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PHENYTOIN SODIUM MILPHARM 50 MG FILM-COATED TABLETS

Active substance(s): PHENYTOIN SODIUM

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Package leaflet: Information for the user

Phenytoin Sodium Milpharm 50 mg
film-coated tablets
phenytoin sodium
Read all of this leaflet carefully before you start taking 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 or your
pharmacist.
• 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.
What is in this leaflet
1. What Phenytoin Milpharm tablets are and what they are used
for
2. What you need to know before you take Phenytoin Milpharm
tablets
3. How to take Phenytoin Milpharm tablets
4. Possible side effects
5. How to store Phenytoin Milpharm tablets
6. Contents of the pack and other information
1. What Phenytoin Milpharm tablets are and what they are
used for
The name of your medicine is Phenytoin Sodium Milpharm 50 mg
film-coated tablets (referred to as Phenytoin tablets or as Phenytoin
throughout this leaflet).Phenytoin is one of a group of medicines
called anti-epileptic drugs; these medicines are used to treat
epilepsy.
Phenytoin Milpharm can be used to control a variety of epileptic
conditions, to control or prevent seizures during or after brain
surgery or severe head injury. Phenytoin can also be used to treat
trigeminal neuralgia (facial nerve pain).
You should ask your doctor if you are unsure why you have been
given Phenytoin.
2. What you need to know before you take Phenytoin
Milpharm tablets
Do not take Phenytoin Milpharm tablets
• If you are allergic to phenytoin, or any of the other ingredients
of Phenytoin Milpharm tablets (listed in section 6).
• If you are allergic to other medicines with a similar chemical
structure to phenytoin (e.g. hydantoins)
• If you have severe damage to the blood cells and bone marrow
• If you have grade II and grade III AV block (disorder of heart
beat regulation)
• If you have a type of disorder that causes fainting and
sometimes fits called Strokes-Adams syndrome.
• If you suffer from sinus bradycardia (slow heart rate of less than
50 beats per minute), sick sinus syndrome or sino-atrial block
(disorders of heart beat regulation)
• If you have a had attack within the last three months
• If the output of your heart is poor (ask your doctor).
Warnings and precautions
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.
Phenytoin Milpharm tablets should not be given in
• heart failure (inability of heart to pump properly)
• impaired breathing function
• severe hypotension (systolic blood pressure less than
90 mm Hg)
• the following heart rhythm disturbances:
- grade I AV block
- atrial fibrillation
- atrial flutter
Phenytoin Milpharm tablets should be given with special precaution
if you suffer from or have suffered in the past from any of the
following conditions:
• impaired liver function
• impaired kidney function
your doctor will take blood and urine samples to monitor your liver
and kidney function. If you are diabetic you are more likely to get
hyperglycaemia (high blood sugar).
• Porphyria (an inherited disease that affects haemoglobin
biosynthesis)
Serious skin side effects can rarely occur during treatment with
phenytoin. This risk may be associated with a variant in genes in a
subject with Chinese or Thai origin. If you are of such origin and
have been tested previously carrying this genetic variant (HLAB*
1502), discuss this with your doctor before taking Phenytoin
Milpharm.
• 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

Black





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Phenytoin Sodium Milpharm 50 mg
film-coated tablets

Phenytoin Sodium Milpharm 50 mg
film-coated tablets

Pharmacode position may change as per Supplier's m/c requirement &additional
small pharma code may appear on the front / back panel

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, you must not be
re-started on Phenytoin at any time.
If you develop a rash or these skin symptoms, seek immediate
advice from a doctor and tell him that you are taking this
medicine.

