Oxcarbazepine Viatris 300 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Oxcarbazepine Viatris 300 mg film-coated tablets EFG

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 must not be given to other people, even if they have the same symptoms as you, because it could be harmful to them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet contents

1. What Oxcarbazepine Viatris is and what it is used for

2. What you need to know before taking Oxcarbazepine Viatris

3. How to take Oxcarbazepine Viatris

4. Possible side effects

5. How to store Oxcarbazepine Viatris

6. Contents of the pack and other information

1. What Oxcarbazepina Viatris is and what it is used for

Oxcarbazepina Viatris contains the active substance oxcarbazepine. Oxcarbazepina Viatris belongs to a group of medicines called anticonvulsants or antiepileptics, which are used to treat epilepsy.

Oxcarbazepine is used to help control seizures or epileptic fits in patients with epilepsy. People with epilepsy are prone to episodes of uncontrolled electrical activity in the brain. These episodes of uncontrolled electrical activity may lead to epileptic seizures. Oxcarbazepine helps control the brain's electrical activity, thereby reducing the likelihood of having epileptic seizures.

Oxcarbazepine is used to treat partial seizures, with or without secondary generalization into tonic-clonic seizures. Partial seizures affect a limited area of the brain but may spread throughout the brain and may lead to a generalized tonic-clonic seizure. There are two types of partial seizures: simple and complex. In simple partial seizures, the patient remains conscious, whereas in complex partial seizures, the patient's consciousness is impaired.

Oxcarbazepine is used in adults and children aged 6 years and older. Usually, your doctor will try to find a single medicine that works best for you or your child. However, in more severe forms of epilepsy, it may be necessary to combine two or more medicines to control epileptic seizures.

Oxcarbazepina Viatris may be used either as monotherapy or in combination with other antiepileptic medicines.

2. What you need to know before starting Oxcarbazepine Viatris

Carefully follow all instructions given by your doctor, even if they differ from those indicated in this leaflet.

Do not take Oxcarbazepine Viatris:

• If you are allergic to oxcarbazepine, eslicarbazepine, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting Oxcarbazepine Viatris:

• If you are allergic (for example, if you have ever developed rashes or other allergic reactions) to carbamazepine, a similar anticonvulsant, as there is a one in four chance (25%) that you may also be allergic to oxcarbazepine.
• If you have liver problems or they develop during treatment (see “Possible side effects”).
• If you have kidney problems, especially conditions associated with low levels of sodium (salt) in the blood. Oxcarbazepine may decrease sodium levels in the blood, which can lead to symptoms related to sodium deficiency (see “Possible side effects”). If you have a kidney disorder, your doctor should perform a blood test before starting treatment with oxcarbazepine and at regular intervals thereafter.
• If you are taking other medicines that may reduce sodium levels in the blood (e.g., diuretics, desmopressin, or non-steroidal anti-inflammatory drugs (NSAIDs) such as indomethacin or ibuprofen). See below “Taking Oxcarbazepine Viatris with other medicines”.
• If you have heart problems, for example, heart failure (difficulty breathing or swollen ankles). Your doctor should monitor your weight regularly to detect possible fluid retention.
• If you have a heart rhythm disorder.
• If you are taking hormonal contraceptives (see below “Taking Oxcarbazepine Viatris with other medicines”).

During treatment

Talk to your doctor if you notice possible signs of blood disorders such as fatigue, shortness of breath during exercise, paleness, headache, chills, dizziness, 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.

A number of patients treated with antiepileptic medicines such as oxcarbazepine have experienced thoughts of self-harm or suicide. If you experience any of these symptoms at any time, contact your doctor immediately.

Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of oxcarbazepine, initially appearing as reddish spots or circular lesions, often with central blisters on the trunk.

Other signs to watch for include mouth, throat, nose, or genital ulcers, and conjunctivitis (red and swollen eyes). These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to blistering or peeling of the skin.

The highest risk of developing serious skin reactions occurs during the first weeks of treatment. The risk of these reactions is higher in patients of Han Chinese, Thai, or other Asian ancestry (see below, “Patients of Han Chinese or Thai origin”).

If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis while taking oxcarbazepine, you must never be treated with oxcarbazepine again.

If you develop a rash or these skin symptoms, consult a doctor immediately and inform them that you are taking this medicine.

This medicine may cause a condition called hypothyroidism (low levels of thyroid hormone). In children, the doctor may perform blood tests at regular intervals after starting treatment with oxcarbazepine.

If you experience an increase in the frequency of epileptic seizures, talk to your doctor to determine whether treatment with oxcarbazepine should be discontinued. This is particularly important in children, although it may also occur in adults.

