Patient leaflet - Oxcarbazepine 300 mg film-coated tablets, Trileptal 300 mg film-coated tablets
1. What Oxcarbazepine is and what it is used for
2. What you need to know before you take Oxcarbazepine 3. How to take Oxcarbazepine
If you have any questions about how Oxcarbazepine works or why this medicine has been prescribed for you, ask your doctor.
- 4. Possible side effects
- 5. How to store Oxcarbazepine
- 6.
2 • For small children who cannot swallow tablets, or who cannot be given the necessary dose in tablet form, Oxcarbazepine is available as an oral suspension.
3. How to take Oxcarbazepine
(used to help the kidneys get rid of salt and water by increasing the amount of urine produced), desmopressin and non-steroidal anti-inflammatory medicines, such as indometacin.
Always take this medicine exactly as your doctor or pharmacist has told you, even if this differs from the information given in this leaflet. Check with your doctor or pharmacist if you are not sure.
- Lithium and monoamine oxidase inhibitors (medicines used to treat mood swings and some types of depression).
If you develop any of the following symptoms after starting Oxcarbazepine, tell your doctor immediately or go to the emergency department at your nearest hospital:
Medicines that control the body’s immune system, such as ciclosporin and tacrolimus.
How much to take
Dose for adults
if you experience an allergic reaction after starting Oxcarbazepine. Symptoms include swelling of lips, eyelids, face, throat, mouth, or sudden breathing problems, fever with swollen glands, rash or skin blistering. • if you notice symptoms of hepatitis, such as jaundice (yellowing of skin or the whites of the eyes).
Oxcarbazepine with food and drink
- The usual starting dose of Oxcarbazepine for adults (including elderly patients) is 600 mg per day.
Oxcarbazepine can be taken with or without food.
- Take one 300 mg tablet twice daily or two 150 mg tablets twice daily. • Your doctor may increase the dose gradually to find the best dose for you. The best results are usually with doses between 600 and 2,400 mg per day. • If you take another antiepileptic medicine, the dose is the same. • If you have kidney disease (with impaired kidney function), the starting dose is half the usual starting dose.
Alcohol may increase the sedative effects of Oxcarbazepine. Avoid alcohol as much as possible and ask your doctor for advice.
if you experience an increase in the frequency of seizures. This is particularly important for children but may also occur in adults. • if you notice possible symptoms of blood disorders such as tiredness, being short of breath when exercising, looking pale, headache, chills, dizziness, frequent infections leading to fever, sore throat, mouth ulcers, bleeding or bruising more easily than normal, nose bleeds, reddish or purplish patches, or unexplained blotches on the skin.
Pregnancy, breast-feeding 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 taking this medicine.
- If you have severe liver disease, your doctor may adjust your dose.
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. Your doctor will tell you the benefits and potential risks involved and help you to decide whether you should take Oxcarbazepine.
Dose for children
Oxcarbazepine can be taken by children aged 6 years or above.
a small number of people being treated with antiepileptics such as Oxcarbazepine have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor. • if you have a fast or unusually slow heart beat.
The dosage for children depends on their weight.
- The starting dose is 8 to 10 milligrams per kilogram of bodyweight per day given in two divided doses. For example, a 30-kg child would start treatment with one 150 mg tablet twice daily.
Do not stop your treatment with Oxcarbazepine during pregnancy without first checking with your doctor.
Children and adolescents
Breast-feeding
- Your doctor may increase the dose gradually to find the best dose for your child. The best results are usually with a dose of 30 milligrams per kilogram of bodyweight per day. The maximum dose for a child is 46 milligrams per kilogram of bodyweight per day.
In children, your doctor may recommend thyroid function monitoring before therapy and during therapy.
You should not breast-feed while taking Oxcarbazepine. The active substance in Oxcarbazepine passes into breast milk. This could cause side effects for breast-fed babies. Ask your doctor or pharmacist for advice before taking this medicine while you are breast-feeding.
Other medicines and Oxcarbazepine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
How to take Oxcarbazepine
- Swallow the tablets with a little water.
