: 231-30-87831 -E LEA TRAMADOL 50MG CAPSTUK 13 October2014

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TRAMADOL 50 mg CAPSULES

PACKAGE LEAFLET: INFORMATION FORTHE USER

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.

♦    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 of the side effects talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. See section 4.

he 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 takeTramadol at the same time. Your doctor will tell you whether Tramadol is suitable for you.

if you are taking certain antidepressants.Tramadol 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 33 °C. I

1.    What Tramadol is and what it is used for

2.    What you need to know before you take Tramadol

3.    How to take Tram ado I

4.    Possible side effects

5.    How to store Tram ado I

6.    Contents of the pack and other information

o

WHATTRAMADOL IS AND WHAT IT IS USED FOR

♦ Tramadol Capsules are part of a group of drugs known as analgesics which act on the central nervous system (the brain and spinal cord). Analgesics are often called 'pain killers' or 'pain relievers'.

Tramadol is

to prevent moderate to severe

§ hA WHAT YOU NEEDTO KNOW BE FORE YOU TAKE £- W TRAMADOL

Talk to your doctor or pharmacist if you are taking, have recently

taken or might take any of the following:

♦    other medicines that slow the nervous system, including tranquillisers, sleeping pills, antidepressants and other pain relievers such as morphine and codeine

♦    lithium (a medicine used to treat certain types of mental

♦    cimetidine (a medicine used to treat certain conditions caused by too much acid being produced in the stomach)

♦    medicines which may cause convulsions (fits), such as certain anti depressants. The risk of having a fit may increase if you takeTramadol at the same time.

♦    selective serotonin reuptake inhibitors (often referred to as SSRIs, used to treat depression). Tramadol may interactwith these medicines and you may experience symptoms such as confusion, restlessness, fever, sweating, uncoordinated movement of limbs or eyes, uncontrollable jerking of muscles, or diarrhoea.

♦    if you take coumarin anticoagulants (medicines for blood thinning), e.g. warfarin, together with Tramadol. The effect of these medicines on blood clotting may be affected and bleeding may occur.

DO NOT take Tramadol if you:

♦    are allergic to Tramadol or any of the other ingredients of this

♦    have taken enough alcohol to make you feel even slightly drunk

♦    have taken several sleeping pills, other pain killers, psychotropic medicine (medicines that affects mood and emotion)

♦    are also taking MAO inhibitors (certain medicines used for treatment of depression) or have taken them in the last

14 days before treatment with Tramadol capsules (see taking other medicines)

♦    are an epileptic and your fits are not adequately controlled by treatment

♦    as a substitute in drug withdrawal.

Before you have general anaesthetics, (medicines used for temporary loss of bodily sensation during an operation) make sure you tell your doctor or dentist that you are taking Tramadol Capsules.

Taking Tramadol with food and drink

♦ DO NOT take alcohol whilst takingTramadol Capsules. Food does not influence the effect of Tramadol.

Warnings and precautions Addiction

Tramadol may cause physical and psychological dependence (addiction) or reliance on the medicine, particularly with long

♦    if you need to takeTramadol for a long period, your doctor should review your treatment regularly

♦    tell your doctor if you have a history of drug abuse or dependence, or you are addicted to other pain relievers (opioids), as you should only use this medicine for short periods and under strict medical supervision.

Pregnancy, breast-feeding and fertility

♦    Tramadol is not recommended if you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacistfor advice before taking this medicine.

Driving and using machines

♦    Tramadol may cause drowsiness, dizziness and blurred vision. This may be made worse if alcohol and/or other medicines that slow the nervous system such as phenobarbital, diazepam, amitriptyline, dilorpromazine are taken at the same time. If you are affected, DO NOT drive or operate machinery.

The medicine can affectyour 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

Talk to your doctor before taking Tramadol if you:

♦    have or recently had a head injury or brain disease and due to that you are suffering from increased pressure in the brain

♦    have had any problems with your kidneys or liver

♦    suffer from epilepsy, fits or seizures or have had them in the past. In such cases please consultyour doctor before taking the medicine. 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).

