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EPANUTIN READY MIXED PARENTERAL 250MG/5ML SOLUTION FOR INJECTION OR INFUSION

Active substance(s): PHENYTOIN SODIUM

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Malta
ADR Reporting website:
www.medicinesauthority.gov.mt/adrportal
5. How to store Epanutin RMP
The storage of Epanutin RMP will not be your
responsibility.
The pharmacist will ensure that your medicine is kept
out of the sight and reach of children.
The pharmacist will ensure that your medicine is not
stored above 25°C, and not used after the expiry
date which is stamped on the pack after EXP. The
expiry date refers to the last day of that month. The
pharmacist will also ensure that Epanutin RMP is kept
in the original package.
Do not throw away any medicine via wastewater. The
pharmacist or nurse will throw away any medicine
you no longer use. These measures will help protect
the environment.
Epanutin RMP is for single use only. Any unused
solution should be discarded immediately after initial
use.
6. Contents of the pack and other information
What Epanutin RMP 250 mg/5 ml Solution for
injection or infusion contains

Package leaflet: Information for the patient
®

Each 5 ml ampoule contains 250 mg of the active
ingredient phenytoin sodium i.e. 50 mg/ml.
The other ingredients are propylene glycol, ethanol
(alcohol), sodium hydroxide and water for injection.
What Epanutin RMP looks like and contents of
the pack
Epanutin RMP 250 mg/5 ml Solution is available in
packs containing 10 ampoules.
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
UK
Manufacturer
Actavis Italy S.p.A.
Viale Pasteur 10
20014 Nerviano (Milan)
ITALY
Company Contact Address
For further information on this medicine, please contact
Medical Information at Pfizer Limited, Walton Oaks,
Tadworth, Surrey, UK. Tel: +44 (0)1304 616161
This leaflet last revised in 11/2017
Ref: EP 35_1

Epanutin RMP

FPO

• Effects on your immune system: problems with
the body’s defence against infection, inflammation
of the wall of the arteries and immunoglobin
abnormalities.
• Effect on your heart and circulation: low blood
pressure, enlargement of blood vessels. Your blood
pressure may also be lowered and experience
heart problems when Epanutin is injected into
your vein too quickly.
• Effects on your bones: 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.
• Effects on injection site: Intramuscular phenytoin
administration may cause pain, dying or sloughing
of skin cells, and formation of an infection at the
injection site.
Reporting of side effects
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 (see details
below). By reporting side effects you can help provide
more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme website:
www.mhra.gov.uk/yellowcard or search for MHRA
Yellow Card in the Google Play or Apple App Store.

(Ready Mixed Parenteral)
250 mg/5 ml Solution
for Injection or Infusion
Phenytoin sodium

FPO

Other side effects that may occur are:
• Effects on your nervous system: Unusual eye
movements, unsteadiness, difficulty in controlling
movements, shaking, abnormal or uncoordinated
movements, slurred speech, confusion, pins and
needles or numbness, drowsiness, dizziness,
vertigo, sleeplessness, nervousness, twitching
muscles, headaches and change in taste.
• Effects on your skin: skin rash including
measles-like rash which is usually mild.
• Effects on your stomach and intestines: Feeling
sick, being sick and constipation.
• Effects on your blood and lymph system: swelling
of the lymph glands.
• Effects on your liver and kidney: inflammation of
the kidneys and liver, liver damage or liver failure
which can lead to death (seen as yellowing of the
skin and whites of the eye).
• Effects on your reproductive system and breasts:
changes in the shape of the penis, painful erection.
• Effects on your hands, face and body: changes in
the hands with difficulty in straightening the fingers,
changes in facial features, enlarged lips or gums,
increased or abnormal body or facial hair.
• Effects on medical tests: Increased levels of
blood sugar, or decreased levels of blood calcium,
phosphates, folic acid and vitamin D. Taking
Phenytoin may cause abnormal thyroid test results.
• Effects on your respiratory system: problems
breathing including complete stopping of breathing,
inflammation of the lining of the lung.
N. EPAN-L03

Read all of this leaflet carefully before you are
given this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor,
pharmacist or nurse.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

