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TRAMADOL HYDROCHLORIDE/PARACETAMOL 37.5 MG / 325 MG FILM-COATED TABLETS

Active substance: TRAMADOL HYDROCHLORIDE

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TEVA UK Ref: 231-30-32117-D LEA TRAMADOL/PARACETAMOL 32.5mg/325mg TAB 60 TUK

Version:

1

04 November 2014

PAGE 1: FRONT FACE (INSIDE OF REEL)

PACKAGE LEAFLET: INFORMATION FOR THE USER

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/Paracetamol is and what
it is used for
2. What you need to know before you take Tramadol
hydrochloride/Paracetamol
3. How to take Tramadol hydrochloride/Paracetamol
4. Possible side effects
5. How to store Tramadol hydrochloride/Paracetamol
6. Contents of the pack and other information

1
Pharma code 106
First bar is 105mm from the top edge of the leaflet.

WHAT TRAMADOL HYDROCHLORIDE/
PARACETAMOL IS AND WHAT IT IS USED FOR

Tramadol hydrochloride/Paracetamol is a combination of
two analgesics, tramadol and paracetamol, which act together
to relieve your pain.
Tramadol hydrochloride/Paracetamol is intended for use in the
treatment of moderate to severe pain when your doctor
recommends that a combination of tramadol and paracetamol
is needed.
Tramadol hydrochloride/Paracetamol should only be taken by
adults and adolescents over 12 years.

2

WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TRAMADOL HYDROCHLORIDE/PARACETAMOL

Do not take Tramadol hydrochloride/Paracetamol
• if you are allergic to tramadol or paracetamol or any of the
other ingredients of this medicine (listed in section 6)
• in acute poisoning with alcohol, sleeping pills, pain relievers
or other psychotropic medicines (medicines that affect
mood and emotions)
• if you are also taking MAO inhibitors (certain medicines
used for treatment of depression or Parkinson’s disease) or
have taken them in the last 14 days before treatment with
Tramadol hydrochloride/Paracetamol
• if you suffer from a severe liver disease
• if you have epilepsy that is not adequately controlled on
your current medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tramadol
hydrochloride/Paracetamol
• if you take other medicines containing paracetamol or
tramadol
• if you have liver problems or liver disease or if you notice
your eyes and skin turning yellow. This may suggest
jaundice or problems with your bile ducts.
• if you have kidney problems
• if you have severe difficulties in breathing for example
asthma or severe lung problems
• if you have epilepsy or have already experienced fits or
seizures
• if you have recently suffered from a head injury, shock or
severe headaches associated with vomiting
• if you are dependent on any medicines including those used
to relieve pain, for example morphine
• if you take other medicines to treat pain that contain
buprenorphine, nalbuphine or pentazocine
• if you are going to have an anaesthetic. Tell your doctor or
dentist that you are taking Tramadol hydrochloride/
Paracetamol.
If any of the above-mentioned points applied to you in the
past or applies to you while you are taking Tramadol
hydrochloride/Paracetamol, please make sure your doctor
knows. He/she can then decide whether you should continue
to use this medicine.
Other medicines and Tramadol hydrochloride/Paracetamol
Please tell your doctor or pharmacist if you are taking or have
recently taken or might take any other medicines.
Important: This medicine contains paracetamol and tramadol.
Tell your doctor if you are taking any other medicine
containing paracetamol or tramadol, so that you do not
exceed the maximum daily doses.

