Lamictal 100mg dispersible tablets

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Lamotrigine
Available from:
Mawdsley-Brooks & Company Ltd
ATC code:
N03AX09
INN (International Name):
Lamotrigine
Dosage:
100mg
Pharmaceutical form:
Dispersible tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 04080100

Other side effects

Other side effects have occurred in a small number of people but

their exact frequency is unknown:

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

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 on this leaflet. You can

also report side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard 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 Lamictal

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not store above 30°C. Store in a dry place. Protect from

light.

Do not use after the expiry date printed on the carton label or

blister strip.

If your doctor tells you to stop using the medicine, please take it

back to the pharmacist for safe disposal. Only keep the

medicine if your doctor tells you to.

If the medicine becomes discoloured or shows any other signs

of deterioration, you should seek the advice of your pharmacist

who will tell you what to do.

If you have any unwanted Lamictal tablets, don’t dispose of

them in your waste water or your household rubbish. Take them

back to your pharmacist, who will dispose of them in a way that

won’t harm the environment.

6

Contents of the pack and other information

What Lamictal contains

Each 100mg dispersible tablet contains 100mg lamotrigine.

Lamictal Dispersible also contain the following inactive

ingredients: calcium carbonate, low substituted

hydroxypropylcellulose, aluminium magnesium silicate, sodium

starch glycollate, povidone K30, saccharin sodium, magnesium

stearate and blackcurrant flavouring.

What Lamictal looks like and contents of the pack

The tablets are white multifaceted, round tablets marked ‘GSCL7’

on one side and ‘100’ on the other.

Lamictal 100mg dispersible Tablets are available as blister packs of

56 tablets.

Product Licence holder

Procured from within the EU and repackaged by the Product

Licence holder: S&M Medical Ltd, Chemilines House, Alperton

Lane, Wembley, Middlesex, HA0 1DX.

Manufacturer

This product is manufactured by Glaxo Operations UK Ltd, Priory

Street, Ware, UK and GlaxoSmithKline Pharmaceuticals S.A., UI

Grunwaldzka 189, 60-322 Poznan, Poland.

PL: 19488/0299

Leaflet revision date: 27 February 2019

Blind or partially sighted? Is

this leaflet hard to see or read?

Call 02087997607 to obtain the

leaflet in large print, tape, CD

or Braille.

Lamictal

®

is a registered trade mark of Glaxo Group Limited, UK.

S299 LEAFLET Lamictal 20190227

S299 LEAFLET Lamictal 20190227

PACKAGE LEAFLET: INFORMATION FOR THE USER

LAMICTAL

®

100mg DISPERSIBLE TABLETS

(lamotrigine)

Your medicine is known as Lamictal 100mg Dispersible Tablets but

will be referred to as Lamictal throughout the remainder of the

leaflet.

Please note that information regarding Lamictal 25mg Dispersible

Tablets, Lamictal 2mg Dispersible Tablets and Lamictal 5mg

Dispersible Tablets may also be present in the below leaflet.

Read all of this leaflet carefully before you start taking this

medicine because it contains important information for you.

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 of the side effects, talk to your doctor or pharmacist.

This includes any possible side effects not listed in this leaflet. See

section 4.

What is in this leaflet

1

What Lamictal is and what it is used for

2

What you need to know before you take Lamictal

3

How to take Lamictal

4

Possible side effects

5

How to store Lamictal

6

Contents of the pack and other information

1

What Lamictal is and what it is used for

Lamictal belongs to a group of medicines called anti-epileptics. It is

used to treat two conditions - epilepsy and bipolar disorder.

Lamictal treats epilepsy by blocking the signals in the brain that

trigger epileptic seizures (fits)

For adults and children aged 13 years and over, Lamictal can

be used on its own or with other medicines, to treat epilepsy.

Lamictal 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, Lamictal 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.

Lamictal 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, Lamictal 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

Lamictal works in the brain to have this effect.

2

What you need to know before you take Lamictal

Do not take Lamictal:

if you are allergic (hypersensitive) 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 Lamictal.

Take special care with Lamictal

Talk to your doctor or pharmacist before taking Lamictal:

if you have any kidney problems

if you have ever developed a rash after taking lamotrigine or

other medicines for bipolar disorder or epilepsy

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 medicine 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.

If any of these applies to you:

Tell your doctor, who may decide to lower the dose or that

Lamictal is not suitable for you.

Important information about potentially life-threatening

reactions

A small number of people taking Lamictal 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 Lamictal.

Read the description of these symptoms in Section 4 of

this leaflet under ‘Potentially life-threatening reactions: get a

doctor’s help straight away’.

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).

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

Lamictal:

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

Lamictal 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 Lamictal for epilepsy

The seizures in some types of epilepsy may occasionally become

worse or happen more often while you’re taking Lamictal. 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 Lamictal:

See a doctor as soon as possible.

Lamictal 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.

Other medicines and Lamictal

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.

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 Lamictal. 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 Lamictal 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

Lamictal 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 coil. If you are using a hormonal

contraceptive like the Pill, your doctor may take samples of your

blood to check the level of Lamictal. 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.

