Oxcarbazepine Normon 300 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Oxcarbazepine NORMON 300 mg film-coated tablets EFG

Oxcarbazepine

Read the entire leaflet carefully before you start taking this medicine.

• 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 and you should not give it to other people, even if they have the same symptoms, as it may harm them.

• If you consider any of the side effects you experience to be severe or if you notice

Contents of the leaflet:

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. How to store 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. Antiepileptic medicines, such as Oxcarbazepine NORMON, are the standard treatment for epilepsy.

Patients diagnosed with epilepsy have experienced repeated seizures or convulsions. Seizures occur due to a temporary malfunction in the brain's electrical system. Normally, brain cells coordinate body movements by sending signals through nerves to muscles in an orderly fashion. When this process is disrupted, it may result in uncoordinated muscle activity known as an epileptic seizure.

Oxcarbazepine NORMON works by keeping overactive nerve cells in the brain under control, thereby suppressing or reducing the frequency of these seizures.

Oxcarbazepine NORMON is used in the treatment of 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 lead to generalized tonic-clonic seizures. There are two types of partial seizures: simple and complex. In simple partial seizures, the patient remains conscious, whereas in complex partial seizures, consciousness is impaired.

Your doctor will usually try to find the medicine that works best for you. However, in severe forms of epilepsy, treatment with a combination of two or more medicines may be needed to control seizures.

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

2. BEFORE TAKING Oxcarbazepine NORMON

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

Do not take Oxcarbazepine NORMON if:

You are allergic (hypersensitive) to the active substance (oxcarbazepine) or to any of the other components of this medicine (see section 6 “Additional Information”).

Take special care with Oxcarbazepine NORMON

• if you have ever had an unusual allergic reaction (rash or any other type of allergy) to carbamazepine or any other medicine. If you are allergic to carbamazepine, the likelihood that you will also be allergic to oxcarbazepine is 1 in 4 (25%)
• if you have severe kidney disease
• if you are taking diuretics (medicines to eliminate salt and water by increasing urine production)
• if you have heart disease, shortness of breath and/or swelling of feet or legs due to fluid retention
• if you know that your blood sodium level is low (see section 4 “Possible Adverse Effects”)
• if you are a woman taking oral contraceptives ("the pill"), Oxcarbazepine NORMON may render the contraceptive ineffective. Therefore, you should use a different or additional non-hormonal contraceptive method while taking this medicine. This can help prevent an unintended pregnancy.

Immediately inform your doctor if you experience 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.

• if during treatment you experience an allergic reaction, such as swelling of lips, eyelids, face, throat, mouth or sudden breathing problems, fever with swollen lymph nodes, skin rash or blisters; in this case, consult your doctor immediately or go to the nearest hospital (see section 4 "Possible Adverse Effects")
• if you notice that your heart rate is fast or unusually slow, inform your doctor immediately
• if you notice symptoms suggesting hepatitis, such as jaundice (yellowing of the skin or whites of the eyes), inform your doctor immediately
• if you notice symptoms suggesting a blood disorder, such as fatigue, shortness of breath during exercise, paleness, headache, chills, dizziness, frequent infections accompanied by fever, sore throat, mouth ulcers, more frequent than normal bleeding or bruising, nosebleeds, red or purple spots, or spontaneous appearance of skin spots, inform your doctor immediately.

A small number of people treated with antiepileptic medicines such as Oxcarbazepine NORMON have had thoughts of self-harm or suicide. If you have such thoughts at any time, contact your doctor immediately.

The risk of serious skin reactions in patients of Han Chinese 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 whether a blood test is necessary before taking oxcarbazepine.

Taking other medicines:

Inform 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 "Take special care with Oxcarbazepine NORMON")
• other antiepileptic medicines (such as carbamazepine, phenobarbital, phenytoin or lamotrigine)
• medicines that reduce sodium levels in blood, such as diuretics (used to help 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 certain types of depression)
• medicines that control your body's immune system (such as cyclosporine, tacrolimus)

Taking Oxcarbazepine NORMON with food and drinks

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

Pregnancy

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

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.

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.

Birth weight

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

Your doctor will inform you about the benefits and potential risks of treatment and help you decide whether to take Oxcarbazepine NORMON.

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

Consult your doctor or pharmacist before using any medicine.

Breast-feeding

If you are taking this medicine, consult your doctor before starting breast-feeding. The active substance in Oxcarbazepine NORMON passes into breast milk. Although available data suggest that the amount of Oxcarbazepine NORMON 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 breast-feeding while using Oxcarbazepine NORMON. If you are breast-feeding during treatment with Oxcarbazepine NORMON and think your baby is experiencing any adverse 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 visual disturbances, and may reduce reaction ability. These effects, as well as the underlying illness itself, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or perform other activities requiring special attention until your doctor has assessed your response to this medicine.

Oxcarbazepine NORMON contains sodium

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

3. How to TAKE Oxcarbazepine NORMON

Follow exactly the administration instructions for this medicine given by your doctor, even if they differ from those indicated in this leaflet.

How much to take

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

Dosage for adults

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

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

The dosage is the same whether Oxcarbazepine NORMON is taken together 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 your dose.

Dosage for children

Oxcarbazepine NORMON may be used in children aged 6 years and older.

The dose for children is calculated based on body weight. The initial dose is 8–10 mg/kg body weight per day, given in two divided doses. For example, a child weighing 30 kg will start treatment with 150 mg twice daily. If necessary, the dose may be gradually increased until the desired effect is 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 and/or route of administration

The tablets can be swallowed with a little water.

If necessary, the tablets may be split into two halves to facilitate administration. The score line on Oxcarbazepine NORMON allows the tablet to be divided into two equal doses.

For young children who cannot swallow tablets or when the prescribed dose is not available in tablet form, other pharmaceutical formulations (oral suspension) containing oxcarbazepine are available.

Oxcarbazepine NORMON may be taken with or without food.

Frequency of administration and duration of treatment

Your doctor will inform you how long your or your child’s treatment will last. The duration of treatment depends on the type of seizures you or your child experience, and continued treatment for several years may be necessary to control epileptic seizures. Do not change the dose or stop treatment without first discussing it with your doctor.

If you take more Oxcarbazepine NORMON than you should:

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

In case of overdose, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested. Symptoms of overdose include: 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 miss a single dose, take it as soon as possible, unless it is almost time for the next dose; in this case, wait and resume your regular dosing 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 first consulting your doctor.

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

If your treatment is to be discontinued, it should be done gradually as directed by your doctor.

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

4. Possible adverse effects

Like all medicines, Oxcarbazepina NORMON can have adverse effects, although not everyone will experience them.

Some of these effects may be serious:

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

• Swelling 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 rash, fever, and joint pain.
• Severe blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages, or genitals (signs of a severe allergic reaction including Lyell's Syndrome, Stevens-Johnson Syndrome, and erythema multiforme).
• Fatigue, shortness of breath during physical activity, paleness, headache, chills, dizziness, frequent infections accompanied by fever, sore throat, mouth ulcers, more frequent bleeding or bruising than normal, nosebleeds, red or purple spots, or spontaneous appearance of skin spots (signs 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, and loss of appetite (signs of systemic lupus erythematosus).
• Numbness, confusion, muscle twitching, or a significant worsening of seizures (symptoms that may be associated with low blood sodium levels) (see section "Take special care with Oxcarbazepina 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 fewer than 1 in 10,000 patients), but potentially serious and may require urgent medical attention. Your doctor will decide whether treatment with Oxcarbazepina NORMON should be stopped immediately and how your treatment should continue in the future.

If any of the following adverse effects occur, consult your doctor as soon as possible, as they may require medical attention.

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

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

Inform your doctor if you experience or are concerned about any of the following adverse 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 out of 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 out of 1,000 people): urticaria. You may also experience increased liver enzymes while taking Oxcarbazepina NORMON.

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

These are mild to moderate adverse effects of Oxcarbazepina NORMON. Most of these effects are transient and usually decrease over time.

Bone abnormalities have been reported, including osteopenia and osteoporosis (bone demineralization) and fractures. Consult your doctor or pharmacist if you are on long-term antiepileptic treatment, have a history of osteoporosis, or are taking steroids.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Oxcarbazepine NORMON

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Oxcarbazepine NORMON after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Oxcarbazepina NORMON

The active substance is oxcarbazepine. Each tablet contains 300 mg of oxcarbazepine.

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

Appearance of the product and contents of the pack

Oxcarbazepina NORMON 300 mg are yellow, elongated, scored, film-coated tablets available in packs of 100 and 500 tablets. The tablet has a score line to allow splitting and facilitate swallowing, and also enables 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 600 mg film-coated tablets EFG

This leaflet was last reviewed in July 2025

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