor will monitor you and change the dose as appropriate.
Use of other medicines while using Tramadol Mylan SR
Using Tramadol Mylan SR with other medicines that can make you feel drowsy such as
sleeping tablets (e.g. benzodiazepines), other pain relievers, antihistamines, antidepressants,
antipsychotics, gabapentinoids (e.g. gabapentin and pregabalin), cannabis and alcohol
may result in severe drowsiness, decreased awareness, breathing problems, coma and
Your doctor will minimise the dose and duration of use; and monitor you for signs
and symptoms of breathing difficulties and sedation. You must not drink alcohol while
using Tramadol Mylan SR.
What is in this leaflet
This leaflet answers some common questions about Tramadol Mylan SR.
It does not contain all the available information. It does not take the place of talking
to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the risks of you taking
Tramadol Mylan SR against the benefits expected for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
What Tramadol Mylan SR is used for
Tramadol Mylan SR is used to relieve severe pain which requires daily, long term treatment.
It belongs to a group of medicines called opioid analgesics (pain relievers).
Tramadol Mylan SR tablets are designed to release the active medicine gradually over
Your doctor may have prescribed Tramadol Mylan SR for another reason. Ask your doctor
why this medicine has been prescribed for you.
Tramadol Mylan SR is available only with a doctor's prescription.
Tramadol Mylan SR is for use in adults and children over 12 years of age. It should
not be used in children under the age of 12 years or following the removal of tonsils
and/or adenoids in people under 18.
Before you take Tramadol Mylan SR
When you must not take it
Do not take Tramadol Mylan SR if you:
have a known allergy to tramadol or any of the ingredients listed at the end of this
have an allergy to other medicines known as opioid analgesic, e.g. morphine or codeine
have respiratory disease or slow or shallow breathing
have taken large amounts of alcohol or other substances which can affect your level
of consciousness. Some examples of these substances include sleeping pills, pain relievers
or other psychotropic medicines (medicines that affect mood and emotions)
are taking medicine for depression containing a monoamine oxidase inhibitor (MAOI)
or have taken a MAOI within the past two weeks
have uncontrolled epilepsy or if your epilepsy is not well controlled by treatment
are younger than 12 years old or if you are between 12 – 18 years of age and are recovering
from an operation to remove your tonsils and/or adenoids.
are having treatment for withdrawal from narcotics.
Some of the symptoms of an allergic reaction may include
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
You can become addicted to Tramadol Mylan SR even if you take it exactly as prescribed.
Tramadol Mylan SR may become habit forming causing mental and physical dependence.
If abused it may become less able to reduce pain.
As with all other opioid containing products, your body may become used to you taking
Tramadol Mylan SR. Taking it may result in physical dependence. Physical dependence
means that you may experience withdrawal symptoms if you stop taking Tramadol Mylan
SR suddenly, so it is important to take it exactly as directed by your doctor.
Tolerance to Tramadol Mylan SR may develop, which means that the effect of the medicine
may decrease. If this happens, more may be needed to maintain the same effect.
Continue taking your medicine for as long as your doctor tells you. If you stop having
this medicine suddenly, your pain may worsen and you may experience some or all of
the following withdrawal symptoms:
nervousness, restlessness, agitation, trouble sleeping or anxiety
body aches, weakness or stomach cramps
loss of appetite, nausea, vomiting or diarrhoea
increased heart rate, breathing rate or pupil size
watery eyes, runny nose, chills or yawning
Very rarely, some patients have experienced the following withdrawal reactions:
tingling or numbness (pins and needles)
ringing in your ears
confusion, delusions or paranoia.
Tramadol Mylan SR given to the mother during labour can cause breathing problems and
signs of withdrawal in the newborn.
If you are not sure whether you should start taking this Tramadol Mylan SR, talk to
Before you start to take it
You must tell your doctor if:
you know you are sensitive to opioids
you drink alcohol
you have any health problems including:
any lung or breathing problems
sleep-related breathing disorders
fits or convulsions, or take medicines for epilepsy
any condition that may affect how your kidney or liver work
any stomach problems
a severe headache or feel sick due to a head injury
you have, or have had, any drug or alcohol dependence
you are pregnant or plan to become pregnant. Tramadol Mylan SR is not recommended
for use during pregnancy. Talk to your doctor about the risks and benefits of using
Tramadol Mylan SR during pregnancy
you are breastfeeding or wish to breastfeed. Tramadol Mylan SR is not recommended
for use during breastfeeding, as it passes into breast milk and may affect your baby
If you have not told your doctor about any of the above, tell them before you start
taking Tramadol Mylan SR.
Taking other medicines
Do not take Tramadol Mylan SR if you are taking any monoamine oxidase inhibitors (MAOIs).
Wait at least 14 days after stopping your MAOI before starting Tramadol Mylan SR.
Tell your doctor if you are taking any other medicines, including any that you buy
without a prescription from a pharmacy, supermarket or health food shop.
Some medicines may be affected by Tramadol Mylan SR, or may affect how well it works.
carbamazepine (e.g. Tegretol®)
coumarin derivatives (e.g. warfarin: Some brand names are Coumadin®, or Marevan®)
medicine for irregular or rapid heart beat
medicines for depression, sleeplessness or mental conditions such as selective serotonin
reuptake inhibitors (SSRI's), serotonin-noradrenaline reuptake inhibitors (SNRI's),
tricyclic anti-depressants, quinidine, phenothiazines or anti-psychotics
Your doctor can tell you what to do if you are taking any of these medicines.
If you are not sure whether you are taking any of these medicines, check with your
doctor or pharmacist.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking Tramadol Mylan SR.
How to take Tramadol Mylan SR
Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the pack, ask your doctor or pharmacist.
Tramadol Mylan SR tablets should be swallowed whole with water. They may be taken,
before, with, or after food.
Tramadol Mylan SR are only designed to work properly if swallowed whole. The tablets
may release all their contents at once if broken, chewed, crushed or dissolved, which
can be dangerous and cause serious problems, such as an overdose which may be fatal.
Unless stated otherwise, they should be swallowed whole.
How much to take
The recommended dosage of Tramadol Mylan SR is either:
one or two Tramadol Mylan SR 100 mg tablet(s) twice a day (morning and evening)
one Tramadol Mylan SR 150 mg or 200 mg tablet twice a day (morning and evening).
As all patients respond to treatment differently, your doctor may start you on a lower
Do not take more than four of the 100 mg tablets per day.
Do not take more than two of the 150 mg or of the 200 mg tablets per day.
If you are over 75 years of age, you may require a lower daily dose of Tramadol Mylan
SR compared to younger adults.
If you forget to take it
If you forget to take one dose, take the dose when you remember. The following dose
should be taken after twelve hours, or as prescribed by your doctor.
Do not take a double dose to make up for the dose you missed. This may increase the
chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
How long to take it
This differs between individuals depending on how severe your pain is, how you respond
to Tramadol Mylan SR, and the cause of your pain. Ask your doctor for advice on how
long you need to take Tramadol Mylan SR.
If you take too much (overdose)
If you or someone else receive too much (overdose), and experience one or more of
the symptoms below, call triple zero (000) for an ambulance. Keep the person awake
by talking to them or gently shaking them every now and then. You should follow the
above steps even if someone other than you have accidentally used Tramadol Mylan SR
that was prescribed for you. If someone takes an overdose they may experience one
or more of the following symptoms:
Slow, unusual or difficult breathing
Drowsiness, dizziness or unconsciousness
Slow or weak heartbeat
Nausea or vomiting
Convulsions or fits
If you think you or someone else may have used too much Tramadol Mylan SR, you should
phone the Poisons Information Centre (by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
When seeking medical attention, take this leaflet and remaining medicine with you
to show the doctor. Also tell them about any other medicines or alcohol which have
While you are taking Tramadol Mylan SR
Things you must do
If you become pregnant while taking this medicine, tell your doctor immediately.
