qanastek/EMEA-V3 huggingface dataset:
A 5ml Dosing spoon with a line at 2.5 ml is provided with the bottle.
Mgħarfa ta ’ kejl ta ’ 5 ml b’ linja għal 2. 5 ml tiġi provduta mal- flixkun.
Not all pack sizes may be marketed.
45 Jista jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
46 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
47 LABELLING
47 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON BOX
IL- KAXXA TAL- KARTUN
Cetirizine dihydrochloride
Cetirizine dihydrochloride
Each tablet contains 10 mg of cetirizine dihydrochloride
Kull pillola fiha 10 mg ta ’ cetirizine dihydrochloride
Film-coated tablets 1 tablet 4 tablets 5 tablets 7 tablets 10 tablets 14 tablets 15 tablets 20 tablets 21 tablets 30 tablets 40 tablets 45 tablets 50 tablets 60 tablets 90 tablets 100 tablets
Pilloli miksija b’ rita Pillola waħda 4 pilloli 5 pilloli 7 pilloli 10 pilloli 14 pilloli 15 pilloli 20 pilloli 21 pilloli 30 pilloli 40 pilloli 45 pilloli 50 pilloli 60 pilloli 90 pilloli 100 pilloli
Keep out of the reach and sight of children.
48 Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Exp:
Jis:
[To be completed nationally] {Name and address} {tel} {fax} {e-mail}
[Biex timtela mill- pajjiż partikolari]
[To be completed nationally]
[Biex timtela mill- pajjiż partikolari] [Isem u indirizz] {telefon} {fax} {e- mail}
[To be completed nationally]
STRUZZJONIJIET DWAR L- UŻU
Zyrtec 10 mg tablets
Zyrtec u ismijiet assoċjati miegħu (ara Anness I) 10 mg pilloli
50 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
49 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
PVC/ ALUMINIUM BLISTERS
Folji tal- aluminju/ PVC
51 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
50 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U IL- PAKKETT LI JMISS MAL- PRODOTT
CARTON BOX AND BOTTLES
Il- kaxxa tal- kartun u l- fliexken
One ml of solution contains 10 mg of cetirizine dihydrochloride, one drop of solution contains 0.5 mg cetirizine dihydrochloride
Ml wieħed tas- soluzzjoni fih 10 mg ta ’ cetirizine dihydrochloride
Contains methylparahydroxybenzoate (E 218) and propylparahydroxybenzoate (E 216), among other substances.
Fih methylparahydroxybenzoate (E 218) u propylparahydroxybenzoate (E 216), fost sustanzi oħra.
Oral drops, solution Bottle of 10 ml Bottle of 15 ml Bottle of 20 ml Bottle of 30 ml
Taqtir tal- ħalq, soluzzjoni Flixkun ta ’ 10 ml Flixkun ta ’ 15 ml Flixkun ta ’ 20 ml Flixkun ta ’ 30 ml
Zyrtec 10 mg/ ml oral drops
Zyrtec u ismijiet assoċjati miegħu (ara Anness I) 10 mg/ ml taqtir tal- ħalq
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
52 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U IL- PAKKETT LI JMISS MAL- PRODOTT
CARTON BOX AND BOTTLE
Il- kaxxa tal- kartun u l- flixkun
1 ml solution contain 1 mg of cetirizine dihydrochloride
1 ml tas- soluzzjoni fih 1 mg ta ’ cetirizine dihydrochloride
Contains methylparahydroxybenzoate (E 218), propylparahydroxybenzoate (E 216), sorbitol (E 420), among other substances.
Fih methylparahydroxybenzoate (E 218) u propylparahydroxybenzoate (E 216), sorbitol (E 420), fost sustanzi oħra.
Oral solution Bottle of 60 ml Bottle of 75 ml Bottle of 100 ml Bottle of 125 ml Bottle of 150 ml Bottle of 200 ml
Taqtir tal- ħalq, soluzzjoni Flixkun ta ’ 60 ml Flixkun ta ’ 75 ml Flixkun ta ’ 100 ml Flixkun ta ’ 125 ml Flixkun ta ’ 150 ml Flixkun ta ’ 200 ml
Zyrtec 1 mg/ ml oral solution
54 FULJETT TA ’ TAGĦRIF
55 PACKAGE LEAFLET
55 FULJETT TA ’ TAGĦRIF Għal prodott mediċinali li jingħata bir- riċetta tat- tabib.
56 PACKAGE LEAFLET For medicinal products available on prescription
56 FULJETT TA ’ TAGĦRIF:
Zyrtec and associated names (see Annex I) 10 mg film-coated tablets
Zyrtec u ismijiet assoċjati miegħu (ara Anness I) 10 mg pilloli miksija b’ rita [Ara Anness I - Biex timtela mill- pajjiż partikolari]
What Zyrtec is and what it is used for 2.
