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Sinemet CR 200/50 Tablets 100

IMPORTANT NOTE – A VALID AUSTRALIAN PRESCRIPTION IS REQUIRED BEFORE THIS ITEM CAN BE SHIPPED

Drug Name: levodopa + carbidopa anhydrous
Private Price $64.69
PBS $37.30
Concession $5.20
Safety Net $0.00

S8 Note - This prescription item is Schedule 8 and can only be supplied on a script from a registered doctor in Queensland. Any prescriptions from any other state cannot be filled and will be returned in the mail

Note: Private, PBS and our prices are available to the general public. Concession and Safety Net prices are only available to people with the appropriate concession or Safety Net cards. See Prescriptions for more details.

GOVERNMENT AUTHORITY SCRIPT

This prescription item requires a pre approved authority from the Government in order to get this item at the quoted price. Authority prescriptions need to be applied for by the doctor writing the script and can include reasons such as increased quantities due to dosage, increased repeats, use for a pre determined specified use, or the nature of the medication itself requiring specialist interaction. In the event that an authority is not granted on the script, the price will revert to the private price quoted for that item

WARNING - MULTIPLE PACK PRESCRIPTION - PLEASE READ CAREFULLY

This item contains more than one pack of a prescription product. Before this can be dispensed the doctor has to give approval. The prescription must be written for the total quantity or the prescription must be endorsed by your doctor "Regulation 24" otherwise we will be unable to dispense the increased amount. If you proceed with the order without approval, we will only send out one pack at the single pack price and refund the difference. Eg If your prescription is written out for 30 Tablets with 5 repeats and it does not have “Regulation 24 “ written on the script, the ONLY quantity we can dispense is 30 at one time. Further dispensing of this product could only occur after an appropriate length of time - usually 21 days but depends on dosage. In this example if you would like to obtain 180 Tablets then the doctor must endorse the prescription “Regulation 24” or the quantity must be written out for 180 and not 30. NB Conditions apply on the writing of a Regulation 24 prescription. Ask your doctor or pharmacist for details.

We can no longer accept signed authority forms from your doctor as permission to dispense more than one pack. Please contact our pharmacist for more information.

If you order this item as Private, NO PBS stickers will be issued. Once any prescription order has been sent the product cannot be returned for a refund even if your doctor changes your medication or you have an adverse reaction.

Sinemet CR 200/50 Tablets 100

Sinemet CR 200/50 Tablets 100

Product ID: 52660
$64.69

Pharmacist Only Medicine

This product is a Pharmacist Only Medicine and requires pharmacist advice before we can dispatch this product. You must first place the order and then contact our pharmacists within 48 hours on 1300 367 283. The pharmacist will determine if this product is appropriate for you and if so, approve the order. In the event that you do not do this, the product will be deleted from your order and the balance of your order will be dispatched. This is not required if you have a doctor's prescription.

 

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®
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