Patient Information Leaflet

Lamotrix, 25 mg, tablets
Lamotrix, 50 mg, tablets
Lamotrix, 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, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm someone else, 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.

Table of Contents
1. What Lamotrix is and what it is used for
2. What you need to know before taking Lamotrix
3. How to take Lamotrix
4. Possible side effects
5. How to store Lamotrix
6. Contents of the pack and other information

1. What Lamotrix is and what it is used for
Lamotrix belongs to a group of medicines called antiepileptic drugs. It is used to treat two conditions: epilepsy and bipolar affective disorder.

The action of Lamotrix in treating epilepsy involves blocking impulses in the brain that cause epileptic seizures.

In adults and children aged 13 years and older, Lamotrix may be used in the treatment of epilepsy either as monotherapy or in combination with other medicines. Lamotrix may also be used in combination with other medicines to treat seizures in a condition called Lennox-Gastaut syndrome.
In children aged 2 to 12 years, Lamotrix may be used in combination with other medicines to treat these conditions. It may also be used as monotherapy in the treatment of a type of epilepsy known as typical absence seizures.

Lamotrix is also used in the treatment of bipolar affective disorder.
In patients with bipolar affective disorder (sometimes called manic-depressive psychosis), extreme mood swings occur, with episodes of mania (excitement or euphoria) alternating with episodes of depression (deep sadness or despair). In adults aged 18 years and older, Lamotrix may be used either as monotherapy or in combination with other medicines to prevent depressive episodes in bipolar affective disorder.
The mechanism by which Lamotrix exerts this effect in the brain has not yet been fully understood.

2. What you need to know before taking Lamotrix

Do not take Lamotrix:

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

If this applies to you:
➔ Tell your doctor and do not take Lamotrix.

Warnings and precautions
Before starting Lamotrix, discuss with your doctor if:

you have any kidney disease
you have ever had a rash after taking lamotrigine or other medicines used to treat bipolar disorder or epilepsy, or if you developed a rash or sunburn after exposure to sunlight or artificial light (e.g. in a solarium) while taking lamotrigine. Your doctor will review your treatment and may advise you to avoid sunlight or to use sun protection (e.g. sunscreen or protective clothing).
you have ever had meningitis after taking lamotrigine (see description of symptoms in section 4 of this leaflet, “Rare side effects”);
you are taking another medicine containing lamotrigine
you have Brugada syndrome. Brugada syndrome is a genetically determined heart condition 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 you, consult your doctor.

If any of the above situations apply:
➔ Tell your doctor, who may recommend reducing the dose or decide that Lamotrix is not suitable for you.

Important information about life-threatening reactions
A small number of patients taking Lamotrix may experience an allergic reaction or a potentially life-threatening skin reaction, which may worsen if left untreated. These reactions include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome).
You should be aware of the symptoms of these conditions and monitor for them while taking Lamotrix. This risk may be associated with a genetic variant found in people of Asian descent (particularly Han Chinese and Thai). If you are of such descent and have previously been found to carry this genetic variant (HLA-B*1502), discuss this with your doctor before taking Lamotrix.
➔ Please read the description of these symptoms in section 4 of this leaflet, under "Life-threatening reactions: contact your doctor immediately".

Hemophagocytic lymphohistiocytosis (HLH)
Cases of a rare but very serious immune system reaction have been reported in patients taking lamotrigine.
➔ If you develop 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 various conditions, including epilepsy and bipolar affective disorder. In patients with bipolar affective disorder, thoughts of self-harm or suicide may sometimes occur. These thoughts may be more likely in patients with bipolar affective disorder if:

treatment is being started for the first time
they have previously had thoughts of self-harm or suicide
they are under 25 years of age.

If you experience disturbing thoughts or feelings, or if you feel worse or develop new symptoms while taking Lamotrix:
➔ Seek medical help immediately by contacting your doctor or going to the nearest hospital.
It may be helpful to inform a relative, caregiver, or friend that you may experience depression or significant mood changes and ask them to read this leaflet. You may ask them to inform you if they notice signs of depression or worrying changes in your behaviour.
A small number of patients taking antiepileptic medicines such as Lamotrix have experienced thoughts of self-harm or suicide. If you ever have such thoughts, contact your doctor immediately.

