TRAMACET 37.5MG/325MG FILM COATED TABLETS

Active substance: TRAMADOL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Tramacet® 37.5mg/325mg, film-coated 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:
Tramacet may increase the risk of side effects if you
1. What Tramacet is and what it is used for
also take the following medicines:
2. Before you take Tramacet
• triptans (used for migraine) or selective serotonin
3. How to take Tramacet
re-uptake inhibitors (SSRIs, used for depression).
4. Possible side effects
Check with your doctor if you experience confusion,
5. How to store Tramacet
restlessness, fever, sweating, uncoordinated
6. Further information
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
Tramacet is used to treat moderate to severe pain
to treat allergies. Check with your doctor if you feel
when your doctor recommends that a combination of
drowsy or feel faint.
tramadol hydrochloride and paracetamol is needed.
• 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
Do not take Tramacet
effectiveness of such medicines may be altered and
• if you are hypersensitive or have had an allergic
bleeding may occur (see section 4).
reaction (for instance skin rash, swelling of the
The effectiveness of Tramacet may be altered if you
face, wheezing or difficulty breathing) to tramadol,
also take the following medicines:
paracetamol or any of the other ingredients (see
• metoclopramide, domperidone or ondansetron
section 6) in Tramacet
(medicines used to treat nausea and vomiting/being
• in cases of acute alcohol poisoning
sick)
• if you are taking sleeping pills, pain relievers or
• cholestyramine (medicine used to reduce
medicines that affect mood and emotions
cholesterol in the blood)
• if you are also taking medicines called monoamine
• ketoconazole or erythromycin (medicines used
oxidase inhibitors (MAOIs) or have taken MAOIs in
against infections).
the last 14 days before treatment with Tramacet.
Taking Tramacet with food and drink
MAOIs are used in the treatment of depression or
Do not drink alcohol while you are taking Tramacet, as
Parkinson’s disease.
you may feel drowsy.
• if you have a severe liver disorder
• if you have epilepsy that is not adequately controlled
Pregnancy and breast-feeding
by your current medicine.
Do not take Tramacet while you are pregnant.
Before you take Tramacet, check with your doctor Check with your doctor if you become pregnant during
or pharmacist if you:
treatment with Tramacet and before taking any further
• take other medicines containing paracetamol or
tablets. Do not take Tramacet while you are breasttramadol
feeding, as small amounts of tramadol may pass into
• have liver problems or disease as your eyes and skin
the breast-milk.
may turn yellow, which may suggest jaundice
Driving and using machines
• have kidney problems
If you feel drowsy while taking Tramacet, do not drive,
• have severe difficulties in breathing, for example
use tools or use machinery.
asthma or severe lung problems
Important information about some of the
• have epilepsy or have already experienced fits or
ingredients of Tramacet
seizures
Lactose is an ingredient in these tablets.
• have recently suffered from a head injury, shock or
If you have been told by your doctor that you have
severe headaches associated with vomiting (being
an intolerance to some sugars, contact your doctor
sick)
before taking this medicinal product.
• are dependent on any medicine (for example
morphine)
• take other medicines to treat pain that contain
buprenorphine, nalbuphine or pentazocine
Take Tramacet as you doctor has told you. Check with
• are going to have an anaesthetic (tell your doctor or
your doctor or pharmacist if you are not sure.
dentist that you are taking Tramacet).
Swallow the tablets whole with sufficient liquid.
Taking other medicines
Do not break or chew the tablets.
Please tell your doctor or pharmacist if you are taking
Take Tramacet for as short a time as possible and no
or have recently taken any other medicines, including
longer than your doctor has told you.
medicines obtained without a prescription. Your doctor
Adults and adolescents over 12 years:
will tell you which medicines are safe to take with
The recommended dosage is to start with 2 tablets,
Tramacet.
unless otherwise prescribed by your doctor. If
Do not exceed the maximum daily doses of
required, further doses may be taken, as instructed by
paracetamol or tramadol from this or other medicines.
your doctor.
Do not take Tramacet with MAOIs (see section ‘Do not
The shortest time between doses must be at least 6
take Tramacet’).
hours.
Tramacet is not recommended with the following
Do not take more than 8 tablets per day.
medicines, as it may affect how well they work:
• carbamazepine (a medicine used to treat epilepsy or Your doctor may increase the time between doses if:
• you are older than 75 years
some types of pain)
• you have kidney problems
• buprenorphine, nalbuphine or pentazocine (opioid• you have liver problems.
type pain relievers).

1. WHAT TRAMACET IS AND
WHAT IT IS USED FOR

2. BEFORE YOU TAKE
TRAMACET

3. HOW TO TAKE TRAMACET

schwarz
Name:

GI TRAMACET FILMTABLETTEN

Größe:

137 x 297 mm

Sprache:

En

8,5 pt

Faserlauf:

297 mm

Code:

XX

Artikel-Nr.:

R-YJ-180314-04

Druckfarbe:

schwarz

Datum:

19.03.2014

Klass.-Nr.:

50/036/23

Flattermarken:

Bez. der Vorgängerdatei:

93018186

Vorgängerdatei gelöscht:



Leistungsindex:

XX

RZ geprüft:

1b/X3

Reinders

V1

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.
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.

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. 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.
One (1) tablet contains 37.5 mg tramadol
hydrochloride and 325 mg paracetamol.
The other ingredients are:
• Tablet core: powdered cellulose, pregelatinised
starch, sodium starch glycolate (type A), maize
starch, magnesium stearate.
• Film-coating: hypromellose, lactose monohydrate,
titanium dioxide (E 171), macrogol 6000, yellow iron
oxide (E 172), propylene glycol, talc.
What Tramacet looks like and contents of the pack
Tramacet film-coated tablets are pale yellow filmcoated tablets, marked with the manufacturer’s logo
on one side, marked T5 on the other side.
Tramacet film-coated tablets are packed in blister strips.
Tramacet comes in cartons of 2, 10, 20, 30, 40, 50,
60, 70, 80, 90 or 100 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, D-52078,
Aachen, Federal Republic of Germany.

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

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, film coated-tablets
• Reference number: PL
21727/0039
This leaflet was approved in:
01/2014

R-YJ-180314-04

50/036/23

schwarz
Name:

GI TRAMACET FILMTABLETTEN

Größe:

137 x 297 mm

Sprache:

En

8,5 pt

Faserlauf:

297 mm

Code:

XX

Artikel-Nr.:

R-YJ-180314-04

Druckfarbe:

schwarz

Datum:

19.03.2014

Klass.-Nr.:

50/036/23

Flattermarken:

Bez. der Vorgängerdatei:

93018186

Vorgängerdatei gelöscht:



Leistungsindex:

XX

RZ geprüft:

1b/X3

Reinders

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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