Lamilept

Package Leaflet: Information for the User

Lamilept, 25 mg, tablets

Lamilept, 50 mg, tablets

Lamilept, 100 mg, tablets

Lamotrigine

You should carefully read this leaflet before taking Lamilept, as it contains important information for you.

• You should keep this leaflet, as 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Lamilept is and what it is used for
• 2. Before you take 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 Lamilept is and what it is used for

Lamilept belongs to a group of medicines called antiepileptics. It is used to treat epilepsyand bipolar disorder. The action of Lamilept in the treatment of epilepsyis to block the impulses in the brain that cause epileptic seizures.

• In adults and children aged 13 years and above, Lamilept may be used alone or with other medicines to treat epilepsy. Lamilept may also be used with other medicines to treat a type of epilepsy called Lennox-Gastaut syndrome.
• In children aged 2 to 12 years, Lamilept may be used with other medicines to treat these conditions. It may be used alone to treat a type of epilepsy called typical absence seizures.

Lamilept also treats bipolar disorder.

In people with bipolar 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 aged 18 years and above, Lamilept may be used alone or with other medicines to prevent episodes of depression that occur in bipolar disorder. It is not yet known how Lamilept works in this way.

2. Before you take Lamilept

When not to take Lamilept

• If you are allergic (hypersensitive) to lamotrigine or any of the other ingredients of this medicine(listed in section 6).

If any of the above apply to you, tell your doctor and do not take Lamilept.

Warnings and precautions

Talk to your doctor or pharmacist before taking Lamilept

If you:

• have any kidney problems
• have ever had a rash after taking lamotrigine or other medicines used to treat epilepsy or bipolar disorder
• have ever had a rash or sunburn after taking lamotrigine or other medicines used to treat epilepsy or bipolar disorder
• have ever had aseptic meningitis after taking lamotrigine(see section 4, Rare side effects)
• are already taking a medicine that contains lamotrigine
• have a condition called Brugada syndrome or other heart conditions. Brugada syndrome is a genetic condition that affects the electrical activity of the heart, which can lead to abnormal heart rhythms. If this applies to you, consult your doctor.

If any of the above apply to you, tell your doctor, who may decide to reduce your dose or decide that Lamilept is not suitable for you.

Important information about potentially life-threatening reactions

A small number of people taking Lamilept have had a severe allergic reaction or potentially life-threatening skin reaction, which may develop into more serious conditions if left untreated. These reactions may occur more frequently during the first few months of treatment with Lamilept, especially if the initial dose is too high or increased too quickly, or if Lamilept is taken with another medicine called valproate. Some of these reactions may be more common in children, so parents should be especially vigilant. The symptoms include:

• tell your doctor about these symptoms (see section 4, "Potentially life-threatening reactions: seek medical attention immediately").

Hemophagocytic Lymphohistiocytosis (HLH)

Rare cases of a very serious reaction called hemophagocytic lymphohistiocytosis (HLH) have been reported in patients taking lamotrigine. If you experience any of the following symptoms, contact your doctor immediately: fever, rash, neurological symptoms (such as tremors or twitching, confusion, or changes in mental status), contact your doctor or pharmacist immediately.

Thoughts of self-harm or suicide

Medicines used to treat epilepsy and bipolar disorder, such as Lamilept, can increase the risk of suicidal thoughts and behavior in some patients. If you have bipolar disorder, you may be more likely to experience these thoughts:

• when you first start treatment
• if you have had suicidal thoughts or behavior before
• if you are under 25 years old

If you experience any disturbing thoughts or feelings, or if your mood worsens or you experience new symptoms while taking Lamilept, seek medical attention immediately.

Children and adolescents

Lamilept should not be used to treat bipolar disorder in patients under 18 years old

Medicines used to treat depression and other mental health conditions can increase the risk of suicidal thoughts and behavior in children and adolescents under 18 years old.

Lamilept and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take

including herbal medicines or other medicines you can buy without a prescription. Your doctor needs to know if you are taking other medicines to treat epilepsy or mental health conditions, so they can adjust the dose of Lamilept accordingly. These medicines include:

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate, zonisamideused to treat epilepsy
• olanzapine or aripiprazoleused to treat mental health conditions
• bupropionused to treat mental health conditions or nicotine addiction
• paracetamolused to treat pain or fever

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

• valproateused to treat epilepsy or mental health conditions
• carbamazepineused to treat epilepsy or mental health conditions
• phenytoin, primidone, or phenobarbitalused to treat epilepsy
• risperidoneused to treat mental health conditions
• rifampicinan antibiotic
• medicines used to treat HIV infection(such as lopinavir/ritonavir or atazanavir/ritonavir)
• hormonal contraceptivessuch as the pill(see below)

