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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 intravenously,
Epanutin RMP must be diluted.
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).

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
occassions, when the amount of the phenytoin
in the blood remains high, irreversible brain injury


Package leaflet: Information for the patient

Epanutin RMP

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


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.

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.
If Epanutin does not stop your seizures, other
treatments will be tried.
Cardiac arrhythmias (variations to normal
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.
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.
Older people
Your doctor will not need to change your dose, but
side effects may occur more often in older people.
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.


3. How Epanutin RMP is given

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).

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.

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

2. What you need to know before you are given
Epanutin RMP

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

Do not take Epanutin RMP
• If you are allergic (hypersensitive) 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


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If you have developed Stevens-Johnson syndrome or
toxic epidermal necrolysis with the use of Epanutin,
you must not be re-started on Epanutin at any time.
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, including medicines
obtained without a prescription.
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:
• Medicines used for heart and circulation problems
(e.g. dicoumarol, amiodarone, reserpine, digitoxin,
digoxin, mexiletine, nisoldipine, furosemide,
quinidine, warfarin and calcium channel blockers
including diltiazem and nifedipine)

in the past from any of the following conditions:
• Low blood pressure or heart failure
• Liver disease where the dosage may need to
be adjusted
• Diabetes
• Porphyria (an inherited disease that affects
haemoglobin biosynthesis)
• Heart rhythm problems (Epanutin RMP can treat
some rhythm problems, but can make others
• Alcohol dependence.
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.

• Medicines used for epilepsy (e.g. carbamazepine,
lamotrigine, phenobarbital, sodium valproate, valproic
acid, oxcarbazepine, topiramate, succinimides
including ethosuximide, and vigabatrin)
• Medicines used to treat fungal infections
(e.g. amphotericin B, fluconazole,
itraconazole, ketoconazole, posaconazole,
• 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.
• Medicines used for pain and inflammation (e.g.
phenylbutazone, salicylates including aspirin and
• 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,
• 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 drinking alcohol
Drinking a lot of alcohol can also affect the concentration
of phenytoin in your blood.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant, or are
planning to have a baby, ask your doctor for advice
before you are given Epanutin.
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 machinery 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.

has occurred. Your doctor may test your blood to
see how much phenytoin is in the blood and may
change your dose.
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 measleslike 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.
• Effects on your respiratory system: problems
breathing including complete stopping of breathing,
inflammation of the lining of the lung.
• 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:
ADR Reporting website:
5. How to store Epanutin RMP
The storage of Epanutin RMP will not be your
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
Epanutin RMP is for single use only. Any unused solution
should be discarded immediately after initial use.
Keep out of the sight and reach of children.
6. Contents of the pack and other information
What Epanutin RMP 250  mg/5  ml Solution for
injection or infusion contains

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
CT13 9NJ
Actavis Italy S.p.A.
Viale Pasteur 10
20014 Nerviano (Milan)
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 09/2016
Ref: EP 32_0 

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.