Oxepilax

Package leaflet: Information for the patient

Oxepilax, 300 mg, tablets
Oxepilax, 600 mg, tablets
Oxcarbazepine
Please read all of this leaflet carefully before taking this medicine, because it contains important information for the patient.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Oxepilax is and what it is used for
2. What you need to know 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 Oxepilax is and what it is used for

What Oxepilax is
The active substance in Oxepilax is oxcarbazepine.
Oxepilax belongs to a group of medicines called antiepileptics.

What Oxepilax is used for
Medicines such as Oxepilax are used in the treatment of epileptic seizures.
Patients diagnosed with epilepsy may experience repeated fits and convulsions.
These seizures occur due to a temporary, uncontrolled electrical activity in the brain.
Nerve cells in a normally functioning brain coordinate body movements by sending organized signals through nerves to muscles. In epilepsy, brain nerve cells send excessive signals in an irregular rhythm. This may result in uncoordinated muscle activity, known as a seizure.

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 may spread to the entire brain and may lead to generalized tonic-clonic convulsions. There are two types of partial seizures: simple and complex. In simple partial seizures, the patient remains conscious, whereas in complex partial seizures, consciousness is impaired.

The action of Oxepilax consists of suppressing the "overexcited" nerve cells in the brain. This helps to prevent or reduce the frequency of such seizures.

Oxepilax may be used as monotherapy (as the only antiepileptic medicine) or in combination with other antiepileptic medicines.
Usually, the doctor will try to find the single most appropriate medicine for treating the patient. However, in patients with severe disorders, controlling seizures may require treatment with two or more medicines.

Oxepilax can be used in adults and children aged 6 years and older.

If you have any questions about how Oxepilax works or why this medicine has been prescribed, please consult your doctor.

2. Important information before using Oxepilax

Follow your doctor's advice, even if it differs from the information contained in this leaflet.

Monitoring during treatment with Oxepilax

Before and during treatment with Oxepilax, your doctor may carry out blood tests to determine the appropriate dose of the medicine for you. Your doctor will inform you when such tests should be performed.

When not to use Oxepilax

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

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

Warnings and precautions

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

• if you have ever experienced severe hypersensitivity (rash or other allergic reaction) to carbamazepine or any other medicine. If you are allergic (hypersensitive) to carbamazepine, there is a 25% chance of being allergic to oxcarbazepine, meaning it may occur in 1 out of 4 patients,
• if you have kidney function disorders,
• if you have liver function disorders,
• if you are taking diuretics ( diuretics – medicines that increase the excretion of minerals and water by increasing urine volume),
• if you have heart function disorders, shortness of breath, or swelling of the feet or lower limbs due to fluid accumulation,
• if laboratory tests have shown low blood sodium levels (see section 4),
• if you are using hormonal contraceptives, such as contraceptive pills, Oxepilax may reduce their effectiveness. It is recommended to use other or additional non-hormonal contraceptive methods during treatment with Oxepilax to prevent unintended pregnancy. Immediately inform your doctor about irregular bleeding or spotting. Consult your doctor or pharmacist if you have any further doubts.

In patients of Han Chinese or Thai origin, there is a risk of severe skin reactions associated with carbamazepine or substances with similar chemical structure. This risk can be predicted by a blood test. Your doctor should advise whether such testing is necessary before starting oxcarbazepine.

If any of the following adverse effects occur while taking Oxepilax, seek immediate medical attention from your doctor or the nearest hospital:

• if you develop an allergic reaction after starting Oxepilax. Symptoms may include swelling of the lips, eyelids, face, throat, or mouth, sudden breathing difficulties, fever with swollen lymph nodes, rash, or skin peeling,
• if you experience symptoms of liver inflammation, such as jaundice (yellowing of the skin or whites of the eyes),
• if seizures increase in frequency; this is particularly important in children but may also affect adults,
• if you experience symptoms of blood disorders, such as fatigue, shortness of breath during physical activity, pale skin, headache, chills, dizziness, frequent infections leading to fever, sore throat, mouth ulcers, bleeding or easy bruising, nosebleeds, or unexplained red or purple spots on the skin,
• in a small number of patients treated with antiepileptic medicines such as Oxepilax, thoughts of self-harm or suicide have occurred. If such thoughts arise, contact your doctor immediately.

