Package Insert: Information for the User

Oxcarbazepine TecniGen 600 mg Tablets EFG

Read this package insert carefully before starting to take the medication.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor or pharmacist.

Oxcarbazepina belongs to a group of medications called anticonvulsants or antiepileptics. Antiepileptics, such as oxcarbazepina, are the standard treatment for epilepsy.

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

Oxcarbazepina acts by keeping the brain's "hyperexcited" nerve cells under control, suppressing or reducing the frequency of these seizures.

Oxcarbazepina is used for the treatment of partial seizures with or without secondary generalization with tonic-clonic seizures. Partial seizures involve a limited area of the brain, but can extend 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 partial seizures, the level of consciousness is altered.

Normally, the doctor will try to find the medication that works best for the patient, but in severe epilepsy, the patient may need a combination of two or more medications to control seizures. Oxcarbazepina can be used alone or in combination with other antiepileptics. Oxcarbazepina is indicated for treatment in adults and children aged 6 or more years.

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

Do not take Oxcarbazepina TecniGen:

If you are allergic (hypersensitive) to the active ingredient (oxcarbazepine) or to any of the other components of this medication (see section 6 “Additional information”)

Be especially careful with Oxcarbazepina TecniGen:

• If you have ever suffered an unusual allergic reaction (rash or any other type of allergy) to carbamazepine or to any other medication. If you are allergic to carbamazepine, the chances of being allergic to oxcarbazepine are 1 in 4 (25%)
• If you have a severe kidney disease
• If you are taking diuretics (medications to eliminate salt and water by increasing urine production)
• If you have any 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 side effects”)
• If you are a woman and taking oral contraceptives (“pill”), oxcarbazepine may make the contraceptive ineffective. Therefore, you should use a non-hormonal contraceptive method or an additional method while taking oxcarbazepine. This may help prevent an unwanted pregnancy. Inform your doctor immediately if you have irregular vaginal bleeding or spotting. If you have any doubts about this, consult your doctor before taking oxcarbazepine.

Inform your doctor before taking oxcarbazepine if you have any of the conditions described above.

• If during treatment you suffer an allergic reaction, such as inflammation of lips, eyelids, face, throat, mouth, or sudden respiratory problems, fever with lymph node inflammation, rash, or blisters on the skin; in this case, consult 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 abnormally slow, inform your doctor immediately
• If you notice symptoms that suggest hepatitis, such as jaundice (yellowing of the skin or white of the eyes), inform your doctor immediately
• If you notice symptoms that suggest blood disorders, such as fatigue, shortness of breath during exercise, paleness, headache, chills, dizziness, frequent infections with fever, sore throat, mouth ulcers, bleeding or bruising more frequently than normal, inform 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.

A reduced number of people who were treated with antiepileptic medications like oxcarbazepine have had thoughts of self-harm or suicide. If you have these thoughts at any time, contact your doctor immediately.

Use of other medications:

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

Especially in the case of:

• oral contraceptives (“pill”)
• other antiepileptic medications (such as carbamazepine, phenobarbital, phenytoin, or lamotrigine)
• medications that reduce blood sodium levels, such as diuretics (used to help the kidneys eliminate salt and water, increasing urine production), desmopressin, and nonsteroidal anti-inflammatory drugs (such as indomethacin)
• lithium and monoamine oxidase inhibitors (medications used to treat mood disorders and some types of depression)
• Medications that control your body's immune system (such as cyclosporine, tacrolimus)

Use of Oxcarbazepina TecniGen with food and drinks:

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

Pregnancy:

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

It is essential to control seizures during pregnancy.However, there may be a risk to your baby if you take antiepileptic medications during pregnancy.

Birth defects

Studies have not shown an increased risk of birth defects associated

with oxcarbazepine administered during pregnancy, however, it cannot be completely ruled

out a risk of birth defects in the fetus.

Neurological development disorders

Some studies have shown that exposure to oxcarbazepine in the womb affects

negatively 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 of the benefits and potential risks of treatment and help you decide if you should take oxcarbazepine. Do not stop taking oxcarbazepine without consulting your doctor.

Consult your doctor or pharmacist before taking a medication during pregnancy.

Breastfeeding:

If you are taking this medication, consult your doctor before starting breastfeeding. The active ingredient of 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 an adverse effect, such as excessive sleepiness or poor weight gain, inform your doctor immediately.

Driving and operating machinery:

Oxcarbazepine may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may decrease your reaction time. These effects, as well as the underlying disease, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention until your doctor assesses your response to this medication.

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

Use in adults

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

The initial dose of Oxcarbazepina TecniGen in adults (including the elderly) is generally 600 mg per day. Take a dose of 300 mg twice a day. If necessary, your doctor may increase this dose gradually to achieve the desired results. This usually occurs at doses between 600 and 2,400 mg per day.

The dose is the same if Oxcarbazepina TecniGen is taken with another antiepileptic medication.

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.

Use in children

Oxcarbazepina TecniGen can be used in children aged 6 years or older.

The dose for children is calculated based on 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 increased gradually to achieve the desired results. A typical 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 Oxcarbazepina TecniGen

The groove in the Oxcarbazepina 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 oxcarbazepina are available. Oxcarbazepina TecniGen can be taken with or without food.

When and for how long to take Oxcarbazepina 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 experience and may require continued treatment for several years to control seizures. Do not change the dose or interrupt treatment without first discussing it with your doctor.

If you take more Oxcarbazepina 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 Oxcarbazepina TecniGen

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

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

If you interrupt treatment with Oxcarbazepina TecniGen

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

To prevent a sudden worsening of seizures, do not interrupt treatment abruptly. If treatment is interrupted, it should be done gradually as instructed by your doctor.

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

Like all medications, oxcarbazepine may have side effects, although not everyone experiences them.

Some side effects can be severe:

Inform your doctor immediately or visit the nearest hospital emergency department if you experience any of the following side effects:

• Lip, eyelid, face, neck, or mouth inflammation, accompanied by difficulty breathing, speaking, or swallowing (signs of anaphylactic and angioedema reactions) or other allergy symptoms 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 severe allergic reactions including Stevens-Johnson syndrome, Lyell syndrome, and erythema multiforme).
• Extreme fatigue, shortness of breath during exercise, paleness, headache, chills, dizziness, frequent infections with fever, sore throat, mouth ulcers, frequent bleeding or bruising, 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 that may be accompanied by fatigue, fever, nausea, loss of appetite (signs of systemic lupus erythematosus).
• Numbness, confusion, muscle contractions, or significant worsening of seizures (symptoms that may be associated with low blood sodium levels)(See “Be especially careful with Oxcarbazepine TecniGen”).
• Symptoms similar to the flu with yellow discoloration of the skin (signs of hepatitis).
• Severe upper abdominal pain, loss of appetite (signs of pancreatitis).

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

The above symptoms are rare (less than 1 in 10,000 patients), but potentially severe and may require urgent medical attention. Your doctor will decide whether to immediately discontinue oxcarbazepine treatment 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 1-10 in 100 people): tremors, coordination problems, involuntary eye movements, anxiety and nervousness, depression, skin rash.

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

Inform your doctor if you experience any of the following side effects:

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

Frequent (affecting 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.

Rare (affecting more than 1 in 1,000 people and less than 1 in 100): urticaria. Oxcarbazepine may also increase liver enzymes.

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

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

If any adverse reaction worsens or if any other reaction not described in this prospectus is observed, consult your doctor or pharmacist.

Keep out of reach and sight of children.

Do not use Oxcarbazepina TecniGen after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use Oxcarbazepina TecniGen if the packaging is damaged or shows signs of manipulation.

Medicines should not be thrown into the drains or trash. Dispose of the packaging and medicines that you do not need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you do not need. In this way, you will help protect the environment.

Oxcarbazepina TecniGen 600 mg Composition:

The active ingredient of Oxcarbazepina TecniGen is oxcarbazepina.

Each tablet contains 600 mg of oxcarbazepina.

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

Product appearance and packaging content

Oblong tablets, bright pink in color, and with a notch on one face.

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 responsible 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

Responsible manufacturer:

Atlantic Pharma – Produções Farmacêuticas SA

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

O

Medinfar Manufacturing, S.A.

Parque Industrial Armando Martins Tavares

Rua Outeiro Da Armada, nº 5.

Condeixa-a-Nova, 3150-194. Portugal

This leaflet was revised in June 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/