Use of Lamotrix in the treatment of epilepsy
In some types of epilepsy, seizures may sometimes worsen or occur more frequently during treatment with Lamotrix. Some patients may experience severe seizures that could pose a serious health risk. If your seizures become more frequent or if you have a severe seizure while taking Lamotrix:
➔ Contact your doctor as soon as possible.

Lamotrix 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 may increase the risk of suicidal thoughts or behaviour in children and adolescents under 18 years of age.

Lamotrix and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including herbal medicines or other medicines obtained without a prescription.
Your doctor needs to know if you are taking other medicines used to treat epilepsy or psychiatric disorders. This will allow your doctor to determine the appropriate dose of Lamotrix. These medicines include:

oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate, zonisamide, used to treat epilepsy
lithium, olanzapine, or aripiprazole, used to treat psychiatric disorders
bupropion, used to treat psychiatric disorders or nicotine dependence.
➔ Tell your doctor if you are taking any of these medicines.

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

valproate, used to treat epilepsy and psychiatric disorders
carbamazepine, used to treat epilepsy and psychiatric disorders
phenytoin, primidone, or phenobarbital, used to treat epilecy
risperidone, used to treat psychiatric disorders
rifampicin, an antibiotic
medicines used to treat human immunodeficiency virus (HIV) infection (lopinavir with ritonavir or atazanavir with ritonavir)
hormonal contraceptives, such as the contraceptive pill (see below).
➔ Tell your doctor if you are taking, have taken, or are starting to take any of these medicines.

Hormonal contraceptives (such as the contraceptive pill) may affect the action of Lamotrix
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 you are using hormonal contraceptives such as the contraceptive pill, your doctor may recommend blood tests to monitor lamotrigine levels. If you are using or plan to start using hormonal contraceptives:
➔ Discuss appropriate contraceptive methods with your doctor.
Lamotrix may also affect the action of hormonal contraceptives, although it is unlikely to reduce their effectiveness. If you are using hormonal contraceptives and notice any changes in your menstrual cycle, such as bleeding or spotting between periods:
➔ Tell your doctor. These symptoms may indicate an effect of Lamotrix on the contraceptive.

Pregnancy and breastfeeding
➔ If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

Do not stop treatment without first consulting your doctor. This is particularly important if you have epilepsy.
Pregnancy may affect the effectiveness of Lamotrix, so blood tests and dose adjustments may be necessary.
There may be a small increased risk of congenital malformations, including cleft lip and palate, if Lamotrix is taken during the first three months of pregnancy.
If you are planning a pregnancy or are pregnant, your doctor may recommend taking folic acid in addition.

➔ If you are breastfeeding or planning to breastfeed, consult your doctor or pharmacist before taking this medicine. The active substance in Lamotrix passes into breast milk and may affect the baby. Your doctor will discuss the risks and benefits of breastfeeding while taking lamotrigine. If you decide to breastfeed, your baby will be monitored periodically for excessive sleepiness, rash, or poor weight gain. If any of these symptoms occur in the baby, inform your doctor.

Driving and operating machinery
Lamotrix may cause dizziness and double vision.
➔ Do not drive or operate machinery unless you are certain that these symptoms do not affect you.
If you have epilepsy, discuss driving and operating machinery with your doctor.

3. How to use Lamotrix

This medicine should always be used exactly as prescribed by your doctor. If you have any doubts,
you should consult your doctor or pharmacist.
What dose of Lamotrix should be used
Determining the appropriate dose of Lamotrix for a patient may take time. The dose taken by a
patient depends on:

the patient's age
whether the patient is taking Lamotrix 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 an effective dose for the patient is reached (called the effective dose). You must never take a
higher dose of Lamotrix than the one prescribed by your doctor.
The usual effective dose of Lamotrix in adults and children aged 13 years and 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 Lamotrix is not recommended in children under 2 years of age.
Taking a dose of Lamotrix
The dose of Lamotrix should be taken once or twice daily, as directed by your doctor.
Lamotrix may be taken with or without food.
Your doctor may also decide to start or discontinue other medications, depending on the indication
and the patient's response to treatment.

