PHENYTOIN SODIUM 100 MG TABLETS

Active substance: PHENYTOIN SODIUM

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Ref:

231-30-86487-Y LEA PENTRAN 100mg TAB TUK

Version:

1

11 November 2013
?????

Trackwise Parent:

PL Number(s),
MA Holder & Packer:
Reason for revision:

231-10-23035
N/A
1613 (1001001110)
N/A
Unknown
Univers
7.5 Pt

?????

PL 00289/5236R. Teva UK Limited Licence, Teva Regulatory Team.
Packed at Teva UK Limited, Eastbourne.
Packing line:
V1: Text update due to printing ink change.

F. P. Code:
EAN Code:
Pharma Code:
Edge Code:
Third party code:
Fonts:
Base Font Size:

Child:

Dimensions:
L:
W:

323 mm
160 mm

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)
Please refer to the latest version of
the full base material specification:
92653, 92655, 92651

PANTONE® GREEN C
BLACK

S3 (PANTONE® 232 C)

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

PAGE 1: FRONT FACE (INSIDE OF REEL)

PACKAGE LEAFLET: INFORMATION
FOR THE USER
Read all of this leaflet carefully before you start
taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor
or pharmacist.
• This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if
their symptoms are the same as yours.
• If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

IN THIS LEAFLET:
1. What Pentran is and what it is used for
2. Before you take Pentran
3. How to take Pentran
4. Possible side effects
5. How to store Pentran
6. Further information

1

WHAT PENTRAN IS AND WHAT IT IS USED
FOR

(Main)

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 chin)
• for the prevention or control of seizures during
or following neurosurgery and or head injury.

2

BEFORE YOU TAKE PENTRAN

DO NOT take Pentran if you:
• are allergic (hypersensitive) to phenytoin sodium
or any of the other ingredients of this medicine
• have a known allergy (hypersensitivity) to
hydantoins (a group of antiepileptic drugs)
• suffer from intermittent porphyria (a deficiency of
specific enzymes within the body, causing an
increase of substances called porphyrins).
Take special care with Pentran
A small number of people being treated with
anti-epileptics such as Pentran 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 Pentran. 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 Pentran.
Tell your doctor before you start to take this medicine
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 lactose deficiency.
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).
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).

Taking other medicines
DO NOT take Pentran in combination with
• 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.
Talk to your doctor if you are taking 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 vigabatrin
• 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 tuberculosis
• 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 inflammation
• 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, clonazepam, chlordiazepoxide
• 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 and mirtazapine
• methylphenidate for treating behavioural disorders
• modafinil for treating sleep disorders
• fluorouracil, methotrexate, etoposide, imatinib and
levamisole for cancer
• 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 zidovudine
• tibolone, thyroid hormones, enteral foods,
influenza vaccine, phenobarbital.
Pentran may also interact with some hormone
replacement therapies (oestrogens), progestogen
(contraceptive pill), other oral contraceptives (the
birth control pill) and toremifene, and 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).

Top of page cut-off to middle of registration mark: 44 mm.

PENTRAN 100 mg TABLETS
Phenytoin Sodium

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.
Taking Pentran tablets with food and drink
Pentran can be taken before or after food and drinks.
Drinking a lot of alcohol can also affect the
concentration of Pentran in your blood.
Pregnancy and breast-feeding
Pentran is not recommended if you are
breast-feeding.
If you are pregnant or planning to become pregnant
ask your doctor or pharmacist for advice before
taking any medicine.

If you are taking Pentran your doctor may recommend Driving and using machines
Pentran may cause dizziness or drowsiness,
the use of folic acid (vitamin B) supplements.
especially during the first few weeks of treatment. If
If you see another doctor or go into hospital, let him you experience these symptoms, do not drive or use
any tools or machinery.
or the staff know what medicines you are taking.

REG0069130

Version 1.2

Approved

Page 1 of 3

Ref:

231-30-86487-Y LEA PENTRAN 100mg TAB TUK

Version:

1

11 November 2013
?????

Trackwise Parent:

PL Number(s),
MA Holder & Packer:
Reason for revision:

231-10-23035
N/A
1613 (1001001110)
N/A
Unknown
Univers
7.5 Pt

?????

PL 00289/5236R. Teva UK Limited Licence, Teva Regulatory Team.
Packed at Teva UK Limited, Eastbourne.
Packing line:
V1: Text update due to printing ink change.