Important information regarding treatment
• If you suffer from slow hydroxylation
Slow hydroxylation is an inherited disorder. It affects the way your
body uses and reacts to medicine.
If you suffer from slow hydroxylation you should therefore take
care. You may develop signs of overdose even at moderate doses.
In this case your dose should be reduced. Your doctor will take a
blood sample to check that the levels of phenytoin are not too high.
• If you suddenly stop taking Phenytoin Milpharm tablets
- you may suffer seizures more often
- you may develop status epilepticus (a state of persistent
seizure).
To avoid these problems your doctor may:
- reduce your dose of Phenytoin slowly
- start the new antiepileptic medication at a low dose and
gradually increase it.
Phenytoin blood levels
Phenytoin is a medicine with a narrow range between an effective
dose and one that is ineffective or cause side effects. The
absorption of phenytoin may also vary from day to day so you
should try to be consistent in taking your dose [for example at a
similar time each day]. If you have to switch to a different
formulation containing phenytoin, your doctor may monitor the
levels of phenytoin in your blood for a week or two to check that the
optimal dose is being prescribed.
Other medicines and Phenytoin Milpharm tablets
Some medicines can affect the way Phenytoin Milpharm
works, or Phenytoin Milpharm itself can reduce the
effectiveness of other medicines taken at the same time.
These include:
• Medicines used for heart and circulation problems (dicoumarol,
digitoxin, amiodarone, furosemide, quinidine, reserpine,
warfarin, and calcium channel blockers e.g. diltiazem and
nifedipine).
• Medicines used for epilepsy (carbamazepine, oxcarbazepine,
eslicarbazepine, zonisamide, topiramate, tigabine, lamotrigine,
phenobarbital, sodium valproate and valproic acid,
succinimides e.g. ethosuximide and vigabatrin).
• Medicines used to treat fungal infections (e.g. amphotericin B,
fluconazole, itraconazole, ketoconazole and miconazole).
• Medicines used for tuberculosis and other infections
(chloramphenicol, isoniazid, rifampicin, sulphonamides,
doxycycline and nelfinavir).
• Medicines used for stomach ulcers (omeprazole, sucralfate, the
medicines known as H2 antagonists e.g. cimetidine, ranitidine,
famotidine and some antacids).
• Medicines used for asthma and bronchitis (theophylline).
• Medicines used for pain and inflammation (phenylbutazone,
salicylates e.g.aspirin and steroids).
• Medicines used for sleeplessness, depression and psychiatric
disorders (chlordiazepoxide, clozapine, diazepam, disulfiram,
fluoxetine, methylphenidate, paroxetine, phenothiazines,
trazodone, tricyclic antidepressants, fluvoxamine, sertraline and
viloxazine).
• Medicines used for diabetes (tolbutamide).
• Some hormone replacement therapies (oestrogens), oral
contraceptives (the birth control pill).
• Medicines used for organ and tissue transplants, to prevent
rejection (ciclosporin).
• Medicines used for cancer (antineoplastic agents)
• Muscle relaxants used for surgery (neuromuscular blockers),
some anaesthetic drugs (halothane) and methadone
• Some products available without a prescription (folic acid,
theophylline, vitamin D).
Your doctor may need to test the amount of Phenytoin in your blood
to help decide if any of these medicines 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 may also interfere with certain laboratory tests that you
may be given.
Tell your doctor or pharmacist if you are taking have recently taken
or might take any other medicines.
Phenytoin Milpharm with food, drink and alcohol
Phenytoin can be taken before or after food and drinks. Drinking a
lot of alcohol can also affect the concentration of Phenytoin in your
blood.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine.
Phenytoin tablets should not be taken during pregnancy, unless
you are told otherwise by your doctor, because it might increase the
risk of birth defects.

If you take Phenytoin Milpharm tablets to treat your seizures, do not
interrupt the therapy during pregnancy without consulting first your
doctor, as any abrupt discontinuation of treatment or uncontrolled
dose reduction can cause recurrence of seizures, which may harm
you and/or your unborn child.

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 (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. 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 medical tests: increased levels of blood sugar, or
decreased levels of blood calcium, folic acid and vitamin D. If
you also do not get enough vitamin D in your diet or from
exposure to sunlight, you may suffer from bone pain or
fractures.
Effects on your respiratory system: problems 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.







You should not take Phenytoin Milpharm if you are breast-feeding.
Driving and using machines
Phenytoin may cause symptoms like dizziness or drowsiness,
especially during the first few weeks of treatment or following a
dose increase. Patients are advised not to drive or use machines
until it is established that their ability to perform such activities is
not affected.



