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OXCARBAZEPINE 300MG FILM COATED TABLETS

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PACKAGE LEAFLET: INFORMATION
FOR THE USER
®

Trileptal 300mg Film-Coated
Tablets
(oxcarbazepine)
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
or your child. 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.

The name of your medicine is Trileptal 300mg
Film-Coated Tablets but will be referred to as
Trileptal throughout this leaflet. Please note
that this leaflet also contains information about
other strengths such as Trileptal 150mg and
600mg Film-Coated Tablets.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Trileptal is and what it is used for
Before you take Trileptal
How to take Trileptal
Possible side effects
How to store Trileptal
Further information

1. WHAT TRILEPTAL IS AND WHAT IT
IS USED FOR
What Trileptal is
The active ingredient of Trileptal is
oxcarbazepine.
Trileptal belongs to a group of medicines called
anticonvulsants or antiepileptics.

What Trileptal is used for
Medicines such as Trileptal are the standard
treatment for epilepsy.
Patients diagnosed with epilepsy have had
repeated seizures, or convulsions. Seizures
happen because of a temporary fault in the
brain’s electrical system. Normally brain cells
coordinate body movements by sending out
signals through the nerves to the muscles in an
organised, orderly way. In epilepsy, brain cells
send out too many signals in a disorderly
fashion. The result can be uncoordinated
muscular activity that is called an epileptic
seizure.
Trileptal 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.
Trileptal works by keeping the brain’s
“overexcitable” nerve cells under control. This
suppresses or reduces the frequency of such
seizures.
Trileptal can be used alone or in combination
with other antiepileptic medicines.
Usually, the doctor will try to find the one
medicine that works best for you or for your
child. However, with more severe epilepsy, a
combination of two or more medicines may be
needed to control seizures.
Trileptal is for use in adults and in children of 6
years of age and above.

2. BEFORE YOU TAKE TRILEPTAL
Follow all instructions given to you by your
doctor carefully, even if they differ from the
information contained in this leaflet.

Do not take Trileptal
• if you are allergic (hypersensitive) to
oxcarbazepine or to any other ingredients
of Trileptal tablets (listed in section 6
Further information).

Take special care with Trileptal
If any of the following apply to you, tell your
doctor before you take Trileptal:
• if you have ever shown unusual
sensitivity (rash or any other signs of
allergy) to carbamazepine or to any other
medicines. If you are allergic to
carbamazepine, the chances are
approximately 1 in 4 (25 %) that you could
also have an allergic reaction to
oxcarbazepine (Trileptal).
• if you have a kidney disease.
• If you have a serious liver disease.
• if you are taking diuretics (medicines
used to help the kidneys get rid of salt and
water by increasing the amount of urine
produced).
• if you have a heart disease, shortness of
breath and/or swelling of the feet or legs
due to fluid build-up.
• if your blood level of sodium is low as
shown by blood tests (see section 4
Possible side effects).
• if you are a woman taking a hormonal
contraceptive, such as the pill, Trileptal
may stop your contraceptive from working.
Use a different or extra (non-hormonal)
method of contraception while taking
Trileptal. This should help to prevent an
unwanted pregnancy. Tell your doctor
immediately if you get irregular vaginal
bleeding or spotting. If you have any
questions about this, ask your doctor or
health professional.
If you develop any of the following
symptoms after starting Trileptal, tell your
doctor immediately or go to the emergency
department at your nearest hospital:
• if you experience an allergic reaction after
starting Trileptal. Symptoms include
swelling of lips, eyelids, face, throat,
mouth, or sudden breathing problems,
fever with swollen glands, rash or skin
blistering.
• if you notice symptoms of hepatitis, such
as jaundice (yellowing of skin or the whites
of the eyes).
• if you notice possible symptoms of blood
disorders such as tiredness, being short of
breath when exercising, looking pale,
headache, chills, dizziness, frequent
infections leading to fever, sore throat,
mouth ulcers, bleeding or bruising more
easily than normal, nose bleeds, reddish or
purplish patches, or unexplained blotches
on the skin.
• a small number of people being treated
with antiepileptics such as Trileptal have
had thoughts of harming or killing
themselves. If at any time you have these
thoughts, immediately contact your doctor.
If you develop the following symptoms after
starting Trileptal, tell your doctor as soon
as possible:
• if you have a fast or unusually slow heart
beat.

