Lamilept

Package Leaflet: Information for the User

Lamilept, 25 mg, tablets

Lamilept, 50 mg, tablets

Lamilept, 100 mg, tablets

Lamotrigine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 only. 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Lamilept and what is it used for
• 2. Important information before taking Lamilept
• 3. How to take Lamilept
• 4. Possible side effects
• 5. How to store Lamilept
• 6. Contents of the pack and other information

1. What is Lamilept and what is it used for

Lamilept belongs to a group of medicines called antiepileptic drugs. It is used to treat
two conditions: epilepsyand bipolar affective disorders.
The action of Lamilept in the treatment of epilepsyis based on blocking impulses in the brain
that cause epileptic seizures.

• In adults and children over 13 years of age, Lamilept can be used alone or in combination with other medicines to treat epilepsy. Lamilept can also be used in combination with other medicines to treat seizures associated with a condition called Lennox-Gastaut syndrome.
• In children between 2 and 12 years of age, Lamilept can be used in combination with other medicines to treat these conditions. It can be used alone to treat a type of epilepsy called typical absence seizures.

Lamilept also treats bipolar affective disorder.

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
can be used alone or with other medicines to prevent episodes of depression 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 diagnosed with an allergy( hypersensitivity) to lamotrigine or any of the other ingredients of this medicine (listed in section 6).

If the above case occurs:
→
Tell your doctorand do not take Lamilept.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Lamilept

Lamilept:

• If the patient has any kidney disease
• If the patient has ever had a rashafter taking lamotrigine or other medicines used to treat affective disorders or epilepsy
• If the patient has ever had a rash or sunburnafter taking lamotrigine and being exposed to sunlight or artificial light (e.g. in a solarium). 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).
• If the patient has ever had meningitisafter taking lamotrigine ( read the description of symptoms in section 4 of this leaflet:Rare side effects)
• If the patient is taking a medicine containing lamotrigine
• If the patient has a condition called Brugada syndrome or other heart diseases.Brugada syndrome is a genetically determined heart condition characterized by electrical disturbances in the heart. Abnormal ECG recordings are associated with arrhythmia (abnormal heart rhythm), which may be caused by taking lamotrigine. If this situation applies to the patient, they should consult a doctor.

If any of the above cases occur:
→
Tell your doctor, 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

In a small number of patients taking Lamilept, an allergic reaction or potentially life-threatening skin reaction occurs, which can worsen if left untreated. These symptoms 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 or drowsiness
• swelling of the face or enlarged lymph nodesin the neck, armpits, and groin
• unexpected bleeding or bruisingor blue discoloration of fingers
• sore throat, or more frequent infections (such as colds)
• increased activity of liver enzymes 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 severe side effects. However, remember that they are potentially life-threateningand if left untreated can lead to serious problems, such as organ failure.
Therefore, if any of them are noticed:
→
Seek medical attention immediately.The doctor may decide to perform tests of liver, kidney, or blood function and may recommend discontinuing 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)

My thoughts of self-harm or suicide

Antiepileptic drugs are used to treat several conditions, including epilepsy and bipolar affective disorder. In patients with bipolar affective disorder, suicidal thoughts or behaviors 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 suicidal thoughts or behaviors before
• if the patient is under 25 years old

If the patient experiences worrying thoughts or feelings, or if their condition worsens or new symptoms appear while taking Lamilept:
→

Seek medical attention 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 tell them if they notice

depression or worrying changes in behavior.
A small number of people taking antiepileptic drugs, such as Lamilept, have thought about harming themselves or killing themselves. If such thoughts ever occur to the patient, they should contact their doctor immediately.

Taking Lamilept for epilepsy

Seizures in some types of epilepsy may sometimes worsen or occur more frequently while taking Lamilept. In some patients, severe seizures may occur, which can pose a serious risk to the patient's health. If the patient experiences more frequent seizures or a severe seizure while taking Lamilept:
→

Seek medical attention immediately.

Children and adolescents

Lamilept should not be used to treat bipolar affective disorder in patients under 18 years of age.

Medicines used to treat depression and other mental disorders increase the risk of suicidal thoughts or behaviors in children and adolescents under 18 years of age.

Lamilept and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take

– including herbal medicines or other medicines available without a prescription.The doctor needs to know that the patient is taking other medicines used to treat epilepsy or mental disorders. This will allow the doctor to determine the correct dose of Lamilept. These medicines include:

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate, zonisamide, used to treat epilepsy
• olanzapineor aripiprazoleused to treat mental disorders
• bupropion, used to treat mental disordersor nicotine addiction
• paracetamol, used to treat pain or fever

Tell your doctorif you are 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 taking hormonal contraceptives, such as the "pill", the doctor may recommend blood tests to check the level of Lamilept in the blood. If the patient is taking or plans to take hormonal contraceptives:
→
Talk to your doctorabout the appropriate method of contraception.
Lamilept may also affect the action of hormonal contraceptives, although it is unlikely to reduce their effectiveness. If the patient is taking hormonal contraceptives and notices any changes in their menstrual cycle, such as bleeding or spotting:
→
Tell your doctor.Such symptoms may indicate that Lamilept is affecting the action of the contraceptive.

Pregnancy and breastfeeding

→

If the patient is pregnant, thinks she may be pregnant, or plans to have a baby, she should consult her doctor or pharmacist before taking this medicine.

• Do not stop treatment without consulting your doctor first.This is especially important if the patient has epilepsy.
• Pregnancy may change the effectiveness of Lamilept, so blood tests and dose adjustments of Lamilept 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 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, she should consult her doctor or pharmacist before taking this medicine.

The active substance of Lamilept passes into breast milkand 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 it is sleepy, has a rash, or has a low weight gain. If any of these symptoms are noticed in the baby, tell the doctor.

