Leaflet: information for the user

Oxcarbazepine NORMON 600 mg film-coated tablets EFG

Oxcarbazepine

Read this leaflet carefully before you start taking the medicine.

• 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. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you think you have suffered a side effect, you can help us by reporting it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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

2. Before taking Oxcarbazepine NORMON

3. How to take Oxcarbazepine NORMON

4. Possible side effects

5. Storage of Oxcarbazepine NORMON

6. Further information

Oxcarbazepina NORMON belongs to a group of medicines called anticonvulsants or antiepileptics. Antiepileptics, such as Oxcarbazepina NORMON, 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 brain's electrical system. Normally, brain cells coordinate the body's movements by sending signals through the muscle nerves in an orderly organized manner. The result can be uncoordinated muscle activity known as an epileptic seizure.

Oxcarbazepina NORMON acts by keeping the brain's "hyperexcited" nerve cells under control, suppressing or reducing the frequency of such seizures.

Oxcarbazepina NORMON is used for the treatment of partial seizures with or without secondary generalization with tonic-clonic seizures. Partial seizures affect 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 state of consciousness is altered.

Normally, the doctor will try to find the medication that works best for the patient, but in severe epilepsy, the patient may need a combination of two or more medications to control seizures.

Oxcarbazepina NORMON can be used alone or in combination with other antiepileptics. Oxcarbazepina NORMON is indicated for use in adults and in children 6 years of age or older.

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

Do not take Oxcarbazepina NORMON if:

You are allergic (hypersensitive) to the active ingredient (oxcarbazepina) or to any of the other components of this medication (see section 6 “Additional Information”).

Be especially careful with Oxcarbazepina NORMON

- if you have ever had an unusual allergic reaction (rash or any other type of allergy) to carbamazepine or to any other medication. If you are allergic to carbamazepine, the chances of being allergic to oxcarbazepina are 1 in 4 (25%).

- if you have a severe kidney disease

- if you are taking diuretics (medications 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(see section 4 “Possible Side Effects”).

- if you are a woman and taking oral contraceptives (“the pill”), Oxcarbazepina NORMON may make the contraceptive ineffective. Therefore, you should use a non-hormonal contraceptive method or an additional method while taking this medication. 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 before taking this medication.

If you have any of the conditions described above, inform your doctor before taking Oxcarbazepina NORMON.

- if during treatment you experience an allergic reaction, such as inflammation of the lips, eyelids, face, throat, mouth, or sudden respiratory problems, fever with lymph node inflammation, rash, or blisters on the skin; in this case, consult your doctor immediately or go to the nearest hospital (see section 4 "Possible Side Effects").

- if you notice that your heart rate is fast or abnormally slow, inform your doctor immediately.

- if you notice symptoms that suggest hepatitis, such as jaundice (yellowing of the skin or the white of the eyes), inform your doctor immediately.

- if you notice symptoms that suggest a blood disorder, such as fatigue, shortness of breath during exercise, paleness, headache, chills, dizziness, frequent infections with fever, sore throat, mouth ulcers, frequent bleeding or bruising, nosebleeds, or red or purple spots, inform your doctor immediately.

A reduced number of people who were treated with antiepileptic medications like Oxcarbazepina NORMON have had thoughts of self-harm or suicide. If you ever have these thoughts, contact your doctor immediately.

The risk of severe skin reactions in patients of Chinese Han or Thai origin associated with carbamazepine or related chemical compounds can be predicted by analyzing a blood sample from these patients. Your doctor will advise you if a blood test is necessary before taking oxcarbazepina.

Concomitant use of other medications:

Inform your doctor or pharmacist if you are taking or have recently taken other medications, including those purchased without a prescription.

Especially in the case of:

- oral contraceptives ("the pill")(see section "Be especially careful with Oxcarbazepina NORMON").

- other antiepileptic medications (such as carbamazepine, phenobarbital, phenytoin, or lamotrigine)

- medications 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 drugs (such as indomethacin)

- lithium and monoamine oxidase inhibitors (medications used to treat mood disorders and some types of depression)

- medications that control your body's immune system (such as cyclosporine, tacrolimus)

Administration of Oxcarbazepina NORMON with food and beverages

Oxcarbazepina NORMON can be taken with or without food. During treatment with oxcarbazepina, avoid consuming alcoholic beverages as they may increase the sedative effects of this medication.

Pregnancy

Inform your doctor if you are pregnant or plan to become pregnant.

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

Birth defects

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

Neurological development disorders

Some studies have shown that exposure to oxcarbazepina in the womb affects the development of the brain's 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 Oxcarbazepina NORMON.

Do not stop your treatment with Oxcarbazepina NORMON without consulting your doctor.

Consult your doctor or pharmacist before using any medication.

Breastfeeding

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

Driving and operating machinery

Oxcarbazepina may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may impair your ability to react. These effects, as well as the underlying disease, 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 medication.

Oxcarbazepina NORMON contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor, even if they differ from those indicated in this leaflet.

How much to take

Always take Oxcarbazepina NORMON exactly as your doctor has instructed. Consult your doctor or pharmacist if you have any doubts.

Dosage for adults

Oxcarbazepina NORMON should be taken twice a day, every day, and approximately at the same hour, unless your doctor tells you otherwise. The best way to control epilepsy is to take the tablets at the same hour every day. This will also help you remember when to take the tablets.

The initial dose of Oxcarbazepina NORMON in adults (including the elderly) is generally 600 mg per day. Take a dose of 300 mg twice a day. If necessary, your doctor may increase this dose gradually to achieve the desired results. This usually occurs at doses between 600 and 2,400 mg per day.

The dose is the same if Oxcarbazepina NORMON is taken with another antiepileptic medication.

The initial dose for patients with kidney disease (renal insufficiency) is half the normal initial dose.

If you have severe liver disease, your doctor will adjust the dose.

Dosage for children

Oxcarbazepina NORMON can be used in children aged 6 years or older.

The dose for children is calculated based on weight. The initial dose is 8-10 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. If necessary, the dose will be increased gradually to achieve the desired results. A typical maintenance dose for a child is 30 mg/kg per day. The maximum dose for a child is 46 mg per kg of body weight per day.

Form of use and/or route of administration

The tablets can be swallowed with a little water.

If necessary, the tablets can be split in half to facilitate administration. The groove in Oxcarbazepina NORMON allows the tablet to be divided into two equal doses.

For small children who cannot swallow tablets or for whom the prescribed dose is not in tablet form, other pharmaceutical forms (oral suspension) containing oxcarbazepina are available.

Oxcarbazepina NORMON can be taken with or without food.

Frequency of administration and duration of treatment

Your doctor will inform you how long your treatment or that of your child will last. The duration of treatment is based on the type of seizures 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 discussing it with your doctor.

If you take more Oxcarbazepina NORMON than you should:

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

In case of overdose, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Overdose symptoms: drowsiness, dizziness, nausea, vomiting, increased motor activity, numbness, confusion, muscle contractions, or significant worsening of seizures, coordination problems, and/or involuntary eye movements.

If you forgot to take Oxcarbazepina NORMON:

If you have forgotten a single dose, take it as soon as possible, except if it is almost time for the next one; 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 Oxcarbazepina NORMON:

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

To prevent a sudden worsening of seizures, do not stop treatment abruptly.

If treatment is interrupted, it should be done gradually as instructed by your doctor.

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

Like all medications, Oxcarbazepina NORMON may have side effects, although not everyone will experience them.

Some side effects can be severe:

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

- 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 allergic reactions such as skin rash, fever, and joint pain.

- Severe appearance of blisters on the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages, or genitals (signs of severe allergic reactions that include Stevens-Johnson syndrome, Lyell syndrome, and erythema multiforme).

- Fatigue, shortness of breath during exercise, paleness, headache, chills, dizziness, frequent infections accompanied by fever, sore throat, mouth ulcers, frequent bleeding or bruising, nosebleeds, red or purple spots, or spontaneous appearance of spots on the skin (sign of decreased platelet count or decreased white blood cell count).

- Rash with red spots mainly on the face that may be accompanied by fatigue, fever, nausea, loss of appetite (sign of systemic lupus erythematosus).

- Numbness, confusion, muscle contractions, or significant worsening of seizures (symptoms that may be associated with low sodium levels in the blood)(see section "Be careful with Oxcarbazepina NORMON").

- Symptoms similar to the flu with yellow discoloration of the skin (signs of hepatitis).

- Severe upper abdominal pain, vomiting, loss of appetite (signs of pancreatitis).

The above symptoms are very rare (may affect fewer than 1 in 10,000 patients), but potentially serious and may require urgent medical attention. Your doctor will decide whether to immediately stop treatment with Oxcarbazepina NORMON and how to continue your treatment in the future.

If you experience any of the following side effects, consult your doctor as soon as possible, as they may require medical attention.

Frequent (may affect between 1 and 10 in 100 people): tremors, coordination problems, involuntary eye movements, feeling of anxiety and nervousness, feeling of depression, skin rash.

Rare (may affect fewer than 1 in 10,000 people): irregular heart rhythm or very fast or very slow heart rhythm.

Inform your doctor if you experience or are concerned about any of the following side effects:

Frequent (may affect more than 1 in 10 people): fatigue, headache, dizziness, drowsiness, nausea, vomiting, and double vision.

Frequent (may affect between 1 and 10 in 100 people): weakness, memory disorders, difficulty concentrating, apathy, agitation, confusion, blurred vision, constipation, diarrhea, abdominal pain, acne, hair loss, vertigo.

Rare (may affect between 1 and 10 in 1,000 people): urticaria. It may also increase liver enzymes while taking Oxcarbazepina NORMON.

Unknown frequency (cannot be estimated from available data): hypertension.

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

Bone alterations, including osteopenia and osteoporosis (bone decalcification), and fractures have been reported. Consult your doctor or pharmacist if you are on long-term antiepileptic treatment, have a history of osteoporosis, or take steroids.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Oxcarbazepina NORMON after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Oxcarbazepina NORMON Composition

The active ingredient is oxcarbazepina. Each tablet contains 600 mg of oxcarbazepina.

The other components (excipients) are: microcrystalline cellulose, crospovidone, hypromellose, sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate, macrogol 6000, titanium dioxide (E-171), talc, and iron oxide red (E-172).

Product Appearance and Packaging Contents

Oxcarbazepina NORMON 600 mg are pink, elongated, scored, and printed tablets that are presented in packs of 100 and 500 tablets. The tablet has a score to allow for fractioning and facilitate swallowing, and also allows the tablet to be divided into two equal doses.

Marketing Authorization Holder and Responsible Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres cantos – Madrid (SPAIN)

OTHER PRESENTATIONS

Oxcarbazepina NORMON 300 mg film-coated tablets

This leaflet was revised in April 2013

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