אריוס סירופ 0.5 מ"ג/מ"ל

ישראל - עברית - Ministry of Health

קנה את זה

עלון מידע עלון מידע (PIL)

24-11-2020

מרכיב פעיל:
DESLORATADINE 0.5 MG/ML
זמין מ:
MERCK SHARP & DOHME ISRAEL LTD
קוד ATC:
R06AX27
טופס פרצבטיות:
SYRUP
מסלול נתינה (של תרופות):
PER OS
תוצרת:
SCHERING-PLOUGH LAB.NV BELGIUM
קבוצה תרפויטית:
DESLORATADINE
סממני תרפויטית:
For the relief of symptoms associated with : allergic rhinitis (AR) and Chronic idiopathic urticaria (CIU) in adults and children 1 year of age and above.
מספר אישור:
129343077800
תאריך אישור:
2013-10-01

מסמכים בשפות אחרות

עלון מידע עלון מידע - אנגלית

24-11-2020

מאפייני מוצר מאפייני מוצר - אנגלית

24-11-2020

עלון מידע עלון מידע - ערבית

24-11-2020

ÌÈÁ˜Â¯‰†˙Â˜˙†ÈÙφÔίˆÏ†ÔÂÏÚ

±π∏∂†≠†Â¢Ó˘˙‰†®ÌÈ¯È˘Î˙©

‡Ù¯†Ì˘¯Ó·†˙·ÈÈÁ†Âʆ‰Ù¯˙

ÂÙÂÒ†„Ú†ÔÂÏÚ‰†˙‡†ÔÂÈÚ·†È؇¯˜

‰Ù¯˙·†ÈØ˘Ó˙˘˙†Ì¯Ë·

˙‡ȯ·‰†„¯˘Ó†È¢Ú†Ú·˜†‰Ê†ÔÂÏÚ†ËÓ¯ÂÙ

≤∞∞∂†¯·Óˆ„·†Â„È≠ÏÚ†¯˘Â‡Â†˜„·†ÂÎÂ˙Â

Ù¯ÈÒ†ÒÂȯ‡

Ï¢ÓØ‚¢Ó†∞Æμ

∫·Î¯‰

∫ÏÈÎӆϢӆÏÎ

Desloratadine 0.5 mg

Æ¯Ó˘Ó†¯ÓÂÁΆˇÂÊ·†Ô¯˙†ԯ˙†¨Ê¯ÎÂÒ†ÏÈÎÓ†¯È˘Î˙‰

∫ÌÈÏÈÚÙ†È˙Ï·†ÌȯÓÂÁ

Propylene glycol, sorbitol, citric acid anhydrous, sodium

citrate dihydrate, sodium benzoate, disodium edetate,

purified water, sucrose, natural and artificial flavour

for bubble gum, dye FD&CYellow No.6 (Color E110).

ÆËÒÈ‚Ë‡† H 1 †‚ÂÒÓ†ÔÈÓËÒȉÈË‡ †∫˙ÈËÈÂÙ¯˙†‰ˆÂ·˜

∫˙ȇÂÙ¯†˙ÂÏÈÚÙ

‰Ù¯˙†ÆÈ‚¯Ï‡ÈË‡†ÆÌÈÈÓËÒȉÈË‡‰†˙ˆÂ·˜Ó†‰Ù¯˙

Û‡†˙ÏÊφÌÈ¯Â˘˜‰†ÌÈÈÓÒ˙‰†˙Ϙ‰Ï†˙„ÚÂÈÓ†ÂÊ

Æ˙ÈËÙÂȄȇ†˙È¯Ά˙„Ù¯ÒφÌÈ¯Â˘˜‰†ÌÈÈÓÒ˙‰Â†˙È‚¯Ï‡

ø¯È˘Î˙·†˘Ó˙˘‰Ï†Ôȇ†È˙Ó

È·ÈίÓÓ†„Á‡Ï†˙Â˘È‚¯†Íφ‰Ú„Ȇ̇†˘Ó˙˘‰Ï†Ôȇ

ÆÔȄ˯ÂÏφ‡†‰Ù¯˙‰

Ɖ˘†ÏȂφ˙Á˙Ó†ÌÈ„ÏÈ·†¯È˘Î˙·†˘Ó˙˘‰Ï†Ôȇ

ÈÙφ‡Ù¯·†ıÚÂÂȉφÈÏ·Ó†‰Ù¯˙·†˘Ó˙˘‰Ï†Ôȇ

∫ÏÂÙÈˉ†˙ÏÁ˙‰

Ɖ˜ÈÈӆ‡†ÔÂȯ‰·†Íȉ†Ì‡†¯È˘Î˙·†˘Ó˙˘‰Ï†ıÏÓÂÓ†‡Ï

„˜Ù˙·†È˜ÈÏÓ†¯·Ú·†˙Ϸ҆‡†˙ØÏ·ÂÒ†Íȉ†Ì‡

ÆÔ˙˘‰†˙ίÚÓ؉ÈÏΉ

∫˙¯‰Ê‡

ÍÈÏÚ†¨È‰˘ÏΆ‰Ù¯˙φ‡†Â‰˘ÏΆÔÂÊÓφ‰Ø˘È‚¯†Íȉ†Ì‡

ƉÙ¯˙‰†˙ÏÈË†ÈÙφ‡Ù¯φÍÎ≠ÏÚ†ÚȄ‰Ï

̯‚φÏÂÏÚ†¯È˘Î˙·†˘ÂÓÈ˘†„‡ӆ˙¯Ȅ†ÌÈ˙ÈÚÏ

‰‚ȉ‰†˙ÏÂÎȆÏÚ†ÚÈÙ˘‰Ï†‰ÏÂÏÚ˘†ÌÂÓ†˙˘ÂÁ˙Ï

Æ˙ÂÂÎÓ·†˘ÂÓÈ˘Â

∫˙ÂÈ˙Ù¯˙≠ÔÈ·†˙·‚˙

‰˙Ú†‰Ê†˙¯Ó‚†Ì‡†Â‡†¨˙ÙÒÂ†‰Ù¯˙†˙ØÏËÂ†Íȉ†Ì‡

ȄΆÏÙËÓ‰†‡Ù¯φÁ„φÍÈÏÚ†¨˙¯Á‡†‰Ù¯˙·†ÏÂÙÈË

˙·‚˙Ó†ÌÈÚ·Â‰†˙ÂÏÈÚÈ≠ȇ†Â‡†ÌÈÂÎÈÒ†ÚÂÓÏ

Æ˙ÂÈ˙Ù¯˙≠ÔÈ·

∫ȇÂÂφ˙ÂÚÙÂ˙

‰·†˘ÂÓÈ˘‰†ÔÓÊ·†¨‰Ù¯˙‰†Ï˘†‰Èˆ¯‰†˙ÂÏÈÚÙφÛÒÂ·

˘·ÂȆ¨˘‡¯†·‡Î†∫Ô‚Ά¨È‡ÂÂφ˙ÂÚÙÂ˙†ÚÈÙ‰φ˙ÂÏÂÏÚ

ÌÈ„ÏÈ·©†‰È˘†È„„†¨ÏÂ˘Ï˘†¨ÌÂÁ†¨®Ìȯ‚·ӷ©†˙ÂÙÈÈÚ†¨‰Ù·

Æ®ÌÈÈ˙˘†ÏȂφ˙Á˙Ó

∫˙„ÁÂÈÓ†˙ÂÒÁÈ˙‰†˙·ÈÈÁÓ‰†È‡ÂÂφ˙ÂÚÙÂ˙

„‡ӆÌȯȄ†Ìȯ˜Ó†ÂÏ‚˙‰†ÒÂȯ‡†Ï˘†˜ÂÂÈ˘‰†Íωӷ

¨ÌÈÙˆو†¨‰ÓÈ˘·†È˘Â˜©†‰¯ÂÓÁ†˙È‚¯Ï‡†‰·Â‚˙†Ï˘

¨˙ÈË·†˙ÂÁÂ†¯ÒÂÁ†¨‰‡˜‰†¨‰ÏÈÁ·†¨ÔË·†·‡Î†¨¯È‰Ó†˜Ù„

·‡Î†¨Ì„¯‰Ï†È˘Â˜†¨ÌÂÓ†˙˘‚¯‰†¨˙¯ÂÁ¯ÁÒ†¨ÏÂ˘Ï˘

˙ÚÂ˙†Û¯ˆ·†‰ÁÂÓ†¯ÒÂÁ†¨˙ÂȈÂÂÎ˙‰†¨˙ÂÈʉ†¨¯È¯˘

¨®¯ÂÚ·†Â‡†ÌÈÈÈÚ·†‰·‰ˆ‰†¨˙ÂÏÈÁ·©†˙·‰ˆ†¨˙¯·‚ÂÓ†Û‚

˘È†Âχ†Ìȯ˜Ó·†≠†„·Î†È„˜Ù˙†Ï˘†ÌÈȘ˙†È˙Ï·†ÌÈίÚ

Æ„ÈÓ†‡Ù¯φ˙ÂÙφÏÂÙÈˉ†˙‡†˜ÈÒÙ‰Ï

ÂÈȈ†‡Ï˘†È‡ÂÂφ˙ÂÚÙÂ˙†‰Ø˘È‚¯Ó†Íȉ†Â·˘†‰¯˜Ó†Ïη

ÍÈÏÚ†¨˙ÈÏÏΉ†Í˙˘‚¯‰·†ÈÂÈ˘†ÏÁ†Ì‡†Â‡†¨‰Ê†ÔÂÏÚ·

Æ„ÈÓ†‡Ù¯‰†ÌÚ†ıÚÈÈ˙‰Ï

∫ÔÂÈÓ

∫ÌÈ„ÏÈφϷ˜ӆÔÂÈÓ

ÆÌÂÈ·†ÌÚÙ†®˙Á‡†‰„È„Ó†˙ÈÙΩ†Ï¢Ó†μ†∫∂≠±±†ÏÈ‚

ÆÌÂÈ·†ÌÚÙ†®‰„È„Ó†˙ÈÙΆ ≤ Ø ± ©†Ï¢Ó†≤Æμ†∫±≠μ†ÏÈ‚

∫®‰ÏÚÓ†±≤†ÏÈ‚Ó©†Ìȯ‚·ÓφϷ˜ӆÔÂÈÓ

ÆÌÂÈ·†ÌÚÙ†®‰„È„Ó†˙ÂÈÙΆ≤©†Ï¢Ó†±∞

‰È‚¯Ï‡‰†‚ÂÒφ̇˙‰·†¨ÏÂÙÈˉ†Í˘Ó†ÏÚ†ËÈÏÁȆ͇Ù¯

Æ˙ØÏ·ÂÒ†‰Ø˙‡†‰ÓÓ

ÆıÏÓÂÓ‰†ÏÂÙÈˉ†Í˘Ó†˙ˆÏÓÂÓ‰†‰Ó‰†ÏÚ†¯Â·ÚφÔȇ

Ɖ˘†ÏȂφ˙Á˙Ó†ÌÈ„ÏÈφ˙„ÚÂÈÓ†‰ȇ†Âʆ‰Ù¯˙

‰Ó†ÏÂËÈφ˘È†¨·Âˆ˜†ÔÓÊ·†Âʆ‰Ù¯˙†ÏÂËÈφ˙Á΢†Ì‡

˙ÂÓ†È˙˘†ÏÂËÈφÔȇ†ÔÙ‡†Ì¢·†Í‡†ª˙¯ÎÊ˘Î†„ÈÓ

‡Ù¯φÈد˘˜˙‰†¨‰ÏÂÙΆ‰Ó†˙ÂÚË·†˙ÏË†Ì‡†°„ÁÈ·

ÆÁ˜Â¯Ï†Â‡

∫˘ÂÓÈ˘‰†ÔÙ‡

ÏÂËÈφÔ˙È†¨ÌÈÓ†˙Â˙˘Ï†ÔÎÓ†¯Á‡Ï†‰Ù¯˙‰†˙‡†ÚÂÏ·Ï

ÆÏ·†‡Ïφ‡†ÌÚ

øÏÂÙÈˉ†˙Áψ‰Ï†ÚÈÈÒφÈØÏÎÂ˙†„ˆÈÎ

ƇÙ¯‰†È„È≠ÏÚ†ıÏÓ‰˘†ÏÂÙÈˉ†˙‡†ÌÈÏ˘‰Ï†ÍÈÏÚ

˙‡†˜ÈÒىφÔȇ†¨Í˙‡ȯ·†·ˆÓ·†¯ÂÙÈ˘†ÏÁ†Ì‡†Ì‚

ƇÙ¯†ÌÚ†˙ˆÚÈÈ˙‰†‡Ïφ‰Ù¯˙·†ÏÂÙÈˉ

°‰ÏÚ¯‰†ÈØÚÓ

¯Â‚̘҆ӷ†¯ÂÓ˘Ï†˘È†˙¯Á‡†‰Ù¯˙†ÏΆÂʆ‰Ù¯˙

