Zyrtec Side Effects and Contraindications, Study notes of Marketing

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LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINALPRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATIONHOLDERS IN THE MEMBER STATESANNEX I

2 Member State^ Marketing AuthorisationInvented nameHolder

Strength^ PharmaceuticalRoute ofContentFormadministration(concentration) Austria^ UCB Pharma GmbH (AT)Zyrtec 10 mg -Jacquingasse,16-18/3.OGFilmtabletten1030 Wien

10mg^ film-coated tablet^ oral use Austria^ UCB Pharma GmbH (AT)Zyrtec 10 mg/ml –Jacquingasse,16-18/3.OGTropfen1030 Wien

10mg/ml^ oral drops,oral use^ 10mg/mlsolution Austria^ UCB Pharma GmbH (AT)Zyrtec 1 mg/ml –Jacquingasse,16-18/3.OGorale Lösung1030 Wien

1mg/ml^ oral solution^ oral use^ 1mg/ml Belgium^ McNeilREACTINE^ Roderveld 1B – 2600 BerchemBelgium

10mg^ film-coated tablet^ oral use Belgium^ UCB Pharma SA (Brussels)CETIRIZINE-Allée de la Recherche, 60UCBB-1070 Brussels

10mg^ film-coated tablet^ oral use Belgium^ UCB Pharma SA (Brussels)CETIRIZINE-Allée de la Recherche, 60UCBB-1070 Brussels

10mg/ml^ oral drops,oral use^ 10mg/mlsolution Belgium^ UCB Pharma SA (Brussels)VIRLIX^ Allée de la Recherche, 60B-1070 Brussels

10mg/ml^ oral drops,oral use^ 10mg/mlsolution Belgium^ UCB Pharma SA (Brussels)ZYRTEC^ Allée de la Recherche, 60B-1070 Brussels

10mg^ film-coated tablet^ oral use Belgium^ UCB Pharma SA (Brussels)ZYRTEC^ Allée de la Recherche, 60B-1070 Brussels

10mg/ml^ oral drops,oral use^ 10mg/mlsolution

4 Member State^ Marketing AuthorisationInvented nameHolder

Strength^ PharmaceuticalRoute ofContentFormadministration(concentration) Denmark^ McNeil Denmark ApsBENADAY^ Bregnerødvej 133DK-3460 Birkerød

10mg^ film-coated tablet^ oral use Denmark^ McNeil Denmark ApsBENADAY^ Bregnerødvej 133DK-3460 Birkerød

1mg/ml^ oral solution^ oral use^ 1mg/ml Denmark^ UCB Nordic A/S (DK) ArneZYRTEC^ Jacobsens Allé 15DK-2300 Kobenhavn S

10mg^ film-coated tablet^ oral use Denmark^ UCB Nordic A/S (DK) ArneZYRTEC^ Jacobsens Allé 15DK-2300 Kobenhavn S

10mg/ml^ oral drops,oral use^ 10mg/mlsolution Denmark^ UCB Nordic A/S (DK) ArneZYRTEC^ Jacobsens Allé 15DK-2300 Kobenhavn S

1mg/ml^ oral solution^ oral use^ 1mg/ml Estonia^ UCB Pharma Oy FinlandZYRTEC^ Malminkaari 5FI-00700 HELSINKI

10mg^ film-coated tablet^ oral use Estonia^ UCB Pharma Oy FinlandZYRTEC^ Malminkaari 5FI-00700 HELSINKI

10mg/ml^ oral drops,oral use^ 10mg/mlsolution Estonia^ UCB Pharma Oy FinlandZYRTEC^ Malminkaari 5FI-00700 HELSINKI

1mg/ml^ oral solution^ oral use^ 1mg/ml Finland^ McNeil, a division of Janssen-BENADAY^ Cilag OyMetsänneidonkuja 802130 ESPOO

10mg^ film-coated tablet^ oral use Finland^ UCB Pharma Oy FinlandZYRTEC^ Malminkaari 5FI-00700 HELSINKI

10mg^ film-coated tablet^ oral use

5 Member State^ Marketing AuthorisationInvented nameHolder

Strength^ PharmaceuticalRoute ofContentFormadministration(concentration) Finland^ UCB Pharma Oy FinlandZYRTEC^ Malminkaari 5FI-00700 HELSINKI

10mg/ml^ oral drops,oral use^ 10mg/mlsolution Finland^ UCB Pharma Oy FinlandZYRTEC^ Malminkaari 5FI-00700 HELSINKI

1mg/ml^ oral solution^ oral use^ 1mg/ml France^ Pfizer Santé Grand Public (FR)REACTINE^ 23-25 avenue du docteurLannelongue75668 Paris cedex 14

10mg^ film-coated tablet^ oral use France^ Sanofi Aventis FranceVIRLIX^ 9 Boulevard Romain Rolland75159 Paris Cedex 14France

10mg^ film-coated tablet^ oral use France^ Sanofi Aventis FranceVIRLIX^ 9 Boulevard Romain Rolland75159 Paris Cedex 14France

10mg/ml^ oral drops,oral use^ 10mg/mlsolution France^ Sanofi Aventis FranceVIRLIX^ 9 Boulevard Romain Rolland75159 Paris Cedex 14France

1mg/ml^ oral solution^ oral use^ 1mg/ml France^ UCB Pharma S.A.21, Rue deCETIRIZINENeuillyUCB 10MGF-92003 Nanterre

10mg^ film-coated tablet^ oral use France^ UCB Pharma S.A.21, Rue deZYRTEC^ NeuillyF-92003 Nanterre

10mg^ film-coated tablet^ oral use France^ UCB Pharma S.A.21, Rue deZYRTEC^ NeuillyF-92003 Nanterre

10mg/ml^ oral drops,oral use^ 10mg/mlsolution

7 Member State^ Marketing AuthorisationInvented nameHolder

Strength^ PharmaceuticalRoute ofContentFormadministration(concentration) Germany^ Pfizer Consumer HealthcareREACTINE^ GmbHPfizerstr. 1D-76139 KarlsruheGERMANY

10mg^ film-coated tablet^ oral use Greece^ UCB A.E. 580 AvenueZIPTEK^ VouliagmenisGR-16452 ArgyroupoliAthens

10mg^ film-coated tablet^ oral use Greece^ UCB A.E. 580 AvenueZIPTEK^ VouliagmenisGR-16452 ArgyroupoliAthens

10mg/ml^ oral drops, solution^ oral use^ 10mg/ml Hungary^ UCB Magyarország Kft ÁrpádZYRTECfejedelem útja 26-28 1023CSEPPEKBudapest Hungary

10mg/ml^ oral drops, solution^ oral use^ 10mg/ml Hungary^ UCB Magyarország Kft ÁrpádZYRTECfejedelem útja 26-28 1023FILMTABLETTABudapest Hungary

10mg^ film-coated tablet^ oral use Hungary^ UCB Magyarország Kft ÁrpádZYRTEC OLDATfejedelem útja 26-28 1023Budapest Hungary

1mg/ml^ oral solution^ oral use^ 1mg/ml Hungary^ UCB Magyarország Kft ÁrpádZYRTEC STARTfejedelem útja 26-28 1023FILMTABLETTABudapest Hungary

10mg^ film-coated tablet^ oral use Ireland^ UCB Pharma Ireland Limited,ZIRTEK ORALUnited Drug House,SOLUTIONMagna Drive1MG/MLCity West RoadDublin 24Ireland

1mg/ml^ oral solution^ oral use^ 1mg/ml

8 Member State^ Marketing AuthorisationInvented nameHolder

Strength^ PharmaceuticalRoute ofContentFormadministration(concentration) Ireland^ UCB Pharma Ireland Limited,ZIRTEKUnited Drug House,TABLETSMagna DriveCity West RoadDublin 24Ireland

10mg^ film-coated tablet^ oral use Italy^ Istituto LusofarmacoFORMISTINVia Walter Tobagi 820068 Peschiera Borromeo (MI)Italy

10mg^ film-coated tablet^ oral use Italy^ Istituto LusofarmacoFORMISTINVia Walter Tobagi 820068 Peschiera Borromeo (MI)Italy

10mg/ml^ oral drops, solution^ oral use^ 10mg/ml Italy^ Pfizer Consumer Healthcare S.r.l.VIRLIX^ SS 156km 5004010 Borgo San Michele (LT)Italy

10mg^ film-coated tablet^ oral use Italy^ Pfizer Consumer Healthcare S.r.l.VIRLIX^ SS 156km 5004010 Borgo San Michele (LT)Italy

10mg/ml^ oral drops, solution^ oral use^ 10mg/ml Italy^ UCB Pharma SpA Via Praglia,ZIRTEC 1^15 MG/MLI-10044 Pianezza (Torino)SOLUZIONEORALE

1mg/ml^ oral solution^ oral use^ 1mg/ml Italy^ UCB Pharma SpA Via Praglia,ZIRTEC 10 MG^15 COMPRESSEI-10044 Pianezza (Torino)RIVESTITE CONFILM

