TRAMADOL HYDROCHLORIDE 50 MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance: TRAMADOL HYDROCHLORIDE

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Package leaflet: Information for the patient

Tramadol Hydrochloride 50mg/ml
Solution for Injection or Infusion
Tramadol hydrochloride
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
! Keep this leaflet. You may need to read it again.
! If you have any further questions, ask your doctor or your pharmacist.
! This medicine has been prescribed for you only. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
! If you get side effects talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Tramadol Hydrochloride Injection or Infusion is and what it is used
for
2. Before you need to know before you take Tramadol Hydrochloride
Injection or Infusion
3. How to take Tramadol Hydrochloride Injection or Infusion
4. Possible side effects
5. How to store Tramadol Hydrochloride Injection or Infusion
6. Contents of the pack and other information
The name of this medicine is Tramadol Hydrochloride 50mg/ml Solution
for Injection or Infusion (referred to as Tramadol Hydrochloride
Injection or Infusion throughout this leaflet).
1. WHAT TRAMADOL HYDROCHLORIDE INJECTION OR
INFUSION IS AND WHAT IT IS USED FOR
Tramadol - the active substance in Tramadol Hydrochloride Injection or
Infusion - is a painkiller belonging to the class of opioids that acts on the central
nervous system. It relieves pain by acting on specific nerve cells of the spinal
cord and brain.
Tramadol Hydrochloride Injection or Infusion is used for the treatment of
moderate to severe pain.
2. . WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TRAMADOL HYDROCHLORIDE INJECTION OR INFUSION

510 mm

Do not take Tramadol Hydrochloride Injection or Infusion
! if you are allergic (hypersensitive) to tramadol or any of the other
ingredients of Tramadol Hydrochloride Injection or Infusion;
! in acute poisoning with alcohol, sleeping pills, pain relievers or other
psychotropic medicines (medicines that affect mood and emotions);
! if you are also taking MAO inhibitors (certain medicines used for treatment
of depression) or have taken them in the last 14 days before treatment with
Tramadol Hydrochloride Injection or Infusion (see “Taking other
medicines”);
! if you are an epileptic and your fits are not adequately controlled by
treatment;
! as a substitute in drug withdrawal.
Take special care with Tramadol Hydrochloride Injection or Infusion
! if you think that you are addicted to other pain relievers (opioids);
! if you suffer from consciousness disorders (if you feel that you are going to
faint);
! if you are in a state of shock (cold sweat may be a sign of this);
! if you suffer from increased pressure in the brain (possibly after a head
injury or brain disease);
! if you have difficulty in breathing;
! if you have a tendency towards epilepsy or fits because the risk of a fit may
increase;
! if you suffer from a liver or kidney disease;
In such cases please consult your doctor before taking the medicine.
Epileptic fits have been reported in patients taking tramadol at the
recommended dose level. The risk may be increased when doses of tramadol
exceed the recommended upper daily dose limit (600 mg).
Please note that Tramadol Hydrochloride Injection or Infusion may lead to
physical and psychological addiction. When Tramadol Hydrochloride
Injection or Infusion is taken for a long time, its effect may decrease, so that
higher doses have to be taken (tolerance development). In patients with a
tendency to abuse medicines or who are dependent on medicines, treatment
with Tramadol Hydrochloride Injection or Infusion should only be carried out
for short periods and under strict medical supervision.
Please also inform your doctor if one of these problems occurs during
Tramadol Hydrochloride Injection or Infusion treatment or if they applied to
you in the past.
Tramadol Hydrochloride Injection or Infusion contains less than 1 mmol
sodium (23 mg) per dose, therefore it is essentially 'sodium-free'.
Taking other medicines.
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
Tramadol Hydrochloride Injection or Infusion should not be taken together
with MAO inhibitors (certain medicines for the treatment of depression).
The pain-relieving effect of Tramadol Hydrochloride Injection or Infusion

The following information is intended for medical or
healthcare professionals only:
Tramadol Hydrochloride 50mg/ml Solution for Injection or Infusion
Please read this information carefully before using Tramadol
Hydrochloride 50mg/ml Solution for Injection or Infusion (referred to as
Tramadol Hydrochloride Injection or Infusion throughout this leaflet).
Further information is available in the Summary of Product
Characteristics.

