Levodopa/carbidopa/entacapone Kern Pharma 50 mg/12.5 mg/200 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Levodopa/Carbidopa/Entacapone Kern Pharma 50 mg/12.5 mg/200 mg film-coated tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Levodopa/Carbidopa/Entacapone Kern Pharma is and what it is used for
2. What you need to know before taking Levodopa/Carbidopa/Entacapone Kern Pharma
3. How to take Levodopa/Carbidopa/Entacapone Kern Pharma
4. Possible side effects
5. How to store Levodopa/Carbidopa/Entacapone Kern Pharma
6. Contents of the pack and other 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 a film-coated tablet. Levodopa/Carbidopa/Entacapone Kern Pharma 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 amount of dopamine and thereby reduces the symptoms of Parkinson's disease. Carbidopa and entacapone enhance the anti-Parkinson effects of levodopa.

2. What you need to know before taking Levodopa/Carbidopa/Entacapona Kern Pharma

Do not take Levodopa/Carbidopa/Entacapona 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 type of eye disorder).
• you have a tumor of the adrenal glands.
• you are taking certain medicines for depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors).
• you have ever had neuroleptic malignant syndrome (NMS – a rare reaction to medicines used in the treatment of serious mental disorders).
• you have ever had non-traumatic rhabdomyolysis (a rare muscle disorder).
• you have 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 heart or blood vessel disease, including arrhythmias.
• asthma or any other lung disease.
• liver problems, as your dose may need to be adjusted.
• kidney disease or hormone-related disorders.
• stomach ulcer or seizures.
• prolonged diarrhea. Consult your doctor, as this may be a sign of inflammation of the colon.
• any form of serious mental disorder, such as psychosis.
• open-angle glaucoma, as your dose may need to be adjusted and your intraocular pressure monitored.

Talk to your doctor if you are taking:

• antipsychotics (medicines used to treat psychosis).
• any medicine that may cause a drop in blood pressure when standing up from sitting or lying down. Be aware that Levodopa/Carbidopa/Entacapona may worsen these reactions.

Talk to your doctor if, during treatment with this medicine, you:

• notice marked muscle rigidity or violent muscle contractions, or experience tremors, agitation, confusion, fever, rapid pulse, or large fluctuations in blood pressure. If any of these occur, contact your doctor immediately.
• feel depressed, have thoughts of suicide, or notice unusual changes in your behavior.
• find yourself falling asleep suddenly or feel very drowsy. If this happens, you must not drive or operate tools or machinery (see also section "Driving and use of machines").
• begin to experience uncontrolled movements or worsening of such movements. If this occurs, your doctor may need to change your dose.
• experience diarrhea; weight monitoring is recommended to avoid excessive weight loss.
• experience progressive loss of appetite, asthenia (weakness, fatigue), and weight loss over a relatively short period. In such cases, a full medical evaluation including liver function tests should be considered.
• are considering stopping this medicine; refer to the section "If you stop taking Levodopa/Carbidopa/Entacapona Kern Pharma".

Inform your doctor if you or your family/caregiver notice that you are developing urges or a tendency to behave in ways that are unusual for you or that you cannot resist the impulse, drive, or temptation to carry out certain activities that may harm you or others. These behaviors are known as impulse control disorders and may include gambling addiction, compulsive eating, excessive spending, or abnormally increased sexual urges or preoccupation with sexual thoughts or sensations. Your doctor may need to review your treatment.

Inform your doctor if you or your family/caregiver notice that you are developing addiction-like symptoms, leading to a desire for high doses of Levodopa/Carbidopa/Entacapona and other medicines used to treat Parkinson's disease.

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

If you are scheduled for surgery, you must inform your doctor that you are taking this medicine.

Levodopa/Carbidopa/Entacapona is not recommended for the treatment of extrapyramidal symptoms (e.g., involuntary movements, restlessness, muscle rigidity, and muscle contractions) caused by other medicines.

Children and adolescents

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

Taking Levodopa/Carbidopa/Entacapona Kern Pharma with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to 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/Entacapona may increase the effect and also the adverse 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 conditions 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/Entacapona. 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/Entacapona may interfere with the gastrointestinal absorption of iron. Therefore, you should not take this medicine at the same time as iron supplements. If you take either, wait at least 2 to 3 hours between taking them.

