LAMOTRIGINE SANDOZ lamotrigine 25 mg dispersible/chewable tablets blister pack

Main information

  • Trade name:
  • LAMOTRIGINE SANDOZ lamotrigine 25 mg dispersible/chewable tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • LAMOTRIGINE SANDOZ lamotrigine 25 mg dispersible/chewable tablets blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 187261
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

187261

LAMOTRIGINE SANDOZ lamotrigine 25 mg dispersible/chewable tablets blister pack

ARTG entry for

Medicine Registered

Sponsor

Sandoz Pty Ltd

Postal Address

54 Waterloo Road,Macquarie Park, NSW, 2113

Australia

ARTG Start Date

3/05/2012

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. LAMOTRIGINE SANDOZ lamotrigine 25 mg dispersible/chewable tablets blister pack

Product Type

Single Medicine Product

Effective date

3/02/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Lamotrigine is an antiepileptic drug for the treatment of partial and generalised seizures in adults and children.,There is extensive experience with

Lamotrigine used initially as Ôadd-onö therapy. The use of Lamotrigine has also been found to be effective as monotherapy following withdrawal of

concomitant antiepileptic drugs.,Initial monotherapy treatment in newly diagnosed paediatric patients is not recommended.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PCTFE (Aclar)/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. LAMOTRIGINE SANDOZ lamotrigine 25 mg dispersible/chewable tablets blister pack

Dosage Form

Tablet, dispersible

Route of Administration

Oral

Visual Identification

White to off-white, rounded square shaped uncoated tablets debossed with

'H' on multifaceted side and '80' on flat side

Active Ingredients

Lamotrigine

25 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 29.11.2017 at 02:04:13 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

LAMOTRIGINE

SANDOZ

®

Lamotrigine dispersible/chewable tablets

Consumer Medicine Information

THERE ARE REPORTS OF SEVERE, POTENTIALLY LIFE-THREATENING RASHES ASSOCIATED WITH

LAMOTRIGINE TREATMENT, PARTICULARLY IN CHILDREN. LAMOTRIGINE SHOULD BE

DISCONTINUED AT THE FIRST SIGN OF RASH UNLESS THE RASH IS CLEARLY NOT DRUG RELATED.

What is in this leaflet

Please read this leaflet carefully

before you take Lamotrigine Sandoz

tablets.

This leaflet answers some common

questions about Lamotrigine Sandoz

tablets. It does not contain all of the

available information.

It does not take the place of talking to

your doctor or pharmacist.

All medicines have risks and

benefits. Sometimes new risks are

found even when a medicine has

been used for many years. Your

doctor has weighed the risks of you

taking Lamotrigine Sandoz against

the benefits they expect it will have

for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Lamotrigine

Sandoz is used for

Lamotrigine Sandoz tablets contain

lamotrigine as the active ingredient

and belongs to a group of medicines

called "anti-epileptic drugs".

Lamotrigine Sandoz tablets are used

for the treatment of epilepsy in

patients over 2 years of age.

In general, it is initially used in

addition to other medicines, for the

treatment of epilepsy including

partial or generalized seizures and

Lennox-Gastaut Syndrome.

It is thought that this medicine works

by changing the levels of some

chemicals associated with seizures.

Ask your doctor if you have any

questions about why Lamotrigine

Sandoz has been prescribed for you.

Your doctor may have prescribed it

for another reason.

This medicine is only available with

a doctor's prescription.

It is not addictive.

Before you take it

When you must not take it:

Do not take Lamotrigine Sandoz if

you have ever had an allergic

reaction to:

lamotrigine

any of the ingredients listed at the

end of this leaflet.

Symptoms of an allergic reaction

may include shortness of breath ,

wheezing or difficulty in breathing;

swelling of the face, lips, tongue or

any other parts of the body; rash,

itching or hives on the skin.

Do not take this medicine:

after the expiry date printed on

the pack has passed

the packaging is torn or shows

signs of tampering.

Before you start to take it:

Tell your doctor if you are taking

any other medicines that contain

lamotrigine.

Tell your doctor if you are allergic

to any other medicines or any

foods, dyes or preservatives.

Tell your doctor if you have or

have had any of the following

medical conditions:

a history of allergy or rash to

other anti-epileptic drugs

liver or kidney disease

Parkinson's disease

if you have ever developed

meningitis after taking

lamotrigine.

Tell your doctor if you are

pregnant or trying to become

pregnant.

