Karbagen

Leaflet included in the packaging: patient information

Karbagen, 150 mg, coated tablets

Karbagen, 300 mg, coated tablets

Karbagen, 600 mg, coated tablets

Oxcarbazepine
You should carefully read the contents of this 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 further questions, you should 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, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Karbagen and what is it used for

Karbagen contains the active substance oxcarbazepine.
Karbagen belongs to a group of antiepileptic or anticonvulsant medicines used to treat epilepsy.
Karbagen helps control seizures or fits in patients with epilepsy.
In people with epilepsy, there are periods of uncontrolled electrical activity in the brain.
These periods of uncontrolled electrical activity can lead to seizures. Oxcarbazepine helps control the electrical activity of the brain. This reduces the likelihood of seizures.
Karbagen is used to treat partial seizures with or without secondary generalized tonic-clonic seizures. Partial seizures affect a limited area of the brain, but can spread to the entire brain and cause 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.
Oxcarbazepine is used in adults and children aged 6 years and older. Usually, the doctor will try to find one medicine that is most suitable for the patient (adult or child). However, in some cases of epilepsy, it may be necessary to take two or more medicines together to control seizures.
Karbagen, coated tablets, can be used as the only medicine or in combination with other antiepileptic medicines.

2. Important information before taking Karbagen

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

When not to take Karbagen:

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

Warnings and precautions

Before starting treatment with Karbagen, you should discuss with your doctor or pharmacist:
• if you have an allergy (hypersensitivity) to carbamazepine, a similar antiepileptic medicine. If you are allergic to carbamazepine, there is a 1 in 4 (25%) chance that you may also be allergic to oxcarbazepine
• if you have liver problems or if they develop during treatment (see: Possible side effects)
• if you have kidney problems, especially those related to low sodium levels in the blood. Oxcarbazepine may further lower sodium levels in the blood, which can lead to symptoms of sodium deficiency (see: Possible side effects). If you have kidney disease, your doctor may order blood tests before starting therapy and regularly after starting treatment with Karbagen
• if you are taking other medicines that may lower sodium levels in the blood (e.g. diuretics, desmopressin, and non-steroidal anti-inflammatory drugs (NSAIDs) such as indomethacin and ibuprofen). See: Karbagen and other medicines
• if you have heart disease, such as heart failure (shortness of breath and swelling of the ankles). Your doctor will regularly check your weight to see if you are retaining water in your body
• if you have a heart rhythm disorder
• if you are taking hormonal contraceptives (see: Karbagen and other medicines)
During treatment
If you experience symptoms of blood disorders, such as feeling tired, shortness of breath during exertion, pallor, headache, chills, dizziness, infections causing fever, sore throat, mouth ulcers, easier than usual bleeding or bruising, nosebleeds, red or purple spots on the skin or unexplained skin changes, you should discuss this with your doctor.
A small number of people treated with antiepileptic medicines, such as oxcarbazepine, have had thoughts of harming themselves or suicidal thoughts. If such thoughts occur, you should contact your doctor immediately.
Potentially life-threatening skin rashes have been reported after taking oxcarbazepine, including Stevens-Johnson syndrome and toxic epidermal necrolysis, which initially appear as red, target-like spots or patches, often with blisters in the center. Other signs include mouth ulcers, throat or nose sores, and red, swollen eyes.
These potentially life-threatening skin rashes often occur in the first few weeks of treatment. There is a higher risk of developing these serious skin reactions in people of Han Chinese, Thai, or other Asian origins (see below, "Patients of Han Chinese and Thai origin").
If you develop Stevens-Johnson syndrome or toxic epidermal necrolysis after taking oxcarbazepine, you should not take this medicine again.
If you develop a rash or any of the above-mentioned skin symptoms, you should contact your doctor immediately and tell them that you are taking this medicine.
This medicine may cause a condition called hypothyroidism (low levels of thyroid hormones). In the case of children, the doctor may order blood tests at regular intervals after starting treatment with oxcarbazepine.
If your seizures become more frequent, you should contact your doctor, who may decide to stop treatment with Karbagen. This is especially important for children, but may also apply to adults.
Before and during treatment with oxcarbazepine, your doctor may perform blood tests to determine the individual dose. Your doctor will inform you when such a test will be performed.

Patients of Han Chinese and Thai origin

The risk of serious skin reactions associated with carbamazepine or its derivatives in patients of Han Chinese and Thai origin can be predicted based on the results of their blood tests. Your doctor will inform you if a blood test is necessary before starting treatment with oxcarbazepine. If you belong to other Asian ethnic groups (e.g. Filipino or Malay), your doctor may also consider the need for a blood test before starting treatment.

