Label: information for the user
Trileptal 60 mg/ml oral suspension
oxcarbazepine
Read this label carefully before starting to take this medicine, as it contains important information for you.
1. What Trileptal is and for what it is used
2. What you need to know before starting to take Trileptal
3. How to take Trileptal
4. Possible adverse effects
5. Storage of Trileptal
6.Contents of the package and additional informationinformation
What is Trileptal
Trileptal contains the active ingredient oxcarbazepine.
Trileptal belongs to a group of medications called anticonvulsants or antiepileptics.
What is Trileptal used for
Medications like Trileptal are the standard treatment for epilepsy.
Epilepsy is a brain disorder that causes people to have recurring seizures and convulsions. Seizures occur due to a temporary failure in the brain's electrical activity. Normally, brain cells coordinate the body's movements by sending signals through the muscle nerves in an orderly organized manner. In epilepsy, brain cells send too many signals in a disorganized manner. The result can be uncoordinated muscle activity known as an epileptic seizure.
Trileptal is used to treat partial seizures with or without secondary generalization with tonic-clonic seizures. Partial seizures affect a limited area of the brain, but can spread to the entire brain and cause generalized tonic-clonic seizures. There are 2 types of partial seizures: simple and complex. In simple partial seizures, the patient remains conscious, while in complex partial seizures, the level of consciousness is altered.
Trileptal acts by keeping the brain's "hyperexcitable" nerve cells under control, suppressing or reducing the frequency of these seizures.
Trileptal can be used alone or in combination with other antiepileptic medications.
Normally, the doctor will try to find the medication that works best for you or your child. However, in severe epilepsy, you may need a combination of two or more medications to control seizures. Trileptal is indicated for use in adults and children 6 years of age or older.
If you have any doubts about how Trileptal works or why you have been prescribed this medication, consult your doctor.
Follow carefully all the instructions given by your doctor, even if they differ from the general information indicated in this leaflet.
Monitoring during treatment with Trileptal
Before and during treatment with Trileptal, your doctor may perform a blood test to establish your dose. Your doctor will tell you when to have the tests.
Do not take Trileptal:
If you are allergic, inform your doctor before taking Trileptal. If you think you are allergic, ask your doctor.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Trileptal:
The risk of severe skin reactions in Han Chinese or Thai patients associated with carbamazepine or chemically related compounds can be predicted by blood tests in these patients. Your doctor will advise if a blood test is necessary before taking oxcarbazepine.
If you experience any of the following symptoms after taking Trileptal, inform your doctor immediately or go to the nearest hospital emergency department:
For treatment in children, your doctor may recommend monitoring thyroid function before and during treatment.
Use of Trileptal with other medications:
Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.
Especially in the case of:
-Oral contraceptives such as the "pill" (see section Warnings and precautions).
Taking Trileptal with food and alcohol
Trileptal can be taken with or without food. During treatment with Trileptal, avoid taking alcoholic beverages as they may increase the sedative effects of this medication; consult your doctor if you have any doubts.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.
It is essential to control seizures during pregnancy. However, there may be a risk to your baby if you take antiepileptic medications during pregnancy.
Birth defects
Studies have not shown an increased risk of birth defects associated with oxcarbazepine administered during pregnancy, however, it cannot be ruled out that there may be a risk of birth defects in the fetus.
Neurological development disorders
Some studies have shown that exposure to oxcarbazepine in the womb affects the development of brain function (neurological development) in children, while in other studies this effect has not been observed. The possibility of an effect on neurological development cannot be ruled out.
Your doctor will inform you of the benefits and potential risks of treatment and help you decide whether to take Trileptal.
Do not stop your Trileptal treatment during pregnancy without consulting your doctor first.
Breastfeeding
If you are taking this medication, consult your doctor before starting breastfeeding. The active ingredient in Trileptal passes into breast milk. Although available data suggest that the amount of Trileptal that passes to the breastfeeding infant is low, a risk of adverse effects in the infant cannot be ruled out. Your doctor will inform you of the potential benefits and risks of breastfeeding while using Trileptal. If you are breastfeeding during treatment with Trileptal and believe your baby is experiencing an adverse effect, such as excessive sleepiness or poor weight gain, inform your doctor immediately.
Driving and operating machinery
Trileptal may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may impair your ability to react. These effects, as well as the underlying condition, may make it difficult for you to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention, until your doctor assesses your response to this medication.
It is essential to consult your doctor if you can drive or operate machinery while taking this medication.
Trileptal contains sorbitol (E420), propylene glycol (E1520), parahydroxybenzoates, sodium, and ethanol
Trileptal oral suspension contains:
Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have a condition that makes you intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medication.
Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.
Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
The dose must be indicated in milliliters (ml)
The dose prescribed by your doctor must be indicated inmilliliters (ml)and not in milligrams (mg). This is important since the oral dosing syringe used to extract the correct dose from the bottle is marked in milliliters.If your prescription is in milligrams, do not take the medication and consult your doctor or pharmacist as soon as possible.
How much to take
Use in adults
Use in children and adolescents
Trileptal can be used in children aged 6 years or older.
