Oxcarbazepin Neuropharma

Leaflet attached to the packaging: information for the user

Oxcarbazepine NeuroPharma, 150 mg, coated tablets

Oxcarbazepine NeuroPharma, 300 mg, coated tablets

Oxcarbazepine NeuroPharma, 600 mg, coated tablets

Oxcarbazepine

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a 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.
• 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 Oxcarbazepine NeuroPharma and what is it used for
• 2. Important information before taking Oxcarbazepine NeuroPharma
• 3. How to take Oxcarbazepine NeuroPharma
• 4. Possible side effects
• 5. How to store Oxcarbazepine NeuroPharma
• 6. Contents of the packaging and other information

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

What is Oxcarbazepine NeuroPharma
Oxcarbazepine NeuroPharma contains the active substance oxcarbazepine.
Oxcarbazepine NeuroPharma belongs to a group of medicines called antiepileptics or anticonvulsants.
When is Oxcarbazepine NeuroPharma used
Medicines like Oxcarbazepine NeuroPharma are used to treat epilepsy.
Epilepsy is a disorder of brain activity that causes patients to have recurring seizures and convulsions. They are caused by temporary periods of uncontrolled electrical activity in the brain. In healthy people, brain cells coordinate body movements by sending organized signals through nerve cells to muscles. In epilepsy, brain cells send too many signals in an uncontrolled way. As a result, uncoordinated muscle movements occur, called epileptic seizures.
Oxcarbazepine NeuroPharma is used to treat partial seizures with or without secondary generalized tonic-clonic seizures. Partial seizures affect a limited area of the brain and may spread to the entire brain, causing generalized tonic-clonic seizures. There are two types of partial seizures: simple and complex. In simple partial seizures, the patient remains conscious, while in complex partial seizures, the patient's consciousness changes.
The action of Oxcarbazepine NeuroPharma is to control the so-called "overexcited" nerve cells in the brain, which inhibits the occurrence or reduces the frequency of epileptic seizures.
Oxcarbazepine NeuroPharma can be used as a single medicine or in combination with other antiepileptic medicines.
Usually, the doctor tries to find one medicine that is most suitable for the adult or child patient. However, in more severe cases of epilepsy, it may be necessary to take two or more medicines together to control seizures.
Oxcarbazepine NeuroPharma is used in adult patients and children aged 6 years and older.
You should ask your doctor if you have any questions about how Oxcarbazepine NeuroPharma works and why it has been prescribed.

2. Important information before taking Oxcarbazepine NeuroPharma

Oxcarbazepine NeuroPharma should always be taken as directed by your doctor, even if it differs from the information in this leaflet.

Monitoring during treatment with Oxcarbazepine NeuroPharma

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

When not to take Oxcarbazepine NeuroPharma

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

Warnings and precautions

Tell your doctor or pharmacist before taking Oxcarbazepine NeuroPharma:

hypersensitivity reaction(rash or other allergic symptoms) to carbamazepine or any other medicine. If you are allergic to carbamazepine, there is a 1 in 4 (25%) chance that you may also be allergic to oxcarbazepine (Oxcarbazepine NeuroPharma).kidney disease;liver disease;diuretics(used to remove salt and water from the body by increasing the amount of urine produced);heart disease,characterized by shortness of breath and/or swelling of the feet or legs due to fluid retention;low sodium levelsin the blood (see section 4: Possible side effects);hormonal contraceptives,(such as birth control pills), Oxcarbazepine NeuroPharma may reduce their effectiveness. You should use other or additional (non-hormonal) methods of contraception while taking Oxcarbazepine NeuroPharma to prevent unwanted pregnancy. If you experience irregular menstrual bleeding or spotting, you should inform your doctor immediately.

