TRAMACET 37.5MG/325MG FILM COATED TABLETS

Active substance: TRAMADOL HYDROCHLORIDE

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By Aneela Mahmood at 9:45 am, Aug 13, 2013

Your medicine is called by the above name but will be referred to as Tramacet throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

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. Before you take Tramacet
Do not take Tramacet
• 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 Tramacet
• 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.
Before you take Tramacet, check with your doctor or pharmacist 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).
Taking other medicines
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
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’).

DATE:

CUSTOMER
APPROVED:

PROOF HISTORY:
v.3 - waymade - 12/08/13

Leaflet Flat Size = 148 x 432

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

In this leaflet:
1. What Tramacet is and what it is used for
2. Before you take Tramacet
3. How to take Tramacet
4. Possible side effects
5. How to store Tramacet
6. Further information

Tramacet 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 Tramacet 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).
• If you are taking medicines which may cause convulsions (fits), such as a certain antidepressants or
antipsychotics. The risk of 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.

12/08/13
DATE OF PROOF:

DATE:

DT

06464/2985D

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)
• ketoconazole or erythromycin (medicines used against infections).

CODE:

Tramacet 37.5mb 325mg tabs

04-1957

ARTWORKER:
PRODUCT:

CUSTOMER:

Waymade

PRE-PRESS NO.:

Q.A.
APPROVED:

Tramacet 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).

Taking Tramacet with food and drink
Do not drink alcohol while you are taking Tramacet, as you may feel drowsy.
Pregnancy and breast-feeding
Do not take Tramacet while you are pregnant. Check with your doctor if you become pregnant during
treatment with Tramacet and before taking any further tablets. Do not take Tramacet 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 Tramacet, do not drive, use tools or use machinery.
3. How to take Tramacet
Take Tramacet 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.
Swallow the tablets whole with sufficient liquid.
Do not break or chew the tablets.
Take Tramacet 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.
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 Tramacet. If in your case the
insufficiency is mild to moderate, your doctor may recommend prolonging the dosage interval.

WARNING!

27mm

(tramadol hydrochloride/Paracetamol)
Patient Information leaflet

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Mock up 

WARNING!

Assessed against UK PIL dated April 2010 & to also include safety warnings
Tramacet® 37.5mg/325mg, film-coated Tablets

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

000-0000B

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
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 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.

PROOF HISTORY:
v.3 - waymade - 12/08/13

Leaflet Flat Size = 148 x 432

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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 Tramacet, please contact your doctor.
Other side effect information is listed in section 4.
4. Possible side effects
Like all medicines, Tramacet 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).
Additionally, if any of the following side effects get serious, contact your doctor or pharmacist:

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Children under 12 years of age:
• not recommended.

WARNING!

Your doctor may increase the time between doses if:
• you are older than 75 years
• you have kidney problems
• you have liver problems.




06464/2985D




5. How to store Tramacet
Keep out of the sight and reach of children.
Do not use Tramacet 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. Further information
What Tramacet contains
The active substances are tramadol hydrochloride and paracetamol.
Each tablet contains 37.5 mg tramadol hydrochloride and 325 mg paracetamol.
The other ingredients are:
• Tablet core: powdered cellulose, pregelatinised starch (potato, maize and rice), sodium starch
glycolate (type A), maize starch, magnesium stearate.
• Film-coating: hypromellose, lactose monohydrate, titanium dioxide (E 171), propylene glycol, talc,
macrogol 6000 and yellow iron oxide (E172).
What Tramacet looks like and contents of the pack
Tramacet 37.5mg/325mg, film-coated tablets are pale yellow film-coated tablets, marked with the
manufacturer’s logo on one side and marked T5 on the other side.
Tramacet 37.5mg/325mg, film-coated tablets are packed in blister strips.
Tramacet 37.5mg/325mg, film-coated tablets comes in packs of 60 tablets
POM

PL No: 06464/2985

This product is manufacturer by Grunenthal GmbH, Zieglerstrasse 6, D-52078, Aachen, Germany and is
procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR.
Leaflet Revision and issue date (ref.) 12.08.2013
Tramacet is a registered trademark of Johnson & Johnson

WARNING!

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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

DATE:
DATE:
12/08/13
DATE OF PROOF:

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.

CODE:

Tramacet 37.5mb 325mg tabs

DT

PRODUCT:

CUSTOMER:

Waymade

04-1957

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.

ARTWORKER:

CUSTOMER
APPROVED:

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).

PRE-PRESS NO.:

Q.A.
APPROVED:

Very common side effects (affecting more than 1 in 10 people treated)
• nausea
• dizziness, drowsiness.

Expand view ⇕

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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