Patient Information Leaflet

Lamilept, 25 mg, tablets
Lamilept, 50 mg, tablets
Lamilept, 100 mg, tablets
Lamotriginum
Please read this leaflet carefully before taking this medicine, as it contains important
information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

What Lamilept is and what it is used for
What you need to know before you take 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 to treat
two conditions: epilepsy and bipolar affective disorder.
The action of Lamilept in treating epilepsy involves blocking abnormal electrical impulses 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 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 aged 2 to 12 years, Lamilept may be used in combination with other medicines to treat these conditions. It may also be used alone in the treatment of a type of epilepsy called typical absence seizures.

Lamilept is also used to treat bipolar affective disorder.
People with bipolar disorder (sometimes called manic-depressive psychosis) experience extreme
mood swings, alternating between episodes of mania (excitement or euphoria) and episodes of
depression (deep sadness or despair). In adults aged 18 years and older, Lamilept may be used alone
or together with other medicines to prevent depressive episodes associated with bipolar disorder.
The exact mechanism by which Lamilept exerts this effect is not yet fully understood.

2. Important information before using Lamilept

When not to use 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:
→ Inform your doctor and do not take Lamilept.

Warnings and precautions
Talk to your doctor or pharmacist before taking Lamilept:

if the patient has any kidney disease
if the patient has ever had a rash after taking lamotrigine or other medicines used to treat mood disorders or epilepsy
if the patient has ever developed a rash or sunburn after exposure to sunlight or artificial light (e.g. in a solarium) while taking lamotrigine. 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 after taking lamotrigine ( see description of symptoms in section 4 of this leaflet: Rare adverse reactions )
if the patient is taking another medicine containing lamotrigine
if the patient has a condition called Brugada syndrome or other heart conditions. 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 your doctor, who may recommend reducing the dose or decide that Lamilept is not suitable for the patient.

Important information about potentially life-threatening reactions
In a small number of patients taking Lamilept, an allergic reaction or potentially severe skin reaction may occur, which, if untreated, can 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 while taking Lamilept. This risk may be associated with a genetic variant found in individuals of Asian origin (mainly Han Chinese and Thai). If the patient is of such origin and has previously been found to carry this genetic variant (HLA-B*1502), this should be discussed with the doctor before starting Lamilept.
→ Read the description of these symptoms in section 4 of this leaflet, under “Potentially life-threatening reactions: contact your doctor as soon as possible”.

Haemophagocytic 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 dysfunction), contact your 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 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 your 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 the patient if they notice signs of depression or concerning changes in behaviour.
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 your doctor immediately.

Use of Lamilept in the treatment of epilepsy
Seizures in certain types of epilepsy may sometimes worsen or occur more frequently while taking Lamilept. Some patients may experience severe seizures that could pose a serious health risk. If seizures become more frequent during treatment with Lamilept or if a severe seizure occurs:
→ See a doctor as soon as possible.

Children and adolescents
Lamilept must 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 behaviour in children and adolescents under 18 years of age.

Lamilept with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take – including herbal remedies or other over-the-counter medicines.

Your doctor needs to know if the patient is taking other medicines used to treat epilepsy or psychiatric disorders. This will allow the correct dose of Lamilept to be determined. 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
paracetamol used in the treatment of pain and fever
→ Inform your doctor if the patient is taking any of these medicines.

Some medicines interact with Lamilept or increase the risk of adverse reactions. 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)
products containing oestrogens, including hormonal contraceptives such as the oral contraceptive pill (see below) and hormone replacement therapy (HRT)
→ Inform your doctor 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
Your doctor may recommend using 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”, your doctor may recommend blood tests to monitor the concentration of Lamilept in the blood. If the patient is using or plans to start using hormonal contraceptives:
→ Talk to your doctor 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 your doctor. These symptoms may indicate an effect of Lamilept on the contraceptive.

Hormone replacement therapy (HRT) may affect the action of Lamilept
If the patient is using hormone replacement therapy (HRT) containing oestrogens, your doctor may recommend blood tests to monitor lamotrigine levels.

Pregnancy and breastfeeding
→ If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Do not stop treatment without first consulting your doctor. 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 slightly increased risk of congenital malformations, 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, her doctor may recommend taking additional folic acid.

→ If the patient is breastfeeding or planning to breastfeed, she should consult her doctor or pharmacist before using this medicine. The active substance in Lamilept passes into breast milk and may affect the infant. The doctor 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 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 that these symptoms do not occur.
If the patient has epilepsy, they should discuss driving and operating machinery with their doctor.

Lamilept contains lactose.
If the patient has been previously diagnosed with an intolerance to certain sugars, they should consult their 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 100 mg tablets contain sunset yellow FCF (E 110).
This medicine may cause allergic reactions.

