LAMOTRIGINE BRISTOL LABS 100 MG TABLETS - patient leaflet, side effects, dosage

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

The name of your medicine is Lamotrigine 25mg or 50mg or 100mg or 200mg Tablets. The active ingredient is Lamotrigine.

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

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

• For adults and children aged 13 years and over, lamotrigine can be used on its own or with other medicines, to treat epilepsy. Lamotrigine 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 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 also treats 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 |

Do not take Lamotrigine tablets if

• you are allergic (hypersensitive) to Lamotrigine or any of the other ingredients of this medicine (the ingredients are listed in section 6).

Warnings and Precautions

Talk to your doctor or pharmacist before taking Lamotrigine tablets.

• if you have problem with your kidneys
• if you have ever developed a rash when you have taken lamotrigine or other medicines for bipolar disorder or epilepsy; 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).
• if you have ever developed meningitis after taking lamotrigine (read the description of these symptoms in Section 4 of this leaflet: Rare side effects)
• if you are already taking medicines that contains lamotrigine
• if you have a condition called 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.

Watch out for important symptoms

If you develop any of these symptoms after you start taking lamotrigine, get a doctor’s help straight away:

• an unusual skin reactions, such as redness or rashes
• a sore mouth or eyes
• a high temperature (fever), flu like symptoms or drowsiness
• swelling around your face, 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

These symptoms are more likely to happen during the first few months of treatment with lamotrigine, especially if you start on too high a dose or if your dose is increased too quickly, or if you’re taking lamotrigine with another medicine called valproate. Children are more likely to be affected than adults. Tell your doctor, who may decide to lower the dose, or that lamotrigine is 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 syndrome (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. Read the description of these symptoms in section 4 of this leaflet under “Allergic reaction or Potentially serious skin reactions: get a doctor’s help straight away.”

If you notice any of these symptoms:

• See a doctor as soon as possible. Your doctor may decide to carry out tests on your liver, kidney or blood, and may tell you to stop taking lamotrigine.

Risk of increased or severe seizures

The seizures in some types of epilepsy may occasionally become worse or happen more often while you’re taking lamotrigine. 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.

See a doctor as soon as possible.

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, 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 with epilepsy being treated with Lamotrigine have also had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Lamotrigine should not be given to people aged 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.

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 you’re taking Lamotrigine for epilepsy

The seizures in some types of epilepsy may occasionally become worse or happen more often while you’re taking Lamotrigine. 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. See a doctor as soon as possible.

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. These medicines include:

• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin topiramate or zonisamide, used to treat epilepsy
• lithium, olanzapine or aripiprazole 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 or make it more likely that you’ll have side effects. These include:

• valproate or carbamazepine for epilepsy and mental health problems
• phenytoin, primidone or phenobarbitone for epilepsy
• risperidone for mental health problems
• rifampicin, an antibiotic
• a combination of lopinavir and ritonavir or, atazanavir and ritonavir used to treat Human Immunodeficiency Virus (HIV) infection
• hormonal contraceptives (Ethinyloestra­diol/levonorges­trel) such as the Pill (see below)

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

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

Your doctor may recommend that you use a particular type of hormonal contraceptive, or another method of contraception, such as condoms, a cap or a 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 can also affect the way hormonal contraceptives work, although it’s unlikely to make them less effective. If you are using 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, breast-feeding and fertility

If you are pregnant, or think you maybe 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, so you may need blood tests and your dose of Lamotrigine 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 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 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 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

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

Information on sodium content:

Lamotrigine tablets contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

| 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 much lamotrigine to take

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

• your age
• whether you are taking lamotrigine with other medicines
• whether you have problems with your kidneys or liver

Your doctor will start you on a low dose, 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 than your doctor tells you to.

The usual effective dose of lamotrigine for adults and children aged over 13 years is between 100mg and 400mg each day.

For children aged 2 to 12 years, the effective dose depends on their body weight usually, it’s between 1mg and 15mg for each kilogram of the child’s weight, up to a maximum of 200mg daily.

