I need to know what is the side effects on tramacet?!

I need to know what is the side effects on tramacet?

i take tramacet i need to know what is the side effects on it

Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. It contains important information regarding your medicine. 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 personally and you should not pass it on to others.

Do not exceed the stated dose.
Use as directed by your doctor.
If symptoms persist, consult your doctor.
Keep out of the reach of children.
Do not take more than 8 tablets of Tramacet in any one day.

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.

In this leaflet:

1. Some information about Tramacet
2. Before you take Tramacet
3. How to use Tramacet
4. Possible side effects
5. Storing Tramacet

1. Some information about Tramacet
The name of your medicine is Tramacet. Each tablet contains a combination of two medicines:

* tramadol hydrochloride (37.5 milligrams)
* paracetamol (325 milligrams).

Each tablet also contains: powdered cellulose, pregelatinised and maize starch, sodium starch glycolate (Type A) and magnesium stearate. The tablets are coated with hypromellose, titanium dioxide (E171), macrogol 400, yellow iron oxide (E172), polysorbate 80 and carnauba wax.

What does Tramacet look like?
Tramacet are pale yellow coloured tablets and are packed in blister strips in cartons containing 10 or 60 tablets.

Who supplies Tramacet?
Tramacet is supplied by the Product Licence holder:
Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire
HP14 4HJ
UK

Tramacet is manufactured by:
Janssen Pharmaceutica NV
Turnhoutseweg 30
B2340
Beerse
Belgium
or
Grunenthal GmbH
Zieglerstrasse 6
D-52078
Aachen
Federal Republic of Germany
or
Janssen- Cilag S.p.A.
Via Janssen
Borgo S. Michele
04010 Latina
Italy

What is Tramacet?
Tramacet is a combination of two analgesics. Analgesics are often called 'pain killers' or 'pain relievers'.

What does Tramacet do?
Tramacet is intended for use in the treatment of moderate to severe pain when your doctor recommends that a combination of tramadol and paracetamol is needed.

Who should take Tramacet?
Tramacet should only be used by adults and children over 12 years.

2. Before you take Tramacet

Do not take Tramacet if you:

* have had an allergic reaction, skin rash, swelling of the face, wheezing or difficulty breathing, after taking tramadol or paracetamol or any of the other ingredients in Tramacet
* have drunk enough alcohol to make you feel 'woozy' or drunk
* have taken any medicine that can make you sleepy or less alert; these include certain medicines for psychiatric disorders including tranquillisers and anti-depressants; sleeping pills; opioid containing pain relievers such as morphine and codeine. It is important that your doctor knows if you are taking any of these medicines.
* are currently taking monoamine oxidase inhibitors (MAOIs) for e.g. depression or have taken any MAOIs within the last two weeks. You should know if you are taking an MAOI because your doctor or pharmacist will have told you and you may also have a treatment card
* suffer from severe liver problems
* have epilepsy that is not adequately controlled on your current medicine
* are pregnant or are planning to become pregnant, or if you are breast feeding.

Take special care with Tramacet
Tramacet should only be used by adults and children over 12 years.

IMPORTANT
Do not take with any other paracetamol or tramadol hydrochloride-containing products (including medicines you have bought yourself) without discussing this with your doctor.

If the answer to any of the following questions is 'Yes', make sure your doctor knows before you start taking Tramacet. He/she will consider your medical history and decide if Tramacet is suitable for you to take.

* Do you have kidney problems?
* Do you have liver problems or alcoholic liver disease; have you noticed your eyes and skin turning yellow, which may suggest jaundice or problems with bile ducts?
* Do you have difficulty breathing, for example, asthma or lung problems?
* Are you dependent on any other medicines used to relieve moderate to severe pain, for example, morphine?
* Are you epileptic or have you experienced fits or seizures?
* Are you taking medicines known as opioids, used to treat moderate to severe pain, eg buprenorphine, nalbuphine and pentazocine?
* Have you suffered from a head injury, shock or severe headaches which may or may not be associated with vomiting?

If you develop any of these while you are taking Tramacet, please tell your doctor. He/she can then decide whether you should continue to use this medicine.

If you are not sure about anything, or any of the above, you should discuss it with your doctor who will consider your medical history and decide whether Tramacet is suitable for you to take.

If you take more Tramacet than is recommended, this may result in severe liver damage and you should seek immediate medical advice.

Tell your doctor or dentist that you are taking Tramadol before you have a general anaesthetic.

Taking other medicines with Tramacet
It is important that you tell your doctor or dentist about any other medicines you are taking, including any that you have bought yourself. Some medicines, when taken with Tramacet, can affect the way Tramacet works.

Tramacet should not be taken together with the following:

* monoamine oxidase inhibitors (MAOIs).

Tramacet is not recommended to be taken with the following:

* a medicine called carbamazepine, commonly used to treat epilepsy or facial neuralgia (severe pain attacks in the face)
* medicines known as opioids, used to treat moderate to severe pain, eg buprenorphine, nalbuphine and pentazocine.

