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TEGRETOL RETARD TABLETS 400MG

Active substance: CARBAMAZEPINE

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S1404-05 LEAFLET Tegretol 20140827

PACKAGE LEAFLET: INFORMATION FOR THE USER

TEGRETOL RETARD 200mg TABLETS
TEGRETOL RETARD 400mg TABLETS
(carbamazepine)
Your medicine is known as above names but will be referred to as
Tegretol Retard Tablets throughout the following leaflet.



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?

Information for other strength of Tegretol Retard Tablets also may
be present in this leaflet.
What you need to know about Tegretol Retard Tablets

Are you taking other medicines?

Your doctor has decided that you need this medicine to help treat
your condition.

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.

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 Retard Tablets are and what they are used for
2. Things to consider before you start to take Tegretol Retard
Tablets
3. How to take Tegretol Retard Tablets

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).

4. Possible side effects
5. How to store Tegretol Retard Tablets
6. Further information
1. WHAT TEGRETOL RETARD TABLETS ARE AND WHAT
THEY ARE USED FOR
Tegretol Retard 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 Retard Tablets are used


To treat some forms of epilepsy





Diuretics (water tablets).

To treat a painful condition of the face called trigeminal
neuralgia



Cimetidine or omeprazole (medicines to treat gastric ulcers).

To help control serious mood disorders when some other
medicines don’t work.



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).



Tadalafil (used to treat impotence).



Albendazole (used to treat worms).



2. THINGS TO CONSIDER BEFORE YOU START TO TAKE
TEGRETOL RETARD TABLETS
Some people MUST NOT take Tegretol Retard 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 Retard 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,



Bupropion (used to help stop smoking).



you have ever had problems with your bone marrow,



A herbal remedy called St John’s Wort or Hypericum.



you have a blood disorder called porphyria,



Drugs or supplements containing Vitamin B (nicotinamide).



you have taken drugs called monoamine oxidase inhibitors
(MAOIs), used to treat depression, within the last 14 days.

Pregnancy and breastfeeding

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.

You must discuss your epilepsy treatment with your doctor well
before you become pregnant. If you do get pregnant while you’re
taking Tegretol Retard Tablets you must tell the doctor
straightaway.

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.

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 Retard Tablets.

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 Retard Tablets. If the answer to any of these
questions is YES, discuss your treatment with your doctor or
pharmacist because Tegretol Retard 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?

Mothers taking Tegretol Retard 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 Retard 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 Retard Tablets and from time to
time during your treatment. This is quite usual and nothing to
worry about.

3. HOW TO TAKE TEGRETOL RETARD TABLETS

Up to 1 in 10,000 people have reported:

The doctor will tell you how many Tegretol Retard 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.

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.

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 Retard 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 Retard 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.

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
Retard Tablets without any problems.

What if you take too many tablets?

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.

If you accidentally take too many Tegretol Retard 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.

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

4. POSSIBLE SIDE EFFECTS
Tegretol Retard 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 Retard Tablets and tell your doctor
straight away if you notice:


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.

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

5. HOW TO STORE TEGRETOL RETARD TABLETS





KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Store in a dry place.

Mouth ulcers or unexplained bruising or bleeding



Do not store your tablets above 25°C.



Sore throat or high temperature, or both





Yellowing of your skin or the whites of your eyes



Swollen ankles, feet or lower legs

Do not use Tegretol Retard Tablets after the expiry date which
is stated on the carton and blister strip. The expiry date refers to
the last day of that month.



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)

If your doctor tells you to stop taking the tablets, please take
them back to the pharmacist for safe disposal. Only keep the
tablets if your doctor tells you to.



If the tablets become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist
who will advise you what to do.



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)

6. FURTHER INFORMATION
What Tegretol Retard Tablets contain


Tegretol Retard 200mg Tablets contain 200mg of the active
ingredient carbamazepine in a modified release formulation.





Tegretol Retard 400mg Tablets contain 400mg of the active
ingredient carbamazepine in a modified release formulation.



Tegretol Retard Tablets also contain the following Silicon
dioxide, ethylcellulose, microcrystalline cellulose, methacrylic
acid copolymer, magnesium stearate, carmellose sodium, talc,
hypromellose, polyethoxylated castor oil, red and yellow iron
oxide (E172) and titanium dioxide (E171).

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.

What Tegretol Retard Tablets look like and contents of the
pack
Tegretol Retard 200mg Tablets are tan coloured, capsule-shaped
tablets with ‘HC’ marked on one side and ‘CG’ on the other and with
a break-line on both sides.
Tegretol Retard 200mg Tablets are available as blister packs of 50
tablets.
Tegretol Retard 400mg Tablets are large brownish orange, capsule
shaped tablets with ‘ENE/ENE’ marked on one side and ‘CG/CG’ on
the other and with a break-line on both sides.
Tegretol Retard 400mg Tablets are available as blister packs of 30
or 50 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Novartis Farma SpA, Torre, Italy.
POM

PL No: 19488/1404
PL No: 19488/1405

Leaflet revision date: 27 August 2014
Tegretol is a registered trademark of Novartis Ag, Switzerland.
S1404-05 LEAFLET Tegretol 20140827

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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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