Oxcarbazepine Pensa 300 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Oxcarbazepine Pensa 300 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, 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 experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

What Oxcarbazepine Pensa is

The active substance in Oxcarbazepine Pensa is oxcarbazepine.

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

What Oxcarbazepine Pensa is used for

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 is used to treat partial seizures, with or without secondary generalization into tonic-clonic seizures. Partial seizures originate in a limited area of the brain but may spread to the entire brain, leading 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.

Oxcarbazepine works by keeping overactive ("hyperexcitable") nerve cells in the brain under control, thereby suppressing or reducing the frequency of these seizures.

Oxcarbazepine may be used alone or in combination with other antiepileptic medicines. Your doctor will usually try to find the medicine that works best for you or your child; however, in severe forms of epilepsy, treatment with a combination of two or more medicines may be needed to control seizures. Oxcarbazepine is indicated for use in adults and in children aged 6 years and older.

2. What you need to know before starting to take Oxcarbazepina Pensa

Carefully 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 determine your dose. Your doctor will tell you when to have the tests done.

Do not take Oxcarbazepina Pensa

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

If you are allergic, inform your doctor before taking Oxcarbazepina Pensa. If you think you may be allergic, consult your doctor.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take Oxcarbazepina Pensa:

• If you have ever experienced an unusual allergic reaction (rash or any other type of allergy) to carbamazepine or any other medicine. If you are allergic to carbamazepine, the likelihood that you will be 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 the feet or legs due to fluid retention.
• If you know that your blood sodium level is low, as shown by your blood test (see section 4).
• If you are a woman taking oral contraceptives (such as the birth control pill), Oxcarbazepina Pensa may cause the contraceptive to become ineffective. Use a different or additional non-hormonal contraceptive method while taking Oxcarbazepina 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 Oxcarbazepina Pensa:

The risk of serious skin adverse reactions in Han Chinese or Thai patients associated with carbamazepine or chemically related compounds can be predicted by blood sample testing in these patients. Your doctor will advise you whether 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 you develop an allergic reaction during treatment. Symptoms include swelling of the lips, eyelids, face, throat, mouth, or sudden breathing problems, fever with swollen lymph nodes, skin rash or blisters.
• If you notice symptoms suggesting hepatitis, such as jaundice (yellowing of the skin or whites of the eyes).
• If you notice an increased frequency of seizures. This is particularly important in children, but may also occur in adults.
• If you notice possible symptoms of blood disorders, 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.
• A small number of patients treated with antiepileptic medicines such as oxcarbazepine have had thoughts of harming themselves or of suicide. If you ever experience such 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.

Taking Oxcarbazepina Pensa with other medicines

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

Especially in the case of:

• Oral contraceptives such as the birth control pill (see section Warnings and precautions).
• Other antiepileptic medicines and enzyme-inducing medicines such as carbamazepine, phenobarbital, phenytoin, or lamotrigine, and rifampicin.
• Medicines that reduce sodium levels in blood, such as diuretics (used to help 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 Oxcarbazepina Pensa with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

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

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.

Birth weight

If you take oxcarbazepine during pregnancy, your child may be small and weigh less than expected at birth [small for gestational age (SGA)]. In a study among women with epilepsy, about 15 out of every 100 children born to mothers who took oxcarbazepine during pregnancy were smaller and weighed less than expected at birth, compared to about 11 out of every 100 children born to women who did not take anticonvulsant medication during pregnancy.

Congenital malformations

Studies have not shown an increased risk of congenital malformations associated with oxcarbazepine taken 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.

Your doctor will inform you about the benefits and possible risks of treatment and help you decide whether to take Oxcarbazepina Pensa.

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

Breastfeeding If you are taking this medicine, consult your doctor before starting breastfeeding. The active ingredient in Oxcarbazepina Pensa passes into breast milk. Although available data suggest that the amount of Oxcarbazepina Pensa 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 potential benefits and risks of breastfeeding while taking Oxcarbazepina Pensa. If you are breastfeeding during treatment with Oxcarbazepina Pensa 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

Oxcarbazepina may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction ability. These effects, as well as the illness itself, may impair your ability to drive 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.

It is important that you consult your doctor about whether you can drive or operate machinery while taking this medicine.