F. P. Code:
EAN Code:
Pharma Code:
Edge Code:
Third party code:
Fonts:
Base Font Size:

Child:

Dimensions:
L:
W:

323 mm
160 mm

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)
Please refer to the latest version of
the full base material specification:
92653, 92655, 92651

PANTONE® GREEN C
BLACK

S3 (PANTONE® 232 C)

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

PAGE 2: REAR FACE (OUTSIDE OF REEL)

Important information about some of the ingredients The following side effects have been reported:
• unusual eye movements, unsteadiness, difficulty in
of Pentran
controlling movements, abnormal or
Patients who are intolerant to sucrose should note
uncoordinated movements, shaking, wrist shaking,
that Pentran tablets contain sucrose. If you have been
slurred speech, aggressive behaviour, confusion,
told by your doctor that you have an intolerance to
abnormal skin sensation, nervousness, memory
some sugars, contact your doctor before taking this
problems, double vision, depression, fits, pins and
medicinal product.
needles or numbness, twitching muscles, loss of
feeling in the hands or feet, drowsiness, dizziness
3 HOW TO TAKE PENTRAN
or vertigo (a feeling of dizziness or “spinning”),
Always take Pentran exactly as your doctor has told
sleeplessness, taste perversion, tiredness,
you. You should check with your doctor or pharmacist
malfunction of nerves in different parts of the body
if you are not sure.
simultaneously
• headaches
The tablets should be swallowed preferably with a
• swelling of the lymph glands (a part of your body's
glass of water.
natural defence system)
• inflammation of the wall of the arteries,
The usual dose is:
enlargement of spleen and liver
• Adults including the Elderly:
• hepatitis (inflammation of the liver) or liver
100 mg taken 2 to 4 times a day but this will be
damage which may be recognised by yellowing of
adjusted to suit you.
the skin and whites of the eyes
The usual maintenance dose is 200 to 500 mg daily
• feeling sick, being sick, constipation,
in divided doses.
Patients with reduced liver or kidney function may • inflammation of the kidneys
• breathing problems, mainly inflammation of the
be given a lower dose.
lining of the lung
• Infants and children:
• changes in the hands with difficulty in
The doctor will calculate the appropriate dose of
straightening the fingers, thickening of tissues in
Pentran for your child based on the child’s body
the palm
weight.
• changes in facial features, enlarged lips or gums
The maximum daily dose is 300 mg.
• increased or abnormal body or facial hair
• Newborn children:
• changes in the shape of the penis and painful
The doctor will monitor your child and determine
erection
the appropriate dose of Pentran.
• a condition affecting your joints known as
If you take more Pentran than you should
polyarthropathy.
If you (or someone else) swallow a lot of the tablets
Pentran Tablets may alter the amount of vitamin D in
all together or if you think a child has swallowed any your body and decrease levels of blood calcium,
of the tablets, contact your nearest hospital casualty phosphate and vitamin D. If you also do not get
department or your doctor immediately. An overdose enough vitamin D in your diet or from exposure to
is likely to cause involuntary movements of the eyes, sunlight, you may suffer from bone pain or fractures.
difficulty in controlling movements, slurred speech,
Rickets (abnormal development of bone) may occur if
coma, fixed enlarged pupils, low blood pressure,
this effect is prolonged.
breathing problems and high levels of sugar in the
There have been reports of bone disorders including
blood. Please take this leaflet, any remaining tablets
osteopenia and osteoporosis (thinning of the bone)
and the container with you to the hospital or doctor
and fractures. Check with your doctor or pharmacist
so that they know which tablets were consumed.
if you are on long-term antiepileptic medication,
have a history of osteoporosis, or take steroids.
If you forget to take Pentran
If you forget to take your medicine, take it as soon as Inflammation of the walls of the arteries and
you remember, unless it is nearly time to take the
problems with the body's defence against infection
next dose. Do not take a double dose to make up for (the immune system) has also been seen.
a forgotten dose.
When extremely high amounts of Pentran are in the
blood, extreme confusion sometimes referred to as
If you stop taking Pentran
delirium, psychosis or encephalopathy (a brain
Do not stop taking your medicine without talking to
disease) has been reported. On rare occasions, when
your doctor first even if you feel better.
the amount of Pentran in the blood has remained
Do not stop taking Pentran suddenly as this may
high for a long time, irreversible brain injury has
cause fits. Your dose should be reduced gradually.
occurred.
If you have any further questions on the use of this
If you are elderly, or have kidney or liver disease, you
product, ask your doctor or pharmacist.
may experience these side effects at lower doses of
Pentran than otherwise.
If any of the side effects get serious, or if you notice
4 POSSIBLE SIDE EFFECTS
any side effects not listed in this leaflet, please tell
Like all medicines, Pentran can cause side effects,
your doctor or pharmacist.
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 the
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)
• serious skin rash or itchiness occurs rarely and
includes Stevens-Johnson Syndrome, or toxic
epidermal necrolysis (TEN), which causes
blistering and can affect the mouth and tongue.
Your doctor may advise you to stop taking Pentran
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 Pentran 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.

REG0069130

Version 1.2

Approved

5

HOW TO STORE PENTRAN

Keep out of the reach and sight of children.
Store below 25°C. Store in the original package. Do
not use Pentran after the expiry date that is stated on
the outer packaging. The expiry date refers to the last
day of that month.
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

FURTHER INFORMATION

What Pentran tablets contain:
• The active ingredient has 100 mg of phenytoin
sodium.
• The other ingredients are calcium hydrogen
phosphate, 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: November 2013
86487-Y
PL 00289/5236R
323 x 160

Page 2 of 3

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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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