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CO-CARELDOPA TABLETS 25/100

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

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PAGE 1: FRONT FACE (INSIDE OF REEL)

carbidopa/levodopa
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Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.
s +EEP THIS LEAFLET9OU MAY NEED TO READ IT AGAIN
s )F YOU HAVE ANY FURTHER QUESTIONS ASK YOUR
doctor or pharmacist.
s 4HIS MEDICINE HAS BEEN PRESCRIBED FOR YOU ONLY
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
s )F YOU GET ANY SIDE EFFECTS TALK TO YOUR DOCTOR OR
pharmacist. This includes any possible side
EFFECTS NOT LISTED IN THIS LEAFLET 3EE SECTION 
7(!4 )3 ). 4()3 ,%!&,%4
1. What Co-Careldopa is and what it is used for
2. What you need to know before you take
Co-Careldopa
3. How to take Co-Careldopa
4. Possible side effects
5. How to store Co-Careldopa
6. Contents of the pack and other information

Children and adolescents
Co-Careldopa should not be used in children and
adolescents under 18 years old.
Other medicines and Co-Careldopa
Do NOT take Co-Careldopa in combination with,
or if you have taken in the last 14 days:
s antidepressants known as MAOIs e.g. phenelzine,
isocarboxazid, tranylcypromine or moclobemide.
Talk to your doctor if you are taking any of the
following:
s anti-psychotic drugs e.g. benperidol, haloperidol,
chlorpromazine, flupentixol, fluphenazine
s ANTIDEPRESSANTS EG AMITRIPTYLINE
s DRUGS TO CONTROL BLOOD PRESSURE
s ANAESTHETICS
s BENZODIAZEPINES EG NITRAZEPAM
s ANTI CONVULSANTS EG PHENYTOIN
s anti-cholinergics e.g. benzatropine, orphenadrine
s PAPAVERINE
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.

0HARMA CODE 

Pregnancy, breast-feeding and fertility
Do NOT take Co-Careldopa if you are pregnant, or
breast-feeding, think you may be pregnant or are
planning to have a baby. Ask your doctor for
advice before taking any medicine.
Driving and using machines
WHAT CO-CARELDOPA IS AND WHAT
Co-Careldopa can very rarely cause somnolence
IT IS USED FOR
EXCESSIVE DROWSINESS AND SUDDEN SLEEP ONSET
Co-Careldopa is known as a dopaminergic medicine. EPISODES WHERE YOU MAY FALL ASLEEP VERY
suddenly, sometimes without prior warning). If
Co-Careldopa Tablets are used to treat Parkinson’s
affected, do NOT drive or operate machinery.
disease, which is caused by a lack of a chemical,
called dopamine in the nervous system. The tablets
HOW TO TAKE CO-CARELDOPA
will help to restore the level of dopamine and help
to reduce the signs and symptoms of the disease.
Always take this medicine exactly as your doctor

1

3

or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
The number of tablets which you should take
each day will depend on your personal needs.
Do NOT take Co-Careldopa if you:
Your doctor will tell you how many tablets to take
s ARE ALLERGIC TO CARBIDOPA MONOHYDRATE OR
levodopa or any of the other ingredients of this each day. During the first few weeks your doctor
may change your dose of Co-Careldopa until it is
MEDICINE LISTED IN SECTION 
exactly right. You may also be given Co-Careldopa
s ARE PREGNANT PLANNING TO BECOME PREGNANT OR
in combination with other medicines.
breast-feeding
s are taking any medicines known as “mono-amine The tablets should be swallowed preferably with
a drink of water.
OXIDASE INHIBITORSv -!/)S WHICH ARE USED TO
treat depression) or have taken these within the The recommended dose is:
s Adults (including the elderly)
LAST  WEEKS SEE4AKING OTHER MEDICINES $O
Your doctor will calculate your dose for you
NOT take Co-Careldopa in combination with)
depending on your needs.
s HAVE NARROW ANGLE GLAUCOMA LOSS OF VISION DUE
to abnormally high pressure in the eye)
s Patients already being treated with
s HAVE EVER SUFFERED FROM SKIN CANCER OR THINK THAT
levodopa, either on its own or in
you may have skin cancer
combination with another medicine
s HAVE SEVERE HEART PROBLEMS WHICH CAN CAUSE
If you are taking levodopa, either on its own or
shortness of breath or ankle swelling
in combination with another medicine, it will be
s SUFFER FROM MENTAL ILLNESS
discontinued at least 12 hours before starting
s ARE UNDER  YEARS OLD
treatment with Co-Careldopa.
Warnings and precautions
Use in children and adolescents
Co-Careldopa should not be used in children and
Talk to your doctor or pharmacist before taking
adolescents under 18 years old.
Co-Careldopa if you:
s HAVE KIDNEY PROBLEMS
If you take more Co-Careldopa than you should
s HAVE HEART PROBLEMS INCLUDING HISTORY OF A
)F YOU OR SOMEONE ELSE SWALLOW A LOT OF THE
heart attack and irregular heart beats
tablets all together, or if you think a child has
s HAVE LUNG PROBLEMS
swallowed any of the tablets, contact your nearest
s HAVE BREATHING DIFFICULTIES
hospital casualty department or your doctor
s HAVE LIVER PROBLEMS
immediately. An overdose is likely to cause
s HAVE HORMONE PROBLEMS
irregular heart beats. Please take this leaflet, any
s HAVE A HISTORY OF FITS
remaining tablets and the container with you to
s HAVE EVER HAD ULCERS OF THE STOMACH OR GUT
the hospital or doctor so that they know which
s HAVE PREVIOUSLY TAKEN LEVODOPA
tablets were consumed.
s HAVE WIDE ANGLE GLAUCOMA LOSS OF VISION DUE
If you forget to take Co-Careldopa
to abnormally high pressure in the eye)
You should continue to take these tablets for as
s ARE FOLLOWING A HIGH PROTEIN DIET
long as your doctor tells you to. If you forget to
Your doctor will want to monitor you during your take a tablet, take one as soon as you remember,
treatment with Co-Careldopa for the development unless it is nearly time to take the next one. Do
of mental changes, depression with suicidal
not take a double dose to make up for a forgotten
TENDENCIES AND OTHER CHANGES IN PERSONALITY see dose. Take the remaining doses at the correct time.
Section 4, Possible Side Effects).
If you stop taking Co-Careldopa
Tell your doctor if you or your family/carer notices Do not stop taking your medicine without talking
you are developing urges or cravings to behave in to your doctor first even if you feel better.
ways that are unusual for you or you cannot resist Do not stop taking Co-Careldopa suddenly as this
the impulse, drive or temptation to carry out certain can cause muscle problems, fever and mental
activities that could harm yourself or others. These changes to occur. When your doctor decides that
behaviours are called impulse control disorders
you should stop taking Co-Careldopa they will
and can include addictive gambling, excessive
reduce your dose gradually over a period of time.
eating or spending, an abnormally high sex drive
or an increase in sexual thoughts or feelings. Your If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
doctor may need to review your treatments.

2

WHAT YOU NEED TO KNOW BEFORE
YOU TAKE CO-CARELDOPA

Top of page cut-off to middle of registration mark: 44 mm.

CO-CARELDOPA 10/100 mg, 25/100 mg
AND 25/250 mg TABLETS

PAGE 2: REAR FACE (OUTSIDE OF REEL)

WEAKNESS TIREDNESS HEADACHE
HOARSENESS A GENERAL FEELING OF BEING UNWELL
sense of stimulation, abnormal breathing
VERY RARELY SOMNOLENCE EXCESSIVE DROWSINESS
or falling asleep suddenly may also occur.
Reporting of side effects
If you get side effects, talk to your doctor or
s AN ALLERGIC REACTION SWELLING OF THE LIPS FACE OR pharmacist. This includes any possible side effects
not listed in this leaflet.
neck leading to severe difficulty in breathing;
skin rash or hives).
You can also report side effects directly via the
This is a very serious but rare side effect. You may Yellow Card Scheme at:
need urgent medical attention or hospitalisation. www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
The following serious side effects have been
more information on the safety of this medicine.
reported commonly (may affect up to 1 in 10
people):
HOW TO STORE CO-CARELDOPA
s MENTAL PROBLEMS INCLUDING DEPRESSION FEELING
suicidal, paranoia, reduction in cognition.
Keep this medicine out of the sight and reach of
children.
If you have thoughts of harming or killing
yourself at any time, contact your doctor or go Do not store above 25°C. Store in the original
to a hospital straight away.
package.
s NEUROLEPTIC MALIGNANT SYNDROME CHARACTERISED Do not use this medicine after the expiry date that
by sweating, fast heart rate, high body
is stated on the outer packaging. The expiry date
temperature, stiff muscles, coma). If you
refers to the last day of that month.
experience these symptoms, contact your
Do not throw away any medicines via wastewater
doctor straight away.
or household waste. Ask your pharmacist how to
s INABILITY TO RESIST THE IMPULSE TO PERFORM AN
throw away medicines you no longer use. These
action that could be harmful, which may
measures will help protect the environment.
include:

4

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Stop taking the tablets and tell your doctor
immediately or go to the casualty department at
your nearest hospital if the following happens:

s
s
s
s

5

s Strong impulse to gamble excessively despite
serious personal or family consequences
s Altered or increased sexual interest and
behaviour of significant concern to you or to
others, for example, an increased sexual drive
s UNCONTROLLABLE EXCESSIVE SHOPPING OR
spending
s 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; they will discuss ways of managing
or reducing the symptoms
The following side effects have also been
reported commonly (may affect up to 1 in 10
people):
s MUSCLE TWITCHING SHAKING OR OTHER UNWANTED
jerky movements of the body, eyelid twitching
s FEELING SICK
The following side effects have been reported less
frequently (may affect up to 1 in 100 people):
s SLOW HEART RATE PALPITATIONS
s A FALL IN BLOOD PRESSURE ON STANDING UP WHICH
causes dizziness, light-headedness or fainting
s LOSS OF APPETITE
s VOMITING
s DIZZINESS
s DROWSINESS
The following side effects have been reported
rarely (may affect up to 1 in 1,000 people):
s BLEEDING IN THE STOMACH
s GUT ULCERS
s HIGH BLOOD PRESSURE
s INFLAMMATION OF A VEIN
s ANAEMIA OR BLOOD DISORDERS
s CHEST PAIN
s DIFFICULTY BREATHING
s TINGLING OR NUMBNESS
s FITS
The following side effects have also been reported
(frequency cannot be estimated from the available
data):
s LACK OF COORDINATION FALLING AND DIFFICULTY IN
walking normally, hand shaking, muscle cramp,
lockjaw
s CONFUSION DELUSIONS AGITATION ANXIETY
s DIFFICULTY SLEEPING NIGHTMARES HALLUCINATIONS
s ABNORMAL FEELING OF WELL BEING
s DRY MOUTH BITTER TASTE EXCESS SALIVA DIFFICULTY
in swallowing, grinding of teeth, burning
sensation of the tongue
s HICCUPS STOMACH PAIN CONSTIPATION DIARRHOEA
wind
s changes in body weight, water retention causing
swelling in the limbs
s FLUSHING HOT FLUSHES INCREASED SWEATING DARK
sweat
s HAIR LOSS
s PROBLEMS WITH PASSING WATER DARK URINE
s PAINFUL AND PROLONGED ERECTION
s DROOPING OF EYELIDS PROBLEMS WITH YOUR VISION

6

CONTENTS OF THE PACK AND OTHER
INFORMATION

What Co-Careldopa Tablets contain:
s 4HE ACTIVE INGREDIENTS ARE CARBIDOPA
monohydrate and levodopa.
s The 10/100 mg tablets contain 10.8 mg carbidopa
MONOHYDRATE CORRESPONDING TO  MG
carbidopa anhydrous) and 100 mg levodopa.
s 4HE  MG TABLETS CONTAIN  MG CARBIDOPA
MONOHYDRATE CORRESPONDING TO  MG
carbidopa anhydrous) and 100 mg levodopa.
s 4HE  MG TABLETS CONTAIN  MG CARBIDOPA
MONOHYDRATE CORRESPONDING TO  MG
carbidopa anhydrous) and 250 mg levodopa.
s 4HE OTHER INGREDIENTS ARE MAIZE STARCH
pregelatinised maize, microcrystalline cellulose,
magnesium stearate. The 10/100 mg and
25/250 mg tablets also contain indigo carmine
% 4HE  MG TABLETS ALSO CONTAIN
QUINOLINE YELLOW ALUMINIUM LAKE % 
What Co-Careldopa Tablets look like and contents
of the pack:
s 4HE  MG TABLETS ARE MOTTLED BLUE ROUND
flat-bevelled tablets, 9.1 mm in diameter, plain
and breakline on each side.
s 4HE  MG TABLETS ARE MOTTLED YELLOW
round, flat-bevelled tablets, 9.1 mm in
diameter, plain and breakline on each side.
s 4HE  MG TABLETS ARE MOTTLED BLUE ROUND
FLAT BEVELLED TABLETS  MM IN DIAMETER PLAIN
on each side and breakline on one side.
s 4HE PRODUCT IS AVAILABLE IN PACK SIZES OF  
50, 60, 100, 200, 500 and 1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder and company
RESPONSIBLE FOR MANUFACTURE IS4%6! 5+ ,IMITED
%ASTBOURNE ". !'
This leaflet was last revised: May 2014
0,  

85811-Y
 X 

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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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