Epitrigine 50 mg tablets: detailed information

Package leaflet: Information for the user

Epitrigine 50 mg tablets
Epitrigine 100 mg tablets
Lamotrigine
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Epitrigine is and what it is used for
What you need to know before taking Epitrigine
How to take Epitrigine
Possible side effects
How to store Epitrigine
Contents of the pack and other information

1. What Epitrigine is and what it is used for

Epitrigine belongs to a group of medicines called antiepileptic drugs. It is used in the treatment of two conditions – epilepsy and bipolar affective disorder.

The action of Epitrigine in the treatment of epilepsy involves blocking nerve signals in the brain that cause epileptic seizures.

In adults and children aged 13 years and older, Epitrigine may be used alone or in combination with other medicines in the treatment of epilepsy. Epitrigine may also be used in combination with other medicines in the treatment of epileptic seizures associated with a condition called Lennox-Gastaut syndrome.

In children aged 2 to 12 years, Epitrigine may be used in combination with other medicines for the treatment of these conditions. It may be used alone in the treatment of a type of epilepsy called typical absence seizures.

Epitrigine is also used in the treatment of bipolar affective disorder.
In patients with bipolar affective disorder (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 aged 18 years and older, Epitrigine may be used alone or in combination with other medicines to prevent depressive episodes in bipolar affective disorder. It is not yet known exactly how Epitrigine produces this effect in the brain.

2. Important information before using Epitrigine

When not to use Epitrigine
if the patient is allergic to lamotrigine or any of the other ingredients of this medicine
(listed in section 6).
If any of the above situations apply

consult your doctor and do not take Epitrigine.

Warnings and precautions
Exercise special caution when using Epitrigine.
Before starting Epitrigine, discuss this with your doctor or pharmacist
if the patient has any kidney disease
if the patient has ever had a rash after taking lamotrigine or other medicines used to treat
bipolar disorder or epilepsy
if the patient has ever developed a rash or sunburn
following exposure to sunlight or artificial light (e.g. in a solarium). Your doctor
will review the patient's treatment and may advise avoiding sunlight or using sun protection (e.g. sunscreen or 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 conditions.
Brugada syndrome is a genetically determined heart condition causing disturbances in the heart's electrical activity. Abnormal ECG findings are associated with arrhythmia (irregular heartbeat), which may be triggered by taking lamotrigine.
If any of the above situations apply

inform your doctor, who may decide to reduce the dose or determine that Epitrigine is not suitable for the patient.

Important information about potentially life-threatening reactions
A small number of patients taking Epitrigine have experienced allergic or potentially life-threatening skin reactions, which may lead to more serious complications if not treated appropriately. These include: Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS syndrome). Patients should be aware of the symptoms they may experience while taking Epitrigine. This risk may be associated with a genetic variant found in people of Asian origin (mainly Han Chinese and Thai). If the patient is of such origin and has previously been tested for this genetic variant (HLA-B*1502), this should be discussed with the doctor before starting Epitrigine.

read the description of these symptoms in section 4 of this leaflet, "Potentially life-threatening reactions: seek immediate medical help".

Haemophagocytic lymphohistiocytosis (HLH)
Cases of a rare but very serious immune system reaction have been reported in patients taking lamotrigine.

contact your doctor or pharmacist immediately if the patient develops the following symptoms while taking lamotrigine: fever, rash, neurological symptoms (e.g. tremors or chills, confusion, brain dysfunction).

Thoughts of self-harm or suicide
Antiepileptic medicines are used to treat several conditions, including epilepsy and bipolar disorder.
Patients with bipolar disorder may sometimes experience thoughts of self-harm or suicide. These thoughts may occur more frequently in patients with bipolar disorder:
when starting treatment for the first time
if the patient has previously had thoughts of self-harm or suicide
if the patient is under 25 years of age
If the patient experiences disturbing thoughts or feelings, or if their condition worsens or new symptoms appear while taking Epitrigine

seek medical help immediately by visiting your doctor or the nearest hospital. 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 him or her if they notice signs of depression or worrying changes in behaviour.

