Lamitrin

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Lamitrin (Lamictal), 25 mg, tablets
Lamotriginum
Lamitrin and Lamictal are different brand names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet to be able to read it again if needed.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Lamitrin is and what it is 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 pack and other information

1. What Lamitrin is and what it is used for

Lamitrin belongs to a group of medicines called antiepileptic drugs. It is used in the treatment of two conditions: epilepsy and bipolar affective disorder.
The action of Lamitrin in treating epilepsy consists of blocking nerve impulses in the brain that cause epileptic seizures.

• In adults and children aged 13 years and older, Lamitrin may be used in the treatment of epilepsy either as monotherapy (alone) or in combination with other medicines. Lamitrin may also be used in combination with other medicines in the treatment of seizures associated with a condition called Lennox-Gastaut syndrome.
• In children aged 2 to 12 years, Lamitrin may be used in combination with other medicines for the treatment of these conditions. It may also be used as the sole treatment for a type of epilepsy known as typical absence seizures.

Lamitrin is also used in the treatment of bipolar affective disorder.
Patients with bipolar affective disorder (sometimes called manic-depressive psychosis) experience extreme mood swings, with episodes of mania (excitement or euphoria) alternating with episodes of depression (deep sadness or despair). In adults aged 18 years and older, Lamitrin may be used alone or in combination with other medicines to prevent depressive episodes in bipolar affective disorder.
The mechanism by which Lamitrin exerts this effect in the brain has not yet been fully understood.

2. Important information before using Lamitrin

When not to use Lamitrin

• If the patient has a known allergy ( hypersensitivity ) to lamotrigine or any of the other ingredients of this medicine (listed in section 6).

In such a case:

• Inform your doctor and do not take Lamitrin.

Warnings and precautions
When to be cautious when using Lamitrin
Before starting Lamitrin, consult your doctor if:

• the patient has any kidney disease;
• the patient has ever developed a rash after taking lamotrigine or other medicines used to treat bipolar disorder or epilepsy;
• the patient has developed a rash or sunburn after exposure to sunlight or artificial light (e.g. in a solarium) following lamotrigine use. Your doctor will review the patient's treatment and may advise avoiding sunlight or using sun protection (e.g. sunscreen or protective clothing).
• the patient has ever experienced meningitis after taking lamotrigine ( see description of symptoms in section 4 of this leaflet: Rare adverse reactions );
• the patient is taking another medicine containing lamotrigine
• the patient has a condition called Brugada syndrome or other heart diseases . Brugada syndrome is a genetically determined heart condition causing disturbances in the heart's electrical activity. Abnormal ECG findings are associated with arrhythmia (irregular heartbeat), which may be triggered by taking lamotrigine.

If any of the above conditions occur:

• Inform your doctor , who may recommend reducing the dose or decide that Lamitrin is not suitable 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 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 be aware of the symptoms of these conditions and monitor for them during Lamitrin treatment.

• Please read the description of these symptoms in section 4 of this leaflet, under "Life-threatening reactions: contact your doctor immediately".

Haemophagocytic lymphohistiocytosis (HLH)
Cases of a rare but very serious immune system reaction have been reported in patients taking lamotrigine.

• If the patient develops the following symptoms while taking lamotrigine: fever, rash, neurological symptoms (e.g. tremors or chills, confusion, brain dysfunction), contact your doctor or pharmacist immediately .

Thoughts of self-harm or suicide
Antiepileptic medicines are used to treat various conditions, including epilepsy and bipolar disorder. Patients with bipolar disorder may occasionally experience thoughts of self-harm or suicide. These thoughts may be more common in patients with bipolar disorder:

• when starting treatment for the first time

• if the patient has previously had thoughts of self-harm or suicide

• if the patient is under 25 years of age. If the patient experiences disturbing thoughts or feelings, or if their condition worsens or new symptoms appear during Lamitrin treatment:

• Seek medical help immediately by contacting your doctor or going to the nearest hospital .
  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 signs of depression or worrying changes in behaviour.
  In a small number of patients treated with antiepileptic medicines such as Lamitrin, thoughts of self-harm or suicide have occurred. If such thoughts occur at any time, contact your doctor immediately.

