Simla

Leaflet accompanying the packaging: patient information

Symla, 25 mg, tablets

Symla, 50 mg, tablets

Symla, 100 mg, tablets

Lamotrigine

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform 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 packaging and other information

1. What is Symla and what is it used for

Symla belongs to a group of medicines called antiepileptic medicines. It is used to treat two diseases - epilepsy and bipolar affective disorders.
The action of Symla in the treatment of epilepsyinvolves blocking 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 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 exerts this effect in the brain 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:
➢ The patient should inform their doctorand not take Symla.

Warnings and precautions

Before starting to take Symla, the patient should discuss with their 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 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),
• The patient has ever had meningitisafter taking lamotrigine (see description of symptoms in section 4 of this leaflet: Rare side effects),
• The patient is taking a medicine containing lamotrigine and has a condition called Brugada syndrome or other heart diseases. Brugada syndrome is a genetically determined heart disease characterized by electrical disturbances in the heart. Abnormal EKG recordings are associated with arrhythmia (abnormal heart rhythm), which may be caused by taking lamotrigine.

In case of any of the above:
➢ The patient should inform their 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, which may worsen if left untreated. Such reactions include:

• Stevens-Johnson syndrome (SJS),
• Toxic epidermal necrolysis (TEN),
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).

The patient should familiarize themselves with 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.
➢ The patient should read the description of these symptoms in section 4 of this leaflet, in the part “Life-threatening reactions: seek medical attention immediately”.

Hemophagocytic Lymphohistiocytosis (HLH)

In patients taking lamotrigine, cases of a rare but very severe reaction of the immune system have been reported.
➢ If the patient experiences any of the following symptoms while taking lamotrigine: fever, rash, neurological symptoms (e.g., tremors or chills, confusion, brain dysfunction), they should 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 disturbing thoughts or feelings, or if they feel worse or experience new symptoms while taking Symla:

➢ The patient should seek medical attention as soon as possible. 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 that the patient is experiencing depression or disturbing changes in behavior.
In a small number of patients treated with antiepileptic medicines, such as Symla, thoughts of self-harm or suicide have also occurred. If the patient has ever had such thoughts, they should seek medical attention immediately.

Taking Symla for epilepsy

In some types of epilepsy, seizures may sometimes worsen or occur more frequently while taking Symla. In some patients, severe seizures may occur, which can pose a serious threat to the patient's health. If the patient experiences more frequent or severe seizures while taking Symla:
➢ The patient should seek medical attention as soon as possible.

Symla should not be used to treat bipolar affective disorders

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

Symla and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they 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 appropriate 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 disordersor nicotine addiction. The patient should inform their doctor if they are taking any of these medicines.

The patient should also inform 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, 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). The patient should inform their doctorif they are taking, have taken, or are about to take any of these medicines.

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

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 Symla in the blood. If the patient is taking or plans to start taking hormonal contraceptives:
➢ The patient should discuss this with their doctorto choose an appropriate 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:
➢ The patient should inform their 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.

• The patient should not stop taking the medicine without consulting their doctor first. This is especially important if the patient has epilepsy.
• Pregnancy may change the effectiveness of Symla, so blood tests and dose adjustments may be necessary.
• 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, will monitor the baby for any signs of excessive sleepiness, rash, or poor weight gain. If any of these symptoms are noticed in the baby, the patient should inform their doctor.

Driving and using machines

Symla may cause dizziness and double vision.
➢ The patient should not drive or operate machinery unless they are 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 previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking Symla.

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 any doubts, the patient should consult their doctor or pharmacist.

What doses of Symla should be taken

Determining the appropriate dose of Symla for the patient may take time. 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 diseases.

The doctor will initially prescribe a small dose and then gradually increase it over several weeks until the effective dose for the patient is reached (called the maintenance dose). The patient should never take a higher dose of Symla than prescribed by their doctor.
Usually, the maintenance dose of Symla for 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 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 score line and can be divided into equal doses.

• The tablets should be swallowed whole ordivided and taken with a small amount of water. The tablets should not be chewed or crushed.
• The patient should always take the entire doseprescribed by the doctor. The patient should never take only part of the dose.

Taking a higher dose of Symla than recommended

➢ The patient should seek medical attention immediatelyat the emergency department of the nearest hospital. If possible, the patient should show the packaging of Symla.
Taking too much Symla may increase the risk of serious side effects, which can be fatal.
In a person who has taken too much Symla, the following symptoms may occur:

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

Missing a dose of Symla

Missing a single dose of Symla

➢ The patient should not take a double dose to make up for the missed dose. The patient should take the next dose at the usual time.

