Patient Leaflet Updated 02-Jul-2018 | Endo Ventures Limited
Tradorec XL 100mg, 200mg & 300mg prolonged-release tablets
Package leaflet: Information for the user
TRADOREC XL® 100 mg, 200 mg, & 300 mg prolonged release tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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 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.
Tramadol is transformed in the liver by an enzyme. Some people have a variation of this enzyme and this can affect people in different ways. In some people, they may not get enough pain relief but other people are more likely to get serious side effects. If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.
This medicine should be used with caution in the case of:
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.
Children and adolescents
The use of this medicine is not recommended in children under 12 years of age.
Use in children with breathing problems
Tramadol is not recommended in children with breathing problems, since the symptoms of tramadol toxicity may be worse in these children.
Other medicines and TRADOREC XL®:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any of the following medicines as they may interact with your TRADOREC XL®.
This medicine may cause seizures at therapeutic doses and in particular when taking high doses and in combination with other medicines including:
The risk of side effects increases
This medicine may also interact with the following medicines:
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 are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
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 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.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
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.
Elderly patients (up to 75 years of age) - no dose adjustment is needed.
Elderly patients (above 75 years of age)
In elderly patients (above 75 years) the excretion of tramadol may be delayed. If this applies to you, your doctor may recommend prolonging the dosage interval.
Severe liver or kidney disease (insufficiency)/dialysis patients
Patients with severe liver and/or kidney insufficiency should not take TRADOREC XL®. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the 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.
If you stop taking TRADOREC XL®
You should not suddenly stop taking this medicine unless your doctor tells you to. If you want to stop taking your medicine, discuss this with your doctor first, particularly if you have been taking it for a long time. Your doctor will advise you when and how to stop, which may be by lowering the dose gradually to reduce the chance of developing unnecessary side effects (withdrawal symptoms).
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 medicine, ask your doctor or pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine 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.
The following side effects have also been reported:
Very common : may affect more than 1 in 10 people
Common : may affect up to 1 in 10 people
Uncommon : may affect up to 1 in 100 people
Rare : may affect up to 1 in 1,000 people
Not Known: Cannot be estimated from the available data
Reporting of side effects
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.
You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
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.
6. Contents of the pack and other information
What TRADOREC XL® contains
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 and Manufacturer
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
Germany Tramadolor einmal taglich
Luxembourg Contramal Uno
UK Tradorec XL
This leaflet was last revised in 05/2018
Contramid® is a registered trademark of Paladin Labs Inc
First Floor, Minerva House, Simmonscourt Road, Ballsbridge, Dublin 4, Ireland
+353 1 268 2000
+353 1 268 2030