Before and during treatment with oxcarbazepine, your doctor may perform blood tests to determine the appropriate dose for you. Your doctor will inform you when to have these tests done.

Patients of Han Chinese or Thai origin

In patients of Han Chinese or Thai origin, the risk of serious skin reactions associated with carbamazepine or chemically related compounds should be assessed by analyzing a blood sample from these patients. Your doctor will advise whether a blood test is necessary before starting oxcarbazepine. If you are of another Asian origin (e.g., Filipino or Malay), your doctor may also consider it necessary to perform a blood test before starting treatment.

Children and adolescents

In children, the doctor may recommend monitoring thyroid function before and during treatment.

Taking Oxcarbazepine Viatris with other medicines

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines, especially any of the following medicines, as they may interact with oxcarbazepine:

-Other anticonvulsants such as phenobarbital, phenytoin, carbamazepine, lamotrigine, and valproic acid. Your doctor will need to adjust the dose of these medications when taken concomitantly with oxcarbazepine. There is an increased risk of adverse effects such as nausea, somnolence, dizziness, and headache if administered together with lamotrigine.

-Hormonal contraceptives (for example, "the pill"). Oxcarbazepine may reduce the effectiveness of these contraceptives. Another reliable method of contraception must be used.

-Medications for treating mental illnesses such as lithium and MAOIs (Monoamine Oxidase Inhibitors), like phenelzine and moclobemide. The combination of lithium and oxcarbazepine may cause an increase in adverse effects.

-Medicines that may decrease blood sodium levels (e.g., diuretics, desmopressin, and non-steroidal anti-inflammatory drugs such as indomethacin and ibuprofen). Treatment with oxcarbazepine may reduce blood sodium levels, which may lead to symptoms related to sodium deficiency (see “Possible side effects”). Your doctor should perform blood tests before starting treatment with oxcarbazepine and at regular intervals once treatment has begun.

-Medicines used to control the body's immune system (immunosuppressants) such as cyclosporine, tacrolimus.

• Rifampicin (an antibiotic used to treat bacterial infections).

Taking Oxcarbazepine Viatris with alcohol

Caution is advised if consuming alcohol during treatment with oxcarbazepine, as it may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Oxcarbazepine affects the effectiveness of hormonal contraceptives and there is a risk of pregnancy. You should use alternative contraceptive methods if you are of childbearing age.

Controlling epileptic seizures during pregnancy is important. However, taking antiepileptic medicines during pregnancy may be harmful to fetal development.

Congenital malformations

Studies have not shown an increased risk of congenital malformations associated with oxcarbazepine administered 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, whereas other studies have not observed this effect. The possibility of an effect on neurological development cannot be excluded.

Your doctor will inform you about the benefits and potential risks of using oxcarbazepine and help you decide whether oxcarbazepine should be taken. Do not stop your oxcarbazepine treatment during pregnancy without first consulting your doctor.

Breastfeeding

If you are taking this medicine, consult your doctor before starting breastfeeding. The active substance oxcarbazepine passes into breast milk. Although available data suggest that the amount of oxcarbazepine transferred 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 oxcarbazepine. If you are breastfeeding during treatment with oxcarbazepine and think your baby may be experiencing any adverse effects such as excessive sleepiness or poor weight gain, inform your doctor immediately.

Driving and use of machines

Oxcarbazepine has a moderate effect on the ability to drive and operate machinery. You should be aware that oxcarbazepine may cause adverse effects such as dizziness, drowsiness, problems with balance or coordination, visual disturbances such as double or blurred vision, and low blood sodium levels which may cause muscle weakness or reduced level of consciousness, especially when starting treatment or increasing the dose. These effects may impair your ability to drive or operate machinery. Do not drive or operate tools or machines if you experience any of these reactions.

Oxcarbazepine Viatris contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Oxcarbazepine Viatris

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist.

When the required dose cannot be administered using whole tablets, other presentations containing oxcarbazepine are available.

Your doctor will likely start your treatment with a low dose and, if necessary, gradually increase it to meet your individual needs. The recommended doses are as follows:

Adults

The initial dose is 300 mg twice daily. If needed, your doctor may slowly increase the dose weekly up to a maximum of 600 mg per day. The maintenance dose ranges from 600 mg to 2,400 mg daily.

If you are taking other anticonvulsant medicines, your doctor may need to reduce their doses or increase the dose of oxcarbazepine more slowly.

When replacing other anticonvulsant medicines with oxcarbazepine, their doses should be gradually reduced.