In patients of Chinese Han descent and in Thai patients, there is a risk of severe skin reactions associated with carbamazepine treatment or a substance with a similar chemical structure, which can be predicted based on blood test results. Your doctor should inform you whether a blood test is necessary before starting oxcarbazepine treatment.
You should immediately tell your doctor or go to the nearest hospital if you experience any of the following symptoms after starting Oxcarbazepine NeuroPharma:

• Allergic reaction;symptoms include swelling of the lips, eyelids, face, throat, mouth, or sudden breathing problems, fever with swollen lymph nodes, rash, or blistering skin changes;
• jaundice (yellowing of the skin and whites of the eyes) - may be a sign of hepatitis;
• increased frequency of seizures; this is especially important in children, but may also apply to adults;
• fatigue, shortness of breath during exertion, pallor, headache, chills, dizziness, frequent infections causing fever, sore throat, mouth ulcers, easier than usual bleeding or bruising, nosebleeds, red or purple spots on the skin, or unexplained skin discoloration - may be signs of blood disorders;
• in a small number of patients taking antiepileptic medicines, such as oxcarbazepine, thoughts of self-harm or suicide have occurred. If such thoughts occur, the patient should immediately consult their doctor;
• rapid or extremely slow heart rate.

Children and adolescents

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

Oxcarbazepine NeuroPharma 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 (see section: Warnings and precautions);
• other antiepileptic medicines and enzyme inducers, such as carbamazepine, phenobarbital, phenytoin, lamotrigine, and rifampicin;
• medicines that lower sodium levels in the blood, such as diuretics (used to remove salt and water from the body by increasing the amount of urine produced), desmopressin, and non-steroidal anti-inflammatory drugs, such as indomethacin;
• lithium and monoamine oxidase inhibitors (medicines used to treat mood disorders and certain types of depression);
• medicines that affect the immune system, such as cyclosporine and tacrolimus.

Taking Oxcarbazepine NeuroPharma with food, drink, and alcohol

Oxcarbazepine NeuroPharma can be taken with or without food.
Alcohol may enhance the sedative effect of Oxcarbazepine NeuroPharma. You should avoid consuming alcohol while taking Oxcarbazepine NeuroPharma. If in doubt, consult your doctor.

Pregnancy, breastfeeding, and fertility

Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medicine.
During pregnancy, it is essential to control epileptic seizures. However, taking antiepileptic medicines during pregnancy may pose a risk to the unborn child. Your doctor will inform you about the benefits and risks of taking Oxcarbazepine NeuroPharma and help you decide whether to take the medicine.
You should not stop taking Oxcarbazepine NeuroPharma during pregnancy without consulting your doctor.
Breastfeeding
Oxcarbazepine NeuroPharma should not be taken during breastfeeding.
The active substance of Oxcarbazepine NeuroPharma passes into breast milk. There is a risk of side effects in breastfed infants. Before taking this medicine while breastfeeding, you should consult your doctor or pharmacist.

Driving and using machines

Oxcarbazepine NeuroPharma may cause drowsiness or dizziness, or blurred vision, double vision, lack of muscle coordination, or reduced awareness, especially at the beginning of treatment or when increasing the dose.
It is crucial to determine with your doctor whether you can drive or operate machinery while taking Oxcarbazepine NeuroPharma.

3. How to take Oxcarbazepine NeuroPharma

This medicine should always be taken as directed by your doctor or pharmacist, even if it differs from the information in this leaflet. If in doubt, consult your doctor or pharmacist.
Recommended dose
The dose used in adult patients

• Usual initial doseof Oxcarbazepine NeuroPharma in adult patients (including elderly patients) is 600 mg per day.
• You should take 1 tablet of 300 mg twice a day or 2 tablets of 150 mg twice a day.
• Your doctor may gradually increase the dose until the best therapeutic effect is achieved. This is usually achieved with doses ranging from 600 mg to 2400 mg per day.
• The dose is the same if Oxcarbazepine NeuroPharma is taken with another antiepileptic medicine.
• In patients with kidney disease (renal impairment), the initial dose is half the usual initial dose.
• In patients with severe liver disease, the doctor will determine the appropriate dose.

Dose used in children and adolescents
Oxcarbazepine NeuroPharma can be used in children aged 6 years and older.
The dose in children depends on their 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 one 150 mg tablet twice a day.
• Your doctor may gradually increase the dose until the best therapeutic effect is achieved for the child. The best therapeutic effect is usually achieved with a dose of 30 mg/kg body weight per day. The maximum daily dose for children is 46 mg/kg body weight per day.

How to take Oxcarbazepine NeuroPharma

• Tablets should be swallowed with a small amount of water.
• Tablets can be divided into equal doses.
• For small children who cannot swallow tablets or for whom the required dose of the medicine cannot be given in tablet form, oxcarbazepine is available in an oral suspension.

