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PHENYTOIN SODIUM PFIZER READY-MIXED PARENTERAL 250MG/5ML SOLUTION FOR INJECTION OR INFUSION

Active substance(s): PHENYTOIN SODIUM / PHENYTOIN SODIUM / PHENYTOIN SODIUM

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Epanutin® Ready-Mixed
Parenteral 250mg/5ml Solution
for Injection or Infusion

2881
08.11.16[5]

(phenytoin sodium)
PATIENT INFORMATION LEAFLET
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 Ready-Mixed 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 Ready-Mixed (or any
other form of phenytoin).
This medicine is available using the above name but will be referred to as
Epanutin Ready-Mixed throughout the leaflet.
What is in this leaflet:
1. What Epanutin Ready-Mixed is and what it is used for
2. What you need to know before you are given Epanutin Ready-Mixed
3. How Epanutin Ready-Mixed is given
4. Possible side effects
5. How to store Epanutin Ready-Mixed
6. Contents of the pack and other information
1. WHAT EPANUTIN READY-MIXED 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 Ready-Mixed 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 Ready-Mixed is
also used to control or prevent seizures for short periods of time when
antiepileptic drugs cannot be taken by mouth.
Epanutin Ready-Mixed 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 Ready-Mixed, if you do not feel better or if you feel worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN
EPANUTIN READY-MIXED
Do not take Epanutin Ready-Mixed
- 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
Ready-Mixed if you suffer from or have suffered 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 Ready-Mixed can treat some rhythm
problems, but can make others worse)
- 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.
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 Ready-Mixed
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 Ready-Mixed works, or
Epanutin Ready-Mixed 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)
- 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, 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 Ready-Mixed may also interfere with certain laboratory tests that
you may be given.
Epanutin Ready-Mixed 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 Ready-Mixed.
Driving and using machines
Epanutin Ready-Mixed may cause dizziness or drowsiness. If you
experience these symptoms, do not drive or use any tools or machinery and
contact your doctor.
Epanutin Ready-Mixed 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 READY-MIXED IS GIVEN
You will be in hospital when you are given Epanutin Ready-Mixed.
Epanutin Ready-Mixed will be either injected into one of your large veins
(intravenously) or into your muscle (intramuscularly). When given
intravenously, Epanutin Ready-Mixed must be diluted.
The dose and concentration of the solution of Epanutin Ready-Mixed 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 Ready-Mixed 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.
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.
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.
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.
Neonates (Very young babies)
The starting dose is usually 15 to 20 mg per kg of baby weight. Intravenous
Epanutin Ready-Mixed 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 Ready-Mixed than you should
Epanutin is dangerous in overdose. If you think you have been given too
much Epanutin Ready-Mixed, 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.
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.
- 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 via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. HOW TO STORE EPANUTIN READY-MIXED
Keep out of the sight and reach of children.
Do not store above 25°C.
Store in the original package.
Do not use after the expiry date. This date is printed on your pack.
The Expiry date refers to last day of that month.
If the solution shows any signs of deterioration or discolouration, you should
seek the advice of your pharmacist who will tell you what to do.
Epanutin Ready-Mixed is for single use only. Any unused solution should be
discarded immediately after initial use.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Epanutin Ready-Mixed contains
The active ingredient is phenytoin sodium.
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 96%, sodium hydroxide,
water for injection and nitrogen (inert gas).
What Epanutin Ready-Mixed looks like and contents of the pack
Epanutin Ready-Mixed is a clear, colourless, sterile solution for injection in
transparent glass ampoules.
Epanutin Ready-Mixed is available in packs containing 5 and 10 ampoules.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Actavis Italy S.p.A, Nerviano, Italy.
Procured from within the EU by Product Licence holder:
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2881

Leaflet revision and issue date (Ref) 08.11.16[5]
Epanutin is a trademark of Parke, Davis & Company LLC.

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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