OXCARBAZEPINE CINFA 600 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

oxcarbazepine cinfa600 mg 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, 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 is oxcarbazepine cinfa and what is it used for
2. What you need to know before you take oxcarbazepine cinfa
3. How to take oxcarbazepine cinfa
4. Possible side effects
5. Storing oxcarbazepine cinfa
6. Contents of the pack and other information

1. What is oxcarbazepine cinfa and what is it used for

What is oxcarbazepine cinfa

The active substance of oxcarbazepine cinfa is oxcarbazepine.

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

What is oxcarbazepine cinfa used for

Medicines like oxcarbazepine are the standard treatment for epilepsy.

Epilepsy is a brain disorder that causes people to have recurring seizures and convulsions. Seizures occur due to a temporary failure in the brain's electrical activity. Normally, brain cells coordinate body movements by sending signals through muscle nerves in an orderly manner. In epilepsy, brain cells send too many signals in a disordered 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 medicines. Normally, your doctor will try to find the medicine that works best for you or your child. However, in severe epilepsy, you may need a combination of two or more medicines to control seizures. Oxcarbazepine is indicated for use in adults and children aged 6 years and older.

If you have any doubts about how oxcarbazepine works or why you have been prescribed this medicine, ask your doctor.

2. What you need to know before you take oxcarbazepine cinfa

Follow carefully all instructions given by your doctor, even if they differ from the general information provided in this leaflet.

Monitoring during treatment with oxcarbazepine

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

Do not take oxcarbazepine cinfa

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take oxcarbazepine cinfa

• 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 you 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 help the kidneys eliminate salt and water by increasing the amount of urine produced).
• if you have 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 taking oral contraceptives (such as the pill), oxcarbazepine may make the contraceptive not work. Use a non-hormonal contraceptive method or an additional one while taking oxcarbazepine. This can 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 or healthcare professional before taking oxcarbazepine.

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, inform your doctor immediately or go to the Emergency Department of the nearest hospital:

• if during treatment you suffer an allergic reaction. The symptoms include swelling of the lips, eyelids, face, throat, mouth, or sudden breathing problems, as well as fever with swelling of the lymph nodes, rash, or blisters on the skin (see section 4).
• 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, dizziness, frequent infections with fever, sore throat, mouth ulcers, more frequent bleeding or bruising than usual, nosebleeds, red or purple 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.

Other medicines and oxcarbazepine cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Especially in the case of:

• Oral contraceptives such as the pill (see section "Warnings and precautions").
• Other antiepileptic medicines and enzyme-inducing medicines such as carbamazepine, phenobarbital, phenytoin, lamotrigine, and rifampicin.
• Medicines that reduce blood sodium levels, such as diuretics (used to help the kidneys eliminate salt and water by increasing urine production), desmopressin, and non-steroidal anti-inflammatory medicines such as indomethacin.
• Lithium and monoamine oxidase inhibitors (medicines used to treat mood disorders and some types of depression).
• Medicines that control the body's immune system such as cyclosporin and tacrolimus.

Taking oxcarbazepine cinfa with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

It is essential 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, 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 affects the development of brain function (neurodevelopment) in children negatively, while others have not observed this effect. The possibility that there is an effect on neurodevelopment cannot be ruled out.

Birth weight

If you use oxcarbazepine during pregnancy, your child may be small and weigh less than expected at birth [small size for gestational age (SGA)]. Among women with epilepsy, in one study, around 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 around 11 out of 100 children born to women who had not taken anticonvulsant medication during pregnancy.

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

Do not stop your treatment with oxcarbazepine without having consulted your doctor.

Breastfeeding

If you are taking this medicine, consult your doctor before starting breastfeeding. The active substance of oxcarbazepine cinfa passes into breast milk. Although the available data suggest that the amount of oxcarbazepine cinfa 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 cinfa. If you are breastfeeding during treatment with oxcarbazepine cinfa and you 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 changes in vision, and may reduce your reaction ability. These effects, as well as the disease itself, may 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.

3. How to take oxcarbazepine cinfa

Follow exactly the instructions for administration of this medicine given 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 gradually increase this dose to obtain the best dose for you. The best results are usually achieved 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 can be used in children aged 6 years or older. The recommended dose for children is calculated based on weight.

