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

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your 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 pack 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 repeated 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 involve 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 is altered.
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 and child patients 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 tell you when to have these tests.

When not to take Oxcarbazepine NeuroPharma

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

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

Warnings and precautions

Tell your doctor or pharmacist before taking Oxcarbazepine NeuroPharma:

• if you have had a 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).
• if you have kidney disease;
• if you have severe liver disease;
• if you are taking diuretics(used to remove salt and water from the body by increasing the amount of urine produced);
• if you have heart disease,characterized by shortness of breath and/or swelling of the feet or ankles due to fluid retention;
• if you have low sodium levelsin the blood (see section 4: Possible side effects);
• if you are taking hormonal contraceptives,(such as birth control pills), Oxcarbazepine NeuroPharma may reduce their effectiveness. It is recommended to 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, tell your doctor immediately.

In patients of Chinese Han and Thai origin, 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 tell you if a blood test is necessary before starting oxcarbazepine.
Tell your doctor or go to the nearest hospital immediately 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;
• 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 bruising or bleeding, 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 a 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 taking, have recently taken, or plan to take.
This includes:

• hormonal contraceptives (see 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 drinking 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, ask your doctor for advice 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.
Do 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 during breastfeeding, consult your doctor or pharmacist.

Driving and using machines

Oxcarbazepine NeuroPharma may cause drowsiness, dizziness, or blurred vision, or 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 you are unsure, ask your doctor or pharmacist.
Recommended dose
Dose used in adult patients

• Usual initial doseof Oxcarbazepine NeuroPharma in adult patients (including elderly patients) is 600 mg per day.
• 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 to achieve the best therapeutic effect. This is usually achieved with doses in the range of 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 body weight.

• 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 with one 150 mg tablet twice a day.
• Your doctor may gradually increase the dose to achieve the best therapeutic effect 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

• Swallow the tablets 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 cannot be given in tablet form, oxcarbazepine is available as 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 will help control epileptic seizures best. It will also help you remember when to take the tablet.
Your doctor will determine the duration of treatment with Oxcarbazepine NeuroPharma for adult and child patients. It depends on the type of seizure. To control seizures, treatment may last for many years. Do 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, contact the nearest hospital or doctor immediately. 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, confusion, muscle tremors, or significantly increased seizures, double vision, pupil constriction, blurred vision,
• fatigue,
• shallow or slow breathing (respiratory depression),
• irregular heartbeat (QTc prolongation),
• tremors, headaches, coma, reduced awareness, uncontrolled movements of the mouth, tongue, and limbs,
• aggression, agitation, disorientation,
• low blood pressure,
• shortness of breath.

Missing a dose of Oxcarbazepine NeuroPharma

If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, do not take the missed dose. Continue treatment according to the prescribed dosing schedule. Never take a double dose to make up for a missed dose. If you are unsure or have missed several doses, consult your doctor.

Stopping treatment with Oxcarbazepine NeuroPharma

Do 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 questions about taking this medicine, ask 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 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 bruising or bleeding, 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 (feeling sick), or loss of appetite (symptoms of systemic lupus erythematosus).
• Lethargy, confusion, muscle tremors, or significantly increased seizures (possible symptoms of low sodium levels in the blood; see 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 problems, uncontrolled eye movements, restlessness and nervousness, depression, mood swings, rash. Very rare(may affect up to 1 in 10,000 people):
• irregular heartbeat, very fast 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 problems, concentration problems, apathy, agitation, confusion, blurred vision, vision problems, constipation, diarrhea, stomach pain (abdominal pain), acne, hair loss, balance problems, 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 problems.

Additionally, bone disorders, including osteopenia and osteoporosis (reduced bone density), and fractures have been reported. 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 those not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Al. Jerozolimskie 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 this medicine.

5. How to store Oxcarbazepine NeuroPharma

• This medicine should be stored out of the 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 storage instructions for this 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. 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 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:silica, colloidal, microcrystalline cellulose, hypromellose 3cP, hypromellose 15cP, crospovidone (type A), magnesium stearate.
• Coating:opadry green 03F510008, hypromellose 6cP, titanium dioxide (E 171), macrogol 8000, iron oxide yellow (E 172), iron oxide red (E 172), iron oxide black (E 172), talc.

300 mg coated tablets

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

600 mg coated tablets

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

What Oxcarbazepine NeuroPharma looks like and contents of the pack

The 150 mg tablets are pale green, oval, with a score line on both sides, approximately 4.4 mm thick, 11.1 mm long, and 5.6 mm wide, with a score line on both sides and marked with the numbers "150" on one side of the score line on one side of the tablet.
The 300 mg tablets are yellow, oval, with a score line on both sides, approximately 5.4 mm thick, 15.1 mm long, and 6.6 mm wide, with a score line on both sides and marked with the numbers "300" on one side of the score line on one side of the tablet.
The 600 mg tablets are pink, oval, with a score line on both sides, approximately 7.0 mm thick, 18.6 mm long, and 8.1 mm wide, with a score line on both sides and marked with the numbers "600" on one side of the score 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.
ul. 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: