Prospect: information for the patient

Oxcarbazepine Viatris 300 mg film-coated tablets EFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

6.Contents of the pack and additional information

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

Oxcarbazepina is used to help control seizures or epileptic crises in patients with epilepsy. People with epilepsy are prone to experiencing periods of uncontrolled electrical activity in the brain. These periods of uncontrolled electrical activity can cause epileptic crises. Oxcarbazepina helps control brain electrical activity. In this way, the chances of experiencing epileptic crises are reduced.

Oxcarbazepina is used to treat partial seizures with or without secondary generalized tonic-clonic seizures. Partial seizures affect a limited area of the brain, but can spread throughout the brain and cause a generalized tonic-clonic seizure. There are two types of partial seizures: simple and complex. In simple partial seizures, the patient remains conscious, while in complex partial seizures, the patient's consciousness is altered.

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

Oxcarbazepina Viatris can be used as a single medicine or in combination with other antiepileptic medicines.

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

Do not take Oxcarbazepina Viatris:

• If you are allergic to oxcarbazepine, eslicarbazepine, or any of the other components of this medication (including those listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Oxcarbazepina Viatris:

• If you areallergic(for example, have ever developed skin eruptions or other allergic reactions) to carbamazepine, a similar anticonvulsant, as there is a possibility of 1 in 4 (25%) that you may also be allergic to oxcarbazepine.
• If you have liver abnormalities or develop them during treatment (see “Adverse reactions”).
• Ifyou have kidney problems, especially those associated with low sodium levels in the blood.Oxcarbazepine may decrease sodium levels in the blood, which can cause symptoms related to sodium deficiency (see “Adverse reactions”). If you have a kidney disorder, your doctor will need to perform a blood test before starting treatment with oxcarbazepine and at regular intervals once started.
• If you are taking other medications that may reduce sodium levels in the blood (for example, diuretics, desmopressin, or nonsteroidal anti-inflammatory drugs (NSAIDs) such as indomethacin or ibuprofen). See below “Taking Oxcarbazepina Viatris with other medications”.
• If you have heart problems, for example, heart failure (difficulty breathing or swollen ankles). Your doctor will need to monitor your weight regularly to determine any possible fluid retention.
• If you have a heart rhythm disorder.
• If you are taking hormonal contraceptives (see below “Taking Oxcarbazepina Viatris with other medications”).

During treatment

Talk to your doctor if you notice possible symptoms of blood abnormalities such as fatigue, shortness of breath when exercising, paleness, headache, chills, dizziness, frequent infections with fever, sore throat, mouth ulcers, bleeding or bruising more frequently than normal, nosebleeds, red or purple spots, or the appearance of spontaneous skin spots.

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

There have been reports of potentially fatal skin eruptions (Stevens-Johnson syndrome, toxic epidermal necrolysis) with the use of oxcarbazepine, appearing initially as red or circular spots, often with central blisters on the trunk.

Other signs to be aware of include mouth, throat, nose, genital, and conjunctivitis (red and swollen eyes). These skin eruptions, potentially fatal, are often accompanied by flu-like symptoms. The eruption may progress to the formation of blisters or skin peeling.

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

If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of oxcarbazepine, you should not be treated with oxcarbazepine at any time.

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

This medication may cause a condition called hypothyroidism (low thyroid hormone levels). In children, your doctor may analyze your blood at regular intervals after starting treatment with oxcarbazepine.

If you experience an increase in seizure frequency, talk to your doctor to decide whether to discontinue treatment with oxcarbazepina. This is especially important in children, although it can also occur in adults.

Your doctor may perform blood tests before and during treatment with oxcarbazepine to determine the appropriate dose for you.Your doctor will inform you when to have the blood tests.

Patients of Chinese Han or Thai origin

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

Children and adolescents

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

Taking Oxcarbazepina Viatris with other medications

Inform your doctor if you are taking, have taken recently, or may need to take any other medication, especially any of the following medications, 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 together with oxcarbazepine. There is a higher risk of adverse effects such as nausea, drowsiness, dizziness, and headache if taken together with lamotrigine.

-Hormonal contraceptives (for example, “the pill”). Oxcarbazepine may reduce the proper functioning of these hormonal contraceptives. Another reliable contraceptive method should be used.

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

-Medications that may reduce sodium levels in the blood (for example, diuretics, desmopressin, and nonsteroidal anti-inflammatory drugs (NSAIDs) such as indomethacin and ibuprofen). Oxcarbazepine treatment may reduce sodium levels in the blood, which can cause symptoms related to sodium deficiency (see “Adverse reactions”). Your doctor will need to perform blood tests before starting treatment with oxcarbazepine and at regular intervals once started.