Lamotrigine Sandoz may affect your

unborn baby if you take it during

pregnancy but it is still important that

you control your fits while you are

pregnant. Your doctor will discuss

the risks and benefits of taking

Lamotrigine Sandoz during

pregnancy.

It is recommended that women on

anti-epileptic drugs, such as

Lamotrigine Sandoz, receive pre-

LAMOTRIGINE SANDOZ

pregnancy counseling with regard to

the possible risk to their unborn

child.

Studies have shown a decrease in the

levels of folic acid during pregnancy

when lamotrigine is also used. It is

therefore recommended that you take

a daily 5 mg folate supplement,

before becoming pregnant and during

the first 12 weeks of your pregnancy.

Tell your doctor if you are breast

feeding or planning to breast feed.

Lamotrigine Sandoz can pass into

breast milk and may affect your

baby. Your doctor will discuss the

risks and benefits of taking

Lamotrigine Sandoz if you are

breastfeeding.

Do not give this medicine to anyone

else even if their symptoms seem

similar to yours.

Do not take Lamotrigine Sandoz to

treat any other complaints unless

your doctor says to.

Use in children

Epilepsy: Lamotrigine Sandoz is not

recommended in children under 2

years of age. Children's weight

should be checked and the dose

reviewed as weight changes with

growth occur.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that you get without a prescription

from a pharmacy, supermarket or

health food shop.

Some medicines may interfere with

Lamotrigine Sandoz. These include:

valproate and carbamazepine,

used to treat both epilepsy and

mental health problems

any form of hormonal medicine,

e.g. "the pill" or HRT

other anti-epileptic drugs, e.g.

phenytoin, primidone or

phenobarbitone

OCT2 substrates such as

dofetilide

rifampicin, an antibiotic, which is

used to treat infections, including

tuberculosis

medicines used to treat Human

Immunodeficiency Virus (HIV)

infection

risperidone, used to treat mental

health problems.

These medicines may be affected by

Lamotrigine Sandoz or may affect

how well it works. You may need to

take different amounts of your

medicine or you may need to take

different medicines.

Your doctor or pharmacist has more

information on medicines to avoid

while taking Lamotrigine Sandoz.

How to take it

Using Lamotrigine Sandoz

for the first time

You may notice that you feel dizzy,

tired, or unsteady in the first few

weeks of treatment with Lamotrigine

Sandoz. During this period you may

also notice that you have slight

problems with your vision. As your

reactions may be slower during this

period you should not operate any

machinery or appliances and you

should not drive a car. If any of these

effects do not go away or are

troublesome you should see your

doctor.

Contact your doctor immediately if

you develop any skin rash such as

spots or 'hives' during Lamotrigine

Sandoz treatment.

There are reports of severe,

potentially life-threatening rashes

associated with Lamotrigine Sandoz

treatment, particularly in children.

Lamotrigine Sandoz should be

discontinued at the first sign of rash

unless the rash is clearly not drug

related.

If you have any questions about

taking Lamotrigine Sandoz tablets

ask your doctor or pharmacist.

How much to take

It may take a while to find the best

dose of Lamotrigine Sandoz for you.

The dose you take will depend on:

your age and weight

whether you are taking

Lamotrigine Sandoz with other

medications

whether you have any kidney or

liver problems

Never take more Lamotrigine

Sandoz than your doctor has told

you to.

Do not increase the dose more

quickly than you have been told.

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.

Women taking hormonal

contraceptives such as the birth

control 'pill' may need a higher

maintenance dose of Lamotrigine

Sandoz. Your doctor will usually

decrease your dose once you stop

taking hormonal contraceptives.

Tell your doctor if there are any

changes in your menstrual pattern

such as breakthrough bleeding

while on the 'pill'.

Your doctor may need to adjust the

dose of Lamotrigine Sandoz as the

'pill' may not work as effectively for

contraception whilst taking it.

How to take it

Lamotrigine Sandoz tablets may be

swallowed whole, chewed or

dispersed in a small volume of water

(at least enough to cover the whole

tablet).

It can be taken with or without food.

Your doctor may also advise you to

start or stop taking other medications,

depending on what condition you are

being treated for and the way you

respond to treatment.

How long to take it

For epilepsy patients, do not stop

taking Lamotrigine Sandoz tablets

LAMOTRIGINE SANDOZ

or change the dose without first

checking with your doctor.

Your doctor will advise you if you

need to stop taking Lamotrigine

Sandoz tablets and how to do this

gradually over a period of two

weeks.

