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CARBAMAZEPINE SUN 100 MG/5 ML ORAL SUSPENSION

Active substance(s): CARBAMAZEPINE / 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 is and what it is used for
2. What you need to know before you take
Carbamazepine SUN
3. How to take Carbamazepine SUN
4. Possible side effects
5. How to store Carbamazepine SUN
6. Contents of the pack and other information
1. What Carbamazepine SUN is and what it is used for
Carbamazepine SUN is a pale orange suspension that
contains carbamazepine, the active ingredient.
Carbamazepine SUN is an anti-convulsant medicine
(prevents fits), it can also modify some types of pain and can
control mood disorders.
Carbamazepine SUN is used
- to treat some forms of epilepsy
- to treat a painful condition of the face called trigeminal
neuralgia
- to help control serious mood disorders when some other
medicines don't work.
2. What you need to know before you take
Carbamazepine SUN
Do not take Carbamazepine SUN
- if you are allergic to carbamazepine or similar drugs such
as oxcarbazepine (Trileptal), or to any of a related group of
drugs known as tricyclic antidepressants (such as
amitriptyline or imipramine) or any of the other
ingredients of this medicine (listed in section 6). If you are
allergic to carbamazepine there is a one in four (25%)
chance that you could also have an allergic reaction to
oxcarbazepine
- if you have any heart problems
- if you have ever had problems with your bone marrow
- if you have a blood disorder called porphyria (an inherited
enzyme disorder)
- if you have taken drugs called monoamine oxidase
inhibitors (MAOIs), used to treat depression, within the
last 14 days.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Carbamazepine SUN 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 medicine)
- you have liver problems
- you have kidney problems associated with low sodium
blood level or do you have kidney problems and you are
taking certain medicines that lower sodium blood levels
(diuretics such as hydrochlorothiazide, furosemide)
- you are elderly
- you have eye problems such as glaucoma (increased
pressure in the eye)
- you have difficulty retaining urine
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 (Stevens-Johnson 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.
Other medicines and Carbamazepine SUN
Tell your doctor or pharmacist if you are using, have recently
used 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
- hormone contraceptives, e.g. pills, patches, injections or
implants. Carbamazepine affects the way contraceptive
works in your body, and you may get breakthrough
bleeding or spotting. It may also make the contraceptive
less effective and there will be a risk of getting pregnant.
Your doctor will be able to advise you about this, and you
should think about using other contraceptives
- Hormone Replacement Therapy such as tibolone.
Carbamazepine can make HRT less effective
- drugs to treat depression or anxiety, such as lithium,
alprazolam, viloxazine, fluoxetine, desipramine,
fluvoxamine
- medicines to treat mental illness (including schizophrenia),
e.g. clozapine, olanzapine, risperidone, haloperidol,
thioridazine, paliperidone or aripiprazole
- corticosteroids (‘steroids’). You might be taking these for
inflammatory conditions such as asthma, inflammatory
bowel disease, muscle and joint pains
- anticoagulants to stop your blood clotting, such as
warfarin
- antibiotics and medicines to treat TB (tuberculosis) such
as doxycycline, rifampicin, erythromycin, clarithromycin,
or isoniazid
- antifungals to treat fungal infections such as itraconazole,
fluconazole, ketoconazole or voriconazole
- painkillers containing paracetamol, dextropropoxyphene,
tramadol, methadone or buprenorphine
- other antiepileptics such as clobazam, clonazepam,
phenytoin, phenobarbitone, primidone, tiagabine,
lamotrigine, topiramate, ethosuximide, valproic acid,
felbamate or oxcarbazepine
- medicines to treat blood pressure or heart problems,
such as digoxin, felodipine, nifedipine, nilvadipine,
verapamil or diltiazem
- antihistamines (medicines to treat allergies) such as
loratadine or terfenadine
- diuretics (‘water’ tablets) e.g. furosemide,
hydrochlorothiazide
- cimetidine or omeprazole (medicines to treat gastric
ulcers)
- isotretinoin (medicine for the treatment of acne)