Lamictal 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 Lamictal is affecting

the way your contraceptive is working.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are

planning to have a baby ask your doctor or pharmacist for

advice before taking this medicine.

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 Lamictal, so you may

need blood tests and your dose of Lamictal may be adjusted.

There may be a small increased risk of birth defects, including a

cleft lip or cleft palate, if Lamictal is taken during the first 3

months of pregnancy.

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 Lamictal passes into breast

milk and may affect your baby. Your doctor will discuss the risks

and benefits of breast-feeding while you’re taking Lamictal 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

Lamictal can cause dizziness and double vision.

Don’t drive or use machines unless you are sure you’re not

affected.

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

using machines.

3

How to take Lamictal

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 Lamictal to take

It may take a while to find the best dose of Lamictal for you.

The dose you take will depend on:

your age

whether you are taking Lamictal with other medicines

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 Lamictal than your

doctor tells you to.

The usual effective dose of Lamictal 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 maintenance dose

of 200 mg daily.

Lamictal is not recommended for children aged under 2 years.

How to take your dose of Lamictal

Take your dose of Lamictal once or twice a day, as your doctor

advises. It can be taken with or without food.

Always take the full dose that your doctor has prescribed.

Never take only part of a tablet.

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.

Lamictal chewable/dispersible tablets can either be swallowed

whole with a little water, chewed or mixed with water to make a

liquid medicine.

To chew the tablet:

You may need to drink a little water at the same time to help the

tablet dissolve in the mouth. Then drink some more water to make

sure all the medicine has been swallowed.

To make a liquid medicine:

Put the tablet in a glass with at least enough water to cover the

whole tablet.

Either stir to dissolve or wait until the tablet is fully dissolved.

Drink all the liquid.

Add a little more water to the glass and drink that, to make sure

no medicine is left in the glass.

If you take more Lamictal than you should

Contact a doctor or nearest hospital emergency

department immediately. If possible, show them the Lamictal

packet.

If you take too much Lamictal you may be more likely to have

serious side effects which may be fatal. Someone who has taken

too much Lamictal 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 (convulsions) or coma.

If you forget to take a single dose of Lamictal

Don’t take extra tablets to make up for a missed dose. Just

take your next dose at the usual time.

In case you forget to take multiple doses of Lamictal

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

It’s important that you do this.

Don’t stop taking Lamictal without advice

Lamictal must be taken for as long as your doctor recommends.

Don’t stop unless your doctor advises you to.

If you’re taking Lamictal for epilepsy

To stop taking Lamictal, it is important that the dose is reduced

gradually, over about 2 weeks. If you suddenly stop taking

Lamictal, your epilepsy may come back or get worse.

If you’re taking Lamictal for bipolar disorder

Lamictal may take some time to work, so you are unlikely to feel

better straight away.

If you stop taking Lamictal, your dose will not need to be reduced

gradually. But you should still talk to your doctor first, if you want to

stop taking Lamictal.

4

Possible side effects

Like all medicines, this medicine can cause side effects, but not

everyone gets them.

Potentially life-threatening reactions: get a doctor’s help

straight away

A small number of people taking Lamictal 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 Lamictal, especially if the starting dose is

too high or if the dose is increased too quickly or if Lamictal 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 Lamictal. 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 Lamictal).

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

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 side effects

These 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).

Rare side effects

These 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 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)

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

in people who already have Parkinson’s disease, worsening of

the symptoms.

lupus-like reaction (symptoms may include: back or joint pain

which sometimes may be accompanied by fever and/or general

ill health).

Haemophagocytic lymphohistiocytosis (HLH) (see Section 2:

What you need to know before you take Lamictal).

S299 LEAFLET Lamictal 20190227

Product Summary

NAME OF THE MEDICINAL PRODUCT

Not applicable

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Not applicable

3.

PHARMACEUTICAL FORM

Not applicable

4.

CLINICAL PARTICULARS

4.1.

Therapeutic indications

Not applicable

4.2.

Posology and method of administration

Not applicable

4.3.

Contraindications

Not applicable

4.4.

Special warnings and precautions for use

Not applicable

4.5.

Interactions with other medicinal products and other forms of interaction

Not applicable

4.6.

Pregnancy and lactation

Not applicable

4.7.

Effects on ability to drive and use machines

Not applicable

4.8.

Undesirable effects

Not applicable

4.9.

Overdose

Not applicable

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic properties

Not applicable

5.2.

Pharmacokinetic properties

Not applicable

5.3.

Preclinical safety data

Not applicable

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of excipients

Not applicable

6.2.

Incompatibilities

Not applicable

6.3.

Shelf life

Not applicable

6.4.

Special precautions for storage

Not applicable

6.5.

Nature and contents of container

Not applicable

6.6.

Instruction for use and handling (, and disposal)

Not applicable

No Data Held

Administrative Data

Marketing Authorisation Holder

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8.

Marketing Authorisation Number

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9.

Date of First Authorisation/Renewal of Authorisation

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10.

Date of (Partial) Revision of Text

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