Epitrigine 100 mg tabletki

Leaflet accompanying the packaging: information for the user

Epitrigine 50 mg tablets

Epitrigine 100 mg tablets

Lamotrigine

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.
• In case of any doubts, 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 not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Epitrigine and what is it used for

Epitrigine belongs to a group of medicines called antiepileptics. It is used to treat two conditions – epilepsy and bipolar affective disorders.
The action of Epitrigine in the treatment of epilepsyinvolves blocking impulses in the brain that cause epileptic seizures
in adults and children over 13 years of age, Epitrigine may be used alone
or in combination with other medicines to treat epilepsy. Epitrigine may also be used in combination with other medicines to treat epileptic seizures associated with a condition called Lennox-Gastaut syndrome.
in children between 2 and 12 years of age, Epitrigine may be used in combination with other medicines
to treat these conditions. It may be used alone to treat a type of epilepsy called typical absence seizures.
Epitrigine is also used to treat bipolar affective disorders.
In patients with bipolar affective disorders (sometimes called manic-depressive psychosis), there are extreme mood swings with episodes of mania (excitement or euphoria) alternating with episodes of depression (deep sadness or despair). In adult patients over 18 years of age, Epitrigine may be used alone or in combination with other medicines to prevent depressive episodes in bipolar affective disorders. It is not yet known how Epitrigine works in the brain to produce this effect.

2. Important information before taking Epitrigine

When not to take Epitrigine

to lamotrigine or any of the other ingredients of this medicine (listed in section 6).
In case of the above,

• the doctor should be informedand Epitrigine should not be taken.

Warnings and precautions

Particular caution should be exercised when taking Epitrigine.

Before starting Epitrigine, the patient should discuss it with their doctor or pharmacist if they have any kidney disease

has ever had a rash after taking lamotrigine or other medicines used to treat bipolar affective disorders or epilepsy a rash has occurred
if the patient has had a rash or sunburn
due to exposure to sunlight or artificial light (e.g. in a solarium). The doctor will check the treatment the patient is taking and may advise avoiding sunlight or using sun protection (e.g. using a sunscreen or wearing protective clothing).
if the patient has ever had meningitis
after taking lamotrigine(see description of symptoms in section 4 of this leaflet
“Rare side effects”)
if the patient is taking a medicine containing lamotrigine
if the patient has a condition called Brugada syndrome or other heart diseases.
Brugada syndrome is a genetically determined heart condition characterized by electrical disturbances in the heart. Abnormal ECG recordings are associated with arrhythmia (abnormal heart rhythm), which may be caused by taking lamotrigine.
In case of any of the above,

• the doctor should be informed, who may decide to reduce the dose or that Epitrigine is not suitable for the patient.

Important information about potentially life-threatening reactions

A small number of patients taking Epitrigine have experienced an allergic reaction
or a potentially life-threatening skin reaction, which can cause more serious conditions,
if left untreated. These reactions include: Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS syndrome). The patient should be aware of the symptoms to expect when taking Epitrigine. This risk may be associated with a genetic variant found in people of Asian descent (mainly Chinese Han and Thai). If the patient has this descent and has been previously tested for this genetic variant (HLA-B* 1502), they should discuss it with their doctor before taking Epitrigine.

• the description of these symptoms should be read in section 4 of this leaflet“Life-threatening reactions: seek medical help immediately”.

Hemophagocytic lymphohistiocytosis (HLH)

In patients taking lamotrigine, there have been reports of a rare but very serious reaction of the immune system

• the doctor or pharmacist should be contacted immediatelyif the patient experiences any of the following symptoms while taking lamotrigine: fever, rash, neurological symptoms (e.g. tremors or chills, confusion, brain disorders).

Thoughts of self-harm or suicide

Antiepileptic medicines are used to treat several conditions, including epilepsy and bipolar affective disorders.
In patients with bipolar affective disorders, thoughts of harming themselves or committing suicide may sometimes occur.
If the patient has bipolar affective disorders, such thoughts may occur more frequently:
when starting treatment for the first time
if the patient has had thoughts of self-harm or suicide before
if the patient is under 25 years of age
If the patient experiences disturbing thoughts or feelings or if they experience a worsening of their condition or new symptoms while taking Epitrigine

• they should see a doctor or go to the nearest hospital for help as soon as possible. It may be helpful to inform a relative, caregiver, or friend that the patient may experience depression or significant mood changes and ask them to read this leaflet. The patient may ask them to inform them if they notice that the patient is experiencing depression or disturbing changes in behavior.

A small number of people taking antiepileptic medicines containing lamotrigine have thought about harming themselves or committing suicide. If such thoughts ever occur to the patient, they should contact their doctor immediately.

