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HALF-SINEMET CR 100MG/25MG TABLETS

Active substance(s): CARBIDOPA MONOHYDRATE / LEVODOPA

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S702 Leaflet Half Sinemet 20160524

PACKAGE LEAFLET: INFORMATION FOR THE USER

HALF-SINEMET CR 100mg/25mg TABLETS
(levodopa / carbidopa)
Your medicine is known as Half-Sinemet CR 100mg/25mg Tablets
but will be referred to as Half-Sinemet CR Tablets throughout the
following patient information 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.

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 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.

In this leaflet:
1. What Half-Sinemet CR is and what it is used for
2. Before you take Half-Sinemet CR
3. How to take Half-Sinemet CR

Medicines for Parkinson’s disease which do not contain levodopa
will usually be continued. However, your dose may be changed.

4. Possible side effects



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.

Half-Sinemet CR improves the signs of Parkinson’s disease.
Parkinson’s disease is a long-term illness where:



Medicines called ‘MAOIs’ (see also ‘Do not take Half-Sinemet
CR if’).



you become slow and unsteady





your muscles feel stiff



you may develop shaking or trembling (called ‘tremor’).

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.

5. How to store Half-Sinemet CR
6. Further information
1. WHAT HALF-SINEMET CR IS AND WHAT IT IS USED FOR

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.

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.
Tests while you are taking Half-Sinemet CR
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

Do not take Half-Sinemet CR if:

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.



Pregnancy and breast-feeding

2. BEFORE YOU TAKE HALF-SINEMET CR
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 HalfSinemet 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 breastfeeding.

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 HalfSinemet CR.
Take special care with Half-Sinemet CR
Check with your doctor or pharmacist before taking your medicine
if:

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.

3. HOW TO TAKE HALF-SINEMET CR
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.



you have a history of fits (convulsions)

Taking this medicine



you have had an ulcer in your gut (called ‘duodenal’ or ‘peptic
ulcer’) or have vomited blood



Take this medicine by mouth. You must swallow your tablets
whole. Do not break, crush or chew the tablets.



you have had a heart attack, heart beat problems, circulation or
breathing problems



Although your medicine can have an effect after one day, it may
take up to seven days to work.



you have had kidney, liver or hormonal problems





you have had depression or other mental problems

Take them at regular time intervals according to your doctor’s
instructions.



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

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. You should not take Sinemet CR or
Half-Sinemet CR tablets at intervals of less than 4 hours apart.



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.

 Try to avoid taking your tablets with a heavy meal.
If you have not had levodopa before
The usual starting dose for Sinemet CR is one tablet twice a day.

If you have had levodopa before


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

The usual starting dose for 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.



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:

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.



drooping eyelid and dilated pupil



changes in vision, irregular movement of the eye

Children under 18 years of age



indigestion, dry mouth, bitter taste



swelling of the salivary glands, difficulty swallowing, grinding of
the teeth

If you take more Half-Sinemet CR than you should



hiccups, abdominal pain and distress, constipation, wind

If you take too many tablets see your doctor immediately.
If you forget to take Half-Sinemet CR



burning sensation of the tongue

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



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

If you stop taking Half-Sinemet CR

Digestive system:

Sexual:

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

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

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



feeling weak, faint or tired



hoarseness, general feeling of being unwell





increased energy or activity, unusual breathing pattern

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

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

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



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

5. HOW TO STORE HALF-SINEMET CR


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



fits (convulsions).



Do not store above 25°C.

The most common side effects are



Store in the original package to protect it from light.





Do not use after the expiry date stated on the carton label or
blister strip.



If the tablets become discoloured or show any other signs of
deterioration, take them back to your pharmacist who will tell
you what to do.



If you are told to stop taking this medicine, return any unused
tablets to your pharmacist.

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

 nausea.
Other side effects include

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 Website:
www.mhra.gov.uk/yellowcard



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 longstanding 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.

6. FURTHER INFORMATION




Each prolonged-release tablet contains 100mg levodopa, and
Carbidopa equivalent to 25mg anhydrous Carbidopa.

dizziness; sleepiness (including excessive drowsiness or
sudden sleep onset episodes), pins and needles





dream abnormalities, confusion, feeling agitated, shortness of
breath, hair loss.

The tablets also contain magnesium stearate, polyvinyl acetatecrotonic acid copolymer, hydroxypropyl cellulose and red ferric
oxide (E 172).

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)

What Half-Sinemet CR contains

What Half-Sinemet CR looks like and contents of the pack
Half-Sinemet CR Tablets tablets are pink oval tablets marked ‘601’
on one side, and plain on the other.
The tablets are available in blister packs of 50 and 60 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer

Tell your doctor if you experience any of these behaviours;
he/she will discuss ways of managing or reducing the
symptoms.

These tablets are manufactured by:


Merck Sharp & Dohme Italia S.p.A., Via Emilia 21, 27100 Pavia,
Italy. OR

Side effects that have been reported with medicines containing
levodopa.



Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands.

These may be experienced when taking Half-Sinemet CR.

POM

Nervous system:

Leaflet revision date: 24 May 2016



loss of control over the voluntary movements of everyday life

PL: 19488/0702 Half-Sinemet CR 100mg/25mg Tablets

Half-Sinemet CR is a registered trade mark of Merck & Co Inc,
USA.
S702 Leaflet Half Sinemet 20160524

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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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