OXCARBAZEPINE NORMON 600 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Oxcarbazepine NORMON 600 mg film-coated tablets EFG

Oxcarbazepine

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any of the side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Contents of the pack:

1. What Oxcarbazepine NORMON is and what it is used for
2. Before taking Oxcarbazepine NORMON
3. How to take Oxcarbazepine NORMON
4. Possible side effects
5. Storing Oxcarbazepine NORMON
6. Further information

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

Oxcarbazepine NORMON belongs to a group of medicines called anticonvulsants or antiepileptics. Antiepileptics, such as Oxcarbazepine NORMON, are the standard treatment for epilepsy.

Patients diagnosed with epilepsy have suffered repeated seizures or convulsions. Seizures occur due to a temporary failure in the brain's electrical system. Normally, brain cells coordinate body movements by sending signals through muscle nerves in an orderly organized manner. The result can be uncoordinated muscle activity known as an epileptic seizure.

Oxcarbazepine NORMON works by keeping the brain's overexcited nerve cells under control, thereby suppressing or reducing the frequency of such seizures.

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

Normally, the doctor will try to find the medicine that works best for you, but in severe cases of epilepsy, you may need a combination of two or more medicines to control the seizures.

Oxcarbazepine NORMON can be used alone or in combination with other antiepileptics. Oxcarbazepine NORMON is indicated for use in adults and children aged 6 years or older.

2. Before taking Oxcarbazepine NORMON

Follow your doctor's instructions carefully, even if they differ from those stated in this leaflet.

Do not take Oxcarbazepine NORMON if:

You are allergic (hypersensitive) to the active substance (oxcarbazepine) or to any of the other ingredients of this medicine (see section 6 "Further information")

Be cautious with Oxcarbazepine NORMON

Tell your doctor immediately if you have irregular vaginal bleeding or spotting. If you have any doubts about this, consult your doctor before taking this medicine.

If you have any of the conditions described above, inform your doctor before taking Oxcarbazepine NORMON.

A small number of people who have been treated with antiepileptics like Oxcarbazepine NORMON have had thoughts of self-harm or suicide. If you ever have these thoughts, contact your doctor immediately

The risk of severe skin reactions in patients of Chinese Han or Thai origin associated with carbamazepine or related chemical compounds can be predicted by analyzing a blood sample from these patients. Your doctor will advise you if a blood test is necessary before taking oxcarbazepine.

Taking other medicines:

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Especially in the case of:

• oral contraceptives ("the pill") (see section "Be cautious with Oxcarbazepine NORMON").
• other antiepileptic medicines (such as carbamazepine, phenobarbital, phenytoin, or lamotrigine)
• medicines that reduce blood sodium levels, 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 some types of depression).
• medicines that control your body's immune system (such as cyclosporine, tacrolimus).

Taking Oxcarbazepine NORMON with food and drinks

Oxcarbazepine NORMON can be taken with or without food. During treatment with oxcarbazepine, avoid drinking alcoholic beverages, as they may increase the sedative effects of this medicine.

Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

It is essential 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 administered during pregnancy; however, it cannot be entirely ruled out that there is a risk of congenital malformations in the fetus.

Neurodevelopmental disorders

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

Birth weight

If you use Oxcarbazepine NORMON during pregnancy, your child may be small and weigh less than expected at birth [small size for gestational age (SGA)]. Among women with epilepsy, in one study, around 15 out of 100 children born to mothers who had taken oxcarbazepine during pregnancy were smaller and weighed less than expected at birth, compared to around 11 out of 100 children born to women who had not taken anticonvulsant medication during pregnancy.

Your doctor will inform you of the benefits and possible risks of treatment and help you decide whether you should take Oxcarbazepine NORMON.

Do not stop your treatment with Oxcarbazepine NORMON without consulting your doctor.

Consult your doctor or pharmacist before using any medicine.

Breastfeeding

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

Driving and using machines

Oxcarbazepine may cause symptoms such as drowsiness, dizziness, or changes in vision, and may reduce your reaction ability. These effects, as well as the disease itself, may make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor assesses your response to this medicine.

Oxcarbazepine NORMON contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially "sodium-free".

3. How to take Oxcarbazepine NORMON

Follow your doctor's instructions for taking this medicine exactly, even if they differ from those stated in this leaflet.

How much to take

Always take Oxcarbazepine NORMON exactly as your doctor has told you. Consult your doctor or pharmacist if you have any doubts.

Dosage for adults

Oxcarbazepine NORMON should be taken twice a day, every day, and approximately at the same time, unless your doctor tells you otherwise. The best way to control epilepsy is to take the tablets at the same time every day. This will also help you remember when to take the tablets.

Generally, the initial dose of Oxcarbazepine NORMON in adults (including the elderly) is 600 mg per day. Take a dose of 300 mg twice a day. If necessary, your doctor may gradually increase this dose until the desired results are achieved. This usually occurs at doses between 600 and 2,400 mg per day.

The dose is the same if Oxcarbazepine NORMON is taken with another antiepileptic medicine.

The initial dose for patients with kidney disease (renal insufficiency) is half the normal initial dose.

If you have severe liver disease, your doctor will adjust the dose

Dosage for children

Oxcarbazepine NORMON can be used in children aged 6 years or older.

The dose for children is calculated based on their weight. The initial dose is 8-10 mg/kg of body weight per day, administered in two doses. For example, a 30 kg child will start treatment with a dose of 150 mg twice a day. If necessary, the dose will be gradually increased until the desired results are achieved. A normal maintenance dose for a child is 30 mg/kg per day. The maximum dose for a child is 46 mg per kg of body weight per day.

Method of administration

The tablets can be swallowed with a little water.

If necessary, the tablets can be broken in half to facilitate administration. The score line of Oxcarbazepine NORMON allows the tablet to be divided into two equal doses.

For small children who cannot swallow tablets or for whom the prescribed dose is not available in tablet form, other pharmaceutical forms (oral suspension) containing oxcarbazepine are available.

Oxcarbazepine NORMON can be taken with or without food.

Frequency of administration and duration of treatment

Your doctor will inform you how long your treatment or your child's treatment will last. The duration of treatment is based on the type of seizures you or your child suffer from and may require continuous treatment for several years to control epileptic seizures. Do not change the dose or stop treatment without talking to your doctor first.

If you take more Oxcarbazepine NORMON than you should:

If you have taken many more tablets than your doctor prescribed, tell your doctor or go to the nearest hospital.

In case of overdose, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken. The symptoms of overdose: drowsiness, dizziness, nausea, vomiting, increased motor activity, numbness, confusion, muscle contractions, or significant worsening of seizures, coordination problems and/or involuntary eye movements.

If you forget to take Oxcarbazepine NORMON:

If you have missed a single dose, take it as soon as you can, except if it is almost time for the next dose; in this case, wait and return to your usual administration schedule. Do not take a double dose to make up for missed doses.

If you are unsure or have missed several doses, inform your doctor.

If you stop taking Oxcarbazepine NORMON:

Do not stop taking your medicine without consulting your doctor first.

To prevent a sudden worsening of seizures, do not stop treatment abruptly.

If you stop your treatment, it should be done gradually, as your doctor has indicated.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Oxcarbazepine NORMON can cause side effects, although not everyone gets them.

Some effects can be serious:

Tell your doctor immediately or go to the emergency department of the nearest hospital if you experience any of the following side effects:

• Inflammation of the lips, eyelids, face, neck, or mouth, accompanied by difficulty breathing, speaking, or swallowing (signs of anaphylactic reactions and angioedema) or other signs of allergic reactions such as skin rash, fever, and joint pain.
• Severe blisters on the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages, or genitals (signs of severe allergic reaction, including Lyell's syndrome, Stevens-Johnson syndrome, and erythema multiforme).
• Fatigue, shortness of breath when exercising, paleness, headache, chills, dizziness, frequent infections with fever, sore throat, mouth ulcers, bleeding or bruising more frequently than usual, nosebleeds, red or purple spots, or spontaneous appearance of spots on the skin (sign of decreased platelet count or decreased white blood cell count).
• Rash with red spots mainly on the face, which may be accompanied by fatigue, fever, nausea, loss of appetite (sign of systemic lupus erythematosus).
• Numbness, confusion, muscle contractions, or significant worsening of seizures (symptom that may be associated with low sodium levels in the blood) (see section "Be cautious with Oxcarbazepine NORMON").
• Flu-like symptoms with yellowing of the skin (signs of hepatitis).
• Severe upper abdominal pain, vomiting, loss of appetite (signs of pancreatitis).

The above symptoms are very rare (may affect less than 1 in 10,000 patients), but potentially serious and may require urgent medical attention. Your doctor will decide whether to stop treatment with Oxcarbazepine NORMON immediately and how to continue your treatment in the future.

If you experience any of the following side effects, consult your doctor as soon as possible, as they may require medical attention.

Frequent (may affect between 1 and 10 in 100 people): tremor, coordination problems, involuntary eye movements, feeling of anxiety and nervousness, feeling of depression, skin rash.

Very rare (may affect less than 1 in 10,000 people): irregular heartbeat or very fast or slow heartbeat.

Tell your doctor if you experience or are concerned about any of the following side effects:

Very frequent (may affect more than 1 in 10 people): fatigue, headache, dizziness, drowsiness, nausea, vomiting, and double vision.

Frequent (may affect between 1 and 10 in 100 people): weakness, memory disorders, difficulty concentrating, apathy, agitation, confusion, blurred vision, constipation, diarrhea, abdominal pain, acne, hair loss, vertigo.

Uncommon (may affect between 1 and 10 in 1,000 people): hives. You may also experience increased liver enzymes while taking Oxcarbazepine NORMON.

Frequency not known (cannot be estimated from available data): hypertension.

These are mild to moderate side effects of Oxcarbazepine NORMON. Most of these effects are temporary and usually decrease over time.

Bone disorders, including osteopenia and osteoporosis (decalcification of bones) and fractures, have been reported. Consult your doctor or pharmacist if you are on long-term treatment with antiepileptics, have a history of osteoporosis, or take steroids.

If you think any of the side effects you are experiencing is serious or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

5. Storage of Oxcarbazepina NORMON

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Oxcarbazepina NORMON after the expiration date stated on the packaging after CAD. The expiration date is the last day of the indicated month.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Oxcarbazepina NORMON

The active ingredient is oxcarbazepine. Each tablet contains 600 mg of oxcarbazepine.

The other components (excipients) are: microcrystalline cellulose, crospovidone, hypromellose, sodium lauryl sulfate, colloidal silica, magnesium stearate, macrogol 6000, titanium dioxide (E-171), talc, and red iron oxide (E-172).

Appearance of the product and packaging content

Oxcarbazepina NORMON 600 mg are pink, elongated, scored, and serigraphed tablets presented in packages of 100 and 500 tablets. The tablet has a score line to allow fractioning and facilitate swallowing, and also allows the tablet to be divided into two equal doses.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

OTHER PRESENTATIONS

Oxcarbazepina NORMON 300 mg film-coated tablets EFG

This leaflet was revised in July 2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/