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SINEMET 100 TABLETS

Active substance(s): CARBIDOPA / LEVODOPA / CARBIDOPA / LEVODOPA

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SINEMET® 100 TABLETS
(carbidopa and levodopa)

Your medicine is available using the above name but will be
referred to as Sinemet throughout this leaflet.

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.
2.
3.
4.
5.
6.

What Sinemet is and what it is used for
Before you take Sinemet
How to take Sinemet
Possible side effects
How to store Sinemet
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.

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 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 have not had levodopa before
The usual starting dose is:

one tablet three or four times a day.

If you have had levodopa 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:

2. Before you take Sinemet
Do not take Sinemet if:

Tests while you are taking Sinemet






Taking Sinemet with food and drink











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.

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.




Pregnancy and breast-feeding



Driving and using machines


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.



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.
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.



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.
Page 1 of 2

your doctor will ask you to stop taking your medicine for
Parkinson’s disease before you start taking Sinemet.

The usual starting dose is:

it will depend on what you were taking before.

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.



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.

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
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:
 strong impulse to gamble excessively despite serious
personal or family consequences
 altered or increased sexual interest and behaviour of
significant concern to you or to others, for example,
an increased sexual drive
 uncontrollable excessive shopping or spending
 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





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




Each tablet contains the active ingredients,
Carbidopa 10mg (as monohydrate) and
Levodopa 100mg.
Sinemet also contains the following:
microcrystalline cellulose, maize starch,
pre-gelatinised maize starch, magnesium stearate,
indigo carmine (E132).

What Sinemet looks like and the contents of the
pack

Each tablet is blue, oval tablet marked 647 and a breakline on
one side and plain on the reverse.
Sinemet is available as blister packs of 100 tablets.
PL No: 21828/0359

POM

This product is manufactured by:
Merck Sharp & Dohme Italia SpA, Via Emilia 21 27100 Pavia
Italy.

Eyes:

Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd, Kirk Sandall,
Doncaster, DN3 1QR.

Digestive system:

Product Licence holder:
Landmark Pharma Ltd, 7 Regents Drive, Prudhoe,
Northumberland, NE42 6PX.




Sinemet® is a registered trademark of Merck & Co Inc.







drooping eyelid and dilated pupil
changes in vision, irregular movement of the eye
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.

Leaflet revision and issue date (Ref.) 09.02.17

Blind or partially sighted?
Is this leaflet hard to see or
read? Call 01302 365000
(Regulatory)
Please be ready to give the
following information:
Product name:
Sinemet 100 Tablets
Reference No: 21828/0359

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






Do not store above 25°C. Store in a cool dry place, and
protected from light.
Keep out of the sight and reach of children.
If your doctor tells you to stop taking the tablets, please
take them back to the pharmacist for safe disposal. Only
keep the tablets if your doctor tells you to.
If the tablets become discoloured or show any other
signs of deterioration, show them to a pharmacist who
will advise you what to do.

Page 2 of 2

Expand Transcript

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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