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SINEMET PLUS 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/levodopa)
This product is available in the above name and strength, but will be
referred to as Sinemet throughout the remainder of this leaflet.
This product is available in multiple strengths and all strengths will
be referred to 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. 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 breastfeeding.
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 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.

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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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