When and for how long to take Oxcarbazepine NeuroPharma
Oxcarbazepine NeuroPharma should be taken twice a day, every day, at the same time, unless your doctor advises otherwise. Taking the medicine in this way has the best effect on controlling epileptic seizures. It will also help you remember when to take the tablet.
Your doctor will determine the duration of treatment with Oxcarbazepine NeuroPharma in adult and child patients. It depends on the type of seizures. To control seizures, treatment may last for many years. You should not change the prescribed dose or stop treatment without consulting your doctor.

Taking a higher dose of Oxcarbazepine NeuroPharma than recommended

If you have taken more tablets than prescribed by your doctor, you should immediately contact the nearest hospital or your doctor. Symptoms of Oxcarbazepine NeuroPharma overdose may include:

• drowsiness, dizziness, coordination problems, and/or involuntary eye movements, muscle tremors, or significantly increased seizures, headache, loss of consciousness, coma,
• nausea, vomiting, increased uncontrolled movements,
• lethargy, double vision, pupil constriction, blurred vision,
• fatigue,
• shallow and rapid breathing (respiratory depression),
• irregular heartbeat (QTc interval prolongation),
• tremors, headaches, coma, reduced awareness, uncontrolled movements of the mouth, tongue, and limbs,
• aggression, restlessness, disorientation,
• low blood pressure,
• shortness of breath.

Missing a dose of Oxcarbazepine NeuroPharma

If you miss a dose of the medicine, you should take it as soon as possible. However, if it is almost time for the next dose, do not take the missed dose. You should continue treatment according to the established dosage schedule. In no case should you take a double dose to make up for the missed dose. If in doubt or if you have missed several doses of the medicine, you should consult your doctor.

Stopping treatment with Oxcarbazepine NeuroPharma

You should not stop taking Oxcarbazepine NeuroPharma without consulting your doctor.
Never stop taking the medicine abruptly, as it may cause a sudden increase in seizures.
If treatment is to be discontinued, the medicine should be withdrawn gradually, as advised by your doctor.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

You should immediately inform your doctor or go to the nearest hospital emergency department if you experience any of the following side effects.

These include the following symptoms, which occur very rarely (may affect 1 to 10,000 people), but may require urgent medical attention.
Your doctor will also decide whether to stop taking Oxcarbazepine NeuroPharma immediately and how to continue treatment.

• Swelling of the lips, eyelids, face, throat, or mouth, accompanied by difficulty breathing, speaking, or swallowing (symptoms of anaphylactic reactions and angioedema) or other hypersensitivity symptoms, such as: rash, fever, and muscle or joint pain.
• Severe blistering skin and/or mucous membrane lesions on the lips, eyes, mouth, nose, or genitals (symptoms of severe hypersensitivity reactions, including Lyell's syndrome, Stevens-Johnson syndrome, and erythema multiforme).
• Fatigue, shortness of breath during exertion, pallor, headache, chills, dizziness, frequent infections causing fever, sore throat, mouth ulcers, easier than usual bleeding or bruising, nosebleeds, red or purple spots on the skin, or unexplained skin discoloration (symptoms of reduced platelet or white blood cell count).
• Red spots on the skin similar to a rash, mainly on the face, accompanied by fatigue, fever, nausea, or loss of appetite (symptoms of systemic lupus erythematosus)
• Lethargy, confusion, tremors, or significantly increased seizures (possible symptoms of low sodium levels in the blood; see section: Warnings and precautions).
• Flu-like symptoms with jaundice (yellowing of the skin or whites of the eyes) (symptoms of hepatitis)
• Severe abdominal pain, vomiting, loss of appetite (symptoms of pancreatitis)
• Weight gain, fatigue, hair loss, muscle weakness, feeling cold (symptoms of hypothyroidism).

You should inform your doctor as soon as possible if you experience any of the following side effects, as medical attention may be required.

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

• tremors, coordination disorders, uncontrolled eye movements, restlessness, and nervousness, depression, mood swings, rash. Very rare(may affect up to 1 in 10,000 people):
• irregular heartbeat, very rapid or very slow heart rate.

