2. What should I know before I take TRAMEDO?
Do not take if you have ever had an allergic reaction to tramadol hydrochloride, other
opioids or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section
2. What should I know before I take TRAMEDO? in the full CMI.
3. What if I am taking other medicines?
4. How do I take TRAMEDO?
Swallow the capsules whole with a glass of water. Your doctor will decide the right
dose for you. Do not take more than eight TRAMEDO capsules in 24 hours. More instructions
can be found in Section
4. How do I take TRAMEDO? in the full CMI.
5. What should I know while taking TRAMEDO?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are taking TRAMEDO.
If you become pregnant or plan to breastfeed while taking TRAMEDO, tell your doctor
immediately.
If your pain is not as severe or if your pain is not helped or gets worse, talk to
your doctor.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine.
If you have to have any blood tests, tell your doctor that you are taking this medicine.
|
|
Things you should not do
|
Do not stop taking your medicine suddenly or change the dosage without checking with
your doctor.
Do not give this medicine to anyone else, even if they have the same conditions as
you.
Do not take this medicine to treat any other conditions unless your doctor tells you
to.
|
|
Driving or using machines
|
Avoid driving, operating heavy machinery until you know how this medicine affects
you. This medicine may cause dizziness, light-headedness, tiredness, drowsiness in
some people. If you have any of these symptoms, do not drive or do anything else that
could be dangerous.
|
|
Drinking alcohol
|
Drinking alcohol while taking this medicine can cause drowsiness, coma or death.
Do not drink alcohol while using this medicine.
|
|
Looking after your medicine
|
Keep your capsules in the pack until it is time to take them.
Keep your capsule below 30°C.
|
6. Are there any side effects?
Tell your doctor if you have these common side effects and they worry you: dizziness,
sedation, fatigue, headache, constipation, nausea or vomiting, sweating or dry mouth.
Seek immediate medical advice if you notice these serious side effects: 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, hallucinations convulsions. Tell your doctor if you have extreme
fatigue, lack of appetite, severe abdominal pain, nausea, vomiting or low blood pressure.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
|
WARNING:
Limitations for use
TRAMEDO 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
TRAMEDO 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
TRAMEDO 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 TRAMEDO 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 TRAMEDO
Using TRAMEDO 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
death.
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 TRAMEDO.
|
Active ingredient(s):
tramadol hydrocholoride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking TRAMEDO. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking TRAMEDO.
Where to find information in this leaflet:
1. Why am I taking TRAMEDO?
TRAMEDO contains the active ingredient tramadol hydrochloride, which belongs to a group of medicines called opioid analgesics (pain relievers).
TRAMEDO is used to relieve severe pain.
TRAMEDO 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 people who are between
12 – 18 years of age and are recovering from an operation to remove tonsils and/or
adenoids.
2. What should I know before I take TRAMEDO?
Warnings
Do not take TRAMEDO if:
you are allergic to:
tramadol hydrochloride
other medicines known as opioid analgesic, e.g. morphine or codeine
any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can take this medicine.
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.
you have respiratory disease or slow or shallow breathing
you 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)
you are taking medicine for depression containing a monoamine oxidase inhibitor (MAOI)
or have taken a MAOI within the past two weeks. Examples of MAOI-containing medicines
are moclobemide and tranylcypromine
you have uncontrolled epilepsy or if your epilepsy is not well controlled by treatment
you 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
you are lactose or galactose intolerant.
This medicine contains lactose.
The expiry date printed on the pack has passed or if the packaging is torn or shows
signs of tampering.
If the medicine has expired or is damaged, return it to your pharmacist for disposal.
Check with your doctor if you:
you have a known allergy to tramadol hydrochloride or any of the ingredients listed
at the end of this leaflet
you are known to be sensitive to opioids
you drink alcohol
you have or have had any problems with drug or alcohol dependence
have or have had any of the following medical conditions:
any lung or breathing problems
sleep - related breathing disorders
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
any fits or convulsions or take medicine for epilepsy
take any medicines for any other conditions
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Addiction
You can become addicted to TRAMEDO even if you take it exactly as prescribed. TRAMEDO
may become habit forming causing mental and physical dependence. If abused, it may
become less able to reduce pain.
Dependence
As with all other opioid containing products, your body may become used to you taking
TRAMEDO. Taking it may result in physical dependence. Physical dependence means that
you may experience withdrawal symptoms if you stop taking TRAMEDO suddenly, so it
is important to take it exactly as directed by your doctor.
Tolerance
Tolerance to TRAMEDO may develop, which means that the effect of the medicine may
decrease. If this happens, more may be needed to maintain the same effect.
Withdrawal
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
increased sweating.
Very rarely, some patients have experienced the following withdrawal reactions:
panic attacks
severe anxiety
hallucinations
tingling or numbness (pins and needles)
ringing in your ears
confusion, delusions or paranoia.
If you are not sure whether you should start taking TRAMEDO, talk to your doctor.
If you have not told your doctor about any of the above, tell them before you start
taking TRAMEDO.
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or plan to become pregnant.
You should not take TRAMEDO during pregnancy unless your doctor has told you to. Taking
TRAMEDO during pregnancy may lead to withdrawal symptoms in the newborn baby.
You should not take TRAMEDO during labour as it can cause breathing problems or signs
of withdrawal in the newborn.
