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CO-BENELDOPA 100 MG/25 MG CAPSULES

Active substance(s): BENSERAZIDE HYDROCHLORIDE / LEVODOPA / BENSERAZIDE HYDROCHLORIDE / LEVODOPA / BENSERAZIDE HYDROCHLORIDE / LEVODOPA

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231-30-86486-ZC LEA CO-BENELDOPA A/S CAP TUK No
460 mm
160 mm
N/A
N/A

PANTONE® GREEN C

Colours Used:

CO-BENELDOPA 50 mg/12.5 mg,
100 mg/25 mg AND 200 mg/50 mg
CAPSULES
(Levodopa/Benserazide)

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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 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. See
section 4.
IN THIS LEAFLET:

1. What Co-Beneldopa is and what it is used for
2. What you need to know before you take
Co-Beneldopa
3. How to take Co-Beneldopa
4. Possible side effects
5. How to store Co-Beneldopa
6. Contents of the pack and other information

1



WHAT CO-BENELDOPA IS AND WHAT IT IS
USED FOR

Levodopa is an anti-Parkinson’s agent and
benserazide is a decarboxylase inhibitor which
helps levodopa to work better
Co-Beneldopa is used to treat the symptoms of
Parkinson’s disease.

2

WHAT YOU NEED TO KNOW BEFORE YOU
TAKE CO-BENELDOPA

Fictitious pharma code will be
updated at supplier proof stage.

Do NOT take Co-Beneldopa
• If you are allergic (hypersensitive) to levodopa,
benserazide or any of the other ingredients of
this medicine
• If you have hyperthyroidism (an overactive
thyroid gland), an excessively fast heartbeat, or
phaeochromocytoma (a tumour of the adrenal
gland that causes hypertension)
• If you have severe hormonal, heart, liver or
kidney disease
• If you have psychosis (a psychiatric condition
characterised by personality derangement and
loss of contact with reality)
• If you have narrow angle glaucoma (high
pressure in the eye)
• If you are under 25 years of age
• If you are pregnant
• If you are a woman of child-bearing age not
using reliable contraception (see section
"Pregnancy and breast-feeding")
• If you are taking reserpine or monoamine
oxidase (MAO) inhibitors (e.g.
tranylcypromine), which are used to treat high
blood pressure and depressed mood. Also do
not take Co-Beneldopa if you have taken a MAO
inhibitor within the last 2 weeks.
Warnings and precautions
Tell your doctor before you take this medicine:
• If your symptoms were caused by another
drug, or if you have another movement
disorder called Huntington's chorea, as this
medicine may not be appropriate
• If you have ever had a heart attack or heart
problems
• If you have orthostatic hypotension (low blood
pressure associated with changes in posture,
which makes you feel light-headed or dizzy)
• If you have ever had a peptic or intestinal ulcer
• If you have ever had convulsions (fits)
• If you have ever had osteomalacia (a bone
disease similar to rickets)
• If you have wide angle glaucoma (high
pressure in the eye)
• If you have diabetes. You should check your
blood sugar levels more often, and your doctor
may need to adjust the dose of your
antidiabetic medicine
• If you are about to undergo surgery.
Depression and suicidal thoughts may occur
during treatment with Co-Beneldopa, although
they can also be caused by your disease. If you
feel depressed whilst on treatment, you should
contact your doctor.
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.
You must continue your treatment as long as your
doctor tells you to. Suddenly stopping it could
cause potentially life-threatening side effects (see
section 3. below, 'If you stop taking Co-Beneldopa).
Your doctor may wish to carry out certain periodic
tests, such as taking blood and urine samples and
checking your heart rate and blood pressure. In
addition, your skin should be tested for malignant
melanomas on a regular basis.

Fictitious pharma code will be
updated at supplier proof stage.

