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TRAMADOL HYDROCHLORIDE 50MG HARD CAPSULES

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Tramadol Hydrochloride 50mg Hard Capsules
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 your 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 become serious, or if you notice any side effects not listed in
the leaflet, please tell your doctor or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Tramadol Is And What It Is Used For
Before You Take Tramadol
How To Take Tramadol
Possible Side Effects
How To Store Tramadol
Further Information

1.

What Tramadol Is And What It Is Used For
Tramadol - the active substance in Tramadol Capsules - 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 is used in the treatment of moderate to severe pain.

2.
Before You Take Tramadol
Do not take Tramadol:
- if you know that you are allergic (hypersensitive) to tramadol or any of the other
ingredients of Tramadol Capsules (see Section 6, Further Information)
- in acute poisoning with alcohol, sleeping pills, pain relievers or psychotropic
medicines (medicines that affect mood and emotions)
- if you are also taking drugs known as monoamine oxidase inhibitors which are used to
treat depression, or have been taking them within the past two weeks before treatment
with Tramadol Capsules (see ‘Taking other medicines’)
- if you suffer from epilepsy not properly controlled by medicines
- as a substitute in drug withdrawal
Take special care with Tramadol and talk to your doctor if:
- you suffer from kidney or liver disease
- you suffer from epilepsy fits or convulsions or have had them in the past because the
risk of a fit may increase
- you suffer from asthma or have trouble breathing
- you are suffering from a head injury or brain disease or other cause of increased
pressure in the brain
- you suffer from consciousness disorders (if you feel that you are going to faint)

-

you are in a state of shock, cold sweat may be a sign of this
you think that you are addicted to other pain relievers (opioids)

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 (400mg).
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 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 obtained without a prescription.
Tramadol Capsules should not be taken together with MAO inhibitors (certain medicines for
the treatment of depression).
The pain-relieving effects of Tramadol Capsules may be reduced and the length of time it
acts may be shortened, if you take medicines which contain:
- carbamazepine (used to treat epilepsy and manic-depressive illness)
- opioid painkillers (such as buprenorphine, pentazocine and nalbuphine)
- ondansetron (prevents nausea)
Your doctor will tell you whether you should take Tramadol Capsules and what dose.
The risk of side effects increases:
- if you take tranquilizers, sleeping pills, other pain relievers such as morphine and
codeine (also as cough medicine) and alcohol while you are taking Tramadol
Capsules. You may feel drowsier or you may feel that you might faint. If this happens
tell your doctor.
- if you are taking medicines which may cause convulsions (fits) such as certain
antidepressants. The risk of having a fit may increase if you take Tramadol Capsules
at the same time. Your doctor will tell you whether Tramadol Capsules are suitable
for you.
- if you are taking selective serotonin reuptake inhibitors (often referred to as SSRI’s)
or MAO inhibitors (for the treatment of depression). Tramadol Capsules may interact
with 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 thinning of blood) e.g. warfarin,
together with Tramadol Capsules. The effect of these medicines on blood clotting
may be affected and bleeding may occur.
Taking Tramadol with food and drink
Do not drink alcohol during treatment with Tramadol as its effect may be intensified.
Food does not alter the effect of Tramadol.
Pregnancy and breast-feeding
Ask your doctor 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 if you are pregnant.
Chronic use during pregnancy may lead to withdrawal symptoms in newborns.
Generally the use of tramadol is not recommend 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 doctor for advice.
Driving and using machines
Tramadol Capsules may cause drowsiness, dizziness and blurred vision and therefore may
impair your reactions. If you are affected, do not drive, operate machinery, use electric tools
and do not work without a firm hold until the symptoms have totally gone away.
Important information about some of the ingredients of Tramadol
Tramadol contains lactose monohydrate (a sugar). If you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How To Take Tramadol
Always take Tramadol 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 or 2 Tramadol capsules (equivalent to 50mg - 100mg).
Do not take more than 8 Tramadol 50mg capsules (equivalent to 400 mg Tramadol
hydrochoride) daily, unless your doctor has instructed you to do so.
Children
Tramadol 50mg 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 (insufficiency) / dialysis patients:
Patients with severe liver and/or kidney insufficiency should not take Tramadol. If in your
case the insufficiency is mild or moderate, your doctor may recommend prolonging the
dosage interval.
How and when to take Tramadol
Tramadol capsules are for oral use.
Always swallow Tramadol capsules whole, not divided or chewed, with sufficient liquid,
preferably in the morning and evening. You may take the capsules on an empty stomach or
with meals.