You must not take Tramadol hydrochloride/Paracetamol
together with monoamine oxidase inhibitors (“MAOIs”) (see
section “Do not take Tramadol hydrochloride/Paracetamol”).
Tramadol hydrochloride/Paracetamol is not recommended to
be taken with the following:
• carbamazepine (a medicine commonly used to treat
epilepsy or some types of pain such as severe pain attacks in
the face called trigeminal neuralgia)
• buprenorphine, nalbuphine or pentazocine (opioid-type pain
relievers). The pain-relieving effect may be reduced.
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/Paracetamol at the same time. Your doctor will
tell you whether Tramadol hydrochloride/Paracetamol is
suitable for you.
• if you are taking certain antidepressants. Tramadol
hydrochloride/Paracetamol 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.
The risk of side effects increases, if you also take:
• tranquillisers, sleeping pills, other pain relievers such as
morphine and codeine (also as cough medicine), baclofen (a
muscle relaxant) medicines used to lower blood pressure,
antidepressants or medicines to treat allergies. You may feel
drowsy or feel faint. If this happens, tell your doctor.
• anaesthetics, neuroleptics (medicines that affect the state of
mind) or bupropion (to help stop smoking). The risk of
having a fit may increase. Your doctor will tell you whether
Tramadol hydrochloride/Paracetamol is suitable for you.
• warfarin or phenprocoumon (for blood thinning). The
effectiveness of such medicines may be altered and
bleeding may occur. Any prolonged or unexpected bleeding
should be reported to your doctor immediately.
The effectiveness of Tramadol hydrochloride/Paracetamol may
be altered if you also take:
• metoclopramide, domperidone or ondansetron (medicines
for treatment of nausea and vomiting)
• cholestyramine (medicine to reduce cholesterol in the blood)
• ketoconazole or erythromycin (medicines against infections).
Your doctor will tell you which medicines are safe to take with
Tramadol hydrochloride/Paracetamol.
Tramadol hydrochloride/Paracetamol with food, drink and
alcohol
Tramadol hydrochloride/Paracetamol may make you feel
drowsy. Alcohol may make you feel more drowsy, so it is best
not to drink alcohol while you are taking Tramadol
hydrochloride/Paracetamol.
Pregnancy, breast-feeding and fertility
As this medicine contains tramadol, you should not take this
medicine during pregnancy. If you become pregnant during
treatment with Tramadol hydrochloride/Paracetamol, please
consult your doctor before taking any further tablets.
Small amounts of tramadol may pass into the breast milk.
Therefore you should not take this medicine during
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 any medicine.
Driving and using machines
Tramadol hydrochloride/Paracetamol may make you feel
drowsy and this may affect your ability to drive, or use tools
and machines, safely.
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.

3

HOW TO TAKE TRAMADOL
HYDROCHLORIDE/PARACETAMOL

Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
You should take Tramadol hydrochloride/Paracetamol for as
short a time as possible.
Unless otherwise prescribed by your doctor, the usual starting
dose for adults and adolescents over 12 years is 2 tablets.

Top of page cut-off to middle of registration mark: 44 mm.

TRAMADOL HYDROCHLORIDE/PARACETAMOL
37.5 mg/325 mg
FILM-COATED TABLETS

TEVA UK Ref: 231-30-32117-D LEA TRAMADOL/PARACETAMOL 32.5mg/325mg TAB 60 TUK

Version:

1

04 November 2014

PAGE 2: REAR FACE (OUTSIDE OF REEL)

If required, further doses may be taken, as recommended by
your doctor. The shortest time between doses must be at least
6 hours.
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.
Do not take more than 8 Tramadol hydrochloride/Paracetamol
Film-coated Tablets per day.
Do not take Tramadol hydrochloride/Paracetamol more often
than your doctor has told you.
Your doctor may increase the time between doses
• if you are older than 75 years
• if you have kidney problems or
• if you have liver problems.
Use in children
The use in children below the age of 12 years is not
recommended.
Method of administration:
The tablets are for oral use.
Swallow the tablets whole with sufficient liquid, they should
not be broken or chewed.
If you think that the effect of Tramadol hydrochloride/
Paracetamol is too strong (i.e. you feel very drowsy or have
difficulty breathing) or too weak (i.e. you have inadequate pain
relief), contact your doctor.
If you take more Tramadol hydrochloride/Paracetamol than
you should
In such cases please contact your doctor or pharmacist
immediately even if you feel well.
There is a risk of liver damage which may only show later.
If you forget to take Tramadol hydrochloride/Paracetamol
If you forget to take the tablets, pain is likely to return. Do not
take a double dose to make up for forgotten doses. Simply
continue taking the tablets as before.
If you stop taking Tramadol hydrochloride/Paracetamol
Generally there will be no after-effects when treatment with
Tramadol hydrochloride/Paracetamol is stopped. However, on
rare occasions, people who have been taking tramadol for
some time may feel unwell if they stop treatment abruptly (see
section 4. “Possible Side Effects”). If you have been taking
Tramadol hydrochloride/Paracetamol for some time, you
should talk to your doctor if you want to stop because your
body may have become used to it.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Very common (may affect more than 1 in 10 people):
• nausea
• dizziness, drowsiness.
Common (may affect up to 1 in 10 people):
• vomiting, digestion problems (constipation, flatulence,
diarrhoea), stomach pain, dry mouth
• itching, sweating
• headache, shaking
• confusion, sleep disorders, mood changes (anxiety,
nervousness, a feeling of high spirits).
Uncommon (may affect up to 1 in 100 people):
• increase in pulse or blood pressure, heart rate or heart
rhythm disorders
• difficulty or pain on passing water
• skin reactions (for example rashes, hives)
• tingling, numbness or feeling of pins and needles in the
limbs, ringing in the ear, involuntary muscle twitching
• depression, nightmares, hallucinations (hearing, seeing or
sensing things that are not really there), memory lapses
• difficulty swallowing, blood in the stools
• shivering, hot flushes, pain in the chest
• difficulty breathing
• increase in liver enzymes (hepatic transaminases).
Rare (may affect up to 1 in 1,000 people):
• fits, difficulties in carrying out coordinated movements
• addiction
• blurred vision.
Not known (frequency cannot be estimated from the available
data):
• decrease in blood sugar level.
The following are recognised side effects which have been
reported by people using medicines that contain only
tramadol or only paracetamol.
However, if you experience any of these while taking Tramadol
hydrochloride/Paracetamol, you should tell your doctor:
• feeling faint when getting up from a lying or sitting position,
slow heart rate, fainting, changes in appetite, muscle
weakness, slower or weaker breathing, mood changes,
changes in activity, changes in perception, worsening of
existing asthma