Other medicines and Co-Beneldopa
Check with your doctor if you are taking any of the
following:
• Monoamine oxidase (MAO) inhibitors (used to
treat depression): the combination of these
medicines with Co-Beneldopa could cause
excessively high blood pressure. This could also
occur if you have taken an MAO inhibitor within
the last 2 weeks (see 'Do NOT take
Co-Beneldopa', above)
• Medicines that could strengthen or weaken the
effect of Co-Beneldopa.
• Other medicines used for the treatment of
Parkinson’s disease, such as bromocriptine,
amantadine, trihexyphenidyl or entacapone
• Ferrous sulphate (used to treat iron deficiency)
• Metoclopramide (used to treat digestive
disorders)
• Medicines belonging to a group called opioids,
such as codeine, oxycodone, morphine, or
tramadol (used to relieve pain)

22 December 2016

Medicines for high blood pressure that contain
reserpine (see 'Do NOT take
Co-Beneldopa',above)
Neuroleptics such as haloperidol, flupenthixol
or chlorpromazine (used to treat some
psychiatric disorders including severe anxiety
and schizophrenia, nausea, sickness and
hiccoughs)
Medicines for high blood pressure: your blood
pressure could become too low. Your doctor
may need to adjust the dose of your treatment
for high blood pressure
Medicines belonging to a group called
sympathomimetics, such as clonidine or
salbutamol, should not be used at the same
time as Co-Beneldopa: the effect of these
medicines could be strengthened. Your doctor
may need to adjust the dose of your
sympathomimetic treatment.

Co-Beneldopa may interfere with the results of
tests for levels of certain chemicals in the blood.

Fictitious pharma code will be
updated at supplier proof stage.

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4

Operations
If you are going to have an operation, tell the
doctor that you are taking Levodopa/Benserazide.
This is because you may need to stop taking it
before you have a general anaesthetic.
Tell your doctor or pharmacist if you are taking or
have recently taken or might take any other
medicines.
Taking Co-Beneldopa with food and drink
Taking Co-Beneldopa with high-protein meals
could reduce its effect.
When possible, you should take Co-Beneldopa
30 minutes to 1 hour after meals.
Pregnancy and breast-feeding
You must not take Levodopa/Benserazide if you are
pregnant. If you are of child-bearing age, you must
use reliable contraception during treatment with
Levodopa/Benserazide.
Nevertheless, if you still become pregnant or think
you may be pregnant, you must consult your
doctor. He/she will advice you how to stop
treatment with Levodopa/Benserazide.
You should not breast-feed during treatment with
Levodopa/Benserazide. If treatment with
Levodopa/Benserazide is necessary during
lactation, you should stop breast-feeding your baby.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
Levodopa is associated with somnolence
(excessive drowsiness) and, very rarely, with
excessive daytime sleepiness and sudden onset
sleep episodes. These can occur without warning
signs. If you experience these symptoms, you
must inform your doctor and you must refrain
from driving or engaging in activities where
impaired alertness may put yourself or others at
risk of serious injury (e.g. operating machines),
until such recurrent episodes and somnolence
have been resolved.

