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OXCARBAZEPINE TEVA 600 MG FILM-COATED TABLETS

Active substance(s): OXCARBAZEPINE / OXCARBAZEPINE / OXCARBAZEPINE

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TEVA UK Ref:

231-30-87238-Z LEA OXCARBAZEPINE A/S FC TAB TUK
Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
323 mm
200 mm
N/A
N/A

Version:

Colours Used:

3

22 February 2017
BLACK

Template
PANTONE® GREEN C

• 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.
Oxcarbazepine
• if you notice possible symptoms of blood disorders such as tiredness, being
short of breath when exercising, looking pale, headache, chills, dizziness,
Package leaflet:Information for the patient
frequent infections leading to fever, sore throat, mouth ulcers, bleeding or
Read all of this leaflet carefully before you start taking this medicine because
bruising more easily than normal, nose bleeds, reddish or purplish patches,
it contains important information for you.
or unexplained blotches on the skin.
• Keep this leaflet. You may need to read it again.
• a small number of people being treated with antiepileptics such as
• If you have any further questions, ask your doctor or pharmacist.
Oxcarbazepine Teva have had thoughts of harming or killing themselves. If
• This medicine has been prescribed for you only. Do not pass it on to others.
at any time you have these thoughts, immediately contact your doctor.
It may harm them, even if their signs of illness are the same as yours.
• if you have a fast or unusually slow heart beat.
• If you get any side effects, talk to your doctor or pharmacist. This includes
Children and adolescents
any possible side effects not listed in this leaflet. See section 4.
In children, your doctor may recommend thyroid function monitoring before
therapy and during therapy.
What is in this leaflet
Other medicines and Oxcarbazepine Teva
1. What Oxcarbazepine Teva is and what it is used for
Tell your doctor or pharmacist if you are taking, have recently taken or might
2. What you need to know before you take Oxcarbazepine Teva
take any other medicines.
3. How to take Oxcarbazepine Teva
This includes medicines bought without a prescription.
4. Possible side effects
This applies especially to:
5. How to store Oxcarbazepine Teva
• Hormonal contraceptives, such as the pill (see ‘Warnings and precautions’)
6. Contents of the pack and other information
• Other antiepileptic medicines, such as carbamazepine, phenobarbital,
phenytoin or lamotrigine
What Oxcarbazepine Teva is and what it is used for
• 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
What Oxcarbazepine Teva is
of urine produced), desmopressin and non-steroidal anti-inflammatory
The active ingredient of Oxcarbazepine Teva is oxcarbazepine.
drugs, such as indometacin
Oxcarbazepine Teva belongs to a group of medicines called anticonvulsants or
• Lithium and monoamine oxidase inhibitors (medicines used to treat mood
antiepileptics.
swings and some types of depression)
What Oxcarbazepine Teva is used for
• Medicines that control the body's immune system, such as ciclosporin and
Medicines such as Oxcarbazepine Teva are the standard treatment for
tacrolimus.
epilepsy.
Epilepsy is a brain disorder that causes people to have recurring seizures and Oxcarbazepine Teva with food, drink and alcohol
Oxcarbazepine Teva can be taken with or without food.
convulsions (also known as fits). Seizures happen because of a temporary
fault in the brain’s electrical activity. Normally brain cells coordinate body
Alcohol may increase the sedative effects of Oxcarbazepine Teva. Avoid
movements by sending out signals through the nerves to the muscles in an
alcohol as much as possible and ask your doctor for advice.
organised, orderly way. In epilepsy, brain cells send out too many signals in a
Pregnancy and breast-feeding
disorderly fashion. The result can be uncoordinated muscular activity that is
If you are pregnant or breast-feeding, think you may be pregnant or are
called an epileptic seizure.
planning to have a baby, ask your doctor or pharmacist for advice before
Oxcarbazepine Teva is used to treat partial seizures with or without
taking this medicine.
secondarily generalised tonic-clonic seizures. Partial seizures involve a limited
Pregnancy
area of the brain, but may spread to the whole brain and may cause
It is important to control epileptic seizures during pregnancy. However, there
generalised tonic-clonic seizure. There are two types of partial seizures:
simple and complex. In simple partial seizures, the patient remains conscious, 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
whereas in complex partial seizures, patients consciousness is altered.
and help you to decide whether you should take Oxcarbazepine Teva.
Oxcarbazepine Teva works by keeping the brain’s “overexcitable” nerve cells
Do not stop your treatment with Oxcarbazepine Teva during pregnancy without
under control. This suppresses or reduces the frequency of such seizures.
first checking with your doctor.
Oxcarbazepine Teva can be used alone or in combination with other
Ask your doctor or pharmacist for advice before taking any medicine during
antiepileptic medicines.
pregnancy.
Usually, the doctor will try to find the one medicine that works best for you or
Breast-feeding
for your child. However, with more severe epilepsy, a combination of two or
