Skip to Content

HALF SINEMET CR TABLETS

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

View full screen / Print PDF » Download PDF ⇩
Transcript
PREVIOUSLY ASSESSED AGAINST UK PIL DATED AUGUST 2015
By Nabeela Farooq at 2:44 pm, May 05, 2016

PATIENT INFORMATION LEAFLET

HALF SINEMET® CR TABLETS
(carbidopa/levodopa)

Your medicine is available using the name HALF SINEMET CR
TABLETS but will be referred to as Half Sinemet CR through
out the 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 get 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 Half Sinemet CR is and what it is used for
Before you take Half Sinemet CR
How to take Half Sinemet CR
Possible side effects
How to store Half Sinemet CR
Further information

1. What Half Sinemet CR is and what it is
used for
Half Sinemet CR 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.
Half Sinemet CR 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 Half Sinemet CR
Do not take Half Sinemet CR if:

you are allergic (hypersensitive) to carbidopa or
levodopa or any of the other ingredients of Half Sinemet
CR (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 Half Sinemet CR (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 Half Sinemet CR if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist before
taking Half Sinemet CR.


Add/Amend created to bring the leaflet in line with the current granted

Dochanges
not change the
times at which you take your tablets
No other
approved.
or take any other medicines for Parkinson’s disease

Tell your doctor if you or your family/carer
you are2016.
leaflet innotices
January
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 Half Sinemet CR can affect the
way some other medicines work. Also some other medicines
can affect the way Half Sinemet CR 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 Half
Sinemet CR.

If they are ‘normal release’, you will need to wait
12 hours after your last dose before starting Half
Sinemet CR.

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 Half
Sinemet CR 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 Half Sinemet CR.

If you have not had levodopa before

The usual starting dose for Half Sinemet CR is one tablet
twice a day.

If you have had levodopa before


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 Half Sinemet CR and are having
any tests.

Taking Half Sinemet CR 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)
Half Sinemet CR may not work as well as it should.

A combination of more than one Sinemet or Sinemet CR
product may be prescribed by your doctor. If you have been
given different Sinemet or Sinemet CR tablets to take make
sure that you are taking the correct one at the right time.
Remember: Half Sinemet CR is a lower dose tablet than
Sinemet CR.

Children under 18 years of age

Half Sinemet CR is not suitable for children under the age of
18 years.

If you take more Half Sinemet CR than you should
If you take too many tablets see your doctor immediately.

If you forget to take Half Sinemet CR

Do not take a double dose to make up for a forgotten dose.

If you stop taking Half Sinemet CR

Do not stop taking Half Sinemet CR or change your dose
without talking to your doctor first. When you stop taking Half
Sinemet CR 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, Half Sinemet CR can cause side effects,
although not everybody gets them.

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









Pregnancy and breast-feeding

Do not take Half Sinemet CR if you are pregnant, might
become pregnant or are breast-feeding. Levodopa, one of the
substances in Half Sinemet CR, 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




Half Sinemet CR 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.
Half Sinemet CR 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.













Taking this medicine






Page 1 of 2

abnormal movements such as twitching or spasms
(which may or may not be like your Parkinson’s
symptoms)
nausea.

Other side effects include

Always take Half Sinemet CR 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. You must swallow your
tablets whole. Do not break, crush or chew the tablets.
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.

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

3. How to take Half Sinemet CR



your doctor will ask you to stop taking your medicine for
Parkinson’s disease for 8 hours before you start taking
Half Sinemet CR.

The usual starting dose for Half Sinemet CR is one tablet
twice a day. Your doctor may ask you to take Half Sinemet
CR to help in determining the correct dose.

Tests while you are taking Half Sinemet CR

Take special care with Half Sinemet CR

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 Half Sinemet CR.



without first consulting your doctor. You should not take
Half Sinemet CR tablets at intervals of less than 4 hours
apart.
Try to avoid taking your tablets with a heavy meal.

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.

PREVIOUSLY ASSESSED AGAINST UK PIL DATED AUGUST 2015

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 Half Sinemet CR.

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

6. Further information
What Half Sinemet CR tablets contain

Half Sinemet CR:
Each tablet contains carbidopa (equivalent to
25mg anhydrous carbidopa) and 100mg Levodopa in a
modified release formulation.
Half Sinemet CR tablets also contain:
hydroxypropylcellulose, magnesium stearate,
poly (vinyl acetate crotonic acid) copolymer and
red iron oxide (E172).

What Half Sinemet CR tablets look like and contents
of the pack
Each tablet is pink-coloured, oval shaped, biconvex,
compressed tablet, engraved on one side with the code
number ‘601’ and plain on the reverse.

Half Sinemet CR are available in blister packs of 50 and
60 tablets.

Manufacturer

Manufactured by: Merck Sharp & Dohme Italia S.p.A.,
via Emilia 21, 27100 Pavia, Italy.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd, Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder:
Doncaster Pharmaceuticals Group Ltd, Kirk Sandall,
Doncaster, DN3 1QR.
POM

PL No: 04423/0476

Leaflet revision and issue date (Ref): 05.05.16
Half Sinemet® CR is a registered trademark of
Merck & Co., Inc.

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 (see details
below). By reporting side effects you can help provide more
information on the safety of this medicine.
United Kingdom: Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

5. How to store Half Sinemet CR
Do not store above 30°C.
Store in the original package to protect from light.
Keep your medicine out of the sight and reach of children.
Please check the expiry date of the product. Do not use after
the expiry date stated.
If your medicine appears to be discoloured or show any other
signs of deterioration, please return this to your pharmacist
who will advise you.
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
protect the environment.

Page 2 of 2

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