LAMOTRIGINE RELONCHEM 200 MG TABLETS - patient leaflet, side effects, dosage

What is in this leaflet

• 1. What Lamotrigine Tablets are and what they are used for

• 2. What you need to know before you take Lamotrigine Tablets

• 3. How to take Lamotrigine Tablets

• 4. Possible side effects

• 5. How to store Lamotrigine Tablets

• 6. Contents of the pack and other information

1. What Lamotrigine Tablets are and what they are used for

Lamotrigine Tablets contain the active substance Lamotrigine and belongs to a group of medicines called anti-epileptics. It is used to treat two conditions-epilepsy and bipolar disorder.

Lamotrigine Tablets treat epilepsy by blocking the signals in the brain that trigger epileptic seizures (fits).

• for adults and children aged 13 years and over, Lamotrigine Tablets can be used on its own or with other medicines, to treat epilepsy.

Lamotrigine Tablets can also be used with other medicines to treat the seizures that occur with a condition called Lennox-Gastaut syndrome.

• for children aged between 2 and 12 years, Lamotrigine Tablets can be used with other medicines, to treat those conditions. It can be used on its own to treat a type of epilepsy called typical absence seizures.

Lamotrigine Tablets also treat bipolar disorder

People with bipolar disorder (sometimes called manic depression) have extreme mood swings, with periods of mania (excitement or euphoria) alternating with periods of depression (deep sadness or despair). For adults aged 18 years and over, Lamotrigine can be used on its own or with other medicines, to prevent the periods of depression that occur in bipolar disorder. It is not yet known how Lamotrigine works in the brain to have this effect.

2. what you need to know before you take lamotrigine tablets are allergic to lamotrigine or any of the other ingredients of this medicine (listed in section 6).

If this applies to you:

Tell your doctor and don’t take Lamotrigine Tablets.

Warnings and precautions

Talk to your doctor or pharmacist before taking Lamotrigine Tablets if you:

• have any kidney problems
• have ever developed a rash after taking Lamotrigine or other medicines for epilepsy or bipolar disorder; or if you experience a rash or sunburn after taking Lamotrigine and having been exposed to sun or artificial light (e.g solarium). Your doctor will check your treatment and may advise you to avoid sunlight or protect yourself against the sun (e.g. use of a sunscreen and/or to wear protective clothing).
• are already taking medicine that contains Lamotrigine
• have ever developed meningitis after taking Lamotrigine (read the description of these symptoms in section 4 of this leaflet: Rare side effects)
• Lamotrigine can occasionally cause some serious allergic reactions or potentially life-threatening skin reaction (incl. DRESS. For more information on these, please read section 4: Possible side effects).

DRESS appears initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.

Brugada syndrome

Brugada syndrome is a genetic disease that results in abnormal electrical activity within the heart. ECG abnormalities which may lead to arrhythmias (abnormal heart rhythm) can be triggered by Lamotrigine. Talk to your doctor, if you have this condition.

Haemophagocytic lymphohistiocytosis (HLH)

There have been reports of a rare but very serious immune system reaction, 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. shaking or tremor, confusional state, disturbances of brain function).

If any of these applies to you: Tell your doctor, who may decide to lower your dose or that Lamotrigine Tablets are not suitable for you.

Important information about potentially life-threatening reactions

A small number of people taking Lamotrigine get an allergic reaction or potentially life-threatening skin reaction, which may develop into more serious problems if they are not treated. These can include Stevens-Johnson syndromes (SJS), toxic epidermal necrolysis (TEN) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). You need to know the symptoms to look out for while you are taking Lamotrigine Tablets.

Read the description of these symptoms in Section 4 of this leaflet under „Potentially life-threatening reactions: get a doctor's help straight away“.

Thoughts of harming yourself or suicide

• Anti-epileptic medicines are used to treat several conditions, including epilepsy and bipolar disorder. People with bipolar disorder can sometimes have thoughts of harming themselves or committing suicide. If you have bipolar disorder, you may be more likely to think like this: when you first start treatment
• if you have previously had thoughts about harming yourself or about suicide
• if you are under 25 years old.

If you have distressing thoughts or experiences or if you notice that you feel worse or develop new symptoms while you're taking Lamotrigine Tablets:

See a doctor as soon as possible or go to the nearest hospital for help.

You may find it helpful to tell a family member, caregiver or close friend that you can become depressed or have significant changes in mood and ask them to read this leaflet. You might ask them to tell you if they are worried about your depression or other changes in your behaviour.

A small number of people being treated with anti-epileptics such as Lamotrigine Tablets have also had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

If you're taking Lamotrigine Tablets for epilepsy

The seizures in some types of epilepsy may occasionally become worse or happen more often while you're taking Lamotrigine Tablets. Some patients may experience severe seizures, which may cause serious health problems. If your seizures happen more often or if you experience a severe seizure while you're taking Lamotrigine Tablets:

See a doctor as soon as possible.

Children and adolescents

Lamotrigine Tablets should not be given to people under 18 years to treat bipolar disorder. Medicines to treat depression and other mental health problems increase the risk of suicidal thoughts and behaviour in children and adolescents aged under 18 years.

Other medicines and Lamotrigine Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including herbal medicines or other medicines bought without a prescription.

It is important to tell your doctor or pharmacist if you are taking any other medicines for epilepsy at the same time as lamotrigine if you are pregnant, think you may be pregnant, or are planning to have a baby (see also the information in Section 2 on Pregnancy and breast-feeding).

Your doctor needs to know if you are taking other medicines to treat epilepsy or mental health problems. This is to make sure you take the correct dose of Lamotrigine Tablets. These medicines include:

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate, lacosamide, perampanel or zonisamide, used to treat epilepsy
• lithium, aripiprazole or olanzapine, used to treat mental health problems
• bupropion, used to treat mental health problems or to stop smoking.

Tell your doctor if you are taking any of these.

Some medicines interact with Lamotrigine Tablets or make it more likely that people will have side effects. These include:

• valproate, used to treat epilepsy and mental health problems
• carbamazepine, used to treat epilepsy and mental health problems
• phenytoin, primidone or phenobarbitone, used to treat epilepsy
• risperidone, used to treat mental health problems
• 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 Pill (see below).

Tell your doctor if you are taking any of these or if you start or stop taking any.

Hormonal contraceptives (such as the Pill) can affect the way Lamotrigine Tablets work

Your doctor may recommend that you use a particular type of hormonal contraceptive or another method of contraception, such as condoms, a cap or coil. If you are using a hormonal contraceptive like the Pill, your doctor may take samples of your blood to check the level of Lamotrigine. If you are using a hormonal contraceptive or if you plan to start using one:

Talk to your doctor, who will discuss suitable methods of contraception with you.

Lamotrigine Tablets can also affect the way hormonal contraceptives work, although it's unlikely to make them less effective. If you are using a hormonal contraceptive and you notice any changes in your menstrual pattern, such as breakthrough bleeding or spotting between periods: Tell your doctor. These may be signs that Lamotrigine is affecting the way your contraceptive is working.

Pregnancy and breast-feeding

If you are pregnant, or think you may be pregnant, you must tell your doctor straight away and discuss possible risks the epilepsy medicine you are taking might pose to your unborn baby.

If you are planning to become pregnant you should discuss your epilepsy treatment with your doctor as early as possible before you become pregnant.

• you should not stop treatment without discussing this with your doctor. This is particularly important if you have epilepsy.
• pregnancy may alter the effectiveness of Lamotrigine Tablets, so you may need blood tests and your dose of Lamotrigine Tablets may be adjusted
• studies of women who took lamotrigine at usual doses while they were pregnant have not shown an increased risk of physical birth abnormalities.
• the risk of physical birth abnormalities may increase when higher doses of epilepsy medicines are taken or more than one epilepsy medicine is used at the same time. Where possible, your doctor will consider using one epilepsy medicine at the lowest effective dose to control your epilepsy.
• your doctor may advise you to take extra folic acid if you're planning to become pregnant and while you're pregnant.

If you are breast-feeding or planning to breast-feed ask your doctor or pharmacist for advice before taking this medicine.

The active ingredient of Lamotrigine Tablets passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breast-feeding while you're taking Lamotrigine Tablets and will check your baby from time to time, whether drowsiness, rash or poor weight gain occurs, if you decide to breast-feed. Inform your doctor if you observe any of these symptoms in your baby.

Driving and using machines

Lamotrigine Tablets can cause dizziness and double vision.

Don't drive or operate machines unless you are sure you're not affected.

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

Lamotrigine Tablets contain lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. how to take lamotrigine tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

How many Lamotrigine Tablets to take

It may take a while to find the best dose of Lamotrigine Tablets for you. The dose you take will depend on:

• your age
• whether you are taking Lamotrigine Tablets with other medicine
• whether you have any kidney or liver problems.

Your doctor will prescribe a low dose to start and gradually increase the dose over a few weeks until you reach a dose that works for you (called the effective dose). Never take more Lamotrigine Tablets than your doctor tells you to.

The usual effective dose of Lamotrigine Tablets for adults and children aged 13 years or over is between 100 mg and 400 mg each day. For children aged 2 to 12 years, the effective dose depends on their body weight- usually, it's between 1 mg and 15 mg for each kilogram of the child's weight, up to a maximum of 200 mg daily.

Lamotrigine Tablets are not recommended for children aged under 2 years.

How to take your dose of Lamotrigine Tablets

• Take your dose of Lamotrigine Tablets once or twice a day, as your doctor advises. It can be taken with or without food. Your doctor may also advise you to start or stop taking other medicines, depending on what condition you're being treated for and the way you respond to treatment. swallow your tablets whole. Don't break, chew or crush them
• always take the full dose that your doctor has prescribed. Never take only part of a tablet.

The score line is only there to help you break the tablet if you have difficulty swallowing it whole.

If you take more Lamotrigine Tablets than you should

Contact a doctor or nearest hospital emergency department immediately. If possible, show them the Lamotrigine Tablets packet.

If you take too much Lamotrigine Tablets you may be more likely to have serious side effects which may be fatal. Someone who has taken too much Lamotrigine may have any of these symptoms;

• rapid, uncontrollable eye movements (nystagmus)
• clumsiness and lack of co-ordination, affecting their balance (ataxia)
• heart rhythm changes (detected usually on ECG)
• loss of consciousness, fits (convulsion) or coma.

If you forget to take Lamotrigine Tablets

Do not take double dose to make up for a forgotten dose. Just take your next dose at the usual time. In case you forget to take multiple doses of Lamotrigine Tablets, ask your doctor for advice on how to start taking it again. It's important that you do this.

If you stop taking Lamotrigine Tablets

Lamotrigine Tablets must be taken for as long as your doctor recommends. Don't stop unless your doctor advises you to.

If you are taking Lamotrigine Tablets for epilepsy

To stop taking Lamotrigine Tablets, it is important that your dose is reduced gradually, over about 2 weeks. If you suddenly stop taking Lamotrigine Tablets, your epilepsy may come back or get worse.

If you are taking Lamotrigine Tablets for bipolar disorder

Lamotrigine Tablets may take some time to work, so you are unlikely to feel better straight away. If you stop taking Lamotrigine Tablets, your dose will not need to be reduced gradually. But you should still talk to your doctor first, if you want to stop taking Lamotrigine Tablets.

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

4. possible side effects

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

Potentially life-threatening reaction: get a doctor’s help straight away

A small number of people taking Lamotrigine Tablets get an allergic reaction or potentially life-threatening skin reaction, which may develop into more serious problems if they are not treated. These symptoms are more likely to happen during the first few months of treatment with Lamotrigine Tablets, especially if the starting dose is too high or if the dose is increased too quickly or if Lamotrigine Tablets are taken with another medicine called valproate. Some of the symptoms are more common in children, so parents should be especially careful to watch out for them.

Symptoms of these reactions include:

• haemophagocytic lymphohistocytosis (HLH) (see section 2 What you need to know before you take Lamotrigine)
• lower immunity because of lower levels of antibodies called immunoglobulins in the blood which help protect against infection.

Very common: may affect more than 1 in 10 people

• skin rashes or redness, which may develop into life-threatening skin reactions including widespread rash with blisters and peeling skin, particularly occurring around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), extensive peeling of the skin (more than 30% of the body surface – toxic epidermal necrolysis) or extended rashes with liver, blood and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS hypersensitivity syndrome).

Common: may affect up to 1 in 10 people

• ulcers in mouth, throat, nose or genitals.

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

• a sore mouth or red or swollen eyes (conjunctivitis).

Very rare: may affect up to 1 in 10,000 people

• a high temperature (fever), flu-like symptoms or drowsiness
• swelling around your face (oedema) or swollen glands in your neck, armpit or groin
• unexpected bleeding or bruising or your fingers turning blue
• a sore throat or more infections (such as colds) than usual
• increased levels of liver enzymes seen in blood tests
• an increase in a type of white blood cell (eosinophils)
• involvement of the organs of the body including liver and kidneys.

Not known: frequency cannot be estimated from the available data

• enlarged lymph nodes.

