Lamitrin

Package Leaflet: Information for the User

Lamitrin, 25 mg, tablets

Lamitrin, 50 mg, tablets

Lamitrin, 100 mg, tablets

Lamotrigine

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• You should 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get 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 Lamitrin is and what it is used for

2. Before you take Lamitrin

3. How to take Lamitrin

4. Possible side effects

5. How to store Lamitrin

6. Contents of the pack and other information

1. What Lamitrin is and what it is used for

Lamitrin belongs to a group of medicines called anti-epileptics. It is used to treat two conditions - epilepsy and bipolar disorder.

The action of Lamitrin in the treatment of epilepsy is to block the impulses in the brain that cause seizures.

• In adults and children aged 13 and above, Lamitrin can be used alone or with other medicines to treat epilepsy. Lamitrin can also be used with other medicines to treat a condition called Lennox-Gastaut syndrome.
• In children aged 2 to 12 years, Lamitrin can be used with other medicines to treat these conditions. It can be used alone to treat a type of epilepsy called typical absence seizures.

Lamitrin is also used to treat bipolar disorder.

In patients with bipolar disorder (sometimes called manic-depressive illness), there are extreme mood swings from depression (feeling very low) to mania (feeling very high). In adults aged 18 and above, Lamitrin can be used alone or with other medicines to prevent episodes of depression in bipolar disorder. The mechanism by which Lamitrin works in the brain is not fully understood.

2. Before you take Lamitrin

Do not take Lamitrin

• If you are allergic (hypersensitive) to lamotrigine or any of the other ingredients of this medicine.If this is the case, tell your doctor and do not take Lamitrin.

Warnings and precautions

When to be extra careful while taking Lamitrin

Before you start taking Lamitrin, tell your doctor if:

• you have any kidney problems;
• you have ever had an allergic reaction to lamotrigine or other medicines used to treat bipolar disorder or epilepsy;
• you have ever developed a rash after taking lamotrigine or other medicines or after exposure to sunlight or artificial light (e.g. sunbeds);your doctor may ask you to take precautions to avoid exposure to sunlight or artificial light;
• you have ever had a condition called meningitis, which may cause a rash and other symptoms;read the description of these symptoms in section 4 of this leaflet;
• you are already taking a medicine that contains lamotrigine;
• you have a condition called Brugada syndrome or other heart conditions;Brugada syndrome is a genetic condition that affects the electrical activity of the heart. Abnormalities in the electrocardiogram (ECG) can be associated with an irregular heartbeat, which can be caused by taking lamotrigine.

If any of these conditions apply to you, tell your doctor, who may decide to lower your dose or decide that Lamitrin is not suitable for you.

Important information about potentially life-threatening reactions

A small number of people taking Lamitrin have had a severe allergic reaction or potentially life-threatening skin reaction, which may develop into a more serious condition if left untreated. These reactions are more likely to happen during the first few months of treatment with Lamitrin, especially if the dose is too high or increased too quickly, or if Lamitrin is taken with another medicine called valproate.

Some of these reactions may be more common in children, so parents should be particularly careful to monitor for any signs.

Hemophagocytic Lymphohistiocytosis (HLH)

Rare cases of a severe immune system reaction have been reported in patients taking lamotrigine.

If you experience any of the following symptoms while taking lamotrigine, contact your doctor or pharmacist immediately:

• fever
• rash
• neurological symptoms (such as tremors or shivering, confusion, or changes in mental status)

Thoughts of harming yourself or suicide

Anti-epileptic medicines, including Lamitrin, are used to treat several conditions, including epilepsy and bipolar disorder. In patients with bipolar disorder, thoughts of self-harm or suicide may occur more often, especially:

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

Go to your doctor or the nearest hospital immediately if you experience:

any thoughts of self-harm or suicide

It may be helpful to tell a relative or close friend that you are taking Lamitrin and ask them to read this leaflet.

You should ask them to tell you if they notice any of the following symptoms:

Patients taking anti-epileptic medicines, such as Lamitrin, have also had thoughts of self-harm or suicide. If you ever have thoughts of self-harm or suicide, contact your doctor immediately.

Taking Lamitrin for epilepsy

In some types of epilepsy, seizures can become worse or more frequent while taking Lamitrin. In some patients, severe seizures can occur, which can be a serious threat to health. If your seizures become more frequent or severe, contact your doctor immediately.

Lamitrin should not be used to treat bipolar disorder in patients under 18 years old.

Medicines used to treat depression or other mental health conditions can increase the risk of thoughts of self-harm or suicide in children and adolescents under 18 years old.

Lamitrin and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.

This includes herbal medicines or medicines you can buy without a prescription. Your doctor needs to know if you are taking other medicines to treat epilepsy or mental health conditions. These include:

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate, zonisamidefor epilepsy
• olanzapine or aripiprazolefor mental health conditions
• bupropionfor mental health conditions or nicotine addiction
• paracetamolfor pain or fever

Tell your doctor if you are taking any of these medicines.

Hormonal contraceptives (such as the pill) may affect how Lamitrin works

Your doctor may recommend a particular type of hormonal contraceptive or another method of contraception, such as a condom, diaphragm, or intrauterine device. If you are taking hormonal contraceptives, such as the pill, your doctor may recommend that you have blood tests to check the levels of Lamitrin in your blood. If you are taking or plan to take hormonal contraceptives, talk to your doctor about the best method of contraception for you. Lamitrin may also affect the effectiveness of hormonal contraceptives, although this is unlikely.

Pregnancy and breastfeeding

If you are pregnant or think you may be pregnant, or if you plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

• Do not stop taking your medicine without consulting your doctor.This is especially important if you have epilepsy.
• Pregnancy may affect how well Lamitrin works, so your doctor may need to take blood tests and adjust your dose.
• There may be a small increased risk of birth defects, including cleft lip or palate, if Lamitrin is taken during the first three months of pregnancy.
• If you plan to become pregnant, your doctor may recommend that you take folic acid.

While breastfeeding or planning to breastfeed, ask your doctor or pharmacist for advice before taking this medicine.

The active ingredient of Lamitrin passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breastfeeding while taking Lamitrin and will monitor your baby for any signs of excessive sleepiness, rash, or poor weight gain.

Driving and using machines

Lamitrin may cause dizziness and double vision.

Do not drive or operate machinery unless you are sure that these effects do not occur.

If you have epilepsy, talk to your doctor about driving and using machinery.

Important information about some of the ingredients of Lamitrin

Lamitrin tablets contain a small amount of sugar called lactose. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Lamitrin tablets contain less than 1 mmol sodium (23 mg) per tablet, which is essentially sodium-free.

3. How to take Lamitrin

Always take this medicine exactly as your doctor has told you.If you are not sure, check with your doctor or pharmacist.

What dose of Lamitrin to take

It may take some time to find the right dose of Lamitrin for you. The dose depends on:

• your age
• whether you are taking Lamitrin with other medicines
• whether you have any kidney or liver problems

Your doctor will start you on a low dose and gradually increase it over a few weeks until you reach a dose that works for you (called the effective dose). Never take more Lamitrin than your doctor has prescribed.

The usual effective dose of Lamitrin for adults and children aged 13 and above is between 100 mg and 400 mg per day.

For children aged 2 to 12 years, the effective dose is based on their weight - usually between 1 mg and 15 mg per kilogram of body weight, up to a maximum maintenance dose of 200 mg per day.

Lamitrin is not recommended for children under 2 years old.

How to take your dose of Lamitrin

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

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

• Swallow the tablets whole.Do not break, chew, or crush them.
• Always take the full dose prescribed by your doctor.Never take only part of a tablet.

What to do if you take too much Lamitrin

Contact your doctor or the nearest hospital emergency department immediately.If possible, show them the Lamitrin packaging.

Taking too much Lamitrin can increase the risk of serious side effects, which can be life-threatening.

If you take too much Lamitrin, you may experience:

• rapid, involuntary movements of the eyes (nystagmus)
• lack of coordination, difficulty walking, or loss of balance (ataxia)
• heart rhythm disturbances (usually detectable on an electrocardiogram)
• loss of consciousness, seizures, or coma

What to do if you forget to take a dose of Lamitrin

Do not take extra tablets to make up for a missed dose.Take your next dose at the usual time.

What to do if you forget to take several doses of Lamitrin

Ask your doctor for advice on how to start taking Lamitrin again.

This is especially important for you.

Do not stop taking Lamitrin unless your doctor tells you to

You should continue to take Lamitrin for as long as your doctor tells you to. Do not stop taking it unless your doctor advises you to.

Taking Lamitrin for epilepsy

To stop taking Lamitrin, it is important to reduce the dose gradually over about two weeks. If you stop taking Lamitrin suddenly, your seizures may come back or become worse.

Taking Lamitrin for bipolar disorder

It may take some time before Lamitrin starts to work, so it is unlikely that you will feel better immediately. If you are going to stop taking Lamitrin, your doctor will advise you on how to do this.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Life-threatening reactions: contact your doctor immediately

A small number of people taking Lamitrin have had a severe allergic reaction or potentially life-threatening skin reaction, which may develop into a more serious condition if left untreated.

These reactions are more likely to happen during the first few months of treatment with Lamitrin, especially if the dose is too high or increased too quickly, or if Lamitrin is taken with another medicine called valproate.

Some of these reactions may be more common in children, so parents should be particularly careful to monitor for any signs.

The symptoms of these reactions include:

• skin rash or redness, which may become severe and spread to other parts of the body, including the eyes, mouth, and genital areas
• ulcers in the mouth, throat, or genital areas
• eye pain or redness(conjunctivitis)
• high fever(feeling very hot)
• swollen face, swollen lymph nodesin the neck, armpits, or groin
• unexpected bleeding or bruising
• sore throat or more frequent infections(such as colds)
• increased levels of liver enzymes in blood tests
• increased white blood cell count (eosinophilia)
• swollen lymph nodes
• changes in other organs, including the liver and kidneys

In many cases, these symptoms are signs of less severe side effects. However, they can be life-threatening and, if left untreated, can develop into more serious conditions, such as organ failure. If you notice any of these symptoms, contact your doctor immediately. Your doctor may decide to perform blood tests or other investigations and may advise you to stop taking Lamitrin.

