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CARBAMAZEPINE SUN 100 MG/5 ML ORAL SUSPENSION

Active substance(s): CARBAMAZEPINE

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Package leaflet: Information for the
patient

Carbamazepine SUN
100 mg/5 ml
Oral Suspension
carbamazepine
Read all of this leaflet carefully before you take
this medicine because it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please 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 Carbamazepine SUN Oral Suspension
is and what it is used for
2. What you need to know before you take
Carbamazepine SUN Oral Suspension
3. How to take Carbamazepine SUN Oral
Suspension
4. Possible side effects
5. How to store Carbamazepine SUN Oral
Suspension
6. Contents of the pack and other information
1. What Carbamazepine SUN Oral Suspension is
and what it is used for
Carbamazepine SUN Oral Suspension is a pale
orange suspension that contains
carbamazepine, the active ingredient.
Carbamazepine SUN Oral Suspension is an
anti-convulsant medicine (prevents fits).
Carbamazepine can also modify some types of
pain and can control mood disorders
Carbamazepine is used:
- to treat some forms of epilepsy
- to treat a painful condition of the face called
trigeminal neuralgia
- to help control serious manic depression
when another medicine (lithium) doesn't
work.
2. What you need to know before you take
Carbamazepine SUN Oral Suspension
Do not take Carbamazepine SUN Oral Suspension:
- if you are allergic to carbamazepine or any
of the other ingredients of this medicine
(listed in section 6)
- if you are allergic to similar drugs such as
oxcarbazepine, or to any of a related group of
drugs known as tricyclic antidepressants
(such as amitriptyline or desipramine)
- if you have any heart problems such as
conduction disorders
- if you have ever had problems with your
bone marrow
- if you have a disorder called porphyria (an
inherited enzyme disorder)
- if you are taking or have taken within the last
14 days, drugs called monoamine oxidase
inhibitors (used to treat depression).
Warnings and precautions
Talk to your doctor or pharmacist before taking
Carbamazepine SUN Oral Suspension if:
- you suffer from the sort of epilepsy where
you get mixed seizures which include
absences
- you have any mental illness
- you are allergic to phenytoin (another
epilepsy treatment)
- you have liver or kidney problems
- you are elderly
- you have eye problems such as glaucoma
(increased pressure in the eye).
You should talk to your doctor if you think any of
the above could apply to you.
A small number of people being treated with
anti-epileptics such as carbamazepine have had
thoughts of harming or killing themselves. If at
any time you have these thoughts, immediately
contact your doctor. Serious skin rashes (StevensJohnson syndrome, toxic epidermal necrolysis)
have been reported with the use of
carbamazepine. Frequently, the rash can involve
ulcers of the mouth, throat, nose, genitals and
conjunctivitis (red and swollen eyes). These serious
skin rashes are often preceded by influenza-like
symptoms fever, headache, body ache (flu-like
symptoms). The rash may progress to widespread
blistering and peeling of the skin. The highest risk
for occurrence of serious skin reactions is within
the first months of treatment.
These serious skin reactions can be more common
in people from some Asian countries. The risk of
these reactions in patients of Han Chinese or Thai
origin 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
carbamazepine.
If you develop a rash or these skin symptoms, stop
taking carbamazepine and contact your doctor
immediately.
Avoid excessive exposure to sunlight as you may
be at increased risk of sunburn.

