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LAMOTRIGINE RANBAXY 50 MG DISPERSIBLE TABLETS

Active substance(s): LAMOTRIGINE

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Lamotrigine Ranbaxy 25mg Dispersible Tablets
Lamotrigine Ranbaxy 50mg Dispersible Tablets
Lamotrigine Ranbaxy 100mg Dispersible Tablets
Lamotrigine Ranbaxy 200mg Dispersible Tablets
Lamotrigine

Read all of this leaflet carefully before you
start taking this medicine.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, please
ask your doctor or pharmacist.
• This medicine has been prescribed for you.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
• If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Lamotrigine are and what are they
used for
2. Before you take Lamotrigine
3. How to take Lamotrigine
4. Possible side effects
5. How to store Lamotrigine
6. Further information

occasionally become worse or happen more often
while you're taking Lamotrigine. Some patients
may experience severe seizures, which may
cause serious health problems. If your seizures
happen more often, or if you experience a severe
seizure while you're taking Lamotrigine.


See a doctor as soon as possible

Lamotrigine should not be given to people
aged under 18 years to treat bipolar disorder.
Medicines to treat depression and other mental
problems increase the risk of suicidal thoughts
and behaviour in children and adolescents aged
under 18 years.
Taking other medicines
Tell your doctor or pharmacist if you're taking
other medicines, if you've taken any recently,
or if you start taking new ones- these include
herbal medicines or other medicines you bought
without a prescription.

1. What lamotrigine is and what it is used for

If you are taking certain medicines, your doctor
may need to check the dose of Lamotrigine.
These include:

Lamotrigine belongs to a group of medicines
known as anti-epileptics. It is used to treat two
conditions – epilepsy and bipolar disease.



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








For adults and children aged 13 years and
over, Lamotrigine can be used on its own or
with other medicines, to treat epilepsy.
Lamotrigine can also be used with other
medicines to treat the seizures that occur with
a condition called Lennox-Gastaut
syndrome.
For children aged between 2 and 12 years,
Lamotrigine can be used with other
medicines, to treat those conditions. It can be
used on its own to treat a type of epilepsy
called typical absence seizures.








2. Before you take lamotrigine



If this applies to you:
• Tell your doctor, and don't take Lamotrigine.
Take special care with Lamotrigine
Your doctor needs to know before you take
Lamotrigine:
• if you have problems with your kidneys
• if you have ever developed a rash when
you've taken lamotrigine or other medicines
for epilepsy
• if you are already taking medicine that
contains lamotrigine.
If any of these applies to you:
• Tell your doctor, who may decide to lower
your dose or that Lamotrigine, is not suitable
for you.
Watch out for important symptoms
If you develop any of these symptoms after you
start taking Lamotrigine, get a doctor's help
straight away:
• an unusual skin reaction, such as redness
or rashes
• a sore mouth or eyes
• a high temperature (fever), flu-like
symptoms or drowsiness
• swelling around the face, or swollen
glands in your neck, armpit or groin
• unexpected bleeding or bruising, or your
fingers turning blue
• a sore throat or more infections (such as
colds) than usual
These symptoms are more likely to happen during
the first few months of treatment with Lamotrigine,
especially if you start on too high dose or if your
dose is increased too quickly, or if you're taking
Lamotrigine with another medicine called
valporate. Children are more likely to be affected
than adults.
The symptoms listed above can develop into
more serious problems, such as organ failure or a
very severe skin condition, if they are not treated,
if you notice any of these symptoms:
• See a doctor as soon as possible. Your
doctor may decide to carry out tests on your liver,
kidneys or blood, and may tell you to stop taking
Lamotrigine.
Thoughts of harming yourself or suicide
Anti-epileptic medicines are used to treat several
conditions, including epilepsy and bipolar
disorder. People with bipolar disorder can
sometimes have thoughts of harming themselves
or committing suicide. If you have bipolar disorder,
you may be more likely to think like this:




when you first start treatment
if you have previously had thoughts about
harming yourself or about suicide
if you are under 25 years old

If you have distressing thoughts or experiences,
or if you notice that you feel worse or develop new
symptoms while you're taking Lamotrigine.


See a doctor as soon as possible or go to
the nearest hospital for help.

A small number of people being treated with antiepileptics such as Lamotrigine 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 Lamotrigine for eplilepsy
The seizures in some types of epilepsy may

Black

Refl. Blue

Tell your doctor if you are taking any of
these.

Some medicines interact with Lamotrigine or
make it more likely that you'll have side effects.
These include:

Lamotrigine also treats bipolar disorder.
People with bipolar disorder (sometimes called
manic depression) have extreme mood swings,
with periods of mania (excitement or euphoria)
alternating with periods of depression (deep
sadness or despair). For adults aged 18 years and
over, Lamotrigine can be used on its own or with
other medicines, to prevent the periods of
depression that occur in bipolar disorder. It is not
yet known how Lamotrigine works in the brain to
have this effect.

Do not take Lamotrigine:
• If you are allergic (hypersensitive) to
lamotrigine or any of the other ingredients of
Lamotrigine (listed in Section 6).

oxcarbazepine, felbamate, gabapentin,
levetiracetam, pregabalin, topiramate or
zonisamide, used to treat epilepsy.
lithium, used to treat mental health
problems
bupropion, used to treat mental health
problems or to stop smoking







valporate, 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
olanzapine, used to treat mental health
problems
risperidone, used to treat mental health
problems
rifampicin, which is an antibiotic
atazanavir, lopinavir and ritonavir
(medicines used to treat Human
Immunodeficiency Virus (HIV) infection).
hormonal contraceptives, such as the Pill
(see below)
Tell your doctor if you are taking, or if you
start or stop taking, any of these.

Hormonal contraceptives (such as the Pill)
can affect the way Lamotrigine works
Your doctor may recommend that you use a
particular type of hormonal contraceptive, or
another method of contraception, such as
condoms, a cap or a coil. If you are using a
hormonal contraceptive like the Pill, your doctor
may take samples of your blood to check the level
of Lamotrigine. If you plan to start using a
hormonal contraceptive:
• Talk to your doctor, who will discuss suitable
methods of contraception with you.
Lamotrigine can also affect the way hormonal
contraceptives work, although it's unlikely to make
them less effective. If you are using 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
Lamotrigine is affecting the way your
contraceptive is working.
Pregnancy and breast feeding

Talk to your doctor if you're pregnant, if
you might be pregnant, or if you're
planning to become pregnant.
You should not stop treatment for your epilepsy
while you're pregnant; however, there is an
increased risk of birth defects in babies whose
mothers took Lamotrigine during pregnancy.
These defects include cleft lip or cleft plate. Your
doctor may advise you to take extra folic acid if
you're planning to become pregnant and while
you're pregnant.
Pregnancy may also alter the effectiveness of
Lamotrigine, so your doctor may take samples of
your blood to check the level of Lamotrigine, and
may adjust your dose.
• Talk to your doctor if you're breast feeding
or planning to breast feed. The active
ingredient of Lamotrigine passes into breast
milk and may affect your baby. Your doctor
will discuss the risks and benefits of breast
feeding while you're taking Lamotrigine, and
will check your baby from time to time if you
decide to breast feed.
Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines
Lamotrigine can cause dizziness and double
vision.
• Don't drive or operate machines unless
you are sure you're not affected.
If you have epilepsy, talk to your doctor about
driving and using machines.
Tablets:
Important information about some of the
ingredients of Lamotrigine
Lamotrigine tablet contains a source of
phenylalanine. May be harmful for people with
phenylketonuria.
3. How to take lamotrigine
Always use Lamotrigine exactly as your
doctor has told you to. Check with your doctor or
pharmacist if you're not sure.
How much Lamotrigine to take
It may take a while to find the best dose of
Lamotrigine for you. The dose you take will
depend on:




your age
whether you are taking Lamotrigine with other
medicines
whether you have problems with your kidneys
or liver.

[ 5107209] - LIT LAMOTRIGINE DIS TAB
PIL size - 140 x 580 mm
Market : UK
RLL-DWS : 22.01.14VS/nj, (99673)

Your doctor will start you on a low dose, and
gradually increase the dose over a few weeks until
you reach a dose that works for you (called the
effective dose). Never take more Lamotrigine
than your doctor tells you to.








The usual effective dose of Lamotrigine for adults
and children aged over 12 years is between
100mg and 400mg each day.

Rare side effects
These may affect up to 1 in 1,000 people:

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 maxiumum of 400mg daily.
How to take your dose of Lamotrigine
Tablets:
Take your dose of Lamotrigine once or twice a
day, as your doctor advises. You can take it with or
without food.
Your doctor may also advise you to start or stop
taking other medicines, depending on what
condition you're being treated for and the way you
respond to treatment.
• Swallow your tablets whole. Don't break,
chew or crush them.
• Always take the full dose that your doctor
has prescribed. Never take only part of a
tablet.
Dispersible/Chewable tablets
Take your dose of Lamotrigine once or twice a
day, as your doctor advises. You can take it 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.
You can take Lamotrigine Dispersible/Chewable
tablets by swallowing them whole with a little water,
by chewing them, or by dissolving them in water.
If you chew the tablet:
You may need to drink a little more water at the
same time to help the tablet dissolve in your
mouth. Then drink some more water to make sure
you have swallowed all the medicine.
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 for about a minute,
until the tablet is fully dissolved.
Drink all the liquid.
Add a little more water to the glass and drink that,
and to make sure you've taken all the medicine.
If you take more Lamotrigine than you should:
If anyone takes too much Lamotrigine
• Contact a doctor or pharmacist
immediately. If possible, show them the
Lamotrigine packet.
Someone who has taken too much Lamotrigine
may have these symptoms:
• rapid, uncontrollable eye movements
(nystagmus)
• clumsiness and lack of co-ordination,
affecting their balance (ataxia)
• loss of consciousness or coma



shaking or tremors
difficulty in sleeping
diarrhoea
dry mouth
feeling tired
pain in your back or joints, or elsewhere.

itchy eyes, with discharge and crusty eylids
(conjunctivitis)

Very rare side effects
These may include up to 1 in 10,000 people:
• hallucinations ('seeing' or 'hearing' things that
aren't really there)
• confusion or agitation
• 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
• changes in liver function, which will show up
in blood tests, or liver failure
• changes which may show up in blood testsincluding reduced numbers of red blood cells
(anaemia), reduced numbers of white blood
cells (leucopoenia, 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
• a disorder of blood clotting, which can cause
unexpected bleeding or bruising
(disseminated intravascular coagulation)
• a high temperature (fever)
• swelling around the face (oedema) or swollen
glands in the neck, armpit or groin
(lymphadenopathy)
• in people who already have Parkinson's
disease, worsening of the symptoms.
Not known side effects: (frequency cannot be
estimated from the available data)
• fever, nausea, vomiting, headache, stiff neck
and extreme sensitivity to bright light. These
symptoms may be due to an infection around
the brain or spinal cord (aseptic meningitis).
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 antiepileptic
medication, have a history of osteoporosis, or
take steroids.
If you get side effects
• If any of the side effects becomes severe or
troublesome, or if you notice any side effects
not listed in this leaflet please tell your
doctor or pharmacist.
Reporting of side effects
Also you can help to make sure that medicines
remain as safe as possible by reporting any
unwanted side effects via the internet at
www.mhra.gov.uk/yellowcard. Alternatively you
can call Freephone 0808 100 3352 (available
from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in
a paper form available from your local pharmacy.
5. How to store Lamotrigine

If you forget to take Lamotrigine
Don't take extra tablets or a double dose to
make up for a forgotten dose.

Keep out of the reach and sight of children.
Do not take after the expiry date on the carton and
blister. The expiry date refers to the last day of that
month.

If you have missed taking a dose of
Lamotrigine:
• Ask your doctor for advice on how to start
taking it again. It's important that you do this.

Do not store above 25oC.
Store in the original package, in order to protect
from moisture
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment
Any unused product or waste material should be
disposed of in accordance with local
requirements.

