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PHENYTOIN WOCKHARDT 100MG COATED TABLETS

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

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Package leaflet: Information for the user
Phenytoin Wockhardt 100mg Coated Tablets
Phenytoin Sodium
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or 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.
The name of your medicine is Phenytoin Wockhardt 100mg Coated Tablets.
In the rest of this leaflet it is called Phenytoin Tablets.
What is in this leaflet:
1. What Phenytoin Tablets are and what they are used for
2. What you need to know before you take Phenytoin Tablets
3. How to take Phenytoin Tablets
4. Possible side effects
5. How to store Phenytoin Tablets
6. Contents of the pack and other information
1. What Phenytoin Tablets are and what they are used for
The active ingredient in Phenytoin Tablets is called phenytoin sodium. Phenytoin belongs to
a group of medicines called anticonvulsants which prevent fits.
Phenytoin Tablets are used in the control of seizures due to various types of epilepsy.
They can also be used to treat seizures during or after brain surgery and/or serious head
injuries.
In addition they may also be used in the treatment of trigeminal neuralgia (face pain) if
carbamazepine does not work or cannot be taken.
2. What you need to know before you take Phenytoin Tablets
Do not take Phenytoin Tablets if you:
• are allergic to phenytoin, other similar anticonvulsant medicines or any of the other
ingredients of this medicine listed in section 6)
• are allergic to other medicines for epilepsy
• are taking medicines for HIV infection, such as delavirdine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Phenytoin Tablets if you suffer from or have
suffered in the past from any of the following conditions:





Liver disease
Porphyria (an inherited disease that affects haemoglobin biosynthesis)
Alcohol dependence.

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.
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, you must not be re-started on phenytoin at any time.
If you develop a rash or these skin symptoms, stop taking Phenytoin Tablets, seek urgent
advice from a doctor and tell him that you are taking this medicine.
This risk of these serious skin side effects 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
Phenytoin Tablets.
Phenytoin may affect the breakdown of the sugar, glucose, and may prevent the release of the
hormone, insulin which could lead to high blood sugar. This is particularly important if you
are diabetic.
Black patients may be at greater risk of loiver problems, serious skin reactions and allergic
reactions.
Warnings and precautions
Talk to your doctor before taking Phenytoin Tablets if you:
• have liver, kidney or thyroid problems
• if you suffer from absence (petit mal) seizures or myoclonic seizures (brief, shock-like jerks
of a muscle or group of muscles)
• if you are currently taking an alternative antiepileptic
• are being fed through a tube or into a vein
• suffer from diabetes mellitus
• are an alcoholic
• suffer from any blood disorders
• have a fever with a temperature above 38ºC for more than 24 hours
• are elderly (aged 65 years or older) or the patient is a neonate (a newborn infant aged less
than four weeks)
• are suffering from a long term or chronic illness
• have porphyria

• have a high level of urea in the blood (uraemia)
• suffer from AIDS and have kidney problems or a low blood albumin level
• are pregnant, planning to become pregnant or you are breast feeding.
If any of the above statements apply to you, you should speak to your doctor before taking
Phenytoin Tablets.
You should make sure you have enough vitamin D in your diet, or get enough exposure to
sunshine, while taking Phenytoin Tablets.
Required tests
If you are required to have blood tests for any reasons other than your treatment with
phenytoin, you should let your doctor or nurse know you are taking this medication since
Phenytoin Tablets may interfere with various laboratory tests including tests for liver and
thyroid function and blood sugar levels.
You will be required to have regular blood tests when you are taking these tablets and your
liver and thyroid will be monitored.
You will also need to have tests to monitor your brain function and physical examinations
including dental check-ups.
Other medicines and Phenytoin Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines or herbal products, even those you may have bought yourself without a
prescription.
Please particularly check with your doctor if you are taking or need to take any of the
following:
Other medicines used to treat epilepsy:
• such as sodium valproate, clonazepam, oxcarbazepine, carbamazepine, lamotrigine,
tiagabine, topiramate, phenobarbital, ethosuximide, primodone and vigabatrin
Medicines that help your nervous system or brain:
• methylphenidate or modafinil, nervous system stimulants
• levodopa used to treat Parkinson’s Disease
• medicines used to treat depression such as bupropion, tricyclic antidepressants,
monoamine oxidase inhibitors (MAOIs), maprotiline, fluoxetine, sertraline, fluvoxamine,
trazodone, viloxazine, mianserin and paroxetine
• medicines used to treat anxiety such as diazepam, chlordiazepoxide, clonazepam or other
benzodiazepines
• medicines used to treat sleeplessness, depression and psychiatric disorders such as
clozapine, quetiapine, sertindole, haloperidol, phenothiazines, thioxanthines, loxapine, and
lithium
• the herbal remedy St John’s wort (Hypericum perforatum).
Medicines that fight infections:
• antibiotics such as isoniazid, chloramphenicol, clarithromycin, cycloserine, metronidazole,

