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Package leaflet:Information for the user

Cetiristad1mg/mloralsolution

Cetirizinedihydrochloride

Readallofthisleafletcarefullybeforeyoustarttakingthismedicinebecause it contains important information for you.

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

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• 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.

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. WhatCetiristad is and what it is used for

Cetirizinedihydrochlorideistheactiveingredient ofCetiristad.Cetiristadisanantiallergicmedication.

Inadultsandchildrenaged2yearandabove,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

YoushouldnottakeCetiristadoralsolution:

Warnings and precautions

Talk to your doctor or pharmacist before takingCetiristad:

• 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

Theuseoftheproductisnotrecommendedinchildrenagedlessthan2years.

Othermedicines and Cetiristad

Tellyourdoctororpharmacistifyouaretaking,haverecentlytakenor might take anyothermedicines.

Duetotheprofileofcetirizine,nointeractionswithotherdrugsareexpected.

TakingCetiristadwithfoodandalcohol

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

YoushouldnottakeCetiristadduringbreastfeedingbecausecetirizinepassesintobreastmilk.

Drivingandusingmachines

Clinicalstudieshaveproducednoevidenceofimpairedattention,alertnessanddrivingcapabilities aftertakingCetiristadattherecommendeddose.

Ifyouareintendingtodrive,engageinpotentiallyhazardousactivitiesoroperatemachinery,you shouldnotexceedtherecommendeddose.Youshouldcloselyobserveyourresponsetothedrug.

Ifyouareasensitivepatient,youmayfindthatthesimultaneoususeofalcoholorothernervous depressantagentsmayadditionallyaffectyourattentionandabilitytoreact.

Cetiristadoralsolutioncontainssorbitol, methylparahydroxybenzoate (E 218) and propylparahydroxybenzoate (E216)

Ifyouhave beentoldbyyourdoctorthatyouhavean intolerancetosomesugars (for example sorbitol),pleasecontactyourdoctorbeforetakingthismedicinalproduct.

Methylparahydroxybenzoate and propylparahydroxybenzoate maycauseallergicreactions(possiblydelayed).

3. How to takeCetiristad

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

10mgoncedailyas10mloralsolution(2fullmeasuringspoons)

Childrenbetween6and12yearsold

5mgtwicedailyas5ml(onefullmeasuringspoon)twicedaily.

Childrenbetween2and6yearsold

2.5mgtwicedailyas2.5mloralsolution(ahalf-measuringspoon)twicedaily

Patientswithmoderatetosevererenalimpairment

Patientswithmoderaterenalimpairmentarerecommendedtotake5mgoncedaily.

Method of administration

Thesolutioncanbeswallowedassuch.

Durationoftreatment

Thedurationoftreatmentdependsonthetype,durationandcourseofyourcomplaintsandis determinedbyyourdoctor.

IfyoutakemoreCetiristadthanyoushould

IfyouthinkyouhavetakenanoverdoseofCetiristadpleaseinformyourdoctor.Yourdoctorwillthen decidewhatmeasures,ifany,shouldbetaken.

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

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 in 10,000 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)

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 Cetiristad

Keep this medicine out of the sight and reach of children.

Do not use this medicineafter the expiry date which is stated on the bottleafter EXP. The expiry date refers to the last day of that month.

After opening Cetiristad should be used within 12 weeks.

Store in original container.

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

6. Contents of the pack and other information

What Cetiristad contains

1 ml oral solution contains 1 mg of cetirizine dihydrochloride.

What Cetiristad looks like and contents of the pack

Clear colourless liquid with banana flavour.

Amber glass bottles containing 75 and 150 ml oral solution.

Marketing Authorisation Holder and Manufacturer

<to be completed nationally>

ThismedicinalproductisauthorisedintheMemberStatesoftheEEAunderthefollowing names:

Germany: Cetirizin AL 1 mg/ml Sirup

Sweden: Cetiristad 1 mg/ml

This leaflet was last revisedin 26 September 2014.