Use of Lamitrin in the treatment of epilepsy
Seizures in some types of epilepsy may occasionally worsen or occur more frequently during Lamitrin treatment. Some patients may experience severe seizures that could pose a serious health risk. If seizures become more frequent or if a severe seizure occurs during treatment with Lamitrin:

• seek medical advice as soon as possible .

Lamitrin should not be used to treat bipolar disorder in patients under 18 years of age . Medicines used to treat depression or other psychiatric disorders may increase the risk of suicidal thoughts or behaviour in children and adolescents under 18 years of age.

Lamitrin and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take , including herbal remedies or other non-prescription medicines.
Your doctor needs to know if the patient is taking other medicines used to treat epilepsy or psychiatric disorders. This will allow the appropriate Lamitrin dose to be determined. These medicines include:

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate, zonisamide used to treat epilepsy

• lithium, olanzapine or aripiprazole used to treat psychiatric disorders

• bupropion used to treat psychiatric disorders or nicotine dependence

• paracetamol used to treat pain and fever

• Inform your doctor if the patient is taking any of these medicines.

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

• valproate used to treat epilepsy and psychiatric disorders

• carbamazepine used to treat epilepsy and psychiatric disorders

• phenytoin, primidone or phenobarbital used to treat epilepsy

• risperidone used to treat psychiatric disorders

• rifampicin , an antibiotic

• medicines used to treat human immunodeficiency virus (HIV) infection (lopinavir with ritonavir or atazanavir with ritonavir)

• hormonal contraceptives , such as the contraceptive pill ( see below )

• Inform your doctor if the patient is taking, has taken, or is starting to take any of these medicines.

Hormonal contraceptives (such as the contraceptive pill) may affect the action of Lamitrin
Your doctor may recommend a specific type of hormonal contraceptive or another method of contraception, such as condoms, a diaphragm, or an intrauterine device. If the patient is using hormonal contraceptives such as the contraceptive pill, your doctor may recommend blood tests to monitor Lamitrin levels. If the patient is using or plans to start hormonal contraceptives:

• discuss with your doctor 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 her menstrual cycle, such as bleeding or intermenstrual spotting:

• inform your doctor . These symptoms may indicate an effect of Lamitrin on the contraceptive.

Pregnancy and breastfeeding

• During pregnancy, if pregnancy is suspected, or if planning a pregnancy, consult your doctor or pharmacist before using this medicine.
• Do not stop treatment without first consulting your doctor. This is particularly important if the patient has epilepsy.
• Pregnancy may affect the effectiveness of Lamitrin, so blood tests and dose adjustments may be necessary.
• There may be a slightly increased risk of congenital malformations, including cleft lip and palate, if Lamitrin is taken during the first three months of pregnancy.
• If the patient is planning a pregnancy or is pregnant, the doctor may recommend taking folic acid additionally.
• During breastfeeding or if planning to breastfeed, consult your doctor or pharmacist before using this medicine . The active substance of Lamitrin passes into breast milk and may affect the infant. The doctor will discuss the risks and benefits of breastfeeding while taking Lamitrin. If the patient decides to breastfeed, the infant will be monitored periodically for excessive sleepiness, rash, or poor weight gain. If any of these symptoms occur in the infant, inform the doctor.

Driving and operating machinery
Lamitrin may cause dizziness and double vision.

• Do not drive or operate machinery unless the patient is certain these symptoms do not occur.

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

Important information about certain ingredients of Lamitrin
Lamitrin tablets contain a small amount of a sugar called lactose. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

Lamitrin tablets contain less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Lamitrin

This medicine should always be taken as prescribed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
Lamitrin is available in the following strengths: 25 mg, 50 mg, 100 mg.
What dose of Lamitrin should be taken
Determining the appropriate dose of Lamitrin for a patient may take time. The dose a patient
should take 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.

