TEGRETOL PROLONGED RELEASE 400MG TABLETS

Active substance: CARBAMAZEPINE

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New Packaging Dimensions:
Due to an update in packaging machinery you will notice a small
change to this pack, although the packaging looks different,
please be assured that the tablets in the pack remain unchanged.
Package Leaflet: Information for the User

TEGRETOL Prolonged Release
200 and 400 mg Tablets
®

(carbamazepine)
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. hat Tegretol Prolonged Release Tablets are and what
W
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. hings to consider before you start to take
T
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.

Approval Box and Ready for Print Box only to be used
in case AWF is not used.
Phone contact:
+39 0818706419
e-mail contact:
pharmadesigners@libero.it

Typesetting order / CTM-Owner: 820596 - N. Gargiulo
Material No.:

1218418 GB TA

Dimension:

Product:

LEAFLET TEGRETOL INC. CR/XR_CR
ALL DOSAGES - GB

ISO-Code:

1218418

Proof date:

27.06.2013

Fonts:

PMS 314 C BLUE

GB

Code-No.::



5666/N

Colours:

Approval Box and Ready for Print Box only to be used
in case AWF is not used.

148 x 630 mm

Drawing No.:

Replaced No.: 1216977 GB TA

TVT compatible
YES
NO

News Gothic Regular, News Gothic Bold

Visual Code: n.a.

PMS BLACK C
Colour/Technical: CUTTING
Receiving Plant:

Smallest font size/line spacing/scale: 9 pt/10.8 pt/100%
Smallest font size:

7 pt

Smallest vectorized text:

Torre

Technical approval. To be signed by Manufacturing Site.

Body text (News Gothic Regular)

n.a.

Item no. (News Gothic Regular)

This information was compiled with utmost care and on completion was subjected to strict internal checks. However, the handling of
data always involves a certain degree of risk and the impossibility of error cannot be guaranteed. Therefore we would ask you to check
the proof throughly. PharmaDesigners s.a.s. assumes no liability for errors identified only after print approval has be given.

1. Proof

F. Giordano

Page 1/2



• 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?
• 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 works, 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 affects 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 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 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 or skin
reactions because you are taking Tegretol Prolonged Release Tablets.
Will there be any problems with driving or using machinery?
Tegretol Prolonged Release 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 and from time to time during your treatment. This
1218418 GB TA
is quite usual and nothing to worry about.

3. ow to take Tegretol Prolonged Release Tablets
H
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.
To treat trigeminal neuralgia the usual dose is: 600-800 mg a day.
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. ossible side effects
P
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.

Approval Box and Ready for Print Box only to be used
in case AWF is not used.
Phone contact:
+39 0818706419
e-mail contact:
pharmadesigners@libero.it

Typesetting order / CTM-Owner: 820596 - N. Gargiulo
Material No.:

1218418 GB TA

Dimension:

Product:

LEAFLET TEGRETOL INC. CR/XR_CR
ALL DOSAGES - GB

ISO-Code:

1218418

Proof date:

27.06.2013

Fonts:

PMS 314 C BLUE

GB

Code-No.::



5666/N

Colours:

Approval Box and Ready for Print Box only to be used
in case AWF is not used.

148 x 630 mm

Drawing No.:

Replaced No.: 1216977 GB TA

TVT compatible
YES
NO

News Gothic Regular, News Gothic Bold

Visual Code: n.a.

PMS BLACK C
Colour/Technical: CUTTING
Receiving Plant:

Smallest font size/line spacing/scale: 9 pt/10.8 pt/100%
Smallest font size:

7 pt

Smallest vectorized text:

Torre

Technical approval. To be signed by Manufacturing Site.

Body text (News Gothic Regular)

n.a.

Item no. (News Gothic Regular)

This information was compiled with utmost care and on completion was subjected to strict internal checks. However, the handling of
data always involves a certain degree of risk and the impossibility of error cannot be guaranteed. Therefore we would ask you to check
the proof throughly. PharmaDesigners s.a.s. assumes no liability for errors identified only after print approval has be given.

1. Proof

F. Giordano

Page 2/2



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.
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.

5. ow to store Tegretol Prolonged Release Tablets
H
Tegretol Prolonged Release Tablets should be stored in a dry place below
25°C.
Keep out of the reach and sight of children.
Do not take Tegretol Prolonged Release Tablets 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.

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 May 2013.
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

6. urther information
F
The tablets come in two strengths containing either 200 or 400 mg
of the active ingredient carbamazepine. The tablets also contain the
inactive ingredients colloidal silicon dioxide, ethylcellulose aqueous
dispersion, microcrystalline cellulose, ethyl acrylate/methyl methacrylate
copolymer, magnesium stearate, croscarmellose sodium type A, talc,
hydroxypropylmethylcellulose, glyceryl polyoxyethylene glycol stearate,
red and yellow iron oxide (E172) and titanium dioxide (E171).
Tegretol Prolonged Release 200 mg Tablets are oval, beige-orange tablets
with a score on each side. One side bears the imprint “HC”, the other
“CG”.
Tegretol Prolonged Release 400 mg are oval, brownish-orange tablets
with a score on each side. One side bears the imprint “ENE/ENE”, the
other “CG/CG”.
They come in blister packs of 56 and 100.
Marketing Authorisation Holder:
Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley,
Camberley, Surrey GU16 7SR, England.

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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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