A small number of people taking antiepileptic medicines containing lamotrigine have had thoughts of harming or killing themselves. If such thoughts ever occur, contact your doctor immediately.
Use of Epitrigine in the treatment of epilepsy
Seizures in certain types of epilepsy may sometimes worsen or occur more frequently during treatment with Epitrigine. Some patients may experience severe seizures that may pose a serious health risk. If seizures occur more frequently during treatment with Epitrigine or if a severe seizure occurs

seek medical help as soon as possible.

Epitrigine must not be used in the treatment of bipolar disorder
in patients under 18 years of age.
Medicines used to treat depression or other psychiatric disorders in children and adolescents under 18 years of age increase the risk of suicidal thoughts or behaviour.
Epitrigine and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including herbal remedies or other non-prescription medicines.
Your doctor needs to know if the patient is taking any of the following medicines, as this may affect the appropriate dose of Epitrigine. These include:
oxcarbazepine, felbamate, gabapentin, levetiracetam, lacosamide, perampanel,
pregabalin, topiramate, zonisamide, used in the treatment of epilepsy
lithium, olanzapine, or aripiprazole, used in the treatment of mental disorders
bupropion, used in the treatment of mental disorders or nicotine dependence
paracetamol, used to treat pain and fever

inform your doctor if 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 and mental disorders
carbamazepine, used to treat epilepsy and mental disorders
phenytoin, primidone, or phenobarbital, used to treat epilepsy
risperidone, used to treat mental disorders
rifampicin, an antibiotic
medicines used to treat human immunodeficiency virus (HIV) infection (combination of lopinavir and ritonavir or atazanavir and ritonavir)
hormonal contraceptives such as the "birth control pill" (see below)
- inform your doctor if the patient is taking, has recently taken, or is starting to take any of these medicines.

Hormonal contraceptives (such as the "birth control pill") may affect the action of Epitrigine
Your doctor may recommend a specific type of hormonal contraceptive or another method of contraception, such as condoms, a diaphragm, or an intrauterine device. If the patient is using hormonal contraceptives such as the "birth control pill", your doctor may recommend blood tests to monitor Epitrigine levels. If the patient is using or plans to start using hormonal contraceptives

talk to your doctor, who will discuss the appropriate contraceptive method with the patient.

Epitrigine may also affect how hormonal contraceptives work, although it is unlikely to reduce their effectiveness. If the patient is using hormonal contraceptives and notices any changes in her menstrual cycle, such as bleeding or spotting between periods

inform your doctor. These symptoms may indicate that Epitrigine is affecting the contraceptive.

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant,
she should consult her doctor or pharmacist before using this medicine.

Do not stop treatment without first consulting your doctor. This is particularly important if the patient has epilepsy.
Pregnancy may alter the effectiveness of Epitrigine, so blood tests and dose adjustments may be necessary.
There may be a slightly increased risk of congenital malformations, including cleft lip or palate, if Epitrigine is taken during the first three months of pregnancy.
If the patient is planning a pregnancy or is pregnant, the doctor may recommend taking folic acid additionally.

If the patient is breastfeeding or planning to breastfeed, she should consult her doctor or
pharmacist before using this medicine.
The active substance in Epitrigine passes into breast milk and may affect the baby. The doctor will discuss the risks and benefits of breastfeeding while taking Epitrigine. If the patient decides to breastfeed, the baby will be monitored periodically for excessive sleepiness, rash, or poor weight gain. If any of these symptoms are observed in the baby, inform the doctor.
Driving and operating machinery
Epitrigine may cause dizziness and double vision

do not drive or operate machinery unless the patient is certain that these symptoms do not occur.

If the patient has epilepsy, they should discuss driving and operating machinery with their doctor.
Epitrigine contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to use Epitrigine 50 mg tablets

This medicine should always be used as directed by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist.

What dose of Epitrigine should be used
Determining the appropriate dose of Epitrigine for the patient may take time. The dose 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 treating doctor will initially prescribe a low dose and then gradually increase it over several weeks until reaching the effective dose for the patient (called the maintenance dose).

Never take a higher dose than the one prescribed by the treating doctor.

The usual effective dose of Epitrigine in adults and children aged 13 years and older is between 100 mg and 400 mg per day.

In children aged 2 to 12 years, the effective dose depends on body weight – usually between 1 mg and 15 mg per kilogram of body weight per day, up to a maximum maintenance dose of 200 mg per day.

