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TRAMADOL HYDROCHLORIDE/PARACETAMOL 37.5/325MG FILM COATED TABLETS

Active substance(s): TRAMADOL HYDROCHLORIDE

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Package leaflet: Information for the user

Tramadol hydrochloride/
Paracetamol
37.5mg/325mg, film-coated tablets

Tramadol hydrochloride/Paracetamol
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, please 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
section4).
What is in this leaflet:
1. What Tramadol/Paracetamol is and what it is used for
2. What you need to know before you take Tramadol/Paracetamol
3. How to take Tramadol/Paracetamol
4. Possible side effects
5. How to store Tramadol/Paracetamol
6. Contents of the pack and other information

• buprenorphine, nalbuphine or pentazocine (opioid-type pain
relievers).

1. What Tramadol/Paracetamol is and what it is used for
Tramadol/Paracetamol is used to treat moderate to severe pain when
your doctor recommends that a combination of tramadol hydrochloride
and paracetamol is needed.
2. What you need to know before you take Tramadol/Paracetamol
Do not take Tramadol/Paracetamol
• if you are allergic to tramadol hydrochloride, 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 Tramadol/Paracetamol. 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 before taking Tramadol/Paracetamol
• if you take other medicines containing paracetamol or tramadol
hydrochloride;
• if you have liver problems or disease as your eyes and skin may turn
yellow, which may suggest jaundice;
• 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 (being sick);
• if you are dependent on any medicine (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/Paracetamol);
If any of the above-mentioned points applied to you in the past or
applies to you while you are taking Tramadol/Paracetamol, please
make sure your doctor knows. He/she can then decide whether you
should continue to use this medicine.
Children and adolescents
This medicine is not recommended for children under 12 years of age.
Other medicines and Tramadol/Paracetamol
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Do not exceed the maximum daily doses of paracetamol or tramadol
from this or other medicines.
Do not take Tramadol/Paracetamol with MAOIs (see section ‘Do not
take Tramadol/Paracetamol’).
Tramadol/Paracetamol is not recommended to be taken with the
following:
• carbamazepine (a medicine used to treat epilepsy or some types of
pain);

Item Code

The risk of side effects increases:
• if you are taking 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.
• if you are taking 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 or
medicines to treat allergies. Check with your doctor if you feel drowsy
or feel faint.
• if you are taking medicines which may cause convulsions (fits), such
as certain antidepressants or antipsychotics. The risk having a fit may
increase if you take Tramadol/Paracetamol at the same time. Your
doctor will tell you whether Tramadol/Paracetamol is suitable for you.
• if you are taking certain antidepressants. Tramadol/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.
• if you are taking warfarin or phenprocoumon (for blood thinning). The
effectiveness of such medicines may be altered and bleeding may
occur (see section 4).
The effectiveness of Tramadol/Paracetamol may be altered if you also
take:
• metoclopramide, domperidone or ondansetron (medicines used to
treat nausea and vomiting/being sick);
• cholestyramine (medicine used to reduce cholesterol in the blood).
Tramadol/Paracetamol with food and alcohol
Do not drink alcohol while you are taking Tramadol/Paracetamol, as
you may feel drowsier.
Pregnancy, breast-feeding and fertility
Do not take Tramadol/Paracetamol while you are
pregnant or 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 Tramadol/Paracetamol Tablets more than once during
breast-feeding, or alternatively, if you take Tramadol/Paracetamol
Tablets more than once, you should stop breast-feeding.
Driving and using machines
If you feel drowsy while taking Tramadol/Paracetamol, 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 Tramadol/Paracetamol
Always take this medicine exactly as you 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.
Take Tramadol/Paracetamol for as short a time as possible as and no
longer than your doctor has told you.

M0251LAMUKNA-S-001
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Proof By
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Date

05/05/2017

MPS No.

847961

Customer

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Description

Tramadol hydrochloride/Paracetamol Leaflet

Item Code

M0251LAMUKNA-S-001

Barcode

N/A not applicable

PharmaCode

MLEAF023
210 x 297mm

Proof By

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Proof No.

2

Date

05/05/2017

Artwork No.

847961

Colours Used
Black
Keyline (non-printing)

Adults and adolescents over 12 years:
The recommended starting dose unless otherwise prescribed by your
doctor is 2 tablets for adults and adolescents over 12 years. 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.
Children under 12 years of age:
• 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/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.
Do not break or chew the tablets.
If you think that the effect of Tramadol/Paracetamol 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 Tramadol/Paracetamol than you should
Talk to a doctor at once if you take too much of this medicine, even
if you feel well. This is because too much paracetamol can cause
delayed, serious liver damage.
If you forget to take Tramadol/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/Paracetamol
Generally, there will be no after-effects when treatment with
Tramadol/Paracetamol 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 Tramadol/Paracetamol for some time and want to
stop, contact your doctor because your body may have become used
to Tramadol/Paracetamol.
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.

• 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.
Rare: may affect up to 1 in 1,000 people
• fits, uncoordinated movements
• addiction, delirium
• vision blurred, constriction of the pupil (miosis)
• speech disorders
• excessive dilation of the pupils (mydriasis)
• transient loss of consciousness (syncope)
Unknown: frequency unknown
• Decrease in blood sugar level
In addition, the following side effects 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.
• very rare cases of serious skin reactions have been reported
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/Paracetamol
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. 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 medicine 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 Tramadol/Paracetamol Tablets contain
- The active substances are tramadol hydrochloride and paracetamol.
One tablet contains 37.5 mg tramadol hydrochloride and 325 mg
paracetamol.
- The other ingredients are:
• Tablet core: pregelatinised starch, sodium starch glycolate,
microcrystalline cellulose and magnesium stearate.
• Tablet coating: hypromellose, titanium dioxide (E171), macrogol
400, iron oxide yellow (E172) and polysorbate 80.
What Tramadol/Paracetamol Tablets look like and contents of
the pack
Tramadol Hydrochloride/Paracetamol Tablets are yellow coloured,
elongated, film-coated tablets with “325” debossed on one side and
“37.5” debossed on other side.
Tramadol/Paracetamol Tablets are packed in white PVC/PVDC/
aluminium blister packs of 10 tablets and are available in boxes of 10,
20, 30, 40, 50, 60, 70, 80, 90 and 100 tablets. Not all pack sizes may
be marketed.
Marketing Authorisation Holder
Morningside Healthcare Ltd
115 Narborough Road
Leicester
LE3 0PA, UK
Manufacturer
Morningside Pharmaceuticals Ltd
5 Pavilion Way
Loughborough
LE11 5GW, UK
This leaflet was last revised in May 2017.

4. Possible side effects
Like all medicines, this medicine can cause side effects, however not
everybody gets them.
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. If this happens to you, stop
treatment. Do not take the medicine again.
• prolonged or unexpected bleeding, from the use of
Tramadol/Paracetamol 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: may affect more than 1 in 10 people
• nausea
• dizziness, drowsiness.
Common: may affect up to 1 in 10 people
• vomiting (being sick), digestion problems (constipation, flatulence,
diarrhoea), stomach pain, dry mouth
• itching, sweating (hyperhidrosis)
• headache, shaking
• confusional state, sleep disorders, mood changes (anxiety,
nervousness, 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

Item Code

M0251LAMUKNA-S-001

Proof By

.

Proof No.

2

Date

05/05/2017

MPS No.

847961

Customer

.

Description

Tramadol hydrochloride/Paracetamol Leaflet

Item Code

M0251LAMUKNA-S-001

Barcode

N/A not applicable

PharmaCode

MLEAF023
210 x 297mm

Proof By

.

Proof No.

2

Date

05/05/2017

Artwork No.

847961

Colours Used
Black
Keyline (non-printing)

+ Expand Transcript

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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