PARACET ELIXIR

Israel - English - Ministry of Health

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Active ingredient:
PARACETAMOL 120 MG / 5 ML
Available from:
VITAMED LTD,BINYAMINA
ATC code:
N02BE01
Pharmaceutical form:
ELIXIR
Administration route:
PER OS
Manufactured by:
VITAMED LTD, BINYAMINA
Therapeutic group:
PARACETAMOL
Therapeutic indications:
Analgesic, antipyretic.
Authorization number:
063192804100
Authorization date:
2009-02-01

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

28-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

28-01-2021

The format of this leafletwassetbytheMinistryofHealthwho

checked and approved its content.

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE

PHARMACISTS' REGULATIONS (PRESCRIPTIONS) – 1986

Read this package insert carefully in its entirety

before using this medicine. . ‚œu�Ëh×Ô� U1⁄4«u²×�ËW×B�«…—«“Ëw�…dAM�« Ác1⁄4b¹b%-

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Paracetamol 120 mg

Sorbitol 70% 716 mg

Sucrose 2.44 g

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Carmoisine,OleumCitri,MethylParaben,Propyl

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∫‰ÏÈÎӮϢӵ©˙ÈÙÎÏÎ∫·Î¯‰

Paracetamol 120 mg

Sorbitol 70% 716 mg

Sucrose 2.44 g

∫ÛÒÂ· ÏÈÎÓ ¯È˘Î˙‰

Alcohol95%,PropyleneGlycol,PurifiedWater,

Carmoisine,OleumCitri,MethylParaben,Propyl

Paraben, Strawberry Flavour

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PARACET

ELIXIR

Composition:Each teaspoon (5ml.) contains:

Paracetamol 120 mg

Sorbitol 70% 716 mg

Sucrose 2.44 g

Theproductalsocontains:Alcohol95%,Propylene

Glycol,PurifiedWater,Carmoisine,OleumCitri,Methyl

Paraben, Propyl Paraben, Strawberry Flavour.

TherapeuticAction:Analgesicandantipyreticinbabies

and children.

When should the product not be used?

Donotuseifyouaresensitivetoanyofits

ingredients.

Thismedicineshouldnotbeusedwithoutconsulting

yourphysicianpriortocommencingtreatmentifyou

arepregnant,orbreastfeeding;ifyousufferorhave

sufferedfrom:imparedfunctionoftheliver(liver

disease or viral hepatitis), the kidney/urinary tract.

Warnings:Paracetamolmaycauseliverdamagein

caseof:takingdoseshigherthantherecommended

dose,useforalongperiodoftime,drinkingalcoholic

beverageswhiletakingthemedicine,taking

concomitantlyothermedicineshavinganimpact

onliverfunction.Ifyoudrink3ormorealcoholic

drinksperday,consultwithyourdoctorasifto

takethismedicineortouseadifferentanalgesic

orantipyretic.Inordertopreventanoverdose/or

Paracetamolpoisonning,donotuseanyadditional

analgesicantipyreticmedicine,oranymedicinefor

cold,withoutconsultingadoctororapharmacist.

Ifyouaresensitivetoanytypeoffoodormedicine,

consultyourdoctorpriortocommencingtreatment.

Consultyourdoctorbeforeadministrationtochildren

under the age of 3 years.

DrugInteractions:Ifyouoryourchildaretaking

anothermedicine,orifyouhavejustfinished

treatmentwithanothermedicine,youshould

consultyourdoctortoavoidrisksorinefficacy

arisingfromdruginteractions,especiallywith

drugsfromthefollowinggroups:anticoagulants,

anticonvulsants,otheranalgesics,antipyreticsornon

steroidalanti-inflammatoryagents,hepaticenzyme

inducers:Barbiturates,Hydantoin,Sulfinpyrazone,

Carbamazepine, Rifampicin.

SideEffects:Inadditiontothedesiredeffectsofthe

drug,somesideeffectsmayappearduringtreatment

with this drug such as: rash, dizziness and irritations.

Effectsthatrequirespecialattention,usualycaused

byoverdosesuchas:diarrhoea,nauseaandabdominal

pain(rare),discontinuetreatmentandcontactyour

doctorimmediately.Inthesecasesandinanycase

younoticesideeffectsnotmentionedinthisleafletor

iftherehasbeenanychangeinyourgeneralhealth,

consult your doctor immediately.

SideEffectsandDrugInteractioninChildrenand

Infants:Parentsshouldinformthedoctorofanyside

effectandofanyothermedicinebeingadministered

tothechild!Seesideeffectsanddruginteractions

listed above.

Dosage:Unless otherwise specifiedbythedoctor:

paracet 10-610506 8/31/06, 9:55 AM 1

Manufacturer:Vitamed Ltd.,

P.o.b. 114, Binyamina 30550, Israel. Ó¢Ú·„Ó‡ËÈÂ∫Ô¯ˆÈ

Æ≥∞µµ∞‰ÈÓÈ·±±¥„Æ˙

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Children:

Find the suitable dosage in the following tables.

Iftheweightofthechildisknown,thedosagehastobe

set according to the table of dosage per weight.

Iftheweightofthechildisnotknown,thedosagewill

be set according to the table of dosage per age.

Dosage per weight:

Thedosageiscalculatedaccordingto15mg/kgbody

weight/dose.

Child's

weight Dosage

in mg Dosage

in ml Maximum

doses/day

3 kg 45 1.9 mlup to 5 times daily

4 kg 60 2.5 mlup to 5 times daily

5 kg 75 3.1 mlup to 5 times daily

6 kg 90 3.8 mlup to 5 times daily

7 kg 105 4.4 mlup to 5 times daily

8 kg 120 5 ml up to 5 times daily

9 kg 135 5.6 mlup to 5 times daily

10 kg 150 6.3 mlup to 5 times daily

11 kg 165 6.9 mlup to 5 times daily

12 kg 180 7.5 mlup to 5 times daily

13 kg 195 8.1 mlup to 5 times daily

14 kg 210 8.8 mlup to 5 times daily

15 kg 225 9.4 mlup to 5 times daily

Dosage per age

Theweightofchildrenofthesameagecanbe

significantlydifferent.Youshouldthusmakeaneffort

andcheckthechild'sweightinordertodeterminethe

dosageperweight.Youmayusethistableonlyincase

there is no possibility to check the child's weight.

Dosage

in mg Dosage

in ml Maximum

doses/day

0-3 months 40 1.7 mlup to 5 times daily

4-11 months 80 3.3 mlup to 5 times daily

12-23 months120 5 mlup to 5 times daily

2-3 years 160 6.7 mlup to 5 times daily

4-5 years 240 10 mlup to 5 times daily

Adults:20 ml., 4-5 times a day.

Donotexceedtherecommendeddoseorthe

numberofrecommendeddailydoses.Ifthereis

noimprovementwithin3days,refertoyourdoctor.Ifa

childhasaccidentalytakenadoubledose,consultwith

your doctor or refer to a hospital emergency room.

Attention:Usethemeasuringcupinclosed,oradropper

with milliliter markings.

Avoidpoisoning!Thismedicineandanyothermedicine

mustbekeptinaclosedplaceoutofthereachof

childrenand/orinfantstoavoidpoisoning.Ifyoutook

anoverdose,orbymistakeachildswallowedthis

medicine,refertotheemergencyroomofthehospital

immediatelyandtakethepackageofthemedicine

withyou.Donotinducevomitingunlessexplicitlyso

instructedbythedoctor.Medicinesshouldnotbetaken

inthedark!Checkthelabelandthedoseeverytimeyou

take the medicine. Wear glasses if you need them.

Storage:Inacoolplace.Evenifstoredaccording

toitsrecommendedinstructions,medicineshave

alimitedshelflife.Payattentiontotheexpirydate

oftheproduct!Ifindoubt,youmustconsultyour

dispensingpharmacist.Differentmedicinesshould

not be stored in the same container.

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