Taking other medicines
Tell your doctor or pharmacist if you are taking
or have recently taken any other medicines.
This includes medicines bought without a
prescription.

This applies especially to:
• Hormonal contraceptives, such as the pill
(see Take special care with Trileptal).
• Other antiepileptic medicines, such as
carbamazepine, phenobarbital, phenytoin
or lamotrigine.
• Medicines that reduce the level of sodium
in your blood, such as diuretics (used to
help the kidneys get rid of salt and water by
increasing the amount of urine produced),
desmopressin and non-steroidal antiinflammatory drugs, such as indometacin.
• Lithium and monoamine oxidase inhibitors
(medicines used to treat mood swings and
some types of depression).
• Medicines that control the body’s immune
system, such as ciclosporin and tacrolimus.

Taking Trileptal with food and drink
Trileptal can be taken with or without food.
Alcohol may increase the sedative effects of
Trileptal. Avoid alcohol as much as possible
and ask your doctor for advice.

Pregnancy
Tell your doctor if you are pregnant or planning
to become pregnant.
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 Trileptal.
Do not stop your treatment with Trileptal during
pregnancy without first checking with your
doctor.
Ask your doctor or pharmacist for advice before
taking any medicine during pregnancy.

Breast-feeding
You should not breast-feed while taking
Trileptal. The active substance in Trileptal
passes into breast milk. This could cause side
effects for breast-fed babies. Ask your doctor
or pharmacist for advice before taking any
medicine while you are breast-feeding.

Driving and using machines
Trileptal may make you feel sleepy or dizzy.
It is important to discuss with your doctor
whether you can drive a vehicle or operate
machines while taking this medicine.

3. HOW TO TAKE TRILEPTAL
Always take Trileptal exactly as your doctor or
pharmacist has told you, even if this differs
from the information given in this leaflet. Check
with your doctor or pharmacist if you are not
sure.

How much to take
Dose for adults
• The usual starting dose of Trileptal for
adults (including elderly patients) is 600mg
per day.
• Take one 300mg tablet twice daily or two
150mg tablets twice daily.
• Your doctor may increase the dose
gradually to find the best dose for you. The
best results are usually with doses
between 600 and 2,400mg per day.
• If you take another antiepileptic medicine,
the dose is the same.
• If you have kidney disease (with impaired
kidney function), the starting dose is half
the usual starting dose.
• If you have severe liver disease, your
doctor may adjust your dose.

Dose for children
Trileptal can be taken by children aged 6 years
or above.

The dosage for children depends on their
weight.
• The starting dose is 8 to 10milligrams per
kilogram of bodyweight per day given in
two divided doses. For example, a 30-kg
child would start treatment with one 150mg
tablet twice daily.
• Your doctor may increase the dose
gradually to find the best dose for your
child. The best results are usually with a
dose of 30milligrams per kilogram of
bodyweight per day. The maximum dose
for a child is 46milligrams per kilogram of
bodyweight per day.

How to take Trileptal





Swallow the tablets with a little water.
If necessary, the tablets can be broken in
half to help swallow them. Do not break the
tablets to take only half of the dose. The
score line was not designed for dividing the
tablet into equal doses.
For small children who cannot swallow
tablets, or who cannot be given the
necessary dose in tablet form, Trileptal is
available as an oral suspension.

When and for how long to take Trileptal
Take Trileptal twice a day, every day, at about
the same time of day, unless the doctor tells
you otherwise. This will have the best effect on
controlling epilepsy. It will also help you to
remember when to take the tablet(s).
Your doctor will tell you how long your or your
child’s treatment with Trileptal will last. The
length of treatment will depend on your or your
child’s seizure type. Treatment may be needed
for many years to control the seizures. Do not
change the dose or stop treatment without
talking to your doctor.

