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LEVODOPA/CARBIDOPA/ENTACAPONE DEMA 175 MG /43.75 MG /200 MG FILM-COATED TABLETS

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PACKAGE LEAFLET

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Package leaflet: Information for the patient
Levodopa/Carbidopa/Entacapone Dema
50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg, 150
mg/37.5 mg/200 mg, 175 mg/43.75 mg/200 mg and 200 mg/50 mg/200 mg
Film-coated Tablets
levodopa/carbidopa/entacapone

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 Levodopa/Carbidopa/Entacapone Dema is and what it is used for
2. What you need to know before you take Levodopa/Carbidopa/Entacapone Dema
3. How to take Levodopa/Carbidopa/Entacapone Dema
4. Possible side effects
5. How to store Levodopa/Carbidopa/Entacapone Dema
6. Contents of the pack and other information

1.

What Levodopa/Carbidopa/Entacapone Dema is and what it is used for

Levodopa/Carbidopa/Entacapone Dema contains three active substances (levodopa, carbidopa and
entacapone) in one film-coated tablet. Levodopa/Carbidopa/Entacapone Dema is used for the treatment of
Parkinson’s disease.
Parkinson’s disease is caused by low levels of a substance called dopamine in the brain. Levodopa increases
the amount of dopamine and hence reduces the symptoms of Parkinson’s disease. Carbidopa and entacapone
improve the antiparkinson effects of levodopa.

2.