• The initial dose is 8 to 10 milligrams per kilogram 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 gradually increase the dose to obtain the best dose for your child. The best results are usually achieved with doses of 30 milligrams per kilogram of body weight per day. The maximum dose for a child is 46 milligrams per kilogram of body weight per day.

How to take oxcarbazepine cinfa

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

When and for how long to take oxcarbazepine cinfa

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 for 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 will depend on the type of seizures you or your child are experiencing. You may need to continue 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 more oxcarbazepine cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested. The symptoms of oxcarbazepine overdose may include:

• drowsiness, dizziness, coordination problems and/or involuntary eye movements, muscle contractions, or significant worsening of convulsions, headache, loss of consciousness, coma,
• nausea, vomiting, increased involuntary movements,
• numbness, double vision, decreased pupil size or contraction, blurred vision,
• fatigue,
• short, shallow, and rapid breathing (respiratory depression),
• irregular heart rhythm (QTc interval prolongation),
• tremor, headache, coma, decreased level of consciousness, involuntary movements of the mouth, tongue, and limbs,
• aggression, agitation, confusion,
• low blood pressure,
• breathing difficulties.

If you forget to take oxcarbazepine cinfa

If you have missed 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 recommended administration schedule.

If you are unsure or have missed several doses, inform your doctor. Do not take a double dose to make up for the missed doses.

If you stop taking oxcarbazepine cinfa

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 indicated by your doctor.

If you have any other doubts about the use of this medicine, 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 are symptoms of potentially serious adverse effects that may require urgent medical treatment.

Your doctor will decide whether to immediately discontinue treatment with oxcarbazepine and how to continue your treatment in the future.

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

• Weight gain, fatigue, hair loss, muscle weakness, feeling of cold (signs of low thyroid gland activity).
• Falls

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

• Inflammation of the lips, eyelids, face, throat, or mouth, accompanied by difficulty breathing, speaking, or swallowing (signs of anaphylactic reactions and angioedema).
• Skin rash and/or fever, which can be manifestations of drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP).
• 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 (signs of a decrease in the number of platelets or a decrease in the number of blood cells).
• Numbness, confusion, muscle contractions, or significant worsening of seizures (possible symptoms of low sodium levels in the blood due to inadequate secretion of antidiuretic hormone (ADH)) (see section "Warnings and Precautions").

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

• Signs of hypersensitivity reactions (allergy) such as skin rash, fever, and pain in the muscles and joints.
• Severe appearance of blisters on 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).
• Rash with red spots mainly on the face that may be accompanied by fatigue, fever, feeling of dizziness (nausea), or loss of appetite (signs of systemic lupus erythematosus).
• 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).

Tell 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):

• 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 a very fast or slow heartbeat.

Other Adverse Effects that May Occur

These are mild to moderate adverse effects of oxcarbazepine. 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 nausea, vomiting, and double vision.

Common(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, weight gain, speech disorders.

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

• High blood pressure (hypertension), hives.
• Liver enzyme levels may also increase while taking oxcarbazepine.

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

• Cases of bone disorders, including osteopenia and osteoporosis (decrease in bone mass) and fractures, have been reported. 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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Oxcarbazepine Cinfa

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

Do not use this medicine after the expiration date that appears on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Oxcarbazepine Cinfa

• The active ingredient is oxcarbazepine. Each coated tablet contains 600 mg of oxcarbazepine
• The other ingredients are:

Tablet core;microcrystalline cellulose, povidone K30, crospovidone, anhydrous colloidal silica, and magnesium stearate.

Tablet coating;hypromellose, titanium dioxide (E-171), and macrogol.

It also contains red iron oxide (E-172).

Appearance of the Product and Package Contents

Coated tablets, oblong, non-scored, and light pink in color.

The film-coated tablets are presented in blisters. Each package contains 50, 100, or 500 (clinical package) tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the Last Revision of this Leaflet:July 2025

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77723/P_77723.html

QR code to: https://cima.aemps.es/cima/dochtml/p/77723/P_77723.html