Your doctor will initially prescribe a low dose and then gradually increase it over several weeks
until reaching the dose effective for the patient (called the effective dose). You must never take a
higher dose of Lamitrin than the one prescribed by your doctor.
Typically, the effective dose of Lamitrin in adults and children aged 13 years and older ranges from
100 mg to 400 mg per day.
In children aged 2 to 12 years, the effective dose depends on body weight – usually from 1 mg to
15 mg per kilogram of body weight, up to a maximum maintenance dose of 200 mg per day.
The use of Lamitrin is not recommended in children under 2 years of age.
Taking a dose of Lamitrin
The dose of Lamitrin should be taken once or twice daily, as directed by your doctor. Lamitrin may
be taken with or without food.
Your doctor may also decide to start or discontinue other medications, depending on the indication
and the patient's response to treatment.

• Tablets should be swallowed whole. Do not break, chew or crush them.
• Always take the full prescribed dose. Never take only part of a tablet.

Taking more Lamitrin than prescribed

• Seek immediate medical advice from your doctor or the nearest emergency department. If possible, bring the Lamitrin packaging.

Taking an excessive dose of Lamitrin may increase the risk of serious adverse reactions, which
could be fatal.
In a person who has taken an overdose of Lamitrin, the following may occur:

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

Missing a dose of Lamitrin

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

If several doses of Lamitrin are missed

• Consult your doctor for advice on how to restart taking Lamitrin. This is important for the patient.

Do not stop taking Lamitrin unless your doctor advises you to do so.
Lamitrin should be taken for as long as your doctor recommends. Do not stop taking it unless
instructed by your doctor.
Taking Lamitrin for the treatment of epilepsy
When stopping Lamitrin, it is essential that the dose is gradually reduced over a period of about
two weeks. Abruptly stopping Lamitrin may cause seizures to recur or worsen.
Taking Lamitrin for the treatment of bipolar affective disorders
It may take some time before Lamitrin starts to work, so improvement is unlikely to occur
immediately. When discontinuing treatment with Lamitrin, gradual dose reduction is not
required. However, you should still consult your doctor if you plan to stop taking Lamitrin.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Life-threatening reactions: contact your doctor immediately.
A small number of patients taking Lamitrin have experienced an allergic reaction or
potentially life-threatening skin reaction, which may worsen if left untreated.
These symptoms may occur more frequently during the first few months of treatment with Lamitrin,
particularly if the patient has been given too high a dose, the dose has been increased too rapidly, or if 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 particular attention to them.
These reactions may include:

• Skin rash or redness of the skin, which may worsen, progressing to severe skin reactions, including widespread blistering rash and peeling of the epidermis, particularly around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome ), extensive peeling of the epidermis (affecting more than 30% of body surface area - toxic epidermal necrolysis ), or widespread rash accompanied by liver, blood and other organ involvement (drug hypersensitivity syndrome with eosinophilia and systemic symptoms, also known as DRESS syndrome)
• Ulceration of the mouth, throat, nose or genitals
• Pain in the mouth or redness and swelling of the eyes ( conjunctivitis )
• High body temperature (fever), flu-like symptoms or drowsiness
• Swelling of the face, enlarged lymph nodes in the neck, under the arms and in the groin
• Unexpected bleeding, bruising or blue discoloration of fingers
• Sore throat or more frequent than usual infections (such as colds)
• Increased liver enzyme levels 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 adverse reactions. However, it should be remembered
that they may potentially be life-threatening and, if left untreated, may progress to
serious conditions, such as organ failure. If any of these symptoms occur:

• Contact your doctor immediately. Your treating physician may decide to
  perform liver, kidney or blood function tests and may recommend discontinuation of
  Lamitrin. If the patient develops Stevens-Johnson syndrome or
  toxic epidermal necrolysis, the doctor will inform the patient that lamotrigine must never be used again.
  Hemophagocytic lymphohistiocytosis (HLH) (see section 2. Important information before using
  Lamitrin).
  Very common adverse reactions
  May occur in more than 1 in 10 patients:

• Headache

• Skin rash.

