150 mg, 300 mg, 600 mg film-coated tablets
oxcarbazepine
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 in brain function that leads to recurrent seizures. The seizures occur due to a temporary error in the electrical activity of the brain. Normally, brain cells coordinate body movements by sending signals through the nerves to the muscles in an organized and orderly manner. In epilepsy, the brain cells send out too many signals in a disorganized way. The result can be an uncoordinated muscle activity called an epileptic seizure.
Trileptal is used for the treatment of partial seizures with or without secondary generalized tonic-clonic seizures. Partial seizures affect a limited part of the brain but can spread to the entire brain and cause a generalized tonic-clonic seizure. There are two types of partial seizures: simple and complex. In simple partial seizures, the patient is conscious, while in contrast, the patient’s consciousness is affected in complex partial seizures.
Trileptal works by helping to normalize the transmission of information between the brain’s “overstimulated” nerve cells. This suppresses or reduces the frequency of seizures.
Trileptal can be used alone or in addition to other antiepileptic drugs.
Usually, the doctor tries to find the medicine that works best for you or your child. In more severe epilepsy, however, a combination of two or more medications may be necessary to control seizures.
Trileptal is used to treat adults and children aged 6 and over.
If you have any questions about how Trileptal works or why this medicine has been prescribed for you, talk to your doctor.
The oxcarbazepine contained in Trileptal may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Trileptal
Follow all the doctor’s instructions carefully, even if they differ from the general information in this leaflet.
Checks during treatment with Trileptal
Before and during treatment with Trileptal, the doctor may take a blood sample to determine your dose. The doctor will tell you when to take the samples.
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.
Talk to your doctor before taking Trileptal if this applies to you. Consult your doctor if you think you may be allergic.
Warnings and precautions
Talk to your doctor or pharmacist before taking Trileptal:
- if you have previously shown signs of hypersensitivity (got a rash or other signs of allergy ) to the substance carbamazepine or other medicines. For people who are hypersensitive to carbamazepine, the risk is that about one in four patients (25%) will also have an allergic reaction to oxcarbazepine (Trileptal).
- if you have kidney disease.
- if you have severe liver disease.
- if you are taking diuretics (medicines that help the kidneys get rid of salt and water by increasing the amount of urine).
- if you have heart disease, are troubled by shortness of breath, or if your feet or legs are swollen because the body retains water.
- if blood tests have shown that the amount of sodium in the blood is too low (see section 4 Possible side effects ).
- if you are a woman and take hormonal contraceptives (e.g. birth control pills ). Trileptal may cause your birth control to not work. Use another or a complementary (non-hormonal) method of contraception while taking Trileptal to prevent unwanted pregnancy. Contact your doctor immediately if you experience irregular bleeding or breakthrough bleeding. Ask your doctor or another healthcare professional if you have any questions about this.
The risk of serious skin reactions in patients of Han Chinese or Thai origin associated with carbamazepine or chemically related substances can be determined by a blood test in these patients. Doctors should be able to tell you if a blood test is necessary before you start taking oxcarbazepine.
Contact your doctor immediately or go to the emergency department of the nearest hospital if you develop any of the following symptoms after starting to take Trileptal:
- if you have an allergic reaction after starting to take Trileptal. Symptoms include swollen lips, eyelids, face, throat, mouth or sudden trouble breathing, fever and swollen lymph nodes, and rash or blistering of the skin.
- if you get symptoms of liver disease, such as jaundice (yellowing of the skin or the whites of the eyes).
- if you have an increased frequency of attacks. This is especially important in children, but can also occur in adults.
- if you get probable symptoms of blood disorders, e.g. if you suffer from fatigue, become short of breath with light exertion, look pale, get headaches, chills, dizziness, repeated infections with fever, sore throat, mouth ulcers, bleed or bruise more easily than usual, nosebleeds, reddish or red-violet marks on the skin or unexplained patchy rashes.
- a small number of people treated with anti-epileptic drugs such as Trileptal have also had thoughts of harming themselves or committing suicide. If you ever have these thoughts, contact your doctor immediately.
- if you have a fast or unusually slow heartbeat.
Children and young people
The doctor may recommend checks of thyroid function before and during treatment in children.
Other medicines and Trileptal
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This applies in particular to:
- Hormonal contraceptives, eg birth control pills (see Warnings and precautions).
- Other antiepileptic or enzyme-inducing drugs, eg carbamazepine, phenobarbital, phenytoin or lamotrigine, and rifampicin.
- Medicines that lower the amount of sodium in the blood, eg diuretics (help the kidneys get rid of salt and water by increasing the amount of urine), desmopressin, and non-steroidal anti-inflammatory medicines, eg indomethacin.
- Lithium and MAO inhibitors (medications for mood swings and some forms of depression).
