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OXCARBAZEPINE MORNINGSIDE 600 MG TABLETS

Active substance(s): OXCARBAZEPINE

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Lethargy, confusion, muscle twitching or significant
worsening of convulsions (possible symptoms of low
sodium levels in the blood) (see Take special care with
Oxcarbazepine Morningside 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).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist
or nurse. 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 Morningside Tablets
Keep out of the sight and reach of children.

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 Morningside Tablets have 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; mood swing; rash.
Very rare:
! irregular heart beat or a very fast or slow heart rate.
Not known:
! speech disorder.
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
Oxcarbazepine Morningside Tablets. 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 Oxcarbazepine Morningside
Tablets.
Not known:
! 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.

Do not use Oxcarbazepine Morningside Tablets after the
expiry date which is stated on the blister and outer carton.
The expiry date refers to the last day of that month.
This medicinal product 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 to
protect the environment.
6. Contents of the pack and other information
What Oxcarbazepine Morningside Tablets contain
! The active substance of Oxcarbazepine Morningside
Tablets is oxcarbazepine. Each tablet contains 300 mg
or 600 mg oxcarbazepine.
! The other ingredients are: microcrystalline cellulose,
hydroxypropyl methylcellulose, croscarmellose
sodium, magnesium stearate, colloidal anhydrous
silica, yellow iron oxide (E 172), red iron oxide (E 172).
What Oxcarbazepine Morningside Tablets look like
and contents of the pack
The Oxcarbazepine Morningside 300 mg Tablets are
oblong, light pink tablets, with a score line on one side and
embossed with a “3” on the other side.
.
The Oxcarbazepine Morningside 600 mg Tablets are
oblong, light pink tablets, with a score line on one side and
embossed with a “6” on the other side.
The tablets are available in blister packs containing 50
tablets.
Marketing Authorisation Holder
Morningside Healthcare Ltd
115 Narborough Road,
Leicester,
LE3 0PA,
United Kingdom
Manufacturer
Atlantic Pharma-Produções Farmacêuticas, S.A.
Rua da Tapada Grande n.º 2, Abrunheira
2710-089 Sintra, Portugal
This leaflet was last revised in May 2015.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Oxcarbazepine Morningside 300 mg Tablets
Oxcarbazepine Morningside 600 mg 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 or your
child. Do not pass it on to others. It may harm them,
even if their symptoms 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.
! This medicine is available under the above product
names but will be called Oxcarbazepine Morningside
Tablets throughout this leaflet.
What is in this leaflet:
1. What Oxcarbazepine Morningside Tablets are and
what they are used for
2. What you need to know before you take
Oxcarbazepine Morningside Tablets
3. How to take Oxcarbazepine Morningside Tablets
4. Possible side effects
5. How to store Oxcarbazepine Morningside Tablets
6. Contents of the pack and other information
1. What Oxcarbazepine Morningside Tablets are and
what they are used for
What Oxcarbazepine Morningside Tablets are
The active ingredient of Oxcarbazepine Morningside
Tablets is oxcarbazepine.
Oxcarbazepine Morningside Tablets belong to a group of
medicines called anticonvulsants or antiepileptics.
What Oxcarbazepine Morningside Tablets are used
for
Medicines such as Oxcarbazepine Morningside Tablets
are the standard treatment for epilepsy.
Epilepsy is a brain disorder that causes people to have
recurring seizures and 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 Morningside 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 generalized 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 Morningside Tablets work by keeping the
brain's “overexcitable” nerve cells under control. This
suppresses or reduces the frequency of such seizures.
Oxcarbazepine Morningside 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 for your child. However, with more
severe epilepsy, a combination of two or more medicines
may be needed to control seizures.
Oxcarbazepine Morningside Tablets are for use in adults
and in children of 6 years of age and above.
2. What you need to know before you take
Oxcarbazepine Morningside Tablets
Follow all instructions given to you by your doctor carefully,
even if they differ from the information contained in this
leaflet.
Monitoring during your treatment with Oxcarbazepine
Morningside Tablets
Before and during your treatment with Oxcarbazepine
Morningside 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 Morningside Tablets
! if you are allergic to oxcarbazepine or to any of other
ingredients of this medicine (listed in section 6).
If this applies to you, tell your doctor before taking
Oxcarbazepine Morningside Tablets. If you think you may
be allergic, ask your doctor for advice.
Warnings and precautions
If any of the following apply to you, tell your doctor
before you take Oxcarbazepine Morningside 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.
! 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 buildup.
! 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
Morningside Tablets may stop your contraceptive from
working. Use a different or extra (non-hormonal)
method of contraception while taking Oxcarbazepine
Morningside 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.
If you develop any of the following symptoms after
starting Oxcarbazepine Morningside Tablets, tell your
doctor immediately or go to the emergency
department at your nearest hospital:
! if you experience an allergic reaction after starting
Oxcarbazepine Morningside 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 Morningside
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 Morningside
Tablets
Tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes
medicines bought without a prescription.
This applies especially to:
! Hormonal contraceptives, such as the pill (see Take
special care with Oxcarbazepine Morningside
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 non-steroidal antiinflammatory 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 Morningside Tablets with food, drink
and alcohol
Oxcarbazepine Morningside Tablets can be taken with or
without food.
Alcohol may increase the sedative effects of
Oxcarbazepine Morningside Tablets. Avoid alcohol as
much as possible and ask your doctor for advice.
Pregnancy, breast-feeding and fertility
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 Morningside Tablets.
Do not stop your treatment with Oxcarbazepine
Morningside 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
Morningside Tablets. The active substance in
Oxcarbazepine Morningside 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 breast-feeding.
Driving and using machines
Oxcarbazepine Morningside 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.
3. How to take Oxcarbazepine Morningside Tablets
Always take Oxcarbazepine Morningside 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
Dose for adults
! The usual starting dose of Oxcarbazepine
Morningside Tablets for adults (including elderly
patients) is 600 mg per day.
! Take one 300 mg tablet 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 Morningside Tablets 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 150
mg dose 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 Oxcarbazepine Morningside 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.
When and for how long to take Oxcarbazepine
Morningside Tablets
Take Oxcarbazepine Morningside 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 Morningside 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 Morningside 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
Morningside 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 Morningside
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 Morningside 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.
4. Possible side effects
Like all medicines, this medicine 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).

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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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