Lamitrin s

Package leaflet: Information for the user

Lamitrin S, 2 mg, chewable and dispersible tablets / for preparation of suspension
Lamitrin S, 5 mg, chewable and dispersible tablets / for preparation of suspension
Lamitrin S, 25 mg, chewable and dispersible tablets / for preparation of suspension
Lamitrin S, 50 mg, chewable and dispersible tablets / for preparation of suspension
Lamitrin S, 100 mg, chewable and dispersible tablets / for preparation of suspension
Lamitrin S, 200 mg, chewable and dispersible tablets / for preparation of suspension
Lamotrigine
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet
1 What Lamitrin S is and what it is used for
2 Important information before taking Lamitrin S
3 How to take Lamitrin S
4 Possible side effects
5 How to store Lamitrin S
6 Contents of the pack and other information

1. What Lamitrin S is and what it is used for

Lamitrin S 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 S in the treatment of epilepsy consists in blocking nerve impulses in the brain that cause epileptic seizures.

• In adults and children aged 13 years and older, Lamitrin S may be used in the treatment of epilepsy either alone or in combination with other medicines. Lamitrin S 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 S may be used in combination with other medicines for the treatment of these conditions. It may be used as monotherapy in the treatment of a type of epilepsy known as typical absence seizures.

Lamitrin S 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 S may be used alone or in combination with other medicines to prevent depressive episodes in bipolar affective disorder. The mechanism by which Lamitrin S exerts this effect in the brain has not yet been fully understood.

2. Important information before using Lamitrin S

When not to use Lamitrin S

• 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 doctor and do not take Lamitrin S.

Warnings and precautions
When to exercise special caution when using Lamitrin S
Before starting treatment with Lamitrin S, consult the doctor or
pharmacist if:

• the patient has any kidney disease;
• the patient has ever experienced a rash after taking lamotrigine or other medicines used to treat bipolar disorder or epilepsy;
• the patient has ever developed a rash or sunburn after exposure to sunlight or artificial light (e.g. in a solarium) following lamotrigine intake. The 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 characterized by disturbances in the heart's electrical activity. Abnormal ECG findings are associated with arrhythmia (irregular heartbeat), which may be triggered by lamotrigine use.

If any of the above conditions apply:
Inform the doctor, who may recommend reducing the dose or
decide that Lamitrin S is not suitable for the patient.
Important information about life-threatening reactions
A small number of patients taking Lamitrin S have experienced an allergic reaction or a potentially
life-threatening skin reaction, which may worsen if left untreated. These include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). Patients should be aware of the symptoms of these conditions and monitor for them during treatment with Lamitrin S. 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 descent and has previously been identified as carrying this genetic variant (HLA-B*1502), this should be discussed with the doctor before starting Lamitrin S.
Please read the description of these symptoms in section 4 of this leaflet, under "Life-threatening reactions: contact the doctor immediately".
Hemophagocytic lymphohistiocytosis (HLH)
Rare but very serious immune system reactions have been reported in patients taking lamotrigine.
If the following symptoms occur during lamotrigine treatment: fever,
rash, neurological symptoms (e.g. tremors or chills, confusion, brain dysfunction),
contact the 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 during treatment with Lamitrin S, or new symptoms appear: Seek medical help immediately by going to the doctor or nearest hospital. It may be helpful to inform a relative, caregiver, or friend that the patient may develop 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 concerning behavioral changes.

In a small number of patients treated with antiepileptic medicines such as Lamitrin S, thoughts of self-harm or suicide have occurred. If such thoughts occur, contact the doctor immediately.
Use of Lamitrin S in the treatment of epilepsy
Seizures in certain types of epilepsy may occasionally worsen or occur more frequently during treatment with Lamitrin S. Some patients may experience severe seizures that could pose a serious health risk. If seizures become more frequent during treatment with Lamitrin S or if a severe seizure occurs:
seek medical help immediately.
Lamitrin S 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 behavior in children and adolescents under 18 years of age.
Lamitrin S and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken by the patient,
as well as any medicines the patient plans to take, including herbal remedies or other non-prescription medicines.
The doctor needs to know if the patient is taking other medicines used to treat epilepsy or psychiatric disorders. This will allow appropriate dosing of Lamitrin S. 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 doctor if the patient is taking any of these medicines.

Some medicines interact with Lamitrin S 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)
• products containing estrogens, including hormonal contraceptives such as the oral contraceptive pill ( see below ) and hormone replacement therapy (HRT).

