Simla

Leaflet accompanying the packaging: patient information

Symla, 25 mg, tablets

Symla, 50 mg, tablets

Symla, 100 mg, tablets

Lamotrigine

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Symla and what is it used for

Symla belongs to a group of medicines called antiepileptics. It is used to treat two diseases - epilepsy and bipolar affective disorders. The action of Symla in the treatment of epilepsyis to block impulses in the brain that cause epileptic seizures.

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

Symla is also used to treat bipolar affective disorders.

In patients with bipolar affective disorders (sometimes called manic-depressive psychosis), there are extreme mood swings with episodes of mania (excitement or euphoria) alternating with episodes of depression (deep sadness or despair). In adults over 18 years of age, Symla can be used alone or in combination with other medicines to prevent depressive episodes in bipolar affective disorders. The mechanism by which Symla works in the brain to produce this effect is not yet known.

2. Important information before taking Symla

When not to take Symla

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

In such a case:
➢ Tell your doctorand do not take Symla.

Warnings and precautions

Before starting to take Symla, discuss with your doctor or pharmacist if:

• The patient has any kidney disease,
• The patient has ever had a rashafter taking lamotrigine or other medicines used to treat bipolar affective disorders or epilepsy,
• 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 check the treatment the patient is taking and may advise avoiding sunlight or using sun protection (e.g. using a sunscreen or wearing protective clothing),
• The patient has ever had meningitisafter taking lamotrigine (read the description of symptoms in section 4 of this leaflet: Rare side effects),
• The patient is taking a medicine containing lamotrigine and has a heart condition called Brugada syndrome or other heart conditions. 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) that may be caused by taking lamotrigine.

If any of these cases occur:
➢ Tell your doctor, who may decide to reduce the dose or decide that Symla is not a suitable medicine for the patient.

Important information about life-threatening reactions

A small number of patients taking Symla may experience an allergic reaction or a potentially life-threatening skin reaction that can worsen if left untreated. Such reactions 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 of these conditions and keep them in mind while taking Symla. This risk may be associated with a genetic variant found in people of Asian descent (mainly Chinese Han and Thai). If the patient is of such descent and has previously been found to have this genetic variant (HLA-B*1502), they should discuss this with their doctor before taking Symla.
➢ Read the description of these symptoms in section 4 of this leaflet, in the section “Life-threatening reactions: seek medical attention immediately”.

Hemophagocytic lymphohistiocytosis (HLH)

Rare but very serious reactions of the immune system have been reported in patients taking lamotrigine.
➢ If the patient experiences any of the following symptoms while taking lamotrigine: fever, rash, neurological symptoms (e.g. tremors or shivers, confusion, brain function disorders), seek medical attention immediately.

Thoughts of self-harm or suicide

Antiepileptic medicines are used to treat various diseases, including epilepsy and bipolar affective disorders. In patients with bipolar affective disorders, thoughts of self-harm or suicide may sometimes occur. If the patient has bipolar affective disorders, such thoughts may occur more frequently:

• when starting treatment for the first time,
• if the patient has had thoughts of self-harm or suicide before,
• if the patient is under 25 years of age. If the patient experiences worrying thoughts or feelings, or if they feel worse or experience new symptoms while taking Symla:

➢ Seek medical attention immediately. 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 that the patient is depressed or has worrying changes in behavior.

Symla and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans 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 Symla. These medicines include:

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate, or zonisamide, used to treat epilepsy,
• lithium, olanzapine, or aripiprazole, used to treat mental disorders,
• bupropion, used to treat mental disorders or nicotine addiction. Tell your doctorif the patient is taking any of these medicines.

The patient should also tell their doctor if they are taking paracetamol, a medicine used to treat pain and fever. Some medicines interact with Symla or increase the risk of side effects. These medicines include:

• valproate, used to treat epilepsy and mental disorders,
• carbamazepine, used to treat epilepsy and mental disorders,
• phenytoin, primidone, or phenobarbital, used to treat epilepsy,
• risperidone, used to treat mental disorders,
• rifampicin, which is an antibiotic,
• medicines used to treat HIV infection(a combination of lopinavir with ritonavir or atazanavir with ritonavir),
• hormonal contraceptives, such as the "pill" (see below). Tell your doctorif the patient is taking, has taken, or is going to take any of these medicines.

Hormonal contraceptives (such as the pill) may affect the action of Symla

The doctor may recommend 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 Symla in the blood. If the patient is taking or plans to take hormonal contraceptives:
➢ Discuss this with your doctorto choose a suitable method of contraception. Symla 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 Symla is affecting the action of the contraceptive.