♦    suffer from asthma or other lung diseases, or have slow or troubled breathing

♦    suffer from consciousness disorders (if you feel that you are going to faint)

♦    are in a state of shock (cold sweat may be a sign of this).

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.

o

HOW TO TAKE TRAMADOL

Tramadol Capsules are for oral use. Always swallow Tramadol whole, not divided or chewed, with sufficient liquid.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

When Tramadol is taken for a long time, its effect may decrease, so that higher doses have to be taken (tolerance development). Other medicines and Tramadol

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

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.

DO NOT takeTramadol if you are taking:

♦    a monoamine oxidase inhibitor (MAOI, which is a type of medicine that can treat Parkinson's Disease or depression) such as selegiline or moclobemide, or if you have taken any of these medicines within the past two weeks.

The pain-relieving effect of Tramadol may be reduced and the

length of time it acts may be shortened, if you take medicines

which contain

♦    carbamazepine (for epileptic fits)

♦    pentazocine, nalbuphine or buprenorphine (pain killers)

♦    ondansetron (prevents nausea).

The capsules should be swallowed preferably with a drink of water. The usual dose is:

♦    Adults, Elderly and Children aged 12 years and over

1 or 2 capsules every four hours.

Do not take more than 3 capsules in 24 hours.

Elderly patients

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 takeTramadol. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.

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♦    Children aged under 12 years

Tramadol is not recommended for use in children under 12 years of age.

♦    How long should you takeTramadol

You should not takeTramadol for longer than necessary. If you need to be treated for a longer period, your doctor will check at regular short intervals (if necessary with breaks in treatment) whether you should continue to take Tramadol and at what dose. If you have the impression that the effect of Tramadol is too strong or too weak, talk to your doctor or pharmacist.

If you take more Tramadol than you should

If you (or someone else) swallow too many capsules all together, or if you think a child has swallowed any of the capsules, contact your nearest hospital casualty department or your doctor immediately.

An overdose is likely to cause contraction of the pupils of the eyes, vomiting, loss of effective blood flow, sedation and coma, fits and difficulties in breathing.

Please take this leaflet, any remaining capsules and the container with you to the hospital or doctor so that they know which capsules were consumed.

If you forget to takeTramadol

if you forget to take this medicine, take one as soon as you remember, unless it is nearly time to take the next one. DO NOT take a double dose to make up for a forgotten dose.

If you stop taking Tramadol

If you interrupt or finish treatment with Tramadol too soon, pain is likely to return. If you wish to stop treatment on account of unpleasant effects, please teii your doctor. Generally there will be no after-effects when treatment with Tramadol is stopped. However, on rare occasions, people who have been taking Tramadol for some time may feel unwell if they abruptly stop taking them.They may feel agitated, anxious, nervous or shaky. They may be confused, hyperactive, have difficulty sleeping, spasm or uncontrolled muscular action, tremor and have stomach or bowel disorders. Very few people may get panic attacks, delusions, paranoia, hallucinations or feeling a loss of identity. They may experience unusual perceptions such as itching, tingling and numbness, and "ringing" in the ears (tinnitus). If you experience any of these complaints after stoppingTramadoi, please consultyour doctor, if you have any further questions on the use of this product, ask your doctor or pharmacist.

o

POSSIBLE SIDE EFFECTS

Like ail medicines, this medicine can not everybody gets them.

cause side effects, although

Stop taking the capsules and tell your doctor immediately or go

to the casualty department at your nearest hospital if the following happens:

♦    an allergic reaction causing swelling of the lips, face or neck leading to severe difficulty in breathing, or severe skin rash or hives

♦    shock/sudden circulation failure

♦    difficulty breathing

♦    a fit

♦    a constant sore throat or high temperature.

These are very serious but rare side effects. You may need urgent medical attention or hospitalisation.

