Lamitrin

Leaflet accompanying the packaging: information for the user

Lamitrin, 25 mg, tablets

Lamitrin, 50 mg, tablets

Lamitrin, 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 them, 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 Lamitrin and what is it used for

2 Important information before taking Lamitrin

3 How to take Lamitrin

4 Possible side effects

5 How to store Lamitrin

6 Contents of the packaging and other information

1. What is Lamitrin and what is it used for

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

• In adults and children over 13 years of age, Lamitrin can be used alone or in combination with other medicines to treat epilepsy. Lamitrin can 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, Lamitrin can be used in combination with other medicines to treat these diseases. It can be used as the only medicine to treat a type of epilepsy called typical absence seizures.

Lamitrin 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 over 18 years of age, Lamitrin can be used alone or in combination with other medicines to prevent depressive episodes in bipolar affective disorders. The mechanism by which Lamitrin works in the brain is not yet fully understood.

2. Important information before taking Lamitrin

When not to take Lamitrin

• If the patient has been diagnosed with an allergy( hypersensitivity) to lamotrigine or any of the other ingredients of this medicine (listed in section 6). In such a case: Inform the treating doctorand do not take Lamitrin.

Warnings and precautions

When to be particularly careful when taking Lamitrin

Before starting to take Lamitrin, consult a 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;
• The patient has ever had a rash or sunburnafter taking lamotrigine and being exposed to sunlight or artificial light (e.g. in a solarium). The doctor will verify the treatment used by the patient and may advise avoiding sunlight or using sun protection (e.g. using a sunscreen or wearing protective clothing);
• The patient has ever had meningitisafter taking lamotrigine ( read the description of symptoms in section 4 of this leaflet: Rare side effects);
• The patient is taking a medicine containing lamotrigine;
• 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: Inform the treating doctor, who may decide to reduce the dose or decide that Lamitrin is not a suitable medicine for the patient.

Important information about life-threatening reactions

A small number of patients taking Lamitrin may experience an allergic reaction or a potentially life-threatening skin reaction, which can worsen if left untreated. Such reactions can occur more frequently during the first few months of taking Lamitrin, especially when the patient has been given too high a dose, the dose has been increased too quickly, or when the patient is taking Lamitrin in combination with another medicine called valproate. Some of these reactions occur more frequently in children, so parents should pay particular attention to them.
These reactions include:

• skin rashes or redness, which can worsen into severe or sometimes life-threatening skin reactions, including a rash with ring-shaped lesions resembling a target ( erythema multiforme), widespread rash with blisters and peeling of the skin, especially around 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 accompanied by liver, blood, and other organ disorders ( Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS).

The patient should familiarize themselves with the symptoms of these conditions and keep them in mind while taking Lamitrin. 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 this with their doctor before taking Lamitrin.
Read the description of these symptoms in section 4 of this leaflet,in the section "Life-threatening reactions: seek medical attention immediately".

Hemophagocytic lymphohistiocytosis (HLH)

In patients taking lamotrigine, cases of a rare but very severe reaction of the immune system have been reported.
If the patient experiences any of the following symptoms while taking lamotrigine: fever, rash, neurological symptoms (such as tremors or shivers, confusion, or impaired brain function), they should contact their doctor or pharmacist 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 had thoughts of self-harm or suicide before
• if the patient is under 25 years of age. If the patient experiences worrying thoughts or feelings, or if they feel worse or experience new symptoms while taking Lamitrin:

They should see a doctor as soon as possible

to get help.

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 depressed or has worrying changes in behavior.

A small number of patients treated with antiepileptic medicines, such as Lamitrin, have also experienced thoughts of self-harm or suicide. If the patient has ever had such thoughts, they should contact their doctor immediately.

Taking Lamitrin for the treatment of epilepsy

Seizures in some types of epilepsy may sometimes worsen or occur more frequently while taking Lamitrin. In some patients, severe seizures may occur, which can pose a serious threat to the patient's health. If the patient experiences more frequent seizures or a severe seizure while taking Lamitrin:
they should see a doctor as soon as possible.

Lamitrin 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 increase the risk of suicidal thoughts or behaviors in children and adolescents under 18 years of age.

Lamitrin and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking

currently or recently, and about medicines the patient plans to take, including herbal medicines or other medicines available without a prescription.
The doctor needs to 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 Lamitrin. These medicines include:

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate, zonisamide, used to treat epilepsy
• olanzapine or aripiprazole, used to treat mental disorders
• bupropion, used to treat mental disordersor nicotine addiction
• paracetamol, used to treat pain or fever. Inform the doctorif the patient is taking any of these medicines.

