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TEGRETOL 400MG TABLETS
Active substance(s): CARBAMAZEPINE
Tegretol 400mg Tablets
Patient Information Leaflet
What you need to know about Tegretol Tablets
Your doctor has decided that you need this medicine to help treat your
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.
You should also ask yourself these questions before taking Tegretol
Tablets. If the answer to any of these questions is YES, discuss your
treatment with your doctor or pharmacist because Tegretol 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,
* 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?
1 What Tegretol Tablets are and what they are used for
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.
2 Things to consider before you start to take Tegretol Tablets
3 How to take Tegretol Tablets
* Hormone contraceptives, e.g. pills, patches, injections or implants. Tegretol
Your medicine is called Tegretol 400mg Tablets but will be referred to as
Tegretol Tablets throughout this leaflet. Please note that the leaflet also
contains information about other strengths of the medicine, Tegretol 100mg
Tablets and Tegretol 200mg Tablets
In this leaflet:
4 Possible side effects
5 How to store Tegretol Tablets
6 Further information
What Tegretol Tablets are and what they are used for
Carbamazepine, the active ingredient in Tegretol Tablets, 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 is 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
Things to consider before you start to take Tegretol
Some people MUST NOT take Tegretol 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
* you think you may be allergic to any of the other ingredients of Tegretol
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
* 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
If you develop a rash or these skin symptoms, stop taking carbamazepine
and contact your doctor immediately.
Tell the doctor if you are taking:
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
* Hormone Replacement Therapy (HRT). Tegretol can make HRT less
* 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
* Anticoagulants to stop your blood clotting.
* Antibiotics to treat infections including skin infections and TB
* 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
* 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
* 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 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 Tablets.
Mothers taking Tegretol 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 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
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.
Tegretol 400mg Tablets
Patient Information Leaflet (continued)
How to take Tegretol Tablets
The doctor will tell you how many Tegretol 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
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 Tablets during, after or between meals. Swallow the
tablets with a drink. 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.
Aged 5-10 years: 400-600 mg a day
Aged 10-15 years: 600-1,000 mg a day.
Tegretol Tablets are not recommended for children under 5.
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 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.
Possible side effects
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 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.
Tegretol 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 Tablets and tell your doctor straight away if you
* 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
* 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
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.
How to store Tegretol Tablets
Do not store above 25°C.
Store in the original package in order to protect from moisture.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not take Tegretol Tablets after the expiry date shown on the blister label
or carton. If your doctor tells you to stop using this medicine, take any
remaining medicine back to the pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
If your medicine becomes discoloured or shows any other signs of
deterioration consult your pharmacist who will tell you what to do.
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.
Each tablet contains 400mg of carbamazepine.
The tablets also contain the inactive ingredients colloidal anhydrous silica,
microcrystalline cellulose, magnesium stearate, and carmellose sodium.
The tablets are white, rod shaped marked 'CG / CG' on one side and 'LR /
LR' on the other side. Both sides are marked with a score line.
Each blister pack contains 28 or 100 tablets
Manufacturer and Licence Holder
This medicine is manufactured by Novartis Farma S.p.A. Via Provinciale
Schito 131, I-80058 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.
PL 15184/0234 Tegretol 400mg Tablets
Tegretol is a registered trademark of Novartis AG.
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.
Revision date: 27/11/14
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Phone Lexon (UK) Limited, Tel: 01527 505414