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Active substance(s): CARBAMAZEPINE

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Carbagen® 100 mg Tablets
Carbagen® 200 mg Tablets
Carbagen® 400 mg Tablets

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
or 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 contains carbamazepine, which belongs
to a group of medicines called antiepileptics.
Carbagen can be used to treat the following
different conditions:
• Some forms of epilepsy.
• Pain in the face caused by trigeminal neuralgia
(nerve pain).
• To help control serious mood disorders when
some other medicines don't work.
If you are not sure why you are taking this
medicine, ask your doctor.
2. What you need to know before you
take Carbagen
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, appearing initially
as reddish target-like spots or circular patches
often with central blisters on the trunk.
Frequently, the rash can involve ulcers of the
mouth, throat, nose, genitals and conjunctivitis
(red and swollen eyes). These potentially lifethreatening skin rashes are often preceded by
influenza-like symptoms fever, headache, body
ache (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 months of treatment.
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.
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
If you develop a rash or these skin symptoms,
stop taking carbamazepine and contact your
doctor immediately.
Do not take Carbagen:
• if you are allergic to carbamazepine or any of the
ingredients of this medicine (see section 6). Signs of
a hypersensitivity reaction include swelling of the
face or mouth (angioedema), breathing problems,
runny nose, skin rash, blistering or peeling
• if you are allergic to similar drugs such as
oxcarbazepine or phenytoin or a tricyclic
antidepressant (e.g. amitriptyline)
• if you have a heart condition or had a problem
with your bone marrow
• if you or a member of your family has the rare
blood pigment disorder called porphyria
• if you are already taking medicine to treat a
mental illness called a monoamine oxidase
inhibitor (MAOI), such as phenelzine (or have
taken an MAOI in the last two weeks).
Warnings and precautions
Talk to your doctor or pharmacist before
taking Carbagen:
• if you have heart disease
• if you have a history of liver or kidney disease
• if you have kidney problems associated with
low sodium blood level or if you have kidney
problems and you are taking certain medicines
that lower sodium blood levels (diuretics such as
hydrochlorothiazide or furosemide)
• if you have glaucoma (increased pressure in the eye)
• if you have a difficulty to retain your urine
• if you have suffered from a mental illness in the past
• if you are elderly
• if you suffer from the sort of epilepsy where you
get mixed seizures, which include absences
• if you have blood disorders (including those
caused by other drugs) or if you have ever
suffered a reaction to any other medicine, which
has affected your blood, for example a low white
blood cell count (leucopenia)
• if you have had interrupted courses of treatment
with carbamazepine.
Your doctor may want to have regular blood and
liver tests and in some cases, urine tests, before
you start taking Carbagen and from time to time
during your treatment. This is quite usual and
nothing to worry about.
Children and adolescents
Do not give this medicine to children less than
5 years old.
Other medicines and Carbagen
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines:
• other antiepileptics e.g. lamotrigine, phenytoin,
fosphenytoin, primidone, sodium valproate,
phenobarbitone, ethosuximide, oxcarbazepine,
tiagabine, topiramate, vigabatrin, levetiracetam,
• anticoagulants to thin the blood e.g. warfarin,
• cimetidine or omeprazole, to treat heartburn or
stomach ulcers

