Lamitrin

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Lamitrin (Lamictal), 25 mg, tablets

Lamotrigine
Lamitrin and Lamictal are different trade names for the same medicine.

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 necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness 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 epilepsyis to block impulses in the brain that cause epileptic seizures.

• In adults and children over 13 years of age, Lamitrin may be used alone or in combination with other medicines to treat epilepsy. Lamitrin may also be used in combination with other medicines to treat seizures associated with a condition called Lennox-Gastaut syndrome.
• In children between 2 and 12 years of age, Lamitrin may be used in combination with other medicines to treat these diseases. It may 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:

• The patient should inform their doctorand not take Lamitrin.

Warnings and precautions

When to exercise special caution 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 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 EKG recordings are associated with arrhythmia (abnormal heart rhythm), which may be caused by taking lamotrigine.

In case of any of the above:

• The patient should inform their doctor, who may recommend reducing the dose or deciding that Lamitrin is not a suitable medicine for the patient.

Important information about life-threatening reactions

In a small number of patients taking Lamitrin, an allergic reaction or potentially life-threatening 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 when the patient has been given too high a dose, the dose has been increased too quickly, or the patient is taking Lamitrin in combination with another medicine called valproate. Some of these symptoms occur more frequently in children, so parents should pay special attention to them.
These symptoms include:

• skin rashes or redness, which may worsen to severe skin reactions, including 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 (affecting more than 30% of the body surface - toxic epidermal necrolysis), or widespread rash accompanied by changes in the liver, blood, and other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS)
• ulcers in the mouth, throat, nose, or genitals
• pain in the mouth or redness and swelling of the eyes(conjunctivitis)
• high fever(fever), flu-like symptoms
• 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 enzymes in blood tests
• increased white blood cell count (eosinophilia)
• enlarged lymph nodes
• changes affecting other organs, including the liver and kidneys.

In many cases, these are symptoms of less severe side effects. However, it should be remembered that they can be life-threatening and, if left untreated, may develop into
serious conditions, such as organ failure. If any of these symptoms are noticed:

• the patient should contact their doctor immediately. The doctor may decide to perform tests of liver, kidney, or blood function 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).

  Thoughts of self-harm or suicide

  Antiepileptic medicines, such as Lamitrin, 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 they feel worse or experience new symptoms while taking Lamitrin:
  • they should see their doctor as soon as possibleto 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 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 ever experiences such thoughts, they should contact their doctor immediately.

  Taking Lamitrin to treat epilepsy

  Seizures in some types of epilepsy may sometimes worsen or occur more frequently when taking Lamitrin. In some patients, severe seizures may occur, which can pose a serious risk to the patient's health. If the patient experiences more frequent seizures or a severe seizure while taking 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 can 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 currently taking or have recently taken, as well as any 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 birth control pills (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 birth control pills) 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 birth control pills, the doctor may recommend performing tests to check the level of Lamitrin in the blood. If the patient is using or plans to start using hormonal contraceptives:

  • they should discuss this with their doctorto choose a suitable 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.
  • The patient should not stop taking their medicine without first consulting their doctor. This is especially important if the patient has epilepsy.
  • Pregnancy may affect the effectiveness of Lamitrin, so there may be a need to perform blood tests and adjust 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, their doctor may recommend taking folic acid in addition.
  • If the patient is breastfeeding or plans to breastfeed, they should consult their doctor or pharmacist before taking this medicine. The active substance of Lamitrin passes into breast milk and 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 regularly check the baby for 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

  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 using machines with their doctor

  Important information about some ingredients of Lamitrin

  The tablets of Lamitrin contain a small amount of sugar called lactose. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.
  Lamitrin tablets contain less than 1 mmol (23 mg) of sodium per tablet, which means that 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, the patient should consult their doctor or pharmacist.
  Lamitrin is available in the following doses: 25 mg, 50 mg, 100 mg.

  What doses of Lamitrin should be taken

  The determination of 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 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 (effective dose). The patient should never take a higher dose of Lamitrin than that recommended 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.
  Lamitrin should not be used 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.

