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TRADOREC XL 100MG PROLONGED RELEASE TABLETS

Active substance(s): TRAMADOL HYDROCHLORIDE

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Package leaflet: Information for the user
TRADOREC XL® 100 mg, 200 mg, & 300 mg prolonged release tablets
Tramadol hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What TRADOREC XL® is and what it is used for
2. What you need to know before you take TRADOREC XL®
3. How to take TRADOREC XL®
4. Possible side effects
5. How to store TRADOREC XL®
6. Contents of the pack and other information

1. What TRADOREC XL® is and what it is used for.
This medicine is used to treat moderate to severe pain in
adults and children over 12 years.
It belongs to a group of painkiller medicines called opiate
analgesics.

2. What you need to know before you take
TRADOREC XL®
Do not take TRADOREC XL®:
• If you are allergic to tramadol or any of the other ingredients
of this medicine (listed in section 6).
• If you are taking linezoid (an antibiotic used to treat severe
bacterial infections such as MRSA)
• In acute poisoning with alcohol, sleeping pills, pain relievers
or other psychotrop medicines (medicines that affect mood
and emotions).
• If you are taking, or have taken in the last two weeks, MAOIs
(medicines used to treat depression).
• If you are suffering from severe liver disease or severe kidney
disease.
• If you are suffering from epilepsy, not adequately controlled
by treatment.
• If you are breastfeeding, in the case of long-term treatment
If you are not sure, it is important to ask your doctor or
pharmacist for advice.
Warning and precautions
Talk to your doctor or pharmacist or nurse before taking
TRADOREC XL®
Tell your doctor if you are addicted to another drug, are being
treated for withdrawal from another drug or are dependent on
another drug.This medicine may cause a psychic or physical
dependence (addiction) with long-term use. In patients with a
tendency to become addicted to drugs, this medicine should
only be used for very short periods and under strict medical
supervision.
This medicine should be used with caution in the case of:
• reduced consciousness
• brain trauma or any brain disorder such as infection or
tumour
• state of shock (cold sweat may be a sign of it)
• breathing difficulties
• a history of epileptic seizures
• kidney or liver disorders
• an increase in normal brain pressure causing symptoms such
as headache and vomiting (increased intracranial pressure)
• diabetes

This medicine may cause seizures at therapeutic doses and in
particular when taking high doses and in combination with
other medicines including:
• bupropion (used to help stopping smoking)
• mefloquine (a treatment for malaria)
The risk of side effects increases
- if you are taking medicines which may cause convulsions
(fits), such as certain antidepressants or antipsychotics. The
risk of having a fit may increase if you take TRADOREC XL® at
the same time. Your doctor will tell you whether TRADOREC
XL® is suitable for you.
- if you are taking certain antidepressants. TRADOREC XL® may
interact with these medicines and you may experience
symptoms such as involuntary, rhythmic contractions of
muscles, including the muscles that control movement of
the eye, agitation, excessive sweating, tremor, exaggeration
of reflexes, increased muscle tension, body temperature
above 38°C.
This medicine may also interact with the following medicines:
• morphine-like drugs such as cough medicines or substitution
treatments such as methadone
• other painkillers
• warfarin (a blood thinner)
• benzodiazepines and other treatments for anxiety
• some treatments for high blood pressure
• antihistamines (for allergies) that cause sleepiness
• thalidomide (for certain cancers and skin conditions)
• barbiturates (sleeping pills)
• neuroleptics, phenothiazine, butyrophenine (to treat mental
illness)
• baclophene (a muscle relaxant)
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.
TRADOREC XL® with food and drink and alcohol
Drinking alcohol is not recommended during treatment.
Pregnancy and breast-feeding and fertility
This medicine should not be taken during pregnancy unless
absolutely necessary.
If you discover that you are pregnant while you are taking
this medication, you should consult your doctor as soon as
possible, who will adjust the treatment to your condition.
Tramadol is excreted into breast milk. For this reason, you
should not take TRADOREC XL® more than once during
breast-feeding, or alternatively, if you take TRADOREC XL®
more than once, you should stop breast-feeding. Ask your
doctor or pharmacist for advice before taking any medicine.

Driving and using machines
TRADOREC XL® may cause drowsiness. Do not drive or do
Epileptic fits have been reported in patients taking tramadol at other activities where you need to be alert (for example using
the recommended dose level. The risk may be increased when any tools or machines), until you know how the medication
doses of tramadol exceed the recommended upper daily dose affects you. Do not take with alcohol or drugs that make you
limit (400 mg).
sleepy.
The medicine can affect your ability to drive as it may make
If you are not sure, do not hesitate to consult your doctor
you sleepy or dizzy.
or pharmacist for advice.
- Do not drive while taking this medicine until you know how
it affects you.
Children and adolescents
- It is an offence to drive if this medicine affects your ability to
The use of this medicine is not recommended in children
drive.
under 12 years of age.
- However, you would not be committing an offence if:
• The medicine has been prescribed to treat a medical or
Other medicines and TRADOREC XL®:
dental problem and
Tell your doctor or pharmacist if you are taking, have recently • You have taken it according to the instructions given by the
taken or might take any of the following medicines as they
prescriber or in the information provided with the medicine
may interact with your TRADOREC XL®.
and
• Carbamazepine (used for the treatment of epilepsy)
• It was not affecting your ability to drive safely
• Buprenorphine, nalbuphine, pentazocine (other painkillers)
• Alcohol,
Talk to your doctor or pharmacist if you are not sure whether it
• Naltrexone (used for alcohol or drug abuse).
is safe for you to drive while taking this medicine.
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3. How to take TRADOREC XL®
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
The dosage should be adjusted to the intensity of your pain
and your individual pain sensitivity. In general the lowest
pain-relieving dose should be taken.
Adults and children over 12 years of age – the usual starting
dose is 100 mg, once daily.
The usual dose after this is 200 mg, once daily. If there is not
enough pain relief, the maximum dose is up to 300 or 400 mg,
once daily.