Tablets should be swallowed whole. Do not break, chew, or crush them.
Always take the full prescribed dose. Never take only part of a tablet.

Taking more than the recommended dose of Lamotrix
➔ Seek immediate medical attention by contacting your doctor or going to the nearest hospital.
If possible, bring the Lamotrix packaging with you.
Taking too high a dose of Lamotrix may increase the risk of serious adverse effects,
which may be life-threatening.
In a person who has taken an excessive dose of Lamotrix, the following symptoms may occur:

rapid, involuntary eye movements ( nystagmus )
unsteadiness, lack of coordination, difficulty maintaining balance ( ataxia )
heart rhythm disturbances (usually detectable on ECG)
loss of consciousness, seizures, or coma.

Missing a single dose of Lamotrix
➔ Do not take extra tablets to make up for a missed dose.
Take the next dose at the usual time.
If several doses of Lamotrix are missed
➔ Consult your doctor for advice on how to resume taking Lamotrix.
This is important for the patient.
Do not stop taking Lamotrix unless your doctor tells you to do so.
Lamotrix must be taken for as long as your doctor recommends. Do not discontinue treatment unless
instructed by your doctor.
Using Lamotrix in the treatment of epilepsy
When stopping Lamotrix treatment, it is essential that the dose be gradually reduced over
approximately two weeks. Suddenly stopping Lamotrix may cause seizures to recur or worsen.
Using Lamotrix in the treatment of bipolar affective disorders
It may take some time before Lamotrix starts to work, so improvement is unlikely to occur immediately.
When discontinuing Lamotrix treatment, gradual dose reduction is not usually required. However, you
should still consult your doctor if you plan to stop taking Lamotrix.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
Life-threatening reactions: contact a doctor immediately.
In a small number of patients taking Lamotrix, an allergic reaction or potentially life-threatening skin reaction may occur, which may worsen if left untreated.
These symptoms may occur more frequently during the first few months of treatment with Lamotrix, especially if the dose was too high, increased too quickly, or if the patient is taking Lamotrix together with another medicine called valproate. Some of these symptoms occur more frequently in children, so parents should pay particular attention to them.
Such reactions include:

Skin rash or redness of the skin, which may worsen into severe skin reactions, including widespread rash with blisters and peeling of the outer layer of skin, particularly affecting 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 with liver, blood and other organ disorders (drug hypersensitivity syndrome with eosinophilia and systemic symptoms, also known as DRESS syndrome)
Ulceration of the mouth, throat, nose or genital organs
Pain in the mouth or redness and swelling around the eyes (conjunctivitis)
High body temperature (fever), flu-like symptoms or drowsiness
Swelling of the face, enlarged lymph nodes in the neck, under the arms or in the groin
Unexpected bleeding, bruising or bluish discoloration of the fingers
Sore throat or more frequent infections than usual (such as colds)
increased liver enzyme activity in blood tests
increased white blood cell count (eosinophilia)
enlarged lymph nodes
disorders of other body organs, including liver and kidneys.

In many cases, these are symptoms of less severe adverse effects. However, it should be remembered
that they may be potentially life-threatening and, if left untreated, may worsen into severe
conditions, such as organ failure. If the patient notices any of these symptoms:
➔ contact a doctor immediately. The treating physician may decide to perform liver, kidney or blood function tests and may recommend discontinuation of Lamotrix. If the patient develops Stevens-Johnson syndrome or toxic epidermal necrolysis, the doctor will inform them that they must never use medicines containing lamotrigine again.
Very common adverse effects
May occur in more than 1 in 10 patients:

headache
skin rash.

