Skip to Content

UK Edition. Click here for US version.

TRAMADOL HYDROCHLORIDE 50 MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance(s): TRAMADOL HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Patient Information Leaflet

hameln

Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion
tramadol hydrochloride

Important information about your medicine
Your doctor or nurse will give you the injection or infusion.
► If this injection or infusion causes you any problems talk to your doctor, nurse or pharmacist.
► Please tell your doctor or pharmacist, if you have any other medical conditions or have an allergy
to any of the ingredients of this medicine.
► Please tell your doctor or pharmacist, if you are taking any other medicines.


Read all of this leaflet carefully before you start using 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 pharmacist.
If you get any side effects, talk to your doctor or pharmacist This includes any possible side
effects not listed in this leaflet. See section 4.




What is in this leaflet
1. What Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion is and what it is used for
2. What you need to know before you use Tramadol hydrochloride 50 mg/ml Solution for Injection or
Infusion
3. How to use Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion
4. Possible side effects
5. How to store Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion
6. Contents of the pack and other information
Parkinson’s disease).
1. What Tramadol hydrochloride 50 mg/ml
Solution for Injection or Infusion is and • Medicines that act on the nervous system such
as hypnotics, tranquillisers, sleeping pills and
what it is used for
Tramadol - the active substance in Tramadol
hydrochloride 50 mg/ml Solution for 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 50 mg/ml Solution for
Injection or Infusion is used for the treatment of
moderate to severe pain.

pain killers may make you feel drowsier or faint
• selective serotonin re- uptake inhibitors (SSRI’s)
to treat depression such as fluoxetine. You
may experience symptoms such as confusion,
restlessness, fever, sweating, uncoordinated
movement of limbs or eyes, uncontrollable
jerking of muscles, or diarrhoea
• medicines which may cause convulsions (fits),
such as certain antidepressants

Pregnancy and breast feeding:
2. What you need to know before you
Tramadol hydrochloride 50 mg/ml Solution for
use Tramadol hydrochloride 50 mg/ml
Injection or Infusion should not be given during
Solution for Injection or Infusion
pregnancy or while breast feeding. If you are pregnant
Do not use Tramadol hydrochloride 50 or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor or
mg/ml Solution for Injection or Infusion:
• if you are allergic to tramadol hydrochloride
or any of the other ingredients of this medicine
(listed in section 6)
• 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 50 mg/
ml Solution for Injection or Infusion (see “Other
medicines and Tramadol hydrochloride 50 mg/ml
Solution for Injection or Infusion”)
• if you are an epileptic and your fits are not
adequately controlled by treatment
• if you have drunk enough alcohol to make you
feel woozy or drunk
• if you have taken more than the prescribed
dose of your sleeping tablets or other pain
killers, which can slow down your breathing and
reactions. (See section “Other medicines and
Tramadol hydrochloride 50 mg/ml Solution for
Injection or Infusion” for details)
You should not take this product for the treatment
of withdrawal symptoms caused by opiates
(morphine- like medicines).

Warnings and precautions:
Talk to your doctor or nurse before
using Tramadol hydrochloride 50 mg/ml
Solution for Injection or Infusion:
• if you have a head injury, breathing difficulties or
severe liver or kidney problems.
• if you think that you are addicted to other pain
relievers (opioids)
• 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 have a tendency towards epilepsy or fits
because the risk of a fit may increase

Children
Tramadol hydrochloride 50mg/ml Solution for
Injection or Infusion is not suitable for children
below the age of 12 years.

pharmacist for advice before taking this medicine.

Driving and using machines:
Details regarding a new driving offence
concerning driving after drugs have
taken in the UK may be found

been
here:

https://www.gov.uk/drug-driving-law
Tramadol hydrochloride 50 mg/ml Solution for
Injection or Infusion may cause drowsiness,
dizziness and blurred vision and therefore may
impair your reactions and your ability to drive.

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:

The medicine has been prescribed to
treat a medical or dental problem and

You have taken it according to the
instructions given by the prescriber or
in the information provided with the
medicine and

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.
If you feel that your reactions are affected, do not
use electric tools or operate machinery, and do not
work without a firm hold!

Tramadol
hydrochloride
50
mg/ml
Solution for Injection or Infusion with
food, drink and alcohol:
Do not drink alcohol during treatment with Tramadol
hydrochloride 50mg/ml Solution for Injection or
Infusion as its effects may be intensified

3. How to use Tramadol hydrochloride
50 mg/ml Solution for Injection or Infusion
Your nurse or doctor will give you the
injection or infusion.
Your doctor will decide the correct dosage for
you and how and when the injection or infusion

Other
medicines
and
Tramadol will be given.
hydrochloride 50mg/ml Solution for Since the injection or infusion will be given to
Injection or Infusion:
you by a doctor or nurse, it is unlikely that
Tell your doctor or nurse if you are using, you will be given too much. If you think you
have recently used or might use any other have been given too much, you must tell
medicines, including medicines obtained without the person giving you the injection or infusion.
a prescription. This is especially important with the
following medicines as they may interact with your
Tramadol hydrochloride 50 mg/ml Solution for
Injection or Infusion:
• Anticoagulants to thin your blood such as
warfarin
• Medicines used to treat epilepsy such as
carbamazepine.
• Ondansetron (prevents nausea)
• Monoamine oxidase inhibitors (moclobemide
or phenezeline for depression, selegiline for

If treatment with Tramadol hydrochloride 50 mg/
ml Solution for 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.

If you stop using Tramadol hydrochloride The other ingredients are sodium acetate
50 mg/ml Solution for Injection or
trihydrate and water for injections.
Infusion
What Tramadol hydrochloride 50 mg/ml
Generally there will be no after-effects when Solution for Injection or Infusion looks
treatment with tramadol is stopped. However, on
like and contents of the pack:
rare occasions, people who have been treated
with tramadol for some time may feel unwell if
the treatment is abruptly stopped. They may feel
agitated, anxious, nervous or shaky. They may
be confused, hyperactive, have difficulty sleeping
and have stomach or bowel disorders. Very few
people may get panic attacks, delusions, paranoia,
hallucinations or feeling a loss of identity. They may
experience unusual perceptions such as itching,
tingling and numbness, and “ringing” in the ears
(tinnitus). If you experience any of these complaints
after stopping treatment tell your nurse or doctor.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
• Allergic reactions to Tramadol hydrochloride
have been reported. If you have any difficulty
breathing, a rash or itchy skin, a swollen
face or tongue or difficulty in swallowing,
stop taking this medicine immediately and
tell your doctor straight away.

• You may suffer from convulsions (fits),
headache, blurred vision or dilated or

constricted pupils

• You may notice that you are sweating more or
are flushed, develop a rash or become itchy
or numb

• You may feel drowsy, sleepy, weary, low
in energy or dizzy or may have difficulty in

speaking

may develop muscle
twitches,
uncoordinated movement, transient
loss of consciousness (syncope), a
tingling sensation and trembling or
muscle weakness
• Elevated liver enzymes may occur.
• You may experience changes in your heart
beat (faster or slower) or high or low blood
pressure.
• You may experience constipation, a dry
mouth, appetite changes or diarrhoea
• You

• You may experience psychic effects including:

changes in mood, activity, behaviour or
perception, hallucinations, confusion,
restlessness,
sleep
disturbances,
delirium, anxiety and nightmares
• You may experience nausea or vomiting,
retching, feeling bloated or full
• Dependency on Tramadol may develop. Tell
your doctor if you notice this

• Shortness of breath, slower breathing or
worsening of asthma may occur
• You may find it difficult to pass urine

• You may experience a decrease in blood
sugar levels, speech disorders or dilated

or constricted pupils
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
(400 mg). Tramadol may lead to physical and
psychological addiction. When it is taken for
a long time, its effect may decrease so that higher
doses have to be taken (tolerance development).
If you think this injection or infusion is causing you
side effects, or you are at all worried, talk to

your doctor, nurse or pharmacist.

This includes any possible side effects not listed
in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor,
pharmacist or nurse: This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Tramadol hydrochloride
50 mg/ml Solution for Injection or Infusion
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the label/ carton after “EXP.”
The expiry date refers to the last day of that month.
The nurse or doctor will check that the injection or
infusion is not past its expiry date before giving you
the injection or infusion.
Your injection or infusion will be stored in a cool
place at a temperature not above 30°C.

6. Contents of
information

the

pack

and

other

What Tramadol hydrochloride 50 mg/ml
Solution for Injection or Infusion contains:
The active substance is tramadol hydrochloride.
In Tramadol hydrochloride 50 mg/ml Solution for
Injection or Infusion each ml of solution contains
50 mg of tramadol hydrochloride.

The solution for injection or infusion is supplied in 1
or 2 ml clear glass ampoules. 1, 5 or 10 ampoules
supplied in each carton.
The marketing authorisation number of this
medicine is: PL 01502/ 0085

Marketing Authorisation Holder:
hameln pharmaceuticals ltd
Gloucester
United Kingdom

Manufacturer:
hameln pharmaceuticals gmbh
Langes Feld 13
31789 Hameln
Germany
hameln rds a.s.
Horná 36
900 01 Modra
Slovak Republic

For
any
information
about
this
medicine, please contact the Marketing
Authorisation Holder
This leaflet was last approved June 2015.
47486/35/15

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