3. How to take Oxcarbazepine Pensa

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. 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 300 mg dose twice daily.
• If necessary, your doctor may gradually increase this dose to obtain the best dose for you. Optimal results are usually achieved with doses between 600 and 2,400 mg per day.
• The dose is the same whether oxcarbazepine is taken together 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 and older.

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

• The initial dose is 8 to 10 mg/kg body weight per day, given in two doses. For example, a child weighing 30 kg will start treatment with 150 mg twice daily.
• Your doctor may gradually increase the dose to obtain the best dose for the child. Optimal results are usually achieved 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 take Oxcarbazepine Pensa

• The tablets can be swallowed with a little water.
• If necessary, the tablets can be split into two halves to facilitate administration. The tablet can be divided into two equal doses.
• For young children who cannot swallow tablets or when the prescribed dose is not available in tablet form, oxcarbazepine is available as an oral suspension.

When and for how long to take Oxcarbazepine Pensa

Take oxcarbazepine twice daily every day, approximately at the same time each day, unless your doctor tells you otherwise. This will provide the best effect in controlling epilepsy. It will also help you remember when to take the tablet(s).

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 Pensa 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 oxcarbazepine overdose may include:

• Drowsiness, dizziness, muscle twitching, or significant worsening of seizures, problems with coordination and/or involuntary eye movements, headache, loss of consciousness, coma.
• Feeling nauseous (nausea), being dizzy (vomiting), increased uncontrolled movements,
• Numbness, double vision, reduction in size or constriction of the black part of the eye (pupil), blurred vision.
• Fatigue,
• Irregular heart rhythm (QTc interval prolongation),
• Tremor, headache, coma, decreased level of consciousness, uncontrolled movements of mouth, tongue, and limbs,
• Aggression, agitation, confusion,
• Low blood pressure,
• Breathing difficulties.

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

If you forget to take Oxcarbazepine Pensa

If you miss a single dose, take it as soon as possible, unless it is almost time for the next dose; in this case, wait and resume your usual dosing schedule. Do not take a double dose to make up for missed doses.

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

If you stop taking Oxcarbazepine Pensa

Do not stop taking your medicine 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, this medicine can cause adverse effects, although not everyone will experience them.

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

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

Your doctor will decide whether you should immediately stop treatment with Oxcarbazepine Pensa and how to proceed with your treatment in the future.

• 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 hypersensitivity reactions (allergy) such as skin rash, fever, and muscle or 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’s 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 spots on the skin (signs of reduced platelet count or reduced blood cell count).
• Skin rash with red spots, mainly on the face, possibly accompanied by fatigue, fever, dizziness (nausea), or loss of appetite (signs of systemic lupus erythematosus).
• Numbness, confusion, muscle twitching, or significant worsening of seizures (possible symptoms of low sodium levels in the blood) (see section Warnings and precautions).
• Flu-like symptoms with jaundice (yellowing of the skin and whites of the eyes) (signs of hepatitis).
• Severe upper abdominal pain, dizziness (vomiting), loss of appetite (signs of pancreatitis).
• Weight gain, fatigue, hair loss, muscle weakness, feeling cold (signs of underactive thyroid gland).

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

Common* (may affect up to 1 in 10 people):*

• Tremor, coordination problems, involuntary eye movements, feeling anxious and nervous, feeling depressed, mood changes, skin rash.

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

• Irregular heartbeat or very fast or slow heart rate.

Other adverse effects that may occur
These are mild to moderate adverse effects of Oxcarbazepine Pensa. Most of these effects are transient and usually decrease over time.

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

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

Common* (may affect up to 1 in 10 people):*

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

Uncommon* (may affect up to 1 in 100 people):*

• Urticaria (hives). Liver enzymes may also increase during treatment with Oxcarbazepine Pensa.

Frequency not known* (frequency cannot be estimated from available data):*

• High blood pressure (hypertension), speech disturbances.

Cases of bone disorders, including osteopenia and osteoporosis (reduced bone mass) and fractures, have been reported. Inform your doctor or pharmacist if you have been taking antiepileptic medicines for a long time, have a medical history of osteoporosis, or are taking steroids.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Oxcarbazepine Pensa

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

Do not use after the expiry date stated on the carton and blister as EXP. The expiry date refers to the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE 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. Contents of the container and additional information

Composition of Oxcarbazepine Pensa

The active substance is oxcarbazepine. Each coated tablet contains 300 mg of oxcarbazepine.

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 contents of the container

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

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

Only certain pack 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 leaflet was approved in: June 2025

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