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OXCARBAZEPINE TEVA 150 MG FILM-COATED TABLETS

Active substance(s): OXCARBAZEPINE

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TEVA UK Ref:

Oxcarbazepine
Package leaflet:Information for the user
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 Teva Film-coated Tablets are and what they are used
for
2. what you need to know before you take Oxcarbazepine Teva Film-coated
Tablets
3. How to take Oxcarbazepine Teva Film-coated Tablets
4. Possible side effects
5. How to store Oxcarbazepine Teva Film-coated Tablets
6. Contents of the pack and other information

What Oxcarbazepine Teva Film-coated Tablets are and what they
are used for

Pharma code 92 (011101)
First bar is 105mm from the top edge of the leaflet.

What Oxcarbazepine Teva Film-coated Tablets are
The active ingredient of Oxcarbazepine Teva Film-coated Tablets is
oxcarbazepine.
Oxcarbazepine belongs to a group of medicines called anticonvulsants or
antiepileptics.
What Oxcarbazepine Teva Film-coated Tablets are used for
Medicines such as Oxcarbazepine Teva Film-coated Tablets are the standard
treatment for epilepsy.
Epilepsy is a brain disorder that causes people to have recurring seizures and
convulsions(also known as fits). Seizures happen because of a temporary fault
in the brain’s electrical activity. 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 Teva Film-coated 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 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 Teva Film-coated Tablets work by keeping the brain’s
“overexcitable” nerve cells under control. This suppresses or reduces the
frequency of such seizures.
Oxcarbazepine Teva Film-coated Tablets 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
your child. However, with more severe epilepsy, a combination of two or more
medicines may be needed to control seizures.
Oxcarbazepine Teva Film-coated Tablets are for use in adults and in children of
6 years of age and above.

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What you need to know before you take Oxcarbazepine Teva
Film-coated Tablets

Follow all the doctor’s instructions carefully. They may differ from the general
information contained in this leaflet.
Monitoring during your treatment with Oxcarbazepine Teva Film-coated Tablets
Before and during your treatment with Oxcarbazepine Teva film-coated tablets,
your doctor may perform blood tests to determine the dose for you. Your doctor
will tell you when to have the tests.
Do not take Oxcarbazepine Teva Film-coated Tablets:
• If you are allergic to oxcarbazepine or to any of the other ingredients of this
medicine(listed in section 6).
If this applies to you, tell your doctor before taking Oxcarbazepine Teva
Film-coated Tablets . If you think you may be allergic, ask your doctor for
advice.
Warnings and precautions
Talk to your doctor or pharmacist before taking Oxcarbazepine Teva
Film-coated Tablets:
• If you have ever shown unusual sensitivity ( rash or other signs of allergy)
to carbamazepine, or to any other medicines. If you are allergic to
carbamazepine, the chances are approximately a 1 in 4 (25%) that you could
also have an allergic reaction to oxcarbazepine.
• If you have kidney disease
• If you have 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 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
birth-control pill') oxcarbazepine may stop your contraceptive from working.
Use a different or extra (non-hormonal) method of contraception while
taking Oxcarbazepine Teva Film-coated 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 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.

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23 February 2016

If you develop any of the following symptoms after starting Oxcarbazepine
Teva Film-coated Tablets tell your doctor immediately or go to the emergency
department at your nearest hospital:
• if you experience an allergic reaction after starting Oxcarbazepine Teva
Film-coated 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 experience an increase in the frequency of seizures. This is
particularly important for children but may also occur in adults.
• 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 Teva Film-coated Tablets have had thoughts of harming or
killing themselves. If at any time you have these thoughts, immediately
contact your doctor.
• if you have a fast or unusually slow heart beat.
Children and adolescents
In children, your doctor may recommend thyroid function monitoring before
therapy and during therapy.
Other medicines and Oxcarbazepine Teva Film-coated Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
• Hormonal contraceptives, such as the pill (see ‘Warnings and precautions’)
• Other antiepileptic medicines, such as carbamazepine, phenobarbital,
phenytoin or lamotrigine
• Medicines that reduce the levels 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 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.
Oxcarbazepine Teva Film-coated Tablets with food, drink and alcohol
Oxcarbazepine Teva Film-coated tablets can be taken with or without food.
Alcohol may increase the sedative effects of Oxcarbazepine Teva Film-coated
Tablets . Avoid alcohol as much as possible and ask your doctor for advice.
Pregnancy and breast-feeding
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.
Pregnancy
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 Teva
Film-coated Tablets .
Do not stop your treatment with Oxcarbazepine Teva Film-coated Tablets
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 Teva Film-coated
Tablets . The active substance in Oxcarbazepine Teva Film-coated 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 brest-feeding.
Driving and using machines
Oxcarbazepine Teva Film-coated Tablets may make you feel sleepy or dizzy, or
may cause blurred vision, double vision, lack of muscle coordination or a
depressed level of consciousness, especially when starting treatment or
increasing the dose.
It is important to discuss with your doctor whether you can drive a vehicle or
operate machines while taking this medicine
Oxcarbazepine Teva Film-coated Tablets contains lactose and sunset yellow
(E110)
Patients who are intolerant to lactose should note that Oxcarbazepine Teva
Film-coated Tablets contain a small amount of lactose. If you have been told by
your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.
This medicinal product contains sunset yellow (E110) and may cause allergic
reactions.

