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OXCARBAZEPINE MYLAN 300MG FILM-COATED TABLETS

Active substance(s): OXCARBAZEPINE

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Package leaflet: Information for the patient

Oxcarbazepine Mylan
150 mg, 300 mg, 600 mg
Film-coated Tablets
(oxcarbazepine)
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 Oxcarbazepine Mylan is and what it is
used for.
2. What you need to know before you take
Oxcarbazepine Mylan.
3. How to take Oxcarbazepine Mylan.
4. Possible side effects.
5. How to store Oxcarbazepine Mylan.
6. Contents of the pack and other information.

1. What Oxcarbazepine Mylan is and
what it is used for
Oxcarbazepine Mylan contains the active ingredient
oxcarbazepine. Oxcarbazepine Mylan belongs to
a group of medicines called anticonvulsants or
antiepileptics which are used in the treatment
of epilepsy.
Oxcarbazepine Mylan is used to help control seizures
or fits in patients that have epilepsy. People with
epilepsy are prone to having periods of uncontrolled
electrical activity in the brain. These periods of
uncontrolled electrical activity may lead to seizures.
Oxcarbazepine helps to control electrical activity in
the brain. This reduces the chances of having seizures.
Oxcarbazepine Mylan is used to treat partial seizures
with or without secondarily generalised tonic-clonic
seizures. Partial seizures involve a limited area of the
brain, but may spread to the whole brain and may
cause a generalised tonic-clonic seizure. There are
two types of partial seizures: simple and complex.
In simple partial seizures, the patient remains
conscious, whereas in complex partial seizures,
patients consciousness is altered.
Oxcarbazepine is used in adults and children aged
6 years and above. Usually, your doctor will try to
find the one medicine that works best for you or
your child. However, for more severe epilepsy, a
combination of two or more medicines may be
needed to control seizures.
Oxcarbazepine Mylan can be used alone or along
with other antiepilepsy medicines.

2. What you need to know before you
take Oxcarbazepine Mylan
Follow all instructions given to you by your doctor
carefully, even if they differ from the information
contained in this leaflet.

Do not take Oxcarbazepine Mylan:

• if you are allergic to oxcarbazepine or any of the
other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking
Oxcarbazepine Mylan:
• if you are allergic (e.g. have ever developed a rash
or other allergic reactions) to carbamazepine, a
similar anticonvulsant, as there is approximately
a 1 in 4 (25%) chance you may be allergic to
oxcarbazepine too
• if you have liver problems or develop liver problems
during treatment (see under Possible side effects)
• if you have kidney problems, especially kidney
problems associated with a low level of sodium
(salt) in your blood. Oxcarbazepine Mylan can lower
the sodium levels in your blood further which may
lead to symptoms of sodium shortage (see under
Possible side effects). If you have a kidney disease
your doctor may examine your blood before and
at regular intervals after starting treatment with
Oxcarbazepine Mylan
• if you are taking other medicines that can
lower sodium levels in the blood (e.g. diuretics,
desmopressin and non-steroidal anti-inflammatory
drugs (NSAIDs) such as indometacin and
ibuprofen). See under Other medicines and
Oxcarbazepine Mylan
• if you have heart problems such as heart failure
(breathlessness and swollen ankles). Your doctor will
measure your weight regularly to make sure that
you do not retain water
• if you have a heart rhythm disorder
• if you are using hormonal contraceptives (see under
Other medicines and Oxcarbazepine Mylan)

During treatment

If you have possible signs of a blood disorder such as
tiredness, breathlessness when exercising, looking
pale, headache, chills, dizziness, infections leading to
fever, sore throat, mouth ulcer, bleeding or bruising
more easily than normal, nose bleeding, reddish or
purplish patches, unexplained blotches on skin, talk
to your doctor.
A small number of people being treated with
anti-epileptics such as Oxcarbazepine Mylan have
had thoughts of harming or killing themselves. If
at any time you have these thoughts, immediately
contact your doctor.
Potentially life-threatening skin rashes (StevensJohnson syndrome, toxic epidermal necrolysis)
have been reported with the use of oxcarbazepine,
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. There
is an increased risk of these reactions occurring in
patients of Han Chinese, Thai or other Asian origin
(see below, “Patients of Han Chinese or Thai origin”).
If you have developed Stevens-Johnson syndrome
or toxic epidermal necrolysis with the use of
oxcarbazepine, you must not be re-started on
oxcarbazepine 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.