Children and adolescents

Your doctor may order thyroid function tests before starting and during treatment in children.

Karbagen and other medicines

You should tell your doctor about all the medicines you are currently taking or plan to take, especially if you are taking any of the following medicines that may interact with oxcarbazepine:
• other antiepileptic medicines, such as phenobarbital, phenytoin, carbamazepine, lamotrigine, and valproic acid. Your doctor may need to adjust the dosage of these medicines if you are also taking Karbagen. When taken in combination with lamotrigine, there is an increased risk of side effects, such as nausea, drowsiness, pain, and dizziness
• hormonal contraceptives ("birth control pills"). Karbagen may reduce their effectiveness. You should use other contraceptive methods
• medicines used to treat mental disorders, such as lithium salts and monoamine oxidase inhibitors (MAOIs), such as phenelzine and moclobemide. Concomitant use with lithium salts may increase the risk of side effects
• medicines that may lower sodium levels in the blood (e.g. diuretics, desmopressin, and non-steroidal anti-inflammatory drugs (NSAIDs) such as indomethacin and ibuprofen). Oxcarbazepine may further lower sodium levels in the blood, which can lead to symptoms of sodium deficiency (see: Possible side effects). Your doctor should order blood tests before starting treatment and regularly after starting treatment with Karbagen
• medicines that affect the immune system (immunosuppressants), such as cyclosporine and tacrolimus
• rifampicin (an antibiotic used to treat infections)

Karbagen with alcohol

You should be careful when consuming alcohol during treatment with Karbagen, as it may cause excessive drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, you should consult your doctor or pharmacist before taking this medicine.

Pregnancy

Oxcarbazepine affects the action of hormonal contraceptives, which can lead to pregnancy. If you are of childbearing age, you should use other contraceptive methods.
Controlling seizures during pregnancy is important, but taking antiepileptic medicines during this time may disrupt the development of the unborn child.
Congenital anomalies
Studies have not shown an increased risk of congenital anomalies associated with oxcarbazepine during pregnancy, but it is not possible to completely rule out the risk of congenital anomalies in the unborn child.
Developmental disorders of the nervous system
Some studies have shown that exposure to oxcarbazepine in the womb may have a negative effect on the development of brain function (development of the nervous system) in children, while other studies have not shown such an effect. It is not possible to rule out the possibility of an effect on the development of the nervous system.
Your doctor will discuss the benefits and potential risks associated with taking Karbagen during pregnancy and help you decide whether to take the medicine.
You should not stop taking Karbagen during pregnancy without first consulting your doctor.

Breastfeeding

If you are taking this medicine, you should consult your doctor before breastfeeding.
The active substance of Karbagen passes into breast milk. Although available data suggest that the amount of Karbagen that passes into the breast milk is small, it is not possible to rule out the risk of side effects in the child.
Your doctor will discuss the benefits and risks associated with breastfeeding while taking Karbagen. If you are breastfeeding while taking Karbagen and notice any side effects in your child, such as excessive drowsiness or slow weight gain, you should inform your doctor immediately.

Driving and using machines

Oxcarbazepine has a moderate effect on the ability to drive and use machines.
You should be aware that oxcarbazepine may cause side effects, such as dizziness, drowsiness, disturbances in balance and coordination, vision problems, including double or blurred vision, low sodium levels in the blood, which can weaken muscles, reduced consciousness, especially at the beginning of treatment or when the dose is increased, which can affect the ability to drive and use machines.
If you experience such side effects, you should not drive or operate machinery.

Karbagen contains lactose

If your doctor has told you that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Karbagen

You should always take this medicine exactly as your doctor has instructed.
If you are unsure, you should ask your doctor or pharmacist.
If the required dose of the medicine cannot be given using whole tablets, other preparations containing oxcarbazepine are available.
Probably, your doctor will start treatment with a low dose of the medicine and, if necessary, gradually increase it according to your individual needs.

Recommended dose:

Adults

The initial dose is 300 mg twice a day.
If necessary, your doctor may gradually increase the dose by a maximum of 600 mg per day at weekly intervals.
The maintenance dose is from 600 mg to 2400 mg per day.
If you are taking other antiepileptic medicines, your doctor may reduce their dose or increase the dose of Karbagen more slowly.
If you are replacing other antiepileptic medicines with Karbagen, the dose of those medicines will be gradually reduced.

