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SINEMET^® information courtesy of Bristol-Myers Squibb Pharmaceuticals Limited

Last updated June 2008

SINEMET^®

What you should know about SINEMET^®

SINEMET® Tablets	Qualitative & Quantitative Composition (per tablet)	Form
SINEMET® CR (Modified-release tablets)	200mg levodopa and carbidopa equivalent to 50mg anhydrous carbidopa in prolonged-release tablets.		peach
Half SINEMET® CR (Modified-release tablets)	100mg levodopa and carbidopa equivalent to 25mg anhydrous carbidopa in prolonged-release tablets.		pink
SINEMET® - 62.5 Tablets	50mg levodopa and carbidopa equivalent to 12.5mg anhydrous carbidopa		yellow
SINEMET® - 110 Tablets	100mg levodopa and carbidopa equivalent to 10mg anhydrous carbidopa		blue
SINEMET® - Plus Tablets	100mg levodopa and carbidopa equivalent to 25mg anhydrous carbidopa		yellow
SINEMET® - 275 Tablets	250mg levodopa and carbidopa equivalent to 25mg anhydrous carbidopa		blue

SINEMET^® CR tablets also contain: hydroxypropylcellulose, magnesium stearate, poly (vinyl acetate-crotonic acid) copolymer, quinoline yellow 10 aluminium lake E104, red iron oxide
E172.

HALF SINEMET^® CR tablets also contain: hydroxypropylcellulose, magnesium stearate, poly (vinyl acetate-crotonic acid) copolymer, red iron oxide E172.

SINEMET^® CR and HALF SINEMET^® CR are available in blister packs of 60 tablets.

SINEMET^®-62.5 Tablets also contain: microcrystalline cellulose, maize starch, magnesium stearate, pregelatinised maize starch, quinoline yellow E104.

SINEMET^®-110 Tablets also contain: microcrystalline cellulose, maize starch, magnesium stearate, pregelatinised maize starch, indigo carmine E132.

SINEMET^®-Plus Tablets also contain: microcrystalline cellulose, maize starch, magnesium stearate , pregelatinised maize starch, quinoline yellow E104.

SINEMET^®-275 Tablets also contain: microcrystalline cellulose, maize starch, magnesium stearate, pregelatinised maize starch, indigo carmine E132.

SINEMET^®-62.5, SINEMET^®-110, SINEMET^®-Plus and SINEMET^®-275 are available in blister packs of 90 tablets.

Your medicine contains levodopa and carbidopa. Levodopa belongs to a group of medicines called antiparkinson's agents. Carbidopa is a chemical which is added to help your levodopa work more effectively by slowing down the speed at which the body breaks down levodopa.

SINEMET^® is registered for use in the following countries

For availability of SINEMET^® or SINEMET^® CR within your country, please contact medical.information@bms.com for further information.

Why has my doctor prescribed this medicine?

Your doctor has prescribed SINEMET^® or SINEMET^® CR Tablets for the treatment of all stages of Parkinson's disease. They may be useful in relieving many of the symptoms of parkinsonism particularly rigidity and slowness of movement.

Are there patients who should not take these tablets?

Do not take the tablets if:

• You are being treated for depression with certain monoamine oxidase inhibitors (MAO-I).
• You have a history of melanoma (a type of skin cancer), an irritated mole, a new mole or changed patches of pigmented skin.
• You have glaucoma or eye discomfort that has not been discussed with your doctor.
• You were ever allergic to these tablets or similar ones before.
• You are planning to become pregnant, are pregnant or breast feeding.
• You have a severe mental condition.

What should I tell my doctor before taking my tablets?

Tell your doctor:

• About all the tablets you are taking even those you buy for yourself, especially if you are being treated for nervous conditions or raised blood pressure.
• If you have a history of convulsions.
• If you have a heart, a hormone, or a blood condition.
• If you have a liver, lung or kidney condition.
• If you have had a stomach ulcer.
• If you are on a high protein diet, since this may affect your tablets.

May I take my tablets with other medication?

You should not take your tablets if:

• You are taking monoamine oxidase inhibitors (MAO-I) - unless your doctor has confirmed that you can use these with this medicine.

For SINEMET^® CR and SINEMET^® Tablets, tell your doctor if you are taking:

• Antidepressants, drugs used to treat depression.
• Antihypertensive agents (used for the treatment of high blood pressure) as the dose may need to be adjusted.
• Anticholinergic drugs (such as orphenadrine, trihexyphenidyl, benzatropine and procyclidine) used to treat excessive salivation and reduce tremor and rigidity.
• Antipsychotic drugs (such as phenothiazines, butyrophenones, and risperidone) used to treat psychiatric conditions or mental depression.
• Isoniazid used in the treatment of tuberculosis (TB).
• Antacids.
• Selegiline used in the treatment of parkinsonism.
• Iron or iron supplements.

For SINEMET^® Tablets, tell your doctor if you are taking:

• Phenytoin, used to treat seizures.
• Papaverine, used to treat impotence in men.

In addition, if you are taking a high protein diet you should consult your doctor as this may affect your absorption of levodopa.

May I drive or operate machinery

Individual responses to medication may vary and certain undesirable effects have been reported. SINEMET^® and SINEMET^® CR can cause somnolence (excessive drowsiness). Patients should therefore refrain from activities where impaired alertness may put themselves or others at risk of serious injury or death (e.g. driving or operating machinery), unless experiences of somnolence have been overcome. (See ‘WHAT UNDESIRABLE EFFECTS MAY SINEMET^® HAVE?’)

What else should I know before taking my tablets?

Please note that when you are on this medication it may affect some tests your doctor may perform on blood or urine samples. Please remind your doctor you are taking SINEMET^® if he or she wants to carry out such a test.

If you have been taking SINEMET^® for some time your doctor may wish to perform additional blood tests for liver function, kidney function or blood counts, as well as an electrocardiogram.

During treatment with SINEMET^® or SINEMETtake special care when you drive or operate a machine. If you experience excessive drowsiness or even a sudden sleep onset episode, refrain from driving and operating machines, and contact your doctor.

How should I take my tablets?

You must take your tablets by mouth.

You must swallow your tablets whole. Do not crush, break or chew them. Try to avoid taking your tablets with a heavy meal.

Take your tablets at regular time intervals according to your doctor's instructions. Do not change the times at which you take your tablets or take any additional antiparkinson's tablets without first consulting your doctor. You should not take SINEMET^® CR or HALF SINEMET^® CR tablets at intervals of less than 4 hours apart.

If you have not previously been taking levodopa the usual starting dose of SINEMET^®-Plus is one tablet three times a day; of SINEMET^®-110 and SINEMET^®-62.5 one tablet three or four times a day; of SINEMET-275 half of one tablet once or twice a day; of SINEMET^® CR is one tablet twice a day.

If you have already been taking levodopa your doctor will ask you to stop taking your antiparkinson’s tablets for 12 hours, or 24 hours if it was a slow release tablet, before you start taking SINEMET^® and for 8 hours before you start taking SINEMET^® CR.

The usual starting dose for SINEMET^® CR is one tablet twice a day. The doctor may ask you to take HALF SINEMET^® CR to help in determining the correct dose.

REMEMBER: HALF SINEMET^® CR is a lower dose tablet than SINEMET^® CR.

The usual dose of SINEMET^®-Plus and SINEMET^®-275 is one tablet three or four times a day.

The dose of SINEMET^®-110 and SINEMET^®-62.5 will depend on what you were taking previously.

SINEMET^® products are not suitable for children under the age of 18 years.

A combination of more than one SINEMET^® product may be prescribed by your doctor. If you have been given different SINEMET^® tablets to take make sure that you are taking the

correct one at the right time.

Keep taking your tablets until your doctor tells you to stop.

Overdose

If you take too many tablets see your doctor immediately.

What should I do if I miss a dose?

If you miss a tablet, you may experience the return of your Parkinson's disease symptoms.

Take the missed tablet as soon as you remember, however, if it is almost time to take your next tablet, do not take the missed tablet, but resume your normal schedule.

What withdrawal symptoms may occur if I stop taking my tablets?

You must not stop taking your tablets unless advised to by your doctor. A rare syndrome with symptoms of stiff muscles, high fever and mental changes can occur.

What undesirable effects may SINEMET^® have?

Most people find SINEMET^® tablets are suitable for them. However as with all medicines, you may have unintended or undesirable effects known as side effects. The most frequent side effects are: abnormal movements including twitching or spasms (which may or may not resemble your Parkinson's symptoms), and nausea.

Details of other possible undesirable effects are listed below.

SINEMET^®

• chest pain
• irregular heart beat and/or palpitations
• dizziness on standing-up quickly
• gastro-intestinal bleeding (bleeding from your gut which may be seen as blood in your faeces or darkened faeces)
• blood disorders of which the symptoms could be pallor, tiredness, fever, sore throat and mild bruising and prolonged bleeding after injury
• stiff muscles, high fever and mental changes
• mental changes including delusions, hallucinations and depression
• convulsions.

Other side effects OF SINEMET^® that have been reported are:

fainting; anorexia; high blood pressure; inflammation of the veins; vomiting; diarrhoea; discolouration of urine, sweat and/or saliva; on-off phenomen (see below); dizziness; sleepiness (including excessive drowsiness or sudden sleep onset episodes); pins and needles; dream abnormalities; confusion; feeling agitated; increased sexual drive; shortness of breath; hair loss and an excessive desire to gamble.

SINEMET^® CR and HALF SINEMET^® CR

• dizziness on standing-up quickly
• palpitations
• chest pain
• stiff muscles
• high fever
• mental changes including delusions, hallucinations and depression.

Other side effects of SINEMET^® CR and HALF SINEMET^® CR that have been reported are:

Sleepiness (including excessive drowsiness or sudden sleep onset episodes) and sleep disturbance; dream abnormalities; depression; general weakness; vomiting; anorexia; headache; on-off phenomenon (see below); constipation; disorientation; pins and needles; shortness of breath; fatigue; indigestion; abdominal pains; muscle cramps; reduced awareness; diarrhoea; weight loss; agitation; anxiety; falling over; abnormal patterns; blurred vision; delusions; increased sexual drive; discoloration of urine, sweat and/or saliva; flushing; hair loss; fainting and an excessive desire to gamble.

The on-off phenomenon is a characteristic of some, but by no means all, people with longstanding Parkinson’s disease. It can best be described as an unpredictable shift from mobility - “on” - to a sudden inability to move - “off”. “Off” to “on” can occur just as suddenly.

If any symptoms persist or you experience any different effects please tell your doctor or pharmacist immediately. It will help if you make a note of what you experienced, when it started and how long it lasted.

If you experience any of the following serious undesirable effects listed below you should contact your doctor immediately as you may have had a serious allergic reaction to SINEMET^®. You may need urgent medical attention or hospitalisation.

• hives, itching, rash
• swelling of the face, lips, tongue and/or throat
• difficulty in breathing or swallowing.

All of these effects are very rare.

How should I store my tablets?

Do not store your SINEMET^® tablets above 25°C (30°C for SINEMET^® CR). Store them in the original package, to protect from light.

Keep your medicine out of the reach and sight of children.

Please check the expiry date of the product. Do not use after the expiry date stated on the pack.

If you are told to stop taking this medicine, return any unused tablets to your pharmacist.

Product Information Downloads

The information on this pageprintout is a general summary of the SINEMET^® medication product.

Please click on the links below to download more detailed information on the specific SINEMET^® medication, its handling and use. Links go to the electronic Medicines Compendium (eMC) website.

Further detailed information can be downloaded via the electronic Medicines Compendium (eMC) website (http://emc.medicines.org.uk/).

Patient Information Leaflets (PIL)

Summary of Product Characteristics (SPC)

Please note that SPCs are designed for healthcare professionals.

Useful Links & References

• Bristol-Myers Squibb Pharmaceuticals Limited [www.bms.com]
• Merck Sharp & Dohme Limited [www.msd-uk.co.uk]
• www.sinemetcr.com

Further Information

SINEMET^® is a registered trademark of Merck & Co Inc, Whitehouse Station, NJ, USA.

Your tablets are manufactured by Merck Manufacturing Division, Merck Sharp & Dohme (Italia) SpA, Via Emilia, Pavia, Italy.

Marketing Authorisation Holder

SINEMET^® is a registered trademark of Merck & Co., Inc., Whitehouse Station, NJ, USA.

Merck Sharp & Dohme Limited
Hertford Road
Hoddesdon
Hertfordshire
EN11 9BU
UK

Distributed in the UK by

Bristol-Myers Squibb Pharmaceuticals Limited
Uxbridge
UB8 1H
UK

Distributed in the Republic of Ireland by

Bristol-Myers Squibb Pharmaceuticals Limited
Swords
County Dublin
Ireland