Trileptal

Leaflet accompanying the packaging: information for the user

Trileptal, 60 mg/mL, oral suspension

Oxcarbazepine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Trileptal and what is it used for
• 2. Important information before taking Trileptal
• 3. How to take Trileptal
• 4. Possible side effects
• 5. How to store Trileptal
• 6. Contents of the packaging and other information

1. What is Trileptal and what is it used for

What is Trileptal

The active substance of Trileptal is oxcarbazepine.
Trileptal belongs to a group of medicines called antiepileptics or anticonvulsants.

When is Trileptal used

Medicines like Trileptal are used to treat epilepsy.
Epilepsy is a disorder of brain function that causes patients to have recurring seizures.
These are caused by temporary disturbances in the brain's electrical activity. In healthy people, brain cells coordinate body movements through organized signals sent by nerve cells to muscles. In epilepsy, brain cells send too many signals in a disorganized way. As a result, uncoordinated muscle movements occur, called epileptic seizures.
Trileptal is used to treat partial seizures with or without secondary generalized tonic-clonic seizures.
In partial seizures, a limited area of the brain is involved, but they can spread to the entire brain, causing tonic-clonic seizures. There are two types of partial seizures: simple and complex. In simple partial seizures, the patient does not lose consciousness. In complex partial seizures, there is a loss of consciousness.
Trileptal works by inhibiting "overexcited" nerve cells in the brain, which reduces or eliminates the frequency of seizures.
Trileptal can be used as a single medicine or in combination with other antiepileptic medicines.
Usually, the doctor tries to find one medicine that works best for the adult or child patient. However, in patients with a more severe form of epilepsy, it may be necessary to take two or more medicines to prevent seizures. Trileptal can be used in adult and child patients aged 6 years and older.
If the patient has questions about how Trileptal works and why it was prescribed, they should consult their doctor.

2. Important information before taking Trileptal

Trileptal should always be taken as directed by the doctor, even if it differs from the information provided in the leaflet.

Monitoring during Trileptal treatment

Before and during Trileptal treatment, the doctor may perform blood tests to determine the correct dose of the medicine for the patient. The doctor will inform when such tests should be performed.

When not to take Trileptal

Warnings and precautions

Before starting Trileptal, the patient should discuss the following with their doctor or pharmacist:

The patient should immediately tell their doctor or go to the nearest hospital if they experience any of the following symptoms after starting Trileptal treatment:

• an allergic reaction; symptoms include swelling of the lips, eyelids, face, throat, mouth, or sudden breathing difficulties, fever with swollen lymph nodes, rash, or blistering skin lesions;
• jaundice (yellowing of the skin and whites of the eyes) - this may be a sign of liver inflammation;
• increased frequency of seizures; this is especially important in children, but may also apply to adults;
• a syndrome of symptoms: fatigue, shortness of breath during physical exertion, pallor, headache, chills, dizziness, frequent infections with fever, sore throat, oral ulcers, easier than normal bleeding and bruising, nosebleeds, red or purple skin discolorations - these may be signs of blood disorders;
• in a small number of patients treated with antiepileptic medicines such as Trileptal, thoughts of self-harm or suicide have occurred. If such thoughts occur, the patient should immediately consult their doctor;
• rapid or extremely slow heart rate.

Children and adolescents

In children, the doctor may recommend monitoring thyroid function before and during treatment.

Trileptal and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
This is especially important for:

• hormonal contraceptives (see Warnings and precautions);
• other antiepileptic medicines and enzyme inducers, such as carbamazepine, phenobarbital, phenytoin, or lamotrigine, and rifampicin;
• medicines that lower sodium levels in the blood, such as diuretics (used to remove salt and water from the body by increasing the amount of urine produced), desmopressin, and non-steroidal anti-inflammatory medicines, such as indomethacin;
• lithium and monoamine oxidase inhibitors (medicines used to treat mood disorders and certain types of depression);
• medicines that affect the immune system, such as cyclosporine and tacrolimus.

Trileptal with food and alcohol

Trileptal can be taken with or without food.
Alcohol may enhance the sedative effect of Trileptal. The patient should avoid consuming alcohol while taking Trileptal. In case of doubts, the patient should consult their doctor.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
During pregnancy, it is essential to keep seizures under control; however, taking antiepileptic medicines during this time may pose a risk to the unborn child.
Congenital anomalies
Studies have not shown an increased risk of congenital anomalies associated with oxcarbazepine use during pregnancy; however, it is impossible to rule out the risk of congenital anomalies in the unborn child. The risk of congenital anomalies in the offspring of women treated with combination therapy is higher than with monotherapy.
Neurodevelopmental disorders
Some studies have shown that exposure to oxcarbazepine in the womb negatively affects brain development (neurodevelopment) in children, while other studies have not shown such an effect. It is impossible to rule out the possibility of an impact on neurodevelopment.
The attending doctor will inform the patient about the benefits and risks of taking Trileptal and help them decide whether to continue taking the medicine.
The patient should not stop taking Trileptal during pregnancy without consulting their doctor first.
Breastfeeding
If the patient is taking this medicine, they should consult their doctor before breastfeeding.
The active substance of Trileptal passes into breast milk. Although available data indicate that the amount of Trileptal that passes into the infant's body through breast milk is small, it is impossible to rule out the risk of side effects in the child. The doctor will discuss the benefits and risks of breastfeeding while taking Trileptal with the patient. If the patient is breastfeeding while taking Trileptal and notices any side effects in their child, such as excessive sleepiness or poor weight gain, they should immediately inform their doctor.

Driving and using machines

Trileptal may cause drowsiness or dizziness, blurred vision, double vision, lack of muscle coordination, or decreased level of consciousness, especially when starting treatment or during dose increases.
It is crucial to determine with the doctor whether the patient can drive vehicles and operate machines while taking Trileptal.

Trileptal contains sorbitol (E420), propylene glycol (E1520), parahydroxybenzoates, sodium, and ethanol

• Sorbitol (E420): This medicine contains 175 mg of sorbitol in 1 mL of oral suspension. Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to some sugars or has a rare genetic disorder, fructose intolerance, in which the patient's body does not break down fructose, they should consult their doctor before taking the medicine or giving it to their child. Sorbitol may cause gastrointestinal discomfort and have a mild laxative effect.
• Propylene glycol (E1520): The medicine contains 25.4 mg of propylene glycol in 1 mL of oral suspension. Patients with liver or kidney disorders should not take this medicine without consulting their doctor. The doctor may decide to perform additional tests on such patients.
• Parahydroxybenzoates: Propyl parahydroxybenzoate (E216) and methyl parahydroxybenzoate (E218) may cause allergic reactions (possible late reactions).
• Sodium: The medicine contains less than 1 mmol (23 mg) of sodium per 1 mL, which means the medicine is considered "sodium-free".
• Etanol: This medicine contains 0.8 mg of ethanol (alcohol) in 1 mL of oral suspension. The amount of alcohol in 1 mL of this medicine is equivalent to less than 0.02 mL of beer or 0.01 mL of wine. The small amount of alcohol in this medicine will not have noticeable effects.
• The medicine also contains cinnamaldehyde, citral, citronellol, geraniol, d-limonene, and linalool, which are components of the yellow citrus-plum flavor 39K020.

3. How to take Trileptal

This medicine should always be taken as directed by the doctor or pharmacist, even if it differs from the information provided in the leaflet. In case of doubts, the patient should consult their doctor or pharmacist.
The dose of the medicine must be prescribed in milliliters (mL), not in milligrams (mg). This is very important, as the dosing syringe used to draw the suspension from the bottle is calibrated in mL.

If the medicine was prescribed in mg, do not take the medicine and consult the doctor or pharmacist as soon as possible.

Doctor or pharmacist.

In what dose to take

Administration in adult patients

• Typically, the initial doseof Trileptal for adult patients (including elderly patients) is 10 mL of oral suspension (600 mg of oxcarbazepine) per day.
• One dose of 5 mL (300 mg of oxcarbazepine) should be taken twice a day.
• The doctor may gradually increase the dose to achieve the best therapeutic effects. These are usually achieved with doses ranging from 10 mL to 40 mL of oral suspension (600 mg to 2400 mg of oxcarbazepine) per day.
• The dose is the same if Trileptal is taken with another antiepileptic medicine.
• In patients with kidney disease (renal impairment), the initial dose is half the usual initial dose.
• In patients with severe liver disease, the doctor will determine the appropriate dose.

Administration in children and adolescents

Trileptal can be used in children aged 6 years and older.
The dose for children will be calculated by the attending doctor and depends on the child's body weight.

• The initial dose is 8 to 10 milligrams per kilogram of body weight per day, given in two divided doses. For example, a child weighing 30 kg would start with a dose of 150 mg (2.5 mL of oral suspension) twice a day.
• The doctor may gradually increase the dose to achieve the best treatment results. The best therapeutic effects are usually achieved with a dose of 30 milligrams per kilogram of body weight per day. The maximum dose for children is 46 milligrams per kilogram of body weight per day.

