Oxepilax

Leaflet accompanying the packaging: patient information

Oxepilax, 300 mg, tablets

Oxepilax, 600 mg, tablets

Oxcarbazepine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Oxepilax and what is it used for
• 2. Important information before taking Oxepilax
• 3. How to take Oxepilax
• 4. Possible side effects
• 5. How to store Oxepilax
• 6. Contents of the pack and other information

1. What is Oxepilax and what is it used for

What is Oxepilax

The active substance of Oxepilax is oxcarbazepine.
Oxepilax belongs to a group of antiepileptic medicines.

What is Oxepilax used for

Medicines like Oxepilax are used to treat epileptic seizures.
Patients diagnosed with epilepsy have recurring seizures and convulsions.
These seizures occur due to temporary uncontrolled electrical activity in the brain.
Normally functioning brain cells coordinate body movements by sending organized signals through nerves to muscles. In epilepsy, brain cells send too many signals in an irregular rhythm. This can result in uncoordinated muscle activity, known as epilepsy.
Oxepilax is indicated for the treatment of partial seizures with or without secondary generalized tonic-clonic seizures. Partial seizures involve a limited area of the brain but can spread to the entire brain and may cause generalized tonic-clonic seizures. There are two types of partial seizures: simple and complex. In simple partial seizures, the patient remains conscious, and in complex partial seizures, the patient's consciousness is impaired.
The action of Oxepilax is to inhibit "overexcited" brain cells.
This helps to prevent or reduce the frequency of similar seizures.
Oxepilax can be used as monotherapy (as the only medicine) or in combination with other antiepileptic medicines.
Usually, the doctor tries to find the most suitable medicine for the patient. However, for patients with severe disorders, it may be necessary to take two or more medicines to control seizures.
Oxepilax can be used in adults and children aged 6 years and older.
If the patient has questions about how Oxepilax works and why it has been prescribed, they should consult their doctor.

2. Important information before taking Oxepilax

Follow the doctor's instructions, even if they differ from the information in this leaflet.

Monitoring during treatment with Oxepilax

Before and during treatment with Oxepilax, the doctor may perform blood tests to determine the correct dose of the medicine for the patient. The doctor will inform when such tests should be performed.

When not to take Oxepilax

If this applies to the patient, they should inform their doctor before taking Oxepilax. If the patient thinks they may be allergic, they should ask their doctor for advice.

Warnings and precautions

Before starting Oxepilax, discuss with your doctor or pharmacist if any of the following situations apply to you:

severe hypersensitivity reaction(rash or other hypersensitivity symptom) to carbamazepine or any other medicine. If you are allergic to carbamazepine, the likelihood of being allergic to oxcarbazepine is 25%, which means it may occur in 1 in 4 patients,kidney problems,liver problems,diuretics(medicines that increase urine production),heart problems, shortness of breath, swelling of the feet or legs due to fluid accumulation,
hormonal contraceptives, such as birth control pills, Oxepilax may reduce their effectiveness. It is recommended to use other or additional non-hormonal contraceptive methods during treatment with Oxepilax to prevent unplanned pregnancy. You should inform your doctor immediately if you experience irregular bleeding or spotting. You should consult your doctor or pharmacist if you have any further doubts.

In patients of Chinese Han population and Thai population, there is a risk of severe skin reactions associated with carbamazepine or substances with a similar chemical structure, which can be predicted by a blood test. The doctor should advise the patient whether such tests are necessary before starting oxcarbazepine.

If you experience any of the following side effects while taking Oxepilax, consult your doctor or the nearest hospital immediately:

Oxepilax:

allergyafter starting Oxepilax. Symptoms such as: swelling of the lips, eyelids, face, throat, or mouth, and sudden breathing difficulties, fever with swollen lymph nodes, rash or skin peeling,hepatitis, such as jaundice (yellowing of the skin or whites of the eyes),blood disorders, such as fatigue, shortness of breath after physical exertion, pale skin, headache, chills, dizziness, frequent infections leading to fever, sore throat, mouth ulcers, bleeding or easy bruising, nosebleeds, red or purple spots, or unexplained skin spots,

If you experience any of the following side effects after starting Oxepilax, consult your doctor as soon as possible:

fast or very slow heart rate.

Children and adolescents

In children, the doctor may recommend monitoring thyroid function before and during treatment.

Oxepilax and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
This is especially important for:

• hormonal contraceptives, such as birth control pills (see: Warnings and precautions),
• other antiepileptic medicines and enzyme inducers, such as carbamazepine, phenobarbital, phenytoin, lamotrigine, or rifampicin,
• medicines that lower sodium levels in the blood, such as diuretics (used to increase urine production), desmopressin, and non-steroidal anti-inflammatory drugs, such as indomethacin,
• lithium and monoamine oxidase inhibitors (used to treat mood swings and certain types of depression),
• immunosuppressants, such as cyclosporine, tacrolimus.

