Package leaflet: Information for the user

TRADOREC XL⁸ 100 mg, 200 mg, & 300 mg prolonged release tablets Tramadol hydrochloride

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 XL⁸ 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 XL⁸

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 (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

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

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.

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®.

•    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:

•    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.

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.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

-    Do not drive while taking this medicine until you know how it affects you.

-    It is an offence to drive if this medicine affects your ability to drive.

-    However, you would not be committing an offence if:

•    The medicine has been prescribed to treat a medical or dental problem and

•    You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

•    It was not affecting your ability to drive safely

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 XL⁸ 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 aae - 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 aae) - no dose adjustment is needed.

Elderly patients (above 75 years of aae) - 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 (insufficiencv)/dialvsis 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®

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

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 people

•    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,

•    low levels of blood sugar.

Reporting of side effects

If you get any side effects talk to your doctor, 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

•    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 (El 442) (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 5,10,1 5,30,60 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

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:

Monotramal L.P.

Noax Uno Contramal Uno Noax Uno

Tramadolor einmal taglich

Dolpar

Unitrama

Contramal Uno

Noax Uno

Tridural

Noax Uno

Tradorec XL

This leaflet was last revised in 11/2014

Contramid® is a registered trademark of Paladin Labs Inc

LF4870 156x316mm 08/10/2014 12:26pm