Use of Epitrigine is not recommended in children under 2 years of age.

How to take Epitrigine tablets
The dose of Epitrigine should be taken once or twice daily, as directed by the treating doctor. Epitrigine may be taken with or without food.

The treating doctor may also recommend starting or stopping other medications, depending on the indication and the patient's response to treatment.

Tablets should be swallowed whole. Do not break, chew, or crush them.

Always take the full prescribed dose. Never take only part of a tablet.

Taking more than the recommended dose of Epitrigine

Seek immediate medical advice from a doctor or the nearest emergency department. If possible, show the Epitrigine medicine packaging.

Taking too high a dose of Epitrigine may increase the risk of serious adverse effects, which could be fatal.
In a person who has taken an excessive dose of Epitrigine, the following may occur:
rapid, involuntary eye movements (nystagmus)
loss of motor control, lack of coordination, inability to maintain balance (ataxia)
heart rhythm disturbances (usually detectable on ECG)
loss of consciousness, seizures, or coma

Missing a dose of Epitrigine
Do not take extra tablets to make up for a missed dose. Take the next dose at the usual time.

If several doses of Epitrigine are missed
Consult the treating doctor regarding resuming treatment with Epitrigine. This is important for the patient.

Do not stop taking Epitrigine unless instructed by the doctor.
Epitrigine should be taken for as long as directed by the doctor. Do not discontinue unless advised by the doctor.

Using Epitrigine in the treatment of epilepsy
When discontinuing Epitrigine, it is essential that the dose be gradually reduced over approximately two weeks. Abruptly stopping Epitrigine may lead to a recurrence of seizures or worsening of seizure control.

Using Epitrigine in the treatment of bipolar affective disorders
It may take some time before the beneficial effects of Epitrigine become apparent, so improvement is unlikely to occur immediately. When discontinuing Epitrigine, there is generally no need to taper the dose gradually. However, patients should consult their treating doctor before stopping treatment with Epitrigine.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Potentially life-threatening reactions: seek medical help immediately
In a small number of patients taking Epitrigine, an allergic reaction or potentially life-threatening skin reaction may occur, which could worsen if left untreated.
These symptoms may occur more frequently during the first few months of treatment with 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 together with another medicine called valproate. Some of these symptoms occur more frequently in children, so parents should pay particular attention to them.
Symptoms of these reactions include:
skin rash or redness of the skin, which may worsen leading to severe skin reactions, including widespread rash with blisters and peeling of the outer layer of skin, particularly around the mouth, nose, eyes, and genital organs (Stevens-Johnson syndrome), extensive peeling of the skin (affecting more than 30% of body surface area – toxic epidermal necrolysis), or severe rashes accompanied by signs of liver, blood, or other internal organ involvement (drug rash with eosinophilia and systemic symptoms, also known as DRESS syndrome)
ulceration of the mouth, throat, nose, or genital organs
pain in the mouth or redness and swelling of the eyes (conjunctivitis)
high body temperature (fever), flu-like symptoms, or drowsiness
swelling of the face, enlarged lymph nodes in the neck, under the arms, or in the groin
unexpected bleeding or bruising or blue discoloration of the fingers
sore throat or more frequent infections (such as colds)
increased liver enzyme levels, evident in blood tests
increased number of white blood cells (eosinophilia)
enlarged lymph nodes
symptoms may also involve other organs of the body, such as the liver and kidneys
In many cases, these symptoms indicate less severe adverse reactions. However, it should be remembered that they may potentially be life-threatening and could progress to serious conditions, such as organ failure, if left untreated. If any of these symptoms occur:

contact your doctor as soon as possible. Your doctor may decide to perform tests to assess liver, kidney, or blood function and may recommend discontinuing Epitrigine. If the patient develops Stevens-Johnson syndrome or toxic epidermal necrolysis, the doctor will inform the patient that lamotrigine must never be used again.

Hemophagocytic lymphohistiocytosis (HLH) (see section 2 "Important information before using Epitrigine")
Very common adverse reactions
May occur in more than 1 in 10 patients:
headache
skin rash
Common adverse reactions
May occur in up to 1 in 10 patients:
aggression or irritability
drowsiness
dizziness
tremor
difficulty falling asleep (insomnia)
feeling of restlessness
diarrhea
dry mouth
nausea or vomiting
feeling tired
back or joint pain, or pain in any other location
Uncommon adverse reactions
May occur in up to 1 in 100 patients:
lack of coordination and unsteady movements (ataxia)
double or blurred vision
unusual hair loss or thinning (alopecia)
skin rash or sunburn after exposure to sunlight or artificial light (photosensitivity)
Rare adverse reactions
May occur in up to 1 in 1,000 patients:
life-threatening skin reaction (Stevens-Johnson syndrome) (also refer to information at the beginning of section 4)
a group of symptoms occurring together: fever, nausea, vomiting, headache, neck stiffness, and extreme sensitivity to bright light. This may be due to inflammation of the membranes surrounding the brain and spinal cord (meningitis). These symptoms usually resolve after stopping treatment, but if they persist or worsen, contact your doctor.
rapid, involuntary eye movements (nystagmus)
itchy eyes with discharge (conjunctivitis)
Very rare adverse reactions
May occur in up to 1 in 10,000 patients:
life-threatening skin reaction (toxic epidermal necrolysis) (also refer to information at the beginning of section 4)
drug hypersensitivity syndrome with eosinophilia and systemic symptoms (DRESS) (also refer to information at the beginning of section 4)
high body temperature (fever) (also refer to information at the beginning of section 4)
swelling of the face or enlarged lymph nodes in the neck, under the arms, or in the groin (generalized lymphadenopathy) (also refer to information at the beginning of section 4)
liver function abnormalities shown in blood tests or liver failure (also refer to information at the beginning of section 4)
severe blood clotting disorder, which may cause unexpected bleeding or bruising (disseminated intravascular coagulation) (also refer to information at the beginning of section 4)
hemophagocytic lymphohistiocytosis (HLH) (see section 2 "Important information before using Epitrigine")
changes in blood test results – including reduced number of red blood cells (anaemia), reduced number of white blood cells (leucopenia, neutropenia, agranulocytosis), reduced number of platelets (thrombocytopenia), reduced number of all blood cells (pancytopenia), and a bone marrow disorder called aplastic anaemia
hallucinations ("seeing" or "hearing" things that are not real)
disorientation
feeling of "unsteadiness" or loss of balance during movement
involuntary, repetitive body movements and/or sounds or words (tics), involuntary muscle spasms affecting the eyes, head, and trunk (choreoathetosis), or other unusual body movements such as jerking, trembling, or stiffness
increased frequency of epileptic seizures in patients with previously diagnosed epilepsy
worsening of symptoms in patients with diagnosed Parkinson's disease
pseudotumour cerebri syndrome (symptoms may include back or joint pain, sometimes accompanied by fever and/or general malaise)
Other adverse reactions
Other adverse reactions may occur in a small number of people, but their frequency is unknown:
bone disorders including osteopenia and osteoporosis (weakening of bones) and fractures have been reported. If the patient is being treated long-term with antiepileptic medicines, has had osteoporosis in the past, or is taking steroids, this should be discussed with the doctor or pharmacist.
inflammation of the kidneys (tubulointerstitial nephritis) or simultaneous inflammation of the kidneys and eye (tubulointerstitial nephritis and uveitis)
nightmares
weakened immunity caused by lower levels in the blood of antibodies called immunoglobulins, which help protect the body against infections
red lumps or spots on the skin (pseudolymphoma)
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Epitrigine 50 mg tablets

Keep this medicine out of sight and reach of children.
No special storage conditions apply for this medicine.
Do not use this medicine after the expiry date stated on the blister and the cardboard box
following the abbreviation: "EXP:". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Epitrigine contains

The active substance is lamotrigine. Each tablet contains 50 mg or 100 mg of lamotrigine.
The other ingredients are: magnesium carbonate heavy, 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 light yellow, round, flat, marked with the number 50, 8 mm in diameter.
Epitrigine 100 mg tablets are light yellow, round, flat, marked with the number 100, 10 mm in diameter.
Blister packs (Aluminium/PVC) in cardboard box: 30 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
For further information about this medicinal product, please contact the representative of the Marketing Authorisation Holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
tel. +48 12 262 32 36