- aprepitant or metoclopramide (medicines often used to
treat sickness)
- acetazolamide (medicine to treat glaucoma – increased
pressure in the eye)
- danazol or gestrinone (medicines for the treatment of
endometriosis)
- theophylline or aminophylline (medicines for the
treatment of asthma)
- cyclosporin, tacrolimus or sirolimus
(immunosuppressants, medicines used after transplant
operations, but also sometimes in the treatment of
arthritis or psoriasis)
- medicines to treat cancer such as toremifene, cisplatin or
doxorubicin
- anti-malaria medicine mefloquine (medicine used to treat
malaria)
- medicines to treat HIV known as protease inhibitors such
as indinavir, saquinavir or ritonavir
- thyroxine (medicine used to treat hypothyroidism)
- tadalafil (medicine used to treat impotence)
- albendazole (medicine used to treat worms)
- bupropion (medicine used to help stop smoking)
- a herbal remedy St. John's wort (Hypericum perforatum)
- medicines or supplements containing vitamin B such as
nicotinamide.
Carbamazepine with food, 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 experiencing side effects.
You can take Carbamazepine SUN during, after or between
meals.
Pregnancy and breast-feeding
You must discuss your epilepsy treatment with your doctor
well before you become pregnant. If you do get pregnant
while you are taking Carbamazepine SUN you must tell the
doctor straightaway. It is important that your epilepsy
remains well controlled, but, as with other anti-epilepsy
treatments, there is a risk of harm to the foetus. Make sure
you are very clear about the risks and the benefits of taking
Carbamazepine SUN.
If you are taking Carbamazepine SUN you can breast-feed
your babies, but you must tell the doctor as soon as possible if
you think that the baby is suffering side effects such as
excessive sleepiness, skin reaction or yellow skin and eyes,
dark urine or pale stools.
Driving and using machines
Carbamazepine SUN can make you feel dizzy or drowsy, or
may cause blurred vision, double vision, or you may have a
lack of muscular coordination, 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 contains sorbitol (E420), potassium
sorbate and orange yellow S
This medicine contains:
- sorbitol (E420). 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. Each 5 ml of suspension contains less
than 1 mmol (39 mg) of potassium, i.e. essentially
"potassium free”.
- orange yellow S, which may cause allergic reactions.
3. How to take Carbamazepine SUN
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 dose.
- Children aged up to and over 1 year: usually 10-20 mg/kg
body weight daily in several divided doses. Your doctor
will tell you how much liquid the child should take.
Trigeminal neuralgia
The usual dose is 600-800 mg a day. The maximum dose is
1,200 mg a day. If you are elderly you might require a lower
dose. Once the pain is controlled, your doctor will probably
reduce the dose.
Mood swings
The usual dose is 400-600 mg a day.
Method of administration
Your doctor will usually start Carbamazepine SUN at a fairly
low dose which can then be increased to suit you individually. The dose needed varies between patients. 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 is given orally, either before, during or between meals.
If you take more Carbamazepine SUN than you should
If you accidentally take too much Carbamazepine SUN, tell
your doctor or your nearest hospital casualty department.
Take your medicine pack with you so that people can see
what you have taken.
If you forget to take Carbamazepine SUN
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
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.
Serious side effects
If you develop any of the following side effects, stop
taking Carbamazepine SUN and contact your doctor
immediately
- serious skin reactions such as rash, red skin, blistering of
the lips, eyes or mouth, or skin peeling accompanied by
fever. These reactions may be more frequent in patients of
Chinese or Thai origin.
- changes in the blood, including unexplained bleeding or
bruising, or making it easier to catch infections with
mouth ulcers, sore throat, or high temperature
- liver problems or failure, including jaundice with
yellowing of your skin or the whites of your eyes
- swollen ankles, feet or lower legs
- any signs of nervous illness or confusion
- pain in your joints and muscles, a rash across the bridge
of the nose and cheeks and problems with breathing
(these may be the signs of a rare reaction known as lupus
erythematosus)
- fever, skin rash, joint pain, and abnormalities in blood and
liver function tests (these may be the signs of a multiorgan sensitivity disorder)
- bronchospasm with wheezing and coughing, difficulty in
breathing, feeling faint, rash, itching or facial swelling
(these may be the signs of a severe allergic reaction)
- pain in the area near the stomach
- severe skin reactions, accompanied by feeling unwell and
changes in blood results
- reactivation of herpes virus infection (can be serious
when immune system is depressed).

The following side effects have also been reported
Very common (may affect more than 1 in 10 people):
- dizziness
- drowsiness
- tiredness
- feeling unsteady or finding it difficult to control
movements
- feeling or being sick
- changes in liver enzyme levels (usually without any
symptoms)
- skin reactions, including urticaria (hives), which may be
severe.
Common (may affect up to 1 in 10 people):
- fluid retention and swelling
- weight increase
- low sodium in the blood which might result in confusion
- headache
- double or blurred vision
- dry mouth.
Uncommon (may affect up to 1 in 100 people):
- abnormal involuntary movements including tremor or
tics
- abnormal eye movements
- diarrhoea
- constipation.
Rare (may affect up to 1 in 1,000 people):
- disease of the lymph glands
- folic acid deficiency (can be detected with a blood test by
your doctor)
- hallucinations
- depression
- loss of appetite
- restlessness
- aggression
- agitation
- confusion
- speech disorders
- numbness or tingling in the hands and feet
- muscle weakness
- high blood pressure (which may make you feel dizzy, with
a flushed face, headache, fatigue and nervousness)
- low blood pressure (the symptoms of which are feeling
faint, light headed, dizzy, confused, having blurred vision)
- changes in heart beat
- stomach pain.
Very rare (may affect up to 1 in 10,000 people):
- changes to the composition of the blood including
anaemia
- porphyria
- 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
- osteomalacia (which may be noticed as pain on walking and
bowing of the long bones in the legs)
- osteoporosis (brittle bones)
- increased blood fat levels
- taste disturbances
- conjunctivitis (red eyes)
- glaucoma (increased pressure in the eyes)
- cataracts
- hearing disorders
- heart and circulatory problems including deep vein
thrombosis (DVT), the symptoms of which could include
tenderness, pain, swelling, warmth, skin discoloration and
prominent superficial veins
- sore mouth or tongue
- increased sensitivity of the skin to sunlight
- changes in skin colour (alteration in skin pigments)
- acne
- excessive sweating
- hair loss
- increased hair growth on the body and face
- muscle pain or spasm
- sexual difficulties which may include reduced male
fertility
- loss of libido or impotence
- kidney failure
- blood spots in the urine
- increased or decreased desire to pass urine or difficulty in
passing urine.
Not known (frequency cannot be estimated from the
available data):
- diarrhoea, abdominal pain and fever (signs of
inflammation of the colon)
- complete loss of nails
- fracture
- decrease in the measure of the bone density
- memory loss
- purple or reddish-purple bumps that may be itchy.
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
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 contains
- The active substance is carbamazepine. 5ml of
suspension contains 100 mg of carbamazepine.
- The other ingredients are: poloxamer 188, sucralose,
xanthan gum, potassium sorbate, propylene glycol, citric
acid monohydrate, orange yellow S, sorbitol (E420), natural
and artificial flavour orange and water, purified.
What Carbamazepine SUN 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
70087-0417-8
583

This leaflet was last revised in 07/2017

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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