3

How to take Oxcarbazepine Teva Film-coated Tablets

Always take this medicine exactly as your doctor has told you. Check with your
doctor or pharmacist if you are not sure.
How much to take
Dose for adults:
• The usual starting dose of Oxcarbazepine Teva Film-coated 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.
• 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.
Use in children
Oxcarbazepine Teva Film-coated Tablets can be taken by children aged 6 years
or above.
The dosage for children depends on their weight.
Children aged 6 years and over:
• The starting dose is 8-10 mg/kg body weight a day given in 2 divided doses.

Top of page cut-off to middle of registration mark: 44 mm.

Oxcarbazepine Teva 150 mg, 300 mg
and 600 mg Film-coated Tablets

1

Version:

231-30-87238-Y LEA OXCARBAZEPINE A/S FC TAB TUK

TEVA UK Ref:

Version:

231-30-87238-Y LEA OXCARBAZEPINE A/S FC TAB TUK

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.
Children aged under 6 years old:
Oxcarbazepine is not recommended for children aged under 6 years as its
safety and efficacy have not been established in this age group.
How to take Oxcarbazepine Teva Film-coated Tablets
• 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 the tablets, or who cannot be given
the necessary dose in tablet form, other pharmaceutical forms of
oxcarbazepine are available.
When and for how long to take Oxcarbazepine Teva Film-coated Tablets
Take Oxcarbazepine Teva Film-coated 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 Film-coated 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 Teva Film-coated 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 Teva Film-coated 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 Teva Film-coated Tablets
If you have forgotten one dose, take it as soon as you remember. However if it
is almost time for your next dose, do not take the missed dose. Go back to your
regular dosing timetable.. Do not take a double dose to make up for a forgotten
tablet.
If you are unsure or have forgotten to take several doses, contact your doctor.
If you stop taking Oxcarbazepine Teva Film-coated Tablets
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 medicine, ask your doctor
or pharmacist.

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23 February 2016

Other side effects: tell a doctor if they worry you
These are usually mild to moderate side effects of Oxcarbazepine Teva
Film-coated Tablets, Most of these effects are transient and ususally diminish
over time.
Very common (may affect more than 1 in 10 people):
• Tiredness; headache; dizziness; drowsiness; feeling sick (nausea); being
sick (vomiting); double vision
Common (may affect up to 1 in 10 people):
• Weakness; memory disturbances; impaired concentration; apathy; agitation;
confusion; blurred vision; visual disturbance; constipation; diarrhoea;
stomach (abdominal) pain; acne; hair loss; balance disturbances
Uncommon (may affect up to 1 in 100 people):
• Hives. You may also have raised levels of liver enzymes while taking
Oxcarbazepine Teva Film-coated Tablets
Not known (frequency cannot be estimated from the available data):
• High blood pressure, fall.
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.
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 at: 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 Teva Film-coated Tablets

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 blister
and carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Teva Film-coated Tablets contains
• The active substance is oxcarbazepine. Each film-coated tablet contains
either 150, 300 or 600 mg oxcarbazepine.
• The other ingredients are:
Tablet core: lactose monohydrate, maize starch, crospovidone, povidone
(K-30), cellulose microcrystalline, sodium starch glycolate (type A), silica
colloidal anhydrous and magnesium stearate.
Film-coating: hypromellose, macrogol 6000, macrogol 400, titanium
dioxide (E171), iron oxide yellow (E172), sunset yellow aluminium lake (E110).
What
Oxcarbazepine Teva Film-coated Tablets look like and contents of the
POSSIBLE SIDE EFFECTS
pack
Film-coated tablet
Like all medicines, this medicine can cause side effects, although not
Oxcarbazepine Teva 150 mg Film-coated Tablets are yellow to dark yellow, film
everybody gets them.
coated capsule shaped tablets. One side of the tablet is scored in half and
Some side effects could be serious: get medical help immediately
debossed with "9" on one side of the score and "3" on the other. The other side
The following are signs of very rare, but potentially serious side effects that
of the tablet is scored in half and debossed with "72" on one side of the score
may require urgent medical treatment.
and "81" on the other. The score line is only there to help you break the tablet if
• Swelling of the lips, eyelids, face, throat or mouth, accompanied by difficulty you have difficulty swallowing it whole.
in breathing, speaking or swallowing (signs of anaphylactic reactions and
Oxcarbazepine Teva 300 mg Film-coated Tablets are yellow to dark yellow, film
angioedema) or other signs of hypersensitivity reactions such as skin rash, coated capsule shaped tablets. One side of the tablet is scored in half and
fever, and pain in the muscles and joints
debossed with "9" on one side of the score and "3" on the other. The other side
• Severe blistering of the skin and/or mucous membranes of the lips, eyes,
of the tablet is scored in half and debossed with "72" on one side of the score
mouth, nasal passages or genitals (signs of a serious allergic reaction
and "82" on the other. The score line is only there to help you break the tablet if
including Lyell’s syndrome, Stevens-Johnson syndrome and erythema
you have difficulty swallowing it whole.
multiforme)
Oxcarbazepine Teva 600 mg Film-coated Tablets are yellow to dark yellow, film
• Tiredness, shortness of breath when exercising, looking pale, headache,
coated capsule shaped tablets. One side of the tablet is scored in half and
chills, dizziness, frequent infections leading to fever, sore throat, mouth
debossed with "9" on one side of the score and "3" on the other. The other side
ulcers, bleeding or bruising more easily than normal, nose bleeds, reddish
of the tablet is scored in half and debossed with "72" on one side of the score
or purplish patches, or unexplained blotches on the skin (signs of a
and "83" on the other. The score line is only there to help you break the tablet if
decrease in the number of blood platelets or decrease in the number of
you have difficulty swallowing it whole.
blood cells)
• Red blotchy rash mainly on face which may be accompanied by fatigue,
Oxcarbazepine Teva 150 mg Film-coated Tablets are available in pack sizes of
fever, feeling sick (nausea) or loss of appetite (signs of systemic lupus
1, 30, 50, 56, 100, 200 & 500 film-coated tablets. Hospital pack: 500 film-coated
erythematosus)
tablets.
• Lethargy, confusion, muscle twitching or significant worsening of
Oxcarbazepine Teva 300 mg Film-coated Tablets are available in pack sizes of
convulsions (possible symptoms of low sodium levels in the blood) (see
1, 30, 50, 56, 100, 200 & 500 film-coated tablets. Hospital packs: 50 & 500
‘Special warnings and precautions’)
film-coated tablets.
• Flu-like symptoms with jaundice (yellowing of the skin or the whites of the
Oxcarbazepine Teva 600 mg Film-coated Tablets are available in pack sizes of
eyes (signs of hepatitis)
1, 30, 50, 56, 100, 200 & 500 film-coated tablets. Hospital packs: 50 & 500
• Severe upper stomach (abdominal) pain, being sick (vomiting), loss of
film-coated tablets.
appetite (signs of inflammation of the pancreas)
• Weight gain, tiredness, hair loss, muscle weakness, feeling cold (signs of
Not all pack sizes may be marketed.
under active thyroid gland)
Marketing Authorisation Holder and Manufacturer
Tell your doctor immediately or go to the emergency department at your
TEVA UK Limited, Eastbourne, BN22 9AG.
nearest hospital if you get any of the above side effects. The doctor will also
This leaflet was last revised in February 2016
decide whether Oxcarbazepine Teva Film-coated Tablets has to be stopped
PL 00289/1084, 1085 and 1086
immediately and how to continue further medical care.
Other side effects: tell a doctor as soon as possible
Common (may affect up to 1 in 10 people):
• Trembling, coordination problems; involuntary movement of the eyes;
anxiety and nervousness; depression, mood swing; rash
Very rare (may affect up to 1 in 10,000 people):
• Irregular heart beat or a very fast or slow heart rate
Not known (frequency cannot be estimated from the available data):
• Speech disorder
Tell your doctor as soon as possible if you get any of the above side effects.
They may require medical attention.
87238-Y

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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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