Karbagen

Leaflet accompanying 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, 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, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

• 1. What is Karbagen and what is it used for
• 2. Before taking Karbagen
• 3. How to take Karbagen
• 4. Possible side effects
• 5. How to store Karbagen
• 6. Contents of the pack 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.
People with epilepsy have periods of uncontrolled electrical activity in the brain.
These periods of uncontrolled electrical activity can cause seizures. Oxcarbazepine helps control the electrical activity of the brain. This reduces the likelihood of seizures occurring.
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 tries 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. Before taking Karbagen

You should carefully follow all the doctor's instructions, even if they differ from the information 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 taking Karbagen, tell 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 nonsteroidal 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
• if you have a heart rhythm disorder
• if you are taking hormonal contraceptives (see "Karbagen and other medicines")

Patient populations of Chinese Han and Thai origin

The risk of serious skin reactions associated with carbamazepine or its derivatives in patients of Chinese Han and Thai origin can be predicted based on blood test results. Your doctor will tell you if a blood test is necessary before starting treatment with oxcarbazepine. If you belong to other Asian ethnic groups (e.g., Filipino or Malaysian), 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 and during treatment in children.

Karbagen and other medicines

Tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you 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 taking Karbagen at the same time. 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 illnesses, 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 nonsteroidal 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 cautious when consuming alcohol while taking 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, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Oxcarbazepine affects the effectiveness 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 harm the unborn baby.
Congenital malformations
Studies have not shown an increased risk of congenital malformations associated with oxcarbazepine during pregnancy, but it cannot be completely ruled out.
Developmental disorders of the nervous system
Some studies have shown that exposure to oxcarbazepine in the womb may have a negative effect on brain development (nervous system development) in children, while others have not shown such an effect. The possibility of an effect on nervous system development cannot be ruled out.
Your doctor will discuss the benefits and risks associated with taking Karbagen during pregnancy and help you decide whether to take the medicine.
Do not stop taking Karbagen during pregnancy without first consulting your doctor.

Breastfeeding

If you are taking this medicine and plan to breastfeed, consult your doctor before breastfeeding.
The active substance of Karbagen passes into breast milk. Although available data indicate that the amount of Karbagen that passes into the baby's body is small, the risk of side effects in the baby cannot be ruled out.
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 baby, such as excessive drowsiness or slow weight gain, tell your doctor immediately.

Driving and using machines

Oxcarbazepine has a moderate effect on the ability to drive and use machines.
Remember that oxcarbazepine can cause side effects such as dizziness, drowsiness, balance and coordination disorders, vision problems (including double vision), decreased sodium levels in the blood, which can weaken muscles, decreased 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, do not drive or operate machinery.

Karbagen contains lactose

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

3. How to take Karbagen

Always take this medicine exactly as your doctor has told you.
If you are unsure, ask your doctor or pharmacist.
If the required dose cannot be given using whole tablets, other preparations containing oxcarbazepine are available.
It is likely that your doctor will start treatment with a low dose and gradually increase it as needed, 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 between 600 mg and 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 the other 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, your 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, your doctor may adjust the dose.
Always follow your doctor's instructions.
If the required dose cannot be given using whole tablets, other pharmaceutical forms of Karbagen containing oxcarbazepine are available.

Method of administration:

Coated 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 not to divide it into equal doses.

Taking a higher dose of Karbagen than recommended

If you have taken a higher dose of Karbagen than recommended, contact your doctor or pharmacist immediately.
Overdose symptoms 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, hypotension, abnormal muscle activity or body movements, loss of coordination, and uncontrolled eye movements.

Missing a dose of Karbagen

Take the missed dose as soon as you remember.
If it is almost time for the next dose, do not take the missed dose and take the next dose at the scheduled time.
Do not take a double dose to make up for the missed dose.

Stopping treatment with Karbagen

Do not stop taking Karbagen suddenly 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 Karbagen, ask your doctor or pharmacist.

