Label: information for the user

LAMICTAL 2 mg chewable/dispersible tablets

lamotrigine

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1.What is Lamictal and how it is used

2.What you need to know before starting to take Lamictal

3.How to take Lamictal

4.Possible adverse effects

5.Storage of Lamictal

6.Contents of the package and additional information

Lamictal belongs to a group of medications calledantiepilepticdrugs. It can be used to treat two diseases: epilepsyand bipolar disorder.

Lamictal is used to treat epilepsybecause it blocks the signals in the brain that trigger epileptic seizures (attacks).

• In adults and children 13 years of age and older, Lamictal can be used alone or in combination with other medications to treat epilepsy. Lamictal can also be used with other medications to treat seizures caused by a condition called Lennox-Gastaut Syndrome.
• In children between 2 and 12 years of age, Lamictal can be used in combination with other medications to treat the same diseases. It can also be used without other medications to treat a type of epilepsy called typical absence seizures.

Lamictal is also used to treat bipolar disorder.

People with bipolar disorder (formerly known as manic-depressive disorder) experience radical mood swings, with periods of mania (excitement or euphoria) alternating with periods of depression (deep sadness or desperation). In adults 18 years of age and older, Lamictal can be used to prevent the periods of depression that occur in bipolar disorder, either alone or in combination with other medications. The exact mechanism of action of Lamictal in the brain is not known.

Do not take Lamictal:

• if you are allergic(hypersensitive) to lamotrigine or to any of the other ingredients of this medicine (listed insection6).

If this is the case:

?Inform your doctorand do not take Lamictal.

Warnings and precautions

Be especially careful with Lamictal

Consult your doctor or pharmacist before starting to take Lamictal:

• if you have any kidney problems
• if you have ever had a skin rashafter taking lamotrigine or other medicines for bipolar disorder or epilepsy
• if you suffer from skin rashes or sunburn after taking lamotrigine and exposure to the sun or artificial light (e.g. in a sunbed). Your doctor will check your treatment and may advise you to avoid sunlight or protect yourself from the sun (e.g. use a sun protection cream and/or protective clothing)
• if you have ever had meningitis after taking lamotrigine(see the description of these symptoms in section 4 of this leaflet: Rare side effects)
• if you are already taking medicines that contain lamotrigine
• if you have a condition called Brugada syndrome or other heart problems.Lamotrigine may cause abnormalities in the electrocardiogram (ECG) that can lead to arrhythmias (abnormal heart rhythm).

If this is the case:

?Inform your doctor, who will decide to reduce the dose or determine that Lamictal is not suitable for you.

Important information about potentially life-threatening reactions

A small number of people taking Lamictal have had allergic reactions or skin reactions that can be life-threatening, which can lead to more serious problems if not treated. These reactions can include Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis (NET) and drug reaction with eosinophilia and systemic symptoms (DRESS). You need to know the symptoms of these reactions and be aware of them while taking Lamictal. This risk may be associated with a genetic variant in people of Asian origin (mainly Chinese Han and Thai). If you are of this origin and have been detected with this genetic variant (HLA-B*1502), talk to your doctor before taking Lamictal.

?Read the description of these symptoms in section 4 of this leaflet“Life-threatening reactions: consult your doctor immediately”.

Lymphohistiocytosis hemophagocytic (LHH)

Cases of a rare but serious immune system reaction have been reported in patients taking lamotrigine.

• Contact your doctor or pharmacist immediatelyif you experience any of the following symptoms while taking lamotrigine: fever, rash, neurological symptoms (e.g. spasms or tremor, confused state, cerebral function alterations).

Thoughts of self-harm or suicide

Antiepileptic drugs are used to treat different conditions, including epilepsy and bipolar disorder. People with bipolar disorder may sometimes have thoughts of self-harm or suicide. If you have bipolar disorder, you may be more likely to have these thoughts in the following situations:

• when starting treatment
• if you have had thoughts of self-harm or suicide before
• if you are under 25 years old.

If you have thoughts or experiences that worry you, or if you notice that you feel worse or develop new symptoms while taking Lamictal:

?Consult your doctor as soon as possible or go to the nearest hospital.

It may be helpful for you to explain to a family member, carer or close friend that you may become depressed or have significant mood changes, and ask them to read this leaflet. You can ask them to tell you if they are worried about your depression or other changes in your behavior.

A small number of people who have been treated with antiepileptic drugs like Lamictal have also had thoughts of self-harm or suicide. If you ever have these thoughts, contact your doctor immediately.

