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TEGRETOL CHEWTABS 100MG

Active substance(s): CARBAMAZEPINE

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Package Leaflet: Information for the User

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. What Tegretol Chewtabs are and what they 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
 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 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 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 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.
 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 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).
 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 Chewtabs you must tell the doctor
straightaway. It is important that your epilepsy remains well controlled, but, as with other antiepilepsy 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.
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.

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.
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 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.
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.

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 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

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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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