Package leaflet: Information for the user

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Lamilept (Lamotrigin-TEVA 100 mg Tabletten)
100 mg, tablets
Lamotriginum
Lamilept and Lamotrigin-TEVA 100 mg Tabletten are different brand names of the same medicine.
Please read the entire leaflet before using the medicine, as it contains important information
for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

What Lamilept is and what it is used for
What you need to know before taking Lamilept
How to take Lamilept
Possible side effects
How to store Lamilept
Contents of the pack and other information

1. What Lamilept is and what it is used for

Lamilept belongs to a group of medicines called antiepileptic drugs. It is used in the treatment of two conditions – epilepsy and bipolar affective disorder.
The action of Lamilept in treating epilepsy consists in blocking nerve signals in the brain that cause epileptic seizures.

In adults and children aged 13 years and older, Lamilept may be used alone or in combination with other medicines in the treatment of epilepsy. Lamilept may also be used in combination with other medicines in the treatment of epileptic seizures associated with a condition called Lennox-Gastaut syndrome.
In children aged 2 to 12 years, Lamilept may be used in combination with other medicines in the treatment of these conditions. It may be used alone in the treatment of 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 episodes of mania (excitement or euphoria) alternating with episodes of depression (deep sadness or despair). In adults aged 18 years and older, Lamilept may be used alone or with other medicines to prevent depressive episodes occurring in bipolar affective disorder. The exact effect of Lamilept in this regard is not yet fully known.

2. Important information before taking Lamilept

When not to take Lamilept

If the patient has a known allergy ( hypersensitivity ) to lamotrigine or to any of the other ingredients of this medicine (listed in section 6).

If any of the above situations apply:
→ Consult the treating physician and do not take Lamilept.

Warnings and precautions
Talk to your doctor or pharmacist before starting treatment with Lamilept:

if the patient has any kidney disease
if the patient has ever developed a rash after taking lamotrigine or other medicines used to treat mood disorders or epilepsy
if the patient has experienced a rash or sunburn after exposure to sunlight or artificial light (e.g. in a solarium) following lamotrigine administration. The doctor will review the patient's treatment and may advise avoiding sunlight or using sun protection (e.g. sunscreen or protective clothing)
if the patient has ever had meningitis following lamotrigine use ( see description of symptoms in section 4 of this leaflet: Rare side effects )
if the patient is already taking a medicine containing lamotrigine
if the patient has a condition called Brugada syndrome or other heart diseases. Brugada syndrome is a genetically determined heart condition characterized by disturbances in the heart's electrical activity. Abnormal ECG findings are associated with arrhythmia (irregular heartbeat), which may be triggered by lamotrigine. If this applies to the patient, consult a doctor.

If any of the above situations apply:
→ Inform the treating physician, who may recommend reducing the dose or decide that Lamilept is not suitable for the patient.

Important information about potentially life-threatening reactions
A small number of patients taking Lamilept may develop an allergic reaction or potentially severe skin reaction, which, if untreated, may lead to more serious conditions. These may include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). Patients should be aware of the symptoms to watch for during treatment with Lamilept. This risk may be associated with a genetic variant found in individuals of Asian ancestry (particularly Han Chinese and Thai). If the patient is of such ancestry and has previously been found to carry this genetic variant (HLA-B*1502), this should be discussed with the treating physician before starting Lamilept.
→ Read the description of these symptoms in section 4 of this leaflet, under "Potentially life-threatening reactions: contact a doctor immediately".

Hemophagocytic 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 while taking lamotrigine: fever, rash, neurological symptoms (e.g. tremors or chills, confusion, brain function disturbances), contact a doctor or pharmacist immediately.

Thoughts of self-harm or suicide
Antiepileptic medicines are used to treat several conditions, including epilepsy and bipolar affective disorders. Patients with bipolar affective disorders may sometimes experience thoughts of self-harm or suicide. These thoughts may be more frequent:

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

If the patient experiences disturbing thoughts or feelings, or if their condition worsens or new symptoms appear during treatment with Lamilept:
→ Contact a doctor immediately 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 depression or concerning changes in behavior.