X’ inhu Zyrtec u għalxiex jintuża 2.
Before you take Zyrtec 3.
Qabel ma tieħu Zyrtec 3.
How to take Zyrtec 4.
Kif għandek Zyrtec 4.
How to store Zyrtec 6.
Kif taħżen Zyrtec 6.
WHAT Zyrtec IS AND WHAT IT IS USED FOR
X’ INHU ZYRTEC U GĦALXIEX JINTUŻA
Cetirizine dihydrochloride is the active ingredient of Zyrtec.
Cetirizine dihydrochloride huwa s- sustanza attiva ta ’ Zyrtec.
Zyrtec is an antiallergic medication.
Zyrtec hija mediċina ta ’ kontra l- allerġiji.
In adults and children aged 6 year and above, Zyrtec is indicated
Fl- adulti, u tfal ta ’ 6 snin ‘ l fuq, Zyrtec huwa indikat
- for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
- għas- serħan minn sintomi nażali u ta’ l- għajnejn ta ’ rinite allerġika staġjonali u perenni.
- for the relief of chronic nettle rash (chronic idiopathic urticaria).
- għas- serħan minn urtikarja kronika (urtikarja idjopatika kronika).
BEFORE YOU TAKE ZYRTEC
QABEL MA TIEĦU ZYRTEC
Do not take Zyrtec
Tieħux Zyrtec:
- if you have a severe kidney disease (severe renal failure with creatinine clearance below 10
- Jekk għandhekk mard tal- kliewi sever (falliment sever tal- kliewi bil- clearance tal- krejatinina
ml/ min);
inqas minn 10 ml/ min);
- if you are known to be hypersensitive to the active substance of Zyrtec, to any of its excipients
- jekk inti tbagħti minn sensittività eċċessiva għas- sustanza attiva ta ’ {Isem (ivvintat)}.
(other constituents), to hydroxyzine or to piperazine derivatives (closely related active substances of other medicines).
- jekk inti tbagħti minn sensittività eċċessiva għal sustanzi oħra relatati strutturalment jew xi
You should not take Zyrtec 10 mg tablets:
M’ għandekx tieħu Zyrtec:
- if you have hereditary problems of galactose intolerance, the Lapp lactase deficiency or
- Jekk għandek problemi ereditarji ta ’ intolleranza għal galactose, id- defiċjenza Lapp lactase jew
glucose-galactose malabsorption
mal- assorbiment ta ’ glucose- galactose.
Take special care with Zyrtec If you are a patient with renal insufficiency, please ask your doctor for advice; if necessary, you will take a lower dose.
Jekk int pazjent li tbagħti minn insuffiċjenza tal- kliewi, jekk jogħġbok staqsi lit- tabib tiegħek għal parir; jekk ikun hemm bżonn, tieħu doża baxxa.
The new dose will be determined by your doctor.
Id- doża ġdida tiġi deċiża mit- tabib tiegħek.
If you are an epileptic patient or a patient at risk of convulsions, you should ask your doctor for advice.
Jekk inti epilettiku jew pazjent f’ riskju ta ’ aċċessjonijiet, għandek tistaqsi lit- tabib tiegħek għal parir.
No interactions suceptible to have a noticeable impact have been observed between alcohol (at the blood level of 0.5 per mille corresponding to one glass of wine) and cetirizine used at the normal doses.
Iżda, bħal
However, as it is the case with all antihistamines, it is recommended to avoid concurrent consumption of alcohol.
57 fil- każ ta ’ kull mediċina ta ’ kontra l- istamina, huwa rrakkomandat li tevita il- konsum ta ’ alkoħol fl - istess ħin.
58 Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Due to the profile of cetirizine, no interactions with other drugs are expected
Minħabba il- profil ta ’ cetirizine, mhux mistenni li jkun hemm effett farmakoloġiku ma ’ mediċini oħra.
Taking Zyrtec with food and drink Food does not affect noticeabily the absorbtion of cetirizine.
Meta tieħu Zyrtec ma ’ l- ikel u max- xorb L- ikel m ’ għandux effett notevoli fuq l- livell t ’ assorbiment ta ’ cetirizine.