Talk to your doctor if you are breastfeeding or plan to breastfeed. TRAMEDO is not
recommended for use during breastfeeding.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with TRAMEDO and affect how it works. These include:
carbamazepine
coumarin derivatives (e.g.warfarin)
medicine for irregular or rapid heartbeat
medicines for depression, sleeplessness, mental or psychiatric conditions such as
selective serotonin reuptake inhibitors (SSRI's), serotonin-noradrenaline reuptake
inhibitors (SNRI's), tricyclic anti-depressants, quinidine, phenothiazines or anti-psychotics
some antibiotics
a group of medicines called anticholinergics. These medicines can be used to treat
a wide range of medical conditions including asthma, a respiratory condition called
chronic obstructive pulmonary disorder (COPD), Parkinson’s Disease, cardiovascular
disease, urinary incontinence (loss of bladder control), psychiatric disorders including
schizophrenia, anxiety, depression, allergies and travel sickness/nausea.
These medicines may be affected by TRAMEDO, or may affect how well it works. You may
need different amounts of your medicine, or you may need to take different medicines.
Other interactions not listed above may also occur.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect TRAMEDO.
4. How do I take TRAMEDO?
How much to take
Your doctor will decide the right dose for you. This may depend on your condition,
age, other medicines you are taking and how you respond to TRAMEDO.
An initial dose of one TRAMEDO capsule may provide sufficient pain relief, followed
by one or two capsules two to three times a day as required.
For more severe pain, two TRAMEDO capsules are usually required for the first dose,
followed by one or two capsules every four to six hours as required.
Patients over 75 years of age may require a lower daily dose.
Do not take more than eight TRAMEDO capsules in 24 hours.
How to take TRAMEDO
Swallow the capsules whole with a glass of water.
TRAMEDO can be taken with or without food.
How long to take TRAMEDO for
This differs between individuals depending on how severe your pain is, how you respond
to TRAMEDO and the cause of your pain.
Your doctor will decide how long you will take TRAMEDO for. Ask your doctor for advice
on how long you need to take TRAMEDO.
If you forget to take TRAMEDO
TRAMEDO capsules should be used regularly at the same time each day.
If you forget to take a dose, take it as soon as you remember. The next dose should
then be taken after four or six hours, or as prescribed by your doctor.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
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.
If you take too much TRAMEDO
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 TRAMEDO 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
Serotonin syndrome symptoms, sweating, agitation, muscle twitching, tremor, spontaneous
muscle contraction, high body temperature.
Other signs of overdose can also include problems with the 'nervous system' caused
by damage to the white matter of the brain (known as toxic leukoencephalopathy).
If you think that you or anyone else has taken too much TRAMEDO, urgent medical attention
may be needed.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26) for advice, 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
been taken.
5. What should I know while taking TRAMEDO?
Things you should do
If you are about to be started on any new medicine, tell your doctor and pharmacist
that you are taking TRAMEDO.
If your pain is not as severe and you feel that you do not need as much TRAMEDO as
your doctor prescribed, consult your doctor.
Tell your doctor if your pain is not helped or gets worse. Do not take increased amounts
or extra doses without checking with your doctor.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine. It may affect other medicines used during surgery.
If you have to have any blood tests, tell your doctor that you are taking this medicine.
It may affect the results of some tests.
Keep all of your doctor’s appointments so that your progress can be checked.
Remind any doctor, dentist or pharmacist you visit that you are taking TRAMEDO.
Call your doctor straight away if you:
become pregnant while taking TRAMEDO.
do not feel well while taking TRAMEDO.
Things you should not do
Do not stop taking your medicine or lower the dosage without checking with your doctor.
Some people may feel unwell if they suddenly stop taking TRAMEDO. If you suddenly
stop taking TRAMEDO you may experience withdrawal symptoms (see 'Withdrawal' section
above).
Do not give this medicine to anyone else, even if they have the same conditions as
you.
Do not use this medicine to treat any other conditions unless your doctor tells you
to.
Driving or using machines
Avoid driving, operating heavy machinery or using any machines or tools until you
know how TRAMEDO affects you.
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.
Drinking alcohol
Tell your doctor if you drink alcohol.
You must not drink alcohol while using TRAMEDO.
Drinking alcohol while taking TRAMEDO may cause serious side effects such as drowsiness,
breathing difficulties, and loss of consciousness.
Looking after your medicine
Keep your capsules in the pack until it is time to take them.
If you take the capsules out of the pack they may not keep well.
Keep your capsule below 30°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What TRAMEDO contains
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Active ingredient
(main ingredient)
|
tramadol hydrochloride 50 mg
|
|
Other ingredients
(inactive ingredients)
|
lactose monohydrate
microcrystalline cellulose
maize starch
sodium starch glycollate
magnesium stearate
empty gelatin capsule RM843 size 2 white OP body – brite orange OP cap (ID 11305)
TekPrint SW-9008 black ink (ID 2328)
|
|
Potential allergens
|
sugars as lactose
trace quantities of sulfites
|
Do not take this medicine if you are allergic to any of these ingredients.
What TRAMEDO looks like
TRAMEDO 50 mg capsules are white and orange in colour.
The capsules have "TL 50" on the white part and a Greek alpha symbol on the orange
part, printed in black ink.
AUST R 114197 (blister pack)
Each blister pack contains 20 capsules.
Who distributes TRAMEDO
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in March 2026.
TRAMEDO® is a Viatris company trade mark
TRAMEDO_cmi\Mar26/00