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OXCARBAZEPINE 150MG FILM-COATED TABLETS

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Package leaflet: Information for the user

Oxcarbazepine 150/300/600 mg film-coated tablets
oxcarbazepine

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
•  you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this
If
leaflet. See section 4.
What is in this leaflet:
1. What Oxcarbazepine is and what it is used for.
2. What you need to know before you take Oxcarbazepine.
3. How to take Oxcarbazepine.
4. Possible side effects.
5. How to store Oxcarbazepine.
6. Contents of the pack and other information.
1. What Oxcarbazepine is and what it is used for
Oxcarbazepine film-coated tablets contain the active ingredient oxcarbazepine. Oxcarbazepine belongs to a group of
medicines called anticonvulsants which are used in the treatment of epilepsy. Oxcarbazepine is designed to help control
seizures or fits in patients that have epilepsy. Oxcarbazepine is used to treat certain types of epilepsy in adults and children
from 6 years old.
Your doctor may prescribe Oxcarbazepine film-coated tablets alone or along with other epilepsy medicine.
2. What you need to know before you take Oxcarbazepine
Follow all instructions given to you by your doctor carefully, even if they differ from the information contained in this leaflet.

Warnings and precautions
Talk to your doctor or pharmacist before taking Oxcarbazepine:
if
•  you are allergic (e.g. have ever developed a rash or other hypersensitivity reaction) to carbamazepine, a similar
anticonvulsant, as there is approximately a 1 in 4 (25%) chance you may be allergic to oxcarbazepine too
• if you develop an inflammation of the liver or a severe skin reaction (see under Possible side effects)
•  you have a kidney disease associated with a low level of sodium (salt) in your blood. Oxcarbazepine can lower
if
the sodium levels in your blood further which may lead to symptoms of sodium shortage (see under Possible side
effects). If you have a kidney disease your doctor may examine your blood before and at regular intervals after
starting treatment with Oxcarbazepine
•  you are taking other medicines that can lower sodium levels in the blood (e.g. diuretics, desmopressin and nonif
steroid anti-inflammatory drugs (NSAIDs) such as indometacin and ibuprofen). See under Other medicines and
Oxcarbazepine
if
•  you have heart problems such as heart failure (breathlessness and swollen ankles). Your doctor will measure your
weight regularly to make sure that you do not retain water
•  you have a heart rhythm disorder
if
•  you are using hormonal contraceptives (see under Other medicines and Oxcarbazepine)
if
•  you have possible signs of a blood disorder such as tiredness, breathlessness when exercising, looking pale,
if
headache, chills, dizziness, infections leading to fever, sore throat, mouth ulcer, bleeding or bruising more easily than
normal, nose bleeding, reddish or purplish patches, unexplained blotches on skin.
A small number of people being treated with anti-epileptics such as Oxcarbazepine have had thoughts of harming or
killing themselves. If at any time you have these thoughts, immediately contact your doctor.
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the
use of oxcarbazepine, appearing initially as reddish target-like spots or circular patches often with central blisters on the
trunk.
Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).
These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to
widespread blistering or peeling of the skin.
The highest risk for occurrence of serious skin reactions is within the first weeks of treatment.
If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of oxcarbazepine, you must not
be re-started on oxcarbazepine at any time.
If you develop a rash or these skin symptoms, seek immediate advice from a doctor and tell him that you are taking this
medicine.
Patients of Han Chinese or Thai origin
The risk of serious skin reactions in patients of Han Chinese or Thai origin associated with carbamazepine or chemicallyrelated 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.
Other medicines and Oxcarbazepine
Tell your doctor if you are taking, have recently taken or might take any other medicines, particularly any of the following
medicines as they may interact with Oxcarbazepine:

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other anticonvulsant medicines such as phenobarbitone, phenytoin, carbamazepine, lamotrigine and valproic
• 
acid. Your doctor may need to adjust the dosage of these medicines when they are given in combination with
Oxcarbazepine. In combination with lamotrigine there is an increased possibility of side effects like nausea, drowsiness,
dizziness and headache occurring
hormonal contraceptives (like the “pill”). Oxcarbazepine can stop these medicines working properly. Another form of
• 
contraception should also be used
• 
medicines to treat mental illness such as lithium and MAOIs (Monoamine Oxidase Inhibitors), like phenelzine and
moclobemide. Combination with lithium might increase the occurrence of side effects
• 
medicines that can lower sodium levels in the blood (e.g. diuretics, desmopressin and non-steroid anti-inflammatory
drugs such as indometacin and ibuprofen). Oxcarbazepine can lower the sodium levels in your blood further which may
lead to symptoms of sodium shortage (see Possible side effects). Your doctor should examine your blood before and
at regular intervals after starting treatment with Oxcarbazepine
• 
medicines used to control the body’s immune system (immunosuppressants) such as. ciclosporin, tacrolimus)
Oxcarbazepine with food, drink and alcohol
Oxcarbazepine can be taken with or without food.
Take special care if drinking alcohol while taking Oxcarbazepine as it may make you feel very drowsy.
Pregnancy and breast-feeding
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.
Do not stop your treatment with Oxcarbazepine during pregnancy without first checking with your doctor.
Breast-feeding
You should not breast-feed while taking Oxcarbazepine. The active substance in Oxcarbazepine passes into breast milk.
This could cause side effects for breast-fed babies.
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.
Driving and using machines
You should be aware that Oxcarbazepine can cause side effects like dizziness and drowsiness which can influence your
ability to drive or operate machines. Do not drive or operate machines if you experience such side effects.
Oxcarbazepine contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking
this medicine.
3. How to take Oxcarbazepine
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Where the required dose cannot be administered using whole tablets, other oxcarbazepine containing preparations are
available.
Your doctor will probably start treatment with a low dose and, if necessary gradually increase it to suit your own needs.
The recommended doses are as follows:
Adults
The starting dose is 300 mg twice daily. If needed your doctor may slowly increase the dose every week by a maximum of
600 mg daily. The maintenance dose is between 600 mg and 2400 mg daily.
If you are also taking other anticonvulsant medicines, your doctor may need to reduce their dose or increase the dose of
Oxcarbazepine more slowly.
If other anticonvulsive medicines are replaced by Oxcarbazepine their dose will be decreased gradually.
Use in children and adolescents of 6 years and older
The starting dose is 8-10 mg/kg of body weight daily, divided into two doses. If needed your doctor may increase the
dose approximately every week by 10 mg/kg/day of body weight daily up to a maximum daily dose of 46 mg/kg of
body weight per day. The maintenance dose in combination with other anticonvulsive medicines is 30 mg/kg body weight
daily.
For children who cannot swallow tablets or where the required dose cannot be administered using tablets, other
oxcarbazepine containing preparations are available.

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Do not take Oxcarbazepine:
• if you are allergic to oxcarbazepine or any of the other ingredients of this medicine (listed in section 6).

Use in children under 6 years of age
Oxcarbazepine is not recommended for children under 6 years old since it has not been shown to be a safe and effective
treatment in this age group.
Patients with kidney problems
If you have kidney problems your doctor will start treatment with half the normal starting dose and increase the dose of
Oxcarbazepine more slowly than that stated above.
Patients with severe liver problems
If you have severe liver problems, you should take the treatment as prescribed by your doctor.
Where the required dose cannot be administered using tablets, other oxcarbazepine containing pharmaceutical forms are
available.
Method of administration:
Swallow the film-coated tablet with a glass of water. Do not crush or chew them. The score line is only there to help you
break the tablet if you have difficulty swallowing it whole.
If you take more Oxcarbazepine than you should:
If you have taken more Oxcarbazepine than you should contact your doctor or pharmacist straight away. Symptoms of
overdose are drowsiness, dizziness, nausea, vomiting, an abnormal degree of muscular or bodily activity, lack of coordination of movements and uncontrolled eye movements.
If you forget to take Oxcarbazepine:
Take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose, take the
next dose on time. Do not take a double dose to make up for forgotten doses.
If you stop taking Oxcarbazepine
Do not stop taking Oxcarbazepine suddenly without consulting your doctor since this could lead to a sudden increase in
seizures/convulsions. If your treatment with Oxcarbazepine is stopped your doctor will do this slowly.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor or go to your nearest hospital casualty department straight away if you have any of
the following serious side effects; you may need medical attention:
Very rare (may affect up to 1 in 10,000 people)
- 
potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2)
-  (moist), itchy and irregular spots similar to the rash of measles, which starts on the limbs and sometimes on the face
red
and the rest of the body. The spots may blister or may progress to form raised, red, pale-centred marks. Those affected
may have fever, sore throat, headache and/or diarrhoea (erythema multiforme).
 such skin reaction has occurred during use of Oxcarbazepine, you must not use Oxcarbazepine. Your doctor may
If
decide to withdraw treatment with Oxcarbazepine
- 
swollen face, lips, eyelids, tongue, throat or mouth, difficulty in speaking, swallowing and sudden signs of nettle rash
with difficulty in breathing, shortness of breath, wheezing (signs of angioedema and anaphylactic reactions) or other
signs of hypersensitivity reactions such as rash, fever and pain in the muscles and joints
-  blotchy rash mainly on face which may be accompanied by fatigue, fever, feeling sick (nausea) or loss of appetite
red
(systemic lupus erythematosus)
- 
signs of inflammation of the liver (nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the
skin or whites of the eyes, light coloured bowel motions, dark coloured urine). Your liver function may need to be checked
- 
inflammation of the pancreas which includes the following signs: severe upper stomach pain, often with nausea and
vomiting (pancreatitis).
Not known (frequency cannot be estimated from the available data):
• 
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).
Tell your doctor as soon as possible if you have any of the following side effects:
Common (may affect up to 1 in 10 people):
- 
confusion, a decreased level of consciousness, blurred vision or notice worsening of your convulsions (these are
symptoms of a low sodium level in the blood).
Very rare (may affect up to 1 in 10,000 people):
• 
irregular heartbeat or a very fast or slow heart beat.
Other side effects that can occur:
Very common side effects (may affect more than 1 in 10 people):
• feeling dizzy
• 
tired or drowsy
• double vision
• 
feeling or being sick
• headaches.
Common side effects (may affect up to 1 in 10 people) include:
• depression
• feeling confused
• 
agitated or other mood changes
• 
disturbance in vision
• blurred vision
• 
uncontrolled eye movement or other eyesight changes
• 
loss of co-ordination
• shaking
• difficulty concentrating
• memory loss
• spinning sensation
• 
diarrhoea or constipation
• stomach pain
• skin rash
• acne
• hair loss
• feeling weak.
Uncommon side effects (may affect up to 1 in 100 people) include:
• itchy skin
• 
blood changes such as raised liver enzymes.
Very rare side effects (may affect up to 1 in 10,000 people) include:
• 
blood changes such as a reduction in the number of cells (platelets - that help your blood clot) and changes to your immune
system leading to allergic reactions affecting other systems and organs causing that may cause joint pain, fever and changes
in the way that your liver, lungs and kidney works, enlargement of the spleen and disease of the brain caused by liver illness.
Not known (frequency cannot be estimated from the available data):
• 
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
• 
high blood pressure (hypertension) weight gain, tiredness, hair loss, muscle weakness, feeling cold (hypothyroidism).
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 procide more information on the safety of this medicine.
5. How to store Oxcarbazepine
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 polypropylene tablet container blister and the carton.
The expiry date refers to the last day of that month.
Do not store above 30ºC.
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 contains
The active substance is oxcarbazepine. Each film-coated tablet contains 150 mg, 300 mg or 600 mg of oxcarbazepine.
The other ingredients (excipients) are:
Tablet core: crospovidone; hypromellose; microcrystalline cellulose; silica, colloidal anhydrous and magnesium stearate.
Tablet coating: black iron oxide (E172); red iron oxide (E172); yellow iron oxide (E172); hypromellose; lactose
monohydrate (see section 2 ‘Oxcarbazepine contains lactose’); macrogol 4000 and titanium dioxide (E171).
What Oxcarbazepine looks like and contents of the pack
Film-coated tablet.
The film-coated tablets are oblong, buff-coloured and have a scoreline on each side. The scoreline is only to facilitate
breaking for ease of swallowing and not to divide into equal doses.
The 150 mg/ 300 mg/ 600 mg film-coated tablets are marked ‘OX/150’/‘OX /300’/‘OX/600’ on one side and ‘G/G’
on the other side.
Oxcarbazepine film-coated tablets are available in plastic tablet containers of 100, 200 and 500 tablets and blister packs
of 10, 20, 30, 50, 60, 100 and 200 tablets.
Not all pack sizes may be marketed.
Oxcarbazepine film-coated tablets are available as Oxcarbazepine 150 mg, 300 mg and 600 mg film-coated tablets.
Marketing Authorisation Holder
Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Manufacturers:
McDermott Laboratories t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Generics [UK] Ltd, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
This leaflet was last revised in: June 2014

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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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