Oxepilax with food, drink, and alcohol

Oxepilax can be taken with or without food.
Alcohol may enhance the sedative effect of Oxepilax. You should avoid drinking alcohol during treatment and 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 taking this medicine.
It is essential to control epileptic seizures during pregnancy. However, taking antiepileptic medicines during pregnancy poses a risk to the baby.
Congenital malformations
Studies have not shown an increased risk of congenital malformations associated with oxcarbazepine use during pregnancy. However, it is impossible to rule out the risk of congenital malformations in the unborn baby.
Developmental disorders of the nervous system
Some studies have shown that exposure to oxcarbazepine in the womb may negatively affect brain development (nervous system development) in children, while other studies have not shown such an effect. It is impossible to rule out the possibility of an impact on nervous system development.
Your doctor will inform you about the benefits and risks of taking Oxepilax and help you decide whether to take the medicine.
Do not stop taking Oxepilax during pregnancy without consulting your doctor.
Before taking any medicine during pregnancy, consult your doctor or pharmacist.
Breastfeeding
If you are breastfeeding, consult your doctor before starting Oxepilax.
The active substance of Oxepilax passes into breast milk. Although available data suggest that the amount of Oxepilax that passes into the baby's body is small, it is impossible to rule out the risk of side effects in the baby. Your doctor will discuss the benefits and risks of breastfeeding while taking Oxepilax. If you are breastfeeding while taking Oxepilax and notice any side effects in your baby, such as excessive sleepiness or poor weight gain, you should inform your doctor immediately.

Driving and using machines

Oxepilax may cause drowsiness, dizziness, blurred vision, double vision, lack of muscle coordination, or reduced consciousness, especially when starting treatment or increasing the dose.
It is essential to consult your doctor about whether you can drive or operate machinery while taking Oxepilax.

Oxepilax contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Oxepilax

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

Adults

• Typically, the initial doseof Oxepilax for adults (including the elderly) is 600 mg per day.
• Take one 300 mg tablet twice a day.
• Your doctor may gradually increase the dose to determine the optimal dose. The best results are usually achieved at a dose between 600 and 2400 mg per day.
• The dose does not change when taking other antiepileptic medicines.
• If you have kidney disease (with renal impairment), the initial dose should be half the typical initial dose.
• If you have severe liver disease, your doctor may adjust the dose accordingly.

Children

Oxepilax can be used in children aged 6 years and older.
The dose used in children depends on their body weight.

• The initial dose is 8-10 mg/kg body weight per day, divided into two doses. For example, a child weighing 30 kg will start treatment with half a 300 mg tablet taken twice a day.
• Your doctor may gradually increase the dose to determine the optimal dose for the child. The best results are usually achieved at a dose of 30 mg/kg body weight per day. The maximum dose used in children is 46 mg/kg body weight per day.

How to take Oxepilax

• Swallow the tablet with a small amount of water.
• If necessary, the tablet can be divided in half.
• For children who cannot swallow tablets or for whom the prescribed dose cannot be given in tablet form, oxcarbazepine is available as an oral suspension.

When and for how long to take Oxepilax

Take Oxepilax twice a day, every day, at approximately the same times, unless your doctor advises otherwise. This will help best control epilepsy. It will also help you remember when to take the tablet.
Your doctor will inform you how long the treatment with Oxepilax will last. The duration of treatment depends on the type of seizures. It may be necessary to take the medicine for several years to control seizures. Do not change the dose or stop treatment without consulting your doctor.

Taking a higher dose of Oxepilax than recommended

If you have taken a higher dose of Oxepilax than recommended, you should immediately consult your doctor or the nearest hospital. Symptoms of overdose with Oxepilax include:

• drowsiness, dizziness, coordination problems, or involuntary eye movements, tremors, or significant worsening of seizures, headache, coma,
• nausea, vomiting, increased uncontrolled movements,
• lethargy, double vision, pupil constriction, blurred vision,
• fatigue,
• shallow or slow breathing (decreased respiratory rate),
• irregular heartbeat (prolonged QTc interval),
• tremors, headache, coma, loss of consciousness, uncontrolled movements of the lips, tongue, limbs,
• aggression, agitation, confusion,
• low blood pressure,
• shortness of breath.

Missing a dose of Oxepilax

If you miss a dose, take it as soon as possible, unless it is almost time for the next dose. Return to your regular dosing schedule. Do not take a double dose to make up for the missed dose.
If you have any doubts or have missed several consecutive doses, consult your doctor.

