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CO-CARELDOPA TABLETS 10/100

Active substance(s): CARBIDOPA MONOHYDRATE / LEVODOPA

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PAGE 1: FRONT FACE (INSIDE OF REEL)

PACKAGE LEAFLET: INFORMATION
FOR THE USER
Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.
• 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 only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
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

feelings. Your doctor may need to review your
treatments.
Tell your doctor if you or your family/carer notices
you are developing addiction-like symptoms
leading to craving for large doses of
Co-Careldopa and other medicines used to treat
Parkinson’s disease.
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
• antidepressants known as MAOIs e.g. phenelzine,
isocarboxazid, tranylcypromine or moclobemide.
Talk to your doctor if you are taking any of the
following:
• anti-psychotic drugs e.g. benperidol, haloperidol,
chlorpromazine, flupentixol, fluphenazine
• anti-depressants e.g. amitriptyline
• drugs to control blood pressure
• anaesthetics
• benzodiazepines e.g. nitrazepam
• anti-convulsants e.g. phenytoin
• anti-cholinergics e.g. benzatropine, orphenadrine
• papaverine.

Pharma code 660

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Pregnancy, breast-feeding and fertility
Co-Careldopa is known as a dopaminergic
Do NOT take Co-Careldopa if you are pregnant, or
medicine.
breast-feeding ,think you may be pregnant or are
Co-Careldopa Tablets are used to treat Parkinson's
planning to have a baby. Ask your doctor for
disease, which is caused by a lack of a chemical,
advice before taking any medicine.
called dopamine in the nervous system. The tablets
will help to restore the level of dopamine and help Driving and using machines
to reduce the signs and symptoms of the disease.
Co-Careldopa can very rarely cause somnolence
(excessive drowsiness) and sudden sleep onset
What you need to know before you
episodes (where you may fall asleep very
take co-careldopa
suddenly, sometimes without prior warning). If
Do NOT take Co-Careldopa if you:
affected, do NOT drive or operate machinery.
• are allergic to carbidopa monohydrate or
How to take co-careldopa
levodopa or any of the other ingredients of this
medicine (listed in section 6)
Always take this medicine exactly as your doctor
• are pregnant, planning to become pregnant or
or pharmacist has told you. Check with your
breast-feeding
doctor or pharmacist if you are not sure.
• are taking any medicines known as
The number of tablets which you should take
“mono-amine oxidase inhibitors”, MAOIs,
each day will depend on your personal needs.
(which are used to treat depression) or have
Your doctor will tell you how many tablets to take
taken these within the last 2 weeks (see Taking
other medicines, Do NOT take Co-Careldopa in each day. During the first few weeks your doctor
may change your dose of Co-Careldopa until it is
combination with)
• have narrow-angle glaucoma (loss of vision due exactly right. You may also be given Co-Careldopa
in combination with other medicines
to abnormally high pressure in the eye)
• have ever suffered from skin cancer or think
The tablets should be swallowed preferably with
that you may have skin cancer
a drink of water.
• have severe heart problems which can cause
The recommended dose is:
shortness of breath or ankle swelling
• Adults (including the elderly)
• suffer from mental illness
• are under 18 years old.
Your doctor will calculate your dose for you
depending on your needs.
Warnings and precautions
• Patients already being treated with levodopa,
Talk to your doctor or pharmacist before taking
either on its own or in combination with
Co-Careldopa if you:
another medicine
• have kidney problems
If you are taking levodopa, either on its own or
• have heart problems including history of a
in combination with another medicine, it will be
heart attack and irregular heart beats
discontinued at least 12 hours before starting
• have lung problems
treatment with Co-Careldopa.
• have breathing difficulties
• have liver problems
Use in Children and adolescents
• have hormone problems
Co-Careldopa should not be used in children
• have a history of fits
and adolescents under 18 years old.
• have ever had ulcers of the stomach or gut
If you take more Co-Careldopa than you should
• have previously taken levodopa
If you (or someone else) swallow a lot of the
• have wide-angle glaucoma (loss of vision due
tablets all together, or if you think a child has
to abnormally high pressure in the eye)
swallowed any of the tablets, contact your nearest
• are following a high-protein diet.
hospital casualty department or your doctor
Your doctor will want to monitor you during your immediately. An overdose is likely to cause
treatment with Co-Careldopa for the development irregular heart beats. Please take this leaflet, any
of mental changes, depression with suicidal
remaining tablets and the container with you to
tendencies, and other changes in personality (see the hospital or doctor so that they know which
Section 4, Possible Side Effects).
tablets were consumed.
Tell your doctor if you or your family/carer notices If you forget to take Co-Careldopa
you are developing urges or cravings to behave in
You should continue to take these tablets for as
ways that are unusual for you cannot resist the
long as your doctor tells you to. If you forget to
impulse, drive or temptation to carry out certain
take a tablet, take one as soon as you remember,
activities that could harm yourself or others.
unless it is nearly time to take the next one. Do
These behaviours are called impulse control
not take a double dose to make up for a forgotten
disorders and can include addictive gambling,
excessive eating or spending, an abnormally high dose. Take the remaining doses at the correct
time.
sex drive or an increase in sexual thoughts or

