General Information
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
activities.
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 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 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 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 activities 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.
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
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 medicines.
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 25/100 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 for help.
How to take it
Swallow SINEMET,
whole or as half tablets, with a glass of water.
The tablets may be broken in half if
necessary.
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 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. 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
standing up.
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 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 driving or operating
machinery until you know how SINEMET affects you.
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 by 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
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 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. 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
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 including muscle twitching or spasms,
which may or may not resemble your Parkinson's
symptoms
dizziness, lightheadedness when
standing quickly
feeling sick (nausea),
vomiting, loss of appetite
dark saliva
dream abnormalities
sleepiness or sudden
onset of sleep
slow movements
twitching or
spasm of the eyelids
increased desire for sex
compulsive behaviours such as - gambling,
shopping, eating, taking medicines and repetitive
purposeless activities
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
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
bleeding from the back passage, black sticky
bowel motions (stools) or bloody diarrhoea
vomiting blood or material that looks like
coffee grounds
chest pain
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 of them.
After using
SINEMET
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 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 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 comes in two types of tablets:
SINEMET - light speckled blue, oval-shaped
tablet with 'MSD 654' marked on one side.
SINEMET 25/100 - yellow with greenish tint,
oval-shaped tablet with 'MSD 650' marked on one
side.
A bottle of SINEMET contains 100
tablets.
Ingredients
Active
ingredients:
SINEMET - 25 mg carbidopa and 250
mg levodopa per tablet
SINEMET 25/100 - 25 mg
carbidopa and 100 mg levodopa per tablet
Inactive ingredients:
microcrystalline
cellulose
magnesium stearate
maize starch
pregelatinised maize starch
indigo carmine
(SINEMET)
quinolone yellow (SINEMET 25/100)
SINEMET does not contain lactose, gluten,
sucrose, tartrazine or any other azo dyes.
Manufacturer SINEMET is made in Australia by:
Merck Sharp & Dohme (Australia) Pty
Limited
A.C.N. 000 173 508
54-68 Ferndell
Street
SOUTH GRANVILLE NSW 2142
This
leaflet was prepared in August 2008.
Australian Register Numbers:
SINEMET -
AUST R 10516 SINEMET 25/100 - AUST R 10517 WPC-
SEM-T-082007 ®Registered Trademark of
Merck & Co., Inc. Whitehouse Station, N.J., U.S.A.
SINEMET®1