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TRAMADOL 50MG CAPSULES

Active substance: TRAMADOL HYDROCHLORIDE

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Tramadol 50mg Capsules
PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
In this leaflet
1. What are Tramadol 50mg Capsules and what are
they used for
2. Before you take Tramadol 50mg Capsules
3. How to take Tramadol 50mg Capsules
4. Possible side effects
5. Storing Tramadol 50mg Capsules
6. Further information
WHAT ARE
ARE THEY USED FOR?
1. AND WHATTRAMADOL 50mg CAPSULES
Tramadol 50mg Capsules are 'analgesics' which act
on the central nervous system (the brain and the
spinal cord). Analgesics are often called 'pain killers'
or 'pain relievers'.
Tramadol 50mg Capsules relieve pain and can also
be taken to prevent pain.
Pain is a symptom not an illness. There are many
types of pain with many different causes, for
example back-ache, toothache, pain after an
operation or pain from broken bones.
Tramadol 50mg Capsules help your body's system
for relieving pain. It does this in two ways:
- Acts directly on parts of your brain and spinal
cord to reduce the amount of pain you feel
- Reduces the size of the pain message passed
from one nerve to another.
Tramadol 50mg Capsules should only be taken by
adults or children over 12.

2.

BEFORE YOU TAKE TRAMADOL 50mg
CAPSULES

Do not take Tramadol 50mg Capsules
• If you have had an allergic reaction, skin rash,
swelling of the face, wheezing or difficulty
breathing after taking tramadol or any of the
other ingredients in Tramadol 50mg Capsules.
• If you are hypersensitive (allergic) to tramadol
hydrochloride or any of the other ingredients in
Tramadol 50mg Capsules
• If you are pregnant or if you are breast-feeding
• If you are taking a monoamine oxidase inhibitor
(MAOI) or have taken one in the past two weeks.
You should know if you are taking MAOI because
your doctor or chemist will have told you, and
you may also have a treatment card.
• If you suffer from epilepsy not controlled by
treatment
• If you have drunk enough alcohol to make you
feel whoozy or drunk.
• If you feel 'high' or excited because you have
taken medicines that slow the nervous system.
These medicines include tranquillisers, sleeping
pills, psycho-tropic medicines (medicines that
affect your mood or emotions) or other pain
relievers such as morphine and codeine.
• If you have severe kidney disease.
• As a substitute in drug withdrawal.
Take special care with Tramadol 50mg 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 have had a head injury or have brain
disease. If you have a very bad headache or
vomit without feeling sick first, this could be a
sign of this.
• If you suffer from epilepsy, convulsions or
seizures (fits) or have had them in the past.
• If you feel light-headed, faint, cold or clammy, or
look pale.
• If you suffer from asthma, or other lung disease
or have difficulty in breathing
• If you suffer from kidney or liver 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 50mg Capsules may lead
to physical and psychological addiction. When
Tramadol 50mg Capsules is 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
Tramadol Capsules should not be taken together
with MAO inhibitors (certain medicines for the
treatment of depression).
The pain-relieving effect of tramadol Capsules 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).
Please tell your doctor or pharmacist:• If you are taking other medicines including
tranquilizers, sleeping pills, antidepressants and
other pain relievers such as morphine and
codeine. You may feel drowsier or feel that you
might faint.
• If you are going to be given a general
anaesthetic tell your doctor or dentist that you
are taking Tramadol 50mg Capsules.
• If you are taking carbamazepine, a treatment for
epilepsy, this may reduce the pain relieving
effect of Tramadol 50mg Capsules. Your doctor
will tell whether Tramadol 50mg Capsules is
suitable for you.
• If you are taking antidepressants these may
cause convulsions (fits). The chance of having a
fit is rare, but if you are also taking Tramadol
50mg Capsules, the risk of having a fit may
increase. Your doctor will tell you whether
having Tramadol 50mg Capsules is suitable for
you.
• If you are taking selective serotonin reuptake
inhibitors (often referred to as SSRI's) or triptans
or MAOI's because it has been shown that
Tramadol may interfere 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 blood thinning), e.g. warfarin, together with
Tramadol Capsules. The effect of these
medicines on blood clotting may be affected
and bleeding may occur.
• If you are taking lithium, make sure your doctor
or dentist knows. Tramadol 50mg Capsules
could alter the effect of lithium.
• If you are taking coumarin anticoagulants
(blood thinning medicines) e.g. warfarin.
Tramadol 50mg Capsules could alter their
effects if taken at the same time.
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 Tramadol 50mg Capsules at
the same time. Your doctor will tell you whether
Tramadol 50mg capsules is suitable for you.
• If you are taking certain antidepressants,
Tramadol 50mg 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.
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines
including medicines obtained without a
prescription and herbal remedies.
Taking Tramadol 50mg Capsules with food and
drink
You should avoid alcohol during treatment with
Tramadol 50mg Capsules. If you use alcohol with
Tramadol 50mg Capsules you may feel drowsier
than when you are taking alcohol alone.
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.
CP.TDL.50C.RC.V3P4

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 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 doctor for
advice.
Driving and using machines
Tramadol can cause drowsiness. Do not drive or
operate any tools or machines if you feel tired or
sleepy after treatment with Tramadol 50mg
Capsules. These effects are made worse if alcohol
and/or CNS depressants are taken at the same time.