As with other drugs, use of Zyrtec should be avoided in pregnant women.
Bħal ma jsir b’ mediċini oħra, l- użu ta ’ Zyrtec għandu jiġu evitat f’ nisa tqal.
Nevertheless, the administration of the medicine should be discontinued.
L- użu aċċidentali tal - mediċina minn mara tqila m’ għandux iħalli ħsara fuq il- fetu, madanakollu, it- teħid tal- mediċina għandha titwaqqaf.
You should not take Zyrtec during breast feeding because cetirizine passes into breast milk.
M’ għandekx tieħu Zyrtec waqt it- treddigħ għaliex cetirizine jgħaddi ġol- ħalib ta ’ l- omm.
Driving and using machines Clinical studies have produced no evidence of impaired attention, alertness and driving capabilities after taking Zyrtec at the recommended dose.
Studji kliniċi ma sabu ebda evidenza ta ’ indeboliment fl- attenzjoni, fil- viġilanża u l- abbilta ’ fis - sewqan wara li ttieħed Zyrtec fid- doża irrakkomandata.
If you are intending to drive, engage in potentially hazardous activities or operate machinery, you should not exceed the recommended dose.
Jekk inti bi ħsiebek issuq, tagħmel xi attivita` li tista ’ tkun ta ’ ħsara jew tħaddem magni, m’ għandekx teċċedi d- doża irrakkomandata.
You should closely observe your response to the drug.
Għandek tosserva mill- qrib ir- rispons tiegħek għal mediċina.
If you are a sensitive patient, you may find that the simultaneous use of alcohol or other nervous depressant agents may additionally affect your attention and ability to react.
Jekk inti pazjent sensittiv, tista ’ ssib li l- uża ta ’ alkoħol jew mediċina depressanti tas- sistema nervuża oħra fl’ istess ħin, jista ’ jkollha effett fuq l- attenzjoni u l- abbilta ’ tiegħek ta ’ reazzjoni.
Important information about some of the ingredients of Zyrtec Zyrtec film-coated tablets contains lactose; if you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicinal product.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Zyrtec Zyrtec pilloli miksija b’ rita fihom lactose; jekk it- tabib tiegħek qallek li għandek intolleranza għal xi tipi ta ’ zokkor, jekk jogħġbok kellem lit- tabib tiegħek qabel ma tieħu din il- mediċina.
HOW TO TAKE ZYRTEC
KIF GĦANDEK TIEĦU ZYRTEC
How and when should you take Zyrtec?
Kif u meta għandek tieħu Zyrtec?
These guidelines apply unless your doctor has given you different instructions on how to use Zyrtec.
Dawn il- linji ta ’ gwida japplikaw sakemm it- tabib tiegħek ma jagħtikx struzzjonijiet oħra kif tuża Zyrtec.
Please follow these instructions, otherwise Zyrtec may not be fully effective.
Segwi dawn l- istruzzjonijiet, għaliex jekk le, Zyrtec jista ’ ma jkunx effettiv daqs kemm suppost.
Tablets need to be swallowed with a glass of liquid.
Il- pilloli jridu jittieħdu ma ’ tazza likwidu.
Adults and adolescents above 12 years old:
Adulti u addoloxxenti ‘ l fuq minn 12- il sena:
10 mg once daily as 1 tablet.
10 mg darba kuljum bħala pillola waħda
Children between 6 and 12 years old:
Tfal ta ’ bejn is- 6 u t- 12- il sena:
5 mg twice daily as a half tablet twice daily.
5 mg darbtejn kuljum bħala nofs pillola darbtejn kuljum.
Patients with moderate to severe renal impairment Patients with moderate renal impairment are recommended to take 5 mg once daily.
Huwa rrakkomandat li pazjenti b’ indeboliment tal- kliewi moderat jieħdu 5 mg darba kuljum.
If you feel that the effect of Zyrtec is too weak or too strong, please consult your doctor.
Jekk tħoss li l- effett ta ’ Zyrtec huwa debboli jew qawwi wisq, kellem lit- tabib tiegħek.
Duration of treatment:
58 Kemm idum it- trattament:
The duration of treatment depends on the type, duration and course of your complaints and is determined by your doctor.
It- tul tat- trattament jiddependi fuq it- tip, it- tul u n- natura tal- problema tiegħek u jiġi deċiż mit- tabib tiegħek.
If you take more Zyrtec than you should
Jekk tieħu Zyrtec aktar milli suppost:
59 If you think you have taken an overdose of Zyrtec please inform your doctor.
Jekk taħseb li ħadt aktar Zyrtec milli suppost jekk jogħġbok għid lit- tabib tiegħek.
Your doctor will then decide what measures, if any, should be taken.
It- tabib tiegħek imbagħad jiddeċiedi jekk ikunx hemm bżonn jittieħdu xi miżuri..
After an overdose, the side effects described below may occur with increased intensity.
Wara doża akbar milli suppost, l- effetti mhux mixtieqa li huma deskritti hawn taħt jistgħu jkunu aktar qawwija.
Adverse effects such as confusion, diarrhoea, dizziness, tiredness, headache, ailing, dilating of pupil, itching, restlessness, sedation, somnolence, stupor, abnormal rapid heart rate, tremors and urinary retention have been reported.
Effetti mhux mixtieqa bħal konfużjoni, dijareja, sturdament, għeja, uġigħ ta ’ ras, tħossok ma tiflaħx, tkabbir tal- pupilla, ħakk, irrekwitezza, sedazzjoni, ngħas tqil, sturdament, il- qalb tħabbat aktar mis- soltu, rogħda, u ma tistax tgħaddi awrina, ġew rapportati.
If you forget to take Zyrtec Do not take a double dose to make up for forgotten dose.
M’ għandekx tieħu doża doppja biex tpatti għal doża li tkun insejt tieħu.
If you stop taking Zyrtec If you have any further questions on the use of this product, ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, Zyrtec can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Zyrtec jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Following side effects have been reported in post marketing experience.
L- effeti mhux mixtieqa li ġejjin kienu rapportati fl- esperjenza ta ’ wara t- tqegħid fis- suq:
The frequencies are defined as such:
Il- frekwenzi huma definiti hekk:
1 patient out of 100 to 1 out of 10, uncommon:
(komuni: pazjent 1 minn kull 100 sa I minn kull 10, mhux komuni:
1 out of 1,000 to 1 out of 100, rare:
1 minn kull 1, 000 sa 1 minn kull 100, rari:
1 out of 10,000 to 1 out of 1,000, very rare: less than 1 out of 10,000).
1 minn kull 10, 000 sa 1 minn kull 1, 000, rari ħafna għal < 1/ 100, rari: ≥1/ 10, 000 għal < 1/ 1, 000, rari ħafna: inqas minn 1 minn kull 10, 000.
- Blood and lymphatic disorders:
- Mard tad- demm u tas- sistema limfatika:
very rare: thrombocytopenia (low levels of blood platelets)
rari ħafna: tromboċitopenja (livell baxx ta ’ plejtlets fid- demm)
- Body as a whole:
- Il- ġisem kollu kemm hu:
common: fatigue
komuni: għeja
- Cardiac disorders:
- Mard tal- qalb:
rare: tachycardia (heart beating too fast)
rari: takikardja (qalb tħabbat mgħaġġla wisq)
- Eye disorders:
- Mard ta ’ l- għajnejn:
very rare: accommodation disorder, blurred vision, oculogyration (eyes having uncontrolled circular movements)
rari ħafna: mard ta ’ akkomodazzjoni, viżżjoni mċajpra, okulogirazzjoni (għajnejn b’ moviment ċirkulari mhux kontrollati)
- Gastro-intestinal disorders:
- Mard gastro- intestinali:
common: dry mouth, nausea, diarrhoea uncommon:, abdominal pain
komuni: ħalq xott, dardir, dijareja mhux komuni: uġigħ addominali
- General disorders and administration site conditions:
- Mard ġenerali u kundizzjonijiet ta ’ mnejn jingħata:
uncommon: asthenia (extreme fatigue), malaise rare: oedema (swelling)
mhux komuni: astenja (għeja estrema), telqa, rari: edima (nefħa)
- Immune system disorders:
- Mard tas- sistema immuni:
rare: allergic reactions, some severe (very rare)
rari: reazzjonijiet allerġiċi, xi wħud severi (rari ħafna)
- Hepatobiliary disorders:
- Mard tal- fwied u tal- marrara:
rare: liver function abnormal
rari: funzjoni tal- fwied abnormali
- Investigations:
- Investigazzjonijiet:
rare: weight increased
rari: żieda fil- piż
- Nervous system disorders:
- Mard tas- sistema nervuża:
common: dizziness, headache uncommon: paresthesia (abnormal feelings of the skin)
komuni: sturdament, uġigħ ta ’ ras mhux komuni: para- esteżija (sensazzjoni abnormali fil- ġilda) rari: aċċessjonijiet, mard tal- moviment, rari ħafna: sinkope, rogħda, disġewsja( tibdil fit- togħma)
- Psychiatric disorders:
- Mard psikjatriku:
common: somnolence uncommon: agitation rare: aggression, confusion, depression, hallucination, insomnia very rare: tic
komuni: ngħas tqil mhux komuni: aġitazzjoni rari: aggressjoni, konfużjoni, depressjoni, alluċinazzjonijiet, insomnija, rari ħafna: tikk
- Renal and urinary disorders:
- Mard tal- kliewi u tas- sistema urinarja:
very rare: abnormal elimination of urine
rari ħafna: eliminazzjoni abnormali tal- awrina
- Respiratory system disorders:
- Mard tas- sistema respiratorja:
common: pharyngitis, rhinitis
komuni: farinġite, rinite
- Skin and subcutaneous tissue disorders:
- Mard tal- ġilda u t- tessut subkutanju:
uncommon: pruritus, rash rare: urticaria very rare: oedema, fixed drug eruption
mhux komuni: anġjonewrotiku, ħakk, raxx, rari: urtikarja, rari ħafna: edema, eruzzjoni fissa għall- mediċina
If you develop one of the side effects described above, please inform your doctor.
