PACKAGE LEAFLET: INFORMATION FOR THE USER

Tramadol Hydrochloride 50mg Capsules

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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Tramadol Capsules are and what they are used for

2.    Before you take Tramadol Capsules

3.    How to take Tramadol Capsules

4.    Possible side effects

5.    How to store Tramadol Capsules

6.    Further information

1. WHAT TRAMADOL CAPSULES ARE AND WHAT THEY ARE USED FOR

Tramadol hydrochloride is the active substance in Tramadol Capsules, it is a painkiller belonging to the class of opioids that acts on the central nervous system. It relieves pain by acting on specific nerve cells of the spinal cord and brain. Tramadol Capsules are used for the treatment of moderate to severe pain.

2. BEFORE YOU TAKE TRAMADOL CAPSULES

Do not take Tramadol Capsules

•    if you are allergic (hypersensitive) to tramadol or any of the other ingredients of Tramadol Capsules;

•    in acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions);

•    if you are also taking monoamine oxidase (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”);

•    if you are dependent upon strong pain relievers (those acting on the central nervous system-opioids);

•    if you are an epileptic and your fits are not adequately controlled by treatment;

•    as a substitute in drug withdrawal.

Take special care with Tramadol Capsules

•    if you think that you are addicted to other pain relievers (opioids);

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

•    if you are in a state of shock (cold sweat may be a sign of this);

•    if you suffer from increased pressure in the brain (possibly after a head injury or brain disease);

•    if you have difficulty in breathing;

•    if you have epilepsy or fits because the risk of a fit may increase;

•    ifyou suffer from a liverorkidney disease.

In such cases please consult your 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).

Please note that Tramadol Capsules may lead to physical and psychological addiction. When Tramadol Capsules are taken for a long time, its effect may decrease, so that higher doses have to be taken (tolerance development).

In patients with a tendency to abuse medicines or who are dependent on medicines, treatment with Tramadol Capsules should only be carried out for short periods and under strict medical supervision.

Please also inform your doctor if one of these problems occurs during Tramadol Capsules treatment or if they applied to you in the past.

Taking other medicines

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

It is important to tell the doctor ifyou are taking:

•    A group called monoamine oxidase inhibitors (MAOIs), or if you have taken them in the previous fourteen days.

•    Carbamazepine (for epileptic fits).

•    Buprenorphine, nalbuphine, or pentazocine (pain killers).

•    Ondansetron (used to stop you feeling sick).

•    Anti-depressants (5HT and noradrenaline potentiating) including serotonin reuptake inhibitors (SSRIs).

•    Sedative medicines such as tranquillisers, sleeping pills, antidepressants and strong pain relievers (morphine, codeine, pethidine). You may feel excessively drowsy or feel that you might faint.

•    Tricyclic antidepressant and antipsychotic medicines. There may be an increased risk of epileptic fits.

•    Blood thinning medicines, such as warfarin. The dose of these medicines may need reducing; otherwise there could be an increased risk of serious bleeding.

•    Anticonvulsant drugs taken with tramadol can lower the seizure threshold and the risk of convulsions may increase in these patients.

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 ifyou take Tramadol Capsules at the same time. Your doctor will tell you whether Tramadol Capsules are suitable for you.

•    if you are taking certain antidepressants. Tramadol Capsules 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.

Taking Tramadol Capsules with food and drink

Do not drink alcohol during treatment with Tramadol Capsules as it may increase the intensity of the side effects. Tramadol Capsules can be taken with or without food.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. There is very little information regarding the safety of tramadol in human pregnancy. Therefore you should not use Tramadol Capsules ifyou are pregnant. Chronic use during pregnancy may lead to withdrawal symptoms in newborns.

Generally, the use of tramadol is not recommended during breast-feeding. Small amounts of tramadol are excreted into breast milk. On a single dose it is usually not necessary to interrupt breast-feeding. Please ask your doctorfor advice.

Driving and using machines

Tramadol Capsules can cause drowsiness and dizziness, and blurred vision. Because of this Tramadol Capsules can affect your ability to drive and operate machinery. Do not drive a car or do other activities that need you to be alert, until you know how tramadol affects you.

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.

How and when should vou take Tramadol Capsules

Always swallow Tramadol Capsules whole, not divided or chewed, with sufficient liquid, preferably in the morning and evening. You may take the capsule on an empty stomach or with meals.

How Iona should vou take Tramadol Capsules You should not take Tramadol Capsules 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 Capsules and at what dose. Ifyou have the impression that the effect of Tramadol Capsules is too strong or too weak, talk to your doctor or pharmacist.

