ESRACAIN CREAM 5 %

Patient Leaflet According to the Pharmacists’ Regulations

(Preparations) - 1986

Please read the entire leaflet carefully before using this medicine

ESRACAIN

Cream

Composition:

Active ingredient

Lidocaine 5%

Inactive ingredients

Emulsifying wax, cetyl alcohol, glycerin, methyl hydroxybenzoate, propyl

hydroxybenzoate, water, lactic acid.

Therapeutic group:

Local anesthetic of the amide group.

Therapeutic activity:

This medicine is indicated as a topical anesthetic

and as local pain relief of the skin and mucous membranes, due to cuts,

abrasions and hemorrhoids and before local skin procedures.

When should this medicine not be used?

Do not use this medicine if you are hypersensitive to any of its ingredients,

or to another local anesthetic of the amide group.

Do not use on festering sores, open wounds, burns or large areas of skin.

Frequent usage of this medicine on large skin areas or for a long period of

time, including use before cosmetic procedures, may result in severe side

effects due to excessive absorption. Those effects are detailed below in

the side effects section.

This medicine is not intended for use in the eyes.

Do not take this medicine without consulting a doctor before

starting treatment, in the following cases:

If you are pregnant

or breastfeeding. If you suffer or have suffered in the past from impaired

function of the: liver, kidneys, heart and/or vascular system, or if you are

a geriatric patient.

Warnings:

Do not take this medicine frequently or for a long period without consulting

your doctor.

If you are sensitive to any type of food or medicine, inform your doctor

before starting treatment with this medication.

Drug interactions:

If you are taking any other medications including non-prescription drugs

and nutrition supplements, or if you have recently finished treatment with

another drug, please notify your doctor in order to prevent any potential

risks

potential

reduction

efficacy

that

result

from

drug

interactions. In particular, medicines of the following therapeutic groups

may interact with your medicine: medications for the treatment of heart

diseases/hypertension, cimetidine, other local anesthetics.

Side effects:

In addition to the desired effect of the medicine, side effects may also

appear during the course of taking this medicine.

If these side effects persist and/or are bothersome, please consult your

doctor.

The following side effects require special attention:

Local irritation, rash or infection (that did not exist prior to the use of this

medicine) (rare): Stop the treatment and refer to your doctor immediately!

Signs of excessive absorption - excessive sweating, pale skin, slow or

irregular heartbeat, breathing difficulties, changes in vision or hearing,

confusion,

spasms,

dizziness,

sensation

heat,

cold

numbness,

tremors, hyper vigilance, drowsiness: Stop the treatment and refer to your

doctor immediately!

In use for hemorrhoids - if there is no improvement within 7 days or if

deterioration occurs, consult your doctor.

If at any time you experience side effects that are not mentioned in this

leaflet or if you feel an adverse change in your general health, consult your

doctor immediately!

Side effects and drug interactions in children and infants:

Parents must inform the 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.

Recommended dosage unless otherwise prescribed by your

doctor:

This medicine is usually not intended for infants under the age of two

years.

Children 2-12 years of age: do not apply more than 0.1 grams of cream

for each kg of body weight (application of approximately 3 cm of cream for

each 10 kg of body weight), up to 3 times per day (every 8 hours).

Adults and children over 12 years of age: do not apply more than 5 grams

of cream (approximately 15 cm of cream) once every 6 hours. Do not use

more than one tube per day.

Do not exceed the recommended dose.

For persistent, severe or extensive skin conditions, consult your doctor.

Attention:

Do not swallow! This medicine is intended for external use only.

Avoid contact with the eyes. In case of contact with the eyes, rinse them

well with water.

Directions for use:

Apply topically in a thin layer to the affected area, as needed. Do not

bandage or heat the area.

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 or a child have/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!

Do not take medicines in the dark! Carefully check the label and dose each

time you take the medicine.

Wear your glasses if you need them.

Storage:

This medicine should be stored below 25°C.

Even if stored properly according to the manufacturer’s recommendations,

all medicines have a limited shelf life. Please pay attention to the expiry date

of your medicine! If you have any doubts, please consult the dispensing

pharmacist.

Do not store different medicines in the same container.

Drug registration number:

163027791

Rafa Laboratories Ltd., P.O.Box 405, Jerusalem 91003

The format of this leaflet was determined by the Ministry of Health that checked and

approved its content in November 2011.

