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Patient Information Leaflet:
(referred to as Tramadol Injection throughout this leaflet)
Please read all of this leaflet carefully before being given
Tramadol Injection.
• Keep this leaflet as you may need to refer to it again.
• If you want to know more about Tramadol Injection, or have
any questions, you should ask your doctor or nurse.
In this leaflet:
1. What Tramadol Injection is and what it is used for
2. What you need to know before you are given Tramadol
3. How Tramadol Injection should be given
4. Possible side effects
5. Storing Tramadol Injection
6. Contents of the pack and other information
Tramadol belongs to a group of medicines known as analgesics
or “pain-killers”. Tramadol is used to relieve pain and can also
be used to prevent pain.
You must NOT be given Tramadol Injection and you should
talk to your doctor immediately if:
• you are allergic to tramadol hydrochloride or any of the other
ingredients of the solution. Allergic reactions to tramadol
could include skin rash, swelling of the face, wheezing or
difficulty breathing
• you are epileptic and your fits are not well controlled by
• the patient is a child under 12 years of age
• you are pregnant or breast-feeding
• you are taking any of the following medicines:
o sleeping tablets or tranquillizers such as nitrazepam
o other pain-killers such as codeine or morphine
o psychotropic medicines such as chlorpromazine
o a monoamine oxidase inhibitor used to treat depression,
or if you have taken one in the past two weeks
• you have recently been drinking alcohol.
It should not be used in narcotic drug withdrawal treatment.
Tell your doctor before you are given Tramadol Injection if:
• you have liver or kidney disease. You may need a lower dose
or a longer interval between doses
• you have a head injury or brain disease
• you have a problem that makes you faint or feel faint
• you are in a state of shock. You may feel light headed, faint,
cold or clammy or look pale
• you suffer from epilepsy, convulsions or seizures (fits) or have
had them in the past
• you suffer from asthma, other lung diseases or have difficulty
in breathing.
• you think you may be addicted to other pain relievers (opioids)
Tramadol may lead to addiction.
In patients with a tendency to drug abuse, Tramadol Injection
should only be given for short periods under strict medical
Other medicines and Tramadol

• tricyclic antidepressants, such as amitriptyline, as this may
increase the chance of having a fit (although this is very rare)
• carbamazepine, a treatment for epilepsy, as this may reduce
the effectiveness of the tramadol
• triptans, such as sumatriptan, used to treat migraines, as this
may increase the effectiveness of the triptans
• coumarin anticoagulants, used to thin the blood, such as
warfarin, as this may alter the effectiveness of the
• selective serotonin reuptake inhibitors (SSRI’s), used to treat
depression, such as fluoxetine, as this may increase the effect
of the SSRI’s
• lithium, used to treat psychotropic disorders, as this may alter
the effect of lithium
• ondansetron, used to prevent nausea and vomiting.
Tell your doctor if you are taking, or have recently taken any
other medicine, including those 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 are given Tramadol
Injection at the same time. Your doctor will tell you whether
Tramadol Injection is suitable for you.
- if you are taking certain antidepressants. Tramadol 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.
This medicinal product contains less than 1 mmol sodium
(1.4mg) per 2ml dose i.e. essentially ‘sodium free’
Pregnancy and breastfeeding
There is very little information on the safety of tramadol in
pregnancy, therefore Tramadol Injection should not be used if
you are pregnant.
Chronic use during pregnancy may lead to withdrawal symptoms
in newborns.
Tramadol may be harmful to the breast fed baby. The use of
Tramadol Injection is not generally recommended during
breastfeeding. However, after a single dose of tramadol it is not
usually necessary to interrupt breastfeeding.
Driving and using machinery
Tramadol Injection may cause drowsiness, dizziness or blurred
vision, these effects may be increased by alcohol and other
depressants. Do not drive or use machinery if you are affected.
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
• However, you would not be committing an offence if:
o The medicine has been prescribed to treat a
medical or dental problem and
o You have taken it according to the instructions given
by the prescriber or in the information provided with
the medicine and
o 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.

