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LEVODOPA/CARBIDOPA/ENTACAPONE 200 MG/50 MG/200 MG FILM-COATED TABLETS

Active substance(s): CARBIDOPA / ENTACAPONE / LEVODOPA

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Package leaflet: Information for the user
Levodopa/Carbidopa/Entacapone 50 mg/12.5 mg/200 mg film-coated tablets
Levodopa/Carbidopa/Entacapone 75 mg/18.75 mg/200 mg film-coated tablets
Levodopa/Carbidopa/Entacapone 100 mg/25 mg/200 mg film-coated tablets
Levodopa/Carbidopa/Entacapone 125 mg/31.25 mg/200 mg film-coated tablets
Levodopa/Carbidopa/Entacapone 150 mg/37.5 mg/200 mg film-coated tablets
Levodopa/Carbidopa/Entacapone 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 is and what it is used for
2. What you need to know before you take Levodopa/Carbidopa/Entacapone
3. How to take Levodopa/Carbidopa/Entacapone
4. Possible side effects
5
How to store Levodopa/Carbidopa/Entacapone
6. Contents of the pack and other information
1. What Levodopa/Carbidopa/Entacapone is and what it is used for
Levodopa/Carbidopa/Entacapone contains three active substances (levodopa, carbidopa and entacapone) in one
film-coated tablet. This medicine 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
Do not take Levodopa/Carbidopa/Entacapone 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if you have or have ever had:
a heart attack or any other diseases of the heart including cardiac arrhythmias, or diseases 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
this medicine may make these reactions worse.
Consult your doctor if during the treatment with this medicine 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 this medicine. 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 this medicine, see section 'If you stop taking Levodopa/Carbidopa/Entacapone'.
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 treatment.
Your doctor may take some regular laboratory tests during a long term treatment with this medicine. If you must
undergo surgery, please tell your doctor that you are using this medicine.
This medicine is not recommended to be used for treatment of extrapyramidal symptoms (for example
involuntary movements, shaking, muscle rigidity and muscle contractions) caused by other medicines.
Children and adolescents
Experience with this medicine in patients under 18 years is limited. Therefore, the use of this medicine in children
is not recommended.
Other medicines and Levodopa/Carbidopa/Entacapone
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Levodopa/Carbidopa/Entacapone if you are taking certain medicines for treating depression
(combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors).
This medicine 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 this medicine 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.
This medicine may make it harder for you to digest iron. Therefore, do not take this medicine 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 with food and drink
This medicine may be taken with or without food. For some patients, this medicine 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 this medicine.
Driving and using machines
This medicine may lower your blood pressure, which may make you feel light-headed 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.
3. How to take Levodopa/Carbidopa/Entacapone
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 elderly:
Your doctor will tell you exactly how many tablets of this medicine 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 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 200 mg/50 mg/200 mg, do not take more than 7 tablets
of this strength per day.
Talk to your doctor or pharmacist if you think the effect of this medicine is too strong or too weak, or if you
experience possible side effects.
If you take more Levodopa/Carbidopa/Entacapone than you should
If you have accidentally taken more film-coated 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 colour of your skin, tongue, eyes or urine may change.
If you forget to take Levodopa/Carbidopa/Entacapone
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 these tablets, to avoid possible side effects.
If you stop taking Levodopa/Carbidopa/Entacapone
Do not stop taking this medicine 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 this medicine 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.
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 this medicine 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 (for example 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)
discolouration other than urine (for example skin, nail, hair, sweat)
swallowing difficulties
inability to urinate
The following side effects have also been reported:
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 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
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 or blister and the carton after EXP. The
expiry date refers to the last day of that month.
Only bottles
Shelf life after first opening of bottles: 6 months
This medicinal product does not require any special storage conditions.
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 contains
The active substances of Levodopa/Carbidopa/Entacapone are levodopa, carbidopa and entacapone.
- Each Levodopa/Carbidopa/Entacapone 50 mg/12.5 mg/200 mg tablet contains 50 mg of levodopa, 12.5
mg of carbidopa and 200 mg of entacapone.
- Each Levodopa/Carbidopa/Entacapone 75 mg/18.75 mg/200 mg tablet contains 75 mg of levodopa, 18.75
mg of carbidopa and 200 mg of entacapone.
- Each Levodopa/Carbidopa/Entacapone 100 mg/25 mg/200 mg tablet contains 100 mg of levodopa, 25
mg of carbidopa and 200 mg of entacapone.
- Each Levodopa/Carbidopa/Entacapone 125 mg/31.25 mg/200 mg tablet contains 125 mg of levodopa,
31.25 mg of carbidopa and 200 mg of entacapone.
- Each Levodopa/Carbidopa/Entacapone 150 mg/37.5 mg/200 mg tablet contains 150 mg of levodopa, 37.5
mg of carbidopa and 200 mg of entacapone.
- Each Levodopa/Carbidopa/Entacapone 175 mg/43.75 mg/200 mg tablet contains 175 mg of levodopa,
43.75 mg of carbidopa and 200 mg of entacapone.
- Each Levodopa/Carbidopa/Entacapone 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, crosspovidone, povidone K-30,
sodium citrate, magnesium stearate.
The ingredients in the film-coating are hypromellose, macrogol 6000, titanium dioxide (E171),
polysorbate 80
colourants: 50 mg, 100 mg, 150 mg red iron oxide (E172) and yellow iron oxide (E172).
colourants: 75 mg, 125 mg, 200 mg red iron oxide (E172)
What Levodopa/Carbidopa/Entacapone looks like and contents of the pack
Levodopa/Carbidopa/Entacapone 50/12.5/200 mg: Light brown to greyish red coloured, round, biconvex, film
coated tablets with a diameter of approx. 11.30 mm, debossed “50” on one side and plain on other side.
Levodopa/Carbidopa/Entacapone 75/18.75/200 mg: Light brown to light pink coloured, oval shaped approx 15.20
x 7.20 mm, film coated tablets, debossed “75” on one side and plain on other side.
Levodopa/Carbidopa/Entacapone 100/25/200 mg: Light brown to greyish red coloured, oval shaped approx 16.70
x 7.70 mm, film coated tablets, debossed “100” on one side and plain on other side.
Levodopa/Carbidopa/Entacapone 125/31.25/200 mg: Light brown to light pink coloured, elongated-ellipse
shaped approx 15.20 x 9.70 mm, film coated tablets, debossed “125” on one side and plain on other side.
Levodopa/Carbidopa/Entacapone 150/37.5/200 mg: Light brown to greyish red coloured, elongated-ellipse
shaped approx 16.20 x 7.10 mm, film coated tablets, debossed “150” on one side and plain on other side.
Levodopa/Carbidopa/Entacapone 200/50/200 mg: Dark brownish red coloured, oval shaped approx 19.15 x 9.05
mm, film coated tablets, debossed "200" on one side and plain on other side.
Levodopa/Carbidopa/Entacapone comes in seven different pack sizes:
OPA/Al/PVC/Al blister packs, HDPE bottles, neck finish with child-resistant closure and induction sealing wad or
HDPE bottle, with continuous threaded closure and induction sealing wad containing 10, 30, 100, 130, 175, 250
and 500 (hospital pack, for use on more than one patient) film-coated tablets.
Each HDPE bottle contains 1 Silica gel canister.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Torrent Pharma (UK) Ltd., Unit 4, Charlwood Court, County Oak Way, Crawley, West Sussex
RH11 7XA
United Kingdom
Email: drugsafety@torrentpharma.co.uk
This leaflet was last revised in 11/2014.

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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.

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