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Cetiristad

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Package leaflet:Information for the user



Cetiristad 10 mgfilm-coatedtablets

Cetirizinedihydrochloride



Readallofthisleafletcarefullybeforeyoustarttakingthismedicinebecause it contains important information for you.



What is inthisleaflet

1. WhatCetiristadisandwhatitisusedfor

2. What you need to know beforeyoutakeCetiristad

3. HowtotakeCetiristad

4. Possiblesideeffects

5. HowtostoreCetiristad

6. Contents of the pack and otherinformation




1. WhatCetiristadis and what it is used for



Cetirizinedihydrochlorideistheactiveingredient ofCetiristad.Cetiristadisanantiallergicmedication.



Inadultsandchildrenaged6yearandabove,Cetiristadisindicated




2.What you need to know before you takeCetiristad



DONOTtakeCetiristad


Warnings and precautions

Talk to your doctor or pharmacist before taking Cetiristad:


Children

The use of the film-coated tablet formulation is not recommended in children aged less than 6 years since this formulation does not allow for appropriate dose adaptation.


Othermedicinesand Cetiristad

Tellyourdoctororpharmacistifyouaretaking,haverecentlytakenor might take anyothermedicines.



Duetotheprofileofcetirizine,nointeractionswithotherdrugsareexpected.



TakingCetiristadwithfoodand alcohol

Fooddoesnotaffectnoticeablytheabsorptionofcetirizine.


Nointeractionssusceptibletohaveanoticeableimpacthavebeenobservedbetweenalcohol(atthe bloodlevelof0.5permillecorrespondingtooneglassofwine)andcetirizineusedatthenormal doses.However,asitisthecasewithallantihistamines,itisrecommendedtoavoidconcurrent consumptionofalcohol.



Pregnancyandbreast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacistfor advice before taking thismedicine.



Pregnancy

Aswithotherdrugs,useofCetiristadshouldbeavoidedinpregnantwomen.Accidentaluseofthedrug byapregnantwomanshouldnotproduceanyharmfuleffectsonthefoetus.Nevertheless,theadministrationofthemedicineshouldbediscontinued.



Breast-feeding

YoushouldnottakeCetiristadduringbreast-feedingbecausecetirizinepassesintobreastmilk.



Drivingandusingmachines

Clinicalstudieshaveproducednoevidenceofimpairedattention,alertnessanddrivingcapabilities aftertakingCetiristadattherecommendeddose.

Ifyouareintendingtodrive,engageinpotentiallyhazardousactivitiesoroperatemachinery,you shouldnotexceedtherecommendeddose.Youshouldcloselyobserveyourresponsetothedrug.

Ifyouareasensitivepatient,youmayfindthatthesimultaneoususeofalcoholorothernervous depressantagentsmayadditionallyaffectyourattentionandabilitytoreact.



Cetiristadfilm-coatedtabletscontainslactose

Ifyouhavebeentoldbyyourdoctorthatyouhavean intolerancetosomesugars,pleasecontactyourdoctorbeforetakingthismedicinalproduct.




3.How to take Cetiristad



Always take this medicine exactly as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.




Adultsandadolescentsabove12yearsold

10mgoncedailyas1tablet.



Childrenbetween6and12yearsold

5mgtwicedailyasahalftablettwicedaily.



Patientswithmoderatetosevererenalimpairment

Patientswithmoderaterenalimpairmentarerecommendedtotake5mgoncedaily.



Method of administration

Tabletsneedtobeswallowedwithaglassofliquid.



Durationoftreatment

Thedurationoftreatmentdependsonthetype,durationandcourseofyourcomplaintsandis determinedbyyourdoctor.



IfyoutakemoreCetiristadthanyoushould

IfyouthinkyouhavetakenanoverdoseofCetiristadpleaseinformyourdoctor.

Yourdoctorwillthendecidewhatmeasures,ifany,shouldbetaken.



Afteranoverdose,thesideeffectsdescribedbelowmayoccurwithincreasedintensity.Adverse effectssuchasconfusion,diarrhoea,dizziness,tiredness,headache,ailing,dilatingofpupil,itching, restlessness,sedation,somnolence,stupor,abnormalrapidheartrate,tremorsandurinaryretentionhavebeenreported.



IfyouforgettotakeCetiristad

Donottakeadoubledosetomakeupforforgottendose.



Ifyouhaveanyfurtherquestionsontheuseofthismedicine,askyourdoctororpharmacist.




4.Possible side effects



Likeallmedicines,this medicinecancauseside effects,althoughnoteverybodygetsthem.



Stop taking Cetiristad and seek for medical attention without delay if you experience symptoms like:

swelling in your mouth, face and/or throat

The symptoms can be signs of hypersensitivityreactions, anaphylactic shock and angio-oedema. These reactions are rare (may affect up to 1 in 1,000 people).



The followingside effects have also been reported:

Common (may affect up to 1 in 10 people):



Uncommon (may affect up to 1 in100 people):



Rare (may affect up to 1 in1,000 people)



Very rare (may affect up to 1 in10,000 people):

Thrombocytopenia (low levels of blood platelets)


Notknown(frequency cannot be estimated from the available data):


Reportingof side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via {to be completed nationally: the national reporting system listed in Appendix V}.By reporting side effects you can help provide more information on the safety of this medicine.




5.How to store Cetiristad



Keepthis medicine out of the sight and reachofchildren.



Donotusethis medicineaftertheexpirydatewhichisstatedontheboxandblisterafter EXP. The expiry date refers to the last day of that month.



Thismedicinedoesnotrequireanyspecialstorageconditions.


Donot throw away any medicinesvia wastewater or household waste. Ask your pharmacist how tothrow awaymedicines you no longer use. These measures will help protect the environment.





6.Contents of the pack and other information



WhatCetiristadcontains

The active substance is cetirizine dihydrochloride.

Onefilm-coatedtabletcontains 10mgcetirizinedihydrochloride.


The other ingredients are microcrystalline cellulose, lactose monohydrate, macrogol (400), magnesium stearate, hypromellose (464), colloidal anhydrous silica, titanium dioxide (E 171).



WhatCetiristadlookslikeandcontentsofthepack

White, round, film-coated tablet bisected on one side and plain on the other.



7,10,15, 20, 30, 50 or 100 film-coated tablets.



Notallpacksizesmaybemarketed



MarketingAuthorisationHolderandManufacturer



[Tobecompletednationally]


ThismedicinalproductisauthorisedintheMemberStatesoftheEEAunderthefollowing names:


Germany: Cetirizin AL 10 mg Filmtabletten

Sweden: Cetiristad 10 mg filmdragerade tabletter




Thisleafletwaslastrevisedin 26 September 2014.