• medicine to treat mental illness e.g. lithium,
haloperidol, thioridazine, olanzapine, risperidone,
clozapine, quetiapine
• paliperidone or aripiprazole, to treat schizophrenia
• sedatives e.g. clobazam, clonazepam,
alprazolam, valnoctamide
• antidepressants e.g. imipramine, fluoxetine,
amitriptyline, clomipramine, nortriptyline,
mianserin, sertraline, paroxteine, fluvoxamine,
citalopram, trazodone
• the herbal remedy St John's wort (Hypericum
perforatum) should not be taken while taking
Carbagen. Consult your doctor before stopping
the St John's wort preparation
• metoclopramide or aprepitant, often used to
treat sickness
• antibiotics e.g. doxycycline, isoniazid,
erythromycin, clarithromycin, ciprofloxacin
• isoniazid, rifampicin (used to treat tuberculosis)
• antifungals e.g. itraconazole, fluconazole,
ketoconazole, voriconazole, albendazole
• corticosteroids e.g. prednisolone, dexamethasone
• ciclosporin, tacrolimus or sirolimus,
• painkillers containing paracetamol,
dextropropoxyphene, methadone, tramadol,
• medicine to treat heart conditions e.g. felodipine,
isradipine, digoxin, verapamil, diltiazem
• diuretics ('water' tablets) e.g. furosemide,
• acetazolamide, to treat glaucoma
• muscle relaxants, often used during operations
e.g. pancuronium
• isotretinoin, used to treat acne
• theophylline and aminophylline, for asthma
• danazol and gestrinone (used in the treatment
of endometriosis)
• hormonal contraceptives e.g. pills, patches,
injections or implants; as the effectiveness of
these may be reduced and there will be a risk of
getting pregnant. Your doctor can advise you
about an alternative form of contraception.
• Hormone Replacement Therapy (HRT) e.g. tibolone
• tadalafil, used to treat impotence
• drugs to treat cancer e.g. imatinib, lapatinib,
toremifene, cisplatin, doxorubicin, temsirolimus,
• mefloquine, used to treat malaria
• drugs to treat HIV known as protease inhibitors
(e.g. indinavir, ritonavir, saquinavir)
• levothyroxine to treat hypothyroidism
• the anti-smoking aid, bupropion
• antihistamines to treat allergies and hayfever,
such as loratadine
• medicine or supplements containing Vitamin B
Carbagen with drink and alcohol
Do not drink alcohol while taking Carbagen as
this may increase the chance of side effects. The
risk of side effects may also be increased if you eat
grapefruit or drink grapefruit juice.
Pregnancy and breast-feeding
If you are planning to become pregnant, talk
to your doctor first. If you do get pregnant
while taking Carbagen you must tell the doctor
straightaway. With all anti-epileptic treatment,
there is a risk of harm to the unborn baby, but
it is important that your epilepsy remains well
controlled. If you are pregnant and need to take an
anticonvulsant, you are likely to be taking only one
anticonvulsant. Your doctor will monitor you and
your unborn child closely. It is important that you
fully understand the risks and benefits, to both you
and your baby, of taking Carbagen tablets.
Carbamazepine can pass into breast milk. Talk to
your doctor before you decide to breast-feed. If
you do breast-feed and you take Carbagen, tell
your doctor straight away if your child becomes
very drowsy or suffers from skin reactions or yellow
skin and eyes, dark urine or pale stools.
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 any medicine.
Driving and operating machines
Carbagen tablets 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 or you have a lack
of muscular coordination, 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 is likely to start treatment with a low
dose and slowly increase it to suit your own needs.
Ask your doctor or pharmacist if you are unsure
about the correct dose but the recommended
doses are as follows:
Adults: The recommended starting dose is 100 mg
to 200 mg of Carbagen once or twice daily. Your
doctor will slowly increase this dose to control
your fits until the best response is obtained, often
800 to 1200 mg daily in divided doses, although
higher doses may be necessary.
Use in children and adolescents: Carbagen tablets
should not be given to children under 5 years old.
The recommended daily dose for children
between 5 and 10 years old is 400 mg to 600 mg of
Carbagen, divided up throughout the day. Children
over 10 years old may be given a total daily dose
of between 600 mg and 1000 mg of Carbagen,
divided up throughout the day.
Your doctor will use another antiepileptic
medicine e.g. phenytoin, if Carbagen is
withdrawn suddenly.
The starting dose is 200 to 400 mg daily (100 mg
twice daily in elderly patients). Your doctor may
increase the dose until you are free from pain. In the
majority of patients a dosage of 200 mg three or
four times a day is enough to treat the pain. In some
cases, a dose of up to 1600 mg Carbagen daily may
be needed. Once the pain goes away (remission),
the doctor will slowly reduce your dose of Carbagen.
The maximum recommended dose is 1200 mg a
day. If possible the doctor may gradually stop your
treatment until another attack occurs.
The starting dose is 400 mg of Carbagen daily,
divided up throughout the day. This dose may
be increased slowly until your symptoms are
controlled or until the maximum daily dose of


Package leaflet: Information for the patient

1600 mg of Carbagen is reached. The usual daily
dose range is 400 – 600 mg in divided doses.
Elderly patients may be more sensitive to the
effects of Carbagen so the doctor may prescribe
smaller doses than those stated above.
Cardiac, hepatic or renal impairment
Patients who suffer from heart, liver or kidney
problems may also be prescribed lower doses
of Carbagen.
Method of administration
Swallow the tablet whole, with a glass of water.
Do not chew, crush or suck the tablet. Take during,
after or between meals.
If you take more Carbagen than you should
If you take more Carbagen than you should,
contact your doctor or local hospital emergency
department immediately. Take the container and
any remaining tablets with you.
If you experience difficulty in breathing, a fast and
irregular heartbeat, loss of consciousness, fainting,
shakiness, sickness and/or vomiting, your dose
may be too high. Stop taking your medicine and
inform your doctor without delay.
If you forget to take a dose
If you forget to take a dose take it as soon as you
remember unless it is nearly time for your next
dose. Do not take double dose to make up for a
forgotten dose.
If you stop taking Carbagen suddenly
If you stop taking Carbagen suddenly you may
suffer unpleasant side effects. Always ask your
doctor first.
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. Side
effects are more common at the start of treatment,
but usually disappear after a few days or when the
dose is adjusted to be right for you.
Tell your doctor or go to your nearest hospital
emergency department immediately if you suffer
from the following serious side effects:
Very common: may affect more than 1 in
10 people
• a low white cell count (leucopenia) causing more
infections than usual.
Uncommon: may affect up to 1 in 100 people
• severe peeling of the skin which can affect a large
area of your body.
Rare: may affect up to 1 in 1,000 people
• have difficulty breathing, experience chest pain,
wheezing and coughing, a rash, itching, facial
swelling or feel faint, all symptoms of a severe
allergic reaction
• fever, skin rash, joint pain, and abnormalities in
blood and liver function tests (these may be the
signs of a multi-organ sensitivity disorder)
• suffer from pain in your joints and muscles, have
a rash across the bridge of your nose and cheeks,
and have problems breathing (symptoms of the
rare reaction, systemic lupus erythematosus)
• experience yellowing of your skin or the whites
of your eyes, which may in some cases indicate
inflammation of the liver.
Very rare: may affect up to 1 in 10,000 people
• notice any unusual signs of mental illness
or confusion
• potentially life-threatening skin rashes (StevensJohnson syndrome, toxic epidermal necrolysis)
have been reported (see section 2). Symptoms
include worsening of a skin rash, blistering of
the lips, eyes or mouth or a severe skin reaction
accompanied by fever. These reactions may be
more frequent in those of Chinese and Thai origin.
• suffer from a sore throat, high temperature or both
• a sudden increase in body temperature,
extremely high blood pressure and severe
convulsions (neuroleptic malignant syndrome)
• have severe or persistent pain in the stomach
region that spreads to the lower back, often with
nausea and vomiting (pancreatitis)
• meningitis (signs and symptoms include fever,
feeling sick, being sick, headache, stiff neck,
extreme sensitivity to sunlight, twitching of
muscles, abnormal blood test results)
• feel feverish or notice unexplained bruising or
bleeding of your skin which could show you have
anaemia (a change in your blood)
• heart and circulatory problems including a blood
clot (thrombosis), which can cause tenderness,
swelling, pain chest, shortness of breath; heart
failure (symptoms include shortness of breath,
swelling of feet or legs due to fluid build-up,
getting tired easily after light physical activity)
• blood changes including:
* decreases in white blood cells
(agranulocytosis) causing more infections
than usual with symptoms like fever, severe
chills, sore throat or mouth ulcers
* conditions in which red blood cells, white
blood cells and platelets are all reduced
in number
• liver failure (symptoms include yellowing of your
skin or the white of your eyes, dark urine, light
coloured bowel motions, nausea, vomiting, and
feeling generally unwell)
• severe allergic reactions (signs include wheezing,
coughing, difficulty in breathing, feeling faint,
rash, itching, swelling of the face, lips, mouth,
tongue or throat).
Not known: frequency cannot be estimated from
the available data
• severe skin reactions, accompanied by feeling
unwell, fever and changes in blood results.
Other side effects that can occur:
Very common (may affect more than 1 in
10 people):
• feeling dizzy, tired or drowsy
• difficulty controlling movements and
feeling unsteady
• feeling or being sick
• skin reactions, including hives (urticaria) which
may be severe
• changes in liver enzyme levels (usually without
any symptoms).
Common (may affect up to 1 in 10 people):
• swollen ankles or lower legs, fluid retention
• weight gain
• low sodium levels in the blood causing headache,
confusion, being sick, lethargy, muscular
twitching, convulsions

• double vision, eyesight changes e.g. blurred vision
• dry mouth
• headache
• changes in the blood including an increased
tendency to bruise or bleed
• eosinophilia (increase in some white blood cells)
• increase in alkaline phosphatase (an enzyme
found in body tissues such as liver and bone).
Uncommon (may affect up to 1 in 100 people):
• abnormal movements or uncontrollable muscle
spasms involving the arms, legs, eye, head, neck
and other parts of the body
• shaking (tremor)
• diarrhoea or constipation
• increased levels of certain enzymes in the body
(seen in a blood test).
Rare (may affect up to 1 in 1000 people):
• folic acid deficiency
• increased levels of white blood cells in the body
(seen in a blood test), fever
• disease of the lymph glands
• hallucinations (seeing or hearing things that are
not there)
• depression or mood changes
• feeling restless, aggressive or agitated
• feeling confused
• numbness or tingling in the hands or feet,
weakness of the arms or legs
• muscle weakness, loss of muscle control, speech
problems, uncontrolled movements of the face
and tongue
• loss of appetite
• raised or low blood pressure
• changes in heart rhythm
• stomach pain
• itching (pruritus).
Very rare (may affect up to 1 in 10,000 people):
• porphyria (a disorder of blood pigment)
• swelling of the breasts, leaking of milk from
the breasts, which may occur in both males
and females
• softening of the bones, osteoporosis
• abnormal results from thyroid tests
• raised fat levels in the blood
• changes in taste or hearing, ringing in the ears
• 'sticky' eyes (conjunctivitis), cataracts, raised
pressure in the eyes
• a racing or slowed heartbeat, feeling faint, collapse
• prominent superficial veins
• difficulty breathing, pneumonia, inflammation of
the lungs, fever
• sore mouth or tongue, swollen tongue
• changes in skin pigmentation
• purple or red-brown spots visible through the
skin (purpura)
• skin sensitive to light, acne, excessive sweating,
hair loss or growth on the body or face
• joint pain, muscle pain or cramp
• kidney problems, difficulty passing urine or
passing more urine than usual, blood or protein
in the urine
• sexual difficulties including reduced male fertility,
loss of sexual desire or drive, inability to get or
maintain an erection
• a decreased quantity of immunoglobulins in the
blood (hypogammaglobulinaemia) which leads
to a lowered immunity and an increase in the
number of infections.
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.
• abdominal pain and fever (signs of inflammation
of the colon)
• reactivation of herpes virus infection
• complete loss of nails
• memory loss.
Reporting of side effects
If you get any side effects talk to your doctor,
pharmacist or nurse. This includes any side effect
not listed in this leaflet.
You can also report side effects directly via the Yellow
Card Scheme at:
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 foil, carton or bottle after
'EXP'. The expiry date refers to the last day of
that month.
Store your medicine in a dry place below 25°C.
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
There are three strengths of your medicine available.
Each tablet contains either 100 mg, 200 mg or
400 mg of the active substance carbamazepine.
The other ingredients are cellulose,
microcrystalline; starch, pregelatinised; silica,
colloidal anhydrous; talc; magnesium stearate and
sodium starch glycollate (Type A).
What Carbagen looks like and contents of
the pack
Your medicine comes as a white tablet. On one
side, the 100 mg tablet is marked 'CB/100', the
200 mg tablet is marked 'CB/200' and the 400 mg
tablet is marked 'CB/400', nothing is marked on
the reverse.
Carbagen is available in plastic bottles or foil
blisters in packs of 5, 7, 10, 14, 15, 20, 21, 25, 28,
30, 50, 56, 60, 84, 90, 100, 112, 120, 168, 180, 250,
500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.
Generics [UK] Limited, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.
Gerard Laboratories, 35/36 Baldoyle Industrial
Estate, Grange Road, Dublin 13, Ireland.

This leaflet was last
revised in 11/2014

LT1413AI 528114

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