CO-CARELDOPA TABLETS 10/100

Active substance: LEVODOPA

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Pharma code 1700

Children and adolescents
Co-Careldopa should not be used in children and
adolescents under 18 years old.
Carbidopa/Levodopa
Other medicines and Co-Careldopa
PACKAGE LEAFLET: INFORMATION
Do NOT take Co-Careldopa in combination with,
FOR THE USER
or if you have taken in the last 14 days:
• antidepressants known as MAOIs e.g. phenelzine,
Read all of this leaflet carefully before you start
isocarboxazid, tranylcypromine or moclobemide.
taking this medicine.
• Keep this leaflet. You may need to read it again. Talk to your doctor if you are taking any of the
• If you have any further questions, ask your
following:
doctor or pharmacist.
• anti-psychotic drugs e.g. benperidol, haloperidol,
• This medicine has been prescribed for you only.
chlorpromazine, flupentixol, fluphenazine
Do not pass it on to others. It may harm them,
• antidepressants e.g. amitriptyline
even if their symptoms are the same as yours.
• drugs to control blood pressure
• If you get any side effects, talk to your doctor or • anaesthetics
pharmacist. This includes any possible side
• benzodiazepines e.g. nitrazepam
effects not listed in this leaflet.
• anti-convulsants e.g. phenytoin
• anti-cholinergics e.g. benzatropine, orphenadrine
• papaverine.
1. What Co-Careldopa is and what it is used for
Please tell your doctor or pharmacist if you are
2. What you need to know before you take
taking or have recently taken any other medicines,
Co-Careldopa
including medicines obtained without a prescription.
3. How to take Co-Careldopa
Pregnancy, breast-feeding and fertility
4. Possible side effects
Do NOT take Co-Careldopa if you are pregnant,
5. How to store Co-Careldopa
planning to become pregnant or breast-feeding.
6. Contents of the pack and other information
Ask your doctor for advice before taking any
1 WHAT CO-CARELDOPA IS AND WHAT medicine.
Driving and using machines
IT IS USED FOR
Co-Careldopa can very rarely cause somnolence
Co-Careldopa is known as a dopaminergic medicine. (excessive drowsiness) and sudden sleep onset
episodes (where you may fall asleep very
Co-Careldopa Tablets are used to treat Parkinson’s
suddenly, sometimes without prior warning). If
disease, which is caused by a lack of a chemical,
called dopamine in the nervous system. The tablets affected do NOT drive or operate machinery.
will help to restore the level of dopamine and help
to reduce the signs and symptoms of the disease.
3 HOW TO TAKE CO-CARELDOPA

2

WHAT YOU NEED TO KNOW BEFORE
YOU TAKE CO-CARELDOPA

Do NOT take Co-Careldopa if you:
• are allergic (hypersensitive) to carbidopa
monohydrate or levodopa or any of the other
ingredients of this medicine
• are pregnant, planning to become pregnant or
breast-feeding
• are taking any medicines known as “mono-amine
oxidase inhibitors” MAOIs, (which are used to
,
treat depression) or have taken these within the
last 2 weeks (see Taking other medicines, Do
NOT take Co-Careldopa in combination with)
• have narrow-angle glaucoma (loss of vision due
to abnormally high pressure in the eye)
• have ever suffered from skin cancer or think that
you may have skin cancer
• have severe heart problems which can cause
shortness of breath or ankle swelling
• suffer from mental illness
• are under 18 years old.
Warnings and precautions
Talk to your doctor before you start to take this
medicine if you:
• have kidney problems
• have heart problems including history of a
heart attack and irregular heart beats
• have lung problems
• have breathing difficulties
• have liver problems
• have hormone problems
• have a history of fits
• have ever had ulcers of the stomach or gut
• have previously taken levodopa
• have wide-angle glaucoma (loss of vision due
to abnormally high pressure in the eye)
• are following a high-protein diet.
Your doctor will want to monitor you during your
treatment with Co-Careldopa for the development
of mental changes, depression with suicidal
tendencies, and other changes in personality (see
Section 4, Possible Side Effects).
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.