If the patient misses several doses of Symla

➢ The patient should consult their doctor about restarting Symla. This is important for the patient.

The patient should not stop taking Symla unless their doctor advises them to do so

Symla should be taken for as long as the doctor recommends. The patient should not stop taking the medicine unless their doctor advises them to do so.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist. Taking Symla for epilepsy
To stop taking Symla, it is essential to gradually reduce the doseover about two weeks. If Symla is stopped abruptly, the patient may experience a recurrence of epileptic seizures or worsening of symptoms.
Taking Symla for bipolar affective disorders
It may take some time before Symla starts to work, so it is unlikely that an 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 if they plan to stop taking 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, which may worsen if left untreated. Such reactions may occur more frequently during the first few months of taking Symla, especially if the patient has taken too much medicine 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 may worsen to severe 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 widespread rash with changes in the liver, blood, and other organs (Drug Reaction with Eosinophilia and Systemic Symptoms, also known as DRESS),
• ulcers in the mouth, throat, nose, or genitals,
• eye ulcers or redness and swelling of the eyes(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 more frequent infections (such as colds),
• increased liver enzyme levels in blood tests,
• increased white blood cell count (eosinophilia),
• enlarged lymph nodes,
• changes in organs, including the liver and kidneys.

In many cases, these are symptoms of less severe side effects. However, the patient should remember that they are potentially life-threateningand, if left untreated, may develop into serious conditions, such as organ failure. If the patient notices any of these symptoms:
➢ The patient should seek medical attention immediately. The doctor may decide to perform liver, kidney, or blood tests and may recommend stopping Symla. If the patient develops 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 occur in more than 1 in 10 patients):

• headache,
• skin rash.

Common side effects

(may occur in up to 1 in 10 patients):

• aggression or irritability,
• drowsiness,
• dizziness,
• tremors,
• difficulty sleeping (insomnia),
• feeling excited,
• 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 100 patients):

• clumsiness and lack of coordination (ataxia),
• double or blurred vision,
• unusual hair loss (alopecia),
• skin rash or sunburn after exposure to sunlight or artificial light (phototoxicity).

Rare side effects

(may occur in up to 1 in 1,000 patients):

• life-threatening skin reaction (Stevens-Johnson syndrome); the patient should 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 resolve after stopping treatment, but if they worsen, the patient should seek medical attention,
• rapid, involuntary eye movements (nystagmus),
• itchy eyes with discharge (conjunctivitis).

Very rare side effects

(may occur in up to 1 in 10,000 patients):

• life-threatening skin reaction (toxic epidermal necrolysis); the patient should also read the information at the beginning of section 4,
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS); see section 4,
• high fever(fever); the patient should also read the information at the beginning of section 4,
• swelling of the face, enlarged lymph nodesin the neck, armpits, and groin; the patient should also read the information at the beginning of section 4,
• changes in liver function, as shown by blood tests, or liver failure; the patient should also read the information at the beginning of section 4,
• severe blood clotting disorder, which may cause unexpected bleeding or bruising (disseminated intravascular coagulation); the patient should also read the information at the beginning of section 4,
• changes in blood test results, including decreased red blood cell count (anemia), decreased white blood cell count (leukopenia, neutropenia, agranulocytosis), decreased platelet count (thrombocytopenia), or decreased counts of all blood cells (pancytopenia), as well as a bone marrow disorder called aplastic anemia,
• hallucinations (seeing or hearing things that are not real),
• disorientation,
• feeling unsteady or lacking balance while moving,
• involuntary, repetitive movements of the body 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 seizures in patients with previously diagnosed epilepsy,
• worsening of symptoms in patients with diagnosed Parkinson's disease,
• a condition that may include back or joint pain, which may be accompanied by fever and/or general malaise (pseudolymphoma),
• 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 the frequency is unknown.

• Reports of 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 (tubulointerstitial nephritis and uveitis),
• Nightmares,
• Decreased immunity due to lower levels of antibodies in the blood, which help protect the body against infections,
• Red bumps or spots on the skin (pseudolymphoma).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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 181C, 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, more information can be collected on the safety of the medicine.

5. How to store Symla

The medicine should be stored out of sight and reach of children.
The patient should not take this medicine after the expiration date stated on the carton and blister pack after: EXP. The expiration date refers to the last day of the month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging 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 score line on one side. The tablet can be divided into equal doses.
Symla 100 mg: yellow, square-shaped tablets, convex on one side, flat, with two intersecting score lines on the other 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 Warszawa
tel.: +48 22 822 93 06
e-mail: biuro@farmakinternational.pl

Importer

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