Use in children and adolescents aged 6 years and older

The initial dose is 8-10 mg/kg body weight per day, given in two doses.
If necessary, your doctor may increase the daily dose by approximately 10 mg/kg body weight at weekly intervals, up to a maximum dose of 46 mg/kg body weight per day.
The maintenance dose of oxcarbazepine used in combination with other antiepileptic medicines is usually 30 mg/kg body weight per day.
For children who cannot swallow tablets or for whom the required dose cannot be given using tablets, other preparations containing oxcarbazepine are available.

Use in children under 6 years of age

Karbagen is not recommended for use in children under 6 years of age, as its efficacy and safety in this age group have not been established.

Patients with renal impairment

In patients with renal impairment, the doctor may start treatment with half the usual initial dose and increase the dose of Karbagen more slowly than indicated above.

Patients with severe hepatic impairment

In patients with severe hepatic impairment, the doctor may adjust the dose.
You should always follow the doctor's instructions.
If the required dose of the medicine cannot be given using whole tablets, other pharmaceutical forms of the medicine containing oxcarbazepine are available.

Method of administration:

The tablets should be swallowed with a glass of water, with or without food.
Do not chew or crush the tablets.
The dividing line on the tablet is only to facilitate breaking the tablet to make it easier to swallow, but it does not allow the tablet to be divided into two equal doses.

Overdose of Karbagen

If you have taken more than the prescribed dose of Karbagen, you should immediately contact your doctor or pharmacist.
Symptoms of overdose include low sodium levels in the blood, aggression, agitation, confusion, drowsiness or dizziness, nausea (vomiting), vomiting, fatigue, changes in heart rhythm (fast, irregular heartbeat), tremors, seizures/convulsions, headaches, itching, loss of consciousness, involuntary movements (muscle spasms or twitching), double or blurred vision, pupil constriction, low blood pressure, shortness of breath, abnormal muscle or body activity, lack of coordination, and involuntary eye movements.

Missed dose of Karbagen

As soon as you remember, you should take the missed tablet.
If it is almost time for the next dose, you should not take the missed dose and take the next dose at the scheduled time.
You should not take a double dose to make up for the missed dose.

Stopping treatment with Karbagen

You should not suddenly stop taking Karbagen without consulting your doctor, as this may lead to a sudden increase in seizures.
If treatment with Karbagen needs to be stopped, your doctor will do it gradually.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

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

You should tell your doctor immediately if you experience any of the following serious side effects:

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

• increased risk of infections that may cause fever, chills, or sore throat (may indicate a low white blood cell count)
• weight gain, feeling tired, hair loss, muscle weakness, feeling cold (symptoms of hypothyroidism)
• falls

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

• facial swelling, lip, eyelid, tongue, or throat swelling, difficulty speaking, swallowing, and sudden onset of rash or hives, accompanied by difficulty breathing, wheezing, and rapid heartbeat (symptoms of angioedema and anaphylactic reaction)
• skin rash and (or) fever, which may be symptoms of a drug rash with eosinophilia and systemic symptoms (DRESS, Drug Rash with Eosinophilia and Systemic Symptoms), acute generalized exanthematous pustulosis (AGEP, Acute Generalized Exanthematous Pustulosis)
• feeling tired, 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 changes (symptoms of decreased platelet count or decreased blood cell count)
• lethargy, disorientation, tremors, or significant increase in seizures (possible symptoms of low sodium levels in the blood due to inappropriate ADH secretion) (see section "Warnings and precautions")

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

• potentially life-threatening skin rashes, such as severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, which initially appear as red, target-like spots or patches, often with blisters in the center, and (or) mucous membrane lesions, including red, swollen eyes (symptoms of severe allergic reaction, including Stevens-Johnson syndrome, Lyell's syndrome, and toxic epidermal necrolysis)
• red, wet, swollen, and irregular spots, similar to a measles rash, which appear first on the extremities, sometimes on the face, and the rest of the body. The spots can form blisters or lead to the formation of raised, red, pale-centered patches. The patient may experience fever, sore throat, headache, and (or) diarrhea (erythema multiforme). If such skin reactions occur while taking Karbagen, you should not take this medicine again. Your doctor may decide to stop treatment with Karbagen.
• allergic reactions that can also affect other parts of the body and cause lung problems (such as breathing difficulties or coughing up phlegm or blood), kidney problems (such as reduced or no urine production, or blood in the urine), or liver problems (such as liver dysfunction, which is presented below, but can also lead to brain swelling causing changes in behavior or drowsiness). Other symptoms include changes in blood tests (described separately in the leaflet), enlarged spleen (causing swelling and pain in the abdomen), or enlarged lymph nodes in the neck, armpits, or groin
• red, spotty rash, mainly on the face, which may be accompanied by feeling tired, fever, nausea (nausea), or loss of appetite (systemic lupus erythematosus)
• easy bruising or bleeding (thrombocytopenia)
• symptoms of liver inflammation (nausea, vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin or eyes (jaundice), pale stools, dark urine). You should have your liver function checked in such cases
• pancreatitis, which includes symptoms such as severe abdominal pain radiating to the back, often accompanied by nausea (nausea)
• heart problems that can cause dizziness, fainting, and irregular heartbeat (atrioventricular block)

