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CARBAGEN 400MG PROLONGED RELEASE TABLETS

Active substance(s): CARBAMAZEPINE

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Carbagen 200 mg
PROLONGED-RELEASE TABLETS
Carbagen 400 mg
PROLONGED-RELEASE TABLETS
(carbamazepine)

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.
• If you get any side effects, talk to your doctor of
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1. What Carbagen is and what it is used for
2. What you need to know before you take Carbagen
3. How to take Carbagen
4. Possible side effects
5. How to store Carbagen
6. Contents of the pack and other information
1. What Carbagen is and what it is used for
Carbagen is specially formulated to release the active
ingredient gradually.
Carbamazepine, the active ingredient, can affect the
body in several different ways. It is an anticonvulsant
medicine (prevents fits), it can also modify some
types of pain and can control mood disorders.
Carbagen 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
Carbagen
A small number of people being treated with
antiepileptics 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 influenzalike 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 have developed Stevens-Johnson syndrome
or toxic epidermal necrolysis with the use of
carbamazepine, you must not be re-started on
carbamazepine at any time.
If you develop a rash or these skin symptoms,
stop taking Carbagen, and contact your doctor
immediately and tell them that you are taking this
medicine.
Do not take Carbagen
• if you are allergic to carbamazepine or similar
medicines such as
oxcarbazepine, or to any of a related group of
medicines known as tricyclic antidepressants (such
as amitriptyline or imipramine). 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 are allergic to any of the other ingredients of
Carbagen (listed in section 6),
• if you have any heart problems,
• if you have ever had problems with your bone
marrow,
• if you have or ever had blood disorders such as
acute intermittent porphyria, variegate porphyria or
porphyria cutanea tarda,
• if you have taken medicines called monoamine
oxidase inhibitors (MAOIs), used to treat depression,
within the last 14 days,
• if you are taking voriconazole for a fungal infection,
• if you are taking anything containing St. John’s wort.

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Warnings and precautions
Talk to your doctor or pharmacist before taking
Carbagen
• if you have liver or kidney disease
• if you suffer from glaucoma (increased pressure
in the eye). It is important to visit your optician
regularly while taking Carbagen
• if you suffer from the sort of epilepsy where you get
mixed seizures which include absences (clouding of
consciousness)
• if you are elderly
• if you are allergic to an epilepsy medicine called
phenytoin
• if you have a condition called hypothyroidism and
are taking hormone replacement therapy (HRT)
• if you suffer from urinary retention, an inability to
urinate
Avoid strong sunlight or excessive lengths of time in
strong sunlight as this may trigger skin reactions.
You may be required to regularly provide blood and/
or urine samples before and during treatment to
check the levels of carbamazepine in your blood and
to identify any problems before they become serious.
Other medicines and Carbagen
Because of the way that Carbagen works, it can affect,
and be affected by lots of other things that you might
be eating or medicines you are taking.
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, including herbal medicines. This is
especially important for the following:
• Hormone contraceptives, e.g. pills, patches,
injections or implants. Carbagen affects the way
the contraceptive works in your body, and you may
get breakthrough bleeding or spotting. It may also
make the contraceptive not work and there will be
a risk of getting pregnant. Your doctor will be able
to advise you about this, and you should use other
contraceptives.
• Hormone Replacement Therapy (HRT) such as
tibolone. Carbagen can make HRT less effective.
• Any medicines for depression or anxiety such as
alprazolam, amitriptyline, citalopram, clobazam,
clomipramine desipamine, fluoxetine, fluvoxamine,
imipramine, mianserin, midazolam, nefazodone,
nortriptyline, paroxetine, sertraline, trazodone or
viloxazine.
• Corticosteroids (‘steroids’) such as dexamethasone
or prednisolone. 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 acenocoumarol, dicoumarol, phenprocoumon,
ticlopidine or warfarin.
• Antibiotics to treat infections including
skin infections and TB such as ciprofloxacin,
clarithromycin, doxycycline, erythromycin, isoniazid,
josamycin, rifampicin, rifabutin or troleandomycin.

• Antifungals to treat fungal infections such
as caspofungin, fluconazole, itraconazole,
ketoconazole or voriconazole.
• Painkillers containing paracetamol,
dextropropoxyphene, fentanyl, ibuprofen,
phenazone, propoxyphene, tramadol, methadone
or buprenorphine.
• Other medicines to treat epilepsy such as clobazam,
clonazepam, felbamate, flunarizine, fosphenytoin,
lamotrigine, levetiracetam, methosuximide,
oxcarbazepine, phenobarbital, phensuximide,
phenytoin, primidone, progabide, stiripentol,
tiagabine, topiramate, valproic acid, valpromide,
vigabatrin or zonisamide.
• Medicines for high blood pressure or heart
problems such as atorvastatin, cerivastatin, digoxin,
diltiazem, felodipine, hydroquinidine, isradipine,
ivradipine, propranolol, quinidine, simvastatin or
verapamil.
• Antihistamines (medicines to treat allergy such as
hayfever, itch, etc) such as loratadine or terfenadine.
• Diuretics (water tablets) such as
hydrochlorothiazide or furosemide.
• Cimetidine or omeprazole (medicines to treat
gastric ulcers).
• Isotretinoin (a medicine for the treatment of acne).
• Metoclopramide (an anti-sickness medication).
• Lithium (a medicine for bipolar disorder).
• Medicines for sickness or nausea (antiemetics) such
as aprepitant.
• Acetazolamide (a medicine to treat glaucoma increased pressure in the eye).
• Danazol or gestrinone (treatments for
endometriosis).
• Theophylline or aminophylline (used in the
treatment of asthma).
• Medicines that reduce the activity of the body’s
natural defences (immunosuppressant) such as
ciclosporin (used after transplant operations, but
also sometimes in the treatment of arthritis or
psoriasis), everolimus, sirolimus or tacolimus.
• Medicines to treat schizophrenia such as
aripiprazole, bromperidol, clozapine, haloperidol,
loxapine, olanzapine, paliperidone, quetiapine,
risperidone or ziprasidone.
• Cancer medicines such as cisplatin
cyclophosphamide, doxorubicin, imatinib, lapatinib,
procarbazine, temsirolimus or toremifene.
• The antimalarial medicine, mefloquine.
• Medicines to treat HIV such as indinavir, ritonavir or
saquinavir.
• Levothyroxine (used to treat hypothyroidism).
• Muscle relaxant medicines such as pancuronium,
dantrolene or oxybutynin.
• Bupropion (used to help stop smoking).
• Methylphenidate (used to treat attention-deficit,
hyperactivity disorder (ADHD).
• Medicines or supplements containing Vitamin B
(nicotinamide).
• Medicines to treat parasitic worm infections such as
albendrazole or praziquantel.
• Tadalafil – a medicine used for men with erection
problems.
If you are taking medicines for depression, tell
your doctor or hospital staff that you are taking
carbamazepine if you need to have a blood test to
monitor the levels of medicine in your blood.
Carbagen with food, drink and alcohol
Do not take your tablets with grapefruit or grapefruit
juice as this may increase the likelihood of side effects
from Carbagen.
Drinking alcohol may affect you more than usual. You
should not drink alcohol during treatment.
Pregnancy, breast-feeding and fertility
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.
Pregnancy
Carbamazepine affects the way hormonal
contraceptives work and there is a risk of getting
pregnant. You should use other contraceptives. You
must discuss your epilepsy treatment with your
doctor well before you become pregnant. If you do
get pregnant while taking Carbagen do not stop
taking this medicine and tell the doctor straightaway.
It is important that your epilepsy remains well
controlled, but, as with other antiepilepsy treatments,
there is a risk of harm to the baby. You should be able
to have an antenatal scan to check for any problems.
Make sure you are very clear about the risks and the
benefits of taking Carbagen.
Breast-feeding
Mothers taking Carbagen can breast-feed their
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 or skin reactions
because you are taking Carbagen.
Fertility
Taking this medicine may affect male fertility. If you
have any questions talk to your doctor.
Driving and using machines
Carbagen may 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 (blurred or double vision), you
should not drive or operate machinery.
3. How to take Carbagen
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Your doctor will usually start Carbagen at a fairly
low dose which can then be increased to suit you
individually. The dose needed varies between
patients. You may be told to take a dose two or three
times a day.
To treat epilepsy the recommended doses are:
Adults:
The recommended starting dose is 100-400 mg a day
in one or two doses. The dose may then be increased
to 800-1,200 mg a day, in two doses, although higher
doses may be necessary. If you are elderly you might
require a lower dose.
Use in children and adolescents:
Aged 5-10 years: The recommended starting dose is
200 mg at night (or 100 mg morning and night). The
dose may then be increased to 300-600 mg a day in
two doses.
Aged 10-15 years: The recommended starting dose is
200 mg at night (or 100 mg morning and night). The
dose may then be increased to 500-1,000 mg a day in
two doses.
Carbagen is not recommended for children under 5.
To treat trigeminal neuralgia the recommended
starting dose is 100-400 mg a day. The dose may be
increased to: 600-800 mg a day in two doses, with a
maximum dose of 1600 mg.
To treat mood swings the recommended starting
dose is 100-400 mg a day. The dose may be increased
to: 400-600 mg a day in two doses with a maximum
dose of 800 mg.
Method of administration
For oral use.
You can take Carbagen during, after or between
meals. Swallow the tablets whole with a drink. Do
not chew them. If you have difficulty swallowing the
tablets you can add them to a glass of water where
the tablets will break apart. If you do this you must
drink all of the mixture as soon as the tablets have
broken apart.
The tablet can be divided into equal doses.