co-trimoxazole, trimethoprim, other sulphonamides, rifamycin, rifampicin and doxycycline,
sulfadiazine, sulfamethiazole, sulfamethoxazole – trimethoprim, sulfaphenazole,
sulfisoxazole, ciprofloxacin
• medicines used to treat fungal infections e.g. miconazole, fluconazole, ketoconazole,
Amphotericin B, voriconazole, posaconazole and itraconazole
• medicines used to treat virus infections such as indinavir, nelfinavir, lopinavir,
saquinavir and zidovudine
• medicines used to treat malaria e.g. pyrimethamine
• influenza (flu) virus vaccine
Medicines to treat cardiovascular or lung problems:
• medicines used to treat heart problems such as, mexilitine, amiodarone, quinidine,
disopyramide, cardiac glycosides (e.g. digoxin and digitoxin)
• medicines to treat high blood pressure e.g. diazoxide, diltiazem, nifedipine, verapamil,
felodipine, isradipine, nisoldipine and nicardapine
• medicines to prevent blood clots e.g. coumarin, nicoumalone, dicoumarol, warfarin and
ticlopidine
• acetazolamide, a diuretic (water tablet), also used for mountain sickness
• medicines used to treat breathing difficulties including asthma and bronchitis, such as
theophylline
Medicines to treat gastric problems:
• medicines used to treat stomach ulcers e.g. cimetidine, esomeprazole, omeprazole and
sucralfate, ranitidine, famotidine and some antacids.
• medicines containing calcium including antacids used to treat indigestion (take them two
to three hours before or after taking your phenytoin tablets)
Anti cancer medicines:
• methotrexate, bleomycin, carmustine, cisplatin, vinblastine, capecitabine, fluorouracil,
levamisonle, busulfan, etoposide and imatinib.
• toremifene and tamoxifen, used to treat breast cancer
Alcohol and drugs of abuse:
• alcohol
• medicines used to treat alcohol abuse e.g. disulfiram
• medicines to treat drug abuse e.g. methadone
Other medicines:
• hormone containing medicines including oestrogens, oral contraceptives (the birth control
pill), gestrinone and tibolone
• medicines used for pain relief and inflammation such as aspirin, paracetamol,
phenylbutazone or other non-steroidal anti-inflammatory drugs, or azapropazone. (Do not
take Phenytoin Tablets if you are taking azapropazone)
• levothyroxine used to treat thyroid problems
• steroids, used to treat a variety of conditions e.g. fludrocortisone, dexamethasone,
methylprednisolone, prednisolone, prednisone and other glucocorticoids.
• medicines used to treat diabetes including tolbutamide and repaglinide. (Do not take
Phenytoin Tablets if you are taking repaglinide)
• anaesthetics (enfluane, halothane and methoxyflurane)

• medicines used to relax the muscles during an anaesthetic, such as pancuronium.
• vitamin D, folic acid and folinic acid
• sulfinpyrazone, used to treat gout
• medicines used to expel parasitic worms from the body such as mebendazole and
praziquantel
• medicines used to treat immune system disorders such as leflunomide, tacrolimus and
ciclosporin
Phenytoin Tablets with alcohol
Your Phenytoin Tablets may not work properly if you drink alcohol whilst taking them.
Pregnancy and breast-feeding
You should speak to your doctor about your epilepsy treatment if you are planning to become
pregnant. If you get pregnant whilst taking Phenytoin Tablets you should tell the doctor
straight away. It is important that your epilepsy remains well controlled but as with other
anti-epilepsy treatments, phenytoin can damage the nervous system of unborn babies as well
as cause other effects. Your doctor may advise you to take extra folic acid if you’re planning
to become pregnant and while you’re pregnant. If taken during pregnancy Phenytoin
Tablets may also cause bleeding in the infant and mother. The risk of this may be reduced by
the administration of vitamin K around the time of delivery.
Phenytoin passes into breast milk.
Breastfeeding is not recommended while taking phenytoin.
You should speak to your doctor if you wish to breast-feed whilst taking Phenytoin Tablets
Driving and using machines
You will need to discuss with your doctor whether you should drive or operate machinery,
which will depend on how well your fits are controlled. Phenytoin Tablets may cause you to
feel drowsy, dizzy or uncoordinated. If you experience any of these symptoms, you should
not drive or operate machinery.
Phenytoin 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 Phenytoin Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
Unless instructed differently, take your tablets with a glass of water.
Adults
The starting dose of Phenytoin Tablets in adults and the elderly varies from person to person
and depends on body weight, but is usually 3 to 4mg/kg.
The usual maintenance dose is 200 to 500mg daily as a single or divided doses.
Children and infants

