Package leaflet: Information for the user

Trileptal, 300 mg, film-coated tablets
Trileptal, 600 mg, film-coated tablets
Oxcarbazepinum
Please read this leaflet carefully before 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 symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Trileptal is and what it is used for
What you need to know before taking Trileptal
How to take Trileptal
Possible side effects
How to store Trileptal
Contents of the pack and other information

1. What Trileptal is and what it is used for

What Trileptal is
The active substance in Trileptal is oxcarbazepine.
Trileptal belongs to a group of medicines called antiepileptics or anticonvulsants.

When Trileptal is used
Medicines such as Trileptal are commonly used in the treatment of epilepsy.
Epilepsy is a disorder of brain function that causes patients to have recurrent seizures. These are caused by temporary disturbances in the brain's electrical activity. In healthy individuals, brain cells coordinate body movements through organized signals sent by nerve cells to muscles. In epilepsy, brain cells send too many signals in a disorganized manner. This results in uncoordinated muscle movements known as epileptic seizures.

Trileptal is used in the treatment of partial seizures, with or without secondary generalized tonic-clonic seizures.
In partial seizures, only a limited area of the brain is involved, but these seizures may 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, loss of consciousness occurs.

Trileptal works by suppressing hyperexcitable nerve cells in the brain, thereby stopping or reducing the frequency of epileptic seizures.
Trileptal can be used as monotherapy or in combination with other antiepileptic medicines.
Usually, doctors try to find one medicine that works best for a particular adult or child. However, in patients with more severe forms of epilepsy, it may be necessary to use two or more seizure-preventing medicines.
Trileptal can be used in adults and children aged 6 years and older.
If you have any questions about how Trileptal works or why this medicine has been prescribed, please consult your doctor.

2. Important information before using Trileptal

Trileptal should always be taken exactly as prescribed by your doctor, even if this differs
from the information provided in this leaflet.
Monitoring during Trileptal treatment
Before and during treatment with Trileptal, your doctor may carry out blood tests to determine
the appropriate dose of the medicine for you. Your doctor will inform you when these tests should be performed.
When not to take Trileptal

if you are allergic to oxcarbazepine, eslicarbazepine, or any of the other ingredients of this medicine (listed in section 6). If this applies to you, inform your doctor before taking Trileptal. If you think you may be allergic, consult your doctor for advice.

Warnings and precautions
Before starting Trileptal, discuss the following with your doctor or pharmacist:

if you have previously experienced a hypersensitivity reaction (rash or other allergic symptoms) to carbamazepine or any other medicines. If you are allergic to carbamazepine, there is a 1 in 4 chance (25%) that you may also be allergic to oxcarbazepine (Trileptal);
if you have kidney disease;
if you have severe liver disease;
if you are taking diuretics (medicines used to remove salt and water from the body by increasing urine production);
if you have heart disease, characterized by difficulty in breathing and/or swelling of the feet or legs due to fluid retention;
if you have low sodium levels in the blood (see section 4: Possible side effects);
if you are taking hormonal contraceptives (such as birth control pills), Trileptal may reduce their effectiveness. It is recommended to use other or additional (non-hormonal) contraceptive methods during treatment with Trileptal to prevent unintended pregnancy. If you experience irregular vaginal bleeding or spotting, inform your doctor immediately. If in doubt, consult your doctor or healthcare provider. Patients of Han Chinese or Thai descent have an increased risk of severe skin reactions associated with carbamazepine or chemically similar active substances, which can be predicted by a blood test. Your doctor should advise whether such testing is necessary before starting oxcarbazepine.

Contact your doctor immediately or go to the nearest hospital if, after starting treatment with Trileptal,
you experience any of the following symptoms:

allergic reaction; symptoms include swelling of the lips, eyelids, face, throat, or mouth, sudden breathing difficulties, fever with swollen lymph nodes, rash, or blistering skin lesions;
jaundice (yellowing of the skin or whites of the eyes) – this may be a sign of liver inflammation;
increased frequency of seizures; this is particularly important in children, but may also occur in adults;
a group of symptoms including fatigue, shortness of breath during physical activity, paleness, headache, chills, dizziness, frequent infections with fever, sore throat, mouth ulcers, unusual bleeding or bruising, nosebleeds, red or purple spots under the skin, or unexplained skin discoloration – these 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, contact your doctor immediately;
rapid or extremely slow heartbeat.