Jekk inti tiżvilluppa wieħed mill- effetti msemmija hawn fuq, jekk jogħġbok, għid lit- tabib tiegħek.
At the first signs of a hypersensitivity reaction, stop taking Zyrtec.
Ma l- ewwel sinjali ta ’ reazzjoni ta ’ sensittivita ’ eċċessiva, ieqaf ħu Zyrtec.
Your doctor will then assess the severity and decide on any further measures that may be necessary.
It- tabib tiegħek imbagħad iqis is- severita` u jiddeċiedi dwar miżuri oħra jekk ikun hemm bżonn.
If you think you have any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Jekk taħseb li għandek xi effetti oħra mhux mixtieqa li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE ZYRTEC
KIF TAĦŻEN ZYRTEC
Do not use Zyrtec after the expiry date which is stated on the box and blister.
Tużax Zyrtec wara d- data ta ’ skadenza li tidher fuq il- kaxxa u l- folja.
This medicine does not require any special storage conditions.
Din il- mediċina m’ għandiex bżonn kundizzjonijiet speċjali għall- ħażna.
What Zyrtec contains
X’ fih Zyrtec:
- The active substance of Zyrtec is cetirizine dihydrochloride.
- Is- sustanza attiva ta ’ Zyrtec hija cetirizine dihydrochloride.
- The other ingredients are microcrystalline cellulose, lactose, macrogol 400, magnesium
- Is- sustanzi l- oħra huma microcrystalline cellulose, lactose, macrogol 400, magnesium stearate,
stearate, hypromellose, colloidal silicon dioxide, titanium dioxide (E 171).
hypromellose, colloidal silicon dioxide, titanium dioxide (E 171).
What Zyrtec looks like and contents of the pack White, oblong, film-coated tablet, with breakline and Y-Y logo
Pillola miksija b’ rita, bajda, oblunga, b’ linja fejn tista ’ tinqasam u logo Y- Y.
Pack with 1, 4, 5, 7, 10, 14, 15, 20, 21, 30, 40, 45, 50, 60, 90, or 100 tablets.
Pakkett oriġinali b ’ 1, 4, 5, 7, 10, 14, 15, 20, 21, 30, 40, 45, 50, 60, 90, jew 100 pillola.