  • 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. 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 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 (usually detectable during an EKG)
  • 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 to treat epilepsy

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

  Taking Lamitrin to treat 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: the patient should contact their doctor immediately

  In a small number of patients taking Lamitrin, an allergic reaction or potentially life-threatening 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 when the patient has been given too high a dose, the dose has been increased too quickly, or the patient is taking Lamitrin in combination with another medicine called valproate. Some of these symptoms occur more frequently in children, so parents should pay special attention to them.
  These symptoms include:

  • skin rashes or redness, which may worsen to severe skin reactions, including 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 (affecting more than 30% of the body surface - toxic epidermal necrolysis), or widespread rash accompanied by changes in the liver, blood, and other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS)
  • ulcers in the mouth, throat, nose, or genitals
  • pain in the mouth or redness and swelling of the eyes(conjunctivitis)
  • high fever(fever), flu-like symptoms
  • 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 enzymes in blood tests
  • increased white blood cell count (eosinophilia)
  • enlarged lymph nodes
  • changes affecting other organs, including the liver and kidneys.

  In many cases, these are symptoms of less severe side effects. However, it should be remembered that they can be life-threatening and, if left untreated, may develop into
  serious conditions, such as organ failure. If any of these symptoms are noticed:

  • the patient should contact their doctor immediately. The doctor may decide to perform tests of liver, kidney, or blood function 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
    • tremor
    • difficulty sleeping (insomnia)
    • feeling of excitement
    • diarrhea
    • dry mouth
    • nausea or vomiting
    • feeling of tiredness
    • 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 read the information at the beginning of section 4).
    • a group of symptoms including fever, nausea, vomiting, headache, stiffness of the 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)
    • itching of the 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 read the information at the beginning of section 4)
    • 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 nodesin 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
    • severe blood clotting disorder, which 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 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 of unsteadiness or lack of balance while moving
    • involuntary movements of the body (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 called pseudolymphoma (symptoms may include back or joint pain, which may be accompanied by fever and general malaise).

    Other side effects

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

    • Reports have been made of bone disorders, including osteopenia and osteoporosis (weakening of the bones) and fractures. If the patient is taking antiepileptic medicines for a long time, has 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.

    Reporting side effects

    If the patient experiences any side effects, including any side effects not listed in the 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
    Reporting side effects can help gather more information on the safety of the medicine.

    5. How to store Lamitrin

    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 packaging. The expiry date refers to the last day of the month.
    There are no special storage precautions.
    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 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 are multi-faceted, square with rounded edges, and are light yellow-brown in color.
    The tablets are marked with the inscription "GSEC7" on one side and "25" on the other side.
    Each pack contains 28 tablets in blisters.
    For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

    Marketing authorization holder in Romania, the country of export:

    GlaxoSmithKline (Ireland) Limited
    12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

    Manufacturer:

    GlaxoSmithKline Pharmaceuticals S.A.
    ul. Grunwaldzka 189, 60-322 Poznań, Poland

    Parallel importer:

    InPharm Sp. z o.o.
    ul. Strumykowa 28/11
    03-138 Warsaw

    Repackaged by:

    InPharm Sp. z o.o. Services sp. k.
    ul. Chełmżyńska 249
    04-458 Warsaw
    Marketing authorization number in Romania, the country of export:1742/2009/03

    Parallel import authorization number: 180/23

    This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

    Austria Lamictal	Belgium Lamictal	Bulgaria Lamictal
    Croatia Lamictal	Cyprus Lamictal	Czech Republic Lamictal
    Denmark Lamictal	Estonia Lamictal	Finland Lamictal
    France Lamictal Lamicstart	Germany Lamictal	Greece Lamictal
    Hungary Lamictal	Iceland Lamictal	Ireland Lamictal
    Italy Lamictal	Latvia Lamictal	Lithuania Lamictal
    Luxembourg Lamictal	Malta Lamictal	Netherlands Lamictal
    Norway Lamictal	Poland Lamitrin	Portugal Lamictal

    Romania Lamictal	Slovakia Lamictal	Slovenia Lamictal
    Spain Lamictal	Sweden Lamictal

    Date of approval of the leaflet: 30.08.2023

    [Information about the trademark]