phenytoin, phenytoin sodium
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Dilantin.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking
Dilantin against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What Dilantin is used for
Dilantin is used to control epilepsy. Epilepsy is a condition where you have repeated
seizures (fits). There are many different types of seizures, ranging from mild to
Dilantin belongs to a group of medicines called anticonvulsants. These drugs are thought
to work by controlling brain chemicals which send signals to nerves so that seizures
do not happen.
Dilantin is also used to help prevent seizures occurring during or after brain surgery.
Dilantin may be used alone, or in combination with other medicines, to treat your
Your doctor may have prescribed Dilantin for another reason. Ask your doctor if you
have any questions about why Dilantin has been prescribed for you.
There is no evidence that Dilantin is addictive.
This medicine is available only with a doctor's prescription.
Before you take Dilantin
When you must not take it
Do not take Dilantin if you have an allergy to:
phenytoin sodium or phenytoin, the active ingredients in Dilantin, or other hydantoin
medicines or any of the ingredients listed at the end of this leaflet
methylphenobarbitone or any other barbiturate medicines
other medicines used to treat fits and convulsions.
Symptoms of an allergic reaction to Dilantin may include:
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Do not take this medicine if you are taking delavirdine, a medicine used in the treatment
of HIV infection.
Do not take Dilantin after the expiry date (EXP) printed on the pack.
Do not take Dilantin if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking Dilantin, talk to your doctor
Before you start to take it
Tell your doctor or pharmacist if you have allergies to:
any other medicines, especially barbiturates or any other anticonvulsant medicines
any other substances, such as foods, preservatives or dyes.
Tell your doctor if you have or have had any medical conditions, especially the following:
high blood sugar levels
lymphadenopathy, a condition of the lymph glands
Systemic Lupus Erythematosus
porphyria, a rare blood pigment disorder
hypoalbuminaemia, a decrease in serum albumin in the blood, causing water retention
hypersensitivity syndrome, which results in fever, rash, blood disorders and hepatitis
a severe skin disorder called Stevens Johnson syndrome
toxic epidermal necrolysis, a severe skin reaction with painful red areas, which blister
Tell your doctor if you are pregnant or intend to become pregnant.
It is very important to control your fits while you are pregnant. Your doctor can
help you decide if it is necessary for you to take Dilantin during pregnancy. Dilantin
has been known to cause abnormalities and malignancies in the newborns, delaying their
growth and causing other harmful side effects.
Tell your doctor if you are breastfeeding or intend to breastfeed.
It is not recommended to breastfeed while taking Dilantin, as it may pass through
breast milk and affect your baby.
If you do breastfeed, watch your baby carefully.
If your baby develops a skin rash, becomes difficult to wake or has unusual symptoms,
don't breastfeed again until you speak to your doctor.
If you have not told your doctor or pharmacist about any of the above, tell them before
you start taking Dilantin.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any
that you buy without a prescription from your pharmacy, supermarket or health food
Some medicines and Dilantin may interfere with each other. These include:
disulfiram, a medicine used to treat alcoholism
other medicines used to treat fits and convulsions
warfarin, a medicine used to prevent blood clots
some pain relievers, such as salicylates and tramadol
benzodiazepines, medicines used as sleeping tablets, sedatives, tranquillisers, or
to treat anxiety and panic attacks
medicines used to treat mental illness such as clozapine, phenothiazines
medicines used to treat depression
medicines used to lower cholesterol
corticosteroids such as cortisone and prednisolone
ciclosporin, a medicine used to prevent organ transplant rejection and to treat severe
rheumatoid arthritis and some severe skin conditions
some medicines used to treat cancer
some medicines used to treat heart problems
some antibiotics and antifungal medicines used to treat infections
isoniazid, a medicine used to prevent and treat tuberculosis (TB)
antiretrovirals, used in the treatment of HIV infection
medicines used to treat parasitic worm infections
furosemide, a diuretic (fluid tablet), which is used to reduce water retention and
high blood pressure
some medicines used to treat stomach or duodenal ulcers, such as omeprazole, sucralfate
general anaesthetics and muscle relaxants, medicines used during an operation
methadone, a medicine used to control severe pain and to treat heroin addiction
methylphenidate, a medicine used to treat Attention Deficit Disorder
St John's wort (Hypericum perforatum), an ingredient used in herbal medicines to treat
anxiety and depression
some medicines used to control diabetes, such as tolbutamide, glibenclamide, chlorpropamide
some vitamins such as folic acid and Vitamin D
theophylline, a medicine used to treat asthma
estrogens, a hormone used in oral contraceptives(birth control pills) and in hormone
Your doctor may advise you to use an additional method of contraception while taking
These medicines may be affected by Dilantin, or may affect how well it works. Your
doctor will tell you if you need different amounts of your medicine, or if you need
to take different medicines.
Your doctor and pharmacist may have more information on medicines to be careful with
or to avoid while taking Dilantin.
How to take Dilantin
How much to take
Your doctor will tell you how much medicine to take each day. This may depend on your
age, your condition and whether or not you are taking any other medicines.
Your doctor may recommend that you start with a low dose of Dilantin and slowly increase
the dose to the lowest amount needed to control your epilepsy/convulsions.
Follow all directions given to you by your doctor carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the label, ask your doctor or pharmacist
How to take it
Capsules: swallow whole with at least half a glass of water.
Infatabs: chew before swallowing.
Suspension: shake the bottle well and accurately measure the dose with a medicine
measure before taking it.
Shaking the bottle and using a medicine measure will make sure that you get the correct
dose. You can get a medicine measure from your pharmacist.
When to take it
Take Dilantin at about the same time each day.
Taking Dilantin at the same time each day will have the best effect. It will also
help you remember when to take your medicine.
Take Dilantin during or immediately after a meal.
This will help prevent stomach upset.
If you forget to take it
If it is almost time for your next dose (within 4 hours), skip the dose you missed
and take your next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking your medicine
as you would normally.
Do not take a double dose to make up for the dose that you missed.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some
How long to take it
Continue taking Dilantin for as long as your doctor tells you to.
Dilantin helps control your condition, but does not cure it. Therefore you must take
your medicine every day, even if you feel well.
Do not stop taking Dilantin, or lower the dosage, without checking with your doctor.
Do not let yourself run out of medicine over the weekend or on holidays.
Stopping Dilantin suddenly may cause unwanted effects or make your condition worse.
Your doctor will slowly reduce your dose before you can stop taking it completely.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone in
Australia - 13 11 26; telephone in New Zealand - 0800 POISON or 0800 764 766), or
go to Accident and Emergency at your nearest hospital, if you think that you or anyone
else may have taken too much Dilantin. Do this even if there are no signs of discomfort
You may need urgent medical attention.
While you are taking Dilantin
Things you must do
Tell your doctor immediately if you notice any of the following:
increase in seizures (fits)
yellowing of the skin and/or eyes
swelling of the face
strong stomach pains
generally feeling unwell with tiredness, weakness and vomiting.
These symptoms may mean that you have a serious condition affecting your liver. You
may need urgent medical attention.
Tell your doctor immediately if you have any thoughts about suicide or self-harm,
any unusual changes in mood or behaviour, or you show signs of depression.
Some people being treated with anti-epileptics such as Dilantin have thoughts of harming
or killing themselves.
Patients and caregivers should be alert and monitor for these effects.
Signs and symptoms of suicide include:
thoughts or talk of death or suicide.
thoughts or talk of self-harm or harm to others
any recent attempts of self-harm
new or increase in aggressive behaviour, irritability or agitation
feelings of depression.
Mention of suicide or violence must be taken seriously.
If you or someone you know is demonstrating these warning signs of suicide while taking
Dilantin, contact your doctor or a mental health professional right away.
Tell any other doctors, dentists, and pharmacists who are treating you that you are
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist
that you are taking Dilantin.
Before you have any surgery or emergency treatment, tell your doctor or dentist that
you are taking Dilantin.
Tell your doctor if you feel Dilantin is not helping your condition.
Your doctor may need to change your medicine.
Tell your doctor if, for any reason, you have not taken Dilantin exactly as prescribed.
Otherwise, your doctor may change your treatment unnecessarily.
If you become pregnant while taking Dilantin, tell your doctor.
Tell your doctor if you want to take oral contraceptives while taking Dilantin.
You may need a higher dose of oral contraceptives than usual to prevent pregnancy,
or you may need to consider other forms of contraception.
If you need to have any medical tests while you are taking Dilantin, tell your doctor.
Dilantin may affect the results of some tests including test for thyroid function.
Be sure to keep all of your doctor's appointments so that your progress can be checked.
Your doctor will check your progress and may want to take some tests from time to
time. This helps to prevent unwanted side effects.
Things you must not do
Do not give Dilantin to anyone else, even if their symptoms seem similar to yours
or they have the same condition as you.
Do not take Dilantin to treat any other complaints unless your doctor tells you to.
Do not stop taking it unless your doctor tells you to.
Things to be careful of
Be careful driving or operating machinery until you know how Dilantin affects you.
As with other anticonvulsant medicines, Dilantin may cause dizziness, light-headedness,
weakness, tiredness, and decreased coordination in some people.
Children should not ride a bike, climb trees or do anything else that could be dangerous
if they are feeling drowsy or sleepy.
Dilantin may cause drowsiness, dizziness or sleepiness in some people and affect alertness.
Be careful when drinking alcohol while taking Dilantin.
Combining Dilantin and alcohol can make you more sleepy, dizzy or lightheaded. Your
doctor may suggest you avoid alcohol while you are being treated with Dilantin.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking Dilantin.
Dilantin helps most people with epilepsy, but it may have unwanted side effects in
a few people. All medicines can have side effects. Sometimes they are serious, most
of the time they are not. You may need medical treatment if you get some of the side
effects. If you are over 65 years of age you may have an increased chance of getting
Ask your doctor or pharmacist to answer any questions you may have.
If you get any side effects, do not stop taking Dilantin without first talking to
your doctor or pharmacist.
Tell your doctor if...
Tell your doctor or pharmacist if you notice any of the following and they worry you:
dizziness or light-headedness
weakness, unsteadiness when walking, reduced co-ordination or slowed reactions
forgetfulness, loss of concentration or confusion
difficulty speaking or slurred speech
sleeplessness or sleepiness
nausea (feeling sick) or vomiting
bleeding, tender or enlarged gums
enlargement of facial features including thickening of lips
raised red skin rash or itchy skin rash
excessive hairiness, especially in women
sexual disturbances, such as painful erection
tingling or numbness of the hands or feet
changes in taste.
These are the more common side effects of Dilantin. Mostly these are mild and short-lived.
Tell your doctor as soon as possible if...
Tell your doctor as soon as possible if you notice any of the following:
unusual changes in mood or behaviour
signs of new or increased irritability or agitation.
Go to hospital if...
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital
if you notice any of the following:
thoughts about suicide or self-harm
more frequent or more severe seizures (fits)
sudden onset of uncontrollable muscle spasms affecting the eyes, head, neck and body
fever, sore throat, swollen glands, mouth ulcers, unusual bleeding or bruising under
tiredness, headache, shortness of breath when exercising, dizziness or pale skin
persistent nausea or vomiting, loss of appetite, generally feeling unwell, fever,
itching, yellowing of the skin and/or eyes, dark coloured urine, light coloured bowel
motions, pain in the abdomen
sudden signs of allergy such as rash, itching or hives, swelling of the face, lips,
tongue or other parts of the body, shortness of breath, wheezing or difficulty breathing
severe skin rash, itching, hives, blisters or peeling skin, which may be accompanied
by fever, chills, headache, swollen glands, stomach pain or aching joints and muscles.
slow heartbeat. You may experience severe fatigue, weakness, sweating or fainting.
These are very serious side effects. You may need urgent medical attention or hospitalisation.
All of these side effects are very rare.
If you are of African or Chinese descent or are immune-deficient you may be at a higher
risk of developing some of the above mentioned serious side effects. If you belong
to this portion of the population, your doctor will discuss the risks versus the benefits
Tell your doctor if you notice anything else that is making you feel unwell.
Other side effects not listed above may happen in some people. Some of these side
effects (for example, changes in thyroid function, structure of bones, high cholesterol
or blood pressure) can only be found when your doctor does blood tests from time to
time to check your progress.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
After taking Dilantin
Keep your tablets and capsules in the bottle until it is time to take them.
If you take the tablets or capsules out of the bottle they will not keep well.
Keep your tablets/capsules/syrup in a cool dry place where the temperature stays below
Do not store Dilantin or any other medicine in the bathroom or near a sink.
Do not leave it on a window sill or in the car on hot days.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
If your doctor or pharmacist tells you to stop taking Dilantin or the medicine has
passed its expiry date, ask your pharmacist what to do with any that are left over.
What it looks like
Dilantin capsules 100 mg - white and orange capsules that are marked PARKE DAVIS on
one side and P-D 100 on the other side. They are available in bottles of 200 capsules.
Dilantin Capsules 30 mg - white capsules marked PARKE DAVIS on one side and P-D 30
on the other side. They are available in bottles of 200 capsules.
Dilantin Infatabs 50 mg - yellow, chewable, spearmint-flavoured triangular tablets.
They are marked P-D 007 on one side and a break bar on the other side. They are available
in bottles of 200 tablets.
Dilantin Paediatric Suspension - a reddish-pink suspension which is available in a
500 mL bottle.
Each white and orange Dilantin Capsule contains 100 mg of the active ingredient phenytoin
Inactive ingredients are lactose monohydrate, Confectioner's sugar (PI: 1749) (sucrose
with 3% maize starch), purified talc, magnesium stearate, titanium dioxide, sunset
yellow FCF, erythrosine, carbon black and gelatin.
Each white Dilantin Capsule contains 30 mg of the active ingredient phenytoin sodium.
Inactive ingredients are lactose monohydrate, Confectioner's sugar (PI: 1749) (sucrose
with 3% maize starch), magnesium stearate, purified talc, titanium dioxide, carbon
black and gelatin.
Note Dilantin 30 mg capsules (AUST R 14306) does not contain lactose monohydrate.
Each Dilantin Infatab contains the active ingredient phenytoin 50 mg.
Inactive ingredients are sucrose, sunset yellow FCF, starch- maize, quinoline yellow,
saccharin sodium, magnesium stearate, purified talc and spearmint flavour.
Dilantin Paediatric Suspension contains the active ingredient phenytoin 30 mg/5 mL.
Inactive ingredients are sodium benzoate, sucrose, glycerol, aluminium magnesium silicate,
carmellose sodium, polysorbate 40, vanillin, orange oil terpeneless, ethanol, carmoisine,
sunset yellow FCF, citric acid monohydrate, hydrochloric acid, banana flavour and
Dilantin is supplied in Australia by:
Pfizer Australia Pty Ltd
ABN 50 008 422 348
38-42 Wharf Road
West Ryde NSW 2114 Australia
Toll Free Number: 1800 675 229
Dilantin is supplied in New Zealand by:
Pfizer New Zealand Limited
PO Box 3998
Auckland, New Zealand
Toll Free Number: 0800 736 363
Australian Registration Numbers:
Dilantin 100 mg AUST R 14305
Dilantin 100 mg AUST R 295265 (new formulation)
Dilantin 30 mg AUST R 14306
Dilantin 30 mg AUST R 295264 (new formulation)
Dilantin Infatabs AUST R 14308
Dilantin Infatabs AUST R 297268
Dilantin Paediatric AUST R 14309
This leaflet was revised in August 2018.
© Pfizer Australia Pty Ltd 2018.