How to take Trileptal

To read the full instructions for taking Trileptal, see the "Instructions for use" at the end of this leaflet.

When and for how long to take Trileptal

Trileptal should be taken twice a day, every day at the same time, unless the doctor advises otherwise. Taking the medicine at the same time every day will provide the best results in controlling seizures.
The doctor will determine the duration of Trileptal treatment for adult and child patients. It depends on the type of seizures. To control the occurrence of seizures, treatment may last for many years. The patient should not change the established dose or stop treatment without consulting their doctor.

Taking more Trileptal than prescribed

If the patient has taken more oral suspension than prescribed, they should immediately go to the nearest hospital or consult their doctor. Symptoms of Trileptal overdose may include: drowsiness, dizziness, nausea, vomiting, increased uncontrolled movements, lethargy, confusion, muscle tremors, or significantly increased seizures, coordination problems, and/or involuntary eye movements, double vision, blurred vision, fatigue, shallow and slow breathing (decreased respiratory rate), irregular heartbeat (prolonged QTc interval), tremors, headache, coma, loss of consciousness, uncontrolled movements of the lips, tongue, limbs, agitation, low blood pressure, shortness of breath.

Missing a dose of Trileptal

If the patient misses a dose, they should take it as soon as possible. However, if it is almost time for the next dose, they should not take the missed dose. The patient should continue treatment according to the established dosing schedule. The patient should not take a double dose to make up for the missed dose.
In case of doubts or missing several doses, the patient should consult their doctor.

Stopping Trileptal treatment

The patient should not stop taking Trileptal without consulting their doctor.
The patient should never suddenly stop taking the medicine, as this may cause a sudden increase in seizures.
If treatment is to be discontinued, the medicine should be gradually withdrawn, as advised by the doctor.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Trileptal can cause side effects, although not everybody gets them.

The patient should immediately inform their doctor or go to the nearest hospital if they experience any of the following side effects.

These include symptoms that occur not very often, rarely, or very rarely. The doctor will also decide whether to stop taking Trileptal immediately and how to continue treatment.
Not very often(may occur in less than 1 in 100 patients):

• Fatigue, hair loss, muscle weakness, feeling of being cold (symptoms of hypothyroidism). Rarely(may occur in less than 1 in 1,000 patients):
• Swelling of the lips, eyelids, face, throat, or mouth, accompanied by difficulty breathing, speaking, or swallowing (symptoms of anaphylactic reactions and angioedema) or other allergic symptoms, such as: rash, fever, and muscle or joint pain.
• Fatigue, shortness of breath during physical exertion, pallor, headache, chills, dizziness, frequent infections with fever, sore throat, oral ulcers, easier than normal bleeding and bruising, nosebleeds, red or purple skin discolorations (symptoms of decreased platelet or white blood cell count). Very rarely(may occur in less than 1 in 10,000 patients):
• Severe blistering skin and/or mucous membrane lesions (symptoms of severe allergic reactions, including Lyell's syndrome, Stevens-Johnson syndrome, and erythema multiforme).
• Red skin discolorations in the form of a rash, mainly on the face, accompanied by a feeling of fatigue, fever, nausea, or loss of appetite (symptoms of systemic lupus erythematosus).
• Lethargy, confusion, muscle tremors, or significantly increased seizures (possible symptoms of low sodium levels in the blood) (see Warnings and precautions).
• Flu-like symptoms with jaundice (yellowing of the skin or whites of the eyes) (symptoms of liver inflammation).
• Severe abdominal pain, vomiting, loss of appetite (symptoms of pancreatitis).

If the patient experiences any of the following side effects, they should immediately inform their doctor. Medical attention may be required:

Often(may occur in less than 1 in 10 patients):

• Tremors, coordination problems, involuntary eye movements, feeling of anxiety and nervousness, depression, mood changes, rash. Very rarely(may occur in less than 1 in 10,000 patients):
• Irregular heartbeat, very rapid or very slow heartbeat.

Other side effects that may occur

These side effects of Trileptal are usually mild to moderate. Most of them are temporary and will gradually disappear.
Very often(may occur in more than 1 in 10 patients):

• Fatigue, headache, dizziness, drowsiness, nausea, vomiting, double vision.

Often(may occur in less than 1 in 10 patients):

• Weakness, memory problems, concentration problems, apathy, agitation, confusion, blurred vision, vision problems, constipation, diarrhea, stomach pain, acne, hair loss, balance problems.
• Weight gain.
• Speech problems. Not very often(may occur in less than 1 in 100 patients):
• High blood pressure.
• Hives, increased liver enzyme activity (in blood test results). Rarely(may occur in less than 1 in 1,000 patients):
• Additionally, bone disorders, including osteopenia and osteoporosis (thinning of the bones) and fractures, have been reported. Patients who have been taking antiepileptic medicines for a long time, who have a history of osteoporosis, or who are taking steroids, should consult their doctor or pharmacist.

The patient should consult their doctor if any of the above side effects worsen.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Trileptal

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and bottle label. The expiry date refers to the last day of the month.
• Shelf life after first opening the bottle: 7 weeks.
• After 7 weeks, the unused oral suspension should be returned to the pharmacy for safe disposal.
• Do not use Trileptal if the packaging has been previously opened or damaged.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Trileptal contains

The active substance of Trileptal is oxcarbazepine.
Each mL of oral suspension contains 60 mg of oxcarbazepine.
The other ingredients of the medicine are: purified water, 70% non-crystallizing sorbitol solution, propylene glycol, dispersible cellulose (containing microcrystalline cellulose and sodium carmellose), ascorbic acid (E 300), yellow citrus-plum flavor (containing ethanol), methyl parahydroxybenzoate (E 218), macrogol 400 stearate, sorbic acid (E 200), sodium saccharin, propyl parahydroxybenzoate (E 216).

What Trileptal looks like and contents of the pack

Trileptal oral suspension is a white to light brown or light red suspension.
A change in color to light brown-red is normal and does not affect the quality of the medicine.
Trileptal oral suspension is available in a 250 mL bottle of orange glass with a child-resistant closure and is packaged in a cardboard box with a 10 mL oral dosing syringe and adapter. Each pack contains one bottle.

Marketing authorization holder

Novartis Poland Sp. z o.o.
Marynarska 15
02-674 Warsaw
Phone: +48 22 375 48 88

Manufacturer/Importer

Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany

Date of last revision of the leaflet: 10/2024

INSTRUCTIONS FOR USE OF TRILEPTAL

Read carefully for proper administration of the medicine

How to use the packaging

The packaging contains three elements:
1.A plastic adapter that should be
placed in the bottle neck after the first
opening.
Once placed in the bottle neck, the adapter
should not be removed.

• 3.A dosing syringe
• 2.A bottle containing 250 mL of oral suspension, with a child-resistant closure. After each use, the bottle should be closed with the closure.

Attaching the adapter to the medicine bottle

• 1. Shake the bottle for at least 10 seconds.
• 2. Open the bottle by stronglypressing the child-resistant closure and turning it counterclockwise (as shown on the top surface of the closure).

Warning:After each use, the bottle should be closed with the child-resistant closure.

• 3. Place the open bottle on the table and stronglypress the plastic adapter into the bottle neck as far as possible.

Warning:It may not be possible to press the adapter all the way in. In this case, closing the bottle with the child-resistant closure will cause it to be pressed in.
To draw the prescribed amount of medicine, follow the instructions in the "Drawing the medicine" section.
Drawing the medicine
The medicine can be administered directly from the dosing syringe or mixed with a small amount of water.

• Shake the bottle well. Immediately draw the prescribed amount of suspension.
• To open the bottle, press and turn the child-resistant closure. ( Warning: After each use, the bottle should be closed with the child-resistant closure.)
• Check that the syringe plunger is fully depressed.
• Hold the bottle upright and place the dosing syringe in the plastic adapter so that it does not fall out.
• Carefully turn the bottle upside down.
• Slowly pull the plunger down to fill the syringe with the suspension. Press the plunger again to remove any large air bubbles that may have formed in the syringe.
• Draw the prescribed amount of medicine: slowly pull the plunger down until the top edge of the black ring on the plunger reaches the scale on the syringe indicating the prescribed dose.

Warning: If the prescribed dose is greater than 10 mL, the patient should draw the prescribed dose in two stages. First, fill the syringe with 10 mL and take 10 mL of the medicine. Then, draw the remaining part of the dose. In case of doubts, the patient should consult their doctor or pharmacist.

• Carefully turn the bottle upside down. Remove the dosing syringe from the adapter by gently twisting it.
• The dose of medicine can be administered directly from the dosing syringe. The patient should sit upright, and the syringe plunger should be pressed slowlyto allow the patient to swallow the administered medicine. The patient can also add a small amount of water to the drawn amount of medicine immediately before administration. The resulting mixture should be stirred and then drunk immediately.
• After use, the bottle should be closed with the child-resistant closure, leaving the adapter in the bottle.
• Cleaning:After use, the outside of the syringe should be wiped with a dry and clean disposable cloth.