LAMOTRIGINE 25MG TABLETS

Active substance: LAMOTRIGINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Lamotrigine 25 mg, 50 mg, 100 mg & 200 mg tablets
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, 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 is and what it is used for
2. Before you take Lamotrigine
3. How to take Lamotrigine
4. Possible side effects
5. How to store Lamotrigine
6. Further information

1.
WHAT LAMOTRIGINE IS AND WHAT IT IS USED FOR
Lamotrigine belongs to a group of medicines called anti-epileptics. It is used to treat
epilepsy.
Lamotrigine treats epilepsy by blocking the 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 LennoxGastaut 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
DO NOT take Lamotrigine:
• if you are allergic (hypersensitive) to lamotrigine or any of the other
ingredients of Lamotrigine (listed in Section 6).
• if you are breast-feeding.
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 your face, or swollen glands in your neck, armpit or groin
• if your epilepsy gets worse, especially during the first month of the treatment
with Lamotrigine tablets
• 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 a dose or if your dose is
increased too quickly, or if you’re taking Lamotrigine with another medicine called
valproate. 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
A small number of people being treated with anti-epileptics 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 epilepsy
The seizures in some types of epilepsy may 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.
Taking other medicines
Tell your doctor or pharmacist if you’re taking any 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.

If you are taking certain medicines, your doctor may need to check the dose of
Lamotrigine. These include:
• 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
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:
• 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
• olanzapine, used to treat mental health problems
• risperidone, used to treat mental health problems
• rifampicin, which is an antibiotic
• a combination of lopinavir and ritonavir, 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
Lamotrigineduring pregnancy. These defects include cleft lip or cleft palate. 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.
Driving and using machines
Lamotriginecan cause dizziness and double vision.
DO NOT 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 tablets contain small amounts of a sugar called lactose. If you have
intolerance to lactose or any other sugars:
Tell your doctor, and don’t take Lamotrigine.
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
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 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 of 400 mg daily. When your child first starts taking Lamotrigine Tablets,
your doctor may prescribe a much lower dose and then gradually increase the dose
over the next few weeks. If your child is already taking other drugs for his/her
epilepsy and Lamotrigine is being added to these, your doctor may prescribe lower
doses or even a different dosing frequency. Your doctor or pharmacist will tell you
which dose is applicable to your child. It is important that you follow these
instructions very carefully.
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.
• 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.

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.
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 any of these symptoms:
• rapid, uncontrollable eye movements (nystagmus)
• clumsiness and lack of co-ordination, affecting their balance (ataxia)
• loss of consciousness or coma
If you forget to take Lamotrigine
If you forgot to take a dose at the correct time, take it as soon as you remember and
then carry on as before.
Don’t take extra tablets or a double dose to make up for a forgotten dose.
If you have missed taking several doses of Lamotrigine:
Ask your doctor for advice on how to start taking it again. It’s important that you
do this.
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.
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
• 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
• if your epilepsy gets worse, especially during the first month of the treatment
with Lamotrigine tablets




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 less 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)
• shaking or tremors
• difficulty in sleeping
• diarrhoea
• dry mouth
• feeling tired
• pain in your back or joints, or elsewhere
Rare side effects
These may affect up to 1 in 1,000 people:
• itchy eyes, with discharge and crusty eyelids (conjunctivitis)
• a rare skin condition, with severe blisters, and bleeding from the lips, eyes,
mouth, nose and genital area (Stevens–Johnson syndrome)
Very rare side effects
These may affect 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
• a severe skin reaction, starting with a painful red area, developing into large
blisters then peeling of layers of skin (toxic epidermal necrolysis)
• 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 tests — including reduced numbers of
red blood cells (anaemia), reduced numbers of white blood cells (leucopoenia,
neutropenia,
agranulo-cytosis),
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

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.
5.

HOW TO STORE LAMOTRIGINE

Keep Lamotrigine out of the sight and reach of children.
Do not use Lamotrigine after the expiry date shown on the blisters, carton or bottle.
The expiry date refers to the last day of that month.
Lamotrigine does not require any special storage conditions.
If you have any unwanted Lamotrigine tablets, don’t dispose of them in your waste
water or your household rubbish. Take them back to your pharmacist, who will
dispose of them in a way that won’t harm the environment.
6.

FURTHER INFORMATION

What Lamotrigine tablets contain
Each tablet contains:
• Lamotrigine 25 mg, 50 mg, 100 mg or 200 mg (active ingredient)
• Lactose monohydrate, microcrystalline cellulose (E460), croscarmellose sodium,
povidone, iron oxide yellow (E172), colloidal anhydrous silica and magnesium
stearate (E572) (inactive ingredients).
What Lamotrigine tablets look like and contents of the pack
Lamotrigine 25 mg Tablets are pale yellow coloured, round, flat, bevelled tablets with
one side plain and the other side debossed with 'LMG 25'.
Lamotrigine 50 mg Tablets are pale yellow coloured, round, flat, bevelled tablets with
one side plain and the other side debossed with 'LMG 50'.
Lamotrigine 100 mg Tablets are pale yellow coloured, round, flat, bevelled tablets
with one side plain and the other side debossed with 'LMG 100'.

Lamotrigine 200 mg Tablets are pale yellow coloured, round, flat, bevelled tablets
with one side plain and other side debossed with 'LMG 200'.
Lamotrigine Tablets are packed in blisters and come in pack sizes of 30, 42, 56 or 100
tablets (only marketed pack sizes will be included in the final mock-up).
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
IVAX Pharmaceuticals UK, Albert Basin, Royal Docks, London, E16 2QJ. UK
This leaflet was last revised in February 2012.

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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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