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CO-CARELDOPA 25MG /100MG TABLETS

Active substance(s): CARBIDOPA ANHYDROUS / LEVODOPA

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SINEMET® Plus 25mg/100mg Tablets
(carbidopa and levodopa)

Your medicine is available using the name Sinemet Plus
25mg/100mg Tablets but will be referred to as Sinemet
throughout this leaflet.
Sinemet is also available as Sinemet 10mg/100mg and
25mg/250mg.

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.

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.

3. How to take Sinemet

Tell your doctor if you or your family/carer notices you are
developing addiction-like symptoms leading to craving for
large doses of Sinemet and other medicines used to treat
Parkinson’s disease. 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 this medicine



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

Always take Sinemet exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are
not sure.







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 25mg/100mg Tablets: one tablet three
times a day.

for Sinemet 10mg/100mg 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 25mg/100mg Tablets and Sinemet
25mg/250mg Tablets: one tablet three or four times a
day.

for Sinemet 10mg/100mg 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

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.

Like all medicines, Sinemet can cause side effects, although
not everybody gets them.

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.

Stop taking Sinemet and see your doctor straight
away, if you notice any of the following side effects:








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.





The most common side effects are




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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).
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:




Craving for large doses of Sinemet in excess of that
required to control motor symptoms, known as
dopamine dysregulation syndrome. Some patients
experience severe abnormal involuntary movements
(dyskinesias), mood swings or other side effects after
taking large doses of Sinemet.
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.
Eyes:

drooping eyelid and dilated pupil

changes in vision, irregular movement of the eye.

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 or
search for MHRA Yellow Card in the Google Play or Apple
App Store.
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 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.
Store in the original package in order to protect from light.
If your doctor decides to stop the treatment, return any
leftover medicine to the pharmacist. Only keep it if your
doctor tells you to.
If your medicine appears to be discoloured or show any other
signs of deterioration, please return to your pharmacist who
will advise you further.
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: carbidopa equivalent to 25mg of
anhydrous carbidopa and 100mg levodopa.
Also contains: microcrystalline cellulose, pregelatinised
starch, maize starch, magnesium stearate and quinoline
yellow aluminium lake (E104).

What Sinemet looks like and contents of the pack

Sinemet are yellow, oval tablets imprinted with ‘650’ and a
break line on one side and plain on the reverse.
Sinemet is available in packs containing 50 or 100 tablets.

Manufacturer

Manufactured by: Merck Sharp & Dohme (Italia) S.p.A.,
Via Emilia, 21 – 27100 Pavia, Italy.
Or
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands.

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.

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

Sexual:

persistent abnormal erection of the penis.

PL No: 21828/0601

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.

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

Leaflet revision and issue date: 15.12.17
SINEMET® is a registered trademark of Merck Sharp & Dohme
Corp.

Blind or partially sighted?
Is this leaflet hard to see or
read?
Call +44 (0) 1302 365000
(Regulatory)
Please be ready to give the
following information:
Product name: SINEMET Plus
25mg/100mg Tablets
Reference No: 21828/0601
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Further information

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