TRAMACET 37.5 MG/325 MG EFFERVESCENT TABLETS

Active substance: TRAMADOL HYDROCHLORIDE

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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.
• 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.
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

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, sunset
yellow (E110) 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’).
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).
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).
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).
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 breastfeeding, 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.
Important information about some of the ingredients
of Tramacet
• 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
Take Tramacet as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
Take effervescent tablets by dissolving in a glass of
drinking water.
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.
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.
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.

schwarz
Name:

GI TRAMACET TABS

Größe:

170 X 367 mm

Sprache:

9,5 pt

Faserlauf:

367 mm

Swissco Code: XXXX

Artikel-Nr.:

R-YJ-180314-03 Swissco-Nr.: X.XXXX.XXXX-XX

Druckfarbe:

schwarz

Datum:

Klass.-Nr.:

50/000/23

Flattermarken:

Bez. der Vorgängerdatei:

93016658

Vorgängerdatei gelöscht:



Leistungsindex:



RZ geprüft:

1B/X3

Reinders

EN
19.03.2014

V1

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
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:
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.

5. HOW TO STORE TRAMACET
Keep out of the reach and sight of children.
Do not use Tramacet 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.
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.
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 approved in:
01/2014

X.XXXX.XXXX-XX

R-YJ-180314-03

50/000/23

schwarz
Name:

GI TRAMACET TABS

Größe:

170 X 367 mm

Sprache:

9,5 pt

Faserlauf:

367 mm

Swissco Code: XXXX

Artikel-Nr.:

R-YJ-180314-03 Swissco-Nr.: X.XXXX.XXXX-XX

Druckfarbe:

schwarz

Datum:

Klass.-Nr.:

50/000/23

Flattermarken:

Bez. der Vorgängerdatei:

93016658

Vorgängerdatei gelöscht:



Leistungsindex:



RZ geprüft:

1B/X3

Reinders

EN
19.03.2014

V1

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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