Children and adolescents
Your doctor may recommend monitoring thyroid function before and during treatment in children.
Trileptal and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
This is especially important for:

hormonal contraceptives (see section: "Warnings and precautions");
other antiepileptic medicines and enzyme-inducing medicines such as carbamazepine, phenobarbital, phenytoin, lamotrigine, and rifampicin;
medicines that reduce 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 drugs 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, food, and alcohol
Trileptal can be taken during or independently of meals.
Alcohol may enhance the sedative effect of Trileptal. Alcohol consumption should be avoided
during treatment with Trileptal. If in doubt, consult your doctor.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant,
you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
During pregnancy, it is important to keep seizures under control, but the use of antiepileptic medicines at this time may pose a risk to the unborn child.
Congenital malformations
Studies have not shown an increased risk of congenital malformations associated with the use of
oxcarbazepine during pregnancy; however, a risk of congenital malformations in the unborn child cannot be completely ruled out. The risk of congenital malformations is higher in children of women treated with combination therapy than with monotherapy.
Neurodevelopmental disorders
Some studies have indicated that exposure to oxcarbazepine in utero may negatively affect brain function development (neurodevelopment) in children, while other studies have not shown such an effect. A potential effect on neurodevelopment cannot be excluded.
Birth weight
If the mother takes Trileptal during pregnancy, the baby may be smaller and weigh less at birth than expected [small for gestational age (SGA)]. In one study among women with epilepsy, about 15 out of 100 babies born to mothers who took oxcarbazepine during pregnancy were smaller and had lower birth weight than expected, compared to about 11 out of 100 babies born to women who did not take antiepileptic medicines during pregnancy.
Your doctor will inform you about the benefits and risks of taking the medicine and help you decide whether to continue taking Trileptal.
Do not stop taking Trileptal during pregnancy without first consulting your doctor.
Breastfeeding
If you are taking this medicine, consult your doctor before starting breastfeeding.
The active substance in Trileptal passes into breast milk. Although available data suggest that the amount of Trileptal transferred to the infant through breastfeeding is low, the risk of adverse effects in the child cannot be excluded. Your doctor will discuss with you the benefits and risks of breastfeeding while taking Trileptal. If you breastfeed while taking Trileptal and notice adverse effects in your child such as excessive sleepiness or poor weight gain, inform your doctor immediately.
Driving and operating machinery
Trileptal may cause drowsiness, dizziness, blurred vision, double vision, lack of muscle coordination, or reduced level of consciousness, especially at the beginning of treatment or during dose escalation.
It is very important to consult your doctor to determine whether you are allowed to drive or operate machinery while taking this medicine.

3. How to take Trileptal

This medicine should always be taken exactly as prescribed by your doctor or pharmacist, even if this differs
from the information provided in the leaflet. If in doubt, consult your doctor or pharmacist.
Other medicines containing oxcarbazepine are also available in the form of 150 mg tablets.
Recommended dose
Use in adult patients

The usual starting dose of Trileptal in adult patients (including elderly patients) is 600 mg of oxcarbazepine per day.
Take one 300 mg tablet twice daily.
Your doctor may gradually increase the dose until the best therapeutic effect is achieved. This is usually achieved with doses ranging from 600 mg to 2400 mg of oxcarbazepine per day.
The dose is the same if Trileptal is used together with another antiepileptic medicine.
In patients with kidney disease (impaired renal function), the starting dose is half the usual starting dose.
In patients with severe liver disease, your doctor will determine the appropriate dose.

Use in children and adolescents
Trileptal may be used in children aged 6 years and older.
The dose in children depends on body weight.

The starting 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 treatment with one 150 mg tablet twice daily.
Your doctor may gradually increase the dose until the best treatment results are achieved. The optimal therapeutic effect is usually achieved at 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

Swallow the tablets whole with a small amount of water.
If necessary, the tablets may be divided along the break line to facilitate swallowing. However, breaking the tablet in this way does not allow for obtaining half the dose. The break line on the tablet is intended solely to facilitate breaking the tablet if the patient has difficulty swallowing it whole.
For young children who cannot swallow tablets, or when the prescribed dose cannot be achieved with tablets, Trileptal oral suspension is available.

When and for how long to take Trileptal
Trileptal should be taken twice daily, at the same time each day, unless otherwise directed by your doctor.
Taking the medicine at the same time each day will provide the best control of seizures. It will also help the patient remember when to take the tablet(s).
Your doctor will determine the duration of treatment with Trileptal for both adult and pediatric patients. This depends on the type of seizures. Treatment may continue for many years to control seizure occurrence. Do not change the prescribed dose or stop treatment without consulting your doctor.
Taking more Trileptal than prescribed
If you take more medicine than prescribed, seek immediate medical attention at the nearest hospital or contact your doctor. Symptoms of Trileptal overdose may include:
drowsiness, dizziness, nausea, vomiting, increased involuntary movements, lethargy, confusion, muscle twitching or markedly increased seizures, problems with coordination and (or) involuntary eye movements, double vision, constricted pupils, blurred vision, feeling of fatigue, shallow and rapid breathing (reduced respiratory rate), irregular heartbeat (prolonged QTc interval), tremor, headache, coma, loss of consciousness, involuntary movements of lips, tongue, limbs, agitation, low blood pressure, shortness of breath.
Missing a dose of Trileptal
If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, do not take the missed dose. Continue treatment according to the prescribed dosing schedule. Do not take a double dose to make up for a missed dose.
If you have any doubts or miss several doses, consult your doctor.
Stopping Trileptal
Do not stop taking this medicine without consulting your doctor.
Never stop the medicine suddenly, as this may cause a sudden increase in seizures.
If treatment needs to be discontinued, the medicine should be withdrawn gradually, as directed by your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will get them.
You should contact your doctor immediately or go to the nearest hospital if any of the
following adverse reactions occur:
These include symptoms that occur uncommonly, rarely or very rarely. Your doctor will decide
whether treatment with Trileptal should be stopped immediately and how treatment should be continued.
Uncommon (may occur in fewer than 1 in 100 patients):

