Lamitrin

Leaflet accompanying the packaging: information for the user

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

Lamitrin (Lamictal), 50 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 you need to.
• If you have 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 epileptic 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 found to be allergic(hypersensitive) 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 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 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 disease 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 the event of any of these cases:

• The patient should inform their 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

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 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.

Haemophagocytic 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 worrying 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 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 that the patient is experiencing depression or worrying 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 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 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 be aware 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
• olanzapineor 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 include:

• valproate, used to treat epilepsy or mental disorders
• carbamazepine, used to treat epilepsy or 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 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 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 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 contraceptive.

Pregnancy and breastfeeding

• If the patient is pregnant or thinks they may be pregnant or is planning 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 Lamitrin dose.
• 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 is planning 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 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

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 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 doubt, 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

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). The patient should never take a higher dose of Lamitrin than prescribed by their doctor.
Usually, the effective dose of Lamitrin for 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 is dependent on body 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 full doseprescribed by their 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 can increase the risk of serious side effects, which can be fatal.
In a person who has taken too much Lamitrin, the following symptoms may occur:

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

Missing a dose of Lamitrin

• The patient should not take extra tablets to make up for a 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 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 Lamitrin for the treatment of epilepsy

To stop taking Lamitrin, it is essential to gradually reduce the dose over about two weeks.
If the patient stops taking Lamitrin suddenly, their epilepsy symptoms may return 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: 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 if 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 reactions occur more frequently in children, so parents should pay particular attention to them.
The symptoms of these reactions include:

• skin rashes or redness, which can 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 (covering more than 30% of the body surface - toxic epidermal necrolysis), or widespread rash with changes in the liver, blood, and other organs ( drug reaction with eosinophilia and systemic symptoms, 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, 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 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, the patient should remember that 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 tests to check 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.
  Haemophagocytic 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:

  • life-threatening skin reaction (Stevens-Johnson syndrome: also see 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:

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

  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 the bones) and fractures. If the patient is taking antiepileptic medicines for a long time, has a history of osteoporosis, or is taking steroids, they should discuss this with their doctor or pharmacist.
  • Kidney inflammation ( tubulointerstitial nephritis) or simultaneous kidney and eye inflammation ( tubulointerstitial 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, 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.
  By reporting side effects, more information can be collected 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 stated.
  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 they no longer need. 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 50 mg of lamotrigine.
  The other ingredients of the medicine are: lactose monohydrate, microcrystalline cellulose, povidone K 30, sodium carboxymethylcellulose (type A), yellow iron oxide (E 172), and magnesium stearate.

  What Lamitrin looks like and contents of the pack

  The tablets of Lamitrin are multi-faceted, square with rounded edges, and are light yellow-brown in color.
  The tablets are marked with the inscription "GSEE1" on one side and "50" on the other side.
  Each pack contains 14, 28, or 42 tablets in blisters
  For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

  Marketing authorization holder in Portugal, the country of export:

  GlaxoSmithKline – Produtos Farmacêuticos, Lda.
  Rua Dr. António Loureiro Borges, 3
  Arquiparque – Miraflores
  1495-131 Algés, Portugal

  Manufacturer:

  Delpharm Poznań Spółka Akcyjna
  ul. Grunwaldzka 189, 60-322 Poznań, Poland

  Parallel importer:

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

  Repackaged by:

  InPharm Sp. z o.o. Services sp. k.
  ul. Chełmżyńska 249
  04-458 Warszawa
  Portuguese marketing authorization number:5792726

  Parallel import authorization number: 257/23

  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 revision of the leaflet: 09.11.2023

  [Information about the trademark]