|PACKAGE LEAFLET: INFORMATION FORTHE USER D02405|

Tramadol Hydrochloride Injection 50mg/ml

Tramadol Hydrochloride

Read all this leaflet carefully before you are given Tramadol Hydrochloride Injection

•    Keep this leaflet, you may need to read it again

•    Ifyou have any further questions, please ask your doctor or nurse

•    lfanyofthesideeffectsgetserious,orifyou notice

any side effects not listed in this leaflet, please tell your doctor or nurse._

In this leaflet:

1.    What Tramadol Hydrochloride Injection is and what it is used for

2.    Before Tramadol Hydrochloride Injection is given

3.    HowTramadol Hydrochloride Injection will be given

4.    Possible side effects

5.    Storing Tramadol Hydrochloride Injection

6.    Further information

1.    What Tramadol Hydrochloride Injection is and what it is used for.

Tramadol Hydrochloride is an alkaloid with powerful pain relieving properties.

This medicine is used for the relief of moderate to severe pain.

2.    Before Tramadol Hydrochloride Injection is given

You should not be given Tramadol Hydrochloride Injection ifyou:

•    are allergic (hypersensitive) to Tramadol Hydrochloride or any of the ingredients of this medicine (listed in section 6 of this leaflet).

•    suffer from alcoholism or you have drunk alcohol recently

•    have taken or been given, drugs to help you sleep

•    have taken, or been given, strong painkillers e.g. morphine or pethidine

•    are taking or have recently taken any drugs used to treat depression known as Monoamine Oxidase Inhibitors (MAOI's) (see'Taking other medicines')

•    are pregnant or breast-feeding

•    are suffering from epilepsy (fits) and are not taking any medicines to control it

•    suffer from a blood disorder known as porphyria

Take special care with Tramadol Hydrochloride Injection

Tell your doctor ifyou:

•    are dependent on drugs

•    think you may be in shock as there is a risk of coma

•    are suffering from severe headaches or have suffered a head injury

•    suffer or have suffered from kidney or liver disease

•    suffer from a convulsive disorder (fits) such as epilepsy

•    are having surgery under a general anaesthetic

•    suffer from asthma, shallow breathing or other breathing difficulties

•    have a cough that is producing a lot of mucus Taking other medicines

Please tell your doctor ifyou are taking or have recently taken any other medicines, including medicines obtained without a prescription.

The risk of side effects increases,

•    ifyou are taking medicines which may cause convulsions (fits), such as certain antidepressants or antipsychotics.

The risk of having a fit may increase ifyou takeTramadol Hydrochloride Injection at the same time. Your doctor will tell you whether Tramadol Hydrochloride Injection is suitable for you.

•    ifyou are taking certain antidepressants.Tramadol Hydrochloride Injection 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.

Tramadol Hydrochloride must not be used with drugs used to treat severe depression, such as phenelzine or moclobemide, or ifyou are within 2 weeks of discontinuing them.These drugs are known as Monoamine Oxidase Inhibitors (MAOI's).

Other medicines which may interact with Tramadol Hydrochloride Injection include:

•    CNS depressants (drugs that act on the brain and make you feel drowsy or faint).These include sleeping pills, anti-histamines (medicines used to treat allergies) that make you drowsy, medicines used to treat certain mental disorders, other pain killers or a general anaesthetic.

•    alcohol

•    cimetidine (a medicine used to treat stomach ulcers)

•    carbamazepine (a medicine used to treat fits)

•    lithium (a medicine used to treat severe mental problems)

•    medicines to treat depression known as tricyclic antidepressants, such as clomipramine

•    medicines to treat depression known as SSRI's (Selective Serotonin Reuptake Inhibitors), such as fluoxetine (prozac)

Pregnancy and breast-feeding

Tramadol Hydrochloride Injection should not be used during pregnancy as there is not enough evidence on the safety of having Tramadol during pregnancy.

This medicine should also not be used whilst breast-feeding as Tramadol is known to be present in breast milk.

Effects on the ability to drive and use machines

This medicine can affect your ability to drive and operate machinery. Do not drive or operate machinery ifyou feel drowsy or cannot think clearly.

3. HowTramadol Hydrochloride Injection will be given

Your doctor will decide on the dose and duration of your therapy. Your doctor or nurse will administer Tramadol Injection to you into a vein (intravenous) or into a muscle (intramuscular).

It may also be given as Patient Controlled Analgesia (PCA), meaning that you will be able to administer pain relief to yourself rather than your doctor or nurse doing it for you.

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.

Your doctor will still determine the dose you need however you will be able to give yourself pain relief as and when you need it. You will not be able to give yourself more than the maximum dose.

Continued overleaf