Use in children and adolescents aged 6 years and older

The initial dose is 8–10 mg/kg body weight per day, divided into two daily doses. If necessary, your doctor may increase the daily dose by 10 mg/kg body weight at approximately weekly intervals, up to a maximum daily dose of 46 mg/kg body weight.

The usual maintenance dose, when used in combination with other anticonvulsant medicines, is 30 mg/kg per day.

For children who cannot swallow tablets or when the required dose cannot be administered using tablets, other pharmaceutical forms containing oxcarbazepine are available.

Use in children under 6 years of age

Oxcarbazepine is not recommended for patients under 6 years of age, as safety and efficacy have not been adequately established.

Patients with kidney problems

If you have kidney problems, your doctor may start treatment with half the usual initial dose and increase the oxcarbazepine dose more slowly than described above.

Patients with severe liver problems

If you have severe liver problems, your doctor may adjust your dose. Always follow your doctor’s instructions.

When the required dose cannot be administered using tablets, other pharmaceutical forms containing oxcarbazepine are available.

Method of administration

Swallow the coated tablets with a glass of water, with or without food. Do not crush or chew them. The score line is intended only to facilitate tablet splitting if you have difficulty swallowing the tablet whole, but it does not allow division into equal doses.

If you take more Oxcarbazepine Viatris than you should

If you have taken more Oxcarbazepine Viatris than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 915620420. Inform them of the medicine taken and the amount ingested. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional. Symptoms of overdose may include low blood sodium levels, anger, agitation, confusion, drowsiness, dizziness, nausea, vomiting, fatigue, changes in heart rhythm (irregular and rapid heartbeat), tremors, epileptic seizures or convulsions, headache, coma, loss of consciousness, palpitations, uncontrolled jerking movements, double or blurred vision, pupil constriction, low blood pressure, breathing difficulties, abnormal levels of muscular or body activity, lack of coordination, and uncontrolled eye movements.

If you forget to take Oxcarbazepine Viatris

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Oxcarbazepine Viatris

Do not stop treatment with oxcarbazepine suddenly without consulting your doctor, as this may trigger epileptic seizures and/or convulsions. If treatment needs to be discontinued, it should be done gradually, following your doctor’s instructions.

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.

Contact your doctor or go to the nearest hospital emergency department immediately if you experience any of the following serious adverse effects, as they may require medical treatment:

Uncommon (may affect up to 1 in 100 people):

• Increased number of infections causing fever, severe chills, sore throat, or mouth ulcers (could be a sign of reduced white blood cell count).
• Weight gain, tiredness, hair loss, muscle weakness, feeling cold (signs of underactive thyroid gland).
• Falls.

Rare (may affect up to 1 in 1,000 people):

• Swelling of the face, lips, eyelids, tongue, throat, or mouth; difficulty speaking or swallowing; and sudden signs of hives associated with breathing difficulties, shortness of breath, or wheezing (signs of angioedema and anaphylactic reactions).
• Skin rash and/or fever, which may be manifestations of drug reaction with eosinophilia and systemic symptoms (DRESS) or acute generalized exanthematous pustulosis (AGEP).
• Tiredness, breathlessness during exertion, paleness, headache, dizziness, frequent infections with fever, more frequent bleeding or bruising than normal, nosebleeds, reddish or purplish spots, or spontaneous appearance of skin spots (signs of reduced platelet count or decreased number of blood cells).
• Lethargy, confusion, muscle pain, or significant worsening of seizures (these may be symptoms of low sodium levels due to inappropriate ADH secretion) (see section “Warnings and precautions”).

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

• Potentially life-threatening skin rashes, such as blisters on the skin or mucous membranes of the lips, eyes, mouth, nasal passages, or genitals, and skin peeling over a large part of the body (signs of severe allergic reaction, including Lyell syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2, “Warnings and precautions”).
• Irregular red (moist) spots causing itching, similar to measles rash, starting on the limbs and sometimes on the face and other parts of the body. The spots may develop into blisters or progress into raised, red lesions with pale centers. Affected individuals may experience fever, sore throat, headache, and/or diarrhea (erythema multiforme).

If these skin reactions occur during treatment with oxcarbazepine, you must stop taking oxcarbazepine. Your doctor may decide to discontinue oxcarbazepine treatment.

