LAMOTRIGINE COMBIX 50 mg DISPERSIBLE/CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the User

LamotrigineCombix50 mg dispersible/chewable tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Lamotrigine Combix and what is it used for
2. Before you take Lamotrigine Combix
3. How to take Lamotrigine Combix
4. Possible side effects

5. Storage of Lamotrigine Combix

1. Further information

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

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

Lamotrigine Combix is used for the treatment of epilepsy becauseit blocks the signals in the brain that trigger seizures (fits).

• In adults and children aged 13 years and above, Lamotrigine can be used alone or in combination with other medicines, for the treatment of epilepsy. Lamotrigine can also be used in combination with other medicines for the treatment of seizures caused by a condition called Lennox-Gastaut syndrome.
• In children between 2 and 12 years of age, Lamotrigine can be used in combination with other medicines for the treatment of the same conditions. It can also be used alone for the treatment of a type of epilepsy called typical absence seizures.

Lamotrigine Combix is also used for the treatment of bipolar disorder.

People with bipolar disorder (previously called manic-depressive disorder) experience extreme mood swings, with periods of mania (excitement or euphoria) alternating with periods of depression (deep sadness or despair). In adults aged 18 years and above, Lamotrigine Combix can be used to prevent the periods of depression that occur in bipolar disorder, either alone or in combination with other medicines. It is not known how lamotrigine works in the brain to have this effect.

2. Before you take Lamotrigine Combix

Do not take Lamotrigine Combix:

• (hypersensitive) to the active substance or any of the other ingredients of Lamotrigine Combix (listed in section 6).

If this applies to you:

? Tell your doctor, and do not take Lamotrigine Combix.

Take special care with Lamotrigine Combix

Your doctor needs to know before you take Lamotrigine Combix:

• If you have had a skin rash after taking lamotrigine or other medicines for bipolar disorder or epilepsy, or if you get skin rashes or sunburn after taking lamotrigine and exposure to sunlight or artificial light (e.g. in a solarium). Your doctor will check your treatment and may advise you to avoid sunlight or protect yourself from the sun (e.g. use sunscreen and/or protective clothing).

If this applies to you:

? Tell your doctor, who will decide whether to reduce your dose or determine that Lamotrigine Combix is not suitable for you.

Important information about potentially life-threatening reactions

A small number of people who take Lamotrigine Combix have 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 (SJS), toxic epidermal necrolysis (TEN), 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 Lamotrigine Combix. This risk may be associated with a genetic variant in people of Asian origin (mainly Chinese Han and Thai). If you are of such origin and have been detected with this genetic variant (HLA-B* 1502), talk to your doctor before taking Lamotrigine Combix.

Important to be aware of symptoms

Seek immediate medical attentionif after starting to take Lamotrigine Combix you experience any of these symptoms:

• skin reaction, such as redness or rash
• irritation of the mouth or eyes
• high temperature(fever), flu-like symptoms or drowsiness (somnolence)
• swelling around the faceor inflammationof the glandsin the neck, armpits, and groin
• unexpected bleeding or bruising, or fingers turning blue
• throat irritation, or more infections (such as colds) than usual.

It is more likely that these symptoms will occur during the first few months of treatment with Lamotrigine Combix, especially if you start treatment with a high dose or if your dose is increased too quickly; it is also more likely to occur if you are taking Lamotrigine Combix with another medicine called valproate.Children are more likely than adults to experience these side effects.

If the symptoms listed above are not treated, they can become more serious problems, such as organ failure (organ failure) or a very serious skin disease.

If you notice any of these symptoms:

? Seek immediate medical attention. Your doctor will decide whether to perform tests to assess liver, kidney, or blood function, and may advise you to stop taking Lamotrigine Combix.

Thoughts of self-harm or suicide

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

• When you start 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 feel worse or develop new symptoms while taking Lamotrigine Combix:

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

A small number of people who have been treated with antiepileptics like lamotrigine have also had thoughts of self-harm or suicide. If you have these thoughts at any time, contact your doctor immediately.

If you are taking Lamotrigine Combix for epilepsy

In some types of epilepsy, during treatment with lamotrigine, seizures may occasionally worsen or occur more frequently. Some patients may experience severe seizures that can cause serious health problems. If you notice that you are having seizures more frequently or if you experience severe seizures while taking Lamotrigine Combix:

? Seek immediate medical attention.

Brugada syndrome

Brugada syndrome is a genetic disease that causes abnormal electrical activity in the heart. Lamotrigine may cause abnormalities in the electrocardiogram (ECG) that can lead to arrhythmias (abnormal heart rhythm). Consult your doctor if you have this disease.

Hemophagocytic lymphohistiocytosis (HLH)

Cases of a rare but very serious reaction of the immune system have been reported in patients taking lamotrigine. Contact your doctor or pharmacist immediately if you experience any of the following symptoms while taking lamotrigine: fever, rash, neurological symptoms (e.g. spasms or tremors, confusion, changes in brain function).

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

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription or herbal remedies.

