TRADOREC XL 100MG PROLONGED RELEASE TABLETS

Active substance: 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.
 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.

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® and tell your doctor :
 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 (more than 2 to 3 days).
If you are not sure, it is important to ask your doctor or pharmacist for advice.
Warning and precautions with TRADOREC XL®
The use of this medicine is not recommended in patients over 75 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.
Children and adolescent
The use of this medicine is not recommended in children under 12 years of age.
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 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.
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.
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.
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 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.
 fits (convulsions),
 breathing difficulties,
 rash or allergic reaction of any kind
Allergic rashes may range in severity from mild itchy skin eruptions to a rarer, more serious
condition called Stevens-Johnson syndrome which may cause ulceration of the mouth, lips and skin.
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,
confusion,
headache,
vomiting.





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).


















Rare : may affect up to 1 in 1,000 peoplemuscle 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,
 low levels of blood sugar.
If you get any side effects talk to your doctor or pharmacist or nurse. This includes
possible side effects not listed in this leaflet.

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
 The active substance in TRADOREC XL® is tramadol hydrochloride 100 mg, 200 mg and 300
mg as prolonged release 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
5, The Seapoint Building
44 Clontarf Road,
Dublin 3

IRELAND

The manufacturer responsible for batch release is:
Labopharm Europe Limited
5, The Seapoint Building
44 Clontarf Road,
Dublin 3
IRELAND
Distributed by:
Merck Sharp & Dohme Ltd
Hertford Road,
Hoddesdon, UK
EN11 9BU
Tel: +44 (0) 1992 467272
medicalinformationhoddesdon@merck.com
This medicinal product is authorised in the Member States of the EEA under the
following names:
France (RMS)
Austria
Belgium
Czech Republic
Germany
Spain
Iceland
Italy
Luxembourg
Poland
Portugal
Slovakia
UK

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

This leaflet was last revised in 03/2012
Contramid® is a registered trademark of Labopharm Inc

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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