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PHENYTOIN ACCORD 50 MG/ML SOLUTION FOR INJECTION/INFUSION

Active substance(s): PHENYTOIN SODIUM

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Package leaflet: Information for the patient

Phenytoin Accord 50 mg/ml
solution for injection or infusion
Phenytoin sodium

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 Phenytoin Accord 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 Phenytoin Accord (or
any other form of phenytoin).
What is in this leaflet:
1. What Phenytoin Accord is and what it is used for
2. What you need to know before you are given Phenytoin
Accord
3. How Phenytoin Accord is given
4. Possible side effects
5. How to store Phenytoin Accord
6. Contents of the pack and other information

1. What Phenytoin Accord 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 medicines.
Phenytoin Accord 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. Phenytoin Accord is also used
to control or prevent seizures for short periods of time
when antiepileptic medicinal products cannot be taken by
mouth.
Phenytoin Accord can also be used to treat specific heart
rhythm problems (cardiac arrhythmias) when these are
caused by the medicine digoxin, or when these do not
respond well to treatment with other medicines, or when
other treatments cannot be used.

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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, propoxyphene, 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 medicinal
products 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.
Phenytoin Accord may also interfere with certain
laboratory tests that you may be given.

You should consult your doctor if you are unsure why you
have been given Phenytoin Accord, if you do not feel
better or if you feel worse.

Phenytoin Accord with drinking alcohol
Drinking a lot of alcohol can also affect the concentration
of phenytoin in your blood.

2. What you need to know before you are
given Phenytoin Accord

Pregnancy and Breast-feeding
If you are or think you may be pregnant or are planning to
become pregnant, whilst having phenytoin, your doctor
will decide if you should continue with this medicine or
whether another would be more suitable during your
pregnancy.
Do not stop taking phenytoin until you have seen your
doctor as it is important to control your fits. If given during
pregnancy phenytoin may affect the baby but your doctor
may decide that it is very important that you continue with
phenytoin. He or she will explain the risks to you. Make
sure you are very clear about the risks and benefits of
taking Epanutin RMP.
As phenytoin is released into breast milk, you should not
breast-feed if you are taking this medicine.

Do not take Phenytoin Accord
- 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 Phenytoin Accord 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
- Kidney disease
- Diabetes
- Porphyria (an inherited disease that affects haemoglobin
biosynthesis)
- Heart rhythm problems (Phenytoin Accord can treat
some rhythm problems, but can make others worse)
- Alcohol dependence.
You should be administered Phenytoin Accord 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 phenytoin, 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 phenytoin injection, you must not be
re-started on phenytoin injection at any time.
If you develop a rash or these skin symptoms, stop taking
Phenytoin Accord, seek urgent advice from a doctor and tell
him that you are taking this medicine. Consult your doctor
before discontinuing Phenytoin Accord. 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 Phenytoin Accord
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 Phenytoin Accord
works, or Phenytoin Accord 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,

Children
Phenytoin is used for newborns, infants and children.
Ask your doctor or pharmacist for advice before taking
any medicine.
Driving and using machines
Phenytoin Accord may cause dizziness or drowsiness. If
you experience these symptoms, do not drive or use any
tools or machinery and contact your doctor.
Phenytoin Accord contains ethanol, sodium and
propylene glycol
This medicinal product contains 10 vol % ethanol
(alcohol), i.e. up to 406 mg per ampoule, equivalent to 10
ml beer, 4.17 ml wine per ampoule.
Harmful for those suffering from alcoholism.
To be taken into account in pregnant or breast-feeding
women, children and high risk groups such as patients
with liver disease, or epilepsy.
This medicinal product contains less than 1 mmol sodium
(23 mg) per ampoule, i.e. essentially ‘sodium- free’.
This medicinal product contains propylene glycol which
may cause alcohol-like symptoms.

