Skip to Content

SINEMET PLUS 25 MG/100MG TABLETS

Active substance(s): CARBIDOPA ANHYDROUS / LEVODOPA

View full screen / Print PDF » Download PDF ⇩
Transcript
®

Sinemet Plus 25 mg/100 mg Tablets
(carbidopa/levodopa)
Patient Information Leaflet
This medicine is available using the above name but will be
referred to as Sinemet throughout this leaflet. Please note that
the leaflet also contains information about other strengths of the
medicine.
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
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 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

Product: Sinemet Plus Tablets
Colours: Black

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.
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.
PLPI: 17211/1190
Item Code: SIN2004I/B

Dimensions: 210mm x 400mm
Proof: 1



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
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).

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.
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. H
5. HOW TO STORE SINEMET to
Keep out of the sight and reach of children.
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’.
If the tablets show visible signs of deterioration, consult your
doctor before using them.
The drug should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of any
unused medicines. This will help to protect the environment.
6. FURTHER INFORMATION
What Sinemet contains
Each tablet contains: carbidopa monohydrate equivalent to
25mg anhydrous carbidopa and 100mg levodopa.
Inactive ingredients: microcrystalline cellulose, pregelatinised
starch, maize starch, magnesium stearate, quinoline yellow
(E104).
What Sinemet looks like and contents of the pack
Yellow oval tablets with ’650’ and a score line on one side and
plain on the other. Sinemet is contained in blister packs of 100
tablets.
Manufacturer
This product is manufactured by Merck Sharp & Dohme B.V.,
Waarderweg 39, 2031 BN - Haarlem, The Netherlands.
Procured from within the EU by the Product Licence Holder
Polyfarma Ltd and repackaged by Kent Pharmaceuticals Ltd
both at Repton Road, Measham, DE12 7DT, UK.

POM

Sinemet Plus 25 mg/100 mg Tablets
PL No: 17211/1190

Sinemet® Plus is a registered trademark of Merck Sharp &
Dohme Corp
Leaflet revision and issue date: 25.01.2016

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
Product: Sinemet Plus Tablets
Colours: Black

PLPI: 17211/1190
Item Code: SIN2004I/B

Dimensions: 210mm x 400mm
Proof: 1

Expand view ⇕

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.

Hide