Isocort Cream_PL

355
Íappleȉ†Ì‡†„ÁÂÈÓ·†¨˙ÂÈ˙Ù¯˙≠ÔÈ·†˙·‚˙Ó†ÌÈÚ·Âapple‰†˙ÂÏÈÚÈ≠ȇ†Â‡
ÆÈappleˆÈÁ†˘ÂÓÈ˘Ï†ÌȯÁ‡†ÌÈ¯È˘Î˙·†˙Ø˘Ó˙˘Ó
∫ȇÂÂφ˙ÂÚÙÂ˙
˙ÂÏÂÏÚ†‰·†˘ÂÓÈ˘‰†ÔÓÊ·†¨‰Ù¯˙‰†Ï˘†‰Èˆ¯‰†˙ÂÏÈÚÙφÛÒÂapple·
¨˙ÂÈÓÂÓ„‡Â†‰Áȯن¨„¯Ȃ†È¯Ȃ†∫Ô‚Ά¨È‡ÂÂφ˙ÂÚÙÂ˙†ÚÈÙ‰Ï
ÆÏÙÂËÓ‰†¯ÂÊȇ·†ıˆ˜Ú†ÌÂÁ†˙˘‚¯‰
¯Á‡Ï†¯ˆ˜†ÔÓʆÍÂ˙†ÏÏÎ≠ͯ„·†ÛÂÏÁφ˙ÂÈ¢چÂχ†˙ÂÚÙÂ˙
Ôappleȇ†Âχ†È‡ÂÂφ˙ÂÚÙÂ˙˘†‰„ÈÓ·†Æ‰Ù¯˙φ˙ÂÏ‚˙Ò‰‰†˙Ù˜˙
‰Ú¯Ï†¯Á‡†ÈÂappleÈ˘†ÏΆ‡†˙È‚¯Ï‡†‰·Â‚˙†‰ÚÈÙÂӆ̇†Â‡†˙ÂÙÏÂÁ
·˘†‰¯˜Ó†Ïη†Æ‡Ù¯φ˙ÂappleÙφÏÂÙÈˉ†˙‡†˜ÈÒىφ˘È†¨¯ÂÚ·
ÏÁ†Ì‡†Â‡†¨‰Ê†ÔÂÏÚ·†ÂappleÈȈ†‡Ï˘†È‡ÂÂφ˙ÂÚÙÂ˙†‰Ø˘È‚¯Ó†Íappleȉ
Æ„ÈÓ†‡Ù¯‰†ÌÚ†ıÚÈÈ˙‰Ï†ÍÈÏÚ†˙ÈÏÏΉ†Í˙˘‚¯‰·†ÈÂappleÈ˘
∫˙˜ÂappleÈ˙†ÌÈ„ÏÈ·†˙ÂÈ˙Ù¯˙†ÔÈ·†˙·‚˙†ȇÂÂφ˙ÂÚÙÂ˙
ÏÚ†ÔΆȇÂÂφ˙ÚÙÂ˙†ÏΆÏÚ†ÏÙËÓ‰†‡Ù¯φÁ„φÌȯ‰‰†ÏÚ
ȇÂÂφ˙ÂÚÙÂ˙†ÏÈÚφÈ؉‡¯†°‰Ø„ÏÈφ˙apple˙Èapple‰†˙ÙÒÂapple†‰Ù¯˙†ÏÎ
ÆÂ˯ÂÙ˘†˙ÂÈ˙Ù¯˙†ÔÈ·†˙·‚˙Â
∫ÔÂappleÈÓ
˙ˆÏÓÂÓ‰†‰appleÓ‰†ÏÚ†¯Â·ÚφÔȇ†Æ„·Ï·†‡Ù¯‰†˙‡¯Â‰†ÈÙφÔÂappleÈÓ
Æ˙ˆÏÓÂÓ‰†ÏÂÙÈˉ†˙Ù˜˙†Ïچ‡
∫‡Ù¯ӆ˙¯Á‡†‰‡¯Â‰†¯„Ú‰·†Ï·Â˜Ó†ÔÂappleÈÓ
ÏÂÙÈˉ†˙‡†ÆÚ‚apple‰†Áˢ‰†ÏÚ†ÌÂÈ·†ÌÈÈÓÚن̯˜‰†˙‡†Á¯Óφ˘È
‰¯ÂÈ˘†‡Ù¯φ˙ÂappleÙφÌÈÈÚ·˘†È¯Á‡†¯Á‡Ӊ†ÏÎφÌÈÈÒφ˘È
Æͯˆ‰†ÈÙφÏÂÙÈˉ†Í˘Ó‰†ÏÚ
ƇÙ¯φ˙ÂappleÙφ˘È†ÌÈÓȆ¯ÙÒÓ†ÍÂ˙†Í·ˆÓ·†¯ÂÙÈ˘†ÏÁ†‡Ï†Ì‡
