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CARBIDOPA/LEVODOPA 10 MG/100 MG TABLETS

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

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Package leaflet: Information for the user
Co-Careldopa 12.5 mg/50 mg tablets
Co-Careldopa 10 mg/100 mg tablets
Co-Careldopa 25 mg/100 mg tablets
Co-Careldopa 25 mg/250 mg tablets
carbidopa/levodopa
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
1. What Co-Careldopa is and what it is used for
Co-Careldopa improves the signs of Parkinson’s disease. Parkinson’s disease is
a long-term illness where:
• you become slow and unsteady
• your muscles feel stiff
• you may develop shaking or trembling (called ‘tremor’).
If not treated, Parkinson’s disease can make it hard for you to continue your
normal daily activities. Co-Careldopa contains two different medicines called:
levodopa and carbidopa.
• levodopa turns into a material called ‘dopamine’ in your brain. The dopamine
helps to improve the signs of your Parkinson’s disease.
• carbidopa belongs to a group of medicines called ‘aromatic amino acid
decarboxylase inhibitors’. It helps levodopa work more effectively by slowing
the speed at which levodopa is broken down in your body.
2. What you need to know before you take Co-Careldopa
Do not take Co-Careldopa:
• if you are allergic to carbidopa or levodopa or any of the other ingredients of
this medicine (listed in section 6).
• if you have ever had skin cancer or you have any unusual moles which have
not been examined by your doctor
• if you are taking certain medicines called ‘MAOIs’ (Monoamine Oxidase
Inhibitors) used for depression. You need to stop using these medicines at
least two weeks before you start Co-Careldopa (see also under ‘Taking other
medicines’ below).
• if you have a condition called ‘narrow-angle glaucoma’ that may cause a
sudden build up of pressure in the eye
• if you suffer from attacks of hypertension induced by tumor of the adrenal
medulla (pheochromocytoma)
• hormonal problems (overproduction of cortisol or thyroid hormone)
• if you have severe heart disease
Do not take Co-Careldopa if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist before taking CoCareldopa.
Warnings and precautions
Talk to your doctor or pharmacist before taking Co-Careldopa:
• if you have a history of fits (convulsions)
• if you have a lung problem (such as bronchial asthma)
• if you have had an ulcer in your gut (called ‘duodenal’ or ‘peptic ulcer’) or
have vomited blood
• if you have had a heart attack, heart beat problems, circulation problems
• if you are taking a medicine which may cause low blood pressure when rising
from a chair or bed (orthostatic hypotension)
• if you have kidneyor liver problems
• if you have hormonal problems
• if you have had depression or other mental problems
• if you have a condition called ‘chronic wide-angle glaucoma’ that may cause
a build-up of pressure in the eye. You will need to have regular checks on the
pressure in your eye.
• if you sometimes have sudden sleep attacks or sometimes feel very sleepy
• if you are due to have surgery.
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.
This medication can affect some laboratory tests that your doctor may perform
on blood or urine samples. Please remind your doctor if you are taking CoCareldopa and are having any tests.
Other medicines and Co-Careldopa
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
This is because Co-Careldopa can affect the way some other medicines work.
Also some other medicines can affect the way Co-Careldopa works.
In particular tell your doctor or pharmacist if you are taking other medicines for:

• Parkinson’s disease (such as tolcapone, entacapone, amantadine)
• Severe allergic reactions, asthma, chronic bronchitis, heart diseases and low
blood pressure (such as anticholinergics and sympathomimetics)
• Fits (convulsions) or epilepsy (such as phenytoin)
• High blood pressure (antihypertensives)
• Mental problems (antipsychotics such as phenothiazines, butyrophenons and
risperidone)
• Depression (such as ‘tricyclic antidepressants’ or ‘non-selective monoamine
oxidase inhibitors’)
• Tuberculosis (such as isoniazide)
• Anxiety (such as benzodiazepines)
• Anaemia (such as iron tablets)
• Sickness (such as metoclopramide)
• Spasms in the blood vessels (such as papaverine).
If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before taking this medicine.
Co-Careldopa with food and drink
Try to avoid taking your tablets with a heavy meal. If your diet contains too
much protein (meat, eggs, milk, cheese) Co-Careldopa may not work as well
as it should.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before taking
this medicine.
Do not take Co-Careldopa if you are breast-feeding.
Driving and using machines
Co-Careldopa may lower your blood pressure, which may make you feel lightheaded or dizzy. Therefore, be particularly careful when you drive or when you
use any tools or machines.
Co-Careldopa can also make you sleepy or cause ‘sudden sleep attacks’. If this
happens to you, you must not drive or use tools or machines. Your doctor will
tell you if you can start driving again if these attacks stop.
3. How to take Co-Careldopa
Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
The dosage will be decided by your doctor who will adjust the dosage individually
for you. Your doctor will monitor you on a regular basis and adjust your dosage
if necessary.
Taking this medicine
• Take this medicine by mouth.
• Although your medicine can have an effect after one day, it may take up to
seven days to work.
• Take them at regular time intervals according to your doctor’s instructions.
• Do not change the times at which you take your tablets or take any other
medicines for Parkinson’s disease without first consulting your doctor.
• Try to avoid taking your tablets with a heavy meal.
For doses not realisable/practicable with this medicinal product, other medicinal
products are available.
If you have not had levodopa before
The usual starting dose is:
• for Co-Careldopa 12.5 mg/50 mg Tablets: one tablet three or four times a
day.
• for Co-Careldopa 25 mg/100 mg Tablets: one tablet three times a day.
• for Co-Careldopa 10 mg/100 mg Tablets: one tablet three or four times a day.
If you have had levodopa before
• your doctor will ask you to stop taking your medicine for Parkinson’s disease
before you start taking Co-Careldopa.
More than one strengths of Co-Careldopa may be prescribed by your doctor.
If you have been given different strengths of Co-Careldopa tablets to take,
make sure that you are taking the correct one at the right time.
Co-Careldopa 12.5 mg/50 mg tablets: The score line is only to facilitate
breaking for ease of swallowing and not to divide into equal doses.
Use in children and adolescents
Co-Careldopa is not recommended for children or adolescents under 18 years.
If you take more Co-Careldopa than you should
If you take too many tablets see your doctor immediately.
If you forget to take Co-Careldopa
Do not take a double dose to make up for a forgotten dose.
If you stop taking Co-Careldopa
Do not stop taking Co-Careldopa or change your dose until your doctor tells
you to. If you stop taking Co-Careldopa the following can occur: stiff muscles,
high temperature (fever) and mental changes.
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 Co-Careldopa and see your doctor straight away, if you
notice any of the following side effects:
• allergic reaction, the signs may include hives (nettle rash), itching, rash,