4. Possible side effects

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

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 can 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):

• swelling of the face, lips, eyelids, tongue, or throat, difficulty speaking, swallowing, and breathing, and sudden rash with blistering (symptoms of angioedema and anaphylactic reaction)
• rash and (or) fever, which may be symptoms of a drug reaction with eosinophilia and systemic symptoms (DRESS)
• feeling tired, shortness of breath during exertion, pale skin, headache, chills, dizziness, frequent infections that cause fever, sore throat, mouth ulcers, easy bruising or bleeding, nosebleeds, red or purple spots on the skin, or unexplained changes on the skin (symptoms of a decrease in blood cell count or platelet count)
• lethargy, disorientation, tremors, or increased seizures (possible symptoms of low sodium levels in the blood due to inappropriate ADH secretion) (see "Warnings and precautions")

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

• potentially life-threatening skin rashes, including severe blistering skin rashes, and peeling of the skin, sometimes with mouth, throat, eye, genital, or other mucosal sores (symptoms of a severe allergic reaction, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms)
• red, itchy, and irregular patches, similar to measles, which start on the extremities and sometimes on the face. These patches can form blisters and lead to peeling of the skin (erythema multiforme). If you experience such skin reactions while taking Karbagen, do not take the medicine again. Your doctor may decide to stop treatment with Karbagen.
• allergic reactions that can also affect other parts of the body and cause problems with the lungs (e.g., breathing difficulties or coughing up mucus or blood), kidneys (e.g., decreased or absent urine production or blood in the urine), or liver (e.g., liver dysfunction, which may be indicated by the following symptoms: nausea, vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin or eyes, pale stools, or dark urine). Other symptoms include changes in blood test results (described separately in the leaflet) and enlargement of the spleen (causing swelling and pain in the abdomen) or lymph nodes in the neck, armpits, or groin
• red, spotty rash, mainly on the face, which may be accompanied by fatigue, fever, nausea (vomiting), or loss of appetite (systemic lupus erythematosus)
• easy bruising or bleeding (thrombocytopenia)
• liver problems, including liver dysfunction (symptoms: nausea, vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin or eyes, pale stools, or dark urine) or pancreatitis (symptoms: severe abdominal pain radiating to the back, often accompanied by nausea and vomiting)
• heart problems that can cause dizziness, fainting, and irregular heartbeat (atrioventricular block)

If you experience any of the following side effects, tell your doctor as soon as possible:

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

• dizziness; coordination disorders; involuntary eye movements; feeling anxious or 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 disappear 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 disorders; difficulty concentrating; lack of emotions or motivation (apathy); restlessness or other mood changes; disorientation; blurred vision; vision disturbances; diarrhea or constipation; abdominal pain; flatulence; hair loss; loss of coordination; weight gain; speech disorders

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):

• reports of bone disorders, including osteopenia and osteoporosis (decreased bone density) and fractures. If you have been taking antiepileptic medicines for a long time, or if you have had osteoporosis in the past, or if you have taken steroids, consult your doctor or pharmacist

Reporting side effects:

If you experience any side effects, including those not listed in this leaflet, 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, 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

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister.
The expiry date refers to the last day of the month.
Store below 30°C.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.

6. Contents of the pack 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 "Karbagen contains lactose"), macrogol 4000, hypromellose, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172); Opadry White II OY-LS-28908: titanium dioxide (E171), lactose monohydrate (see "Karbagen contains lactose"), macrogol 4000, hypromellose

What Karbagen looks like and contents of the pack

Coated tablet.
The tablets are oval, convex, and light yellow, with a dividing line on both sides.
The dividing line on the tablet is only to facilitate breaking the tablet to make it easier to swallow, but not to divide it into equal doses.
Karbagen 150 mg, coated tablets, are marked with "OX/150" on one side and "G/G" on the other.
Karbagen 300 mg, coated tablets, are marked with "OX/300" on one side and "G/G" on the other.
Karbagen 600 mg, coated tablets, are marked with "OX/600" on one side and "G/G" on the other.
Karbagen is 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 is 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: Oxcarbazepin 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, contact the local representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

Phone: +48 22 546 64 00

Date of last revision of the leaflet: