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CARAMET 25 MG / 100 MG CR TABLETS

Active substance(s): CARBIDOPA MONOHYDRATE / LEVODOPA

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Caramet® 25 mg/100 mg
& 50 mg/200 mg CR Tablets
Carbidopa/Levodopa
PACKAGE LEAFLET:

Children and adolescents
This medicine is not recommended
for children and adolescents under
18 years of age.

INFORMATION FOR THE USER
Other medicines and Caramet
Read all of this leaflet carefully before
• Medicines to lower blood pressure,
you start using this medicine because
such as an ACE inhibitor (e.g.
it contains important information for
captopril, enalapril), a thiazide (e.g.
you.
bendroflumethiazide), a
beta-blocker (e.g. sotalol,
• Keep this leaflet. You may need to
propranolol), a calcium-channel
read it again.
blocker (e.g. verapamil),
• If you have any further questions,
moxonidine or reserpine
ask your doctor or pharmacist.
• This medicine has been prescribed • Tricyclic antidepressants, e.g.
amitriptyline
for you only. Do not pass it on to
• Medicines that help relax muscles
others. It may harm them, even if
and stop shaking, such as atropine
their signs of illness are the same as
sulphate, hyoscine butylbromide
yours.
or papavarine
• If you get any side effects talk to
• Selegiline or entacapone, used to
your doctor or pharmacist. This
treat Parkinson’s disease
includes any possible side effects
• Amantadine (used to treat
not listed in this leaflet.
Parkinson’s disease and viral
What is in this leaflet:
infections)
1. What Caramet is and what it is used • Metoclopramide (used to treat
for
nausea and sickness)
2.What you need to know before you • Sympathomimetic active
take Caramet
substances e.g. adrenaline,
3.How to take Caramet
noradrenaline, or ephedrine.
4.Possible side effects
Ephedrine may be present in
5.How to store Caramet
medicines for colds and nasal
6.Contents of the pack and other
stuffiness
information
• Iron tablets for anaemia
• Phenytoin, used in the treatment of
1 WHAT CARAMET IS AND WHAT epilepsy
IT IS USED FOR
• Monoamine oxidase inhibitors
(MAOIs) used to treat depression
• Caramet contains levodopa, which
e.g. phenelzine
is a dopaminergic agent and

An
anticholinergic agent (used to
carbidopa, which is a
treat nerve impulses) e.g.
dopa-decarboxylase inhibitor.
trihexyphenidyl
• Caramet is used in the therapy of
• If you are also taking a
Parkinson’s disease.
neuroleptic/antipsychotic
• Parkinson’s disease is caused by a
medicinal product (used to treat
lack of a chemical called dopamine
mental illness) e.g. chlorpromazine
in the nervous system. Levodopa is
converted in the brain to dopamine, • Isoniazid.

increasing the amount in the brain
to a normal level. Carbidopa itself
does not enter the brain but is there
to prevent the conversion of
levodopa to dopamine outside the
brain. This helps to reduce
unwanted effects in other parts of
the body. The controlled release
tablets are generally used if therapy
with the normal rapid release tablets
or with levodopa alone does not
adequately control your symptoms.

2

WHAT YOU NEED TO KNOW
BEFORE YOU TAKE CARAMET

Please also tell your doctor or
pharmacist if you are taking or have
recently taken any other medicines,
including medicines obtained
without a prescription.
Caramet with food and drink
Tell your doctor if you are on a
high-protein diet, as it may affect the
effectiveness of Caramet.
Caramet should be taken 30 minutes
before a meal.
Pregnancy, breast-feeding and
fertility

Do NOT take Caramet:
• If you are allergic (hypersensitive) to
carbidopa, levodopa or any of the
ingredients of this medicine
• If you suffer from narrow-angle
glaucoma (increased pressure in the
eye)
• If you suffer from severe heart
disease
• If you have had an acute stroke
• If you have ever suffered from skin
cancer or think that you may have
skin cancer
• If you are taking or have recently
taken medicines known as
non-selective monoamine oxidase
inhibitors (MAO inhibitors) and
selective MAO-A inhibitors, used to
treat depression, such as
phenelzine, isocarboxazid or
moclobemide. These medicines
must be discontinued at least two
weeks before you start taking
Caramet
• If you suffer from hallucinations,
delusions or mental confusion
• If you have an abnormal heart beat
• If you know that you are not allowed
to take sympathomimetic agents
e.g. ephedrine (may be present in
medicines for colds and nasal
stuffiness), adrenaline or
noradrenaline.
Warnings and precautions
Talk to your doctor:
• If you have previously taken
levodopa for your illness, as this
treatment should be stopped at
least 12 hours before you start to
take Caramet, and you may be more
prone to abnormal muscle
movements at the beginning of
treatment
• If you have previously suffered from
severe abnormal muscle movements
or mental illness, including
depression as you will need to be
closely monitored by your doctor in
case these symptoms return
• If you have heart or lung disease,
asthma, kidney or liver problems
• If you have been told by your doctor
that you have an endocrine
(hormone) disturbance
• If you have a history of stomach
ulcers, coughing up blood or fits
• If you have recently suffered a heart
attack, as you will require more
careful monitoring.
• 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.

