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PHENYTOIN SODIUM TEVA 100 MG TABLETS
Active substance(s): PHENYTOIN SODIUM / PHENYTOIN SODIUM / PHENYTOIN SODIUM
231-30-86487-ZB LEA PHENYTOIN (PENTRAN) 100mg TAB TUK
PACKAGE LEAFLET: INFORMATION FOR THE USER
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
• 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 of the 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:
What Pentran is and what it is used for
What you need to know before you take Pentran
How to take Pentran
Possible side effects
How to store Pentran
Contents of the pack and other information
1 WHAT PENTRAN IS AND WHAT IT IS USED FOR
Pharma code 1613
Pentran is an anticonvulsant. The active ingredient in this
medicine is Phenytoin Sodium. This medicine will be referred to
as Pentran throughout this leaflet.
Pentran is used:
• to control or prevent seizures (fits)
• to treat trigeminal neuralgia (severe stabbing pain on one
side of the face affecting the forehead, cheek, lips, gums or
• for the prevention or control of seizures during or following
neurosurgery and or head injury.
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE
Do NOT take Pentran:
• If you are allergic (hypersensitive) to Phenytoin Sodium or any
of the other ingredients of this medicine
• If you have a known allergy (hypersensitivity) to hydantoins (a
group of antiepileptic drugs)
Take special care with Pentran
Warnings and precautions
-Potentially life-threatening skin rashes (Stevens-Johnson
syndrome, toxic epidermal necrolysis) have been reported with
the use of Pentran, 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 Pentran, you must not be
re-started on Pentran at any time.
-A small number of people being treated with anti-epileptics such
as Phenytoin Sodium have had thoughts of harming or killing
themselves. If at any time you have these thoughts, immediately
contact your doctor.
-Serious skin side effects can rarely occur during treatment with
Phenytoin Sodium. This risk may be associated with a variant in
genes in a subject of Chinese or Thai origin. If you are of such
origin and have been tested positively carrying this genetic variant
(HLA-B*1502), discuss this with your doctor before taking
If you develop a rash or these skin symptoms, seek immediate
advice from a doctor and tell him that you are taking this
Talk to your doctor before taking Pentran if you;
• are diabetic
• are pregnant or planning to become pregnant
• have liver or kidney problems
• suffer from petit mal fits as you may need additional medicine
to control your fits
• have low blood pressure
• are suffering from fever, rash, swelling of glands and liver
disease after starting this medicine
• have skin rash, fever, blistering on skin immediately contact
your doctor. Treatment may be discontinued in these cases.
• are being treated for alcohol addiction (e.g. taking disulfiram)
• have a rare hereditary problem of galactose intolerance or Lapp
• suffer from intermittent porphyria (a deficiency of specific
enzymes within the body, causing an increase of substances
Phenytoin may cause or aggravate absence seizures and
If you are to undergo surgery you should ensure that your doctor
and the anaesthetist are aware you are taking Pentran, as it may
interact with halothane and lidocaine (anaesthetics).
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Your doctor will be carrying out regular blood and urine tests
particularly at the start of your treatment and every month
afterwards. These may include blood glucose tests and tests to
check your liver is working properly, as well as tests to see how
much Pentran is in your blood.
Pentran can affect the results of other blood tests you may have;
make sure the doctor knows you are taking Pentran if you have
any other blood tests.
If you are taking Pentran for a long period of time your doctor may
recommend the use of Vitamin D supplements to prevent rickets
or osteomalacia (softening and weakening of the bones).
If you are taking Pentran your doctor may recommend the use of
folic acid (vitamin B) supplements.
If you see another doctor or go into hospital, let the staff know
what medicines you are taking.
Other medicines and PentranDo NOT take Pentran in combination
• the herbal remedy, St John’s Wort (Hypericum perforatum). If
you already take St John’s Wort, talk to your doctor before
stopping the St John’s Wort preparation.
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any of the following:
• other medicines for treatment of epilepsy e.g. carbamazepine,
lamotrigine, tiagabine, zonisamide, oxcarbazepine, valproate,
primidone, topiramate, succinimides e.g. ethosuximide, and
• medicines for treatment of fungal infections, such as
voriconazole, caspofungin, fluconazole, itraconazole,
ketoconazole and miconazole
• anti-malarial medicines such as chloroquine,
hydroxychloroquine, mefloquine and pyrimethamine
• medicines to thin the blood known as coumarins e.g. warfarin
• isoniazid and rifamycins (such as rifampicin) used to treat
• antibiotics for treatment of infections such as chloramphenicol,
sulphonamides, doxycycline, ciprofloxacin, clarithromycin,
metronidazole, telithromycin, or trimethoprim
• theophylline for asthma and bronchitis
• diazoxide, eplerenone and carbonic anhydrase inhibitors e.g.
