TEGRETOL TABLETS 100MG

Active substance: CARBAMAZEPINE

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Package Leaflet: Information for the User

TEGRETOL® 100, 200
and 400 mg Tablets
(carbamazepine)

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

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

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.

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.
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

Phone contact:
+39 0818706419
e-mail contact:
pharmadesigners@libero.it
Live Text:
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Comp. Description:

LEAFLET TEGRETOL TAB
ALL DOSAGES - GB

Comp. No. New:
Comp. No. Old:
Format/Dimension:
Tech. Drawing No.:

1239242 GB TA
n.a.
148 x 314.96 mm
5595/AA

Min. Font Size Text:
Proof No.: 1
Braille:

9 pt
08.07.2014

Yes /
1239242



No

Production Site:
CTM:

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Checking against manuscript according to
SOP-0022667. To be signed by AwOps.

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in case AWF is not used.

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oxcarbazepine (Trileptal), or to any of a related
group of drugs 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.
• 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.
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
influenza-like symptoms fever, headache, body
ache (flu-like symptoms). The rash may progress to

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Technical approval. To be signed by Manufacturing Site.

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
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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).

Phone contact:
+39 0818706419
e-mail contact:
pharmadesigners@libero.it
Live Text:
WO:



Comp. Description:

LEAFLET TEGRETOL TAB
ALL DOSAGES - GB

Comp. No. New:
Comp. No. Old:
Format/Dimension:
Tech. Drawing No.:

1239242 GB TA
n.a.
148 x 314.96 mm
5595/AA

Min. Font Size Text:
Proof No.: 1
Braille:

9 pt
08.07.2014

Yes /
1239242



No

Production Site:
CTM:

Torre
N. Gargiulo

Printing Colours:

Pantone 314

Technical Colours:

Cutting

F Giordano
.

n.a.

! PLEASE TURN OVERPRINTING ON !

• 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.
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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.
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 1200mg
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 multi-organ 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.

Phone contact:
+39 0818706419
e-mail contact:
pharmadesigners@libero.it
Live Text:
WO:



Comp. Description:

LEAFLET TEGRETOL TAB
ALL DOSAGES - GB

Comp. No. New:
Comp. No. Old:
Format/Dimension:
Tech. Drawing No.:

1239242 GB TA
n.a.
148 x 314.96 mm
5595/AA

Min. Font Size Text:
Proof No.: 1
Braille:

9 pt
08.07.2014

Yes /
1239242



No

Production Site:
CTM:

Torre
N. Gargiulo

Printing Colours:

Pantone 314

Technical Colours:

Cutting

F Giordano
.

n.a.

! PLEASE TURN OVERPRINTING ON !

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 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
Stevens-Johnson 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
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urine.

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
Also you can help to make sure that medicines
remain as safe as possible by reporting any
unwanted side effects via the internet at
www.mhra.gov.uk/yellowcard. Alternatively you
can call Freephone 0808 100 3352 (available from
10 a.m. to 2 p.m. Mondays to Fridays) or fill in a
paper form available from your local pharmacy.

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. urther information
F
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.
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.

Phone contact:
+39 0818706419
e-mail contact:
pharmadesigners@libero.it
Live Text:
WO:



Comp. Description:

LEAFLET TEGRETOL TAB
ALL DOSAGES - GB

Comp. No. New:
Comp. No. Old:
Format/Dimension:
Tech. Drawing No.:

1239242 GB TA
n.a.
148 x 314.96 mm
5595/AA

Min. Font Size Text:
Proof No.: 1
Braille:

9 pt
08.07.2014

Yes /
1239242



No

Production Site:
CTM:

Torre
N. Gargiulo

Printing Colours:

Pantone 314

Technical Colours:

Cutting

F Giordano
.

n.a.

! PLEASE TURN OVERPRINTING ON !

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.
This leaflet was revised in July 2014.
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

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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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