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Active substance: LEVODOPA

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Apodespan PR 50/200 mg
Prolonged release tablets
Carbidopa and 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, pharmacist or nurse.
- This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their sign of illness are the same as yours.
- If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Apodespan PR is and what it is used for
2. What you need to know before you take
Apodespan PR
3. How to take Apodespan PR
4. Possible side effects
5. How to store Apodespan PR
6. Contents of the pack and other information

1. What Apodespan PR is and
what it is used for
Apodespan PR are used in the treatment of
Parkinson’s disease. It reduces the “off” time (a
sudden onset of muscle stiffness that can last for
minutes or even hours) if you are being treated
with levodopa alone, levodopa/decarboxylase
inhibitor tablets with an immediate-release
formulation (e.g. carbidopa) and if you suffer from
sudden uncontrolled movements.
Apodespan PR belongs to a class of drugs used
to treat Parkinson’s disease.
The symptoms of this disease are probably
caused by a lack of dopamine, a substance that
is normally produced by the brain. Dopamine
plays a role in controlling muscle movement. A
lack of it causes problems in muscle movement.
Levodopa compensates for the lack of dopamine,
whilst carbidopa ensures that enough levodopa
reaches the brain.

2. What you need to know before
you take Apodespan PR
Do not take Apodespan PR:
• if you are allergic (hypersensitive) to
carbidopa or levodopa or any of the other
ingredients of Apodespan PR
• if you have increased eye pressure
(narrow-angle glaucoma)
• if you are suffering from severe heart failure
• if you have a serious heart rhythm disorder
• in the event of a sudden stroke
• if you are not allowed to use drugs that act on
the central nervous system
(sympathomimetic agents)
• if you are using non-selective monoamine
oxidase inhibitors and selective, type-A
MAO inhibitors (MAO inhibitors; drugs used in
depression). You must stop taking these drugs
for at least two weeks before starting treatment
with Apodespan PR .
• Apodespan PR may be co-administered with the
recommended dose of a MAO inhibitor which is
selective for MAO type B (e.g. selegiline).
Because levodopa may activate a malignant
melanoma, Apodespan PR should not be used in
patients with suspicious undiagnosed skin
lesions or a history of melanoma.
Take special care with Apodespan PR
If you are currently being, or have ever been,
treated with levodopa on its own. You must wait
for at least 12 hours before you can start taking
Apodespan PR
• if you suffer from movement disorders such as
facial muscle twitches, muscle rigidity and
stiffness, difficulties in starting to move,
trembling of the fingers or hands. It may be
necessary to reduce the dose.
• if you have ever suffered from involuntary
movements in the past
• if you have ever had a psychotic episode or
suffered from psychosis. Psychosis is a severe
mental illness whereby control over one’s own
conduct and behaviour is impaired. Very rarely,
there have been reports of patients who
became depressed and who later developed
suicidal tendencies. If you think that this also
applies to you, you are advised to contact your
doctor immediately.
• if you are constantly tired and/or prone to falling
asleep without warning. You must not drive or
operate machines; your doctor will adjust your dose
if necessary, or stop your treatment altogether.
• if you have a severe cardiovascular condition
• if you have a severe lung disease or if you
experience sudden attacks of breathlessness
caused by muscular spasms and swelling of the
mucous membrane inside the airways, often
accompanied by coughing and the production of
phlegm (bronchial asthma)
• if you have a kidney or liver disorder, or if you
have problems with your endocrine system
(glands that secrete hormones internally into
the blood stream)
• if you have ever had stomach or intestinal
ulcers, as there is a greater risk of stomach
• if you are vomiting blood
• if you have ever had seizures/ convulsions
• if you have recently had a heart attack and are
still suffering from heart rhythm disorders
• if you have chronic glaucoma (increased eye
• if your levodopa/carbidopa dose is suddenly
lowered or stopped, particularly if you are receiving
drugs to treat psychosis; as this may trigger off a
change in your mental condition; muscle rigidity
and increased body temperature may occur
• if you have an hereditary disease characterised
by sudden involuntary but coordinated
movements (Huntington’s chorea). Use of
Apodespan PR is not recommended.
• if you have ever had a malignant melanoma
• if you have a skin condition that has not yet
been diagnosed by your doctor
• Apodespan PR could give rise to abnormalities
in several laboratory tests. These include:
- liver function tests
- a false positive coombs test
- decreased haemoglobin and haemotocrit,
elevated serum glucose and white blood cells,
bacteria and blood in the urine
• when a test strip is used to determine ketonuria
a false positive result for urinary ketone bodies
can be shown. This reaction is not altered by
boiling the urine sample.
• false negative results can also occur in the
examination of glycosuria with the use of
glucose oxidase methods
• the safety and efficacy of Apodespan PR in
newly-born infants and children under the age
of 18 has not been established; the use of
Apodespan PR in patients under the age of 18
is therefore not recommended
• pathologically driven gambling and obsessive
increased sexual desire have been reported in
patients treated for Parkinson’s disease with
drugs belonging to the group of dopamine
agonists, including Apodespan PR.