How long should you take Tramadol?
You should not take Tramadol capsules for longer than necessary. If you need to be treated
for a long period, your doctor will tell you to go for checks to decide 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 accidentally take more than your prescribed dose, this will generally have no negative
effects. Take your next dose as prescribed. If you (or someone else) swallow a lot of
Tramadol Capsules at the same time, contact your nearest hospital casualty department or tell
your doctor immediately. Signs of an overdose include very small pupils, being sick, a fall in
blood pressure, a fast heart rate, collapse, unconsciousness, fits and breathing difficulties or
shallow breathing.
If you forget to take Tramadol
If you forget to take the capsules, pain is likely to return. Do not take a double dose to make
up for forgotten individual doses, simply continue taking the capsules as before.
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 side effects, please tell 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 overactive, 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). If you experience any of these complaints after
stopping Tramadol, please consult your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible Side Effects
Like all medicines, Tramadol can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience any of the following side effects, which
occur rarely:
- allergic reactions (e.g. difficulty breathing, wheezing or swelling of the skin)
- shock (sudden circulation failure),
- swollen face, tongue and/or throat, difficulty in swallowing or hives (dark red, raised,
itchy bumps on the skin, together with difficulties in breathing
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 and less than 1 out of 10 persons),
- Uncommon (more than 1 out of 1,000 persons and less than 1 out of 100 persons),
- Rare (more than 1 out of 10,000 persons and less than 1 out of 1,000 persons),
- Very rare (less than 1 out of 10,000 persons),
- Not known (cannot be estimated from the available data).

The most common side effects during treatment with Tramadol 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 heartbeat,
feeling faint or collapse). These adverse effects may particularly occur in patients who are 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 and numbness
occurring over the body but often hands and feet), trembling, slow breathing, epileptic fits. If
the recommended doses are exceeded or other medicines that depress the 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.
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 (usually suppression, occasionally increase) and decreased
cognitive and sensory perception (changes in senses and recognition, which may lead to
errors in judgement).
Dependence may occur.
Eye 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: nausea.
Common: vomiting, constipation, dry mouth.
Uncommon: 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.
Blood and lymphatic disorders
Rare: disorders of the blood cells which may cause bruising, tiredness and susceptibility to
infections.
General disorders
Common: tiredness, weariness, weakness, low energy.
There have been some reports of speech disorders and dilated pupils.
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").
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.
5. How To Store Tramadol
Keep out of the reach and sight of children.
Do not use Tramadol after the expiry date which is stated on the carton and blister. The
expiry date refers to the last day of that month.
Do not store above 25°C.
Store in the original package in order to protect from moisture.
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 contains
The active substance is Tramadol hydrochloride. Each capsule contains 50mg of the active
ingredient tramadol hydrochloride.
The other ingredients are lactose monohydrate, microcrystalline cellulose (E460(i)),
croscarmellose sodium (E466), magnesium stearate (E572).
Capsule shell excipients:
Erythrosin (E127), titanium dioxide (E171), yellow and black iron oxides (E172),
indigocarmine (E132), gelatin and S-1-27794 (black ink, which contains shellac, black iron
oxide (E172), propylene glycol (E1520), N-butyl alcohol).

What Tramadol looks like and contents of the pack
The capsules have a yellow and olive capsule shell, imprinted TRM on the capsule cap and
50 on the capsule body, containing a white powder.
The capsules are packaged in blister strips and supplied in cartons of 10, 20, 30, 50, 60 and
100.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Niche Generics Limited,
1 The Cam Centre,
Wilbury Way,
Hitchin,
Hertfordshire,
SG4 0TW,
United Kingdom

Manufacturers
Niche Generics Limited, 1 The Cam Centre,
Wilbury Way, Hitchin, Hertfordshire, SG4 0TW,
United Kingdom.
Chanelle Medical, Loughrea, Co. Galway,
Ireland.
This leaflet was last revised in 07/2013

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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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