̇†Æ‡Ù¯‰†˙‡¯Â‰†È¢ÙÚ†‡Ï‡†˙Óˇ†‰˘È·Á·†˘Ó˙˘‰Ï†Ôȇ
≤¥†≠Ó†¯˙ÂȆ‡Ï†È¯Á‡†‰˘È·Á‰†˙‡†ÛÈÏÁ‰Ï†˘È†¨˘ÂÓÈ˘‰†¯˙‰
Æ®˙Óˇ†‰˘È·Á†Ìȉӆ˜ÂappleÈ˙φ˜ÈËÒÏÙÓ†ÌÈÏÂ˙ÈÁ©†˙ÂÚ˘
∫·Ï†ÈØÌÈ˘
Æ„·Ï·†ÈappleˆÈÁ†˘ÂÓÈ˘Ï†˙„ÚÂÈÓ†Âʆ‰Ù¯˙†°ÚÂϷφ‡Ï
øÏÂÙÈˉ†˙Áψ‰Ï†ÚÈÈÒφÈØÏÎÂ˙†„ˆÈÎ
ƇÙ¯‰†È„È≠ÏÚ†ıÏÓ‰˘†ÏÂÙÈˉ†˙‡†ÌÈÏ˘‰Ï†ÍÈÏÚ
ÏÂÙÈˉ†˙‡†˜ÈÒىφÔȇ†Í˙‡ȯ·†·ˆÓ·†¯ÂÙÈ˘†ÏÁ†Ì‡†Ì‚
ƇÙ¯†ÌÚ†˙ˆÚÈÈ˙‰†‡Ïφ‰Ù¯˙·
ÌÈÈ˙ÈȯËÙ†ÌÈÓ‰ÈÊ·†ÛÒÂapple†ÈÙȈÙÒ†ÏÂÙȈÏÚ†‰¯ÂȆ‡Ù¯‰†ÌÈÓÚÙÏ
ÆÈχȯ˘·†Ì‰ÈʆÌÚ†„ÁÈ·†ÌÈ·¯ÂÚÓ‰
°‰ÏÚ¯‰†ÈØÚappleÓ
ıÂÁÓ†¯Â‚̘҆ӷ†¯ÂÓ˘Ï†˘È†˙¯Á‡†‰Ù¯˙†ÏΆÂʆ‰Ù¯˙
ƉÏÚ¯‰†ÈØÚappleÓ˙†ÍΆȄÈ≠ÏÚ†˙˜ÂappleÈ˙†Â‡Ø†ÌÈ„ÏÈ†Ï˘†Ì„Ȇ‚˘È‰Ï
Ï˘†ÔÂÈÓ†¯„Áφ„ÈÓ†È؉appleÙ†¨‰Ù¯˙‰†ÔÓ†„ÏȆÚÏ·†˙ÂÚË·†Ì‡
ÆÍ˙ȇ†‰Ù¯˙‰†˙Êȯ‡†È؇·‰Â†¨ÌÈÏÂÁ≠˙È·
°‡Ù¯ӆ˙˘¯ÂÙÓ†‰‡¯Â‰†‡Ïφ‰‡˜‰Ï†Ì¯‚φÔȇ
‰ÏÂÏÚ†‡È‰†˙دÁ‡†‰ÏÂÁ·†¨Í˙ÏÁÓ·†ÏÂÙÈËφ‰Ó˘¯apple†Âʆ‰Ù¯˙
ÆÍȯÎӆ‡†ÍÈapple΢†¨Íȷ¯˜Ï†Âʆ‰Ù¯˙†ÈØÔ˙˙†Ï‡†Æ˜ÈʉÏ
Ï熉appleӉ†˙ÈÂÂ˙‰†˙‡†˜Â„·Ï†˘È†°Í˘ÂÁ·†˙ÂÙ¯˙†ÏÂËÈφÔȇ
Íappleȉ†Ì‡†ÌÈÈÙ˜˘Ó†·Èί‰Ï†˘È†Æ‰Ù¯˙†˙ØÏËÂapple†Íappleȉ˘†ÌÚÙ
Æ̉φ‰Ø˜Â˜Ê
Ưȯ˜†Ì˜ӷ†∫‰appleÒÁ‡
˙Â¯Ó˘apple†˙ÂÙ¯˙†¨ÌȈÏÓÂÓ‰†‰appleÒÁ‡‰Ø‰Êȯ‡‰†È‡apple˙†ÈÙφ̂
Ï˘†‰‚ÂÙ˙‰†Íȯ‡˙φ·Ï†ÌÈ˘Ï†‡apple†Æ„·Ï·†˙Ï·‚ÂÓ†‰Ù˜˙Ï
˜ÙÈÒ˘†Á˜Â¯·†ıÚÂÂȉφÍÈÏÚ†¨˜ÙÒ†Ï˘†‰¯˜Ó†Ïη†°¯È˘Î˙‰
