Lamilept

Leaflet accompanying the packaging: information for the user

Lamilept, 25 mg, tablets

Lamilept, 50 mg, tablets

Lamilept, 100 mg, tablets

Lamotrigine

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Lamilept and what is it used for
• 2. Important information before taking Lamilept
• 3. How to take Lamilept
• 4. Possible side effects
• 5. How to store Lamilept
• 6. Contents of the packaging and other information

1. What is Lamilept and what is it used for

Lamilept belongs to a group of medicines called antiepileptic medicines. It is used to treat two conditions: epilepsyand bipolar affective disorders.
The action of Lamilept in the treatment of epilepsyinvolves blocking impulses in the brain that cause epileptic seizures.

• In adults and children over 13 years of age, Lamilept can be used alone or in combination with other medicines to treat epilepsy. Lamilept can also be used in combination with other medicines to treat epileptic seizures associated with a condition called Lennox-Gastaut syndrome.
• In children between 2 and 12 years of age, Lamilept can be used in combination with other medicines to treat these conditions. It can be used alone to treat a type of epilepsy called typical absence seizures.

Lamilept also treats bipolar affective disorders.

In people with bipolar affective disorder (sometimes called manic-depressive psychosis), there are extreme mood swings, with periods of mania (excitement or euphoria) alternating with periods of depression (deep sadness or despair). In adults over 18 years of age, Lamilept can be used alone or with other medicines to prevent episodes of depression that occur in bipolar affective disorder. It is not yet known what effect Lamilept has when it works in this way.

2. Important information before taking Lamilept

When not to take Lamilept

• If the patient has been found to be hypersensitive(allergic) to lamotrigine or any of the other ingredients of this medicine (listed in section 6).

If the above case occurs:
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The patient should inform their doctorand not take Lamilept.

Warnings and precautions

The patient should talk to their doctor or pharmacist before starting to take Lamilept

Lamilept:

• after taking lamotrigine or other medicines used to treat affective disorders or epilepsy
• as a result of exposure to sunlight or artificial light (e.g. in a solarium) after taking lamotrigine. The doctor will verify the treatment used by the patient and may advise avoiding sunlight or using sun protection (e.g. using a sunscreen or wearing protective clothing).
• after taking lamotrigine (read the description of symptoms in section 4 of this leaflet:Rare side effects)
• Brugada syndrome is a genetically determined heart condition characterized by electrical disturbances in the heart. Abnormal EKG recordings are associated with arrhythmia (abnormal heart rhythm), which may be caused by taking lamotrigine. If this situation applies to the patient, they should consult a doctor.

If any of the above cases occur:
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The patient should inform their doctor, who may recommend reducing the dose or deciding that Lamilept is not a suitable medicine for the patient.

Important information about potentially life-threatening reactions

In a small number of patients taking Lamilept, an allergic reaction or potentially life-threatening skin reaction occurs, which can worsen if left untreated. These symptoms may occur more frequently during the first few months of taking Lamilept, especially if the patient has been given too high an initial dose or if the dose has been increased too quickly, or if Lamilept is taken in combination with another medicine called valproate. Some of these symptoms occur more frequently in children, so parents should pay particular attention to them.
The patient should be aware of the symptoms to look out for while taking Lamilept. This risk may be associated with a genetic variant that occurs in people of Asian descent (mainly Chinese Han and Thai). If the patient is of such descent and has previously been found to have this genetic variant (HLA-B*1502), they should discuss this with their doctor before taking Lamilept. →The patient should read the description of these symptoms in section 4 of this leaflet,in the part “Potentially life-threatening reactions: seek medical help immediately”.

• If the patient has this genetic variant, they should discuss it with their doctor before taking Lamilept. →The patient should read the description of these symptoms in section 4 of this leaflet,in the part “Potentially life-threatening reactions: seek medical help immediately”.

Hemophagocytic lymphohistiocytosis (HLH)

In patients taking lamotrigine, cases of a rare but very serious reaction of the immune system have been reported.
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The patient should contact their doctor or pharmacist immediatelyif they experience any of the following symptoms while taking lamotrigine: fever, rash, neurological symptoms (e.g. tremors or shivers, confusion, brain function disorders), the patient should contact their doctor or pharmacist immediately.

Thoughts of self-harm or suicide

Antiepileptic medicines are used to treat several conditions, including epilepsy and bipolar affective disorders. In patients with bipolar affective disorders, thoughts of self-harm or suicide may sometimes occur. If the patient has bipolar affective disorders, such thoughts may occur more frequently:

• when starting treatment for the first time
• if the patient has had thoughts of self-harm or suicide before
• if the patient is under 25 years of age

If the patient experiences worrying thoughts or feelings, or if their condition worsens or they experience new symptoms while taking Lamilept:
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The patient should contact their doctor or go to the nearest hospital for help as soon as possible.

It may be helpful for the patient to inform a relative, caregiver, or friend that they 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

depression or worrying changes in behavior.
A small number of people taking antiepileptic medicines, such as Lamilept, have thought about harming themselves or killing themselves. If the patient ever has such thoughts, they should contact their doctor immediately.

Taking Lamilept for epilepsy

Seizures in some types of epilepsy may sometimes worsen or occur more frequently while taking Lamilept. In some patients, severe seizures may occur, which can pose a serious risk to the patient's health. If the patient experiences more frequent or severe seizures while taking Lamilept:
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The patient should see their doctor as soon as possible.

Children and adolescents

Lamilept should not be used to treat bipolar affective disorders in patients under 18 years of age.

Lamilept and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take

– including herbal medicines or other medicines available without a prescription.The doctor will need to know that the patient is taking other medicines used to treat epilepsy or psychiatric disorders. This will allow the doctor to determine the correct dose of Lamilept. These medicines include:

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate, zonisamide, used to treat epilepsy
• olanzapine or aripiprazoleused to treat psychiatric disorders
• bupropion, used to treat psychiatric disordersor nicotine addiction
• paracetamol, used to treat pain or fever

Some medicines interact with Lamilept or increase the risk of side effects. These medicines include:

• valproate, used to treat epilepsy or psychiatric disorders
• carbamazepine, used to treat epilepsy or psychiatric disorders
• phenytoin, primidoneor phenobarbital, used to treat epilepsy
• risperidone, used to treat psychiatric disorders
• rifampicin, which is an antibiotic
• medicinesused to treat HIV infection(a combination of lopinavir with ritonavir or atazanavir with ritonavir),
• hormonal contraceptivessuch as the pill(see below) →The patient should inform their doctorif they are taking any of these medicines or if they start or stop taking any of these medicines.

Hormonal contraceptives (such as the pill) may affect the action of Lamilept

The doctor may recommend using a specific type of hormonal contraceptive or another method of contraception, such as a condom, diaphragm, or intrauterine device. If the patient is taking hormonal contraceptives, such as “the pill”, the doctor may recommend blood tests to check the level of Lamilept in the blood. If the patient is taking hormonal contraceptives or plans to start taking them:
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The patient should talk to their doctorabout the appropriate method of contraception.
Lamilept may also affect the action of hormonal contraceptives, although it is unlikely to reduce their effectiveness. If the patient is taking hormonal contraceptives and notices any changes in their menstrual cycle, such as bleeding or spotting:
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The patient should inform their doctor.Such symptoms may indicate that Lamilept is affecting the action of the contraceptive.

Pregnancy and breastfeeding

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If the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

• The patient should not stop treatment without first consulting their doctor.This is especially important if the patient has epilepsy.
• Pregnancy may change the effectiveness of Lamilept, so there may be a need for blood tests and adjustment of the dose of Lamilept.
• There may be a small increased risk of birth defects, including cleft lip and palate, if Lamilept is taken during the first three months of pregnancy.
• If the patient plans to become pregnant or is pregnant, their doctor may recommend taking folic acid in addition.

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If the patient is breastfeeding or plans to breastfeed, they should consult their doctor or pharmacist before taking this medicine.

The patient should consult their doctor or pharmacist before taking this medicine.The active substance of Lamilept passes into breast milk and may affect the baby. The doctor will discuss the risks and benefits of breastfeeding while taking Lamilept, and if the patient decides to breastfeed, the doctor will check the baby from time to time to see if they are experiencing any symptoms such as excessive sleepiness, rash, or poor weight gain. If any of these symptoms are noticed in the baby, the patient should inform their doctor.

Driving and using machines

Lamilept may cause dizziness and double vision.
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The patient should not drive or operate machinery unless they are sure that these symptoms do not occur.

If the patient has epilepsy, they should talk to their doctor about driving and using machinery.

Lamilept contains lactose.

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Lamilept contains sodium.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially “sodium-free”.

Lamilept, 100 mg, tablets contain orange yellow FCF (E 110).

The medicine may cause allergic reactions.

3. How to take Lamilept

This medicine should always be taken as directed by the doctor or pharmacist.If the patient is unsure, they should consult their doctor or pharmacist.

What dose of Lamilept should be taken

The dose of Lamilept that the patient takes will depend on:

• the patient's age
• whether the patient is taking Lamilept in combination with other medicines
• whether the patient has any kidney or liver disease.

The doctor will prescribe a small dose to start with, and then gradually increase the dose over a few weeks until the patient reaches the effective dose (called the “effective dose”). The patient should never take a higher dose of Lamilept than that recommended by their doctor.
Usually, the effective dose of Lamilept for adults and children over 13 years of age is between 100 mg and 400 mg per day.
For children between 2 and 12 years of age, the effective dose is dependent on the child's weight - usually between 1 mg and 15 mg per kilogram of body weight, up to a maximum maintenance dose of 200 mg per day.
Lamilept should not be used in children under 2 years of age.

Taking the dose of Lamilept

The dose of Lamilept should be taken once or twice a day, as directed by the doctor. Lamilept can be taken with or without food.

• The patient should always take the whole doseprescribed by the doctor. The patient should never take only part of a tablet.

The doctor may also recommend starting or stopping other medicines, depending on the indication and the patient's response to treatment.
25 mg and 100 mg tablets
The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow. The tablets should not be chewed or crushed.
50 mg tablets
The patient should take the whole tablet. The tablets should not be broken, chewed, or crushed.

Taking a higher dose of Lamilept than recommended

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The patient should contact their doctor or the nearest emergency department immediately.

If possible, the patient should show the packaging of Lamilept.If the patient takes too much Lamilept, there is a higher risk of serious side effects, which can be fatal.
If the patient takes too much Lamilept, they may experience:

• rapid, involuntary eye movements ( nystagmus)
• lack of coordination, difficulty walking, or inability to maintain balance ( ataxia)
• changes in heart rhythm (usually detected by EKG)
• loss of consciousness, seizures, or coma.

Missing a single dose of Lamilept

The patient should not take extra tablets to make up for a missed dose. The patient should take the next dose at the usual time.

If the patient misses several doses of Lamilept

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The patient should consult their doctor about restarting Lamilept.

This is important for the patient.

The patient should not stop taking Lamilept unless their doctor tells them to.

Lamilept must be taken for as long as the doctor recommends. The patient should not stop taking it unless their doctor tells them to.

Taking Lamilept for epilepsy

To stop taking Lamilept, it is essential to reduce the dose gradually, over about two weeks. If the patient stops taking Lamilept suddenly, they may experience a recurrence of epilepsy symptoms or worsening of symptoms.

Taking Lamilept for bipolar disorder

It may take some time before Lamilept starts to work, so it is unlikely that improvement will occur immediately. If the patient wants to stop taking Lamilept, they should consult their doctor. There is no need to reduce the dose gradually, but the patient should consult their doctor if they want to stop taking Lamilept.

4. Possible side effects

Like all medicines, Lamilept can cause side effects, although not everyone gets them.

Potentially life-threatening reactions: seek medical help immediately

In a small number of patients taking Lamilept, an allergic reaction or potentially life-threatening skin reaction occurs, which can worsen if left untreated. These symptoms may occur more frequently during the first few months of taking Lamilept, especially if the patient has been given too high an initial dose or if the dose has been increased too quickly, or if Lamilept is taken in combination with another medicine called valproate. Some of these symptoms occur more frequently in children, so parents should pay particular attention to them.
These symptoms include:

• skin rash or redness, which can develop into life-threatening skin reactions, including widespread rash with blisters and peeling of the skin, especially on the lips, eyes, mouth, and genitals ( Stevens-Johnson syndrome), widespread peeling of the skin (affecting more than 30% of the body surface - toxic epidermal necrolysis), or widespread rash accompanied by changes in the liver, blood, and other organs ( Drug Rash with Eosinophilia and Systemic Symptoms, DRESS)
• ulcers in the mouth, throat, nose, or genitals
• eye pain or red, swollen eyes( conjunctivitis)
• high fever(fever), flu-like symptoms, or drowsiness
• swelling of the face or enlarged lymph nodesin the neck, armpits, and groin
• unexpected bleeding or bruisingor blue discoloration of the fingers
• sore throat, or more frequent infections (such as colds)
• increased liver enzyme activity in blood tests
• increased number of a certain type of white blood cell (eosinophilia)
• enlarged lymph nodes
• organ symptoms, including liver and kidney symptoms.

In many cases, these symptoms indicate less serious side effects. However, the patient should remember that they are potentially life-threateningand if left untreated may lead to serious problems, such as organ failure.
Therefore, if the patient notices any of these symptoms:
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The patient should contact their doctor immediately.The doctor may decide to perform liver, kidney, or blood tests and may recommend stopping Lamilept. If the patient has experienced Stevens-Johnson syndrome or toxic epidermal necrolysis, the doctor will inform them that they should never take lamotrigine again.
Hemophagocytic lymphohistiocytosis (HLH)(see section 2. Important information before taking Lamilept)

Very common side effects

May occur in more than 1 in 10patients:

• headache
• skin rash.

Common side effects

May occur in up to 1 in 10patients:

• aggression or irritability
• drowsiness
• dizziness
• tremors
• difficulty sleeping ( insomnia)
• feeling agitated
• diarrhea
• dry mouth
• nausea or vomiting
• feeling tired
• back pain, joint pain, or pain in any other location.

Uncommon side effects

May occur in up to 1 in 100patients:

• lack of coordination and balance ( ataxia)
• double or blurred vision
• unusual hair loss or thinning ( alopecia)
• skin rash or sunburn after exposure to sunlight or artificial light (phototoxicity).

Rare side effects

May occur in up to 1 in 1000patients:

• life-threatening skin reaction ( Stevens-Johnson syndrome) :( see also the information at the beginning of section 4)
• a group of symptoms including fever, nausea, vomiting, headache, stiff neck, 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 do not resolve or worsen, the patient should contact their doctor
• rapid, involuntary eye movements ( nystagmus)
• itchy eyes with discharge ( conjunctivitis).

Very rare side effects

May occur in up to 1 in 10,000patients:

• life-threatening skin reaction ( toxic epidermal necrolysis): ( see also the information at the beginning of section 4)
• drug rash with eosinophilia and systemic symptoms (DRESS): ( see also the information at the beginning of section 4)
• high fever ( fever): ( see also the information at the beginning of section 4)
• swelling of the face or enlarged lymph nodes in the neck, armpits, and groin ( generalized lymphadenopathy): ( see also the information at the beginning of section 4)
• changes in liver function, which can be seen in blood tests, or liver failure: ( see also the information at the beginning of section 4)
• serious blood clotting disorder, which can cause unexpected bleeding or bruising ( disseminated intravascular coagulation): ( see also the information at the beginning of section 4)
• hemophagocytic lymphohistiocytosis (HLH) ( see section 2. Important information before taking Lamilept)
• changes in blood test results, including decreased red blood cell count ( anemia), decreased white blood cell count ( leukopenia, neutropenia, agranulocytosis), decreased platelet count ( thrombocytopenia), decreased count of all blood cells ( pancytopenia), and a bone marrow disorder called aplastic anemia
• hallucinations (seeing or hearing things that are not real)
• disorientation
• feeling unsteady or unstable while moving
• involuntary repetitive movements of the body and/or sounds or words ( tics), involuntary muscle contractions affecting the eyes, head, 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
• a reaction similar to lupus (symptoms may include back or joint pain, which may be accompanied by fever and/or general feeling of being unwell)

Other side effects

A small number of people have experienced other side effects, but the exact frequency is unknown:

• There have been reports of bone disorders, including osteopenia and osteoporosis (thinning of the bone's outer layer) and fractures. If the patient is taking antiepileptic medicines for a long time, has previously had osteoporosis, or is taking steroids, they should discuss this with their doctor or pharmacist
• Kidney inflammation (interstitial nephritis) or simultaneous kidney and eye inflammation (interstitial nephritis and uveitis)
• Nightmares
• Decreased immunity due to lower levels of antibodies in the blood, called immunoglobulins, which help protect the body against infections
• Red lumps or spots on the skin (pseudolymphoma).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Lamilept

The medicine should be stored out of sight and reach of children.
The patient should not take this medicine after the expiry date stated on the blister packs or cartons after “Expiry date”. The expiry date refers to the last day of the month stated.
The medicine does not require special storage conditions.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the packaging and other information

What Lamilept contains

• The active substance of Lamilept is lamotrigine. Each tablet contains 25 mg, 50 mg, or 100 mg of lamotrigine.
• The other ingredients of Lamilept are: lactose monohydrate, microcrystalline cellulose, maize starch, povidone K-30, colloidal anhydrous silica, sodium carboxymethylcellulose (type A), magnesium stearate. The 100 mg tablets also contain orange yellow FCF (E110).

What Lamilept looks like and contents of the pack

• Lamilept, 25 mg, tablets are white or almost white tablets, diamond-shaped, with the number “93” embossed on one side and a score line between the numbers “9” and “3”, and the number “39” embossed on the other side.
• Lamilept, 50 mg, tablets are white or almost white tablets, round, with the number “50” embossed on one side and the letters “LT” embossed on the other.
• Lamilept, 100 mg, tablets are peach-colored tablets, diamond-shaped, with the number “93” embossed on one side and a score line between the numbers “9” and “3”, and the number “463” embossed on the other side.

Lamilept, 25 mg and 50 mg, tablets are available in packs of 30 or 42 tablets.
Lamilept, 100 mg, tablets are available in packs of 30, 42, 56, 60, or 90 tablets
Not all pack sizes may be marketed.

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
phone: (22) 345 93 00

Manufacturer

Pharmachemie B.V., Swensweg 5, Postbus 552, 2003 RN Haarlem, Netherlands
Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków
Teva Pharmaceuticals Ltd, Pallagi Street 13, Debrecen, HU-4042, Hungary
Balkanpharma Dupnitsa AD, 3 Samokovsko Shosse Str, Dupnitsa, 2600, Bulgaria
Merckle GmbH Graf-Arco-Strasse 3, 89079 Ulm, Germany

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

Denmark: Lamotrigin Teva
Germany: Lamotrigin-TEVA 25 / 50 / 100 / 200 mg Tablets
Poland: Lamilept
Portugal: Lamotrigina Teva 25 / 50 / 100 / 200 mg Comprimidos
Sweden: Lamotrigin Teva
United Kingdom (Northern Ireland): Lamotrigine Teva 25 / 50 / 100 / 200 mg Tablets

Date of last revision of the leaflet: October 2023