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TRAMACET 37.5 MG/325 MG FILM-COATED TABLETS

Active substance(s): TRAMADOL HYDROCHLORIDE / TRAMADOL HYDROCHLORIDE / TRAMADOL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

TRAMACET® 37.5 mg/325 mg FILM-COATED TABLETS
ZALDIAR® 37.5 mg/325 mg FILM-COATED TABLETS
(tramadol hydrochloride/paracetamol)
This product is available as any of the above names but will be referred to as Tramacet throughout the
remainder of this leaflet.
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 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
• if you have liver problems or disease as your eyes and skin may turn yellow, which may suggest jaundice
• if you have kidney problems
• if you have severe difficulties in breathing, for example asthma or severe lung problems
• if you have epilepsy or have already experienced fits or seizures
• if you have recently suffered from a head injury, shock or severe headaches associated with vomiting
(being sick)
• if you are dependent on any medicine (for example morphine)
• if you take other medicines to treat pain that contain buprenorphine, nalbuphine or pentazocine
• if you are going to have an anaesthetic (tell your doctor or dentist that you are taking Tramacet.
If any of the above-mentioned points applied to you in the past or applies to you while you are taking
Tramacet, please make sure your doctor knows. He/she can then decide whether you should continue to
use this medicine.
Other medicines and Tramacet
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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:
• metoclopramide, domperidone or ondansetron (medicines used to treat nausea and vomiting/being sick)
• cholestyramine (medicine used to reduce cholesterol in the blood)
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.
3. HOW TO TAKE TRAMACET
Always take this medicine exactly 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.
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 starting dose unless otherwise prescribed by your doctor is 2 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.
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 or moderate, your doctor may recommend prolonging the dosage interval.
Method of administration:
The tablets are for oral use.
Swallow the tablets whole with sufficient liquid.
Do not break or chew the tablets.
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).
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
• 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: may affect up to 1 in 1,000 people
• fits, uncoordinated movements
• addiction, delirium
• vision blurred, constriction of the pupil (miosis)
• speech disorders
• excessive dilation of the pupils (mydriasis)
• transient loss of consciousness (syncope)
Unknown: frequency unknown
• 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.
• very rare cases of serious skin reactions have been reported
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 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.
• If your medicine becomes discoloured, or shows any signs of deterioration, consult your pharmacist who
will tell you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Tramacet contains
The active substances are tramadol hydrochloride and paracetamol.
Each film-coated tablet contains 37.5 mg tramadol hydrochloride and 325 mg paracetamol.
The other ingredients are:
Tablet core: microcrystalline cellulose, pregelatinised starch, sodium carboxymethyl starch, corn starch,
magnesium stearate.
Film-coating: Opadry YS-1-6382-G light yellow (hypromellose 2910 3 cP, hypromellose 2910 6 cP, titanium
dioxide, macrogol 400, yellow iron oxide (E172) and polysorbate 80), carnauba wax.
What Tramacet looks like and contents of the pack
Tramacet is a pale yellow film-coated tablet, marked with the manufacturer's logo on one side and marked
"T5" on the other side.
Tramacet is available in blister pack of 50 and 60 tablets.
PL No: 15814/1084
POM
CD
Tramacet is manufactured by STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany.
Procured from within the EU and repackaged by the Product Licence holder: O.P.D. Laboratories Ltd., Unit
6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 06.02.2017.
Tramacet is a trademark of Johnson & Johnson, USA.
Zaldiar is a trademark of Grunenthal GmbH, Germany.

To request a copy of this leaflet in Braille, large print or
audio please call 01923 332 796.

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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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