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SINEMET 25MG/250MG TABLETS

Active substance(s): CARBIDOPA / LEVODOPA

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PACKAGE LEAFLET: INFORMATION FOR THE USER

6 Further information
What Sinemet contains

Sinemet® 25mg/250mg Tablets
(carbidopa/levodopa)

Each tablet contains carbidopa equivalent to 25mg anhydrous carbidopa and 250mg levodopa.
The other ingredients are microcrystalline cellulose, maize starch, magnesium stearate, indigo
carmine (E132) and pregelatinised maize starch.

What Sinemet looks like and contents of the pack
Sinemet is dappled blue, oval-shaped tablet, scored and marked „654‟ on one side, with no
markings on the other.
Sinemet are available as blister packs of 50 tablets.

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 get serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

Manufacturer: 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.

Procured from within the EU and repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
®

Sinemet 25mg/250mg Tablets; PL 18799/1330
Leaflet date: 18.12.2017

POM

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 0208 515 3763 to obtain the leaflet in a format
suitable for you.

The name of your medicine is Sinemet 25mg/250mg Tablets but will be referred to as Sinemet
throughout this leaflet. Please note that this leaflet also contains information about other
strengths Sinemet 10mg/100mg Tablets and Sinemet Plus 25mg/100mg Tablets.

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.
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 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.

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

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

You may experience the following 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.




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 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.



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:
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 you take too many tablets see your doctor immediately.

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.

If you forget to take Sinemet

Reporting of side effects

If you take more Sinemet than you should

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).

If you get any side effects, talk to your doctor or pharmacist. 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 store above 25°C. Store in the original package in order to protect from light.
 Do not take the tablets after the expiry date which is stated on the carton and blister labels
after „Exp.‟ The expiry date refers to the last day of that month.
 If the tablets becomes discoloured or show any signs of deterioration, seek the advice of
your pharmacist.
 Remember if your doctor tells you to stop taking this medicine, return any unused medicine
to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.
 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.

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Further information

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