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-C LEA TRAMADOL/PARACETAMOL 32.5mg/325mg TAB 60 TUK

Version:

1

19 February 2014

PAGE 1: FRONT FACE (INSIDE OF REEL)

Read all of this leaflet carefully before you start taking this
medicine.
The risk of side effects increases:

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

The risk of side effects increases, if you also take:

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

The effectiveness of Tramadol hydrochloride/Paracetamol may
be altered if you also take:

2

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

Do not take Tramadol hydrochloride/Paracetamol

Tramadol hydrochloride/Paracetamol with food, drink and
alcohol

Pregnancy, breast-feeding and fertility

Warnings and precautions

Driving and using machines

Other medicines and Tramadol hydrochloride/Paracetamol

3
Important

HOW TO TAKE TRAMADOL
HYDROCHLORIDE/PARACETAMOL

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

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

Version:

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

1

19 February 2014

PAGE 2: REAR FACE (OUTSIDE OF REEL)

The following are recognised side effects which have been
reported

Use in children

Elderly patients

Severe liver or kidney disease (insufficiency)/dialysis patients

Method of administration:

If you take more Tramadol hydrochloride/Paracetamol than
you should

If you forget to take Tramadol hydrochloride/Paracetamol

5
If you stop taking Tramadol hydrochloride/Paracetamol

4

HOW TO STORE TRAMADOL HYDROCHLORIDE/
PARACETAMOL

Keep out of the sight and reach of children.

POSSIBLE SIDE EFFECTS

6

CONTENTS OF THE PACK AND OTHER INFORMATION

What Tramadol hydrochloride/Paracetamol contains

II
Very common:
Common:

Uncommon:

What Tramadol hydrochloride/Paracetamol looks like and
contents of the pack

Marketing Authorisation Holder and Manufacturer
This leaflet was last revised in February 2014.

Rare:

TEVA UK Ref:

231-30-19083-C LEA TRAMADOL/PARACETAMOL 37.5mg/325mg TAB 60 TUK
TRAMADOL HYDROCHLORIDE/
PARACETAMOL
37.5 mg/325 mg
FILM-COATED TABLETS
:

Read all of this leaflet carefully before you
start taking this medicine.
again.

Version:

1

19 February 2014

You must not take Tramadol hydrochloride/
Paracetamol together with monoamine
“Do not take Tramadol hydrochloride/
Paracetamol”).
Tramadol hydrochloride/Paracetamol is
not recommended to be taken with the
following:
used to treat epilepsy or some types of
pain such as severe pain attacks in the
face called trigeminal neuralgia),

your doctor or pharmacist.
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
doctor or pharmacist. This includes any
antidepressants or antipsychotics. The
possible side effects not listed in this
risk of having a fit may increase if you
leaflet.
take Tramadol
hydrochloride/Paracetamol at the same
time. Your doctor will tell you whether
1. What Tramadol hydrochloride/
Tramadol hydrochloride/Paracetamol is
Paracetamol is and what it is used for
suitable for you.
2. What you need to know before you take
if you are taking certain antidepressants.
Tramadol hydrochloride/Paracetamol
Tramadol hydrochloride/Paracetamol
3. How to take Tramadol hydrochloride/
may interact with these medicines and
Paracetamol
you may experience symptoms such as
4. Possible side effects
involuntary, rhythmic contractions of
5. How to store Tramadol hydrochloride/
muscles, including the muscles that
Paracetamol
control movement of the eye, agitation,
6. Contents of the pack and other information
excessive sweating, tremor,
exaggeration of reflexes, increased
WHAT TRAMADOL
1
muscle tension, body temperature
HYDROCHLORIDE/
above 38°C.
PARACETAMOL IS AND WHAT IT
The risk of side effects increases, if you
IS USED FOR
also take:
Tramadol hydrochloride/Paracetamol is a
combination of two analgesics, tramadol
relievers such as morphine and codeine
and paracetamol, which act together to
(also as cough medicine), baclofen (a
relieve your pain.
muscle relaxant) medicines used to
lower blood pressure, antidepressants
Tramadol hydrochloride/Paracetamol is
or medicines to treat allergies. You may
intended for use in the treatment of
feel drowsy or feel faint. If this happens,
moderate to severe pain when your doctor
tell your doctor.
recommends that a combination of
tramadol and paracetamol is needed.
that affect the state of mind) or
Tramadol hydrochloride/Paracetamol
bupropion (to help stop smoking). The
should only be taken by adults and
risk of having a fit may increase. Your
adolescents over 12 years.
doctor will tell you whether Tramadol
WHAT YOU NEED TO KNOW
hydrochloride/Paracetamol is suitable
2
for you.
BEFORE YOU TAKE
warfarin or phenprocoumon (for blood
TRAMADOL HYDROCHLORIDE/
thinning). The effectiveness of such
PARACETAMOL
medicines may be altered and bleeding
Do not take Tramadol hydrochloride/
Paracetamol
unexpected bleeding should be
reported to your doctor immediately.
instance skin rash, swelling of the face,
The effectiveness of Tramadol
hydrochloride/Paracetamol may be altered
taking tramadol or paracetamol or any of if you also take:
the other ingredients in Tramadol
hydrochloride/Paracetamol;
ondansetron (medicines for treatment
of nausea and vomiting),
pills, pain relievers or other psychotropic
medicines (medicines that affect mood
cholesterol in the blood),
and emotions);
(medicines against infections).
(certain medicines used for treatment of Your doctor will tell you which medicines
depression or Parkinson’s disease) or
are safe to take with Tramadol
have taken them in the last 14 days
hydrochloride/Paracetamol.
before treatment with Tramadol
Tramadol hydrochloride/Paracetamol with
hydrochloride/Paracetamol;
food, drink and alcohol
Tramadol hydrochloride/Paracetamol may
if you have epilepsy that is not
adequately controlled on your current
you feel more drowsy, so it is best not to
medicine.
drink alcohol while you are taking
Warnings and Precautions
Tramadol hydrochloride/Paracetamol.
Talk to your doctor or pharmacist
Pregnancy, breast-feeding and fertility
you only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours.

should not take this medicine during
pregnancy. If you become pregnant during
treatment with Tramadol hydrochloride/
disease or if you notice your eyes and
Paracetamol, please consult your doctor
skin turning yellow. This may suggest
jaundice or problems with your bile ducts; before taking any further tablets.
Small amounts of tramadol may pass into
the breast-milk. Therefore you should not
breathing for example asthma or severe take this medicine during breast-feeding.
If you are pregnant or breast-feeding, think
lung problems;
you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist
for advice before taking any medicine.
head injury, shock or severe headaches
Driving and using machines
associated with vomiting;
Tramadol hydrochloride/Paracetamol may
make you feel drowsy and this may affect
including those used to relieve pain, for your ability to drive, or use tools and
example morphine;
machines, safely.
The medicine can affect your ability to
that contain buprenorphine, nalbuphine
paracetamol or tramadol;

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 any other
medicines, including medicines obtained
without a prescription.
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.

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until you know how it affects you
affects your ability to drive.
However, you would not be committing an
offence if:
treat a medical or dental problem and
instructions given by the prescriber or in
the information provided with the
medicine and
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

Paracetamol exactly as your doctor has
told you. You should check with your

6/17/10 8:52:50 AM

TEVA UK Ref:

231-30-19083-C LEA TRAMADOL/PARACETAMOL 37.5mg/325mg TAB 60 TUK
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
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.
Use in children
The use in children below the age of
12 years is not recommended.
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
hydrochloride/Paracetamol. If in your case
the insufficiency is mild or moderate, your
doctor may recommend prolonging the
dosage interval.
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 individual 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 product, ask your doctor or
pharmacist.

4 POSSIBLE SIDE EFFECTS

Version:

1

19 February 2014

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:
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.
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.
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.
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.
should be reported to your doctor
immediately.
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/
PARACETAMOL

Keep out of the sight and reach of
children.
Do not use Tramadol hydrochloride/
Paracetamol 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
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

Like all medicines, Tramadol
hydrochloride/Paracetamol can cause side What Tramadol hydrochloride/
effects, although not everybody gets them. Paracetamol contains
The following side effects have been
hydrochloride and paracetamol.
reported at the approximate frequencies
Each film-coated tablet contains 37.5 mg
shown:
tramadol hydrochloride and 325 mg
very common: affects more than 1 user in 10
paracetamol
common: affects 1 to 10 users in 100
uncommon: affects 1 to 10 users in 1,000
rare: affects 1 to 10 users in 10,000
alcohol) grafted copolymer],
very rare: affects less than 1 user in 10,000
not known: frequency cannot be estimated
microcrystalline, sodium starch
from the available data
Very common:
magnesium stearate; film-coating:
opadry II beige 85F97409: polyvinyl
alcohol, titanium dioxide (E171),
macrogol, talc, iron oxide yellow (E172),
Common:
iron oxide red (E172), iron oxide black
(E172).
(constipation, flatulence, diarrhoea),
What Tramadol hydrochloride/
stomach pain, dry mouth,
Paracetamol looks like and contents of the
pack
Tramadol hydrochloride/Paracetamol
changes (anxiety, nervousness, a feeling Film-coated Tablets are peach coloured,
capsule-shaped, engraved with T37.5 on
of high spirits).
Uncommon:
Tramadol hydrochloride/Paracetamol
increase in pulse or blood pressure,
comes in cartons with blister packs of 2,
heart rate or heart rhythm disorders,
10, 15, 20, 30, 40, 60 and 90 tablets and
difficulty or pain on passing water,
bottles with 10 tablets and 100 tablets.
skin reactions (for example rashes,
hives),
Marketing Authorisation Holder and
tingling, numbness or feeling of pins
Manufacturer
and needles in the limbs, ringing in the
ear, involuntary muscle twitching,
depression, nightmares, hallucinations
Eastbourne,
(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, This leaflet was last revised in February
2014.
difficulty breathing,
PL 00289/1731
transaminases).
Rare:
coordinated movements,
19083-C

Neutralna uputa-155 x 450mm.indd 1

6/17/10 8:52:50 AM

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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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