swelling of your face, lips, tongue or throat. This may cause difficulty in
breathing or swallowing
• chest pain
• uneven (irregular) heart beat or palpitations
• bleeding from your gut which may be seen as blood in your faeces or darkened
faeces (gastro- intestinal bleeding)
• blood problems, the signs may include pale skin (pallor), tiredness, fever,
sore throat or mild bruising and prolonged bleeding after injury
• muscle stiffness, severe inability to sit still, high fever, sweating, increased
salivation and impaired consciousness (neuroleptic malignant syndrome)
• mental changes including delusions, hallucinations and depression (very
rarely) suicidal tendencies
• fits (convulsions).
Other side effects that may occur:
Common (may affect up to 1 in 10 people):
- loss of appetite (anorexia)
- confusion, dizziness, nightmares, drowsiness, tiredness, sleeplessness, feeling
of well-being (euphoria), dementia, feeling of stimulation, dream abnormalities
- movement disorders (dyskinesia), a disorder characterised by sudden
involuntary movements (chorea), muscle tone disorder (dystonia), movement
disorders caused from outside the nervous system , sudden changes in
Parkinson’s symptoms (“on-off” symptoms), slowdown in movements during
“on-off” periods (bradykinesia)
- a drop in blood pressure caused e.g. by getting up too quickly from a sitting or
lying position, sometimes accompanied by dizziness (orthostatic hypotension),
tendency to faint
- sudden loss of consciousness
- nausea, vomiting, dry mouth, bitter taste
Uncommon (may affect up to 1 in 100 people):
- weight loss or weight gain
-

disturbance of muscle coordination (ataxia), increase in hand tremors
increase in blood pressure
hoarseness, chest pain
constipation, diarrhea, wind
increased salivation, difficulties in swallowing
fluid accumulation (oedema)
muscle spasms
dark urine
loss of strength (asthenia), weakness
feeling of being unwell (malaise)
hot flushes

Rare (may affect up to 1 in 1,000 people):
- a blood disorder (lack of white blood cells) accompanied by an increased
susceptibility to infections (leukopenia), anaemia , a blood disorder (lack
of blood platelets) accompanied by bruising and a tendency to bleed
(thrombocytopenia)
- excitement (agitation), anxiety, impaired ability to think, disorientation,
headache, increased sexual desire, numbness, fits/ seizures
- episodes of serious mental illness, during which control over one’s own
conduct and behaviour is impaired
- a serious condition as a result of using neuroleptics, which may manifest as
muscle stiffness, a severe inability to sit still, high fever, sweating, increased
salivation and impaired consciousness (neuroleptic malignant syndrome),
- feelings of prickling, tingling and itchiness without any apparent cause ,
- more frequent falling, gait disorders, lockjaw
- blurred vision, spasm of the orbicularis oculi muscle surrounding the eye
(this may be a sign of overdosage), activation of a pre-existing Horner’s
syndrome (an eye disorder), double vision, dilated pupils, a deterioration in
eye movements,
- inflammation of the veins
- breathlessness, abnormal breathing patterns
- impaired digestion with symptoms such as feelings of fullness in the upper
abdomen, upper abdominal pain, belching, nausea, vomiting and heartburn
(dyspepsia), stomach and intestinal pain, dark saliva, grinding of teeth, hiccups,
stomach and intestinal bleeding , burning tongue, duodenal ulcers
- sudden build-up of fluid in the skin and mucous membranes (e.g. throat and
tongue), breathing difficulties and/or itching and skin rash, often appearing as
an allergic reaction (angioedema)
- skin rash with severe itching and the formation of wheals (urticaria), itching,
facial redness, hair loss, skin rash, increased sweating, dark sweat
- in children, allergy-related bleeding in the skin and gastrointestinal tract wall
(Schönlein- Henoch purpura)
- urine retention, involuntary passing of urine, persistent erection (priapism)
Very rare (may affect up to 1 in 10,000 people):
- a very serious blood disorder (lack of white blood cells) accompanied by
sudden high fever, severe sore throat and mouth ulcers (agranulocytosis)
- drowsiness and constant daytime fatigue/ sudden attacks of sleep
Not known (frequency cannot be estimated from the available data):
- muscle twitching
- 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)