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

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

• dizziness; disturbances in coordination; involuntary eye movements; feeling anxious and nervous; depression; mood changes; rash

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

• irregular heartbeat or very fast or slow heart rate

Other side effects that may occur:

These side effects of Karbagen are usually mild to moderate. Most of them are temporary and usually resolve gradually.

Very common(may affect more than 1 in 10 people):

• feeling tired, headaches, dizziness, fatigue, or drowsiness, nausea, vomiting, double vision

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

• feeling weak; memory loss and (or) memory disturbances; difficulty concentrating; lack of emotions or motivation (apathy); restlessness or other mood changes; disorientation; blurred vision; vision disturbances; diarrhea or constipation; abdominal pain; tremors; weight gain; speech disturbances; coordination disturbances

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

• high blood pressure; hives
• increased activity of liver enzymes during treatment with Karbagen

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

• there have been reports of bone disorders, including osteopenia and osteoporosis (decreased bone density) and fractures. You should consult your doctor or pharmacist if you have been taking antiepileptic medicines for a long time, if you have a history of osteoporosis, or if you have taken steroids

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 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 Karbagen

You should keep this medicine out of the sight and reach of children.
You should not use this medicine after the expiry date stated on the carton, blister, or tablet container.
The expiry date refers to the last day of the month stated.
You should store this medicine below 30°C.
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.
Such actions will help protect the environment.

6. Contents of the packaging and other information

What Karbagen contains

The active substance of Karbagen 150 mg, coated tablets, is 150 mg of oxcarbazepine per tablet.
The active substance of Karbagen 300 mg, coated tablets, is 300 mg of oxcarbazepine per tablet.
The active substance of Karbagen 600 mg, coated tablets, is 600 mg of oxcarbazepine per tablet.
The other ingredients are:
tablet core: crospovidone, hypromellose, microcrystalline cellulose, colloidal anhydrous silica, and magnesium stearate
tablet coating: Opadry Buff II OY-LS-37200: titanium dioxide (E171), lactose monohydrate (see section "Karbagen contains lactose"), macrogol 4000, hypromellose, iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172); Opadry White II OY-LS-28908: titanium dioxide (E171), lactose monohydrate (see section "Karbagen contains lactose"), macrogol 4000, hypromellose

What Karbagen looks like and contents of the pack

Coated tablet.
The tablets are oblong, convex, and light yellow, with a dividing line on both sides.
The dividing line on the tablet facilitates breaking the tablet to make it easier to swallow, but does not allow the tablet to be divided into two equal doses.
The 150 mg coated tablets are marked with "OX/150" on one side and "G/G" on the other side.
The 300 mg coated tablets are marked with "OX/300" on one side and "G/G" on the other side.
The 600 mg coated tablets are marked with "OX/600" on one side and "G/G" on the other side.
Karbagen, coated tablets, are available in plastic containers of 100, 200, and 500 tablets, and in blisters of 10, 20, 30, 50, 60, 100, and 200 tablets.*
*Not all pack sizes may be marketed.
Karbagen, coated tablets, are available as Karbagen 150 mg, 300 mg, and 600 mg, coated tablets.

Marketing authorization holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturer

McDermott Laboratories Ltd. T/A Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan Hungary Kft., Mylan utca 1., Komárom, 2900, Hungary

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Belgium: Oxcarbazepine Viatris 150 mg, 300 mg, 600 mg film-coated tablets
Denmark: Oxcarbazepine Viatris
France: Oxcarbazepine Viatris 150 mg, 300 mg, 600 mg film-coated tablets
Germany: Oxcarbazepine dura 150 mg, 300 mg, 600 mg film-coated tablets
Poland: Karbagen
Slovenia: KARBOX 150 mg, 300 mg, 600 mg film-coated tablets
Spain: Oxcarbazepina VIATRIS 300 mg, 600 mg film-coated tablets EFG
Netherlands: Oxcarbazepine Viatris 150 mg, 300 mg, 600 mg film-coated tablets
United Kingdom (Northern Ireland): Oxcarbazepine Mylan 150 mg, 300 mg, and 600 mg film-coated tablets

For more information about this medicine, you should contact the local representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

Tel: +48 22 546 64 00

Date of last revision of the leaflet: