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Package leaflet: Information for the user

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

Children and adolescents
This medicine is not recommended in children and adolescents under

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

Do not take Tramadol/Paracetamol with MAOIs (see section ‘Do not
take Tramadol/Paracetamol’).

1. What Tramadol/Paracetamol is and what it is used for
Tramadol/Paracetamol contains a combination of the active substances
Tramadol Hydrochloride/Paracetamol, which belongs to a group of
medicines used to treat pain.
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/
Do not take Tramadol/Paracetamol
• if you are allergic 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
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
Warnings and precautions
Talk to your doctor or pharmacist before taking Tramadol/Paracetamol.
Your doctor needs to know before you take Tramadol/Paracetamol if
you have or have had any of the following conditions:
• taking other medicines containing Tramadol/Paracetamol
• 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 anaesthetic (tell your doctor or dentist that you
are taking Tramadol/Paracetamol).

prescribed by your doctor. If required, further doses may be taken, as
instructed by your doctor.

Your doctor may increase the time between doses if:

• you have kidney problems
• you have liver problems.

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 Tramadol/Paracetamol.
Do not exceed the maximum daily doses of Tramadol/Paracetamol
from this or other medicines.

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

Tramadol/Paracetamol with food, drink and alcohol
Do not drink alcohol or alcoholic drinks or medicinal products containing
alcohol while you are taking Tramadol/Paracetamol, as you may feel drowsy.
Tramadol/Paracetamol can be taken with food.
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 Tramadol/Paracetamol while you are pregnant. Check
with your doctor if you become pregnant during treatment with
Tramadol/Paracetamol and before taking any further tablets.
Do not take Tramadol/Paracetamol while you are breast-feeding, as
small amounts of tramadol may pass into the breast-milk.
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
• 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 your doctor or pharmacist 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.
Take Tramadol/Paracetamol for as short a time as possible and no
longer than your doctor has told you.

prescribed by your doctor. If required, further doses may be taken, as
instructed by your doctor.

Your doctor may increase the time between doses if:

• you have kidney problems
• you have liver problems.
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
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 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
• ringing in the ears.
If you experience any of these complaints after stopping Tramadol/
Paracetamol, please contact your doctor. Other side effect information
is listed in section 4.
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 Tramadol/
Pracetamol with medicines used to thin the blood (e.g. warfarin,
Additionally, if any of the following side effects get serious, contact
your doctor or pharmacist:
• nausea
• dizziness, drowsiness.
• 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).

• 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.

fits, uncoordinated movements
blurred vision
transient loss of consciousness (syncope).

Not known (frequency cannot be estimated from the available data)
• 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.
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. Website: www. 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 stated 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.
Store in the original package.
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 Tramadol/Paracetamol contains
The active substances are Tramadol Hydrochloride/Paracetamol.
Each film-coated tablet contains 37.5mg tramadol hydrochloride and
325mg paracetamol.
The other ingredients are: Tablet core: microcrystalline cellulose,
pregelatinised starch maize starch, sodium starch glycolate,
magnesium stearate. Film-coating: hypromellose, titanium dioxide
(E171), macrogol, yellow iron oxide (E172), polysorbate 80.
What Tramadol/Paracetamol looks like and contents of the
Pale yellow colour capsule shaped biconvex film-coated tablets with
engraved “SP” on one side and plain on other side.
They come in PVC/PVDC blister packs with Glassine paper (35 GSM)
soft/ temper printed aluminium foil of 10 tablets.
Marketing Authorisation Holder
Somex Pharma
Ilford, Essex
Somex Pharma
Ilford, Essex
This leaflet was last revised in

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