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CO-CARELDOPA 25/100 TABLETS

Active substance(s): CARBIDOPA MONOHYDRATE / LEVODOPA

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Package Leaflet: Information for the user
®

SINEMET PLUS TABLETS /
CO-CARELDOPA 25/100 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.
This product is available using either of the above names but will be
referred to as Sinemet throughout this leaflet.
This product is available in other strengths.
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
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.
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.

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 other
diseases related to involuntary movements. Your dose may need
to be changed.
• Medicines 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 is:
• for Sinemet Plus 25 mg/100 mg Tablets: one tablet three times a
day.
• for Sinemet 10 mg/100 mg Tablets: 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 is:
• for Sinemet Plus 25 mg/100 mg Tablets and Sinemet 25 mg/250
mg Tablets: one tablet three or four times a day.
• for Sinemet 10 mg/100 mg Tablets it 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.
4. Possible side effects
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 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 longstanding 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.5
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. How to store Sinemet
• Keep out of the sight and reach 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.

If the capsules become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who
will tell you what to do.
6. Further information
What Sinemet contains
• The active substances in Sinemet are carbidopa (equivalent to
25 mg anhydrous carbidopa) and levodopa (100 mg).
• The other ingredients are microcrystalline cellulose, maize starch,
magnesium stearate, pregelatinised maize starch and quinoline
yellow (E104).
What Sinemet looks like and contents of the pack
Sinemet are yellow, half scored oval tablet imprinted 650 on one side and
plain on the reverse.
Tablets are available in blister packs of 100 tablets.
POM
Manufacturer:
Merck Sharp & Dohme B.V.,
Waarderweg 39, 2031 BN Haarlem,
The Netherlands
Procured from within the E.U. and re-packaged by Munro Wholesale
Medical Supplies Ltd., 3 Young Place, East Kilbride, G75 0TD.
Product Licence holder: Ecosse Pharmaceuticals Ltd.,
3 Young Place, East Kilbride, G75 0TD.
PL 19065/0269
This leaflet was revised: 24/02/2015 E0269-7
® denotes registered trademark of Merck & Co., Inc.,

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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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