Other side effects may occur:

These side effects of Oxcarbazepine NeuroPharma are usually mild to moderate.
Most of them are temporary and usually resolve gradually.
Very common(may affect more than 1 in 10 people)

• fatigue, headache, dizziness, drowsiness, feeling sick (nausea), vomiting, double vision. Common(may affect up to 1 in 10 people):
• weakness, memory disorders, concentration disorders, apathy, restlessness, confusion, blurred vision, vision disorders, constipation, diarrhea, stomach pain (abdominal pain), acne, hair loss, balance disorders, weight gain. Uncommon(may affect up to 1 in 100 people):
• hives, increased liver enzyme activity during Oxcarbazepine NeuroPharma treatment. Frequency not known(frequency cannot be estimated from the available data):
• high blood pressure, speech disorders.

Additionally, reports have been made of bone disorders, including osteopenia and osteoporosis (reduced bone density), as well as fractures. You should consult your doctor or pharmacist if you have been taking antiepileptic medicines for a long time, if you have had osteoporosis in the past, or if you have taken steroids.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Oxcarbazepine NeuroPharma

• This 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 medicine.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
• 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 packaging and other information

What Oxcarbazepine NeuroPharma contains

• The active substance is oxcarbazepine.
• Each Oxcarbazepine NeuroPharma 150 mg coated tablet contains 150 mg of oxcarbazepine.
• Each Oxcarbazepine NeuroPharma 300 mg coated tablet contains 300 mg of oxcarbazepine.
• Each Oxcarbazepine NeuroPharma 600 mg coated tablet contains 600 mg of oxcarbazepine.

Other ingredients of the medicine are:

150 mg coated tablets

• Core:dental silica, microcrystalline cellulose, hypromellose 3cP, hypromellose 15cP, crospovidone (type A), magnesium stearate.
• Coating:opadry green 03F510008, hypromellose 6cP, titanium dioxide (E 171), macrogol 8000, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172), talc.

300 mg coated tablets

• Core:dental silica, microcrystalline cellulose, hypromellose 3cP, hypromellose 15cP, crospovidone (type A), magnesium stearate.
• Coating:opadry yellow 03F520067, hypromellose 6cP, titanium dioxide (E 171), macrogol 8000, yellow iron oxide (E 172), red iron oxide (E 172), talc.

600 mg coated tablets

• Core:dental silica, microcrystalline cellulose, hypromellose 3cP, hypromellose 15cP, crospovidone (type A), magnesium stearate.
• Coating:opadry pink 03F540043, hypromellose 6cP, titanium dioxide (E 171), macrogol 8000, yellow iron oxide (E 172), red iron oxide (E 172), talc.

What Oxcarbazepine NeuroPharma looks like and contents of the pack

The 150 mg tablets are light greenish-gray, oval, with a dividing line on both sides, approximately 4.4 mm thick, 11.1 mm long, and 5.6 mm wide, with a dividing line on both sides and marked with the numbers "150" on one side of the dividing line on one side of the tablet.
The 300 mg tablets are yellow, oval, with a dividing line on both sides, approximately 5.4 mm thick, 15.1 mm long, and 6.6 mm wide, with a dividing line on both sides and marked with the numbers "300" on one side of the dividing line on one side of the tablet.
The 600 mg tablets are pink, oval, with a dividing line on both sides, approximately 7.0 mm thick, 18.6 mm long, and 8.1 mm wide, with a dividing line on both sides and marked with the numbers "600" on one side of the dividing line on one side of the tablet.
Tablets can be divided into equal doses.
The coated tablets are available in blisters containing 10, 50, 100, 200, and 1000 (for hospital use) coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Straße 23
40764 Langenfeld
Germany
To obtain more detailed information, please contact the representative of the marketing authorization holder in Poland:
Neuraxpharm Polska sp. z o.o.
Domaniewska 37
02-672 Warsaw
info-poland@neuraxpharm.com

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

Germany: Oxcarbazepin-neuraxpharm 150 mg Filmtabletten
Oxcarbazepin-neuraxpharm 300 mg Filmtabletten
Oxcarbazepin-neuraxpharm 600 mg Filmtabletten
Poland: Oxcarbazepine NeuroPharma, 150 mg coated tablets
Oxcarbazepine NeuroPharma, 300 mg coated tablets
Oxcarbazepine NeuroPharma, 600 mg coated tablets

Date of last revision of the leaflet: