Lamotrix

Leaflet accompanying the packaging: patient information

Lamotrix, 25 mg, tablets

Lamotrix, 50 mg, tablets

Lamotrix, 100 mg, tablets

Lamotrigine

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that 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 specifically for you. Do not pass it on to others. The medicine may harm another person, 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 Lamotrix and what is it used for

2. Important information before taking Lamotrix

3. How to take Lamotrix

4. Possible side effects

5. How to store Lamotrix

6. Contents of the packaging and other information

1. What is Lamotrix and what is it used for

Lamotrix belongs to a group of medicines called antiepileptic medicines. It is used to treat
two diseases – epilepsy and bipolar affective disorders.
The action of Lamotrix in the treatment of epilepsyinvolves blocking impulses in the brain
that cause epileptic seizures.

• In adults and in children aged 13 and above, Lamotrix can be used to treat epilepsy as a single medicine or in combination with other medicines. Lamotrix can also be used in combination with other medicines to treat seizures in a condition called Lennox-Gastaut syndrome.
• In children aged 2 to 12, Lamotrix can be used in combination with other medicines to treat these diseases. It can be used as a single medicine to treat a type of epilepsy called typical absence seizures.

Lamotrix 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 adults aged 18 and above, Lamotrix can be used as a single medicine or in combination with other medicines to prevent episodes of depression in bipolar affective disorders.
The mechanism by which Lamotrix exerts this effect in the brain is not yet known.

2. Important information before taking Lamotrix

When not to take Lamotrix:

• If the patient is allergicto lamotrigine or any of the other ingredients of this medicine (listed in section 6).

If this situation applies to the patient:
➔
The patient should inform their doctorand not take Lamotrix.

Warnings and precautions

Before starting treatment with Lamotrix, the patient should discuss it with their doctor if:

• The patient has any kidney disease
• The patient has ever had a rashafter taking lamotrigine or other medicines used to treat bipolar affective disorders or epilepsy, or if the patient has had a rash or sunburn after exposure to sunlight or artificial light (such as in a solarium). The doctor will verify the treatment used by the patient and may advise avoiding sunlight or using sun protection (such as using a sunscreen or wearing protective clothing).
• The patient has ever had meningitis after taking lamotrigine(see description of symptoms in section 4 of this leaflet, "Rare side effects");
• The patient is taking a medicine containing lamotrigine
• The patient has Brugada syndrome.Brugada syndrome is a genetically determined heart disease characterized by electrical disturbances in the heart. Abnormal EKG recordings are associated with arrhythmia (abnormal heart rhythm), which may be caused by taking lamotrigine. If this situation applies to the patient, they should consult a doctor.

If any of these situations occur:
➔
The patient should inform their doctor, who may recommend reducing the dose or deciding that Lamotrix is not a suitable medicine for the patient.

Important information about life-threatening reactions

A small number of patients taking Lamotrix have experienced an allergic reaction or a potentially life-threatening skin reaction, which can worsen if left untreated. These reactions include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). The patient should familiarize themselves with the symptoms of these diseases and keep them in mind while taking Lamotrix. This risk may be associated with a genetic variant found in people of Asian descent (mainly Chinese Han and Thai). If the patient is of such descent and has previously been found to have this genetic variant (HLA-B*1502), they should discuss it with their doctor before taking Lamotrix.
➔
The patient should read the description of these symptoms in section 4 of this leaflet,in the part "Life-threatening reactions: seek medical attention immediately".

Hemophagocytic lymphohistiocytosis (HLH)

In patients taking lamotrigine, there have been reports of a rare but very severe reaction of the immune system.
➔
If the patient experiences any of the following symptoms while taking lamotrigine: fever, rash, neurological symptoms (such as tremors or shivers, confusion, or brain function disorders),they should seek medical attention immediately.

Thoughts of self-harm or suicide

Antiepileptic medicines are used to treat various diseases, including epilepsy and bipolar affective disorders. In patients with bipolar affective disorders, thoughts of self-harm or 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 previously had thoughts of self-harm or suicide
• if the patient is under the age of 25.

If the patient experiences disturbing thoughts or feelings, or if they feel worse while taking Lamotrix, or if new symptoms occur:
➔

The patient should seek medical attention as soon as possible

to get help.

It may be helpful for the patient to inform a relative, caregiver, or friend that they 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

depression or disturbing changes in behavior.
In a small number of patients taking antiepileptic medicines, such as Lamotrix, thoughts of self-harm or suicide have also occurred. If the patient has ever had such thoughts, they should seek medical attention immediately.

Taking Lamotrix for the treatment of epilepsy

In some types of epilepsy, seizures may sometimes worsen or occur more frequently while taking Lamotrix. In some patients, severe seizures may occur, which can pose a serious risk to the patient's health. If the patient experiences more frequent or severe seizures while taking Lamotrix:
➔
they should seek medical attention as soon as possible.