Common adverse effects
May occur in up to 1 in 10 patients:

aggression or irritability
feeling sleepy
dizziness
tremor
difficulty falling asleep (insomnia)
feeling of restlessness
diarrhoea
dry mouth
nausea or vomiting
feeling tired
back, joint or other pain anywhere in the body.

Uncommon adverse effects
May occur in up to 1 in 100 patients:

lack of coordination and unsteady movements ( 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 effects
May occur in up to 1 in 1,000 patients:

life-threatening skin reaction ( Stevens-Johnson syndrome: also refer to information at the beginning of section 4 )
a group of symptoms occurring together: fever, nausea, vomiting, headache, neck stiffness, 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, contact a doctor.
rapid, involuntary eye movements ( nystagmus )
itchy eyes with discharge ( conjunctivitis ).

Very rare adverse effects
May occur in up to 1 in 10,000 patients:

life-threatening skin reaction ( toxic epidermal necrolysis: also refer to information at the beginning of section 4 )
drug hypersensitivity syndrome with eosinophilia and systemic symptoms (DRESS) (see section 4)
high body temperature ( fever: also refer to information at the beginning of section 4 )
swelling of the face, enlarged lymph nodes in the neck, under the arms and in the groin ( generalized lymphadenopathy: also refer to information at the beginning of section 4 )
liver function abnormalities detected in blood tests or liver failure: also refer to information at the beginning of section 4
severe blood clotting disorder which may cause unexpected bleeding or bruising ( disseminated intravascular coagulation: also refer to information at the beginning of section 4 )
changes in blood test results - including reduced number of red blood cells ( anaemia ), reduced number of white blood cells ( leukopenia , neutropenia , agranulocytosis ), reduced number of platelets ( thrombocytopenia ), reduced number of all blood cells ( pancytopenia ) and bone marrow disorder known as aplastic anaemia
hallucinations ("seeing" or "hearing" things that are not real)
disorientation
feeling of unsteadiness or loss of balance during movement
involuntary, repetitive body movements and (or) sounds or words ( tics ), involuntary muscle contractions affecting 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
pseudotumor cerebri syndrome (symptoms may include: back or joint pain, sometimes accompanied by fever and (or) general malaise).
haemophagocytic lymphohistiocytosis (HLH) (see section 2. Important information before using Lamotrix).

Other adverse effects:
Other adverse effects occurred in a small number of patients, but with unknown frequency.

Bone disorders have been reported, including osteopenia and osteoporosis (weakening of bones) and fractures. If the patient is being treated long-term with antiepileptic medicines, has had osteoporosis in the past, or is taking steroids, they should discuss this with their doctor or pharmacist.
Nightmares.
Weakened immunity due to lower levels in the blood of antibodies called immunoglobulins, which help protect the body against infections.
Red nodules or spots on the skin (pseudolymphoma).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products at Al. Jerozolimskie 181C, 02-222 Warsaw; tel.: +48 22 49 21 301; fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Lamotrix

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box following the words: "Expiry date (EXP)". The expiry date refers to the last day of the specified month.
Do not store above 25°C.
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 Lamotrix contains

The active substance is lamotrigine. Each tablet contains 25 mg, 50 mg, or 100 mg of lamotrigine.
The other ingredients are: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium croscarmellose, povidone, magnesium stearate, and talc.

What Lamotrix looks like and contents of the pack
Lamotrix tablets are white, round, and biconvex.
The tablets are packed in PVC/Aluminum blisters within a cardboard carton.
Pack sizes available:
Lamotrix 25 mg, 50 mg: 30 tablets
Lamotrix 100 mg: 30 or 90 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert Str. 23
40764 Langenfeld
Germany
Manufacturer
Glenmark Pharmaceuticals s.r.o.
Fibíchova 143
566 17 Vysoké Mýto
Czech Republic
For further information, contact the local representative of the Marketing Authorisation Holder:
Neuraxpharm Polska Sp. z o.o.
ul. Poleczki 35
02-822 Warsaw