What you need to know before you take Levodopa/Carbidopa/Entacapone Dema

Do NOT take Levodopa/Carbidopa/Entacapone Dema if you
- are allergic to levodopa, carbidopa or entacapone, or any of the other ingredients of this medicine (listed
in section 6)
- have narrow-angle glaucoma (an eye disorder)
- have a tumour of the adrenal gland
- are taking certain medicines for treating depression (combinations of selective MAO-A and MAO-B
inhibitors, or non-selective MAO-inhibitors)
- have ever had neuroleptic malignant syndrome (NMS – this is a rare reaction to medicines used to treat
severe mental disorders)
- have ever had non-traumatic rhabdomyolysis (a rare muscle disorder)
- have a severe liver disease.
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Warnings and precautions
Talk to your doctor or pharmacist before taking Levodopa/Carbidopa/Entacapone Dema if you have or have
ever had:
- a heart attack or any other diseases of the heart including cardiac arrythmias, or of the blood vessels
- asthma or any other disease of the lungs
- a liver problem, because your dose may need to be adjusted
- kidney or hormone-related diseases
- stomach ulcers or convulsions
- if you experience prolonged diarrhoea consult your doctor as it may be a sign of inflammation of the
colon
- any form of severe mental disorder like psychosis
- chronic wide-angle glaucoma, because your dose may need to be adjusted and the pressure in your eyes
may need to be monitored.
Consult your doctor if you are currently taking:
- antipsychotics (medicines used to treat psychosis)
- a medicine which may cause low blood pressure when rising from a chair or bed. You should be aware
that Levodopa/Carbidopa/Entacapone Dema may make these reactions worse.
Consult your doctor if during the treatment with Levodopa/Carbidopa/Entacapone Dema you:
- notice that your muscles get very rigid or jerk violently, or if you get tremors, agitation, confusion,
fever, rapid pulse, or wide fluctuations in your blood pressure. If any of this happens, contact your
doctor immediately
- feel depressed, have suicidal thoughts, or notice unusual changes in your behaviour
- find yourself suddenly falling asleep, or if you feel very drowsy. If this happens, you should not drive or
use any tools or machines (see also section 'Driving and using machines')
- notice that uncontrolled movements begin or get worse after you started to take
Levodopa/Carbidopa/Entacapone Dema. If this happens, your doctor may need to change the dose of
your antiparkinson medicine
- experience diarrhoea: monitoring of your weight is recommended in order to avoid potentially excessive
weight loss
- experience progressive anorexia, asthenia (weakness, exhaustion) and weight decrease within a
relatively short period of time. If this happens, a general medical evaluation including liver function
should be considered
- feel the need to stop using Levodopa/Carbidopa/Entacapone Dema, see section 'If you stop taking
Levodopa/Carbidopa/Entacapone Dema'.
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 a preoccupation with an
increase in sexual thoughts or feelings. Your doctor may need to review your treatments.
Your doctor may take some regular laboratory tests during a long term treatment with
Levodopa/Carbidopa/Entacapone Dema.
If you must undergo surgery, please tell your doctor that you are using Levodopa/Carbidopa/Entacapone
Dema.
Levodopa/Carbidopa/Entacapone Dema is not recommended to be used for treatment of extrapyramidal
symptoms (e.g. involuntary movements, shaking, muscle rigidity and muscle contractions) caused by other
medicines.
Children and adolescents
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Experience with levodopa/carbidopa/entacapone in patients under 18 years is limited. Therefore, the use of
Levodopa/Carbidopa/Entacapone Dema in children is not recommended.
Other medicines and Levodopa/Carbidopa/Entacapone Dema
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Levodopa/Carbidopa/Entacapone Dema if you are taking certain medicines for treating
depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors).
Levodopa/Carbidopa/Entacapone Dema may increase the effects and side effects of certain medicines.
These include:
- medicines used to treat depression such as moclobemide, amitryptiline, desipramine, maprotiline,
venlafaxine and paroxetine
- rimiterole and isoprenaline, used to treat respiratory diseases
- adrenaline, used for severe allergic reactions
- noradrenaline, dopamine and dobutamine, used to treat heart diseases and low blood pressure
- alpha-methyldopa, used to treat high blood pressure
- apomorphine, which is used to treat Parkinson’s disease.
The effects of Levodopa/Carbidopa/Entacapone Dema may be weakened by certain medicines. These
include:
- dopamine antagonists used to treat mental disorders, nausea and vomiting
- phenytoin, used to prevent convulsions
- papaverine used to relax the muscles.
Levodopa/Carbidopa/Entacapone Dema may make it harder for you to digest iron. Therefore, do not take
Levodopa/Carbidopa/Entacapone Dema and iron supplements at the same time. After taking one of them,
wait at least 2 to 3 hours before taking the other.
Levodopa/Carbidopa/Entacapone Dema with food and drink
Levodopa/Carbidopa/Entacapone Dema may be taken with or without food. For some patients,
Levodopa/Carbidopa/Entacapone Dema may not be well absorbed if it is taken with, or shortly after eating
protein-rich food (such as meats, fish, dairy products, seeds and nuts). Consult your doctor if you think this
applies to you.
Pregnancy, breast-feeding and fertility
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.
You should not breast-feed during treatment with Levodopa/Carbidopa/Entacapone Dema.
Driving and using machines
Levodopa/Carbidopa/Entacapone Dema 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.
If you feel very drowsy, or if you sometimes find yourself suddenly falling asleep, wait until you feel fully
awake again before driving or doing anything else that requires you to be alert. Otherwise, you may put
yourself and others at risk of serious injury or death.
Levodopa/Carbidopa/Entacapone Dema contains lactose, 100 mg/25 mg/200 mg also contains allura
red and 150 mg/37.5 mg/200 mg also contains carmoisine
Levodopa/Carbidopa/Entacapone Dema contains anhydrous lactose (80 mg/tablet). If you have been told by
your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal
product.
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Levodopa/Carbidopa/Entacapone Dema 100 mg/25 mg/200 mg also contains allura red (E129). May cause
allergic reactions.
Levodopa/Carbidopa/Entacapone Dema 150 mg/37.5 mg/200 mg also contains carmoisine (E122). May
cause allergic reactions.

3.

How to take Levodopa/Carbidopa/Entacapone Dema

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
For adults and older people:
- Your doctor will tell you exactly how many tablets of Levodopa/Carbidopa/Entacapone Dema to take
each day.
- The tablets are not intended to be split or broken into smaller pieces.
- You should take only one tablet each time.
- Depending on how you respond to treatment, your doctor may suggest a higher or lower dose.
- If you are taking Levodopa/Carbidopa/Entacapone Dema 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200
mg, 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg or 150 mg/37.5 mg/200 mg tablets, do not take
more than 10 tablets per day.
- If you are taking Levodopa/Carbidopa/Entacapone Dema 175 mg/43.75 mg/200 mg tablets, do not take
more than 8 tablets of this strength per day.
- If you are taking Levodopa/Carbidopa/Entacapone Dema 200 mg/50 mg/200 mg tablets, do not take
more than 7 tablets of this strength per day.
Talk to your doctor or pharmacist if you think the effect of Levodopa/Carbidopa/Entacapone Dema is too
strong or too weak, or if you experience possible side effects
If you take more Levodopa/Carbidopa/Entacapone Dema than you should
If you have accidentally taken more Levodopa/Carbidopa/Entacapone Dema tablets than you should, talk to
your doctor or pharmacist immediately. In case of an overdose you may feel confused or agitated, your heart
rate may be slower or faster than normal or the color of your skin, tongue, eyes or urine may change.
If you forget to take Levodopa/Carbidopa/Entacapone Dema
Do not take a double dose to make up for a forgotten tablet.
If it is more than 1 hour until your next dose:
Take one tablet as soon as you remember, and the next tablet at the normal time.
If it is less than 1 hour until your next dose:
Take a tablet as soon as you remember, wait 1 hour, then take another tablet. After that carry on as normal.
Always leave at least an hour between Levodopa/Carbidopa/Entacapone Dema tablets, to avoid possible side
effects.
If you stop taking Levodopa/Carbidopa/Entacapone Dema
Do not stop taking Levodopa/Carbidopa/Entacapone Dema unless your doctor tells you to. In such a case
your doctor may need to adjust your other antiparkinson medicines, especially levodopa, to give sufficient
control of your symptoms. If you suddenly stop taking Levodopa/Carbidopa/Entacapone Dema and other
antiparkinsonian medicines it may result in unwanted side effects.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Many of the side
effects can be relieved by adjusting the dose.
If you during the treatment with Levodopa/Carbidopa/Entacapone Dema experience the following
symptoms, contact your doctor immediately:
- Your muscles get very rigid or jerk violently, you get tremors, agitation, confusion, fever, rapid pulse, or
wide fluctuations in your blood pressure. These can be symptoms of neuroleptic malignant syndrome
(NMS, a rare severe reaction to medicines used to treat disorders of the central nervous system) or
rhabdomyolysis (a rare severe muscle disorder).
- Allergic reaction, the signs may include hives (nettle rash), itching, rash, swelling of your face, lips,
tongue or throat. This may cause difficulties in breathing or swallowing.
Very common (may affect more than 1 in 10 people)
- uncontrolled movements (dyskinesias)
- feeling sick (nausea)
- harmless reddish-brown discoloration of urine
- muscle pain
- diarrhoea
Common (may affect up to 1 in 10 people)
- light-headedness or fainting due to low blood pressure, high blood pressure
- worsening of Parkinson`s symptoms, dizziness, drowsiness
- vomiting, abdominal pain and discomfort, heartburn, dry mouth, constipation
- inability to sleep, hallucinations, confusion, abnormal dreams (including nightmares), tiredness
- mental changes – including problems with memory, anxiety and depression (possibly with thoughts of
suicide)
- heart or artery disease events (e.g. chest pain), irregular heart rate or rhythm
- more frequent falling
- shortness of breath
- increased sweating, rashes
- muscle cramps, swelling of legs
- blurred vision
- anaemia
- decreased appetite, decreased weight
- headache, joint pain
- urinary tract infection
Uncommon (may affect up to 1 in 100 people)
- heart attack
- bleeding in the gut
- changes in the blood cell count which may result in bleeding, abnormal liver function tests
- convulsions
- feeling agitated
- psychotic symptoms
- colitis (inflammation of the colon)
- discolourations other than urine (e.g. skin, nail, hair, sweat)
- swallowing difficulties
- inability to urinate
The following side effects have also been reported:
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-

hepatitis (inflammation of the liver)
itching

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 or personal 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 behaviours; they will discuss ways of managing or
reducing the symptoms.
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 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.

5.

How to store Levodopa/Carbidopa/Entacapone Dema

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 bottle and the carton after EXP.
The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Use the tablets within 175 days after first opening of the bottle.
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 Levodopa/Carbidopa/Entacapone Dema contains
The active substances of Levodopa/Carbidopa/Entacapone Dema are levodopa, carbidopa and entacapone.
- Each Levodopa/Carbidopa/Entacapone Dema 50 mg/12.5 mg/200 mg tablet contains 50 mg of levodopa,
12.5 mg of carbidopa and 200 mg of entacapone.
- The other ingredients in the tablet core are microcrystalline cellulose, anhydrous lactose,
hydroxypropylcellulose, povidone (K-30), colloidal anhydrous silica and magnesium stearate
- The ingredients in the film-coating are titanium dioxide (E171), hypromellose, glycerol (E422), yellow
iron oxide (E172), polysorbate 80, red iron oxide (E172), black iron oxide (E172) and magnesium
stearate.
The active substances of Levodopa/Carbidopa/Entacapone Dema are levodopa, carbidopa and entacapone.
- Each Levodopa/Carbidopa/Entacapone Dema 75 mg/18.75 mg/200 mg tablet contains 75 mg of
levodopa, 18.75 mg of carbidopa and 200 mg of entacapone.
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The other ingredients in the tablet core are microcrystalline cellulose, anhydrous lactose,
hydroxypropylcellulose, povidone (K-30), colloidal anhydrous silica and magnesium stearate
The ingredients in the film-coating are titanium dioxide (E171), hypromellose, glycerol (E422), yellow
iron oxide (E172), polysorbate 80, red iron oxide (E172) and magnesium stearate.

