Prospect: Information for the user
Levodopa/Carbidopa/Entacapona Kern Pharma 75 mg/18.75 mg/200 mg film-coated tablets EFG
Read this prospect carefully before starting to take this medicine, as it contains important information for you.
1.What is Levodopa/Carbidopa/Entacapona Kern Pharma and for what it is used
2.What you need to know before starting to take Levodopa/Carbidopa/Entacapona Kern Pharma
3.How to take Levodopa/Carbidopa/Entacapona Kern Pharma
4.Possible adverse effects
5Storage of Levodopa/Carbidopa/Entacapona Kern Pharma
6.Contents of the package and additional information
This medication contains three active principles (levodopa, carbidopa and entacapona) in a coated tablet. Levodopa/Carbidopa/Entacapona Kern Pharma is used to treat Parkinson's disease.
Parkinson's disease is due to low concentration 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 entacapona improve the antiparkinsonian effects of levodopa.
Do not take Levodopa/Carbidopa/Entacapona Kern Pharma if
Warnings and precautions
Consult your doctor or pharmacist before starting to takethis medication if you suffer or have ever suffered from:
Consult your doctor if you are taking:
Consult your doctor if during treatment with this medication:
Inform your doctor if you or your family/caregiver notice that you are developing unusual desires or propensities to behave in an unusual way in yourself or that you cannot resist the impulse, determination, or temptation to perform certain activities that may harm you or others. These behaviors are known as impulse control disorders and may include excessive gaming, eating, or spending, and an abnormally elevated sex drive or concern with an increase in 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 symptoms similar to addiction, which lead to a desire for large doses of Levodopa/Carbidopa/Entacapona Kern Pharma and other medications used to treat Parkinson's disease
During prolonged treatment with Levodopa/Carbidopa/Entacapona, your doctor may perform regular laboratory tests
If you need to undergo surgery, inform your doctor that you are taking this medication
Levodopa/Carbidopa/Entacapona is not recommended for the treatment of extrapyramidal symptoms (e.g., involuntary movements, agitation, muscle rigidity, and muscle contractions) caused by other medications
Children and adolescents
The experience of using Levodopa/Carbidopa/Entacapona in patients under 18 years old is limited. Therefore, its administration is not recommended in children
Taking Levodopa/Carbidopa/Entacapona Kern Pharma with other medications
Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication
Do not take this medication if you are taking certain medications for depression (combinations of 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 medications. These include:
Certain medications may reduce the effects of Levodopa/Carbidopa/Entacapona. These medications are:
Levodopa/Carbidopa/Entacapona may make it difficult for your body to absorb iron at the digestive level. Therefore, do not take this medication at the same time as iron supplements. If you take any of them, wait at least 2 or 3 hours before taking the other
Taking Levodopa/Carbidopa/Entacapona Kern Pharma with food and drinks
This medication can be taken with or without food
In some patients, Levodopa/Carbidopa/Entacapona may not be absorbed well if taken with foods high in protein (meat, fish, dairy products, cereals, and nuts) or shortly after consuming them
Consult your doctor if you think this occurs in your case
Levodopa/Carbidopa/Entacapona Kern Pharma 75 mg/18.75 mg/200 mg contains lactose
This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication
Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
Adults and elderly:
Speak with your doctor or pharmacist if you believe the effect of this medication is too intense or too weak, or if you experience possible side effects.
If you take more Levodopa/Carbidopa/Entacapona Kern Pharma than you should
In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 915 620 420, indicating the medication and the amount ingested.
You may feel dizzy or agitated, that the heart rate is slower or faster than normal, or that the color of your skin, tongue, eyes, or urine changes.
If you forgot to take Levodopa/Carbidopa/Entacapona Kern Pharma
Do not take a double dose to compensate for the missed doses.
If more than 1 hour until the next dose:
Take a tablet as soon as you remember, and the next one at the regular time.
If less than 1 hour until the next dose:
Take a tablet as soon as you remember, wait 1 hour, and then take another tablet. Continue as usual.
Always allow 1 hour to pass between tablets of this medication, to avoid possible side effects.
If you interrupt treatment with Levodopa/Carbidopa/Entacapona Kern Pharma
Do not stop taking this medication unless your doctor tells you to. In that case, your doctor may need to adjust the dose of other Parkinson's medications, especially levodopa, to ensure sufficient control of your symptoms. If you stop taking Levodopa/Carbidopa/Entacapona and other Parkinson's medications abruptly, you may experience unwanted side effects.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
Like all medicines, this medicinecan cause side effects, although not everyone will experience 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:
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Rare (may affect up to 1 in 100 people):
The following adverse effects have also been reported:
You may experience the following adverse effects:
Inability to resist the urge to perform an action that could be harmful, and which could include:
Inform your doctor if you experience any of these behaviors, and 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 it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: www.notificaram.es.
By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.
No special storage conditions are required.
Dispose of the product 175 days after opening the packaging.
Medications should not be thrown down the drains or in the trash. Deposit the packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.
Composition of Levodopa/Carbidopa/EntacaponaKern Pharma
The active principles are levodopa, carbidopa, and entacapona. Each coated tablet contains 75 mg of levodopa, 18.75 mg of carbidopa, and 200 mg of entacapona.
The other components are: microcrystalline cellulose, anhydrous lactose, hydroxypropyl cellulose, 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).
Appearance of the product and content of the packaging
Biconvex, oval, light orange-colored tablets, engraved with “75” on one face, smooth on the other.
Levodopa/Carbidopa/Entacapona Kern Pharma 75 mg/18.75 mg/200 mg is available in packaging of 100 tablets.
Holder of the marketing authorization and responsible for manufacturing
Holder of the marketing authorization:
Kern Pharma, S.L.
Venus, 72 - Pol. Ind.Colón II
08228 Terrassa - Barcelona
Spain
Responsible for manufacturing:
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
Last review date of this leaflet: September 2019.
The detailed and updated information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.