What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL21727/0040.

Tramacet 37.5 mg/325 mg effervescent tablets

Package leaflet: Information for the user

TRAMACET® 37.5mg/325mg effervescent 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 section 4).

What is in this leaflet:

1. What TRAMACET is and what it is used for
2. What you need to know before you take TRAMACET
3. How to take TRAMACET
4. Possible side effects
5. How to store TRAMACET
6. Contents of the pack and other information

1. What TRAMACET is and what it is used for

TRAMACET 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 TRAMACET

Do not take TRAMACET

  • if you are allergic to tramadol hydrochloride, paracetamol, sunset yellow (E110) 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 TRAMACET. 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 TRAMACET 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 TRAMACET.

Other medicines and TRAMACET

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 TRAMACET.

Do not exceed the maximum daily doses of paracetamol or tramadol from this or other medicines. Do not take TRAMACET with MAOIs (see section ‘Do not take TRAMACET’).

TRAMACET is not recommended to be taken with the following:

  • carbamazepine (a medicine used to treat epilepsy or some types of pain)
  • buprenorphine, nalbuphine or pentazocine (opioid-type pain relievers).

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 TRAMACET at the same time. Your doctor will tell you whether TRAMACET is suitable for you.
  • if you are taking certain antidepressants, TRAMACET 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 TRAMACET 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)

Taking TRAMACET with food and alcohol

Do not drink alcohol while you are taking TRAMACET, as you may feel drowsier.

Pregnancy, breast-feeding and fertility

Do not take TRAMACET while you are pregnant or breast-feeding.

Check with your doctor if you become pregnant during treatment with TRAMACET and before taking any further tablets. Tramadol is excreted into breast milk. For this reason, you should not take TRAMACET more than once during breast-feeding, or alternatively, if you take TRAMACET more than once, you should stop breast-feeding.

Based on human experience tramadol is suggested not to influence female or male fertility. No data on the influence of the combination of tramadol and paracetamol on fertility are available.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

If you feel drowsy while taking TRAMACET, 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.

TRAMACET contains Sunset yellow (E110)

  • The medicinal product contains the colorant sunset yellow (E110) which may cause allergic reactions.
  • This medicinal product contains 179.4 mg sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

3. How to take TRAMACET

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Take TRAMACET for as short a time as possible and no longer than your doctor has told you.

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.

Adults and adolescents over 12 years:

The recommended starting dose, unless otherwise prescribed by your doctor is 2 effervescent 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.

Older people:

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 TRAMACET. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.

Method of administration:

The effervescent tablets are for oral use.

Take effervescent tablets by dissolving in a glass of drinking water.

If you think that the effect of TRAMACET 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 TRAMACET 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 TRAMACET

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 TRAMACET

Generally, there will be no after-effects when treatment with TRAMACET 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 TRAMACET for some time and want to stop, contact your doctor because your body may have become used to TRAMACET.

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

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 TRAMACET with medicines used to thin the blood (e.g. warfarin, phenprocoumon).
  • serious skin reactions; very rare cases have been reported with paracetamol.
  • respiratory depression (decrease in the ability to breathe in and out); rare cases have been reported with tramadol.
  • decrease in blood sugar level.

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
  • tingling, numbness or feeling of pins and needles in the limbs, ringing in the ears, involuntary muscle twitching
  • depression, nightmares, hallucination (hearing, seeing or sensing things that are not really there), memory lapses
  • difficulty breathing
  • difficulty swallowing, blood in the stools
  • skin reactions (for example rashes, hives)
  • increase in liver enzyme values
  • presence of albumin in the urine, difficulties or pain on passing urine
  • shivering, hot flushes, pain in the chest.

Rare: may affect up to 1 in 1,000 people

  • fits, uncoordinated movements, transient loss of consciousness (syncope)
  • drug dependence
  • delirium
  • vision blurred, constriction of the pupil (miosis)
  • speech disorders
  • excessive dilation of the pupils (mydriasis)

Unknown: frequency unknown

  • decrease in blood sugar level (hypoglycaemia)

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 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 TRAMACET

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 or bottom of the plastic tube. The expiry date refers to the last day of that month.

Tablets packed in blister strips (aluminium foil):

  • Do not store above 25°C.

Tablets packed in plastic tubes:

  • Do not store above 30°C.
  • After first opening: Keep the container tightly closed in order to protect from moisture.
  • Shelf-life after first opening: 1 year, not exceeding the expiry date.

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 TRAMACET contains

The active substances are tramadol hydrochloride and paracetamol.

One (1) tablet contains 37.5 mg tramadol hydrochloride and 325 mg paracetamol.

The other ingredients are:

monosodium citrate anhydrous, citric acid anhydrous, polyvinylpyrrolidone, sodium hydrogen carbonate, macrogol 6000, silica colloidal anhydrous, magnesium stearate, orange flavouring (maltodextrin (maize), modified starch (E1450), natural and artificial flavourings)), acesulfame potassium, saccharin sodium, sunset yellow (E110).

What TRAMACET looks like and contents of the pack

TRAMACET effervescent tablets look off white to slightly rosy coloured with some coloured speckles. The tablets may be available in strips of coated aluminium foil or plastic tubes.

In aluminium strips: packs of 2, 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 effervescent tablets.

In plastic tubes: packs of 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 effervescent tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Grünenthal Ltd
Regus Lakeside House
1 Furzeground Way
Stockley Park East
Uxbridge
Middlesex UB11 1BD
United Kingdom

Manufacturers:

Grunenthal GmbH
Zieglerstrasse 6
52078 Aachen
Germany

Other formats of this leaflet

A service is available to listen to or request a copy of this leaflet in Braille, large print or audio.

  • Please call free of charge: 0800 198 5000 (UK only)

Please be ready to give the following information:

  • Product name: TRAMACET 37.5 mg/325 mg effervescent tablets
  • Reference number: PL 21727/0040

This leaflet was last revised in

07/2017