TRAMADOL 50MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance: TRAMADOL HYDROCHLORIDE

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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.
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
drive.
• 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.
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.

• 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

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.

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

Common side effects (occurring in less than 1 in 10 patients):
• headache, drowsiness, fatigue
• vomiting, constipation, dry mouth, sweating.

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.

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

Date of revision: 07/2014

----------------------------------------------------------------------------------------------------------------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

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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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