3

HOW TO TAKE CO-BENELDOPA

Always take Co-Beneldopa exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.
50 mg/12.5 mg strength:
Treatment with Co-Beneldopa is usually started
with low doses, e.g. one capsule two to four times
a day.
100 mg/25 mg strength:
Treatment with Co-Beneldopa is usually started
with low doses. Co-Beneldopa 100 mg/25 mg
Capsules are not appropriate for this and the
50 mg/12.5 mg strength is available for this purpose.
200 mg/50 mg strength:
Treatment with Co-Beneldopa is usually started
with low doses. Co-Beneldopa 200 mg/50 mg
Capsules are not appropriate for this and the
50 mg/12.5 mg strength is available for this purpose.
50 mg/12.5 mg strength: After three to seven days,
your doctor may, if necessary, begin to increase
your dose by one or two capsules every third to
seventh day, until you achieve suitable control of
your symptoms.
100 mg/25 mg strength: After three to seven days,
your doctor may, if necessary, begin to increase
your dose by one capsule every third to seventh
day, until you achieve suitable control of your
symptoms.
200 mg/50 mg strength: After three to seven days,
your doctor may, if necessary, begin to increase
your dose every third to seventh day, until you
achieve suitable control of your symptoms.
Co-Beneldopa 200 mg/50 mg Capsules are not
appropriate for this and other strengths are
available to this end.
The maximum dose is generally no more than
50 mg/12.5 mg: sixteen capsules a day.
100 mg/25 mg: eight capsules a day.
200 mg/50 mg: four capsules a day.
The daily dose should be spread out over the day
into several smaller doses. The size of individual
doses and the way they are spread throughout the
day must be adjusted to suit the needs of each
individual patient.
It may take several weeks for the full effect of your
medicine to become apparent.
If you have previously taken levodopa on its own
or with another decarboxylase inhibitor, you
should stop taking it twelve hours before you start
taking Co-Beneldopa.
When possible, you should take Co-Beneldopa
30 minutes to 1 hour after meals. You must
swallow the capsules whole, without chewing
them, with a drink.
If you take more Co-Beneldopa than you should
If you (or someone else) swallow a lot of the
capsules all together, or if you think a child has
swallowed any of the capsules, contact your
nearest hospital casualty department or your
doctor immediately. Please take this leaflet, any
remaining capsules and the container with you to
the hospital or doctor so that they know which
capsules were consumed.
Overdose may cause a worsening of your
symptoms, as well as confusion, hallucinations
and sleep disturbances. Nausea and vomiting
(feeling and being sick) and abnormal heart
rhythms may rarely occur.

Fictitious pharma code will be
updated at supplier proof stage.

TEVA UK Ref:

TEVA UK Ref:

Version:

231-30-86486-ZC LEA CO-BENELDOPA A/S CAP TUK Dim’s Changed?:
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No
460 mm
160 mm
N/A
N/A

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Keep out of the sight and reach of children.

If you stop taking Co-Beneldopa
Your doctor will advise you when you should stop
taking Co-Beneldopa. Usually, it is taken for a long
time since it replaces a substance, dopamine,
which is not produced in sufficient amounts by
patients with Parkinson’s disease.

This medicinal product does not require any
special storage conditions.

You must tell your doctor if you want to stop
taking Co-Beneldopa. Although it is rare, sudden
discontinuation of treatment can cause potentially
life-threatening side effects, including a condition
called neuroleptic malignant-like syndrome, which
involves greatly elevated body temperature,
muscle stiffness and psychological changes, and
akinetic crisis (inability to move). To avoid these,
your doctor will advise you how to end your
treatment.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
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
behaviors; they will discuss ways of managing or
reducing the symptoms
The following side effects have been reported at
the approximate frequencies shown:
Very common (may affect more than 1 in 10
people)
• Sleep disturbances, especially in the elderly
• Depressed mood*, especially in the elderly
• Loss of appetite
• Fluctuations in response such as ‘freezing’
(movement suddenly becoming difficult),
‘end-of-dose’ (a return of symptoms before the
next dose of medicine is due) and ‘on-off’
phenomena (sudden changes from periods of
good symptom control to periods where
symptoms are less controlled)*
• Distorted or impaired voluntary movement
(dyskinesia)
• Involuntary movements
In the later stages of treatment, and in many cases
after the medicine has been taken for many
years, uncontrollable, unusual movements of
the arms, legs, face and tongue can occur.
These may disappear if the daily dose is
changed or if the spread of doses throughout
the day can be improved.
• Nausea*
• Vomiting*
• Diarrhoea*
• Increased levels of the substance alkaline
phosphatase in blood
• Increased levels of the substances uric acid or
urea nitrogen in blood.

22 December 2016
PANTONE® GREEN C

Colours Used:

If you forget to take Co-Beneldopa
Do not take a double dose to make up for a
forgotten dose. Take your next dose as usual;
however, you may experience some return of
Parkinson’s disability in the meantime.

