Label: information for theuser

Oxcarbazepine600 mg film-coated tablets EFG

Read this label carefully before starting to take this medication, because it contains important information for you.

• Keep this label, as you may need to read it again
• If you have any doubts, consult your doctor or pharmacist
• This medication has been prescribed only for you and should not be given to otherseven if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label.

What isOxcarbazepinaPensa

The active ingredient ofOxcarbazepinaPensais oxcarbazepina.

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

What is it used forOxcarbazepinaPensa

Medicines likeoxcarbazepina 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 electrical system of the brain.Normally, brain cells coordinate body movements by sending signals through muscle nerves in an orderly organized manner.The result can be uncoordinated muscle activity, which is called an epileptic seizure.

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 2 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.

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

Oxcarbazepinamaybe usedaloneor in combination with otherantiepileptic medicines.Normally, the doctor will try to findthe medicine that works best for youoryour child,however, in severe epilepsy, you may need a combination of two or more medicines to control your seizures.Oxcarbazepina is indicated for use in adults and in children aged 6 or more years.

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

Monitoring during treatment with Oxcarbazepina Pensa

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

Do not takeOxcarbazepinaPensa

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

Inform your doctor before taking Oxcarbazepina Pensa if you are allergic. If you think you are allergic, ask your doctor.

Warnings and precautions

Consult your doctor or pharmacist or nurse before starting to takeOxcarbazepinaPensa:

• If you have ever had anyunusual allergic reaction(rash or any other type of allergy) to carbamazepine or any other medicine. If you are allergic to carbamazepine, the chances of being allergic to oxcarbazepine are 1 in 4 (25%).
• If you have arenal disease.
• If you have asevere liver disease.
• If you aretaking diuretics(medicines to eliminate salt and water by increasing urine production).
• If you have anyheart disease, shortness of breath and/or swelling of feet or legs, due to fluid retention.
• If you know that yourblood sodium level is lowas shown by your blood test(see section 4).
• If you are a woman and are takingoral contraceptives(such as the contraceptive pill),OxcarbazepinaPensamay make the contraceptive not work. Use a non-hormonal contraceptive method or an additional method while takingOxcarbazepinaPensa. 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 takingOxcarbazepinaPensa:

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

If you experience any of the following symptoms after taking Oxcarbazepina Pensa, inform your doctor immediately or go to the nearest hospital emergency department:

• If during treatment you experience anallergic reaction. Symptoms include inflammation of lips, eyelids, face, throat, mouth or sudden respiratory problems, fever with lymph node inflammation, rash or blisters on the skin.
• If you notice symptoms that suggesthepatitis, such as jaundice (yellowing of the skin or white of the eyes).
• If you notice an increase in seizure frequency. This is especially important in children, but can also occur in adults.
• If you notice possible symptoms ofblood disordersuch as fatigue, shortness of breath on exercise, paleness, headache, chills, dizziness, frequent infections with fever, sore throat, mouth ulcers, bleeding or bruising more frequently than normal, your nose bleeds, red or purple spots, spontaneous appearance of skin spots.
• A small number of people treated with antiepileptic drugs like oxcarbazepine have had thoughts of self-harm or suicide. If you experience these thoughts at any time, contact your doctor immediately.
• If you notice that yourheart 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 ofOxcarbazepinaPensawithother medicines

Please consult your doctor or pharmacist if you are taking or have taken recently 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 drugs 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 ciclosporin, tacrolimus.

TakingOxcarbazepinaPensawith food, drinks and alcohol

OxcarbazepinaPensacan be taken with or without food. During treatment withOxcarbazepinaPensaavoid taking alcoholic beverages, as it may increase the sedative effects of this medicine, consult your doctor if you have any doubts.

Pregnancy, breastfeeding and fertility

Pregnancy
If you are pregnant or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Birth defects

Studies have not shown an increased risk of birth defects associated with oxcarbazepine administered during pregnancy, however, a risk of birth defects in the fetus cannot be completely ruled out.

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 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 whether to takeOxcarbazepinaPensa.

Do not stop your treatment with oxcarbazepine without consulting your doctor.

Breastfeeding
If you are taking this medicine, consult your doctor before starting breastfeeding.The active ingredient ofOxcarbazepinaPensapasses into breast milk. Although available data suggest that the amount of Oxcarbazepina Pensa 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 Oxcarbazepina Pensa. If you are breastfeeding during treatment with Oxcarbazepina Pensa and believe your baby is experiencing an adverse effect such as excessive sleepiness or poor weight gain, inform your doctor immediately.