3. How to use Lamilept

This medicine should always be taken as directed by your doctor or pharmacist. If you have
any doubts, you should contact your doctor or pharmacist.
What dose of Lamilept should be taken
Determining the appropriate dose of Lamilept for a 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.

Your doctor will initially prescribe a low dose and then gradually increase it over several weeks
until reaching the dose effective for the patient (called the effective dose). You must never take a
higher dose of Lamilept than the one prescribed by your doctor.
Typically, the 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.
The use of Lamilept is not recommended in 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 prescribed dose. You should never take only part of a tablet.

Your doctor may also decide to start or stop other medicines, depending on the indication and the
patient's response to treatment.
Tablets 25 mg, 100 mg
The score line on the tablet is only intended to facilitate breaking the tablet for easier swallowing.
Tablets must not be chewed or crushed.
Tablets 50 mg
The whole tablet must be taken. Tablets must not be split, chewed, or crushed.
Taking more Lamilept than prescribed
→ Immediately contact your doctor or the nearest emergency department. 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 )
unsteadiness of movement, lack of coordination, inability to maintain balance ( ataxia )
changes in heart rhythm (usually detected on ECG)
loss of consciousness, seizures, or coma.

Missing a single 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 tells you to.
Lamilept must be taken for as long as your doctor recommends. Do not stop taking it unless your
doctor advises you to do so.
Using Lamilept in the treatment of epilepsy
When stopping Lamilept, it is essential that the dose be gradually reduced 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, there is no need to gradually reduce the dose; however,
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: seek medical advice immediately
A small number of patients taking Lamilept have experienced an allergic reaction or a 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, particularly if the initial 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 special attention to them.
Symptoms of these reactions include:

Skin rash or redness of the skin, which may progress to severe or, in some cases, life-threatening skin reactions, including rashes with target-like lesions ( erythema multiforme ), widespread blistering rash with 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 reaction 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 body temperature (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 the fingers
Sore throat, or more frequent infections than usual (such as colds)
Increased liver enzyme activity detectable 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:
→ Seek immediate medical advice. The treating physician may decide to perform tests to assess liver, kidney, or blood function and may recommend discontinuation of Lamilept. If the patient has experienced Stevens-Johnson syndrome or toxic epidermal necrolysis, the physician 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 not more than 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, joint, or other pain anywhere in the body.

Uncommon adverse reactions
May occur in not more than 1 in 100 patients:

Impaired movement and lack of coordination ( 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 not more than 1 in 1,000 patients:

Skin reaction causing red spots and patches on the skin, which may resemble a target or "bull's eye" with a dark red center surrounded by lighter red rings ( erythema multiforme )
Life-threatening skin reaction ( Stevens-Johnson syndrome ): ( see also information at the beginning of section 4 )
A group of symptoms occurring together: fever, nausea, vomiting, headache, neck stiffness, 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 persist or worsen, seek medical advice
Rapid, involuntary eye movements ( nystagmus )
Itchy eyes with discharge ( conjunctivitis ).

Very rare adverse reactions
May occur in not more than 1 in 10,000 patients:

Life-threatening skin reaction ( toxic epidermal necrolysis ): ( see also information at the beginning of section 4 )
Drug reaction 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, and 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 taking Lamilept )
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 a 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 repetitive movements of the body and (or) sounds or words ( tics ), involuntary muscle contractions affecting the 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 had osteoporosis in the past, or is taking steroids, this should be discussed with a physician or pharmacist
Kidney inflammation (tubulointerstitial nephritis), or simultaneous kidney and eye inflammation (tubulointerstitial nephritis and uveitis)
Nightmares
Weakened immunity due to lower levels of antibodies in the blood, called 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 your doctor or pharmacist.
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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Lamilept

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blisters or carton after "Expiry date". The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Lamilept contains

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

What Lamilept looks like and contents of the pack

Lamilept 25 mg tablets are white or almost white, diamond-shaped tablets, with the number "93" embossed on one side and a dividing line between the digits "9" and "3", and the number "39" embossed on the other side.
Lamilept 50 mg tablets are white or almost white, round tablets, with the number "50" embossed on one side and the letters "LT" embossed on the other.
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 25 mg and 50 mg tablets are available in packs containing 30 or 42 tablets.
Lamilept 100 mg tablets are available in packs containing 30, 42, 56, 60, or 90 tablets.
Not all pack sizes may be marketed.

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

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

This medicinal product is authorised in the European Economic Area countries
and in the United Kingdom (Northern Ireland) under the following names:
Denmark: Lamotrigin Teva
Germany: Lamotrigin-TEVA 25 / 50 / 100 / 200 mg Tabletten
Poland: Lamilept
Portugal: Lamotrigina Teva 25 / 50 / 100 / 200 mg Comprimidos
Sweden: Lamotrigin Teva
United Kingdom (Northern Ireland): Lamotrigine Teva 25 / 50 / 100 / 200 mg Tablets