Lamilept

Leaflet accompanying the packaging: information for the user

Warning! The leaflet should be kept. 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 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 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, pharmacist, or nurse. 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 epileptic 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

Lamilept:

• after taking lamotrigine or other medicines used to treat affective disorders or epilepsy
• . 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)
• ( 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 ECG recordings are associated with arrhythmia (abnormal heart rhythm) that 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:
→
The doctor should be informed, 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

A small number of patients taking Lamilept have experienced an allergic reaction or a potentially serious skin reaction that can worsen if left untreated. These symptoms may 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
• swelling of the faceor enlarged lymph nodes in the neck, armpits, and groin
• unexpected bleeding or bruising
• sore throat, or more frequent 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 can be 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 old. 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 as soon as possible.

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 is experiencing

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 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 that can pose a serious risk to their health. If the patient experiences more frequent or severe seizures while taking Lamilept:
→
The doctor should be contacted 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 can 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 should know that the patient is taking other medicines used to treat epilepsy or mental disorders. This will allow the doctor to determine the appropriate dose of Lamilept. These medicines include:

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate, zonisamide, used to treat epilepsy
• lithium, olanzapineor aripiprazoleused to treat mental disorders
• bupropion, used to treat mental disordersor nicotine addiction
• paracetamol, used to treat pain or fever. → The doctor should be informedif the patient is taking any of these medicines.

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

• valproate, used to treat epilepsy or mental disorders
• carbamazepine, used to treat epilepsy or 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 the pill( see below). → The doctor should be informedif the patient is 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 using hormonal contraceptives, such as "the pill", the doctor may recommend performing tests to check the level of Lamilept in the blood. If the patient is using or plans to use hormonal contraceptives:
→
The doctor should be consultedabout 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:
→
The doctor should be informed. 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 treatment should not be stopped without prior consultation with the doctor. This is especially important if the patient has epilepsy.
• Pregnancy may change the effectiveness of Lamilept, so there may be a need to perform blood tests and adjust 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, 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 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 discuss driving and operating machinery with their doctor.

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, 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. In case of doubts, the patient should contact their doctor or pharmacist.

What doses of Lamilept should be taken

Determining the appropriate dose of Lamilept for the patient may take time. 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 prescribe a small dose initially and then gradually increase the dose over several weeks until an effective dose is reached 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 in 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 patient should always take the entire 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.
The line on the tablet is only to facilitate breaking it, to make it easier to swallow. The tablets should not be chewed or crushed.

Taking a higher dose of Lamilept than recommended

→

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

If possible, the patient should show the packaging of Lamilept.
In case of overdose, there is a higher risk of serious side effects that can be life-threatening.
In a person who has taken too high a dose of Lamilept, the following symptoms may occur:

• rapid, involuntary eye movements ( nystagmus)
• clumsiness or lack of coordination, 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 Lamilept

This is important for the patient.

The patient should not stop taking Lamilept unless their doctor advises them to do so.

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

Taking Lamilept for epilepsy

To stop taking Lamilept, it is essential to reduce the dose gradually, over about two weeks. If Lamilept is stopped suddenly, the patient's epilepsy symptoms may worsen or return.

Taking Lamilept for bipolar disorder

It may take some time for Lamilept to start working, so it is unlikely that improvement will occur immediately. If the patient wants to stop taking Lamilept, they should consult their doctor, as there is no need to gradually reduce the dose.

4. Possible side effects

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

Potentially life-threatening reactions: the patient should contact their doctor immediately.

A small number of patients taking Lamilept have experienced an allergic reaction or a potentially life-threatening skin reaction that can worsen if left untreated. These symptoms may 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
• swelling of the faceor enlarged lymph nodes in the neck, armpits, and groin
• unexpected bleeding or bruising
• sore throat, or more frequent 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 can be 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:

• clumsiness or lack of coordination, 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 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 that 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 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 lupus-like reaction (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
• Reduced 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, pharmacist, or nurse.
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
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Lamilept

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.

Translation of some entries on the blister pack:

Ch.-B./Verw. bis siehe Prägung – batch number/expiry date see imprint
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. 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 Lamilept are: lactose monohydrate, microcrystalline cellulose, maize starch, povidone K 30, colloidal anhydrous silica, sodium carboxymethylcellulose (type A), magnesium stearate, and orange yellow FCF (E 110).

What Lamilept looks like and contents of the pack

Lamilept is a peach-colored, rhomboid tablet with the number "93" embossed on one side and a break line between the numbers "9" and "3", and the number "463" embossed on the other side.
The tablets are available in packs of 30, 60, or 90 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, 2031 GA Haarlem, Netherlands
Merckle GmbH, Ludwig-Merckle-Str. 3, 89143 Blaubeuren, Germany
Balkanpharma – Dupnitsa AD, Samokovsko Shosse Str. 3, 2600 Dupnitsa, Bulgaria

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
German authorization number: 64817.00.00

Parallel import authorization number: 337/22

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 100 mg Tablets
Poland: Lamilept
Portugal: Lamotrigina Teva 100 mg Comprimidos
Sweden: Lamotrigin Teva
United Kingdom (Northern Ireland): Lamotrigine Teva 100 mg Tablets

Date of approval of the leaflet: 13.05.2024

[Information about the trademark]