In many cases, these symptoms will be signs of less serious side effects but you must be aware that they are potentially life-threatening and can develop into more serious problems, such as organ failure, if they are not treated. If you notice any of these symptoms: Contact a doctor immediately. Your doctor may decide to carry out tests on your liver, kidneys or blood and may tell you to stop taking Lamotrigine Tablets. In case you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis your doctor will tell you that you must not use Lamotrigine again.

Very common: may affect more than 1 in 10 people

• headache
• skin rash.

Common: may affect up to 1 in 10 people

• aggression or irritability
• feeling sleepy or drowsy
• feeling dizzy
• shaking or tremors
• difficulty in sleeping (Insomnia)
• feeling agitated
• diarrhoea
• dry mouth
• feeling sick (nausea) or being sick (vomiting)
• feeling tired
• pain in your back or joints or elsewhere.

Uncommon: may affect up to 1 in 100 people

• clumsiness and lack of co-ordination (ataxia)
• double vision or blurred vision
• unusual hair loss or thinning (alopecia)
• skin rash or sunburn after exposure to sun or artificial light (photosensitivity).

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

• a life-threatening skin reaction (Stevens-Johnson syndrome): (see also the information at the beginning of Section 4)
• itchy eyes, with discharge and crusty eyelids (conjunctivitis)
• a group of symptoms together including: fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light. This may be caused by an inflammation of the membranes that cover the brain and spinal cord (meningitis). These symptoms usually disappear once treatment is stopped however if the symptoms continue or get worse contact your doctor
• rapid, uncontrollable eye movements (nystagmus).

Very rare: may affect up to 1 in 10,000 people

• in people who already have Parkinson’s di­sease, worsening of the symptoms
• a serious disorder of blood clotting, which can cause unexpected bleeding or bruising (disseminated intravascular coagulation): (see also the information at the beginning of Section 4)
• hallucinations (‚seeing‘ or ‚hearing‘ things that aren't really there)
• confusion
• feeling ‚wobbly‘ or unsteady when you move about
• uncontrollable body movements (tics), uncontrollable muscle spasms affecting the eyes, head and torso (choreoathetosis) or other unusual body movements such as jerking, shaking or stiffness
• in people who already have epilepsy, seizures happening more often
• changes which may show up in blood tests- including reduced numbers of red blood cells (anaemia), reduced numbers of white blood cells (leucopoenia, neutropenia, agranulocytosis), reduced numbers of platelets (thrombocytopenia), reduced numbers of all these types of cell (pancytopenia) and a disorder of the bone marrow called aplastic anaemia
• lupus-like reaction (symptoms may include: back or joint pain which sometimes may be accompanied by fever and/or general ill health).

Not known: frequency cannot be estimated from the available data

• there have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures. Check with your doctor or pharmacist if you are on long-term anti-epileptic medication, have a history of osteoporosis or take steroids
• nightmares
• inflammation of the kidney (tubulointerstitial nephritis), or inflammation of both the kidney and the eye (tubulointerstitial nephritis and uveitis syndrome).

5. how to store lamotrigine tabletsdo not use this medicine after the expiry date which is stated on the blisters, carton or bottle after exp. the expiry date refers to the last day of that month.

Store in the original package.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other informationthe active substance is lamotrigine.

Lamotrigine Relonchem 25 mg tablets: each tablet contains 25 mg of Lamotrigine.

Lamotrigine Relonchem 50 mg tablets: each tablet contains 50 mg of Lamotrigine.

Lamotrigine Relonchem 100 mg tablets: each tablet contains 100 mg of Lamotrigine.

Lamotrigine Relonchem 200 mg tablets: each tablet contains 200 mg of Lamotrigine.

The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium starch glycolale, maize starch, magnesium stearate and iron oxide yellow (E172).

What Lamotrigine Tablets look like and contents of the pack

Lamotrigine Relonchem 25 mg tablets are yellow, round tablets with „25“ on one side and scored on the other.

Lamotrigine Relonchem 50 mg tablets are yellow, round tablets with „50“ on one side and scored on the other.

Lamotrigine Relonchem 100 mg tablets are yellow, round tablets with „100“ on one side and scored on the other.

Lamotrigine Relonchem 200 mg tablets are yellow, capsule-shaped tablets with „200“ on one side and plain on the other.

Lamotrigine Relonchem Tablets are available in packs of 21, 28, 42, 56, or 100 tablets.

Not all pack sizes may be marketed.

Relonchem Limited, Cheshire House, Gorsey Lane, Widnes, Cheshire, WA8 0RP, United Kingdom.

Product Licence Number: PL 20395/0261 – 0264

[POM

This leaflet was last revised in February 2022.

180 mm