• Hypersensitivity reactions that may also affect other parts of the body and may cause problems in the lungs (such as difficulty breathing or coughing, possibly accompanied by mucus or blood), kidneys (difficulty urinating or blood in the urine), or liver (signs of liver problems are described below; however, these may also lead to brain inflammation, causing changes in thinking or behavior, or drowsiness). Other possible effects include: blood changes (described separately in this leaflet), enlargement of the spleen (causing swelling, pain, or tenderness in the abdomen), or swollen and painful lymph nodes in the neck, armpits, or groin.
• Skin rash, mainly on the face, possibly accompanied by fatigue, fever, dizziness (nausea), or loss of appetite (systemic lupus erythematosus).
• Bleeding or bruising more easily than normal (thrombocytopenia).
• Signs of liver inflammation (nausea, vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin or whites of the eyes (jaundice), pale stools, dark urine). Liver function should be monitored.
• Pancreatitis (inflammation of the pancreas), including the following signs: severe pain in the upper abdomen spreading to the back, often accompanied by nausea or vomiting.
• Heart disorder that may cause unsteadiness, fainting, and irregular heartbeat (atrioventricular block).

Inform your doctor as soon as possible if you experience any of the following adverse effects, as you may need medical attention:

Frequent (may affect up to 1 in 10 people):

• Tremors; coordination problems; involuntary eye movements; anxiety and nervousness; depression; mood changes; skin rash.

Rare (may affect up to 1 in 10,000 people):

• Irregular heartbeat or a very fast or slow heart rate.

Other adverse effects that may occur:

These are usually mild or moderate adverse effects of oxcarbazepine. Most of these effects are transient and tend to decrease over time.

Very frequent (may affect more than 1 in 10 people):

• Tiredness, headache, dizziness, fatigue or drowsiness, malaise (nausea), stomach discomfort (vomiting), double vision.

Frequent (may affect up to 1 in 10 people):

• Feeling of weakness; memory loss or disturbances; difficulty concentrating; lack of emotion or motivation (apathy); agitation or other mood changes; confusion; blurred vision; diarrhea or constipation, stomach (abdominal) pain; acne, hair loss, loss of coordination; weight gain, speech disorder.

Uncommon (may affect up to 1 in 100 people):

• High blood pressure; hives.
• You may also have elevated liver enzyme levels while taking oxcarbazepine.

Rare (may affect up to 1 in 1,000 people):

• Bone disorders have been reported, including osteopenia and osteoporosis (bone weakening) and fractures. Consult your doctor or pharmacist if you have been taking antiepileptic medicines for a long time, have a history of osteoporosis, or are taking steroids.

Reporting of adverse effects

If you experience any type of adverse effect, talk to 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Oxcarbazepine Viatris

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the container, blister pack, or cardboard box. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to 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 Oxcarbazepine Viatris

• The active substance is oxcarbazepine. Each film-coated tablet contains 300 mg of oxcarbazepine.
• The other components (excipients) are:

Tablet core: crospovidone, hypromellose, microcrystalline cellulose, anhydrous colloidal silica, and magnesium stearate.

Tablet coating: black iron oxide (E-172), red iron oxide (E-172), yellow iron oxide (E-172), hypromellose, monohydrate lactose (see section 2 “Oxcarbazepine Viatris contains lactose”), macrogol 4000, and titanium dioxide (E-171).

Nature of the product and pack size

Oxcarbazepine Viatris is available as film-coated, oval-shaped tablets, beige in colour, with a notch on each side. The notch is intended only to assist in breaking the tablet if you have difficulty swallowing it whole and does not allow for division into equal doses.

The 300 mg film-coated tablets are marked with “OX/300” on one side and “G/G” on the other.

Oxcarbazepine Viatris is available in plastic containers containing 100, 200 and 500 tablets, and in blister packs containing 10, 20, 30, 50, 60, 100 and 200 tablets.

Only certain pack sizes may be marketed.

Oxcarbazepine Viatris is available as 300 mg and 600 mg film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer:

McDermott Laboratories Ltd. T/A Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland

or

Mylan B.V.
Krijgsman 20
1186 DM Amstelveen
The Netherlands

or

Mylan Hungary Kft.
Mylan utca 1
Komárom, 2900
Hungary

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Oxcarbazepin dura 300 mg Filmtabletten
Belgium: Oxcarbazepine Mylan 300 mg filmomhulde tabletten
Denmark: Oxcarbazepin Mylan 300 mg filmovertrukne tabletter
Slovenia: KARBOX 300 mg filmsko obložene tablete
Spain: Oxcarbazepina Viatris 300 mg comprimidos recubiertos con película EFG
France: OXCARBAZEPINE MYLAN 300 mg, comprimé pelliculé
The Netherlands: Oxcarbazepine Mylan 300 mg, filmomhulde tabletten
Poland: Karbagen, 300 mg, tabletki powlekane
United Kingdom: Oxcarbazepine Mylan 300 mg film-coated tablets

Date of the most recent review of this leaflet: August 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) https://www.aemps.gob.es/