10mg^ film-coated tablet^ oral use

10 Member State^ Marketing AuthorisationInvented nameHolder

Strength^ PharmaceuticalRoute ofContentFormadministration(concentration) Luxemburg^ UCB Pharma SA (Brussels) AlléeVIRLIX^ de la Recherche, 60B-

10mg/ml^ oral drops, solution^ oral use^ 10mg/ml Luxemburg^ UCB Pharma SA (Brussels) AlléeZYRTEC^ de la Recherche, 60B-

10mg^ film-coated tablet^ oral use Luxemburg^ UCB Pharma SA (Brussels) AlléeZYRTEC^ de la Recherche, 60B-

10mg/ml^ oral drops, solution^ oral use^ 10mg/ml Luxemburg^ UCB Pharma SA (Brussels) AlléeZYRTEC^ de la Recherche, 60B-

1mg/ml^ oral solution^ oral use^ 1mg/ml Luxemburg^ UCB Pharma SA (Brussels) AlléeCETIRIZINE-de la Recherche, 60UCBB-

10mg^ film-coated tablet^ oral use Luxemburg^ UCB Pharma SA (Brussels) AlléeCETIRIZINE-de la Recherche, 60UCBB-

10mg/ml^ oral drops, solution^ oral use^ 10mg/ml Malta^ Pharmasud Ltd.ZYRTEC^ 38 Triq L-IsturnellSan Gwann SGN02Malta

10mg^ film-coated tablet^ oral use Malta^ Pharmasud Ltd.ZYRTEC^ 38 Triq L-IsturnellSan Gwann SGN02Malta

1mg/ml^ oral solution^ oral use^ 1mg/ml Netherlands^ Pfizer Consumer Healthcare BVREACTINE^ Rivium Westlaan 142NL-2909 LD Capelle a/d IJselNederland

10mg^ film-coated tablet^ oral use

11 Member State^ Marketing AuthorisationInvented nameHolder

Strength^ PharmaceuticalRoute ofContentFormadministration(concentration) Netherlands^ UCB Pharma B.V.ZYRTEC^ Lage Mosten 33NL-4822 NK^ BredaNederland

10mg^ film-coated tablet^ oral use Netherlands^ UCB Pharma B.V.ZYRTEC^ Lage Mosten 33NL-4822 NK^ BredaNederland

1mg/ml^ oral solution^ oral use^ 1mg/ml McNeil^ Sweden^ AB,Norway REACTINE^ SollentunaSweden 10mg^ film-coated tablet^ oral use Norway^ UCB Nordic A/S (DK) ArneZYRTEC^ Jacobsens Allé 15DK-2300 Kobenhavn S

10mg^ film-coated tablet^ oral use Norway^ UCB Nordic A/S (DK) ArneZYRTEC^ Jacobsens Allé 15DK-2300 Kobenhavn S

10mg/ml^ oral drops, solution^ oral use^ 10mg/ml Norway^ UCB Nordic A/S (DK) ArneZYRTEC^ Jacobsens Allé 15DK-2300 Kobenhavn S

1mg/ml^ oral solution^ oral use^ 1mg/ml Poland^ Pfizer Consumer HealthcareREACTINE^ (GB)Walton Oaks Dorking Road,Walton on the HillKT 20 7 NS, SurreyGreat Britain

10mg^ film-coated tablet^ oral use Poland^ PLIVA Kraków ZakładyVIRLIX^ Farmaceutyczne S.A.ul. Mogilska 8031-546 KrakowPoland

10mg^ film-coated tablet^ oral use

13 Member State^ Marketing AuthorisationInvented nameHolder

Strength^ PharmaceuticalRoute ofContentFormadministration(concentration) Portugal^ UCB Pharma Ed. Maria I, Q 60,ZYRTEC^ piso 1 AQuinta da Fonte2770-229 PACO DE ARCOS

1mg/ml^ oral solution^ oral use^ 1mg/ml Portugal^ Vedim Pharma LdaVIRLIX^ Ed. D. Maria IPiso 1 AQuinta da Fonte2770-229 Paco de ArcosPortugal

10mg^ film-coated tablet^ oral use Portugal^ Vedim Pharma LdaVIRLIX^ Ed. D. Maria IPiso 1 AQuinta da Fonte2770-229 Paco de ArcosPortugal

1mg/ml^ oral solution^ oral use^ 1mg/ml Romania^ UCB GmbH Huttenstraße 205ZYRTEC^ D-50170 KerpenGermany

10mg^ film-coated tablet^ oral use Romania^ UCB GmbH Huttenstraße 205ZYRTEC^ D-50170 KerpenGermany

10mg/ml^ oral drops, solution^ oral use^ 10mg/ml Slovakia^ UCB SA Pharma SecteurZYRTEC GTTChemin du Foriest,POR 10MG/MLB-1420 Braine l´AlleudBelgium

10mg/ml^ oral drops, solution^ oral use^ 10mg/ml Slovakia^ UCB SA Pharma SecteurZYRTEC TBLChemin du Foriest,FLM 10MGB-1420 Braine l´AlleudBelgium

10mg^ film-coated tablet^ oral use

14 Member State^ Marketing AuthorisationInvented nameHolder

Strength^ PharmaceuticalRoute ofContentFormadministration(concentration) Slovenia^ Medis Podjetje za proizvodnjo inZYRTEC 1trzenje, D.O.O. (Slovenia)MG/MLBrnciceva 1PERORALNASLO - 1001 LjubljianaRAZTOPINASlovenia

1mg/ml^ oral solution^ oral use^ 1mg/ml Slovenia^ Medis Podjetje za proizvodnjo inZYRTEC 10 MGtrzenje, D.O.O. (Slovenia)FILMSKOBrnciceva 1OBLOZENESLO - 1001 LjubljianaTABLETESlovenia

10mg^ film-coated tablet^ oral use Slovenia^ Medis Podjetje za proizvodnjo inZYRTEC 10trzenje, D.O.O. (Slovenia)MG/MLBrnciceva 1PERORALNESLO - 1001 LjubljianaKAPLJICE,SloveniaRAZTOPINA

10mg/ml^ oral drops, solution^ oral use^ 10mg/ml Spain^ Laboratorios Menarini S.A.ALERLISINAlfonso XII, 58708918 Badalona (Barcelona)Spain

10mg^ film-coated tablet^ oral use Spain^ Laboratorios Menarini S.A.ALERLISINAlfonso XII, 58708918 Badalona (Barcelona)Spain

10mg/ml^ oral drops, solution^ oral use^ 10mg/ml Spain^ Laboratorios Menarini S.A.ALERLISINAlfonso XII, 58708918 Badalona (Barcelona)Spain

1mg/ml^ oral solution^ oral use^ 1mg/ml Spain^ Lacer SAVIRDOS^ Sardenya 346 - 350E - 08025 BarcelonaSpain

10mg/ml^ oral drops, solution^ oral use^ 10mg/ml

16 Member State^ Marketing AuthorisationInvented nameHolder

Strength^ PharmaceuticalRoute ofContentFormadministration(concentration) Spain^ Vedim Pharma S.A.ALERRID 10 MGAvenida de Barcelona, 239COMPRIMIDOS08750 Molins de Rei (Barcelona)RECUBIERTOSpainCON PELICULA

10mg^ film-coated tablet^ oral use Sweden^ UCB Nordic A/SALERID^ Arne Jacobsens Allé 15DK-2300 Kobenhavn SDenmark

10mg^ film-coated tablet^ oral use Sweden^ UCB Nordic A/SZYRLEX^ Arne Jacobsens Allé 15DK-2300 Kobenhavn SDenmark

10mg^ film-coated tablet^ oral use Sweden^ UCB Nordic A/SZYRLEX^ Arne Jacobsens Allé 15DK-2300 Kobenhavn SDenmark

10mg/ml^ oral drops, solution^ oral use^ 10mg/ml Sweden^ UCB Nordic A/SZYRLEX^ Arne Jacobsens Allé 15DK-2300 Kobenhavn SDenmark

1mg/ml^ oral solution^ oral use^ 1mg/ml UnitedMcNeil Products LimitedBENADRYLKingdomFoundation Park, RoxboroughALLERGY ORALway, Maidenhead, Berkshire,SYRUPSL6 3UG, UK

1mg/ml^ oral solution^ oral use^ 1mg/ml UnitedMcNeil Products LimitedBENADRYL FORKingdomFoundation Park, RoxboroughCHILDRENway, Maidenhead, Berkshire,ALLERGYSL6 3UG, UKSOLUTION

1mg/ml^ oral solution^ oral use^ 1mg/ml

17 Member State^ Marketing AuthorisationInvented nameHolder

Strength^ PharmaceuticalRoute ofContentFormadministration(concentration) UnitedMcNeil Products LimitedBENADRYLKingdomWalton Oaks, Dorking Road,ONE A DAYWalton on the Hill, Surrey KT207NS UK