• In some rare cases a skin rash, indicating an allergic
reaction, may develop with sudden swelling of the face and
neck, difficulties breathing or drop of blood pressure and
fainting. If this happens to you, stop treatment and see a
doctor immediately. You must not take the medicine again.
• Very rare cases of serious skin reactions have been reported.
In rare cases, using a medicine of the type of tramadol may
make you become dependent on it, making it hard to stop
taking it.
On rare occasions, people who have been taking tramadol for
some time may feel unwell if they stop treatment abruptly.
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 also 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
hydrochloride/Paracetamol, please consult your doctor.
In exceptional cases blood tests may reveal certain
abnormalities, for instance, low counts of blood platelets, which
may result in nose bleeds or bleeding gums.
Use of Tramadol hydrochloride/Paracetamol together with
medicines used to thin the blood (e.g. phenprocoumon,
warfarin) may increase the bleeding risk. Any prolonged or
unexpected bleeding should be reported to your doctor
immediately.
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 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 HYDROCHLORIDE/
PARACETAMOL

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated
on the carton and the blister after EXP The expiry date refers
.
to the last day of that month.
Discard the bottle 50 days after first opening
This medicinal product does not require any special storage
conditions.
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 to
protect the environment.

6

CONTENTS OF THE PACK AND OTHER INFORMATION

What Tramadol hydrochloride/Paracetamol contains
• The active substances are tramadol hydrochloride and
paracetamol.
Each film-coated tablet contains 37.5 mg tramadol
hydrochloride and 325 mg paracetamol.
• The other ingredients are: tablet core: kollicoat IR coating
[Macrogol poly (vinyl alcohol) grafted copolymer],
pregelatinised maize starch, cellulose microcrystalline,
sodium starch glycolate (type A), Hyprolose, magnesium
stearate; film-coating: opadry II beige 85F97409: polyvinyl
alcohol, titanium dioxide (E171), macrogol, talc, iron oxide
yellow (E172), iron oxide red (E172), iron oxide black (E172).
What Tramadol hydrochloride/Paracetamol looks like and
contents of the pack
Tramadol hydrochloride/Paracetamol Film-coated Tablets are
peach coloured, capsule-shaped, engraved with T37.5 on one
side and A325 on the other side.
Tramadol hydrochloride/Paracetamol comes in cartons with
blister packs of 2, 10, 15, 20, 30, 40, 60 and 90 tablets and
bottles with 10 tablets and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Teva UK Limited, Eastbourne, BN22 9AG, UK.
This leaflet was last revised in 09/2014.
PL 00289/1731

323 x 200 mm
32117-D

TEVA UK Ref:

231-30-19083-D LEA TRAMADOL/PARACETAMOL 37.5mg/325mg TAB 60 TUK
TRAMADOL HYDROCHLORIDE/
PARACETAMOL
37.5 mg/325 mg
FILM-COATED TABLETS
PACKAGE LEAFLET:
INFORMATION FOR THE USER

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/
Paracetamol is and what it is used for
2. What you need to know before you take
Tramadol hydrochloride/Paracetamol
3. How to take Tramadol hydrochloride/
Paracetamol
4. Possible side effects
5. How to store Tramadol hydrochloride/
Paracetamol
6. Contents of the pack and other information

1

WHAT TRAMADOL
HYDROCHLORIDE/
PARACETAMOL IS AND WHAT IT
IS USED FOR

Tramadol hydrochloride/Paracetamol is a
combination of two analgesics, tramadol
and paracetamol, which act together to
relieve your pain.
Tramadol hydrochloride/Paracetamol is
intended for use in the treatment of
moderate to severe pain when your doctor
recommends that a combination of
tramadol and paracetamol is needed.
Tramadol hydrochloride/Paracetamol
should only be taken by adults and
adolescents over 12 years.

2

WHAT YOU NEED TO KNOW
BEFORE YOU TAKE
TRAMADOL HYDROCHLORIDE/
PARACETAMOL

Version:

1

04 November 2014

You must not take Tramadol
hydrochloride/Paracetamol together with
monoamine oxidase inhibitors (“MAOIs”)
(see section “Do not take Tramadol
hydrochloride/Paracetamol”).
Tramadol hydrochloride/Paracetamol is not
recommended to be taken with the
following:
• carbamazepine (a medicine commonly
used to treat epilepsy or some types of
pain such as severe pain attacks in the
face called trigeminal neuralgia)
• buprenorphine, nalbuphine or
pentazocine (opioid-type pain relievers).
The pain-relieving effect may be reduced.
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/
Paracetamol at the same time. Your
doctor will tell you whether Tramadol
hydrochloride/Paracetamol is suitable
for you.
• if you are taking certain antidepressants.
Tramadol hydrochloride/Paracetamol
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.
The risk of side effects increases, if you
also take:
• tranquillisers, sleeping pills, other pain
relievers such as morphine and codeine
(also as cough medicine), baclofen (a
muscle relaxant) medicines used to
lower blood pressure, antidepressants
or medicines to treat allergies. You may
feel drowsy or feel faint. If this happens,
tell your doctor.
• anaesthetics, neuroleptics (medicines
that affect the state of mind) or
bupropion (to help stop smoking). The
risk of having a fit may increase. Your
doctor will tell you whether Tramadol
hydrochloride/Paracetamol is suitable
for you.
• warfarin or phenprocoumon (for blood
thinning). The effectiveness of such
medicines may be altered and bleeding
may occur. Any prolonged or
unexpected bleeding should be
reported to your doctor immediately.
The effectiveness of Tramadol
hydrochloride/Paracetamol may be altered
if you also take:
• metoclopramide, domperidone or
ondansetron (medicines for treatment
of nausea and vomiting)
• cholestyramine (medicine to reduce
cholesterol in the blood)
• ketoconazole or erythromycin
(medicines against infections).
Your doctor will tell you which medicines
are safe to take with Tramadol
hydrochloride/Paracetamol.
Tramadol hydrochloride/Paracetamol with
food, drink and alcohol
Tramadol hydrochloride/Paracetamol may
make you feel drowsy. Alcohol may make
you feel more drowsy, so it is best not to
drink alcohol while you are taking
Tramadol hydrochloride/Paracetamol.
Pregnancy, breast-feeding and fertility
As this medicine contains tramadol, you
should not take this medicine during
pregnancy. If you become pregnant during
treatment with Tramadol hydrochloride/
Paracetamol, please consult your doctor
before taking any further tablets.
Small amounts of tramadol may pass into
the breast-milk. Therefore you should not
take this medicine during 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 any medicine.
Driving and using machines
Tramadol hydrochloride/Paracetamol may
make you feel drowsy and this may affect
your ability to drive, or use tools and
machines, safely.
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.

Do not take Tramadol hydrochloride/
Paracetamol
• if you are allergic to tramadol or
paracetamol or any of the other
ingredients of this medicine (listed in
section 6)
• in acute poisoning with alcohol, sleeping
pills, pain relievers or other psychotropic
medicines (medicines that affect mood
and emotions)
• if you are also taking MAO inhibitors
(certain medicines used for treatment of
depression or Parkinson’s disease) or
have taken them in the last 14 days
before treatment with Tramadol
hydrochloride/Paracetamol
• if you suffer from a severe liver disease
• if you have epilepsy that is not adequately
controlled on your current medicine.
Warnings and Precautions
Talk to your doctor or pharmacist before
taking Tramadol hydrochloride/
Paracetamol
• if you take other medicines containing
paracetamol or tramadol
• if you have liver problems or liver
disease or if you notice your eyes and
skin turning yellow. This may suggest
jaundice or problems with your bile ducts
• if you have kidney problems
• if you have severe difficulties in
breathing for example asthma or severe
lung problems
• if you have epilepsy or have already
experienced fits or seizures
• if you have recently suffered from a
head injury, shock or severe headaches
associated with vomiting
• if you are dependent on any medicines
including those used to relieve pain, for
example morphine
• if you take other medicines to treat pain
that contain buprenorphine, nalbuphine
or pentazocine
• if you are going to have an anaesthetic.
Tell your doctor or dentist that you are
taking Tramadol hydrochloride/
Paracetamol.
If any of the above-mentioned points
applied to you in the past or applies to you
while you are taking Tramadol
hydrochloride/Paracetamol, please make
sure your doctor knows. He/she can then
decide whether you should continue to
use this medicine.
Other medicines and Tramadol
hydrochloride/Paracetamol
Please tell your doctor or pharmacist if you
are taking or have recently taken or might
take any other medicines.
3 HOW TO TAKE TRAMADOL
Important: This medicine contains
HYDROCHLORIDE/
paracetamol and tramadol. Tell your doctor
PARACETAMOL
if you are taking any other medicine
containing paracetamol or tramadol, so
Always take this medicine exactly as your
that you do not exceed the maximum
doctor has told you. Check with your
daily doses.
doctor or pharmacist if you are not sure.

Neutralna uputa-155 x 450mm.indd 1

6/17/10 8:52:50 AM

TEVA UK Ref:

231-30-19083-D LEA TRAMADOL/PARACETAMOL 37.5mg/325mg TAB 60 TUK
You should take Tramadol hydrochloride/
Paracetamol for as short a time as
possible.
Unless otherwise prescribed by your doctor,
the usual starting dose for adults and
adolescents over 12 years is 2 tablets.
If required, further doses may be taken, as
recommended by your doctor. The shortest
time between doses must be at least 6 hours.
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.
Do not take more than 8 Tramadol
hydrochloride/Paracetamol Film-coated
Tablets per day.
Do not take Tramadol hydrochloride/
Paracetamol more often than your doctor
has told you.
Your doctor may increase the time
between doses
• if you are older than 75 years
• if you have kidney problems or
• if you have liver problems.
Use in children
The use in children below the age of
12 years is not recommended.
Method of administration:
The tablets are for oral use.
Swallow the tablets whole with sufficient
liquid, they should not be broken or chewed.
If you think that the effect of Tramadol
hydrochloride/Paracetamol is too strong
(i.e. you feel very drowsy or have difficulty
breathing) or too weak (i.e. you have
inadequate pain relief), contact your doctor.
If you take more Tramadol hydrochloride/
Paracetamol than you should
In such cases please contact your doctor
or pharmacist immediately even if you feel
well. There is a risk of liver damage which
may only show later.
If you forget to take Tramadol
hydrochloride/Paracetamol
If you forget to take the tablets, pain is likely
to return. Do not take a double dose to
make up for forgotten doses. Simply
continue taking the tablets as before.
If you stop taking Tramadol
hydrochloride/Paracetamol
Generally there will be no after-effects
when treatment with Tramadol
hydrochloride/Paracetamol is stopped.
However, on rare occasions, people who
have been taking tramadol for some time
may feel unwell if they stop treatment
abruptly (see section 4. “Possible Side
Effects”). If you have been taking Tramadol
hydrochloride/Paracetamol for some time,
you should talk to your doctor if you want
to stop because your body may have
become used to it.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

Version:

1

weakness, slower or weaker breathing,
mood changes, changes in activity,
changes in perception, worsening of
existing asthma
• in some rare cases a skin rash,
indicating an allergic reaction, may
develop with sudden swelling of the
face and neck, difficulties breathing or
drop of blood pressure and fainting. If
this happens to you, stop treatment and
see a doctor immediately. You must not
take the medicine again.
• very rare cases of serious skin reactions
have been reported.
In rare cases, using a medicine of the type
of tramadol may make you become
dependent on it, making it hard to stop
taking it.
On rare occasions, people who have been
taking tramadol for some time may feel
unwell if they stop treatment abruptly.
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
also 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
hydrochloride/Paracetamol, please consult
your doctor.
In exceptional cases blood tests may
reveal certain abnormalities, for instance,
low counts of blood platelets, which may
result in nose bleeds or bleeding gums.
Use of Tramadol hydrochloride/
Paracetamol together with medicines used
to thin the blood (e.g. phenprocoumon,
warfarin) may increase the bleeding risk.
Any prolonged or unexpected bleeding
should be reported to your doctor
immediately.
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 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
HYDROCHLORIDE/
PARACETAMOL

Keep out of the sight and reach of
children.
Do not use this medicine after the expiry
date which is stated on the carton and the
blister after EXP The expiry date refers to
.
the last day of that month. Discard the
bottle 50 days after first opening.
This medicinal product does not require
any special storage conditions.
Do not throw away any medicines via
4 POSSIBLE SIDE EFFECTS
wastewater or household waste. Ask your
pharmacist how to throw away medicines
Like all medicines, this medicine can cause you no longer use. These measures will
side effects, although not everybody gets
help to protect the environment.
them.
Very common: (may affect more than 1 in
6 CONTENTS OF THE PACK AND
10 people):
OTHER INFORMATION
• nausea
• dizziness, drowsiness.
What Tramadol hydrochloride/
Paracetamol contains
Common: (may affect up to 1 in 10
• The active substances are tramadol
people):
hydrochloride and paracetamol.
• vomiting, digestion problems
Each film-coated tablet contains 37.5 mg
(constipation, flatulence, diarrhoea),
tramadol hydrochloride and 325 mg
stomach pain, dry mouth
paracetamol
• itching, sweating
• The other ingredients are: tablet core:
• headache, shaking
kollicoat IR coating [Macrogol poly (vinyl
• confusion, sleep disorders, mood
alcohol) grafted copolymer],
changes (anxiety, nervousness, a feeling
pregelatinised maize starch, cellulose
of high spirits).
microcrystalline, sodium starch
Uncommon: (may affect up to 1 in 100
glycolate (type A), Hyprolose,
people):
magnesium stearate; film-coating:
• increase in pulse or blood pressure,
opadry II beige 85F97409: polyvinyl
heart rate or heart rhythm disorders
alcohol, titanium dioxide (E171),
• difficulty or pain on passing water
macrogol, talc, iron oxide yellow (E172),
• skin reactions (for example rashes,
iron oxide red (E172), iron oxide black
hives)
(E172).
• tingling, numbness or feeling of pins
What Tramadol hydrochloride/
and needles in the limbs, ringing in the
Paracetamol looks like and contents of the
ear, involuntary muscle twitching
pack
• depression, nightmares, hallucinations
Tramadol hydrochloride/Paracetamol
(hearing, seeing or sensing things that
Film-coated Tablets are peach coloured,
are not really there), memory lapses
• difficulty swallowing, blood in the stools, capsule-shaped, engraved with T37.5 on
one side and A325 on the other side.
• shivering, hot flushes, pain in the chest
Tramadol hydrochloride/Paracetamol
• difficulty breathing
comes in cartons with blister packs of 2,
• increase in liver enzymes (hepatic
10, 15, 20, 30, 40, 60 and 90 tablets and
transaminases).
bottles with 10 tablets and 100 tablets.
Rare: (may affect up to 1 in 1,000 people):
Not all pack sizes may be marketed.
• fits, difficulties in carrying out
Marketing Authorisation Holder and
coordinated movements
Manufacturer
• addiction
• blurred vision.
Teva UK Limited
Eastbourne,
Not known: (frequency cannot be
BN22 9AG,
estimated from the available data):
United Kingdom
• decrease in blood sugar level
This leaflet was last revised in 09/2014.
The following are recognised side effects
which have been reported by people using PL 00289/1731
medicines that contain only tramadol or
only paracetamol.
However, if you experience any of these
while taking Tramadol hydrochloride/
Paracetamol, you should tell your doctor:
• feeling faint when getting up from a
lying or sitting position, slow heart rate,
19083-D
fainting, changes in appetite, muscle

Neutralna uputa-155 x 450mm.indd 1

04 November 2014

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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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