ÍΆȄÈ≠ÏÚ†˙˜ÂÈ˙†Â‡Ø†ÌÈ„ÏÈ†Ï˘†Ì„Ȇ‚˘È‰Ï†ıÂÁÓ

ƉÏÚ¯‰†ÚÓ˙

¨‰Ù¯˙‰†ÔÓ†„ÏȆÚÏ·†˙ÂÚË·†Ì‡†Â‡†¯˙Ȇ˙Ó†˙ÏË†Ì‡

˙Êȯ‡†È؇·‰Â†¨ÌÈÏÂÁ≠˙È·†Ï˘†ÔÂÈÓ†¯„Áφ„ÈÓ†È؉Ù

ÆÍ˙ȇ†‰Ù¯˙‰

‰Ù¯˙†°‡Ù¯ӆ˙˘¯ÂÙÓ†‰‡¯Â‰†‡Ïφ‰‡˜‰Ï†Ì¯‚φÔȇ

‰ÏÂÏÚ†‡È‰†˙دÁ‡†‰ÏÂÁ·†¨Í˙ÏÁÓ·†ÏÂÙÈËφ‰Ó˘¯†ÂÊ

ÆÍȯÎӆ‡†ÍÈ΢†¨Íȷ¯˜Ï†Âʆ‰Ù¯˙†ÈØÔ˙˙†Ï‡†Æ˜ÈʉÏ

‰Ӊ†˙ÈÂÂ˙‰†˙‡†˜Â„·Ï†˘È†°Í˘ÂÁ·†˙ÂÙ¯˙†ÏÂËÈφÔȇ

ÌÈÈÙ˜˘Ó†·Èί‰Ï†˘È†Æ‰Ù¯˙†˙ØÏËÂ†Íȉ˘†ÌÚÙ†Ïη

Æ̉φ‰Ø˜Â˜Ê†Íȉ†Ì‡

C†≠φ˙Á˙ÓÔÒÁ‡Ï†˘È†∫‰ÒÁ‡

Ɖ¢‡¯‰†‰ÁÈ˙Ù‰†ÌÂÈÓ†ÌÂȆ±¥†≠φ¯·ÚÓ†˘Ó˙˘‰Ï†Ôȇ

˙ÂÙ¯˙†¨ÌȈÏÓÂÓ‰†‰ÒÁ‡‰Ø‰Êȯ‡‰†È‡˙†ÈÙφ̂

Íȯ‡˙φ·Ï†ÌÈ˘Ï†‡†Æ„·Ï·†˙Ï·‚ÂÓ†‰Ù˜˙φ˙Â¯Ó˘

ıÚÂÂȉφÍÈÏÚ†¨˜ÙÒ†Ï˘†‰¯˜Ó†Ïη†°¯È˘Î˙‰†Ï˘†‰‚ÂÙ˙‰

ƉÙ¯˙‰†˙‡†Íφ˜ÙÈÒ˘†Á˜Â¯·

ƉÊȯ‡†‰˙‡·†˙Â¢†˙ÂÙ¯˙†ÔÒÁ‡Ï†Ôȇ

±≤π≠≥¥≠≥∞∑∑∏≠∞∞ †∫‰Ù¯˙‰†ÌÂ˘È¯†ßÒÓ

ƉȂϷ†¨‚¯·≠Ô„≠Ù‡≠ËÒÈȉ†¨ÆÈÂÆ‡†Â·‡Ï†Â‡ÏÙ≠‚ȯ˘ †∫Ô¯ˆÈ

∫ÌÂ˘È¯‰†ÏÚ·

¨Ó¢Ú·†®±ππ∂≠χ¯˘È©†Ì‰Â„†ٯ‡˘†˜¯Ó†˙¯·Á

Æ¥π±∑∞†‰Â˜˙≠Á˙Ù†¨∑±≤±†Æ„Æ˙

AERI SYR PL SH 030213

PATIENT PACKAGE INSERT IN ACCORDANCE

WITHTHE 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 which also checked

and approved its content in December 2006

AERIUS ® SYRUP

0.5 mg/ml

Composition:

Each 1 ml contains:Desloratadine 0.5 mg.

