Lamitrin

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Lamitrin (Lamictal), 50 mg, tablets
Lamotriginum
Lamitrin and Lamictal are different trade names for the same medicine.
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, 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 package 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 involves 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 epileptic seizures associated with a condition known as 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.
In patients with bipolar affective disorder (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 aged 18 years and older, Lamitrin may be used either alone or in combination with other medicines to prevent depressive episodes occurring in bipolar affective disorder.
The mechanism by which Lamitrin exerts this effect in the brain has not yet been established.

2. Information before using Lamitrin

When not to take Lamitrin

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

In such a case:

• Inform the treating physician and do not take Lamitrin.

Warnings and precautions
When to exercise particular caution when taking Lamitrin
Before starting Lamitrin, consult the treating physician 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 ever experienced a rash or sunburn after exposure to sunlight or artificial light (e.g. in a solarium) while taking lamotrigine. The physician will review the patient's treatment and may recommend avoiding sunlight or using sun protection (e.g. sunscreen or protective clothing).
• the patient has ever had meningitis ( aseptic 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 characterized by 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 the treating physician, 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 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 treatment with Lamitrin.

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

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

• If, during treatment with lamotrigine, the patient develops the following symptoms: fever, rash, neurological symptoms (e.g. tremors or chills, confusion, brain dysfunction), seek immediate medical advice from a doctor or pharmacist.

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 frequent 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 treatment with Lamitrin:

• Seek medical help immediately by visiting a doctor or 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 the patient ever experiences such thoughts, they should contact their treating physician immediately.

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

• seek medical advice from a doctor 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
Inform the doctor or pharmacist about all medicines currently taken, recently taken, or planned for use, including herbal remedies or other non-prescription medicines.

The treating physician must be aware if the patient is taking other medicines used to treat epilepsy or psychiatric disorders. This will allow appropriate dosing of Lamitrin. 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 the treating physician 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 oral contraceptive pill ( see below )
• Inform the treating physician if the patient is taking, has taken, or is starting to take any of these medicines.

Hormonal contraceptives (e.g. oral contraceptive pill) may affect the action of Lamitrin
The treating physician 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 oral contraceptive pill, the treating physician may recommend blood tests to monitor Lamitrin levels. If the patient is using or planning to start hormonal contraceptives:

• discuss with the treating physician 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 uses hormonal contraceptives and notices any changes in the menstrual cycle, such as bleeding or intermenstrual spotting:

• inform the treating physician. These symptoms may indicate that Lamitrin is affecting the contraceptive.

Pregnancy and breastfeeding

• During pregnancy, if pregnancy is suspected, or when planning pregnancy, consult the treating physician or pharmacist before taking this medicine.
• Do not stop treatment without first consulting the treating physician. This is particularly important if the patient has epilepsy.
• Pregnancy may alter 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 pregnancy or is pregnant, the treating physician may recommend additional folic acid supplementation.
• During breastfeeding or if the patient plans to breastfeed, consult the treating physician or pharmacist before taking this medicine. The active substance in Lamitrin passes into breast milk and may affect the infant. The physician will discuss the risks and benefits of breastfeeding during Lamitrin treatment. If the patient decides to breastfeed, the infant should be monitored periodically for excessive drowsiness, rash, or poor weight gain. If any of these symptoms occur in the infant, inform the physician.

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

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

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

Important information about certain ingredients in 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 exactly as prescribed by your doctor. If in doubt,
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 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.

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.
The usual 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
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 too high a dose of Lamitrin may increase the risk of serious adverse reactions, which may 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.

If a dose of Lamitrin is missed

• 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 resuming treatment with Lamitrin. This is important for the patient.

Do not stop taking Lamitrin unless your doctor tells you to do so.
Lamitrin should be taken for as long as your doctor recommends. Do not discontinue treatment
unless instructed by your doctor.
Use of Lamitrin in the treatment of epilepsy
When stopping Lamitrin treatment, it is essential that the dose be gradually reduced over a period
of approximately two weeks. Abruptly stopping Lamitrin may cause seizures to recur or worsen.
Use of Lamitrin in 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 Lamitrin treatment, gradual dose reduction is not usually required. However, you should consult your doctor if you intend to stop taking Lamitrin.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Life-threatening reactions: contact a doctor immediately.
A small number of patients taking Lamitrin have experienced an allergic reaction or a potentially life-threatening skin reaction, which may worsen if left untreated.
These symptoms 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 quickly, 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 special attention to them.
Symptoms of these reactions include:

• Skin rash or redness of the skin, which may progress to severe skin reactions, including widespread rash with blisters and peeling of the outer layer of skin, particularly around the mouth, nose, eyes, and genitals ( Stevens-Johnson syndrome ), extensive peeling of the skin (affecting more than 30% of body surface area - toxic epidermal necrolysis ), or widespread rash accompanied by abnormalities affecting the liver, blood, and other organs (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 the fingers
• Sore throat or more frequent infections than usual (such as colds)
• Increased liver enzymes in blood tests
• Increased number of white blood cells (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 be potentially life-threatening and, if left untreated, may progress to serious conditions,
such as organ failure. If any of these symptoms occur:

• Contact a doctor immediately. The treating physician may decide to perform tests assessing liver, kidney, or blood function and may recommend discontinuation of Lamitrin. If the patient develops Stevens-Johnson syndrome or toxic epidermal necrolysis, the doctor will inform them 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 sleeping ( insomnia )
• Feeling of restlessness
• Diarrhea
• Dry mouth
• Nausea or vomiting
• Feeling of fatigue
• Back, joint, or other 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, 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 persist or worsen, contact a 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 detected in blood tests or liver failure: also refer to information at the beginning of section 4
• Severe blood clotting disorder that 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 number of platelets ( thrombocytopenia ), reduced number 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 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 seizures in patients with previously diagnosed epilepsy
• Worsening of symptoms in patients with diagnosed Parkinson's disease
• Pseudotumor cerebri syndrome (symptoms may include back or joint pain, sometimes 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 (weakening of 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, they should discuss this with their doctor or pharmacist.
• Kidney inflammation ( tubulointerstitial nephritis ), or simultaneous kidney and eye inflammation ( tubulointerstitial nephritis and uveitis )
• Nightmares
• Weakened immunity due to lower levels in the blood of antibodies called immunoglobulins, which help protect the body against infections.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform a 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Lamitrin

Keep this medicine out of 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 specified month.
No special storage instructions apply.
Medicines must 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 pack and other information

What Lamitrin contains
The active substance is lamotrigine. Each tablet contains 50 mg of lamotrigine.
The other ingredients are: monohydrate lactose, microcrystalline cellulose, povidone K 30,
sodium carboxymethyl starch (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 "GSEE1" on one side and "50" on the other side.
Each pack contains 14, 28 or 42 tablets in blisters.

For further detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Portugal, 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 Warsaw, Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing Authorisation Number in Portugal, country of export: 5792726
Parallel Import Licence Number: 257/23

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