TRAMADOL HYDROCHLORIDE INJECTION 50MG/ML

Active substance: TRAMADOL HYDROCHLORIDE

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Package leaflet: information for the 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
• If you have any further questions, please ask your
doctor or nurse
• 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 nurse.

In this leaflet:
1. What Tramadol Hydrochloride Injection is and what it is
used for
2. Before Tramadol Hydrochloride Injection is given
3. How Tramadol 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

Tramadol Hydrochloride must not be used with drugs
used to treat severe depression, such as phenelzine or
moclobemide, or if you 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 if you feel
drowsy or cannot think clearly.

3. How Tramadol 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

Adults and children over 12 years
For the treatment of pain:
The usual dose is 50 or 100mg every 4 to 6 hours by
intravenous or intramuscular injection. The dose will be
adjusted according to the severity of the pain and your
response to the drug. If given intravenously the drug will be
given slowly through a drip or a pump that allows
you to administer your own medicine (PCA pump).
For treatment of pain following an operation:
The first dose will be a single injection of 100mg. During
the next 60 minutes 50mg may be given at intervals of 10-20
minutes. The maximum total dose to this point should not
be more than 250mg. After this time you should receive
the doses shown above (“For the treatment of pain”). The
maximum daily dose should not be more than 600mg.
Children under 12 years
This medicine is not recommended for children under 12
years.
Severe liver or kidney disease (insufficiency)/dialysis
patients
Patients with severe liver and/or kidney insufficiency should
not take Tramadol Hydrochloride Injection. If in your case
the insufficiency is mild or moderate, your doctor may
recommend prolonging the dosage interval.
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.
If you are given too much Tramadol Hydrochloride
Injection:
This medicine will be given to you in hospital so it is unlikely
you will receive too much. Your doctor has information on
how to recognise and treat an overdose.

• dry mouth
• retching
• passing wind (flatulence)
• loss of appetite
• tingling, pricking or numbness of the skin (‘pins and
needles’)
• muscle weakness
• certain blood disorders. These will show up in blood
tests.
Rarely you may experience:
• a slow or fast heart beat
• fainting
• feeling dizzy on standing up
• an increase in blood pressure
• fits
• flushing
• feeling sad, irritable or restless.
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 nurse

5. Storing Tramadol Hydrochloride Injection
Keep all medicines out of the reach and sight of children.
You should not be given Tramadol Hydrochloride Injection
after the expiry date which is stated on the carton and
ampoule label. The doctor or nurse will check that the expiry
date on the label has not been passed before administering
the injection to you. The expiry date refers to the last day
of that month. The ampoule should be kept in the outer
carton.
Do not store above 25°C

6. Further Information

If you feel unwell after being given this medicine, or
are at all concerned you have been given too much,
tell your doctor or nurse.

What Tramadol Hydrochloride Injection contains:
Active ingredient: Tramadol Hydrochloride 100mg in each
2ml of solution.

If you have any further questions on the use of this product,
ask your doctor or nurse.

Other ingredients: sodium acetate and water for injection.
What Tramadol Hydrochloride Injection looks like and
contents of the pack:
The clear, colourless solution is supplied in 2ml clear glass
ampoules.
Marketing Authorisation Holder:
Aurum Pharmaceuticals Ltd, Bampton Road, Harold Hill,
Romford, Essex, RM3 8UG, UK
Manufacturer:
G.L. Pharma GmbH, Schlossplatz 1, A-8502 Lannach, Austria

4. Possible side effects
Like all medicines Tramadol Hydrochloride Injection can
cause side effects but not everybody gets them
Repeated use of tramadol can result in tolerance and
addiction
If any of the following symptoms occur tell your doctor
or nurse immediately. These are symptoms of a serious
allergic reaction.
• sudden wheeziness and tightness of chest
• swelling of eyelids, face or lips
• skin lumps or hives
• skin rash (red spots), itchiness, fever
• collapse

Product Licence No.: PL 12064/0066
Date of approval: September 2012

Other side effects that may occur include:
• headache
• feeling sick (nausea)
• being sick (vomiting)
• constipation
• an itchy rash or redness
• shallow breathing, difficulty breathing, wheezing, or
worsening of asthma
• feeling very tired, drowsy or sleepy
• dizziness
• hallucinations (seeing or hearing things that aren’t real)
• confusion
• excessive sweating

D02405

You should not be given Tramadol Hydrochloride
Injection if you:
• 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 if you:
• 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 if you are taking or have recently
taken any other medicines, including medicines obtained
without a prescription.

The risk of side effects increases,
• if you are taking medicines which may cause convulsions
(fits), such as certain antidepressants or antipsychotics.
The risk of having a fit may increase if you take Tramadol
Hydrochloride Injection at the same time. Your doctor
will tell you whether Tramadol Hydrochloride Injection is
suitable for you.
• if you 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.

2405-E

100mm Measurement Verification Bar

DEVELOPMENT ARTWORK
Component Code: D02405
Paper size: 148 x 210mm
Version Control Date

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Version A Created 14/09/12 AC
Version B

18/09/12 AC

Version C

19/09/12 AC

Version D

24/09/12 AC

Version E

28/11/12 AC

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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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