Oxepilax

Leaflet attached to the packaging: patient information

Oxepilax, 300 mg, tablets

Oxepilax, 600 mg, tablets

Oxcarbazepine

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects 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 who have been diagnosed with epilepsy have recurring seizures and convulsions. These seizures occur because of 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. The result can be uncoordinated muscle activity, which is referred to 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 can 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 such seizures. Oxepilax can be used as monotherapy (as the only medicine) or in combination with other antiepileptic medicines. Usually, the doctor tries to find one medicine that is most suitable for the patient. However, in the case of patients with severe disorders, it may be necessary to administer 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

You should follow your doctor's instructions, even if they differ from the information contained in this leaflet.

Monitoring during treatment with Oxepilax

Before and during treatment with Oxepilax, your doctor may perform blood tests to determine the correct dose of the medicine for you. Your doctor will inform you when to perform such tests.

When not to take Oxepilax

If this applies to you, you should inform your doctor before taking Oxepilax. If you think you may be allergic, you should ask your doctor for advice.

Warnings and precautions

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

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 performing a blood test. Your doctor should advise you whether such tests are necessary before starting oxcarbazepine treatment.

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

Oxepilax:

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

Children and adolescents

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

Oxepilax and other medicines

You should 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 reduce sodium levels in the blood, such as diuretics (used to increase the excretion of mineral salts and water through increased urine production), desmopressin, and non-steroidal anti-inflammatory drugs, such as indomethacin,
• lithium and monoamine oxidase inhibitors (medicines used to treat mood swings and certain types of depression),
• medicines that control the immune system, 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 consuming alcohol during treatment and consult your doctor.

Pregnancy, breastfeeding, and fertility

Pregnancy If you are pregnant, think you may be pregnant, or plan to have a child, you should 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 child. 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 child. Developmental disorders Some studies have shown that exposure to oxcarbazepine in the womb may negatively affect brain development (neurodevelopment) in children, while other studies have not shown such an effect. It is impossible to rule out the possibility of an impact on neurodevelopment. Your doctor will inform you about the benefits and risks of taking Oxepilax and help you decide whether to take the medicine. You should not stop taking Oxepilax during pregnancy without consulting your doctor. Before taking any medicine during pregnancy, you should consult your doctor or pharmacist. Breastfeeding If you are breastfeeding, you should 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 infant's body is small, it is impossible to rule out the risk of side effects in the child. 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 child, such as excessive sleepiness or poor weight gain, you should immediately inform your doctor.

Driving and using machines

Oxepilax may cause drowsiness or 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 the medicine.

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

You should always take this medicine exactly as your doctor has instructed, even if it differs from the information provided in the leaflet. If you have any doubts, you should consult your doctor or pharmacist.

Adults

• The usual initial dose of Oxepilax in adults (including the elderly) is 600 mg per day.
• You should 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 usual 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 who have been prescribed a dose that cannot be given in tablet form, oxcarbazepine is available as an oral suspension.

When and for how long to take Oxepilax

Oxepilax should be taken twice a day, every day, at approximately the same times, unless your doctor instructs otherwise. This will help best control epilepsy. It will also make it easier to 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. You should 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 significantly increased seizures, headache, coma,
• nausea, vomiting, increased uncontrolled movements,
• lethargy, double vision, pupil constriction, blurred vision,
• fatigue,
• shallow or slow breathing (reduced 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, you should take it as soon as possible, unless it is almost time for the next dose. You should then return to your regular dosing schedule. You should not take a double dose to make up for a missed dose. If you have any doubts or have missed several consecutive doses, you should consult your doctor.

Stopping Oxepilax treatment

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

4. Possible side effects

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

You should immediately inform your doctor or go to the nearest hospital 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 immediately and how to continue treatment. Uncommon(may occur in less than 1 in 100 patients):

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

Rare(may occur in less than 1 in 1,000 patients):

• Swelling of the lips, eyelids, face, throat, or mouth, and accompanying difficulty breathing, speaking, and swallowing (symptoms of anaphylactic reaction and angioedema).
• Rash and/or fever, which may be symptoms of drug rash 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, unexplained skin spots (symptoms of reduced platelet count 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 occur in less than 1 in 10,000 patients):

• Symptoms of hypersensitivity reactions, such as rash, fever, muscle and joint pain.
• Blisters on the skin and/or mucous membranes of the mouth, eyes, and genitals (symptoms of severe allergic reactions, including Lyell's syndrome, Stevens-Johnson syndrome, and erythema multiforme).
• Red spotted 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).
• Severe abdominal pain (stomach), nausea (vomiting), loss of appetite (symptoms of pancreatitis).

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

Your doctor will decide whether to stop taking Oxepilax immediately and what further medical care is necessary. Frequent(may occur in less than 1 in 10 patients):

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

Very rare(may occur in less than 1 in 10,000 patients):

• Irregular heartbeat, very fast or very slow heartbeat.

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

Very common(may occur in more than 1 in 10 patients):

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

Common(may occur in less than 1 in 10 patients):

• 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 occur in less than 1 in 100 patients):

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

Rare(may occur in less than 1 in 1,000 patients):

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

You should inform your doctor if any of the above side effects worsen.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Oxepilax

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the blister 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. You should 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 dividing line on one side and the marking "3" on the other side. Oxepilax, 600 mg, tablets are: elongated, light pink tablets with a dividing 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