Reporting of side effects
If you get any 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 to 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 use this medicine after the expiry date which is stated on the blister and
carton after EXP. 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 contains
- The active substances are carbidopa and levodopa.
Each tablet of Co-Careldopa contains 13.5 mg carbidopa monohydrate
(equivalent to 12.5 mg of anhydrous carbidopa) and 50 mg levodopa.
Each tablet of Co-Careldopa contains 10.8 mg carbidopa monohydrate
(equivalent to 10 mg of anhydrous carbidopa) and 100 mg levodopa.
Each tablet of Co-Careldopa contains 27.0 mg carbidopa monohydrate
(equivalent to 25 mg of anhydrous carbidopa) and 100 mg levodopa.
Each tablet of Co-Careldopa contains 27.0 mg carbidopa monohydrate
(equivalent to 25 mg of anhydrous carbidopa) and 250 mg levodopa.
- The other excipients are:
10 mg/100 mg and 25 mg/250 mg: crospovidone, indigo carmine lake (E132),
magnesium stearate, cellulose microcrystalline, pregelatinised starch
12.5mg/50 mg and 25 mg/100 mg: crospovidone, quinoline yellow lake
(E104), magnesium stearate, cellulose microcrystalline, pregelatinised starch
What Co-Careldopa looks like and contents of the pack
Co-Careldopa 12.5 mg/50 mg tablets are light yellow colored, oval shaped,
with dimensions of 9.65 mm x 5.00 mm, with “C” on one side and “17” on
other side of tablet.
Co-Careldopa 10 mg/100 mg tablets are light blue colored, round shaped, with
a diameter of 8 mm, with “C” on one side and “18” on other side of tablet.
Co-Careldopa 25 mg/100 mg tablets are light yellow colored, round shaped,
with a diameter of 8 mm, with “C” on one side and “19” on other side of tablet.
Co-Careldopa 25 mg/250 mg tablets are light blue colored, round shaped, with
a diameter of 10.40 mm, with “C” on one side and “20” on other side of tablet.
Pack-sizes:
12.5 mg/50 mg and 10 mg /100mg: blister packs of 30, 50, 90, 100 tablets
25 mg /100mg and 25 mg /250mg: blister packs of 30, 50, 60, 90, 100, 200
tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Fair-Med Healthcare GmbH Planckstrasse 13
Hamburg 22765 Germany
Manufacturer:
Fair-Med Healthcare GmbH Industriestr. 32-36
23843 Bad Oldesloe
Germany
Pharmadox Healthcare Ltd KW20A – Kordin Industrial Park – Paola, PLA 3000
Malta
This medicinal product is authorised in the Member States of the EEA
under the following names:
Czech Republic: Carbidopa/Levodopa Fair-Med 25mg/100mg, 25mg/250mg
Denmark: Carbidopa/Levodopa Fair-Med 12,5mg/50mg, 25mg/100mg
SE (RMS): Carbidopa/Levodopa 12,5mg/50mg, 10mg/100mg, 25mg/100mg,
25mg/250mg tabletter
Finland: Carbidopa/Levodopa Fair-Med 12,5mg/50mg, 25mg/100mg tabletti
Germany: Levodopa/Carbidopa Fair-Med Healthcare 25mg/100mg,
25mg/250mg Tabletten
Ireland: Carbidopa/Levodopa Fair-Med 12.5mg/50mg, 10mg/100mg,
25mg/100mg, 25mg/250mg Tablets
Malta: Carbidopa/Levodopa Fair-Med 12.5mg/50mg, 10mg/100mg,
25mg/100mg, 25mg/250mg Tablets
Netherlands: Carbidopa/Levodopa Fair-Med, 12,5mg/50mg, 10mg/100mg,
25mg/100mg, 25mg/250mg tabletten
Norway: Carbidopa/Levodopa Fair-Med 12,5mg/50mg, 25mg/ 100mg
Portugal: Levodopa + Carbidopa Fair-Med 25mg/100mg, 25mg/250mg blister
United Kingdom: Co-Careldopa 12.5mg/50mg, 10mg/100mg, 25mg/100mg,
25mg/250mg Tablets
This leaflet was last revised in Januar 2017.

Tell your doctor if you experience any of these behaviors; they will discuss
ways of managing or reducing the symptoms.
If any symptoms persist or you experience any other side effects please tell your
doctor or pharmacist. It will help if you make a note of what you experienced,
when it started and how long it lasted.
CoCa all uk v002 on

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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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