Trileptal

Leaflet accompanying the packaging: information for the user

Trileptal, 300 mg, coated tablets

Trileptal, 600 mg, coated tablets

Oxcarbazepine

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should 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 as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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 by sending organized signals through nerve cells to muscles. In epilepsy, brain cells send too many signals in a disorganized way. As a result, uncoordinated muscle movements occur, known as 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 eliminates or reduces 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 more severe 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 or why it has been prescribed, they should consult their doctor.

2. Important information before taking Trileptal

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

Monitoring during treatment with Trileptal

Before and during treatment with Trileptal, 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

• if the patient is allergic to oxcarbazepine, eslicarbazepine, or any of the other ingredients of this medicine (listed in section 6). If this applies to the patient, they should inform their doctor before taking Trileptal. If the patient thinks they may be allergic, they should ask their doctor for advice.

Warnings and precautions

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

• if they have had a hypersensitivity reaction(rash or other allergic symptoms) to carbamazepine or any other medicines. If the patient is allergic to carbamazepine, there is a 1 in 4 (25%) chance that they may also be allergic to oxcarbazepine (Trileptal);
• if they have kidney disease;
• if they have severe liver disease;
• if they are taking diuretics(medicines used to remove salt and water from the body by increasing the amount of urine produced);
• if they have heart disease, characterized by difficulty breathing and/or swelling of the feet or ankles due to fluid retention;
• if they have low sodium levelsin the blood (see section 4: Possible side effects);
• if they are taking hormonal contraceptives(such as birth control pills), Trileptal may reduce their effectiveness. It is recommended to use other or additional (non-hormonal) methods of contraception during treatment with Trileptal to prevent unwanted pregnancy. If irregular menstrual bleeding or spotting occurs, the patient should inform their doctor immediately. In case of doubt, the patient should consult their doctor or healthcare provider. In patients of Chinese Han descent and Thai origin, there is a risk of severe skin reactions associated with carbamazepine treatment or substances with a similar chemical structure, which can be predicted by a blood test. The doctor should advise the patient whether such tests are necessary before starting oxcarbazepine treatment.

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

• allergic reaction; symptoms include swelling of the lips, eyelids, face, throat, or tongue, sudden breathing difficulties, fever with swollen lymph nodes, rash, or blistering of the skin;
• jaundice (yellowing of the skin and whites of the eyes) - 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, mouth ulcers, easier than normal bleeding and bruising, nosebleeds, red or purple spots under the skin, or unexplained skin discoloration - 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-inducing agents, 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 urine production), 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 drinking alcohol while taking Trileptal. In case of doubt, 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.

Birth defects

Studies have not shown an increased risk of birth defects associated with oxcarbazepine use during pregnancy; however, it is not possible to completely rule out the risk of birth defects in the unborn child. The risk of birth defects in the offspring of women treated with combination therapy is higher than with monotherapy.

Disorders of the nervous system

Some studies have shown that exposure to oxcarbazepine in the womb may have a negative effect on brain development (nervous system development) in children, while other studies have not shown such an effect. It is not possible to rule out the possibility of an effect on nervous system development.
The treating doctor will inform the patient about the benefits and risks of taking Trileptal and help them decide whether to continue taking the medicine.

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 baby's body is small, it is not possible 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 reduced level of consciousness, especially when starting treatment or increasing the dose.
It is crucial to determine with the doctor whether the patient can drive vehicles and operate machines while taking Trileptal.

3. How to take Trileptal

This medicine should always be taken as directed by the doctor or pharmacist, even if this differs from the information provided in the leaflet. In case of doubt, the patient should consult their doctor or pharmacist.
Other medicines containing oxcarbazepine are also available in 150 mg tablet form.

Recommended dose

Use in adult patients

• Usual initial doseof Trileptal in adult patients (including elderly patients) is 600 mg of oxcarbazepine per day.
• The patient should take one 300 mg tablet twice a day.
• The doctor may gradually increase the dose to achieve the best therapeutic effect. This is usually achieved with doses in the range of 600 mg to 2400 mg of oxcarbazepine per day.
• The dose is the same if Trileptal is used 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.

Use in children and adolescents

Trileptal can be used in children aged 6 years and older.
The dose in children depends on their 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 one 150 mg tablet twice a day.
• The doctor may gradually increase the dose to achieve the best therapeutic effect. The best therapeutic effect is usually achieved with a dose of 30 milligrams per kilogram of body weight per day. The maximum daily dose for children is 46 milligrams per kilogram of body weight per day.