ƉÊȯ‡†‰˙‡·†˙Âapple¢†˙ÂÙ¯˙†ÔÒÁ‡Ï†Ôȇ†Æ‰Ù¯˙‰†˙‡†ÍÏ
¥∏∂≤Æ≤¥±≤≥†∫‰Ù¯˙‰†ÌÂ˘È¯†ßÒÓ
ÆÌÁ¯Ȇ¨Ó¢Ú·†‰˜ÈË·ˆÓ¯Ù†Ï‡¯˘È†Â‚ȯن∫Ô¯ˆÈ
±±Æ±≤Æ∞∏ 30200770
355
ÌÈÁ˜Â¯‰†˙Âapple˜˙†ÈÙφÔίˆÏ†ÔÂÏÚ
±π∏∂†≠†Â¢Ó˘˙‰†®ÌÈ¯È˘Î˙©
‡Ù¯†Ì˘¯Ó·†˙·ÈÈÁ†Âʆ‰Ù¯˙
‰Ù¯˙·†ÈØ˘Ó˙˘˙†Ì¯Ë·†ÂÙÂÒ†„Ú†ÔÂÏÚ‰†˙‡†ÔÂÈÚ·†È؇¯˜
˙‡ȯ·‰†„¯˘Ó†È¢Ú†Ú·˜apple†‰Ê†ÔÂÏÚ†ËÓ¯ÂÙ
„È≠ÏÚ†¯˘Â‡Â†˜„·apple†ÂappleÎÂ˙Â
˯˜ÂÊȇ
̯˜
∫·Î¯‰
∫ÏÈÎӆ̯˜†Ë¯Â˜ÂÊȇ†Ï˘†Ì¯‚†±†ÏÎ
Isoconazole nitrate 10 mg
Diflucortolone valerate 1 mg
∫ÌÈÏÈÚÙ†È˙Ï·†ÌȯÓÂÁ
Polysorbate 60, sorbitan monostearate, cetostearyl
alcohol, white petrolatum, heavy liquid paraffin, disodium
EDTA, purified water
∫˙ÈËÈÂÙ¯˙†‰ˆÂ·˜
ÆÏÂʇ„ÈÓȇ¯ËÈapple†Ï˘†˙¯Ê‚apple†‡Â‰†Isoconazole
Ƅȇ¯ËÒ˜È˯˜†‡Â‰†Diflucortolone
∫˙ȇÂÙ¯†˙ÂÏÈÚÙ
·Èίӆ˙ÙÒÂ˙·†·Á¯†Áˆ˙ÏÚ·†˙È˙ÈȯËÙ≠ÈËapple‡†‰Ù¯˙
ÆȄȇ˜È˯˜
ÏÂÙÈËφ ˙·ȂӉ† ¯ÂÚ† ˙˜τ·† ÏÂÙÈËφ ˘Ó˘Ó† ˯˜ÂÊȇ
ÆÈapple˘Ó†È˙ÈȯËن̉ÈÊ·†˙ÂÂÏÓ‰†¨È„ȇ˜È˯˜
ø‰Ù¯˙·†˘Ó˙˘‰Ï†Ôȇ†È˙Ó
ÆÔ¢‡¯†˘ÈÏ˘·†ÔÂȯ‰·†Íappleȉ†¯˘‡Î†‰Ù¯˙·†È˘Ó˙˘˙†Ï‡
ƉÙ¯˙‰†È·ÈίÓÓ†„Á‡Ï†˙Â˘È‚¯†Íφ‰Ú„Ȇ̇†˘Ó˙˘‰Ï†Ôȇ
Èχȯ˘·†Â‡†Èχ¯È†Ì‰ÈÊ†Ï˘†Ìȯ˜Ó·†‰Ù¯˙·†˘Ó˙˘‰Ï†Ôȇ
Æ®¯ÂÚ‰†˙ÙÁ˘†Ô‚Ω
˙ÏÁ˙‰†ÈappleÙφ‡Ù¯·†ıÚÂÂȉφÈÏ·Ó†‰Ù¯˙·†˘Ó˙˘‰Ï†Ôȇ
∫Ìȇ·‰†ÌÈ·ˆÓ·†ÏÂÙÈˉ
