Package Insert: Information for the User

Trileptal300 mg Film-Coated Tablets

oxcarbazepina

Read this package insert carefully before starting to take this medication, as it contains important information for you.

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

1. What is Trileptal 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 information

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

Monitoring during treatment with Trileptal

Your doctor may perform blood tests before and during treatment with Trileptal to determine your dosage. Your doctor will tell you when to have the blood tests.

Do not take Trileptal:

• if you are allergic to oxcarbazepine or any of the other ingredients in 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 are allergic, ask your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Trileptal:

• if you have ever had any unusual allergic reaction (rash or any other type of allergy) to carbamazepine or any other medicine. If you are allergic to carbamazepine, the chances of being allergic to oxcarbazepine (Trileptal) are 1 in 4 (25%).
• if you have kidney disease.
• if you have severe liver disease.
• if you are taking diuretics (medicines to help the kidneys get rid of salt and water by increasing the amount of urine produced).
• 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 taking oral contraceptives (such as the pill), Trileptal may make the contraceptive not work. Use a non-hormonal contraceptive method or extra precautions while taking Trileptal. This may help prevent an unplanned pregnancy. Inform your doctor immediately if you have irregular vaginal bleeding or spotting. If you have any doubts 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 tests. 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:

• if during treatment you suffer an allergic reaction. The symptoms include inflammation of the lips, eyelids, face, throat, mouth, or sudden respiratory problems, as well as fever with lymph node inflammation, skin rash, or blisters (see section 4).
• if you notice symptoms that suggest hepatitis, such as jaundice (yellowing of the skin or the white of the eyes).
• if you notice an increase in seizure frequency. This is especially important in children, but can also occur in adults.
• if you notice possible symptoms of blood disorder such as fatigue, shortness of breath on exercise, paleness, headache, chills, dizziness, frequent infections with fever, sore throat, mouth ulcers, bleeding or bruising more frequently than normal, your nose bleeds, red or purple spots, or spontaneous appearance of skin spots.
• if you experience thoughts of self-harm or suicide. If you experience these thoughts at any time, contact your doctor immediately.
• if you notice that your heart rate is fast or abnormally slow.

• Children and adolescents

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

Use of Trileptal with other medicines

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

Especially in the case of:

-Oral contraceptives such as the pill (see Advertencias and precautions).

-Other antiepileptic medicines and enzyme-inducing medicines such as carbamazepine, phenobarbital, phenytoin, or lamotrigine and rifampicin.

-Medicines that reduce blood sodium levels, such as diuretics (used to help the kidneys get rid of salt and water 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 some types of depression).

-Medicines that control the body's immune system, such as ciclosporin and tacrolimus.

Taking Trileptal with food and alcohol

Trileptal can be taken with or without food. During treatment with Trileptal, avoid drinking alcoholic beverages as it 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 essential to control seizures during pregnancy. However, there may be a risk to your baby if you take antiepileptic medicines 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 treatment with Trileptal during pregnancy without consulting your doctor first.

Breastfeeding

If you are taking this medicine, 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 benefits and potential risks of breastfeeding while taking Trileptal. If you are breastfeeding during treatment with Trileptal and believe your baby is experiencing any adverse effects 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 medicine.

It is essential to consult your doctor if you can drive or operate machinery while taking this medicine.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How much to take

Use in adults

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

Use in children and adolescents

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

The recommended dose for children is calculated based on weight.

• The initial dose is 8 to 10 milligrams per kilogram of body weight per day administered in two doses. For example, a 30 kg child will start treatment with a dose of 150 mg twice a day.
• Your doctor may increase the dose gradually to obtain the best dose for your child. The best results are usually obtained 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 can be swallowed with a little water.
• If necessary, the tablets can be split in half to facilitate administration. The groove is only for splitting the tablet if it is difficult to swallow it whole.
• For small children who cannot swallow tablets or for whom the prescribed dose is not available in tablet form, Trileptal is also available in oral suspension form.

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 tablet or tablets.

Your doctor will inform you how long your treatment or that of your child 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:

• drowsiness, dizziness, coordination problems, and/or involuntary eye movements, muscle contractions, or significant worsening of seizures, headache, loss of consciousness, coma,
• nausea, feeling dizzy (vomiting), increased involuntary movements,
• drowsiness, double vision, decreased pupil size or contraction of the black part of the eye (pupil), blurred vision,
• fatigue,
• shallow, rapid, and short breathing (respiratory depression),
• irregular heart rhythm (prolonged QTc interval),
• tremors, headache, coma, decreased level of consciousness, involuntary movements of the mouth, tongue, and limbs,
• aggression, agitation, confusion,
• low blood pressure,
• respiratory difficulty.

If you forget to take Trileptal

If you have forgotten a single 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 doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can 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):

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

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

• Lip, eyelid, face, throat, or mouth inflammation, accompanied by difficulty breathing, speaking, or swallowing (signs of anaphylactic reactions and angioedema).
• Skin rash and/or fever, which may be manifestations of rash with eosinophilia and systemic symptoms (DRESS, by its English acronym), generalized acute exanthematous pustulosis (AGEP, by its English acronym).
• Fatigue, shortness of breath during exercise, pallor, 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 (signs of a decrease in platelet count or a decrease in blood cell count).
• Numbness, confusion, muscle contractions, or significant worsening of seizures (possible symptoms of low sodium levels in the blood due to inadequate secretion of the antidiuretic hormone (ADH)(see Warnings and Precautions section).

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 severe allergic reaction including Lyell syndrome, Stevens-Johnson syndrome, and erythema multiforme).
• Rash with red spots mainly on the face, which may be accompanied by fatigue, fever, dizziness, or loss of appetite (signs of systemic lupus erythematosus).
• Symptoms similar to the flu with jaundice (yellowing of the skin and eyes) (signs of hepatitis).
• Severe upper abdominal pain, dizziness, loss of appetite (signs of pancreatitis inflammation).

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):

• Tremors, 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 slow heart rate.

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):

• Fatigue, headache, dizziness, drowsiness, feeling dizzy (nausea), dizziness (vomiting), and double vision.

Common(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.

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

• High blood pressure (hypertension), urticaria.
• Also, your liver enzyme levels may increase while taking Trileptal.

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

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

Reporting 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 prospectus. 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 reach and sight 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.

Do not use this medication if you observe that the packaging is damaged or shows signs of manipulation.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Trileptal

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

Core of the tablet: anhydrous colloidal silica, microcrystalline cellulose, hypromellose, crospovidone, magnesium stearate.

Coating of the tabletfor the 300 mg tablets:hypromellose, macrogol 8000, yellow iron oxide (E172), talc, titanium dioxide (E171).

Appearance of the product and contents of the package

Trileptal 300 mg film-coated tablets are yellow, oval, scored on both sides, and have the inscription TE/TE on one face and CG/CG on the other.

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

Not all presentations may be marketed.

Marketing authorization holder and responsible manufacturer

Novartis Farmacéutica, S.A.

Gran Vía de les Corts Catalanes, 764

08013 Barcelona

Spain

Responsible 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 Healthcare A/S

Edvard Thomsen Vej 14

Copenhagen. DK-2300

Denmark

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

Netherlands

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

Nuremberg 90443

Germany

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) under 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 on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/