Very common side effects

These may affect more than 1 in 10 people:

• headache
• skin rash

Common side effects

These may affect up to 1 in 10 people:

• aggression or irritability
• drowsiness
• dizziness
• tremors
• difficulty sleeping (insomnia)
• feeling agitated
• diarrhea
• dry mouth
• nausea or vomiting
• feeling tired
• back pain, joint pain, or pain in any other part of the body

Uncommon side effects

These may affect up to 1 in 100 people:

• lack of coordination or balance (ataxia)
• double vision or blurred vision
• unusual hair loss or thinning (alopecia)
• skin rash or sunburn after exposure to sunlight or artificial light (photosensitivity)

Rare side effects

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

• a skin reaction that causes red spots or patches, which may look like a target or "bull's eye" (erythema multiforme)
• a life-threatening skin reaction (Stevens-Johnson syndrome; see also the information at the beginning of section 4)

Very rare side effects

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

• a life-threatening skin reaction (toxic epidermal necrolysis; see also the information at the beginning of section 4)
• a condition that causes a rash, fever, and swollen lymph nodes, which can also affect other organs, including the liver and kidneys (DRESS syndrome; see also section 4)
• high fever (see also the information at the beginning of section 4)
• swollen face, swollen lymph nodes in the neck, armpits, or groin (see also the information at the beginning of section 4)
• changes in liver function, which can be detected in blood tests, or liver failure (see also the information at the beginning of section 4)
• a serious blood disorder that can cause unexpected bleeding or bruising (disseminated intravascular coagulation; see also the information at the beginning of section 4)
• hemophagocytic lymphohistiocytosis (HLH; see section 2, "Important information before taking Lamitrin")
• changes in blood test results, including a decrease in red blood cells (anemia), white blood cells (leukopenia, neutropenia, agranulocytosis), or platelets (thrombocytopenia), or a decrease in all blood cells (pancytopenia), as well as a condition that affects the bone marrow (aplastic anemia)
• hallucinations (seeing or hearing things that are not real)
• disorientation
• feeling unsteady or losing balance while moving
• involuntary movements, such as tics, or other unusual movements, such as twitching, tremors, or stiffness
• increased frequency of seizures in patients with previously diagnosed epilepsy
• worsening of symptoms in patients with Parkinson's disease
• a condition that causes joint pain or stiffness, fever, and general feeling of being unwell (serum sickness-like reaction)

Other side effects

Other side effects have been reported in a small number of people, but the frequency is not known.

• bone disorders, including osteopenia and osteoporosis (weak bones) and fractures; if you are taking anti-epileptic medicines for a long time, have had osteoporosis, or are taking steroids, you should discuss this with your doctor or pharmacist
• kidney inflammation (interstitial nephritis) or inflammation of the kidneys and eyes (tubulointerstitial nephritis and uveitis)
• nightmares
• reduced immunity due to low levels of antibodies in the blood, which help protect against infections
• red spots or patches on the skin (pseudolymphoma)

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. You can also report side effects directly to the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lamitrin

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

Do not use this medicine after the expiry date, which is stated on the blister, carton, or bottle. The expiry date refers to the last day of the month.

There are no special storage instructions for Lamitrin.

Medicines should 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 Lamitrin contains

The active substance is lamotrigine. Each tablet contains 25 mg, 50 mg, or 100 mg of lamotrigine.

The other ingredients are lactose monohydrate, microcrystalline cellulose, povidone K30, sodium starch glycolate (type A), yellow iron oxide (E 172), and magnesium stearate.

What Lamitrin looks like and contents of the pack

Lamitrin tablets (all strengths) are multi-faceted, square-shaped with rounded edges, and are pale yellow-brown in color. Not all pack sizes may be marketed.

Lamitrin, 25 mg, tablets are marked with "GSEC7" on one side and "25" on the other side. Each pack contains 14, 21, 28, 30, 42, 50, 56, or 100 tablets in blisters. Starter packs containing 21 or 42 tablets are also available for use during the first few weeks of treatment, when the dose is being gradually increased.

Lamitrin, 50 mg, tablets are marked with "GSEE1" on one side and "50" on the other side. Each pack contains 14, 28, 30, 42, 56, 90, 98, or 100 tablets in blisters. A starter pack containing 42 tablets is also available for use during the first few weeks of treatment, when the dose is being gradually increased.

Lamitrin, 100 mg, tablets are marked with "GSEE5" on one side and "100" on the other side. Each pack contains 28, 30, 42, 50, 56, 60, 90, 98, or 100 tablets in blisters.

Marketing authorization holder and manufacturer

Marketing authorization holder: GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland

Manufacturer: Delpharm Poznań Spółka Akcyjna, ul. Grunwaldzka 189, 60-322 Poznań, Poland

This medicine is authorized in the European Economic Area under the following names:

For more information, contact the marketing authorization holder: GSK Services Sp. z o. o., tel. +48 22 576 90 00

Date of last revision of the leaflet: January 2025