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LAMOTRIGINE BRISTOL LABS 200MG TABLETS

Active substance(s): LAMOTRIGINE

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LAMOTRIGINE BRISTOL LABS 25MG TABLETS
LAMOTRIGINE BRISTOL LABS 50MG TABLETS
LAMOTRIGINE BRISTOL LABS 100MG TABLETS
LAMOTRIGINE BRISTOL LABS 200MG TABLETS
(Lamotrigine)
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. 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 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:
1 What Lamotrigine tablets are and what they are used for
2 What you need to know before you take Lamotrigine tablets
3 How to take Lamotrigine tablets
4 Possible side effects
5 How to store Lamotrigine tablets
6 Contents of the pack and other information

1. What Lamotrigine tablets are and what they are used for
The name of your medicine is Lamotrigine 25mg or 50mg or 100mg or 200mg
Tablets. The active ingredient is Lamotrigine.
Lamotrigine belongs to a group of medicines called anti-epileptics. It is used
to treat two conditions – epilepsy and bipolar disorder.
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 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.
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.

2. What you need to know before you take Lamotrigine tablets
Do not take Lamotrigine tablets if
• you are allergic to Lamotrigine or any of the other ingredients of this medicine
(the ingredients are listed in section 6, Contents of the pack and other
information).

Lamotrigine insert two
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Warnings and Precautions
Talk to your doctor or pharmacist before taking Lamotrigine tablets.
• if you have problem with your kidneys
• if you have ever developed a rash when you have taken lamotrigine or
other medicines for epilepsy
• if you have ever developed meningitis after taking lamotrigine
• if you are already taking medicines that contains lamotrigine
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 reactions, 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
• 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.
Important information about potentially life-threatening reactions
A small number of people taking Lamotrigine 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 Lamotrigine. Read the description of these symptoms
in section 4 of this leaflet under “Allergic reaction or Potentially serious skin
reactions: get a doctor’s help straight away.”
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, kidney or blood, and may tell you to stop taking lamotrigine.
Risk of increased or severe seizures
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.
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 with epilepsy being treated with Lamotrigine have
also had thoughts of harming or killing themselves. If at any time you have
these thoughts, immediately contact your doctor.
Lamotrigine 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 Lamotrigine Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
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, 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 Lamotrigine or make it more likely that you’ll
have side effects. These include:
• valproate or carbamazepine for epilepsy and mental health problems
• phenytoin, primidone or phenobarbitone for epilepsy
• risperidone for mental health problems
• rifampicin, an antibiotic
• a combination of lopinavir, atazanavir and ritonavir used to treat Human
Immunodeficiency Virus (HIV) infection
• hormonal contraceptives (Ethinyloestradiol/levonorgestrel) such as the Pill
(see below)
• orlistat used in obesity.
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 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, breast-feeding and Fertility
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
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.
• 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.
• 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 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
• 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.
Lamotrigine tablets contain Lactose
Lamotrigine tablets contain small amount 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 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 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
13 years 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 of 200mg daily.
Lamotrigine is not recommended for children aged under 2 years
IXXXXXX

PACKAGE LEAFLET: INFORMATION FOR USER

4. Possible Side Effects
Like all medicines, Lamotrigine can cause side effects, although not everybody
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 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 Lamotrigine, especially if the starting dose is too high or if the
dose is increased too quickly or if Lamotrigine 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.

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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 (DRESS).
• 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 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: may affect more than 1 in 10 people
• headache
• skin rash.
Common: 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: may affect up to 1 in 100 people
• clumsiness and lack of co-ordination (ataxia)
• double vision or blurred vision.
Rare: 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: 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
• lupus-like reaction (symptoms may include: back or joint pain which sometimes
may be accompanied by fever and/or general ill health).
• in people who already have Parkinson’s disease, worsening of the symptoms
Not Known: frequency cannot be estimated from the available data
• 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.
• Nigthmares
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.

conditions. Store in the original container. Keep the container tightly
closed.
• Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.

6. Contents of the pack and other information
What Lamotrigine Tablets contain
• The active substance is Lamotrigine. Each tablet contains either 25mg,
50mg, 100mg or 200mg of the active substance.
• The other ingredients are: lactose monohydrate, microcrystalline
cellulose, povidone, sodium starch glycollate (type A), ferric oxide yellow
E172, purified talc and magnesium stearate.
What Lamotrigine Tablets look like and contents of the pack
• Lamotrigine 200mg, 100mg and 50mg tablets are pale yellow coloured,
circular, flat faced bevelled edged, uncoated tablets with ‘L200’, ‘L100’
and ‘L50’ embossing respectively on one side and ‘B’ and ‘L’ logo on
either side of breakline.
• Lamotrigine 25 mg tablet is available as pale yellow, flat, bevelled
edged, circular, uncoated tablets with ‘L25’ embossed on one side and
plain on the other side.
• Lamotrigine tablets are packaged in blister packs of 14, 28, 56, 84 tablets
or in containers of 100, 250, 500 and 1000 tablets. Not all pack sizes may
be marketed.
Marketing Authorisation Holder and Manufacturer:
Name and address: Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road
Berkhamsted, Hertfordshire,
United Kingdom, HP4 1EG
Telephone:
0044 (0)1442 200922
Fax:
0044 (0)1442 873717
E-mail:
info@bristol-labs.co.uk
Lamotrigine Bristol Labs 25mg Tablets; PL 17907/0118
Lamotrigine Bristol Labs 50mg Tablets; PL 17907/0119
Lamotrigine Bristol Labs 100mg Tablets; PL 17907/0120
Lamotrigine Bristol Labs 200mg Tablets; PL 17907/0121
This leaflet was last revised in September 2015
To request a copy of this leaflet in Braille, large print or audio please
contact the licence holder at the address (or telephone, fax, email) above.

5. How to store Lamotrigine tablets
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date (EXP.) which is stated on the
label. The expiry date refers to the last day of that month.
• Blisters: Lamotrigine tablets does not require any special storage
conditions. Store in the original package.
• Container: Lamotrigine tablets does not require any special storage

V10 14-09-15 D0

IXXXXXX

How to take your dose of Lamotrigine Tablets
Take your dose of lamotrigine once or twice a day, as your doctor advises you.
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.
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
• clumsiness and lack of co-ordination, affecting their balance
• loss of consciousness or coma
If you forget to take Lamotrigine
Do not take a double dose to make up for a forgotten dose.
If you have missed taking a dose of Lamotrigine tablets ask your doctor for
advice on how to start taking it again. It’s important that you do this.
If you stop taking Lamotrigine
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.

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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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