A small number of people taking antiepileptic medicines, such as Lamilept, have had thoughts of harming or killing themselves. If such thoughts ever occur, contact a doctor immediately.

Use of Lamilept in epilepsy treatment
Seizures in certain types of epilepsy may occasionally worsen or occur more frequently during treatment with Lamilept. Some patients may experience severe seizures that could pose a serious health risk. If seizures become more frequent or if a severe seizure occurs during treatment with Lamilept:
→ Seek medical attention immediately.

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 psychiatric disorders may increase the risk of suicidal thoughts or behaviors in children and adolescents under 18 years of age.

Lamilept and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including herbal medicines or other over-the-counter medicines.

The treating physician must be informed if the patient is taking other medicines used to treat epilepsy or psychiatric disorders. This will allow for appropriate dose adjustment of Lamilept. These medicines include:

oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate, zonisamide, used in the treatment of epilepsy
lithium, olanzapine, or aripiprazole, used in the treatment of psychiatric disorders
bupropion, used in the treatment of psychiatric disorders or nicotine addiction
paracetamol, used to treat pain and fever.
→ Inform the treating physician if the patient is taking any of these medicines.

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

valproate, used in the treatment of epilepsy and psychiatric disorders
carbamazepine, used in the treatment of epilepsy and psychiatric disorders
phenytoin, primidone, or phenobarbital, used in the treatment of epilepsy
risperidone, used in the treatment of psychiatric disorders
rifampicin, an antibiotic
medicines used to treat human immunodeficiency virus (HIV) infection (lopinavir with ritonavir or atazanavir with ritonavir)
hormonal contraceptives, such as the oral contraceptive pill ( see below ).
→ Inform the treating physician if the patient is taking any of these medicines or if they start or stop taking any of them.

Hormonal contraceptives (such as the oral contraceptive pill) may affect the action of Lamilept
The treating physician may recommend a specific type of hormonal contraceptive or another method of contraception, such as condoms, diaphragm, or intrauterine device. If the patient is using hormonal contraceptives, such as the "oral contraceptive pill", the treating physician may recommend blood tests to monitor Lamilept levels. If the patient is using or planning to start hormonal contraceptives:
→ Talk to the treating physician about 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 the menstrual cycle, such as bleeding or intermenstrual spotting:
→ Inform the treating physician. These symptoms may indicate an interaction between Lamilept and the contraceptive.

Pregnancy and breastfeeding
→ If the patient is pregnant, suspects she may be pregnant, or is planning a pregnancy, she should consult a doctor or pharmacist before taking this medicine.

Do not stop treatment without first consulting the treating physician. This is particularly important if the patient has epilepsy.
Pregnancy may alter the effectiveness of Lamilept, 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 Lamilept is taken during the first three months of pregnancy.
If the patient plans to become pregnant or is pregnant, the treating physician may recommend additional folic acid supplementation.

→ If the patient is breastfeeding or planning to breastfeed, she should consult a doctor or pharmacist before taking this medicine. The active substance in Lamilept passes into breast milk and may affect the infant. The treating physician will discuss the risks and benefits of breastfeeding during Lamilept treatment. If the patient decides to breastfeed, the infant should 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
Lamilept 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, they should discuss driving and operating machinery with their treating physician.

Lamilept contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.

Lamilept contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

Lamilept 100 mg tablets contain sunset yellow FCF (E 110)
This medicine may cause allergic reactions.

3. How to take Lamilept

This medicine should always be taken exactly as recommended by your doctor or pharmacist. If you
have any doubts, you should contact your doctor or pharmacist.
What dose of Lamilept should be taken
Finding the appropriate dose of Lamilept for the patient may take some 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.

