Lamitrin

Leaflet accompanying the packaging: information for the user

Lamitrin, 25 mg, tablets

Lamitrin, 50 mg, tablets

Lamitrin, 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 doubts, you should 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 side effects 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 medicines. 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 found to be allergic( hypersensitive) to lamotrigine or any of the other ingredients of this medicine (listed in section 6). In such cases: the doctor should be informedand Lamitrin should not be taken.

Warnings and precautions

When to be particularly careful when taking Lamitrin

Before starting to take Lamitrin, the patient should consult 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;
• 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:
the doctor should be informed, 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

In a small number of patients taking Lamitrin, a life-threatening allergic reaction or skin reaction may occur, which may worsen if left untreated. Such 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 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 help immediately”.

Hemophagocytic lymphohistiocytosis (HLH)

In patients taking lamotrigine, cases of a rare but very serious reaction of the immune system have been reported.
If the patient experiences any of the following symptoms while taking lamotrigine: fever, rash, neurological symptoms (e.g. tremors or shivers, confusion, brain function disorders), 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 disturbing thoughts or feelings, or if their condition worsens while taking Lamitrin, or if new symptoms occur:

They should see their doctor as soon as possible

for 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 disturbing changes in behavior.

In a small number of patients treated with antiepileptic medicines, such as Lamitrin, thoughts of self-harm or suicide have also occurred. 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 their 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

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

currently or recently, and about medicines they plan to take, including herbal medicines 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 appropriate 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. The patient should inform their doctorif they are 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). The patient should inform their doctorif they are taking, have taken, or are 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 taking 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 taking or plans to take 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 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 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.

• The patient should not stop taking their medicine without first consulting their doctor. This is especially important if the patient has epilepsy.
• Pregnancy may change the effectiveness of Lamitrin, so there may be a need for blood tests and adjustment of the dose of Lamitrin.
• 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.

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

Important information about some of the 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. If the patient has any doubts, they should consult their doctor or pharmacist.

What dose of Lamitrin to take

Determining the appropriate 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 diseases.

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 effective dose) is reached. The patient should never take a higher dose of Lamitrin than prescribed by their 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.

• Tablets should be swallowed whole. They should not be broken, chewed, or crushed.
• The patient should always take the entire doseprescribed by the doctor. They should never take only part of a tablet.

Taking a higher dose of Lamitrin than recommended

The patient should contact their doctor or the nearest emergency department immediately.
If possible, they should show the packaging of Lamitrin.
Taking too much Lamitrin may increase the risk of serious side effects, which can be fatal.
If someone has taken too much Lamitrin, they may experience:

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

Missing a single dose of Lamitrin

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

They should take the next dose at the usual time.

If the patient misses several doses of Lamitrin

The patient should consult their doctor about restarting treatment with

Lamitrin. This is important for the patient.

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

Lamitrin 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 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 recur or worsen.

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 help immediately

In a small number of patients taking Lamitrin, a life-threatening allergic reaction or skin reaction may occur, which may worsen if left untreated. Such reactions may occur more frequently during the first few months of taking Lamitrin, especially if the patient has been given too high a dose, if the dose has been increased too quickly, or if 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 may worsen to severe or life-threatening skin reactions, including erythema multiforme(a rash with ring-shaped lesions), widespread rash with blisters and skin peeling, especially on the face, nose, eyes, and genitals ( Stevens-Johnson syndrome), widespread skin peeling (affecting 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, DRESS)
• mouth ulcers, throat ulcers, nose ulcers, or genital ulcers
• eye ulcers, redness, or swelling( 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 of the fingers
• sore throator more frequent infections (such as colds)
• increased liver enzyme levels in blood tests
• increased white blood cell count (eosinophilia)
• enlarged lymph nodes
• organ disorders, including liver and kidney disorders.

In many cases, these are symptoms of less severe side effects. However, they can be life-threatening and, if left untreated, can develop into
serious conditions, such as organ failure. If the patient notices any of these symptoms:
they should contact their doctor immediately. The doctor may decide to perform liver, kidney, or blood tests and may recommend stopping Lamitrin. 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 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 agitated
• 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 may 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)
• a group of symptoms including fever, nausea, vomiting, headache, stiff neck, and extreme sensitivity to bright 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 contact their doctor.
• rapid, involuntary eye movements ( nystagmus)
• itchy eyes with discharge ( conjunctivitis)

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 reaction that causes a group of symptoms including fever, rash, swollen lymph nodes, and other organ disorders ( Drug Reaction 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)
• liver function changes, which have been detected in blood tests, or liver failure: also read the information at the beginning of section 4
• a serious 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)
• blood test changes, including decreased red blood cell count ( anemia), decreased white blood cell count ( leukopenia, neutropenia, agranulocytosis), decreased platelet count ( thrombocytopenia), decreased count 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 losing balance while moving
• involuntary repetitive body movements 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 causes symptoms such as back or joint pain, which may be accompanied by fever and (or) general malaise (pseudolymphoma syndrome).

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 (weakened 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
• weakened immune system due to lower levels of antibodies in the blood, which help protect the body against infections
• red lumps or spots on the skin (pseudolymphoma).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, 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.
By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Lamitrin

The medicine should be stored in a place that is out of sight and reach of children.
The patient should not take 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. The patient should ask their 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 are also available, containing 21 or 42 tablets, 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 is also available, containing 42 tablets, 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, the patient should 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