Skip to Content

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

Active substance(s): TRAMADOL HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
8

24 mm

8

Tramadol hydrochloride/
Paracetamol 37.5 mg/325 mg
film-coated tablets
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 this medicine is and what it
is used for
2. What you need to know before you
take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other
information

1. What this medicine is and
what it is used for
Tramadol hydrochloride and Paracetamol
Tablets is a combination of two analgesics,
tramadol and paracetamol, which act
together to relieve your pain.
This medicine 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.

2. What you need to know before
you take this medicine
Do not take this medicine:
• if you are hypersensitive or have had an
allergic reaction (for instance skin rash,
swelling of the face, wheezing or
difficulty breathing) to tramadol,
paracetamol or any of the other
ingredients of this medicine (listed in
section 6)
• in cases of acute alcohol poisoning
• if you are taking sleeping pills, pain
relievers or medicines that affect mood
and emotions
• if you are also taking medicines called
monoamine oxidase inhibitors (MAOIs)
or have taken MAOIs in the last 14 days
before treatment with this medicine
MAOIs are used in the treatment of
depression or Parkinson’s disease
• if you have a severe liver disorder
• if you have epilepsy that is not
adequately controlled by your current
medicine.
Warnings and precautions
Talk to your doctor or pharmacist
before taking this medicine if you:
• take other medicines containing
paracetamol or tramadol
• have liver problems or disease as your
eyes and skin may turn yellow, which
may suggest jaundice
• have kidney problems
• have severe difficulties in breathing, for
example asthma or severe lung problems
• have epilepsy or have already
experienced fits or seizures
• have recently suffered from a head
injury, shock or severe headaches
associated with vomiting (being sick)
• are dependent on any medicine (for
example morphine)
• take other medicines to treat pain that
contain buprenorphine, nalbuphine or
pentazocine
• are going to have an anesthetic (tell your
doctor or dentist that you are taking
medicine).

Taking this medicine with food, drink
and alcohol
Do not drink alcohol while you are taking
this medicine, as you may feel drowsy.
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.
Breast-feeding
Tramadol is excreted into breast milk. For
this reason, you should not take this
medicine more than once during breastfeeding, or alternatively, if you take this
medicine more than once, you should stop
breast-feeding.
Driving and using machines
If you feel drowsy while taking this
medicine, do not drive, use tools or use
machinery.
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 this medicine
Always take this medicine exactly as your
doctor has told you. Check with your
doctor or pharmacist if you are not sure.
Swallow the tablets whole with sufficient
liquid. Do not break or chew the tablets.
The dosage should be adjusted to the
intensity of your pain and your individual
pain sensitivity. In general the lowest painrelieving dose should be taken. Take this
medicine for as short a time as possible and
no longer than your doctor has told you.
Adults and adolescents of 12 years and
over:
The recommended dosage is to start with 2
tablets, unless otherwise prescribed by your
doctor. If required, further doses may be
taken, as instructed by your doctor.
The shortest time between doses must be at
least 6 hours.
Do not take more than 8 tablets per day.
Your doctor may increase the time between
doses if:
• you are older than 75 years
• you have kidney problems
• you have liver problems.
Children under 12 years of age:
• not recommended.
If you think that the effect of this
medicine is too strong (you feel very
drowsy or have difficulty breathing) or too
weak (you do not have enough pain relief),
contact your doctor.
If you take more tablets than you
should
Immediate medical advice should be sought
in the event of an overdose, even if you
feel well, because of the risk of delayed,
serious liver damage.

IXXXX

Taking other medicines
Tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription. Your doctor will tell
you which medicines are safe to take with
this medicine.
Do not exceed the maximum daily doses of
paracetamol or tramadol from this or
other medicines. Do not take this medicine
with MAOIs (see section ‘Do not take this
medicine’).
This medicine is not recommended with the
following medicines, as it may affect how
well they work:
• carbamazepine (a medicine used to treat
epilepsy or some types of pain)
• buprenorphine, nalbuphine or
pentazocine (opioid type pain relievers).
This medicine may increase the risk of side
effects if you also take the following
medicines:

• triptans (used for migraine) or selective
serotonin re-uptake inhibitors (SSRIs,
used for depression). Check with your
doctor if you experience confusion,
restlessness, fever, sweating,
uncoordinated movement of limbs or
eyes, uncontrollable jerking of muscles
or diarrhoea.
• tranquilizers, 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. Check with
your doctor if you feel drowsy or feel
faint.
• antidepressants, anesthetics, medicines
that affect the state of mind, or
bupropion (used to help stop smoking).
The risk of having a fit may increase.
Your doctor will tell you whether this
medicine is suitable for you.
• warfarin or phenprocoumon (for blood
thinning). The effectiveness of such
medicines may be altered and bleeding
may occur (see section 4).
The effectiveness of this medicine may be
altered if you also take the following
medicines:
• metoclopramide, domperidone or
ondansetron (medicines used to treat
nausea and vomiting/being sick)
• cholestyramine (medicine used to reduce
cholesterol in the blood)
• ketoconazole or erythromycin
(medicines used against infections).

480 mm

Package leaflet: Information for the
user

10 mm

130 mm

Tramadol & Paracetamol tablets
Front

8 mm

24 mm

8 mm

If you forget to take this medicine
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 this medicine
Generally, there will be no after-effects
when treatment with Tramadol and
Paracetamol tablets is stopped.
Rarely, people who have been using a
medicine containing tramadol may become
dependent on it, making it hard to stop
taking it. If you have been taking this
medicine for some time and want to stop,
contact your doctor because your body may
have become used to these tablets
People may:
• feel agitated, anxious, nervous or shaky
• be over active
• have difficulty sleeping
• have stomach or bowel disorders.
Very few people may also get:
• panic attacks
• hallucinations, unusual perceptions such
as itching, tingling and numbness
• ringing in the ears.
If you experience any of these complaints
after stopping this medicine, please contact
your doctor. Other side effect information
is listed in section 4.

4. Possible side effects

Some side effects could be serious.
Contact your doctor immediately if
any of the following occur:
• rarely cases of 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. Very rare cases of
serious skin reactions have been reported
with paracetamol. If this happens to
you, stop treatment. Do not take the
medicine again.
• prolonged or unexpected bleeding, from
the use of these tablets with medicines
used to thin the blood (e.g. warfarin,
phenprocoumon).
Additionally, if any of the following
side effects get serious, contact your
doctor or pharmacist:
Very common side effects (may affect
more than 1 in 10 people )
• nausea
• dizziness, drowsiness.
Common side effects (may affect more
than 1 in 10 people )
• vomiting (being sick), digestion problems
(constipation, flatulence, diarrhoea),
stomach pain, dry mouth
• itching, sweating
• headache, shaking
• confusion, sleep disorders, mood changes
(anxiety, nervousness, feeling of high
spirits).
Uncommon side effects (may affect
more than 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 ears,
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.

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 this medicine
• Keep this medicine out of the sight and
reach of children.
• Do not use this medicine after the expiry
date which is printed on the carton and
blister after (EXP.). The expiry date
refers to the last day of that month.
• This medicinal product does not require
any special storage conditions.
• Do not throw away any medicines via
waste water 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 this medicine contains
• The active substances are Tramadol
Hydrochloride and Paracetamol. Each
tablet contains 37.5 mg tramadol
hydrochloride and 325 mg paracetamol.
• The other ingredients are:
Tablet core: powdered cellulose,
pregelatinised maize starch, sodium
starch glycolate (type A), maize starch,
magnesium stearate.
Film-coating: hypromellose, titanium
dioxide (E171), macrogol 400, iron
oxide yellow (E172), polysorbate 80.
What these tablets look like and
contents of the pack
• These tablets are light yellow, capsule
shaped, biconvex tablets embossed with
‘C8’ on one side and plain on other side.
• This medicine is available in packs of
2,10,20,30,40,50,60,70,80,90 and 100
tablets. Not all pack sizes may be
marketed.
Marketing Authorisation Holder and
Manufacturer
Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road,
Berkhamsted, Hertfordshire,
HP4 1EG, UK.
Telephone: 0044 (0) 1442 200922
Fax: 0044 (0) 1442 873717
Email: info@bristol-labs.co.uk
Tramadol hydrochloride/Paracetamol
37.5 mg/325 mg film-coated tablets;
PL 17907/0392
This leaflet was last revised in
May 2016
To request a copy of this leaflet in Braille,
large print or audio format, please contact
the licence holder at address (or telephone,
fax, e-mail) above.

Rare side effects (may affect more
than 1 in 1,000 people)
• fits, uncoordinated movements
• addiction
• blurred vision
• transient loss of consciousness
(syncope).
Not known side effects (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.
• 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
• nose bleeds or bleeding gums, which may
result from a low blood platelet count.
V5 31-05-16 D1

IXXXXXX

480 mm

Like all medicines, this medicine can cause
side effects, although not everybody gets
them.

If this happens to you, stop treatment and
see a doctor immediately. You must not
take the medicine again.

10 mm

130 mm

SAME SIZE ARTWORK
130 x 480 mm
Back

Expand view ⇕

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.

Hide