Your doctor will initially prescribe a low dose and then gradually increase it over several weeks until
the effective dose for the patient (called the effective dose) is reached. You must never take a
higher dose of Lamilept than the one prescribed by your doctor.
The usual effective dose of Lamilept in adults and children aged 13 years or 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 from 1 mg to
15 mg per kilogram of body weight, up to a maximum maintenance dose of 200 mg per day.
Lamilept is not recommended for children under 2 years of age.
Taking a dose of Lamilept
The dose of Lamilept should be taken once or twice daily, as directed by your doctor. Lamilept may
be taken with or without food.

You must always take the full dose prescribed by your doctor. You should never take only part of a tablet.

Your 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 intended to facilitate breaking the tablet for easier swallowing.
Tablets must not be chewed or crushed.
Taking more Lamilept than recommended
→ You should contact your doctor or the nearest emergency department immediately. If
possible, show the Lamilept packaging.
If too high a dose of Lamilept is taken, there is an increased risk of severe adverse effects,
which may result in death.
In a person who has taken an excessive dose of Lamilept, the following may occur:

rapid, involuntary eye movements ( nystagmus )
uncoordinated movements, lack of coordination, inability to maintain balance ( ataxia )
changes in heart rhythm (usually detected on ECG)
loss of consciousness, seizures, or coma.

Missing a dose of Lamilept
Do not take extra tablets to make up for a missed dose. Take the next dose at the usual time.
If several doses of Lamilept are missed
→ You should consult your doctor about resuming treatment with Lamilept. This is important
for the patient.
Do not stop taking Lamilept unless your doctor advises you to do so.
Lamilept must be taken for as long as your doctor recommends. Do not stop taking it unless your
doctor tells you to.
Taking Lamilept for epilepsy treatment
When stopping Lamilept, it is essential that the dose is gradually reduced over approximately
two weeks. If Lamilept is stopped suddenly, seizures may recur or worsen.
Taking Lamilept for bipolar disorder treatment
It may take some time before Lamilept starts to work, so improvement is unlikely to occur
immediately. When stopping Lamilept, there is no need to gradually reduce the dose, but you should
consult your doctor if you intend to discontinue treatment with Lamilept.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Potentially life-threatening reactions: contact a doctor immediately.
In a small number of patients taking Lamilept, an allergic reaction or potentially life-threatening skin reaction may occur, which could worsen if left untreated.
These symptoms may occur more frequently during the first few months of treatment with Lamilept, especially if the starting dose was too high, increased too quickly, or if Lamilept is taken concomitantly with another medicine called valproate. Some of these symptoms occur more frequently in children, so parents should pay particular attention to them.
Symptoms of these reactions include:

Skin rash or redness of the skin, which may progress to life-threatening skin reactions, including widespread blistering rash and peeling of the skin, particularly around the mouth, nose, eyes, and genital organs ( Stevens-Johnson syndrome ), extensive skin peeling (affecting more than 30% of body surface area - toxic epidermal necrolysis ), or widespread rash accompanied by liver, blood, and other organ involvement (drug hypersensitivity syndrome with eosinophilia and systemic symptoms, DRESS)
Ulceration of the mouth, throat, nose, or genital organs
Pain in the mouth or red, swollen eyes ( conjunctivitis )
High fever (fever), flu-like symptoms, or drowsiness
Swelling of the face or enlarged lymph nodes in the neck, underarms, or groin
Unexpected bleeding or bruising, or blue discoloration of fingers
Sore throat, or more frequent infections than usual (such as colds)
Increased liver enzyme activity evident in blood tests
Increased number of a certain type of white blood cells (eosinophilia)
Enlarged lymph nodes
Organ-related symptoms, including those affecting the liver and kidneys.

In many cases, these symptoms indicate less severe adverse reactions. However, it should be remembered that they are potentially life-threatening and, if left untreated, may lead to serious problems, such as organ failure.
Therefore, if any of these symptoms occur:
→ Contact a doctor immediately. The treating physician may decide to perform tests assessing liver, kidney, or blood function and may recommend discontinuation of Lamilept. If the patient has experienced Stevens-Johnson syndrome or toxic epidermal necrolysis, the doctor will inform them that lamotrigine must never be used again.
Hemophagocytic lymphohistiocytosis (HLH) (see section 2. Important information before using Lamilept).

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 sleeping ( insomnia )
Feeling of restlessness
Diarrhea
Dry mouth
Nausea or vomiting
Feeling tired
Back, joint, or other body pain.

Uncommon adverse reactions
May occur in 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 1000 patients:

Life-threatening skin reaction ( Stevens-Johnson syndrome ): ( see also information at the beginning of section 4 )
A group of symptoms occurring simultaneously: fever, nausea, vomiting, headache, neck stiffness, and 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 a 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 ): ( see also information at the beginning of section 4 )
Drug hypersensitivity syndrome with eosinophilia and systemic symptoms (DRESS): ( see also information at the beginning of section 4 )
High body temperature ( fever ): ( see also information at the beginning of section 4 )
Swelling of the face, enlarged lymph nodes in the neck, underarms, or groin ( generalized lymphadenopathy ): ( see also information at the beginning of section 4 )
Liver function abnormalities detected in blood tests or liver failure: ( see also information at the beginning of section 4 )
Serious blood clotting disorder that may cause unexpected bleeding or bruising ( disseminated intravascular coagulation ): ( see also information at the beginning of section 4 )
Hemophagocytic lymphohistiocytosis (HLH) ( see section 2. Important information before using Lamilept )
Changes in blood test results – including reduced number of red blood cells ( anemia ), reduced number of white blood cells ( leukopenia, neutropenia, agranulocytosis ), reduced platelet count ( thrombocytopenia ), reduced number of all blood cells ( pancytopenia ), and bone marrow disorder known as aplastic anemia
Hallucinations (seeing or hearing things that are not real)
Disorientation
Feeling of unsteadiness and lack of stability during movement
Involuntary, repetitive body movements and/or sounds or words ( tics ), involuntary muscle contractions affecting eyes, head, or 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
Lupus-like reaction (symptoms may include: back or joint pain, sometimes accompanied by fever and/or general malaise).

Other adverse reactions
Other adverse reactions have been observed in a small number of individuals, but the exact frequency is unknown:

There have been reports of bone disorders, including osteopenia and osteoporosis (thinning of the cortical bone layer) and fractures. If the patient is on long-term antiepileptic therapy, has a history of osteoporosis, or is taking steroids, this should be discussed with a doctor or pharmacist.
Kidney inflammation (tubulointerstitial nephritis), or simultaneous kidney and eye inflammation (tubulointerstitial nephritis and uveitis)
Nightmares
Weakened immunity due to reduced levels of antibodies in the blood, known as immunoglobulins, which help protect the body against infections
Red nodules or spots on the skin (pseudolymphoma).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Lamilept

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Translation of some inscriptions appearing on the blister:
Ch.-B./Verw. bis siehe Prägung – batch number/expiry date see embossing
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Lamilept contains

The active substance is lamotrigine. Each tablet contains 100 mg of lamotrigine.
The other ingredients are: monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch, povidone K 30, colloidal anhydrous silica, sodium carboxymethyl starch (type A), magnesium stearate, sunset yellow FCF (E 110).

What Lamilept looks like and contents of the pack
Lamilept is a peach-coloured, diamond-shaped tablet, with the number "93" embossed on one side
and a dividing line between the digits "9" and "3", and the number "463" embossed on the other side.
The tablets are available in packs containing 30, 60 or 90 tablets.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Germany, country of export:
TEVA GmbH, Graf-Arco-Str. 3, 89079 Ulm, Germany
Manufacturer:
Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, The 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, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
German Marketing Authorisation number (country of export): 64817.00.00
Parallel Import Authorisation number: 337/22
This medicinal product is authorised for marketing in the European Economic Area and in the United Kingdom (Northern Ireland) 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