ÆÔ¯Á‡†˘ÈÏ˘·†ÔÂȯ‰·†Íappleȉ†Ì‡
˙‡†Á¯ÓφÔȇ†¨‰Ù¯˙·†˘ÂÓÈ˘†¯˘È‡†‡Ù¯‰Â†‰˜ÈappleÈÓ†Íappleȉ†Ì‡
Ɖ˜apple‰‰†ÈappleÙφ‰ÊÁ‰†ÏÚ†¯È˘Î˙‰
˙ίÚÓ†„˜Ù˙·†È˜ÈÏÓ†¯·Ú·†˙Ϸ҆‡†˙ØÏ·ÂÒ†Íappleȉ†Ì‡
ÆÔÂÒÈÁ‰†˙ίÚÓ†¨„·Î‰†¨Ì„‰†ÈÏΆ¨®‰Ó˙Ò‡†Ô‚Ω†‰ÓÈ˘apple‰
ÆÌ˘¯apple†‰Ó˘Ï˘†ÂÊÓ†‰apple¢†‰¯ËÓφ‰Ù¯˙·†˘Ó˙˘‰Ï†Ôȇ
∫˙¯‰Ê‡
Ú‚Ó†Ï˘†‰¯˜Ó·†ÆÌÈÈappleÈÚ‰†ÌÚ†Ú‚Ó·†‡Â·Ï†‰Ù¯˙φ˙˙φÔȇ
Æ·Ëȉ†Ô˙‡†ÛÂË˘Ï†˘È†ÌÈÈappleÈÚ‰†ÌÚ
ƇÙ¯‰†˙‡¯Â‰†È¢ÙÚ†‡Ï‡†ÌÈappleÙ‰†ÏÚ†‰Ù¯˙‰†˙‡†Á¯ÓφÔȇ
˘ÂÓÈ˘‰†ÆÌȯ‚·˙ӷ†ÌÈ„ÏÈ·†˘ÂÓÈ˘·†˙˘¯„apple†˙„ÁÂÈÓ†˙¯ȉÊ
ÆȇÂÙ¯†·˜ÚÓ·†‰ÂÂÏÓ†˙Âȉφ·ÈÈÁ
ÚȄ‰φÍÈÏÚ†¨È‰˘ÏΆ‰Ù¯˙φ‡†Â‰˘ÏΆ¯ÓÂÁφ‰Ø˘È‚¯†Íappleȉ†Ì‡
ƉÙ¯˙·†˘ÂÓÈ˘‰†ÈappleÙφ‡Ù¯φÍÎ≠ÏÚ
∫˙ÂÈ˙Ù¯˙≠ÔÈ·†˙·‚˙
ÏÂÙȈ‰˙Ú†‰Ê†˙¯Ó‚†Ì‡†Â‡†¨˙ÙÒÂapple†‰Ù¯˙†˙ØÏËÂapple†Íappleȉ†Ì‡
ÌÈappleÂÎÈÒ†ÚÂappleÓφȄΆÏÙËÓ‰†‡Ù¯φÁ„φÍÈÏÚ†¨˙¯Á‡†‰Ù¯˙·

PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986
The dispensing of this medicine requires a doctor's prescription
Read this package insert 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
ISOCORT
Cream
Composition:
Each 1 gram of Isocort cream contains:
Isoconazole nitrate 10 mg
Diflucortolone valerate 1 mg
Inactive ingredients: See the Hebrew section.