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

• valproate, used to treat epilepsy or mental disorders
• carbamazepine, used to treat epilepsy or mental disorders
• phenytoin, primidone, or 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 the contraceptive pill ( see below). Inform the doctorif the patient is taking, has taken, or is about to take any of these medicines.

Hormonal contraceptives (such as the contraceptive pill) may affect the action of Lamitrin

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 using hormonal contraceptives, such as the contraceptive pill, the doctor may recommend blood tests to check the level of Lamitrin in the blood. If the patient is using or plans to use hormonal contraceptives:
they should discuss this with their doctorabout the appropriate method of contraception.
Lamitrin may also affect the action of hormonal contraceptives, although it is unlikely to reduce their effectiveness. If the patient is using 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 Lamitrin is affecting the action of the contraceptive.

Pregnancy and breastfeeding

If the patient is pregnant or thinks they may be pregnant, or if they plan to become pregnant, they should consult their doctor or pharmacist before taking this medicine.

• Do not stop treatment without consulting the doctor. This is especially important if the patient has epilepsy.
• Pregnancy may affect the effectiveness of Lamitrin, 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 and palate, if Lamitrin 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.

During breastfeeding or if the patient plans to breastfeed, they should consult their doctor or pharmacist before taking this medicine

The active substance of Lamitrin passes into breast milkand may affect the baby.
The doctor will discuss the risks and benefits of breastfeeding while taking Lamitrin, and if the patient decides to breastfeed, the doctor will periodically check the baby for 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

Lamitrin may cause dizziness and double vision.

Do not drive or operate machinery unless the patient is sure that these symptoms do not occur

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

Important information about some ingredients of Lamitrin

Lamitrin tablets contain a small amount of sugar called lactose. If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.
Lamitrin tablets contain less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Lamitrin

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

What doses of Lamitrin should be taken

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

• the patient's age
• whether the patient is taking Lamitrin 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). Never take a higher dose of Lamitrin than recommended by the doctor.
Usually, the effective dose of Lamitrin in 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 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.
Taking Lamitrin is not recommended in children under 2 years of age.

Taking the dose of Lamitrin

The dose of Lamitrin should be taken once or twice a day, as directed by the doctor. Lamitrin 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.

• Swallow the tablets whole. Do not break, chew, or crush them.
• Always take the entire doseprescribed by the doctor. Never take only part of a tablet.

Taking a higher dose of Lamitrin than recommended

Contact a doctor or the nearest emergency department immediately.
If possible, show the packaging of Lamitrin.
Taking too high a dose of Lamitrin may increase the risk of serious side effects, which can be fatal.
In a person who has taken too high a dose of Lamitrin, the following symptoms may occur:

• rapid, involuntary eye movements ( nystagmus)
• clumsiness, lack of coordination, or inability to maintain balance ( ataxia)
• heart rhythm disturbances (detectable by ECG)
• loss of consciousness, seizures, or coma.

Missing a single dose of Lamitrin

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

If several doses of Lamitrin are missed

Consult the doctor about restarting treatment with Lamitrin

This is important for the patient.

Do not stop taking Lamitrin unless the doctor recommends it

Lamitrin must be taken for as long as the doctor recommends. Do not stop taking it unless the doctor recommends it.

Taking Lamitrin for the treatment of epilepsy

To stop taking Lamitrin, it is essential to gradually reduce the doseover about two weeks. If Lamitrin is stopped abruptly, the patient's epilepsy symptoms may worsen or return.

Taking Lamitrin for the treatment of bipolar affective disorders

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

4. Possible side effects

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

Life-threatening reactions: seek medical attention immediately

A small number of patients taking Lamitrin may experience an allergic reaction or a potentially life-threatening skin reaction, which can worsen if left untreated.
Such reactions can occur more frequently during the first few months of taking Lamitrin, especially when the patient has been given too high a dose, the dose has been increased too quickly, or when the patient is taking Lamitrin in combination with another medicine called valproate. Some of these reactions occur more frequently in children, so parents should pay particular attention to them.
These reactions include:

• skin rashes or redness, which can worsen into severe or sometimes life-threatening skin reactions, including a rash with ring-shaped lesions resembling a target ( erythema multiforme), widespread rash with blisters and peeling of the skin, especially around 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 accompanied by liver, blood, and other organ disorders ( Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS)
• mouth ulcers, throat ulcers, nose ulcers, or genital ulcers
• eye ulcers, red or inflamed eyes (conjunctivitis)
• high fever(fever), flu-like symptoms, or drowsiness
• swelling of the face, enlarged lymph nodesin the neck, armpits, and groin
• unexpected bleeding, bruising, or blue discoloration
• sore throator more frequent infections (such as colds)
• increased liver enzymes in blood tests
• increased white blood cell count (eosinophilia)
• enlarged lymph nodes
• changes in other organs, including the liver and kidneys.

