TEGRETOL PROLONGED RELEASE 200MG TABLETS

Active substance: CARBAMAZEPINE

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Assessed against UK PIL dated February 2012
Patient Information Leaflet

TEGRETOL® Prolonged-release 200 mg Tablets
(carbamazepine)

What you need to know about Tegretol Prolonged-Release 200
mg 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.
Your medicine is called Tegretol Prolonged-release 200 mg Tablets
but throughout this leaflet will be referred to as Tegretol Prolongedrelease tablets
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 Prolongedrelease 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 side effects can rarely occur during treatment with
carbamazepine. This risk can be predicted with a blood sample in
people of Chinese and Thai origin. Discuss this with your doctor before
taking carbamazepine if you are of such origin.
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?







Include Carbamazepine EU Safety Warnings
requested by Sara Berry on 16/07/2012
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 Prolonged-release tablets 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 Prolonged-release tablets 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 Prolongedrelease 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.
• 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).
• lsotretinoin (a medicine for the treatment of acne).
• Metoclopramide (an anti-sickness medication).
• 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 (an immunosuppressant, used after transplant
operations, but also sometimes in the treatment of arthritis or
psoriasis).
• Drugs to treat schizophrenia.
• Cancer drugs.
• The anti-malarial drug, to:
Amend highlighted mefloquine.
• Drugs to treat HIV.
Serious skin rashes (Stevens- Johnson syndrome,
• Levothyroxine (used necrolysis) have been reported with
toxic epidermal to treat hypothyroidism).
• Muscle relaxant drugs.
the use of carbamazepine. Frequently, the rash can
• Bupropion (used to help stop smoking).
involve ulcers of the mouth, throat, nose, genitals and
• A herbal remedy called St Johns Wort or Hypericum.
conjunctivitis (redcontaining Vitamin B (nicotinamide).
and swollen eyes). These serious
• Drugs or supplements
skin rashes are often preceded by influenza-like
Pregnancy and breastfeeding

symptoms fever, headache, body ache (flu-like

You must discuss your epilepsymay progress to widespread
symptoms). The rash treatment with your doctor well before
you become pregnant. If you do get pregnant while you’re taking
blistering and peeling of the skin. The doctor
Tegretol Prolonged-release tablets you must tell thehighest risk for
occurrence of serious skinepilepsy remains well controlled,
straightaway. It is important that your reactions is within the first
months of treatment.
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.
These serious skin reactions can be more common in
Mothers taking Tegretol Prolonged-release tablets can breastfeed their
people from some Asian countries. The risk of these
babies, but you must tell the doctor as soon as possible if you think
reactions in patients of Han Chinese or Thai origin
that the baby is suffering side effects such as excessive sleepiness or
may be predicted by testing a blood sample of these
skin reactions because you are taking Tegretol Prolonged-release
patients. Your doctor should be able to advise if a
tablets.

blood test is necessary before taking carbamazepine.

Will there be any problems with driving or using machinery?
Tegretol Prolonged-release tablets can make you feel dizzy or drowsy,
If you the start a rash or or when the symptoms, stop
especially at developof treatment these skindose is changed. If you
are affected in this way, or if your eyesight is affected,doctor
taking carbamazepine and contact your you should not
drive immediately.
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 Prolonged-release tablets 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. lf 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.

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.
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. How to store Tegretol Prolonged-release tablets









Do not store above 25oC.
Store in the original package.
Protect from moisture.
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.
If your tablets show any sign of deterioration seek the advice of
your pharmacist who will advise you what to do.

6. Further information
Each Prolonged-Release tablet contains 200 mg carbamazepine. The
tablets also contain the inactive ingredients colloidal silicon dioxide,
ethylcellulose aqueous dispersion, microcrystalline cellulose,
polyacrylate dispersion 30%,magnesium stearate,
carboxymetheylcellulose, talc, hypromellose, glyceryl polyoxyethylene
glycol stearate, red and yellow iron oxide (E172) and titanium dioxide
(E171).
Tegretol Prolonged-Release 200 mg 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 come in blister packs of 50.
Manufactured by: Novartis Pharma GmbH, Roonstrasse 25,
D-90429 Nurnberg.
Procured from within the EU by the Product Licence Holder: Ecosse
Pharmaceuticals Limited, 3 Young Place, East Kilbride, G75 0TD. Repackaged by Munro Wholesale Medical Supplies Ltd.,3 Young Place,
East Kilbride, G75 0TD.
PL 19065/0310
This leaflet was revised: 28/06/2012

POM

Revise date

E0310L-2
TEGRETOL PROLONGED-RELEASE TABLETS® is a Registered Trade Mark

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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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