SINEMET 12.5 MG/50 MG TABLETS

Active substance: LEVODOPA

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SINEMET® 12.5 mg/50 mg Tablets
(Carbidopa/levodopa)
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1 What Sinemet is and what it is used for
2 Before you take Sinemet
3 How to take Sinemet
4 Possible side effects
5 How to store Sinemet
6 Further information
1  What Sinemet is and what it is used for
Sinemet improves the signs of Parkinson’s disease. Parkinson’s disease is a long-term illness where:
• you become slow and unsteady
• your muscles feel stiff
• you may develop shaking or trembling (called ‘tremor’).
If not treated, Parkinson’s disease can make it hard for you to continue your normal daily activities.
Sinemet contains two different medicines called: levodopa and carbidopa.
• levodopa turns into a material called ‘dopamine’ in your brain. The dopamine helps to improve the signs of your
Parkinson’s disease.
• carbidopa belongs to a group of medicines called ‘aromatic amino acid decarboxylase inhibitors’. It helps
levodopa work more effectively by slowing the speed at which levodopa is broken down in your body.
2 Before you take Sinemet
Do not take Sinemet if:
• you are allergic (hypersensitive) to carbidopa or levodopa or any of the other ingredients of Sinemet (listed in
Section 6)
• you have ever had skin cancer or you have any unusual moles which have not been examined by your doctor
• you are taking certain medicines called ‘MAOIs’ (Monoamine Oxidase Inhibitors) used for depression. You
need to stop using these medicines at least two weeks before you start Sinemet (see also under ‘Taking other
medicines’ below).
• you have a condition called ‘narrow-angle glaucoma’ that may cause a sudden build up of pressure in the eye
• you have a severe mental disorder
• you are pregnant, might become pregnant, or are breast-feeding.
Do not take Sinemet if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking
Sinemet.
Take special care with Sinemet
Check with your doctor or pharmacist before taking your medicine if:
• you have a history of fits (convulsions)
• you have had an ulcer in your gut (called ‘duodenal’ or ‘peptic ulcer’) or have vomited blood
• you have had a heart attack, heart beat problems, circulation or breathing problems
• you have had kidney, liver or hormonal problems
• you have had depression or other mental problems
• you have a condition called ‘chronic wide-angle glaucoma’ that may cause a build up of pressure in the eye. You
will need to have regular checks on the pressure in your eye.
• you sometimes have sudden sleep attacks or sometimes feel very sleepy
• you are due to have surgery.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Sinemet.
Tell your doctor if you or your family/carer notices you are developing urges or cravings to behave in ways that
are unusual for you or you cannot resist the impulse, drive, or temptation to carry out certain activities that could
harm yourself or others. These behaviours are called impulse control disorders and can include addictive gambling,
excessive eating or spending, an abnormally high sex drive or an increase in sexual thoughts or feelings. Your doctor
may need to review your treatments.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription. This includes herbal medicines. This is because Sinemet can affect the
way some other medicines work. Also some other medicines can affect the way Sinemet works.
In particular tell your doctor or pharmacist if you are taking any of the following medicines:
• Medicines for Parkinson’s disease containing levodopa:
- If they are ‘slow release’, you will need to wait 24 hours after your last dose before starting Sinemet.
- If they are ‘normal release’, you will need to wait 12 hours after your last dose before starting Sinemet.
- Tell the doctor or pharmacist even if you have only taken them in the past.
Medicines for Parkinson’s disease which do not contain levodopa will usually be continued. However, your dose
may be changed.
• Medicines for mental problems (including depression), tuberculosis (TB), high blood pressure, muscle spasms,
epilepsy or to treat low iron. Your dose may need to be changed.
• Medicines called ‘MAOIs’ (see also ‘Do not take Sinemet if’).
• Anticholinergic medicines (such as orphenadrine, trihexyphenidyl, benzatropine and procyclidine). Your dose
may need to be changed.
• Phenytoin which is used to treat fits (convulsions).
• Papaverine which is used to treat impotence in men.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.
Your doctor or pharmacist has a more complete list of medicines to avoid while taking Sinemet.
Tests while you are taking Sinemet
This medication can affect some laboratory tests that your doctor may perform on blood or urine samples. Please
remind your doctor if you are taking Sinemet and are having any tests.
Taking Sinemet with food and drink
Try to avoid taking your tablets with a heavy meal. If your diet contains too much protein (meat, eggs, milk, cheese)
Sinemet may not work as well as it should.
Pregnancy and breast-feeding
Do not take Sinemet if you are pregnant, might become pregnant or are breast-feeding. Levodopa, one of the
substances in Sinemet, is passed into human milk.
Ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant or breast-feeding.
Driving and using machines
• Sinemet affects different people in different ways. Some people have side effects which affect their ability to drive
or use tools or machines. (see Section 4  Possible side effects). Do not drive or use tools or machines if you get
these effects.
• Sinemet can also make you sleepy or cause ‘sudden sleep attacks’. If this happens to you, you must not drive or
use tools or machines. Your doctor will tell you if you can start driving again if these attacks stop.
3 How to take Sinemet
Always take Sinemet exactly as your doctor has told you. You should check with your doctor or pharmacist if you are
not sure.
Taking this medicine
• Take this medicine by mouth.
• Although your medicine can have an effect after one day, it may take up to seven days to work.
• Take them at regular time intervals according to your doctor’s instructions.
• Do not change the times at which you take your tablets or take any other medicines for Parkinson’s disease
without first consulting your doctor.
• Try to avoid taking your tablets with a heavy meal.
If you have not had levodopa before
The usual starting dose for Sinemet 12.5 mg/50 mg Tablets is one tablet three or four times a day.
If you have had levodopa before
Your doctor will ask you to stop taking your medicine for Parkinson’s disease before you start taking Sinemet.
The usual starting dose will depend on what you were taking before.
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.
Children under 18 years of age
Sinemet is not suitable for children under the age of 18 years.
If you take more Sinemet than you should
If you take too many tablets see your doctor immediately.
If you forget to take Sinemet
Do not take a double dose to make up for a forgotten dose.
If you stop taking Sinemet
Do not stop taking Sinemet or change your dose without talking to your doctor first. When you stop taking
Sinemet the following can occur: stiff muscles, high temperature (fever) and mental changes.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

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4 Possible side effects

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Like all medicines, Sinemet can cause side effects, although not everybody gets them.
Stop taking Sinemet and see your doctor straight away, if you notice any of the following side effects:
• allergic reaction, the signs may include hives (nettle rash), itching, rash, swelling of your face, lips, tongue or
throat. This may cause difficulty in breathing or swallowing
• chest pain
• uneven (irregular) heart beat or palpitations
• dizziness on standing-up quickly
• bleeding from your gut which may be seen as blood in your faeces or darkened faeces (gastro-intestinal bleeding)
• blood problems, the signs may include pale skin (pallor), tiredness, fever, sore throat or mild bruising and

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5 How to store Sinemet
• Keep out of the reach and sight of children
• Do not store above 25°C. Store in the original package in order to protect from light
• Do not use Sinemet after the expiry date which is stated on the blister and carton after ‘EXP.’ The expiry date
refers to the last day of that month.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will help to protect the environment.
6 Further information
What Sinemet contains
• The active substances in Sinemet 12.5 mg/50 mg Tablets are carbidopa (equivalent to 12.5 mg anhydrous carbidopa)
and levodopa (50 mg).
• The other ingredients in Sinemet 12.5 mg/50 mg Tablets are microcrystalline cellulose, maize starch, magnesium
stearate, pregelatinised maize starch, and quinoline yellow (E104).
What Sinemet looks like and contents of the pack

For Position Only

Sinemet ® 12.5 mg/50 mg Tablets:
Yellow, oval-shaped tablets, one side scored and the other marked ‘520’.
Sinemet 12.5 mg/50 mg Tablets are available in blister packs of 90 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK.
Manufacturer: Merck Manufacturing Division, Merck Sharp & Dohme (Italia) SpA, Via Emilia, Pavia, Italy.
This leaflet was last revised in November 2012
© Merck Sharp & Dohme Limited 2012. All rights reserved.
PIL.SEM62.5.12.UK/IRL.3729

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prolonged bleeding after injury
• stiff muscles, high fever
• mental changes including delusions, hallucinations and depression
• fits (convulsions).
The most common side effects are
• abnormal movements such as twitching or spasms (which may or may not be like your Parkinson’s symptoms)
• nausea.
Other side effects include
• fainting, anorexia, high blood pressure
• inflammation of the veins, being sick (vomiting) diarrhoea, discoloration of urine, sweat or saliva
• on-off phenomenon, characteristic of some people with long-standing Parkinson’s disease. This is when you can have
unpredictable changes from being mobile - “on” - to a sudden inability to move - “off”. “Off” to “on” can occur just as
suddenly.
• dizziness; sleepiness (including excessive drowsiness or sudden sleep onset episodes), pins and needles
• dream abnormalities, confusion, feeling agitated, shortness of breath, hair loss
You may experience the following side effects:
• inability to resist the impulse to perform an action that could be harmful, which may include:
o strong impulse to gamble excessively despite serious personal or family consequences
o altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an
increased sexual drive
o uncontrollable excessive shopping or spending
o binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than
normal and more than is needed to satisfy your hunger)
Tell your doctor if you experience any of these behaviours; he/she will discuss ways of managing or reducing
the symptoms.
Side effects that have been reported with medicines containing levodopa.
These may be experienced when taking Sinemet.
Nervous system:
• loss of control over the voluntary movements of everyday life
• numbness, increased hand tremor, muscle twitching, muscle cramp, irregular movement of jaw muscles
resulting in difficulty opening the mouth
• difficulty sleeping, feeling anxious or high, falling over and abnormal walking patterns
• headache
Eyes:
• drooping eyelid and dilated pupil
• changes in vision, irregular movement of the eye
Digestive system:
• indigestion, dry mouth, bitter taste
• swelling of the salivary glands, difficulty swallowing, grinding of the teeth
• hiccups, abdominal pain and distress, constipation, wind
• burning sensation of the tongue.
Sexual:
• persistent abnormal erection of the penis
Urinary:
• difficulty passing urine or incontinence (inability to control urine flow);
Skin:
• changed patches of pigmented skin, including, irritated or irregular moles, or moles in which you have noticed
changes (melanoma)
General:
• weight gain or loss, swelling in the limbs
• flushing, hot flushes, increased sweating
• feeling weak, faint or tired
• hoarseness, general feeling of being unwell
• increased energy or activity, unusual breathing pattern
If any symptoms persist or you experience any other side effects please tell your doctor or pharmacist. It will help if
you make a note of what you experienced, when it started and how long it lasted.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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