Your doctor will calculate the recommended dose for children based on their weight.
How to take Trileptal
For complete instructions on how to take Trileptal, see theInstructions for usesection at the end of this leaflet..
When and for how long to take Trileptal
Take Trileptal twice a day every day, approximately at the same time of day, unless your doctor tells you otherwise. This will have the best effect in controlling epilepsy. It will also help you remember when to take the oral suspension.
Your doctor will inform you how long your treatment or your child's treatment will last. The duration of treatment will depend on the type of seizure you or your child suffers. It may be necessary to continue treatment for several years to control seizures. Do not change the dose or interrupt treatment without first talking to your doctor.
If you take more Trileptal than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.The symptoms of overdose with Trileptal may include:
If you forget to take Trileptal
If you have forgotten a dose, take it as soon as you can, except if it is almost time for the next one; in this case, wait and return to the usual administration schedule. Do not take a double dose to compensate for the missed doses.
If you are unsure or have forgotten several doses, inform your doctor.
If you interrupt treatment with Trileptal
Do not stop taking your medication without first consulting your doctor.
To prevent a sudden worsening of seizures, do not stop treatment abruptly.
If treatment is interrupted, it should be done gradually as indicated by your doctor.
If you have any other questions about the use of thismedication, ask your doctor or pharmacist.
Like all medicines, this medicine may cause side effects, although not everyone will experience them.
Inform your doctor immediately or go to the nearest hospital emergency service if any of the following side effects occur:
The following are symptoms of potentially serious side effects that may require urgent medical treatment.
Your doctor will decide whether to stop treatment with Trileptal immediately and how to continue your treatment in the future.
Rare(may affect up to 1 in 100 patients):
Very rare(may affect up to 1 in 1,000 patients):
Very rare(may affect up to 1 in 10,000 patients):
Inform your doctor as soon as possible if you experience any of the following side effects.They may require medical attention:
Common(may affect up to 1 in 10 patients):
Very rare(may affect up to 1 in 10,000 patients):
Other side effects that may occur:
These are mild to moderate side effects of Trileptal. Most of these side effects are transient and usually decrease over time.
Very common(may affect more than 1 in 10 patients):
Common(may affect up to 1 in 10 patients):
Rare(may affect up to 1 in 100 patients):
Very rare(may affect up to 1 in 1,000 patients):
Reporting of side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use,www.notificaRAM.es. By reporting side 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. The expiration date is the last day of the month indicated.
Once the packaging is opened, use it within the next 7 weeks.
After 7 weeks, return the unused oral suspension to your pharmacy for safe disposal.
Do not use this medication if you observe that the packaging is damaged or shows signs of tampering.
Medications should not be disposed of through drains or trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointat your pharmacy. In case of doubtask your pharmacisthow to dispose ofthepackaging and themedications you no longerneed.This will help protect the environment.
Composition of Trileptal
Appearance of the product and contents of the package
Trileptal oral suspension is presented as a white suspension that tends to turn brownish-red. The decoloration of the oral suspension to a slightly brownish-red color is normal and does not affect the quality of the product.
Trileptal oral suspension is presented in amber-colored glass bottles containing 250 ml of oral suspension. The bottles come with a child-resistant cap, a 10 ml oral syringe, and a bottle adapter.
Marketing authorization holder and responsible for manufacturing
Novartis Farmacéutica, S.A.
Gran Vía de les Corts Catalanes, 764
08013 Barcelona
Spain
Responsible for manufacturing
Novartis Pharma GmbH
Roonstrasse 25 (Nuremberg)
D-90429 – Germany
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
Nuremberg 90443
Germany
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764,
08013 Barcelona
Spain
This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:
Austria: Trileptal
Belgium: Trileptal
Croatia: Trileptal
Denmark: Trileptal
Finland: Trileptal
France: Trileptal
Germany: Trileptal
Greece: Trileptal
Island: Trileptal
Ireland: Trileptal
Netherlands: Trileptal
Portugal: Trileptal
Spain: Trileptal
Sweden: Trileptal
United Kingdom (Northern Ireland): Trileptal
Last review date of this leaflet:March 2023
The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/
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Page 1
Instructions for use
Please read these instructions carefully to learn how to use this medicine
How to use the medicine kit
The medicine kit consists of three parts
Page 2
How to adjust the plastic adapter on a new medicine bottle
Note:Keep the cap handy to close the bottle after each use | |
Note:You may not be able to push the adapter all the way down, but it will be fully seated when you reattach the cap. Please follow all instructions to dispense the dose inPreparing a dose of medicine. |
Page 3
Preparing a dose of medicine
The medicine can be taken directly from the oral syringe or mixed with a small amount of water before taking it.
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Note: If the prescribed dose is greater than 10 ml, extract the prescribed dose in two steps. First, fill the syringe to the 10 ml mark, and load the 10 ml. Then, reload the oral syringe to complete the dose. Ask your pharmacist if you are unsure. | |
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The average price of Trileptal 60 mg/ml suspension oral in July, 2025 is around 11.04 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.