How to take Trileptal

• Tablets should be swallowed with a small amount of water.
• If necessary, tablets can be divided along the score line to facilitate swallowing. However, this does not allow for half the dose to be obtained. The score line on the tablet is only to facilitate breaking the tablet if the patient has difficulty swallowing it whole.
• For small children who cannot swallow tablets or if the prescribed dose cannot be obtained in tablet form, Trileptal is available as an oral suspension.

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. It will also help the patient remember when to take the tablet (tablets).
The treating doctor will determine the duration of treatment with Trileptal in adult and child patients. This 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 a higher dose of Trileptal than recommended

If the patient has taken more Trileptal 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, constricted pupils, blurred vision, fatigue, shallow and short 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 doubt or if the patient misses several doses, they should consult their doctor.

Stopping treatment with Trileptal

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 stopped gradually, 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 cold (symptoms of hypothyroidism). Rarely(may occur in less than 1 in 1,000 patients):
• Swelling of the lips, eyelids, face, throat, or tongue, accompanied by difficulty breathing, speaking, or swallowing (symptoms of anaphylactic reactions and angioedema) or other hypersensitivity symptoms, such as: rash, fever, and muscle and joint pain.
• Fatigue, shortness of breath during physical exertion, pallor, headache, chills, dizziness, frequent infections with fever, sore throat, mouth ulcers, easier than normal bleeding and bruising, nosebleeds, red or purple spots under the skin, or unexplained skin discoloration (symptoms of decreased platelet count or white blood cell count). Very rarely(may occur in less than 1 in 10,000 patients):
• Severe blistering skin and/or mucous membrane reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.
• Red skin rash, mainly on the face, accompanied by feelings of fatigue, fever, nausea, or loss of appetite (symptoms of systemic lupus erythematosus).
• Lethargy, disorientation, muscle tremors, or significantly increased seizures (possible symptoms of low sodium levels in the blood) (see section "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 inform their doctor as soon as possible. Medical attention may be necessary:

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

• tremors, coordination disorders, 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 fast 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 common(may occur in more than 1 in 10 patients):

• fatigue, headache, dizziness, drowsiness, nausea, vomiting, double vision. Common(may occur in less than 1 in 10 patients):
• weakness, memory disorders, concentration disorders, apathy, agitation, disorientation, blurred vision, vision disorders, constipation, diarrhea, stomach pain (abdominal pain), acne, hair loss, balance disorders.
• weight gain.
• speech disorders. 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, reports have been made of bone disorders, including osteopenia and osteoporosis (thinning of the bones) and fractures. Patients who have been taking antiepileptic medicines for a long time, who have had osteoporosis in the past, 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 side effects not listed in this leaflet, they should tell 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.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Trileptal

• The medicine should be stored out of sight and reach of children.
• Store in a temperature below 30°C.
• Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the month.
• Do not use the medicine 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.
Trileptal, 300 mg, coated tablets
Each Trileptal 300 mg coated tablet contains 300 mg of oxcarbazepine.
Trileptal, 600 mg, coated tablets
Each Trileptal 600 mg coated tablet contains 600 mg of oxcarbazepine.
The other ingredients of Trileptal are:
Tablet core: colloidal anhydrous silica, microcrystalline cellulose, hypromellose, crospovidone, magnesium stearate.

Tablet coating:

300 mg tablets: hypromellose, talc; titanium dioxide (E171), macrogol 8000, yellow iron oxide (E172);
600 mg tablets: hypromellose, talc, titanium dioxide (E171), macrogol 4000, red iron oxide (E172), black iron oxide (E172).

What Trileptal looks like and contents of the pack

Trileptal, 300 mg, coated tablets are yellow, oval, with a score line on both sides, with the inscription "TE", score line, inverted "TE" on one side and "CG", score line, inverted "CG" on the other side.
Trileptal, 600 mg, coated tablets are pale pink, oval, with a score line on both sides, with the inscription "TF", score line, inverted "TF" on one side and "CG", score line, inverted "CG" on the other side.
The carton contains 50 coated tablets (5 blisters of 10 tablets).
Trileptal, coated tablets, are available in two strengths: 300 mg, 600 mg.

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
Novartis Farma S.p.A.
Via Provinciale Schito, 131
80058 Torre Annunziata (NA)
Italy

Date of last revision of the leaflet: 10/2024