If you are taking Lamictal for epilepsy

Seizures in some types of epilepsy may occasionally worsen or occur more frequently while taking Lamictal. Some patients may experience severe seizures, which can cause serious health problems. If seizures occur more frequently or if you experience severe seizures while taking Lamictal:

?Go to a doctor immediately.

Lamictal should not be given to children under 18 years for the treatment of bipolar disorder. Medicines used to treat depression and other mental health problems increase the risk of suicidal thoughts and behaviors in children and adolescents under 18 years.

Other medicines and Lamictal

Inform your doctor or pharmacistifyouaretaking, have taken recently or may need to take any other medicine,including herbal medicines or other medicines obtained without a prescription.

Your doctor needs to know if you are taking other medicines for the treatment of epilepsy or mental health problems. This is to ensure that you take the correct dose of Lamictal. These medicines include:

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramateorzonisamide, used for the treatment ofepilepsy
• lithium, olanzapine or aripiprazole, used for the treatment ofmental health problems
• bupropion, used for the treatment ofmental health problemsor tostop smoking
• paracetamol,used to treatpainandfever.

?Inform your doctorif you are using any of these medicines.

Some medicines interact with Lamictal or make people more likely to have side effects. These include:

• valproate, used for the treatment ofepilepsyandmental health problems
• carbamazepine, used for the treatment ofepilepsyandmental health problems
• phenytoin, primidoneorphenobarbital, used for the treatment ofepilepsy
• risperidone, used for the treatment ofmental health problems
• rifampicin, which is anantibiotic
• medicines used to treat HIV infection (a combination of lopinavir and ritonavir or atazanavir and ritonavir)
• hormonal contraceptives, such asthe pill(see below).

?Inform your doctorif you are using any of these medicines, or if you start or stop using any of these medicines.

Hormonal contraceptives (such as the pill) may affect the way Lamictal works.

Your doctor may recommend a specific hormonal contraceptive or suggest using a different method of contraception, such as condoms, diaphragm or IUD. If you are taking a hormonal contraceptive, such as the pill, your doctor may perform a blood test to check your Lamictal levels. If you are using a hormonal contraceptive or plan to start using one:

?Consult your doctor, who will advise you on the most suitable methods of contraception for you.

Lamictal may also affect the way hormonal contraceptives work, although it is unlikely to reduce their effectiveness. If you are taking a hormonal contraceptive and notice changes in your menstrual cycle, such as intermenstrual bleeding or loss between periods:

?Inform your doctor. These may be signs that Lamictal is affecting the way your contraceptive is working.

Pregnancy and breastfeeding

?If you are pregnant, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

• Do not stop your treatment without consulting your doctor. This is particularly important if you have epilepsy.
• Pregnancy may alter the effectiveness of Lamictal treatment, so you may need to have blood tests and have your dose adjusted.
• If Lamictal is taken during the first 3 months of pregnancy, there may be a small increase in the risk of birth defects, including cleft lip and/or palate.
• Your doctor may advise you to take folic acid supplements if you are planning to become pregnant and also during pregnancy.

?If you are breastfeeding or plan to start breastfeeding, consult your doctor or pharmacist before using this medicine.Lamictal's active ingredient passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breastfeeding while taking Lamictal and will perform regular checks on your baby if you decide to start breastfeeding, as your baby may experience drowsiness, rash or poor weight gain. Inform your doctor if you observe any of these symptoms in your baby.

Driving and using machines

Lamictal may cause dizziness and double vision.

?Do not drive or use machines unless you are sure you do not feel these effects.

If you have epilepsy, consult your doctor about the possibility of driving or using machines.

Important information about some of the components ofLamictal

This medicine contains less than 1mmolof sodium (23mg) per tablet; this is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

What dose of Lamictal to take

It may take some time for your doctor to find the appropriate dose of Lamictal for you. The dose you should take will depend on:

• your age
• whether you are taking Lamictal with other medications
• whether you have any liver or kidney problems.

Your doctor will prescribe a low dose at the beginning of treatment and gradually increase the dose over several weeks to reach the most appropriate dose for you (called theeffective dose).Do not take more Lamictal than your doctor has indicated.

Normally, the effective dose of Lamictal for adults and children 13 years of age and older is between 100 mg and 400 mg per day.

For children between 2 and 12 years of age, the effective dose depends on their body weight, usually between 1 mg and 15 mg per kilogram of the child's weight, up to a maximum maintenance dose of 200 mg per day.

Lamictal is not recommended for children under 2 years of age.

How to take the dose of Lamictal

Take your dose of Lamictal once or twice a day, as advised by your doctor. They can be taken with or without food.