Driving and operating machines

Oxcarbazepine may cause symptoms such as drowsiness, dizziness or visual disturbances, and decrease your reaction time. These effects, as well as the underlying disease, may impair your ability 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.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.This medication should be taken exactly as directed by your doctor or pharmacist.In case of 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 increase this dose gradually to obtain 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 whether oxcarbazepine is taken alone or with another antiepileptic medication.
• If you have kidney problems (renal insufficiency), the initial dose is half the usual initial dose.
• If you have severe liver disease, your doctor will adjust your dose.

Use in children

Oxcarbazepine Pensa may be used in children 6 years of age or older.

Your doctor will calculate the recommended dose for children based on their weight.

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

How to take Oxcarbazepine Pensa

• Tablets can be swallowed with a little water.
• For small children who cannot swallow tablets or for whom the prescribed dose is not available in tablet form, oxcarbazepine is available in oral suspension form.

When and for how long to take Oxcarbazepine Pensa

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 in 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 seizure 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 talking to your doctor.

If you take more Oxcarbazepine Pensa than you should

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

The symptoms of overdose with oxcarbazepine 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 involuntary movements,
• Feeling drowsy, double vision, decreased or constricted pupil size, blurred vision.
• Tiredness,
• Irregular heart rhythm (prolonged QTc interval),
• Trembling, headache, coma, decreased level of consciousness, involuntary movements of the mouth, tongue, and limbs,
• Aggression, agitation, confusion,
• Low blood pressure,
• Respiratory difficulty.

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 medication and the amount ingested.

If you forget to take Oxcarbazepine Pensa

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 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 Oxcarbazepine Pensa

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

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform your doctor immediately or go to the nearest hospital emergency service if any of the following side effects occur:

The following symptoms are very rare (they may affect up to 1 in 10,000 people), but are potentially serious side 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.

• Swelling of the lips, eyelids, face, neck, or mouth, accompanied by difficulty breathing, speaking, or swallowing (signs of anaphylactic and angioedema reactions) 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 reactions including Stevens-Johnson syndrome, Lyell syndrome, and erythema multiforme).
• Fatigue, shortness of breath on exertion, paleness, headache, chills, dizziness, frequent infections accompanied by fever, sore throat, mouth ulcers, easy bruising or bleeding, nosebleeds, or the appearance of spontaneous skin spots (signs of decreased platelet count or decreased blood cell count).
• Rash with red spots mainly on the face that may be accompanied by fatigue, fever, sensation of dizziness (nausea) or loss of appetite (signs of systemic lupus erythematosus).
• Numbness, confusion, muscle contractions, or significant worsening of seizures (possible sign of low blood sodium levels)(seeWarnings and Precautions).
• Symptoms similar to the flu with jaundice (yellowing of the skin and eyes), (signs of hepatitis).
• Severe upper abdominal pain, dizziness (vomiting), loss of appetite (signs of pancreatitis inflammation).
• Weight gain, fatigue, hair loss, muscle weakness, sensation of cold (signs of low thyroid gland activity).

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

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

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

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

• Irregular heart rhythm or very fast or slow heart rate.

Other side effects that may occur:

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

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

• Fatigue, headache, dizziness, drowsiness, sensation of dizziness (nausea), dizziness (vomiting), and double vision.

Frequent(they 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.

Rare(they may affect up to 1 in 100 people):

• Urticaria. It may also increase liver enzymes while takingOxcarbazepinaPensa.

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

• High blood pressure (Hypertension), speech disorders.

There have been reports of bone disorders including osteopenia and osteoporosis (bone mass decrease) and fractures. Inform 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 of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines and Medical Devices Agency's website:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout 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 useOxcarbazepinaPensaif the packaging is damaged or shows signs of tampering.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. In case of doubtask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition ofOxcarbazepinaPensa

The active ingredient is oxcarbazepine. Each coated tablet contains 600 mg of oxcarbazepine

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

Appearance of the product and contents of the packaging

The 600 mg tablet is coated, oblong, biconvex, and light pink in color.

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

Responsible for manufacturing

Laboratorios Cinfa, S.A.

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

31620 Huarte - Pamplona (Navarra)-Spain

This leaflet was approved in: July 2022

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