TRAMADOL 50MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance: TRAMADOL HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
Patient Information Leaflet:
TRAMADOL 50MG/ML SOLUTION FOR INJECTION OR
INFUSION
(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. Before you are given Tramadol Injection
3. How Tramadol Injection should be given
4. Possible side effects
5. Storing Tramadol Injection
6. Further information
1. WHAT TRAMADOL INJECTION IS AND WHAT IT IS
USED FOR
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.
2. BEFORE YOU ARE GIVEN TRAMADOL INJECTION
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
treatment
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
supervision.
Taking/using other medicines
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.
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
anticoagulant
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
pentazocine, nalbuphine or buprenorphine (pain killers)
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.
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.
Presentation
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
analgesia.
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.
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 600mg.
Elderly
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.

3. HOW TRAMADOL INJECTION SHOULD BE GIVEN
Your doctor or nurse will usually give you Tramadol Injection.
The solution may be given by an injection into either a vein or
muscle.
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.
4. POSSIBLE SIDE EFFECTS
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
attention.
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
patients):
nausea, dizziness.
Common side effects (occurring in less than 1 in 10
patients):
headache, drowsiness, fatigue
vomiting, constipation, dry mouth, sweating.
Uncommon side effects (occurring in less than 1 in 100
patients):
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
slowing of the heart rate, increased blood pressure
nightmares, disturbed sleep patterns, hallucinations
(seeing things), feeling confused, changes in mood, activity
or awareness, anxiety
blurred vision
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 occurred.
Other side effects (frequency unknown):
speech disorder
dilation of the pupil.
If you notice any other side effects please tell your
doctor or nurse.
5. STORING TRAMADOL INJECTION
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.
6. FURTHER INFORMATION
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
Ltd. Tunbridge Wells, Kent TN1 1YG
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: 09/2012

----------------------------------------------------------------------------------------------------------------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 requirements
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.

Incompatibilities
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

Expand view ⇕

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.

Hide
(web4)