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 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 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 is and what it is used for
2. What you need to know before you take
Tramadol
3. How to take Tramadol
4. Possible side effects
5. How to store Tramadol
6. Contents of the pack and other
information
1. What Tramadol is and what it is used
for
Tramadol hydrochloride - the active
substance in Tramadol - 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 is used for the treatment of
moderate to severe pain.
You must talk to a doctor if you do not feel
better or if you feel worse after number of
days.
2. What you need to know before you
take Tramadol
Do not take Tramadol
- if you are allergic to active substance
or any of the other ingredients of this
medicine (listed in section 6).
- if you are under the influence of alcohol
or sedative drugs including sleeping
pills, other pain-killers or tranquiliser
medicines
- if you are taking, or have taken in the
last two weeks, certain medicines called
“monoamine oxidase inhibitors” or
MAOIs (used to treat e.g. depression,
and the antibiotic linezolid). The
combination could result in a serious,
potentially life threatening interaction
- if you have epilepsy that is not controlled
with your current medicine;
- as a substitute in drug withdrawal.
Warnings and precautions
Talk to your doctor or pharmacist
before taking Tramadol
- if you suffer from epilepsy or
seizures (fits) or have had them
in the past because tramadol
could increase the risk of you
having further fits
- if you have liver or kidney
problems.
- Suffer from depression and you
are taking antidepressants as
some of them may interact with
tramadol (see ‘Other medicines
and Tramadol’).
- There is a small risk that you may
experience a so-called serotonin
syndrome that can occur after having
taken tramadol in combination with
certain antidepressants or tramadol
alone. Seek medical advice immediately
if you have any of the symptoms related
to this serious syndrome (see section 4
‘Possible side effects’).
As with all painkillers of this type (opioid
analgesics), tramadol should be used with
caution, and only under medical supervision
in seriously ill patients including those with
breathing difficulties, excessively low blood
pressure (shock), decreased consciousness,
serious head injury or brain diseases that
may cause elevated pressure in the skull.
As with all medicines of this type, tramadol
may lead to psychological and physical
dependence or addiction in some people,
especially with long term use. The dose
needed to achieve the desired effect
may increase with time. Tramadol should
be used with caution, and only for short
periods, in patients who are addicted to
other opioid pain-killers.
Tramadol is transformed in the liver by an
enzyme. Some people have a variation of this
enzyme and this can affect people in different
ways. In some people, they may not get
enough pain relief but other people are more
likely to get serious side effects. If you notice
any of the following side effects, you must
stop taking this medicine and seek immediate
medical advice: slow or shallow breathing,
confusion, sleepiness, small pupils, feeling
or being sick, constipation, lack of appetite.
Sleep-related breathing disorders
Tramadol can cause sleep-related breathing
disorders such as sleep apnoea (breathing
pauses during sleep) and sleep related
hypoxemia (low oxygen level in the blood).
The symptoms can include breathing
pauses during sleep, night awakening
due to shortness of breath, difficulties to
maintain sleep or excessive drowsiness
during the day. If you or another person
observe these symptoms, contact your
doctor. A dose reduction may be considered
by your doctor.
Talk to your doctor or pharmacist if you
experience any of the following symptoms
while taking Tramadol.
Extreme fatigue, lack of appetite, severe
abdominal pain, nausea, vomiting or low
blood pressure. This may indicate that you
have adrenal insufficiency (low cortisol
levels). If you have these symptoms, contact
your doctor, who will decide if you need to
take hormone supplement.
Children and adolescents
Use in children with breathing problems
Tramadol is not recommended in children
with breathing problems, since the
symptoms of tramadol toxicity may be worse
in these children.
Other medicines and Tramadol
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.
Do not take Tramadol at the same time
as medicines called “monoamine oxidase
inhibitors” or MAOIs (which are used to
treat e.g. depression), or if you have taken
MAOIs in the past 2 weeks.
The pain-relieving effect of Tramadol may
be weakened and/or shortened if you also
take medicines containing:
- carbamazepine (used to treat epilepsy)
- pentazocine, nalbuphine or
buprenorphine (pain killers)
- ondansetron (used to stop you feeling
sick).
The risk of side effects increases if you take
Tramadol at the same time as:
- if you are taking medicines which may
cause convulsions (fits), such as certain
antidepressants or antipsychotics. The
risk having a fit may increase if you take
Tramadol at the same time. Your doctor
will tell you whether Tramadol is suitable
for you.
- if you are taking certain antidepressants.
Tramadol may interact with these
medicines and you may experience
serotonin syndrome (see section 4
‘Possible side effects’).
- sedative medicines such as tranquillizers,
sleeping pills, antidepressants and other
pain relievers (morphine, codeine); you
may feel excessively drowsy or feel that
you might faint
- medicines that prevent blood clotting,
such as warfarin; the dose of these
medicines may need to be reduced,
otherwise there could be an increased
risk of potentially serious bleeding.
Concomitant use of Tramadol and sedative
medicines such as benzodiazepines
or related drugs increases the risk of
drowsiness, difficulties in breathing
(respiratory depression), coma and may
be life-threatening. Because of this,
concomitant use should only be considered
when other treatment options are not
possible.
However if your doctor does prescribe
Tramadol together with sedative medicines
the dose and duration of concomitant
treatment should be limited by your doctor.
Please tell your doctor about all sedative
medicines you are taking, and follow your
doctor’s dose recommendation closely. It
could be helpful to inform friends or relatives
to be aware of the signs and symptoms
stated above. Contact your doctor when
experiencing such symptoms.
Tramadol with food and drink and
alcohol
You should not drink alcohol during treament
with Tramadol, as its effect may be intensified.
Pregnancy and 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.
Pregnancy
There is very little information regarding
the safety of tramadol during pregnancy.
Tramadol should therefore not be used
during pregnancy. If you become pregnant
you should inform your doctor as soon as
possible.
Breast-feeding
Tramadol is excreted into breast milk. For
this reason, you should not take Tramadol
more than once during breast-feeding, or
alternatively, if you take Tramadol more
than once, you should stop breast-feeding.
Based on human experience tramadol is
suggested not to influence female or male
fertility.
Driving and using machines
Tramadol may cause side effects such as
sleepiness and dizziness. If this happens,
do not drive or operate machinery.
Tramadol contains Sodium:
Tramadol capsule contains sodium. This
medicine contains less than 1 mmol
sodium (23 mg) per capsule, that is to say
essentially ‘sodium-free’.
3. How to take Tramadol
Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are not
sure.
The capsules should be swallowed whole
with a glass of water.
The capsules can be taken with or without
food and should not be chewed.
The usual doses are given below. Your
doctor may gradually increase or decrease
your dose depending on how you respond
to the treatment.
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.
Package leaflet:
Information for the user
Tramadol 50 mg capsules,
hard
tramadol hydrochloride
N04313
Black
Version: 08
Date & Time: 07.09.2021 & 4:10 pm
Submision: N04313
