Package leaflet: Information for the user

Warning! Keep this 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 for the same medicine.
Please read the entire leaflet before taking 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, 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 identical.
If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. 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 of blocking nerve impulses in the brain that cause epileptic seizures.

In adults and children aged 13 years and older, Lamilept may be used either 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 is also used to treat bipolar affective disorder.
In people with bipolar affective disorder (sometimes called manic-depressive psychosis), extreme mood swings occur, with episodes of mania (excitement or euphoria) alternating with episodes of depression (deep sadness or despair). In adults aged 18 years and older, Lamilept may be used either alone or in combination 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:

→ Contact the treating physician and do not take Lamilept.
Warnings and precautions
Talk to your doctor or pharmacist before starting Lamilept if:

the patient has any kidney disease
the patient has ever had a rash after taking lamotrigine or other medicines used to treat mood disorders or epilepsy, or if the patient develops a rash or sunburn following exposure to sunlight or artificial light (e.g. in a solarium). The doctor will review the patient's treatment and may advise avoiding sunlight or using sun protection (e.g. sunscreen or protective clothing).
the patient has ever had meningitis after taking lamotrigine ( see description of symptoms in section 4 of this leaflet: Rare side effects )
the patient is taking another medicine containing lamotrigine
the patient has a condition called Brugada syndrome. Brugada syndrome is a genetically determined heart disease characterized by disturbances in the heart's electrical activity. Abnormal ECG findings are associated with arrhythmia (irregular heartbeat), which may be triggered by taking 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 experience an allergic reaction or a potentially serious skin reaction, which, if untreated, may lead to more severe conditions. These may include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). The patient should be aware of the symptoms to watch for while taking Lamilept.
→ Read the description of these symptoms in section 4 of this leaflet, under “Potentially life-threatening reactions: contact a doctor as soon as possible”.
Hemophagocytic lymphohistiocytosis (HLH)
Cases of a rare but very serious immune system reaction have been reported in patients taking lamotrigine.
→ If the patient experiences the following symptoms while taking lamotrigine: fever, rash, neurological symptoms (e.g. tremors or chills, confusion, brain dysfunction), 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 occasionally experience thoughts of self-harm or suicide. These thoughts may be more common in patients with bipolar disorder:

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 while taking 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 signs of depression or worrying changes in behavior.
A small number of people taking antiepileptic medicines such as Lamilept have had thoughts about harming themselves or suicide. If such thoughts ever occur, contact a doctor immediately.
Use of Lamilept in the treatment of epilepsy
Seizures in certain types of epilepsy may sometimes 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 a severe seizure occurs while being treated with Lamilept:
→ Seek medical advice as soon as possible.
Children and adolescents
Lamilept should not be used in the treatment of 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 behavior 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 or has recently taken, including herbal remedies or other medicines obtained without a prescription, as well as any medicines the patient plans to take.
The treating physician must be aware 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 dependence → 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 (combination of 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, a diaphragm, or an 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 plans to start using 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 her menstrual cycle, such as bleeding or spotting between periods:
→ Inform the treating physician. These symptoms may indicate an effect of Lamilept on the contraceptive.
Pregnancy and breastfeeding
→ If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant,
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 affect the effectiveness of Lamilept, so blood tests and dose adjustments may be necessary.
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 is planning a pregnancy or is pregnant, the treating physician may recommend taking folic acid additionally.

→ 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 while taking Lamilept. If the patient decides to breastfeed, the infant will be monitored periodically for excessive sleepiness, rash, or poor weight gain. If any of these symptoms are observed in the infant, inform the doctor.
Driving and using machines
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 the medicine is considered "sodium-free".
Lamilept contains sunset yellow FCF (E 110)
This medicine may cause allergic reactions.

3. How to use Lamilept

This medicine should always be used exactly as your doctor or pharmacist has told you.
If you are unsure, you should contact your doctor or pharmacist.

What dose of Lamilept should be taken

Finding the right 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 with other medicines
whether the patient has any kidney or liver problems.

Your doctor will initially prescribe a low dose and then gradually increase it over several weeks until an effective dose for the patient (called the effective dose) is reached.
You must never take more Lamilept than the dose prescribed by your doctor.

The usual effective dose of Lamilept in adults and children aged 13 years and older is between 100 mg and 400 mg per day.

In children aged 2 to 12 years, the effective dose depends on body weight – usually between 1 mg and 15 mg per kilogram of body weight, up to a maximum maintenance dose of 200 mg per day.

Lamilept is not recommended for use in children under 2 years of age.

How to take a dose of Lamilept

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

Your doctor may also decide to start or stop other medicines, depending on the condition being treated and your response to therapy.

The breakline on the tablet is only intended to facilitate breaking the tablet for easier swallowing. Tablets must not be chewed or crushed.

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

Taking more Lamilept than prescribed
→ Contact your doctor or the nearest emergency department immediately. If possible, show the Lamilept packaging to the medical staff.

If too high a dose of Lamilept is taken, there is an increased risk of severe adverse reactions, which may result in death.

Symptoms that may occur in someone who has taken too much Lamilept include:

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

If you miss a dose of Lamilept
Do not take extra tablets to make up for the missed dose. Take the next dose at your usual time.

If you miss several doses of Lamilept
→ You should consult your doctor about restarting Lamilept. This is important for the patient.

Do not stop taking Lamilept unless your doctor tells you to.
Lamilept should be taken for as long as your doctor recommends. Do not stop taking it unless instructed by your doctor.

Using Lamilept in the treatment of epilepsy
When stopping Lamilept, it is important that the dose is reduced gradually over approximately two weeks. If Lamilept is stopped suddenly, seizures may recur or worsen.

Using Lamilept in the treatment of bipolar disorder
It may take some time before Lamilept starts to work, so improvement is unlikely to occur immediately. When stopping Lamilept, gradual dose reduction is not usually necessary, but you should consult your doctor before discontinuing treatment.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Potentially life-threatening reactions: contact your doctor immediately
A small number of patients taking Lamilept have experienced an allergic reaction or
potentially life-threatening skin reaction, which may worsen if left untreated.
These symptoms may occur more frequently during the first few months of treatment with Lamilept,
especially if the starting dose was too high or 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 rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genital organs ( Stevens-Johnson syndrome ), extensive peeling of the skin (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)
Ulcers in the mouth, throat, nose or genital organs
Pain in the mouth or red or swollen eyes ( conjunctivitis )
High body temperature (fever), flu-like symptoms or drowsiness
Swelling of the face or enlarged lymph nodes in the neck, under the arms or in the groin
Unexpected bleeding or bruising or blue discoloration of the fingers
Sore throat, or more frequent infections than usual (such as colds)
Increased liver enzyme activity observed 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 your 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 taking 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
Drowsiness
Dizziness
Tremor
Difficulty falling asleep ( insomnia )
Feeling of restlessness
Diarrhea
Dry mouth
Nausea or vomiting
Feeling of fatigue
Back pain, joint pain or pain in any other location.

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 do not resolve or worsen, contact your doctor
Rapid, involuntary eye movements ( nystagmus )
Itchy eyes with discharge ( conjunctivitis ).

Very rare adverse reactions
May occur in up to 1 in 10,000 patients:

Life-threatening skin reaction ( toxic epidermal necrolysis ): ( 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, under the arms or in the 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 which may cause unexpected bleeding or bruising ( disseminated intravascular coagulation ): ( see also information at the beginning of section 4 )
Changes in blood test results – including reduced number of red blood cells ( anemia ), reduced number of white blood cells ( leukopenia, neutropenia, agranulocytosis ), reduced number of platelets ( thrombocytopenia ), reduced number of all blood cells ( pancytopenia ) and bone marrow disorder called aplastic anemia
Hallucinations ("seeing" or "hearing" things that are not real)
Disorientation
Feeling of unsteadiness and lack of stability during movement
Involuntary body movements ( 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
Lupus-like reaction (symptoms may include: back or joint pain, sometimes accompanied by fever and/or general malaise)
Hemophagocytic lymphohistiocytosis (HLH) (see section 2. Important information before taking Lamilept).

Other adverse reactions
Other adverse reactions have been reported in a small number of people, 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 being treated long-term with antiepileptic medicines, has had osteoporosis in the past, or is taking steroids, this should be discussed with a doctor or pharmacist
Nightmares
Weakened immunity due to lower levels in the blood of antibodies called immunoglobulins, which help protect the body against infections.

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

5. How to store the medicine Lamilept

Keep this medicine out of 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 information on the immediate packaging:
Ch.-B./Verwendbar bis: siehe Prägung – batch number/expiry date: see imprint.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help protect
the environment.

6. Contents of the package 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 100 mg tablets are peach-coloured, diamond-shaped tablets, 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.
Lamilept 100 mg tablets are available in packages containing 30 tablets.
For more detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation 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, The 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 Warsaw, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
German marketing authorisation number (country of export): 64817.00.00
Parallel import authorisation number: 80/22
This medicinal product is authorised in the European Economic Area countries 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