3. HOW TO TAKE TRAMADOL 50mg
CAPSULES
Follow your doctor's instructions on how many
Tramadol 50mg Capsules to take and when to take
them. You will also find this information on the label.
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.
You should usually swallow one or two capsules at a
time. Do not take them more often than every four
hours and do not take more than eight capsules in
any 24 hours unless your doctor tells you to. Swallow
the capsules whole, not divided or chewed, with
sufficient liquid. Tramadol capsules do not need to
be taken with food. If you are not sure, ask your
doctor or pharmacist.
Do not take a different amount of Tramadol 50mg
Capsules or take it more often than your doctor has
told you to. These Tramadol 50mg Capsules are for
you. You must not give them to other people.
If you have chronic pain (pain that lasts for long
periods of time) it is best to take Tramadol 50mg
Capsules over short periods and only when you
need it.
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 50mg Capsules. If in your
case the insufficiency is mild or moderate, your
doctor may recommend prolonging the dosage
interval.
If you take more Tramadol 50mg Capsules than
you should:If you take two single doses of Tramadol 50mg
capsules at once by mistake, this will generally not
be harmful. If pain returns, continue taking Tramadol
50mg Capsules as usual.
If high doses are taken accidentally (e.g. a dose of
more than two Tramadol 50mg Capsules at once), a
number of symptoms may occur. These might
include:- 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. If you suspect that you or someone else
has taken an overdose of Tramadol 50mg Capsules,
contact your doctor or go to your local hospital
immediately. Always take the carton and this leaflet
with you if possible.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
If you forget to take Tramadol 50mg Capsules
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 50mg Capsules
Tramadol 50mg Capsules may cause dependence
(addiction / reliance on a medicine). Although this is
rare, when you stop taking Tramadol 50mg
Capsules, you may feel agitated, anxious, nervous or
shaky. You may become hyperactive and have
difficulty sleeping. Very few people may experience
unusual effects on the nervous system such as
confusion, delusions or unusual perceptions such as
itching, tingling or numbness or noise in the ear
(tinnitus) or stomach and bowel disorders. These
effects usually disappear after a few days. Tell your
doctor if you experience any of these symptoms
after stopping Tramadol 50mg Capsules.

4.

them. If you notice any side effects not mentioned in
this leaflet, please inform your doctor or pharmacist.
Very common (> 1/10)
• Some people may feel dizzy or nauseous
Common (<1/100, 1> 1/10)
• Some people may vomit or sweat, have a dry
mouth and have diarrhoea or constipation, or
suffer headaches or drowsiness.
• tiredness, weariness, weakness, low energy
Uncommon (<1/1000, 1> 1/100)
• Some people may suffer from palpitations
(awareness of your heartbeat), or tachycardia
(rapid heart beat), irregular heartbeat, retching,
gastro-intestinal irritation, skin irritation and
develop a rash. Some people may suffer postural
hypotension (dizziness or light headedness
when standing up too quickly).
Rare (<1/10,000, 1> 1/1000)
• Some people may develop high blood pressure,
bradycardia (slow heartbeat) or changes in
appetite. Parasthesia (pins and needles),
convulsions, hallucinations, sleep pattern
disturbances and nightmares can also occur.
Some people may get blurred vision or have
difficulty in passing urine. Very few people may
experience unusual effects on the nervous
system such as confusion, changes of mood,
delusions, feelings of loss of identity or unusual
perceptions such as itching, tingling or
numbness. Rarely, people have also suffered
allergic or anaphylactic reactions. These may
include a rash, itching, swelling of the face or
breathing problems (shortness of breath and
wheezing). In a few isolated cases, blood
disorders have also been reported.
Very rare (<1/10000):
• Increase in liver enzyme values
Contact your doctor immediately if:
• You have difficulty breathing
• Your asthma gets worse
• You get an allergic reaction, skin rash, swelling of
the face, or wheezing
• You have a fit
• You constantly have a sore throat or high
temperature
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 TRAMADOL 50mg
CAPSULES

Keep out of the sight and reach of children.
Do not use Tramadol 50mg Capsules after the expiry
date which is stated on the carton. The expiry date
refers to the last day of that month.
Do not store above 30ºC.
Medicines should not be disposed of via waste water
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 50mg Capsules contain
The active substance is called tramadol
hydrochloride. Each Capsule contains 50mg of
tramadol hydrochloride. The other ingredients are
Calcium
hydrogen
phosphate
(dihydrate),
Magnesium Stearate and Silica (Colloidal
anhydrous). The capsule is made of gelatine and
contains the colour Titanium dioxide (E171). The
printing ink contains the ingredients shellac, Black
Iron oxide, Soya Lecithin and Antifoam DC 1510.
What Tramadol 50mg Capsules look like and the
contents of the pack
Tramadol 50mg Capsules are all white and have
'TR50' printed on the outside. They are packed in
blister strips and supplied in boxes of 30 or 100
capsules.
Marketing Authorisation Holder and
Manufacturer
Relonchem Ltd, Cheshire House, Gorsey Lane,
Widnes, Cheshire, WA8 0RP. UK
Distributor
Kent Pharmaceuticals Limited, Repton Road,
Measham, DE12 7DT, UK
Date leaflet revised in: June 2015

POSSIBLE SIDE EFFECTS

Like all medicines. Tramadol 50mg Capsules can
cause side effects, although not everybody gets

Customer: Relon Chem Designer:

CP.TDL.50C.RC.V3P4

Colours

Product: Tramadol 50mg Capsules
Dimensions: 160mm x 320mm
Item Code: CP.TDL.50C.RC.V3P4
Date: 04/06/2015
Revision: Yellowcard updates
ARTWORK FOR SUBMISSION
Supersedes: n/a

Pantone
280 C

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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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