acetazolamide for high blood pressure
• corticosteroids, aspirin, leflunomide or steroids for pain and
• medicines for treatment of stomach ulcers such as some
antacids, omeprazole, esomeprazole, sucralfate, and medicines
known as H2 antagonists e.g. cimetidine
• medicines known as 5HT3 antagonists e.g. ondansetron or
aprepitant, used to treat nausea
• medicines for treating psychiatric disorders such as clozapine,
phenothiazines , aripiprazole, quetiapine, sertindole, or lithium
• medicines known as benzodiazepines such as diazepam,
• medicines for treatment of depression known as MAOIs such as
moclobemide and phenelzine
• medicines for treatment of depression known as SSRIs such as
fluoxetine, sertraline, fluvoxamine, paroxetine
• other antidepressant medicines such as trazodone, mianserin
• methylphenidate for treating behavioural disorders
• modafinil for treating sleep disorders
• fluorouracil, methotrexate, etoposide, imatinib and levamisole
• bupropion for smoking addiction
• ciclosporins to prevent rejection of organ and tissue transplants
• medicines for heart problems such as dicoumarol, amiodarone,
reserpine, digitoxin, digoxin, furosemide, quinidine,
disopyramide, mexiletine, felodipine, isradipine, verapamil,
nisoldipine, dihydropyridines, nicardipine or calcium channel
blockers e.g. diltiazem and nifedipine
• tolbutamide for diabetes
• fluvastatin for high cholesterol
• disulfiram for alcohol abuse
• levodopa for Parkinson’s disease
• sulfinpyrazone, phenylbutazone for gout and arthritis
• medicines for the treatment of HIV infection such as abacavir,
amprenavir, indinavir, lopinavir, saquinavir, nelfinavir and
• tibolone, thyroid hormones, enteral foods, influenza vaccine,
Pentran may also interact with some hormone replacement
therapies (oestrogens), progestogen (contraceptive pill), other
oral contraceptives (the birth control pill) and toremifene,
gestrinone, the anaesthetic agent halothane, muscle relaxants
used for surgery (neuromuscular blockers), methadone and some
products available without a prescription (folic acid, antacids,
theophylline, vitamin D, salicylates e.g. aspirin).
Pentran tablets may also interfere with certain laboratory tests that
you may be given.
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
Pentran with food and drink and alcohol
Pentran can be taken before or after food and drinks. Drinking a lot
of alcohol can also affect the concentration of Pentran in your
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Top of page cut-off to middle of registration mark: 44 mm.
PENTRAN 100 mg TABLETS
TEVA UK Ref:
231-30-86487-ZB LEA PHENYTOIN (PENTRAN) 100mg TAB TUK
Pregnancy, breast-feeding and fertility
Pentran is not recommended if you are breast-feeding.
If you are pregnant, think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
Driving and using machines
Pentran may cause dizziness or drowsiness, especially during the
first few weeks of treatment. If you experience these symptoms,
do not drive or use any tools or machinery.
Pentran contains sucrose
Patients who are intolerant to sucrose should note that Pentran
tablets contain sucrose. If you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.
3 HOW TO TAKE PENTRAN
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
• Adults including the Elderly:
100 mg taken 2 to 4 times a day but this will be adjusted to suit
The usual maintenance dose is 200 to 500 mg daily in divided
Patients with reduced liver or kidney function may be given a
• Infants and children:
The doctor will calculate the appropriate dose of Pentran for
your child based on the child’s body weight.
The maximum daily dose is 300 mg.
• Newborn children:
The doctor will monitor your child and determine the
appropriate dose of Pentran.
The tablets should be swallowed preferably with a glass of water.
If you take more Pentran than you should
If you (or someone else) swallow a lot of the tablets all together or
if you think a child has swallowed any of the tablets contact your
nearest hospital casualty department or your doctor immediately.
An overdose is likely to cause involuntary movements of the eyes,
difficulty in controlling movements, slurred speech, coma, fixed
enlarged pupils, low blood pressure, breathing problems and high
levels of sugar in the blood. Please take this leaflet, any remaining
tablets and the container with you to the hospital or doctor so that
they know which tablets were consumed.
If you forget to take Pentran
If you forget to take your medicine, take it as soon as you
remember, unless it is nearly time to take the next dose. Do not
take a double dose to make up for a forgotten dose.
If you stop taking Pentran
Do not stop taking your medicine without talking to your doctor
first even if you feel better.
Do not stop taking Pentran suddenly as this may cause fits. Your
dose should be reduced gradually.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
4 POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
If the following happens, stop taking the tablets and tell your
doctor immediately or go to the casualty department at your
nearest hospital. Although following side effects are very rare,
these symptoms can be serious.