Therapeutic group:
Isoconazole is a nitroimidazole derivative.
Diflucortolone is a corticosteroid.
Therapeutic activity:
A broad-spectrum antifungal medicine with corticoid additive.
Isocort is used for the treatment of corticoid-responsive
inflammatory skin conditions associated with secondary fungal
infection.
When should the medicine not be used?
Do not use this medicine if you are pregnant in the first
trimester.
Do not use this medicine if you are sensitive to any of its
ingredients.
Do not use this medicine in cases of viral or bacterial infections
(such as skin tuberculosis).
Do not use this medicine without consulting a doctor
before starting treatment in the following cases:
If you are pregnant in the third trimester.
If you are breastfeeding and the doctor approved the treatment
with this medicine, do not apply the preparation to the breasts
prior to nursing.
If you are suffering, or have suffered in the past, from impaired
function of the respiratory system (e.g. asthma), the vascular
system, the liver, the immune system.
Do not use this medicine for any purpose other than that for
which it was prescribed.
Warnings:
Do not allow this medicine to come into contact with the eyes.
In case of such contact, wash the eyes thoroughly.
Do not apply this medicine to the face unless directed to do
so by the doctor.
Special caution is required when using this preparation in
children and adolescents - use should be under medical
supervision.
If you are sensitive to any substance or medicine, inform your
doctor before commencing treatment with this medicine.
Drug interactions:
If you are taking another drug concomitantly or if you have just
finished treatment with another medicine, inform the attending
doctor, in order to prevent hazards or lack of efficacy arising
from drug interactions, especially if you are using other topical
preparations.
Side effects:
In addition to the desired effect of the medicine, adverse
355
reactions may occur during the course of treatment with this
medicine, such as: irritation and itching, rash and redness,
heat and stinging sensation in the treated area.
These side effects usually disappear within a short time following
the period of adaptation to the medicine. If these side effects
do not disappear, or an allergic reaction appears, or any
worsening of the skin condition occurs - discontinue the
treatment and refer to the doctor. 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 doctor immediately.
Adverse reactions and drug interactions in children and
infants:
Parents must inform the attending doctor about any side effects,
as well as any additional medicine being taken by the child!
See above for details of side effects and drug interactions.
Dosage:
Dosage is according to doctor's instructions only.
Do not exceed the recommended dosage or the recommended
period of treatment.
Recommended dosage unless otherwise prescribed by your
doctor: Apply the cream twice daily to the affected area.
The treatment period should not exceed two weeks and then
the doctor should be consulted concerning the necessity for
continuing therapy.
If there is no improvement in your condition within a few days,
refer to your doctor.
Do not use occlusive bandaging unless otherwise instructed
by the doctor. If allowed by the doctor, change the bandaging
within 24 hours (plastic diapers for infants are considered
occlusive bandaging).
Attention:
Do not swallow! This medicine is intended for external use
only.
How can you contribute to the success of the treatment?
Complete the full course of treatment as instructed by the
doctor. Even if there is an improvement in your health, do not
discontinue use of this medicine without consulting your doctor.
Sometimes your doctor may prescribe specific concomitant
treatment for combined fungal and bacterial infections.
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 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 doctor!
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, neighbours 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 cool place.
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 preparation! In case
of doubt, consult the pharmacist who dispensed the medicine
to you. Do not store different medications in the same package.
License number: 4862.24123
Manufacturer: Perrigo Israel Pharmaceuticals Ltd., Yeruham.
355