Tell your doctor if you are taking, or have recently taken, any of
the following medicines. This is important because Tramadol
Injection could alter how other medicines work.

Continued overleaf……


Information for the Healthcare Professional
Tramadol 50mg/ml Solution for Injection or Infusion
Please read this information carefully before using
Tramadol 50mg/ml Solution for Injection or Infusion
(referred to as Tramadol Injection). Further information is
contained in the Summary of Product Characteristics.
Tramadol Injection is presented as a clear colourless solution in
a neutral glass ampoule. Each ampoule contains 2ml of
tramadol hydrochloride 50mg/ml.
Dosage and Method of Administration
Whenever solution and container permit, parenteral drug
products should be inspected visually for particulate matter and
discolouration prior to administration. Only a clear solution
should be used.
Tramadol Injection is for parenteral injection either
intramuscularly, by slow intravenous injection or diluted in
solution for administration by infusion or patient controlled
The dose should be adjusted to the intensity of the pain and the
sensitivity of the individual patient. The lowest effective dose for
analgesia should generally be selected. The total daily dose of
400mg tramadol hydrochloride should not be exceeded, except
in special clinical circumstances.
Tramadol Injection should not be given for longer than
absolutely necessary. If long term pain treatment is necessary
then careful regular monitoring should be carried out, with
breaks in treatment if necessary.
Adults and Children over 12 years
The usual dose is 50 or 100mg 4 to 6 hourly by either
intramuscular or intravenous routes. Intravenous injections must
be given slowly over 2–3 minutes. The dose should be adjusted
according to the severity of the pain and the response.
For post-operative pain, an initial bolus of 100mg is
administered. During the 60 minutes following the initial bolus,
further doses of 50mg may be given every 10-20 minutes, up to
a total dose of 250mg including the initial bolus. Subsequent
doses should be 50mg or 100mg 4-6 hourly up to a total daily
dose of 400mg.
A dose adjustment is not usually necessary in patients up to 75
years without clinically manifest hepatic or renal insufficiency. In
elderly patients over 75 years elimination may be prolonged.
Therefore, if necessary the dosage interval is to be extended
according to the patient's requirements.

Your doctor or nurse will usually give you Tramadol Injection.
The solution may be given by an injection into either a vein or
If you are in hospital you may receive tramadol through a drip
(infusion) or from a small machine that allows you to have
tramadol when you need it by pushing a button. The doctor or
nurse will explain how to use the machine.
The usual dose is one injection of 50mg or 100mg every 4 to 6
hours. After an operation you may need injections more often.
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
should not be given Tramadol Injection. If in your case the
insufficiency is mild or moderate, your doctor may recommend
prolonging the dosage interval.
Tramadol Injection should not be given to children under 12
years of age.
The dosage should be adjusted to the intensity of your pain and
your individual pain sensitivity.
In general, the lowest dose to relieve pain should be given for
the shortest possible time.
If you receive too much Tramadol Injection.
If you think you have been given or have given yourself too
much Tramadol Injection tell a doctor or nurse immediately.
If you stop receiving Tramadol Injection
Rarely when some people stop treatment with tramadol they get
withdrawal symptoms. These symptoms include agitation,
nervousness, shaking, hyperactivity and difficulty in sleeping.
Like all medicines, Tramadol Injection can cause side effects.
However, do not be alarmed, as most patients do not have
problems with this medicine.
Tell your doctor or a nurse immediately if you experience
any of the following:
• swelling around the throat, tightness in your chest or difficulty
in breathing.
You may have had an allergic reaction, these are rare but, if
severe, can be serious and you may need urgent medical
Tell a doctor or nurse if you get any of the following other
side effects:
Very common side effects (occurring in more than 1 in 10
• nausea, dizziness.
Common side effects (occurring in less than 1 in 10
• headache, drowsiness, fatigue
• vomiting, constipation, dry mouth, sweating.
Uncommon side effects (occurring in less than 1 in 100
• changes in heart beat or rhythm which may make you feeling
faint or dizzy especially if you stand up quickly
• retching, stomach irritation or feeling bloated
• diarrhoea
• rash.

Rare side effects (occurring in less than 1 in 1000 patients):
• changes in appetite, abnormal touch sensations, trembling,
difficulty breathing, fits, fainting, speech disorders
• slowing of the heart rate, increased blood pressure
• nightmares, disturbed sleep patterns, hallucinations (seeing
things), feeling confused, changes in mood, activity or
awareness, anxiety, delirium
• blurred vision, excessive dilation or constriction of the pupils
• muscle weakness or twitching, abnormal coordination
• increase in liver enzymes
• difficulty or pain passing water (urine)
• worsening of asthma, shortness of breath
• Rarely when some people stop taking tramadol they get
withdrawal symptoms. These symptoms include agitation,
nervousness, shaking, hyperactivity and difficulty in sleeping.
Very rarely panic attacks, severe anxiety, hallucinations,
tinnitus or abnormal skin sensations, as well as confusion,
delusions, personalisation, derealisation and paranoia, have
Other side effects (frequency unknown):
• low blood sugar levels.
Reporting of side effects
If you get any side effects, talk to your doctor, nurse 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:
By reporting side effects you can help provide more information
on the safety of this medicine.
The hospital will store the medicines. Keep out of reach and
sight of children. This medicinal product does not require any
special storage conditions. Keep ampoule in the outer carton.
Do not use this product if there are signs of damage to the
ampoule or if the solution is cloudy or contains particles.
Tramadol Injection should not be used after the ‘use by’ date on
the carton.
What is in this medicine:
Each 2 ml ampoule contains 100mg of tramadol hydrochloride.
The ampoules also contain sodium acetate trihydrate and water
for injections.
What this medicine looks like and contents of the pack:
Tramadol Injection is a clear colourless solution. Each pack
contains 5 glass ampoules
Marketing authorisation holder: Beacon Pharmaceuticals
Limited, DCC Vital, Westminster Industrial Estate, Repton
Road, Measham, DE12 7DT, England.
Manufacturer: Biologici Italia Laboratories S.r.l., Via F.
Serpero, 2 – 20060 Masate (MI), Italy
This leaflet does not include all the information about this
medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist.
Date of revision: 09/2016

----------------------------------------------------------------------------------------------------------------Renal insufficiency/dialysis and hepatic impairment
In patients with renal and/or hepatic insufficiency the elimination of
tramadol is delayed. In these patients prolongation of the dosage
intervals should be carefully considered according to the patient's
Children under 12 years Not recommended. Contraindications
Tramadol Injection should not be given to patients who have
previously demonstrated hypersensitivity towards tramadol or any
of the other ingredients in this medicine. Tramadol Injection should
not be given to patients suffering from acute intoxication with
alcohol, hypnotics, centrally acting analgesics, opioids or
psychotropic drugs.
In common with other opioid analgesics, tramadol should not be
administered to patients who are receiving monoamine oxidase
inhibitors or within two weeks of their withdrawal.
Tramadol Injection is contraindicated in patients with epilepsy not
adequately controlled by treatment. Tramadol must not be used in
narcotic withdrawal treatment.
Pharmaceutical Information
Excipients Sodium acetate trihydrate and Water for Injections.
Precipitation will occur if Tramadol Injection is mixed in the same
syringe with injections of diazepam, diclofenac sodium,
indomethacin, midazolam and piroxicam.
Shelf-life 3 years
Storage Precautions Keep ampoule in the outer carton. This
medicinal product does not require any special storage conditions.
Nature of Container 2ml neutral glass type I glass ampoules for
injections. Box of 5 ampoules.
Instructions for Use and Handling.
The prepared infusion solution should be made up immediately
before use.
Tramadol Injection is physically and chemically compatible for up
to 24 hours with 4.2% sodium bicarbonate and Ringer's solution;
and for up to 5 days with the following infusion solutions:
• 0.9% sodium chloride
• 0.18% sodium chloride and 4% glucose
• sodium lactate compound
• 5% glucose

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