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Cetirizin Stada

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Package leaflet:Information for the user



Cetirizin STADA 10 mgfilm-coatedtablets

Cetirizinedihydrochloride


Readallofthisleafletcarefullybeforeyoustarttakingthismedicine becauseitcontainsimportantinformationforyou.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.




What is inthisleaflet

1. WhatCetirizin STADAisandwhatitisusedfor

2. What you need to know beforeyoutakeCetirizin STADA

3. HowtotakeCetirizin STADA

4. Possiblesideeffects

5. HowtostoreCetirizin STADA

6. Contents of the pack and other information




1. WhatCetirizin STADAis and what it is used for



Cetirizinedihydrochlorideistheactiveingredient ofCetirizin STADA.Cetirizin STADAisanantiallergicmedication.



Inadultsandchildrenaged6yearandabove,Cetirizin STADAisindicated




2.What you need to know before you take CetirizinSTADA



DONOTtakeCetirizin STADA


Warnings and precautions

Talk to your doctor or pharmacist before taking Cetirizin STADA:


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.


Othermedicines and Cetirizin STADA

Tellyourdoctororpharmacistifyouaretaking,haverecentlytakenor might take anyothermedicines.



Duetotheprofileofcetirizine,nointeractionswithotherdrugsareexpected.



TakingCetirizin STADAwithfoodand 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 pharmacist for advice before taking this medicine.



Pregnancy

Aswithotherdrugs,useofCetirizin STADAshouldbeavoidedinpregnantwomen.Accidentaluseofthedrug byapregnantwomanshouldnotproduceanyharmfuleffectsonthefoetus.Nevertheless,the administrationofthemedicineshouldbediscontinued.



Breast-feeding

YoushouldnottakeCetirizin STADAduringbreast-feedingbecausecetirizinepassesintobreastmilk.



Drivingandusingmachines

Clinicalstudieshaveproducednoevidenceofimpairedattention,alertnessanddrivingcapabilities aftertakingCetirizin STADAattherecommendeddose.

Ifyouareintendingtodrive,engageinpotentiallyhazardousactivitiesoroperatemachinery,you shouldnotexceedtherecommendeddose.Youshouldcloselyobserveyourresponsetothedrug.

Ifyouareasensitivepatient,youmayfindthatthesimultaneoususeofalcoholorothernervous depressantagentsmayadditionallyaffectyourattentionandabilitytoreact.


Cetirizin STADAfilm-coatedtabletscontainslactose

Ifyouhavebeentoldbyyourdoctorthatyouhavean intolerancetosomesugars,pleasecontactyourdoctorbeforetakingthismedicinalproduct.




3.How to take Cetirizin STADA



Always take this medicine exactly as described in this leaflet or 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.



IfyoutakemoreCetirizin STADAthanyoushould

IfyouthinkyouhavetakenanoverdoseofCetirizin STADApleaseinformyourdoctor.

Yourdoctorwillthendecidewhatmeasures,ifany,shouldbetaken.



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



IfyouforgettotakeCetirizin STADA

Donottakeadoubledosetomakeupforforgottendose.



Ifyouhaveanyfurtherquestionsontheuseofthismedicine,askyourdoctororpharmacist.




4.Possible side effects



Likeallmedicines,this medicinecancauseside effects,althoughnoteverybodygetsthem.



Stop taking Cetirizin STADA 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 following side effects have also been reported:

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



Uncommon (may affect up to 1 in 100 people):



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



Very rare (may affect up to 1 in 10,000 people):

Thrombocytopenia (low levels of blood platelets)


Not known (frequency cannot be estimated from the available data):


Reporting of 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 CetirizinSTADA



Keepthis medicine out of the sight and reachofchildren.



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



Thismedicinedoesnotrequireanyspecialstorageconditions.


Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.





6.Contents of the pack and other information



WhatCetirizin STADAcontains

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).



WhatCetirizin STADAlookslikeandcontentsofthepack

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



7, 10, 14, 15, 20, 30, 40, 50 or 100 film-coated tablets.



Notallpacksizesmaybemarketed



MarketingAuthorisationHolderandManufacturer



[Tobecompletednationally]


ThismedicinalproductisauthorisedintheMemberStatesoftheEEAunderthefollowing names:


Austria: Cetiristad 10mg, Filmtabletten

Belgium: Cetirizine EG 10 mg filmomhulde tabletten

Denmark: Cetirizin “PCD”

Luxembourg: Cetirizine EG 10 mg comprimés pelliculés

Netherlands: Cetirizine diHCl CF 10mg, filmomhulde tabletten

Portugal: Cetirizina Ciclum 10mg comprimidos

Sweden: Cetirizin Stada 10 mg, filmdragerade tabletter






Thisleafletwaslastrevisedin 26 September 2014.