Ifyou take more Tramadol Capsules than you should

If you have taken too many Tramadol Capsules you should immediately contact your doctor, nearest hospital or clinic. The possible symptoms that may occur are: pin-point pupils, vomiting, a fall in blood pressure, a fast heartbeat, collapse, disturbed consciousness including coma (deep unconsciousness), epileptic fits and difficulties in breathing.

Ifyou forget to take Tramadol Capsules

If you forget to take a dose, leave out the missed dose and take the next dose on time. Never take two doses together.

Ifyou stop taking Tramadol Capsules

If you interrupt or finish treatment with Tramadol Capsules too soon, pain is likely to return. Ifyou wish to stop treatment on account of unpleasant effects, please tell your doctor. Generally there will be no after - effects when treatment with Tramadol Capsules is stopped. However, on rare occasions, people who have been taking Tramadol Capsules for some time may feel unwell if they abruptly stop taking them. They may feel agitated, anxious, nervous or shaky. They may be hyperactive, have difficulty sleeping and have stomach or bowel disorders. Very few people may get panic attacks, hallucinations, unusual perceptions such as itching, tingling and numbness, and noise in the ears (tinnitus). Ifyou experience any of these complaints after stopping Tramadol Capsules, please consult your doctor.

Eve disorders rare:

•    blurred vision.

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.

Urinarvdisorders

rare:

•    passing water difficult or painful, less urine than normal.

General disorders common:

•    tiredness, weariness, weakness, low energy.

If Tramadol Capsules 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 "Ifyou stop taking Tramadol Capsules").

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOWTOSTORETRAMADOLCAPSULES

3. HOWTO TAKE TRAMADOL CAPSULES

Always take Tramadol Capsules exactly as your doctor has told you. You should 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.

Unless otherwise prescribed by your doctor, the usual dose is:

Adults and adolescents from the age of 12 years

1 (One) or 2 (two) Tramadol Capsules (equivalent to 50 mg-100 mg) with subsequent doses of 50 mg or 100 mg, every 4 (four) to 6 (six) hours.

Do not take more than 8 (eight) Tramadol Capsules (equivalent to 400 mg tramadol hydrochloride) daily, except if your doctor has instructed you to do so.

Dependent upon pain severity, your doctor may prescribe a different, more appropriate dosage of Tramadol Capsules if necessary.

Children

Tramadol Capsules are not suitable for children below the age of 12 years.

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 finsufficiencvV dialysis patients

Patients with severe liver and/or kidney insufficiency should not take Tramadol Capsules. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Tramadol Capsules can cause side effects, although not everybody gets them.

In case one of the following situations occur, see your doctor straight away:

•    allergic reactions e.g. difficulty in breathing, wheezing, swelling of skin (occurs rarely),

•    swollen face, tongue and/or throat and/or difficulty to swallow or hives together with difficulties in breathing (occurs rarely),

•    shock/sudden circulation failure (occurs rarely).

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). The most common side effects during treatment with Tramadol Capsules are nausea and dizziness, which occur in more than in 1 out of 10 patients.

Heart and blood circulation disorders uncommon:

•    effects on the heart and blood circulation (pounding of the heart, fast heart beat, 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.

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).

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 of tramadol or when tramadol was taken at the same time as other medicines which may induce fits.

Psychiatric disorders rare:

•    hallucinations, confusion, sleep disorders, anxiety and nightmares. 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.

Keep out of the reach and sight of children. Tramadol Capsules should be stored below 25°C, in the original package, to protect from moisture and light.

Do not use Tramadol Capsules after the expiry date which is stated on the blister and the carton after “exp”. The expiry date refers to the last day of that month.

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.

6. FURTHER INFORMATION

What Tramadol Capsules contain

Each capsules contains 50 mg of tramadol hydrochloride.

The other ingredients are croscarmellose sodium, povidone (polyvinylpyrrolidone), microcrystalline cellulose, silicon dioxide, magnesium stearate, gelatin, titanium dioxide, iron oxide yellow, quinoline yellow and brilliant blueFD&CNo. 1.

What Tramadol Capsules look like and contents of the pack

Tramadol Capsules are yellow and green. Tramadol Capsules are presented in combination aluminium/polyvinylchloride blisters strips and are supplied in boxes of 10,20,30,40, 50,60,70,80,90 or 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Morningside Healthcare Limited

115 Narborough Road, Leicester, LE3 0PA, UK

Manufacturer:

Medochemie Ltd Central Factory (PlantA)

1-10 Constantinoupoleos Str.,

Zakaki, Limassol, Cyprus

Facility A-Z, Mich. ErakleousStr.,

Ag.Athanasios, Industrial Area,

Limassol, Cyprus

This leaflet was last revised in July 2014