• Always take the complete dosethat your doctor has prescribed. Never take part of the tablet.

Your doctor may advise you to start or stop taking other medications, depending on the problem you are being treated for and how you respond to treatment.

Lamictal chewable/dispersible tablets can be swallowed whole with a little water, chewed, or added to water to dissolve them. Never take just a part of the liquid.

Chew the tablet:

It may be necessary to drink a little water to help the tablet dissolve in your mouth. After swallowing it, drink a little more water to make sure you have taken all the medication.

To dissolve the medication:

• place the tablet in a glass containing enough water to cover the entire tablet
• shake to dissolve or wait until the tablet is completely dissolved
• drink all the liquid
• add a little more water to the glass and drink to make sure there is no medication left in the glass.

If you take more Lamictal than you should

?In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount ingested.

If you take moreLamictal than you should, you may be more prone to severe side effects that can be fatal.

Someone who has taken too much Lamictal may have some of these symptoms:

• rapid and uncontrolled eye movements (nystagmus)
• clumsiness and loss of coordination, affecting balance (ataxia)
• changes in heart rhythm (usually detected with an ECG)
• loss of consciousness, seizures, or coma.

If you forgot to take a dose of Lamictal

?Do not take a double dose to compensate for the missed doses. Takethe next dose at the usual time.

If you forget to take multiple doses of Lamictal

?Ask your doctor for advice on how to start treatment again.It is essential to do this.

Do not stop taking Lamictal without your doctor's advice

You must take Lamictal for as long as your doctor recommends. Do not stop taking it unless your doctor advises you to.

If you are taking Lamictal for the treatment of epilepsy

To stop taking Lamictal,it is essential to gradually reduce the doseover approximately 2 weeks. If you stop taking Lamictal suddenly, you may experience a recurrence of epilepsy symptoms or the disease may worsen.

If you are taking Lamictal for bipolar disorder

Lamictal may take some time to act, so it is unlikely that you will feel better immediately. If you stop taking Lamictal, you do not need to gradually reduce your dose. However, before interrupting treatment with Lamictal, you should consult with your doctor.

Like all medications, this medication may cause side effects, although not everyone will experience them.

Reactions that may potentially threaten life: consult your doctor immediately.

A reduced number of people taking Lamictal have allergic reactions or skin reactions that may potentially threaten their life, which can lead to more serious problems if not treated.

It is more likely that these symptoms will appear during the first months of treatment with Lamictal, especially if the initial dose is very high or if the dose increase is very rapid, or if you are taking Lamictal with another medication calledvalproate. Some of these symptoms are more common in children, so parents should pay special attention.

The symptoms of these reactions include:

• skin rashes or redness, which can lead to skin reactions that can be severe or, in some cases, potentially life-threatening, including a rash with lesions in the shape of a target (erythema multiforme), a widespread rash with blisters and skin peeling, which occurs especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), widespread skin peeling in an extensive area of the skin (more than 30% of the body surface –toxic epidermal necrolysis) or a widespread skin rash with liver, blood, and other organ involvement (pharmacological reaction with eosinophilia and systemic symptoms also known as drug reaction with eosinophilia and systemic symptoms (DRESS))
• mouth ulcers, throat, nose, or genital ulcers
• mouth or eye pain, or red or swollen eyes (conjunctivitis)
• high temperature (fever), symptoms similar to the flu or drowsiness (somnolence)
• swelling around the face,orinflammationof the lymph nodes in the neck, armpits, or groin
• unexplained bleeding or bruising, or fingers turning blue
• throat painor experiencing more infections than usual (such as colds)
• increased levels of liver enzymes in blood tests
• increased levels of a type of white blood cell (eosinophils)
• enlarged lymph nodes
• organ damage, including the liver and kidneys.

In many cases, these symptoms can be signs of less serious side effects.However, you should be aware that they may potentially threaten lifeand can lead to more serious problems,such as organ failure, if not treated. If you notice any of these symptoms:

?Contact your doctor immediately.. Your doctor will decide if you need to undergo tests to assess the function of the liver, kidneys, or blood and may instruct you to stop taking Lamictal. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis, your doctor will instruct you never to take lamotrigine again.

Lymphohistiocytosis hemophagocytic (LHH)(see section 2. What you need to know before starting to take Lamictal).

Very common side effects

These affect more than 1 in 10 people:

• headache
• skin rash.