This medicine can lead to a condition called
hypothyroidism (low levels of thyroid hormone).
If you are a child, your doctor may examine your
blood at regular intervals after starting treatment
with Oxcarbazepine Mylan.
If you experience an increase in the frequency of
seizures, speak to your doctor as he/she may decide
to stop your treatment with Oxcarbazepine Mylan.
This is particularly important for children but may
also occur in adults.
Before and during your treatment with
Oxcarbazepine Mylan, your doctor may perform
blood tests to determine the dose for you. Your
doctor will tell you when to have the tests.

Patients of Han Chinese or Thai origin

The risk of serious skin reactions in patients of Han
Chinese or Thai origin associated with carbamazepine
or chemically-related compounds may be predicted
by testing a blood sample of these patients. Your
doctor should be able to advise if a blood test is
necessary before taking oxcarbazepine.
If you are of other Asian origin, (e.g. Phillipino or
Malaysian) your doctor may also consider testing a
blood sample before treatment.

Children and adolescents

In children, your doctor may recommend
thyroid function monitoring before therapy and
during therapy.

Other medicines and Oxcarbazepine Mylan

Tell your doctor if you are taking, have recently taken
or might take any other medicines, particularly any
of the following medicines as they may interact with
Oxcarbazepine Mylan:
• other anticonvulsant medicines such as
phenobarbital, phenytoin, carbamazepine,
lamotrigine and valproic acid. Your doctor may
need to adjust the dosage of these medicines when
they are given in combination with Oxcarbazepine
Mylan. In combination with lamotrigine there is
an increased possibility of side effects like nausea,
drowsiness, dizziness and headache occurring
• hormonal contraceptives (like the “pill”).
Oxcarbazepine Mylan can stop these medicines
working properly. Another form of contraception
should also be used
• medicines to treat mental illness such as lithium
and MAOIs (Monoamine Oxidase Inhibitors), like
phenelzine and moclobemide. Combination with
lithium might increase the occurrence of side effects
• medicines that can lower sodium levels in the
blood (e.g. diuretics, desmopressin and non-steroid
anti-inflammatory drugs such as indometacin and
ibuprofen). Oxcarbazepine Mylan can lower the
sodium levels in your blood further which may lead
to symptoms of sodium shortage (see Possible
side effects). Your doctor should examine your
blood before and at regular intervals after starting
treatment with Oxcarbazepine Mylan
• medicines used to control the body’s immune system
(immunosuppressants) such as ciclosporin, tacrolimus.

Oxcarbazepine Mylan with alcohol

Take special care if drinking alcohol while taking
Oxcarbazepine Mylan as it may make you feel
very drowsy.

Pregnancy and breast-feeding

Pregnancy
Oxcarbazepine Mylan affects the way hormonal
contraceptives work and there is a risk of getting
pregnant. You should use other contraceptives if you
are of a child-bearing age.
It is important to control epileptic seizures during
pregnancy. However, there may be a risk to your baby
if you take antiepileptic medicines during pregnancy.
Your doctor will tell you the benefits and potential
risks involved and help you to decide whether you
should take Oxcarbazepine Mylan.
Do not stop your treatment with Oxcarbazepine
Mylan during pregnancy without first checking with
your doctor.
Breast-feeding
You should not breast-feed while taking
Oxcarbazepine Mylan. The active substance in
Oxcarbazepine Mylan passes into breast milk. This
could cause side effects for breast-fed babies.
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking
this medicine.

Driving and using machines

You should be aware that Oxcarbazepine Mylan can
cause side effects like dizziness, drowsiness, balance
or co-ordination problems, eye problems including
double or blurred vision, low levels of sodium in the
blood which can cause muscle weakness, reduced
levels of consciousness, especially when starting
treatment or increasing the dose which can influence
your ability to drive or operate machines. Do not
drive or operate machines if you experience such
side effects.

Oxcarbazepine Mylan contains lactose

If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicine.

3. How to take Oxcarbazepine Mylan
Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
Where the required dose cannot be administered
using whole tablets, other oxcarbazepine containing
preparations are available.
Your doctor will probably start treatment with a
low dose and, if necessary gradually increase it to
suit your own needs. The recommended doses are
as follows:

Adults

The starting dose is 300 mg twice daily. If needed
your doctor may slowly increase the dose every week
by a maximum of 600 mg daily. The maintenance
dose is between 600 mg and 2400 mg daily.
If you are also taking other anticonvulsant
medicines, your doctor may need to reduce their
dose or increase the dose of Oxcarbazepine Mylan
more slowly.
If other anticonvulsive medicines are replaced by
Oxcarbazepine Mylan their dose will be decreased
gradually.

Use in children and adolescents of 6 years
and older

The starting dose is 8-10 mg/kg of body weight
daily, divided into two doses. If needed your doctor
may increase the dose approximately every week
by 10 mg/kg of body weight daily up to a maximum
daily dose of 46 mg/kg of body weight per day.
The maintenance dose in combination with other
anticonvulsive medicines is normally 30 mg/kg body
weight daily.

For children who cannot swallow tablets or where the
required dose cannot be administered using tablets,
other oxcarbazepine containing pharmaceutical
forms are available.

• weight gain, tiredness, hair loss, muscle weakness,
feeling cold (hypothyroidism).

Use in children under 6 years of age

Very common (may affect more than 1 in 10 people)
• feeling dizzy
• tired or drowsy/sleepy
• double vision
• feeling or being sick
• headaches.

Oxcarbazepine Mylan is not recommended for
children under 6 years old since it has not been
shown to be a safe and effective treatment in this
age group.

Patients with kidney problems

If you have kidney problems your doctor may start
treatment with half the normal starting dose and
increase the dose of Oxcarbazepine Mylan more
slowly than that stated above.

Patients with severe liver problems

If you have severe liver problems, your doctor may
need to alter the amount you take. Always follow your
doctor’s instructions.
Where the required dose cannot be administered
using tablets, other oxcarbazepine containing
pharmaceutical forms are available.

Method of administration

Swallow the film-coated tablet with a glass of water
with or without food. Do not crush or chew them. The
score line is only there to help you break the tablet if
you have difficulty swallowing it whole.

If you take more Oxcarbazepine Mylan than
you should

If you have taken more Oxcarbazepine Mylan than
you should, contact your doctor or pharmacist
straight away. Symptoms of overdose are low levels
of sodium in the blood, anger, agitation, being
confused, drowsiness or sleepiness, dizziness, feeling
sick (nausea), being sick (vomiting), tiredness,
changes to your heart rhythm (fast, irregular
heartbeat), shaking, seizures/convulsions, headache,
coma, loss of consciousness, uncontrolled twitching
or jerking, double or blurred vision, narrowing of the
pupil, low blood pressure, shortness of breath, an
abnormal degree of muscular or bodily activity, lack
of co-ordination of movements and uncontrolled
eye movements.

If you forget to take Oxcarbazepine Mylan

Take it as soon as you remember. However, if it is
almost time for your next dose, do not take the
missed dose, take the next dose on time. Do not take
a double dose to make up for a forgotten dose.

If you stop taking Oxcarbazepine Mylan

Do not stop taking Oxcarbazepine Mylan suddenly
without consulting your doctor since this could lead
to a sudden increase in seizures/convulsions. If your
treatment with Oxcarbazepine Mylan is stopped your
doctor will do this slowly.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.

Tell your doctor or go to your nearest hospital
casualty department straight away if you have
any of the following serious side effects; you
may need medical attention:
Uncommon (may affect up to 1 in 100 people):
• an increase in the number of infections you get
which may cause fever, severe chills, sore throat,
or mouth ulcers (this may indicate you have a low
number of white blood cells in your body)

Very rare (may affect up to 1 in 10,000 people)
• potentially life-threatening skin rashes such
as severe blistering of the skin and/or mucous
membranes of the lips, eyes, mouth, nasal passages
or genitals and skin peeling on much of the
body surface (Stevens-Johnson syndrome, toxic
epidermal necrolysis) (see section 2, “Warnings
and precautions”)
• red (moist), itchy and irregular spots similar to the
rash of measles, which starts on the limbs and
sometimes on the face and the rest of the body.
The spots may blister or may progress to form
raised, red, pale-centred marks. Those affected may
have fever, sore throat, headache and/or diarrhoea
(erythema multiforme).
If such skin reactions have occurred during use of
oxcarbazepine, you must not use Oxcarbazepine
Mylan. Your doctor may decide to withdraw
treatment with Oxcarbazepine Mylan
• swollen face, lips, eyelids, tongue, throat or mouth,
difficulty in speaking, swallowing and sudden
signs of nettle rash with difficulty in breathing,
shortness of breath, wheezing (signs of angioedema
and anaphylactic reactions) or other signs of
hypersensitivity (allergic) reactions such as rash,
fever, pain in the muscles and joints
• hypersensitivity reactions can also affect other parts
of the body and may cause problems with your
lungs (such as breathing difficulties or coughing,
which may produce phlegm or blood), kidneys
(producing little or no urine, or blood in the urine)
or liver (signs of liver problems are described below,
however this may also lead to swelling of the brain,
causing changes in the way you think or act, or
make you very sleepy). Other effects you may see
include changes to your blood (described separately
in this leaflet), an enlarged spleen (causing swelling
and pain/tenderness in the belly) or swollen and
painful glands in the neck, armpit or groin
• red blotchy rash mainly on face which may be
accompanied by fatigue, fever, feeling sick (nausea)
or loss of appetite (systemic lupus erythematosus)
• bleeding or bruising more easily than normal
(thrombocytopenia)
• signs of inflammation of the liver (nausea, vomiting,
loss of appetite, feeling generally unwell, fever,
itching, yellowing of the skin or whites of the eyes,
light coloured bowel motions, dark coloured urine).
Your liver function may need to be checked
• inflammation of the pancreas which includes the
following signs: severe upper stomach pain that
spreads to the back, often with feeling or being
sick (pancreatitis).
• heart condition which can cause light-headedness,
fainting and irregular heart rhythm (atrioventricular
block).

Other possible side effects:

Common (may affect up to 1 in 10 people):
• depression
• confusion
• low levels of sodium in the blood. Very rarely,
this can lead to confusion, decreased level of
consciousness, swelling of the brain, problems with
vision, feeling or being sick or worsening of seizures
• agitated or other mood changes
• lack of emotion or motivation
• disturbance in vision
• blurred vision
• uncontrolled eye movement or other eyesight
changes
• loss of co-ordination
• shaking
• difficulty concentrating
• memory loss
• spinning sensation
• diarrhoea or constipation
• stomach pain
• skin rash
• acne
• hair loss
• feeling weak.
Uncommon (may affect up to 1 in 100 people):
• itchy skin
• increased liver enzymes such as alkaline
phosphatase, seen in a blood test.
Very rare (may affect up to 1 in 10,000 people):
• irregular heartbeat or a very fast or slow heart beat.
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 antiepileptic medication,
have a history of osteoporosis, or take steroids
• high blood pressure (hypertension)
• decreased thyroxine in the blood, seen in a thyroid
function test
• fall
• speech disorder
• red, swollen skin with small pus-filled spots (Acute
Generalised Exanthematous Pustulosis (AGEP)).

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 via the website:
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 Oxcarbazepine Mylan
Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date which
is stated on the container or blister and the carton.
The expiry date refers to the last day of that month.
Do not store above 30ºC.
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 Oxcarbazepine Mylan contains

The active substance is oxcarbazepine. Each
film-coated tablet contains 150 mg, 300 mg or
600 mg of oxcarbazepine.
The other ingredients (excipients) are:
Tablet core: crospovidone; hypromellose;
microcrystalline cellulose; silica, colloidal anhydrous
and magnesium stearate.
Tablet coating: black iron oxide (E172); red iron
oxide (E172); yellow iron oxide (E172); hypromellose;
lactose monohydrate (see section 2 ‘Oxcarbazepine
Mylan contains lactose’); macrogol 4000 and titanium
dioxide (E171).

What Oxcarbazepine Mylan looks like and
contents of the pack

Film-coated tablet.
The film-coated tablets are oblong, buff-coloured and
have a scoreline on each side. The scoreline is only to
facilitate breaking for ease of swallowing and not to
divide into equal doses.
The 150 mg, 300 mg, 600 mg film-coated tablets are
marked ‘OX/150’/‘OX /300’/‘OX/600’ on one side and
‘G/G’ on the other side.
Oxcarbazepine Mylan film-coated tablets are
available in plastic tablet containers of 100, 200 and
500 tablets and blister packs of 10, 20, 30, 50, 60,
100 and 200 tablets.*
*Not all pack sizes may be marketed.
Oxcarbazepine Mylan film-coated tablets are
available as Oxcarbazepine Mylan 150 mg, 300 mg
and 600 mg film-coated tablets.

Marketing Authorisation Holder:

Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.

Manufacturers:

Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.
Generics [UK] Ltd, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom
This leaflet was last revised in April 2015

Not known (frequency cannot be estimated from the
available data):
• a lower than normal level of sodium in the blood,
which may make you feel tired, feel sick, dizzy, be
sick, have a headache, feel confused with aching
of muscles. This may be due to inappropriate ADH
secretion, a hormone that causes the body to retain
water and dilute the blood, reducing the amount
of sodium.
• tiredness, shortness of breath when exercising,
looking pale, headache, dizziness, frequent
infections leading to fever, bleeding or bruising
more easily than normal, nose bleeds, reddish or
purplish patches, or unexplained blotches on the
skin (signs of a decrease in the number of blood
platelets or decrease in the number of blood cells).
• disturbances in the production of blood cells
(bone marrow depression), shortage of red and
white blood cells, as well as blood platelets
(aplastic anaemia)

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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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