OXCARBAZEPINE PENSA 300 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for theuser

Oxcarbazepinethinks300mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Oxcarbazepine Pensa is and what it is used for
2. What you need to know before you take Oxcarbazepina Pensa
3. How to take Oxcarbazepina Pensa
4. Possible side effects
5. Storage of Oxcarbazepina Pensa
6. Contents of the pack and other information

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

What it isOxcarbazepinePensa

The active substance of Oxcarbazepine Pensa is oxcarbazepine.

Oxcarbazepine belongs to a group of medicines called anticonvulsants or antiepileptics.

What it is used forOxcarbazepinePensa

Medicines like 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 is used to treat partial epileptic seizures with or without secondary generalization with tonic-clonic seizures. Partial seizures involve a limited area of the brain but can spread to the entire brain and produce generalized tonic-clonic seizures. There are 2 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.

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

Oxcarbazepine can be used alone or in combination with other antiepileptic medications. Normally, your doctor will try to find the medication that works best for you or your child; however, in severe epilepsy, you may need a combination of two or more medications to control seizures. Oxcarbazepine is indicated for use in adults and children aged 6 years or older.

2. What you need to know before you take Oxcarbazepine Pensa

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

Monitoring during treatment with Oxcarbazepine Pensa

Before and during treatment with Oxcarbazepine Pensa, your doctor may perform a blood test to determine your dose. Your doctor will tell you when to have the tests.

Do not takeOxcarbazepinePensa

If you are allergic to oxcarbazepine or eslicarbazepine or any of the other components of this medicine (listed in section 6).

If you are allergic, inform your doctor before taking Oxcarbazepine Pensa. If you think you are allergic, ask your doctor.

Warnings and precautions

Consult your doctor or pharmacist or nurse before starting to take Oxcarbazepine Pensa:

• If you have ever suffered any unusual allergic reaction(rash or any other type of allergy) to carbamazepine or any other medicine. If you are allergic to carbamazepine, the likelihood of being allergic to oxcarbazepine is 1 in 4 (25%).
• If you have kidney disease.
• If you have severe liver disease.
• If you are taking diuretics(medicines 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 lowas shown by your blood test (see section 4).
• If you are a woman and are taking oral contraceptives(such as the birth control pill), Oxcarbazepine Pensa may make the contraceptive not work. Use a non-hormonal contraceptive method or an additional one while taking Oxcarbazepine Pensa. This can help prevent an unwanted 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 Pensa:

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

If you notice any of the following symptoms after taking Oxcarbazepine Pensa, inform your doctor immediately or go to the Emergency Department of the nearest hospital:

• If during treatment you suffer an allergic reaction. Symptoms include swelling of lips, eyelids, face, throat, mouth, or sudden respiratory problems, fever with swelling of lymph nodes, rash, or blisters on the skin.
• If you notice symptoms suggesting hepatitis, such as jaundice (yellowing of the skin or the whites of the eyes).
• If you notice an increase in the frequency of seizures. This is especially important in children, but it can also occur in adults.
• If you notice possible symptoms of blood disorderssuch as fatigue, shortness of breath when exercising, paleness, headache, chills, dizziness, frequent infections with fever, sore throat, mouth ulcers, more frequent bleeding or bruising than usual, nosebleeds, reddish or purplish spots, or spontaneous appearance of spots on the skin.
• A small number of people treated with antiepileptics like oxcarbazepine have had thoughts of self-harm or suicide. If at any time you experience these thoughts, contact your doctor immediately.
• If you notice that your heart rate is fast or unusually slow.

Children and adolescents

For treatment in children, your doctor may recommend monitoring thyroid function before and during treatment.

Use ofOxcarbazepinePensawithother medicines

Please consult your doctor or pharmacist if you are taking or have recently taken or may need to take any other medicine.

