General Information
Consumer Medicine Information
What is in
this leaflet
This leaflet answers some
common questions about SINEMET CR. It does not
contain all the available information.
It
does not take the place of talking
to your
doctor or pharmacist.
All medicines have
risks and benefits. Your doctor has weighed the
risks of you taking SINEMET
CR against the
benefits they expect it will have for you.
If you have any concerns about taking this
medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may
need to read it again.
What SINEMET CR is
used for
SINEMET CR is used to treat some
of the symptoms of Parkinson's disease. This is a
disease of the nervous system that mainly affects
body movement. The three main symptoms are shaking
(tremor), muscle stiffness and slow and unsteady
movement. People with Parkinson's disease often
walk with a shuffle as they have difficulty in
initiating movement. If untreated, Parkinson's
disease can cause difficulty in performing normal
daily activities.
SINEMET CR is most
helpful in improving slow movement and muscle
stiffness. It is also frequently helpful in
treating shaking, difficulty in swallowing and
drooling.
The symptoms of Parkinson's
disease are caused by a lack of dopamine, a
naturally occurring chemical
produced by
certain brain cells. Dopamine relays messages in
the part of the brain that controls muscle
movement.
When too little dopamine
is
produced slowness of movement results.
SINEMET CR contains two active ingredients,
levodopa and carbidopa. Levodopa is a chemical
closely related to dopamine which allows the body
to make its own dopamine. Carbidopa makes sure
that enough levodopa gets to the brain where it is
needed. SINEMET CR is formulated to slowly release
the levodopa and carbidopa. This keeps the amount
of levodopa in your brain as even as possible. In
many patients, SINEMET CR reduces some of the
symptoms of Parkinson's disease.
Your
doctor may have prescribed SINEMET CR for another
reason. Ask your doctor if you have any questions
about why SINEMET CR has been prescribed for you.
Before you take SINEMET CR
When you
must not take it
Do not take SINEMET CR if:
you have an allergy to SINEMET CR or any of
the ingredients listed at the end of this leaflet
you have any unusual skin lumps or moles which
have not been examined by your doctor, or if you
have ever had skin cancer or melanoma
you have
a type of glaucoma called narrow-angle glaucoma
are being treated for depression with certain
medicines called monoamine oxidase (MAO)
inhibitors
Ask your doctor or pharmacist if
you are not sure whether you are taking one of
these medicines.
you are breast-feeding or plan
to breast-feed
It has been shown that one
of the active ingredients of SINEMET CR passes
into breast milk. Therefore, because of the
potential harm to the baby, SINEMET CR should not
be
used during breast-feeding.
the packaging
is torn or shows signs of tampering
the expiry
date on the pack has passed.
If you take
this medicine after the expiry date has passed, it
may not work.
If you are not sure whether
you should start taking SINEMET CR, talk to your
doctor.
Do not give SINEMET CR to a child
or teenager below the age of 18, unless advised by
the child's doctor. The safety and effectiveness
of SINEMET CR in children and teenagers under 18
years of age has not been established.
Before you start to take it
Tell your
doctor if:
1. you are pregnant or intend to
become pregnant
Your doctor will discuss
the possible risks and benefits of using SINEMET
CR during pregnancy.
2. you have or have had
any medical conditions, especially the following:
depression or mental
disturbances
heart
disease, including irregular heart beat, also
known as arrhythmia
lung disease, including
asthma
kidney, liver or hormonal problems
convulsions or fits
glaucoma
peptic
ulcer disease
3. you have had an increased
desire for sex or compulsive behaviours such as
gambling, shopping, eating, medicine use or
repetitive purposeless activites with other
medicines for Parkinson's Disease
4. you have
previously been or are currently being treated
with levodopa
5. you have any allergies to any
other medicines or any other substances, such as
foods, preservatives or dyes.
If you have
not told your doctor about any of the above, tell
them before you take any SINEMET CR.
Taking
other medicines
Tell your doctor if you are
taking any other medicines, including any that you
buy without a prescription from your pharmacy,
supermarket or health food shop. Some medicines
and SINEMET CR may interfere with each other.
These include:-
some medicines used to treat
high blood pressure
some medicines used to
treat
depression
some medicines used to
treat psychiatric problems
phenytoin, a
medicine used to treat convulsions
isoniazid,
a medicine used to treat tuberculosis
selegiline, another medicine used to treat
Parkinson's disease
iron supplements and
multivitamins containing iron
These
medicines may be affected by SINEMET CR, or may
affect how well the tablets work. You may need
different amounts of your medicine, or you may
need to take different medicines.
Your
doctor or pharmacist has more information on
medicines to be careful with or avoid while taking
SINEMET CR.
How to take SINEMET CR
How much to take
Take SINEMET CR only
when prescribed by your doctor.
Your doctor
will tell you how many tablets to take each day.
This depends on the severity of your condition,
your response to treatment and whether you are
taking other medicines. The dose varies
considerably from patient to patient. Most
patients need 2-8 tablets per day, taken in
divided doses.
Follow all directions given
to you by your doctor carefully. They may differ
from the information contained in this leaflet.
If you do not understand the instructions
on the bottle, ask your doctor or pharmacist for
help.
How to take it
Swallow SINEMET
CR, whole or as half tablets, with a glass of
water.
Do not chew or crush the tablets. If
the tablets are crushed or chewed, they will no
longer have their
slow-release properties. The
tablets may be broken in half if necessary.
How long to take it
SINEMET CR helps
control some of your symptoms of Parkinson's
disease, but does not cure it. Therefore SINEMET
CR must be taken every day. Continue taking
SINEMET CR for as long as your doctor prescribes.
Do not stop taking SINEMET CR, or lower
the dosage, without checking with your doctor.
Your doctor may want you to gradually reduce
the amount of SINEMET CR you are using before
stopping completely. This may help reduce the
possibility of withdrawal symptoms such as muscle
stiffness, fever and mental changes.
If you
forget to take it
If it is almost time for
your next dose, skip the dose you missed and take
your next dose when you are meant to. Otherwise,
take it as soon as you remember, and then go back
to taking your tablet(s) as you would normally.
If you are not sure whether to skip the
dose, talk to your doctor or pharmacist.
Do
not take a double dose to make up for the dose
that you missed.
If you have trouble
remembering to take your tablets, ask your
pharmacist for some hints.
If you take too
much (overdose)
Immediately telephone your
doctor or Poisons Information Centre (telephone 13
11 26), or go to accident and emergency at your
nearest hospital, if you think that you or anyone
else may have taken too much SINEMET CR. Do this
even if there are no signs of discomfort or
poisoning.
While you are using SINEMET
CR
Things you must do
If you feel
light-headed, dizzy or faint, get up slowly when
getting out of bed or standing up.
Although
rare, you may feel
light-headed or dizzy while
taking SINEMET CR. This is because your blood
pressure is falling suddenly.
Standing up
slowly, especially when you get up from bed or
chairs, will help your body get used to the change
in position and blood pressure. If this problem
continues or gets worse, tell your doctor.
If you are about to be started on any new
medicine, tell your doctor and pharmacist that you
are taking SINEMET CR.
If you experience
times where SINEMET CR does not appear to be
working as well as it did previously, tell your
doctor.
After taking this medicine for long
periods of time, such as a year or more, some
people suddenly lose the ability to move. This
loss of movement may last from a few minutes to
several hours. The person is then able to move as
before. This condition may unexpectedly occur
again and again. This problem is called the "on-
off" effect. Your doctor may prescribe you a
stronger dose of SINEMET CR or may ask you to take
it more frequently. Your doctor may need to
prescribe you a different medicine.
Have
blood tests when your doctor says to make sure
SINEMET CR is not causing any problems with your
blood, liver, kidneys or heart.
If you plan
to have surgery that needs a general anaesthetic,
tell your doctor or dentist that you are taking
SINEMET CR.
If you become pregnant while
taking SINEMET CR, tell your doctor.
Things
you must not do
Do not give SINEMET CR to
anyone else, even if they have the same condition
as you.
Things to be careful of
Be
careful driving or operating machinery until you
know how SINEMET CR affects you. SINEMET CR may
cause dizziness or light-headedness in some
people. Make sure you know how you react to
SINEMET CR before you drive a car, operate
machinery, or do anything else that could
be
dangerous if you are dizzy or
light-
headed. If you drink alcohol, dizziness or light-
headedness may by worse.
In addition, in
very rare cases, SINEMET CR may cause excessive
sleepiness and sudden onset of sleep. If you
experience these effects, do not drive or operate
machinery until these effects have resolved.
Be careful not to eat a diet high in protein.
The amount of levodopa absorbed by the
body may be impaired if you eat a diet high in
protein. Ask your doctor, pharmacist or dietician
to check your diet.
If you are diabetic,
check with your doctor or pharmacist before using
urine sugar tests. SINEMET CR may cause false test
results with some urine sugar tests.
Side
Effects
Tell your doctor or pharmacist as
soon as possible if you do not feel well while you
are taking SINEMET CR. SINEMET CR helps most
people with Parkinson's disease, but it may have
unwanted side effects in a few people. All
medicines can have side effects. Sometimes they
are serious, most of the time they are not. You
may need medical treatment if you
get some of
the side effects.
Ask your doctor or
pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the
following and they worry you:
abnormal
uncontrolled movements, which may or may not
resemble your Parkinson's symptoms
feeling
sick (nausea), vomiting, loss of appetite
dizziness, lightheadedness when standing
quickly
dry mouth, dark saliva
dream
abnormalities, sleeping difficulty
sleepiness
or sudden onset of sleep
weakness
confusion
increased desire for sex
compulsive behaviours such as
-gambling,
shopping, eating, taking medicines and repetitive
purposeless activities
Most of these are
the more common side effects of SINEMET CR. For
the most part, these have been mild.
Tell
your doctor immediately if you notice any of the
following:
difficult or painful urination
changes in mood such as depression
forgetfulness
signs of anaemia, such as
tiredness, being short of breath, and looking pale
signs of frequent or worrying infections such
as fever, severe chills, sore throat or mouth
ulcers
bruising or bleeding more easily than
normal, nose bleeds
fainting
skin rash,
itchiness
pinkish, itchy swellings on the
skin, also called hives or nettlerash
numbness
or tingling in the
hands or feet
signs of
melanoma, such as
new
skin spots or changes
to the size, shape, colour or edges of an existing
skin spot, freckle or mole.
These are
serious side effects. You may need urgent medical
attention. Serious side effects are generally
rare.
Tell your doctor immediately or go to
accident and emergency at your nearest hospital if
you notice any
of the following:
swelling
of the face, lips, mouth, throat or tongue which
may cause difficulty in swallowing or breathing
vomiting blood or material that looks like
coffee grounds
bleeding from the back passage,
black sticky bowel motions (stools) or bloody
diarrhoea
chest pain
fast or irregular
heartbeats, also called palpitations
it
becomes impossible to empty your bladder (urinary
retention)
mental changes such as feeling very
fearful or paranoid, hallucinations
muscle
stiffness accompanied by fever
shortness of
breath, difficulty breathing
These are all
serious side effects that need urgent medical
attention. Serious side effects are generally
rare.
Other side effects not listed above
may also occur in some patients. Tell your doctor
if you notice any other effects.
Do not be
alarmed by this list of possible side effects. You
may not experience any of them.
After using
SINEMET CR
Storage
Keep your tablets
in the bottle until it is time to take them. If
you take the tablets out of the bottle they may
not keep well.
Keep SINEMET CR in a cool
dry place where the temperature stays below 30
°C. Do not store it or any
other medicine in the bathroom or near a sink.
Do not leave it in the car or on window sills.
Heat and dampness can damage some medicines.
Keep it where children cannot reach it. A
locked cupboard at least
one-and-a-half metres
above the ground is a good place to store
medicines.
Disposal
If your doctor
tells you to stop taking SINEMET CR or the tablets
have passed their expiry date, ask your pharmacist
what to do with any that are left over.
Product description
What it looks
like
SINEMET CR comes as a speckled peach
coloured, oval-shaped tablet with 'SINEMET CR'
marked on one side and 'MSD 521' marked on the
other. The tablets are scored.
A bottle of
SINEMET CR contains 100 tablets.
Ingredients
Active ingredients:
SINEMET CR - 50 mg carbidopa and 200 mg
levodopa per tablet
Inactive ingredients:
hydroxypropyl cellulose
magnesium stearate
VA/Crotonates copolymer
iron oxide red
CI77491
quinoline yellow CI47005
SINEMET CR
does not contain lactose, gluten, sucrose,
tartrazine or any other azo dyes.
Supplier
SINEMET CR is supplied in
Australia by:
Merck Sharp & Dohme
(Australia) Pty Limited
A.C.N. 000 173 50854-68
Ferndell StreetSOUTH GRANVILLE NSW 2142
This
leaflet was prepared in August 2008
Australian
Register Number:
SINEMET CR - AUST R 20322
WPC-SCR-T-082007 ® Registered
Trademark of Merck & Co., Inc. Whitehouse Station,
N.J., U.S.A. SINEMET CR®