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PHENYTOIN 100MG COATED TABLETS

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Custom Pharmaceuticals
PHENYTOIN 50MG & 100MG
COATED TABLETS
PM/20/459
SO32495
Nine
29/11/2012

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PACKAGE LEAFLET: INFORMATION FOR
THE USER
Phenytoin 100mg
Coated Tablets
Phenytoin Sodium
Read all of this leaflet carefully before
you start using this medicine.
- Keep this leaflet. You may need to read
it again.
- If you have further questions, please
ask your doctor or pharmacist.
- This medicine has been prescribed for
you personally and you should not
pass it on to others. It may harm them,
even if their symptoms are the same
as yours.
- If any of the side effects get serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.
The name of your medicine is Phenytoin
100mg Coated Tablets. In the rest of this
leaflet it is called Phenytoin Tablets.
In this leaflet:
1. What Phenytoin Tablets are and what
they are used for
2. Before you take Phenytoin Tablets
3. How to take Phenytoin Tablets
4. Possible side effects
5. How to store Phenytoin Tablets
6. Further information
1. WHAT PHENYTOIN TABLETS
ARE AND WHAT THEY ARE
USED FOR
The active ingredient in Phenytoin Tablets
is called phenytoin sodium. Phenytoin
belongs to a group of medicines called
anticonvulsants which prevent fits.
Phenytoin Tablets are used in the control of
seizures due to various types of epilepsy.
They can also be used to treat seizures
during or after brain surgery and/or
serious head injuries.
In addition they may also be used in the
treatment of trigeminal neuralgia (face
pain) if carbamazepine does not work or
cannot be taken.
2. BEFORE YOU TAKE PHENYTOIN
TABLETS
Do not take Phenytoin Tablets if you:
• are allergic to phenytoin, other similar
anticonvulsant medicines or any of the
other ingredients in Phenytoin Tablets
(see ‘What Phenytoin Tablets contain’ in
section 6)
• have acute intermittent porphyria (a
rare condition affecting the production
of haem, the red colouring in blood)

Serious skin side effects can rarely
occur during treatment with Phenytoin
Tablets. This risk may be associated
with a variant in genes in a subject of
Chinese or Thai origin. If you are of
such origin and have been tested
positively carrying this genetic
variant (HLA-B*1502), discuss this
with your doctor before taking
Phenytoin Tablets.
Speak to your doctor before taking
Phenytoin Tablets if you:
• have liver, kidney or thyroid problems
• if you suffer from absence (petit mal)
seizures.
• if you are currently taking an alternative
antiepileptic
• are being fed through a tube or into
a vein
• suffer from diabetes mellitus
• are an alcoholic
• suffer from any blood disorders
• have a fever with a temperature above
38ºC for more than 24 hours
• are elderly (aged 65 years or older) or
the patient is a neonate (a newborn
infant aged less than four weeks)
• are suffering from a long term or chronic
illness
• have porphyria
• have a high level of urea in the blood
(uraemia)
• suffer from AIDS and have kidney
problems or a low blood albumin level
• are pregnant, planning to become
pregnant or you are breast feeding.
If any of the above statements apply to
you, you should speak to your doctor
before taking Phenytoin Tablets.
You should make sure you have enough
vitamin D in your diet, or get enough
exposure to sunshine, while taking
Phenytoin Tablets.
Required tests
If you are required to have blood tests for
any reasons other than your treatment
with phenytoin, you should let your doctor
or nurse know you are taking this
medication since Phenytoin Tablets may
interfere with various laboratory tests
including tests for liver and thyroid function
and blood sugar levels.
You will be required to have regular blood
tests when you are taking these tablets
and your liver and thyroid will be
monitored.
You will also need to have tests to monitor
your brain function and physical
examinations including dental check-ups.

Taking other medicines
Taking another medicine while you are
taking Phenytoin Tablets can affect how it
If any of the above statements apply to
or the other medicine works. Please
you, you should not take Phenytoin Tablets.
inform your doctor or pharmacist if you are
taking or have recently taken any other
Potentially life-threatening skin rashes (Stevens- medicines or herbal products, even those
Johnson syndrome, toxic epidermal necrolysis) you may have bought yourself without a
have been reported with the use of Phenytoin,
prescription.
appearing initially as reddish target-like spots or
circular patches often with central blisters
Please particularly check with your doctor
on the trunk.
if you are taking or need to take any of the
Additional signs to look for include itching,
following:
ulcers in the mouth, throat, nose, genitals and
conjunctivits (red and swollen eyes).
Other medicines used to treat epilepsy:
These potentailly life-threatening skin rashes are • such as sodium valproate, clonazepam,
often accompanied by flu-like symptoms. The
oxcarbazepine, carbamazepine,
rash may progress to widespread blistering or
lamotrigine, tiagabine, topiramate,
peeling of the skin.
phenobarbital, ethosuximide,
The highest risk for occurrence of serious skin
primodone and vigabatrin
reactions is within the first weeks of treatment.
Medicines that help your nervous
If you have developed Stevens-Johnson
syndrome or toxic epidermal necrolysis with the system or brain:
use of phenytoin, you must not be re-started on • methylphenidate or modafinil, nervous
system stimulants
phenytoin at any time.
If you develop a rash or these skin symptoms, • levodopa used to treat Parkinson’s
Disease
seek immediate advice from a doctor and tell
• medicines used to treat depression
him that you are taking this medicine.
such as bupropion, tricyclic
antidepressants, monoamine oxidase
Take special care with
inhibitors (MAOIs), maprotiline,
Phenytoin Tablets
fluoxetine, sertraline, fluvoxamine,
A small number of people being
trazodone, viloxazine, mianserin and
treated with anti-epileptics such as
paroxetine
phenytoin sodium have had thoughts
• medicines used to treat anxiety such
of harming or killing themselves. If
as diazepam, chlordiazepoxide,
at any time you have these thoughts,
clonazepam or other benzodiazepines
immediately contact your doctor.
• medicines used to treat psychiatric

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disorders such as clozapine, quetiapine,
sertindole, haloperidol, phenothiazines,
thioxanthines, loxapine, and lithium
• the herbal remedy St John’s wort
(Hypericum perforatum).
Medicines that fight infections:
• antibiotics such as isoniazid,
chloramphenicol, clarithromycin,
cycloserine, metronidazole,
co-trimoxazole, trimethoprim, other
sulphonamides, rifamycin, rifampicin
and doxycycline
• medicines used to treat fungal
infections e.g. miconazole,
fluconazole, ketoconazole, Amphotericin B,
voriconazole and itraconazole
• medicines used to treat virus infections
such as indinavir, nelfinavir, lopinavir,
saquinavir and zidovudine
• medicines used to treat malaria e.g.
pyrimethamine
• influenza (flu) virus vaccine
Medicines to treat cardiovascular or
lung problems:
• medicines used to treat heart
problems such as, mexilitine,
amiodarone, quinidine, disopyramide,
cardiac glycosides (e.g. digoxin and
digitoxin)
• medicines to treat high blood
pressure e.g. diazoxide, diltiazem,
nifedipine, verapamil, felodipine,
isradipine, nisoldipine and nicardapine
• medicines to prevent blood clots e.g.
coumarin, nicoumalone, dicoumarol,
warfarin and ticlopidine
• acetazolamide, a diuretic (water
tablet), also used for mountain sickness
• medicines used to treat breathing
difficulties including asthma and
bronchitis, such as theophylline
Medicines to treat gastric problems:
• medicines used to treat stomach
ulcers e.g. cimetidine, esomeprazole,
omeprazole and sucralfate
• medicines containing calcium
including antacids used to treat
indigestion (take them two to three
hours before or after taking your
phenytoin tablets)
Anti cancer medicines:
• methotrexate, bleomycin, carmustine,
cisplatin, vinblastine, capecitabine,
fluorouracil, levamisonle, busulfan,
etoposide and imatinib.
• toremifene and tamoxifen, used to
treat breast cancer
Alcohol and drugs of abuse:
• alcohol
• medicines used to treat alcohol
abuse e.g. disulfiram
• medicines to treat drug abuse e.g.
methadone
Other medicines:
• hormone containing medicines
including oral contraceptives,
gestrinone and tibolone
• medicines used for pain relief and
inflammation such as aspirin,
paracetamol, phenylbutazone or
other non-steroidal anti-inflammatory
drugs, or azapropazone. (Do not
take Phenytoin Tablets if you are
taking azapropazone)
• levothyroxine used to treat thyroid
problems
• steroids, used to treat a variety of
conditions e.g. fludrocortisone,
dexamethasone, methylprednisolone,
prednisolone, prednisone and other
glucocorticoids.
• medicines used to treat diabetes
including tolbutamide and repaglinide.
(Do not take Phenytoin Tablets if you
are taking repaglinide)
• anaesthetics (enfluane, halothane and
methoxyflurane)
• medicines used to relax the muscles
during an anaesthetic, such as
pancuronium.
• vitamin D, folic acid and folinic acid
• sulfinpyrazone, used to treat gout
• medicines used to expel parasitic
worms from the body such as
mebendazole and praziquantel
• medicines used to treat immune
system disorders such as leflunomide
and ciclosporin

29/11/2012 10:25

Product: PM/20/336
Product: PM/20/336
Product: Product: PM/20/336
PM/20/336
Customer: CUSTOM
Customer: CUSTOM
Customer: CUSTOM
Customer: CUSTOM
W/T No: 172976
W/T No: 172976
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172976
Cutter Size: 280X148MM
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Drinking alcohol whilst taking Phenytoin
Tablets
Your Phenytoin Tablets may not work
properly if you drink alcohol whilst taking
them.
Pregnancy and breast-feeding
You should speak to your doctor about
your epilepsy treatment if you are
planning to become pregnant . If you get
pregnant whilst taking Phenytoin Tablets
you should tell the doctor straight away.
It is important that your epilepsy remains well
controlled but as with other antiepilepsy treatments, phenytoin can
damage the nervous system of unborn
babies as well as cause other effects.
Your doctor may advise you to take extra
folic acid if you’re planning to become
pregnant and while you’re pregnant
If taken during pregnancy Phenytoin
Tablets may also cause bleeding in the
infant and mother. The risk of this may be
reduced by the administration of vitamin K
around the time of delivery.
Phenytoin passes into breast milk.
Breastfeeding is not recommended while
taking phenytoin.
You should speak to your doctor if you wish to
breast-feed whilst taking Phenytoin Tablets
Driving and using machines
You will need to discuss with your doctor
whether you should drive or operate
machinery, which will depend on howTablets
The starting dose of Phenytoin
well
in adults of Phenytoin Phenytoin
The yourstarting the elderly drowsy, Tablets
starting dose of of Phenytoin
The fits are doseto feel varies
The starting doseandcontrolled. Tablets from
Tablets may cause you Phenytoin Tablets
in adults to and elderly varies from
in adults person If you experience
in adultspersonand thetheand depends on
and the elderly varies from
dizzy or uncoordinated.elderly varies from
body weight, depends should not
person to to person and on on on
personanypersonperson andusually 3 to 4mg/kg.
to person and but is youdepends
of these symptoms, depends
The operate machinery. 3 to is
bodyorbut is usually is to 4mg/kg. 200 to
body weight, is usually
body weight, usual maintenance dose4mg/kg.
drive weight, butbut 3 usually 3 to 4mg/kg.

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pharmacist or nearest hospital casualty
department immediately. Take this leaflet
and any remaining tablets with you.
If you accidentally take too many tablets,
initially you may have blurred vision,
involuntary movement of the eyes from
side to side, loss of coordination, fits and
slurred speech. This may be followed by
unconsciousness, enlarged or fixed pupils
and low blood pressure.
Serious breathing and blood circulation
problems can be life-threatening.
If you miss a dose of Phenytoin Tablets
If you miss a dose of Phenytoin Tablets,
take another dose as soon as you
remember. If it is almost time for your
next dose, then do not take the missed
dose at all. Do not take a double dose to
make up for a forgotten dose.
Stopping Phenytoin Tablets
Do not stop taking this medicine
without speaking to your doctor first.
Phenytoin Tablets should be withdrawn
slowly as sudden withdrawal may cause
your fits/epilepsy to reoccur.
4. POSSIBLE SIDE EFFECTS
Like many medicines, Phenytoin Tablets
may cause side effects in some patients,
although not everybody gets them.
Potentially life-threatening skin rashes
(Stevens-Johnson syndrome, toxic
epidermal necrolysis) have been reported
rarely (see section 2).
If you experience any of the following
side effects, contact your doctor

500mg daily as a single or divided
The maintenance dose is 200 is 200 to
usual maintenance dose to
The usualThe usual maintenance dose is 200 to immediately:
Important information for or divided
• fever, sore throat, mouth ulcers,
doses. single or single
500mg daily as as adividedor divided
500mg
500mg daily as adaily a singlepatients with
an intolerance to some sugars
bruising or bleeding which may be
doses.
doses.doses.
If you have been told by your doctor that
you have an intolerance to some sugars,
The starting dose of Phenytoin Tablets
contact your of Phenytoindepends
in starting and of Phenytoin Tablets
The childrendose before taking this Tablets
The starting dose of Tablets
The starting dose doctorinfantsPhenytoinon
medicinal infantsinfants depends on on
in body weight, butinfants depends
children and is usually
in children and
in children and product.depends on 5mg/kg in

two but is but is usually 5mg/kg
body weight,usually 5mg/kg in5mg/kg
body three doses. usually
body weight,or weight, but isThe usual in in
3.maintenance dose is 4 to 8mg/kg
or or three PHENYTOIN
twothree The usual
two ortwoHOW TO TAKEdoses. The usual daily
three doses.doses. The usual
TABLETS
in divided dose 8mg/kgto 8mg/kg daily
maintenanceis 4 dose to48mg/kg dose
maintenance to The daily
maintenance dosedoses. is 4ismaximumdaily
in isdoses.doses. The maximum isdose
divided adoses. the dose which
divided decide
in dividedindoctor The maximum dose dose
Your300mgwillday. The maximum
is 300mg a Always
is 300mg isfor you. day. follow your doctor’s
a day.
best 300mg a day.
instructions completely, and also follow
any special instructions or warnings
which appear on the label which the
pharmacist has put on the package. If you
do not understand, or are in any doubt,
ask your doctor or pharmacist.
Unless instructed differently, take your
tablets with a glass of water.
Adults
The starting dose of Phenytoin Tablets
in adults and the elderly varies from
person to person and depends on
body weight, but is usually 3 to 4mg/kg.
The usual maintenance dose is 200 to
500mg daily as a single or divided doses.
Children and infants
The starting dose of Phenytoin Tablets
in children and infants depends on
body weight, but is usually 5mg/kg in
two or three doses. The usual
maintenance dose is 4 to 8mg/kg daily
in divided doses. The maximum dose
is 300mg a day.
Neonates (Infants aged less than four
weeks)
It is important that the levels of phenytoin
are measured since the absorption of
phenytoin in neonates is variable.
Elderly
The same doses may be given as for
other adults unless you have liver or
kidney problems or a low albumin level in
your blood.
These doses may be adjusted by your
doctor.
Patients with liver problems
If you have liver problems a reduced dose
will be given.
If you take more Phenytoin Tablets
than you should
If you take more Phenytoin Tablets than
you should, contact your doctor,

caused by blood disorders
• rash or acne, particularly if associated
with fever, redness and blistering of
the skin (this can also affect the mouth
and tongue)
• sudden wheeziness, difficulty in
breathing, swelling of the eyelids,
face or lips, rash or itching (especially
affecting the whole body) as this
may be due to an allergic reaction
• yellowing of the skin and/or whites
of the eyes which may be due to a
liver reaction
• large lymph glands, since these can be
a sign of cancer of the lymph system
Other side effects to tell your doctor about
immediately include:
• involuntary movement of the eyes
from side to side
• seeing double
• more frequent seizures
• high blood sugar (which may cause
extreme thirst)
• loss of coordination, slurred speech,
confusion and twitching (‘tics’)
• involuntary movements or spasms
(muscle contractions)
• shaking
• pins and needles or numbness of your
hands and fingers or the loss of the
sensation of pain
• effects on mental function and the
ability to think (especially in children)
If you get any of the above side effects,
you should tell your doctor immediately,
since the level of phenytoin in your blood
may be too high.
Common side effects include:
• loss of appetite
• headache
• dizziness
• nervousness
• sleeping problems
• drowsiness
• feeling sick
• being sick
• constipation
• gum problems (particularly in younger
patients)
• increased body hair in females.
Other side effects include:
• enlargement of facial features
• enlargement of lips
• men may experience genital pain or
abnormal bending of the penis when
sexually aroused (Peyronie’s disease),
or breast enlargement

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• fatigue (feeling tired), feeling unwell,
flu like symptoms, muscle or joint
pains, or lumps on your legs
• hepatitis (a liver disease) or other liver
problems
• kidney problems
• lung problems
• bent fingers (Dupuytren’s contracture)
• bone problems due to low levels of
calcium or vitamin D
• swelling of glands around the mouth
• increased levels of cholesterol or
triglycerides in your blood
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.
If any of the side effects get serious, or
if you notice any side effects not listed in
this leaflet, please contact your doctor or
pharmacist immediately.
5. HOW TO STORE PHENYTOIN
TABLETS
Phenytoin Tablets must be kept out of
the reach and sight of children.
• Phenytoin Tablets should not be used
after the expiry date stated on the
packet. The expiry date refers to the
last day of that month.
• The tablets should not be used if they
show any signs of deterioration such
as discolouration.
• Phenytoin Tablets should not be stored
above 25°C. The tablets should be kept
in their original container, in order to
protect from moisture. Do not transfer
the tablets to another container.
• Two desiccants have been placed on
top of the tablets. These are not to be
eaten; they protect the tablets from
moisture.
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.
6. FURTHER INFORMATION
What Phenytoin Tablets contain
The active substance is phenytoin sodium.
92mg of phenytoin is equivalent to 100mg
of phenytoin sodium.
The other ingredients are icing sugar,
calcium hydrogen phosphate, sucrose,
purified water, magnesium stearate,
Byco-C (gelatin), titanium dioxide (E171),
sucrose, talc and Opaglos 6000P (E901,
E903, E904).
What Phenytoin Tablets look like and
contents of the pack
The tablets are white, circular, sugar
coated tablets that are rounded on both
sides.
The registered pack sizes are 100, 250,
500, 1000 and 5000 tablets in
polyethylene/polypropylene containers.
Not all pack sizes may be marketed.
Other formats
To listen to or request a copy of this leaflet
in Braille, large print or audio please call,
free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following
information:
Product Name
Reference

Number
Phenytoin 100mg
Coated Tablets
29831/0176
This is a service provided by the Royal
National Institute of Blind People.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Wockhardt UK Ltd, Ash Road North,
Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Ltd,
Ash Road North, Wrexham, LL13 9UF, UK.
This leaflet was revised in November 2012


February 2010
104261/5
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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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