Fatigue, hair loss, muscle weakness, feeling cold (symptoms of hypothyroidism). Rare (may occur in fewer than 1 in 1,000 patients):
Swelling of the lips, eyelids, face, throat or mouth, accompanied by difficulty breathing, speaking or swallowing (symptoms of anaphylactic reactions and angioedema), or other signs of hypersensitivity 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, bleeding and bruising more easily than normal, nosebleeds, red or purple subcutaneous spots, unexplained skin discoloration (symptoms of reduced platelet or white blood cell counts). Very rare (may occur in fewer than 1 in 10,000 patients):
Severe blistering skin rash and (or) mucosal lesions of the lips, eyes, oral cavity, nasal passages or genital organs (symptoms of severe hypersensitivity reactions, including Lyell's syndrome, Stevens-Johnson syndrome and erythema multiforme).
Red skin rash, mainly on the face, accompanied by fatigue, fever, nausea or loss of appetite (symptoms of systemic lupus erythematosus).
Lethargy, disorientation, muscle twitching or markedly increased seizures (possible symptoms of low blood sodium levels) (see section "Warnings and precautions").
Flu-like symptoms with jaundice (yellowing of the skin or whites of the eyes) (symptoms of hepatitis).
Severe pain in the upper abdomen, vomiting, loss of appetite (symptoms of pancreatitis).

If any of the adverse reactions listed below occur, you should contact your doctor as
soon as possible. Medical help may be required:
Common (may occur in fewer than 1 in 10 patients):

Tremor, impaired coordination, involuntary eye movements, restlessness and anxiety, depression, mood swings, rash. Very rare (may occur in fewer than 1 in 10,000 patients):
Irregular heartbeat, very fast or very slow heartbeat.

Other adverse reactions that may occur:
These adverse reactions of Trileptal are usually mild to moderate. Most of them are transient and usually gradually resolve.
Very common (may occur in more than 1 in 10 patients):

Fatigue, headache, dizziness, drowsiness, nausea, vomiting, double vision. Common (may occur in fewer than 1 in 10 patients):
Weakness, memory impairment, difficulty concentrating, apathy, agitation, disorientation, blurred vision, visual disturbances, constipation, diarrhoea, stomach (abdominal) pain, acne, hair loss, loss of balance.
Weight gain.
Speech disorders. Uncommon (may occur in fewer than 1 in 100 patients):
High blood pressure.
Urticaria, increased liver enzyme activity (seen in blood test results). Rare (may occur in fewer than 1 in 1,000 patients):
There have also been reports of bone disorders, including osteopenia and osteoporosis (thinning of the bones) and fractures. Patients who have been taking antiepileptic medicines long-term, who have previously been diagnosed with osteoporosis, or who are taking steroids should consult their doctor or pharmacist.

You should see your doctor if any of the above adverse reactions worsen.
Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Faks: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Trileptal

Keep the medicine out of sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the blister pack and carton. The expiry date refers to the last day of the specified month.
Do not use the medicine if the packaging has been previously opened or damaged.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Trileptal contains
The active substance is oxcarbazepine.
Trileptal 300 mg, coated tablets
Each coated tablet of Trileptal 300 mg contains 300 mg of oxcarbazepine.
Trileptal 600 mg, coated tablets
Each coated tablet of Trileptal 600 mg contains 600 mg of oxcarbazepine.

The other ingredients are:
Tablet core: anhydrous colloidal 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-shaped, biconvex tablets with a score line on both sides, embossed with "TE", score line, reversed "TE" on one side and "CG", score line, reversed "CG" on the other side.
Trileptal 600 mg, coated tablets are light pink, oval-shaped, biconvex tablets with a score line on both sides, embossed with "TF", score line, reversed "TF" on one side and "CG", score line, reversed "CG" on the other side.
The cardboard carton contains 50 coated tablets (5 blisters with 10 tablets each).
Trileptal coated tablets are available in two strengths: 300 mg and 600 mg.

Marketing Authorisation Holder
Novartis Poland Sp. z o.o.
ul. Marynarska 15
02-674 Warszawa
Tel. +48 22 375 48 88

Manufacturer/Importer:
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Farma S.p.A.
Via Provinciale Schito, 131
80058 Torre Annunziata (NA)
Italy