Esracain PIL PB0811-05

רישכתה םש םרק ןיאקרזע אפר ט"קמ

194076

הרודהמ 'סמ

076006-

הסירפ 'ד / 3 חפסנ יפל מ"ס

21X16

עבצ רוחש תופש )תיברעו תילגנא ,תירבע(

סופד לאידיא םילופיק 'סמ אלל ריינ גוס םרג 60 ע"נ דוקהמרפ

דוקהמרפ יוקל תודימ םומיסקמ וטנ ךרוא ;מ"מ 1 םיווקה ןיב חוור ;מ"מ 1.5 הבע וק ;מ"מ 0.5 קד וק )תילמיסקמ הדימל תופידע - מ"מ 8 םומינימ( מ"מ 10 )בויח אלל דוקהמרפה תא ףיסוי סופדה תיב( י"ע ןכוה םייטבצמרפ םיתוריש ואלב ךיראת

18.08.2011

ىلع يمرك مس ٣ براقي ام ينهدت( مسج نزو مغك لك ىلع يمرك مارغ ٠٫١ .)تاعاس ٨ لك( مويلا في تا

رم ثلاث تىح .)مسلجا نزو نم مغك ١٠ لك ٥ نم رثكأ ينهدت زويج لا :ةنس ۱۲ رمع قوف ام لافطلأاو ينغلابلا ىدل رثكأ لامعتسا زويج لا .تاعاس ٦ لك ةرم )مس ١٥ براقي ام( يمرك مارغ .مويلا في ةدحاو ةبوبنأ نم .اهب ىصولما ةعرلجا زواتج زويج لا .بيبطلا ةراشتسا بيج ,ةدتملما وأ ةميخولا ,ةنمزلما دللجا لكاشلم .اهب ىصولما ةعرلجا زواتج زويج لا :هبتنإ .طقف يجرالخا لامعتسلال صصمخ ءاودلا اذه !علبلل سيل اهفطش بيج ,يننيعلا عم سامتلا ةلاح في .يننيعلا عم سامتلا بنتج بيج

ديج ءالماب :لامعتسلاا ةيفيك لا .ةجالحا بسح ,ةباصلما ةقطنلما ىلع ا

يعضوم ةقيقر ةقبط ينهدت بيج .عضولما ينخست وأ ديمضت زويج !ممستلا بنتج يديأ لوانتم نع ا

ديعب قلغم ناكم في رخآ ءاود لكو ءاودلا اذه ظفح بيج .ممستلا عنتم كلذبو ,عضرلا وأ/و لافطلأا لىإ ا

روف هجوتلا بجيف ,أطلخاب ءاودلا نم ءزج علبب لفط وأ تنأ تم

ق اذإ .كعم ءاودلا ةوبع ا

بحطصم ,ىفشتسلما في ئراوطلا ةفرغ !بيبطلا نم ةيحرص تاميلعت نودب ؤيقتلا ببست لا ةعرلجا نمو ءاودلا ىلع قصللما نم ققتح !ملاظلا في ءاودلا لوانت زويج لا اذإ ةيبطلا تاراظنلا عضو بيج .ءاود اهيف لوانتت ةرم لك في ةيئاودلا .اله ةجابح تنك .ةيوئم ةجرد ۲٥ تتح نيزختلا بيج :نيزختلا /بيلعتلا فورظ في تىح ,طقف ةدودمح تاترفل ةلحاص ةيودلأا ىقبت في !رضحتسلما ة

يحلاص ءاهتنا خيرات ةظحلام ءاجرلا .اهب ىصولما نيزختلا .ءاودلا اذه كل فرص يذلا ليديصلا ةراشتسا كيلع ,كش ةلاح

يأ .ةوبعلا سفن في ةفلتمخ ةيودأ نيزتخ زويج لا

۱٦۳۰۲۷۷۹۱ :ءاودلا ليجست مقر .۹۱۰۰٣ سدقلا ,٤۰٥ .ب.ص ,ض.م افار تابرتمخ .۲۰۱۱ نياثلا نيرشت في اهلبق نم صخ

رو اهاوتمح صح

فو ةرشنلا هذه ةغيص ةحصلا ةرازو ترقأ