Oxcarbazepine Tecnigen 600 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Oxcarbazepine TecniGen 600 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 and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you think any of the side effects you experience is serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

What this leaflet contains

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

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

Oxcarbazepine belongs to a group of medicines called anticonvulsants or antiepileptics. Antiepileptic medicines, such as oxcarbazepine, 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 works by keeping the "hyperexcitable" nerve cells in the brain under control, thereby suppressing or reducing the frequency of such seizures.

Oxcarbazepine is used in the treatment of partial seizures, with or without secondary generalization to 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 may require a combination of two or more medicines to control seizures effectively. Oxcarbazepine may be used alone or in combination with other antiepileptic medicines. Oxcarbazepine is indicated for treatment in adults and children aged 6 years and older.

2. BEFORE TAKING OXCARBAZEPINE TECNIGEN

Carefully follow all instructions given by your doctor, even if they differ from those indicated 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”).

Take special care with Oxcarbazepine TecniGen:

• if you have ever had an unusual allergic reaction (rash or any other type of allergy) to carbamazepine or to 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 that help the kidneys eliminate salt and water by increasing urine production)
• if you have heart disease, shortness of breath and/or swelling of the feet or legs due to fluid retention
• if you know that your blood sodium level is low (see section 4 “Possible side effects”)
• if you are a woman taking oral contraceptives (“the pill”), oxcarbazepine may render the contraceptive ineffective. Therefore, you should use a different or additional non-hormonal contraceptive method while taking oxcarbazepine. This can help prevent an unintended pregnancy. Inform your doctor immediately if you experience irregular vaginal bleeding or spotting. If you have any doubts about this, consult your doctor before taking oxcarbazepine.

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

• if during treatment you experience an allergic reaction, such as swelling of the lips, eyelids, face, throat, or mouth, sudden breathing problems, fever with swollen lymph nodes, skin rash or blisters; in this case, contact your doctor immediately or go to the nearest hospital (see section 4 “Possible side 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 with fever, sore throat, mouth ulcers, more frequent bleeding or bruising than normal, nosebleeds, red or purple spots, or spontaneous appearance of skin spots, inform 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 starting oxcarbazepine.

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

Taking other medicines:

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

Particularly in the case of:

• oral contraceptives (“the pill”)
• other antiepileptic medicines (such as carbamazepine, phenobarbital, phenytoin, or lamotrigine)
• medicines that reduce sodium levels in the blood, 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 certain types of depression)
• medicines that control your body’s immune system (such as cyclosporine, tacrolimus).

Taking Oxcarbazepine TecniGen with food and drink:

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

Pregnancy:

Inform your doctor if you are pregnant or planning 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, while other studies have not observed this effect. The possibility of an effect on neurological development cannot be excluded.

Birth weight

If you use Oxcarbazepine TecniGen 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 took oxcarbazepine during pregnancy were smaller and weighed less than expected at birth, compared with approximately 11 out of every 100 children born to women who did not take anticonvulsant medication during pregnancy.

Your doctor will inform you about 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.

Breast-feeding:

If you are taking this medicine, consult your doctor before starting breast-feeding. The active substance of 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 benefits and potential risks of breast-feeding while taking oxcarbazepine. If you are breast-feeding during treatment with oxcarbazepine 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.

3. HOW TO TAKE OXCARBAZEPINE TECNIGEN

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

Use in adults

Oxcarbazepine TecniGen should be taken twice daily, every day, and approximately at the same time, unless your doctor advises 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 them.

The usual initial dose of Oxcarbazepine TecniGen 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 to achieve the desired effect. This usually occurs at doses between 600 and 2,400 mg per day.

The dose is the same whether Oxcarbazepine TecniGen is taken together with another antiepileptic medicine.

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

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

Use in children

Oxcarbazepine TecniGen 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 a dose of 150 mg twice daily. If necessary, the dose may be gradually increased to achieve the desired effect. A normal maintenance dose for a child is 30 mg/kg per day. The maximum dose for a child is 46 mg per kg body weight per day.

How to take Oxcarbazepine TecniGen

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

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

When and for how long to take Oxcarbazepine TecniGen

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 TecniGen than you should

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

Symptoms of overdose: drowsiness, dizziness, nausea, vomiting, increased motor activity, numbness, confusion, muscle twitching, significant worsening of seizures, coordination problems, and/or involuntary eye movements.

If you forget to take Oxcarbazepine TecniGen

If you miss a single dose, take it as soon as you remember, 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 a missed dose.

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

If you stop taking Oxcarbazepine TecniGen

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

To prevent a sudden worsening of seizures, do not stop treatment abruptly. If 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, oxcarbazepine may cause adverse effects, although not everyone experiences them.

Some of these effects may be serious:

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

• 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 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 syndrome, Stevens-Johnson syndrome, and erythema multiforme).
• Fatigue, shortness of breath during physical activity, paleness, headache, chills, dizziness, frequent infections with fever, sore throat, mouth ulcers, more frequent bleeding or bruising than normal, nosebleeds, reddish or purplish spots, or spontaneous appearance of skin spots (signs of reduced platelet count or reduced white blood cell count).
• Skin rash with red spots, mainly on the face, possibly accompanied by fatigue, fever, nausea, and loss of appetite (signs of systemic lupus erythematosus).
• Numbness, confusion, muscle twitching, or significant worsening of seizures (symptoms that may be associated with low blood sodium levels) (See “Take special care with Oxcarbazepina TecniGen”).
• Flu-like symptoms with yellowing of the skin (signs of hepatitis).
• Severe upper abdominal pain, loss of appetite (signs of pancreatitis).

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

The above symptoms are very rare (occurring in fewer than 1 in 10,000 patients), but potentially serious and may require urgent medical attention. Your doctor will decide whether you should immediately stop treatment with oxcarbazepine and how to proceed with your treatment 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 every 100 people): tremor, coordination problems, involuntary eye movements, feelings of anxiety and nervousness, feelings of depression, skin rash.

Very rare (may affect fewer than 1 in every 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 common (affecting more than 1 in every 10 people): fatigue, headache, dizziness, drowsiness, nausea, vomiting, and double vision.

Common (affecting more than 1 in every 100 people and fewer than 1 in every 10): weakness, memory impairment, difficulty concentrating, apathy, agitation, confusion, blurred vision, constipation, diarrhea, abdominal pain, acne, hair loss, vertigo.

Uncommon (affecting more than 1 in every 1,000 people and fewer than 1 in every 100): urticaria (hives). You may also experience increased liver enzymes while taking oxcarbazepine.

Not known (frequency cannot be estimated from available data): hypertension.

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

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

5. Storage of OXCARBAZEPINE PREMIUM PHRMA

Keep out of the reach and sight of children.

Do not use Oxcarbazepine TecniGen after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their packaging should be returned to the SIGRE collection point at your pharmacy. If 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 Oxcarbazepine TecniGen 600 mg:

The active substance in Oxcarbazepine TecniGen is oxcarbazepine.

Each tablet contains 600 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 contents of the container

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

The tablet can be divided into equal halves.

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 has been 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 Medical Devices (AEMPS): http://www.aemps.es/