TEGRETOL 200MG PROLONGED RELEASE TABLETS

Active substance: CARBAMAZEPINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

TEGRETOL® 200MG
PROLONGED RELEASE TABLETS
(carbamazepine)
Tegretol Prolonged Release Tablets are available in the following
strengths: 200mg & 400mg. This leaflet only applies to Tegretol
200mg Prolonged Release Tablets which will be referred to as
Tegretol Prolonged Release Tablets throughout this leaflet.

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

1. What Tegretol Prolonged Release Tablets
are and what they are used for
Tegretol Prolonged Release Tablets are specially formulated to
release the active ingredient gradually. 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 Prolonged Release 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 Prolonged Release Tablets
Some people MUST NOT take Tegretol Prolonged
Release 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 Prolonged Release 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.

Pregnancy and breast-feeding

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.

Mothers taking Tegretol Prolonged Release 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.

If you develop a rash or these skin symptoms, stop taking
carbamazepine and contact your doctor immediately.

Will there be any problems with driving or using
machinery?

You should also ask yourself these questions before taking
Tegretol Prolonged Release Tablets. If the answer to any of
these questions is YES, discuss your treatment with your
doctor or pharmacist because Tegretol Prolonged Release
Tablets might not be the right medicine for you.
Are you pregnant or planning to become pregnant?
Are you breast-feeding?
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 Prolonged Release 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 Prolonged Release 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 Prolonged
Release 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).
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).

Page 1 of 2

You must discuss your epilepsy treatment with your doctor well
before you become pregnant. If you do get pregnant while you’re
taking Tegretol Prolonged Release 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 Prolonged Release
Tablets.

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

3. How to take Tegretol Prolonged Release
Tablets
The doctor will tell you how many Tegretol Prolonged
Release 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 Prolonged Release 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 Prolonged Release Tablets during, after or between
meals. Swallow the tablets with a drink. Do not chew them.
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 Prolonged Release Tablets are not recommended for
children under 5.

To treat trigeminal neuralgia the usual dose is:

600-800mg 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:
400-600mg 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 Prolonged Release
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 Prolonged Release 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 Prolonged Release 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:

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.

Do not be alarmed by this list. Most people take Tegretol
Prolonged Release 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, pharmacist or
nurse. 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. How to store Tegretol Prolonged Release
Tablets
Do not store above 25°C.
Store in a cool dry place.
Keep out of the sight and reach of children.
The expiry date for these tablets is given on the carton and
blister label. Do not take the tablets after this date. If your
tablets are out of date, take them to your pharmacist who
will get rid of them safely.
If your tablets appear discoloured or show any other signs of
deterioration, take them back to your pharmacist who will
advise you.
If your doctor tells you to stop taking the tablets, please
take any unused tablets back to your pharmacist to be
destroyed.
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 Prolonged Release Tablets contain

Each film-coated tablet contains 200mg of carbamazepine in a
special controlled-release form.

They also contain the following inactive ingredients:
microcrystalline cellulose, carmellose sodium,
ethyl acrylate/methyl methacrylate copolymer,
ethylcellulose aqueous dispersion, talc,
hydroxypropylmethylcellulose, colloidal silicon dioxide,
magnesium stearate, titanium dioxide (E171),
polyoxyl 40 hydrogenated castor oil, yellow iron oxide (E172) and
red iron oxide (E172).

Warning: Contains polyoxyl 40 hydrogenated castor oil.
May cause stomach upset and diarrhoea.
What Tegretol Prolonged Release Tablets look like
and contents of the pack

Tegretol Prolonged Release Tablets are beige-orange,
capsule-shaped, coated tablets with a breakline on each side.
One side of the tablet is marked ‘H C’ and on the reverse they are
marked ‘C G’.
They are available in blister packs of 50 tablets.

Manufacturer

Manufactured by: Novartis Pharma GmbH, Roonstrasse 25,
D - 90429 Nürnberg, Germany.
Or
Novartis Pharma Produktions GmbH, Wehr, Germany.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0305

POM

®

TEGRETOL is a registered trademark of Novartis AG.
Leaflet revision & issue date (Ref): 22.05.14
If you would like any more information, or would like the leaflet in
a different format, please contact 01302 365000 and ask for the
Regulatory Department.

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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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