If the following adverse effects occur after starting Oxepilax, contact your doctor as soon as possible:

• if you experience rapid or very slow heartbeat.

Children and adolescents

Your doctor may recommend monitoring thyroid function before and during treatment in children.

Oxepilax and other medicines

Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. This especially includes:

• hormonal contraceptives, such as oral contraceptive pills (see: Warnings and precautions),
• other antiepileptic drugs and enzyme-inducing medicines such as carbamazepine, phenobarbital, phenytoin, lamotrigine, or rifampicin,
• medicines that reduce blood sodium levels, such as diuretics (used to facilitate removal of salts and water from the body by increasing urine production), desmopressin, and non-steroidal anti-inflammatory drugs (NSAIDs) such as indomethacin,
• lithium and monoamine oxidase inhibitors (medicines used to treat mood disorders and certain types of depression),
• immunosuppressive medicines such as cyclosporine and tacrolimus.

Oxepilax, food, drink, and alcohol

Oxepilax may be taken with or without food.

Alcohol may enhance the sedative effect of Oxepilax. Avoid alcohol consumption during treatment and consult your doctor.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant, suspect you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before using this medicine.

It is important that seizures are controlled during pregnancy. However, taking antiepileptic medicines during pregnancy carries risks for the unborn child.

Congenital malformations

Studies have not shown an increased risk of congenital malformations associated with oxcarbazepine use during pregnancy. However, a risk of congenital malformations in the unborn child cannot be completely ruled out.

Neurodevelopmental disorders

Some studies suggest that prenatal exposure to oxcarbazepine may negatively affect brain development (nervous system development) in children, while other studies have not shown such an effect. A potential impact on neurodevelopment cannot be excluded.

Your doctor will inform you about the benefits and risks of taking the medicine and help you decide whether to take Oxepilax.

Do not stop taking Oxepilax during pregnancy without consulting your doctor.

During pregnancy, consult your doctor or pharmacist before taking any medicine.

Breastfeeding

If you are taking this medicine, consult your doctor before starting breastfeeding.

The active substance in Oxepilax passes into breast milk. Although available data indicate that the amount of Oxepilax transferred to the nursing infant is low, the risk of adverse effects in the child cannot be excluded. Your doctor will discuss with you the benefits and risks of breastfeeding while taking Oxepilax. If you breastfeed while taking Oxepilax and notice adverse effects in your child such as excessive sleepiness or poor weight gain, inform your doctor immediately.

Driving and operating machinery

Oxepilax may cause drowsiness, dizziness, blurred vision, double vision, lack of muscle coordination, or reduced level of consciousness, especially at the beginning of treatment or during dose escalation.

It is important to consult your doctor whether you may drive or operate machinery while taking this medicine.

Oxepilax contains sodium

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

3. How to take Oxepilax

This medicine should always be taken exactly as prescribed by your doctor, even if this differs from the information provided in this leaflet. If in doubt, consult your doctor or pharmacist.

Use in adults

• The usual starting dose of Oxepilax in adults (including elderly patients) is 600 mg per day.
• Take one 300 mg tablet twice daily.
• Your doctor may gradually increase the dose to determine the optimal dose. The best results are usually achieved with a dose between 600 and 2400 mg per day.
• The dose does not need to be adjusted when other antiepileptic medicines are used.
• If the patient suffers from kidney disease (with renal impairment), the starting dose should be half the usual recommended starting dose.
• If the patient suffers from severe liver disease, the doctor may adjust the dose accordingly.

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

• The initial dose is 8 to 10 mg/kg body weight per day, given in two divided doses. For example, a child weighing 30 kg would start treatment with half of a 300 mg tablet taken twice daily.
• The 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 may be divided into halves.
• For children who cannot swallow tablets or for whom the prescribed dose cannot be administered in tablet form, oxcarbazepine is available as an oral suspension.

When and for how long to take Oxepilax
Oxepilax should be taken twice daily, at approximately the same times each day, unless otherwise directed by your doctor. This helps control epilepsy most effectively and makes it easier to remember when to take the tablet.
Your doctor will inform you how long treatment with Oxepilax will last. The duration of treatment depends on the type of seizures. Long-term treatment, possibly lasting many years, may be necessary to control seizures. Do not change the dose or stop treatment without consulting your doctor.

If you take more Oxepilax than you should
If you take more Oxepilax than recommended, you should immediately contact your doctor or go to the nearest hospital. Symptoms of overdose with Oxepilax may include:

• drowsiness, dizziness, problems with coordination and/or involuntary eye movements, muscle twitching or significantly worsened seizures, headache, coma,
• nausea, vomiting, increased uncontrolled movements,
• lethargy, double vision, constricted pupils, blurred vision,
• feeling of fatigue,
• shallow and shortened breathing (reduced respiratory rate),
• irregular heartbeat (prolongation of QTc interval),
• tremor, headache, coma, loss of consciousness, uncontrolled movements of lips, tongue, limbs,
• aggression, agitation, confusion,
• low blood pressure,
• breathing difficulties.

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

Stopping Oxepilax
Do not stop taking this medicine unless your doctor advises you to do so.
To prevent a sudden increase in seizures, do not stop taking the medicine abruptly.
If treatment needs to be discontinued, it should be done gradually, according to your doctor's instructions.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Oxepilax may cause adverse reactions, although not everyone will experience them.
You should immediately inform your doctor or go to the nearest hospital if any of the following adverse reactions occur:
Below are signs of potentially serious adverse reactions that may require medical attention. Your doctor will decide whether treatment with Oxepilax should be stopped immediately and how therapy should be continued.

Uncommon (may occur in fewer than 1 in 100 patients):

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

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

• Swelling of lips, eyelids, face, throat or mouth, accompanied by difficulty breathing, speaking or swallowing (symptoms of anaphylactic reaction and angioedema).
• Skin rash and/or fever, which may be signs of drug reaction with eosinophilia and systemic symptoms (DRESS), or acute generalized exanthematous pustulosis (AGEP).
• Fatigue, shortness of breath during 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 or blood cell counts).
• Drowsiness, confusion, muscle tremor or significant worsening of seizures (possible symptoms of low blood sodium levels due to inappropriate ADH secretion) (see: Warnings and precautions).

Very rare (may occur in fewer 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, nasal passages or genitalia (symptoms of severe allergic reactions, including Lyell syndrome, Stevens-Johnson syndrome and erythema multiforme).
• Red, blotchy rash mainly on the face, possibly 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 pain in the upper abdomen (stomach), nausea (vomiting), loss of appetite (symptoms of pancreatitis).

If any of the above adverse symptoms occur, you should immediately consult a doctor or go to the emergency department of the nearest hospital.
Your doctor will decide whether treatment with Oxepilax should be stopped immediately and what further medical care should be provided.

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

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

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

• Irregular heartbeat, very fast or very slow heart rate.

If any of the above adverse symptoms occur, you should consult a doctor as soon as possible. Additional medical care may be necessary.

Other adverse reactions that may occur:
These are usually mild to moderate adverse reactions associated with Oxepilax. Most of these effects are transient and resolve over time.

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

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

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

• Weakness, memory disturbances, concentration difficulties, apathy, agitation, disorientation, blurred vision, visual disturbances, constipation, diarrhoea, stomach (abdominal) pain, acne, hair loss, balance disorders, weight gain, speech disorders.

Uncommon (may occur in fewer than 1 in 100 patients):

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

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

• In addition, bone disorders have been reported, including osteopenia and osteoporosis (bone thinning) and fractures. Patients who are taking antiepileptic drugs long-term, who have previously been diagnosed with osteoporosis, or who are taking steroids should consult their doctor or pharmacist.

You should inform your doctor if any of the symptoms listed above worsen.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Oxepilax

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

6. Contents of the pack and other information

What Oxepilax contains

• The active substance in 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: elongated, light pink tablets with a division line on one side and
imprinted with the mark "3" on the other side.
Oxepilax 600 mg tablets: elongated, light pink tablets with a division line on one side
and imprinted with the mark "6" on the other side.
The tablets are available in blisters containing 50 tablets.

Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

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
Poland
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 authorised for sale in the European Economic Area under the following names:
Poland Oxepilax