Lamitrin

Package leaflet: information for the user

Lamitrin 25 mg tablets
Lamitrin 50 mg tablets
Lamitrin 100 mg tablets
Lamotrigine
Please read carefully the entire leaflet before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please 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 others, 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.

Leaflet contents
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 to treat two conditions: epilepsy and bipolar affective disorder.

The action of Lamitrin in treating epilepsy involves blocking nerve signals in the brain that trigger epileptic seizures.

• In adults and children aged 13 years and older, Lamitrin may be used alone (as monotherapy) or in combination with other medicines for the treatment of epilepsy. Lamitrin may also be used in combination with other medicines to treat 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 monotherapy 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 produces 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 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 special caution when using Lamitrin
Before starting Lamitrin, consult the treating physician or
pharmacist 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 administration of lamotrigine. The physician 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 disease characterized by disturbances in the electrical activity of the heart. Abnormal ECG findings are associated with arrhythmia (irregular heartbeat), which may be triggered by taking lamotrigine.

If any of the above conditions apply:
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 develop 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 read about the symptoms of these conditions and remain vigilant during treatment with Lamitrin. This risk may be associated with a genetic variant found in individuals of Asian descent (particularly Han Chinese and Thai). If the patient is of such ancestry and has previously been found to carry this genetic variant (HLA-B*1502), this should be discussed with the treating physician before starting Lamitrin.
Please read the description of these symptoms in section 4 of this leaflet, under "Life-threatening reactions: contact a doctor immediately".
Hemophagocytic 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 a 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 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 the patient if they notice signs of depression or concerning behavioral changes.
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 the 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 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 behaviors in children and adolescents under 18 years of age.
Lamitrin and other medicines
Tell the 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 over-the-counter 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 reactions. 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 (combination of lopinavir with ritonavir or atazanavir with ritonavir)
• products containing estrogens, including hormonal contraceptives, such as the oral contraceptive pill ( see below ) and hormone replacement therapy (HRT) .
  Inform the treating physician if the patient is taking, has taken, or plans to start taking any of these medicines.

Hormonal contraceptives (such as the 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, diaphragms, or intrauterine devices. 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 plans to start using hormonal contraceptives:
discuss appropriate contraceptive methods with the treating physician .
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 the menstrual cycle, such as bleeding or intermenstrual spotting:
inform the treating physician . These symptoms may indicate an interaction between Lamitrin and the contraceptive.
Hormone replacement therapy (HRT) may affect the action of Lamitrin
If the patient is using hormone replacement therapy (HRT) containing estrogens, the treating physician may recommend blood tests to monitor Lamitrin levels.
Pregnancy and breastfeeding
During pregnancy, if pregnancy is suspected, or if planning a pregnancy, consult the treating physician or pharmacist before using 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 plans to become pregnant or is already pregnant, the treating physician may recommend additional folic acid supplementation.

During breastfeeding or if planning to breastfeed, consult the treating physician or pharmacist before using 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 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 are observed 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 these symptoms do not occur.
If the patient has epilepsy, discuss driving and operating machinery with the physician.
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 a 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 directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
What dose of Lamitrin should be taken
Determining the appropriate dose of Lamitrin for a patient may take time. The dose prescribed 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.
How to take 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 stop 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
Contact your doctor or the nearest emergency department immediately.
If possible, bring the Lamitrin packaging with you.
Taking too high a dose of Lamitrin may increase the risk of serious adverse reactions, which could be fatal.
Symptoms in a person who has taken an excessive dose of Lamitrin may include:

• rapid, involuntary eye movements ( nystagmus )
• unsteadiness, lack of coordination, inability to maintain balance ( ataxia )
• heart rhythm disturbances (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 resume taking 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.
Stopping Lamitrin when used to treat epilepsy
When discontinuing Lamitrin, it is essential that the dose be gradually reduced over approximately two weeks.
Suddenly stopping Lamitrin may cause seizures to return or worsen.
Stopping Lamitrin when used to treat bipolar affective disorder
It may take some time before Lamitrin starts to work, so improvement is unlikely to occur immediately. When stopping treatment with Lamitrin, gradual dose reduction is not usually required. However, you should always consult your doctor before discontinuing Lamitrin.

4. Possible adverse reactions

Like any medicine, 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 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,
especially 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 particular attention to them.
Symptoms of these reactions include:

• skin rash or redness of the skin, which may worsen into severe or, in some cases, life-threatening skin reactions, including rashes with target-like lesions resembling a bull's eye ( erythema multiforme ), extensive rash with blisters and peeling of the 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 extensive rash accompanied by changes 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 potentially be 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 doctor may decide that liver, kidney or blood function tests are necessary 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 taking 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
• diarrhoea
• dry mouth
• nausea or vomiting
• feeling tired
• back, joint or other pain anywhere in the body.

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:

• skin reaction causing red spots and patches on the skin, which may look like a target or "bull's eye" with a dark red center surrounded by lighter red rings ( erythema multiforme )
• life-threatening skin reaction ( Stevens-Johnson syndrome: also refer to information at the beginning of section 4 )
• a group of symptoms occurring together: fever, nausea, vomiting, headache, neck stiffness, extreme sensitivity to bright light. This may be due to 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) (also refer to information at the beginning of 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 taking Lamitrin)
• changes in blood test results - including reduced number of red blood cells ( anaemia ), 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 anaemia
• hallucinations ("seeing" or "hearing" things that are not real)
• disorientation
• feeling of unsteadiness or loss of balance while moving
• involuntary, repetitive body movements and (or) sounds or words (tics), involuntary muscle contractions affecting the eyes, head and trunk (choreoathetosis), or other unusual body movements such as jerks, tremors or stiffness
• increased frequency of seizures in patients with previously diagnosed epilepsy
• worsening of symptoms in patients with diagnosed Parkinson's disease
• pseudotumor 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 a doctor or pharmacist
• Kidney inflammation ( tubulointerstitial nephritis ) or simultaneous kidney and eye inflammation ( tubulointerstitial nephritis and uveitis )
• Nightmares
• Weakened immunity caused by lower levels in the blood of antibodies called immunoglobulins, which help protect the body against infections
• Red nodules or spots on the skin (pseudolymphoma).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring of 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
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, more 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 blister pack, cardboard box, or bottle. The expiry date refers to the last day of the stated month.
No special precautions for storage of Lamitrin.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Lamitrin contains
The active substance is lamotrigine. Each tablet contains 25 mg, 50 mg or 100 mg of lamotrigine.
The other ingredients are: monohydrate lactose, microcrystalline cellulose, povidone K30,
sodium carboxymethyl starch (type A), yellow iron oxide (E 172) and magnesium stearate.

What Lamitrin looks like and contents of the pack
Lamitrin tablets (all strengths) are square with rounded corners, in a light yellow-brown colour.
Not all pack types may be marketed.

Lamitrin 25 mg tablets are marked with the code "GSEC7" on one side and "25" on the other side. Each pack contains 14, 21, 28, 30, 42, 50, 56 or 100 tablets in blister packs. Starter packs containing 21 or 42 tablets are also available, intended for use during the first few weeks of treatment, during the phase of gradual dose escalation.

Lamitrin 50 mg tablets are marked with the code "GSEE1" on one side and "50" on the other side. Each pack contains 14, 28, 30, 42, 56, 90, 98 or 100 tablets in blister packs. A starter pack containing 42 tablets is also available, intended for use during the first few weeks of treatment, during the phase of gradual dose escalation.

Lamitrin 100 mg tablets are marked with the code "GSEE5" on one side and "100" on the other side. Each pack contains 28, 30, 42, 50, 56, 60, 90, 98 or 100 tablets in blister packs.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
D24 YK11
Ireland

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

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

For further information, please contact the representative of the marketing authorisation holder:
GSK Services Sp. z o.o.
tel. +48 22 576 90 00