TEGRETOL CR 400MG TABLETS

Active substance: CARBAMAZEPINE

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Ref: 06489/260214/1/F

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Tegretol 200mg prolonged-release Tablets / Tegretol ® CR 200mg Tablets
Tegretol ® 400mg prolonged-release Tablets / Tegretol CR 400mg Tablets
(carbamazepine)
Patient Information Leaflet
Your medicine is called Tegretol 200mg prolonged-release Tablets/Tegretol
CR 200mg Tablets or Tegretol 400mg prolonged-release Tablets/Tegretol CR
400mg Tablets but 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 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 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,
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 and from time to time during your treatment.
This is quite usual and nothing to worry about.

Ref: 06489/260214/1/B

®

®

Tegretol 200mg prolonged-release Tablets / Tegretol ® CR 200mg Tablets
®
Tegretol 400mg prolonged-release Tablets / Tegretol CR 400mg Tablets
(carbamazepine)
Patient Information Leaflet (continued)
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.

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.

To treat mood swings the usual dose is: 400-600 mg a day

Do not be alarmed by this list. Most people take Tegretol prolongedrelease 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.

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.

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.

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.

Reporting of side effects
If you get and 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.

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.

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.

5

How to store Tegretol prolonged-release Tablets

Tegretol prolonged-release Tablets should be stored in a dry place below
25°C.
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 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 this medicine contains
The tablets come in two strengths containing either 200 or 400 mg of the
active ingredient carbamazepine.
The tablets also contain the inactive ingredients microcrystalline cellulose,
carmellose sodium, ethyl acrylate-methyl-methacrylate copolymer,
ethylcellulose aqueous polymer dispersion, talc, hypromellose, collodial
anhydrous silica, magnesium stearate, titanium dioxide (E171), Glyceryl
polyoxyethylene glycol stearate, yellow iron oxide (E172), red iron oxide
(E172).
What this medicine looks like and contents of the pack
Tegretol 200 mg prolonged-release Tablets are beige-orange, capsule
shaped, slightly biconvex coated tablets with a score on each side. One side
bears the imprint “H/C”, the other “C/G”.
Tegretol 400 mg prolonged-release Tablets are brownish-orange, capsule
shaped, slightly biconvex coated tablets with a score on each side. One side
bears the imprint ‘ENE/ENE’, the other ‘CG/CG’.
Each blister strip contains 10 tablets and comes in pack sizes of 30, 50, 60
& 100 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Novartis Farma, S.p.A. Via Provinciale
Schito 131, Torre Annunziata, Italy and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0648 Tegretol 400 mg prolonged-release Tablets
PL 15184/0649 Tegretol 200 mg prolonged-release Tablets

Tegretol is a registered trademark of Novartis AG.
Revision date: 26/02/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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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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