LEVODOPA 50 mg /12.5 Mg/200 Mg Film-Coated Tablets

Зміст інструкції

1. Levodopa/Carbidopa/Entacapone Mylan 50 mg/12,5 mg/200 mg film-coated tablets, 75 mg/18,75 mg/200 mg film-coated tablets, 100 mg/25mg/200 mg film-coated tablets, 125 mg/31,25 mg/200 mg film-coated tablets, 150 mg/37,5 mg/200 mg film-coated tablets
   1. What is Levodopa/Carbidopa/Entacapone Mylan and what is it used for
   2. What you need to know before taking Levodopa/Carbidopa/Entacapone Mylan
   3. How to take Levodopa/Carbidopa/Entacapone Mylan
   4. Possible side effects
   5. How to store Levodopa/Carbidopa/Entacapone Mylan
   6. Package Contents and Other Information

Levodopa/Carbidopa/Entacapone Mylan 50 mg/12,5 mg/200 mg film-coated tablets, 75 mg/18,75 mg/200 mg film-coated tablets, 100 mg/25mg/200 mg film-coated tablets, 125 mg/31,25 mg/200 mg film-coated tablets, 150 mg/37,5 mg/200 mg film-coated tablets

Levodopa/Carbidopa/Entacapone Mylan 175 mg/43,75 mg/200 mg film-coated tablets
Levodopa/Carbidopa/Entacapone Mylan 200 mg/50 mg/200 mg film-coated tablets
levodopa/carbidopa/entacapone
Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Levodopa/Carbidopa/Entacapone Mylan and what is it used for

Levodopa/Carbidopa/Entacapone Mylan contains three active substances (levodopa, carbidopa, entacapone) in
a film-coated tablet. Levodopa/Carbidopa/Entacapone Mylan is used to treat Parkinson's disease.
Parkinson's disease is caused by low levels in the brain of a substance called dopamine.
Levodopa increases the level of dopamine and consequently reduces the symptoms of Parkinson's disease. Carbidopa and entacapone improve the effectiveness of the antiparkinsonian effects of levodopa.

2. What you need to know before taking Levodopa/Carbidopa/Entacapone Mylan

Do not take Levodopa/Carbidopa/Entacapone Mylan if you

• are allergic to levodopa, carbidopa or entacapone or to any of the other ingredients of this medicine (listed in section 6)
• suffer from closed-angle glaucoma (an eye disorder)
• have a tumor of the adrenal gland
• are taking medicines to treat depression (combinations of MAO-A selective inhibitors and MAO-B inhibitors, or non-selective MAO inhibitors, e.g. phenelzine, tranylcypromine)
• have suffered from neuroleptic malignant syndrome (NMS - a rare reaction to some drugs used to treat serious mental disorders)
• have suffered from rhabdomyolysis of non-traumatic origin (a rare muscle disease)
• are affected by a severe liver disease.

Warnings and precautions
Talk to your doctor or pharmacist before taking Levodopa/Carbidopa/Entacapone Mylan if
you suffer or have ever suffered in the past:

• from a heart attack, other heart diseases, including cardiac arrhythmias, or diseases of the blood vessels
• from asthma or other lung diseases
• from liver disorders, as the dose may need to be adjusted
• from kidney or hormonal disorders
• from gastric ulcer or convulsions
• - serious mental health problems of any kind, such as psychosis
• from open-angle chronic glaucoma, as the dose may need to be adjusted and eye pressure monitored.

Talk to your doctor if you are taking:

• antipsychotic drugs (drugs used to treat psychoses)
• a medicine that can cause a drop in blood pressure when you get up from a chair or bed. You should be aware that Levodopa/Carbidopa/Entacapone Mylan may worsen these reactions.