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

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

Taking Oxcarbazepina Viatris with alcohol

Care should be taken if alcohol is consumed during treatment with oxcarbazepine, as it may cause drowsiness.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Oxcarbazepine affects the functioning of hormonal contraceptives and there is a risk of pregnancy. You should use other reliable contraceptive methods if you are fertile.

It is essential to control seizures during pregnancy. However, taking antiepileptic medications during pregnancy can be hazardous to fetal development.

Birth defects

Studies have not shown an increased risk of birth defects associated with oxcarbazepine administered during pregnancy, however, it cannot be ruled out that there may be a risk of birth defects in the fetus.

Neurological developmental disorders

Some studies have shown that exposure to oxcarbazepine in the womb affects the development of brain function (neurological development) in children, while in other studies, this effect has not been observed. The possibility of an effect on neurological development cannot be ruled out.

Your doctor will inform you about the benefits and possible risks of using oxcarbazepine and help you decide whether to take oxcarbazepine. Do not discontinue your treatment with oxcarbazepine during pregnancy without consulting your doctor first.

Lactation

If you are taking this medication, consult your doctor before starting breastfeeding. The active ingredient oxcarbazepine passes into breast milk. Although available data suggest that the amount of oxcarbazepine that passes to the breastfeeding infant is low, a risk of adverse effects in the infant cannot be ruled out. Your doctor will inform you of the benefits and potential risks of breastfeeding while using oxcarbazepine. If you are breastfeeding during treatment with oxcarbazepine and believe your baby is experiencing any adverse effects such as excessive sleepiness or failure to gain weight, inform your doctor immediately.

Driving and operating machinery

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, balance and coordination problems, eye problems such as double vision or blurred vision, low sodium levels in the blood that may cause muscle weakness, reduced level of consciousness, especially when starting treatment or increasing the dose, which may affect your ability to drive or operate machinery.Do not drive or operate tools or machinery if you experience any of these reactions.

Oxcarbazepina Viatriscontains lactose

This medication contains lactose. If your doctor has indicated that you have anintolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor.In case of doubt,consult your doctor or pharmacist.

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

Your doctor will probably start your treatment with a small dose and, if necessary, will gradually increase it to adapt to your needs. The recommended doses are as follows:

Adults

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

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

When replacing other anticonvulsant medications with oxcarbazepine, your doses should be gradually reduced.

Use in children and adolescents from 6 years old

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

The maintenance dose,combined with other anticonvulsant medications, is normally 30 mg/kg per day.

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

Use in children under 6 years old

Oxcarbazepine is not recommended in patients under 6 years old, as safety and efficacy have not been adequately demonstrated.

Patients with kidney problems

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

Patients with severe liver problems

If you have severe liver problems,your doctor may modify the amount you should take. Always follow your doctor's instructions.

If 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 wateraccompanied by food or not.Do not crush or chewthem. The grooveserves onlyto break the tablet if it is difficult to swallow it whole, but it cannot be divided into equal doses.

If you take more Oxcarbazepine Viatris than you should

If you have taken more Oxcarbazepine Viatristhan you should, consult your doctor or pharmacist immediately or call the toxicology information service, phone 915620420, indicating the medication and the amount taken, and it is recommended to bring the packaging and the medication leaflet to the healthcare professional. The symptoms of overdose arelow sodium levels in the blood, anger, agitation, feeling of confusion, drowsiness, dizziness, nausea (nausea), discomfort (vomiting), fatigue, changes in heart rhythm (irregular and rapid heartbeat), tremors, seizures or convulsions, headache, coma, loss of consciousness, palpitations or uncontrolled jerks, double or blurred vision, pupil constriction, low blood pressure, difficulty breathing, abnormal degree of muscular or bodily activity, lack of coordination in movements, and uncontrolled eye movements.

If you forgot to take Oxcarbazepine Viatris

Take the dose as soon as you remember. However, if it is almost time to take your next dose, do not take the missed dose and take your next dose as prescribed. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Oxcarbazepine Viatris

You should not stop treatment with oxcarbazepine suddenly without consulting your doctor, as it may cause the onset of a seizure or convulsion. If you interrupt treatment, you should do it progressively following your doctor's instructions.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Go to your doctor or go to the nearest hospital emergency department if you experience any of these severe side effects, which may require medical treatment:

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

• Increased risk of infections that can cause fever, intense chills, sore throat, or mouth ulcers (may be a sign that the number of white blood cells has decreased).
• Weight gain, fatigue, hair loss, muscle weakness, feeling cold (signs of low thyroid activity).
• Falls.

