Lamotrigine Pharma Combix 200 mg chewable and dispersible tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lamotrigine Pharma Combix 200 mg dispersible and chewable tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

What Lamotrigine Pharma Combix is and what it is used for
What you need to know before taking Lamotrigine Pharma Combix
How to take Lamotrigine Pharma Combix
Possible side effects
How to store Lamotrigine Pharma Combix
Contents of the pack and other information

1. What Lamotrigine Pharma Combix is and what it is used for

Lamotrigine belongs to a group of medicines called antiepileptics. It can be used to treat two conditions: epilepsy and bipolar disorder.

Lamotrigine is used to treat epilepsy because it blocks signals in the brain that trigger epileptic seizures (attacks).

In adults and children aged 13 years and older, lamotrigine may be used alone or in combination with other antiepileptic medicines. Lamotrigine may also be used together with other medicines to treat seizures associated with a condition called Lennox-Gastaut syndrome.
In children between 2 and 12 years of age, lamotrigine may be used in combination with other medicines to treat the same conditions. It may also be used without other medicines to treat a type of epilepsy known as typical absence seizures.

Lamotrigine is also used to treat bipolar disorder.

People with bipolar disorder (previously called manic-depressive illness) experience extreme mood swings, with episodes of mania (excitement or euphoria) alternating with episodes of depression (deep sadness or despair). In adults aged 18 years and older, lamotrigine may be used to help prevent depressive episodes associated with bipolar disorder, either alone or in combination with other medicines. It is not known how lamotrigine works in the brain to produce this effect.

2. What you need to know before taking Lamotrigine Pharma Combix

Do not take Lamotrigine Pharma Combix

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:

Inform your doctor and do not take lamotrigine.

Warnings and precautions

Talk to your doctor or pharmacist before starting Lamotrigine Pharma Combix:

if you have any kidney problems,
if you have ever developed a skin rash after taking lamotrigine or other medicines for bipolar disorder or epilepsy,
if you experience skin rashes or sunburns after taking lamotrigine and being exposed to sunlight or artificial light (e.g., in a tanning bed). Your doctor will review your treatment and may advise you to avoid sunlight or protect yourself from the sun (e.g., by using sunscreen and/or protective clothing),
if you have ever had meningitis after taking lamotrigine (see description of these symptoms in section 4 of this leaflet: Rare adverse effects),
if you are already taking medicines containing lamotrigine,
if you have a condition called Brugada Syndrome or other heart problems. Brugada Syndrome is a genetic condition causing abnormal electrical activity in the heart. Lamotrigine may cause abnormalities in the electrocardiogram (ECG) that could lead to arrhythmias (abnormal heart rhythm).

If this applies to you:

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

Important information about potentially life-threatening reactions

A small number of people taking lamotrigine may experience allergic reactions or skin reactions that could potentially be life-threatening, which may lead to more serious problems if not treated. These reactions may include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). It is important that you recognize the symptoms of these reactions and monitor for them while taking lamotrigine. This risk may be associated with a genetic variant in people of Asian origin (mainly Han Chinese and Thai). If you are of such origin and have been found to carry this genetic variant (HLA-B*1502), speak with your doctor before taking lamotrigine.

Read the description of these symptoms in section 4 of this leaflet: "Reactions that may potentially be life-threatening: consult your doctor immediately".

Hemophagocytic lymphohistiocytosis (HLH)

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

Contact your doctor or pharmacist immediately if you develop any of the following symptoms while taking lamotrigine: fever, rash, neurological symptoms (e.g., seizures or tremors, confusion, changes in brain function).

Thoughts of self-harm or suicide

Antiepileptic drugs are used to treat various 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 previously had thoughts of self-harm or suicide.
If you are under 25 years of age.

If you have troubling thoughts or experiences, or if you feel worse or develop new symptoms while being treated with lamotrigine:

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

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

A small number of people treated with antiepileptic drugs such as lamotrigine have also had thoughts of self-harm or suicide. If at any time you have such thoughts, contact your doctor immediately.

If you are taking lamotrigine for epilepsy

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

Seek medical attention immediately.

Lamotrigine should not be given to children under 18 years of age for the treatment of bipolar disorder. Medicines indicated for the treatment of depression and other mental health conditions increase the risk of suicidal thoughts and behaviors in children and adolescents under 18 years of age.