If you take too much

(Overdose)

Immediately telephone your doctor

or Poisons Information Centre

(telephone 13 11 26) for advice, or

go to Accident or Emergency

department at your nearest

hospital if you think you or anyone

else may have taken too many

Lamotrigine Sandoz tablets. Do

this even if there are no signs of

discomfort or poisoning.

If you take too much Lamotrigine

Sandoz you may be more likely to

have serious side effects which may

be fatal.

Symptoms of Lamotrigine Sandoz

overdose can include rapid,

uncontrollable eye movements,

clumsiness and lack of coordination

affecting your balance, impaired or

loss of consciousness, fit or coma.

While you are taking it

Things you must do

Take Lamotrigine Sandoz exactly

as your doctor has prescribed.

Contact your doctor immediately if

you develop any skin rash such as

spots or 'hives' during Lamotrigine

Sandoz treatment.

There are reports of severe,

potentially life-threatening rashes

associated with Lamotrigine Sandoz

treatment, particularly in children.

Lamotrigine Sandoz should be

discontinued at the first sign of rash

unless the rash is clearly not drug

related.

Tell any other doctor, dentist or

pharmacist who is treating you

that you are taking Lamotrigine

Sandoz, especially if you are about

to be started on any new

medicines.

If you require a laboratory test, tell

your doctor or hospital that you

are taking this medicine.

Lamotrigine Sandoz may interfere

with some laboratory tests to detect

other drugs.

Talk to your doctor as soon as

possible if you are pregnant or if

you are planning to become

pregnant.

Your doctor will discuss the risks and

benefits of taking Lamotrigine

Sandoz during pregnancy.

Talk to your doctor if you're breast

feeding or planning to breast feed.

Lamotrigine Sandoz can pass into

breast milk and may affect your

baby. Your doctor will discuss the

risks and benefits of breastfeeding

while you are taking it.

Tell your doctor if, for any reason,

you have not taken your medicine

exactly as directed.

Otherwise, your doctor may think

that it was not working as it should

and change your treatment

unnecessarily.

Things you must not do

For epilepsy patients, do not stop

taking Lamotrigine Sandoz or

change the dose without first

checking with your doctor.

If you stop taking Lamotrigine

Sandoz tablets suddenly, your

epilepsy may come back or become

worse. This is known as "rebound

seizures". Your doctor will advise

you if you need to stop taking

Lamotrigine Sandoz and how to do

this gradually over about 2 weeks.

Do not take a double dose to make

up for any that you may have

missed.

Things to be careful of

Be careful driving or operating

machinery until you know how

Lamotrigine Sandoz affects you.

Make sure you know how you react

to Lamotrigine Sandoz before you

drive a car, operate machinery, or do

anything else that could be dangerous

if you are dizzy or light-headed. If

this occurs do not drive.

Children should not ride a bike,

climb trees or do anything else that

could be dangerous if they are feeling

dizzy or sleepy.

Tell your doctor immediately or go

to Accident and Emergency

department of your nearest

hospital if you or someone you

know has any suicidal thoughts or

other mental/mood changes.

All mentions of suicide or violence

must be taken seriously. Families and

caregivers of children and

adolescents who are taking

Lamotrigine Sandoz should be

especially watchful for any changing

behavior. Anti-epileptic medicines

such as Lamotrigine Sandoz may

increase the risk of suicidal behavior

(including suicidal thoughts and

suicide attempts).

Side Effects

Tell your doctor as soon as possible

if you do not feel well while you are

taking Lamotrigine Sandoz.

All medicines can have side effects.

Sometime they are serious, most of

the time they are not. You may need

medical treatment if you get some of

the side effects

Ask your doctor or pharmacist to

answer any questions you may

have.

The most commonly reported side

effects are:

dizziness

movement problems such as tics,

unsteadiness and jerkiness

tremors

skin rash

headache

nausea

vomiting

feeling drowsy or tired

LAMOTRIGINE SANDOZ

blurred or double vision

rapid, uncontrollable eye

movements

trouble sleeping

feeling sleepy

irritability, aggression or agitation

hallucinations, confusion

increased activity in children

joint, back or stomach pain

respiratory or lung problems

depression

loss of memory

liver problems

diarrhoea

dry mouth.

In general these side effects usually

happen during the first few weeks of

treatment with Lamotrigine Sandoz.

Tell your doctor immediately or go

to Accident and Emergency

department of your nearest

hospital if you or someone you

know has any suicidal thoughts or

other mental/mood changes whilst

taking Lamotrigine Sandoz.

All mentions of suicide or violence

must be taken seriously. Families and

caregivers of children and

adolescents who are taking

Lamotrigine Sandoz should be

especially watchful for any changing

behavior. Anti-epileptic medicines

such as Lamotrigine Sandoz may

increase the risk of suicidal behavior

(including suicidal thoughts and

suicide attempts).

Potentially serious skin

reaction.

A small number of people taking

Lamotrigine Sandoz get an allergic

reaction or potentially serious skin

reaction, which may develop into

more serious problems if they are not

treated. Severe allergic reactions are

rare.

These symptoms are more likely to

happen during the first few months of

treatment with Lamotrigine Sandoz,

especially if the dose is too high or if

the dose is increased too quickly, of

if Lamotrigine Sandoz is taken with a

medicine called valproate. Serious

skin reactions are more common in

children. Symptoms of these serious

allergic reactions include:

any skin reaction e.g. rash or

'hives'

wheezing, difficulty in breathing

swelling of the face, lips or

tongue

sore mouth or sore eyes

fever

swollen glands.

Tell your doctor immediately if

you notice any of the above

symptoms.

Liver and blood problems

Tell your doctor if you notice any

of these symptoms:

drowsiness

itching

abdominal pain or tenderness

feeling very tired

easy bruising or unusual bleeding

a sore throat, or more infections

such as a cold, than usual

yellow skin (jaundice).

Your doctor may decide to carry out

tests on your liver, kidneys or blood

and may tell you to stop taking

Lamotrigine Sandoz if you

experience these rare symptoms.

If you are taking Lamotrigine

Sandoz for epilepsy tell your

doctor as soon as possible if your

seizures get worse or if you have a

new type of seizure.

You may need urgent medical

attention or hospitalisation.

Serious side effects are rare.

Tell your doctor if you notice

anything else that is making you

feel unwell, even if you think the

problems are not connected with

this medicine and are not referred

to in this leaflet.

Other side effects not listed above

may also occur in some people.

Do not be alarmed by this list of

possible side-effects.

You may not experience any of them.

After taking it

Storage

Keep Lamotrigine Sandoz tablets

in a cool dry place where the

temperature stays below 25°C.

Protect from moisture.

Keep this medicine where children

cannot reach it.

A locked cupboard at least one-and-

a-half meters of the ground is a good

place to store medicine.

Product Description

What it looks like

Lamotrigine Sandoz 25 mg:

Lamotrigine Sandoz dispersible/

chewable tablets are white to off-

white, rounded square shaped

uncoated tablets debossed with 'H' on

multifaceted side and '80' on flat side.

Lamotrigine Sandoz 50 mg:

Lamotrigine Sandoz dispersible/

chewable tablets are white to off-

white rounded square shaped

uncoated tablets debossed with 'H' on

multifaceted side and '79' on flat side.

Lamotrigine Sandoz 100mg:

Lamotrigine Sandoz dispersible/

chewable tablets are white to off

white rounded square shaped

uncoated tablets debossed with 'H' on

multifaceted side and '78' on flat side.

Lamotrigine Sandoz 200mg:

Lamotrigine Sandoz dispersible/

chewable tablets 200 mg are white to

off-white rounded square shaped

uncoated tablets debossed with 'H' on

multifaceted side and '77' on flat side.

Available in blister packs of 56

tablets.

LAMOTRIGINE SANDOZ

Ingredients

Active ingredient:

Each Lamotrigine Sandoz tablet

contains either 25 mg, 50 mg, 100

mg, 200 mg of lamotrigine.

Inactive ingredients:

Microcrystalline cellulose

(PH-101)

Microcrystalline cellulose

(PH-102)

Heavy magnesium carbonate

Polacrilin potassium

Sucralose

Povidone

Magnesium stearate

Black currant flavour 501017

AP0551 (PI-ARTG No.106513).

Supplier

Sandoz Pty Ltd

ABN 60 075 449 553

54 Waterloo Road

Macquarie Park, NSW 2113

Australia

Tel: 1800 634 500

Australian Register Numbers:

25 mg dispersible/chewable tablet:

AUST R 187261

50 mg dispersible/chewable tablet:

AUST R 187272

100 mg dispersible/chewable tablet:

AUST R 187278

200 mg dispersible/chewable tablet:

AUST R 187254

This leaflet was revised in January

2017

LAMOTRIGINE SANDOZ