Talk to your doctor if during treatment with Levodopa/Carbidopa/Entacapone Mylan:

• you notice the onset of muscle rigidity or severe contractions, or if you experience tremors, agitation, confusion, fever, increased heart rate or significant fluctuations in blood pressure. In such cases contact your doctor immediately
• you feel depressed, have suicidal thoughts, or notice any changes in your behavior
• you experience sudden attacks of sleepiness, or if you feel particularly drowsy. If this happens, you should not drive or operate tools or machinery (see also section “Driving and using machines”)
• you notice the onset of uncontrolled movements or if these worsen after taking Levodopa/Carbidopa/Entacapone Mylan. In such cases, your doctor may decide to change the dosage of your anti-Parkinsonian medicines
• you experience diarrhea: it is recommended to monitor body weight to avoid possible excessive weight loss
• if you have prolonged diarrhea, consult your doctor as it may be a sign of colon inflammation
• you experience progressive anorexia (loss of appetite), asthenia (weakness, fatigue) and weight loss over a relatively short period of time. This may be a sign of a liver problem and your doctor may want to prescribe laboratory tests.
• you feel the need to stop taking Levodopa/Carbidopa/Entacapone Mylan, see section “If you stop taking Levodopa/Carbidopa/Entacapone Mylan”.

Tell your doctor if you notice, or your family members/caregivers notice that you develop impulses or strong
desires to behave in an unusual way or cannot resist the urge, drive or temptation to perform
activities that may be harmful to yourself or others. These behaviors are called impulse control disorder and may include gambling addiction, overeating or excessive spending, heightened sexual drive in an abnormal way, or preoccupation with an increase in sexual thoughts or desires. Your doctor may review your treatment.
During prolonged treatment with Levodopa/Carbidopa/Entacapone Mylan, your doctor may regularly request
laboratory investigations.
If you are to undergo surgery, tell your doctor that you are taking
Levodopa/Carbidopa/Entacapone Mylan.
The use of Levodopa/Carbidopa/Entacapone Mylan is not recommended for the treatment of extrapyramidal
symptoms (e.g. involuntary movements, tremors, muscle rigidity and muscle contractions) caused by other
medicines.

Children and adolescents
Experience in patients under the age of 18 years treated with levodopa/carbidopa/entacapone
is limited. Therefore, the use of Levodopa/Carbidopa/Entacapone Mylan is not recommended in children.

Other medicines and Levodopa/Carbidopa/Entacapone Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including medicines obtained without a prescription and herbal medicines.
Do not take Levodopa/Carbidopa/Entacapone Mylan if you are taking some medicines for the treatment
of depression (combinations of MAO-A selective inhibitors and MAO-B inhibitors, or non-selective
MAO inhibitors) e.g. phenelzine, tranylcypromine) (see above “Do not take Levodopa/Carbidopa/Entacapone
Mylan if you”).
Levodopa/carbidopa/entacapone can enhance the action and side effects of some medicines. These
include:

• medicines used to treat depression such as moclobemide, amitriptyline, desipramine, maprotiline, venlafaxine and paroxetine
• - medicines used to treat high blood pressure.

The effects of levodopa/carbidopa/entacapone can be decreased by some medicines.
These include:

• dopamine antagonists used to treat mental health conditions, or to prevent nausea and vomiting
• phenytoin, used to prevent convulsions
• papaverine, used to relax muscles.

Levodopa/carbidopa/entacapone can make it more difficult to absorb iron. Therefore, do not take
Levodopa/Carbidopa/Entacapone Mylan at the same time as iron supplements. After taking one of the two, wait at least 2-3 hours before taking the other.

Levodopa/Carbidopa/Entacapone Mylan with food and drink
For some patients, levodopa/carbidopa/entacapone may not be absorbed well if it is taken with, or
immediately after, protein-rich foods (such as meat, fish, dairy products, seeds and nuts). Consult your doctor if you think
this is the case.

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.
Levodopa/Carbidopa/Entacapone Mylan is not recommended during pregnancy unless the benefit for
the mother outweighs the potential risk to the child.
Breastfeeding
Women should not breastfeed during treatment with Levodopa/Carbidopa/Entacapone Mylan.

Driving and using machines
Levodopa/carbidopa/entacapone can lower blood pressure and this can cause
a feeling of dizziness and lightheadedness. Therefore, be particularly careful when driving and operating
tools or machinery.
If you experience drowsiness or sudden attacks of sleepiness, wait until you recover and feel fully awake
before resuming driving or performing any other activity that requires vigilance. Otherwise, you could
expose yourself and others to the risk of serious injury or death.

Levodopa/Carbidopa/Entacapone Mylan contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before
taking this medicine.

3. How to take Levodopa/Carbidopa/Entacapone Mylan

Take this medicine exactly as your doctor or pharmacist has told you. If you
have any doubts, ask your doctor or pharmacist.
For adult and elderly patients:

• Your doctor will tell you exactly how many Levodopa/Carbidopa/Entacapone Mylan tablets to take each day.
• The tablet is not intended to be divided or broken into smaller parts.
• Take only one tablet at a time.
• Based on your response to therapy, your doctor may recommend a higher or lower dose.
• Levodopa/Carbidopa/Entacapone Mylan can be taken with or without food. For some patients, this medicine may not be absorbed well if it is taken with, or immediately after, protein-rich foods (see section 2 “Levodopa/Carbidopa/Entacapone Mylan with food and drinks”)
• If you are taking Levodopa/Carbidopa/Entacapone Mylan tablets of 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, do not take more than 10 tablets a day.
• If you are taking Levodopa/Carbidopa/Entacapone Mylan tablets of 175 mg/43.75 mg/200mg, do not take more than 8 tablets a day.
• If you are taking Levodopa/Carbidopa/Entacapone Mylan tablets of 200 mg/50 mg/200mg, do not take more than 7 tablets a day.

If you feel that the effect of Levodopa/Carbidopa/Entacapone Mylan is too strong or too weak, or
if you experience any possible side effects, contact your doctor or pharmacist.

If you take more Levodopa/Carbidopa/Entacapone Mylan than you should
Immediately notify your doctor or pharmacist if you have accidentally taken more tablets of
Levodopa/Carbidopa/Entacapone Mylan than you should. In case of overdose, you may experience changes
in breathing, feel confused or agitated, your heartbeat 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 Mylan
Do not take a double dose to make up for a missed tablet.
If more than one hour remains until your next dose:
Take a tablet as soon as you remember and the next one at the scheduled time.
If less than one hour remains until your next dose:
Take a tablet as soon as you remember, wait one hour, then take another tablet. Then
continue normally.
Always allow at least one hour between taking successive doses of
Levodopa/Carbidopa/Entacapone Mylan, to avoid possible side effects

If you stop taking Levodopa/Carbidopa/Entacapone Mylan
Do not stop treatment with Levodopa/Carbidopa/Entacapone Mylan unless your doctor
tells you to. In this case, your doctor may consider it necessary to adjust the dose of other
antiparkinsonian medicines you are taking, especially levodopa, to adequately control
your symptoms. Abrupt discontinuation of treatment with Levodopa/Carbidopa/Entacapone Mylan and
other antiparkinsonian medicines can cause side effects.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of these side effects, contact your doctor as soon as possible. Many of the
side effects can be reduced simply by adjusting the dose.
If you experience the following symptoms during treatment with Levodopa/Carbidopa/EntacaponeMylan,
seek immediate medical attention or go to the nearest hospital emergency room:

Common(may affect up to 1 in 10 people)

• heart problems that can cause chest pain (angina pectoris), shortness of breath and swelling of the feet or legs due to fluid retention.

Uncommon(may affect up to 1 in 100 people)

• heart attack. You may experience severe chest pain, tingling, or a feeling of cold sweat
• bleeding from the intestine. You may feel nauseous or notice blood in your stool that is bloody or black.

Rare(may affect up to 1 in 1,000 people)

• An allergic reaction, the signs of which may include hives, itching, rash, swelling of the face, lips, tongue or throat. This can cause difficulty breathing or swallowing.

Not known(frequency cannot be estimated from available data)

• muscle stiffness or severe contractions, tremors, agitation, confusion, fever, increased heart rate or significant fluctuations in blood pressure or reddish-brown discoloration of the urine due to muscle fiber destruction. These may be symptoms of malignant neuroleptic syndrome (MNS, a rare and serious reaction to medicines used to treat central nervous system disorders) or rhabdomyolysis (a rare and serious muscle condition)
• seizures
• suicidal thoughts or behavior. Tell your doctor immediately if you experience any of the following symptoms:

Common(may affect up to 1 in 10 people)

• sudden sleepiness
• depression

Uncommon(may affect up to 1 in 100 people)

• severe mental condition in which you lose touch with reality and are unable to think and judge clearly
• difficulty urinating or emptying the bladder

Not known(frequency cannot be estimated from available data)

• yellowing of the whites of the eyes or skin, dark urine, pale stools, itching caused by liver problems
• Inability to resist the urge to perform an action that could be harmful, which may
• include:
• - a strong urge to gamble excessively, despite serious personal or family consequences;
• - altered or increased sexual interests and behaviors, of significant concern to you or others, for example, an accentuated sexual drive;
• - uncontrollable excessive shopping or spending;
• -uncontrolled eating (eating large amounts of food quickly) or compulsive eating (eating more food than usual and more than is needed to satisfy hunger).

Tell your doctor if you experience any of these behaviors; he/she will assess a way to manage
or reduce these symptoms.

Other possible side effects
Very common(may affect more than 1 in 10 people)

• involuntary movements (dyskinesia)
• feeling unwell (nausea)
• harmless brownish-reddish discoloration of the urine
• muscle pain
• diarrhea

Common(may affect up to 1 in 10 people)

• feeling dizzy or fainting due to low blood pressure, increased blood pressure
• worsening of Parkinsonian symptoms, such as slow or unstable movements, uncontrollable muscle spasms affecting eyes, head, neck and body, memory loss
• dizziness, drowsiness
• vomiting, abdominal pain and discomfort, heartburn, dry mouth, constipation,
• insomnia
• seeing, perceiving or hearing things that are not there (hallucinations), confusion, abnormal dreams (including nightmares)
• unusual fatigue or weakness
• mental disorders - including memory problems and anxiety
• irregularities in heart rate or rhythm
• increased frequency of falls
• shortness of breath
• increased sweating
• skin rash
• muscle cramps
• swelling of the legs
• disorders of the way you walk
• blurred vision
• reduction in the number of red blood cells (anemia)
• decreased appetite, weight loss
• headache
• joint pain
• urinary tract infection

Uncommon(may affect up to 1 in 100 people)

• changes in blood cells that can cause bleeding for longer than normal or unexpected bruising due to a reduction in the number of platelets, abnormalities in liver function tests observed in laboratory tests
• agitation
• inflammation of the colon (colitis) which can cause persistent abdominal cramps and diarrhea
• color changes in addition to that of the urine (e.g. of skin, nails, hair, sweat)
• difficulty swallowing
• general feeling of discomfort

Not known(frequency cannot be estimated from available data):

• skin rash with redness and itching.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
You can also report side effects directly through the national reporting system at the following address"http://www.agenziafarmaco.gov.it/it/responsabili".
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Levodopa/Carbidopa/Entacapone Mylan

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.
Shelf life after first opening of the container: 3 months
Store at a temperature below 25°C.

Only for the blister packaged product: Store in the original packaging to protect the product
from humidity

Only for the bottle product:Store in the original packaging and keep the bottle tightly closed to
protect the product from humidity.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Levodopa/Carbidopa/Entacapone Mylan contains

