Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I taking DILANTIN?
DILANTIN contains the active ingredient phenytoin sodium or phenytoin. DILANTIN is
used to control epilepsy. Epilepsy is a condition where you have repeated seizures
(fits).
For more information, see Section
1. Why am I taking DILANTIN? in the full CMI.
2. What should I know before I take DILANTIN?
Do not take if you have ever had an allergic reaction to phenytoin sodium or phenytoin
or other hydantoin medicines, methylphenobarbitone or any other barbiturate medicines,
other medicines used to treat fits and convulsions or any of the ingredients listed
at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section
2. What should I know before I take DILANTIN? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with DILANTIN and affect how it works.
4. How do I take DILANTIN?
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. More instructions
can be found in Section
4. How do I take DILANTIN? in the full CMI.
5. What should I know while taking DILANTIN?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using DILANTIN.
Tell your doctor immediately if you have any thoughts about suicide or self-harm or
have any symptoms of a serious condition affecting your liver.
Tell your doctor if you become pregnant while taking DILANTIN.
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Things you should not do
|
Do not stop taking DILANTIN and use to treat any other complaints unless your doctor
tells you to.
Do not give DILANTIN to anyone else, even if they have the same condition as you.
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Driving or using machines
|
Be careful driving or operating machinery until you know how DILANTIN affects you.
Children should not ride a bike, climb trees or do anything else that could be dangerous
if they are feeling drowsy or sleepy.
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Drinking alcohol
|
Be careful when drinking alcohol while taking DILANTIN as this can make you more sleepy,
dizzy or lightheaded.
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Looking after your medicine
|
Keep your tablets/capsules/syrup in a cool dry place where the temperature stays below
25°C.
Keep your tablets and capsules in the bottle until it is time to take them.
|
6. Are there any side effects?
Tell your doctor if you experience these side effects and they worry you: nausea,
vomiting, constipation, dizziness, headache, weakness, reduced coordination, confusion,
difficulty speaking, sleeplessness or sleepiness, enlarged gums, enlargement of facial
features, raised red skin rash. Tell your doctor as soon as possible if you experience
unusual changes in mood or behaviour, signs of new or increased irritability or agitation.
Tell your doctor immediately or go to the Emergency Department at your nearest hospital
if you experience thoughts about suicide, fever, unusual bruising under the skin,
persistent nausea or vomiting, yellowing of the skin and/or eyes, strong stomach pains,
more frequent/severe seizures, sudden uncontrollable muscle spasms, sudden signs of
allergy, severe skin rash.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s): Phenytoin sodium or Phenytoin
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using DILANTIN. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking DILANTIN.
Where to find information in this leaflet:
1. Why am I taking DILANTIN?
DILANTIN contains the active ingredient phenytoin sodium or phenytoin. 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 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 severe.
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
condition. 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.
2. What should I know before I take DILANTIN?
Warnings
Do not take DILANTIN if:
you have an allergy to:
phenytoin sodium or phenytoin, the active ingredients in DILANTIN or other hydantoin
medicines
methylphenobarbitone or any other barbiturate medicines
other medicines used to treat fits and convulsions
any of the ingredients listed at the end of this leaflet.
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.
you are taking delavirdine, a medicine used in the treatment of HIV infection.
packaging is torn or shows signs of tampering.
Always check the ingredients to make sure you can take this medicine.
If you are not sure whether you should start taking DILANTIN, talk to your doctor
or pharmacist.
Check with your doctor if you:
have allergies to any other medicines, especially barbiturates or any other anticonvulsant
medicines, any other substances such as foods, preservatives or dyes.
have any other medical conditions
liver problems
heart problems
diabetes
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
and peel.
take any medicines for any other condition
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with 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.
Talk to 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.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with DILANTIN and affect how it works. 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
and cimetidine
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
and diazoxide
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
replacement therapy. Your doctor may advise you to use an additional method of contraception while taking
DILANTIN.
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.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect DILANTIN.
4. How do I 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
for help.
When to take DILANTIN
DILANTIN should be taken 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.
How to take DILANTIN
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.
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 forget to take DILANTIN
DILANTIN should be taken regularly at the same time each day.
If you miss your dose at the usual time and 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 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
hints.
If you take too much DILANTIN
If you think that you or anyone else may have taken too much DILANTIN, urgent medical
attention may be needed.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while taking DILANTIN?
Things you should do
Tell any other doctors, dentists, and pharmacists who are treating you that you are
taking DILANTIN.
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.
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.
Call your doctor straight away 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.
If you become pregnant while taking DILANTIN
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.
Remind any doctor, dentist or pharmacist you visit that you are taking DILANTIN.
Things you should 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
Driving or using machines
Be careful before you drive or use any machines or tools 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.
Drinking alcohol
Tell your doctor if you drink alcohol.
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.
Looking after your medicine
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 medicine in a cool dry place where the temperature stays:
below 30°C (tablets/capsules)
below 25°C(syrup)
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine.
If your doctor or pharmacist tells you to stop taking DILANTIN and you no longer need
it or it is out of date, take it to any pharmacy for safe disposal.
Do not take this medicine after the expiry date (EXP) printed on the pack.
6. Are there any side effects?
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking DILANTIN.
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. Sometimes they are serious, most of the time they are
not. However, some side effects may need medical attention.
If you are over 65 years of age you may have an increased chance of getting side effects.
If you get any side effects, do not stop taking DILANTIN without first talking to
your doctor or pharmacist.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
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
with you.
Tell your doctor or pharmacist if you notice anything else that may be 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.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What DILANTIN contains
DILANTIN 100 mg capsule
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Active ingredient
(main ingredient)
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Phenytoin sodium
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Other ingredients
(inactive ingredients)
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lactose monohydrate
Confectioner's sugar
(ARTG PI No.: 1749)
purified talc
magnesium stearate
titanium dioxide
sunset yellow FCF
erythrosine
carbon black
gelatin.
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Potential allergens
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Lactose and sugars
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DILANTIN 30 mg capsule
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Active ingredient
(main ingredient)
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Phenytoin sodium
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Other ingredients
(inactive ingredients)
|
lactose monohydrate
Confectioner's sugar (ARTG PI No.: 1749)
magnesium stearate
purified talc
titanium dioxide
carbon black
gelatin.
|
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Potential allergens
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Lactose and sugars
|
DILANTIN Infatab 50 mg chewable tablet
|
Active ingredient
(main ingredient)
|
Phenytoin
|
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Other ingredients
(inactive ingredients)
|
sunset yellow FCF
Confectioner's sugar (ARTG PI No.: 1749)
quinoline yellow
saccharin sodium
magnesium stearate
purified talc
spearmint flavour natural 11584 (ARTG PI No.:1228)
|
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Potential allergens
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Saccharin and sugars
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DILANTIN Paediatric Suspension 30 mg/5 mL oral liquid
|
Active ingredient
(main ingredient)
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Phenytoin
|
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Other ingredients
(inactive ingredients)
|
sodium benzoate
sucrose
glycerol
aluminium magnesium silicate
carmellose sodium
polysorbate 40
vanillin
orange flavour 310003E (ARTG PI No.: 10231)
ethanol
carmoisine
sunset yellow FCF
citric acid monohydrate
hydrochloric acid
Imitation Banana Flavour 510120E (ARTG PI No.: 10222)
purified water
|
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Potential allergens
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Sugars and benzoates
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Do not take this medicine if you are allergic to any of these ingredients.
What DILANTIN 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. (AUST R 295265)
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. (AUST R 295264)
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. (AUST R 297268) (new formulation)
DILANTIN Paediatric Suspension - a reddish-pink suspension which is available in a 500 mL bottle
(AUST R 14309)
Who distributes DILANTIN
Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276
This leaflet was prepared in November 2022.
DILANTIN® is a Viatris company trade mark
DILANTIN_cmi\Nov22/00