Common adverse reactions
May occur in up to 1 in 10 patients:

• Aggression or irritability
• Feeling sleepy
• Dizziness
• Tremor
• Difficulty falling asleep ( insomnia )
• Feeling of restlessness
• Diarrhea
• Dry mouth
• Nausea or vomiting
• Feeling of fatigue
• Back, joint or other body pain.

Uncommon adverse reactions
May occur in up to 1 in 100 patients:

• Lack of coordination and unsteady movements ( ataxia )
• Double or blurred vision
• Unusual hair loss or thinning ( alopecia )
• Skin rash or sunburn after exposure to sunlight or artificial light (photosensitivity).

Rare adverse reactions
May occur in up to 1 in 1,000 patients:

• Life-threatening skin reaction ( Stevens-Johnson syndrome: also refer to information at the beginning of section 4 ).
• A group of symptoms occurring simultaneously: fever, nausea, vomiting, headache, neck stiffness, 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 persist or worsen, contact your doctor.
• Rapid, involuntary eye movements ( nystagmus )
• Itchy eyes with discharge ( conjunctivitis ).

Very rare adverse reactions
May occur in up to 1 in 10,000 patients:

• Life-threatening skin reaction ( toxic epidermal necrolysis: also refer to information at the beginning of section 4 )
• Drug hypersensitivity syndrome with eosinophilia and systemic symptoms (DRESS) (see section 4)
• High body temperature ( fever: also refer to information at the beginning of section 4 )
• Swelling of the face, enlarged lymph nodes in the neck, under the arms and in the groin ( generalized lymphadenopathy: also refer to information at the beginning of section 4 )
• Liver function abnormalities shown in blood tests or liver failure: also refer to information at the beginning of section 4
• Severe blood clotting disorder which may cause unexpected bleeding or bruising ( disseminated intravascular coagulation: also refer to information at the beginning of section 4 )
• Hemophagocytic lymphohistiocytosis (HLH) (see section 2. Important information before using Lamitrin)
• Changes in blood test results – including reduced number of red blood cells ( anemia ), reduced number of white blood cells ( leukopenia , neutropenia , agranulocytosis ), reduced platelet count ( thrombocytopenia ), reduced number of all blood cells ( pancytopenia ) and bone marrow disorder known as aplastic anemia
• Hallucinations ("seeing" or "hearing" things that are not real)
• Disorientation
• Feeling of unsteadiness or loss of balance during movement
• Involuntary body movements ( 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 epileptic seizures in patients with previously diagnosed epilepsy
• Worsening of symptoms in patients with diagnosed Parkinson's disease
• Pseudotumour cerebri syndrome (symptoms may include: back or joint pain, which may sometimes be accompanied by fever and/or general malaise).

Other adverse reactions
Other adverse reactions have occurred in a small number of patients, but with unknown frequency.

• Bone disorders including osteopenia and osteoporosis (weakened bones) and fractures have been reported. If the patient is being treated long-term with antiepileptic medicines, has had osteoporosis in the past, or is taking steroids, this should be discussed with the doctor or pharmacist.
• Kidney inflammation ( tubulointerstitial nephritis ), or simultaneous kidney and eye inflammation ( tubulointerstitial nephritis and uveitis )
• Nightmares
• Weakened immunity caused by lower blood levels of antibodies called immunoglobulins, which help protect the body against infections.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the 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.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Lamitrin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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 components of the medicine are: monohydrate lactose, microcrystalline cellulose,
povidone K 30, sodium carboxymethylstarch (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-shaped with rounded corners, in a light yellow-brown colour.
The tablets are marked with the code "GSEC7" on one side and "25" on the other side.
Each pack contains 28 tablets in blisters.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation 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, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing authorisation number in Romania, the country of export: 1742/2009/03
Parallel import authorisation number: 180/23
This medicine is authorised in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names: