Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about SINEMET. 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 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 is used for
SINEMET 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
SINEMET 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 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. In many patients,
SINEMET reduces some of the symptoms of Parkinson's disease.
Your doctor may have prescribed SINEMET for another reason. Ask your doctor if you
have any questions about why SINEMET has been prescribed for you.
Before you take SINEMET
When you must not take it
Do not take SINEMET if:
you have an allergy to SINEMET or any of the ingredients listed at the end of this
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)
Ask your doctor or pharmacist if you are not sure whether you are taking one of these
you are breast-feeding or plan to breast-feed
It has been shown that one of the active ingredients of SINEMET passes into breast
milk. Therefore, because of the potential harm to the baby, SINEMET 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, talk to your doctor.
Do not give SINEMET to a child or teenager below the age of 18 years, unless advised
by the child's doctor.
The safety and effectiveness of SINEMET 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 during pregnancy.
2. you have or have had any medical conditions, especially the following:
depression or mental disturbances
heart disease, including irregular heartbeat, also known as arrhythmia
lung disease, including asthma
kidney, liver or hormonal problems
convulsions or fits
peptic ulcer disease
3. you or your family member/caregiver notices you are developing urges to gamble, excessive
eating or spending, medicine use or repetitive purposeless activities with other medicines
for Parkinson's Disease, and/or other intense urges that could harm yourself or others.
These behaviours are called impulse control disorders. Your doctor may need to review
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
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 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
some medicines used to treat diseases related to involuntary movements
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, or may affect how well the tablets work.
You may need different amounts of your medicine, or you may need to take different
Your doctor or pharmacist has more information on medicines to be careful with or
avoid while taking SINEMET.
How to take SINEMET
How much to take
Take SINEMET only when prescribed by your doctor.
Your doctor will tell you how many tablets to take each day. The dose varies considerably
from patient to patient.
The usual starting dose is one 100/25 mg tablet taken three times a day. Your doctor
will then adjust this dose depending on the severity of your condition, your response
to treatment and whether you are taking other medicines.
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
How to take it
Swallow SINEMET, whole or as half tablets, with a glass of water.
For SINEMET 100/25, the score-line on the tablets is not for dividing the tablets
into smaller doses and should not be used that way. If you must divide a tablet to
help you swallow it, make sure you have all of the tablet pieces (the full dose).
If you do not have all the pieces, throw them away and take another tablet from the
For SINEMET 250/25, the score-line on the tablets is for dividing the tablets into
How long to take it
SINEMET helps control some of your symptoms of Parkinson's disease, but does not cure
it. Therefore SINEMET must be taken every day. Continue taking SINEMET for as long
as your doctor prescribes.
Do not stop taking SINEMET, or lower the dosage, without checking with your doctor.
Your doctor may want you to gradually reduce the amount of SINEMET 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
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. Do this even if there are no signs of
discomfort or poisoning.
While you are using SINEMET
Things you must do
If you feel light-headed, dizzy or faint get up slowly when getting out of bed or
You may feel light-headed or dizzy while taking SINEMET. 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.
If you experience times where SINEMET 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 or may ask you to take it
more frequently. Your doctor may need to prescribe you a different medicine.
Have blood tests taken when your doctor says to make sure SINEMET 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.
If you become pregnant while taking SINEMET, tell your doctor.
Things you must not do
Do not give SINEMET to anyone else, even if they have the same condition as you.
Things to be careful of
Be careful when driving or operating machinery until you know how SINEMET affects
SINEMET may cause dizziness or light-headedness in some people. Make sure you know
how you react to SINEMET 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 be worse.
In addition, in very rare cases, SINEMET may cause excessive sleepiness and sudden
onset of sleep.
If you experience these effects, do not drive or operate machinery until these effects
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
SINEMET may cause false test results with some urine sugar tests.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking SINEMET.
SINEMET 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
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 including muscle twitching or spasms, which may or
may not resemble your Parkinson's symptoms
dizziness, light-headedness when standing quickly
feeling sick (nausea), vomiting, loss of appetite
discolouration of urine, sweat and/or saliva
sleepiness or sudden onset of sleep
twitching or spasm of the eyelids
Tell your doctor if you experience any of these behaviours:
You may experience an inability to resist the impulse to perform an action that could
be harmful, which may include:
strong impulses to gamble
increased sexual drive
uncontrollable excessive shopping
spending, binge/compulsive eating
taking medicines and repetitive purposeless activities
and/or other urges
These are possible side effects of SINEMET. For the most part these have been mild.
Tell your doctor immediately if you notice any of the following:
blood in the urine
difficult or painful urination
changes in mood such as depression
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
skin rash, itchiness
pinkish, itchy swellings on the skin, also called hives or nettle rash
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
bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea
vomiting blood or material that looks like coffee grounds
fast or irregular heartbeats, also called palpitations
muscle stiffness accompanied by fever
mental changes such as feeling very fearful or paranoid, hallucinations
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
After using SINEMET
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 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.
If your doctor tells you to stop taking SINEMET or the tablets have passed their expiry
date, ask your pharmacist what to do with any that are left over.
You may be prescribed any ONE of the following:
1) SINEMET 250/25
AUST R NUMBER: 319331
What it looks like
Light, dappled blue, oval-shaped tablet with '654' and a score line on one side and
plain on the other.
SINEMET - 250 mg levodopa and 25 mg carbidopa per tablet.
pregelatinised maize starch
2) SINEMET 100/25
AUST R NUMBER: 319330
What it looks like
Yellow, oval-shaped tablet with '650' and a score line on one side and plain on the
SINEMET 100/25 - 100 mg levodopa and 25 mg carbidopa per tablet.
pregelatinised maize starch
All bottles of SINEMET tablets contain 100 tablets.
None of the SINEMET tablets contain lactose, gluten, sucrose, tartrazine or any other
SINEMET is supplied in Australia by:
Organon Pharma Pty Ltd
26 Talavera Road
This leaflet was prepared in April 2021.