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Tell your doctor if you or your
family/carer notices you are
developing addiction-like symptoms
leading to craving for large doses of
Caramet and other medicines used to
treat Parkinson’s disease.

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Do not take Caramet if you are
pregnant, planning to become
pregnant or breast-feeding.
Women of child-bearing age must
use a reliable form of contraception
whilst taking Caramet.
Ask your doctor or pharmacist for
advice before taking any medicine.
Driving and using machines
Some people treated with Caramet
may suffer from light-headedness or
drowsiness and sudden onset of
sleep without any prior warning. If
this side effect happens to you, you
must not drive or operate machinery.
This applies until you are sure that
these recurrent episodes or the
drowsiness have subsided.

3

HOW TO TAKE CARAMET

Always take Caramet exactly as your
doctor has told you. You should
check with your doctor or pharmacist
if you are not sure.
The tablets should be swallowed
whole, with a drink of water and be
taken 30 minutes before a meal.
The usual dosage instructions are
given below:
The number of tablets you should
take each day will depend upon your
personal needs. Your doctor will tell
you how many tablets to take each
day. During the first few weeks your
doctor may change your dose of
Caramet until it is exactly right. It is
important to follow your doctor’s
instructions carefully. If you are not
sure of anything, always ask your
doctor.
Depending on your needs, the
dosage may be as low as one
prolonged-release tablet taken twice
daily. Higher dosages should not
normally exceed 8 tablets per day,
taken in three or more divided
doses, at intervals of between 4 and
12 hours.
If you are taking levodopa with
another medicine, this treatment will
be discontinued at least 12 hours
before starting treatment with
Caramet.
Use in children and adolescents
This medicine is not recommended
for children and adolescents under
18 years of age.
If you take more Caramet than you
should
If you (or someone else) swallow a
lot of the tablets all together, or if
you think a child has swallowed any
of the tablets, contact your nearest
hospital casualty department or your
doctor immediately.
If you forget to take Caramet
If you forget to take a dose, take it as
soon as you remember, unless it is
nearly time to take the next one.
Never take two doses together. Take
the remaining doses at the correct
time.

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If you stop taking Caramet
You should continue to take these
tablets for as long as your doctor tells
you to. Do not stop taking your
medicine unless your doctor tells you
to. If this is the first time you are
taking this type of medicine for your
symptoms, it may be up to 6 months
before you can see the full benefit of
your treatment. If your treatment is
discontinued or reduced abruptly you
will require careful monitoring by
your doctor.
If you have any further questions on
the use of this product, ask your
doctor or pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Caramet can
cause side effects, although not
everybody gets them.
If the following happens, stop taking
Caramet and tell your doctor
immediately or go to the casualty
department at your nearest hospital:
• Fever and serious deterioration of
your general condition
• An allergic reaction: swelling of the
face, hands, feet, lips, tongue or
throat, or difficulty in breathing or
swallowing. This is a very serious
but rare side effect. You may need
urgent medical attention or
hospitalisation.
The following side effects have been
reported at the approximate
frequencies shown:
Common (affecting fewer than one
person in 10 but more than one
person in 100):
• Loss of appetite
• Hallucinations, confusion,
light-headedness
• Nightmares, drowsiness,
exhaustion,
• Problems sleeping, depression
• Abnormal feeling of well-being
• Memory loss, periods of mental
illness
• Abnormal muscle movements,
including uncontrolled movements
that seem to move around the
body, abnormal muscle rigidity
• Impairment of voluntary movement
i.e. tremors, tics, changes in muscle
tone, slowness of movement,
problems with speech
• Palpitations, irregular heart beat
• Problems with balance, feeling faint
and fainting
• Nausea, vomiting, dry mouth and
bitter taste in the mouth.