Hormonal contraceptives (such as the pill) may affect Lamilept

Your doctor may recommend a specific type of hormonal contraceptive or another method of contraception, such as a condom, diaphragm, or intrauterine device. If you are taking hormonal contraceptives, such as the pill, your doctor may recommend that you have blood tests to check the levels of Lamilept in your blood. If you are taking hormonal contraceptives or plan to start taking them, talk to your doctor about the best method of contraception. Lamilept may also affect the effectiveness of hormonal contraceptives, although this is unlikely. If you are taking hormonal contraceptives and experience any changes in your menstrual cycle, such as breakthrough bleeding or spotting, tell your doctor. These symptoms may indicate that Lamilept is affecting the effectiveness of your contraceptive.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• Do not stop taking your medicine without consulting your doctor. This is especially important if you have epilepsy.
• Pregnancy may affect the effectiveness of Lamilept, so your doctor may need to monitor your blood levels and adjust your dose.
• There may be a small increased risk of birth defects, including cleft lip or palate, if Lamilept is taken during the first three months of pregnancy.
• If you are planning to become pregnant, your doctor may recommend that you take folic acid supplements.

If you are breastfeeding or plan to breastfeed, ask your doctor or pharmacist for advice before taking this medicine.

The active ingredient of Lamilept, lamotrigine, passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breastfeeding while taking Lamilept, and if you decide to breastfeed, your doctor will monitor your baby for any signs of side effects, such as excessive sleepiness, rash, or poor weight gain. If you notice any of these symptoms in your baby, tell your 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 affect you

If you have epilepsy, talk to your doctor about driving and using machinery

Lamilept contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Lamilept contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially "sodium-free".

Lamilept, 100 mg, tablets contain sunset yellow FCF (E 110)

This may cause allergic reactions.

3. How to take Lamilept

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

What dose of Lamilept to take

It may take some time to find the right dose of Lamilept for you. The dose you take will depend on:

• your age
• whether you are taking Lamilept with other medicines
• whether you have any kidney or liver problems

Your doctor will start you on a low dose and gradually increase it over a few weeks to find the right dose for you (called the effective dose). Never take more Lamilept than your doctor has told you to. The effective dose of Lamilept for adults and children aged 13 years and above is usually between 100 mg and 400 mg per day. For children aged 2 to 12 years, the effective dose is based on their weight, usually between 1 mg and 15 mg per kilogram of body weight, up to a maximum of 200 mg per day. Lamilept is not recommended for children under 2 years old.

How to take your dose of Lamilept

Take your dose of Lamilept once or twice a day, as advised by your doctor. You can take Lamilept with or without food.

• Always take the full dose prescribed by your doctor. Never take only part of a tablet.

Your doctor may also advise you to start or stop taking other medicines, depending on the condition being treated and how you respond to treatment. The 25 mg and 100 mg tablets have a score line to help you break the tablet into two equal halves, if needed. The 50 mg tablets should be swallowed whole, without breaking or chewing.

If you take too much Lamilept

Contact your doctor or the nearest hospital emergency department immediately. If possible, show them the Lamilept packet. If you have taken too much Lamilept, you may be more likely to experience serious side effects, which can be life-threatening. Symptoms of overdose may include:

• rapid, involuntary eye movements (nystagmus)
• lack of coordination, unsteadiness, or inability to walk (ataxia)
• changes in heart rhythm (detected by ECG)
• loss of consciousness, seizures, or coma

If you forget to take a dose of Lamilept

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

If you miss several doses of Lamilept

Consult your doctor before taking Lamilept again. This is especially important for you.

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 tells you to.

Stopping treatment with Lamilept

To stop taking Lamilept, it is important to reduce the dose gradually over a period of about two weeks. If you stop taking Lamilept suddenly, you may experience a return of your seizures or they may become worse.

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

A small number of people taking Lamilept have had a severe allergic reaction or potentially life-threatening skin reaction, which may develop into more serious conditions if left untreated. These reactions may occur more frequently during the first few months of treatment with Lamilept, especially if the initial dose is too high or increased too quickly, or if Lamilept is taken with another medicine called valproate. Some of these reactions may be more common in children, so parents should be especially vigilant. The symptoms include:

• skin rash or redness, which may 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 (toxic epidermal necrolysis), or a rash with fever, swollen lymph nodes, and liver or blood problems (DRESS syndrome)
• sores in the mouth, throat, or genitals
• eye problems, such as blurred vision or eye pain (conjunctivitis)
• high fever, flu-like symptoms, or swollen lymph nodes
• unexplained bruising or bleeding, or purple spots on the skin
• sore throat or frequent infections, such as colds
• increased liver enzymes, which may indicate liver damage
• increased white blood cell count (eosinophilia)
• enlarged lymph nodes
• organ problems, including liver, kidney, or blood disorders

In many cases, these symptoms are signs of less serious side effects. However, they can be life-threatening if left untreatedand may lead to serious complications, such as organ failure. If you experience any of these symptoms, seek medical attention immediately. Your doctor may decide to perform blood tests or other investigations to monitor your condition and may need to stop your treatment with Lamilept. If you have had Stevens-Johnson syndrome or toxic epidermal necrolysis, your doctor will tell you that you must not take lamotrigine again.

Very common side effects

These may affect more than 1 in 10 people:

• headache
• skin rash

Common side effects

These may affect up to 1 in 10 people:

• aggression or irritability
• drowsiness
• dizziness
• tremors
• difficulty sleeping (insomnia)
• feeling agitated
• diarrhea
• dry mouth
• nausea or vomiting
• feeling tired
• back pain, joint pain, or pain in any other part of the body

Uncommon side effects

These may affect up to 1 in 100 people:

• lack of coordination or unsteadiness (ataxia)
• double vision or blurred vision
• unusual hair loss or thinning (alopecia)
• skin rash or sunburn after exposure to sunlight or artificial light (photosensitivity)

Rare side effects

These may affect up to 1 in 1,000 people:

• life-threatening skin reactions, including Stevens-Johnson syndrome (see also the information at the beginning of section 4)
• a group of symptoms including fever, nausea, vomiting, headache, stiff neck, and extreme sensitivity to light, which may be signs of meningitis (inflammation of the membranes surrounding the brain and spinal cord)
• rapid, involuntary eye movements (nystagmus)
• eye inflammation (conjunctivitis)

Very rare side effects

These may affect up to 1 in 10,000 people:

• life-threatening skin reactions, including toxic epidermal necrolysis (see also the information at the beginning of section 4)
• DRESS syndrome (see also the information at the beginning of section 4)
• high fever (see also the information at the beginning of section 4)
• swollen face, swollen lymph nodes in the neck, armpits, or groin (see also the information at the beginning of section 4)
• liver problems, including liver failure (see also the information at the beginning of section 4)
• serious blood clotting disorders, which may cause unexpected bleeding or bruising (disseminated intravascular coagulation) (see also the information at the beginning of section 4)
• hemophagocytic lymphohistiocytosis (HLH) (see section 2, "Important information before taking Lamilept")
• changes in blood test results, including anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, pancytopenia, or aplastic anemia
• hallucinations (seeing or hearing things that are not real)
• disorientation
• feeling unsteady or unstable while moving
• involuntary movements, such as tics, choreoathetosis, or other abnormal movements
• increased frequency of seizures in patients with previously diagnosed epilepsy
• worsening of symptoms in patients with Parkinson's disease
• a reaction similar to lupus (lupus-like reaction), with symptoms such as joint pain or swelling, fever, and general feeling of being unwell

Other side effects

Some people have experienced other side effects, but the frequency of these is unknown:

• bone disorders, including osteopenia and osteoporosis (thinning of the bone), and fractures. If you are taking long-term antiepileptic medication, have had osteoporosis, or are taking steroids, you should discuss this with your doctor or pharmacist.
• kidney inflammation (interstitial nephritis) or kidney and eye inflammation (tubulointerstitial nephritis and uveitis)
• Nightmares
• Decreased immunity due to low levels of immunoglobulins in the blood, which help protect the body against infections
• Red lumps or spots on the skin (pseudolymphoma)

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the national reporting system via the contact details below. By reporting side effects, you can help 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, which is stated on the blister packs or cartons after "EXP". The expiry date refers to the last day of the month stated.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures 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.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch, povidone K-30, colloidal anhydrous silica, sodium starch glycollate (type A), and magnesium stearate. The 100 mg tablets also contain sunset yellow FCF (E 110).

What Lamilept looks like and contents of the pack

• Lamilept, 25 mg, tablets are white or almost white, diamond-shaped tablets with "93" engraved on one side and a score line between the "9" and "3", and "39" engraved on the other side.
• Lamilept, 50 mg, tablets are white or almost white, round tablets with "50" engraved on one side and "LT" engraved on the other.
• Lamilept, 100 mg, tablets are peach-colored, diamond-shaped tablets with "93" engraved on one side and a score line between the "9" and "3", and "463" engraved 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 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

Date of last revision of the leaflet: October 2023