Driving and using machines
This applies especially to:
- If necessary, the tablets can be broken in half to help swallow them. Do not break the tablets to take only half of the dose. The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
Oxcarbazepine may make you feel sleepy or dizzy, or may cause blurred vision, double vision, lack of muscle coordination or a depressed level of consciousness, especially when starting treatment or increasing the dose. It is important to discuss with your doctor whether you can drive a vehicle or operate machines while taking this medicine.
- Hormonal contraceptives, such as the pill (see Warnings and precautions). • Other antiepileptic and enzyme inducing medicines, such as carbamazepine, phenobarbital, phenytoin or lamotrigine and rifampicin. • Medicines that reduce the level of sodium in your blood, such as diuretics
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Oxcarbazepine 300 mg film-coated tablets: Each film-coated tablet contains 300 mg of oxcarbazepine.
- You may also have raised levels of liver enzymes while taking Oxcarbazepine. If you stop taking Oxcarbazepine
- (possible symptoms of low sodium levels in the blood due to inappropriate ADH secretion) (see Warnings and precautions).
Do not stop taking your medicine unless your doctor tells you to. To prevent sudden worsening of your seizures, never discontinue your medicine abruptly.
Very rare (may affect up to 1 in 10,000 people):
- signs of hypersensitivity reactions such as skin rash, fever and pain in the muscles and joints.
When and for how long to take Oxcarbazepine
If your treatment is stopped, it should be done gradually as instructed by your doctor.
Take Oxcarbazepine twice a day, every day, at about the same time of day, unless the doctor tells you otherwise. This will have the best effect on controlling epilepsy. It will also help you to remember when to take the tablet(s).
- Severe blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genitals (signs of serious allergic reaction including Lyell’s syndrome, Stevens-Johnson syndrome and erythema multiforme). • Red blotchy rash mainly on face which may be accompanied by fatigue, fever, feeling sick (nausea) or loss of appetite (signs of systemic lupus erythematosus).
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Your doctor will tell you how long your or your child’s treatment with Oxcarbazepine will last. The length of treatment will depend on your or your child’s seizure type. Treatment may be needed for many years to control the seizures. Do not change the dose or stop treatment without talking to your doctor.
4. Possible side effects
- Flu-like symptoms with jaundice (yellowing of the skin or the whites of the eyes) (signs of hepatitis).
Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor immediately or go to the emergency department at your nearest hospital if you get any of the following side effects: The following are signs of potentially serious side effects that may require urgent medical treatment. The doctor will also decide whether Oxcarbazepine has to be stopped immediately and how to continue further medical care. Uncommon (may affect up to 1 in 100 people):
- Severe upper stomach (abdominal) pain, being sick (vomiting), loss of appetite (signs of inflammation of the pancreas).
If you take more Oxcarbazepine than you should
If you have taken more tablets than your doctor prescribed, contact the nearest hospital or your doctor immediately. Symptoms of overdose with Oxcarbazepine may include: drowsiness, dizziness, problems with coordination and/or involuntary movement of the eyes, muscular twitching or significant worsening of convulsions, headache, loss of consciousness, coma, • feeling sick (nausea), being sick (vomiting), increased uncontrolled movements, • lethargy, double vision, narrowing of black part of the eye, blurred vision, • tiredness,
Tell your doctor as soon as possible if you get any of the following side effects, they may require medical attention:
Common (may affect up to 1 in 10 people):
- trembling; coordination problems; involuntary movement of the eyes; anxiety and nervousness; depression, mood swing; rash. Very rare (may affect up to 1 in 10,000 people):
Weight gain, tiredness, hair loss, muscle weakness, feeling cold (signs of under active thyroid gland).
- irregular heart beat or a very fast or slow heart rate.
- Fall
short and shallow breathing (respiratory rate depression),
Other side effects that may occur:
Rare (may affect up to 1 in 1,000 people):
irregular heart beat (QTc prolonged interval),
These are usually mild to moderate side effects of Oxcarbazepine. Most of these effects are transient and usually diminish over time. Very common (may affect more than 1 in 10 people):
Swelling of the lips, eyelids, face, throat or mouth, accompanied by difficulty in breathing, speaking or swallowing (signs of anaphylactic reactions and angioedema).
trembling, headache, coma, decreased consciousness, uncontrollable movements of mouth, tongue and limbs,
•
aggression, agitation, confusion,
- tiredness; headache; dizziness; drowsiness; feeling sick (nausea); being sick (vomiting); double vision.