- Medicines that inhibit the body’s immune system, eg ciclosporin, and tacrolimus.
Trileptal with food and drink
Trileptal can be taken with or without food.
Alcohol can increase the sedative effect of Trileptal. Therefore, avoid alcohol as much as possible and consult your doctor if necessary.
Pregnancy, breastfeeding, and fertility
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 using this medicine.
Epileptic seizures must be kept under control during pregnancy. If you take anti-epileptic drugs during pregnancy, however, it may pose a risk to the baby. Your doctor will tell you about the benefits of the treatment and any risks and help you decide whether to take Trileptal.
Do not stop treatment with Trileptal during pregnancy without first discussing it with your doctor.
Breast-feeding
You should not breastfeed while taking Trileptal. Trileptal’s active substance passes into breast milk and can cause side effects in children who are breastfed. Consult a doctor or pharmacist before taking this medicine while breastfeeding.
Driving ability and use of machinery
Trileptal may make you sleepy or dizzy. It may also cause blurred vision, double vision, lack of muscle coordination, or reduced level of consciousness, especially at the beginning of treatment or when the dose is increased.
You must discuss with your doctor whether you can drive or operate machinery while taking this medicine.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
How to take Trileptal
Always take this medicine as directed by your doctor or pharmacist, even if they differ from the information provided in this leaflet. Ask your doctor or pharmacist if you are unsure.
How much to take
Dosage for adults
- The usual starting dose of Trileptal for adults (including elderly patients) is 600 mg daily.
- Take one 300 mg tablet twice daily or two 150 mg tablets twice daily.
- Your doctor may gradually increase this dosage to find the best dose for you. The maintenance dose is usually between 600 and 2,400 mg per day.
- Dosage one is the same if you take other antiepileptic drugs.
- If you have kidney disease (reduced kidney function), the starting dose is half of the usual starting dose.
- If you have severe liver disease, your doctor may adjust the dosage.
Dosage for children
Trileptal can be taken by children from the age of 6.
The dose for children depends on the child’s body weight.
- The starting dose is 8 to 10 milligrams per kilogram of body weight per day divided into two doses. For example, the treatment of a 30 kg child starts with one 150 mg tablet twice a day.
- The doctor can gradually increase this dosage to find the best dose for your child. The maintenance dose is usually 30 milligrams per kilogram of body weight per day. The maximum dose for children is 46 milligrams per kilogram of body weight per day.
How to take Trileptal
- Swallow the tablets with a little water.
- The tablets can be split to make them easier to swallow. Do not split the tablets to take only half the dose. The notch is only for you to be able to divide the tablet if you have difficulty swallowing it whole.
- For small children who cannot swallow tablets or those who cannot be given the necessary dose in tablet form, Trileptal is also available as an oral suspension.
When and for how long should you take Trileptal
Take Trileptal twice a day at about the same time every day, unless your doctor tells you otherwise. The best effect against epilepsy is then achieved. It also makes it easier for you to remember when to take your medicine.
Your doctor will tell you how long you or your child will be treated with Trileptal. The length of treatment depends on the type of seizure you or your child has. It may be necessary to treat for many years to keep seizures under control. You should not change the dose or stop the treatment without talking to your doctor.
If you have taken too much Trileptal
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, immediately contact a doctor or hospital for an assessment of the risk and advice. In case of overdose with Trileptal, signs such as:
- sleepiness (drowsiness), dizziness, problems with coordination and/or involuntary eye movements, muscle twitching or significant worsening of seizures, headache, loss of consciousness, coma
- nausea, vomiting, increase in uncontrolled movements
- lethargy, double vision, reduction of the pupils, blurred vision
- fatigue
- short and shallow breathing ( respiratory depression )
- irregular heart rhythm (prolonged QTc interval )
- tremors; headache; coma; decreased level of consciousness; uncontrollable movements of the mouth, tongue, arms, and legs
- aggression, anxiety, confusion
- low blood pressure
- shortness of breath
If you forget to take Trileptal
If you have forgotten to take a dose, take it as soon as you remember. However, if it is time for the next dose, do not take the one you forgot. Continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.
Contact your doctor if you are unsure or have forgotten to take several doses.
If you stop taking Trileptal
Never stop taking your medicine yourself, unless your doctor has told you to stop.
To prevent a sudden worsening of your seizure pattern, you must never stop the medication suddenly.
If treatment is to be discontinued, it should be done gradually as directed by your doctor.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor immediately or visit the emergency department of the nearest hospital if you experience any of the following side effects:
The following signs may be serious side effects that may require immediate medical treatment. The doctor will then also decide whether the treatment with Trileptal must be stopped immediately and what the continued medical treatment should look like.
Uncommon (may affect up to 1 in 100 users):
- Weight gain, fatigue, hair loss, muscle weakness, feeling frozen (signs of hypothyroidism).