Inform the doctor if the patient is taking, has taken, or is starting to take any of these medicines.
Hormonal contraceptives (such as the oral contraceptive pill) may affect the action of Lamitrin S
The doctor may recommend a specific type of hormonal contraceptive or another method of contraception, such as condoms, diaphragm, or intrauterine device. If the patient is using hormonal contraceptives such as the oral contraceptive pill, the doctor may recommend blood tests to monitor Lamitrin S levels. If the patient is using or plans to start using hormonal contraceptives:
discuss appropriate contraceptive methods with the doctor.
Lamitrin S may also affect the action of hormonal contraceptives, although it is unlikely to reduce their effectiveness. If the patient using hormonal contraceptives notices any changes in the menstrual cycle, such as bleeding or spotting between periods:
inform the doctor. These symptoms may indicate an effect of Lamitrin S on the contraceptive.
Hormone replacement therapy (HRT) may affect the action of Lamitrin S
If the patient is using hormone replacement therapy (HRT) containing estrogens, the doctor may recommend blood tests to monitor Lamitrin S levels.
Pregnancy and breastfeeding
If pregnant, suspecting pregnancy, or planning pregnancy, consult the doctor or pharmacist before using this medicine.

• Do not stop treatment without first consulting the doctor. This is particularly important if the patient has epilepsy.
• Pregnancy may affect the effectiveness of Lamitrin S, so blood tests and dose adjustments may be necessary.
• There may be a slight increase in the risk of congenital malformations, including cleft lip and palate, if Lamitrin S is taken during the first three months of pregnancy.
• If the patient plans to become pregnant or is pregnant, the doctor may recommend taking folic acid additionally.

If breastfeeding or planning to breastfeed, consult the doctor or pharmacist before using this medicine. The active substance in Lamitrin S passes into breast milk and may affect the infant. The doctor will discuss the risks and benefits of breastfeeding during treatment with Lamitrin S. 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 doctor.
Driving and operating machinery
Lamitrin S 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.
Lamitrin S dispersible and chewable tablets / for oral suspension contain less than 1 mmol
(23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Lamitrin S

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are
unsure, you should consult your doctor or pharmacist.
What dose of Lamitrin S should be taken
Determining the appropriate dose of Lamitrin S for a patient may take time. The dose prescribed to a
patient depends on:

• the patient's age
• whether the patient is taking Lamitrin S 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 maintenance dose). You must never take a higher
dose of Lamitrin S than that prescribed by your doctor.
Typically, the effective dose of Lamitrin S 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 between 1 mg and 15
mg per kilogram of body weight per day, up to a maximum maintenance dose of 200 mg per day.
The use of Lamitrin S is not recommended in children under 2 years of age.
Taking a dose of Lamitrin S
The dose of Lamitrin S should be taken once or twice daily, as directed by your doctor. Lamitrin S may be
taken with or without food.

• You must always take the full prescribed dose. Never take only part of a tablet.

Your doctor may also decide to start or discontinue other medications, depending on the indication and
the patient's response to treatment.
Lamitrin S dispersible and chewable tablets / tablets for oral suspension can either be swallowed whole
with a small amount of water, or chewed, or taken as a liquid after mixing with water. Never take only part
of a suspension.

Removing a tablet from the blister pack
These tablets are supplied in special child-resistant packaging. Each blister section containing one tablet
is numbered. Tablets should be taken sequentially in numerical order, starting from number 1.

1. Separating one tablet: to separate a blister section with one tablet, tear the blister along the perforated lines.

2. Peeling back the outer layer: starting at the corner, lift and peel back the outer layer from the separated blister section.

3. Removing the tablet: gently push one edge of the tablet through the foil layer.

Chewing the tablet:
Drinking a small amount of water at the same time will help dissolve the tablet in the mouth. The patient
should then drink additional water to ensure the entire dose has been swallowed.
To prepare an oral suspension, follow these steps:

• place the tablet in a glass and add enough water to cover the tablet completely;
• stir or wait until the tablet is completely dissolved;
• drink the entire suspension immediately;
• add a small amount of water to the glass and drink it to ensure no medicine remains in the glass.

Taking more than the recommended dose of Lamitrin S
You should contact your doctor or the nearest emergency department immediately.
If possible, show the Lamitrin S packaging to medical staff.
Taking more than the recommended dose of Lamitrin S may increase the risk of serious adverse
reactions, which could be fatal.
In a person who has taken an excessive dose of Lamitrin S, the following may occur:

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

Missing a single dose of Lamitrin S
Do not take extra tablets to make up for a missed dose. Take the next dose at the usual time.
If you miss several doses of Lamitrin S
You should consult your doctor about how to resume taking Lamitrin S. This is important for the
patient.
Do not stop taking Lamitrin S unless your doctor tells you to do so
Lamitrin S should be taken for as long as your doctor recommends. Do not stop taking it unless your
doctor advises.
Using Lamitrin S in the treatment of epilepsy
When stopping Lamitrin S, it is essential that the dose is gradually reduced over approximately two
weeks. Suddenly stopping Lamitrin S may cause seizures to return or worsen.
Using Lamitrin S in the treatment of bipolar affective disorders
It may take some time before Lamitrin S begins to work, so improvement is unlikely to occur immediately.
When discontinuing treatment with Lamitrin S, gradual dose reduction is not usually required. However,
you should consult your doctor before stopping Lamitrin S.

4. Possible adverse reactions

Like all medicines, 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 S have experienced an allergic reaction or 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 S,
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 S 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 and lead to severe or, in some cases, life-threatening skin reactions, including rashes with target-like lesions ( erythema multiforme ), widespread blistering rash with peeling of the epidermis, 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 involvement of 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
• mouth pain or redness and swelling of the eyes ( conjunctivitis )
• high body temperature (fever), flu-like symptoms, or drowsiness
• facial swelling, enlarged lymph nodes in the neck, armpits, or groin
• unexpected bleeding, bruising, or blue discoloration of the fingers
• sore throat or more frequent infections (such as colds)
• increased liver enzyme levels 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 your doctor immediately. The treating physician may decide to perform liver, kidney, or blood function tests and may recommend discontinuation of Lamitrin S. If the patient develops Stevens-Johnson syndrome or toxic epidermal necrolysis, the doctor will inform them that they must never take lamotrigine again.
Hemophagocytic lymphohistiocytosis (HLH) (see section 2. Important information before taking Lamitrin S).
Very common adverse reactions
May occur in more than 1 in 10 patients:

• headache
• skin rash.

Common adverse reactions
May occur in no more than 1 in 10 patients:

• aggression or irritability
• feeling sleepy
• dizziness
• tremor
• difficulty sleeping ( insomnia )
• feeling of restlessness
• diarrhea
• dry mouth
• nausea or vomiting
• feeling tired
• back, joint, or other body pain.

Uncommon adverse reactions
May occur in no more than 1 in 100 patients:

• impaired coordination and lack of motor control ( 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 no more than 1 in 1,000 patients:

• skin reaction causing red spots and patches on the skin, which may resemble 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 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 no more than 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)
• facial swelling, enlarged lymph nodes in the neck, armpits, and 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, 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 S)
• changes in blood test results – including decreased number of red blood cells ( anemia ), decreased number of white blood cells ( leukopenia , neutropenia , agranulocytosis ), decreased number of platelets ( thrombocytopenia ), decreased 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, repetitive movements of the body 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, 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, 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 due to 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 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Lamitrin S

Keep the 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 S are required.
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 S chewable and dispersible tablets / oral suspension contain
The active substance is lamotrigine. Each chewable and dispersible tablet / tablet for oral suspension contains: 2 mg, 5 mg, 25 mg, 50 mg, 100 mg or 200 mg of lamotrigine, respectively.
The other ingredients are: calcium carbonate, low-substituted hydroxypropylcellulose, magnesium aluminium silicate, sodium carboxymethylstarch (type A), povidone K30, sodium saccharin, magnesium stearate, blackcurrant flavour.

What Lamitrin S chewable and dispersible tablets / oral suspension look like and contents of the pack
Lamitrin S chewable and dispersible tablets / tablets for oral suspension (all strengths) are white to almost white in colour and may be slightly mottled. They have a blackcurrant odour. Not all pack sizes may be marketed.

Lamitrin S 2 mg chewable and dispersible tablets / tablets for oral suspension are round. One side is marked with the letters “LTG” above the number “2”; on the reverse side there are two ellipses crossing at right angles. Each bottle contains 30 tablets.

Lamitrin S 5 mg chewable and dispersible tablets / tablets for oral suspension are oblong, biconvex. One side is marked with “GS CL2”, the other side with “5”. Each pack contains 10, 14, 28, 30, 42, 50 or 56 tablets in blisters, or 14, 28, 30, 42, 56 or 60 tablets in a bottle.

Lamitrin S 25 mg chewable and dispersible tablets / tablets for oral suspension are square with rounded corners. One side is marked with “GSCL5”, the other side with “25”. Each pack contains 10, 14, 21, 28, 30, 42, 50, 56 or 60 tablets in blisters.

Lamitrin S 50 mg chewable and dispersible tablets / tablets for oral suspension are square with rounded corners. One side is marked with “GSCX7”, the other side with “50”. Each pack contains 10, 14, 28, 30, 42, 50, 56, 60, 90, 98, 100, 196 or 200 tablets in blisters.

Lamitrin S 100 mg chewable and dispersible tablets / tablets for oral suspension are square with rounded corners. One side is marked with “GSCL7”, the other side with “100”. Each pack contains 10, 14, 28, 30, 42, 50, 56, 60, 90, 98, 100, 196 or 200 tablets in blisters.

Lamitrin S 200 mg chewable and dispersible tablets / tablets for oral suspension are square with rounded corners. One side is marked with “GSEC5”, the other side with “200”. Each pack contains 10, 14, 28, 30, 42, 50, 56, 60, 90, 98, 100, 196 or 200 tablets in blisters.

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 more detailed information, please contact the representative of the responsible entity:
GSK Services Sp. z o.o.
tel.: +48 22 576 90 00