General Information
Consumer Medicine Information
Important
The name of your medicine
is TRAMAL® SR. Before taking TRAMAL® SR ,
please read this leaflet carefully. It is
intended to answer questions you may have about
TRAMAL® SR. It does not contain all the
available information. It does not replace
talking to your doctor or pharmacist.
You may wish to read this leaflet again, do
not throw it away until you have finished using
this medicine.
All medicines have risks
and benefits. If you have any concerns or want
more information about your medicine, ask your
doctor or pharmacist.
What is TRAMAL®
SR used for?
TRAMAL® SR is used to
relieve moderate to severe pain. It belongs to
the group of medicines called analgesics (pain
relievers). TRAMAL® SR tablets are designed to
release the pain reliever gradually over
several hours. Before taking TRAMAL® SR for
the first time Tell your doctor
if you are
allergic to any of the ingredients in TRAMAL®
SR (see "What is in TRAMAL® SR?")
if you
are known to be sensitive to opioids
if you
have lung or breathing problems
if you are
taking any medicines for depression, or mental
or psychiatric disorder or to help you sleep
if you are taking medication known as
SSRI's, tricyclic anti-depressants, quinidine,
phenothiazines or anti psychotics
if you
have had any fits or convulsions, or take
medicines for epilepsy
if you are taking
the medicine carbamazepine (one Brand name is
Tegretol)
if you have any disorder of the
kidney, liver or pancreas, including any
related to alcohol intake, for example,
cirrhosis of the liver
if you have a
stomach problem
if you have a severe
headache or have had a head injury
if you
have, or have had, any drug or alcohol
dependence
if you are taking any other
medicine, including those you buy from a
pharmacy or supermarket
if you have
galactose intolerance, or lactase deficiency or
glucose-galactose malabsorption.
Use in
children
TRAMAL® SR is not recommended
for children under 12 years.
Use in
elderly
Patients over 75 years may need
a reduced daily dose of TRAMAL® SR compared to
younger adults.
If you are pregnant or
intend to become pregnant: TRAMAL® SR is not
recommended for use during pregnancy. Talk to
your doctor about the risks and benefits of
using TRAMAL® SR during pregnancy.
If
you are breast-feeding or plan to breast feed:
TRAMAL is not recommended for use during
breast-feeding. Talk to your doctor about the
risks and benefits using TRAMAL when breast-
feeding.
If you are driving or operating
machinery TRAMAL® SR may make you drowsy or
dizzy. Ask your doctor for advice about whether
it is safe for you to drive or operate
machinery while taking TRAMAL® SR.
Taking other medicines
Tell your
doctor if you are taking any other medicines,
including medicines that you buy without a
prescription from your pharmacy, supermarket or
health food shop. Some medicines may interfere
with TRAMAL® SR. These include:
carbamazepine (eg. Tegretol)
coumarin
derivatives (eg. Warfarin: some Brand names are
Coumadin, or Marevan)
medicine for
irregular or rapid heart beat
medicines for
depression, sleeplessness or mental conditions
such as selective serotonin reuptake inhibitors
(SSRI's), tricyclic anti-depressants,
quinidine, phenothiazines or anti-psychotics
some antibiotics.
These medicines
may be affected by TRAMAL® SR, or may affect
how well it works. You may need different
amounts of your medicine, or you may need to
take different medicines. Other interactions
not listed above may also occur.
Your
doctor or pharmacist has more information on
medicines to be careful with or avoid while
taking TRAMAL® SR.
When should TRAMAL®
SR not be used?
You should NOT use
TRAMAL® SR
if you have an allergy to any
of the ingredients (see "What is in TRAMAL®
SR?" for details)
if you have an allergy to
any other medicines known as opioid analgesics,
eg. morphine or codeine.
if you have taken
large amounts of alcohol or other substances
which can affect your level of consciousness
if you are taking medicine for depression
containing a "monoamine oxidase inhibitor" also
known as MAOI, or have taken any within the
past two weeks. Examples of
MAOI-
containing medicines are Nardil, Parnate.
if you are having treatment for withdrawal
from narcotics
if the packaging is torn or
shows signs of tampering
if any tablets
look damaged or discoloured
if it is after
the expiry date which is printed on the carton
box.
How should TRAMAL® SR be used?
TRAMAL® SR tablets should be swallowed
whole with water. They maybe taken, before,
with, or after food. They must NOT be chewed,
crushed or dissolved. This will release all the
analgesic quite quickly. Side-effects may then
occur. The recommended dosage of TRAMAL® SR is
either:
two TRAMAL® SR 50 tablets twice a
day (morning and evening)
OR
one or
two TRAMAL® SR 100 mg tablet(s) twice a day
(morning and evening)
OR
one
TRAMAL® SR 150 mg or 200 mg tablet twice a day
(morning and evening).
As all patients
respond to treatment differently, your doctor
may start you on a lower dose.
Do not
take more than eight of the 50 mg tablets per
day.
Do not take more than four of the
100 mg tablets per day
Do not take more
than two of the 150 mg or of the 200 mg tablets
per day.
What to do if you have missed
your dose
If you forget to take one
dose, take the dose when you remember. The
following dose should be taken after twelve
hours, or as prescribed by your doctor.
For how long should you take TRAMAL® SR?
This is very individual: it depends for
example how severe your pain is, how you
respond to TRAMAL® SR, and the cause of your
pain. Ask your doctor for advice on how long
you need to take TRAMAL® SR tablets. TRAMAL
(capsules and injection) are also available and
they provide moderate to severe pain relief. As
with all medicine,
take only as your doctor
has told you.
if you feel that you do not
need as much TRAMAL® SR as your doctor has
prescribed for you, talk to your doctor.
tell your doctor if your pain is not helped
or gets worse. Do not take increased amounts or
extra doses of TRAMAL® SR unless your doctor
advises you to.
What are the side
effects of TRAMAL® SR?
All medicines
can cause unwanted effects, and some side-
effects have been reported with TRAMAL® SR.
Side-effects reported with TRAMAL® SR are
usually minor and temporary, but some may be
serious. The most common side-effects of
TRAMAL® SR are:
dizziness
sedation,
fatigue
headache
constipation
nausea, vomiting
sweating
dry
mouth.
The following side-effects are
less common:
indigestion
changes in
appetite
skin reactions
sudden onset of
low blood pressure, collapse
muscle
weakness
tremor
seizures
respiratory depression
improvement of
mood
confusion
sleep disturbance
blurred vision
difficulty in passing
urine
Serotonin Syndrome: signs of this
vary and are not specific; they may include
fever, sweating, confusion, agitation,
diarrhoea, muscle twitching, difficulty with
walking and balance. Serotonin Syndrome may
result from interaction of tramadol with other
medicines which increase serotonin effects, for
example, the SSRI antidepressants.
This
is not a complete listing. Occasionally, other
side-effects may be experienced. Tell your
doctor immediately if you experience any of the
following side-effects, as urgent medical
treatment may be required:
skin rash (red
spots or patches), itching hives, skin lumps
swelling or puffiness of the eyelids, face
or lips
chest tightness, wheezing or pain
in the chest
heart palpitations, faintness
or collapse
hallucinations
convulsions
If you experience any
side-effects that have not been mentioned here,
consult your doctor or pharmacist as soon as
possible. You should remember that all
medicines carry some risks. It is possible that
some risks might not yet have been detected
despite many years of experience with the
medicine.
Can TRAMAL® SR be addictive?
When used as prescribed by your doctor,
addiction to TRAMAL® SR is very unlikely. If
you are taking TRAMAL® SR for a prolonged
period of time, your body may become used to
the medicine and mild withdrawal symptoms may
occur if you suddenly stop taking the medicine.
It is important therefore to take TRAMAL® SR
only as directed by your doctor. What to do in
the case of overdosage In the event of
overdose, you should contact your nearest
Poisons Information Centre (tel: 13 11 26),
doctor or hospital emergency department
immediately. Overdosage with TRAMAL® SR will
result in decrease in breathing and fits or
convulsions. How should TRAMAL® SR be stored?
Keep TRAMAL® SR in a safe place, where
children cannot reach it.
Store in a cool,
dry place, below 30 °C.
Keep away from
direct sunlight.
Do not use TRAMAL® SR
after the use-by-date printed on the label of
the pack.
What is in TRAMAL® SR
The active medicine in TRAMAL® SR is
called tramadol hydrochloride. It is specially
made up into tablets that allow the body to
absorb the tramadol over a long period, so that
dosing need be only twice a day.
TRAMAL® SR is available as four distinct
strengths of tablet. Each strength of tablet
contains a different amount of the active
ingredient, tramadol hydrochloride.
TRAMAL® SR Tablet 50 mg Pale yellow,
round. One side imprinted with GRUNENTHAL logo.
Other side engraved with "T0"
Available
in packs of 20 or 60 tablets. TRAMAL® SR
Tablet 100 mg White, round. One side imprinted
with GRUNENTHAL logo. Other side engraved with
"T1" Available in packs of 20 or 60 tablets
TRAMAL® SR Tablet 150 mg Pale orange. One side
imprinted with GRUNENTHAL logo. Other side
engraved with "T2" Available in packs of 20 or
60 tablets TRAMAL® SR Tablet 200 mg Deep
orange to brown. One side imprinted with
GRUNENTHAL logo. Other side engraved with "T3"
Available in packs of 20 or 60 tablets TRAMAL®
SR tablets also contain the inactive
ingredients:
hypromellose
silica-
colloidal anhydrous
microcrystalline
cellulose
magnesium stearate
lactose
macrogol 6000
propylene glycol
talc
titanium dioxide
quinoline yellow
aluminium lake CI47005 (150 and 200 mg tablets)
iron oxide red CI77491 (150 and 200 mg
tablets)
iron oxide yellow CI77492 (50 mg
and 200 mg tablets only)
iron oxide black
CI77499 (200 mg tablets).
TRAMAL® SR
tablets are sealed in a blister foil pack.
Other information you need to know about
TRAMAL® SR
TRAMAL® SR is available only on
a doctor's prescription.
Do not give your
medicine to anyone else, even if they have
similar symptoms to you. Your medicine is for
your use only, it may harm other people.
This leaflet does not contain all the
available information about TRAMAL® SR.
Contact your doctor or pharmacist if you have
any questions about the information in this
leaflet or other questions about your medicine.
TRAMAL® SR is made by Grunenthal GmbH
in Germany and supplied in Australia by:
CSL Limited
ABN 99 051 588 348
45
Poplar Road
Parkville 3052
Victoria
Australia
Date of Preparation of this
Information:
August 2000 Date of Update
of this Information: September 2006 AUST R
121845: Tablets 50 mg
AUST R 75947: Tablets
100mg
AUST R 75948: Tablets 150mg
AUST
R:75949: Tablets 200mg
TRAMAL® SR is a
registered trademark of Grunenthal GmbH used by
CSL Limited as authorised user.