Package Leaflet: Information for the User

Oxcarbazepine Cinfa600 mg Film-Coated Tablets

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

What is oxcarbazepina cinfa

The active ingredient of oxcarbazepina cinfa is oxcarbazepina.

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

What is oxcarbazepina cinfa used for

Medicines like oxcarbazepina 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 electrical activity of the brain. Normally, brain cells coordinate the body's movements by sending signals through muscle nerves in an orderly organized manner. In epilepsy, brain cells send too many signals in a disorganized manner. The result can be uncoordinated muscle activity known as an epileptic seizure.

Oxcarbazepina is used to treat 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 the brain's "hyperexcited" nerve cells under control, suppressing or reducing the frequency of these seizures.

Oxcarbazepina may be used alone or in combination with other antiepileptic medications. Normally, the 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 your seizures. Oxcarbazepina is indicated for use in adults and children aged 6 or older.

If you have any doubts about how oxcarbazepina works or why you have been prescribed this medication, consult your doctor.

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

Monitoring during treatment with oxcarbazepine

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

Do not take oxcarbazepine cinfa

• if you are allergic to oxcarbazepine or any of the other ingredients in this medicine (including those 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 had any unusual 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 kidney disease.
• if you have severe liver disease.
• if you are taking diuretics (medicines to help the kidneys get rid of salt and water by increasing the amount of urine produced).
• if you have 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 contraceptive pill), oxcarbazepine may make the contraceptive not work. Use a non-hormonal contraceptive method or extra precautions while taking oxcarbazepine. This may help prevent an unplanned 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 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 oxcarbazepine, inform your doctor immediately or go to the nearest hospital emergency department:

• if during treatment you experience an allergic reaction. Symptoms include inflammation of the lips, eyelids, face, throat, mouth, or sudden respiratory problems, as well as fever with lymph node inflammation, skin rash, or blisters.
• if you notice symptoms that suggest hepatitis, such as jaundice (yellowing of the skin or the 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 of blood disorder, such as fatigue, shortness of breath when exercising, paleness, headache, chills, dizziness, frequent infections with fever, sore throat, mouth ulcers, bleeding or bruising more easily than normal, nosebleeds, or red or purple spots, or spontaneous skin rash.
• if you experience thoughts of self-harm or suicide. If you experience these thoughts at any time, contact your doctor immediately.
• if you notice that your heart rate is fast or abnormally slow.

Children and adolescents

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

Other medicines and oxcarbazepine cinfa

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

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 get rid of 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 ciclosporin and tacrolimus.

Taking oxcarbazepine cinfa with food, drinks, and alcohol

Oxcarbazepine can be taken with or without food. During treatment with oxcarbazepine, avoid drinking alcohol, 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, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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 defects

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

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 take oxcarbazepine.

Do not stop taking oxcarbazepine without consulting your doctor.

Breastfeeding

If you are taking this medicine, consult your doctor before starting breastfeeding. The active ingredient in oxcarbazepine cinfa passes into breast milk. Although available data suggest that the amount of oxcarbazepine cinfa that passes to the breastfeeding baby is low, a risk of adverse effects in the baby cannot be ruled out.

Your doctor will inform you of the benefits and potential risks of breastfeeding while taking oxcarbazepine cinfa. If you are breastfeeding during treatment with oxcarbazepine cinfa and believe your baby is experiencing any adverse effects, 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 impair your ability to react. These effects, as well as the underlying condition, may make it difficult for you 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 medicine.

Follow exactly the administration instructions of this medication as indicated 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 if oxcarbazepine is taken with another antiepileptic medication.
• 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 6 years of age 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 increase the dose gradually to obtain the best dose for your child. The best results are usually obtained 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 available in tablet form, oxcarbazepine is also available in oral suspension form.

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 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 that of your child will last. The duration of treatment will depend on the type of seizure you or your child suffer from. It may be necessary to continue treatment for several years to control seizures. Do not change the dose or stop treatment without first talking to your doctor.

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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. The symptoms of overdose with oxcarbazepine may include:

• drowsiness, dizziness, coordination problems, and/or involuntary eye movements, muscle contractions, or significant worsening of seizures, headache, loss of consciousness, coma,
• nausea, feeling dizzy (vomiting), increased involuntary movements,
• numbness, double vision, decreased size or contraction of the black part of the eye (pupil), blurred vision,
• fatigue,
• shallow, rapid, and short breathing (respiratory depression),
• irregular heart rhythm (prolonged QTc interval),
• tremors, 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 forgotten a single dose, take it as soon as you can, except if it is almost time for the next one; in this case, wait and return to the recommended administration schedule.

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

If you interrupt treatment with oxcarbazepine cinfa

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 your doctor has indicated.

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

Like all medications, this medication may 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 are symptoms of potentially serious side effects that may require urgent medical treatment.

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

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

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

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

• Lip, eyelid, face, throat, or mouth inflammation, accompanied by difficulty breathing, speaking, or swallowing (signs of anaphylactic reactions and angioedema).
• Skin rash and/or fever, which may be manifestations of rash with eosinophilia and systemic symptoms (DRESS, by its English acronym), generalized acute exanthematous pustulosis (AGEP, by its English acronym).
• Fatigue, shortness of breath during exercise, pallor, 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 spots on the skin (signs of a decrease in platelet count or a decrease in blood cell count).
• Numbness, confusion, muscle contractions, or significant worsening of seizures (possible symptoms of low blood sodium levels due to inadequate secretion of the antidiuretic hormone (ADH))(see the 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 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).
• Rash with red spots mainly on the face, which may be accompanied by fatigue, fever, dizziness, or loss of appetite (signs of systemic lupus erythematosus).
• Symptoms similar to the flu with jaundice (yellowing of the skin and eyes), (signs of hepatitis).
• Severe upper abdominal pain, dizziness, loss of appetite (signs of pancreatitis inflammation).

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

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

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

Other side effects that may occur

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

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

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

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

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

Reporting 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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

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

This medication does not require special storage conditions.

Do not use this medication if you observe that the packaging is damaged or shows signs of manipulation.

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

Oxcarbazepine cinfa composition

• The active ingredient is oxcarbazepine. Each coated tablet contains 600 mg of oxcarbazepine
• The other components 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 iron oxide red (E-172).

Product appearance and packaging contents

Coated, oblong, non-scored, and pale pink tablets.

Coated tablets with a film coating are presented in blisters. Each package contains 50, 100, or 500 (clinical package) tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:October 2022

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

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your 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 link to:https://cima.aemps.es/cima/dochtml/p/77723/P_77723.html