LEVODOPA/CARBIDOPA/ENTACAPONA KERN PHARMA 75 mg / 18.75 mg / 200 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Levodopa/Carbidopa/Entacapone Kern Pharma 75 mg/18.75 mg/200 mg film-coated tablets EFG

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.

Contents of the pack

1. What Levodopa/Carbidopa/Entacapone Kern Pharma is and what it is used for
2. What you need to know before you take Levodopa/Carbidopa/Entacapone Kern Pharma
3. How to take Levodopa/Carbidopa/Entacapone Kern Pharma
4. Possible side effects

5 Conservation of Levodopa/Carbidopa/Entacapone Kern Pharma

1. Package contents and additional information

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

This medicine contains three active substances (levodopa, carbidopa, and entacapone) in one film-coated tablet. Levodopa/Carbidopa/Entacapone Kern Pharma is used to treat Parkinson's disease.

Parkinson's disease is due to a low concentration in the brain of a substance called dopamine. Levodopa increases the amount of dopamine and, in this way, reduces the symptoms of Parkinson's disease. Carbidopa and entacapone improve the antiparkinsonian effects of levodopa.

2. What you need to know before you take Levodopa/Carbidopa/Entacapone Kern Pharma

Do not take Levodopa/Carbidopa/Entacapone Kern Pharma if

• you are allergic to levodopa, carbidopa, or entacapone, or to any of the other ingredients of this medicine (listed in section 6)
• you have narrow-angle glaucoma (a condition of the eye).
• you have a tumor of the adrenal gland.
• you are taking certain medicines for depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors).
• you have ever suffered from neuroleptic malignant syndrome (NMS - a rare reaction to medicines used to treat severe mental disorders).
• you have ever suffered from non-traumatic rhabdomyolysis (a rare muscle disorder).
• you have severe liver disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine if you suffer or have ever suffered from:

• a heart attack or any other heart disease, including arrhythmias, or blood vessel disease.
• asthma or any other lung disease.
• a liver problem, as the dose you receive may need to be adjusted.
• any kidney disease or hormone-related disorder.
• stomach ulcers or seizures.
• prolonged diarrhea. Consult your doctor as it may be a sign of colon inflammation.
• any severe mental disorder, such as psychosis.
• open-angle glaucoma, as the dose may need to be adjusted and your intraocular pressure monitored.

Consult your doctor if you are taking:

• antipsychotics (medicines for treating psychosis).
• any medicine that may cause a drop in blood pressure when standing up from a chair or bed. You should be aware that Levodopa/Carbidopa/Entacapone may worsen these reactions.

Consult your doctor if, during treatment with this medicine, you:

• notice great stiffness in the muscles or violent contractions, or if you suffer from tremors, agitation, confusion, fever, rapid pulse, or large fluctuations in blood pressure. If any of these circumstances occur, contact your doctor immediately.
• feel depressed, have suicidal thoughts, or notice unusual changes in your behavior.
• feel suddenly sleepy or very drowsy. If this happens, do not drive or operate tools or machinery (see also the section "Driving and using machines").
• start to notice uncontrolled movements or if they worsen. If this occurs, your doctor may need to adjust your medication dose.
• suffer from diarrhea; it is recommended to monitor your weight to avoid excessive weight loss.
• suffer from progressive loss of appetite, asthenia (weakness, exhaustion), and weight loss over a relatively short period. In these cases, a complete medical evaluation, including a liver function test, should be considered.
• consider stopping treatment with Levodopa/Carbidopa/Entacapone Kern Pharma; consult the section "If you stop taking Levodopa/Carbidopa/Entacapone Kern Pharma".

Tell your doctor if you or your family/caregiver notice that you are developing desires or tendencies to behave abnormally, which you cannot resist, or that you are unable to control the impulse, determination, or temptation to perform certain activities that may harm you or others. These behaviors are called impulse control disorders and may include addiction to gambling, eating, or excessive spending, and an abnormally high sexual drive or concern with an increase in sexual thoughts or feelings. Your doctor may need to review your treatment.

