Consumer Medicine Information

SINEMET^®

carbidopa/levodopa

25/100 mg & 25/250 mg tablet

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.

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 inhibitors (MAOI).
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
Levodopa, one of the components of SINEMET, is passed into human milk.
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, 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:

you are pregnant or intend to become pregnant
Your doctor will discuss the possible risks and benefits of using SINEMET during pregnancy.
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
you have previously been or are currently being treated with levodopa
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
Isoniazide, a medicine used to treat tuberculosis
Selegiline, another medicine used to treat Parkinson's disease
Iron or iron supplements

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 National Poisons Centre (telephone 0800 POISON or 0800 764 766), 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. Keep telephone numbers of these places handy.

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 be worse.

SINEMET can cause somnolence (excessive drowsiness) and sudden sleep onset episodes. Therefore you must refrain from driving or engaging in activities where impaired alertness may put yourself or others at risk of injury or death (e.g. operating machines) until such recurrent episodes and somnolence 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.

Adverse 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 adverse effects in a few people. All medicines can have adverse effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the adverse 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, light-headedness when standing quickly
feeling sick (also called nausea), vomiting, loss of appetite
dark saliva
dream abnormalities
sleepiness
sudden sleep onset episodes
slow movements
twitching or spasm of the eyelids
increased desire for sex
compulsive gambling
melanoma

These are possible adverse 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 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

These are serious adverse effects. You may need urgent medical attention. Serious adverse 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 adverse effects that need urgent medical attention. Serious adverse effects are generally rare.

Other adverse 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 adverse 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 25/250 - 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 25/250 - 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 25/250)
quinolone yellow (SINEMET 25/100)

SINEMET does not contain lactose, gluten, sucrose, tartrazine or any other azo dyes.

Supplier

SINEMET is supplied in New Zealand by:

Merck Sharp & Dohme (New Zealand) Limited
P O Box 99 851
Newmarket
Auckland
NEW ZEALAND

Tel: 0800 500 673

This leaflet was prepared in September 2007

CP-SIN-0807(070907)

^®Registered Trademark of Merck & Co Inc., Whitehouse Station, NJ, USA

INFORMATION FOR CONSUMERS