Lamictal 50 mg chewable/dispersible tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Lamotrigine
Available from:
Lexon (UK) Ltd
ATC code:
N03AX; N03AX09
INN (International Name):
Lamotrigine
Dosage:
50 milligram(s)
Pharmaceutical form:
Chewable/dispersible tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Other antiepileptics; lamotrigine
Authorization status:
Authorised
Authorization number:
PPA1097/007/004
Authorization date:
2017-05-19

Read the complete document

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 is and what it is used for

What you need to know before you take Lamictal

How to take Lamictal

Possible side effects

How to store Lamictal

Contents of the pack and other information

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.

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

Lamictal 50 mg chewable/dispersible tablets

Package leaflet: Information for the User

*

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).

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 in this leaflet. You can also report side

effects directly via HPRA Pharmacovigilance Website: www.hpra.ie

By reporting side effects you can help provide more information on the safety

of this medicine.

How to store Lamictal

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

Do not use this medicine after the expiry date shown on the blisters and

carton. The expiry date refers to the last day of that month.

Lamictal does not require any special storage conditions.

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.

Contents of the pack and other information

What Lamictal chewable/dispersible tablets contain

The active substance is lamotrigine. Each chewable/dispersible tablet

contains 50 mg lamotrigine.

The other ingredients are: calcium carbonate,

low-substituted hydroxypropyl cellulose, aluminium magnesium silicate,

sodium starch glycolate, povidone K30, sodium saccharine,

magnesium stearate (Ph. Eur.), blackcurrant flavour.

What Lamictal chewable/dispersible tablets look like and contents of

the pack

Lamictal 50 mg chewable/dispersible tablet are a white to off-white

multi

faceted, super elliptical, tablets with a blackcurrant odour, marked

"GSCX7" on one side and "50" on the other. The tablets may be slightly

mottled. Each pack contains blisters of 56 tablets.

Product procured from within the EU, repackaged and distributed by the

Parallel Product Authorisation Holder: Lexon (UK) Limited, Unit 18,

Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE, UK.

The manufacturer is:

GlaxoSmithKline Pharmaceuticals S.A., UI Grunwaldzka 189,

60-322 Poznan, Poland.

Lamictal is a registered trademark of, GlaxoSmithKline Group of Companies.

PPA1097/007/004

Revision date: 29/07/2020

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited,

Tel: +44 (0)1527 505414 for help.

This medicinal product is authorised in the Member States of the EEA

under the following names:

*

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,

neuro logical 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.

Ref:1097/007/004/290720/1/F

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1

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lamotrigine

6

Austria

Lamictal

Belgium Lamictal

Bulgaria Lamictal

Cyprus Lamictal

Czech Republic

Lamictal

Denmark Lamictal

Estonia Lamictal

Finland Lamictal

France Lamictal

Germany Lamictal

Greece Lamictal

Hungary Lamictal

Iceland Lamictal

Ireland Lamictal

Italy Lamictal

Latvia Lamictal

Lithuania Lamictal

Luxemburg Lamictal

Malta Lamictal

The Netherlands

Lamictal

Norway Lamictal

Poland Lamitrin

Lamitrin S

Spain Lamictal

Romania Lamictal

Slovak Republic Lamictal

Slovenia Lamictal

Portugal Lamictal

Sweden Lamictal

United Kingdom

Lamictal

Croatia

Lamictal

2

5

POM

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.

Lamictal chewable/dispersible tablets contains less than 1 mmol

sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

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.

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

3

*

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)

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.

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

Ref:1097/007/004/290720/1/B

4

Read the complete document

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Lamictal 50 mg chewable/dispersible tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each Lamictal 50 mg chewable/dispersible tablet contains 50 mg lamotrigine.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Chewable/dispersible tablet.

Product imported from Germany

White to off-white multi-faceted, super-elliptical, tablets with a blackcurrant odour, marked "GSCX7" on one side and

"50" on the other. The tablets may be slightly mottled.

4 CLINICAL PARTICULARS

As per PA1077/061/008

5 PHARMACOLOGICAL PROPERTIES

As per PA1077/061/008

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Calcium carbonate

Hyprolose

Aluminium magnesium silicate

Poly(O-carboxymethyl) starch, sodium salt

Povidone K30

Sodium saccharine

Magnesium stearate (Ph. Eur.)

Blackcurrant flavour

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

The shelf life expiry date for this product shall be the date shown on the blister and outer package of the product on the

market in the country of origin.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

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6.5 Nature and contents of container

Blister packs of 56 tablets.

6.6 Special precautions for disposal

No special requirements.

7 PARALLEL PRODUCT AUTHORISATION HOLDER

Lexon (UK) Ltd

Unit 18

Oxleasow Road

East Moons Moat

Redditch

Worcestershire

B98 0RE

United Kingdom

8 PARALLEL PRODUCT AUTHORISATION NUMBER

PPA1097/007/004

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 19

May 2017

10 DATE OF REVISION OF THE TEXT

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