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Lamotrigine is not recommended for children aged under 2 years

How to take your dose of Lamotrigine Tablets

Take your dose of lamotrigine once or twice a day, as your doctor advises you. You can take it 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.

If you take more Lamotrigine than you should

Contact a doctor or pharmacist immediately. If possible, show them the lamotrigine packet.

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)
• loss of consciousness or coma, fits (convulsions)
• heart rhythm changes (detected usually on ECG)

If you forget to take Lamotrigine

Do not take a double dose to make up for a forgotten dose.

If you have missed taking a dose 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

Take lamotrigine for as long as your doctor recommends. Don’t stop unless your doctor advises you to.

If you are taking Lamotrigine for epilepsy

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

If you are taking Lamotrigine for bipolar disorder

Lamotrigine may take some time to work, so you are unlikely to feel better straight away. If you stop taking lamotrigine, 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.

4. Possible Side Effects

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

Allergic reaction or potentially serious skin reaction: get a doctor’s help straight away

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 symptoms are more likely to happen during the first few months of treatment with Lamotrigine, especially if the starting dose is too high or if the dose is increased too quickly or if Lamotrigine is 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:

• 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).
• ulcers in the mouth, throat, nose or genitals
• a sore mouth or red or swollen eyes (conjunctivitis)
• a high temperature (fever), flu-like symptoms or drowsiness
• swelling around your face or swollen glands in your neck, armpit or groin
• unexpected bleeding or bruising, or the 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)
• enlarged lymph nodes
• involvement of the organs of the body including liver and kidneys.

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. In case you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis your doctor will tell you that you must never use lamotrigine again.

Haemophagocytic lymphohistiocytosis (HLH) (see section 2 What you need to know before you take lamotrigine).

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

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

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
• 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)
• itchy eyes, with discharge and crusty eyelids (conjunctivitis).

Very rare: 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
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): (see also the information at the beginning of Section 4)
• a high temperature (fever): see also the information at the beginning of Section 4
• swelling around the face (oedema) or swollen glands in the neck, armpit or groin (lymphadenopathy): see also the information at the beginning of section 4
• changes in liver function, which will show up in blood tests, or liver failure: see also the information at the beginning of Section 4
• 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
• changes which may show up in blood tests – including reduced numbers of red blood cells (anaemia), reduced numbers of white blood cells (leucopenia, 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
• 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
• lupus-like reaction (symptoms may include: back or joint pain which sometimes may be accompanied by fever and/or general ill health).
• in people who already have Parkinson’s di­sease, worsening of the symptoms

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.
• Nigthmares
• inflammation of the kidney (tubulointerstitial nephritis), or inflammation of both the kidney and the eye (tubulointerstitial nephritis and uveitis syndrome).
• Lower immunity because of lower levels of antibodies called immunoglobulins in the blood which help protect against infection.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: , or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

| 5. how to store lamotrigine tablets                     ~|

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date (EXP.) which is stated on the label. The expiry date refers to the last day of that month.
• Lamotrigine tablets does not require any special storage conditions. 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 information              ~|

What Lamotrigine Tablets contain

• The active substance is Lamotrigine. Each tablet contains either 25mg, 50mg, 100mg or 200mg of the active substance.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, povidone, sodium starch glycollate (type A), ferric oxide yellow E172, purified talc and magnesium stearate.

What Lamotrigine Tablets look like and contents of the pack

• Lamotrigine 200mg, 100mg and 50mg tablets are pale yellow coloured, circular, flat faced bevelled edged, uncoated tablets with ‘L200’, ‘L100’ and ‘L50’ debossed respectively on one side and ‘B’ and ‘L’ logo on either side of breakline.
• Lamotrigine 25 mg tablet is available as pale yellow, flat, bevelled edged, circular, uncoated tablets with ‘L25’ debossed on one side and plain on the other side.
• Lamotrigine tablets are packaged in blister packs of 14, 28, 56, 84 tablets. Not all pack sizes may be marketed.