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TRAMADOL HYDROCHLORIDE 50MG TABLETS

Active substance(s): TRAMADOL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION
FOR THE USER

-

Tramadol Hydrochloride 50 mg tablets
Tramadol Hydrochloride
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 side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1.
What Tramadol Hydrochloride is and what
it is used for
2.
What you need to know before you take
Tramadol Hydrochloride
3.
How to take Tramadol Hydrochloride
4.
Possible side effects
5.
How to store Tramadol Hydrochloride
6.
Contents of the pack and other information

1.

WHAT TRAMADOL
HYDROCHLORIDE IS AND WHAT IT
IS USED FOR

Tramadol is one of a group of medicines called
analgesics which are more commonly known as
pain killers. Tramadol acts on the brain and
spinal cord to reduce the amount of pain you feel.
Tramadol is for the treatment and prevention of
moderate to severe pain.
2.

WHAT YOU NEED TO KNOW
BEFORE YOU TAKE TRAMADOL
HYDROCHLORIDE

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Warnings and precautions
Talk to your doctor or pharmacist before taking
Tramadol Hydrochloride.
if you suffer from kidney or liver disease
if you suffer from epilepsy or convulsions or
have had them in the past
if you suffer from asthma or have trouble
breathing
if you have had a recent head injury or
increased intracranial pressure.
if you are taking antidepressants known as
selective serotonin re-uptake inhibitors (for
example, fluoxetine and paroxetine) and
tricyclic antidepressants (for example,
amitriptyline and desipramine) or
carbamazepine (used to treat epilepsy and
manic-depressive illness) or lithium (used to
treat mania and depression)
if you are hypersensitive to opiates (for
example morphine, codeine en similar
agents)
if you have a decreased level of
consciousness
before you have a general anaesthetic
Other medicines and Tramadol Hydrochloride
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, including medicines obtained without
prescription.

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Do not take Tramadol Hydrochloride
-

if you are allergic to Tramadol or any of the
other ingredients of this medicine (listed in
section 6)

if you have been drinking enough alcohol to
make you feel even slightly drunk or have
taken several doses of other medicines that
affect the nervous system such as sleeping
tablets, morphine-like drugs or psychotropic
drugs which are used to treat schizophrenia
and severe anxiety
if you are also taking drugs known as
monoamine oxidase inhibitors (for example,
phenelzine and isocarboxazid), which are
used to treat depression, or have been taking
them within the past two weeks
if you are suffering from uncontrolled
epilepsy
if you are undergoing narcotic withdrawal
treatment

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Tramadol suppresses the central nervous
system. Concomitant administration of
tramadol with other centrally acting drugs
including alcohol may potentiate this
depressant effect.
Simultaneous
administration
of
carbamazepine
(anti-epilepticum)
may
decrease the effectiveness of tramadol.

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Tramadol may interact with lithium
Concomitant treatment with tramadol and
blood diluting drugs as warfarine can
increase extravasations of blood (bruises).
In case of concomitant administration of
digoxine rare cases of toxicity signs have
been observed such as nausea, vomiting and
cardiac arrhythmias.
Simultaneous administration of ritonavir
(drug used to treat HIV-infection) can
potentiate the respiratory depression caused
by tramadol. The dose of tramadol will
possibly be reduced.
Concomitant
administration
of
e.g.
buprenorphine, nalbuphine or pentazocine
and tramadol can decrease the effect of
tramadol.
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 hydrochloride 50 mg
tablets at the same time. Your doctor will
tell you whether Tramadol hydrochloride
50 mg tablets is suitable for you.
• if you are taking certain antidepressants.
Tramadol hydrochloride 50 mg tablets
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.

Tramadol Hydrochloride with food and drink
Not applicable
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
This medicine is not recommended during
pregnancy, unless your doctor considers it as
necessary.
Tramadol has been found in breast milk of women
using this medicine. Therefore tramadol should
not be used by women breastfeeding their child.
Driving and using machines
Tramadol may make you sleepy so be careful
about driving or operating machinery.

The medicine can affect you 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:
o The medicine has been prescribed
to treat a medical of dental
problem and
o You have taken it according to the
instructions
given
by
the
prescriber or in the information
provided with the medicine and
o 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.
Tramadol Hydrochloride contains lactose
This medicine contains 100 mg lactose per tablet.
If you have been told by your doctor that you
have an intolerance to some sugars, contact your
doctor before taking this medicinal product

3.

HOW TO TAKE TRAMADOL
HYDROCHLORIDE

Always take this medicine exactly as your doctor
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.
1) Adults and Children aged 12 years and over:
Acute pain (i.e. pain lasting a short time):
An initial dose of 100mg (i.e. two tablets) is
usually necessary. Your doctor may advise you to
take either 1 or 2 tablets after this, not more
frequently than every four hours.
Pain associated with chronic conditions (i.e. pain
lasting a long time):
Use an initial dose of 50mg (i.e. one tablet). Your
doctor will advise you how much to take
following this initial dose. You should never take
more than 400mg (i.e. 8 tablets) in any 24 hours,
unless prescribed by your doctor.

2) 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.
3)
Severe
liver
or
kidney
disease
(insufficiency)/dialysis patients
Patients with severe liver and/or kidney
insufficiency should not take Tramadol
hydrochloride 50 mg tablets. If in your case the
insufficiency is mild or moderate, your doctor
may recommend prolonging the dosage interval.
If you take more Tramadol Hydrochloride
than you should
If you accidentally take more than your prescribed
dose, contact your nearest hospital casualty
department or tell your doctor immediately.
If you forget to take Tramadol Hydrochloride
Do not take a double dose to make up for a
forgotten tablet.
If you forget to take a dose, do so as soon as you
remember and then go on as before.
If you stop taking Tramadol hydrochloride 50
mg tablets
Stopping treatment suddenly can cause
withdrawal symptoms.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Tramadol can cause allergic reactions (e.g.
difficulty breathing, constriction of the muscles of
the bronchi, wheezing, swelling of the head and
neck),
serious
hypersensitivity
reaction
(generalized allergic reaction)). This occurs rarely
(may affect up to 1 in 1,000 people). Stop taking
Tramadol Hydrochloride 50 mg tablets and
contact your doctor straight away if any of these
symptoms occur.
Other side effects
Very common (may affect more than 1 in 10
people)
• dizziness
• nausea

Common (may affect up to 1 in 10 people)
• headache, muzziness
• vomiting, constipation, diarrhoea, dry mouth
• sweating
Uncommon (may affect up to 1 in 100 people)
• heart palpitation, increased heart rate,
postural hypotension, cardiovascular collapse
• flatulency, retching; a feeling of pressure in
the stomach, bloating
• itching, rash, hives
Rare (may affect up to 1 in 1,000 people)
• decreased heart rate, increase in blood
pressure, fainting, pathological condition of
the blood.
• changes in appetite, tingling, tremor,
respiratory depression, epileptiform
convulsions
• hallucinations, confusion, somnolence, sleep
disturbance and nightmares. Psychic side
effects such as changes in mood (usually
elation, occasionally dysphoria), changes in
activity (usually suppression, occasionally
increase) and changes in cognitive and
sensorial ability (e.g. decision behaviour,
perception disorders) which can vary from
nature and intensity
• blurred vision
• flushing
• muscle weakness
• increase in liver enzyme values
• difficulty in passing urine and urinary
retention
• symptoms of withdrawal reactions: agitation,
anxiety, nervousness, insomnia,
hyperkinesia, tremor and gastrointestinal
symptoms
Not known (frequency cannot be estimated from
the available data)
• decrease in blood sugar level
Worsening of asthma has been reported, though a
causal relationship has not been established.
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 national
reporting system listed in Appendix V. By
reporting side effects you can help provide more
information on the safety of this medicine.

5.
HOW TO STORE TRAMADOL
HYDROCHLORIDE
Keep this medicine out of the reach and sight of
children.
Store below 25°C. Store in the original package in
order to protect from moisture.
Do not use this medicine after the expiry date
which is stated on the label and the carton after
“EXP”. The expiry date refers to the last day of
that month.
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 Tramadol Hydrochloride contains
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The active substance is tramadol
hydrochloride. One tablets contains 50 mg
tramadol hydrochloride.
The other ingredients are lactose
monohydrate
(see
also
“Tramadol
Hydrochloride contains lactose” under
section 2), microcrystalline cellulose,
carmellose sodium and magnesium stearate.

What Tramadol Hydrochloride looks like and
contents of the pack
It is a white, round oral tablet containing 50mg of
tramadol hydrochloride. Each tablet has T printed
on one face with a breakline on the reverse.
The tablets are packaged in blister strips made of
PVC or aluminium foil and supplied in cartons of
10, 30, 60 and 100.
Marketing Authorisation Holder and
Manufacturer
Eurogenerics NV - Heizel, Esplanade b22 - 1020
Brussels - Belgium
Manufacturer
[to be completed nationally]
This medicinal product is authorised in the
Member States of the EEA under the following
names:

UK:
BE:
LU:

Tramadol Hydrochloride
50 mg tablets
Tramadol EG 50 mg tabletten
Tramadol EG 50 mg
comprimés

PL 02907/0002
This leaflet was last revised in 04/2016
This leaflet was last approved in XX/XXXX

POM

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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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