Taking Epitrigine for the treatment of epilepsy

Seizures in some types of epilepsy may sometimes worsen or occur more frequently when taking Epitrigine. In some patients, severe seizures may occur, which can pose a serious risk to the patient's health. If the patient experiences more frequent seizures or a severe seizure while taking Epitrigine

• they should see a doctor as soon as possible.

Epitrigine should not be used to treat bipolar affective disorders

in patients under 18 years of age.
Medicines used to treat depression or other mental disorders in children and adolescents under 18 years of age increase the risk of suicidal thoughts or behaviors.

Epitrigine and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking

currently or recently, and about any medicines they plan to take, including herbal medicines
or other medicines available without a prescription.
The doctor should be aware that the patient is taking the following medicines. This will allow the doctor to determine the appropriate dose of Epitrigine. These medicines include:
oxcarbazepine, felbamate, gabapentin, levetiracetam, lacosamide, perampanel,
pregabalin, topiramate, zonisamide, used to treat epilepsy
lithium, olanzapineor aripiprazole, used to treat mental disorders
bupropion, used to treat mental disordersor nicotine addiction
paracetamol, used to treat pain or fever

• the doctor should be informedif the patient is taking any of these medicines.

Some medicines interact with Epitrigine or increase the risk of side effects. These include:

• valproate, used to treat epilepsy or mental disorders
• carbamazepine, used to treat epilepsy or mental disorders
• phenytoin, primidoneor phenobarbital, used to treat epilepsy
• risperidone, used to treat mental disorders
• rifampicin, which is an antibiotic
• medicines used to treat HIV infection(a combination of lopinavir and ritonavir or atazanavir and ritonavir)
• hormonal contraceptivessuch as “the pill”(see below)
• the doctor should be informedif the patient is taking, has taken, or is about to take any of these medicines.

Hormonal contraceptives (such as “the pill”) may affect the action of Epitrigine

The doctor may recommend a specific type of hormonal contraceptive or another method of contraception, such as a condom, diaphragm, or intrauterine device. If the patient is taking hormonal contraceptives, such as “the pill”, the doctor may recommend blood tests to check the level of Epitrigine in the blood. If the patient is taking or plans to start taking hormonal contraceptives

• they should discuss it with their doctor, who will discuss the appropriate method of contraception with them.

Epitrigine may also affect the action of hormonal contraceptives, although it is unlikely to reduce their effectiveness. If the patient is taking hormonal contraceptives and experiences any changes in their menstrual cycle, such as bleeding or spotting

• they should inform their doctor. These symptoms may indicate that Epitrigine is affecting the action of the contraceptive.

Pregnancy and breastfeeding

If the patient is pregnant, thinks they may be pregnant, or plans to have a baby,

they should consult their doctor or pharmacist before taking this medicine.

• the patient should not stop taking Epitrigine without first consulting their doctor. This is especially important if the patient has epilepsy.
• Pregnancy may affect the effectiveness of Epitrigine, so there may be a need for blood tests and dose adjustment.
• There may be a small increased risk of birth defects, including cleft lip or palate, if Epitrigine is taken during the first three months of pregnancy.
• If the patient plans to become pregnant or is pregnant, the doctor may recommend taking folic acidin addition.

If the patient is breastfeeding or plans to breastfeed, they should consult their doctor or

pharmacist before taking this medicine.
The active substance of Epitrigine passes into breast milk and may affect the baby. The doctor will discuss the risks and benefits of breastfeeding while taking Epitrigine
and if the patient decides to breastfeed, the doctor will check the baby from time to time to see if they are experiencing any side effects, such as excessive sleepiness, rash, or poor weight gain. If any of these symptoms are noticed in the baby, the doctor should be informed.

Driving and using machines

Epitrigine may cause dizziness and double vision

• the patient should not drive or operate machinery unless they are sure they are not experiencing these symptoms.

If the patient has epilepsy, they should discuss driving and using machines with their doctor

driving and using machines.

Epitrigine contains lactose

If the patient has been diagnosed with an intolerance to some sugars, they should contact their doctor before taking Epitrigine.

3. How to take Epitrigine

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts,
the patient should consult their doctor or pharmacist.

What dose of Epitrigine should be taken

It may take some time to determine the appropriate dose of Epitrigine for the patient. The dose taken by the patient depends on:
the patient's age
whether the patient is taking Epitrigine in combination with other medicines
whether the patient has any kidney or liver disease
The doctor will initially prescribe a small dose and then gradually increase it over several weeks
until the effective dose for the patient (called the maintenance dose) is reached.
The patient should never take a higher dose than that recommended by their doctor.
Usually, the maintenance dose of Epitrigine for adults and children over 13 years of age is
between 100 mg and 400 mg per day.
In children between 2 and 12 years of age, the maintenance dose is dependent on body weight – usually between 1 mg and 15 mg per kilogram of body weight, up to a maximum maintenance dose of 200 mg per day.
Epitrigine is not recommended for children under 2 years of age.

