TRILEPTAL 300 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Trileptal300 mg film-coated tablets

oxcarbazepine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Trileptal and what is it used for

What is Trileptal

Trileptal contains the active substance oxcarbazepine.

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

What Trileptal is used for

Medicines like Trileptal are standard treatments for epilepsy.

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

Trileptal is used to treat partial epileptic 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 two types of partial seizures: simple and complex. In simple partial seizures, the patient remains conscious, while in complex seizures, the state of consciousness is altered.

Trileptal works by keeping the "overexcited" nerve cells in the brain under control, thus suppressing or reducing the frequency of these seizures.

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

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

If you have any doubts about how Trileptal works or why you have been prescribed this medicine, ask your doctor.

2. What you need to know before you take Trileptal

Follow your doctor's instructions carefully, even if they differ from the general information given 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 to oxcarbazepine or 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 are allergic, ask your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Trileptal:

• if you have ever suffered from an unusual allergic reaction(rash or any other type of allergy) to carbamazepine or any other medicine. If you are allergic to carbamazepine, the likelihood of being 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 to help the kidneys eliminate salt and water by increasing urine production).
• if you have heart disease, shortness of breath, and/or swelling of feet or legs due to fluid retention.
• if you know that your blood sodium level is lowas 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 an extra one while taking Trileptal. This can help prevent an unwanted 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 serious 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 you if a blood test is necessary before taking oxcarbazepine.

If you notice any of the following symptoms after taking Trileptal, inform your doctor immediately or go to the Emergency Department of the nearest hospital:

• if during treatment you suffer an allergic reaction. Symptoms include swelling of the lips, eyelids, face, throat, mouth, or sudden breathing problems, as well as fever with swelling of the lymph nodes, rash, or blisters on the skin (see section 4).
• if you notice symptoms suggesting hepatitis, such as jaundice (yellowing of the skin or the white of the eyes).
• if you notice an increase in the frequency of seizures. This is especially important in children, but it can also occur in adults.
• if you notice possible symptoms of blood disorderssuch as fatigue, shortness of breath when exercising, paleness, headache, dizziness, frequent infections with fever, sore throat, mouth ulcers, bleeding or bruising more often than usual, nosebleeds, red or purple spots, or spontaneous appearance of spots on the skin.
• a small number of people treated with antiepileptics like Trileptal have had thoughts of self-harm or suicide. If at any time you experience these thoughts, 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.

Using Trileptal with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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 blood sodium levels, such as diuretics (used to help the kidneys eliminate 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 cyclosporin 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; if in doubt, consult your doctor.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is important to control epileptic seizures during pregnancy. However, there may be a risk 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, it cannot be completely ruled out that there is a risk of congenital malformations in the fetus.

Neurodevelopmental disorders

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

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

Do not stop your treatment with Trileptal during pregnancy without first discussing it with your doctor.

Breastfeeding

If you are taking this medicine, ask your doctor for advice before breastfeeding. The active substance of Trileptal passes into breast milk. Although the available data suggest that the amount of Trileptal that passes into the breastfed child is low, a risk of adverse effects in the baby cannot be ruled out. Your doctor will inform you of the benefits and potential risks of breastfeeding while using Trileptal. If you are breastfeeding while taking Trileptal and you 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 changes in vision, and may reduce your reaction ability. These effects, as well as the disease itself, may impair your ability 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 important to consult your doctor if you can drive or operate machinery while taking this medicine.

3. How to take Trileptal

Follow the instructions for administration of this medicine given by your doctor or pharmacist carefully. If in doubt, consult your doctor or pharmacist again.

How much to take

Use in adults

• The recommended dosefor adults (including elderly patients) is 600 mg per day.
• Take a dose of 300 mg twice a day.
• If necessary, your doctor may gradually increase this dose 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 medicine.
• 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 gradually increase the dose 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 broken into two halves to facilitate administration. The score line is only for breaking the tablet if you find it difficult to swallow it whole.
• For small children who cannot swallow tablets or for whom the prescribed dose is not in tablet form, Trileptal is also available as an oral suspension.

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 for 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 your child's treatment will last. The duration of treatment will depend on the type of seizures you or your child suffer from. It may be necessary to continue treatment 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine 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, vomiting, increased involuntary movements,
• numbness, double vision, decreased pupil size or contraction, blurred vision,
• fatigue,
• short, shallow, and rapid breathing (respiratory depression),
• irregular heart rhythm (QTc interval prolongation),
• tremor, headache, coma, decreased level of consciousness, involuntary movements of the mouth, tongue, and limbs,
• aggression, agitation, confusion,
• low blood pressure,
• breathing difficulties.

If you forget to take Trileptal

If you have missed a single dose, take it as soon as you can, except if it is almost time for the next dose; in this case, wait and return to your usual administration 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 taking 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 you stop your treatment, it should be done gradually as indicated by your doctor.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

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

Your doctor will decide whether to immediately stop treatment with Trileptal and how to continue your treatment in the future.

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

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

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

• Inflammation of the 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 can be manifestations of drug reaction with eosinophilia and systemic symptoms (DRESS), or acute generalized exanthematous pustulosis (AGEP).
• Fatigue, shortness of breath when exercising, paleness, headache, chills, dizziness, frequent infections with fever, sore throat, mouth ulcers, bleeding or bruising more often than usual, nosebleeds, red or purple spots or spontaneous appearance of spots on the skin (signs of a decrease in the number of platelets or a decrease in the number of blood cells).
• Numbness, confusion, muscle contractions, or significant worsening of seizures (possible symptoms of low sodium levels in the blood due to inadequate secretion of 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 pain in the muscles and joints.

• 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's syndrome, Stevens-Johnson syndrome, and erythema multiforme).
• Rash with red spots mainly on the face, which may be accompanied by fatigue, fever, feeling of 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, nausea (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:

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

• Tremors, coordination problems, involuntary eye movements, feeling of anxiety and nervousness, feeling of depression, mood changes, skin rash.

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

• Irregular heartbeat or a very fast or slow heartbeat.

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 Common(may affect more than 1 in 10 patients):

• Fatigue, headache, dizziness, drowsiness, feeling of dizziness (nausea), 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.

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

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

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

• There have been reports of bone disorders, including osteopenia and osteoporosis (decrease in bone mass) and fractures. Tell your doctor or pharmacist if you have been taking antiepileptics for a long time, have a medical history of osteoporosis, or are taking steroids.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, www.notificaRAM.es. By reporting adverse effects, you can contribute to providing 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 expiration date that appears on the packaging after CAD. The expiration date is 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 should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Trileptal

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

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

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

Appearance of the Product and Package Contents

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 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 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 Wien

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

Iceland: Trileptal

Ireland: Trileptal

Netherlands: Trileptal

Portugal: Trileptal

Spain: Trileptal

Sweden: Trileptal

United Kingdom (Northern Ireland): Trileptal

Date of the Last Revision of this Leaflet:March 2023

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/