Tell your doctor if you, or your family/caregiver, notice that you are developing symptoms similar to addiction, leading to a desire for high doses of Levodopa/Carbidopa/Entacapone Kern Pharma and other medicines used to treat Parkinson's disease.

During prolonged treatment with Levodopa/Carbidopa/Entacapone, your doctor may perform regular blood tests.

If you need to undergo surgery, you must inform your doctor that you are taking this medicine.

It is not recommended to use Levodopa/Carbidopa/Entacapone for the treatment of extrapyramidal symptoms (e.g., involuntary movements, agitation, muscle stiffness, and muscle contractions) caused by other medicines.

Children and adolescents

Experience with the use of Levodopa/Carbidopa/Entacapone in patients under 18 years of age is limited. Therefore, it is not recommended for use in children.

Taking Levodopa/Carbidopa/Entacapone Kern Pharma with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take this medicine if you are taking certain medicines for depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors).

Levodopa/Carbidopa/Entacapone may increase the effect and also the side effects of certain medicines. These include:

• medicines used to treat depression, such as moclobemide, amitriptyline, desipramine, maprotiline, venlafaxine, and paroxetine
• rimiterol 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, used to treat Parkinson's disease.

Certain medicines may reduce the effects of Levodopa/Carbidopa/Entacapone. These medicines are:

• dopamine antagonists used to treat mental disorders, nausea, and vomiting
• phenytoin, used to prevent seizures
• papaverine, used to relax muscles

Levodopa/Carbidopa/Entacapone may hinder the absorption of iron in the digestive tract. Therefore, you should not take this medicine at the same time as taking iron supplements. If you take any of them, you should wait at least 2 or 3 hours before taking the other.

Taking Levodopa/Carbidopa/Entacapone Kern Pharma with food and drinks

This medicine can be taken with or without food.

It may be that in some patients, Levodopa/Carbidopa/Entacapone is not well absorbed if taken with foods rich in protein (meat, fish, dairy products, cereals, and nuts) or shortly after eating them.

Consult your doctor if you think this is happening in your case.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.

You should not breastfeed while taking this medicine.

Driving and using machines

Levodopa/Carbidopa/Entacapone may reduce your blood pressure, which can cause dizziness or fainting. Therefore, be careful when handling tools or machinery.

If you feel very tired or notice that you suddenly fall asleep, wait until you feel fully awake again before driving or doing anything that requires you to be alert. Otherwise, you may put yourself and others at risk of a serious or even fatal accident.

Levodopa/Carbidopa/Entacapone Kern Pharma 75 mg/18.75 mg/200 mg contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Levodopa/Carbidopa/Entacapone Kern Pharma

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults and elderly:

• Your doctor will tell you the exact number of Levodopa/Carbidopa/Entacapone tablets you should take per day.
• The tablets should not be broken or divided into smaller pieces.
• Take only one tablet at a time.
• Depending on how you respond to the treatment, your doctor may tell you to increase or reduce the dose.
• If you are taking Levodopa/Carbidopa/Entacapone 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 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 suffer from possible side effects.

If you take more Levodopa/Carbidopa/Entacapone Kern Pharma than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 915 620 420, indicating the medicine and the amount ingested.

You may feel dizzy 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 Kern Pharma

Do not take a double dose to make up for forgotten doses.

If it is more than 1 hour until the next dose:

Take a tablet as soon as you remember, and the next one at the usual time.

If it is less than 1 hour until the next dose:

Take a tablet as soon as you remember, wait 1 hour, and take another tablet then. Then, continue as usual.

There should always be 1 hour between tablets of this medicine to avoid possible side effects.

