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ƉÊȯ‡†‰˙‡·†˙Â¢†˙ÂÙ¯˙†ÔÒÁ‡Ï†Ôȇ
±∞¥≤∑Æ≤¥∂∑∏†∫‰Ù¯˙‰†ÌÂ˘È¯†ßÒÓ
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EPAN CAPS PL SH 220307
±π∏∂†≠†Â¢Ó˘˙‰†®ÌÈ¯È˘Î˙©†ÌÈÁ˜Â¯‰†˙Â˜˙†ÈÙφÔίˆÏ†ÔÂÏÚ
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¯˘Â‡Â†˜„·†ÂÎÂ˙†˙‡ȯ·‰†„¯˘Ó†È¢Ú†Ú·˜†‰Ê†ÔÂÏÚ†ËÓ¯ÂÙ
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Phenytoin Sodium 100 mg†∫‰ÏÈÎÓ†‰ÒÂÓΆÏÎ
‚¢Ó†π∂Ʊµ†≠†Ê¢φ‰ÏÈÎÓ†‰ÒÂÓΉ
∫ÌÈÏÈÚÙ†È˙Ï·†ÌȯÓÂÁ
Lactose monohydrate, magnesium stearate, maize starch, gelatin,
water, erythrosine E127, quinoline yellow E104, titanium dioxide
E171, shellac, propylene glycol, iron oxide, butyl alcohol, isopropyl
alcohol and methylated spirit, or alcohol, ammonium solution,
potassium hydroxide.
ÆÌÈÒÂίن„‚Â†∫˙ÈËÈÂÙ¯˙†‰ˆÂ·˜
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∫ÏÂÙÈˉ†˙ÏÁ˙‰†ÈÙφ‡Ù¯·†ıÚÂÂȉφÈÏ·Ó†‰Ù¯˙·†˘Ó˙˘‰Ï†Ôȇ
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ıÂÚÈȉ†ÈÊίÓÓ†„Á‡†ÌÚ†ıÚÂÂȉφÍÈÏÚ†¨Ô¢‡¯‰†˘ÈÏ˘·†„ÁÂÈÓ·†¨ÔÂȯ‰‰†Íωӷ†ÂÊ
Ư·ÂÚ·†‰ÚÈ‚ÙφÔÂÎÈÒ‰†˙ίډ†Ì˘Ï†¨ÌÈÈ‚ÂÏÂ˯ˉ
Íȉ†Ì‡†ÏÂÙÈˉ†˙ÏÁ˙‰†ÈÙφ‡Ù¯·†ıÚÂÂȉφÈÏ·Ó†‰Ù¯˙·†˘Ó˙˘‰Ï†Ôȇ
∫„˜Ù˙·†È˜ÈÏÓ†¯·Ú·†˙Ϸ҆‡†˙ØÏ·ÂÒ†Íȉ†Ì‡†¨‰È¯ÈÙ¯ÂÙ‰†˙ÏÁÓÓ†˙ØÏ·ÂÒ
Æ˙¯ÎÂÒ†¨®‰˘È¯˜©†Ì„‰†˙ίÚÓ†¨Ô˙˘‰†˙ίÚÓ؉ÈÏΉ†¨„·Î‰†¨Ì„†ÈÏΆ·Ï‰
øÍÏ˘†ÌÂȆÌÂȉ†ÈÈÁ†ÏÚ†‰Ù¯˙‰†ÚÈÙ˘˙†Íȇ
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˘È†ÌÈ„ÏÈφ¯˘‡·†Æ˙Â¯ÈÚ†˙·ÈÈÁÓ‰†˙ÂÏÈÚÙ†Ïη†˙ÂÎÂÒÓ†˙ÂÂÎÓ†˙ÏÚÙ‰·
ƉӄΆ˘È·Î‰†˙·¯˜·†ÌȘÁ˘Óӆ‡†ÌÈÈÙ‡†ÏÚ†‰·Èίӆ̯ȉʉÏ
ƉÙ¯˙‰†ÌÚ†ÏÂÙÈˉ†˙Ù˜˙·†ÌÈÙȯÁ†˙‡˜˘Ó†Â‡†˙ÂÈȆ˙Â˙˘Ï†Ôȇ
˙ÂÈÚ·†ÚÂÓφȄΆ‰Ù‰†˙ÈȂȉ†ÏÚ†„ÈÙ˜‰Ï†˘È†‰Ù¯˙·†ÏÂÙÈˉ†˙Ù˜˙·
ÆÌÈÈÎÈÁ·
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̯‚ÂÏÙˆ‡Â¯Ë˜Ï‡†¨„·Î†È„˜Ù˙†¨Ì„†˙˜Ȅ·†Í¯Úφ˘È†Âʆ‰Ù¯˙·†ÏÂÙÈˉ†˙Ù˜˙·
ÆÌ„·†ÔȇÂËÈÙ†˙Ó¯†¨(EEG)
˙Â˙ÈÂÂچȄ‚Âφ„ÁÂÈÓ·†¨È‰˘ÏΆ‰Ù¯˙φ‡†Â‰˘ÏΆÔÂÊÓφ‰Ø˘È‚¯†Íȉ†Ì‡
ƉÙ¯˙‰†˙ÏÈË†ÈÙφ‡Ù¯φÍÎ≠ÏÚ†ÚȄ‰φÍÈÏÚ†¨ÔȇÂË„ȉ‰†˙ˆÂ·˜Ó
˙ÏÈË†ÏÚ†‡Ù¯φÚȄ‰φÍÈÏچȇÂÙ¯†ÏÂÙȈ‡†®ÈÏË„†ÏÏÂΩ†ÁÂ˙È†ÏΆÈÙÏ
ÆÂʆ‰Ù¯˙
‰„·ÚÓ†˙˜Ȅ·Â†Ì„·†˙ÂÓ¯‰†˙‡ˆÂ˙†ÏÚ†ÚÈÙ˘‰Ï†‰ÏÂÎȆÂʆ‰Ù¯˙†∫·Ï†ÈØÌÈ˘
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ƯÎÂÒ†ԄÈÒ†¨GGT
ÆÊ¢ÏφÌÈ˘È‚¯‰†ÌÈ˘‡†Ïˆ‡†‰È‚¯Ï‡Ï†Ì¯‚φÏÂÏچʢφÏÈÎÓ†¯È˘Î˙‰
∫˙ÂÈ˙Ù¯˙≠ÔÈ·†˙·‚˙
¨˙¯Á‡†‰Ù¯˙·†ÏÂÙȈ‰˙Ú†‰Ê†˙ÓÈÈ҆̇†Â‡†¨˙ÙÒÂ†‰Ù¯˙†˙ØÏËÂ†Íȉ†Ì‡
˙·‚˙Ó†ÌÈÚ·Â‰†˙ÂÏÈÚÈ≠ȇ†Â‡†ÌÈÂÎÈÒ†ÚÂÓφȄΆÏÙËÓ‰†‡Ù¯φÁ„φÍÈÏÚ
∫˙‡·‰†˙ˆ·˜‰Ó†˙ÂÙ¯˙†È·‚φ„ÁÂÈÓ·†¨˙ÂÈ˙Ù¯˙≠ÔÈ·
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ÆÔÈϘȈ¯Ëˆ¨ÏË‡Â˜Èʇ¯Ù†¨ÔÈϘȈÈҘ„†¨ÔÈÒ‡Ò˜ÂÏÙ¯ÙȈ†¨„ÈʇÈÂÊȇ
¨B†ÔȈȯËÂÙÓ‡†¨ÏÂÊ˜ÈÓ†¨ÏÂÊ˜Â˘†¨ÏÂÊ˜ÂÏÙ†∫˙ÂÈ˙ÈȯËÈÙ†ÈË‡†˙ÂÙ¯˙
ÆÌÈÏÂʇ†¨ÏÂÊ˜‡¯Ëȇ
ÆÏÂʯÙÓ‡†¨ËÙϯ˜ÂÒ†¨ÔÈ„ÈËÓÈÒ†∫‰·È˜†·Èη†ÏÂÙÈËφ˙ÂÙ¯˙
PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The dispensing of this medicine requires a doctor’s prescription
Read the entire leaflet carefully in its entirety before using this medicine
The format of this leaflet was determined by the Ministry of Health
and its content was checked and approved
Epanutin 100 mg
Capsules
Composition:
Each capsule contains 100 mg Phenytoin Sodium.
The capsule contains lactose - 96.15 mg
Inactive ingredients: Lactose monohydrate, magnesium stearate, maize starch,
gelatin, water, erythrosine E127, quinoline yellow E104, titanium dioxide E171,
shellac, propylene glycol, iron oxide, butyl alcohol, isopropyl alcohol and methylated
spirit, or alcohol, ammonium solution, potassium hydroxide.
Therapeutic group: Anticonvulsant.
Therapeutic activity: Antiepileptic drug.
When should the preparation not be used?
Do not use this medicine if you are breastfeeding.
Do not use this medicine if you are sensitive to any of its ingredients.
Do not use this medicine without consulting a physician before starting
treatment:
If you are pregnant, because this medicine may harm the fetus. If you were exposed
to this medicine during pregnancy, especially in the first trimester, you should
consult with one of teratological centers for assessment of the risk of harming the
fetus.
Do not use this medicine without consulting a physician before starting treatment
if you are suffering from porphyria, if you are suffering or have suffered in the past,
from impaired function of the heart and vascular system, the liver, the kidney/urinary
tract, the blood system (e.g. coagulation disorder), from diabetes.
How will this medicine affect your daily life?
Use of this medicine may impair alertness and therefore caution should be
exercised when engaging in activities such as driving a car, operating dangerous
machinery and in any other activity which requires alertness.
Children should be cautioned against engaging in activities such as bicycle riding,
playing near roads and the like.
Do not drink wine or alcoholic beverages while under treatment with this medicine.
During treatment with this medicine it is important to maintain good oral hygiene
in order to avoid gum problems.
Warnings:
During treatment with this medicine, the following tests should be performed: blood,
hepatic function, electroencephalogram (EEG), and phenytoin concentrations in
the serum.
