Levodopa/carbidopa/entacapone Mylan

Patient Information Leaflet

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/25 mg/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, 175 mg/43.75 mg/200 mg film-coated tablets, 200 mg/50 mg/200 mg film-coated tablets

levodopa/carbidopa/entacapone
Equivalent medicine
Please read this entire leaflet carefully before 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 give it to others, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 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. Contents of the pack and other information

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

Levodopa/Carbidopa/Entacapone Mylan contains three active substances (levodopa, carbidopa and 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 thereby reduces the symptoms of Parkinson's disease. Carbidopa and entacapone enhance the effectiveness of the anti-Parkinson 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)
• have closed-angle glaucoma (an eye disorder)
• have a tumour of the adrenal gland
• are taking medicines to treat depression (combinations of selective MAO-A inhibitors and MAO-B inhibitors, or non-selective MAO inhibitors, such as phenelzine, tranilcypramine)
• have previously suffered from neuroleptic malignant syndrome (NMS – a rare reaction to certain medicines used to treat serious mental disorders)
• have previously suffered from non-traumatic rhabdomyolysis (a rare muscle disorder)
• have severe liver disease.

Warnings and precautions
Talk to your doctor or pharmacist before taking Levodopa/Carbidopa/Entacapone Mylan if you
have or have previously had:

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

Talk to your doctor if you are taking:

• antipsychotic medicines (medicines used to treat psychosis)
• a medicine that may cause low blood pressure when standing up from sitting or lying down. You should be aware that Levodopa/Carbidopa/Entacapone Mylan may worsen such reactions.

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

• you notice the onset of muscle stiffness or strong contractions, or if you experience tremors, agitation, confusion, fever, increased heart rate or severe fluctuations in blood pressure. In such cases, contact your doctor immediately
• you feel depressed or have thoughts of suicide, or if you notice any changes in your behaviour
• you experience sudden attacks of sleep, or feel unusually sleepy. If this occurs, you must not drive or operate tools or machinery (see also section “Driving and use of machines”)
• you notice the onset of uncontrolled movements or if such movements worsen after taking Levodopa/Carbidopa/Entacapone Mylan. In this case, your doctor may decide to change the dosage of your anti-Parkinson’s medicines
• you develop diarrhoea: monitoring of body weight is recommended to avoid potentially excessive weight loss
• if you have prolonged diarrhoea, consult your doctor as this 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 liver problems and your doctor may wish to perform laboratory tests
• you feel the need to stop taking Levodopa/Carbidopa/Entacapone Mylan; see section “If you stop taking Levodopa/Carbidopa/Entacapone Mylan”.

Inform your doctor if you, or your family members/caregivers, notice that you develop impulses or strong
urges to behave in an unusual way or are unable to resist the impulse, drive or temptation to carry out
activities that could be harmful to yourself or others. These behaviours are known as impulse control disorders
and may include compulsive gambling, eating or spending, abnormally increased sexual drive or preoccupation
with an increase in sexual thoughts or desires. Your doctor may need to review your treatment.
During prolonged treatment with Levodopa/Carbidopa/Entacapone Mylan, your doctor may request regular
laboratory tests.
If you are scheduled for surgery, inform 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 with levodopa/carbidopa/entacapone in patients under 18 years of age is limited. Therefore, the use of Levodopa/Carbidopa/Entacapone Mylan is not recommended in children.
Other medicines and Levodopa/Carbidopa/Entacapone Mylan
Inform your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including those obtained without a prescription and herbal medicines.
Do not take Levodopa/Carbidopa/Entacapone Mylan if you are taking certain medicines for depression (combinations of selective MAO-A inhibitors and MAO-B inhibitors, or non-selective
MAO inhibitors, e.g. phenelzine, tranilcypramine) (see above “Do not take Levodopa/Carbidopa/Entacapone
Mylan if you”).
Levodopa/carbidopa/entacapone may enhance the action and side effects of certain 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 may be reduced by certain medicines.
These include:

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

Levodopa/carbidopa/entacapone may impair iron absorption. Therefore, do not take
Levodopa/Carbidopa/Entacapone Mylan at the same time as iron supplements. After taking
either one, wait at least 2–3 hours before taking the other.
Levodopa/Carbidopa/Entacapone Mylan with food and drink
In some patients, levodopa/carbidopa/entacapone may not be well absorbed if taken with, or immediately after, high-protein foods (such as meat, fish, dairy products, seeds and nuts). Consult your doctor if you think this may apply to you.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant, think you may be pregnant or are planning to become pregnant, consult your doctor or
pharmacist before taking this medicine.
Levodopa/Carbidopa/Entacapone Mylan is not recommended during pregnancy unless the benefit to the
mother outweighs the potential risk to the foetus.
Breastfeeding
Women must not breastfeed during treatment with Levodopa/Carbidopa/Entacapone Mylan.
Driving and use of machines
Levodopa/carbidopa/entacapone may lower blood pressure, which may cause
dizziness and lightheadedness. Therefore, exercise particular caution when driving or operating
tools or machinery.
If you experience drowsiness or sudden sleep attacks, wait until you are fully awake and alert
before resuming driving or any other activity requiring vigilance. Otherwise, you may put yourself and others at risk of serious injury or death.
Levodopa/Carbidopa/Entacapone Mylan contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before
taking this medicine.

3. How to take Levodopa/Carbidopa/Entacapone Mylan

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

For adult and elderly patients:

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

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

If you take more Levodopa/Carbidopa/Entacapone Mylan than you should
Contact your doctor or pharmacist immediately if you have accidentally taken more tablets than prescribed. In case of overdose, you may notice changes in breathing, confusion or agitation, a slower or faster heartbeat than normal, or changes in the colour of your skin, tongue, eyes, or urine.

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 before your next dose:
Take one tablet as soon as you remember, then take the next dose at the usual time.
If less than one hour remains before your next dose:
Take one tablet as soon as you remember, wait one hour, then take another tablet. After that, continue as normal.
Always allow at least one hour between consecutive 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 such a case, your doctor may consider it necessary to adjust the dose of other anti-Parkinson’s medicines you are taking, especially levodopa, to adequately control your symptoms. Abruptly stopping treatment with Levodopa/Carbidopa/Entacapone Mylan and other anti-Parkinson’s medicines may cause unwanted side effects.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody 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 any of the following symptoms while taking Levodopa/Carbidopa/Entacapone Mylan, contact your doctor immediately or go to the nearest hospital emergency department:

Common (may affect up to 1 in 10 people)

• Heart disorder that may 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 sensations, or feel as if you are sweating coldly.
• Bleeding in the intestine. You may feel nauseous or notice blood in your stools, which may be 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 may cause difficulty breathing or swallowing.

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

• Muscle stiffness or severe contractions, tremors, agitation, confusion, fever, increased heart rate, severe fluctuations in blood pressure, or red-brown discoloration of the urine due to destruction of muscle fibers. These may be symptoms of neuroleptic malignant syndrome (NMS, a rare and serious reaction to medicines used to treat disorders of the central nervous system) or rhabdomyolysis (a rare and serious muscle disorder).
• Seizures
• Suicidal thoughts or behaviour. Contact your doctor immediately if you experience any of the following symptoms:

Common (may affect up to 1 in 10 people)

• Sudden sleep
• 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 or judge clearly
• Difficulty urinating or emptying the bladder

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

• Yellowing of the whites of the eyes or skin, dark urine, pale stools, itching caused by liver problems
• Inability to resist the impulse to carry out an action that could be harmful, which may include:
  • Strong urge to gamble excessively, despite serious personal or family consequences;
  • Altered or increased sexual interests and behaviours, causing significant concern to you or others, for example, increased sexual drive;
  • Uncontrollable excessive shopping or spending;
  • Binge eating (eating large amounts of food in a short time) or compulsive eating (eating more food than usual and more than needed to satisfy hunger).

Inform your doctor if you experience any of these behaviours; they will assess ways 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-red discoloration of the urine
• Muscle pain
• Diarrhoea

Common (may affect up to 1 in 10 people)

• Dizziness or fainting due to low blood pressure, increased blood pressure
• Worsening of Parkinsonian symptoms, such as slow or unstable movements, uncontrollable muscle spasms affecting the eyes, head, neck, and body, memory loss
• Dizziness, drowsiness
• Vomiting, abdominal pain and discomfort, heartburn, dry mouth, constipation
• Insomnia
• Seeing, sensing, or hearing things that are not there (hallucinations), confusion, abnormal dreams (including nightmares)
• Unusual tiredness or weakness
• Mental disorders – including memory problems and anxiety
• Irregular heart rate or rhythm
• Increased frequency of falls
• Shortness of breath
• Increased sweating
• Rash
• Muscle cramps
• Swelling in the legs
• Walking disturbances
• Blurred vision
• Reduction in red blood cell count (anaemia)
• Decreased appetite, weight loss
• Headache
• Joint pain
• Urinary tract infection

Uncommon (may affect up to 1 in 100 people)

