TRAMADOL HYDROCHLORIDE 50MG TABLETS

Active substance: TRAMADOL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION
FOR THE USER

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Tramadol Hydrochloride 50 mg tablets
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 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 Tramadol Hydrochloride 50 mg
tablets is and what it is used for
2.
Before you take Tramadol Hydrochloride
50 mg tablets
3.
How to take Tramadol Hydrochloride
50 mg tablets
4.
Possible side effects
5.
How to store Tramadol Hydrochloride 50
mg tablets
6.
Further information

1.

WHAT TRAMADOL
HYDROCHLORIDE 50 MG TABLETS
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.

BEFORE YOU TAKE TRAMADOL
HYDROCHLORIDE 50 MG TABLETS

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Take special care with Tramadol
Hydrochloride 50 mg tablets
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if you are allergic to Tramadol or to any of
the other ingredients

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

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.

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Do not take Tramadol Hydrochloride 50 mg
tablets
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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.

Taking Tramadol Hydrochloride 50 mg tablets
with food and drink
Not applicable
Pregnancy and breast-feeding
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.
Ask your doctor or pharmacist for advice before
taking any medicine.
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.
Important information about some of the
ingredients of X
Contains 100 mg lactose per tablet. This should be
taken into account in patients with diabetes
mellitus.

3.

HOW TO TAKE TRAMADOL
HYDROCHLORIDE 50 MG TABLETS

Always take use Tramadol Hydrochloride 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.
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 50
mg tablets 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
50 mg tablets
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, Tramadol Hydrochloride can
cause side effects, although not everybody gets
them.
Very common
Common
Uncommon
Rare
Not known

> 10% of the treated patients
1-10% of the treated patients
<1% of the treated patients
< 0,1% of the treated patients
cannot be estimated from the
available data

Cardiovascular system disorders:
Uncommon (<1%): heart palpitation, increased
heart rate, postural hypotension, cardiovascular
collapse.

Rare (<0.1%): decreased heart rate, increase in
blood pressure, fainting, pathological condition of
the blood.
Metabolism and nutrition disorders:
Not known: decrease in blood sugar level
Central and peripheral nervous system disorders:
Very common: dizziness
Common (1-10%): headache, muzziness.
Rare (<0.1%): changes in appetite, tingling,
tremor, respiratory depression, epileptiform
convulsions.
Psychiatric disorders:
Rare
(<0.1%):
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.
Vision disorders:
Rare (<0.1%): blurred vision.
Respiratory system disorders:
Worsening of asthma has been reported, though a
causal relationship has not been established.
Gastrointestinal disorders:
Very common (>10%): nausea
Common (1-10%):
vomiting, constipation,
diarrhoea, dry mouth.
Uncommon (<1%): flatulency, retching; a feeling
of pressure in the stomach, bloating.
Skin and appendages disorders:
Common (1-10%): sweating
Uncommon (<1%): pruritus, rash, urticaria
Rare (<0.1%): flushing
Musculo-Skeletal System Disorders:
Rare (<0.1%): muscle weakness
Liver and biliary system disorders:
Rare (<0.1%): increase in liver enzyme values
Urinary System Disorders:
Rare (0.1%): difficulty in passing urine and
urinary retention.
Body as a Whole:

Rare (<0.1%): allergic reactions (e.g. dyspnoea,
bronchospasm, wheezing, oedema of head and
neck), anaphylaxis (generalized allergic reaction).
Symptoms of withdrawal reactions: agitation,
anxiety, nervousness, insomnia, hyperkinesia,
tremor and gastrointestinal symptoms.
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
HYDROCHLORIDE 50 MG TABLETS

This medicinal product is authorised in the
Member States of the EEA under the following
names:
United Kingdom : Tramadol Hydrochloride
50 mg tablets
Belgium :
Tramadol EG 50 mg tabletten
Luxembourg :
Tramadol EG 50 mg
comprimés
PL

Keep out of the reach and sight of children.
Do not store above 25°C.
Store in the original package in order to protect
from moisture.
Do not use Tramadol Hydrochloride 50 mg tablets
after the expiry date which is stated on the
label/carton after “Exp.” or “Ex”. The expiry
date refers to the last day of that month.
6.

FURTHER INFORMATION

What Tramadol Hydrochloride 50 mg tablet
contains
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The active substance is tramadol
hydrochloride. One tablets contains 50 mg
tramadol hydrochloride.
The other ingredients are lactose
monohydrate, microcrystalline cellulose,
carmellose sodium and magnesium stearate.

What Tramadol Hydrochloride 50 mg tablet
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]

02907/0002

This leaflet was last reviewed in 04/2014
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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