Uncommon(may affect up to 1 in 1,000 people)

• Swelling of the face, lips, eyelids, tongue, throat, or mouth, difficulty speaking, swallowing, and sudden signs of urticaria associated with respiratory difficulties, shortness of breath, wheezing (signs of angioedema and anaphylactic reactions).
• Skin rash and/or fever that may be manifestations of drug-induced rash with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).
• Fatigue, shortness of breath during exercise, pallor, headache, dizziness, frequent infections accompanied by fever, bleeding or bruising more frequently than normal, nosebleeds, red or purple spots, or spontaneous appearance of skin spots (signs of a decrease in platelet count or a decrease in blood cell count).
• Lethargy, confusion, muscle pain, or significant worsening of seizures (these may be symptoms of low sodium levels due to inadequate ADH secretion) (see "Warnings and precautions" section).

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

• Potentially fatal skin eruptions, such as blisters on the skin or mucous membranes of the lips, eyes, mouth, nasal passages, or genitals, and widespread skin peeling (signs of severe allergic reaction, including Lyell syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2, "Warnings and precautions").
• Irregular red spots (moist) causing itching, similar to measles rash, that start on the extremities and sometimes on the face and the rest of the body. The spots may turn into blisters or progress to raised, red marks with a pale center. Affected individuals may experience fever, sore throat, headache, and/or diarrhea (erythema multiforme).

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

• Hypersensitivity reactions that can also affect other parts of the body and may cause respiratory problems (such as difficulty breathing or coughing, which may be accompanied by mucus or blood), kidney problems (difficulty urinating or blood in the urine), or liver problems (see below for signs of liver problems, however, these may also lead to brain inflammation, causing changes in your thinking or behavior, or drowsiness). Other effects that may be observed are: changes in blood (described separately in this prospectus), an enlarged spleen (causing inflammation and pain or sensitivity in the abdomen) or painful and swollen lymph nodes in the neck, armpits, or groin.
• Skin rash, primarily on the face, that may be accompanied by fatigue, fever, dizziness, or loss of appetite (systemic lupus erythematosus).
• Bleeding or petechiae more easily than normal (thrombocytopenia).
• Signs of liver inflammation (nausea, vomiting, loss of appetite, general feeling of discomfort, fever, itching, yellowing of the skin or white of the eyes (jaundice), light-colored stools, dark-colored urine). Liver function should be monitored.
• Pancreatitis, which includes the following signs: intense pain in the upper abdomen that radiates to the back, often accompanied by nausea or vomiting.
• Cardiac disorder that may cause instability, fainting, and irregular heart rhythm (atrioventricular block).

Inform your doctor as soon as possible if you experience any of the following side effects,which may require medical attention:

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

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

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

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

Other side effects that may occur:

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

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

• Fatigue, headache, dizziness, feeling of vertigo, exhaustion or drowsiness, feeling unwell (nausea), feeling unwell (vomiting), double vision.

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

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

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

• High blood pressure; urticaria
• You may also have an elevated level of liver enzymes while taking oxcarbazepine.

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

-Bone alterations, including osteopenia and osteoporosis (bone weakening) and fractures. Consult your doctor or pharmacist if you have been taking antiepileptics for a long time, have a history of osteoporosis, or are taking steroids.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not usethis medicationafter the expiration date that appears on the packaging, blisteror in the carton box. The expiration date is the last day of the month indicated.

Do not store at a temperature above30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Oxcarbazepine Viatris Composition

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

Core of the tablets: crospovidone, hypromellose, microcrystalline cellulose, anhydrous colloidal silica, and magnesium stearate.

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

Appearance of the product and contents of the package

Oxcarbazepine Viatris is presented in the form of oblong, beige-colored film-coated tablets with a notch on each side. The notch is only for breaking the tablet if it is difficult to swallow whole and not for dividing it into equal doses.

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

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

Only some package sizes may be marketed.

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

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible 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

Netherlands

or

Mylan Hungary Kft.

Mylan utca 1

Komárom, 2900

Hungary

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area with the following names:

GermanyOxcarbazepin dura 300 mg Filmtabletten

BelgiumOxcarbazepine Mylan 300 mg filmomhulde tabletten

DenmarkOxcarbazepin Mylan 300 mg filmovertrukne tabletter

SloveniaKARBOX 300 mg filmsko obložene tablete

SpainOxcarbazepina Viatris 300 mg comprimidos recubiertos con película EFG

FranceOXCARBAZEPINE MYLAN 300 mg,comprimé pelliculé

NetherlandsOxcarbazepine Mylan 300 mg, filmomhulde tabletten

PolandKarbagen, 300mg, tabletki powlekane

United KingdomOxcarbazepine Mylan 300 mg film-coated tablets

Last review date of this leaflet:October2022

More detailed and up-to-date information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/