Lamotrigine Combix 200 mg dispersible/masticable tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lamotrigina Combix 200 mg dispersible / chewable tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• 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 and you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Lamotrigina Combix is and what it is used for
2. Before you take Lamotrigina Combix
3. How to take Lamotrigina Combix
4. Possible side effects
5. How to store Lamotrigina Combix
6. Further information

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

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

Lamotrigina Combix is used to treat epilepsy because it blocks signals in the brain that trigger seizures (fits).

• In adults and children aged 13 years and older, Lamotrigina may be used alone or in combination with other medicines to treat epilepsy. Lamotrigina 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, Lamotrigina may be used in combination with other medicines to treat the same conditions. It may also be used without combination with other medicines to treat a type of epilepsy called typical absence seizures.

Lamotrigina Combix is also used to treat bipolar disorder.

People with bipolar disorder (previously known as manic-depressive disorder) 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, Lamotrigina Combix may be used, either alone or in combination with other medicines, to prevent depressive episodes associated with bipolar disorder. It is not known how lamotrigine works in the brain to produce this effect.

2. Before taking Lamotrigina Combix

Do not take Lamotrigina Combix:

• if you are allergic (hypersensitive) to the active substance or to any of the other components of Lamotrigina Combix (listed in section 6).

If this applies to you:

? Inform your doctor and do not take Lamotrigina Combix.

Take special care with Lamotrigina Combix

Your doctor needs to know before you take Lamotrigina Combix:

• If you have kidney problems
• If you have previously developed a skin rash after taking lamotrigine or other medicines for bipolar disorder or epilepsy, or if you suffer from skin rashes or sunburn after taking lamotrigine and being exposed to sunlight or artificial light (for example, in a tanning bed). Your doctor will review your treatment and may advise you to avoid sunlight or protect yourself from the sun (for example, by using sunscreen and/or protective clothing).
• If you are already taking medicines containing lamotrigine

If this applies to you:

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

Important information about potentially life-threatening reactions

A small number of people taking Lamotrigina Combix experience allergic reactions or skin reactions that may potentially be life-threatening, which could 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).

You need to be aware of the symptoms of these reactions and monitor for them while taking Lamotrigina Combix. 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 Lamotrigina Combix.

Important to be alert for symptoms

Seek immediate medical help if, after starting Lamotrigina Combix, you develop any of the following symptoms:

• Skin reaction, such as redness or rash
• Irritation in the mouth or eyes
• High temperature (fever), flu-like symptoms, or drowsiness (stupor)
• Swelling around the face or swelling of the glands in the neck, armpits, or groin
• Unexpected bleeding or bruising, or fingers turning blue
• Sore throat, or more infections than usual (such as colds).

These symptoms are more likely to occur during the first few months of treatment with Lamotrigina Combix, especially if you start treatment at too high a dose or if your dose is increased too quickly. They are also more likely if you are taking Lamotrigina Combix together with a medicine called valproate. Children are more likely than adults to experience these adverse effects.

If the symptoms listed above are not treated, they may progress to more serious problems, such as organ failure or a severe skin disease.

If you notice any of these symptoms:

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

Thoughts of self-harm or suicide

Antiepileptic medicines are used to treat various conditions, including epilepsy and bipolar disorder. People with bipolar disorder may have previously experienced thoughts of self-harm or suicide. If you have bipolar disorder, you may be more likely to have such 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 worrying thoughts or experiences, or if you feel worse or develop new symptoms while taking Lamotrigina Combix:

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

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

If you are taking Lamotrigina Combix for epilepsy

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

? Seek medical attention immediately.

Brugada syndrome

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

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 experience any of the following symptoms while taking lamotrigine: fever, rash, neurological symptoms (e.g., spasms or tremors, confusion, changes in brain function).

Lamotrigina Combix 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 problems may increase the risk of suicidal thoughts and behaviors in children and adolescents under 18 years of age.

Use of other medicines

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

If you are taking certain medicines, your doctor may need to adjust the dose of Lamotrigina Combix. These include:

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate, or zonisamide, indicated for the treatment of epilepsy
• lithium, indicated for the treatment of mental health problems
• bupropion, indicated for the treatment of mental health problems or for smoking cessation

? Inform your doctor if you are taking any of these medicines.

Some medicines interact with Lamotrigina Combix or make adverse effects more likely. These include:

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

? Inform your doctor if you are taking, or if you start or stop taking, any of these medicines.

Hormonal contraceptives (such as the Pill) may affect how Lamotrigina Combix works

Your doctor may recommend that you use a specific hormonal contraceptive or use another method of contraception, such as condoms, diaphragm, or intrauterine device (IUD). If you are taking a hormonal contraceptive such as the Pill, your doctor may ask you to have blood tests to check lamotrigine levels. If you are considering starting a hormonal contraceptive:

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

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 between periods:

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

Pregnancy and breastfeeding

? Consult your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant.

You should not stop treatment for epilepsy during pregnancy. However, there is an increased risk of birth defects in babies born to mothers who took lamotrigine during pregnancy. These defects include cleft lip or cleft 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 Lamotrigina Combix, so your doctor may ask you to have blood tests to monitor lamotrigine levels 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 in Lamotrigina 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 arrange periodic check-ups for 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

Lamotrigina Combix may cause dizziness and double vision.

? Do not drive or operate machinery unless you are certain you are not affected by 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 as 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 most appropriate dose of Lamotrigine Combix for you. The dose you should take will depend on:

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

Your doctor will ask you to start treatment with a low dose, gradually increasing it until reaching 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 of age ranges 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 of 400 mg daily.

How to take your dose of Lamotrigine Combix

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

• Always take the full dose prescribed by your doctor. Never take only 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 therapy.

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

If you chew 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 the medicine.

To dissolve the medicine (to make a liquid medicine):

• Place the tablet in a glass containing enough water to completely cover the tablet.
• Shake to dissolve, or wait for one minute, until the tablet is completely dissolved.
• Drink all the liquid.
• Add a little more water to the glass and drink it, to ensure you have taken all the medicine.

If you take more Lamotrigine Combix than you should

If someone takes too much Lamotrigine Combix:

• Contact your doctor or pharmacist immediately. If possible, show them the Lamotrigine Combix packaging.
• You may also call the Toxicology Information Service at telephone: 91 562 04 20.

Someone who has taken too much Lamotrigine Combix may experience any of the following symptoms:

• 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 double dose to make up for a missed dose.

If you have missed a dose of Lamotrigine Combix:

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

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

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

If you are taking Lamotrigine Combix for epilepsy

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

If you are taking Lamotrigine Combix for bipolar disorder

Lamotrigine Combix may take some time to work, so you are unlikely to feel better immediately. When stopping Lamotrigine Combix, you do not need to gradually reduce the dose. However, even so, you must consult your doctor before stopping treatment with Lamotrigine Combix.

4. Possible adverse effects

Like all medicines, Lamotrigina Combix may produce adverse effects, although not everyone experiences them.

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

A small number of people taking lamotrigine experience allergic reactions or potentially serious skin reactions. If left untreated, these reactions may worsen and even become life-threatening. Symptoms of these reactions include:

• skin rash or redness
• ulcers and pain in the mouth or eyes
• high temperature (fever), flu-like symptoms, or drowsiness (somnolence)
• swelling of the face or inflammation of the glands in the neck, armpits, and groin
• unexpected bleeding or bruising, or fingers turning blue
• sore throat, or experiencing more infections than usual (such as colds)

In many cases, these symptoms may be signs of less serious adverse effects. However, you should be aware that they can potentially be serious. If you experience any of these symptoms:

?Seek medical advice immediately. Your doctor will decide whether you need tests to assess liver, kidney, or blood function, and may advise you to stop treatment with Lamotrigina Combix.

Very common adverse effects

These affect more than 1 in 10 people:

• headache
• dizziness
• feeling sleepy or drowsy
• 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 10 people:

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

Uncommon adverse effects

These affect up to 1 in 100 people:

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

Rare adverse effects

These affect up to 1 in 1,000 people:

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

Very rare adverse effects

These affect up to 1 in 10,000 people:

• hallucinations (hearing or seeing things that are not really there)
• confusion or agitation
• feeling tremors or instability when moving
• repeated body movements and/or uncontrollable sounds or words (tics), muscle spasms affecting the eyes, head, and torso (choreoathetosis), or other unusual movements such as jerking, spasms, or stiffness
• severe skin reaction, starting with a painful red area, followed by large blisters, and eventually peeling off in layers of skin (toxic epidermal necrolysis)
• in people who have previously had epilepsy, increased frequency of seizures
• changes in liver function, which may be seen in blood tests, or liver failure
• changes detectable in blood tests including reduced number of red blood cells (anemia), reduced number of white blood cells (leukopenia, neutropenia, agranulocytosis), reduced number of platelets (thrombocytopenia), reduced number of all types of blood cells (pancytopenia), and a bone marrow disorder known as aplastic anemia
• disturbance in blood clotting, which may cause bleeding or unexpected bruising (disseminated intravascular coagulation)
• high temperature (fever)
• swelling around the face (edema) or inflammation of 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)
• Reduced immunity due to decreased levels of antibodies called immunoglobulins in the blood, which help protect against infection
• Red skin nodules or spots (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: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging and on the blister, after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Additional information

Composition of Lamotrigina Combix dispersible/chewable tablets

The active substance is lamotrigine. Each dispersible/chewable tablet contains 200 mg of lamotrigine.

The other components 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 flavour, and magnesium stearate (E470b).

Appearance of the product and contents of the container of Lamotrigina Combix 200 mg dispersible/chewable tablets

Lamotrigina Combix 200 mg dispersible/chewable tablets are flat, round, white or almost white.

Each pack contains a blister with 30 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 patient information leaflet has been reviewed in March 2024