You should not breast-feed while taking Oxcarbazepine Teva. The active
more medicines may be needed to control seizures.
substance in Oxcarbazepine Teva passes into breast milk. This could cause
Oxcarbazepine Teva is for use in adults and in children of 6 years of age and
side effects for breast-fed babies. Ask your doctor or pharmacist for advice
above.
before taking any medicine while you are breast-feeding.
Driving and using machines
What you need to know before you take Oxcarbazepine Teva
Oxcarbazepine Teva may make you feel sleepy or dizzy, or may cause blurred
Follow all the doctor’s instructions carefully. They may differ from the general vision, double vision, lack of muscle coordination or a depressed level of
consciousness, especially when starting treatment or increasing the dose.
information contained in this leaflet.
It is important to discuss with your doctor whether you can drive a vehicle or
Monitoring during your treatment with Oxcarbazepine Teva
operate machines while taking this medicine
Before and during your treatment with Oxcarbazepine Teva, your doctor may
Oxcarbazepine Teva contains lactose and sunset yellow (E110)
perform blood tests to determine the dose for you. Your doctor will tell you
Patients who are intolerant to lactose should note that Oxcarbazepine Teva
when to have the tests.
contains a small amount of lactose. If you have been told by your doctor that
Do not take Oxcarbazepine Teva:
you have an intolerance to some sugars, contact your doctor before taking this
• If you are allergic to oxcarbazepine or any of the other ingredients of this
medicinal product.
medicine (listed in section 6).
If this applies to you, tell your doctor before taking Oxcarbazepine Teva. If you This medicinal product contains sunset yellow (E110) and may cause allergic
reactions.
think you may be allergic, ask your doctor for advice.
Warnings and precautions
How to take Oxcarbazepine Teva
Talk to your doctor or pharmacist before taking Oxcarbazepine Teva:
• If you have ever shown unusual sensitivity (rash or any other signs of
Always take this medicine exactly as your doctor has told you. Check with your
allergy) to carbamazepine or to any other medicines. If you are allergic to
doctor or pharmacist if you are not sure.
carbamazepine, the chances are approximately 1 in 4 (25%) that you could
How much to take
also have an allergic reaction to oxcarbazepine.
Dose for adults:
• If you have kidney disease
• The recommended starting dose of Oxcarbazepine Teva for adults (including
• If you have serious liver disease
elderly patients) is 600 mg per day.
• If you are taking diuretics (medicines used to help the kidneys get rid of salt • Take one 300 mg tablet twice daily or two 150 mg tablets twice daily.
and water by increasing the amount of urine produced)
• Your doctor may increase the dose gradually to find the best dose for you.
• If you have heart disease, shortness of breath and/or swelling of the feet
The best results are usually with doses between 600 and 2,400 mg per day.
or legs due to fluid build-up
• If you take another antiepileptic medicine, the dose is the same.
• If your blood level of sodium is low as shown by blood tests (see
• If you have kidney disease (with impaired kidney function), the starting dose
section 4 Possible side effects)
is half the usual starting dose.
• If you are a woman taking a hormonal contraceptive (such as 'the
• If you have severe liver disease, your doctor may adjust your dose.
birth-control pill') oxcarbazepine may stop your contraceptive from working.
Use in children
Use a different or extra (non-hormonal) method of contraception while
Oxcarbazepine Teva can be taken by children aged 6 years or above.
taking Oxcarbazepine Teva. This should help to prevent an unwanted
pregnancy. Tell your doctor immediately if you get irregular vaginal bleeding The dosage for children depends on their weight.
or spotting. If you have any questions about this, ask your doctor or health
• The recommended starting dose is 8 to 10 milligrams per kilogram of
professional
bodyweight per day given in two divided doses. For example, a 30-kg child
would start treatment with one 150 mg tablet twice daily.
The risk of serious skin reactions in patients of Han Chinese or Thai origin
associated with carbamazepine or chemically-related compounds may be
Your doctor may increase the dose gradually to find the best dose for your
predicted by testing a blood sample of these patients. Your doctor should be
child. The best results are usually with a dose of 30 milligrams per kilogram of
able to advise if a blood test is necessary before taking oxcarbazepine.
bodyweight per day. The maximum dose for a child is 46 milligrams per
kilogram of bodyweight per day.
If you develop any of the following symptoms after starting Oxcarbazepine
Teva tell your doctor immediately or go to the emergency department at your How to take Oxcarbazepine Teva
nearest hospital:
• Swallow the tablets with a little water.
• if you experience an allergic reaction after starting Oxcarbazepine Teva.
• If necessary, the tablets can be broken in half to help swallow them. Do not
Symptoms include swelling of lips, eyelids, face, throat, mouth, or sudden
break the tablets to take only half of the dose. The score line was not
breathing problems, fever with swollen glands, rash or skin blistering.