• You may have been given Epanutin RMP as a
single dose to control seizures in an emergency
(status epilepticus). In this case, you will only
be able to read this leaflet after you have had
the product given to you. Your doctor will have
considered the important safety information in
this leaflet, but your urgent need for treatment
may have been more important than some
of the normal cautions. Check them now,
especially if you are going to continue to be given
Epanutin RMP (or any other form of phenytoin).
What is in this leaflet
1. What Epanutin RMP is and what it is used for
2. What you need to know before you are given
Epanutin RMP
3. How Epanutin RMP is given
4. Possible side effects
5. How to store Epanutin RMP
6. Contents of the pack and other information
1. What Epanutin RMP is and what it is used for
This medicine is a solution for injection or infusion
containing phenytoin, which belongs to a group of
medicines called antiepileptic drugs.
Epanutin RMP can be used to treat severe epileptic
seizures or fits (status epilepticus). It can also be used to
control or prevent seizures during or after brain surgery
and/or severe head injury. Epanutin RMP is also used

to control or prevent seizures for short periods of time
when antiepileptic drugs cannot be taken by mouth.
Epanutin RMP can also be used to treat specific heart
rhythm problems (cardiac arrhythmias) when these
are caused by the drug digoxin, or when these do not
respond well to treatment with other medicines, or when
other treatments cannot be used.
You should consult your doctor if you are unsure why
you have been given Epanutin RMP, if you do not feel
better or if you feel worse.
2. What you need to know before you are given
Epanutin RMP
Do not take Epanutin RMP
• If you are allergic to phenytoin, or any of the other
ingredients of this medicine (listed in section 6).
• If you are allergic to other medicines for epilepsy.
• If you suffer from certain conditions that affect the
heart rhythm for example a decreased heart rate
(sinus bradycardia), heart block (sinoatrial block or
A-V block) or Adams-Stoke Syndrome.
• If you are taking medicines for HIV infection such
as delavridine.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are
given Epanutin RMP if you suffer from or have suffered
in the past from any of the following conditions:
• Low blood pressure or heart failure

N. EPAN-L03

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If you develop a rash or these skin symptoms, stop
taking Epanutin, seek urgent advice from a doctor and
tell him that you are taking this medicine. Consult your
doctor before discontinuing Epanutin. If you suddenly
stop taking this medicine you may have a seizure.
If you are taking phenytoin at the same time as you
receive radiation therapy to your head and the dose of
another medication called corticosteroids is reduced,
you may more likely to develop a severe skin rash called
erythema multiform or one that causes blistering called
Stevens Johnson Syndrome or Toxic Epidermal Necrosis
(see Possible Side Effects in section 4).
Other medicines and Epanutin RMP
Tell your doctor if you are taking, have recently taken or
might take any other medicines.
Some medicines can affect the way Epanutin RMP works,
or Epanutin RMP itself can reduce the effectiveness of
other medicines taken at the same time. These include
(Not all medicines are listed here. Talk with your doctor
or pharmacist):
• Medicines used for heart and circulation problems (e.g.
dicoumarol, amiodarone, reserpine, digitoxin, digoxin,
disopyramide, mexiletine, nisoldipine, furosemide,
quinidine, warfarin and calcium channel blockers
including diltiazem and nifedipine)
• Medicines used for epilepsy (e.g. carbamazepine,
lamotrigine, phenobarbital, sodium valproate, valproic
acid, oxcarbazepine, topiramate, succinimides
including ethosuximide, and vigabatrin)
N. EPAN-L03

• Liver disease where the dosage may need to be
adjusted
• Kidney disease
• Diabetes
• Porphyria (an inherited disease that affects
haemoglobin biosynthesis)
• Heart rhythm problems (Epanutin RMP can treat
some rhythm problems, but can make others worse)
• Alcohol dependence.
You should be administered Epanutin RMP with caution
if you suffer from kidney or liver problems.
A small number of people being treated with
antiepileptics such as phenytoin sodium have had
thoughts of harming or killing themselves. If at any
time you have these thoughts, immediately contact
your doctor.
Potentially life-threatening skin rashes (Stevens Johnson
syndrome, toxic epidermal necrolysis) have been
reported with the use of Epanutin, appearing initially as
reddish target-like spots or circular patches often with
central blisters on the trunk. Additional signs to look for
include ulcers in the mouth, throat, nose, genitals and
conjunctivitis (red and swollen eyes). These potentially
life-threatening skin rashes are often accompanied by
flu-like symptoms. The rash may progress to widespread
blistering or peeling of the skin. The highest risk for
occurrence of serious skin reactions is within the first
weeks of treatment. If you have developed StevensJohnson syndrome or toxic epidermal necrolysis with
the use of Epanutin, you must not be re-started on
Epanutin at any time.