Please tell your doctor if any one of the
above-mentioned warnings applies to you, or has
ever applied to you in the past.
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.
Taking Apodespan PR with other medicines
Apodespan PR may interfere with the effects/side
effects of other drugs, and vice versa. This is
particularly true in the case of:
• drugs used to treat high blood pressure; your
doctor will need to adjust the dosage
• drugs used to treat depression (see also section
"Do not take Levodopa/Carbidopa")
• drugs that act on the central nervous system
(anticholinergics; bronchodilators used in
asthma), such as ipratropium and tiotropium.
The effect of levodopa may be reduced; your
doctor will adjust the dosage if necessary
• drugs used to treat psychosis
• isoniazid (a drug used to treat tuberculosis)
• benzodiazepines (certain sleeping pills and
tranquilisers), such as diazepam, oxazepam
and lormetazepam; the effect of Apodespan PR
may be reduced
• Phenytoin (a drug used in epilepsy); the effect
of Apodespan PR may be reduced
• Papaverine (a drug used to treat spasms in the
gastrointestinal tract); the effect of Apodespan
PR may be reduced
• selegiline (a drug used in Parkinson’s disease);
when used at the same time as Apodespan PR,
severe low blood pressure may occur
• COMT inhibitors (used in Parkinson’s disease);
when used at the same time as Apodespan PR,
the levels of levodopa reaching the brain may
increase. The Levodopa/Carbidopa dose may
need to be adjusted.
• amantadine (used in Parkinson’s disease). The
side effects of levodopa may increase. The
Levodopa/Carbidopa dose may need to be
• metoclopramide (a gastrointestinal drug)
• drugs that act on the central nervous system
(sympathomimetics; bronchodilators used in
asthma), such as apraclonidine, dipivefrin and
brimonidine. Cardiovascular-related side effects
may increase.
• ferrous sulphate. Levodopa absorption may
Please tell your doctor or pharmacist if you are
taking, or have recently taken, any other medicines,
including medicines obtained without a prescription.
Taking Apodespan PR with food and drink
The effect of levodopa can sometimes be
impaired in patients on a high-protein diet.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicine.
- Any woman of childbearing potential who is
receiving Apodespan PR 50/200 mg must
practise effective contraception.
- Not enough is known about the use of
Apodespan PR during human pregnancies. It
was shown to be harmful in animal experiments.
It is not known whether carbidopa is excreted in
human milk. Do not take Apodespan PR if you
are pregnant, or trying to conceive.
- Levodopa is excreted into breast milk.
You must therefore not breastfeed during
treatment with Apodespan PR.
Driving and using machines
Apodespan PR cause side effects such as
- dizziness,
- drowsiness,
- double vision,
which may affect your ability to react.
You should bear this in mind if you intend driving
or using machines. Patients who are known to be
prone to drowsiness and falling asleep without
warning may not drive or use machines.
Apodespan PR contains lactose monohydrate
This medicine contains lactose. If you have been
told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking
this medicine.

3. How to take Apodespan PR
Adults and the elderly
Your doctor has prescribed how much
Apodespan PR you should take.
Generally speaking, the following doses apply:
If you have never been treated with levodopa:
Starting dose
1 Apodespan PR 50/200 mg twice daily.
Maximum starting dose
3 tablets of 1 Apodespan PR 50/200 mg daily
(600 mg of levodopa per day).
Doses should be taken at intervals of at least 6
If you are switching from normal
Levodopa/Carbidopa tablets to prolonged
release tablets:
Such a switch should take place gradually and
under the supervision of a doctor.
If you are currently being treated with
levodopa alone (i.e. on its own):
Treatment with levodopa should be stopped for at
least 12 hours before using Apodespan PR.
Starting dose in patients with a mild-to-moderate
form of Parkinson’s disease:
1 Apodespan PR 50/200 mg twice daily
Maintenance dose:
Your doctor will monitor you on a regular basis
and adjust your dosage if necessary.
An interval of at least three days should be
allowed between each dose adjustment.
Swallow the tablet whole with a glass of water
irrespective of meals, do not break or chew the
If you have the impression that the effect of
Apodespan PR is too strong or too weak, talk to
your doctor or pharmacist.
Children and adolescents (under 18 years of
The use of Apodespan PR in patients under the
age of 18 is not recommended (see section “Take
special care with Apodespan PR”)
Length of treatment
Your doctor will tell you how long you must keep
using Apodespan PR. Do not stop treatment
before you should; otherwise, your symptoms
may return.
If you take more Apodespan PR than you should
If you have taken too much Apodespan PR
contact your doctor or pharmacist immediately.
Overdose symptoms may include: spasms of the
orbicularis oculi muscle surrounding the eye (see
also section 4. “Possible side effects").

If you forget to take Apodespan PR
Do not take a double dose of Apodespan PR to
make up for a forgotten dose. If you have
forgotten a dose, you can still take it unless it is
almost time for your next dose. If this occurs,
continue on your normal dosage schedule.
If you stop taking Apodespan PR
Your doctor will monitor you regularly if your
dosage is suddenly lowered or if your treatment
is stopped. Please read the section: “Take special
care with Apodespan PR”, particularly if you are
using drugs in the treatment of psychosis
(antipsychotic agents).
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Apodespan PR can cause
side effects, although not everybody gets them.
Side effects that may occur are:
-very common
in more than one in 10 patients
in more than one in 100 patients,
but less than one in 10 patients
in more than one in 1,000
patients, but less than one in
100 patients
in more than one in 10,000
patients, but less than one in
1,000 patients
-very rare
in less than one in 10,000
Blood and lymphatic system disorders
- a blood disorder (lack of white blood cells)
accompanied by an increased susceptibility to
infections (leukopenia)
- anaemia (haemolytic and non-haemolytic)
- a blood disorder (lack of blood platelets)
accompanied by bruising and a tendency to
bleed (thrombocytopenia)
Very rare:
- a very serious blood disorder (lack of white
blood cells) accompanied by sudden high fever,
severe sore throat and mouth ulcers
Metabolism and nutrition disorders
- loss of appetite (anorexia)
- weight loss
- weight gain.
Psychiatric disorders
- seeing things that are not there (hallucinations)
- confusion
- dizziness
- nightmares
- drowsiness
- tiredness
- sleeplessness
- depression with (very rarely) suicidal tendencies
- feeling of well-being (euphoria)
- dementia
- episodes of serious mental illness, during which
control over one’s own conduct and behaviour
is impaired (psychosic episodes including
delusions and paranoid ideation)
- feeling of stimulation
- dream abnormalities
- excitement (agitation)
- anxiety
- impaired ability to think
- disorientation
- headache
- increased sexual desire
- numbness
- fits/ seizures.
Not known:
- It was reported that patients treated for
Parkinson’s disease with drugs belonging to the
group of dopamine agonists, including
Apodespan PR, have shown signs of
pathologically driven gambling and obsessive
increased sexual desire, especially at high
doses. These side effects generally
disappeared upon reduction of the dose or
treatment discontinuation.
Nervous system disorders
- movement disorders (dyskinesia)
- a disorder characterised by sudden involuntary
movements (chorea)
- muscle tone disorder (dystonia)
- movement disorders caused from outside the
nervous system (extrapyramidal)
- sudden changes in Parkinson’s symptoms
("on-off" symptoms)
- slowdown in movements during "on-off" periods
- ataxia
- increase in hand tremors
- 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 (paraesthesia)
- fits
- gait disorders
- lockjaw.
- increased libido
Not known:
- Drowsiness and (very rarely) constant daytime
fatigue/ sudden attacks of sleep.
- muscle twitching
Eyes disorders
- blurred vision
- spasm of the orbicularis oculi muscle
surrounding the eye (this may be a sign of
- activation of a pre-existing Horner's syndrome
(an eye disorder)
- double vision
- dilated pupils
- a deterioration in eye movements.
Cardiac (heart) disorders
- palpitations
- irregular heartbeat.
Vascular disorders
- 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
- increase in blood pressure
- inflammation of the veins (phlebitis).
Respiratory, thoracic (chest) and mediastinal
disorders (i.e. the area between the lungs)
- hoarseness
- chest pain

