OXCARBAZEPINE TECNIGEN 300 mg TABLETS

Introduction

Package Leaflet: Information for the User

Oxcarbazepine TecniGen 300 mg tablets EFG

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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack

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

1. What is OXCARBAZEPINE TECNIGEN and what is it used for

Oxcarbazepine belongs to a group of medicines called anticonvulsants or antiepileptics. Antiepileptics, such as oxcarbazepine, 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 acts by keeping the brain's overexcited nerve cells under control, thus suppressing or reducing the frequency of such seizures.

Oxcarbazepine 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 produce 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 epilepsy, you may need a combination of two or more medicines to control the seizures. Oxcarbazepine can be used alone or in combination with other antiepileptics. Oxcarbazepine is indicated for the treatment of adults and children aged 6 years or older.

2. BEFORE TAKING OXCARBAZEPINE TECNIGEN

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

Do not take Oxcarbazepine TecniGen:

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

Be especially careful with Oxcarbazepine TecniGen:

see section 4 "Possible side effects")

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

see section 4 "Possible side effects")

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.

A small number of people who have been treated with antiepileptics such as oxcarbazepine have had thoughts of self-harm or suicide. If at any time you have these thoughts, contact your doctor immediately.

Taking other medicines:

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

Especially in the case of:

• oral contraceptives ("the pill")
• other antiepileptic medicines (such as carbamazepine, phenobarbital, phenytoin, or lamotrigine)
• medicines that lower sodium levels in the blood, such as diuretics (used to help the kidneys eliminate salt and water, 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 the immune system in your body (such as cyclosporine, tacrolimus)

Taking Oxcarbazepine TecniGen with food and drink:

During treatment with oxcarbazepine, avoid taking alcoholic beverages, as it may increase the sedative effects of the medicine.

Pregnancy:

Inform 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. Your doctor will inform you of the benefits and potential risks of treatment and help you decide whether you should take oxcarbazepine. Do not stop your treatment with oxcarbazepine without consulting your doctor.

Consult your doctor or pharmacist before taking any medicine during pregnancy.

Congenital malformations

Studies have not shown an increased risk of congenital malformations associated with oxcarbazepine administered during pregnancy; however, it cannot be completely ruled out that there is a risk of congenital malformations in the fetus.

Neurological development disorders

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

Birth weight

If you use Oxcarbazepine TecniGen during pregnancy, your child may have a low birth weight 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.

Breast-feeding:

If you are taking this medicine, consult your doctor before breast-feeding. The active substance of oxcarbazepine passes into breast milk. Although the available data suggest that the amount of oxcarbazepine 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 breast-feeding while using oxcarbazepine. If you are breast-feeding during treatment with oxcarbazepine 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 decrease your reaction time. 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.

3. HOW TO TAKE OXCARBAZEPINE TECNIGEN

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

Use in adults

Oxcarbazepine TecniGen 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 TecniGen 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 to achieve the desired results. This usually occurs at doses between 600 and 2400 mg per day.

The dose is the same if Oxcarbazepine TecniGen 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.

Use in children

Oxcarbazepine TecniGen 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 child weighing 30 kg will start treatment with a dose of 150 mg twice a day. If necessary, the dose will be gradually increased to achieve the desired results. 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.

How to take Oxcarbazepine TecniGen

The score line on the Oxcarbazepine TecniGen tablets allows the tablet to be divided into two equal doses, making it easier for the patient to swallow the tablets.

For children who cannot swallow the tablets or when the required dose cannot be administered using tablets, other pharmaceutical forms containing oxcarbazepine are available. Oxcarbazepine TecniGen can be taken with or without food.

When and for how long to take Oxcarbazepine TecniGen

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 the epileptic seizures. Do not change the dose or stop treatment without consulting your doctor.

If you take more Oxcarbazepine TecniGen than you should

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

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 TecniGen

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 regular dosing schedule. Do not take a double dose to make up for the missed doses.

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

If you stop taking Oxcarbazepine TecniGen

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 other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, oxcarbazepine 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:

• 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 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 reactions, including Lyell 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 normal, nosebleeds, red or purple spots, or spontaneous appearance of spots on the skin (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, loss of appetite (sign of systemic lupus erythematosus).
• Numbness, confusion, muscle contractions, or significant worsening of seizures (symptoms that may be associated with low sodium levels in the blood) (See "Be especially careful with Oxcarbazepine TecniGen").
• Symptoms similar to flu with yellowing of the skin (signs of hepatitis).
• Severe abdominal pain, loss of appetite (signs of pancreatitis).

Bone disorders, including osteopenia and osteoporosis (decalcification of bones) and fractures, have been reported. Consult your doctor or pharmacist if you are undergoing prolonged treatment with antiepileptics, have a history of osteoporosis, or are taking steroids.

The above symptoms are very rare (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 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 1 to 10 out of 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 (more than 1 in 10 people): fatigue, headache, dizziness, drowsiness, nausea, vomiting, and double vision.

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

Uncommon (more than 1 in 1000 people and less than 1 in 100): hives. Oxcarbazepine may also increase your liver enzymes.

Unknown (the exact frequency cannot be estimated from the available data): hypertension.

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

If any adverse reaction worsens or if you notice any other reaction not described in this leaflet, consult your doctor or pharmacist.

5. Storing OXCARBAZEPINE TECNIGEN

Keep out of the reach and sight of children.

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

Do not use Oxcarbazepine TecniGen if the packaging is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Oxcarbazepina TecniGen 300 mg:

The active ingredient of Oxcarbazepina TecniGen is oxcarbazepine.

Each tablet contains 300 mg of oxcarbazepine.

The other components are: Microcrystalline cellulose, hydroxypropylcellulose, sodium croscarmellose, magnesium stearate, colloidal silicon dioxide, yellow iron oxide, and red iron oxide.

Appearance of the product and packaging content

Oblong tablets, bright pink in color and with a score line on one side.

The tablet can be divided into two equal halves.

The tablets are available in blister packs containing 100 or 500 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) SPAIN

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas SA

Rua da Tapada Grande nº 2, Abrunheira. 2710 – 089 Sintra (Portugal).

or

Medinfar Manufacturing, S.A.

Parque Industrial Armando Martins Tavares

Rua Outeiro Da Armada, nº 5.

Condeixa-a-Nova, 3150-194. Portugal

This leaflet was last 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.es/