Skip to Content

UK Edition. Click here for US version.

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

Active substance(s): TRAMADOL HYDROCHLORIDE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

Package leaflet: Information for the user

Trapadex 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, 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 Trapadex is and what it is used for
2. What you need to know before you take Trapadex
3. How to take Trapadex
4. Possible side effects
5. How to store Trapadex
6. Contents of the pack and other information
1. What Trapadex is and what it is used for
Trapadex 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 Trapadex
Do not take Trapadex:
• 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
(see section 6) in Trapadex
• 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 Trapadex . 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 Trapadex 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 anaesthetic (tell your doctor or dentist that you are taking Trapadex).
Other medicines and Trapadex
Please 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 Trapadex.
Do not exceed the maximum daily doses of paracetamol or tramadol from this or other medicines.
Do not take Trapadex with MAOIs (see section ‘Do not take Trapadex’).
Trapadex 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).
Trapadex 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, 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 Trapadex
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 Trapadex 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).
Trapadex with food and drink
Do not drink alcohol while you are taking Trapadex, as you may feel drowsy.
Pregnancy and breast-feeding
Do not take Trapadex while you are pregnant.
Check with your doctor if you become pregnant during treatment with Trapadex and before taking
any further tablets. Do not take Trapadex 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 Trapadex, 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 Trapadex
Take Trapadex as you 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.
Take Trapadex for as short a time as possible and no longer than your doctor has told you.
Adults and adolescents over 12 years:
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.
1

121XXXX-V1

If you think that the effect of Trapadex 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 Trapadex 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 Trapadex
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 Trapadex
Generally, there will be no after-effects when treatment with Trapadex 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 Trapadex for some time and want to stop,
contact your doctor because your body may have become used to Trapadex. 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 Trapadex, please contact your doctor. Other
side effect information is listed in section 4
4. Possible side effects
Like all medicines, Trapadex 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 Trapadex 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 (affecting more than 1 in 10 people treated)
• nausea
• dizziness, drowsiness
Common side effects (affecting less than 1 in 10, but more than 1 in 100 people treated)
• 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 (affecting less than 1 in 100, but more than 1 in 1,000 people treated)
• 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.
Rare side effects (affecting less than 1 in 1,000, but more than 1 in 10,000 people treated)
• fits, uncoordinated movements
• addiction
• blurred vision
• transient loss of consciousness (syncope).
Unknown frequency:
• 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.
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 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 Trapadex
Keep out of the reach and sight of children.
Do not use Trapadex 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.
Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
What Trapadex contains
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, maize starch, sodium starch glycolate, microcrystalline cellulose,
magnesium stearate
Film-coating: (Hypromellose (E464), Titanium dioxide (E171), Triacetin, Iron oxide yellow (E172))
What Trapadex looks like and contents of the pack
Light yellow, oblong, biconvex, film-coated tablet, plain on both sides.
Trapadex comes in cartons of 60 tablets and 20 tablets.
Marketing Authorization Holder:
NOUMED LIFE SCIENCES LIMITED
Noumed House, Shoppenhangers Road
Maidenhead, Berkshire, SL6 2RB, United Kingdom.

Manufacturer: MEDREICH PLC
Warwick house, Plane Tree Crescent,
Feltham, TW 13 7 HF United Kingdom

POM

Manufacturer: MEDIS INTERNATIONAL as
Výrobní závod Bolatice Prúmyslová 961/16,
747 23 Bolatice Czech republic

OR

This leaflet was last approved in {11/2017}.
2

121XXXX-V1

+ 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.

Hide