10mg^ film-coated tablet^ oral use UnitedMcNeil Products LimitedBENADRYLkingdomFoundation Park, RoxboroughONE A DAYway, Maidenhead, Berkshire,RELIEFSL6 3UG, UK

10mg^ film-coated tablet^ oral use UnitedUCB PHARMA LIMITEDZIRTEKKingdom208 Bath RoadALLERGYSLOUGHRELIEF FORBerkshireCHILDRENSL1 3WE

1mg/ml^ oral solution^ oral use^ 1mg/ml UnitedUCB PHARMA LIMITEDZIRTEKKingdom208 Bath RoadALLERGYSLOUGHRELIEFBerkshireTABLETSSL1 3WE

10mg^ film-coated tablet^ oral use UnitedUCB PHARMA LIMITEDZIRTEKKingdom208 Bath RoadALLERGYSLOUGHSOLUTIONBerkshireSL1 3WE

1mg/ml^ oral solution^ oral use^ 1mg/ml UnitedUCB PHARMA LIMITEDBENADRYLKingdom208 Bath RoadALLERGYSLOUGHSOLUTIONBerkshireSL1 3WE

1mg/ml^ oral solution^ oral use^ 1mg/ml

19

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE SUMMARIES OF PRODUCTCHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE^ ANNEX IIEMEA

20

SCIENTIFIC CONCLUSIONS OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ZYRTEC ANDASSOCIATED NAMES Zyrtec (cetirizine dihydrochloride) is an antiallergic drug indicated for the relief of nasal symptoms ofseasonal and perennial allergic rhinitis. The drug is authorised for the symptomatic treatment ofseasonal allergic rhinitis, perennial allergic rhinitis, and various types of pruritus and dermatologicalconditions from allergic origin, in particular chronic idiopathic urticaria. In adults, all threeindications are treated by a 10 mg daily dose of cetirizine. The drug is indicated in adults and childrenaged 2 years and older in all the member states. In 16 member states, treatment with cetirizine is alsorecommended in infants and toddlers aged 1 to 2 years. The liquid formulations are primarily forchildren up to 12 years, the solid tablets are for children from 12 years on and for adults. Due to thedivergent national decisions taken by Member States concerning the authorisation of Zyrtec, a numberof divergences exist in the product information and a referral was therefore triggered by the EuropeanCommission Article 30 of Directive 2001/83/EC as amended in order to harmonise the divergentProduct Information texts across the EU. A list of Questions was adopted by the CHMP, highlightingthe main areas of divergences.The CHMP asked the MAH to revise the wording, restrict and define the indication inrhinoconjunctivitis rather than in conjunctivitis alone and discuss seasonal conjunctivitis, itching andallergic pruritis, severe skin reactions induced by mosquito and atopic dermatitis, as they should beconsidered as separate entities requiring more supportive data.The MAH acknowledged that the indication section varies a lot from one Member State to the other (SEE ANNEX I) but that the wording differences corresponded to three well-identified indications. The MAH providedextensive testing data from the review of therapeutic trials and the corresponding clinical studyreports in support of these indications and proposed the removal of the other indications such asatopic dermatitis, prevention of asthma, mosquito bites as the clinical evidences available to supportthese indications was considered insufficient. The corresponding section of the PL was revisedaccordingly. The following indications were agreed upon: In adults, children, infants and toddlers 2 year and above: • • The current paediatric indications are not disharmonised based on the indication itself but withregards to the definition of the paediatric age groups and with regards to the dosing for these groups.Depending on the member state, the posology is based on the weight or the age, or even acombination of both and a number of age groups and posology groups were identified. The MAHargued that the paediatric use of cetirizine in the same indications as in adults is justified, as nopathophysiological reason was identified for not using antihistamines in the paediatric population,provided the dose is adequately adapted to different body weight, age and clearance of the drug. Aharmonized wording for age groups and relevant posology was agreed upon: • • • Cetirizine is indicated for the relief of nasal and ocular symptoms of seasonal and perennialallergic rhinitisCetrizine is indicated for the relief of chronic idiopathic urticaria.Children aged from 2 to 6 years: 2.5 mg twice daily (5 drops twice daily).Children aged from 6 to 12 years: 5 mg twice daily (10 drops twice daily).Adults and adolescents over 12 years of age: 10 mg once daily (20 drops). The posology proposed for children has been tested in clinical trials, but also results from dosingadaptations based on body weight and clearance that varies according to the maturation of the renalsystem. This is why the harmonized wording does not propose a weight – based posology, as weightis clearly not the only factor to define the dose.