Tramadol Mylan SR (formerly Tramedo SR)

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

tramadol hydrochloride modified release tablets
CONSUMER MEDICINE INFORMATION
WARNING
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 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 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 several hours.
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 leaflet
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.
Addiction
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.
Dependence
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
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.
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.
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 your doctor.

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. These include:
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
some antibiotics.
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)
OR
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 dose.
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 immediately:
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 been taken.

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 this medicine.
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 medicine.
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 to.
Do not give this medicine to anyone else, even if they have the same conditions as you.

Things to be careful of

Be careful when driving or operating 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, operate machinery or do anything else that could be dangerous.

Side effects

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:
dizziness
sedation, fatigue
headache
constipation
nausea, vomiting
sweating
dry mouth.
Less common side effects:
indigestion
changes in appetite
skin reactions
sudden onset of low blood pressure, collapse
muscle weakness
tremor
seizures
respiratory depression
improvement of mood
confusion
sleep disturbance
blurred vision
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
hallucinations
convulsions
The side effects listed above are very serious and may require urgent medical attention or hospitalisation.
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

Storage

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.

Disposal

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.

Product description

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.

Ingredients

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:
glyceryl behenate
calcium hydrogen phosphate dihydrate
povidone
colloidal anhydrous silica

Supplier

Alphapharm Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.mylan.com.au
 
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
February 2021.
 
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