blurred vision,
difficulty in passing urine,
mood changes (such as feeling unusually happy),
changes in activity (such as being less active), and changes
in thought,
hallucinations (seeing or hearing things),
confusion,
trouble with sleep, nightmares,
allergic reactions,
worsening of asthma,
dependence (side effects that occur when you stop taking
the drug),
epileptic fits,
in a few isolated cases increases in liver enzymes,
miosis
delirium
anxiety





Elderly patients (up to 75 years of age) – no dose adjustment is •
needed.
Not Known: Cannot be estimated from the available data
Elderly patients (above 75 years of age)
• Low levels of blood sugar.
In elderly patients (above 75 years) the excretion of tramadol
Reporting of side effects
may be delayed. If this applies to you, your doctor may
If you get any side effects talk to your doctor or pharmacist or
recommend prolonging the dosage interval.
nurse. This includes any possible side effects not listed in this
leaflet.
Severe liver or kidney disease (insufficiency)/dialysis patients
You can also report side effects directly via the Yellow Card
Patients with severe liver and/or kidney insufficiency should
not take TRADOREC XL®. If in your case the insufficiency is mild Scheme at: www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on the safety of
or moderate, your doctor may recommend prolonging the
this medicine.
dosage interval.
These are oral tablets. Swallow the tablets whole with a glass
of water, preferably in the evening. TRADOREC XL® may be
taken with food or drink. Do not chew or crush them.
TRADOREC XL® tablets should be taken once every 24 hours.
Strictly follow your doctor’s advice at all times.
If you take more TRADOREC XL® than you should
Contact your doctor immediately.
If you forget to take TRADOREC XL®
Do not take a double dose to make up for a forgotten tablet.

5. How to store TRADOREC XL®
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated
on the box. The expiry date refers to the last day of that
month.
Blisters: Do not store above 30°C.
HDPE Bottles: This medicinal product does not require any
special storage conditions.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help protect
the environment.

If you stop taking TRADOREC XL®
Rarely when some people stop taking TRADOREC XL® after
long-term use, they get withdrawal symptoms. They may feel 6. Contents of the pack and other information
agitated, anxious, nervous or shaky. They may become
What TRADOREC XL® contains
over-active and have difficulty sleeping. These effects usually
• The active substance in TRADOREC XL® is tramadol
disappear in a few days. Tell your doctor if this happens to you.
hydrochloride 100 mg, 200 mg and 300 mg as prolonged
released tablets
If you have any further questions on the use of this medicine,
• The other ingredients are:
ask your doctor or pharmacist or nurse.
polyvinyl acetate, povidone, sodium lauryl sulphate and
silica (Kollidon® SR), xanthan gum, hydrogenated vegetable
4. Possible side effects
oil ( from cotton seed), magnesium stearate (vegetable
origin), silica colloidal anhydrous, hydroxypropyl distarch
Like all medicines, this medicine can cause side effects,
phosphate (E1442) (Contramid®).
although not everybody gets them. All medicines can cause
allergic reactions, although serious allergic reactions are very
What TRADOREC XL® looks like and contents of the pack
rare. Tell your doctor straight away if you get any sudden
This medicine is presented as white to off-white, plain,
wheeziness, difficulty in breathing, swelling of the eyelids, face bevelled edge, round, biconvex prolonged release tablets in
or lips, rash or itching (especially affecting your whole body).
the following pack sizes:
Serious side effects
If you notice any of these symptoms, stop taking the tablets
and consult your doctor straight away.
• fits (convulsions),
• breathing difficulties,
• rash or allergic reaction of any kind
The following side effects have also been reported:
Very common : may affect more than 1 in 10 people
• feeling sick (nausea),
• dizziness.
Common : may affect up to 1 in 10 people
• constipation,
• sweating,
• dry mouth,
• headache,
• vomiting.
• fatigue
• drowsiness
Uncommon : may affect up to 1 in 100 people
• gastrointestinal irritation (a feeling of pressure in the
stomach and wind),
• cardiac and vascular problems (increased heart rate, low
blood pressure on standing, feeling unwell with drop in
blood pressure),
• skin reactions (itching, rash, hives).

Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Endo Ventures Limited
First Floor
Minerva House
Simmonscourt Road
Ballsbridge
Dublin 4
IRELAND
This medicinal product is authorised in the Member States
of the EEA under the following names:
France (RMS)
Austria
Belgium
Germany
Spain
Italy
Luxembourg
Poland
Portugal
UK

Monotramal L.P.
Noax Uno
Contramal Uno
Tramadolor einmal taglich
Dolpar
Tridural
Contramal Uno
Noax Uno
Tridural
Tradorec XL

This leaflet was last revised in 06/2017
Contramid® is a registered trademark of Paladin Labs Inc

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Rare : may affect up to 1 in 1,000 people
• muscle weakness,
• changes in appetite,
• feelings of numbness, itch or pins and needles, tremors,
• slow heart rate or breathing,
• increase in blood pressure,

PVC/PVDC blisters with Aluminium backing foil (containing 5,
10, 15, 20, 30, 50, 60 or 100 prolonged-release tablets) or
PVC/PE/PCTFE blisters with Aluminium backing foil (containing
5, 10, 15, 30, 60 or 100 prolonged-release tablets) or
HDPE Bottles containing 100 prolonged-release tablets

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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