- Case
Rare (may affect up to 1 in 1,000 users):
- Swelling of the lips, eyelids, face, throat, or mouth, together with difficulty in breathing, speaking or swallowing (signs of so-called anaphylactic reaction and angioedema ).
- Skin rash and/or fever may be symptoms of DRESS (drug-related rash with eosinophilia and systemic symptoms) or AGEP ( acute generalized exanthematous pustulosis ).
- Tiredness, shortness of breath with light exertion, paleness, headache, chills, dizziness, repeated infections with fever, sore throat, mouth sores, bleeding or bruising that occurs more easily than usual, nosebleeds, reddish or purple-red marks on the skin, or unexplained patchy skin rash (signs of a decrease in the number of platelets or decrease in the number of blood cells ).
- Lethargy, confusion, muscle twitching, or significant worsening of seizures (these symptoms may be signs of low sodium in the blood due to SIADH-like conditions, i.e. increased fluid in the body) (See Warnings and Precautions).
Very rare (may affect up to 1 in 10,000 users):
- Signs of hypersensitivity reaction, e.g. rash, fever, and muscle and joint pain.
- Severe blistering of the skin and/or mucous membranes on and around the lips, eyes, mouth, nostrils, and genitals (signs of a severe allergic reaction including Lyell’s syndrome, Stevens-Johnson syndrome, and erythema multiforme).
- Red, patchy rashes, mainly on the face, may appear at the same time as fatigue, fever, nausea, or loss of appetite (signs of systemic lupus erythematosus).
- Flu-like symptoms with jaundice (yellowing of the skin or the whites of the eyes) (a sign of liver disease).
- Severe pain in the upper stomach area, vomiting, loss of appetite (signs of pancreatitis).
Contact a doctor as soon as possible if you experience any of the following side effects. Medical treatment may be necessary:
Common (may affect up to 1 in 10 users):
- tremors, impaired muscle coordination, involuntary eye movements, anxiety or nervousness, low mood, mood swings, rash.
Very rare (may affect up to 1 in 10,000 users):
- irregular heartbeat or a very fast or slow heartbeat.
Other side effects that may occur:
These are usually mild to moderate side effects of Trileptal. Most are transient and usually subside with time.
Very common (may affect more than 1 in 10 users):
- fatigue, headache, dizziness, drowsiness, nausea, vomiting, and double vision.
Common (may affect up to 1 in 10 users):
- weakness, memory disturbances, difficulty concentrating, indifference, agitation, confusion, blurred vision, visual disturbances, constipation, diarrhea, abdominal pain, acne, hair loss, balance disorder, weight gain, and speech difficulties.
Uncommon (may affect up to 1 in 100 users):
- high blood pressure, hives.
- you may also have elevated levels of liver enzymes while taking Trileptal.
Rare (may affect up to 1 in 1,000 users):
- there have been reports of bone diseases, eg reduced bone density in the skeleton, osteoporosis, and bone fractures. Contact a doctor or pharmacist if you are being treated with epilepsy medication for a long time, if you know you have osteoporosis or if you are taking steroids.
How to store Trileptal
- Keep this medicine out of the sight and reach of children.
- Use before the expiry date which is stated on the printed packaging and the outer carton after EXP. The expiration date is the last day of the specified month.
- Do not use this medicine if the package is damaged or shows signs of having been opened.
- Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is oxcarbazepine.
Trileptal 150 mg film-coated tablets
Each film-coated tablet contains 150 mg of oxcarbazepine.
Trileptal 300 mg film-coated tablets
Each film-coated tablet contains 300 mg of oxcarbazepine.
Trileptal 600 mg film-coated tablets
Each film-coated tablet contains 600 mg of oxcarbazepine.
Other ingredients are:
Tablet core: colloidal anhydrous silica, microcrystalline cellulose, hypromellose, crospovidone, magnesium stearate.
Tablet case:
- 150 mg tablet: hypromellose, macrogol 4000, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172), talc, titanium dioxide (E 171);
- 300 mg tablet: hypromellose, macrogol 8000, yellow iron oxide (E 172), talc, titanium dioxide (E 171);
- 600 mg tablet: hypromellose, macrogol 4000, red iron oxide (E 172), black iron oxide (E 172), talc, titanium dioxide (E 171).
Appearance and package sizes of the medicine
Trileptal 150 mg film-coated tablets are light green-grey, oval with a score on both sides, marked T/D on one side and C/G on the other.
Trileptal 300 mg film-coated tablets are yellow, and oval scored on both sides, marked TE/TE on one side, and CG/CG on the other.
Trileptal 600 mg film-coated tablets are light pink, oval with a score on both sides, marked with TF/TF on one side and CG/CG on the other.
Trileptal film-coated tablets are supplied in pressure packs of 30, 50, 100, 200, and 500 tablets.