If you are about to be started on any new medicine, tell your doctor and pharmacist
that you are taking this medicine.
Tell any other doctors, dentists and pharmacists who treat you that you are taking
If you are going to have surgery (including dental surgery), tell the surgeon or anaesthetist
that you are taking this medicine.
If your pain is not as severe and you feel that you do not need to take as many Tramadol
Mylan SR tablets as your doctor prescribed, consult your doctor.
If you feel that your pain gets worse or is not relieved at the dose prescribed, do
not take extra doses without checking with your doctor.
Your doctor will advise you on what to do.
If you are about to have any blood tests, tell your doctor that you are taking this
It may interfere with the results of some tests.
Visit your doctor regularly so they can check on your progress.
Things you must not do
Do not use this medicine to treat any other conditions unless your doctor tells you
Do not give this medicine to anyone else, even if they have the same conditions as
Things to be careful of
Be careful when driving or operating machinery until you know how this medicine affects
This medicine may cause dizziness, light-headedness, tiredness, drowsiness in some
people. If you have any of these symptoms, do not drive, operate machinery or do anything
else that could be dangerous.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking Tramadol Mylan SR.
Tramadol Mylan SR relieves pain in most people, but it may have unwanted side effects
in some people.
All medicines can have side effects. Sometimes they are serious, most of the time
they are not. You may need medical treatment if you get some of the side effects.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
Common side effects:
Less common side effects:
changes in appetite
sudden onset of low blood pressure, collapse
improvement of mood
difficulty in passing urine
Serotonin Syndrome: signs of this vary and are not specific: they may include sweating,
agitation, muscle twitching, tremor, spontaneous muscle contraction, high body temperature.
Serotonin Syndrome may result from interaction of tramadol with other medicines which
increase serotonin effects, for example, the SSRI antidepressants.
The above list includes common and mild side effects of Tramadol Mylan SR.
See your doctor immediately or go to Accident and Emergency at the nearest hospital
if you notice any of the following:
skin rash (red spots or patches), itching, hives, skin lumps
swelling or puffiness of the eyelids, face or lips
chest tightness, wheezing or pain in the chest
heart palpitations, faintness or collapse
The side effects listed above are very serious and may require urgent medical attention
Tell your doctor if you notice anything that is making you feel unwell.
This is not a complete list of all possible side effects.
Other side effects not listed above may also occur in some people.
After taking Tramadol Mylan SR
Keep your tablets in the pack until it is time to take them. If you take the tablets
out of the pack they may not keep well.
Keep your tablet in a cool dry place where the temperature stays below 25°C.
Do not store Tramadol Mylan SR or any other medicine in the bathroom or near a sink.
Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep medicines where children cannot reach them.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
If the medicine is damaged, you no longer need to use this medicine or it is out of
date, take it to any pharmacy for safe disposal.
Do not use this medicine after the expiry date.
What it looks like
Tramadol Mylan SR is available in three strengths:
Tramadol Mylan SR 100 tablets are almost white, round, biconvex, marked with TL 100
on one side.
Tramadol Mylan SR 150 tablets are almost white, oval, marked with TL 150 on one side.
Tramadol Mylan SR 200 tablets are almost white, oval, marked with TL 200 on one side.
Each pack contains 20 tablets.
The active ingredient in Tramadol Mylan SR is tramadol hydrochloride.
Each Tramadol Mylan SR 100 tablet contains 100 mg of tramadol hydrochloride.
Each Tramadol Mylan SR 150 tablet contains 150 mg tramadol hydrochloride
Each Tramadol Mylan SR 200 tablet contains 200 mg of tramadol hydrochloride
The Tramadol Mylan SR tablets also contain the following inactive ingredients:
calcium hydrogen phosphate dihydrate
colloidal anhydrous silica
Alphapharm Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Australian registration numbers:
Tramadol Mylan SR 100
AUST R 133147
Tramadol Mylan SR 150
AUST R 133157
Tramadol Mylan SR 200
AUST R 133158.
This leaflet was prepared in
Tramadol Mylan SR_cmi\Feb21/00