If you take more Trileptal than you
should
If you have taken more tablets than your doctor
prescribed, contact the nearest hospital or your
doctor immediately. Symptoms of overdose
with Trileptal may include: drowsiness,
dizziness, feeling sick (nausea), being sick
(vomiting), increased uncontrolled movements,
lethargy, confusion, muscular twitching or
significant worsening of convulsions, problems
with coordination and/or involuntary movement
of the eyes.

If you forget to take Trileptal
If you have forgotten one dose, take it as soon
as you remember. However, if it is time for your
next dose, do not take the missed dose. Go
back to your regular dosing timetable. Do not
double the dose at any time.
If you are unsure or have forgotten to take
several doses, contact your doctor.

If you stop taking Trileptal
Do not stop taking your medicine unless your
doctor tells you to.
To prevent sudden worsening of your seizures,
never discontinue your medicine abruptly.
If your treatment is stopped, it should be done
gradually as instructed by your doctor.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Trileptal can cause side
effects, although not everybody gets them.
These side effects may occur with certain
frequencies, which are defined as follows:
Very common: affects more than 1 patient in 10
Common: affects 1 to 10 patients in 100
Uncommon: affects 1 to 10 patients in 1,000
Very rare: affects less than 1 patient in 10,000
Not known: frequency cannot be estimated from
the available data

Some side effects could be serious: get
medical help immediately
The following are signs of very rare, but
potentially serious side effects that may require
urgent medical treatment.
• Swelling of the lips, eyelids, face, throat or
mouth, accompanied by difficulty in
breathing, speaking or swallowing (signs of
anaphylactic reactions and angioedema) or
other signs of hypersensitivity reactions
such as skin rash, fever, and pain in the
muscles and joints.
• Severe blistering of the skin and/or mucous
membranes of the lips, eyes, mouth, nasal
passages or genitals (signs of serious
allergic reaction including Lyell’s syndrome,
Stevens-Johnson syndrome and erythema
multiforme).
• Tiredness, shortness of breath when
exercising, looking pale, headache, chills,
dizziness, frequent infections leading to
fever, sore throat, mouth ulcers, 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).
• Red blotchy rash mainly on face which may
be accompanied by fatigue, fever, feeling
sick (nausea) or loss of appetite (signs of
systemic lupus erythematosus).
• Lethargy, confusion, muscle twitching or
significant worsening of convulsions
(possible symptoms of low sodium levels in
the blood) (see Take special care with
Trileptal).
• Flu-like symptoms with jaundice (yellowing
of the skin or the whites of the eyes) (signs
of hepatitis).
• Severe upper stomach (abdominal) pain,
being sick (vomiting), loss of appetite
(signs of inflammation of the pancreas).
• Weight gain, tiredness, hair loss, muscle
weakness, feeling cold (signs of under
active thyroid gland).
Tell your doctor immediately or go to the
emergency department at your nearest
hospital if you get any of the above side
effects. The doctor will also decide whether
Trileptal has to be stopped immediately and
how to continue further medical care.

Other side effects: tell a doctor as
soon as possible
Common
• trembling; coordination problems;
involuntary movement of the eyes; anxiety
and nervousness; depression; rash.

Very rare
• irregular heart beat or a very fast or slow
heart rate.

Tell your doctor as soon as possible if
you get any of the above side effects.
They may require medical attention.

Uncommon
• hives. You may also have raised levels of
liver enzymes while taking Trileptal.

Not known
• high blood pressure
Tell your doctor if any of the above side
effects gets severe.
There have been reports of bone disorders
including osteopenia and osteoporosis
(thinning of the bone) fractures. Check with
your doctor of pharmacist if you are on longterm antiepileptic medication, have a history of
osteoporosis, or take steroids.
If you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE TRILEPTAL
• Keep out of the sight and reach of children.
• Do not use Trileptal after the expiry date
which is stated on the carton/ blister label
after ‘Exp’. The expiry date refers to the last
day of that month.
• If your tablets become discoloured or show
signs of deterioration, you should seek the
advice of your pharmacist.
• Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6. FURTHER INFORMATION
What Trileptal contains
Each film-coated tablet contains 300mg
oxcarbazepine.
The other ingredients are:
Tablet core: colloidal anhydrous silica,
microcrystalline cellulose, crospovidone,
hypromellose, and magnesium stearate.
Tablet coating: hypromellose, macrogol
8000, titanium dioxide (E171), yellow iron
oxide (E172) and talc.

What Trileptal looks like and contents of
the pack
Trileptal are yellow, ovaloid, film-coated tablets
scored on both sides, engraved with
‘TE | TE’ on one side and ‘CG | CG’ on the
other side.
The tablets come in blister packs of 100 tablets
Manufactured by: Novartis Farmaceutica,
S.A., Ronda Santa Maria, 158 08210 Barbera
del Valles, Barcelona, Spain.
Procured from within the EU and
repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road,
Ruislip, Middlesex, HA4 0NU, UK
®

Other side effects: tell a doctor if they
worry you:

Trileptal 300mg Film-Coated Tablets
PL No: 18799/2197

These are usually mild to moderate side effects
of Trileptal. Most of these effects are transient
and usually diminish over time.

POM

Leaflet date: 22.10.2012

Very common
• tiredness; headache; dizziness;
drowsiness; feeling sick (nausea); being
sick (vomiting); double vision.

Common
• weakness; memory disturbances; impaired
concentration; apathy; agitation; confusion;
blurred vision; visual disturbance;
constipation; diarrhoea; stomach
(abdominal) pain; acne; hair loss, balance
disturbances.

Trileptal is a registered trademark of Novartis
Pharmaceuticals.

PACKAGE LEAFLET: INFORMATION
FOR THE USER

2. BEFORE YOU TAKE
OXCARBAZEPINE

Oxcarbazepine 300mg FilmCoated Tablets

Follow all instructions given to you by your
doctor carefully, even if they differ from the
information contained in this leaflet.

Read all of this leaflet carefully before
you start taking this medicine.

Do not take Oxcarbazepine
• if you are allergic (hypersensitive) to







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
or your child. 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.

The name of your medicine is Oxcarbazepine
300mg Film-Coated Tablets but will be referred
to as Oxcarbazepine throughout this leaflet.
Please note that this leaflet also contains
information about other strengths such as
Oxcarbazepine 150mg and 600mg FilmCoated Tablets.

In this leaflet:
1. What Oxcarbazepine is and what it is used
for
2. Before you take Oxcarbazepine
3. How to take Oxcarbazepine
4. Possible side effects
5. How to store Oxcarbazepine
6. Further information

1. WHAT OXCARBAZEPINE IS AND
WHAT IT IS USED FOR
What Oxcarbazepine is
The active ingredient of Oxcarbazepine is
oxcarbazepine.
Oxcarbazepine belongs to a group of
medicines called anticonvulsants or
antiepileptics.

What Oxcarbazepine is used for
Medicines such as Oxcarbazepine are the
standard treatment for epilepsy.
Patients diagnosed with epilepsy have had
repeated seizures, or convulsions. Seizures
happen because of a temporary fault in the
brain’s electrical system. Normally brain cells
coordinate body movements by sending out
signals through the nerves to the muscles in an
organised, orderly way. In epilepsy, brain cells
send out too many signals in a disorderly
fashion. The result can be uncoordinated
muscular activity that is called an epileptic
seizure.
Oxcarbazepine is used to treat partial seizures
with or without secondarily generalised tonicclonic 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 works by keeping the brain’s
“overexcitable” nerve cells under control. This
suppresses or reduces the frequency of such
seizures.
Oxcarbazepine can be used alone or in
combination with other antiepileptic medicines.
Usually, the doctor will try to find the one
medicine that works best for you or for your
child. However, with more severe epilepsy, a
combination of two or more medicines may be
needed to control seizures.
Oxcarbazepine is for use in adults and in
children of 6 years of age and above.

oxcarbazepine or to any other ingredients
of Oxcarbazepine tablets (listed in section
6 Further information).

Take special care with Oxcarbazepine
If any of the following apply to you, tell your
doctor before you take Oxcarbazepine:
• if you have ever shown unusual
sensitivity (rash or any other signs of
allergy) to carbamazepine or to any other
medicines. If you are allergic to
carbamazepine, the chances are
approximately 1 in 4 (25 %) that you could
also have an allergic reaction to
oxcarbazepine (Oxcarbazepine).
• if you have a kidney disease.
• If you have a serious liver disease.
• if you are taking diuretics (medicines
used to help the kidneys get rid of salt and
water by increasing the amount of urine
produced).
• if you have a heart disease, shortness of
breath and/or swelling of the feet or legs
due to fluid build-up.
• if your blood level of sodium is low as
shown by blood tests (see section 4
Possible side effects).
• if you are a woman taking a hormonal
contraceptive, such as the pill,
Oxcarbazepine may stop your
contraceptive from working. Use a different
or extra (non-hormonal) method of
contraception while taking Oxcarbazepine.
This should help to prevent an unwanted
pregnancy. Tell your doctor immediately if
you get irregular vaginal bleeding or
spotting. If you have any questions about
this, ask your doctor or health professional.
If you develop any of the following
symptoms after starting Oxcarbazepine, tell
your doctor immediately or go to the
emergency department at your nearest
hospital:
• if you experience an allergic reaction after
starting Oxcarbazepine. Symptoms include
swelling of lips, eyelids, face, throat,
mouth, or sudden breathing problems,
fever with swollen glands, rash or skin
blistering.
• if you notice symptoms of hepatitis, such
as jaundice (yellowing of skin or the whites
of the eyes).
• if you notice possible symptoms of blood
disorders such as tiredness, being short of
breath when exercising, looking pale,
headache, chills, dizziness, frequent
infections leading to fever, sore throat,
mouth ulcers, bleeding or bruising more
easily than normal, nose bleeds, reddish or
purplish patches, or unexplained blotches
on the skin.
• a small number of people being treated
with antiepileptics such as Oxcarbazepine
have had thoughts of harming or killing
themselves. If at any time you have these
thoughts, immediately contact your doctor.
If you develop the following symptoms after
starting Oxcarbazepine, tell your doctor as
soon as possible:
• if you have a fast or unusually slow heart
beat.

Taking other medicines
Tell your doctor or pharmacist if you are taking
or have recently taken any other medicines.
This includes medicines bought without a
prescription.

This applies especially to:
• Hormonal contraceptives, such as the pill
(see Take special care with
Oxcarbazepine).
• Other antiepileptic medicines, such as
carbamazepine, phenobarbital, phenytoin
or lamotrigine.
• Medicines that reduce the level of sodium
in your blood, such as diuretics (used to
help the kidneys get rid of salt and water by
increasing the amount of urine produced),
desmopressin and non-steroidal antiinflammatory drugs, such as indometacin.
• Lithium and monoamine oxidase inhibitors
(medicines used to treat mood swings and
some types of depression).
• Medicines that control the body’s immune
system, such as ciclosporin and tacrolimus.

Taking Oxcarbazepine with food and
drink
Oxcarbazepine can be taken with or without
food.
Alcohol may increase the sedative effects of
Oxcarbazepine. Avoid alcohol as much as
possible and ask your doctor for advice.

Pregnancy
Tell your doctor if you are pregnant or planning
to become pregnant.
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.
Do not stop your treatment with Oxcarbazepine
during pregnancy without first checking with
your doctor.
Ask your doctor or pharmacist for advice before
taking any medicine during pregnancy.

Breast-feeding
You should not breast-feed while taking
Oxcarbazepine. The active substance in
Oxcarbazepine passes into breast milk. This
could cause side effects for breast-fed babies.
Ask your doctor or pharmacist for advice before
taking any medicine while you are breastfeeding.

Driving and using machines
Oxcarbazepine may make you feel sleepy or
dizzy.
It is important to discuss with your doctor
whether you can drive a vehicle or operate
machines while taking this medicine.

3. HOW TO TAKE OXCARBAZEPINE
Always take Oxcarbazepine exactly as your
doctor or pharmacist has told you, even if this
differs from the information given in this leaflet.
Check with your doctor or pharmacist if you are
not sure.

How much to take
Dose for adults
• The usual starting dose of
Oxcarbazepine for adults (including elderly
patients) is 600mg per day.
• Take one 300mg tablet twice daily or two
150mg tablets twice daily.
• Your doctor may increase the dose
gradually to find the best dose for you. The
best results are usually with doses
between 600 and 2,400mg per day.
• If you take another antiepileptic medicine,
the dose is the same.
• If you have kidney disease (with impaired
kidney function), the starting dose is half
the usual starting dose.
• If you have severe liver disease, your
doctor may adjust your dose.

Dose for children
Oxcarbazepine can be taken by children aged
6 years or above.
The dosage for children depends on their
weight.
• The starting dose is 8 to 10milligrams per
kilogram of bodyweight per day given in
two divided doses. For example, a 30-kg
child would start treatment with one 150mg
tablet twice daily.
• Your doctor may increase the dose
gradually to find the best dose for your
child. The best results are usually with a
dose of 30milligrams per kilogram of
bodyweight per day. The maximum dose
for a child is 46milligrams per kilogram of
bodyweight per day.

How to take Oxcarbazepine





Swallow the tablets with a little water.
If necessary, the tablets can be broken in
half to help swallow them. Do not break the
tablets to take only half of the dose. The
score line was not designed for dividing the
tablet into equal doses.
For small children who cannot swallow
tablets, or who cannot be given the
necessary dose in tablet form,
Oxcarbazepine is available as an oral
suspension.

When and for how long to take
Oxcarbazepine
Take Oxcarbazepine twice a day, every day, at
about the same time of day, unless the doctor
tells you otherwise. This will have the best
effect on controlling epilepsy. It will also help
you to remember when to take the tablet(s).
Your doctor will tell you how long your or your
child’s treatment with Oxcarbazepine will last.
The length of treatment will depend on your or
your child’s seizure type. Treatment may be
needed for many years to control the seizures.
Do not change the dose or stop treatment
without talking to your doctor.

If you take more Oxcarbazepine than you
should
If you have taken more tablets than your doctor
prescribed, contact the nearest hospital or your
doctor immediately. Symptoms of overdose
with Oxcarbazepine may include: drowsiness,
dizziness, feeling sick (nausea), being sick
(vomiting), increased uncontrolled movements,
lethargy, confusion, muscular twitching or
significant worsening of convulsions, problems
with coordination and/or involuntary movement
of the eyes.

If you forget to take Oxcarbazepine
If you have forgotten one dose, take it as soon
as you remember. However, if it is time for your
next dose, do not take the missed dose. Go
back to your regular dosing timetable. Do not
double the dose at any time.
If you are unsure or have forgotten to take
several doses, contact your doctor.

If you stop taking Oxcarbazepine
Do not stop taking your medicine unless your
doctor tells you to.
To prevent sudden worsening of your seizures,
never discontinue your medicine abruptly.
If your treatment is stopped, it should be done
gradually as instructed by your doctor.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Oxcarbazepine can cause
side effects, although not everybody gets them.
These side effects may occur with certain
frequencies, which are defined as follows:
Very common: affects more than 1 patient in 10
Common: affects 1 to 10 patients in 100
Uncommon: affects 1 to 10 patients in 1,000
Very rare: affects less than 1 patient in 10,000
Not known: frequency cannot be estimated from
the available data

Some side effects could be serious: get
medical help immediately
The following are signs of very rare, but
potentially serious side effects that may require
urgent medical treatment.
• Swelling of the lips, eyelids, face, throat or
mouth, accompanied by difficulty in
breathing, speaking or swallowing (signs of
anaphylactic reactions and angioedema) or
other signs of hypersensitivity reactions
such as skin rash, fever, and pain in the
muscles and joints.
• Severe blistering of the skin and/or mucous
membranes of the lips, eyes, mouth, nasal
passages or genitals (signs of serious
allergic reaction including Lyell’s syndrome,
Stevens-Johnson syndrome and erythema
multiforme).
• Tiredness, shortness of breath when
exercising, looking pale, headache, chills,
dizziness, frequent infections leading to
fever, sore throat, mouth ulcers, 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).
• Red blotchy rash mainly on face which may
be accompanied by fatigue, fever, feeling
sick (nausea) or loss of appetite (signs of
systemic lupus erythematosus).
• Lethargy, confusion, muscle twitching or
significant worsening of convulsions
(possible symptoms of low sodium levels in
the blood) (see Take special care with
Oxcarbazepine).
• Flu-like symptoms with jaundice (yellowing
of the skin or the whites of the eyes) (signs
of hepatitis).
• Severe upper stomach (abdominal) pain,
being sick (vomiting), loss of appetite
(signs of inflammation of the pancreas).
• Weight gain, tiredness, hair loss, muscle
weakness, feeling cold (signs of under
active thyroid gland).
Tell your doctor immediately or go to the
emergency department at your nearest
hospital if you get any of the above side
effects. The doctor will also decide whether
Oxcarbazepine has to be stopped immediately
and how to continue further medical care.

Other side effects: tell a doctor as
soon as possible
Common
• trembling; coordination problems;
involuntary movement of the eyes; anxiety
and nervousness; depression; rash.

Very rare
• irregular heart beat or a very fast or slow

Very common
• tiredness; headache; dizziness;
drowsiness; feeling sick (nausea); being
sick (vomiting); double vision.

Common
• weakness; memory disturbances; impaired
concentration; apathy; agitation; confusion;
blurred vision; visual disturbance;
constipation; diarrhoea; stomach
(abdominal) pain; acne; hair loss, balance
disturbances.

Uncommon
• hives. You may also have raised levels of
liver enzymes while taking Oxcarbazepine.

Not known
• high blood pressure
Tell your doctor if any of the above side
effects gets severe.
There have been reports of bone disorders
including osteopenia and osteoporosis
(thinning of the bone) fractures. Check with
your doctor of pharmacist if you are on longterm antiepileptic medication, have a history of
osteoporosis, or take steroids.
If you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE OXCARBAZEPINE
• Keep out of the sight and reach of children.
• Do not use Oxcarbazepine after the expiry
date which is stated on the carton/ blister
label after ’Exp’. The expiry date refers to the
last day of that month.
• If your tablets become discoloured or show
signs of deterioration, you should seek the
advice of your pharmacist.
• Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6. FURTHER INFORMATION
What Oxcarbazepine contains
Each film-coated tablet contains 300mg
oxcarbazepine.
The other ingredients are:
Tablet core: colloidal anhydrous silica,
microcrystalline cellulose, crospovidone,
hypromellose, and magnesium stearate.
Tablet coating: hypromellose, macrogol 8000,
titanium dioxide (E171), yellow iron oxide
(E172) and talc.

What Oxcarbazepine looks like and
contents of the pack
Oxcarbazepine yellow, ovaloid, film-coated
tablets scored on both sides, engraved with
‘TE | TE’ on one side and ‘CG | CG’ on the
other side.
The tablets come in blister packs of 100
tablets.
Manufactured by: Novartis Farmaceutica,
S.A., Ronda Santa Maria, 158 08210 Barbera
del Valles, Barcelona, Spain.

heart rate.

Tell your doctor as soon as possible if
you get any of the above side effects.
They may require medical attention.

Other side effects: tell a doctor if they
worry you:
These are usually mild to moderate side effects
of Oxcarbazepine. Most of these effects are
transient and usually diminish over time.

Procured from within the EU and
repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road,
Ruislip, Middlesex, HA4 0NU, UK
POM
Oxcarbazepine 300mg Film-Coated Tablets
PL No: 18799/2197
Leaflet date: 22.10.2012

Expand Transcript

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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