Trileptal 60 mg/ml oral suspension
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Trileptal 60 mg/ml oral suspension
oxcarbazepine
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask 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 could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- 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
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 out too many signals in a disorganized way. This may result in uncoordinated muscle activity known as an epileptic seizure.
Trileptal is used to treat 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 overactive nerve cells in the brain under control, thereby suppressing or reducing the frequency of such seizures.
Trileptal may 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 it 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 these tests should be 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 treatment with 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, 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 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 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 reduce their effectiveness. 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 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 testing. 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:
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if you develop an allergic reaction during treatment. Symptoms include swelling of the lips, eyelids, face, throat, mouth, or sudden breathing problems, fever with swollen lymph nodes, skin rash or blisters.
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if you notice symptoms suggesting hepatitis, such as jaundice (yellowing of the skin or whites of the eyes).
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if you notice an increased frequency of seizures. This is particularly important in children, but may also occur in adults.
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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.
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a small number of patients treated with antiepileptic medicines such as Trileptal have had thoughts of harming themselves or of suicide. If you experience such thoughts at any time, contact your doctor immediately.
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if you notice that your heart rate is fast or unusually slow.
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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 affect 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. If in doubt, consult your doctor.
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 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 taken 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 take 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, approximately 15 out of every 100 babies 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 babies born to women who did not take anticonvulsant medication during pregnancy.
Your doctor will inform you about the benefits and potential risks of treatment and help you decide whether you should take Trileptal.
Do not stop your treatment with Trileptal during pregnancy without first consulting your doctor.
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 passed 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 treatment with Trileptal 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 visual disturbances, and may reduce reaction ability. These effects, as well as the underlying condition itself, may impair your ability to drive or operate machinery. Therefore, do not drive or operate machinery, or engage in any other activity 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.
Trileptal contains sorbitol (E420), propylene glycol (E1520), parahydroxybenzoates, sodium and ethanol
Trileptal oral suspension contains:
- Sorbitol (E420): This medicine contains 175 mg of sorbitol in each 1 ml of oral suspension.
Sorbitol is a source of fructose. If your doctor has told you (or your child) that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic condition in which the patient cannot break down fructose, consult your doctor (or your child’s doctor) before taking this medicine.
Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.
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Propylene glycol (E1520): this medicine contains 25 mg of propylene glycol in each 1 ml of oral suspension.
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Parahydroxybenzoates: propyl parahydroxybenzoate (E216) and methyl parahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed).
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Sodium: this medicine contains less than 1 mmol of sodium (23 mg) per 1 ml; hence, it is essentially “sodium-free”.
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Ethanol: This medicine contains 0.8 mg of alcohol (ethanol) in each 1 ml of oral suspension. The amount in 1 ml of this medicine is equivalent to less than 0.02 ml of beer or 0.01 ml of wine. The small amount of alcohol contained in this medicine does not produce any noticeable effect.
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.
The dose must be indicated in millilitres (ml)
The dose prescribed by your doctor must be indicated in millilitres (ml) and not in milligrams (mg). This is important because the oral dosing syringe used to withdraw the correct dose from the bottle is marked in millilitres. If your prescription is in milligrams, do not take the medicine and consult your doctor or pharmacist as soon as possible.
How much to take
Use in adults
- The recommended usual dose for 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 daily.
- Your doctor may gradually increase this dose until the best dose for you is achieved. Optimal results are usually obtained with doses between 10 ml and 40 ml of oral suspension (from 600 mg oxcarbazepine to 2,400 mg oxcarbazepine) per day.
- The dose is the same whether Trileptal is taken together with another antiepileptic medicine.
- If you have kidney problems (renal impairment), the initial dose is half the normal starting dose.
- If you have severe liver disease, your doctor will adjust your dose.
Use in children and adolescents
Trileptal may be used in children aged 6 years and older.
The recommended dose for children will be calculated by the doctor and depends on the child's 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 will start treatment with a dose of 150 mg (2.5 ml of oral suspension) twice daily.
- Your doctor may gradually increase the dose until the best dose for the child is reached. Optimal results are usually achieved 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 the section Instructions for use at the end of this leaflet.
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 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 seizures you or your child experience. 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, stating 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 sick (nausea), being sick (vomiting), increased uncontrolled movements,
- numbness, double vision, reduction in size or constriction of the black part of the eye (pupil), blurred vision,
- tiredness,
- short, shallow and rapid breathing (respiratory depression),
- irregular heartbeat (prolonged QTc interval),
- 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 forget a dose, take it as soon as you can, unless it is almost time for your next dose; in this case, wait and return to your usual dosing schedule. Do not take a double dose to make up for forgotten 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 your treatment is stopped, 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 cause adverse effects, although not everyone will experience 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, nosebleeds, red or purple spots, or spontaneous appearance of skin spots (signs of a reduced platelet count or reduced blood cell counts).
- Numbness, confusion, muscle twitching, or a 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 (sign 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, anxiety and restlessness, depression, 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 temporary and usually decrease over time.
Very frequent (may affect more than 1 in 10 patients):
- Fatigue, headache, dizziness, somnolence, dizziness (nausea), dizziness (vomiting), and double vision.
Frequent (may affect up to 1 in 10 patients):
- Weakness, memory disturbances, 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 on long-term antiepileptic treatment, 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 it is a possible adverse effect not listed in this leaflet. You can 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. The expiry date refers to the last day of the month indicated.
Once the container has been opened, use within the following 7 weeks.
After 7 weeks, return any unused oral suspension to your pharmacy for safe disposal.
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 medicines and their containers at the SIGRE Point located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Trileptal
- The active substance is oxcarbazepine. Each ml of oral suspension contains 60 mg of oxcarbazepine.
- The other components (excipients) are: purified water, sorbitol (E420) 70% (non-crystalline), propylene glycol (E1520), dispersible cellulose, ascorbic acid (E300), lemon plum yellow flavour (contains ethanol), methyl parahydroxybenzoate (E218), macrogol stearate 400, sorbic acid (E200), sodium saccharin, propyl parahydroxybenzoate (E216).
Nature of the product and contents of the container
Trileptal oral suspension is a slightly reddish or slightly brownish white suspension. Discoloration of the oral suspension to a slightly reddish-brown colour is normal and does not affect the quality of the product.
Trileptal oral suspension is supplied in amber-coloured glass bottles containing 250 ml of oral suspension. The bottles come with a child-resistant closure, a 10 ml dosing syringe, and a press-in bottle adapter.
Marketing Authorisation Holder and Manufacturer
Novartis Farmacéutica, S.A.
Gran Vía de les Corts Catalanes, 764
08013 Barcelona
Spain
Manufacturer
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 medicinal product is authorised in the European Economic Area member states 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
Date of the most recent revision of this leaflet: October 2025
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (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 attach the plastic adapter to a new medicine bottle
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Note: Keep the cap nearby to close the bottle after each use. |
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Note: You may not be able to push the adapter all the way down at this point, but it will fully insert into the bottle when you screw the cap back on. Please follow all instructions for dispensing the dose in Preparing a Dose of Medication. |
Page 3
Prepare a dose of medication
| The medication can be taken directly from the oral syringe or mixed in a small glass of water before taking it.
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Note: If the prescribed dose is greater than 10 ml, withdraw the prescribed dose in two steps. First, fill the syringe up to the 10 ml mark and administer this amount. Then, refill the oral syringe to complete the remaining dose. Ask your pharmacist if you are unsure. |
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