Don't stop taking Lamotrigine without advice.
Take Lamotrigine for as long as your doctor
recommends. Don't stop unless your doctor
advises you to.
If you are taking Lamotrigine for epilepsy
To stop taking Lamotrigine, it is important that
your dose is reduced gradually , over about 2
weeks. If you suddenly stop taking Lamotrigine,
your epilepsy may come back or get worse.
If you are taking Lamotrigine for bipolar
disorder
Lamotrigine may take some time to work, so you
are unlikely to feel better straight away. If you stop
taking Lamotrigine, your dose will not need to be
reduced gradually. But you should still talk to your
doctor first, if you want to stop taking Lamotrigine.
4.

Possible side effects

Like all medicines, Lamotrigine can cause side
effects, but not everyone gets them.
Allergic reaction or potentially serious skin
reaction: get a doctor's help straight away
A small number of people taking Lamotrigine get
an allergic reaction or potentially serious skin
reaction, which may develop into more serious,
and even life-threatening, problems if they are not
treated. Symptoms of these reactions include:








skin rashes or redness including a rare skin
condition, with severe blisters, and bleeding
from the lips, eyes, mouth, nose and genital
area (Stevens-Johnson syndrome); a severe
skin reaction, starting with a painful red area,
developing into large blisters then peeling of
layers of skin (toxic epidermal nercolysis)
a sore mouth or eyes
a high temperature (fever), flu-like
symptoms or drowsiness
swelling around your face, or swollen
glands in your neck, armpit or groin
unexpected bleeding or bruising, or your
fingers turning blue
a sore throat, or more infections (such as
colds) than usual.

In many cases, these symptoms will be signs of
serious side effects. But you must be aware that
they are potentially serious- so, if you notice
any of these symptoms:


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

Very common side effects
These may affect more than 1 in 10 people:
• headache
• feeling dizzy
• feeling sleepy or drowsy
• clumsiness and lack of co-ordination (ataxia)
• double vision or blurred vision
• feeling sick(nausea) or being sick (vomiting)
• skin rash
Common side effects
These may affect up to 1 in 10 people:
• aggression or irritability
• rapid, uncontrollable eye movements
(nystagmus)

6. Further information
What Lamotrigine contains
The active substance is lamotrigine
Each dispersible tablet contains 25mg lamotrigine.
Each dispersible tablet contains 50mg lamotrigine.
Each dispersible tablet contains 100mg
lamotrigine.
Each dispersible tablet contains 200mg
lamotrigine.
The other ingredients are:Microcrystalline
Cellulose, Calcium carbonate, Maltodextrin,
Crospovidone, Povidone K30, Aspartame (E951),
Low substituted Hydroxypropylcellulose, Mixed
Berries flavour (Contains flavouring substances,
maltodextrin and glyceryl triacetate), Magnesium
stearate, Colloidal anhydrous silica Talc
What Lamotrigine looks like and contents of
the pack
Dispersible tablet
Lamotrigine Ranbaxy 25mg Dispersible
Tablets are white to off white round tablets,
debossed with 'LI2' on one side and plain on the
other side.
Lamotrigine Ranbaxy 50mg Dispersible
Tablets are white to off white round tablets,
debossed with 'LI3' on one side and plain on the
other side.
Lamotrigine Ranbaxy 100mg Dispersible
Tablets are white to off white round tablets,
debossed with 'LI4' on one side and plain on the
other side.
Lamotrigine Ranbaxy 200mg Dispersible
Tablets are white to off white round tablets,
debossed with 'LI5' on one side and plain on the
other side.
Lamotrigine Ranbaxy 25/50/100/200 mg
dispersible tablets are available in PVC/ PVdC/
Blister packs or polyamide /Aluminium / PVC
/Aluminium foil blister containing
1,2,4,7,10,14,28,30, 56, 98 and 100 dispersible
tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Ranbaxy (UK) Limited
Building 4, Chiswick Park
566 Chiswick High Road
London, W4 5YE
United Kingdom
Manufacturer:
Ranbaxy Ireland Limited, Spafield, Cork Road,
Cashel, Co Tipperary, Ireland
For any information about this medicinal product,
or to obtain the leaflet in a different format please
contact the Marketing Authorisation Holder
This leaflet was last revised in January 2014.

5107209

PACKAGE LEAFLET: INFORMATION FOR THE USER

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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