• Changes in blood cells that may cause longer-than-normal bleeding or unexpected bruising due to reduced platelet count, abnormalities in liver function tests observed in laboratory exams
• Agitation
• Inflammation of the colon (colitis) which may cause persistent abdominal cramps and diarrhoea
• Changes in pigmentation in addition to that of the urine (e.g. of the skin, nails, hair, sweat)
• Difficulty swallowing
• General feeling of being unwell

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

• Skin rash with redness and itching.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: 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 stated on the bottle and the outer packaging, following
"EXP.".
The expiry date refers to the last day of that month.
Shelf life after first opening of the container: 3 months
Store below 25°C.
For blister pack presentation only: Store in the original packaging to protect the product from moisture.
For bottle presentation only: Store in the original packaging and keep the bottle tightly closed to protect the product from moisture.
Do not dispose of any medicine via 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 substances are levodopa, carbidopa, and entacapone.
• Each film-coated tablet contains 50 mg of levodopa, 12.5 mg of anhydrous carbidopa (equivalent to 13.5 mg of carbidopa monohydrate) and 200 mg of entacapone.
• Each film-coated tablet contains 75 mg of levodopa, 18.75 mg of anhydrous carbidopa (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 anhydrous carbidopa (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 anhydrous carbidopa (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 anhydrous carbidopa (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 anhydrous carbidopa (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 anhydrous carbidopa (equivalent to 54 mg of carbidopa monohydrate) and 200 mg of entacapone.
• The other components of the tablet core are croscarmellose sodium E 468, microcrystalline cellulose E 460, poloxamer 188, hydroxypropylcellulose E 463, lactose monohydrate, magnesium stearate E 470b.
• The components of the tablet coating are:

50 mg/12.5 mg/200 mg; 100 mg/25 mg/200 mg; 150 mg/37.5 mg/200 mg:
Hypromellose, type 2910
Titanium dioxide E 171
Glycerol E 422
Iron oxide red E 172
Iron oxide yellow E 172
Magnesium stearate E 470b
Polysorbate 80 E 433
Hydroxypropylcellulose E 463

75 mg/18.75 mg/200 mg; 125 mg/31.25 mg/200 mg; 175 mg/43.75 mg/200 mg:
Hypromellose, type 2910
Titanium dioxide E 171
Glycerol E 422
Iron oxide red E 172
Magnesium stearate E 470b
Polysorbate 80 E 433
Hydroxypropylcellulose E 463

200 mg/50 mg/200 mg:
Hypromellose, type 2910
Titanium dioxide E 171
Glycerol E 422
Iron oxide red E 172
Magnesium stearate E 470b
Polysorbate 80 E 433
Hydroxypropylcellulose E 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, reddish-brown in colour, round, biconvex, engraved with "50" on one side and smooth on the other.

Levodopa/Carbidopa/Entacapone Mylan 75 mg/18.75 mg/200 mg: film-coated tablets, light reddish-brown in colour, oval-shaped, biconvex, engraved with "75" on one side and smooth on the other.

Levodopa/Carbidopa/Entacapone Mylan 100 mg/25 mg/200 mg: film-coated tablets, reddish-brown in colour, oval-shaped, biconvex, engraved with "100" on one side and smooth on the other.

Levodopa/Carbidopa/Entacapone Mylan 125 mg/31.25 mg/200 mg: film-coated tablets, light reddish-brown in colour, oval-shaped, biconvex, engraved with "125" on one side and smooth on the other.

Levodopa/Carbidopa/Entacapone Mylan 150 mg/37.5 mg/200 mg: film-coated tablets, reddish-brown in colour, oval-shaped, biconvex, engraved with "150" on one side and smooth on the other.

Levodopa/Carbidopa/Entacapone Mylan 175 mg/43.75 mg/200 mg: film-coated tablets, light reddish-brown in colour, oval-shaped, biconvex, engraved with "175" on one side and smooth on the other.

Levodopa/Carbidopa/Entacapone Mylan 200 mg/50 mg/200 mg: film-coated tablets, dark reddish-brown in colour, oval-shaped, biconvex, engraved with "200" on one side and smooth on the other.

Levodopa/Carbidopa/Entacapone Mylan is available in various pack sizes, either as HDPE bottles with an aluminium induction seal and a small capsule containing silica gel desiccant (as a separate component) inside the HDPE bottle, or in aluminium-aluminium blister packs containing 30 or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

Manufacturer:
Wessling Hungary Kft.
1047, Budapest, Foti ut. 56,
Hungary

Mylan Hungary Kft.
Mylan utca 1, Komárom
H-2900 Hungary