If you stop taking Levodopa/Carbidopa/Entacapone Kern Pharma

Do not stop taking this medicine unless your doctor tells you to. In that case, your doctor may need to adjust the dose of your other Parkinson's medicines, especially levodopa, to ensure sufficient control of your symptoms. If you stop taking Levodopa/Carbidopa/Entacapone and other Parkinson's medicines abruptly, you may suffer from 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 can be alleviated by adjusting the dose.

If you experience any of these symptoms during treatment with this medicine, contact your doctor immediately:

• Great stiffness or violent contractions of the muscles, tremors, agitation, confusion, fever, rapid pulse, or large fluctuations in blood pressure. These may be symptoms of neuroleptic malignant syndrome (NMS - a rare and severe reaction to medicines used to treat central nervous system disorders) or rhabdomyolysis (a rare and severe muscle disorder).
• An allergic reaction characterized by signs such as hives, itching, rash, and swelling of the face, lips, tongue, or throat. This reaction can cause difficulty breathing or swallowing.

Very common (may affect more than 1 in 10 people):

• uncontrolled movements (dyskinesias)
• feeling of discomfort (nausea)
• brown-red discoloration of urine (harmless)
• muscle pain
• diarrhea

Common (may affect up to 1 in 10 people):

• fainting or fainting due to low blood pressure, hypertension
• worsening of Parkinson's symptoms, dizziness, drowsiness
• vomiting; abdominal pain and discomfort; heartburn; dry mouth; constipation
• sleep disorders; hallucinations; confusion; abnormal dreams (with nightmares); fatigue
• changes in mental state, including memory problems, anxiety, and depression (possibly with suicidal thoughts)
• heart or blood vessel disorders (e.g., chest pain), irregular heart rhythms
• more frequent falls
• breathlessness
• increased sweating, rash
• muscle cramps, swelling of the legs
• blurred vision
• anemia
• decreased appetite, weight loss
• headache, joint pain
• urinary tract infections

Uncommon (may affect up to 1 in 100 people):

• heart attack
• intestinal bleeding
• changes in blood cell count that can cause bleeding and abnormalities in liver function tests
• seizures
• feeling of agitation
• psychotic symptoms
• colitis (inflammation of the colon)
• color changes other than those of urine (e.g., skin, nails, hair, sweat)
• difficulty swallowing
• 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, and which could include:

• a strong impulse to gamble excessively despite serious personal or family consequences
• an increased or altered interest in sex and a concerning behavior for you or others, such as an increased sexual drive
• excessive or uncontrolled shopping or spending
• eating excessively (eating large amounts of food in short periods) or compulsively (eating more food than usual and more than needed to satisfy hunger).

Tell your doctor if you experience any of these behaviors; they will discuss how to manage or reduce these symptoms.

Reporting of side effects

If you experience 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 through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Levodopa/Carbidopa/Entacapone Kern Pharma

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 carton after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Discard the product 175 days after opening the package.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Levodopa/Carbidopa/EntacaponeKern Pharma

The active ingredients are levodopa, carbidopa, and entacapone. Each coated tablet contains 75 mg of levodopa, 18.75 mg of carbidopa, and 200 mg of entacapone.

The other components are: microcrystalline cellulose, anhydrous lactose, hydroxypropylcellulose, povidone (E-1201), anhydrous colloidal silica, magnesium stearate, titanium dioxide (E-171), hypromellose, glycerol (E-422), yellow iron oxide (E-172), polysorbate 80, and red iron oxide (E-172).

Product Appearance and Package Contents

Biconvex, oval, light orange tablets, engraved with "75" on one side, smooth on the other.

Levodopa/Carbidopa/Entacapone Kern Pharma 75 mg/18.75 mg/200 mg is available in packages of 100 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer:

Teva Pharmaceutical Works Private

Pallagi út 13, 4042 Debrecen

Hungary

or

Teva UK Limited

Brampton Road, Hampden Park,

Eastbourne, East Sussex, BN22 9AG,

United Kingdom

Date of the Last Revision of this Leaflet: September 2019.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/