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.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1.What TRADOREC XL is and what it is used for
- 2.Before you take TRADOREC XL
- 3.How to take TRADOREC XL
- 4.Possible side effects
- 5.How to store TRADOREC XL
- 6.Further information
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 painkillers medicines called opiate analgesics.
Before you take TRADOREC XL
Do not take TRADOREC XL and tell your doctor :
- If you are allergic (hypersensitive) to tramadol or any of the other ingredients in this medicine (see list of ingredients in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.
- 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 (more than 2 to 3 days).
If you are not sure, it is important to ask your doctor or pharmacist for advice.
Take special care with TRADOREC XL
The use of this medicine is not recommended in patients over 75 years of age.
The use of this medicine is not recommended in children under 12 years of age.
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)
Epileptic fits have been reported in patients taking tramadol at the recommended dose level. The risk may be increased when doses of tramadol exceed the recommended upper daily dose limit (400 mg).
If you are not sure, do not hesitate to consult your doctor or pharmacist for advice.
Taking other medicines:
You should tell your doctor if you are taking or have taken any of the following medicines as they may interact with your TRADOREC XL.
- Carbamazepine (used for the treatment of epilepsy)
- Buprenorphine, nalbuphine, pentazocine (other painkillers)
- Alcohol,
- Naltrexone (used for alcohol or drug abuse).
This medicine may cause seizures at therapeutic doses and in particular when taking high doses and in combination with other medicines including:
- drugs used to treat depression
- bupropion (used to help stopping smoking)
- mefloquine (a treatment for malaria)
- and some medicines used for personality disorders.
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.
Taking TRADOREC XL with food and drink
Drinking alcohol is not recommended during treatment.
Pregnancy and breast-feeding
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.
You can usually continue breast-feeding if you take one single dose.
If your treatment lasts for more than 2 to 3 days, breast-feeding may be interrupted. You must not breast-feed during long-term treatment.
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 other activities where you need to be alert (for example using any tools or machines), until you know how the medication affects you. Do not take with alcohol or drugs that make you sleepy.
How to take TRADOREC XL
Always take TRADOREC XL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
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.
Elderly patients (up to 75 years of age) – no dose adjustment is needed.
Patients with liver or kidney problems, or those on dialysis - may need a lower dose.
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.
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 agitated, anxious, nervous or shaky. They may become over-active and have difficulty sleeping. These effects usually disappear in a few days. Tell your doctor if this happens to you.
If you have any further questions on the use of this product, ask your doctor or pharmacist for more information.
Possible side effects
Like all medicines, TRADOREC XL can cause side effects, although not everybody gets them. All medicines can cause allergic reactions, although serious allergic reactions are very rare. Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).
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 (affects more than 1 user in 10)
- feeling sick (nausea),
- dizziness.
Common (affects 1 to 10 users in 100)
- constipation,
- sweating,
- dry mouth,
- confusion,
- headache,
- vomiting.
Uncommon (affects 1 to 10 users in 1,000)
- gastrointestinal irritation (a feeling of pressure in the stomach and wind),
- cardiac and vascularproblems (increased heart rate, low blood pressure on standing, feeling unwell with drop in blood pressure),
- skin reactions (itching, rash, hives).
Rare (affects 1 to 10 users in 10,000)
- muscle weakness,
- changes in appetite,
- feelings of numbness, itch or pins and needles, tremors,
- slow heart rate or breathing,
- increase in blood pressure,
- 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 have been reported.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How to store TRADOREC XL
Keep out of the reach and sight of children.
Do not use TRADOREC XL 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
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further information
What TRADOREC XL contains
- The active substance in TRADOREC XL is tramadol hydrochloride 100 mg, 200 mg and 300 mg as prolonged released tablets
- The other ingredients are: polyvinyl acetate, povidone, sodium lauryl sulphate and silica (Kollidon SR), xanthan gum, hydrogenated vegetable oil ( from cotton seed), magnesium stearate (vegetable origin), silica colloidal anhydrous, hydroxypropyl distarch phosphate (E1442) (Contramid).
What TRADOREC XL looks like and contents of the pack
This medicine is presented as white to off-white, plain, bevelled edge, round, biconvex prolonged release tablets in the following pack sizes:
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
Not all pack sizes may be marketed
Marketing Authorisation Holder
Labopharm Europe Limited
The manufacturer responsible for batch release is:
Labopharm Europe Limited
Distributed by:
Merck Sharp & Dohme Ltd
This medicinal product is authorised in the Member States of the EEA under the following names:
France (RMS): Monotramal L.P.
Austria: Noax Uno
Belgium: Contramal Uno
Cyprus; Tramadur
Czech Republic: Noax Uno
Germany: Tramadolor einmal taglich
Spain: Dolpar
Iceland: Tridural
Italy: Unitrama
Luxembourg: Contramal Uno
Poland: Noax Uno
Portugal: Tridural
Slovakia: Noax Uno
UK: Tradorec XL
This leaflet was last approved in 03/2010
Contramid is a registered trademark of Labopharm Inc
PIL.TRA.10.UK.3206
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