may be reduced and the length of time it acts may be shortened, if you take
medicines which contain:
! carbamazepine (for epileptic fits);
! pentazocine, nalbuphine or buprenorphine (pain killers);
! ondansetron (prevents nausea).
Your doctor will tell you whether you should take Tramadol Hydrochloride
Injection or Infusion, and what dose.
The risk of side effects increases,
! if you are taking tranquillizers, sleeping pills, other pain relievers such as
morphine and codeine (also as cough medicine), and alcohol while you are
taking Tramadol Hydrochloride Injection or Infusion. You may feel more
drowsy or feel that you might faint. If this happens tell your doctor.
! 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 or Infusion at the
same time. Your doctor will tell you whether Tramadol Hydrochloride
Injection or Infusion is suitable for you.
! if you are taking certain antidepressants. Tramadol Hydrochloride
Injection or Infusion 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.
! if you are taking selective serotonin reuptake inhibitors (often referred to as
SSRIs) or MAO inhibitors (for the treatment of depression). Tramadol
Hydrochloride Injection or Infusion may interact with these medicines and
you may experience symptoms such as confusion, restlessness, fever,
sweating, uncoordinated movement of limbs or eyes, uncontrollable
jerking of muscles, or diarrhoea.
! if you are taking coumarin anticoagulants (medicines for blood thinning),
e.g. warfarin, together with Tramadol Hydrochloride Injection or Infusion.
The effect of these medicines on blood clotting may be affected and
bleeding may occur.
Taking Tramadol Hydrochloride Injection or Infusion with food and
drink
Do not drink alcohol during treatment with Tramadol Hydrochloride Injection
or Infusion as its effects may be intensified.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
There is very little information regarding the safety of tramadol in human
pregnancy. Therefore you should not use Tramadol Hydrochloride Injection or
Infusion if you are pregnant.
Chronic use during pregnancy may lead to withdrawal symptoms in newborns.
Generally, the use of tramadol is not recommended during breast-feeding.
Small amounts of tramadol are excreted into breast milk. On a single dose it is
usually not necessary to interrupt breast-feeding. Please ask your doctor for
advice.
Driving and using machines
Tramadol Hydrochloride Injection or Infusion may cause drowsiness,
dizziness and blurred vision and therefore may impair your reactions. If you
feel that your reactions are affected, do not drive a car or other vehicle, do not
use electric tools or operate machinery, and do not work without a firm hold!
3. HOW TO TAKE TRAMADOL HYDROCHLORIDE INJECTION
OR INFUSION
Tramadol Hydrochloride Injection or Infusion should always be used exactly
as prescribed by your doctor. You should check with your doctor or pharmacist
if you are not sure.
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.
Unless otherwise prescribed by your doctor, the usual dose is:
Adults and adolescents from the age of 12 years:
Depending on your pain you will have 1-2 ml of Tramadol Hydrochloride
Injection or Infusion (equivalent to 50 – 100 mg Tramadol Hydrochloride)
every 4 to 6 hours. After an operation you may need injections more often.
Your doctor may prescribe a different, more appropriate dosage of Tramadol
Hydrochloride Injection or Infusion.
Children
Tramadol Hydrochloride Injection or Infusion is not suitable for children
below the age of 12 years.
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
Patients with severe liver and/or kidney insufficiency should not take
Tramadol Hydrochloride Injection or Infusion. If in your case the insufficiency
is mild or moderate, your doctor may recommend prolonging the dosage
interval.
How and when should you have Tramadol Hydrochloride Injection or
Infusion?
Tramadol Hydrochloride Injection or Infusion will be injected slowly usually
into a blood vessel under the surface of the arm or injected into muscle (usually
the buttocks).

slow intravenous injection, or diluted in solution for administration by
infusion or patient controlled analgesia.
The usual dose is 50 or 100 mg 4-6 hourly by the intravenous or intramuscular
route. Dosage should be adjusted according to pain severity and response.
Intravenous injections must be given slowly over 2-3 minutes.
For post-operative pain administer an initial bolus of 100 mg. During the 60
minutes following the initial bolus, further doses of 50 mg may be given every
10-20 minutes, up to a total dose of 250 mg including the initial bolus.
Subsequent doses should be 50 mg or 100 mg 4-6 hourly up to a total daily dose
of 600 mg.

Presentation
The product is presented in clear type I glass ampoules containing either 1ml
or 2ml of tramadol hydrochloride solution.
Each 1ml ampoule contains 50 mg tramadol hydrochloride and each 2 ml
ampoule contains 100 mg tramadol hydrochloride. Pack sizes include 1
ampoule per carton, 2 ampoules per carton, 5 ampoules per carton, 10
ampoules per carton and 20 ampoules per carton. Not all pack sizes may be
marketed.

Tramadol Hydrochloride should under no circumstances be administered for
longer than absolutely necessary. If long-term pain treatment with Tramadol
Hydrochloride is necessary in view of the nature and severity of the illness,
then careful regular monitoring should be carried out (if necessary with breaks
in treatment) to establish whether and to what extent further treatment is
necessary.

Indications
Treatment of moderate to severe pain.

Children:
Tramadol Hydrochloride Solution for Injection is not suitable for children
below the age of 12 years.