Other medicines and Lamotrigine Pharma Combix

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including herbal remedies or other medicines obtained without a prescription.

Your doctor needs to know if you are taking other medicines for epilepsy or mental health conditions. This is to ensure you receive the correct dose of lamotrigine. These medicines include:

Oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate, or zonisamide, used to treat epilepsy.
Lithium, olanzapine, or aripiprazole, used to treat mental health conditions.
Bupropion, used to treat mental health conditions or to quit smoking.
Paracetamol, used to treat pain and fever.
Inform your doctor if you are taking any of these medicines.

Some medicines interact with lamotrigine or make it more likely for people to experience adverse effects. These include:

Valproate, used to treat epilepsy and mental health conditions.
Carbamazepine, used to treat epilepsy and mental health conditions.
Phenytoin, primidone, or phenobarbital, used to treat epilepsy.
Risperidone, used to treat mental health conditions.
Rifampicin, which is an antibiotic.
Medicines used to treat Human Immunodeficiency Virus (HIV) infection (a combination of lopinavir and ritonavir or atazanavir and ritonavir).
Hormonal contraceptives, such as the contraceptive pill (see below).
Inform your doctor if you are taking any of these medicines, or if you start or stop taking any of them.

Hormonal contraceptives (such as the contraceptive pill) may affect how lamotrigine works.

Your doctor may recommend that you use a specific hormonal contraceptive or use another contraceptive method, such as condoms, diaphragm, or intrauterine device (IUD). If you are taking a hormonal contraceptive, such as the contraceptive pill, your doctor may perform a blood test to check your lamotrigine levels. If you are using or plan to start using a hormonal contraceptive:

Consult your doctor, who will advise you on the most appropriate contraceptive methods for you.

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

Inform your doctor. These may be signs that lamotrigine is affecting how your contraceptive works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Do not stop your treatment without consulting your doctor. This is especially important if you have epilepsy.
Pregnancy may alter the effectiveness of lamotrigine treatment, so you may need blood tests and dose adjustments.
If lamotrigine is taken during the first three months of pregnancy, there may be a small increased risk of birth defects, including cleft lip and/or cleft palate.
Your doctor may advise you to take folic acid supplements if you are planning to become pregnant and during pregnancy.
If you are breastfeeding or plan to breastfeed, consult your doctor or pharmacist before using this medicine. Lamotrigine passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breastfeeding while taking lamotrigine and will perform periodic check-ups on your baby if you decide to breastfeed, as the baby may experience drowsiness, rash, or poor weight gain. Inform your doctor if you notice any of these symptoms in your baby.

Driving and using machines

Lamotrigine may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may reduce reaction ability. These effects, as well as the underlying illness itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities requiring special attention until your doctor has assessed your response to this medicine.

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

Lamotrigine Pharma Combix contains sodium

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

3. How to take Lamotrigina Pharma Combix

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

What dose of lamotrigine to take

It may take some time for your doctor to find the most appropriate dose of lamotrigine for you. The dose you should take depends on:

Your age.
Whether you are taking lamotrigine together with other medicines.
Whether you have any liver or kidney problems.

Your doctor will initially prescribe a low dose and gradually increase it over several weeks until reaching the most appropriate dose for you (called the effective dose). Never take more lamotrigine than your doctor has prescribed.

Normally, the effective dose of lamotrigine for adults and children aged 13 years 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 body weight, usually between 1 mg and 15 mg per kilogram of body weight, up to a maximum maintenance dose of 200 mg per day.

The use of lamotrigine is not recommended in children under 2 years of age.

How to take your dose of lamotrigine

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

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

Your doctor may advise you to start or stop taking other medicines, depending on the condition being treated and your response to treatment.

The lamotrigine orodispersible and chewable tablets can be swallowed whole with a little water, chewed, or dissolved in water. Never take only part of the liquid.

Chewing the tablet

When chewing the tablet, you may need to drink a little water to help dissolve it in your mouth. After swallowing, drink a little more water to ensure you have taken all of the medicine.

To dissolve the medicine

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 it to ensure no medicine remains in the glass.

If you take more Lamotrigina Pharma Combix than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you take more lamotrigine than you should, you may be more likely to experience serious adverse effects, which can be fatal.