Lamotrix should not be used to treat bipolar affective disorders in patients under the age of 18

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

Lamotrix and other medicines

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

currently or recently, as well as any medicines they plan to take, including herbal or other medicines available without a prescription.
The doctor should know that the patient is taking other medicines used to treat epilepsy or mental disorders. This will allow the doctor to determine the correct dose of Lamotrix. These medicines include:

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate, zonisamide, used to treat epilepsy
• olanzapineor aripiprazole, used to treat mental disorders
• bupropion, used to treat mental disordersor nicotine addiction. The patient should inform their doctor if they are taking any of these medicines.

Some medicines interact with Lamotrix 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, 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 with ritonavir or atazanavir with ritonavir)
• hormonal contraceptives, such as birth control pills ( see below). ➔ The patient should inform their doctorif they are taking, have taken, or plan to take any of these medicines.

Hormonal contraceptives (such as birth control pills) may affect the action of Lamotrix

The doctor may recommend using 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 birth control pills, the doctor may recommend blood tests to check the level of Lamotrix in the blood. If the patient is taking or plans to take hormonal contraceptives:
➔
they should discuss suitable contraceptive methods with their doctor.
Lamotrix may also affect the action of hormonal contraceptives, although it is unlikely to reduce their effectiveness. If the patient is taking hormonal contraceptives and notices any changes in their menstrual cycle, such as bleeding or spotting:
➔
they should inform their doctor. Such symptoms may indicate that Lamotrix 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 treatment without first consulting their doctor. This is especially important if the patient has epilepsy.
• Pregnancy may change the effectiveness of Lamotrix, so blood tests and dose adjustments may be necessary.
• There may be a small increased risk of birth defects, including cleft lip and palate, if Lamotrix is taken during the first three months of pregnancy.
• If the patient plans to become pregnant or is pregnant, their 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 patient should consult their doctor or pharmacist before taking this medicine. The active substance of Lamotrix passes into breast milk and may affect the baby. The doctor will discuss the risks and benefits of breastfeeding while taking lamotrigine, and if the patient decides to breastfeed, the doctor will monitor the baby for any signs of excessive sleepiness, rash, or poor weight gain. If any of these symptoms are noticed in the baby, the patient should inform their doctor.

Driving and using machines

Lamotrix may cause dizziness and double vision.
➔

The patient should not drive or operate machinery unless they are sure that these symptoms do not occur.

If the patient has epilepsy, they should discuss driving and operating machinery with their doctor.

3. How to take Lamotrix

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

What dose of Lamotrix to take

Determining the correct dose of Lamotrix for the patient may take time. The dose taken by the patient depends on:

• the patient's age
• whether the patient is taking Lamotrix 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 is reached (called the effective dose). The patient should never take a higher dose of Lamotrix than the one recommended by their doctor.
Usually, the effective dose of Lamotrix for adults and children aged 13 and above is between 100 mg and 400 mg per day.
In children aged 2 to 12, the effective dose depends on the child's weight – usually between 1 mg and 15 mg per kilogram of body weight, up to a maximum maintenance dose of 200 mg per day.
Lamotrix is not recommended for children under the age of 2.

Taking the dose of Lamotrix

The dose of Lamotrix should be taken once or twice a day, as directed by the doctor.
Lamotrix 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 the doctor. The patient should never take only part of a tablet.

Taking a higher dose of Lamotrix than recommended

➔
The patient should seek medical attention immediately. If possible, the patient should show the packaging of Lamotrix.
Taking too high a dose of Lamotrix may increase the risk of severe side effects,
which can be fatal.
In a person who has taken too high a dose of Lamotrix, the following symptoms may occur:

• rapid, involuntary eye movements ( nystagmus)
• clumsiness, lack of coordination, difficulty maintaining balance ( ataxia)
• heart rhythm disorders (usually detectable during an EKG examination)
• loss of consciousness, seizures, or coma.

Missing a single dose of Lamotrix

➔

The patient should not take extra tablets to make up for the missed dose.

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

If the patient misses several doses of Lamotrix

➔

The patient should consult their doctor for advice on how to restart treatment with Lamotrix

This is important for the patient.

The patient should not stop taking Lamotrix unless their doctor advises them to do so.

Lamotrix must 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 Lamotrix for the treatment of epilepsy

To stop taking Lamotrix, it is essential to gradually reduce the doseover about two weeks. If the patient stops taking Lamotrix suddenly, their epilepsy symptoms may return or worsen.

Taking Lamotrix for the treatment of bipolar affective disorders

It may take some time for Lamotrix to start working, so it is unlikely that improvement will occur immediately. When stopping treatment with Lamotrix, there is no need to gradually reduce the dose. However, the patient should consult their doctor if they plan to stop taking Lamotrix.

4. Possible side effects

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

Life-threatening reactions: seek medical attention immediately.

