LEVODOPA/CARBIDOPA/ENTACAPONA KERN PHARMA 125 mg / 31.25 mg / 200 mg FILM-COATED TABLETS

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine if you have or have had:

• a heart attack or any other heart disease, including arrhythmias, or blood vessel disease.
• asthma or any other lung disease.
• a liver problem, as your dose may need to be adjusted.
• any kidney disease or hormone-related disease.
• stomach ulcers or convulsions.
• 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 your dose may need to be adjusted and your intraocular pressure monitored.

Tell 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.

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

• notice great stiffness in your muscles or violent muscle 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 very sleepy or notice that you are 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 happens, 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 member/caregiver notice that you are developing desires or tendencies to behave in an unusual way for you or that you cannot resist 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 member/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.

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

Children and adolescents

Experience with the use of Levodopa/Carbidopa/Entacapone in patients under 18 years 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 convulsions
• papaverine, used to relax muscles

Levodopa/Carbidopa/Entacapone may interfere with the absorption of iron in the gut. Therefore, do not take this medicine at the same time as iron supplements. If you take any, 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.

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

Consult your doctor if you think this is happening 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 while taking this medicine.

Driving and using machines

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

If you feel very tired or notice that you have fallen asleep suddenly, wait until you are fully awake 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 125 mg/31.25 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

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Adults and elderly:

• Your doctor will tell you exactly how many Levodopa/Carbidopa/Entacapone tablets to take each 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 treatment, your doctor may tell 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 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 taken.

You may feel dizzy or agitated, your heart rate may be slower or faster than normal, or your skin, tongue, eyes, or urine may change color.

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 an interval of 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 control your symptoms. If you stop taking Levodopa/Carbidopa/Entacapone and other Parkinson's medicines suddenly, you may experience 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 relieved by adjusting the dose.

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

• Great 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, severe reaction to medicines used to treat central nervous system disorders) or rhabdomyolysis (a rare, 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 sick (nausea)
• brownish-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, high blood pressure
• worsening of Parkinson's symptoms, dizziness, drowsiness
• vomiting; abdominal pain and discomfort; heartburn; dry mouth; constipation
• sleeplessness; 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 problems (e.g., chest pain), irregular heartbeats
• 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 counts that can cause bleeding or abnormalities in liver function tests
• seizures
• feeling agitated
• psychotic symptoms
• colitis (inflammation of the colon)
• color changes different from 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 disturbing 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 via the Spanish Medicines Monitoring System: www.notificaram.es.

By reporting side 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 which is stated on the carton after EXP. The expiry date refers to the last day of that month.

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. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 film-coated tablet contains 125 mg of levodopa, 31.25 mg of carbidopa, and 200 mg of entacapone.

The other ingredients 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, and red iron oxide (E-172).

Appearance of the product and pack contents

The tablets are biconvex, round, and yellowish-brown in color, engraved with "125" on one side and smooth on the other.

Levodopa/Carbidopa/Entacapone Kern Pharma 125mg/31.25 mg/200 mg is available in packs of 100 tablets. Not all pack sizes may be marketed.

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 last revision of this leaflet: September 2019.

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