Especially in the case of:

• Oral contraceptives such as the pill(see sectionWarnings and precautions).
• Other antiepileptic medicines and enzyme-inducing medicines such as carbamazepine, phenobarbital, phenytoin, or lamotrigine and rifampicin.
• Medicines that reduce blood sodium levels 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 your body's immune system such as cyclosporine, tacrolimus.

TakingOxcarbazepinePensawith food, drinks, and alcohol

Oxcarbazepine Pensa can be taken with or without food. During treatment with Oxcarbazepine Pensa, avoid taking alcoholic beverages, as it may increase the sedative effects of this medicine. If in doubt, consult your doctor.

Pregnancy, breastfeeding, and fertility

PregnancyIf you are pregnant or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Birth weight

If you use oxcarbazepine during pregnancy, your child may have a small size and weigh less than expected at birth [small size for gestational age (SGA)]. Among women with epilepsy, in one study, about 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 about 11 out of 100 children born to women who had not taken anticonvulsant medication 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 negatively affects the development of brain function (neurodevelopmental development) in children, while in other studies, this effect has not been observed. The possibility that there is an effect on neurodevelopmental development cannot be ruled out.

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

Do not stop your treatment with oxcarbazepine during pregnancy without consulting your doctor first.

BreastfeedingIf you are taking this medicine, consult your doctor before starting breastfeeding.

The active substance of Oxcarbazepine Pensa passes into breast milk. Although the available data suggest that the amount of Oxcarbazepine Pensa 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 Pensa. If you are breastfeeding during treatment with Oxcarbazepine Pensa and 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 vision changes, and may reduce your reaction ability. These effects, as well as the disease itself, can 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.

It is essential to consult your doctor if you can drive or operate machines while taking this medicine.

3. How to take Oxcarbazepine Pensa

Follow your doctor's or pharmacist's instructions for taking this medicine exactly. If in doubt, consult your doctor or pharmacist again.

How much to take

Use in adults

• The recommended dose for adults (including elderly patients) is 600 mg per day.
• Take a dose of 300 mg twice a day.
• If necessary, your doctor may gradually increase this dose until you get the best dose for you. The best results are usually obtained with doses between 600 and 2,400 mg per day.
• The dose is the same if oxcarbazepine is taken with another antiepileptic medicine.
• If you have kidney problems (renal insufficiency), the initial dose is half the normal initial dose.
• If you have severe liver disease, your doctor will adjust the dose.

Use in children

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

The recommended dose for children will be calculated by the doctor and depends on weight.

• The initial dose is 8 to 10 mg/kg 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.
• Your doctor may gradually increase the dose until you get the best dose for the child. The best results are usually obtained with a dose of 30 mg per kg body weight per day. The maximum dose for a child is 46 mg per kg body weight per day.

How to takeOxcarbazepinePensa

• The tablets can be swallowed with a little water.
• If necessary, the tablets can be broken in half to facilitate administration. The tablet can be divided into two equal doses.
• For small children who cannot swallow tablets or for whom the prescribed dose is not in tablet form, oxcarbazepine is available in oral suspension form.

When and for how long to takeOxcarbazepinePensa

Take oxcarbazepine twice a day, every day, approximately at the same time of day, unless your doctor tells you otherwise. This will have the best effect on controlling epilepsy. It will also help you remember when to take the tablet or tablets.

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 continued 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 moreOxcarbazepinePensathan you should

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

The symptoms of oxcarbazepine overdose may include:

• drowsiness, dizziness, muscle contractions, or significant worsening of seizures, coordination problems, and/or involuntary eye movements, headache, loss of consciousness, coma.
• Feeling of dizziness (nausea), being dizzy (vomiting), increased uncontrolled movements,
• Numbness, double vision, decreased pupil size, or constriction (pupil), blurred vision.
• Fatigue,
• Irregular heartbeat (prolonged QTc interval),
• Tremors, headache, coma, decreased level of consciousness, uncontrolled movements of the mouth, tongue, and limbs,
• aggression, agitation, confusion,
• Low blood pressure,
• Breathing difficulties.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to takeOxcarbazepinePensa

If you have forgotten 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 forgotten doses.

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

If you stop takingOxcarbazepinePensa

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

The following symptoms are very rare (may affect up to 1 in 10,000 people), but they are potentially serious adverse effects that may require urgent medical treatment.

Your doctor will decide whether to stop treatment with Oxcarbazepina Pensa immediately and how to continue your treatment in the future.

• 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 hypersensitivity reactions (allergy) such as skin rash, fever, and muscle 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 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 often than usual, nosebleeds, red or purple spots, or spontaneous appearance of spots on the skin (sign of decreased platelet count or decreased blood cell count).
• Rash with red spots mainly on the face, which may be accompanied by fatigue, fever, feeling of dizziness (nausea), or loss of appetite (signs of systemic lupus erythematosus).
• Numbness, confusion, muscle contractions, or significant worsening of seizures (possible symptom of low sodium levels in the blood) (see Warnings and Precautions section).
• Flu-like symptoms with jaundice (yellowing of the skin and whites of the eyes), (signs of hepatitis).
• Severe upper abdominal pain, nausea (vomiting), loss of appetite (signs of pancreatitis).
• Weight gain, fatigue, hair loss, muscle weakness, feeling of cold (signs of low thyroid activity).

Tell your doctor as soon as possible if you experience any of the following adverse effects.They may require medical attention:

Frequent(may affect up to 1 in 10 people):

• Tremors, coordination problems, involuntary eye movements, feeling of anxiety and nervousness, feeling of depression, mood changes, skin rash.

Very Rare(may affect up to 1 in 10,000 people):

• Irregular heartbeat or very fast or slow heartbeat.

Other Adverse Effects that May OccurThese are mild to moderate adverse effects of Oxcarbazepina Pensa. Most of these effects are transient and usually decrease over time.

Very Frequent(may affect more than 1 in 10 people):

• Fatigue, headache, dizziness, somnolence, feeling of nausea, vomiting, and double vision.

Frequent(may affect up to 1 in 10 people):

• Weakness, memory disorders, difficulty concentrating, apathy, agitation, confusion, blurred vision, constipation, diarrhea, abdominal pain, acne, hair loss, vertigo.

Infrequent(may affect 1 in 100 people):

• Hives. Oxcarbazepina Pensa may also increase liver enzymes while you are taking it.

Unknown Frequency(frequency cannot be estimated from available data):

• High blood pressure (hypertension), speech disorders.

There have been reports of bone disorders, including osteopenia and osteoporosis (decreased bone mass) and fractures. Tell your doctor or pharmacist if you have been taking antiepileptics for a long time, have a medical history of osteoporosis, or are taking steroids.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report it directly through the Spanish Pharmacovigilance System for Human Use website: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Oxcarbazepina Pensa

Keep this medicine out of the sight and reach of children.

Do not use after the expiration date indicated on the box and blister as CAD. The expiration date refers to the last day of the month indicated.

Do not use Oxcarbazepina Pensa if the packaging is damaged or shows signs of tampering.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and unused medicines at the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Oxcarbazepina Pensa

The active ingredient is oxcarbazepina. Each coated tablet contains 300 mg of oxcarbazepina.

The other components are microcrystalline cellulose, povidone K30, crospovidone, anhydrous colloidal silica, and magnesium stearate in the tablet core; and Opadry white Y-1-7000 (hypromellose, titanium dioxide (E171), macrogol PEG 400) and yellow iron oxide (E 172) in the tablet coating.

Appearance of the Product and Package Contents

The 300 mg tablet is coated, cylindrical, biconvex, scored, yellow, and marked with the code “O3”.

The coated tablets are available in blister packs containing 50, 100, and/or 500 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Laboratorios Cinfa, S.A.

C/Olaz-Chipi, 10 - Polígono Industrial Areta.

31620 Huarte - Pamplona (Navarra)-Spain

This prospectus was approved in: June 2025

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