Description

Product Overview

What Carbamazepine Tablets are and what they are used for

Carbamazepine, the active ingredient in Carbamazepine 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.
Carbamazepine 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 work.

Things to consider before you start to take Carbamazepine Tablets

Some people MUST NOT take Carbamazepine 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 anti depressants (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 Carbamazepine 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 Carbamazepine Tablets. If the answer to any of these questions is YES; discuss your treatment with your doctor or pharmacist because Carbamazepine 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 taking other medicines?

Because of the way that Carbamazepine 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. Carbamazepine 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). Carbamazepine 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.
•Other medicines to treat epilepsy.

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 Carbamazepine 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 Carbamazepine Tablets.

Mothers taking Carbamazepine 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?

Carbamazepine 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 Carbamazepine and from time to time during your treatment. This is quite usual and nothing to worry about.

How to take Carbamazepine Tablets

The doctor will tell you how many Carbamazepine 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 Carbamazepine at a fairly low dose which can then be increased to suit you individually. The dose needed varies between patients. You can take Carbamazepine 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.

Children:
Aged 5-10 years: 400-600 mg a day
Aged 10-15 years: 600-1,000 mg a day.
CarbamazepineTablets 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 Carbamazepine 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

CarbamazepineTablets do not usually cause problems, but like all medicines, they can sometimes
cause side effects.

Some side effects can be serious

Stop taking Carbamazepine 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

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.

How to store Carbamazepine Tablets

Do not store above 25°C.
Store in the original package in order to protect from moisture.
Keep out of the reach and sight of children.
Do not take Carbamazepine 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.