- breathlessness
- abnormal breathing patterns.
Gastrointestinal disorders
- nausea
- vomiting
- dry mouth
- bitter taste
- constipation
- diarrhoea
- increased salivation
- difficulties in swallowing (dysphagia)
- wind
- 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
- bruxism (grinding of teeth)
- hiccups
- stomach and intestinal bleeding
burning tongue
- duodenal ulcers.
Skin and subcutaneous tissue disorders:
- fluid accumulation (oedema)
- 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).
Musculoskeletal and connective tissue disorders
- muscle spasms.
Renal and urinary disorders:
- dark urine
- urine retention
- involuntary passing of urine
- persistent erection (priapism).
General disorders and administration site
- weakness
- feeling of being unwell (malaise)
- hot flushes
- asthenia
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.
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:
reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Apodespan PR
-Children: Keep out of the reach and sight of
-Use by Date: Do not take Apodespan PR
50/200 mg after the expiry date which is stated
on the blister, HDPE label and carton after
‘EXP.’ The expiry date refers to the last day of
that month.
HDPE bottle pack should be used within 2
months after first opening.
- Storage conditions:
This medicinal product does not require any
special storage conditions.
Medicines should not be disposed of 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 Apodespan PR contains
Apodespan PR contains two active substances i.e.
Each prolonged release tablet contains 50 mg of
Carbidopa and 200 mg of Levodopa.
The other ingredients are:
Cellulose microcrystalline, Lactose monohydrate,
Ferric oxide red (E172), Ferric oxide yellow
(E172), Hypromellose K4M, Hypromellose E5,
Silica, colloidal anhydrous, Magnesium stearate.
What Apodespan PR looks like and contents
of the pack
Apodespan PR 50 mg/200 mg
Prolonged-Release Tablets:
Peach to light peach colored with mosaic
appearance, oval shaped, biconvex tablets of
approximately 13.0 mm in length and
approximately 7.0 mm in width debossed with
‘L200’on one side and plain on other side.
Apodespan PR are available in the following pack
Blister(s) in outer carton:
Alu/Alu blister of 10, 20, 30, 49, 50, 56, 60, 84,
98, 100, 196, 200 and/or 300 Tablets.
HDPE bottle inserted with cotton and desiccant,
fitted with PPCRC closure. Each bottle contains
30, 56, 84 and/or 100 tablets.
Not all pack sizes may be marketed.
Marketing authorisation holder and
Accord Healthcare Limited,
Sage house, 319 Pinner road, Harrow, HA1 4HF
United Kingdom
This leaflet was last revised in 10/2014.

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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.