Marketing Authorisation Holder and Manufacturer
60 Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur:
61 {tel} {fax} {e-mail}
[Biex timtela mill- pajjiż partikolari] [Isem u indirizz] {telefon} {fax} {e- mail}
Zyrtec 10 mg -Filmtabletten Belgium:
Zyrtec 10 mg – Filmtabletten Il- Belġju:
Reactine, Cetirizine-UCB, Zyrtec Bulgaria:
Reactine, Cetirizine- UCB, Zyrtec Il- Bulgarija:
Zyrtec Cyprus:
Zyrtec Ċipru:
Zyrtec Czech Republic:
Zyrtec Ir- Repubblika Ċeka:
Zyrtec Denmark:
Zyrtec Id- Danimarka:
Benaday, Zyrtec Estonia:
Benaday, Zyrtec L- Estonja:
Zyrtec Finland:
Zyrtec Il- Finlandja:
Benaday, Zyrtec France:
Benaday, Zyrtec Franza:
Reactine, Virlix, Cetirizine UCB 10mg, Zyrtec, Actifed Allergie cetirizine 10mg, Zyrtecset Germany:
Reactine, Virlix, Cetirizine UCB 10mg, Zyrtec, Actifed Allergie cetirizine 10mg, Zyrtecset Il- Ġermanja:
Zyrtec, Zyrtec P, Reactine Greece:
Zyrtec, Zyrtec P, Reactine Il- Greċja:
Ziptek Hungary:
Ziptek L- Ungerija:
Zyrtec filmtabletta, Zyrtec start filmtabletta Ireland:
Zyrtec filmtabletta, Zyrtec start filmtabletta L- Irlanda:
Zirtek tablets Italy:
Zirtek tablets L- Italja:
Formistin, Virlix, Zirtec 10 mg compresse rivestite con film Latvia:
Formistin, Virlix, Zirtec 10 mg compresse rivestite con film Il- Latvja:
Zyrtec Lithuania:
Zyrtec Il- Litwanja:
Zyrtec Luxembourg:
Zyrtec Il- Lussemburgu:
Zyrtec Netherlands:
Zyrtec L- Olanda:
Reactine, Zyrtec Norway:
Reactine, Zyrtec In- Norveġja:
Reactine, Zyrtec Poland:
Reactine, Zyrtec Il- Polonja:
Reactine, Virlix, Zyrtec, Zyrtec UCB Portugal:
Reactine, Virlix, Zyrtec, Zyrtec UCB Il- Portugall:
Zyrtec, Virlix Romania:
Zyrtec, Virlix Ir- Rumanija:
Zyrtec Slovak Republic:
Zyrtec Is- Slovakkja:
Zyrtec tbl flm 10mg Slovenia:
Zyrtec tbl flm 10mg Slovenja:
Zyrtec10 mg filmsko oblozene tablete Spain:
Zyrtec10 mg filmsko oblozene tablete Spanja:
Alerlisin, Virlix, Reactine, Zyrtec comprimidos recubiertos con pelicula, Alerrid 10 mg comprimidos recubiertos con pelicula Sweden:
Alerlisin, Virlix, Reactine, Zyrtec comprimidos recubiertos con pelicula, Alerrid 10 mg comprimidos recubiertos con pelicula L- Isvezja:
Alerid, Zyrlex United Kingdom:
Alerid, Zyrlex Ir- Renju Unit:
63 PACKAGE LEAFLET:
61 FULJETT TA ’ TAGĦRIF:
Zyrtec and associated names (see Annex I) 10 mg film-coated tablets
Zyrtec u ismijiet assoċjati miegħu (ara Anness I) 10 mg/ ml taqtir tal- ħalq, soluzzjoni [Ara Anness I - Biex timtela mill- pajjiż partikolari]
Read all of this leaflet carefully because it contains important information for you.
Aqra sew dan il- fuljett kollu qabel tibda tieħu din il- mediċina
This medicine is available without prescription.
- Żomm dan il- fuljett.
However, you still need to use Zyrtec carefully to get the best results from it.
Jista ’ jkollok bżonn terġa ’ taqrah.
- Keep this leaflet.
- Din il- mediċina ġiet mogħtija lilek.
You may need to read it again.
M’ għandekx tgħaddiha lil persuni oħra.
- Ask your pharmacist if you need more information or advice.
Tista ’ tagħmlilhom
- You must contact a doctor if your symptoms worsen or do not improve after 3 days.
il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
Possible side effects 6.
Effetti sekondarji li jista ’ jkollu 5.
In adults and children aged 6 year and above, Zyrtec is indicated
Fl- adulti, tfal, trabi ta ’ sentejn ‘ l fuq, Zyrtec huwa indikat
- for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
- għas- serħan minn sintomi nażali u tal- għajnejn ta ’ rinite allerġika staġjonali u perenni.
- if you are known to be hypersensitive to the active substance of Zyrtec, to any of its excipients
- jekk inti tbagħti minn sensittività eċċessiva għas- sustanza attiva ta ’ Zyrtec, għal xi sustanzi mhux
(other constituents), to hydroxyzine or to piperazine derivatives (closely related active substances of other medicines).
attivi (kostitwenti oħra), għal hydroxyzine jew għal xi derattiv ta ’ piperazine (li jixbħu mill- qrib għal sustanzi attivi ta ’ mediċini oħra).
glucose-galactose malabsorption
Oqgħod attent ħafna b’ Zyrtec:
The new dose will be determined by your doctor.
