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TEGRETOL PROLONGED RELEASE 200 MG TABLETS

Active substance(s): CARBAMAZEPINE

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T05225

Tegretol® Prolonged Release 200 mg Tablets
(carbamazepine)

The name of your medicine is Tegretol Prolonged Release 200 mg Tablets but will be
referred to as Tegretol Prolonged Release Tablets throughout the following:
Tegretol Prolonged Release Tablets are also available in 400 mg strength.
Patient Information 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. What Tegretol Prolonged Release Tablets are and what they are used for
2. Things to consider before you start to take Tegretol Prolonged Release Tablets
3. How to take Tegretol Prolonged Release Tablets
4. Possible side effects
5. How to store Tegretol Prolonged Release Tablets
6. 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.
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 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 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 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).
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 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.
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.
Will there be any problems with driving or using machinery?
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 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:
800-1,200 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 Prolonged Release Tablets are not recommended for children under 5.

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To treat trigeminal neuralgia the usual dose is: 600-800 mg a day.
The maximum dose is 1200 mg 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 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.

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. Protect from moisture.
Keep out of the sight and reach of children.
Do not take Tegretol Prolonged Release Tablets after the expiry date which is printed on
the outside of the pack.
If the medicine becomes discoloured or shows any other signs of deterioration, you should
seek the advice of your pharmacist who will tell you what to do.
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
What Tegretol Prolonged Release Tablets contain
Each film-coated tablet contains 200 mg of carbamazepine in a prolonged release
formulation.
The tablets also contain the inactive ingredients colloidal silicon dioxide, ethylcellulose
aqueous dispersion, microcrystalline cellulose, methacrylic acid copolymer, magnesium
stearate, croscarmellose sodium, polyoxyl 40 hydrogenated castor oil, talc, hypromellose,
red iron oxide (E172), yellow iron oxide (E172) and titanium dioxide (E171).
What Tegretol Prolonged Release Tablets looks like and contents of the pack
Tegretol Prolonged Release 200 mg Tablets tablets are beige-orange, oval, slightly
biconvex, coated tablets with a score on each side. One side bears the imprint "H/C", the
other "C/G".
They are available as blister packs of 50 and 60 tablets.
Product Licence Holder and Manufacturer:
This product is manufactured by Novartis Farma SpA, Italy. It is procured from within the
EU by the Product Licence Holder: Swinghope Ltd, Brandon House, Marlowe Way,
Croydon CR0 4XS and repackaged by Interport Ltd, Brandon House, Marlowe Way,
Croydon CR0 4XS.
POM

PL No: 10380/1409

Leaflet revision date: 15/01/2015
Tegretol® is a registered trademark of Novartis AG.

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.

T05225

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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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