TEGRETOL 200MG PROLONGED-RELEASETABLETS

Active substance: CARBAMAZEPINE

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Package Leaflet: Information for the User
®

TEGRETOL 200 mg Prolonged Release
Tablets
(carbamazepine)
®

The name of your medicine is TEGRETOL 200 mg Prolonged
Release 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.
This product is also available as the 400 mg strength.
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.

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.
To treat trigeminal neuralgia the usual dose is: 600–800 mg a day.
The maximum dose is 1200 mg 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 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.
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 itchy.
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.
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/yellocard.
By reporting side effects, you can help provide more information on the
safety of this medicine.

5. How to store Tegretol Prolonged Release Tablets
Do not store above 25°C. Protect from moisture.
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
The tablets contain 200 mg of the active ingredient carbamazepine.
The tablets also contain the inactive ingredients microcrystalline
cellulose, carboxymethylcellulose sodium, polyacrylate dispersion
30%, talc, ethylcellulose aqueous dispersion, hypromellose, colloidal
anhydrous silica, magnesium stearate, titanium dioxide E171,
polyethylene glycol stearate, yellow iron oxide E172, red iron oxide
E172.
Tegretol Prolonged Release tablets are film-coated, oval, slightly
biconvex, orange beige with a line on one side, printed on one side
with the specification “H/C” and other side “C/G”, having length about
12.2 mm, width about 5.6 mm and height about 5 mm.
They come in blister packs of 30, 50, 60 or 100 tablets.
Manufactured by: Novartis Pharma GmbH, Roonstrasse 25,
D-90429, Nurnberg, Germany.
Procured from within the EU & repackaged by PL holder:
Kosei Pharma UK Ltd, 956 Buckingham Avenue, Slough Trading
Estate, SL1 4NL, UK.
®

TEGRETOL 200 mg Prolonged Release Tablets,
PL: 39352/0206
®

POM

TEGRETOL is a registered trade mark of Novartis Pharmaceuticals
UK Limited
Leaflet date: 28.01.2014

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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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