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Package leaflet: Information for the patient

37.5mg / 325mg Tablets
Tramadol Hydrochloride/ Paracetamol

 ead all of this leaflet carefully before you start using
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,
pharmacist or nurse.

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 have any side effects including any side effects not
listed in the leaflet, talk to your doctor, pharmacist or nurse.
See section 4.


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

This medicine 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
this medicine
Do not take this medicine
If you are allergic (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 taking medicines called monoamine oxidase
inhibitors (MAOIs) or if you have taken MAOIs in the last 14
days before treatment. MAOIs are used in the treatment of
depression or Parkinson’s disease.
If you suffer from a severe liver disorder.
If you suffer from epilepsy that is not adequately controlled by
your current medicine.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking this
medicine if you:
are taking 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
headache associated with vomiting (being sick);
became dependent on any medicine (for example, morphine);
are taking medicines to treat pain that contain buprenorphine,
nalbuphine or pentazocine;
are going to have an anaesthetic (tell your doctor or dentist that
you are taking this medicine).
Other medicines and Tramadol/Paracetamol
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines. 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’).
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 this medicine at the same
time. Your doctor will tell you whether this medicine is
suitable for you.



If you are taking certain antidepressants. This medicine 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.
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 killers)
This medicine may increase the risk of side effects if you also
take the following medicines:
Triptans (used for migraine) or selective serotonin reuptake
inhibitors (SSRIs, used for depression). Check with your doctor if
you experience confusion, restlessness, fever, sweating,
uncoordinated movements 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, anaesthetics, 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 can be altered and
bleeding may occur.
The effectiveness of this medicine may be altered if you also take
the following medicines:
Metoclopramide, domperidone and ondansetron (medicines
used to treat nausea and vomiting/being sick).
Cholestyramine (medicine used to reduce cholesterol in blood).
Ketoconazole and erythromycin (medicine used against
This medicine with food, drink and alcohol
Do not drink alcohol while you are taking this medicine, as you
may feel drowsy.
Pregnancy, breast-feeding and fertility
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. Do not take this medicine
while you are pregnant. If you become pregnant while taking this
medicine, talk to your doctor before taking the next tablet.
Tramadol is excreted into breast milk. For this reason, you should
not take Tramadol/Paracetamol more than once during
breast-feeding, or alternatively, if you take Tramadol/Paracetamol
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.
This 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
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 or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
As you prefer the tablets can be swallowed whole or you can halve
them and have with a glass of liquid, preferably water.
Take this medicine for as short a time as possible and no longer
than your doctor has told you.

Adults and adolescents over 12 years:
Unless your doctor says otherwise, the normal starting dose for
adults and children over 12 years old is 2 tablets. If required,
further doses may be taken, as instructed by your doctor.
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.
The shortest time between doses must be at least 6 hours.
Do not take more than 8 tablets per day.
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 this medicine. If in your case the insufficiency is mild
or moderate, your doctor may recommend prolonging the
dosage interval.
Children under 12 years of age:
Not recommended.
If you think 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 of this medicine 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.
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 this
medicine 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 this medicine.
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.
If you have any further questions on the use of this medicine,
ask your doctor, pharmacist or nurse.


4. Possible side effects

Like all medicines, this medicine can cause side effects, although
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
this medicine with medicines used to thin the blood
(e.g. warfarin, phenprocoumon).
Additionally, if any of the following side effects become serious,
contact your doctor or pharmacist:
Very common: may affect more than 1 in 10 people;
dizziness, drowsiness.
Common: may affect up to 1 in 10 people;
vomiting (being sick), digestion problems (constipation,
flatulence, diarrhoea), stomach pain, dry mouth.


•• itching,
headache, shaking.
confusion, 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
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 1000 people;
fits, uncoordinated movements
addiction, delirium
blurred vision, constriction of the pupil (miosis)
speech disorders
excessive dilation of the pupils (mydriasis)
transient loss of consciousness (syncope).
Not known (frequency cannot be estimated from the
available data)
Decrease in the blood sugar level
In addition, the following side effects have been reported by
people using medicines that contain only tramadol or only
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, 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 (website:
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.
This medicine does not require special storage conditions.
Do not use this medicine after the expiry date which is stated on
the carton (after EXP). The expiry date refers to the last day of
that month.
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 protect the environment.

6. Contents of the pack and other information
What this medicine contains
The active substances are tramadol hydrochloride and paracetamol.
A tablet contains 37.5mg of tramadol hydrochloride and 325mg
of paracetamol.
The other ingredients (excipients) are: Povidone (E1201),
magnesium stearate (E152), colloidal anhydrous silicon, sodium
starch glycolate (Type A) of potato and pregelatinized corn starch.
What this medicine looks like and contents of the pack
These tablets are oval and white for oral administration packed in
cartons containing 2, 10, 20, 30, 40, 50, 60, 70, 80, 90 and 100
tablets. Not all pack sizes may be marketed. The tablets are scored
and can be cut in half to make swallowing easier. Half doses
should not be taken.
Marketing Authorisation Holder:
Aspire Pharma Ltd., Unit 4, Rotherbrook Court,
Bedford Road, Petersfield, Hampshire, GU32 3QG, UK.
Ferrer Internacional, S.A., Joan Buscallà, 1-9,
Sant Cugat del Vallès (Barcelona), Spain.
This leaflet was last revised in

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Aspire Pharma Limited
Tramadol/Paracetamol 37.5mg/325mg Tablets
280mm x 175mm
9 February 2015
safety variation
As swatch(es)
Strada pro Condensed 9pt line feed
InDesign CS6
T022 (formerly S842)

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