Dosage and Method of Administration
The dose should be adjusted to the intensity of the pain and the sensitivity of
the individual patient.
Unless otherwise prescribed, Tramadol Hydrochloride should be administered
as follows:

Geriatric patients:
A dose adjustment is not usually necessary in elderly 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.

Adults and adolescents above the age of 12 years:
Tramadol Hydrochloride injection may be administered intramuscularly, by

Renal Insufficiency/Dialysis and Hepatic Insufficiency:
The elimination of tramadol may be prolonged. The usual initial dosage should

Alternatively, Tramadol Hydrochloride Injection or Infusion will be diluted
and infused into a vein.
For medical and healthcare professionals further information on
administration is given in a separate leaflet.
How long should you have Tramadol Hydrochloride Injection or Infusion?
You should not have Tramadol Hydrochloride Injection or Infusion for longer
than necessary. If you need to be treated for a longer period, your doctor will
check at regular short intervals (if necessary with breaks in treatment) whether
you should continue to have Tramadol Hydrochloride Injection or Infusion
and at what dose.
If you have the impression that the effect of Tramadol Hydrochloride Injection
or Infusion is too strong or too weak, talk to your doctor or pharmacist.
If you have more Tramadol Hydrochloride Injection or Infusion than you
should
If you have had an additional dose by mistake, this will generally have no
negative effects. You should have your next dose as prescribed. After very high
doses, pin-point pupils, vomiting, fall in blood pressure, fast heart beat,
collapse, disturbed consciousness up to coma (deep unconsciousness),
epileptic fits, and difficulty in breathing up to cessation of breathing may
occur. In such cases a doctor should be called immediately.
If the use of Tramadol Hydrochloride Injection or Infusion has been
forgotten
If you do not have your Tramadol Hydrochloride Injection or Infusion or
infusion, pain is likely to return. You should not have a double dose to make up
for forgotten individual doses; simply continue having Tramadol
Hydrochloride Injection or Infusion as before.
If the use of Tramadol Hydrochloride Injection or Infusion is stopped
If treatment with Tramadol Hydrochloride Injection or Infusion is interrupted
or finished too soon, pain is likely to return. If you wish to stop treatment on
account of unpleasant effects, please tell your nurse or doctor.
Generally there will be no after-effects when treatment with Tramadol
Hydrochloride Injection or Infusion is stopped. However, on rare occasions,
people who have been treated with Tramadol Hydrochloride Injection or
Infusion for some time may feel unwell if the treatment is abruptly stopped.
They may feel agitated, anxious, nervous or shaky. They may be hyperactive,
have difficulty sleeping and have stomach or bowel disorders. Very few people
may get panic attacks, hallucinations, unusual perceptions such as itching,
tingling and numbness, and “ringing” in the ears (tinnitus).
If you experience any of these complaints after stopping Tramadol
Hydrochloride Injection or Infusion, please tell your nurse or doctor. If you
have any further questions on the use of this product, ask your doctor or
pharmacist.

Dependence may occur.
Eye disorders
rare: blurred vision.
Respiratory disorders
rare: shortness of breath (dyspnoea).
Worsening of asthma has been reported, however it has not been established
whether it was caused by tramadol.
Stomach and bowel disorders
very common: feeling sick.
common: being sick, constipation, dry mouth.
uncommon: urge to be sick (retching), stomach trouble (e.g. feeling of
pressure in the stomach, bloating), diarrhoea.
Skin disorders
common: sweating
uncommon: skin reactions (e.g. itching, rash).
Muscle disorders
rare: weak muscles.
Liver and biliary disorders
very rare: increase in liver enzyme values.
Urinary disorders
rare: passing water difficult or painful, less urine than normal.
General disorders
common: tiredness, weariness, weakness, low energy.
If Tramadol Hydrochloride is taken over a long period of time dependence may
occur, although the risk is very low. When treatment is stopped abruptly signs
of withdrawal may appear.
If any of the side effects gets serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE TRAMADOL HYDROCHLORIDE INJECTION
OR INFUSION
Keep out of the reach and sight of children.
Do not use Tramadol Hydrochloride Injection or Infusion after the expiry date
which is stated on the carton and the label. The expiry date refers to the last day
of that month. This medicinal product does not require any special storage
conditions.
Medicines should not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Tramadol Hydrochloride Injection or Infusion contains
The active substance is tramadol hydrochloride. Each ampoule contains 50 mg
Tramadol Hydrochloride in 1ml solution or 100 mg Tramadol Hydrochloride
in 2ml solution.
The other ingredients are: sodium acetate trihydrate and water for injections

4. POSSIBLE SIDE EFFECTS

510 mm

Like all medicines, Tramadol Hydrochloride Injection or Infusion can cause
side effects, although not everybody gets them.
In case one of the following situations occurs, see your doctor straight away:
! allergic reactions e.g. difficulty in breathing, wheezing, swelling of skin
(occurs rarely),
! swollen face, tongue and/or throat and/or difficulty to swallow or hives
together with difficulties in breathing (occurs rarely),
! shock/sudden circulation failure (occurs rarely).
Usually the frequency of side effects is classified as follows:
! very common (more than 1 out of 10 persons),
! common (more than 1 out of 100 persons),
! uncommon (more than 1 out of 1,000 persons),
! rare (more than 1 out of 10,000 persons)
! very rare (less than 1 out of 10,000 persons).

