OXCARBAZEPINE 600 MG TABLETS

Active substance: OXCARBAZEPINE

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S143 LEAFLET Trileptal 20120920

TRILEPTAL 600mg TABLETS
OXCARBAZEPINE 600mg 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:


(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 and 300mg is also
present in the below leaflet




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:



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
4. Possible side effects

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

5. How to store Trileptal

This applies especially to:

6. 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.



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.

Trileptal works by keeping the brain’s “overexcitable” nerve cells under
control. This suppresses or reduces the frequency of such seizures.

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.

Trileptal can be used alone or in combination with other antiepileptic
medicines.

Do not stop your treatment with Trileptal during pregnancy without first
checking with your doctor.

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.

Ask your doctor or pharmacist for advice before taking any medicine
during pregnancy.

Trileptal is for use in adults and in children of 6 years of age and
above.

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.

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).

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

If any of the following apply to you, tell your doctor before you
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

Take special care with 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.








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

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:


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:


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).

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





Do not stop taking your medicine unless your doctor tells you to.
To prevent sudden worsening of your seizures, never discontinue your
medicine abruptly.

trembling; coordination problems; involuntary movement of the
eyes; anxiety and nervousness; depression; rash.

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.
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.

6. FURTHER INFORMATION
What Trileptal contains



The active substance in Trileptal is oxcarbazepine. Each Trileptal
600mg Tablets contains 600mg of the active ingredient,
oxcarbazepine.
The other ingredients are: anhydrous colloidal silica,
microcrystalline cellulose, hypromellose, crospovidone,
magnesium stearate, macrogol 8000, iron oxides (E172), talc and
titanium dioxide (E171).

What Trileptal looks like and contents of the pack
Trileptal tablets are yellow ovaloid film-coated tablet marked ‘CG’ each
side of a score line on one side and ‘TF’ each side of a score line on
the other side.
Trileptal tablets are available as blister packs of 50 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 Pharma AG, Stein,
Switzerland.
POM

PL No. 19488/0143 Trileptal 600mg Tablets

Leaflet revision date: 20 September 2012
Trileptal is a registered trade mark of Novartis AG, Switzerland.
S143 LEAFLET Trileptal 20120920

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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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