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LAMOTRIGINE ACTAVIS 100MG TABLETS

Active substance(s): LAMOTRIGINE

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Package leaflet: Information for the patient
Lamotrigine Actavis 25mg, 50mg, 100mg and 200mg tablets
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 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
Lamotrigine tablets belong to a group of medicines called anti-epileptics. They are used to treat two
conditions - epilepsy and bipolar disorder.
Lamotrigine tablets treat epilepsy by blocking the signals in the brain that trigger epileptic seizures (fits).
 For adults and children aged 13 years and over Lamotrigine tablets can be used on their own or
with other medicines, to treat epilepsy. Lamotrigine tablets 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 tablets can be used with other medicines, to
treat the same conditions. They can be used on their own to treat a type of epilepsy called typical
absence seizures.
Lamotrigine tablets also treat 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 tablets can be used on their own or with other medicines, to
prevent the periods of depression that occur in bipolar disorder. It is not yet known how Lamotrigine tablets
work 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 (listed in Section 6)
 have liver problems.
If these apply to you, tell your doctor, and don't take Lamotrigine tablets.

Warnings and precautions
Talk to you doctor or pharmacist before taking /…/ if you:




have problems with your kidneys
have ever developed a rash when you've taken lamotrigine or other medicines for epilepsy
are already taking medicine that contains lamotrigine



have Parkinsons disease.

If any of these apply to you, tell your doctor, who may decide to lower your dose or that Lamotrigine
tablets are not suitable for you.

Watch out for important symptoms
If you develop any of these symptoms after you start taking Lamotrigine tablets, 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
 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
tablets, especially if you start on too high a dose, if your dose is increased too quickly or if you're taking
Lamotrigine tablets 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 tablets.

Severe skin reactions
Potentially life-threatening skin rashes (Steven-Johnson syndrome, toxic epidermal necrolysis, DRESS)
have been reported with the use of Lamotrigine, appearing initially as reddish target-like spots or circular
patches often with central blisters on the trunk. Additional signs to look for include ulcers in the mouth,
throat, nose, genitals and conjunctivitis (red and swollen eyes)
These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may
progress to widespread blistering or peeling of the skin. The highest risk for occurrence of serious skin
reactions is within the first weeks of treatment. If you have developed Stevens-Johnson syndrome or toxic
epidermal necrolysis with the use of lamotrigine, you must not be re-started on lamotrigine at any time.
If you develop a rash or these skin symptoms, seek immediate advice from a doctor and tell them that you
are taking this medicine.

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 tablets. 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 tablets, 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 tablets, 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 tablets have also had thoughts of
harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
Children and adolescents
Lamotrigine tablets 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: 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 tablets. These
include:
 oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate or zonisamide for epilepsy
 lithium for mental health problems
 bupropion for mental health problems or to stop smoking
Tell your doctor if you are taking any of these.
Some medicines interact with Lamotrigine tablets 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
 olanzapine or 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, 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 tablets work
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 tablets. If you plan to start
using a hormonal contraceptive talk to your doctor, who will discuss suitable methods of contraception
with you.
Lamotrigine tablets 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 tablets are 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 tablets 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 tablets, so your doctor may take samples of your
blood to check the level of Lamotrigine tablets, and may adjust your dose.
Talk to your doctor if you're breast feeding or planning to breast feed. 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 tablets, and will check your baby from time to time if you decide to breast feed.

Driving and using machines
If you have epilepsy, talk to your doctor about driving and using machines.
Lamotrigine tablets can cause dizziness and double vision, do not drive or operate machines if you are
affected.

Lamotrigine tablets contains Lactose
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 tablets

3. How to take Lamotrigine tablets
Always use this medicine exactly as your doctor has told you to. 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 tablets for you. The dose you take will depend on:
 your age
 whether you are taking Lamotrigine tablets 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 tablets than your
doctor tells you to.
The usual effective dose of Lamotrigine tablets for adults and children aged over 12 years is between
100mg and 400mg each day.
Use in children and adolescents
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 400mg daily.
How to take your dose of Lamotrigine tablets
Take your dose of Lamotrigine tablets 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.

If you take more Lamotrigine tablets than you should
If anyone takes too many Lamotrigine tablets, contact a doctor or pharmacist immediately. If
possible, show them the Lamotrigine tablets packet.
Someone who has taken too many Lamotrigine tablets 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 tablets
Don't take extra tablets or 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.

Don't stop taking Lamotrigine tablets without advice

Take Lamotrigine tablets for as long as your doctor recommends. Don't stop unless your doctor advises you
to.
If you are taking Lamotrigine tablets for epilepsy, to stop taking Lamotrigine tablets, it is important that
your dose is reduced gradually, over about 2 weeks. If you suddenly stop taking Lamotrigine tablets your
epilepsy may come back or get worse.
If you are taking Lamotrigine tablets for bipolar disorder, Lamotrigine tablets may take some time to work,
so you are unlikely to feel better straight away. If you stop taking Lamotrigine tablets your dose will not
need to be reduced gradually. However you should still talk to your doctor first if you want to stop
taking Lamotrigine tablets.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although 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 tablets have 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
 sore mouth or eyes
 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
 sore throat, or more infections (such as colds) than usual
 very rarely potentially life-threatening skin rashes, Stevens-Johnson syndrome (skin condition, with
severe blisters, and bleeding from the lips, eyes, mouth, nose and genital area) or Toxic epidermal
necrolysis (severe skin reaction, starting with a painful red area, developing into large blisters then
peeling of layers of skin) or DRESS
In many cases these symptoms will be signs of less serious side effects. However, 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 tablets.
Other side effects
Very common side effects: (may affect more than 1 in 10 people):
 headache
 feeling dizzy or sleepy
 clumsiness and lack of co-ordination
 double or blurred vision
 feeling or being sick
 skin rash.
Common side effects: (may affect up to 1 in 10 people):
 aggression or irritability
 rapid, uncontrollable eye movements
 shaking or tremors
 difficulty in sleeping
 diarrhoea
 dry mouth
 feeling tired
 pain in your back or joints, or elsewhere.
Rare side effects: (may affect up to 1 in 1,000 people):



itchy eyes, with discharge and crusty eyelids (conjunctivitis)

Very rare side effects: (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, 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 tests - including reduced numbers of red blood cells (anaemia),
reduced numbers of white blood cells, reduced numbers of platelets (thrombocytopenia), reduced
numbers of all these types of cell, and a disorder of the bone marrow called aplastic anaemia
 a disorder of blood clotting, which can cause unexpected bleeding or bruising
 in people who already have Parkinson's disease, worsening of the symptoms.
Not known (frequency cannot be estimated from the available data)

aseptic meningitis (symptom include sensitivity to light, rash, muscle pain, fever and stiff neck), hair
loss, DRESS.
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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

5. How to store Lamotrigine tablets
Keep out of the sight and reach of children.
Do not use after the expiry date shown on the blisters, carton or bottle. The expiry date refers to the last day
of that month.
Lamotrigine tablets do not require any special storage conditions.
Do not throw away any medicine via waste water or your household waste. Ask your pharmacist, how to
throw away any medicine 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 (the ingredient that makes the medicine work) is lamotrigine. Each tablet contains


either 25mg, 50mg, 100mg or 200mg of the active substance.
The other ingredients are colloidal anhydrous silica, iron oxide hydrate yellow (E172), lactose
monohydrate, magnesium stearate, microcrystalline cellulose, povidone K30, sodium starch glycollate
and talc.

What Lamotrigine tablets looks like and contents of the pack
Lamotrigine tablets are light yellow, round, flat, uncoated tablets with a score line on one side.
Available pack sizes are 30, 56 tablets.
Marketing Authorisation Holder
Actavis, Barnstaple, EX32 8NS, UK

Manufacturer
Balkanpharma-dupnitsa AD,
3 Samokovsko Shosse Str, Dupnitsa 2600, Bulgaria
or
Actavis, Barnstaple, EX32 8NS, UK
Revision date: July 2015

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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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