Id- doża ġdida tiġi deċiża mit- Tabib tiegħek.
If you are an epileptic patient or a patient at risk of convulsions, you should ask your doctor for advice.
Jekk inti epilettiku jew pazjent f’ riskju ta ’ aċċessjonijiet, għandek istaqsi lit- tabib tiegħek għal parir.
No interactions suceptible to have a noticeable impact have been observed between alcohol (at the blood level of 0.5 per mille corresponding to one glass of wine) and cetirizine used at the normal
Iżda, bħal fil- każ ta ’ kull mediċina ta ’ kontra il- histamine, huwa rrakkomandat li tevita il- konsum ta ’ alkoħol fl- istess ħin.
However, as it is the case with all antihistamines, it is recommended to avoid concurrent consumption of alcohol.
Jekk inti epilettiku jew pazjent f’ riskju ta ’ aċċessjonijiet, għandek tistaqsi lit- tabib tiegħek għal parir.
Accidental use of the drug by a pregnant woman should not produce any harmful effects on the foetus.
L- użu aċċidentali tal - mediċina minn mara tqila m’ għandux iħalli ħsara fuq il- fetu.
Nevertheless, the administration of the medicine should be discontinued.
Madanakollu, it- teħid tal- mediċina għandu jitwaqqaf.
Important information about some of the ingredients of Zyrtec Zyrtec film-coated tablets contain lactose; if you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicinal product.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Zyrtec Zyrtec soluzzjoni ta ’ taqtir tal- ħalq fih methyl (4- hydroxybenzoate) E 218 u propyl (4 - hydroxybenzoate) E 216, li jistgħu jikkawżaw reazzjonijiet allerġiċi (li jistgħu jdumu biex joħorġu).
These guidelines apply unless your doctor has given you different instructions on how to use Zyrtec.
Dawn il- linji ta ’ gwida japplikaw sakemm it- tabib tiegħek ma jagħtikx struzzjonijiet oħra kif tuża Zyrtec u ismijiet assoċjati miegħu (ara Anness I).
Please follow these instructions, otherwise Zyrtec may not be fully effective.
Segwi dawn l- istruzzjonijiet, għaliex jekk le, Zyrtec jista ’ ma jkunx effettiv daqs kemm suppost
Tablets need to be swallowed with a glass of liquid.
10 mg darba kuljum bħala 20 taqtira.
Adults and adolescents above 12 years old:
Tfal ta ’ bejn is- 6 u t- 12- il sena:
10 mg once daily as 1 tablet.
5 mg darbtejn kuljum bħala 10 taqtiriet, darbtejn kuljum.
Children between 6 and 12 years old:
Tfal ta ’ bejn is- sentejn u s- 6 snin:
5 mg twice daily as a half tablet twice daily.
2. 5 mg darbtejn kuljum li jingħataw bħala 5 taqtiriet darbtejn kuljum.
Patients with moderate to severe renal impairment Patients with moderate renal impairment are recommended to take 5 mg once daily.
Huwa irrakkomandat li pazjenti b’ indeboliment renali moderat jieħdu 5 mg bħala 10 taqtiriet darba kuljum.
Duration of treatment:
Kemm idum it- trattament:
The duration of treatment depends on the type, duration and course of your complaints and is determined by your doctor.
It- trattament idum skond it- tip, it- tul u n- natura tal- problema tiegħek u jiġi deċiż mit- tabib tiegħek.
65 If you take more Zyrtec than you should If you think you have taken an overdose of Zyrtec please inform your doctor.
Jekk taħseb li ħadt aktar Zyrtec milli suppost jekk jogħġbok igħid lit- tabib tiegħek.
Your doctor will then decide what measures, if any, should be taken.
It- tabib tiegħek imbagħad jiddeċiedi jekk ikunx hemm bżonn jittieħdu xi miżuri.
After an overdose, the side effects described below may occur with increased intensity.