A small number of patients taking Lamotrix 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 treatment with Lamotrix, especially if the patient has taken too high a dose or has taken it too quickly, or if the patient is taking Lamotrix with another medicine called valproate. Some of these symptoms occur more frequently in children, so parents should pay particular attention to them. These symptoms include:

• skin rashes or redness, which can worsen into severe skin reactions, including widespread rash with blisters and peeling of the skin, especially on the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), widespread peeling of the skin (covering more than 30% of the body surface - toxic epidermal necrolysis) or widespread rash with liver, blood, and other organ disorders (drug reaction with eosinophilia and systemic symptoms, also known as DRESS)
• ulcers in the mouth, throat, nose, or genitals
• eye pain or redness and swelling around the eyes(conjunctivitis)
• high fever(fever), flu-like symptoms, or drowsiness
• swelling of the face, enlarged lymph nodesin the neck, armpits, or groin
• unexplained bleeding, bruising, or blue discoloration of the fingers
• sore throator more frequent infections (such as colds)
• increased liver enzyme activity in blood tests
• increased white blood cell count (eosinophilia)
• enlarged lymph nodes
• disorders of other organs, including liver and kidney disorders.

In many cases, these are symptoms of less severe side effects. However, the patient should remember that they can be life-threatening and, if left untreated, can worsen to severe conditions, such as organ failure. If the patient notices any of these symptoms:
➔
they should seek medical attention immediately. The doctor may decide to perform liver, kidney, or blood tests and may recommend stopping Lamotrix. If the patient has Stevens-Johnson syndrome or toxic epidermal necrolysis, the doctor will inform them that they should never take medicines containing lamotrigine again.

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
• drowsiness
• dizziness
• tremor
• difficulty sleeping (insomnia)
• feeling excited
• diarrhea
• dry mouth
• nausea or vomiting
• feeling tired
• back pain, 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 (phototoxicity).

Rare side effects

May occur in up to 1 in 1,000patients:

• life-threatening skin reaction (Stevens-Johnson syndrome: also see information at the beginning of section 4)
• a group of symptoms including fever, nausea, vomiting, headache, neck stiffness, extreme sensitivity to light. This may be caused by inflammation of the membranes surrounding the brain and spinal cord (meningitis). These symptoms usually resolve after stopping treatment, but if they worsen, the patient should seek medical attention.
• rapid, involuntary eye movements ( nystagmus)
• itchy eyes with discharge ( conjunctivitis).

Very rare side effects

May occur in up to 1 in 10,000patients:

• life-threatening skin reaction (toxic epidermal necrolysis: also see information at the beginning of section 4)
• drug reaction with eosinophilia and systemic symptoms (DRESS) (see section 4)
• high fever(fever) (also see information at the beginning of section 4)
• swelling of the face, enlarged lymph nodesin the neck, armpits, and groin (generalized lymphadenopathy: also see information at the beginning of section 4)
• liver function changes, which have been detected in blood tests, or liver failure (also see information at the beginning of section 4)
• severe blood clotting disorder, which can cause unexpected bleeding or bruising ( disseminated intravascular coagulation: also see information at the beginning of section 4)
• blood test changes, including reduced red blood cell count ( anemia), reduced white blood cell count ( leukopenia, neutropenia, agranulocytosis), reduced platelet count ( thrombocytopenia), and reduced count of all blood cells ( pancytopenia), as well as a bone marrow disorder called aplastic anemia
• hallucinations (seeing or hearing things that are not real)
• disorientation
• feeling unsteady or losing balance while moving
• involuntary, repetitive movements of the body and (or) sounds or words ( tics), involuntary muscle contractions 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
• pseudolymphoma syndrome (symptoms may include back or joint pain, which may be accompanied by fever and (or) general malaise).
• hemophagocytic lymphohistiocytosis (HLH) (see section 2. Important information before taking Lamotrix).

Other side effects:

Other side effects have occurred in a small number of patients, but the frequency is unknown.

• Bone disorders, including osteopenia and osteoporosis (weakened bones), and fractures have been reported. If the patient is taking antiepileptic medicines for a long time, has previously had osteoporosis, or is taking steroids, they should discuss this with their doctor or pharmacist.
• Nightmares.
• Decreased immunity due to lower levels of antibodies in the blood, called immunoglobulins, which help protect the body against infections.
• Red nodules or spots on the skin (pseudolymphoma).

Reporting side effects

If the patient experiences any side effects, including those 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; fax: +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 gather more information on the safety of this medicine.

5. How to store Lamotrix

The medicine should be stored out of sight and reach of children.
The patient should not take this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month stated.
The patient should not store the medicine at temperatures above 25°C.
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 Lamotrix contains

• The active substance of Lamotrix is lamotrigine. Each tablet contains 25 mg, 50 mg, or 100 mg of lamotrigine.
• The other ingredients are calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium croscarmellose, povidone, magnesium stearate, talc.

What Lamotrix looks like and contents of the pack

Lamotrix tablets are white, round, and biconvex.
The tablets are packaged in PVC/Aluminum blisters in a cardboard box.
Available pack sizes:
Lamotrix, 25 mg, 50 mg: 30 tablets
Lamotrix, 100 mg: 30 or 90 tablets
Not all pack sizes may be marketed.

Marketing authorization holder

neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert Str. 23
40764 Langenfeld
Germany

Manufacturer

Glenmark Pharmaceuticals s.r.o.
Fibíchova 143
566 17 Vysoké Mýto
Czech Republic

To obtain more detailed information, the patient should contact their local representative of the marketing authorization holder:

Neuraxpharm Polska Sp. z o.o.
ul. Poleczki 35
02-822 Warszawa
Date of last revision of the leaflet:10/2023