Other medicines and Carbamazepine SUN Oral
Suspension
Tell your doctor or pharmacist if you are taking,
have recently taken or might use any other
medicines.
Taking some medicines together can be harmful.
Remember that the doctor at the hospital may not
have been informed if you have recently begun a
course of treatment for another illness.
In particular tell your doctor if you are taking:
- other drugs for epilepsy and trigeminal
neuralgia, such as clobazam, clonazepam,
phenytoin, phenobarbitone, primidone,
tiagabine, lamotrigine, topiramate,
ethosuximide, valproic acid, felbamate or
oxcarbazepine
- drugs to treat major psychiatric and related
disorders, such as alprazolam, viloxazine,
fluoxetine, desipramine fluvoxamine
- imipramine, lithium, clozapine, olanzapine,
risperidone, haloperidol or thioridazine
- painkillers containing methadone, tramadol or
dextropropoxyphene
- oral contraceptives. These may not work as
well and you may notice breakthrough
bleeding or spotting, and your doctor may
consider an alternative form of contraception
would be best for you
- Hormone Replacement Therapy such as
tibolone. Carbamazepine SUN Oral
Suspension can make HRT less effective
- drugs for the treatment of endometriosis such
as danazol or gestrinone
- drugs used to treat blood pressure or heart
problems, such as digoxin, felodipine,
nifedipine, nilvadipine, frusemide, warfarin,
verapamil or diltiazem
- drugs to treat gastro-intestinal problems such
as cimetidine or metoclopramide
- antibiotics and medicines to treat TB
(tuberculosis) such as doxycycline,
rifampicin, erythromycin, clarithromycin, or
isoniazid
- antifungal drugs such as itraconazole,
fluconazole, ketoconazole or voriconazole
- drugs which depress your immune system
such as corticosteroids or cyclosporin
- drugs to treat HIV such as indinavir,
saquinavir or ritonavir
- anti-cancer drugs such as toremifene,
cisplatin or doxorubicin
- drugs to treat allergies such as loratadine or
terfenadine
- theophylline to treat asthma
- acetazolamide to treat glaucoma
- isotretinoin to treat acne
- mefloquine to treat malaria
- thyroxine to treat hypothyroidism
- any vitamin B supplements
- St. John's wort (a herbal remedy).
Carbamazepine with food and drink and
alcohol
Drinking alcohol may affect you more than usual.
Discuss with your doctor whether you should stop
drinking.
Eating grapefruit, or drinking grapefruit juice,
may increase your chance of having side effects.
You can take Carbamazepine during, after or
between meals.
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.
A small amount of carbamazepine can get into
breast milk. If you think that the baby is suffering
side effects such as excessive sleepiness or skin
reactions tell your doctor straight away.
Driving and using machines
Carbamazepine SUN Oral Suspension can make
you feel dizzy or drowsy, especially at the start of
treatment or when the dose is changed. If you are
affected in this way, or if your eyesight is affected,
you should not drive or operate machinery.
Carbamazepine SUN Oral Suspension contains
sorbitol, potassium sorbate (E202) and sunset
yellow (E110)
This medicine contains:
- sorbitol. If you have been told by your doctor
that you have an intolerance to some sugars,
contact your doctor before taking this
medicine.
- potassium sorbate (E202). Each 5 ml of
suspension contains less than 1 mmol
(39 mg) of potassium, i.e. essentially
“potassium free”.
- sunset yellow (E110), which may cause
allergic reactions.
3. How to take Carbamazepine SUN Oral
Suspension
Always take this medicine exactly as your doctor
has told you. Check with your doctor or
pharmacist if you are not sure.
The recommended dose is:
Epilepsy
- Adults: The usual dose is 800-1,200 mg a
day, although higher doses may be
necessary.
- Elderly: You might need a lower starting
dose.
- Children: the usual dose is as below in
several divided doses.