If you are sensitive to any type of food or medicine, especially to hydantoin
anticonvulsants, inform your physician before commencing treatment with this
medicine.
Before any kind of surgery (including dental surgery) or medical treatment inform
your physician that you are taking this medicine.
Attention: This medicine may affect serum levels and laboratory test results of PBI
(protein-bound iodine), dexamethasone, metyrapone, alkaline phosphatase, glucose,
GGT, calcium and sugar.
The preparation contains lactose and may cause an allergic reaction in patients
sensitive to lactose.
Drug Interactions:
If you are taking another drug concomitantly or if you have just finished treatment
with another medicine, inform the attending physician, in order to prevent hazards
or lack of efficacy arising from drug interactions. This is especially important for
medicines belonging to the following groups:
Drugs affecting the central nervous system [e.g. sedatives (such as: chlordiazepoxide,
diazepam, disulfiram, methylphenidate, trazodone, viloxazine), anesthetics (such
as: halothane), antidepressants (such as: tricyclics, fluoxetine, fluvoxamine, sertraline,
clozapine, paroxetine), antihistamines].
Antibacterial drugs: chloramphenicol, sulfonamides, rifampin, erythromycin, isoniazid,
ciprofloxacin, doxycycline, praziquantel, tetracycline.
Antifungal drugs: fluconazole, ketoconazole, miconazole, amphotericin B, itraconazole,
azoles.
Antiulcer drugs: cimetidine, sucralfate, omeprazole.
Xanthines: aminophylline, theophylline.
Anticoagulants.
Other antiepileptic and anticonvulsant drugs (felbamate, succinimide, vigabatrin,
carbamazepine, barbiturates, valproic acid, sodium valproate, lamotrigine).
Hormones: estrogens, corticosteroids.
Hypoglycemic drugs: tolbutamide, diazoxine, chlorpropamide, glyburide.
Analgesic and anti-inflammatory drugs: azapropazone, phenylbutazone, salicylates.
Cardiovascular agents and drugs treating hypertension: amiodarone, dicumarol,
diltiazem, nifedipine, ticlopidine, reserpine, digitoxin, nicardipine, nimodipine,
quinidine, verapamil.
Diuretics: furosemide.
Neuromuscular blocking agents: alcuronium, pancuronium, vercuronium.
Other drugs: cyclosporine, methadone, nelfinavir, vitamin D and nutritional
supplements.
Do not take or stop taking another kind of medicine without consulting your physician.
Use of this drug may decrease the effect of oral contraceptive, therefore you should
use a different or additional means of birth control.
Side Effects:
In addition to the desired effect of the medicine, adverse reactions may occur
during the course of taking this medicine, for example: constipation, dizziness, mild
drowsiness.
Side effects that require special attention:
Confusion, mild nervousness, insomnia, headache, speech or coordination disorders,
tingling sensation, hypotension, respiratory distress up to loss of consciousness,
nausea, vomiting, fever, increase in convulsions, tremor, muscle weakness or pain,
joint pains, bleeding of the gums, swelling of the lips, skin rash with irritation, sore
throat: continue treatment and refer to your physician immediately.
In the event that you experience side effects not mentioned in this leaflet, or if there
is a change in your general health, consult your physician immediately.
Adverse reactions and drug interactions in children and infants:
Parents must inform the attending doctor about any side effect, as well as any
additional medicine being taken by the child!
Dosage:
Dosage is according to physician’s instructions only.
Do not exceed the recommended dosage.
In children: If the daily dosage cannot be divided equally, the larger dose should
be given at bedtime.
Attention:
Allow a lapse of at least two hours between taking this medicine and taking antacids
that include calcium, other preparations that include calcium and molindone
hydrochloride.
Directions for Use:
Swallow the capsule with a glass of water. Take the medicine with food.
How can you contribute to the success of the treatment?
Complete the full course of treatment as instructed by the physician.
Even if there is an improvement in your health, do not discontinue use of this
medicine before consulting your physician. Reduction in dosage will usually be
done gradually. Your physician may want you to carry a medical identification card
stating that you are taking this medicine.
Avoid Poisoning!
This medicine, and all other medicines, must be stored in a safe place out of the
reach of children and/or infants, to avoid poisoning. If you have taken an overdose,
or if a child has accidentally swallowed the medicine, proceed immediately to a
hospital emergency room and bring the package of the medicine with you.
Do not induce vomiting unless explicitly instructed to do so by a physician!
This medicine has been prescribed for the treatment of your ailment; in another
patient it may cause harm. Do not give this medicine to your relatives, neighbors
or acquaintances.
Do not take medicines in the dark! Check the label and the dose each time you
take your medicine. Wear glasses if you need them.
Storage: Store in a dark place below 25oC.
Even if kept in their original container and stored as recommended, medicines may
be kept for a limited period only. Please note the expiry date of the medicine! In
case of doubt, consult the pharmacist who dispensed the medicine to you.
Do not store different medications in the same package.
License Number: 10427.24678
Manufacturer: Godecke, Parke-Davis, Germany.
For: Pfizer Pharmaceuticals Israel Ltd., 9 Shenkar St., Herzeliya Pituach 46725.