In many cases, these are symptoms of less severe side effects. However, remember that
they can be life-threatening and, if left untreated, can develop into
serious conditions, such as organ failure. If any of these symptoms are noticed:
seek medical attention immediately. The doctor may decide to perform tests of liver, kidney, or blood function and may recommend stopping Lamitrin. If the patient experiences 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 Lamitrin).

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
• tremors
• 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:

• a skin reaction that causes red spots and patches on the skin, which can look like a target or "bull's eye" with a dark red center surrounded by lighter red rings ( erythema multiforme)
• a life-threatening skin reaction ( Stevens-Johnson syndrome: also read the information at the beginning of section 4)

Very rare side effects

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

• a life-threatening skin reaction ( toxic epidermal necrolysis: also read the information at the beginning of section 4)
• a syndrome of hypersensitivity to the medicine with eosinophilia and systemic symptoms (DRESS) ( see section 4)
• high fever ( fever: also read the information at the beginning of section 4)
• swelling of the face, enlarged lymph nodes in the neck, armpits, and groin ( generalized lymphadenopathy: also read the information at the beginning of section 4)
• changes in liver function, which have been detected in blood tests, or liver failure: also read the information at the beginning of section 4
• a severe blood clotting disorder that can cause unexpected bleeding or bruising ( disseminated intravascular coagulation: also read the information at the beginning of section 4)
• hemophagocytic lymphohistiocytosis (HLH) (see section 2. Important information before taking Lamitrin)
• changes in blood test results, including a decrease in red blood cells ( anemia), white blood cells ( leukopenia, neutropenia, agranulocytosis), or platelets ( thrombocytopenia), or a decrease in 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 lacking 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
• a condition that can cause back or joint pain, which may be accompanied by fever and/or general feeling of being unwell (serum sickness-like reaction).

Other side effects

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

• Reports of bone disorders, including osteopenia and osteoporosis (weakening of bones) and fractures. 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
• Kidney inflammation ( interstitial nephritis) or simultaneous kidney and eye inflammation ( interstitial nephritis and uveitis)
• Nightmares
• Decreased immunity due to lower levels of antibodies in the blood, called immunoglobulins, which help protect the body against infections
• Red lumps or patches on the skin (pseudolymphoma).

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Lamitrin

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, carton, or bottle. The expiry date refers to the last day of the month.
There are no special precautions for storing Lamitrin.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Lamitrin contains

The active substance is lamotrigine. Each tablet contains 25 mg, 50 mg, or 100 mg of lamotrigine.
The other ingredients of the medicine are: lactose monohydrate, microcrystalline cellulose, povidone K30, sodium carboxymethylcellulose (type A), yellow iron oxide (E 172), and magnesium stearate.

What Lamitrin looks like and contents of the pack:

Lamitrin tablets (all strengths) are multi-faceted, square with rounded edges, and are pale yellow-brown in color. Not all pack sizes may be marketed.
Lamitrin, 25 mg, tablets are marked with "GSEC7" on one side and "25" on the other side. Each pack contains 14, 21, 28, 30, 42, 50, 56, or 100 tablets in blisters. Starter packs containing 21 or 42 tablets are also available for use during the first few weeks of treatment, during the gradual dose increase phase.
Lamitrin, 50 mg, tablets are marked with "GSEE1" on one side and "50" on the other side. Each pack contains 14, 28, 30, 42, 56, 90, 98, or 100 tablets in blisters. A starter pack containing 42 tablets is also available for use during the first few weeks of treatment, during the gradual dose increase phase.
Lamitrin, 100 mg, tablets are marked with "GSEE5" on one side and "100" on the other side. Each pack contains 28, 30, 42, 50, 56, 60, 90, 98, or 100 tablets in blisters.

Marketing authorization holder and manufacturer

Marketing authorization holder:
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
D24 YK11
Ireland
Manufacturer:
Delpharm Poznań Spółka Akcyjna
ul. Grunwaldzka 189
60-322 Poznań
Poland

This medicine is authorized in the Member States of the European Economic Area under the following names:

For more information, contact the representative of the marketing authorization holder:
GSK Services Sp. z o. o.
tel. +48 22 576 90 00
Date of last revision of the leaflet:January 2025