Stopping Oxepilax

Do not stop taking Oxepilax unless your doctor advises you to do so.
To avoid a sudden increase in seizures, do not stop taking the medicine abruptly.
If treatment needs to be stopped, it should be done gradually, following your doctor's instructions.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Oxepilax can cause side effects, although not everybody gets them.

Consult your doctor or the nearest hospital immediately if you experience any of the following side effects:

The following are signs of potentially serious side effects that may require medical attention. Your doctor will also decide whether to stop taking Oxepilax and how to continue treatment.
Uncommon(may affect up to 1 in 100 people):

• Weight gain, fatigue, hair loss, muscle weakness, feeling cold (symptoms of hypothyroidism).
• Falls.

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

• Swelling of the lips, eyelids, face, throat, or mouth, and difficulty breathing, speaking, or swallowing (symptoms of anaphylactic reaction and angioedema).
• Rash and/or fever, which may be symptoms of a drug reaction with eosinophilia and systemic symptoms (DRESS) or acute generalized exanthematous pustulosis (AGEP).
• Fatigue, shortness of breath after physical exertion, pale skin, headache, chills, dizziness, frequent infections leading to fever, sore throat, mouth ulcers, bleeding or easy bruising, nosebleeds, red or purple spots, or unexplained skin spots (symptoms of decreased platelet or blood cell count).
• Lethargy, confusion, tremors, or significant worsening of seizures (possible symptoms of low sodium levels in the blood due to inappropriate ADH secretion) (see: Warnings and precautions).

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

• Symptoms of hypersensitivity reactions, such as rash, fever, muscle or joint pain.
• Blisters on the skin and/or mucous membranes of the mouth, eyes, or genitals (symptoms of severe allergic reactions, including Lyell's syndrome, Stevens-Johnson syndrome, and erythema multiforme).
• Red, patchy rash on the face, which may be accompanied by fatigue, fever, nausea, or loss of appetite (symptoms of systemic lupus erythematosus).
• Flu-like symptoms and jaundice (yellowing of the skin and whites of the eyes) (symptoms of hepatitis).
• Sudden, severe abdominal pain (stomach), nausea (vomiting), loss of appetite (symptoms of pancreatitis).

If you experience any of the above side effects, consult your doctor or the nearest hospital immediately.

Your doctor will decide whether to stop taking Oxepilax and what further medical care is necessary.
Common(may affect up to 1 in 10 people):

• tremors, coordination problems, involuntary eye movements, anxiety, nervousness, depression, mood swings, rash.

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

• irregular heartbeat, very fast or very slow heartbeat.

If you experience any of the above side effects, consult your doctor as soon as possible.

As soon as possible.Additional medical care may be necessary.

Other side effects that may occur:

These are usually mild to moderate side effects of Oxepilax. Most of these side effects are temporary and will resolve on their own over time.
Very common(may affect more than 1 in 10 people):

• fatigue, headache, dizziness, drowsiness, nausea, vomiting, double vision.

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

• weakness, memory problems, concentration problems, apathy, agitation, disorientation, blurred vision, vision problems, constipation, diarrhea, stomach pain (abdominal pain), acne, hair loss, balance problems, weight gain, speech problems.

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

• high blood pressure,
• hives. During treatment with Oxepilax, elevated liver enzyme levels may also occur.

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

• Additionally, reports have been made of bone disorders, including osteopenia and osteoporosis (thinning of the bones) and fractures. Patients who have taken antiepileptic medicines for a long time, who have had osteoporosis in the past, or who are taking steroids, should consult their doctor or pharmacist.

Inform your doctor if any of the above side effects worsen.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: 22 49 21 301, fax: 22 49 21 309, website:
https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Oxepilax

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton. The expiry date refers to the last day of the month.
There are no special precautions for storing the medicinal product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Oxepilax contains

• The active substance of Oxepilax is oxcarbazepine. Each tablet contains 300 mg or 600 mg of oxcarbazepine.
• The other ingredients are: microcrystalline cellulose, hypromellose, sodium croscarmellose, magnesium stearate, colloidal anhydrous silica, yellow iron oxide (E 172), red iron oxide (E 172).

What Oxepilax looks like and contents of the pack

Oxepilax, 300 mg, tablets are: elongated, light pink tablets with a score line on one side and the marking "3" on the other side.
Oxepilax, 600 mg, tablets are: elongated, light pink tablets with a score line on one side and the marking "6" on the other side.
The tablets are available in blisters containing 50 tablets.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande nº 2, Abrunheira
2710-089 Sintra
Portugal
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Medinfar Manufacturing, S.A.
Parque Industrial Armando Martins Tavares
Rua Outeiro da Armada Nº 5
3150-194 Condeixa-a-Nova
Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Poland
Oxepilax
Date of last revision of the leaflet:07.2024