Age:
up to 1 year: 5 - 10 ml per day
1 - 5 years: 10 - 20 ml per day
5 - 10 years: 20 - 30 ml per day
10 - 15 years: 30 - 50 ml per day
Trigeminal neuralgia
The usual dose is 600-800 mg, (100 mg starting
dose for elderly) a day. Once the pain is controlled
your doctor will probably reduce the dose.
Manic depression
The usual dose is: 400-600 mg a day.
Method of administration
Your doctor will usually start Carbamazepine SUN
Oral Suspension at a low dose, which can then be
increased to suit you. Shake the bottle before you
measure out your dose. You are usually told to take
a dose two or three times a day. Carbamazepine
SUN Oral Suspension is given orally, either before,
during or between meals.
If you take more Carbamazepine SUN Oral
Suspension than you should
If you accidentally take too much Carbamazepine
Oral Suspension, tell your doctor or your nearest
hospital casualty department.
If you forget to take Carbamazepine SUN Oral
Suspension
If you forget to take a dose, take one as soon as
you remember. Do not take a double dose to make
up for a forgotten dose.
If you stop taking Carbamazepine SUN Oral
Suspension
Do not stop taking your medicine suddenly, as this
may result in you having a seizure. Only stop
taking your medicine if your doctor tells you to do
so.
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.
Tell your doctor straight away if you get any
sudden wheeziness, difficulty in breathing,
swelling of the eyelids, face or lips, rash or itching
(especially affecting your whole body).
Serious side effects
If you develop any of the following side effects,
stop taking Carbamazepine SUN Oral Suspension and contact your doctor immediately:
- fever, rash, sore throat, unusual/unexpected
bleeding or bruising, joint pains
- skin reactions with inflammation, blistering,
sloughing of the skin, and/or inflammation of
eyes, mouth or tongue. These may be severe
and be accompanied by feeling generally
unwell
- yellowing of skin and eyes, pale stools and
dark urine and/or upper abdominal pain or
swelling as these may indicate liver damage.
- potentially life-threatening skin rashes
(Stevens-Johnson syndrome, toxic epidermal
necrolysis) have been reported
(see section 2).
Side effects can be listed according to how often
they occur:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
The following side effects have also been
reported:
Very common
- reduction in the number of white blood cells
- changes in liver enzyme levels (your doctor
can detect these with a blood test)
- dizziness
- tiredness
- feeling unsteady or finding it difficult to
control movements
- feeling sick
- vomiting
- skin reactions
- urticaria (hives) and fatigue
Common
- changes in the number of white blood cells
and platelets
- low blood sodium (your doctor can detect
these with a blood test)
- fluid retention and swelling
- drowsiness (lethargy)
- weight increase
- headache
- double or blurred vision
- dry mouth
- vomiting
- mental confusion
- liver disorders

-

loss of appetite
restlessness
aggression
agitation
speech disorders
numbness or tingling in the hands and feet
muscle weakness
changes in heart beat
stomach pain
liver problems
rashes
partial immobility (partial paralysis)

Very rare
- changes in the blood including anaemia
- meningitis (inflammation of the brain lining)
- swelling of the breasts and discharge of milk
which may occur in both male and females
- abnormal thyroid function tests
- pain on walking and bow legs
- brittle bones
- increased blood fat levels
- taste disturbances
- red eyes
- glaucoma (increased pressure in the eyes)
- cataracts
- hearing disorders
- heart and circulatory problems including deep
vein thrombosis (DVT)
- lung or breathing problems
- sore mouth or tongue
- liver failure
- increased sensitivity of the skin to sunlight
- changes in skin colour
- acne
- sweating
- hair loss
- increased hair growth on the body and face
- muscle pain or spasm
- sexual problems including reduced male
fertility
- loss of sex drive or failure to get an erection
- kidney failure
- blood spots in the urine
- increased or decreased desire to pass urine
or difficulty in passing urine
- skin rashes (Stevens-Johnson syndrome,
toxic epidermal necrolysis)
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,
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 Carbamazepine SUN Oral
Suspension
Keep this medicine out of the sight and reach of
children.
Store below 25°C. Keep the bottle tightly closed
between doses.
Do not use this medicine after the expiry date
which is stated on the label. The expiry date refers
to the last day of that month.
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 Carbamazepine SUN Oral Suspension
contains
The active substance is carbamazepine. 5ml of
suspension contains 100 mg of carbamazepine.
The other ingredients are: poloxamer 188,
sucralose (E955), xanthan gum, potassium sorbate,
propylene glycol, citric acid monohydrate, sunset
yellow (E110), sorbitol, flavour orange natural and
artificial and purified water.
What Carbamazepine SUN Oral Suspension
looks like and content of the pack
Amber bottles with a child resistant plastic cap.
Pack size: 300 ml and 500 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer:
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Uncommon
- abnormal movements such as tremor or tics
- abnormal eye movements
- diarrhoea
- constipation
- skin problems
Rare
- disease of the lymph glands
- folic acid deficiency (can be detected with a
blood test by your doctor)
hallucinations
- depression
This leaflet was last revised in 06/2016

PL 31750/0096

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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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