Pregnancy and breastfeeding

➢ If the patient is pregnant, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

• Do not stop treatment without consulting your doctor. This is especially important if the patient has epilepsy.
• Pregnancy may change the effectiveness of Symla, so blood tests may be necessary to adjust the dose of Symla.
• There may be an increased risk of birth defects, including cleft lip and palate, if Symla 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 acidin addition.

If the patient is breastfeeding or plans to breastfeed, they should consult their doctor or pharmacist before taking this medicine

The active substance of Symla passes into breast milkand may affect the baby. The doctor will discuss the risks and benefits of breastfeeding while taking Symla, and if the patient decides to breastfeed, the doctor will monitor the baby for any signs of excessive sleepiness, rash, or poor weight gain. If any of these symptoms occur in the baby, tell the doctor.

Driving and using machines

Symla may cause dizziness and double vision.
➢ Do not drive or operate machinery unless the patient is sure that these symptoms do not occur.

If the patient has epilepsy, they should discuss driving and using machines with their doctor.

Symla contains lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

Symla contains sodium

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

3. How to take Symla

This medicine should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist.

What dose of Symla to take

It may take some time to find the right dose of Symla for the patient. The dose taken by the patient depends on:

• the patient's age,
• whether the patient is taking Symla in combination with other medicines,
• whether the patient has any kidney or liver disease.

The doctor will initially prescribe a small dose and then gradually increase it over several weeks until the effective dose for the patient (called the maintenance dose) is reached. Never take more Symla than the dose recommended by the doctor. The maintenance dose of Symla for adults and children over 13 years of age is usually between 100 mg and 400 mg per day. For children between 2 and 12 years of age, the maintenance dose depends on the child's weight - usually between 1 mg and 15 mg per kilogram of body weight, up to a maximum maintenance dose of 200 mg per day. Symla is not recommended for children under 2 years of age.

How to take Symla

Symla should be taken once or twice a day, as directed by the doctor. The medicine can be taken with or without food. The doctor may also recommend starting or stopping other medicines, depending on the indication and the patient's response to treatment. Symla tablets have a dividing line and can be divided into equal doses.

• Swallow the tablets whole ordivided and wash down with a small amount of water. Do not chew or crush the tablets.
• Always take the entire doseprescribed by the doctor. Never take only part of the dose.

Taking more Symla than recommended

➢ Seek medical attention immediatelyor go to the emergency department of the nearest hospital. If possible, show the packaging of Symla. Taking too much Symla can increase the risk of serious side effects, which can be fatal. If a person takes too much Symla, they may experience:

• rapid, involuntary eye movements (nystagmus),
• clumsiness, lack of coordination, or difficulty maintaining balance (ataxia),
• heart rhythm disturbances (usually detected by ECG),
• loss of consciousness, seizures, or coma.

Missing a dose of Symla

Missing a single dose of Symla

➢ Do not take a double dose to make up for the missed dose. Take the next dose at the usual time.

If the patient misses several doses of Symla

➢ Consult the doctor about how to restart taking Symla. This is important for the patient.

Do not stop taking Symla unless the doctor advises it

Symla must be taken for as long as the doctor recommends. Do not stop taking it unless the doctor advises it. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist. Taking Symla to treat epilepsy
To stop taking Symla, the dose should be gradually reducedover about two weeks. If Symla is stopped suddenly, the patient's epilepsy symptoms may return or worsen. Taking Symla to treat bipolar affective disorders
It may take some time for Symla to start working, so it is unlikely that improvement will occur immediately. When stopping treatment with Symla, there is no need to gradually reduce the dose. However, the patient should consult their doctor before stopping treatment with Symla.

4. Possible side effects

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

Life-threatening reactions: seek medical attention immediately

A small number of patients taking Symla may experience an allergic reaction or a potentially life-threatening skin reaction that can worsen if left untreated. Such reactions can occur more frequently during the first few months of taking Symla, especially if the patient has been given too high a dose or if the dose has been increased too quickly, or if the patient is taking Symla in combination with another medicine called valproate. Some of these reactions occur more frequently in children, so parents should pay particular attention to them. The symptoms of these reactions include:

• skin rashes or rednessthat can worsen into severe skin reactions, including a widespread rash with blisters and peeling of the skin, especially on the face, nose, eyes, and genitals (Stevens-Johnson syndrome), widespread peeling of the skin (toxic epidermal necrolysis), or a widespread rash with liver, blood, and other systemic disorders (drug reaction 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, enlarged lymph nodesin the neck, armpits, and groin,
• unusual bleeding or bruising,
• sore throator frequent infections (such as colds),
• increased liver enzymes in blood tests,
• increased white blood cell count (eosinophilia),
• enlarged lymph nodes,
• organ disorders, including liver and kidney disorders.