Usually the frequency of side effects is classified as follows:

♦    very common (more than 1 out of 10 persons)

♦    common (more than 1 out of 100 persons)

♦    uncommon (more than 1 out of 1,000 persons)

♦    rare (more than 1 out of 10,000 persons)

♦    very rare (less than 1 out of 10,000 persons)

♦    not known (can not be estimated from the available data).

Heart and blood circulation disorders

uncommon: effects on the heart and blood circulation (pounding of the heart, fast heart beat a fall in blood pressure on standing up which causes dizziness, light-headedness, feeling faint or collapse). These adverse effects may particularly occur in patients in an upright position or under physical strain, rare: slow heart beat, increase in blood pressure.

Psychiatric disorders

rare: hallucinations, confusion, sleep disorders, anxiety and

Psychological complaints may appear after treatment with Tramadol capsules.Their intensity and nature may vary (according to the patient's personality and length of therapy). These may appear as a change in mood (mostly high spirits, occasionally irritated mood), changes in activity (slowing down but sometimes an increase in activity) and being less aware and less able to make decisions, which may lead to errors in judgement Dependence may occur.

Metabolism and nutrition disorders not known: decrease in blood sugar level.

Eye disorders

rare: blurred vision

not known: dilation of the pupil.

Respiratory disorders

rare: shortness of breath (dyspnoea).

Worsening of asthma has been reported, however it has not been established whether it was caused by tramadol.

Stomach and bowel disorders

very common: feeling sick.

common: being sick, constipation, dry mouth.

uncommon: urge to be sick (retching), stomach trouble (e.g.

feeling of pressure in the stomach, bloating), diarrhoea.

Skin disorders common: sweating

uncommon: skin reactions (e.g. itching, rash).

Muscle disorders rare: weak muscles.

Liver and biliary disorders

very rare: increase in liver enzyme values.

Urinary disorders

rare: passing water difficult or painful, less urine than normal. General disorders

common: tiredness, weakness, low energy.

Excessive sweating has been reported during the treatmentwith Tramadol, although the frequency is not known.

Feeling flushed (feeling hot and red skin) has rarely been seen during the treatment. Blood disorders have been reported. Blood disorders may be characterised by fever or chills, sore throat, ulcers in your mouth or throat, unusual tiredness or weakness, unusual bleeding or unexplained bruising.

If Tramadol is taken over a long period of time dependence may occur, although the risk is very low. When treatment is stopped abruptly signs of withdrawal may appear (see 'If you stop taking Tramadol Capsules').

Reporting of side effects:

If you get any side effects, talk to your doctor or pharmacist.

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/yelIowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

^ HOWTO STORE TRAMADOL

Keep this medicine out of the sight and reach of children.

Keep this medicine in a dry place below 30°C.

Do not use this medicine after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month.

Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

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CONTENTS OFTHE PACK AND OTHER INFORMATION

Nervous system disorders very common: dizziness, common: headaches, drowsiness.

rare: changes in appetite, abnormal sensations (e.g. itching, tingling, numbness), trembling, slow breathing, epileptic fits, muscle twitches, uncoordinated movement, transient loss of consciousness (syncope).

Not known: difficulty in speaking.

If the recommended doses are exceeded, or if other medicines that depress brain function are taken at the same time, breathing may slow down.

Epileptic fits have occurred mainly at high doses ofTramadol or when Tramadol was taken at the same time as other medicines which may induce fits.

What Tramadol Capsules contain:

♦    The active ingredient is Tramadol Hydrochloride 50 mg.

♦    The other ingredients are microcrystalline cellulose, sodium starch glycolate, magnesium stearate, colloidal anhydrous silica.

♦    The capsule shell contains gelatin, indigo carmine E132, iron oxide yellow E172, titanium dioxide E171, shellac, iron oxide black E172 and propylene glycol E1520.

What Tramadol Capsules look like and contents of the pack:

♦    Tramadol 50 mg Capsules are green and pale yellow capsules marked with 9T1 50.

♦    Tramadol 50 mg Capsules are available in pack sizes of 10, 20, 30, and 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation holder and Company responsible for manufacture:TEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised: 09/2014.

PL 00239/1603

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