In certain circumstances, Tramacet may be taken with the following:

* medicines known as serotonin reuptake inhibitors (SSRIs), used to treat depression
* certain morphine-like medicines used, for example, to prevent or relieve coughing
* sedatives, for example, benzodiazepines
* sleeping pills, for example, barbiturates
* certain medicines used to lower blood pressure
* a medicine called thalidomide
* a medicine called baclofen, used as a muscle relaxant
* a medicine called warfarin, used to thin the blood
* medicines known as CYP3A4 inhibitors, for example, ketoconazole (an antifungal) or erythromycin (an antibacterial)
* a medicine called bupropion, used to help people to stop smoking
* tricyclic antidepressants
* tranquillisers.

Taking the following medicines together with Tramacet may affect how Tramacet works in your body:

* metoclopramide and domperidone, used in nausea and vomiting
* cholestyramine, used to treat diarrhoea and itchy skin.

Your doctor will know which medicines are safe to take with Tramacet.

Alcohol and Tramacet
Tramacet may make you feel drowsy. Alcohol may make you feel more drowsy. It is best not to drink alcohol while you are taking Tramacet.

Driving or using machines
Tramacet may make you feel drowsy. Do not drive, operate machinery or perform other activities for which you need to be alert until you know how Tramacet affects you.

3. How to use Tramacet
Tramacet should only be used by adults and children over 12 years.

Always take Tramacet exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

The tablets must be swallowed with some liquid. They should not be broken or chewed.

Adults and children over 12 years: The usual starting dose is two tablets. If required, further doses can be taken after every six hours, as recommended by your doctor.

Do not take more than 8 tablets per day (equivalent to 300 mg tramadol and 2600 mg paracetamol).

The tablets should be taken for as short a time as possible.

If you have a history of kidney or liver problems, your doctor may increase the time between doses.

Do not take Tramacet more often than your doctor has told you to. The shortest time between doses must be at least 6 hours.

If you think that the effect of Tramacet is too strong (ie you feel very drowsy or have difficulty with breathing) or too weak (ie you have inadequate pain relief), contact your doctor or pharmacist. If your symptoms do not get any better, see your doctor.

If you forget to take Tramacet
If you miss a dose of Tramacet, take your next tablet as usual; do not double the dose to make up for forgotten individual doses.

Effects that may appear when the treatment with Tramacet is stopped
If you have been using Tramacet for some time, you should talk to your doctor if you want to stop because your body may have got used to it. If you do suddenly stop using Tramacet you may feel unwell. You may experience anxiety, agitation, nervousness, sleeplessness, hyperactivity, tremors and/or an upset stomach.

If you take too many tablets
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 necessary, go to the nearest hospital Accident and Emergency Department and tell them what you have taken.

4. Possible side effects
As with any medicine, Tramacet may cause some unwanted effects, but this is not common. If you are worried about side effects, talk to your doctor.

Side effects may include: nausea, dizziness, drowsiness. These are usually mild and not troublesome.

Some people experience: vomiting, constipation, flatulence, diarrhoea, stomach pain, digestion problems, a dry mouth, headache, shaking, confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria (a sense of feeling 'high' all the time)), increased sweating, itching.

A few people may develop: high blood pressure. heart rhythm and heart rate disorders, difficulty or pain on passing urine/protein in the urine, skin reactions/hives, ringing in the ear, depression, nightmares, hallucinations (hearing, seeing or sensing things that are not really there), loss of memory, difficulty swallowing, blood in the stools, shivers, hot flushes, pains in the chest, uncoordinated movement, muscle cramps, unusual tingling feeling ('pins and needles'), convulsions, drug dependence, blurred vision, shortness of breath, raised liver enzymes.

In rare cases, using a medicine of this type may make you become dependent on it, making it hard to stop taking it. You may experience withdrawal symptoms such as agitation, anxiety, nervousness, sleeplessness, hyperactivity, tremors and/or an upset stomach.

Do not be alarmed by the above lists - you may not experience any of these effects. However, if you do notice any of these effects, or any other unusual symptoms, please tell your doctor or pharmacist as soon as possible.

The following are recognised side effects which have been reported by people using medicines that contain only tramadol or only paracetamol. However, if you experience any of these while taking Tramacet, you should tell your doctor:

Tramadol
Feeling faint when getting up from a lying or sitting position, slow heart rate, fainting, allergic reactions, such as itching, swollen face or lips, or shortness of breath, changes in appetite, muscle weakness, slower or weaker breathing, mood changes, changes in activity, changes in perception, worsening of existing asthma, symptoms of withdrawal, such as agitation, anxiety, nervousness, sleeplessness, hyperactivity, tremors and/or an upset stomach.

There have also been reports of an alteration in the way a medicine called warfarin (used to thin the blood) affects the body when it is used together with tramadol. Any prolonged or unexpected bleeding should be reported to your doctor immediately.

Paracetamol
Allergic reactions, such as itching, swollen face or lips, or shortness of breath, hypoprothrombinaemia (a blood clotting deficiency), when paracetamol is given with warfarin (a medicine used to thin the blood).

Other blood disorders have been reported, including thrombocytopenia (where the number of platelets in the blood is reduced) and agranulocytosis (where the number of white blood cells is severely reduced), although these were not necessarily as a result of taking paracetamol.

5. Storing Tramacet
There are no particular storage conditions. Keep out of reach and sight of children.

Do not use these tablets:

* After the expiry date shown on the label
* If the pack is damaged
* If the tablets are discoloured.