Label: information for the user

Trileptal 60 mg/ml oral suspension

oxcarbazepine

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

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine 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 label. See section 4.

1. What Trileptal is 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 informationinformation

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 the 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 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 carefully all the instructions given by your doctor, even if they differ from the general information indicated 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 to any of the other components of this medication (including those 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 to any other medication. 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 (medications 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 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 birth control pill), Trileptal may make the contraceptive not work. Use a non-hormonal contraceptive method or extra protection while taking Trileptal. This may 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 severe skin reactions in Han Chinese or Thai patients associated with carbamazepine or chemically related compounds can be predicted by blood tests in these patients. 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 experience an allergic reaction. Symptoms include inflammation of lips, eyelids, face, throat, mouth, or sudden respiratory problems, fever with lymph node inflammation, rash, or blisters on the skin.
• if you notice symptoms that suggest hepatitis, such as jaundice (yellowing of the skin or 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 during exercise, paleness, headache, chills, dizziness, frequent infections with fever, sore throat, mouth ulcers, bleeding or bruising more frequently than normal, nosebleeds, red or purple spots, or spontaneous appearance of skin spots.
• a low number of people treated with antiepileptic medications like Trileptal have had 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 medications:

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

Especially in the case of:

-Oral contraceptives such as the "pill" (see section Warnings and precautions).

• Other antiepileptic medications and enzyme-inducing medications such as carbamazepine, phenobarbital, phenytoin, or lamotrigine and rifampicin.
• Medications 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 medications such as indomethacin.
• Lithium and monoamine oxidase inhibitors (medications used to treat mood disorders and some types of depression).
• Medications 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 taking alcoholic beverages as they may increase the sedative effects of this medication; consult your doctor if you have any doubts.

Pregnancy and breastfeeding

Pregnancy

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

It is essential to control seizures during pregnancy. However, there may be a risk to your baby if you take antiepileptic medications 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 Trileptal treatment during pregnancy without consulting your doctor first.

Breastfeeding

If you are taking this medication, 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 potential benefits and risks of breastfeeding while using Trileptal. If you are breastfeeding during treatment with Trileptal and believe your baby is experiencing an adverse effect, 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 medication.

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

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

Trileptal oral suspension contains:

• Sorbitol (E420): This medication contains 175 mg of sorbitol in each 1 ml of oral suspension.

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have a condition that makes you intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medication.

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

• Propylene glycol (E1520): This medication contains 25 mg of propylene glycol in each 1 ml of oral suspension.
• Parahydroxybenzoates: parahydroxybenzoic acid propyl ester (E216) and parahydroxybenzoic acid methyl ester (E218), which may cause allergic reactions (possibly delayed).
• Sodium: This medication contains less than 1 mmol of sodium (23 mg) per 1 ml; it is essentially "sodium-free".

• Ethanol: This medication contains 0.8 mg of alcohol (ethanol) in each 1 ml of oral suspension. The amount in 1 ml of this medication is equivalent to less than 0.02 ml of beer or 0.01 ml of wine. The small amount of alcohol contained in this medication has no perceptible effect.

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

The dose must be indicated in milliliters (ml)

The dose prescribed by your doctor must be indicated inmilliliters (ml)and not in milligrams (mg). This is important since the oral dosing syringe used to extract the correct dose from the bottle is marked in milliliters.If your prescription is in milligrams, do not take the medication and consult your doctor or pharmacist as soon as possible.

How much to take

Use in adults

• Theusual recommended dosefor adults (including elderly patients) is 10 ml of oral suspension (600 mg of oxcarbazepine) per day.
• Take a dose of 5 ml of oral suspension (300 mg of oxcarbazepine) twice a day.
• Your doctor may increase this dose gradually to obtain the best dose for you. The best results are usually with doses between 10 ml and 40 ml of oral suspension (600 mg of oxcarbazepine to 2,400 mg of oxcarbazepine) 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 usual 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.

Your doctor will calculate the recommended dose for children based on their 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 (2.5 ml of oral suspension) twice a day.
• Your doctor may increase the dose gradually to obtain the best dose for the child. The best results are usually with a dose 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

For complete instructions on how to take Trileptal, see theInstructions for usesection at the end of this leaflet..

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 oral suspension.

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 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 of dizziness (vomiting), increased involuntary movements,
• numbness, double vision, constriction 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 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 questions about the use of thismedication, ask your doctor or pharmacist.

Like all medicines, this medicine may 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 pustular exanthema (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 that may be accompanied by fatigue, fever, dizziness, or loss of appetite (sign 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, anxiety and nervousness, depression, mood changes, skin rash.

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

• Irregular or very fast or slow heart rhythm.

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, 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 changes.

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

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

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

• There have been cases of bone disorders including osteopenia and osteoporosis (bone mass decrease) and fractures. 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 of 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 leaflet. 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 sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Once the packaging is opened, use it within the next 7 weeks.

After 7 weeks, return the unused oral suspension to your pharmacy for safe disposal.

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

Medications should not be disposed of through drains or trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointat your pharmacy. In case of doubtask your pharmacisthow to dispose ofthepackaging and themedications you no longerneed.This will help protect the environment.

Composition of Trileptal

• The active ingredient is oxcarbazepine. Each ml of oral suspension contains 60 mg of oxcarbazepine.
• The other components (excipients) are: purified water, sorbitol (E420) 70% (non-crystallized), propylene glycol (E1520), dispersible cellulose, ascorbic acid (E300), yellow apricot kernel flavor (contains ethanol), methyl parahydroxybenzoate (E218), macrogol stearate 400, sorbic acid (E200), sodium saccharin, propyl parahydroxybenzoate (E216).

Appearance of the product and contents of the package

Trileptal oral suspension is presented as a white suspension that tends to turn brownish-red. The decoloration of the oral suspension to a slightly brownish-red color is normal and does not affect the quality of the product.

Trileptal oral suspension is presented in amber-colored glass bottles containing 250 ml of oral suspension. The bottles come with a child-resistant cap, a 10 ml oral syringe, and a bottle adapter.

Marketing authorization holder and responsible for manufacturing

Novartis Farmacéutica, S.A.

Gran Vía de les Corts Catalanes, 764

08013 Barcelona

Spain

Responsible for manufacturing

Novartis Pharma GmbH

Roonstrasse 25 (Nuremberg)

D-90429 – Germany

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

Nuremberg 90443

Germany

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

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

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Page 1

Instructions for use

Please read these instructions carefully to learn how to use this medicine

How to use the medicine kit

The medicine kit consists of three parts

Page 2

How to adjust the plastic adapter on a new medicine bottle

Page 3

Preparing a dose of medicine