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Pharma code 92 (011101)
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Oxcarbazepine Teva 150 mg, 300 mg
and 600 mg film-coated tablets

TEVA UK Ref:

231-30-87238-Z LEA OXCARBAZEPINE A/S FC TAB TUK
Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
323 mm
200 mm
N/A
N/A

Version:

Colours Used:

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
Take Oxcarbazepine Teva 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 Teva 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 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 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
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 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
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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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

• 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 contains
• The active substance is oxcarbazepine. Each film-coated tablet contains
150, 300, 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 looks like and contents of the pack
Film-coated tablet
Oxcarbazepine Teva 150 mg Film-coated Tablets are yellow to dark yellow, film
coated capsule shaped tablets. One side of the tablet is scored in half and
debossed with "9" on one side of the score and "3" on the other. The other side
Possible side effects
of the tablet is scored in half and debossed with "72" on one side of the score
and "81" on the other. The score line is only there to help you break the tablet if
Like all medicines, this medicine can cause side effects, although not
you have difficulty swallowing it whole.
everybody gets them.
Oxcarbazepine Teva 300 mg Film-coated Tablets are yellow to dark yellow, film
Some side effects could be serious: get medical help immediately
coated capsule shaped tablets. One side of the tablet is scored in half and
The following are signs of very rare (may affect up to 1 in 10,000 people), but
debossed with "9" on one side of the score and "3" on the other. The other side
potentially serious side effects that may require urgent medical treatment.
of the tablet is scored in half and debossed with "72" on one side of the score
• Swelling of the lips, eyelids, face, throat or mouth, accompanied by difficulty
and "82" on the other. The score line is only there to help you break the tablet if
in breathing, speaking or swallowing (signs of anaphylactic reactions and
you have difficulty swallowing it whole.
angioedema) or other signs of hypersensitivity reactions such as skin rash,
Oxcarbazepine Teva 600 mg Film-coated Tablets are yellow to dark yellow, film
fever, and pain in the muscles and joints
coated capsule shaped tablets. One side of the tablet is scored in half and
• Severe blistering of the skin and/or mucous membranes of the lips, eyes,
debossed with "9" on one side of the score and "3" on the other. The other side
mouth, nasal passages or genitals (signs of a serious allergic reaction
of the tablet is scored in half and debossed with "72" on one side of the score
including Lyell’s syndrome, Stevens-Johnson syndrome and erythema
and "83" on the other. The score line is only there to help you break the tablet if
multiforme)
you have difficulty swallowing it whole.
• Tiredness, shortness of breath when exercising, looking pale, headache,
chills, dizziness, frequent infections leading to fever, sore throat, mouth
Oxcarbazepine Teva 150 mg Film-coated Tablets are available in pack sizes of
ulcers, bleeding or bruising more easily than normal, nose bleeds, reddish
1, 30, 50, 56, 100, 200 & 500 film-coated tablets. Hospital pack: 500 film-coated
or purplish patches, or unexplained blotches on the skin (signs of a
tablets.
decrease in the number of blood platelets or decrease in the number of
Oxcarbazepine Teva 300 mg Film-coated Tablets are available in pack sizes of
blood cells)
1, 30, 50, 56, 100, 200 & 500 film-coated tablets. Hospital packs: 50 & 500
• Red blotchy rash mainly on face which may be accompanied by fatigue,
film-coated tablets.
fever, feeling sick (nausea) or loss of appetite (signs of systemic lupus
Oxcarbazepine Teva 600 mg Film-coated Tablets are available in pack sizes of
erythematosus)
1, 30, 50, 56, 100, 200 & 500 film-coated tablets. Hospital packs: 50 & 500
• Lethargy, confusion, muscle twitching or significant worsening of
film-coated tablets.
convulsions (possible symptoms of low sodium levels in the blood) (see
‘Special warnings and precautions’)
Not all pack sizes may be marketed.
• Flu-like symptoms with jaundice (yellowing of the skin or the whites of the
Marketing Authorisation Holder and Manufacturer
eyes (signs of hepatitis)
TEVA UK Limited, Eastbourne, BN22 9AG.
• Severe upper stomach (abdominal) pain, being sick (vomiting), loss of
This leaflet was last revised in February 2017.
appetite (signs of inflammation of the pancreas)
• Weight gain, tiredness, hair loss, muscle weakness, feeling cold (signs of
PL 00289/1084, 1085 and 1086
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 Teva has to be stopped immediately and how
to continue further medical care.
Other side effects: tell a doctor as soon as possible
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
• Low sodium levels in the blood, trembling, coordination problems;
involuntary movement of the eyes; anxiety and nervousness; depression,
mood swing; rash
• 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
• Low number of white blood cells
• Hives. You may also have raised levels of liver enzymes while taking
Oxcarbazepine Teva
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
• High blood pressure, fall
Tell your doctor as soon as possible if you get any of the above side effects.
They may require medical attention.
These are usually mild to moderate side effects of Oxcarbazepine Teva. Most
of these effects are transient and usually diminish over time.
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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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