1

What co-careldopa is and what it is
used for

2

3

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
carbidopa / levodopa

PAGE 2: REAR FACE (OUTSIDE OF REEL)

If you stop taking Co-Careldopa
Do not stop taking your medicine without talking
to your doctor first even if you feel better.
Do not stop taking Co-Careldopa suddenly as this
can cause muscle problems, fever and mental
changes to occur. When your doctor decides that
you should stop taking Co-Careldopa they will
reduce your dose gradually over a period of time.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

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:
• an allergic reaction (swelling of the lips, face or
neck leading to severe difficulty in breathing;
skin rash or hives).
This is a very serious but rare side effect. You may
need urgent medical attention or hospitalisation.
The following serious side effects have been
reported commonly (may affect up to 1 in 10
people):
• mental problems including depression, feeling
suicidal, paranoia, reduction in cognition.
If you have thoughts of harming or killing
yourself at any time, contact your doctor or go
to a hospital straight away
• neuroleptic malignant syndrome (characterised
by sweating, fast heart rate, high body
temperature, stiff muscles, coma). If you
experience these symptoms, contact your
doctor straight away
• 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
behaviors; they will discuss ways of managing or
reducing the symptoms














excess of that required to control motor
symptoms, known as dopamine dysregulation
syndrome. Some patients experience severe
abnormal involuntary movements (dyskinesias),
mood swings or other side effects after taking
large doses of Co-Careldopa.
dry mouth, bitter taste, excess saliva, difficulty
in swallowing, grinding of teeth, burning
sensation of the tongue
hiccups, stomach pain, constipation, diarrhoea,
wind
changes in body weight, water retention
causing swelling in the limbs
flushing, hot flushes, increased sweating, dark
sweat
hair loss
problems with passing water, dark urine
painful and prolonged erection
drooping of eyelids, problems with your vision
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
pharmacist. 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

How to store co-careldopa

Keep this medicine out of the sight and reach of
children.
Do not store above 25ºC. Store in the original
package.
Do not use this medicine after the expiry date that
is stated on the outer packaging. The expiry date
refers to the last day of that month.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

6

Contents of the pack and other
information

What Co-Careldopa Tablets contains:
• The active ingredients are carbidopa
monohydrate and levodopa.
• The 10/100 mg tablets contain 10.8 mg carbidopa
monohydrate (corresponding to 10 mg
The following side effects have also been reported
carbidopa anhydrous) and 100 mg levodopa.
commonly (may affect up to 1 in 10 people):
• The 25/100 mg tablets contain 27 mg carbidopa
monohydrate
(corresponding to 25 mg
• muscle twitching, shaking or other unwanted
carbidopa anhydrous) and 100 mg levodopa.
jerky movements of the body, eyelid twitching
• The 25/250 mg tablets contain 27 mg carbidopa
• feeling sick.
monohydrate (corresponding to 25 mg
The following side effects have been reported less
carbidopa anhydrous) and 250 mg levodopa.
frequently (may affect up to 1 in 100 people):
• The other ingredients are maize starch,
• slow heart rate, palpitations
pregelatinised maize, microcrystalline cellulose,
• a fall in blood pressure on standing up which
magnesium stearate. The 10/100 mg and 25/250
causes dizziness, light-headedness or fainting
mg tablets also contain indigo carmine (E132).
• loss of appetite
The 25/100 mg tablets also contain quinoline
• vomiting
yellow aluminium lake (E104).
• dizziness
What Co-Careldopa Tablets look like and contents
• drowsiness.
of the pack:
The following side effects have been reported
• The 10 /100 mg tablets are mottled blue, round,
rarely (may affect up to 1 in 1,000 people):
flat-bevelled tablets, 9.1 mm in diameter, plain
and breakline on each side.
• bleeding in the stomach
• The 25 / 100 mg tablets are mottled yellow,
• gut ulcers
round, flat-bevelled tablets, 9.1 mm in
• high blood pressure
diameter, plain and breakline on each side.
• inflammation of a vein

The 25 / 250 mg tablets are mottled blue, round,
• anaemia or blood disorders
flat-bevelled tablets, 10.3 mm in diameter, plain
• chest pain
on each side and breakline on one side.
• difficulty breathing

The product is available in pack sizes of 20, 30,
• tingling or numbness
50, 60, 100, 200, 500 and 1000 tablets.
• fits.
Not all pack sizes may be marketed.
The following side effects have also been
Marketing Authorisation Holder and Manufacturer
reported (frequency cannot be estimated from
The Marketing Authorisation holder and company
the available data):
responsible for manufacture is TEVA UK Limited,
• lack of coordination, falling and difficulty in
Eastbourne, BN22 9AG.
walking normally, hand shaking, muscle cramp,
This leaflet was last revised: August 2017
lockjaw
PL 00289/0783-5
• confusion, delusions, agitation, anxiety
• difficulty sleeping, nightmares, hallucinations
EAS1512a
• abnormal feeling of well-being
85811-Z
• craving for large doses of Co-Careldopa in
160 x 323

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