What Tramadol Hydrochloride Injection or Infusion looks like and
contents of the pack
Tramadol Hydrochloride Injection or Infusion is a clear colourless solution
supplied in clear glass ampoules. Each ampoule with a green ring contains 1 ml
solution and each ampoule with a red ring contains 2 ml solution.
Tramadol Hydrochloride Injection or Infusion is packed as 1 ampoule per
carton, 2 ampoules per carton, 5 ampoules per carton, 10 ampoules per carton
and 20 ampoules per carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Brown & Burk UK Ltd.
5 Marryat Close, Hounslow West
Middlesex, TW4 5DQ
United Kingdom
This leaflet was last revised : 09/2012

The most common side effects during treatment with Tramadol Hydrochloride
Injection or Infusion are nausea and dizziness, which occur in more than in 1
out of 10 patients.
Heart and blood circulation disorders
uncommon: effects on the heart and blood circulation (pounding of the heart,
fast heart beat, feeling faint or collapse). These adverse effects may
particularly occur in patients in an upright position or under physical strain.
rare: slow heart beat, increase in blood pressure.
Nervous system disorders
very common: dizziness.
common: headaches, drowsiness.
rare: changes in appetite, abnormal sensations (e.g. itching, tingling,
numbness), trembling, slow breathing, epileptic fits, muscle twitches,
uncoordinated movement, transient loss of consciousness (syncope).
If the recommended doses are exceeded, or if other medicines that depress
brain function are taken at the same time, breathing may slow down.
Epileptic fits have occurred mainly at high doses of tramadol or when tramadol
was taken at the same time as other medicines which may induce fits.
Psychiatric disorders
rare: hallucinations, confusion, sleep disorders, anxiety and nightmares.
Psychological complaints may appear after treatment with Tramadol
Hydrochloride. Their intensity and nature may vary (according to the
patient's personality and length of therapy). These may appear as a change in
mood (mostly high spirits, occasionally irritated mood), changes in activity
(slowing down but sometimes an increase in activity) and being less aware and
less able to make decisions, which may lead to errors in judgement.

be used. For patients with creatinine clearance <30ml/min, the dosage interval
should be increased to 12 hours. Tramadol is not recommended for patients
with severe renal impairment (creatinine clearance <10ml/min). As tramadol
is only removed very slowly by haemodialysis or haemofiltration, postdialysis administration to maintain analgesia is not usually necessary.

Instructions for opening the glass ampoule:
Using a blade, cut the Ampoule at the snap off point, depicted by a green ring
(for 1 ml ampoules) or a red ring (for 2 ml ampoules).
After opening the ampoule, the contents should be filtered using a suitable
filter device or filter straw prior to use.

Hepatic impairment:
The elimination of tramadol may be prolonged. The usual initial dosage should
be used but in severe hepatic impairment the dosage interval should be
increased to 12 hours.

Tramadol Hydrochloride solution for injection or infusion is physically and
chemically compatible for up to 24 hours with 4.2% sodium bicarbonate and
Ringer's solution and for up to 4 days with the following infusion solutions:
0.9% sodium chloride
0.18% sodium chloride and 4% glucose
sodium lactate compound
5% glucose
haemaccel

Incompatibilities
Precipitation will occur if Tramadol Hydrochloride injection is mixed in the
same syringe with injections of diazepam, diclofenac sodium, indomethacin,
midazolam and piroxicam.
Shelf life and storage condition
3 years
This medicinal product does not require any special storage conditions.
From a microbiological point of view, the product should be used immediately.
If not used immediately, in-use storage times and conditions prior to use are the
responsibility of the user and would not normally be longer than 24 hours at 2
to 8°C, unless opening/ dilution has taken place in controlled and validated
aseptic conditions.
Special precautions for disposal and other handling
The product should be inspected visually for particles and discoloration prior
to administration. Only clear colourless solution free from particles should be
used. Do not use the product if there are signs of damage to the ampoule.

For single use only. Discard any unused solution.
Any unused product or waste material should be disposed of in accordance
with local requirements.
Last revision: 09/2012

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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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