If you are using certain medicines, your doctor may need to check the dose of Lamotrigine Combix. These include:

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramateor zonisamide, used for the treatment of epilepsy
• lithium, used for the treatment of mental health problems
• bupropion, used for the treatment of mental health problemsor for smoking cessation

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

Some medicines interact with Lamotrigine Combix or make side effects more likely. These include:

• valproate, used for the treatment of epilepsyand mental health problems
• carbamazepine, used for the treatment of epilepsyand mental health problems
• phenytoin, primidone or phenobarbitone, used for the treatment of epilepsy
• olanzapine, used for the treatment of mental health problems
• risperidone, used for the treatment of mental health problems
• rifampicin, which is an antibiotic
• a combination of lopinavir and ritonavir, used for the treatment of Human Immunodeficiency Virus (HIV) infection (AIDS)
• hormonal contraceptives, such as the Pill(see below).

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

Hormonal Contraceptives (such as the Pill) may affect the way Lamotrigine Combix works

Your doctor may recommend that you use a specific hormonal contraceptive, or that you use a different method of contraception, such as condoms, diaphragm, or IUD. If you are taking a hormonal contraceptive like the Pill, your doctor may ask you to have blood tests to check the levels of Lamotrigine. If you are thinking of starting to use a hormonal contraceptive:

? Tell your doctor, as he will advise you on the most suitable contraceptive methods for you.

It is possible that the administration of Lamotrigine may alter the way hormonal contraceptives work, although it is unlikely to reduce their effectiveness. If you are using a hormonal contraceptive and experience changes in your menstrual cycle, such as intermenstrual bleeding or spotting:

? Tell your doctor. These may be signs that Lamotrigine is affecting the way your contraceptive is working.

Pregnancy and breastfeeding

? Consult your doctorif you are pregnant, think you may be pregnant or are planning to become pregnant.

You should not stop treatment for epilepsy while you are pregnant. However, there is a higher risk of birth defects in newborns whose mothers took lamotrigine during pregnancy. These defects include cleft lip or palate. Your doctor may advise you to take folic acid supplements if you are planning to become pregnant and also during pregnancy.

Pregnancy may alter the effectiveness of treatment with Lamotrigine Combix, so your doctor may ask you to have a blood test to check the levels of lamotrigine and adjust your dose accordingly.

? If you are breastfeeding or planning to breastfeed, consult your doctor or pharmacist before using this medicine.The active ingredient of Lamotrigine Combix 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 regular checks on your baby if you decide to breastfeed, as it may cause drowsiness, rash, or poor weight gain. Tell your doctor if you notice any of these symptoms in your baby.

Driving and using machines

Lamotrigine Combix 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.

3. How to take Lamotrigine Combix

Follow exactly the instructions for taking Lamotrigine Combix given by your doctor. Consult your doctor or pharmacist if you have any doubts.

What dose of Lamotrigine Combix to take

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

• your age
• whether you are taking Lamotrigine Combix with other medicines
• whether you have liver or kidney problems

Your doctor will ask you to start treatment with a low dose, and gradually increase the dose until you reach the most suitable dose for you (called the effective dose). Never take more Lamotrigine Combix than your doctor has prescribed.

Normally, the effective dose of Lamotrigine Combix for adults and children over 12 years 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 body weight, up to a maximum of 400 mg per day.

How to take the dose of Lamotrigine Combix

Take your dose of Lamotrigine Combix once or twice a day, as advised by your doctor. You can take it with or without food.

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

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

Take the dispersible/chewable tablets of Lamotrigine Combix by swallowing them whole with a little water, or by dissolving them in water:

If you chew the tablet:

You may need to drink a little water to help the tablet dissolve in your mouth. After swallowing, drink a little more water to make sure you have taken all the medicine.

To dissolve the medicine (make a liquid medicine):

• Put the tablet in a glass that contains enough water to cover the tablet completely.
• Shake to dissolve, or wait for 1 minute, until the tablet is completely dissolved.
• Drink all the liquid.
• Add a little more water to the glass and drink it, to make sure you have taken all the medicine.

If you take more Lamotrigine Combix than you should

If someone takes too much Lamotrigine Combix:

• Consult your doctor or pharmacist immediately, if possible, show them the pack of Lamotrigine Combix.
• You can also call the Toxicology Information Service, phone: 91 562 04 20.

Someone who takes too much Lamotrigine Combix may experience:

• rapid, uncontrolled eye movements (nystagmus)
• clumsiness and loss of coordination, affecting balance (ataxia)
• loss of consciousness or coma

If you forget to take Lamotrigine Combix

Do not take an extra tablet or a double dose to make up for forgotten doses.

If you have not taken a dose of Lamotrigine Combix:

? Ask your doctor to explain how to start treatment again. It is important that you do this.

Do not stop taking Lamotrigine Combix without your doctor's advice

You should take Lamotrigine Combix for as long as your doctor recommends. Do not stop treatment until your doctor advises you to.

If you are taking Lamotrigine Combix for the treatment of epilepsy

To stop taking Lamotrigine Combix, it is important that the dose is reduced gradually, over approximately 2 weeks. If you stop taking Lamotrigine Combix suddenly, you may experience seizures again or your condition may worsen.

If you are taking Lamotrigine Combix for bipolar disorder

Lamotrigine Combix may take some time to work, so it is unlikely that you will feel better immediately. To stop taking Lamotrigine Combix, you do not need to reduce the dose gradually. However, before stopping treatment with Lamotrigine Combix, you should consult your doctor.

4. Possible Adverse Effects

Like all medicines, Lamotrigina Combix can cause adverse effects, although not all people suffer from them.

Allergic reactions or potentially serious skin reactions: consult your doctor immediately.

A small number of people taking lamotrigina have allergic reactions or potentially serious skin reactions. If left untreated, these reactions can worsen and even become life-threatening. The symptoms of these reactions include:

• skin rashes or redness
• ulcers and pain in the mouth or eyes
• high temperature(fever), flu-like symptoms or drowsiness (sopor)
• swelling of the face or inflammationof the neck, armpit, and groin glands
• unexpected bleeding or bruising, or fingers turning blue
• sore throat, or suffering from more infections than usual (such as colds).

In many cases, these symptoms can be signs of less serious adverse effects. But you should be aware that they are potentially serious- if you experience any of these symptoms:

?See a doctor immediately. Your doctor will decide if you need to undergo tests to assess liver, kidney, or blood function and may also tell you to stop treatment with Lamotrigina Combix.

Very Common Adverse Effects

These affect more than 1 in 10people:

• headache
• dizziness
• drowsiness or sleepiness
• clumsiness and loss of coordination (ataxia)
• double vision or blurred vision
• nausea or vomiting
• skin rash

Common Adverse Effects

These affect up to 1 in 10people:

• aggression or irritability
• rapid, uncontrollable eye movements (nystagmus)
• spasms or tremors
• difficulty sleeping
• diarrhea
• dry mouth
• fatigue
• back pain or joint pain, or pain in other areas.

Uncommon Adverse Effects

These affect up to 1 in 100people:

• skin rash or sunburn after exposure to sun or artificial light (photosensitivity)

Rare Adverse Effects

These affect up to 1 in 1,000people:

• itchy eyes, with discharge and crust on the eyelids (conjunctivitis)
• Rare skin disease, characterized by severe blisters and bleeding on the lips, eyes, mouth, nose, and genital area (Stevens-Johnson syndrome)

Very Rare Adverse Effects

These affect up to 1 in 10,000people:

• hallucinations (hearing or seeing things that are not really there).
• confusion or agitation.
• feeling shaky or unsteady when moving.
• repeated body movements and/or sounds or words that cannot be controlled (tics), muscle spasms that affect the eyes, head, and torso (choreoathetosis), or other unusual movements such as jerks, spasms, or stiffness
• severe skin reaction, which starts with a painful red area, followed by large blisters, and finally, these blisters peel off in layers of skin (toxic epidermal necrolysis).
• in people who have already had epilepsy, that seizures occur more frequently.
• changes in liver function, which can be seen in blood tests, or liver failure.
• changes that can be seen in blood tests, including a reduced number of red blood cells (anemia), a reduced number of white blood cells (leukopenia, neutropenia, agranulocytosis), a reduced number of platelets (thrombocytopenia), a reduced number of all types of blood cells (pancytopenia), and a bone marrow disorder called aplastic anemia.
• coagulation disorder, which can cause bleeding or unexpected bruising (disseminated intravascular coagulation).
• high temperature (fever).
• swelling around the face (edema) or inflammation of the glands in the neck, groin, or armpits (lymphadenopathy).
• in people with Parkinson's disease, worsening of symptoms.

Other Adverse Effects

• Hemophagocytic lymphohistiocytosis (HLH) (see section 2. Before taking Lamotrigina Combix).
• Decreased immunity due to reduced levels of antibodies called immunoglobulins in the blood that help protect against infection.
• Reddish nodules or patches on the skin (pseudolymphoma).

Reporting Adverse Effects:

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects that are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Lamotrigina Combix

Keep out of the reach and sight of children.

Do not use Lamotrigina Combix after the expiration date stated on the packaging and blister, after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C.

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

6. Additional Information

Composition of Lamotrigina Combix dispersible/chewable tablets

The active ingredient is lamotrigina. Each dispersible/chewable tablet contains 50 mg of lamotrigina.

The other ingredients are: Heavy magnesium carbonate (E504), microcrystalline cellulose (E460), povidone (E1201), low-substituted hydroxypropylcellulose (E463), sodium saccharin (E954), crospovidone (E1202), microcrystalline cellulose (E460), guar gum (E412), blackcurrant flavor, and magnesium stearate (E470b).

Appearance and Packaging of Lamotrigina Combix 50 mg dispersible/chewable tablets

The Lamotrigina Combix 50 mg dispersible/chewable tablets are round, flat, white or almost white.

Each package contains a blister pack with 56 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer:

Actavis Ltd

BLB015-016

Bulebel Industrial Estate

Zejtun ZTN

3000 Malta

This leaflet was last revised inMarch 2024