The starting dose of Phenytoin Tablets in children and infants depends on body weight, but is
usually 5mg/kg in two or three doses. The usual maintenance dose is 4 to 8mg/kg daily in
divided doses. The maximum dose is 300mg a day.
Neonates (Infants aged less than four weeks)
It is important that the levels of phenytoin are measured since the absorption of phenytoin in
neonates is variable.
Elderly
The same doses may be given as for other adults unless you have liver or kidney problems or
a low albumin level in your blood.
These doses may be adjusted by your doctor.
Patients with liver problems
If you have liver problems a reduced dose will be given.
If you take more Phenytoin Tablets than you should
If you take more Phenytoin Tablets than you should, contact your doctor, pharmacist or
nearest hospital casualty department immediately. Take this leaflet and any remaining tablets
with you.
If you accidentally take too many tablets, initially you may have blurred vision, involuntary
movement of the eyes from side to side, loss of coordination, fits and slurred speech. This
may be followed by unconsciousness, enlarged or fixed pupils and low blood pressure.
Serious breathing and blood circulation problems can be life-threatening.
If you forget to take Phenytoin Tablets
If you miss a dose of Phenytoin Tablets, take another dose as soon as you remember. If it is
almost time for your next dose, then do not take the missed dose at all. Do not take a double
dose to make up for a forgotten dose.
Stopping Phenytoin Tablets
Do not stop taking this medicine without speaking to your doctor first.
Phenytoin Tablets should be withdrawn slowly as sudden withdrawal may cause your
fits/epilepsy to reoccur.
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.
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal
necrolysis) have been reported rarely (see section 2).
If you experience any of the following side effects, contact your doctor immediately:
• fever, sore throat, mouth ulcers, bruising or bleeding which may be caused by blood
disorders
• rash or acne, particularly if associated with fever, redness and blistering of the skin (this can
also affect the mouth and tongue)

• sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or
itching (especially affecting the whole body) as this may be due to an allergic reaction
• yellowing of the skin and/or whites of the eyes which may be due to a liver reaction
• large lymph glands, since these can be a sign of cancer of the lymph system
Other side effects to tell your doctor about immediately include:
• involuntary movement of the eyes from side to side
• seeing double
• more frequent seizures
• high blood sugar (which may cause extreme thirst)
• loss of coordination, slurred speech, confusion and twitching (‘tics’)
• involuntary movements or spasms (muscle contractions)
• shaking
• pins and needles or numbness of your hands and fingers or the loss of the sensation of pain
• effects on mental function and the ability to think (especially in children)
If you get any of the above side effects, you should tell your doctor immediately, since the
level of phenytoin in your blood may be too high.
Common side effects include:
• loss of appetite
• headache
• dizziness
• nervousness
• sleeping problems
• drowsiness
• feeling sick
• being sick
• constipation
• gum problems (particularly in younger patients)
• increased body hair in females.
Other side effects include:
• enlargement of facial features
• enlargement of lips
• men may experience genital pain or abnormal bending of the penis when sexually aroused
(Peyronie’s disease), or breast enlargement
• fatigue (feeling tired), feeling unwell, flu like symptoms, muscle or joint pains, or lumps on
your legs
• hepatitis (a liver disease) or other liver problems
• kidney problems
• lung problems
• bent fingers (Dupuytrens’ contracture)
• bone problems due to low levels of calcium or vitamin D
• swelling of glands around the mouth
• increased levels of cholesterol or triglycerides in your blood
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.

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 Phenytoin Tablets
Phenytoin Tablets must be kept out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the packet. The expiry date
refers to the last day of that month.
• The tablets should not be used if they show any signs of deterioration such as
discolouration.
• Phenytoin Tablets should not be stored above 25°C. The tablets should be kept in their
original container, in order to protect from moisture. Do not transfer the tablets to another
container.
• Two desiccants have been placed on top of the tablets. These are not to be eaten; they
protect the tablets from moisture.
Do not throw away any medicines via wastewater 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 Tablets contain
The active substance is phenytoin sodium.
92mg of phenytoin is equivalent to 100mg of phenytoin sodium.
The other ingredients are icing sugar, calcium hydrogen phosphate, sucrose, purified water,
magnesium stearate, Byco-C (gelatin), titanium dioxide (E171), sucrose, talc and Opaglos
6000P (E901, E903, E904).
What Phenytoin Tablets look like and contents of the pack
The tablets are white, circular, sugar coated tablets that are rounded on both sides.
The registered pack sizes are 100, 250, 500, 1000 and 5000 tablets in
polyethylene/polypropylene containers.
Not all pack sizes may be marketed.
Other formats
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of
charge: 0800 198 5000 (UK Only)
Please be ready to give the following information:
Product Name
Phenytoin Wockhardt 100mg Coated Tablets

Reference Number
29831/0176

This is a service provided by the Royal National Institute of Blind People.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13
9UF, UK.
Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK.
This leaflet was last revised in 12/2016

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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