• Medicines used to treat fungal infections
(e.g. amphotericin B, f luconazole,
itraconazole, ketoconazole, posaconazole,
voriconazole,miconazole)
• Medicines used for tuberculosis and other infections
(e.g. chloramphenicol, isoniazid, rifampicin,
sulfonamides, sulfadiazine, sulfamethizole,
sulfamethoxazole-trimethoprim, sulfaphenazole,
sulfisoxazole, doxycycline, ciprofloxacin)
• Medicines used for stomach ulcers (e.g. omeprazole,
sucralfate and the medicines known as H2 antagonists
including cimetidine, ranitidine, famotidine and some
antacids)
• Medicines used for asthma and bronchitis (e.g.
theophylline)
• Medicines used for pain and inflammation (e.g.
phenylbutazone, salicylates including aspirin and
steroids)
• Medicines used for sleeplessness, depression and
psychiatric disorders (e.g. chlordiazepoxide, clozapine,
diazepam, disulfiram, fluoxetine, methylphenidate,
paroxetine, phenothiazines, quetiapine, trazodone,
tricyclic antidepressants, fluvoxamine, sertraline and
viloxazine)
• Medicines used for diabetes (e.g. tolbutamide)
• Some hormone replacement therapies (oestrogens),
oral contraceptives (the birth control pill)
• Medicines used for organ and tissue transplants, to
prevent rejection (e.g. ciclosporin, tacrolimus)

• Medicines used for cancer (e.g. antineoplastic agents
including teniposide, fluorouracil, capecitabine,
bleomycin, carboplatin, cisplatin, doxorubicin,
methotrexate)
• Medicines used to lower high blood cholesterol and
triglycerides (e.g. atorvastatin, fluvastatin, simvastatin)
• Medicines used in the treatment of HIV infection
(e.g. delavirdine, efavirenz, fosamprenavir, indinavir,
lopinavir, nelfinavir, ritonavir, saquinavir)
• Medicines used to expel parasitic worms from the
body (e.g. albendazole, praziquantel)
• Muscle relaxants used for surgery (neuromuscular
blockers), some anaesthetic medicines (halothane)
and methadone
• Some products available without a prescription (folic
acid, vitamin D).
Your doctor may need to test the amount of phenytoin
in your blood to help decide if any of these drugs are
affecting your treatment.
The herbal preparation St John’s wort (Hypericum
perforatum) should not be taken at the same time as this
medicine. If you already take St John’s wort, consult your
doctor before stopping the St John’s wort preparation.
Epanutin RMP may also interfere with certain laboratory
tests that you may be given.
Epanutin RMP with food, drink and alcohol
Drinking a lot of alcohol can also affect the concentration
of phenytoin in your blood.

Pregnancy, breast-feeding and fertility
If you do get pregnant while you are given Epanutin RMP
you must tell your doctor straight away. 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 benefits
of being given Epanutin RMP.
You should not breast-feed if you are being given
Epanutin RMP.
Driving and using machines
Epanutin RMP may cause dizziness or drowsiness. If
you experience these symptoms, do not drive or use
any tools or machines and contact your doctor.
Epanutin RMP contains ethanol and sodium
This medicinal product contains 8.8% ethanol (alcohol),
i.e. up to 440.4 mg per 5 ml ampoule, equivalent to
8.8 ml beer, 3.7 ml wine per dose. It may be harmful
if you suffer from alcoholism. It should be taken into
account in pregnant or breast-feeding women, children
and high risk groups such as patients with liver disease.
This medicine contains up to 1.1 mmol sodium (24.6 mg)
per 5 ml ampoule. This should be considered if you are
on a sodium-controlled diet.
3. How Epanutin RMP is given
You will be in hospital when you are given Epanutin RMP.
Epanutin RMP will be either injected into one of your large
veins (intravenously) or into your muscle (intramuscularly).

When given as an intravenous infusion, Epanutin RMP
must be diluted with normal saline. Intramuscular or
intravenous Epanutin RMP should not be added to
dextrose or dextrose-containing solutions as this could
interfere with the dose of this medicine.
The dose and concentration of the solution of
Epanutin RMP you are given will be decided by your
doctor and will be written as the equivalent dose of
phenytoin sodium (PE). The dose will be as mg per
dose if given as an injection or mg per ml of solution if
given as an infusion (drip).
Sometimes it is necessary to give Epanutin RMP into your
muscle if you cannot continue to take it by mouth. This is
not normally continued for longer than one week. When
switching from oral Epanutin to intramuscular injection,
the dose needs to be increased by approximately 50%.
When switching back to oral Epanutin, the dose should
be reduced to half the original oral dose for the same
period of time that the intramuscular injection was given.
This is because phenytoin continues to be released
from your muscles for sometime after the injections
have been given.
The recommended dose is as follows:
Adults
Severe epileptic seizure or fits (Status Epilepticus)
A dose of 10 to 15 mg per kg of body weight is given
intravenously at a rate not exceeding 50 mg per minute
in adults. This is followed by more Epanutin given every
6 to 8 hours either by injection or by mouth.
N. EPAN-L03

If Epanutin does not stop your seizures, other treatments
will be tried.
Cardiac arrhythmias (variations to normal heartbeat)
A dose of 3.5 to 5 mg per kg of body weight is given
intravenously, at a rate not exceeding 50 mg per minute.
This may be repeated a second time.
Neurosurgery
A dose of 100 to 200 mg may be given into your
muscle (intramuscularly) approximately every 4 hours
during surgery and for two to three days afterwards to
prevent seizures. This dosage may then be reduced
to a maintenance dose of 300 mg daily and adjusted
according to your blood levels.
Elderly
Lower or less frequent dosing may be needed in some
elderly patients due to decreased clearance of Epanutin
RMP. Your doctor may not need to change your dose,
but side effects can occur more often in the elderly.
Kidney or liver problems
Make sure your doctor knows if you have liver or kidney
problems as you may need your dose adjusted.
Use in children and adolescents
No dosage adjustment is required, but children tend
to breakdown the medicine faster than adults and this
may mean that your doctor has to change the number
or timing of the Epanutin doses.
Use in neonates (Very young babies)
The starting dose is usually 15 to 20 mg per kg of baby
weight. Intravenous Epanutin RMP should not be given

to neonates at a rate faster than 1 to 3 mg per kg body
weight per minute.
Intravenous Epanutin is more reliably absorbed than
oral Epanutin in very young babies.
If you are given more Epanutin RMP than you should
Epanutin is dangerous in overdose. If you think you
have been given too much Epanutin RMP, contact your
doctor immediately.
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects
although not everybody gets them.
Tell your doctor immediately if you experience any of
the following symptoms after being given this medicine.
• Sudden wheeziness, difficulty in breathing, swelling
of eyelids, face or lips, rash or itching (especially
affecting the whole body). There is a higher incidence
of this in black patients.
• If you experience skin discolouration, swelling and
pain where the injection was given which then starts
to spread down your arm to your hands and fingers.
This may mean you have a condition known as Purple
Glove Syndrome. In most cases this will improve
on its own but in some cases it can be serious and
require urgent medical treatment.
• If you develop potentially life-threatening skin rashes
that causes blistering (this can affect the mouth and

tongue). These may be signs of a condition known
as Stevens Johnson Syndrome, or toxic epidermal
necrolysis (TEN). These have been reported very
rarely.
• If you notice bruising, fever, you are looking pale or
you have a severe sore throat. These may be the
first signs of an abnormality of the blood, including
decreases in the number of red blood cells, white
cells or platelets. Your doctor may take regular
blood samples to test for these effects.
• Skin rash, fever, swollen glands, increase in a type
of white blood cell (eosinophilia), and inflammation
of internal organs (liver, lungs, heart, kidneys and
large intestine), you may also experience pain
and inflammation of the joints, these may be
signs of a hypersensitivity reaction (e.g. drug
reaction or rash with Eosinophilia and Systemic
Symptoms (DRESS)) or be related to a condition
called systemic lupus erythematosus (SLE).
• If you experience confusion or have a severe
mental illness, as this may be a sign that you have
high amounts of phenytoin in your blood. On rare
occasions, when the amount of the phenytoin in
the blood remains high, irreversible brain injury
has occurred. Your doctor may test your blood
to see how much phenytoin is in the blood and
may change your dose.

+ Expand Transcript

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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