Lamilept

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Lamilept(Lamotrigine-TEVA 100 mg Tablets)

100 mg, tablets

Lamotrigine
Lamilept and Lamotrigine-TEVA 100 mg Tablets are different trade names for the same medicine.

You should read 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 to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• 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 may be used alone or in combination with other medicines to treat epilepsy. Lamilept may also be used in combination with other medicines to treat seizures associated with a condition called Lennox-Gastaut syndrome.
• In children between 2 and 12 years of age, Lamilept may be used in combination with other medicines to treat these conditions. It may 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
may be used alone or with other medicines to prevent depressive episodes that occur in bipolar affective disorder. It is not yet known how Lamilept works in this way.

2. Important information before taking Lamilept

When not to take Lamilept

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

→ The doctor should be informedand Lamilept should not be taken.

Warnings and precautions

You should talk to your doctor or pharmacist before starting to take

Lamilept:

• if the patient has any kidney disease
• if the patient has ever had a rashafter taking lamotrigine or other medicines used to treat affective disorders or epilepsy or if the patient has had a rash or sunburn after taking lamotrigine due to exposure to sunlight or artificial light (e.g. in a solarium). The doctor will check the treatment used by the patient and may advise avoiding sunlight or using sun protection (e.g. using a sunscreen or wearing protective clothing).
• if the patient has ever had meningitisafter taking lamotrigine ( read the description of symptoms in section 4 of this leaflet: Rare side effects)
• if the patient is taking a medicine containing lamotrigine
• if the patient has a condition called Brugada syndrome.Brugada syndrome is a genetically determined heart condition characterized by electrical disturbances in the heart. Abnormal ECG recordings are associated with arrhythmia (abnormal heart rhythm), which may be caused by taking lamotrigine. If this applies to the patient, they should consult a doctor.

If any of the above cases occur:
→ The doctor should be informed, who may decide to reduce the dose or
decide 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 serious skin reaction occurs, which can worsen if left untreated.
These symptoms can occur more frequently during the first few months of taking Lamilept,
especially when the patient has been given too high an initial dose or when the dose has been increased too quickly, or when 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 around the mouth, nose, eyes, 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 redness( conjunctivitis)
• high fever(fever), flu-like symptoms or drowsiness
• swelling of the faceor enlargement of lymph nodes in the neck, armpits, and groin
• unexpected bleeding or bruisingor blue discoloration of fingers
• sore throat, or more frequent than usual infections (such as colds)
• increased liver enzyme activity visible 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, they are potentially life-threateningand if left untreated can lead to serious problems, such as organ failure.
Therefore, if any of them are noticed:
→ The doctor should be contacted immediately.The doctor may decide to perform tests of liver, kidney, or blood function and may recommend stopping Lamilept. If the patient has had 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)

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 disorder, 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 has worrying thoughts or feelings, or if their condition worsens or new symptoms occur while taking Lamilept:
→ They should contact their doctor or go to the nearest hospital for help.

It may be helpful to inform a relative, caregiver, or friend that the patient may experience depression or significant mood changes and ask them to read this leaflet. The patient may ask them to inform them if they notice that the patient has

depression or worrying changes in behavior.
A small number of people taking antiepileptic medicines, such as Lamilept, have thought about harming or killing themselves. If such thoughts ever occur to the patient, 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 seizures or a severe seizure while taking Lamilept:
→ They 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. Medicines used to treat depression and other mental disorders increase the risk of suicidal thoughts or behaviors in children and adolescents 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 needs to know that the patient is taking other medicines used to treat epilepsy or mental 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
• olanzapineor aripiprazoleused to treat mental disorders
• bupropion, used to treat mental disordersor to treat nicotine addiction→ The patient should inform their doctor if they are taking any of these medicines.

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

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

Hormonal contraceptives (such as birth control pills) 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 using hormonal contraceptives, such as "birth control pills", the doctor may recommend blood tests to check the level of Lamilept in the blood. If the patient is using hormonal contraceptives or plans to start using them:
→ They 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 using hormonal contraceptives and notices any changes in their menstrual cycle, such as bleeding or spotting:
→ They should inform their doctor.Such symptoms may indicate that Lamilept is affecting the action of the contraceptive.

Pregnancy and breastfeeding → If the patient is pregnant, thinks they may be pregnant, or plans to have a child, 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 Lamilept dose.
• 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, the doctor may recommend taking folic acid in addition.

→ If the patient is breastfeeding or plans to breastfeed, they 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 side effects, such as excessive sleepiness, rash, or poor weight gain. If any of these symptoms are noticed in the baby, the doctor should be informed.

Driving and using machines

Lamilept may cause dizziness and double vision.
→ 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 machines.

Lamilept contains lactose monohydrate

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 that it is considered "sodium-free".

Lamilept contains 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 to take

It may take some time to determine the correct dose of Lamilept for the patient. The dose taken by the patient depends 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 initially prescribe a small dose, and then gradually increase the dose over several weeks to the effective dose for the patient (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.
In children between 2 and 12 years of age, 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.
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 doctor may also recommend starting or stopping other medicines, depending on the indication and the patient's response to treatment.
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.
The patient should always take the whole doseprescribed by the doctor. The patient should never take only part of a tablet.

Taking a higher dose of Lamilept than recommended → The patient should contact their doctor or the nearest emergency department immediately.

There is a higher risk of serious side effects
that can be fatal.
If the patient takes too much Lamilept, they may experience:

• rapid, involuntary eye movements ( nystagmus)
• lack of coordination, clumsiness, or inability to maintain balance ( ataxia)
• changes in heart rhythm (usually detected by ECG)
• 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 next dose should be taken at the usual time.

If the patient misses several doses of Lamilept → The patient should consult their doctor about restarting treatment with 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 gradually reduce the doseover about two weeks. If the patient stops taking Lamilept suddenly, their epilepsy symptoms may return or worsen.

Taking Lamilept for bipolar disorder

It may take some time for Lamilept to start working, so it is unlikely that the patient will experience improvement immediately. If the patient wants to stop taking Lamilept, they should consult their doctor.

4. Possible side effects

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

Potentially life-threatening reactions: the patient should contact their doctor 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 can occur more frequently during the first few months of taking Lamilept,
especially when the patient has been given too high an initial dose or when the dose has been increased too quickly, or when 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 around the mouth, nose, eyes, 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 redness( conjunctivitis)
• high fever(fever), flu-like symptoms or drowsiness
• swelling of the faceor enlargement of lymph nodes in the neck, armpits, and groin
• unexpected bleeding or bruisingor blue discoloration of fingers
• sore throat, or more frequent than usual infections (such as colds)
• increased liver enzyme activity visible 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, they are potentially life-threateningand if left untreated can lead to serious problems, such as organ failure.
Therefore, if any of them are noticed:
→ The doctor should be contacted immediately.The doctor may decide to perform tests of liver, kidney, or blood function and may recommend stopping Lamilept. If the patient has had 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
• tremor
• 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, clumsiness, or inability to maintain 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 faceor enlargement of 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)
• a serious blood clotting disorder, which can cause unexpected bleeding or bruising ( disseminated intravascular coagulation): ( see also the information at the beginning of section 4)
• changes in blood test results, including a decrease in the number of red blood cells ( anemia), white blood cells ( leukopenia, neutropenia, agranulocytosis), or platelets ( thrombocytopenia), or a decrease in the number of all blood cells ( pancytopenia) and a condition affecting the bone marrow called aplastic anemia
• hallucinations (seeing or hearing things that are not real)
• disorientation
• feeling unsteady or unstable while moving
• involuntary movements of the body ( 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, fever, and general ill health)
• hemophagocytic lymphohistiocytosis (HLH) (see section 2. Important information before taking Lamilept).

Other side effects

In a small number of people, other side effects have occurred, but their 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 had osteoporosis before, or is taking steroids, they should discuss this with their doctor or pharmacist
• Nightmares
• Decreased immunity due to lower levels of antibodies in the blood, called immunoglobulins, which help protect the body against infections.

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, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl.
Reporting side effects will help to gather more information on the safety of this 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 packaging.
The expiry date refers to the last day of the month.
Translation of some information on the immediate packaging:

Ch.-B./Verwendbar bis: siehe Prägung– batch number/expiry date: see imprint.
There are no special storage precautions.
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 use. 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 100 mg of lamotrigine.
• The other ingredients of the medicine are: lactose monohydrate, microcrystalline cellulose, maize starch, povidone K 30, colloidal anhydrous silica, sodium carboxymethylcellulose (type A), magnesium stearate, orange yellow FCF (E 110).

What Lamilept looks like and contents of the pack

Lamilept, 100 mg, tablets are peach-colored, rhomboid tablets 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, 100 mg, tablets are available in packs of 30 tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Germany, the country of export:

TEVA GmbH
Graf-Arco-Str. 3
89079 Ulm, Germany

Manufacturer:

Pharmachemie B.V., Swensweg 5, PO BOX 552, 2003 RN Haarlem, Netherlands
Teva Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen, Hungary
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80, 31-546 Kraków, Poland

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warszawa

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warszawa
License number in Germany, the country of export:64817.00.00

Parallel import license number: 80/22

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

Denmark: Lamotrigin Teva
Germany: Lamotrigin-TEVA 100 mg Tabletten
Poland: Lamilept
Portugal: Lamotrigina Teva 100 mg Comprimidos
Sweden: Lamotrigin Teva
United Kingdom (Northern Ireland): Lamotrigine Teva 100 mg Tablets
Date of revision of the leaflet: 08.02.2022
[Information about the trademark]