Skip to Content

TRAMADOL HYDROCHLORIDE 50 MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance: 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

1. What Tramadol hydrochloride 50 mg/ml
Solution for Injection or Infusion is and
what it is used for

Other medicines and Tramadol
hydrochloride 50mg/ml Solution for
Injection or Infusion:

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.

Tell your doctor or nurse if you are using,
have recently used or might use any other
medicines, including medicines obtained
without 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.
• Buprenorphine, nalbuphine, or pentazocine
(pain killers)
• Ondansetron (prevents nausea)
• Monoamine oxidase inhibitors (moclobemide
or phenezeline for depression, selegiline for
Parkinson’s disease).
• Medicines that act on the nervous system such
as hypnotics, tranquillisers, sleeping pills and
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

2. What you need to know before you
use Tramadol hydrochloride 50 mg/ml
Solution for Injection or Infusion
Do not use Tramadol hydrochloride 50
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.

Pregnancy and breast feeding:
Tramadol hydrochloride 50 mg/ml Solution for
Injection or Infusion should not be given during
pregnancy or while breast feeding. If you are
pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.

Driving and using machines:
Details regarding a new driving offence

concerning driving after drugs have been taken in
the UK may be found 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
will be given.
Since the injection or infusion will be given to
you by a doctor or nurse, it is unlikely that you
will be given too much. If you think you have
been given too much, you must tell the
person giving you the injection or infusion.
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
50 mg/ml Solution for Injection or
Infusion
Generally there will be no after-effects when
treatment with tramadol is stopped. However,
on 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

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

• You 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 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 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 (600 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 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
- website: www.mhra.gov.uk/yellowcard.
Alternatively you can call Freephone 0808 100
3352 (available from 10 a.m. to 2 p.m. Mondays
to Fridays) or fill in a paper form available from
your local pharmacy. 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 the pack and other
information
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 other ingredients are sodium acetate
trihydrate and water for injections.

What Tramadol hydrochloride 50 mg/ml
Solution for Injection or Infusion looks
like and contents of the pack:
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 March 2014.
47486/11/15

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