Trileptal 300 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Trileptal 300 mg film-coated tablets

oxcarbazepine

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Trileptal is and what it is used for

What Trileptal is

Trileptal contains the active substance oxcarbazepine.

Trileptal belongs to a group of medicines called anticonvulsants or antiepileptics.

What Trileptal is used for

Medicines such as Trileptal are the standard treatment for epilepsy.

Epilepsy is a disorder of the brain that causes people to have recurrent seizures and convulsions. Seizures occur due to a temporary disturbance in the brain's electrical activity. Normally, brain cells coordinate body movements by sending signals through nerves to muscles in an orderly fashion. In epilepsy, brain cells send too many signals in a disorganized manner. The result may be uncoordinated muscle activity known as an epileptic seizure.

Trileptal is used in the treatment of partial seizures with or without secondary generalization to tonic-clonic seizures. Partial seizures originate in a limited area of the brain but may spread throughout the brain and lead to generalized tonic-clonic seizures. There are two types of partial seizures: simple and complex. In simple partial seizures, the patient remains conscious, whereas in complex partial seizures, consciousness is impaired.

Trileptal works by keeping the overactive ("hyperexcitable") nerve cells in the brain under control, thereby suppressing or reducing the frequency of these seizures.

Trileptal can be used alone or in combination with other antiepileptic medicines.

Your doctor will usually try to find the medicine that works best for you or your child. However, in severe forms of epilepsy, you may need a combination of two or more medicines to control seizures. Trileptal is indicated for use in adults and in children aged 6 years and older.

If you have any questions about how Trileptal works or why this medicine has been prescribed for you, consult your doctor.

2. What you need to know before taking Trileptal

Carefully follow all instructions given by your doctor, even if they differ from the general information provided in this leaflet.

Monitoring during treatment with Trileptal

Before and during treatment with Trileptal, your doctor may perform a blood test to determine your dose. Your doctor will tell you when to have these tests done.

Do not take Trileptal:

• if you are allergic to oxcarbazepine or to any of the other ingredients of this medicine (listed in section 6), or if you are allergic to eslicarbazepine.

If you are allergic, inform your doctor before taking Trileptal. If you think you may be allergic, consult your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting Trileptal:

• if you have ever had an unusual allergic reaction (rash or any other type of allergy) to carbamazepine or any other medicine. If you are allergic to carbamazepine, the chance that you will also be allergic to oxcarbazepine (Trileptal) is 1 in 4 (25%).
• if you have kidney disease.
• if you have severe liver disease.
• if you are taking diuretics (medicines that help the kidneys eliminate salt and water by increasing urine production).
• if you have heart disease, shortness of breath, and/or swelling of the feet or legs due to fluid retention.
• if you know that your blood sodium level is low, as shown by your blood test (see section 4).
• if you are a woman who is taking oral contraceptives (such as the birth control pill), Trileptal may reduce the effectiveness of the contraceptive. Use a different or additional non-hormonal contraceptive method while taking Trileptal. This can help prevent an unintended pregnancy. Inform your doctor immediately if you experience irregular vaginal bleeding or spotting. If you have any questions about this, consult your doctor or healthcare professional before taking 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 sample testing in these patients. Your doctor will advise whether a blood test is necessary before starting oxcarbazepine.

If you experience any of the following symptoms after taking Trileptal, inform your doctor immediately or go to the nearest hospital emergency department:

• if during treatment you develop an allergic reaction. Symptoms include swelling of the lips, eyelids, face, throat, mouth, or sudden breathing problems, as well as fever with swollen lymph nodes, skin rash, or blisters (see section 4).

• if you notice symptoms suggesting hepatitis, such as jaundice (yellowing of the skin or whites of the eyes).

• if you notice an increase in the frequency of seizures. This is especially important in children, but may also occur in adults.

