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 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 a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents
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 to treat two conditions: epilepsy and bipolar disorder.
The action of Lamitrin S in treating epilepsy involves 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 to treat these conditions. It may also 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 disorder.
In patients with bipolar disorder (sometimes called manic-depressive psychosis), extreme mood swings occur, 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 disorder. The mechanism by which Lamitrin S produces 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 any of the other ingredients of this medicine (listed in section 6). In such a case: Consult the doctor in charge 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 in charge 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 developed a rash or sunburn after exposure to sunlight or artificial light (e.g. in a solarium) following lamotrigine use. 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 had 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 may lead to arrhythmia (irregular heartbeat), which can be triggered by lamotrigine use.

If any of the above conditions apply:
Consult the doctor in charge, 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 may develop an allergic reaction or a 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 treatment with Lamitrin S. This risk may be associated with a genetic variant found in individuals of Asian origin (mainly Han Chinese and Thai). If the patient is of such origin and has previously been found to carry 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 a 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 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 affective disorder. Patients with bipolar affective disorder may sometimes experience thoughts of self-harm or suicide. These thoughts may occur more frequently in patients with bipolar affective disorder:

• when starting treatment for the first time
• if the patient 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 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 S, thoughts of self-harm or suicide have also occurred. If the patient ever experiences such thoughts, contact the doctor in charge 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 occur more frequently during treatment with Lamitrin S or if a severe seizure occurs:
seek medical advice as soon as possible.
Lamitrin S should not be used to treat bipolar affective 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 S 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 non-prescription medicines.
The doctor in charge must be informed if the patient is taking other medicines used to treat epilepsy or psychiatric disorders. This will allow the appropriate dose of Lamitrin S 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 the doctor in charge 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 epileyptic seizures
• 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 doctor in charge 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 in charge may recommend using 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 in charge may recommend blood tests to monitor Lamitrin S levels. If the patient is using or plans to start using hormonal contraceptives:
discuss appropriate contraception with the doctor in charge.
Lamitrin S 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 doctor in charge. 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 in charge may recommend blood tests to monitor Lamitrin S levels.
Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, plans to become pregnant, or is breastfeeding, consult the doctor in charge or pharmacist before using this medicine.

• Do not stop treatment without first consulting the doctor in charge. 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 in charge may recommend taking folic acid additionally.

If the patient is breastfeeding or plans to breastfeed, consult the doctor in charge 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 Lamitrin S treatment. 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 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 chewable tablets / oral suspension tablets 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 the patient may take some time. The dose taken
by the 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 the one 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, 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. You should 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 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. You must 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 the 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 more water to ensure the entire dose has been swallowed.
To prepare an oral suspension:

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

Taking more Lamitrin S than recommended
You should contact your doctor or the nearest emergency department immediately.
If possible, show the Lamitrin S packaging to the medical staff.
Taking too high a dose of Lamitrin S may increase the risk of serious adverse effects, 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 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 regarding resuming treatment with
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 instructed by your doctor.
Using Lamitrin S in the treatment of epilepsy
When stopping Lamitrin S, it is essential that the dose be gradually reduced over approximately two weeks.
Suddenly stopping Lamitrin S may cause seizures to recur 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 required. However, you should
consult your doctor if you intend to stop taking 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 may 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 together with another medicine called valproate. Some of these symptoms
occur more frequently in children, so parents should pay particular attention to them.
Such 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 ( erythema multiforme ), widespread blistering rash with 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 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
• 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, underarms, or groin
• unexpected bleeding, bruising, or blue discoloration of fingers
• sore throat or more frequent infections (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 your doctor immediately. Your treating physician may decide to perform tests assessing liver, kidney, or blood function and may recommend discontinuation of Lamitrin S. If the patient develops Stevens-Johnson syndrome or toxic epidermal necrolysis, the doctor will inform them that lamotrigine must never be used again.
Haemophagocytic 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 up to 1 in 10 patients:

• aggression or irritability
• feeling sleepy
• dizziness
• tremor
• difficulty falling asleep ( insomnia )
• feeling of restlessness
• diarrhoea
• dry mouth
• nausea or vomiting
• feeling tired
• 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:

• 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 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 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): (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, underarms, 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 )
• haemophagocytic lymphohistiocytosis (HLH) (see section 2. Important information before taking Lamitrin S)
• 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 bone marrow disorder known as aplastic anaemia
• hallucinations ("seeing" or "hearing" things that are not real)
• disorientation
• feeling of unsteadiness or loss of balance during movement
• involuntary repetitive movements and/or sounds or words (tics), involuntary muscle contractions affecting 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 their frequency is unknown.

• 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 inflammation of the kidneys and eyes ( 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.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Lamitrin S

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 the storage of Lamitrin S.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Lamitrin S dispersible and chewable / oral suspension tablets contain
The active substance is lamotrigine. Each dispersible and chewable / oral suspension tablet 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 carboxymethyl starch (type A), povidone K30, sodium saccharin, magnesium stearate, blackcurrant flavour.

What Lamitrin S dispersible and chewable / oral suspension tablets look like and contents of the pack
Lamitrin S dispersible and chewable / oral suspension tablets (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 dispersible and chewable / oral suspension tablets are round. They are marked with the code "LTG" above the number "2" on one side; on the other side, two ellipses intersecting at right angles are visible. Each bottle contains 30 tablets.

Lamitrin S 5 mg dispersible and chewable / oral suspension tablets are oblong, biconvex. They are marked with "GS CL2" on one side and "5" on the other side. 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 dispersible and chewable / oral suspension tablets are square with rounded corners. They are marked with "GSCL5" on one side and "25" on the other side. Each pack contains 10, 14, 21, 28, 30, 42, 50, 56 or 60 tablets in blisters.

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

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

Lamitrin S 200 mg dispersible and chewable / oral suspension tablets are square with rounded corners. They are marked with "GSEC5" on one side and "200" on the other side. 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 marketing authorization holder:
GSK Services Sp. z o.o.
Tel.: +48 22 576 90 00