• an allergic reaction (swelling of the lips, face or neck leading to
severe difficulty in breathing; skin rash or hives)
• potentially life-threatening skin rashes (Stevens-Johnson
syndrome, toxic epidermal necrolysis) have been reported (see
section 2), or toxic epidermal necrolysis (TEN), which causes
blistering and can affect the mouth and tongue.
Your doctor may advise you to stop taking Petran Tablets until it
clears up. If the rash does not clear up or a serious reaction is
suspected, your doctor may advise you not to take Petran again.
• hypersensitivity syndrome has been reported, the symptoms of
which include inflammation in the joints, skin rash, fever,
swollen glands and liver problems. A condition known as
systemic lupus erythematosus may occur on rare occasions. A
rash may be the first sign of this condition but it may also be
noticed as fever, pain in the joints and general ill health.
Although still rare, you may be more likely to get this
syndrome, skin rash or liver damage, if you are black.
• If you experience confusion or have a severe mental illness, as
this may be a sign that you have high amounts of Pentran in
your blood. On rare occasions, when the amount of Pentran in
the blood remains high, irreversible brain injury has occurred.
Your doctor may test your blood to see how much Pentran is in
the blood and may change your dose.
• 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 (parts of the blood which help
it to clot). Your doctor may take regular blood samples to test
for these effects.
23 March 2016
The following side effects have been reported:
• unusual eye movements, unsteadiness, difficulty in controlling
movements, abnormal or uncoordinated movements, shaking,
wrist shaking, slurred speech, aggressive behaviour, confusion,
abnormal skin sensation, nervousness, memory problems,
double vision, depression, fits, pins and needles or numbness,
twitching muscles, loss of feeling in the hands or feet,
drowsiness, dizziness or vertigo (a feeling of dizziness or
“spinning”), sleeplessness, taste perversion, tiredness
malfunction of nerves in different parts of the body
• swelling of the lymph glands (a part of your body's natural
• inflammation of the wall of the arteries, enlargement of spleen
• hepatitis (inflammation of the liver) or liver damage which may
be recognised by yellowing of the skin and whites of the eyes
• feeling sick, being sick, constipation
• inflammation of the kidneys
• breathing problems, mainly inflammation of the lining of the
• changes in the hands with difficulty in straightening the fingers,
thickening of tissues in the palm
changes in facial features, enlarged lips or gums
• increased or abnormal body or facial hair
• changes in the shape of the penis and painful erection
• a condition affecting your joints known as polyarthropathy
• bleeding, tender or enlarged gums (may be reduced by
maintaining good oral hygiene and massaging the gums)
Pentran Tablets may alter the amount of vitamin D in your body
and decrease levels of blood calcium, phosphate 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.
Rickets (abnormal development of bone) may occur if this effect is
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.
Inflammation of the walls of the arteries and problems with the
body's defence against infection (the immune system) has also
When extremely high amounts of Pentran are in the blood,
extreme confusion sometimes referred to as delirium, psychosis
or encephalopathy (a brain disease) has been reported. On rare
occasions, when the amount of Pentran in the blood has remained
high for a long time, irreversible brain injury has occurred.
If you are elderly, or have kidney or liver disease, you may
experience these side effects at lower doses of Pentran than
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 PENTRAN
Keep this medicine out of the sight and reach of children.
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 that
Store below 25°C. Store in the original package.
Do not throw away any medicine via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help to protect the environment.
6 CONTENTS OF THE PACK AND OTHER
What Pentran tablets contain:
• The active ingredient has 100 mg of phenytoin sodium.
The other ingredients are calcium hydrogen phosphate dihydrate,
sucrose (icing sugar), sucrose , purified water and magnesium
stearate (E572). The coating consists of gelatin, sucrose, talc,
shellac (E904), beeswax (E901), carnauba wax (E903) and the
colour, titanium dioxide (E171). The printing ink contains shellac,
black iron oxide (E172) and propylene glycol (E1520).
What Pentran tablets look like and contents of the pack:
• Pentran 100 mg Tablets are white coated with APS or plain on
one side and 100/2302 on the reverse.
• The product is available in pack sizes of 7, 10, 14, 21, 28, 30, 50,
56, 60, 84, 90, 100, 110, 112, 120, 150, 160, 168 and 500. See
outer packaging or the pharmacy label for contents i.e. the
number of tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company responsible for
manufacture: TEVA UK Limited, Eastbourne, BN22 9AG
This leaflet was last revised: February 2016
323 x 200
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THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE
Teva Pharmaceuticals Europe B.V
Meaning of Signature
Regulatory Affairs Approval
21-Apr-2016 09:18:05 AM
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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.