Taking Levodopa/Carbidopa/Entacapona Kern Pharma with food and drink

This medicine may be taken with or without food.

In some patients, Levodopa/Carbidopa/Entacapona may not be well absorbed when taken with high-protein foods (meat, fish, dairy products, cereals, and nuts) or shortly after consuming them.

Consult your doctor if you think this applies to you.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

You must not breastfeed while taking this medicine.

Driving and use of machines

Levodopa/Carbidopa/Entacapona may lower your blood pressure, which could cause dizziness or fainting. Therefore, take special care when operating tools or machinery.

If you feel very tired or notice that you fall asleep suddenly, wait until you are fully awake again before driving or doing anything else that requires alertness. Otherwise, you may put yourself and others at risk of serious or even fatal accidents.

Levodopa/Carbidopa/Entacapona Kern Pharma 50 mg/12.5 mg/200 mg contains lactose

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

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

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in 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 each day.
• The tablets must not be split or divided into smaller pieces.
• Take only one tablet at a time.
• Depending on your response to treatment, your doctor may instruct you to increase or decrease 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 experience possible adverse effects.

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

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Poison Information Service at telephone number: 915 620 420, indicating the medicine and the amount ingested.

You may feel dizzy or restless, your heartbeat may be slower or faster than normal, or you may notice changes in the colour of your skin, tongue, eyes or urine.

If you forget to take Levodopa/Carbidopa/Entacapone Kern Pharma

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

If more than 1 hour remains until the next dose:

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

If less than 1 hour remains until the next dose:

Take one tablet as soon as you remember, wait 1 hour, and then take another tablet. After that, continue as usual.

There must always be an interval of 1 hour between tablets of this medicine to avoid possible adverse 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 medications, especially levodopa, to ensure adequate symptom control. If you suddenly stop taking Levodopa/Carbidopa/Entacapone and other Parkinson's medications, you may experience unwanted adverse effects.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. Many of these can be relieved by adjusting the dose.

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

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

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

• Uncontrolled movements (dyskinesias)
• Feeling unwell (nausea)
• Harmless reddish-brown discoloration of the urine
• Muscle pain
• Diarrhea

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

• Fainting or collapse due to low blood pressure, hypertension
• Worsening of parkinsonism symptoms, dizziness, drowsiness
• Vomiting; abdominal pain and discomfort; heartburn; dry mouth; constipation
• Inability to sleep; hallucinations; confusion; abnormal dreams (including nightmares); fatigue
• Changes in mental state, including memory problems, anxiety, and depression (possibly with suicidal thoughts)
• Heart or arterial problems (e.g., chest pain), irregular heartbeat
• More frequent falls
• Labored breathing
• Increased sweating, rashes
• 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 counts that may lead to bleeding and abnormalities in liver function tests
• Seizures
• Feeling of restlessness
• Psychotic symptoms
• Colitis (inflammation of the colon)
• Changes in pigmentation other than in the urine (e.g., skin, nails, hair, sweat)
• Difficulty swallowing
• Inability to urinate

The following adverse effects have also been reported:

• Hepatitis (inflammation of the liver)
• Itching

You may experience the following adverse effects:

Inability to resist the impulse to carry out an action that could be harmful, which may include:

• A strong urge to gamble excessively despite serious personal or family consequences
• Increased or altered interest in sex and behavior that is concerning to you or others, such as increased sexual drive
• Excessive or uncontrolled shopping or spending
• Excessive (eating large amounts of food in short periods of time) or compulsive (eating more food than usual and more than needed to satisfy hunger) eating.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es

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

5. Storage 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 stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not store above 25°C.

Discard the product 175 days after opening the container.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levodopa/Carbidopa/Entacapone Kern Pharma

The active substances are levodopa, carbidopa and entacapone. Each coated tablet contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone.

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

Appearance of the product and contents of the container

Round, biconvex tablets, light brown in colour, with a score line on one side and smooth on the other.

Levodopa/Carbidopa/Entacapone Kern Pharma 50 mg/12.5 mg/200 mg is available in packs 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 most recent revision of this leaflet: September 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/