Always take Co-Careldopa exactly as your doctor
has told you. You should 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.
Your doctor will tell you how many tablets to take
each day. During the first few weeks your doctor
may change your dose of Co-Careldopa until it is
exactly right. You may also be given Co-Careldopa
in combination with other medicines.
The tablets should be swallowed preferably with
a drink of water.
The recommended dose is:
• Adults (including the elderly)
Your doctor will calculate your dose for you
depending on your needs.
• Patients already being treated with
levodopa, either on its own or in
combination with another medicine
If you are taking levodopa, either on its own or
in combination with another medicine, it will be
discontinued at least 12 hours before starting
treatment with Co-Careldopa.
Use in children and adolescents
Co-Careldopa should not be used in children and
adolescents under 18 years old.
If you take more Co-Careldopa 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. An overdose is likely to cause
irregular heart beats. Please take this leaflet, any
remaining tablets and the container with you to
the hospital or doctor so that they know which
tablets were consumed.
If you forget to take Co-Careldopa
You should continue to take these tablets for as
long as your doctor tells you to. If you forget to
take a tablet, take one as soon as you remember,
unless it is nearly time to take the next one. Do
not take a double dose to make up for a forgotten
dose. Take the remaining doses at the correct time.
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 product, ask your doctor or pharmacist.

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

4

POSSIBLE SIDE EFFECTS

Like all medicines, Co-Careldopa 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:
• 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).
The following side effects have also been
reported commonly:
• muscle twitching, shaking or other unwanted
jerky movements of the body, eyelid twitching
• feeling sick.
The following side effects have been reported less
frequently:
• slow heart rate, palpitations
• a fall in blood pressure on standing up which
causes dizziness, light-headedness or fainting
• loss of appetite
• vomiting
• dizziness
• drowsiness.
The following side effects have been reported
rarely:
• bleeding in the stomach
• gut ulcers
• high blood pressure
• inflammation of a vein
• anaemia or blood disorders
• chest pain
• difficulty breathing
• tingling or numbness
• fits.
The following side effects have also been reported:
• lack of coordination, falling and difficulty in
walking normally, hand shaking, muscle cramp,
lockjaw
• confusion, delusions, agitation, anxiety
• difficulty sleeping, nightmares, hallucinations
• abnormal feeling of well-being
• 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.
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 CO-CARELDOPA

Keep out of the sight and reach of children.
These tablets should not be stored above 25°C
and should be kept in the package or container
supplied. Do not transfer them to another
container.
Do not use Co-Careldopa 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 to protect the environment.

6

CONTENTS OF THE PACK AND OTHER
INFORMATION

What Co-Careldopa Tablets contain:
• The active ingredients are carbidopa
monohydrate and levodopa.
• The 10/100 mg tablets contain 10.8 mg carbidopa
monohydrate (corresponding to 10 mg
carbidopa anhydrous) and 100 mg levodopa.
• The 25/100 mg tablets contain 27 mg carbidopa
monohydrate (corresponding to 25 mg
carbidopa anhydrous) and 100 mg levodopa.
• The 25/250 mg tablets contain 27 mg carbidopa
monohydrate (corresponding to 25 mg
carbidopa anhydrous) and 250 mg levodopa.
• The other ingredients are maize starch,
pregelatinised maize, microcrystalline cellulose,
magnesium stearate. The 10/100 mg and
25/250 mg tablets also contain indigo carmine
(E132). The 25/100 mg tablets also contain
quinoline yellow aluminium lake (E104).
What Co-Careldopa Tablets look like and contents
of the pack:
• The 10/100 mg tablets are mottled blue, round,
flat-bevelled tablets, 9.1 mm in diameter, plain
and breakline on each side.
• The 25/100 mg tablets are mottled yellow,
round, flat-bevelled tablets, 9.1 mm in
diameter, plain and breakline on each side.
• The 25/250 mg tablets are mottled blue, round,
flat-bevelled tablets, 10.3 mm in diameter, plain
on each side and breakline on one side.
• The product is available in pack sizes of 20, 30,
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 is TEVA UK Limited,
Eastbourne, BN22 9AG.
This leaflet was last revised: April 2013
PL 00289/0783-5

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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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