The active substances of Levodopa/Carbidopa/Entacapone Dema are levodopa, carbidopa and entacapone.
- Each Levodopa/Carbidopa/Entacapone Dema 100 mg/25 mg/200 mg tablet contains 100 mg of
levodopa, 25 mg of carbidopa and 200 mg of entacapone.
- The other ingredients in the tablet core are microcrystalline cellulose, anhydrous lactose,
hydroxypropylcellulose, povidone (K-30), colloidal anhydrous silica and magnesium stearate
- The ingredients in the film-coating are titanium dioxide (E171), hypromellose, glycerol (E422),
polysorbate 80, allura red ac (E129), carmine (E120) and magnesium stearate.
The active substances of Levodopa/Carbidopa/Entacapone Dema are levodopa, carbidopa and entacapone.
- Each Levodopa/Carbidopa/Entacapone Dema 125 mg/31.25 mg/200 mg tablet contains 125 mg of
levodopa, 31.25 mg of carbidopa and 200 mg of entacapone.
- The other ingredients in the tablet core are microcrystalline cellulose, anhydrous lactose,
hydroxypropylcellulose, povidone (K-30), colloidal anhydrous silica and magnesium stearate
- The ingredients in the film-coating are titanium dioxide (E171), hypromellose, glycerol (E422), yellow
iron oxide (E172), polysorbate 80, red iron oxide (E172) and magnesium stearate.
The active substances of Levodopa/Carbidopa/Entacapone Dema are levodopa, carbidopa and entacapone.
- Each Levodopa/Carbidopa/Entacapone Dema 150 mg/37.5 mg/200 mg tablet contains 150 mg of
levodopa, 37.5 mg of carbidopa and 200 mg of entacapone.
- The other ingredients in the tablet core are microcrystalline cellulose, anhydrous lactose,
hydroxypropylcellulose, povidone (K-30), colloidal anhydrous silica and magnesium stearate
- The ingredients in the film-coating are titanium dioxide (E171), hypromellose, glycerol (E422),
polysorbate 80, red iron oxide (E172), carmoisine (E122) and magnesium stearate.
The active substances of Levodopa/Carbidopa/Entacapone Dema are levodopa, carbidopa and entacapone.
- Each Levodopa/Carbidopa/Entacapone Dema 175 mg/43.75 mg/200 mg mg tablet contains 175 mg of
levodopa, 43.75 mg of carbidopa and 200 mg of entacapone.
- The other ingredients in the tablet core are microcrystalline cellulose, anhydrous lactose,
hydroxypropylcellulose, povidone (K-30), colloidal anhydrous silica and magnesium stearate
- The ingredients in the film-coating are titanium dioxide (E171), hypromellose, glycerol (E422), yellow
iron oxide (E172), polysorbate 80, red iron oxide (E172), black iron oxide (E172) and magnesium
stearate.
The active substances of Levodopa/Carbidopa/Entacapone Dema are levodopa, carbidopa and entacapone.
- Each Levodopa/Carbidopa/Entacapone Dema 200 mg/50 mg/200 mg tablet contains 200 mg of
levodopa, 50 mg of carbidopa and 200 mg of entacapone.
- The other ingredients in the tablet core are microcrystalline cellulose, anhydrous lactose,
hydroxypropylcellulose, povidone (K-30), colloidal anhydrous silica and magnesium stearate
- The ingredients in the film-coating are titanium dioxide (E171), hypromellose, glycerol (E422), yellow
iron oxide (E172), polysorbate 80, red iron oxide (E172), black iron oxide (E172) and magnesium
stearate.
What Levodopa/Carbidopa/Entacapone Dema looks like and contents of the pack
Levodopa/Carbidopa/Entacapone Dema 50 mg/12.5 mg/200 mg: Round, biconvex, light brown tablet,
marked with “50” on one side, plain on the other. Dimension: approx. 14 mm diameter.
Levodopa/Carbidopa/Entacapone Dema 75 mg/18.75 mg/200 mg: Oval, biconvex, light orange tablet,
marked with “75” on one side, plain on the other. Dimensions: approx. 16x10 mm.
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Levodopa/Carbidopa/Entacapone Dema 100 mg/25 mg/200 mg: Oblong, biconvex, pale red tablet, marked
with “100” on one side, plain on the other. Dimensions: approx. 17x9 mm.
Levodopa/Carbidopa/Entacapone Dema 125 mg/31.25 mg/200 mg: Round, biconvex, yellowish brown
tablet, marked with “125” on one side, plain on the other. Dimension: approx. 14 mm diameter.
Levodopa/Carbidopa/Entacapone Dema 150 mg/37.5 mg/200 mg: Oval, biconvex, dark red tablet, marked
with “150” on one side, plain on the other. Dimensions: approx. 16x10 mm.
Levodopa/Carbidopa/Entacapone Dema 175 mg/43.75 mg/200 mg: Ellipse, biconvex, pale brown tablet,
marked with “175” on one side, plain on the other. Dimensions: approx. 17x10 mm
Levodopa/Carbidopa/Entacapone Dema 200 mg/50 mg/200 mg: Oblong, biconvex, brown tablet, marked
with “200” on one side, plain on the other. Dimensions: approx. 17x9 mm.
Levodopa/Carbidopa/Entacapone Dema is available in bottles containing 10, 28, 30, 50, 60, 90, 98, 100,
130, 150, 175, 200 or 250 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Dema Consult s.r.o.
Slunná 16, 617 00 Brno
617 00
Czech Republic

This leaflet was last revised in {08/2014}

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Expand Transcript

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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