3. How to take Phenytoin Milpharm tablets.
Always take this medicine exactly as your doctor has told you.
Check with your doctor if you are not sure.



It is best to take Phenytoin at the same time each day.
Swallow the tablets whole, with plenty of water.



Adults
The amount of Phenytoin needed varies from one person to
another. Most adults need between 200mg and 500mg a day either
as a single or divided dose. Occasionally higher doses are needed.
Children
Infants and children usually start on a dose that depends on their
weight (5mg per day for every kg they weigh) and is given as a
divided dose, twice a day. The dose is then adjusted up to a
maximum of 300mg a day.
Elderly
The dose of Phenytoin for elderly patients who may be taking other
medicines may also need careful consideration and adjustment by
their doctor.
If you take more Phenytoin Milpharm tablets than you should
Phenytoin is dangerous in overdose. If you accidentally take too
much Phenytoin contact your doctor at once or go to the nearest
hospital casualty department. Always take the labelled medicine
package with you, whether there is any Phenytoin left or not.
If you forget to take Phenytoin Milpharm tablets
If you forget to take a dose, take it as soon as you remember
unless it is time for your next dose.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Phenytoin Milpharm tablets
Do not stop taking Phenytoin Milpharm unless your doctor tells you
to. If you suddenly stop taking this medicine you may have a
seizure. Should you need to stop taking Phenytoin, your doctor will
have decided which the best method is for you.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
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 Phenytoin Milpharm tablets
Keep this medicine out of the sight and reach of children
Store in the original package in order to protect from moisture.
Keep the HDPE container tightly closed
Do not use this medicine after the expiry date which is stated on
the carton after EXP. The expiry date refers to the last day of the
month.
Do not throw away any medicines via waste water or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Phenytoin Milpharm contain
• The active substance is phenytoin sodium. Each film-coated
tablet contains 50 mg of phenytoin sodium.


Tablet coat:
Hypromellose
Macrogol 400
Titanium dioxide
Sodium lauryl sulfate

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 taking this medicine. Although they are
very rare, these symptoms can be serious.
• Sudden wheeziness, difficulty in breathing, swelling of eyelids,
face or lips, rash or itching (especially affecting the whole
body).
• 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 cells, white cells or platelets. Your doctor may take regular
blood samples to test for these effects.
• Skin rash and fever with swollen glands, particularly in the first
two months of treatment, as these may be signs of a
hypersensitivity reaction. If these are severe and you also
experience pain and inflammation of the joints this could be
related to a condition called systemic lupus erythematosus.
• 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 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.
Tell your doctor immediately if you experience any of the
following symptoms after taking this medicine. Although they are
rare, these symptoms can be serious.
• Potentially life-threatening skin rashes (Stevens-Johnson
syndrome, toxic epidermal necrolysis) have been reported (see
section 2).
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 taste change.
Effects on your skin: skin rash including measles-like
reactions which are mild.

The other ingredient are
Tablet core:
Mannitol
Crospovidone
Magnesium stearate
Croscarmellose sodium

What Phenytoin Milpharm tablets look like and contents of the
pack
White to off-white, oval shaped, film-coated tablets debossed with
‘C’ on one side and ‘69’ on the other side. The tablets size is
10.1 mm x 5.6 mm.
Polyamide / aluminium / PVC / aluminium blister pack:
10, 14, 20, 28, 30, 50, 60, 84, 100, 112, 200 and 250 film-coated
tablets
HDPE container with a polypropylene closure and silica gel
desiccant:
30 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares Block
Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Or
Milpharm Limited
Ares Block
Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
This leaflet was last revised in 02/2016.

P15xxxxx

If treatment with Phenytoin Milpharm tablets is essential, your
doctor will prescribe the lowest effective daily dose to control your
seizures. Pregnancy may also alter the effectiveness of Phenytoin
Milpharm tablets, so you may need blood tests and your dose of
Phenytoin Milpharm tablets may have to be adjusted.

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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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