Common side effects

These affect up to 1 in 10 people:

• aggression or irritability
• feeling sleepy or drowsy
• feeling dizzy
• muscle spasms or tremors
• difficulty sleeping (insomnia)
• feeling agitated
• diarrhea
• dry mouth
• nausea or vomiting
• feeling tired
• back, joint, or other pain.

Uncommon side effects

These may affect up to 1 in 100 people:

• clumsiness and loss of coordination (ataxia)
• double vision or blurred vision
• hair loss or thinning (alopecia)
• skin rash or sun sensitivity after exposure to the sun or artificial light (photosensitivity)

Rare side effects

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

• a skin reaction that can be life-threatening (erythema multiforme) (see also the information at the beginning of section 4)
• a skin reaction that can be life-threatening (Stevens-Johnson syndrome) (see also the information at the beginning of section 4)
• a group of symptoms that include: fever, nausea, vomiting, headache, neck stiffness, and extreme sensitivity to bright light.

This can be caused by inflammation of the membranes that cover the brain and spinal cord (meningitis). These symptoms usually disappear when treatment is stopped. However, if symptoms continue or worsen,contact your doctor.

• rapid, uncontrolled eye movements (nystagmus)
• eye itching, with discharge and crusts on the eyelids (conjunctivitis).

Very rare side effects

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

• a skin reaction that can be life-threatening (toxic epidermal necrolysis) (see also the information at the beginning of section 4)
• pharmacological reaction with eosinophilia and systemic symptoms (DRESS) (see also the information at the beginning of section 4)
• high temperature (fever) (see also the information at the beginning of section 4)
• swelling around the face (edema) or inflammation of the lymph nodes in the neck, armpits, or groin (lymphadenopathy) (see also the information at the beginning of section 4)
• liver function changes, which can be seen in blood tests, or liver failure (see also the information at the beginning of section 4)
• severe blood clotting disorder, which can cause bleeding or unexplained bruising (disseminated intravascular coagulation) (see also the information at the beginning of section 4)
• lymphohistiocytosis hemophagocytic (LHH) (see section 2. What you need to know before starting to take Lamictal)
• blood test changes, including a reduced number of red blood cells (anemia), a reduced number of white blood cells (leucopenia, neutropenia, agranulocytosis), a reduced number of platelets (trombocytopenia), a reduced number of all types of blood cells (pancytopenia), and a bone marrow disorder called aplastic anemia
• hallucinations (hearing or seeing things that are not really there)
• confusion
• feeling insecure or unstable when moving
• repeated body movements or uncontrollable sounds or words (tics), uncontrollable muscle spasms affecting the eyes, head, and torso (coreoatetosis), or other unusual movements such as jerking, spasms, or rigidity
• more frequent seizures in people with epilepsy
• emergence of Parkinson's disease symptoms in people with the disease
• reaction similar to lupus(the symptoms may include: back or joint pain, which may sometimes be accompanied by fever and/or generalized illness).

Other side effects

Other side effects have appeared in a small number of people, but their exact frequency is unknown:

• bone changes, including osteopenia and osteoporosis (bone thinning) and fractures. Consult your doctor or pharmacist if you have taken antiepileptics for a long time, if you have a history of osteoporosis, or if you take steroids
• inflammation of the kidney (interstitial nephritis) or inflammation of the kidney and eye (acute interstitial nephritis and uveitis)
• nightmares
• reduced immunity, due to a reduction in the levels of antibodies called immunoglobulins in the blood that help protect against infection
• red or brown spots on the skin (pseudolymphoma).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, includingsif it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack, case, or bottle. The expiration date is the last day of the month indicated.

Lamictal does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lamictal 2 mg chewable/dispersible tablets

The active ingredient is lamotrigine. Each chewable/dispersible tablet contains 2 mg of lamotrigine.

The other components are: calcium carbonate, low-substitution hydroxypropylcellulose, aluminium and magnesium silicate, sodium carboxymethylcellulose (Type A) from potato, povidone K30, sodium saccharin, magnesium stearate, blackcurrant flavoring.

Appearance of the product and contents of the packaging of Lamictal chewable/dispersible tablets

Lamictal chewable/dispersible tablets are white to off-white and may be slightly speckled. The tablets have a blackcurrant odor.

Lamictal 2 mg chewable/dispersible tablets are round. The tablets are marked with “LTG” over the number “2”; the other side is marked with two overlapping ellipses that intersect perpendicularly. Each bottle contains 30 tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Phone: +34 900 202 700

[email protected]

Responsible manufacturer:

Delpharm Poznan Spólka Akcyjna

ul. Grunwaldzka 189

60-322 Pozna

Poland

This medicine is authorized in the member states of the European Economic Area with the following names: