ZALDIAR 37.5MG/325MG FILM-COATED TABLETS

Active substance: TRAMADOL HYDROCHLORIDE

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Tramacet® 37.5mg/325mg Film-coated Tablets/Zaldiar® 37.5mg/325mg Film-coated Tablets
(Tramadol hydrochloride/Paracetamol)
Package Leaflet: Information for the User
Your medicine is known by one of the above names 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, 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 get 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 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).

 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.
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 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.
Important information about some of the ingredient of Tramacet
Tramacet contain lactose. Therefore, if you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor before taking
this medicinal product.

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.

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’).

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.

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).

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.

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.

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

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.

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.

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.

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.
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, pharmacist or nurse. 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 all medicines out of the sight and reach of children.
 This medicinal product does not require any special storage conditions.
 If the tablets become discoloured or show any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to do.
 Do not use Tramacet after the expiry date which is stated on the carton and
blister. The expiry date refers to the last day of that month.
 Medicines should not be disposed of via wastewater 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 tablets are pale yellow film-coated tablets, marked with the
manufacturer’s logo on one side and marked T5 on the other side.
Tramacet tablets are packed in blister strips.
Tramacet tablets come in packs of 20 tablets.
PL 10383/2086

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.

Tramacet® 37.5mg/325mg Film-coated
Tablets/Zaldiar® 37.5mg/325mg Filmcoated Tablets

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Grunenthal GmbH, Zieglerstrasse 6, D52078, Aachen, Germany. Procured from within the EU and repackaged by
the Product Licence Holder: Primecrown Ltd., 4/5 Northolt Trading Estate,
Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 27.01.2014

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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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