Lamictal 5mg dispersible tablets

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Lamotrigine
Available from:
CST Pharma Ltd
ATC code:
N03AX09
INN (International Name):
Lamotrigine
Dosage:
5mg
Pharmaceutical form:
Dispersible tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 04080100; GTIN: 5055946805887 05055946807881

Page 1 of 2

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lamictal

®

25mg

Dispersible/Chewable Tablets

(lamotrigine)

Lamictal Dispersible/Chewable Tablets are available in the

following strengths: 2mg, 5mg, 25mg & 100mg. This leaflet

only applies to the 25mg Dispersible/Chewable Tablets which

will be referred to as Lamictal Dispersible/Chewable Tablets

throughout this 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

What Lamictal Dispersible/Chewable Tablets are and

what they are used for

What you need to know before you take Lamictal

Dispersible/Chewable Tablets

How to take Lamictal Dispersible/Chewable Tablets

Possible side effects

How to store Lamictal Dispersible/Chewable Tablets

Contents of the pack and other information

1.

What Lamictal Dispersible/Chewable

Tablets are and what they are used for

Lamictal Dispersible/Chewable Tablets belong to a group of

medicines called anti-epileptics. They are used to treat two

conditions - epilepsy and bipolar disorder.

Lamictal Dispersible/Chewable Tablets treat

epilepsy by blocking the signals in the brain that trigger

epileptic seizures (fits)

For adults and children aged 13 years and over, Lamictal

Dispersible/Chewable Tablets can be used on their own

or with other medicines, to treat epilepsy. Lamictal

Dispersible/Chewable 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, Lamictal

Dispersible/Chewable Tablets can be used with other

medicines, to treat those conditions. They can be used

on their own to treat a type of epilepsy called typical

absence seizures.

Lamictal Dispersible/Chewable 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, Lamictal Dispersible/Chewable Tablets can be

used on their own or with other medicines, to prevent the

periods of depression that occur in bipolar disorder. It is not

yet known how Lamictal Dispersible/Chewable Tablets work in

the brain to have this effect.

2.

What you need to know before you take

Lamictal Dispersible/Chewable Tablets

Do not take Lamictal Dispersible/Chewable Tablets:

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

Dispersible/Chewable Tablets.

Take special care with Lamictal

Dispersible/Chewable Tablets

Talk to your doctor or pharmacist before taking

Lamictal Dispersible/Chewable Tablets:

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 any of these applies to you:

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

that Lamictal Dispersible/Chewable Tablets are not

suitable for you.

Important information about potentially

life-threatening reactions

A small number of people taking Lamictal

Dispersible/Chewable Tablets 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

Dispersible/Chewable 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 Lamictal Dispersible/Chewable 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 Lamictal Dispersible/Chewable 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 Lamictal Dispersible/Chewable

Tablets for epilepsy

The seizures in some types of epilepsy may occasionally

become worse or happen more often while you’re taking

Lamictal Dispersible/Chewable 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 Lamictal

Dispersible/Chewable Tablets:

See a doctor as soon as possible.

Lamictal Dispersible/Chewable Tablets 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 Dispersible/Chewable

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.

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

Dispersible/Chewable Tablets. 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 Dispersible/Chewable

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 Lamictal Dispersible/Chewable

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 Lamictal

Dispersible/Chewable Tablets.

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 Dispersible/Chewable 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 Lamictal

Dispersible/Chewable Tablets are 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

Dispersible/Chewable Tablets, so you may need blood

tests and your dose of Lamictal Dispersible/Chewable

Tablets may be adjusted.

There may be a small increased risk of birth defects,

including a cleft lip or cleft palate, if Lamictal

Dispersible/Chewable Tablets are 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 Dispersible/Chewable 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 Lamictal Dispersible/Chewable Tablets and

will check your baby from time to time if you decide to

breast-feed.

Driving and using machines

Lamictal Dispersible/Chewable Tablets 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

Dispersible/Chewable 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 Lamictal Dispersible/Chewable Tablets

to take

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

Dispersible/Chewable Tablets for you. The dose you take will

depend on:

your age

whether you are taking Lamictal Dispersible/Chewable

Tablets 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 Dispersible/Chewable Tablets than your

doctor tells you to.

The usual effective dose of Lamictal Dispersible/Chewable

Tablets for adults and children aged 13 years or over 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

maintenance dose of 200mg daily.

Lamictal Dispersible/Chewable Tablets are not recommended

for children aged under 2 years.

How to take your dose of Lamictal

Dispersible/Chewable Tablets

Take your dose of Lamictal Dispersible/Chewable Tablets 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 Dispersible/Chewable 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 Dispersible/Chewable

Tablets than you should

Contact a doctor or nearest hospital emergency

department immediately. If possible, show them the

Lamictal Dispersible/Chewable Tablets packet.

If you take too many Lamictal Dispersible/Chewable

Tablets you may be more likely to have serious side

effects which may be fatal.

Someone who has taken too many Lamictal

Dispersible/Chewable Tablets 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

Dispersible/Chewable Tablets

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 Dispersible/Chewable Tablets

Ask your doctor for advice on how to start taking it

again. It’s important that you do this.

Page 2 of 2

Don’t stop taking Lamictal Dispersible/Chewable

Tablets without advice

Lamictal Dispersible/Chewable Tablets must be taken for as

long as your doctor recommends. Don’t stop unless your

doctor advises you to.

If you’re taking Lamictal Dispersible/Chewable

Tablets for epilepsy

To stop taking Lamictal Dispersible/Chewable Tablets, it is

important that the dose is reduced gradually, over about

2 weeks. If you suddenly stop taking Lamictal

Dispersible/Chewable Tablets, your epilepsy may come back

or get worse.

If you’re taking Lamictal Dispersible/Chewable

Tablets for bipolar disorder

Lamictal Dispersible/Chewable Tablets may take some time to

work, so you are unlikely to feel better straight away. If you

stop taking Lamictal Dispersible/Chewable 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 Lamictal

Dispersible/Chewable Tablets.

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

Dispersible/Chewable 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 Lamictal Dispersible/Chewable

Tablets, especially if the starting dose is too high or if the

dose is increased too quickly or if Lamictal

Dispersible/Chewable 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:

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

Dispersible/Chewable Tablets. In case you have

developed Stevens-Johnson syndrome or toxic

epidermal necrolysis your doctor will tell you that you

must never use lamotrigine again.

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).

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.

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: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more

information on the safety of this medicine.

5.

How to store Lamictal

Dispersible/Chewable Tablets

KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH

OF CHILDREN.

Do not store above 30

C. Store in a dry place.

Do not use after the expiry date printed on the carton and

blister strip. The expiry date refers to the last day of that

month.

If your doctor tells you to stop taking the tablets, please

return any which are left over to your pharmacist. Only keep

them if your doctor tells you to.

If the tablets become discoloured or show any signs of

deterioration, you should seek the advice of your doctor or

pharmacist.

If you have any unwanted tablets, them back to your

pharmacist, who will dispose of them in a way that won’t

harm the environment.

Do not throw away any medicines via wastewater or

household waste. Ask your pharmacist how to throw away

medicines you no longer use. This will help protect the

environment.

6.

Contents of the pack and other

information

What Lamictal Dispersible/Chewable Tablets

contain

The active substance is lamotrigine.

Each dispersible/chewable tablet contains 25mg of

lamotrigine.

Lamictal Dispersible/Chewable Tablets also contain the

following as inactive ingredients: calcium carbonate;

hydroxypropylcellulose; aluminium magnesium silicate;

sodium starch glycollate; povidone; saccharine sodium;

magnesium stearate, blackcurrant flavouring.

What Lamictal Dispersible/Chewable Tablets look

like and contents of the pack

The tablets are white, blackcurrant flavoured, multifaceted,

marked with ‘25’ on one side and flat with ‘GSCL5’ on the

reverse.

Lamictal Dispersible/Chewable Tablets are supplied in packs

of 56 tablets.

Manufacturer

Manufactured by: GlaxoSmithKline Pharmaceuticals S.A.,

Ul. Grunwaldzka 189, 60-322 Poznan, Poland.

Procured from within the EU and repackaged by:

Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,

Doncaster, DN3 1QR.

Product Licence holder: Landmark Pharma Ltd.,

7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.

PL No: 21828/0725

Lamictal

is a registered trademark of the GlaxoSmithKline

group of companies.

Leaflet revision date: 24.04.17

Other formats:

To request a copy of this leaflet in Braille, large print or

audio, please call 01302 365000 and ask for the Regulatory

Department.

Please be ready to give the following information:

Product name:

Lamictal 25mg

Dispersible/Chewable Tablets

Reference number:

21828/0725

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

Not applicable

8.

MARKETING AUTHORISATION NUMBER

Not applicable

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Not applicable

10.

DATE OF REVISION OF THE TEXT

Not applicable

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