4

4

5

HOW TO STORE CO-BENELDOPA

Do not use this medicine after the expiry date
which is stated on the bottle and outer packaging.
The expiry date refers to the last day of the month.

Do not throw away medicines via wastewater or
household waste. Ask your pharmacist how to
dispose of medicines no longer required.These
measures will help to protect the environment.

6

CONTENTS OF THE PACK AND OTHER
INFORMATION

What Co-Beneldopa contains
• The active substances are levodopa and
benserazide.
• One capsule contains 50/100/200 mg of
levodopa and 12.5/25/50 mg of benserazide
(as hydrochloride).
• The other ingredients are as follows:
Capsule contents: mannitol, cellulose
microcrystalline, povidone K-30, talc,
magnesium stearate
Capsule shell: gelatin, titanium dioxide (E171),
black iron oxide (E172), 200/50 mg: red iron
oxide (E172), erythrosin (E127), indigo carmine
(E132).
Printing ink: shellac, propylene glycol,
potassium hydroxide, black iron oxide.
What Co-Beneldopa looks like and contents of the
pack
• Co-Beneldopa 50 mg/12.5 mg Capsules are
hard gelatin capsules with an opaque grey cap
imprinted ‘62.5’ axially in black ink, and an
opaque blue body imprinted ‘BL’ axially in black
ink, and filled with off-white to brownish white
granules. Available in white opaque bottles with
a white cap with desiccant containing 30, 50,
60, 90 and 100 capsules.
• Co-Beneldopa 100 mg/25 mg Capsules are hard
gelatin capsules with an opaque pink cap
imprinted ‘125’ axially in black ink, and an
opaque blue body imprinted ‘BL’ axially in black
ink, and filled with off-white to brownish white
granules. Available in white opaque bottles with
white cap with desiccant containing 20, 30, 50,
60, 90 and 100 capsules in container.
• Co-Beneldopa 200 mg/50 mg Capsules are hard
gelatin capsules with an opaque maroon cap
imprinted ‘250’ axially in black ink, and an
opaque blue body imprinted ‘BL’ axially in black
ink, and filled with off-white to brownish white
granules. Available in white opaque bottles with
white cap with desiccant containing 30, 60 and
100 capsules in container.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder: TEVA UK Limited,
Eastbourne, BN22 9AG
Company responsible for manufacture: TEVA
Pharmaceutical Works Private Limited Company,
Pallagi út 13, 4042 Debrecen, Hungary.
This leaflet was last revised in 12/2016.
PL 00289/0992
PL 00289/0993
PL 00289/0994

Common (may affect up to 1 in 10 people):
• Hallucinations, especially in the elderly
• Anxiety, especially in the elderly
• Abnormal heart rhythm
• Changes in blood pressure, which can be
improved by reducing the dose
• Taste alterations*.
Uncommon (may affect up to 1 in 100 people)
• Taste loss*.
Rare (may affect up to 1 in 1,000 people):
• Decreased white blood cell counts.
Not known (frequency cannot be estimated from
the available data)
• Decreased red blood cell or platelet counts
• Disorientation in time, especially in the elderly
• Agitation, especially in the elderly
• Delusions, especially in the elderly
• Mild elation
• Drowsiness
• Aggression
• 'Unmasking' of psychosis (a psychiatric
condition characterised by personality
derangement and loss of contact with reality)
• Dopamine dysregulation syndrome
• Confusion
• Excessive daytime sleepiness
• Sleep episodes
• Discoloured urine, usually red-tinged*
• Illness accompanying kidney failure (uraemia)
• Increased levels of the substances
transaminases in blood
• Allergic skin reactions such as itching and rash
• Irresistible urge to move your legs to stop
uncomfortable or odd sensations
• Bleeding in digestive tract
• Discoloured saliva, tongue, tooth or mouth
• Flushing and sweating.
** These side effects typically occur at the
beginning of treatment and can usually be
controlled by taking Co-Beneldopa with food or
drink and by increasing the dose more slowly.
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.

TEVA UK Limited

86486-ZC

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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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