LAMOTRIGINE DR REDDYS 50MG TABLETS

Active substance: LAMOTRIGINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Lamotrigine Dr. Reddy’s 25mg, 50mg, 100mg &200mg
Tablets
Read all of this leaflet carefully before you start taking this
medicine, even if this is a repeat prescription.
- 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, tell your doctor or pharmacist.
In this leaflet
1. What Lamotrigine Tablets are and what
they are used for
2. Before you take Lamotrigine Tablets
3. How to take
4. Possible side effects
5. How to store
6. Further information

• bupropion used to treat for mental health problems or to
stopsmoking.
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 (for epilepsy and mental health problems)
• carbamazepine used to treat epilepsy and mental health
• problems
• phenytoin, primidone or phenobarbitone (for epilepsy)
• olanzapine (for mental health problems)
• risperidone, used to treat mental health problems
• rifampicin (an antibiotic)
• a combination of lopinavir and ritonavir or atazanavir and
ritonavir (to treat Human Immunodeficiency Virus 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 tablets work.
Your doctor may recommend that you use a particular type of
hormonal contraceptive, or another method of contraception,
1. What Lamotrigine Tablets are and what they are used
such as condoms, a cap or a coil. If you are using a hormonal
for
contraceptive like the Pill, your doctor may take samples of your
Lamotrigine tablets belong to a group of medicines called antiblood to check the level of Lamotrigine tablets. If you plan to
epileptics. They are used to treat epilepsy by blocking the
start using a hormonal contraceptive, talk to your doctor, who
signals in the brain that trigger epileptic seizures (fits).
will discuss suitable methods of contraception with you.
• For adults and children aged 13 years and over
Lamotrigine tablets can also affect the way hormonal
Lamotrigine tablets can be used on their own or with other
contraceptives work, although it’s unlikely to make them less
medicines to treat epilepsy. Lamotrigine tablets can also be
effective. If you are using a hormonal contraceptive and you
used with other medicines to treat the seizures that occur
notice any changes in your menstrual pattern, such as
with a condition called Lennox-Gastaut syndrome.
breakthrough bleeding or spotting between periods, tell your
• For children aged between 2 and 12 years
Lamotrigine tablets can be used with other medicines, to treat doctor. These may be signs that Lamotrigine tablets are
affecting the way your contraceptive is working.
the same conditions as above. They can be used on their
own to treat a type of epilepsy called typical absence
Pregnancy and breast-feeding
seizures.
Talk to your doctor if you’re pregnant, if you might be
pregnant, or if you’re planning to become pregnant.
2. Before you takeLamotrigine Tablets
You should not stop treatment for your epilepsy while you’re
Do not take Lamotrigine if
pregnant. However, there is an increased risk of birth defects in
• you are allergic (hypersensitive) to lamotrigine or any of the
babies whose mothers take Lamotrigine tablets during
other ingredients (see Section 6).
pregnancy. These defects include cleft lip or cleft palate. To
If this applies to you tell your doctor and don’t take
reduce this risk, your doctor may advise you to take extra folic
Lamotrigine.
acid if you’re planning to become pregnant and while you’re
Take special care with Lamotrigine.
pregnant.
Your doctor needs to know before you take Lamotrigine if
Pregnancy may also alter the effectiveness of Lamotrigine
you:
tablets, so your doctor may take blood samples to check the
• have kidney or liver problems
level of Lamotrigine and may adjust your dose.
• have ever developed a rash when you’ve taken lamotrigine
Talk to your doctor if you’re breast-feeding or planning to
or other medicines for epilepsy
breast-feed. Lamotrigine passes into breast milk and may
• are already taking a medicine that contains lamotrigine.
affect your baby. Your doctor will discuss the risks and benefits
If any of these applies to you, tell your doctor, who may
of breast-feeding while you’re taking Lamotrigine tablets, and
decide to lower your dose or that Lamotrigine is not suitable for
will check your baby from time to time if you decide to breastyou.
feed.
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
• 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 carry out tests
on your liver, kidneys or blood, and may tell you to stop taking
Lamotrigine.

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.
3. How to take
Always take Lamotrigine exactly as your doctor has told
you. If you are not sure, ask your doctor or pharmacist.
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.

For adults and children aged over 12 years:
The usual effective dose of Lamotrigine tablets 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
Thoughts of harming yourself or suicide
A small number of people being treated with anti-epileptics such and 15mg for each kilogram of the child’s weight, up to a
as Lamotrigine have had thoughts of harming or killing
maximum of 400mg daily.
themselves. If at any time you have these thoughts,immediately How to take your dose of Lamotrigine tablets
contact your doctor or go to the nearest hospital for help.
Take your dose of Lamotrigine tablets once or twice a day,
as your doctor advises. You can take it with or without food.
If you’re taking Lamotrigine for epilepsy
Your doctor may also advise you to start or stop taking other
The seizures in some types of epilepsy may occasionally
medicines, depending on what condition you’re being treated for
become worse or happen more often while taking Lamotrigine.
and the way you respond to treatment.
Some patients may experience severe seizures, which may
• Swallow your tablets whole. Don't break, chew or crush
cause serious health problems. If your seizures happen more
them.
often, or if you have a severe seizure while you’re taking
Always take the full dose that your doctor has prescribed.
Lamotrigine, see a doctor as soon as possible.
Never take only part of a tablet.
Taking other medicines
If you take more Lamotrigine tablets than you should
Please tell your doctor or pharmacist if you are taking or have
If anyone takes too many Lamotrigine tablets, contact a doctor
recently taken any medicines including herbal medicines or
or pharmacist immediately. If possible, show them the
other medicines bought without a prescription.
Lamotrigine packet.
If you are taking certain medicines, your doctor may
Someone who has taken too many Lamotrigine tablets may
need to check the dose of Lamotrigine. These include:
have any of these symptoms:
• oxcarbazepine, felbamate, gabapentin, levetiracetam,
• rapid, uncontrollable eye movements (nystagmus)
pregabalin, topiramate or zonisamide to treat for epilepsy
• clumsiness and lack of co-ordination, affecting
• lithium used to treat mental health problems
• balance (ataxia)
• 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. 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.
4. Possible side effects
Like all medicines, Lamotrigine tablets 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 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 are:
• skin rashes or redness
• sore mouth or eyes
• high temperature (fever), flu-like symptoms or
drowsiness
• swelling of the face, swollen glands in your neck, armpit, groin
• unexpected bleeding or bruising, or your fingers turning blue
• sore throat, or more infections (such as colds) than usual
• rare skin condition with severe blisters, and bleeding
from the lips, eyes, mouth, nose and genital area
(Stevens-Johnson syndrome)
• severe skin reaction, starting with a painful red area,
developing into large blisters, then peeling of layers
of skin (toxic epidermal necrolysis).
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 at once. Your doctor may carry out tests on your
liver, kidneys or blood, and may tell you to stop taking
Lamotrigine tablets.
Very common side effects (affects more than 1 in 10 people)
• headache or drowsy
• feeling dizzy
• feeling sleepy or drowsy
• clumsiness and lack of co-ordination
• double or blurred vision
• feeling (nausea) or being sick (vomiting)
• skin rash.
Common side effects (affects less than 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 (affects less than 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 (StevensJohnson syndrome).
Very rare side effects (affects less than 1 in 10,000 people)
• hallucinations ('seeing' or 'hearing' things that aren't 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
• 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 (as shown 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 cells, and a disorder of the bone marrow
called aplastic anaemia
• a disorder of blood clotting, which can cause unexpected
bleeding or bruising
• a high temperature (fever)
• worsening of the symptoms in people who already have
Parkinson's disease.

Frequency not known
• 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)
• swelling around the face (oedema) or swollen glands in the
neck, armpit or groin (lymphadenopathy).
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 any of the above side effects become 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
Keep out of the sight and reach of children. Do not store
above 25°C and keep in the original packaging. Protect from
light.
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.
If you have any unwanted 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
The active ingredient (which makes the tablets work) is
lamotrigine. Each tablet contains either 25mg, 50mg, 100mg or
200mg of lamotrigine. The other ingredients are: mannitol
(E421), powdered cellulose (E460), l-hydroxypropyl cellulose
(E463), hydroxypropyl cellulose (E463),iron oxide yellow (E172),
magnesium stearate (E470b) and talc (E553b).
What Lamotrigine Tablets look like and packcontents
Lamotrigine Tablets are yellow, round, flat, bevelled edged
tablets with LMT marked on one side and with a score line
and the tablet strength marked on the other side.
The 25mg tablets are available in pack sizes of 21 or 56.
The 50mg tablets are available in pack sizes of 42 or 56.
The 100mg and 200mg tablets are available in pack sizes of
56.
Manufacturer and marketing authorisation holder:
Dr. Reddy’s Laboratories (UK) Ltd.,
6 Riverview Road, Beverley,
East Yorkshire,
HU17 0LD
This leaflet was revised in 12/2013
Lamotrigine Dr. Reddy’s 25mg Tablets: PL 08553/0221
Lamotrigine Dr. Reddy’s 50mg Tablets: PL 08553/0222
Lamotrigine Dr. Reddy’s 100mg Tablets: PL 08553/0223
Lamotrigine Dr. Reddy’s 200mg Tablets: PL 08553/0224

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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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