Taking the dose of Epitrigine

The dose of Epitrigine should be taken once or twice a day, as directed by the doctor.
Epitrigine can be taken with or without food.
The doctor may also recommend starting or stopping other medicines,
depending on the indication and the patient's response to treatment.
The tablets should be swallowed whole. They should not be broken, chewed, or crushed.
The patient should always take the entire doseprescribed by their doctor. They should never take part of a tablet.

Taking a higher dose of Epitrigine than recommended

• the patient should contact their doctor or the nearest emergency department immediately. If possible, they should show the packaging of Epitrigine.

Taking too much Epitrigine may increase the risk of serious side effects, which can be fatal.
In a person who has taken too much Epitrigine, the following symptoms may occur:
rapid, involuntary eye movements (nystagmus)
clumsiness and lack of coordination, inability to maintain balance (ataxia)
heart rhythm disturbances (usually detectable on an ECG)
loss of consciousness, seizures, or coma

Missing a dose of Epitrigine Do not take extra tablets to make up for a missed dose

the patient should take the next dose at the usual time.

If the patient misses several doses of Epitrigine

The patient should consult their doctor about restarting Epitrigine

Epitrigine. This is important for the patient.
The patient should not stop taking Epitrigine unless their doctor advises them to do so.
Epitrigine should be taken for as long as the doctor recommends. The patient should not stop taking it unless their doctor advises them to do so.

Taking Epitrigine for the treatment of epilepsy

To stop taking Epitrigine, it is essential to gradually reduce the dose over about two weeks.
If Epitrigine is stopped suddenly, the patient's epilepsy may worsen or seizures may occur more frequently.

Taking Epitrigine for the treatment of bipolar affective disorders

It may take some time before the beneficial effects of Epitrigine are seen, so it is unlikely that an improvement will occur immediately. When stopping Epitrigine, there is no need to gradually reduce the dose. However, the patient should consult their doctor if they plan to stop taking Epitrigine.

4. Possible side effects

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

Life-threatening reactions: seek medical help immediately

A small number of patients taking Epitrigine have experienced an allergic reaction
or a potentially life-threatening skin reaction, which can worsen if left untreated.
These symptoms may occur more frequently during the first few months of taking Epitrigine,
especially if the patient has been given too high a dose, the dose has been increased too quickly, or if the patient is taking Epitrigine in combination with another medicine called valproate. Some of these symptoms occur more frequently in children, so parents should pay particular attention to them.
The symptoms include:
skin rashes or redness, which can worsen to severe skin reactions,
including widespread rash with blisters and peeling of the skin, especially on the lips, eyes, mouth, and genitals (Stevens-Johnson syndrome), widespread peeling of the skin (toxic epidermal necrolysis), or severe rash with symptoms from the liver, blood, and other organs (drug rash with eosinophilia and systemic symptoms, also known as DRESS syndrome)
ulcers in the mouth, throat, nose, or genitals
pain in the mouth or redness and swelling of the eyes(conjunctivitis)
high fever(fever), flu-like symptoms, or drowsiness
swelling of the face or enlarged lymph nodesin the neck, armpits, and groin
unexplained bleeding or bruisingor blue discoloration of the fingers
sore throator more frequent infections (such as colds)
increased liver enzyme levels, which can be seen in blood tests
increased white blood cell count (eosinophilia)
enlarged lymph nodes
symptoms may also affect other parts of the body, such as the liver and kidneys
In many cases, these symptoms indicate less serious side effects. However, they can be life-threatening and can develop into serious conditions,
such as organ failure, if left untreated. If the patient notices any of these symptoms

• they should contact their doctor as soon as possible. The doctor may decide to perform tests to check liver, kidney, or blood function and may recommend stopping Epitrigine. If the patient develops Stevens-Johnson syndrome or toxic epidermal necrolysis, the doctor will inform them that they should never take lamotrigine again.

Hemophagocytic lymphohistiocytosis (HLH)(see section 2 “Important information before taking Epitrigine”)

Very common side effects

May occur in more than 1 in 10patients:
headache
skin rash

Common side effects

May occur in up to 1 in 10patients:
aggression or irritability
feeling drowsy
dizziness
tremors
difficulty sleeping (insomnia)
feeling agitated
diarrhea
dry mouth
nausea or vomiting
feeling tired
back pain or joint pain, or pain in any other location

Uncommon side effects

May occur in up to 1 in 100patients:
clumsiness and lack of coordination (ataxia)
double or blurred vision
unusual hair loss or thinning (alopecia)
skin rash or sunburn after exposure to sunlight or artificial light (photosensitivity)
seizures