Driving and using machines

Lamilept may cause dizziness and double vision.
→

Do not drive or operate machinery unless you are sure that these symptoms do not occur.

If the patient has epilepsy, they should talk to their doctor about driving and operating machinery.

Lamilept contains lactose.

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 it is essentially '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 your doctor or pharmacist.If you are unsure, consult your doctor or pharmacist.

What dose of Lamilept to take

The dose of Lamilept that the patient takes 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 to start with, and then gradually increase the dose over a few weeks until the effective dose for the patient is reached (called the effective dose). Never take more Lamilept than prescribed by your 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 is dependent on body weight - usually between 1 mg and 15 mg per kilogram of body weight per day, 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.

• Always take the whole doseprescribed by the doctor. 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.
25 mg and 100 mg tablets
The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow. The tablets should not be chewed or crushed.
50 mg tablets
Take the whole tablet. The tablets should not be broken, chewed, or crushed.

Taking a higher dose of Lamilept than recommended

→

Seek medical attention immediately or go to the nearest emergency department.

If too much Lamilept is taken, there is a higher risk of serious side effects, which can be life-threatening.
In a person who has taken too much Lamilept, the following symptoms may occur:

• rapid, involuntary eye movements ( nystagmus)
• lack of coordination, unsteadiness, or difficulty walking ( ataxia)
• changes in heart rhythm (detected by 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

→

Consult your doctor about restarting 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 the doctor recommends. Do not stop taking it unless the doctor tells you to.

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 may worsen or seizures may occur more frequently.

Taking Lamilept for bipolar disorder

It may take some time before Lamilept starts to work, so it is unlikely that improvement will occur immediately. When stopping Lamilept, there is no need to reduce the dose gradually, but the patient should consult their doctor if they want to stop taking Lamilept.

4. Possible side effects

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

Potentially life-threatening reactions: seek medical attention immediately

In a small number of patients taking Lamilept, an allergic reaction or potentially life-threatening skin reaction occurs, which can worsen if left untreated. These symptoms 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 or drowsiness
• swelling of the face or enlarged lymph nodesin the neck, armpits, and groin
• unexpected bleeding or bruisingor blue discoloration of fingers
• sore throat, or more frequent infections (such as colds)
• increased activity of liver enzymes 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 severe side effects. However, remember that they are potentially life-threateningand if left untreated can lead to serious problems, such as organ failure.
Therefore, if any of them are noticed:
→
Seek medical attention immediately.The doctor may decide to perform tests of liver, kidney, or blood function and may recommend discontinuing Lamilept. If the patient has had Stevens-Johnson syndrome or toxic epidermal necrolysis, the doctor will inform them that they should never take lamotrigine again.
Hemophagocytic lymphohistiocytosis (HLH)(see section 2. Important information before taking Lamilept)

Very common side effects

May occur in more than 1 in 10patients:

• headache
• skin rash.

Common side effects

May occur in up to 1 in 10patients:

• aggression or irritability
• drowsiness
• dizziness
• tremor
• difficulty sleeping ( insomnia)
• feeling agitated
• diarrhea
• dry mouth
• nausea or vomiting
• feeling tired
• back pain, joint pain, or pain in any other location.

Uncommon side effects

May occur in up to 1 in 100patients:

• lack of coordination or unsteadiness ( 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 information at the beginning of section 4)
• a group of symptoms including fever, nausea, vomiting, headache, stiff neck, and extreme sensitivity to bright light. This may be caused by inflammation of the membranes surrounding the brain and spinal cord ( meningitis). These symptoms usually resolve after stopping treatment, but if they do not resolve or worsen, seek medical attention
• 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 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 fever (fever): ( see also 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 information at the beginning of section 4)
• changes in liver function, visible in blood tests, or liver failure: ( see also information at the beginning of section 4)
• serious blood clotting disorder, which can 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 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 reaction similar to lupus (symptoms may include back or joint pain, fever, and general feeling of being unwell)

Other side effects

In a small number of people, other side effects have occurred, but their frequency is unknown:

• There have been reports of bone disorders, including osteopenia and osteoporosis (thinning of the bone's outer layer) and fractures. If the patient is taking antiepileptic drugs for a long time, has had osteoporosis before, 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
• Decreased 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 you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181 C, 02-222 Warszawa, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lamilept

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister packs or cartons after 'EXP'. The expiry date refers to the last day of the month.
The medicine does not require special storage conditions.
Medicines should 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 of Lamilept is lamotrigine. Each tablet contains 25 mg, 50 mg, or 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. The 100 mg tablets also contain orange yellow FCF (E110).

What Lamilept looks like and contents of the pack

• Lamilept, 25 mg, tablets are white or almost white tablets, rhomboid in shape, with the number "93" embossed on one side and a score line between the numbers "9" and "3", and the number "39" embossed on the other side.
• Lamilept, 50 mg, tablets are white or almost white tablets, round in shape, with the number "50" embossed on one side and the letters "LT" embossed on the other.
• Lamilept, 100 mg, tablets are orange-colored tablets, rhomboid in shape, with the number "93" embossed on one side and a score line between the numbers "9" and "3", and the number "463" embossed on the other side.

Lamilept, 25 mg and 50 mg, tablets are available in packs of 30 or 42 tablets.
Lamilept, 100 mg, tablets are available in packs of 30, 42, 56, 60, or 90 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warszawa, tel.: (22) 345 93 00

Manufacturer

Pharmachemie B.V., Swensweg 5, Postbus 552, 2003 RN Haarlem, Netherlands
Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków
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 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 25 / 50 / 100 / 200 mg Tablets
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

Date of last revision of the leaflet: October 2023