TBC
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Package Leaflet: Information for the patient

If you take more Carbagen than you should
If you take too many Carbagen immediately tell your
doctor or your nearest hospital casualty department.
Take the medicine pack with you so that people
can see what you have taken. You may feel sick, be
sick, constipated, you may be unable to urinate,
hallucinate, be confused, have blurred vision, slurred
speech, uncontrollable eye movements, dilated
pupils, uncontrollable movements such as muscle
spasms, loss of coordination, shallow, difficulty or
stopping breathing, respiratory, changes to your
heart beat or a heart attack.
If you forget to take Carbagen
Take it as soon as you remember unless it is almost
time for your next dose. Do not take a double dose to
make up for a forgotten tablet.
If you stop taking Carbagen
Do not stop taking your tablets suddenly. Speak to
your doctor first. If your dose needs to be reduced,
this will be done slowly.
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.
Some side effects can be serious
Stop taking Carbagen and tell your doctor straight
away if you notice:
Very common (may affect more than 1 in 10 people)
• an increase in the number of infections you get
which may cause fever, severe chills, sore throat,
or mouth ulcers (this may indicate you have a low
number of white blood cells in your body)
Uncommon (may affect up to 1 in 100 people)
• difficulty breathing, especially with exercise. You
may have a dry, hacking cough or wheezing with
rapid or irregular heartbeats, swelling to ankles, feet
or lower legs, loss of appetite, dizziness, tiredness
or confusion (this may indicate your heart isn’t
working properly)
• fever, skin rash, swollen glands, joint pain, and
abnormalities in blood and liver function tests
(these may be the signs of a multi-organ sensitivity
disorder)
• difficulty thinking, seeing or hearing things that
aren’t there (hallucinations), increased agitation or
false-beliefs (delusions)
Rare (may affect up to 1 in 1,000 people)
• tingling, pins and needles sensation, numbness,
burning or sharp stabbing pain in your hands and
feet, feel physically weak or uncoordinated ( this
may indicate you have inflammation in or damaged
some of the nerves in the body)
• yellowing of your skin or whites of the eyes,
dark urine, pale stools, tiredness, fever, nausea,
weakness, drowsiness and abdominal pain, with
test results showing abnormal liver function (these
may indicate you have problems with your liver or a
blockage in the bile duct)
• 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 systemic lupus erythematosus)
• inability to completely empty your bladder. You
may have a poor urinary stream with an interrupted
flow, be straining to urinate with a delay in trying to
urinate and urinating (these signs indicate you may
have a condition called urinary retention)
Very rare (may affect up to 1 in 10,000 people)
• tiredness, shortness of breath, cold hands or feet
or pale skin, difficulty in healing after a cut or
unexplained bruising or bleeding (this may indicate
you have a low number of red blood cells or
platelets in your body)
• wheezing and coughing, difficulty in breathing,
feeling faint, rash, itching or swelling in the face,
lips, tongue or throat (these may be the signs of a
severe allergic reaction)
• severe abdominal pain, red urine, severe
constipation or hallucinations (these are signs that
you have a condition called porphyria). Your skin
may also become fragile and blister when exposed
to light
• shortness of breath, difficulty swallowing
or difficulty walking. You may shake or have
uncontrollable movements (this may indicate you
have a condition called neuroleptic malignant
syndrome)
• sensitivity to light, stiff neck, body aches, sore
throat, severe headache, flu-like symptoms (these
may indicate you have a type of meningitis that
can’t be passed on to others)
• circulatory problems such as cold hands and
feet, prominent veins in the neck, rapid shallow
breathing or weak, irregular heart beat
• Serious skin reactions such as rash, red skin,
blistering and bleeding of the lips, eyes or mouth,
or skin peeling accompanied by fever have been
reported (these may indicate Stevens-Johnson
syndrome or toxic epidermal necrolysis – see
section 2). These reactions may be more frequent in
patients of Chinese or Thai origin
• severe pain in the area near the stomach that
spreads to the back (this may indicate you have
problems with your pancreas)
• producing little or no urine, pain or difficulty when
passing urine, cloudy or dark urine, blood in the
urine or lower back pain (these may indicate serious
problems with your kidneys)
• increase in eye pressure (this is known as glaucoma)
• lung or breathing problems with fever, coughing
which may produce phlegm or blood, or chills
Not known (cannot be estimated from the available
data)
• infection caused by human herpes virus 6
Other side effects include:
Very common (may affect more than 1 in 10 people)
• Dizziness, tiredness or drowsiness
• feeling unsteady or finding it difficult to control
movements
• feeling or being sick
• changes in liver enzyme levels (usually without any
symptoms)
• skin reactions, with or without fever, for example a
red itchy rash (known as hives) which may be severe
Common (may affect up to 1 in 10 people)
• fluid retention and swelling
• weight increase
• low sodium or other salts (electrolytes) in the
blood that might result in confusion or behavioural
changes.
• headache
• double or blurred vision, problems with your eye
• dry mouth, loss of appetite
Uncommon (may affect up to 1 in 100 people)
• fever, skin rash, swollen glands, joint pain, and
abnormalities in blood and liver function tests
(these may be the signs of a multi-organ sensitivity
disorder)
• confusion, agitation (these may occur especially in
the elderly)
• feeling sad or low (also known as depression)
• aggression
• abnormal involuntary movements including tremor,
spasms, or tics
• lack of drive or motivation
• abnormal eye movements
• ringing in the ear (also known as tinnitus)
• irregular or slow heartbeat, you may faint
• chest pain, a thumping sensation in your chest
together with breathlessness

• diarrhoea, constipation
• itchy skin, scaly or flaky skin, areas of redness which
may be sore and tender due to inflammation of
blood vessels
• hair loss
• excessive sweating
• increase in urea or nitrogen containing compounds
in the blood
Rare (may affect up to 1 in 1,000 people)
• lumps on the neck or armpit (may be signs of a
disease of the lymph glands)
• sore mouth or dark skin (may be signs of a lack of
folic acid in the body)
• restlessness
• over-excitable moods with uninhibited behaviour
• involuntary movements of the face (such as a
grimace) or twisting or writhing movements of the
body
• speech problems
• muscle weakness causing loss of movement
• swelling of the breasts and discharge of milk which
may occur in both males and females
• cloudy vision
• high blood pressure (which may make you feel
dizzy, with flushed face, headache, fatigue and
nervousness)
• low blood pressure (the signs of which are feeling
faint, light headed, dizzy, confused, having blurred
vision)
• stomach pain
• increased or decreased desire to pass urine
Very rare (may affect up to 1 in 10,000 people)
• unable to eat a large meal or feeling full without
eating, discomfort, fullness or pain in the upper left
side of the stomach. You may also be tired, have
weight loss or bleed easily. These are signs you may
have an enlarged spleen
• persistent fear of (and desire to avoid) a particular
object or situation (phobias)
• abnormal thyroid function tests
• osteomalacia (which may be noticed as pain on
walking and bowing of the long bones in the legs)
• brittle bones (known as osteoporosis)
• increased blood fat levels, increased blood cortisol
or prolactin levels in the blood
• taste disturbances
• itchy, watery, sore eyes with crusty eyelids (known
as conjunctivitis)
• hearing disorders such as pitch changes in sound,
loss of hearing or increased sensitivity to sound
• swelling or redness along a vein which is painful or
tender to touch or skin discoloration and prominent
superficial veins (may be signs of circulatory
problems such as a blood clot)
• inflammation or swelling of the stomach, mouth
(gums) or tongue
• increased sensitivity of the skin to sunlight
• changes in skin colour
• acne
• increased hair growth on the body and face
• purple or brown spots on the skin
• pain in the joints or muscles
• sexual difficulties which may include reduced male
fertility such as abnormal sperm
• loss of libido or impotence
Not known (cannot be estimated from the available
data)
• problems with your memory
• diarrhoea which may contain mucus or blood. You
may have stomach pain or a fever
• single small skin lesion
• shedding of finger and toe nails
• broken bones
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, Website: 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 Carbagen
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 carton after EXP. The expiry date
refers to the last day of that month.
This medicine has no special storage requirements.
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 Carbagen contains
The active substance is carbamazepine.
Each prolonged-release tablet contains either
200mg or 400mg of carbamazepine. The other
ingredients are ammonio methacrylate copolymer
type B (contains sorbic acid and sodium hydroxide),
methacrylic acid-ethyl acrylate copolymer (contains
sodium laurilsulfate and polysorbate), triacetin, talc,
microcrystalline cellulose, crospovidone, colloidal
anhydrous silica and magnesium stearate.
What Carbagen looks like and contents of the pack
The tablets are white or yellowish, round, flat,
cloverleaf shaped tablets with double-sided cross
break-mark and four notches on the band.
Carbagen is available in blister packs of 15 (200 mg
only) 20, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 150,
168, 180, 200, 250 OR 500 prolonged-release tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar,
Hertfordshire, England, EN6 1TL.
Manufacturer
Generics [UK] Limited, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom
McDermott Laboratories Ltd t/a Gerard Laboratories,
35 Baldoyle Industrial Estate, Grange Road, Dublin 13,
Ireland
Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1,
Hungary
This medicinal product is authorised in the Member
States of the EEA under the following names:
Germany 
Carbadura 200 mg Retardtabletten

Carbamazepin 400 mg Generics Retard
France 
Carbamazépine Mylan LP 200 mg &
400 mg, comprimé sécable à libération
prolongée
Gericarb SR 200 mg & 400 mg
Ireland 
prolonged-release tablets
Portugal
Carbamazepine Mylan 200 mg &

400 mg comprimidos
United
Kingdom Carbagen PR Tablets 200 mg & 400 mg

This leaflet was last revised in {07/2014}.

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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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