Rare side effects

May occur in up to 1 in 1,000patients:
life-threatening skin reaction (Stevens-Johnson syndrome) (also see the information at the beginning of section 4)
abnormal blood test results, including decreased red blood cell count (anemia), decreased white blood cell count (leukopenia, neutropenia, agranulocytosis), decreased platelet count (thrombocytopenia), and decreased counts of all blood cells (pancytopenia) and a bone marrow disorder called aplastic anemia
hallucinations (seeing or hearing things that are not real)
disorientation
feeling “unsteady” or off-balance when moving
involuntary, repetitive movements of the body and/or sounds or words (tics), involuntary muscle twitches affecting the eyes, head, and trunk (choreoathetosis) or other unusual body movements, such as jerks, tremors, or stiffness
increased frequency of seizures in patients with previously diagnosed epilepsy
worsening of symptoms in patients with diagnosed Parkinson's disease
a syndrome characterized by symptoms including back or joint pain, which may be accompanied by fever and/or general malaise (serum sickness-like syndrome)

Very rare side effects

May occur in up to 1 in 10,000patients:
life-threatening skin reaction (toxic epidermal necrolysis) (also see the information at the beginning of section 4)
a syndrome characterized by symptoms including fever, rash, and swollen lymph nodes (DRESS syndrome) (also see the information at the beginning of section 4)
high fever (fever) (also see the information at the beginning of section 4)
swelling of the face or enlarged lymph nodes in the neck, armpits, and groin (generalized lymphadenopathy) (also see the information at the beginning of section 4)
changes in liver function, which can be seen in blood tests, or liver failure (also see the information at the beginning of section 4)
a serious blood clotting disorder, which can cause unexpected bleeding or bruising (disseminated intravascular coagulation) (also see the information at the beginning of section 4)
hemophagocytic lymphohistiocytosis (HLH) (see section 2 “Important information before taking Epitrigine”)
changes in blood test results, including decreased red blood cell count (anemia), decreased white blood cell count (leukopenia, neutropenia, agranulocytosis), decreased platelet count (thrombocytopenia), and decreased counts of all blood cells (pancytopenia) and a bone marrow disorder called aplastic anemia
hallucinations (seeing or hearing things that are not real)
disorientation
feeling “unsteady” or off-balance when moving
involuntary, repetitive movements of the body and/or sounds or words (tics), involuntary muscle twitches affecting the eyes, head, and trunk (choreoathetosis) or other unusual body movements, such as jerks, tremors, or stiffness
increased frequency of seizures in patients with previously diagnosed epilepsy
worsening of symptoms in patients with diagnosed Parkinson's disease
a syndrome characterized by symptoms including back or joint pain, which may be accompanied by fever and/or general malaise (serum sickness-like syndrome)

Other side effects

In a small number of people, other side effects may occur, but their frequency is unknown:
reports of bone disorders, including osteopenia and osteoporosis (weakening of the bones), and fractures. If the patient is taking antiepileptic medicines for a long time, has a history of osteoporosis, or is taking steroids, they should discuss this with their doctor or pharmacist.
kidney inflammation (interstitial nephritis) or simultaneous kidney and eye inflammation (interstitial nephritis and uveitis)
nightmares
reduced immunity due to lower levels of antibodies in the blood, called immunoglobulins, which help protect the body against infections
red bumps or spots on the skin (pseudolymphoma)

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych,
Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: +48 22 49 21 301, faks: +48 22 49 21 309,
website: https://smz.ezdrowie.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 Epitrigine

The medicine should be stored out of sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the blister and carton after “EXP:”. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Epitrigine contains

• The active substance of Epitrigine is lamotrigine. Each tablet contains 50 mg or 100 mg of lamotrigine.
• The other ingredients are: heavy magnesium carbonate, microcrystalline cellulose, povidone, lactose monohydrate, crospovidone, magnesium stearate, yellow iron oxide (E 172)

What Epitrigine looks like and contents of the pack

Epitrigine 50 mg tablets are yellow, round, flat, marked with the number 50, and 8 mm in diameter.
Epitrigine 100 mg tablets are yellow, round, flat, marked with the number 100, and 10 mm in diameter.
Blisters (Aluminium/PVC) in a carton: 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

+pharma arzneimittel gmbh
Hafnerstraße 211
A-8054 Graz
Austria

Manufacturer

Actavis Group PTC ehf
Reykjavíkurvegur 76-78
220 Hafnarfjörður
Iceland
BALKANPHARMA – DUPNITSA AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
Tjoapack Netherlands B.V.
Nieuwe Donk 9
4879 AC Etten-Leur
Netherlands
PharmaPath S.A.
28is Oktovriou 1
Agia Varvara, 123 51
Greece
To obtain more detailed information on this medicine, the patient should contact the representative of the marketing authorization holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
tel. +48 12 262 32 36
Date of last revision of the leaflet: November 2023