3. How Phenytoin Accord is given
You will be in hospital when you are given Phenytoin
Accord.
Phenytoin Accord will be either injected into one of your
large veins (intravenously) or into your muscle
(intramuscularly). When given intravenously, Phenytoin
Accord must be diluted.
The dose and concentration of the solution of Phenytoin
Accord 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 Phenytoin Accord 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 phenytoin to intramuscular
injection, the dose needs to be increased by
approximately 50%. When switching back to oral
Phenytoin, 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
some time 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 phenytoin given every 6
to 8 hours either by injection or by mouth.
If phenytoin 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
Due to decreased clearance of Epanutin, lower or less
frequent dosing may be needed. The dose of Epanutin for
elderly patients who may be taking other medicines may
also need careful consideration and adjustment by their
doctor.
Kidney or liver problems
Make sure your doctor knows if you have liver or kidney
problems as you may need your dose adjusted
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 phenytoin doses.
Neonates (very young babies)
The starting dose is usually 15 to 20 mg per kg of baby
weight. Intravenous Phenytoin Accord should not be given
to neonates at a rate faster than 1 to 3 mg per kg body
weight per minute.
Intravenous phenytoin is more reliably absorbed than oral
phenytoin in very young babies.
If you are given more Phenytoin Accord than you
should
Phenytoin is dangerous in overdose. If you think you have
been given too much phenytoin, contact your doctor
immediately.
If you have any further questions on how to take this
product, ask your doctor, pharmacist or nurse.

4. Possible side-effects
Like all medicines, Phenytoin Accord 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. medicine 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 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 Phenytoin Accord 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.
- Endocrine disorders: There have been reports of
secondary hyperparathyroidism associated with
phenytoin use.

Reporting of side effects
If you get any side effects, talk to your doctor or
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, Website:
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 Phenytoin Accord
Keep this medicine out of the sight and reach of children.
The pharmacist will ensure that your medicine is not
stored above 25°C, or used after the expiry date which is
stamped on the pack. The expiry date refers to the last
day of that month. The pharmacist will also ensure that
Phenytoin Accord is kept in the original package.
The medicine should be used immediately, once opened
and discard any unused contents.

6. Contents of the pack and other
information
What Phenytoin Accord 50 mg/ml Solution for
injection or infusion contains
Each 5 ml ampoule contains 250 mg of the active
substance phenytoin sodium i.e. 50 mg/ml.
The other ingredients are propylene glycol, ethanol
(alcohol), sodium hydroxide (for pH-adjustment) and water
for injection.
What Phenytoin Accord looks like and contents of the
pack
Phenytoin Accord 50 mg/ml solution is available in glass
ampoule, is packed in a polystyrene tray or pvc/paper
blister within a carton, together with a patient information
leaflet.
Pack sizes
1 x 5 ml
5 x 5 ml
10 x 5 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow, Middlesex, HA1 4HF
United Kingdom
Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF
United Kingdom
This medicinal product is authorised in the Member
States of the EEA under the following names:
Name of the
Member State
Italy
Ireland
Romania
United Kingdom

Name of the medicinal product
Fenitoina Accord
Phenytoin 50 mg/ml solution for
injection/infusion
Fenitoină sodică Accord 50 mg/ml
soluţie injectabilă/perfuzabilă
Phenytoin Accord 50 mg/ml solution for
injection/infusion

This leaflet was last revised in 07/2017.
------------------------------------------------------------------------The following information is intended for healthcare
professionals only:
Practical information on the preparation/handling of the
medicinal product is provided here.
Intra-arterial administration must be avoided in view
of the high pH of the preparation.
Incompatibilities
Phenytoin Accord should not be mixed with other
medicinal products because of precipitation of phenytoin
acid.
Instructions for use and handling
For single use only. Once opened, use immediately and
discard any unused contents.
Parenteral medicinal products should be inspected
visually for particulate matter and discolouration prior to
administration, whenever solution and container permit.
Parenteral Phenytoin Accord is suitable for use as long as
it remains free of haziness and precipitate.
For infusion administration the parenteral phenytoin
should be diluted in 50-100 ml of normal saline, with the
final concentration of phenytoin in the solution not
exceeding 10 mg/ml. Administration should commence
immediately after the mixture has been prepared and
must be completed within one hour (the infusion mixture
should not be refrigerated). An in-line filter (0.22-0.50
microns) should be used. The diluted form is suitable for
use as long as it remains free of haziness and precipitate.

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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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