Someone who has taken too much lamotrigine may experience one or more of the following symptoms:

Rapid, uncontrolled eye movements (nystagmus).
Clumsiness and loss of coordination, affecting balance (ataxia).
Changes in heart rhythm (usually detected by ECG).
Loss of consciousness, seizures, or coma.

If you forget to take Lamotrigina Pharma Combix

If you forget to take a dose of lamotrigine

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

If you forget to take multiple doses of lamotrigine

Ask your doctor for advice on how to restart treatment. It is important that you do so.

If you stop taking Lamotrigina Pharma Combix

Do not stop taking lamotrigine without consulting your doctor.

You should take lamotrigine for as long as your doctor recommends. Do not stop taking it unless your doctor advises you to do so.

If you are taking lamotrigine for epilepsy

To stop taking lamotrigine, it is important that the dose is gradually reduced over approximately 2 weeks. If you stop taking lamotrigine suddenly, your epilepsy symptoms may return or your condition may worsen.

If you are taking lamotrigine for bipolar disorder

Lamotrigine may take some time to work, so you are unlikely to feel better immediately. If you stop taking lamotrigine, you do not need to gradually reduce the dose. However, you should still consult your doctor before stopping treatment with lamotrigine.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Reactions that may potentially be life-threatening: consult your doctor immediately.

A small number of people taking lamotrigine may experience allergic reactions or skin reactions that may potentially be life-threatening, which could lead to more serious problems if left untreated.

These symptoms are more likely to occur during the first few months of treatment with lamotrigine, especially if the initial dose is too high, if the dose is increased too quickly, or if lamotrigine is taken together with another medicine called valproate. Some of these symptoms are more common in children, so parents should pay special attention.

Symptoms of these reactions include:

Skin rash or redness, which may progress to life-threatening skin reactions, including widespread blistering rash with peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), peeling of a large area of skin (more than 30% of body surface – toxic epidermal necrolysis), or widespread rash with involvement of the liver, blood, and other body organs (drug reaction with eosinophilia and systemic symptoms, also known as hypersensitivity syndrome (DRESS)).
Ulcers in the mouth, throat, nose, or genitals.
Pain in the mouth or red, swollen eyes (conjunctivitis).
High temperature (fever), flu-like symptoms, or drowsiness (stupor).
Swelling around the face, or swollen lymph nodes in the neck, armpits, or groin.
Unexpected bleeding or bruising, or fingers turning blue.
Sore throat or experiencing more infections than usual (such as colds).
Increased levels of liver enzymes in blood tests.
Increase in a type of white blood cells (eosinophils).
Enlarged lymph nodes.
Involvement of body organs including the liver and kidneys.

In many cases, these symptoms may be signs of less serious adverse effects. However, you should be aware that they may potentially be life-threatening and could lead to more serious problems, such as organ failure, if not treated. If you notice any of these symptoms:

Contact a doctor immediately. Your doctor will decide whether you need tests to assess liver, kidney, or blood function and may instruct you to stop taking lamotrigine. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis, your doctor will advise you never to take lamotrigine again.

Haemophagocytic lymphohistiocytosis (HLH) (see section 2. What you need to know before taking Lamotrigina Pharma Combix).

Very common adverse effects

These affect more than 1 in 10 people:

Headache.
Skin rash.

Common adverse effects

These affect up to 1 in 10 people:

Aggression or irritability.
Drowsiness or feeling sleepy.
Dizziness.
Spasms or tremors.
Difficulty sleeping (insomnia).
Feeling restless.
Diarrhea.
Dry mouth.
Nausea or vomiting.
Feeling tired.
Back, joint, or other pain.

Uncommon adverse effects

These may affect up to 1 in 100 people:

Clumsiness and loss of coordination (ataxia).
Double vision or blurred vision.
Decrease in hair volume or unusual hair loss (alopecia).
Skin rash or sunburn after exposure to sunlight or artificial light (photosensitivity).

Rare adverse effects

These affect up to 1 in 1,000 people:

Skin reaction that may be life-threatening (Stevens-Johnson syndrome) (see also information at the beginning of section 4).
A group of symptoms including: fever, nausea, vomiting, headache, neck stiffness, and extreme sensitivity to bright light.