• if you notice possible symptoms of blood disorders, such as fatigue, shortness of breath during exercise, paleness, headache, chills, dizziness, frequent infections with fever, sore throat, mouth ulcers, more frequent bleeding or bruising than normal, nosebleeds, red or purple spots, or spontaneous appearance of skin spots.

• a small number of patients treated with antiepileptic medicines such as Trileptal have had thoughts of self-harm or suicide. If you experience such thoughts at any time, contact your doctor immediately.

• if you notice that your heart rate is fast or unusually slow.

• Children and adolescents

For treatment in children, your doctor may recommend monitoring thyroid function before and during treatment.

Taking Trileptal with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Especially in the case of:

• Oral contraceptives such as the "pill" (see section Warnings and precautions).
• Other antiepileptic medicines and enzyme-inducing medicines such as carbamazepine, phenobarbital, phenytoin, or lamotrigine, and rifampicin.
• Medicines that reduce sodium levels in the blood, such as diuretics (used to help the kidneys eliminate salt and water by increasing urine production), desmopressin, and non-steroidal anti-inflammatory drugs such as indomethacin.
• Lithium and monoamine oxidase inhibitors (medicines used to treat mood disorders and certain types of depression).
• Medicines that control the body's immune system, such as cyclosporine and tacrolimus.

Taking Trileptal with food and alcohol

Trileptal can be taken with or without food. During treatment with Trileptal, avoid alcoholic drinks, as they may increase the sedative effects of this medicine; consult your doctor if you have any doubts.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

It is important to control epileptic seizures during pregnancy. However, there may be risks to your baby if you take antiepileptic medicines during pregnancy.

Congenital malformations

Studies have not shown an increased risk of congenital malformations associated with oxcarbazepine administered during pregnancy; however, a risk of congenital malformations in the fetus cannot be completely ruled out.

Neurological developmental disorders

Some studies have shown that in utero exposure to oxcarbazepine negatively affects brain function development (neurological development) in children, while other studies have not observed this effect. The possibility of an effect on neurological development cannot be ruled out.

Birth weight

If you use Trileptal during pregnancy, your child may be small and weigh less than expected at birth [small for gestational age (SGA)]. Among women with epilepsy, in one study, about 15 out of every 100 children born to mothers who took oxcarbazepine during pregnancy were smaller and weighed less than expected at birth, compared to about 11 out of every 100 children born to women who did not take anticonvulsant medication during pregnancy.

Your doctor will inform you about the benefits and possible risks of treatment and help you decide whether to take Trileptal.

Do not stop your Trileptal treatment during pregnancy without first consulting your doctor.

Breastfeeding

If you are taking this medicine, consult your doctor before starting breastfeeding. The active ingredient of Trileptal passes into breast milk. Although available data suggest that the amount of Trileptal passing to the nursing infant is low, a risk of adverse effects in the baby cannot be ruled out. Your doctor will inform you about the potential benefits and risks of breastfeeding while taking Trileptal. If you are breastfeeding during Trileptal treatment and think your baby is experiencing any adverse effects such as excessive sleepiness or poor weight gain, inform your doctor immediately.

Driving and using machines

Trileptal may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction ability. These effects, as well as the condition itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or perform other activities requiring special attention until your doctor has assessed your response to this medicine.

It is important that you consult your doctor about whether you can drive or operate machinery while taking this medicine.

3. How to take Trileptal

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How much to take

Use in adults

• The recommended usual dose for adults (including elderly patients) is 600 mg per day.
• Take a 300 mg dose twice daily.
• If necessary, your doctor may gradually increase this dose to obtain the best dose for you. Optimal results are usually achieved with doses between 600 and 2,400 mg per day.
• The dose is the same whether Trileptal is taken together with another antiepileptic medicine.
• If you have kidney problems (renal insufficiency), the starting dose is half the normal initial dose.
• If you have severe liver disease, your doctor will adjust your dose.

Use in children and adolescents

Trileptal can be used in children aged 6 years and older.

The recommended dose for children is calculated based on 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 30 kg child would start treatment with 150 mg twice daily.
• Your doctor may gradually increase the dose to obtain the best dose for your child. Optimal results are usually achieved with doses of 30 milligrams per kilogram of body weight per day. The maximum dose for a child is 46 milligrams per kilogram of body weight per day.

How to take Trileptal

• The tablets may be swallowed with a little water.
• If necessary, the tablets may be split into two halves to facilitate administration. The score line is intended only to help break the tablet if you find it difficult to swallow it whole.
• For young children who cannot swallow tablets or when the prescribed dose is not available in tablet form, Trileptal is also available as an oral suspension.

When and for how long to take Trileptal

Take Trileptal twice daily every day, approximately at the same time each day, unless your doctor tells you otherwise. This will provide the best effect in controlling epilepsy. It will also help you remember when to take your tablet(s).

Your doctor will inform you how long your or your child's treatment will last. The duration of treatment depends on the type of seizures you or your child experience. Treatment may need to continue for several years to control epileptic seizures. Do not change the dose or stop treatment without first discussing it with your doctor.

If you take more Trileptal than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested. Symptoms of overdose with Trileptal may include:

• drowsiness, dizziness, coordination problems and/or involuntary eye movements, muscle twitching, or significant worsening of seizures, headache, loss of consciousness, coma,
• feeling nauseous (nausea), being dizzy (vomiting), increased uncontrolled movements,
• numbness, double vision, reduction in size or constriction of the black part of the eye (pupil), blurred vision,
• fatigue,
• short, shallow, and rapid breathing (respiratory rate depression),
• irregular heartbeat (QTc interval prolongation),
• tremor, headache, coma, decreased level of consciousness, uncontrolled movements of mouth, tongue, and limbs,
• aggression, agitation, confusion,
• low blood pressure,
• breathing difficulty.

If you forget to take Trileptal

If you miss a single dose, take it as soon as you can, unless it is almost time for the next dose; in this case, wait and resume your regular dosing schedule. Do not take a double dose to make up for missed doses.

If you are unsure or have missed several doses, inform your doctor.

If you stop treatment with Trileptal

Do not stop taking your medicine without first consulting your doctor.

To prevent a sudden worsening of seizures, do not stop treatment abruptly.

If treatment is to be discontinued, it should be done gradually as directed by your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can produce adverse effects, although not everyone experiences them.

Tell your doctor immediately or go to the nearest hospital emergency department if any of the following adverse effects occur:

The following are symptoms of potentially serious adverse effects that may require urgent medical treatment.

Your doctor will decide whether treatment with Trileptal should be stopped immediately and how your treatment should continue in the future.

Uncommon (may affect up to 1 in 100 patients):

• Weight gain, fatigue, hair loss, muscle weakness, feeling cold (signs of reduced thyroid gland activity).
• Falls

Rare (may affect up to 1 in 1,000 patients):

• Swelling of lips, eyelids, face, throat, or mouth, accompanied by difficulty breathing, speaking, or swallowing (signs of anaphylactic reactions and angioedema).
• Skin rash and/or fever, which may be manifestations of drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP).
• Fatigue, shortness of breath during exercise, paleness, headache, chills, dizziness, frequent infections with fever, sore throat, mouth ulcers, more frequent bleeding or bruising than normal, nosebleeds, red or purple spots, or spontaneous appearance of spots on the skin (signs of a decreased platelet count or reduced number of blood cells).
• Numbness, confusion, muscle twitching, or significant worsening of seizures (possible symptoms of low sodium levels in the blood due to inappropriate antidiuretic hormone (ADH) secretion) (see section Warnings and precautions).

Very rare (may affect up to 1 in 10,000 patients):

• Signs of hypersensitivity reactions (allergy) such as skin rash, fever, and muscle and joint pain.

• Severe blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages, or genitals (signs of a severe allergic reaction including Lyell’s syndrome, Stevens-Johnson syndrome, and erythema multiforme).