• The active ingredients are levodopa, carbidopa and entacapone.
• Each film-coated tablet contains 50 mg of levodopa, 12.5 mg of carbidopa anhydrous (equivalent to 13.5mg of Carbidopa monohydrate) and 200 mg of entacapone.
• Each film-coated tablet contains 75 mg of levodopa, 18.75 mg of carbidopa anhydrous (equivalent to 20.24 mg of Carbidopa monohydrate) and 200 mg of entacapone.
• Each film-coated tablet contains 100 mg of levodopa, 25 mg of carbidopa anhydrous (equivalent to 27 mg of Carbidopa monohydrate) and 200 mg of entacapone.
• Each film-coated tablet contains 125 mg of levodopa, 31.25 mg of carbidopa anhydrous (equivalent to 33.74 mg of Carbidopa monohydrate) and 200 mg of entacapone.
• Each film-coated tablet contains 150 mg of levodopa, 37.5 mg of carbidopa anhydrous (equivalent to 40.48 mg of Carbidopa monohydrate) and 200 mg of entacapone.
• Each film-coated tablet contains 175 mg of levodopa, 43.75 mg of carbidopa anhydrous (equivalent to 47.23 mg of Carbidopa monohydrate) and 200 mg of entacapone.
• Each film-coated tablet contains 200 mg of levodopa, 50 mg of carbidopa anhydrous (as 54 mg of Carbidopa monohydrate) and 200 mg of entacapone.
• The other components of the tablet core are sodium croscarmellose E 468, microcrystalline cellulose E 460, poloxamer 188, hydroxypropyl cellulose E 463, lactose monohydrate, magnesium stearate E470b.
• The components of the tablet coating are:

50mg/12,5mg/200mg; 100mg/25mg/200mg; 150mg/37,5mg/200mg:
Hypromellose, type 2910
Titanium Dioxide E 171
Glycerol E 422
Red Iron Oxide E172
Yellow Iron Oxide E172
Magnesium Stearate E 470b
Polysorbate 80 E433
Hydroxypropylcellulose E 463
75mg/18,75mg/200mg; 125mg/31,25mg/200mg; 175mg/43,75mg/200mg:
Hypromellose, type2910
Titanium DioxideE 171
GlycerolE 422
Red Iron Oxide E172
Magnesium StearateE 470b
Polysorbate80 E433
HydroxypropylcelluloseE 463
200mg/50mg/200mg
Hypromellose, type2910
Titanium DioxideE 171
GlycerolE 422
Red Iron Oxide E172
Magnesium StearateE 470b
Polysorbate80 E433
HydroxypropylcelluloseE 463

Description of the appearance of Levodopa/Carbidopa/Entacapone Mylan and package contents
Levodopa/Carbidopa/Entacapone Mylan 50 mg/12,5 mg/200 mg: film-coated tablets of reddish-brown color,
round in shape, biconvex, with the inscription `50` on one side and smooth on the other side.
Levodopa/Carbidopa/Entacapone Mylan 75 mg/18,75 mg/200mg: film-coated tablets of light reddish-brown color, oval in shape, biconvex, with the inscription `75` on one side and smooth on the other side.
Levodopa/Carbidopa/Entacapone Mylan 100 mg/25 mg/200 mg: film-coated tablets of reddish-brown color, oval in shape, biconvex, with the inscription `100` on one side and smooth on the other side.
Levodopa/Carbidopa/Entacapone Mylan 125 mg/31,25 mg/200 mg: film-coated tablets of light reddish-brown color, oval in shape, biconvex, with the inscription `125` on one side and smooth on the other side.
Levodopa/Carbidopa/Entacapone Mylan 150 mg/37,5 mg/200 mg: film-coated tablets of reddish-brown color, oval in shape, biconvex, with the inscription `150` on one side and smooth on the other side.
Levodopa/Carbidopa/Entacapone Mylan 175 mg/43,75 mg/200 mg: film-coated tablets of light reddish-brown color, oval in shape, biconvex, with the inscription `175` on one side and smooth on the other side.
Levodopa/Carbidopa/Entacapone Mylan 200 mg/50 mg/200 mg: film-coated tablets of dark reddish-brown color, oval in shape, biconvex, with the inscription `200` on one side and smooth on the other side.
Levodopa/Carbidopa/Entacapone Mylan is available in various sizes both as an HDPE bottle, with an aluminum induction seal and with silica gel desiccant contained in a small capsule (as a separate component) inside the HDPE bottle, and in blister packs (Aluminum-Aluminum) containing 30 or 100
tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Mylan S.p.A. Via Vittor Pisani 20, 20124 Milano, Italy

Manufacturer:
Wessling Hungary Kft.
1047, Budapest, Fotiut.56,
Hungary
Mylan HungaryKft.Mylanutca 1,Komárom
H-2900 Hungary