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TEGRETOL 100MG TABLETS

Active substance: CARBAMAZEPINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

TEGRETOL® 100MG TABLETS
(carbamazepine)
Tegretol Tablets are available in the following strengths: 100mg,
200mg and 400mg. The name of your medicine is Tegretol 100mg
Tablets but will be referred to as Tegretol Tablets throughout this
leaflet.

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.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Tegretol Tablets are and what they are used for
Things to consider before you start to take Tegretol Tablets
How to take Tegretol Tablets
Possible side effects
How to store Tegretol Tablets
Further information

1. What Tegretol Tablets are and what they
are used for
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 Tablets are 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. Things to consider before you start to 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 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 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?
Are you elderly?
Do you have any eye problems such as glaucoma (increased
pressure in the eye)?

Are you taking other medicines?

Because of the way that Tegretol Tablets work, 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 Tablets 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 Tablets 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).
Muscle relaxant drugs.
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 breast-feeding

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 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 Tegretol Tablets.

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Will there be any problems with driving or using
machinery?

Tegretol 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, 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 Tablets and from time to
time during your treatment. This is quite usual and nothing
to worry about.

3. How to take Tegretol Tablets
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 Tablets 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 - 1,200mg a day, although higher doses may be
necessary. If you are elderly you might require a lower dose.
Children:
Aged 5 - 10 years: 400 - 600mg a day
Aged 10 - 15 years: 600 - 1,000mg a day.
Tegretol Tablets are not recommended for children
under 5.

To treat trigeminal neuralgia the usual dose is:
600 - 800mg a day.

To treat mood swings the usual dose is:
400 - 600mg 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. Possible side effects
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.

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:

5. How to store Tegretol Tablets
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Store in the original container to protect from moisture.
Do not store above 25ºC.
Do not take Tegretol Tablets after the expiry date which is
printed on the outside of the pack. The expiry date refers to
the last day of the month.
If your doctor tells you to stop taking the tablets, please
take any unused tablets back to your pharmacist to be
destroyed.
If your medicine appears to be discoloured or shows any
other signs of deterioration, please return it to your
pharmacist who will advise you.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6. Further information
What Tegretol Tablets contain

Each tablet contains 100mg of the active ingredient
carbamazepine.
They also contain the inactive ingredients:
colloidal silica anhydrous, microcrystalline cellulose,
magnesium stearate and carmellose sodium.

What Tegretol Tablets look like and contents of the
pack
Tegretol are white, round tablets with “GEIGY” impressed on one
side and “B/W” on either side a score line on the other.

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 tablets come in blister packs of 28, 56, 84 and 100 tablets.

The following have also been reported, but the frequency
cannot be estimated from the available information:

Leaflet issue and revision date (Ref): 29.10.13

Manufacturer

Manufactured by: Novartis Pharmaceuticals UK Ltd., Horsham,
Sussex, RH12 5AB, UK.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0463

POM

To listen to or request a copy of this leaflet in Braille, large print
or audio please call 01302 552940 and ask for the Regulatory
Department.
TEGRETOL® is a registered trademark of Novartis AG.

Severe skin reactions, accompanied by feeling unwell and changes
in blood results.
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.

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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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