TEGRETOL CHEWTABS 100MG

Active substance: CARBAMAZEPINE

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TEGRETOL® Chewtabs
100 and 200 mg
(carbamazepine)

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

1.  hat Tegretol Chewtabs are and what they
W
are used for
Tegretol Chewtabs should be chewed before
swallowing, so they are particularly useful for people
who have difficulty in swallowing. Carbamazepine,
the active ingredient, 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 Chewtabs are used
• To treat some forms of epilepsy
•  treat a painful condition of the face called
To
trigeminal neuralgia
•  help control serious mood disorders when
To
some other medicines don’t work.

2.  hings to consider before you start to take
T
Tegretol Chewtabs
Some people MUST NOT take Tegretol Chewtabs.
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
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 Chewtabs (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 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 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 Chewtabs. If the answer to any of
these questions is YES, discuss your treatment with
your doctor or pharmacist because Tegretol
Chewtabs might not be the right medicine for you.

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TABC_100MG + 200MG_GB

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14/04/2014

• 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).
•  herbal remedy called St John’s Wort or Hypericum.
A
• 
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 Chewtabs 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 Chewtabs.
Mothers taking Tegretol Chewtabs 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 Chewtabs 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.

14/04/2014 14:47

Brewery House,

The Maltings

• Are you pregnant or planning to become pregnant?
• Are you breast feeding?
•  you suffer from the sort of epilepsy where you
Do
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?
•  you have kidney problems associated with low
Do
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?
•  you have any eye problems such as glaucoma
Do
(increased pressure in the eye) or do you have
difficulty retaining your urine?
Are you taking other medicines?
Because of the way that Tegretol Chewtabs work, they
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 Chewtabs affect
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
Chewtabs 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).

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3. How to take Tegretol Chewtabs
The doctor will tell you how many Tegretol
Chewtabs 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 Chewtabs at a
fairly low dose which can then be increased to suit
you individually. The dose needed varies between
patients. You can take Tegretol Chewtabs during,
after or between meals. Chew the tablets before
swallowing and then rinse your mouth with water to
wash down the last bits of tablet. You are usually
told to take a dose two or three times a day.
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 1–5 years: 200–400 mg a day
Aged 5–10 years: 400–600 mg a day
Aged 10–15 years: 600–1,000 mg a day.
Tegretol Chewtabs are not recommended for very
young children.
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 Chewtabs,
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. Possible side effects
Tegretol Chewtabs do not usually cause problems,
but like all medicines, they can sometimes cause
side effects.
Some side effects can be serious
Stop taking Tegretol Chewtabs 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.
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.

1029207_GB_p3_LFT.indd 2

The Maltings,
The Maltings

Silvester Street
Kingston-Upon-Hull

Live Text:
WO:
Comp. Description:

x Yes
/
No
1029207
Leaflet_TEGRETOL INC.CR/XR_
TABC_100MG + 200MG_GB

Comp. Number New:
Comp. Number Old:
Format/Dimension:
Tech. Drawing Number:

1029207_GB
1406703a
350 x 210 mm
N/A
9.0pt
14/04/2014

Do not be alarmed by this list. Most people take
Tegretol Chewtabs 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.

5. How to store Tegretol Chewtabs
Tegretol Chewtabs must be stored below 30°C.
Keep out of the reach and sight of children.
Do not take Tegretol Chewtabs 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 two strengths containing either
100 or 200 mg of the active ingredient
carbamazepine. Each tablet contains crospovidone,
red and yellow iron oxide (E172), magnesium stearate,
orange flavour 51.941/AP sorbitol and stearic acid.
,
They are pale orange, square tablets which smell
strongly of orange. They have ‘T’ on one side and
either 100 or 200 on the other.
Tegretol Chewtabs 100 and 200 mg come in
aluminium blister packs of 56 and 100 tablets.
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 March 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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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 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.

1029207_GB

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
Chewtabs and from time to time during your
treatment. This is quite usual and nothing to
worry about.

Production Site:
CTM:
Printing Colours:

PharmOps, Horsham
Andersen, Claire
PANTONE 314 C

Technical Colours: Cutting
Dimensions

Jed Carter

! P L EASE TU R N OV E R P R I NT I N G O N !
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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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