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significant concern to the patient or
others).
• 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)
Very rare (affecting fewer than one
person in 10,000):
• Severe reduction in the number of
white blood cells, which makes
infections more likely
• Extreme daytime drowsiness and
sudden on-set of sleep.
Not known (cannot be estimated
from the available data)
• Craving for large doses of Caramet
in 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 Caramet.
If any of the side effects get serious, if
you notice any side effects not listed
in this leaflet or if you experience any
of these unusual behaviours
mentioned before, please tell your
doctor or pharmacist; they will
discuss ways of managing or
reducing the symptoms.

5

HOW TO STORE CARAMET

Keep out of the reach and sight of
children. Do not take after the expiry
date that is stated on the outer
packaging. This medicinal product
does not require any special storage
instructions.
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 Caramet contains:
• The active ingredients are levodopa
and carbidopa
• Each 25 mg/100 mg
prolonged-release tablet contains
100 mg of levodopa and 25 mg of
carbidopa as carbidopa
monohydrate
• Each 50 mg/200 mg
prolonged-release tablet contains
200 mg of levodopa and 50 mg of
carbidopa as carbidopa
Uncommon (affecting fewer than one
monohydrate
person in 100 but more than one
• The other ingredients are:
person in a 1,000):
In the core: fumaric acid,
• Weight loss or weight gain
hypromellose, sodium stearyl
• Lethargy, increased tremor and
fumarate, colloidal silica anhydrous,
shaking in the hands
and quinoline yellow (E104)
• High blood pressure
In the coating: hypromellose,
• Hoarseness, chest pain
macrogol, iron oxides (E172) and
• Constipation, diarrhoea, excess
titanium dioxide (E171).
production of saliva
• Difficulty in swallowing, wind
What Caramet looks like and
• Generalised swelling
contents of the pack:
• Muscle spasms
• Caramet 25 mg/ 100 mg CR tablets
• Dark discolouration of the urine
are orange-brown , round ,
• Feeling of weakness, a general
biconcave prolonged-release
feeling of being unwell
tablets
• An apparent worsening of
Parkinson symptoms (“flare-ups”). • Caramet 50 mg/ 200 mg CR tablets
are orange-brown , round ,
Rare (affecting fewer than one person biconvex prolonged-release tablets
in 1,000 but more than one person in • The 25 mg/100 mg product is
available in pack sizes of 20, 30, 50,
10,000):
60 & 100 tablets
• Agitation, fear, difficulty thinking
• The 50 mg/200 mg product is
• Blood disorders which may be
characterised by fever or chills, sore available in pack sizes of 20, 25, 30,
60 & 100 tablets.
throat, ulcers in your mouth or
throat, unusual tiredness or
Marketing Authorisation Holder and
unusual bleeding or unexplained
Manufacturer
bruising
The Marketing Authorisation holder
• Disorientation, headache,
is TEVA UK Limited, Eastbourne,
sluggishness, fits
BN22 9AG and the company
• A reaction to an active substance
responsible for manufacture is
characterised by fever, muscle
Pharmachemie B.V., Haarlem, The
rigidity, feeling dizzy or faint,
tremor, drowsiness and confusion. Netherlands.
Other symptoms can include fits
This leaflet was last revised:
and changes in heart rate
September 2017
• Pins and needles and numbness,
falling over, problems walking
• Restriction in the opening of the
mouth, blurred vision, a
dysfunction of the nerves in the
face and around the eye which
causes uncontrollable prolonged
blinking
• Horner’s syndrome which causes a
constricted pupil, drooping eyelids
and facial dryness
• Eye problems including double
vision and dilation of the pupils in
the eye
• Inflammation of a vein (sometimes
accompanied by a clot)
• Shortness of breath and other
breathing problems
• Increased sexual desire
• Heartburn/indigestion, stomach
pain, a dark discolouration of the
saliva
• Teeth clenching, hiccups, stomach
ulcers, dark tarry stools, burning
sensation in the mouth
• Nettle rash, itching, flushing, hair
loss, redness and swelling
• Increased sweating, a dark
discolouration of the sweat
• Activation of skin cancer, a rash
caused by inflammation and
leaking of blood vessels
• Difficulty in passing urine or
incontinence
• Serious, painful, persistent erection
• Pathological gambling (failure to
resist gambling impulses despite
serious personal or family
consequences)
• Increased sex drive
• Hypersexuality (altered sexual
interest and behaviour of
EAS1467b

Version 2.4

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