• Rash with red spots mainly on the face, possibly accompanied by fatigue, fever, dizziness (nausea), or loss of appetite (signs of systemic lupus erythematosus).

• Flu-like symptoms with jaundice (yellowing of the skin and whites of the eyes) (signs of hepatitis).

• Severe upper abdominal pain, dizziness (vomiting), loss of appetite (signs of pancreatitis).

Tell your doctor as soon as possible if you experience any of the following adverse effects. They may require medical attention:

Frequent (may affect up to 1 in 10 patients):

• Tremor, coordination problems, involuntary eye movements, feeling anxious and nervous, feeling depressed, mood changes, skin rash.

Very rare (may affect up to 1 in 10,000 patients):

• Irregular heartbeat or a very fast or very slow heart rate.

Other adverse effects that may occur:

These are mild to moderate adverse effects of Trileptal. Most of these effects are transient and usually decrease over time.

Very frequent (may affect more than 1 in 10 patients):

• Fatigue, headache, dizziness, somnolence, feeling of dizziness (nausea), dizziness (vomiting), and double vision.

Frequent (may affect up to 1 in 10 patients):

• Weakness, memory disorders, difficulty concentrating, apathy, agitation, confusion, blurred vision, constipation, diarrhea, abdominal pain, acne, hair loss, vertigo, weight gain, speech disorders.

Uncommon (may affect up to 1 in 100 patients):

• High blood pressure (hypertension), urticaria.
• Liver enzyme levels may also increase while taking Trileptal.

Rare (may affect up to 1 in 1,000 patients):

• Cases of bone disorders including osteopenia and osteoporosis (reduced bone mass) and fractures have been reported. Inform your doctor or pharmacist if you have been taking antiepileptic medicines for a long time, have a medical history of osteoporosis, or are taking steroids.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Trileptal

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Trileptal

• The active substance is oxcarbazepine. Each film-coated tablet contains 300 mg of oxcarbazepine.
• The other components (excipients) are:

Tablet core: anhydrous colloidal silica, microcrystalline cellulose, hypromellose, crospovidone, magnesium stearate.

Film coating for the 300 mg tablets: hypromellose, macrogol 8000, iron oxide yellow (E172), talc, titanium dioxide (E171).

Appearance of the product and contents of the pack

Trileptal 300 mg film-coated tablets are yellow, oval-shaped, biconvex, scored on both sides, with the imprint “TE”, score, inverted “TE” on one side and “CG”, score, inverted “CG” on the other side.

Trileptal film-coated tablets are available in blister packs containing 30, 50, 100, 200 and 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Novartis Farmacéutica, S.A.
Gran Vía de les Corts Catalanes, 764
08013 Barcelona
Spain

Manufacturer

Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain

Novartis Farma – Produtos Farmacêuticos S.A.
Avenida Professor Doutor Cavaco Silva, nº 10E
Taguspark
District: Lisbon
Municipality: Oeiras
Parish: Porto Salvo
2740-255 Portugal

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

NOVARTIS SVERIGE AB
Torshamnsgatan 48
16440 Kista
Sweden

Novartis Pharma GmbH
Jakov-Lind-Straße 5, Top 3.05
1020 Vienna
Austria

Novartis Pharma B.V.
Haaksbergweg 16
1101 BX Amsterdam
The Netherlands

Novartis Pharma GmbH
Sophie-Germain-Strasse 10
Nuremberg 90443
Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria: Trileptal
Belgium: Trileptal
Croatia: Trileptal
Denmark: Trileptal
Finland: Trileptal
France: Trileptal
Germany: Trileptal
Greece: Trileptal
Iceland: Trileptal
Ireland: Trileptal
The Netherlands: Trileptal
Portugal: Trileptal
Spain: Trileptal
Sweden: Trileptal

Date of the most recent revision of this leaflet: October 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/