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 being treated with DBL Phenytoin Injection?
DBL Phenytoin Injection contains the active ingredient phenytoin. DBL Phenytoin Injection
is used to control epilepsy. It can also be used to prevent seizures during or after
brain surgery and to treat a rapid or irregular heartbeat.
For more information, see Section
1. Why am I being treated with DBL Phenytoin Injection? in the full CMI.
2. What should I know before treatment with DBL Phenytoin Injection?
Do not start treatment if you have ever had an allergic reaction to phenytoin, or
to a group of medicines called hydantoins 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 treatment with DBL Phenytoin Injection? in the full CMI.
3. What if I am taking other medicines?
4. How is DBL Phenytoin Injection given?
Your doctor will decide what dose you will receive. This depends on your condition
and other factors, such as your weight. DBL Phenytoin Injection is given as a slow
injection into a vein. It must only be given by a doctor or nurse.
More instructions can be found in Section
4. How is DBL Phenytoin Injection given? in the full CMI.
5. What should I know during treatment with DBL Phenytoin Injection?
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Things you should do
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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
and generally feeling unwell with tiredness, weakness and vomiting, any thoughts of
suicide or self harm, or other mood changes.
You should use effective contraception advised by your doctor during treatment and
for one month after stopping treatment.
Call your doctor straight away if you become pregnant or think you may be pregnant.
Remind any doctor, nurse, pharmacist or dentist you visit that you are using this
medicine
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Things you should not do
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Do not stop treatment of this medicine suddenly without checking with your doctor.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how DBL Phenytoin
Injection affects you. This medicine may cause dizziness, lightheadedness and tiredness.
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Drinking alcohol
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Your doctor may suggest you avoid alcohol while you are being treated with this medicine.
Drinking alcohol while using this medicine can make you more sleepy, dizzy or light-headed.
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6. Are there any side effects?
Side effects include: pain or redness at the injection site, nervous system related
issues (e.g. drowsiness, confusion, nervousness), gastrointestinal related issues
(e.g. nausea or vomiting), changes to the skin, hair and mouth, eye-related issues,
sexual disturbances, breast enlargement in males. Serious side effects include: swelling,
discolouration and pain below the injection site; changes in behaviour thinking or
mood (e.g. thoughts of suicide or self-harm); sudden onset of uncontrollable muscle
spasms; numbness or weakness of the arms or legs; persistent nausea or vomiting, loss
of appetite, generally feeling unwell, itching, yellowing of the skin and/or eyes,
dark coloured urine, light coloured bowel motions, pain in the abdomen, unusual bleeding
or bruising under the skin; sudden allergic reaction symptoms; severe skin reactions
which may be accompanied by fever, swollen glands, mouth ulcers and other symptoms;
respiratory-related issues; heart-related issues and bone fracture.
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 (FEN-i-toyn)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using DBL Phenytoin Injection. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using DBL Phenytoin Injection.
Where to find information in this leaflet:
1. Why am I being treated with DBL Phenytoin Injection?
DBL Phenytoin Injection contains the active ingredient phenytoin. DBL Phenytoin Injection 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.
DBL Phenytoin Injection is used to control epilepsy. Epilepsy is a condition where
you have repeated seizures (fits). There are many types of seizures, ranging from
mild to severe.
DBL Phenytoin Injection is also used to help prevent seizures during or after brain
surgery.
It may also be used to treat a rapid or irregular heartbeat.
Your doctor may have prescribed it for another reason.
Ask your doctor if you have any questions about why it has been prescribed for you.
There is no evidence that DBL Phenytoin Injection is addictive.
2. What should I know before treatment with DBL Phenytoin Injection?
Warnings
You must not be given DBL Phenytoin Injection if:
1. you are allergic to phenytoin, or to a group of medicines called hydantoins or any
of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction 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.
Always check the ingredients to make sure you can use this medicine.
2. you have or have had certain types of irregular heartbeat conditions.
3. you are taking delavirdine, a medicine used in the treatment of HIV infection.
If you are not sure whether you should be given DBL Phenytoin Injection, talk to your
doctor or pharmacist.
Check with your doctor if you:
have allergies to:
any other medicines, especially any other anticonvulsant medicines
any other substances, such as foods, preservatives or dyes.
have or have had any other medical conditions, especially the following:
depression
a lowered resistance to disease
thoughts of suicide or self-harm
liver problems
heart problems
low blood pressure
diabetes
kidney problems
a rare blood pigment disorder called porphyria
lymphadenopathy, a condition of the lymph glands
hypoalbuminaemia, a decrease in albumin in the blood, causing water retention
a severe skin disorder called Stevens Johnson syndrome
toxic epidermal necrolysis, a severe skin reaction with painful red areas which blister
and peel
anticonvulsant hypersensitivity syndrome, which results in fever, rash and hepatitis.
take any medicines for any other condition
If you have not told your doctor about any of the above, tell them before you are
given this medicine.
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.
DBL Phenytoin Injection may affect your developing baby if you are given it during
pregnancy. However, it is very important to control your fits while you are pregnant.
If it is necessary for you to be given this medicine, your doctor can help you decide
whether or not you should be given it during pregnancy. Phenytoin 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.
DBL Phenytoin Injection passes into breast milk; therefore, there is a possibility
that the breastfeed baby may be affected.
If there is a need to consider using this medicine while you are breastfeeding, your
doctor will discuss with you the benefits and risks of you being given it.
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 DBL Phenytoin Injection and affect how it works.
These include:
medicines used to treat infections such as amphotericin B, chloramphenicol, doxycycline,
erythromycin, fluoroquinolones (such as ciprofloxacin), isoniazid, praziquantel, rifampicin,
sulfadiazine, sulfamethoxazole-trimethoprim, tetracycline, fluconazole, voriconazole,
posaconazole, albendazole, itraconazole, ketoconazole and miconazole
medicines used to treat HIV infection including delavirdine, amprenavir, efavirenz,
lopinavir/ritonavir, indinavir, nelfinavir, ritonavir, saquinavir, and fosamprenavir
medicines used to prevent blood clots such as warfarin, apixaban, dabigatran, edoxaban,
rivaroxaban and ticagrelor
disulfiram, a medicine used to treat alcohol dependency
benzodiazepines, medicines used as sedatives or to treat mental disorders such as
anxiety (e.g. chlordiazepoxide and diazepam)
medicines used to treat mental disorders such as clozapine, haloperidol, phenothiazines
and thiothixene
methylphenidate used to treat ADHD (Attention Deficit Hyperactivity Disorder)
anticonvulsants, medicines used to treat epilepsy such as barbiturates, carbamazepine,
phenobarbital, ethosuximide, lamotrigine, primidone, topiramate, oxcarbazepine, valproate,
valproic acid, lacosamide and vigabatrin
medicines used to treat depression such as tricyclic antidepressants, MAO inhibitors,
trazodone and serotonin reuptake inhibitors (such as fluoxetine, sertraline and paroxetine)
hormones such as oestrogens in hormone replacement therapy and oral contraceptives
Your doctor may advise you to use an additional method of contraception while you
are given DBL Phenytoin Injection. You should use effective contraception advised
by your doctor during treatment and for one month after stopping treatment.
muscle relaxants or general anaesthetics (e.g. halothane, cisatracurium and rocuronium),
medicines used during an operation
medicines used to manage heart and blood pressure problems such as, beta blockers,
calcium channel blockers, diazoxide, digoxin, disopyramide, dopamine, lignocaine,
mexiletine, amiodarone, diltiazem, nifedipine, ticlopidine, nimodipine, quinidine
and verapamil
medicines used to treat cancer such as bleomycin, carboplatin, carmustine, cisplatin,
dacarbazine, methotrexate, vinblastine, calcium folinate, doxorubicin, fluorouracil
and capecitabine
some vitamins such as folic acid and vitamin D
medicines used to treat cholesterol levels such as atorvastatin, simvastatin and fluvastatin
medicines used to treat stomach ulcers such as cimetidine, omeprazole, ranitidine
and sucralfate
theophylline a medicine used to treat asthma
medicines used to treat immune conditions such as ciclosporin and corticosteroids
some pain relievers such as salicylates, azapropazone and phenylbutazone
L-dopa, a medicine used to treat Parkinson’s disease
frusemide, a medicine used to treat fluid retention
medicines used to treat diabetes, such as tolbutamide and glibenclamide
methadone, a medicine used to control severe pain or treat opioid dependence
St John’s Wort (hypericum perforatum)
medicines used in organ transplant such as tacrolimus.
These medicines may be affected by DBL Phenytoin Injection or may affect how well
it works. You may need different amounts of your medicine, or you may need to take/use
different medicines. Your doctor or pharmacist will advise you.
Your doctor and pharmacist may have more information on medicines to be careful with
or avoid while you are being given this medicine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect DBL Phenytoin Injection.
4. How is DBL Phenytoin Injection given?
How much is given
Your doctor will decide what dose you will receive. This depends on your condition
and other factors, such as your weight.
How it is given
DBL Phenytoin Injection is given as a slow injection into a vein. It must only be
given by a doctor or nurse.
How many injections will you need
This medicine helps control epilepsy, but will not cure it. Therefore, you may need
regular injections. Your doctor will decide how long you should continue to be given
DBL Phenytoin Injection.
Treatment with phenytoin should not be stopped suddenly.
If you are given too much DBL Phenytoin Injection
As DBL Phenytoin Injection is given to you under the supervision of your doctor, it
is very unlikely that you will receive too much.
However, if you think that you have been given too much DBL Phenytoin Injection and/or
if you experience severe side effects, you should immediately:
contact your doctor, or
phone the Poisons Information Centre
(by calling
13 11 26), or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
Ask your doctor or pharmacist if you have any concerns.
5. What should I know during treatment with DBL Phenytoin Injection?
Things you should do
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.
have any thoughts of suicide or self harm, or other mental/mood changes
Antiepileptic drugs, including phenytoin increase the risk of suicidal thoughts or
behaviour in patients taking these drugs. You should be careful of worsening depression,
suicidal thoughts or behaviour, and/or any unusual changes in mood or behaviour.
You should use effective contraception advised by your doctor during treatment and
for one month after stopping treatment.
Call your doctor straight away if you become pregnant or think you may be pregnant.
Your doctor will check your progress and may want to take some tests from time to
time. This helps to prevent unwanted side effects.
Remind any doctor, nurse, pharmacist or dentist you visit that you are using DBL Phenytoin
Injection.
Things you should not do
Do not stop treatment of this medicine suddenly without checking with your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how DBL Phenytoin
Injection affects you.
As with other anticonvulsant medicines, DBL Phenytoin Injection may cause dizziness,
lightheadedness and tiredness in some people. Make sure you know how you react to
this medicine before you drive a car, operate machinery, or do anything else that
could be dangerous if you are dizzy or light-headed. If this occurs do not drive.
If you drink alcohol, dizziness or lightheadedness may be worse.
Drinking alcohol
Tell your doctor if you drink alcohol.
Your doctor may suggest you avoid alcohol while you are being treated with this medicine.
Drinking alcohol while using this medicine can make you more sleepy, dizzy or light-headed.
6. Are there any side effects?
This medicine helps most people with epilepsy, but it may have unwanted side effects
in a few people. All medicines can have side effects. If you do experience any side
effects, most of them are minor and temporary. Many of the side effects occur only
with long term treatment with phenytoin. 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.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Side effects
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Side effects
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What to do
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Administration site reactions
pain or redness at the injection site
Nervous system related issues
drowsiness or feeling tired
sleeplessness
dizziness or light-headedness
headache
weakness, unsteadiness when walking, reduced coordination
muscle twitching
trembling hands
confusion
slurred speech
Changes in behaviour, thinking or mood
nervousness, excitement, irritability or stuttering
Gastrointestinal-related issues
stomach pain
nausea or vomiting
loss of appetite
loss of weight
loss of taste
difficulty in swallowing
constipation
Changes in skin, hair and mouth
bleeding, tender or enlarged gums
enlargement of facial features including thickening of lips
raised, red, skin discoloration or rash
excessive hairiness
Eye-related issues
uncontrollable jerky eye movements
blurred vision
Reproductive system issues
sexual disturbances, such as painful erection
breast enlargement in males
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Speak to your doctor if you have any of these side effects and they worry you.
These side effects are usually mild.
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Serious side effects
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Serious side effects
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What to do
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Administration site reactions
swelling, discolouration and pain below the injection site
Changes in behaviour thinking or mood
depression
thoughts of suicide or self-harm
unusual changes in mood or behaviour
Nervous system-related issues
sudden onset of uncontrollable muscle spasms affecting the eyes, head, neck and body
numbness or weakness of the arms or legs
Liver problems
persistent nausea or vomiting
loss of appetite, generally feeling unwell
itching
yellowing of the skin and/or eyes
dark coloured urine, light coloured bowel motions, pain in the abdomen
Sudden allergic reaction symptoms
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 reaction symptoms
severe skin rash, itching, hives, blisters or peeling skin, which may be accompanied
by:
fever, chills, headache, swollen glands, stomach pain, sore mouth, inflammation of
the eye or penis, hayfever, aching joints and muscles
swelling and redness of the skin with small pus-filled spots or painful lumps under
the skin with a fast heartbeat, fever and weight loss
Respiratory-related issues
difficulty breathing, wheezing, chest congestion, cough and phlegm
Heart and blood-related issues
changes in heartbeat, sometimes with fainting
low blood pressure
shortness of breath, swelling of feet and ankles and face, weight increase due to
fluid build-up
tiredness, headache, shortness of breath when exercising, chest discomfort, dizziness,
lethargy or pale skin
fever, sore throat, swollen glands, mouth ulcers, unusual bleeding or bruising under
the skin
Bone-related issues
bone fracture
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
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
treatment with any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What DBL Phenytoin Injection contains
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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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Propylene glycol
Ethanol absolute
Water for injections
Sodium hydroxide
Hydrochloric acid
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DBL Phenytoin Injection does not contain lactose, sucrose, gluten, tartrazine or any
other azo dyes.
Do not use this medicine if you are allergic to any of these ingredients.
What DBL Phenytoin Injection looks like
DBL Phenytoin Injection is available in 2 strengths:
100 mg/2 mL, 5 x 2 mL ampoules (AUST R 46942)
250 mg/5 mL, 5 x 5 mL ampoules (AUST R 46943)
How is DBL Phenytoin Injection stored
DBL Phenytoin Injection will be stored in the pharmacy or on the ward. The injection
is kept in a cool dry place, protected from light, where the temperature stays below
25°C.
Who distributes DBL Phenytoin Injection
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
This leaflet was prepared in July 2023.
™ Trademark
© Pfizer Australia Pty Ltd 2023