Skin rash and/or fever which may be manifestations of DRESS (Drug Rash with Eosinophilia and Systemic Symptoms), AGEP (Acute Generalized Exanthematous Pustulosis).
•
- low blood pressure,
breathlessness.
Common (may affect up to 1 in 10 people):
- weakness; memory disturbances; impaired concentration; apathy; agitation; confusion; blurred vision; visual disturbance; constipation; diarrhoea; stomach (abdominal) pain; acne; hair loss, balance disturbances; weight increased; speech disorder.
- Tiredness, shortness of breath when exercising, looking pale, headache, chills, dizziness, frequent infections leading to fever, sore throat, mouth ulcers, bleeding or bruising more easily than normal, nose bleeds, reddish or purplish patches, or unexplained blotches on the skin (signs of a decrease in the number of blood platelets or decrease in the number of blood cells). • Lethargy, confusion, muscle twitching or significant worsening of convulsions
If you forget to take Oxcarbazepine
If you have forgotten one dose, take it as soon as you remember. However, if it is time for your next dose, do not take the missed dose. Go back to your regular dosing timetable. Do not take a double dose to make up for a forgotten dose.
Uncommon (may affect up to 1 in 100 people):
If you are unsure or have forgotten to take several doses, contact your doctor.
- High blood pressure; hives.
Rare (may affect up to 1 in 1,000 people):
- there have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures. Check with your doctor or pharmacist if you are on long-term antiepileptic medication, have a history of osteoporosis or take steroids.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see below). By reporting side effects, you can help provide more information on the safety of this medicine.
United Kingdom Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
5. How to store Oxcarbazepine
- Keep this medicine out of the sight and reach of children. • Do not use this medicine after the expiry date which is stated on the blister and the outer carton. The expiry date refers to the last day of that month. • Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
- Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Oxcarbazepine contains
The active substance of Oxcarbazepine is oxcarbazepine.
Oxcarbazepine 150 mg film-coated tablets: Each film-coated tablet contains 150 mg of oxcarbazepine.
Oxcarbazepine 600 mg film-coated tablets: Each film-coated tablet contains 600 mg of oxcarbazepine.
The other ingredients are:
Tablet core: silica colloidal anhydrous, microcrystalline cellulose, hypromellose, crospovidone, magnesium stearate.
Tablet coating:
- 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).
What Oxcarbazepine looks like and contents of the pack
Oxcarbazepine 150 mg film-coated tablets are pale grey green, ovaloid, scored on both sides and embossed with T/D on one side and C/G on the other side.
Oxcarbazepine 300 mg film-coated tablets are yellow, ovaloid, scored on both sides, and embossed with TE/TE on one side and CG/CG on the other side.
Oxcarbazepine 600 mg film-coated tablets are light pink, ovaloid, scored on both sides, and embossed with TF/TF on one side and CG/CG on the other side.
Oxcarbazepine film-coated tablets are available in blister packs of 30, 50, 100, 200 and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Novartis Pharmaceuticals UK Limited,
2nd Floor, The WestWorks Building,
White City Place,
195 Wood Lane,
London,
W12 7FQ
United Kingdom.
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Manufacturer
Novartis Pharmaceuticals UK Limited,
2nd Floor, The WestWorks Building,
White City Place,
195 Wood Lane,
London,
W12 7FQ
United Kingdom.
Novartis Farma S.p.A.
Via Provinciale Schito, 131
80058 Torre Annunziata (NA)
Italy
Distributor
Sandoz Limited
Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom
This leaflet was last revised in 03/2021.
You can get more information about your epilepsy by contacting these independent patient groups:
Telephone
N.S.E. The National Society for Epilepsy 01494 601400 B.E.A. The British Epilepsy Association 0808 8005050 E.A.S The Epilepsy Association of Scotland 0808 8002200
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