The preparation contains sucrose, sodium and sodium

benzoate as a preservative.

Inactive ingredients:

Propylene glycol, sorbitol, citric acid anhydrous, sodium

citrate dihydrate,sodium benzoate,disodium edetate,

purified water, sucrose, natural and artificial flavour for

bubble gum, dye FD&CYellow No.6 (Color E110).

Therapeutic group:

Antihistamines (H1receptor antagonists).

Therapeutic activity:

Antihistaminic antiallergic medicine.

This medicine is intended for the relief of symptoms

associated with allergic rhinitis and symptoms of chronic

idiopathic urticaria.

When should the preparation not be used?

Do not use this medicine if you are sensitive to any

of its ingredients or to loratadine.

Do notusethis medicine in children below oneyear

of age.

Do not take this medicine without consulting a

doctor before starting treatment:

The use of the preparation is not recommended, if you

are pregnant or breastfeeding.

If you are suffering, or havesuffered in the past, from

impaired function of the kidney/urinary tract.

Warnings:

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

inform your doctor before commencing treatment with

this medicine.

In veryrare cases use of the preparation may cause

drowsiness which may affect the ability to drive and

use machines.

Drug interactions:

If you are taking another drug concomitantly or if you

havejust finished treatment with another medicine,

inform the attending doctor, in order to prevent hazards

or lackof efficacy arising from drug interactions.

Side effects:

In addition to the desired effect of the medicine,adverse

reactions may occur during the course of taking this

medicine, for example:headache, dry mouth, fatigue

(in adults), fever, diarrhoea, sleeplessness (in children

below2 years of age).

Side effects that require special attention:

During the marketing ofAeriusveryrare cases of severe

allergic reaction (difficulty breathing, wheezing, itching,

swelling, rash) havebeen reported.Cases of tachycardia

and palpitations, abdominal pain, nausea, vomiting,

difficulty falling asleep, muscle pain, hallucinations,

seizures, restlessness accompanied byexcessivebody

movements, jaundice (nausea, yellowing of the eyes

or skin), abnormal values of liver functions - inthese

cases stoptreatmentand refertothe doctor 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 doctor immediately.

Dosage:

Recommended dosage for children:

6-11 years of age:5 ml (1 measuring teaspoonful) once

a day.

1-5 years of age:2.5 ml ( 1 2 / measuring teaspoonful)

once a day.

Recommended dosage for adults (above 12 years

of age):

10 ml (2 measuring teaspoonfuls) once a day.

Depending on the type of allergy you are suffering from,

the doctor will decide regarding the treatment duration.

Do not exceed the recommended dosage and the

recommended duration of treatment.

This medicine is not intended for administration to

children below one year of age.

If you forget to take this medicine at the specified time,

take the dose as soon as you remember, but never

take a double dose to compensate for a missed one!

If you takea double dose bymistake,contact your

doctor or pharmacist.

Directions for use:

Swallow the medicine and then drink some water.

The medicine can be taken with or without a meal.

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.

Avoidpoisoning!

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 havetaken 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.

Donotinducevomiting unless explicitly instructed to

do so bya 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.

Donottakemedicinesinthedark! Check the label and

the doseeachtime you takeyour medicine.Wear

glasses if you need them.

Storage:

Storebelow25 o C.

Do not use beyond 14 days from first opening.

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:129-34-30778-00

Manufacturer:

Schering-Plough Labo N.V.,

Heist-Op-Den-Berg, Belgium

License Holder:

MerckSharp & Dohme (Israel-1996) Company Ltd.,

P.O.Box 7121, Petah-Tikva 49170.

מוצרים דומים

חיפוש התראות הקשורות למוצר זה

צפו בהיסטוריית המסמכים

שתף מידע זה