Most of these symptoms are signs of less serious side effects. However, remember that they can be life-threateningand, if left untreated, can develop into serious conditions, such as organ failure. If the patient experiences any of these symptoms:
➢ Seek medical attention immediately. The doctor may decide to perform liver, kidney, or blood tests and may recommend stopping Symla. If the patient experiences 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 Symla).

Very common side effects

(may affect more than 1 in 10 people):

• headache,
• skin rash.

Common side effects

(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 location.

Uncommon side effects

(may affect up to 1 in 100 people):

• clumsiness 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 (phototoxicity).

Rare side effects

(may affect up to 1 in 1,000 people):

• life-threatening skin reaction (Stevens-Johnson syndrome); also, read the information at the beginning of section 4,
• a group of symptoms including fever, nausea, vomiting, headache, stiff neck, and extreme sensitivity to light. This may be caused by inflammation of the membranes surrounding the brain and spinal cord (meningitis). These symptoms usually go away after stopping treatment, but if they worsen, seek medical attention,
• rapid, involuntary eye movements (nystagmus),
• itchy eyes with discharge (conjunctivitis).

Very rare side effects

(may affect up to 1 in 10,000 people):

• life-threatening skin reaction (toxic epidermal necrolysis); also, read the information at the beginning of section 4,
• drug reaction with eosinophilia and systemic symptoms (DRESS); see section 4,
• high fever; also, read the information at the beginning of section 4,
• swelling of the face, enlarged lymph nodes in the neck, armpits, and groin; also, read the information at the beginning of section 4,
• liver function changes, which can be seen in blood tests, or liver failure; also, read the information at the beginning of section 4,
• severe blood clotting disorder, which can cause unexpected bleeding or bruising (disseminated intravascular coagulation); also, read the information at the beginning of section 4,
• blood test changes, 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 losing balance while moving,
• involuntary, repetitive body movements or sounds or words (tics), involuntary muscle contractions of the eyes, head, and trunk (choreoathetosis), or other unusual body movements, such as jerks, tremors, or stiffness,
• increased frequency of epileptic seizures in patients with previously diagnosed epilepsy,
• worsening of symptoms in patients with diagnosed Parkinson's disease,
• a condition characterized by symptoms such as back or joint pain, which may be accompanied by fever and/or general malaise (pseudolymphoma syndrome),
• hemophagocytic lymphohistiocytosis (HLH) (see section 2. Important information before taking Symla).

Other side effects

Other side effects have occurred in a small number of patients, but their frequency is unknown.

• Bone disorders, including osteopenia and osteoporosis (weakened bones) and fractures. If the patient is taking antiepileptic medicines for a long time, has osteoporosis, 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, which help protect the body against infections,
• Red lumps or spots on the skin (pseudolymphoma).

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, tell the doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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. Side effects can also be reported to the marketing authorization holder. Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Symla

Keep the medicine out of sight and reach of children.
Do not take this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month stated.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Symla contains

• The active substance of Symla is lamotrigine, in a dose of 25 mg, 50 mg, or 100 mg, respectively, for Symla 25 mg, Symla 50 mg, and Symla 100 mg.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, yellow iron oxide (E 172), povidone K30, sodium carboxymethylcellulose (type A), magnesium stearate, talc, anhydrous colloidal silica.

What Symla looks like and contents of the pack

Symla 25 mg and Symla 50 mg: yellow, round, flat tablets with a dividing line on one side. The tablet can be divided into equal doses. Symla 100 mg: yellow, square-shaped, convex tablets with two intersecting dividing lines on one side. The tablet can be divided into two equal doses (each containing 50 mg of lamotrigine) or into four equal doses (each containing 25 mg of lamotrigine). Symla 25 mg: packs containing 30, 50, 60, 90, or 100 tablets. Symla 50 mg: packs containing 30, 50, 60, 90, or 100 tablets. Symla 100 mg: packs containing 30, 50, 60, 90, or 100 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization holder

Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
tel.: +48 22 822 93 06
e-mail: [email protected]

Importer

Farmak International Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw
Date of last revision of the leaflet:May 2025