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TEGRETOL TABLETS 100MG

Active substance(s): CARBAMAZEPINE

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In this leaflet:
1. What Tegretol Tablets are and what they
are used for
2. Things to consider before you start to take
Tegretol Tablets
3. How to take Tegretol Tablets
4. Possible side effects
5. How to store Tegretol Tablets
6. Further information

Package Leaflet: Information for the User

TEGRETOL® 100, 200
and 400 mg Tablets

1. hat Tegretol Tablets are and what
W
they are used for

(carbamazepine)

Carbamazepine, the active ingredient in
Tegretol Tablets, can affect the body in several
different ways. It is an anti-convulsant medicine
(prevents fits), it can also modify some types
of pain and can control mood disorders.

What you need to know about
Tegretol Tablets
Your doctor has decided that you need this
medicine to help treat your condition.
Please read this leaflet carefully before you
start to take your medicine. It contains
important information. Keep the leaflet in a safe
place because you may want to read it again.
If you have any other questions, or if there is
something you don’t understand, please ask
your doctor or pharmacist.
This medicine has been prescribed for you.
Never give it to someone else. It may not be
the right medicine for them even if their
symptoms seem to be the same as yours.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

Tegretol 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. hings to consider before you start to
T
take Tegretol Tablets
Some people MUST NOT take Tegretol
Tablets. Talk to your doctor if:
• you think you may be hypersensitive
(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). If you are

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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.
You should also ask yourself these questions
before taking Tegretol Tablets. If the answer
to any of these questions is YES, discuss
your treatment with your doctor or
pharmacist because Tegretol Tablets might
not be the right medicine for you.
• Are you pregnant or planning to become
pregnant?
• Are you breastfeeding?
• Do you suffer from the sort of epilepsy
where you get mixed seizures which
include absences?
• Do you have any mental illness?
• Are you allergic to an epilepsy medicine
called phenytoin?
• Do you have liver problems?
• Do 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)?
• Are you elderly?

• Do you have any eye problems such as
glaucoma (increased pressure in the eye) or
do you have difficulty retaining your urine?
Are you taking other medicines?
Because of the way that Tegretol works, it can
affect, and be affected by, lots of other things
that you might be eating or medicines that you
are taking. It is very important to make sure
that your doctor knows all about what else you
are taking, including anything that you have
bought from a chemist or health food shop. It
may be necessary to change the dose of some
medicines, or stop taking something altogether.
Tell the doctor if you are taking:
• Hormone contraceptives, e.g. pills, patches,
injections or implants. Tegretol affects the
way the 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 (HRT).
Tegretol can make HRT less effective.
• Any medicines for depression or anxiety.
• 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.
• Antibiotics to treat infections including skin
infections and TB (e.g. ciprofloxacillin).
• Antifungals to treat fungal infections.

• Painkillers containing paracetamol,
dextropropoxyphene, tramadol, methadone
or buprenorphine.
• Other medicines to treat epilepsy.
• Medicines for high blood pressure or heart
problems.
• Antihistamines (medicines to treat allergy
such as hayfever, itch, etc).
• Diuretics (water tablets).
• Cimetidine or omeprazole (medicines to
treat gastric ulcers).
• Isotretinoin (a medicine for the treatment
of acne).
• Metoclopramide or aprepitant
(­anti-sickness medications).
• 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).
• Ciclosporin, tacrolimus or sirolimus
(immunosuppressants used after
transplant operations, but also sometimes
in the treatment of arthritis or psoriasis).
• Drugs to treat schizophrenia (e.g.
paliperidone, aripiprazole).
• Cancer drugs (e.g. temsirolimus,
cyclophasphamide, lapatinib).
• The anti-malarial drug, mefloquine.
• Drugs to treat HIV.
• Levothyroxine (used to treat hypothyroidism).
• Tadalafil (used to treat impotence).
• Albendazole (used to treat worms).

• Bupropion (used to help stop smoking).
• A herbal remedy called St John’s Wort or
Hypericum.
• Drugs or supplements containing Vitamin
B (nicotinamide).
Pregnancy and breastfeeding
You must discuss your epilepsy treatment with
your doctor well before you become pregnant. If
you do get pregnant while you’re taking Tegretol
Tablets 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 Tegretol Tablets.
Mothers taking Tegretol Tablets can
breastfeed 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, skin reaction or yellow
skin and eyes, dark urine or pale stools.
Will there be any problems with driving or
using machinery?
Tegretol Tablets 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.
Other special warnings
• Drinking alcohol may affect you more than
usual. Discuss whether you should stop
drinking with your doctor.

• Eating grapefruit, or drinking grapefruit
juice, may increase your chance of
experiencing side effects.
• Your doctor may want you to have a
number of blood tests before you start
taking Tegretol and from time to time
during your treatment. This is quite usual
and nothing to worry about.

3. ow to take Tegretol Tablets
H
The doctor will tell you how many Tegretol
Tablets to take and when to take them.
Always follow his/her instructions carefully.
The dose will be on the pharmacist’s label.
Check the label carefully. It is important to
take the tablets at the right times. If you are
not sure, ask your doctor or pharmacist.
Keep taking your tablets for as long as you
have been told, unless you have any problems.
In that case, check with your doctor.
Your doctor will usually start Tegretol at a
fairly low dose which can then be increased
to suit you individually. The dose needed
varies between patients. You can take
Tegretol Tablets during, after or between
meals. Swallow the tablets with a drink. You
are usually told to take a dose two or three
times a day. If necessary you may break the
tablets in half along the scored line.
To treat epilepsy the usual doses are:
Adults: 800–1,200 mg a day, although higher
doses may be necessary. If you are elderly
you might require a lower dose.
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allergic to carbamazepine there is a one in
four (25%) chance that you could also have
an allergic reaction to oxcarbazepine.
you think you may be allergic to any of the
other ingredients of Tegretol Tablets (these
are listed at the end of the leaflet). Signs of
a hypersensitivity reaction include swelling
of the face or mouth (angioedema),
breathing problems, runny nose, skin rash,
blistering or peeling.
you have any heart problems,
you have ever had problems with your
bone marrow,
you have a blood disorder called porphyria,
you have taken drugs called monoamine
oxidase inhibitors (MAOIs), used to treat
depression, within the last 14 days.

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Children:
Aged 5–10 years: 400–600 mg a day
Aged 10–15 years: 600–1,000 mg a day.
Tegretol Tablets are not recommended for
children under 5.



To treat trigeminal neuralgia the usual dose is:
600–800 mg a day. The maximum dose is
1200 mg a day. If you are elderly you might
require a lower dose.
To treat mood swings the usual dose is:
400–600 mg a day
What if you forget to take a dose?
If you forget to take a dose, take one as soon
as you remember. If it is nearly time for your
next dose, though, just take the next dose and
forget about the one you missed.
What if you take too many tablets?
If you accidentally take too many Tegretol
Tablets, tell your doctor or your nearest
hospital casualty department. Take your
medicine pack with you so that people can
see what you have taken.

4. ossible side effects
P
Tegretol Tablets do not usually cause
problems, but like all medicines, they can
sometimes cause side effects.
Some side effects can be serious
Stop taking Tegretol Tablets and tell your
doctor straight away if you notice:
• 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
Mouth ulcers or unexplained bruising or
bleeding
Sore throat or high temperature, or both
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.

The side effects listed below have also been
reported.
More than 1 in 10 people have experienced:
Leucopenia (a reduced number of the cells
which fight infection making it easier to catch
infections); dizziness and 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 which may be
severe.

Up to 1 in 10 people have experienced:
Changes in the blood including an increased
tendency to bruise or bleed; fluid retention
and swelling; weight increase; low sodium in
the blood which might result in confusion;
headache; double or blurred vision; dry mouth.
Up to 1 in 100 people have reported:
Abnormal involuntary movements including
tremor or tics; abnormal eye movements;
diarrhoea; constipation.
Up to 1 in 1,000 people have reported:
Disease of the lymph glands; folic acid
deficiency; a generalised allergic reaction
including rash, joint pain, fever, problems with
the kidneys and other organs; 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 to heart beat; stomach pain;
liver problems including jaundice; symptoms
of lupus.
Up to 1 in 10,000 people have reported:
Changes to the composition of the blood
including anaemia; porphyria; meningitis;
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

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The following have also been reported, but
the frequency cannot be estimated from the
available information:
Severe skin reactions, accompanied by
feeling unwell and changes in blood results.
Diarrhoea, abdominal pain, and fever (signs
of inflammation of the colon), reactivation
of herpes virus infection (can be serious
when immune system is depressed),
complete loss of nails, fracture, decrease in
the measure of the bone density, drowsiness,
memory loss, purple or reddish-purple
bumps that may be itchy.

Do not be alarmed by this list. Most people
take Tegretol Tablets without any problems.
If any of the symptoms become troublesome,
or if you notice anything else not mentioned
here, please go and see your doctor. He/she
may want to give you a different medicine.
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 at: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide
more information on the safety of this
medicine.

5. ow to store Tegretol Tablets
H
Do not store above 25°C.
Store in the original package in order to
protect from moisture.
Keep out of the reach and sight of children.
Do not take Tegretol Tablets after the expiry date
which is printed on the outside of the pack.
If your doctor tells you to stop taking the
tablets, please take any unused tablets back
to your pharmacist to be destroyed. Do not

throw them away with your normal household
water or waste. This will help to protect the
environment.

6. Further information
The tablets come in three strengths containing
either 100, 200 or 400 mg of the active
ingredient carbamazepine. The tablets also
contain the inactive ingredients silicon dioxide,
microcrystalline cellulose, magnesium
stearate and sodium carboxymethylcellulose.

This leaflet was revised in April 2015.
If you would like any more information, or
would like the leaflet in a different format,
please contact Medical Information at
Novartis Pharmaceuticals UK Ltd, telephone
number 01276 698370.
TEGRETOL is a registered trade mark
Copyright Novartis Pharmaceuticals UK Limited

Tegretol 100 Tablets are round, white tablets
with one side impressed “GEIGY”, the other
“B/W” and a score line.
Tegretol 200 Tablets are round, white tablets
with one side impressed “CG”, the other
“G/K” and a score line.
The 100 mg and 200 mg tablets come in
blister packs of 84.
Tegretol 400 mg Tablets are rod-shaped, white
tablets with CG/CG on one side and LR/LR on
the other. Both sides have a score line.
The 400 mg tablets come in blister packs of 56.
Marketing Authorisation Holder:
Novartis Pharmaceuticals UK Ltd, Frimley
Business Park, Frimley, Camberley, Surrey
GU16 7SR, England.
Manufacturer
Novartis Pharmaceuticals UK Ltd,
Wimblehurst Road, Horsham, West Sussex,
RH12 5AB, England, United Kingdom and
Frimley Business Park, Frimley, Camberley,
Surrey, GU16 7SR, England, United Kingdom.

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and bowing of the long bones in the legs);
osteoporosis; increased blood fat levels; taste
disturbances; conjunctivitis; glaucoma;
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; lung or breathing problems;
severe skin reactions including StevensJohnson syndrome (These reactions may be
more frequent in patients of Chinese or Thai
origin); sore mouth or tongue; liver failure;
increased sensitivity of the skin to sunlight;
alterations in skin pigmentation; 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.

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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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