This may be caused by inflammation of the membranes covering the brain and spinal cord (meningitis). These symptoms usually resolve when treatment is stopped. However, if symptoms persist or worsen, contact your doctor.

Rapid, uncontrolled eye movements (nystagmus).
Itchy eyes, with discharge and crusts on the eyelids (conjunctivitis).

Very rare adverse effects

These affect up to 1 in 10,000 people:

A skin reaction that may be life-threatening (toxic epidermal necrolysis) (see also information at the beginning of section 4).
Drug reaction with eosinophilia and systemic symptoms (DRESS) (see also information at the beginning of section 4).
High temperature (fever) (see also information at the beginning of section 4).
Swelling around the face (edema) or swollen glands in the neck, groin, or armpits (lymphadenopathy) (see also information at the beginning of section 4).
Changes in liver function, which may show up in blood tests, or liver failure (see also information at the beginning of section 4).
Serious blood clotting disorder, which may cause bleeding or unexpected bruising (disseminated intravascular coagulation) (see also information at the beginning of section 4).
Haemophagocytic lymphohistiocytosis (HLH) (see section 2. What you need to know before taking Lamotrigina Pharma Combix).
Changes detectable in blood tests including reduced number of red blood cells (anaemia), reduced number of white blood cells (leucopenia, neutropenia, agranulocytosis), reduced number of platelets (thrombocytopenia), reduced number of all types of blood cells (pancytopenia), and a bone marrow disorder called aplastic anaemia.
Hallucinations (hearing or seeing things that are not really there).
Confusion.
Feeling unsteady or unstable when moving.
Repetitive body movements and/or uncontrollable sounds or words (tics), uncontrolled muscle spasms affecting the eyes, head, and trunk (choreoathetosis), or other unusual movements such as jerking, spasms, or stiffness.
In people with epilepsy, more frequent seizures.
In people with Parkinson's disease, worsening of symptoms.
Lupus-like reaction (symptoms may include back or joint pain, sometimes accompanied by fever and/or general illness).

Other adverse effects

Other adverse effects have been reported in a small number of people, but their exact frequency is unknown:

Bone disorders including osteopenia and osteoporosis (reduced bone density) and fractures have been reported. Consult your doctor or pharmacist if you have taken antiepileptic medicines for a long time, if you have a history of osteoporosis, or if you are taking steroids.
Inflammation of the kidney (tubulointerstitial nephritis) or inflammation of the kidney and the eye (acute tubulointerstitial nephritis and uveitis syndrome).
Nightmares.
Reduced immunity due to decreased levels of antibodies called immunoglobulins in the blood, which help protect against infection.
Red nodules or spots on the skin (pseudolymphoma).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Conservation of Lamotrigine Pharma Combix

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

Do not use this medicine after the expiry date stated on the packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and further information

Composition of Lamotrigina Pharma Combix 200 mg

The active substance is lamotrigine. Each chewable and dispersible tablet contains 200 mg of lamotrigine.
The other components are: microcrystalline cellulose, calcium carbonate, sodium carboxymethyl starch type A (from potato), low-substituted hydroxypropyl cellulose, povidone, sodium saccharin, magnesium aluminium silicate, magnesium stearate, colloidal anhydrous silica, and blackcurrant flavour.

Appearance of the product and contents of the pack

Round, flat, white or almost white chewable and dispersible tablets, slightly mottled, with a blackcurrant odour. The tablets are marked with “200” on one side and are smooth on the other side, with an approximate diameter of 10.7 mm.

Lamotrigina Pharma Combix 200 mg is available in PVC/PVDC-Aluminium blisters containing 30 tablets.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

Centre Specialites Pharmaceutiques

Z.A.C. des Suzots

35 Rue de la Chapelle

63450 Saint Amant Tallende

France

Netpharmalab Consulting Services

Carretera de Fuencarral 22,

Alcobendas,

28108 Madrid

Spain

Flavine Pharma France

3 Voie d’Allemagne

13127 Vitrolles

France

Misom Labs Ltd.

Malta Life Sciences Park

LS2.01.06

Industrial Estate

San Gwann, SGN 3000

Malta

Date of the most recent revision of the leaflet: March 2024

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/ (http://www.aemps.gob.es/).