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OXCARBAZEPINE 600MG FILM - COATED TABLETS

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S1107 LEAFLET Trileptal 20120626

PACKAGE LEAFLET: INFORMATION FOR THE USER

TRILEPTAL 300mg FILM-COATED TABLETS
TRILEPTAL 600mg FILM-COATED TABLETS

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:


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.
In this leaflet:

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:

1. What Trileptal is and what it is used for



2. Before you take Trileptal

Taking other medicines

3. How to take Trileptal

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

(oxcarbazepine)
Your medicine is marketed using the above names but will be referred
to as Trileptal throughout the following patient information leaflet.
Information regarding other strengths i.e. 150mg is also present in the
below leaflet.
Read all of this leaflet carefully before you start taking this
medicine.
-

4. Possible side effects
5. How to store Trileptal
6. Further information

This applies especially to:


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 have a fast or unusually slow heart beat.




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 nonsteroidal anti-inflammatory 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 600 mg per day.
Take one 300 mg tablet twice daily or two 150 mg tablets twice
daily or two 150 mg 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
2,400 mg 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 10 milligrams per kilogram of bodyweight
per day given in two divided doses. For example, a 30-kg child
would start treatment with one 150 mg 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 30
milligrams per kilogram of bodyweight per day. The maximum
dose for a child is 46 milligrams 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.

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.
Other side effects: tell a doctor if they worry you:
These are usually mild to moderate side effects of Trileptal. Most of
these effects are transient and usually diminish over time.
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 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) 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 you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
5. HOW TO STORE TRILEPTAL






To prevent sudden worsening of your seizures, never discontinue your
medicine abruptly.

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use after the expiry date printed on the carton label or
blister strip.
If the medicine becomes discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist who
will tell you what to do.
There are no special storage instructions.
If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the medicine if
your doctor tells you to.

If your treatment is stopped, it should be done gradually as instructed
by your doctor.

6. FURTHER INFORMATION

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).

What Trileptal contains
Trileptal 300mg Tablets. Each film-coated tablet contains 300mg of
the active ingredient, oxcarbazepine.
Trileptal 600mg Tablets. Each film-coated tablet contains 600mg of
the active ingredient, oxcarbazepine.
The other ingredients are: colloidal silica anhydrous,
microcrystalline cellulose, hypromellose, crospovidone,
magnesium stearate, talc and titanium dioxide (E171).
The 300mg tablets also contain macrogol 8000 and yellow iron
oxide (E172).
The 600mg tablets also contain macrogol 4000, red iron oxide
(E172) and black iron oxide (E172).

What Trileptal looks like and contents of the pack
Trileptal 300mg Tablets are yellow ovaloid film-coated tablet marked
‘CG’ each side of a score line on one side and ‘TE’ each side of a
score line on the other side.
Trileptal 600mg Tablets are light pink film-coated, ovaloid, biconvex
tablets, scored on both sides. Embossed with TF|TF on one side and
CG|CG on the other side.
Trileptal tablets are available as blister packs of 50 or 100 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product Licence
holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley,
HA0 1DX.
Manufacturer
This product is manufactured by Novartis Farmaceutica S.A, Barbera
del Valles, Barcelona, E-08210 Spain.
POM

PL No. 19488/1107 Trileptal 300mg Film-coated Tablets
PL No. 19488/1108 Trileptal 600mg Film-coated Tablets

Leaflet revision date: 20 September 2012
Trileptal is a registered trade mark of Novartis AG, Switzerland.
S1107 LEAFLET Trileptal 20120920

S1107 LEAFLET Oxcarbazepine 20120920

PACKAGE LEAFLET: INFORMATION FOR THE USER

OXCARBAZEPINE 300mg FILM-COATED TABLETS
OXCARBAZEPINE 600mg FILM-COATED TABLETS
(oxcarbazepine)
Your medicine is marketed using the above names but will be referred
to as Oxcarbazepine Tablets throughout the following patient
information leaflet.
Information regarding other strengths i.e. 150mg is also present in the
below leaflet.

If you develop any of the following symptoms after starting
Oxcarbazepine Tablets, tell your doctor immediately or go to the
emergency department at your nearest hospital:





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.
In this leaflet:
1. What Oxcarbazepine Tablets are and what they are used for



if you experience an allergic reaction after starting Oxcarbazepine
Tablets. 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 Tablets 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 Tablets, tell your doctor as soon as possible:


if you have a fast or unusually slow heart beat.

Taking other medicines

3. How to take Oxcarbazepine Tablets

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

4. Possible side effects

This applies especially to:

5. How to store Oxcarbazepine Tablets



2. Before you take Oxcarbazepine Tablets

6. Further information
1. WHAT OXCARBAZEPINE TABLETS ARE AND WHAT THEY ARE
USED FOR
What Oxcarbazepine Tablets are
The active ingredient of Oxcarbazepine Tablets is oxcarbazepine.
Oxcarbazepine Tablets belong to a group of medicines called
anticonvulsants or antiepileptics.
What Oxcarbazepine Tablets are used for
Medicines such as Oxcarbazepine Tablets 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 Tablets are 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 Tablets work by keeping the brain’s “overexcitable”
nerve cells under control. This suppresses or reduces the frequency of
such seizures.
Oxcarbazepine Tablets can be used alone or in combination with other
antiepileptic medicines.

Hormonal contraceptives, such as the pill (see Take special care
with Oxcarbazepine Tablets).
 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 nonsteroidal anti-inflammatory 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 Tablets with food and drink
Oxcarbazepine Tablets can be taken with or without food.
Alcohol may increase the sedative effects of Oxcarbazepine Tablets.
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 Tablets.
Do not stop your treatment with Oxcarbazepine Tablets during
pregnancy without first checking with your doctor.
Ask your doctor or pharmacist for advice before taking any medicine
during pregnancy.
Breast-feeding

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.

You should not breast-feed while taking Oxcarbazepine Tablets. The
active substance in Oxcarbazepine Tablets 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.

Oxcarbazepine Tablets are for use in adults and in children of 6 years
of age and above.

Driving and using machines

2. BEFORE YOU TAKE OXCARBAZEPINE TABLETS
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 Tablets


if you are allergic (hypersensitive) to oxcarbazepine or to any
other ingredients of Oxcarbazepine Tablets (listed in section 6
Further information).

Oxcarbazepine Tablets 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 TABLETS
Always take Oxcarbazepine Tablets 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

Take special care with Oxcarbazepine Tablets

Dose for adults

If any of the following apply to you, tell your doctor before you
take Oxcarbazepine Tablets:














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 Tablets).
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 Tablets may stop your contraceptive from
working. Use a different or extra (non-hormonal) method of
contraception while taking Oxcarbazepine Tablets. 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.






The usual starting dose of Oxcarbazepine Tablets for adults
(including elderly patients) is 600 mg per day.
Take one 300 mg tablet twice daily or two 150 mg tablets twice
daily or two 150 mg 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
2,400 mg 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 Tablets can be taken by children aged 6 years or
above.

The doctor will also decide whether Oxcarbazepine Tablets has to be
stopped immediately and how to continue further medical care.
Other side effects: tell a doctor as soon as possible

The dosage for children depends on their weight.

Common:







The starting dose is 8 to 10 milligrams per kilogram of bodyweight
per day given in two divided doses. For example, a 30-kg child
would start treatment with one 150 mg 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 30
milligrams per kilogram of bodyweight per day. The maximum dose
for a child is 46 milligrams per kilogram of bodyweight per day.

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.

How to take Oxcarbazepine Tablets

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




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



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 Tablets are
available as an oral suspension.

When and for how long to take Oxcarbazepine Tablets
Take Oxcarbazepine Tablets 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 Tablets 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 Tablets 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 Tablets 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 Tablets
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 Tablets
Do not stop taking your medicine unless your doctor tells you to.

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 Tablets.
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) 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 you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
5. HOW TO STORE OXCARBAZEPINE TABLETS






To prevent sudden worsening of your seizures, never discontinue your
medicine abruptly.

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use after the expiry date printed on the carton label or blister
strip.
If the medicine becomes discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist who
will tell you what to do.
There are no special storage instructions.
If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the medicine if
your doctor tells you to.

If your treatment is stopped, it should be done gradually as instructed
by your doctor.

6. FURTHER INFORMATION

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 Tablets 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 Tablets).
 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.

What Oxcarbazepine Tablets contain
Oxcarbazepine 300mg Tablets. Each film-coated tablet contains
300mg of the active ingredient, oxcarbazepine.
Oxcarbazepine 600mg Tablets. Each film-coated tablet contains
600mg of the active ingredient, oxcarbazepine.
The other ingredients are: colloidal silica anhydrous,
microcrystalline cellulose, hypromellose, crospovidone, magnesium
stearate, talc and titanium dioxide (E171).
The 300mg tablets also contain macrogol 8000 and yellow iron
oxide (E172).
The 600mg tablets also contain macrogol 4000, red iron oxide
(E172) and black iron oxide (E172).

What Oxcarbazepine Tablets look like and contents of the pack
Oxcarbazepine 300mg Tablets are yellow ovaloid film-coated tablet
marked ‘CG’ each side of a score line on one side and ‘TE’ each side of
a score line on the other side.
Oxcarbazepine 600mg Tablets are light pink film-coated, ovaloid,
biconvex tablets, scored on both sides. Embossed with TF|TF on one
side and CG|CG on the other side.
Oxcarbazepine Tablets are available as blister packs of 50 or 100
tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product Licence
holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley,
HA0 1DX.
Manufacturer
This product is manufactured by Novartis Farmaceutica S.A, Barbera
del Valles, Barcelona, E-08210 Spain.
POM
Tablets

PL No. 19488/1107 Oxcarbazepine 300mg Film-coated
PL No. 19488/1108 Oxcarbazepine 600mg Film-coated

Tablets
Leaflet revision date: 20 September 2012
S1107 LEAFLET Oxcarbazepine 20120920

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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