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Package leaflet:Information for the user

Cetiristad 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.

• Keep this leaflet. You may need to read it again.

• Ask your pharmacist if you need more information or advice.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

• You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

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

• for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.

• for the relief of chronic nettle rash (chronic idiopathic urticaria).

2.What you need to know before you take Cetiristad

DONOTtakeCetiristad

• if you are allergic to cetirizine dihydrochloride, to hydroxyzine or to piperazine derivatives (closely related active substances of other medicines) or any of the other ingredients of this medicine (listed in section 6).

• if you have a severe kidney disease (severe renal failure with creatinine clearance below 10 ml/min).

Warnings and precautions

Talk to your doctor or pharmacist before taking Cetiristad:

• If you are a patient with renal insufficiency, please ask your doctor for advice; if necessary, you will take a lower dose. The new dose will be determined by your doctor.

• If you have problems passing urine (like spinal cord problems or prostate or bladder problems).

• If you are an epileptic patient or a patient at risk of convulsions.

• If you are going to have an allergy skin test, stop taking this medicine 3 days before the test.

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, askyour doctor or pharmacist for advice before taking thismedicine.

Pregnancy

Aswithotherdrugs,useofCetiristadshouldbeavoidedinpregnantwomen.Accidentaluseofthedrug byapregnantwomanshouldnotproduceanyharmfuleffectsonthefoetus.Nevertheless,the administrationofthemedicineshouldbediscontinued.

Breast-feeding

YoushouldnottakeCetiristadduringbreast-feedingbecausecetirizinepassesintobreastmilk.

Drivingandusingmachines

Clinicalstudieshaveproducednoevidenceofimpairedattention,alertnessanddrivingcapabilitiesaftertakingCetiristadattherecommendeddose.

Ifyouareintendingtodrive,engageinpotentiallyhazardousactivitiesoroperatemachinery,youshouldnotexceedtherecommendeddose.Youshouldcloselyobserveyourresponsetothedrug.

Ifyouareasensitivepatient,youmayfindthatthesimultaneoususeofalcoholorothernervousdepressantagentsmayadditionallyaffectyourattentionandabilitytoreact.

Cetiristadfilm-coatedtabletscontainslactose

Ifyouhavebeentoldbyyourdoctorthatyouhavean intolerancetosomesugars,pleasecontactyourdoctorbeforetakingthismedicinalproduct.

3.How to take Cetiristad

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,durationandcourseofyourcomplaintsandisdeterminedbyyourdoctor.

IfyoutakemoreCetiristadthanyoushould

IfyouthinkyouhavetakenanoverdoseofCetiristadpleaseinformyourdoctor.

Yourdoctorwillthendecidewhatmeasures,ifany,shouldbetaken.

Afteranoverdose,thesideeffectsdescribedbelowmayoccurwithincreasedintensity.Adverseeffectssuchasconfusion,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:

• difficulties in breathing (chest tightness or wheezing)

• sudden drop in your blood pressure with subsequent fainting or shock

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):

• Fatigue

• Dry mouth

• Nausea (feeling sick)

• Dizziness

• Headache

• Somnolence

• Pharyngitis (sore throat)

• Rhinitis

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

• Abdominal pain

• Asthenia (extreme fatigue)

• Malaise (feeling weak or generally unwell)

• Paraesthesia (abnormal feelings of the skin)

• Agitation

• Pruritus (itchy skin)

• Rash

• Diarrhoea

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

• Tachycardia (heart beating too fast)

• Oedema (swelling)

• Liver function abnormal

• Weight increased

• Convulsions

• Aggression

• Confusion

• Depression

• Hallucination

• Insomnia

• Urticaria (hives)

• Movements disorders

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

• Accommodation disorder (difficulty focusing)

• Blurred vision

• Oculogyration (eyes having uncontrolled circular movements)

• Syncope

• Tremor

• Tics

• Dyskinesia (involuntary movements)

• Dystonia (involuntary muscular contractions)

• Dysgeusia (altered taste)

• Abnormal elimination of urine (bed wetting, pain and/or difficulty passing water)

• Fixed drug eruption

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

• Impairment or loss of memory

• Increased appetite

• Suicidal ideation

• Vertigo sensation of rotation or movement)

• Urinary retention (inability to completely empty the urinary bladder)

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

Onefilm-coatedtabletcontains 10mgcetirizinedihydrochloride.

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.