Wara doża li tkun aktar milli suppost, l- effetti mhux mixtieqa li huma deskritti hawn taħt jistgħu jkunu aktar qawwija.
very rare: accommodation disorder, blurred vision, oculogyration (eyes having uncontrolled circular movements)
rari ħafna: mard ta ’ akkomodazzjoni, viżżjoni mċajpra, okulogirazzjoni b’ moviment ċirkulari mhux kontrollati)
- Gastro-intestinal disorders:
(għajnejn
common: dry mouth, nausea, diarrhoea uncommon:, abdominal pain
Mard gastro- intestinali: komuni: ħalq xott, dardir, dijareja mhux komuni: uġigħ addominali
66 common: dizziness, headache uncommon: paresthesia (abnormal feelings of the skin) rare: convulsions, movements disorders very rare: syncope, tremor, dysgeusia (altered taste)
komuni: sturdament, uġigħ ta ’ ras mhux komuni: para- esteżija (sensazzjoni abnormali fil- ġilda) rari: aċċessjonijiet, mard tal- moviment, rari ħafna: sinkope, rogħda, disġewsja( tibdil fit- togħma)
- Skin and subcutaneous tissue disorders:
- Mard tal- ġilda u t- tessut ta ’ taħt il- ġilda:
Your doctor will then assess the severity and decide on any further measures that may be necessary.
Ma l- ewwel sinjali ta ’ reazzjoni ta ’ sensittivita ’ eċċessiva, ieqaf ħu Zyrtec It- tabib tiegħek imbagħad iqis is- severita` u jiddeċiedi dwar miżuri oħra jekk ikun hemm bżonn.
Do not use Zyrtec after the expiry date which is stated on the box and blister.
Tużax Zyrtec wara d- data ta ’ skadenza li tidher fuq il- kaxxa.
This medicine does not require any special storage conditions.
Din il- mediċina m’ għandiex bżonn kundizzjonijiet speċjali għal- ħażna.
- The active substance of Zyrtec is cetirizine dihydrochloride.
- Is- sustanza attiva ta ’ Zyrtec Soluzzjoni ta ’ taqtir tal- ħalq hija cetirizine dihydrochloride.
One film-coated tablet contains
Ml
10 mg cetirizine dihydrochloride.
wieħed (ekwivalenti għal 20 taqtira) fih 10 mg ta ’ cetirizine dihydrochloride taqtira waħda fiha 0. 5 mg ta ’ cetirizine dihydrochloride.
- The other ingredients are microcrystalline cellulose, lactose, macrogol 400, magnesium
- Is- sustanzi l- oħra huma glycerol, propylène glycol, saccharine sodium, methyl (4 -
stearate, hypromellose, colloidal silicon dioxide, titanium dioxide (E 171).
hydroxybenzoate) / propyl (4- hydroxybenzoate) = E 218 / E 216, sodium acetate, acetic acid, ilma purifikat.
What Zyrtec looks like and contents of the pack White, oblong, film-coated tablet, with breakline and Y-Y logo
Zyrtec issibu bħala likwidu car u bla kulur.
Pack with 1, 4, 5, 7, 10, 14, 15, 20, 21, 30, 40, 45, 50, 60, 90, or 100 tablets.
Pakkett oriġinali b’ flixkun ta ’ 10, 15, 20, jew 30 ml ta ’ soluzzjoni.
Not all pack sizes may be marketed
Jista jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
Marketing Authorisation Holder and Manufacturer
65 Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur:
67 [To be completed nationally] {Name and address} {tel} {fax} {e-mail}
[Biex timtela mill- pajjiż partikolari] [Isem u indirizz] {telefon} {fax} {e- mail}
Zyrtec 10 mg -Filmtabletten Belgium:
Zyrtec 10 mg/ ml - Tropfen Il- Belġju:
Reactine, Cetirizine-UCB, Zyrtec Bulgaria:
Cetirizine- UCB, Zyrtec, Virlix Il- Bulgarija:
Benaday, Zyrtec Estonia:
Zyrtec L- Estonja:
Benaday, Zyrtec France:
Zyrtec Franza:
Reactine, Virlix, Cetirizine UCB 10mg, Zyrtec, Actifed Allergie cetirizine 10mg, Zyrtecset Germany:
VirlixZyrtec Il- Ġermanja:
Zyrtec, Zyrtec P, Reactine Greece:
Zyrtec P tropfen, Zyrtec tropfen Il- Greċja:
Zirtek tablets Italy:
Zyrtec cseppek L- Italja:
Formistin, Virlix, Zirtec 10 mg compresse rivestite con film Latvia:
Formistin, Virlix, Zirtec 10mg/ ml gocce orali soluzione Il- Latvja:
Reactine, Zyrtec Norway:
Virlix, Zyrtec, Cetirizine- UCB In- Norveġja:
Reactine, Zyrtec Poland:
Zyrtec Il- Polonja:
Reactine, Virlix, Zyrtec, Zyrtec UCB Portugal:
Zyrtec Il- Portugall:
Zyrtec, Virlix Romania:
Zyrtec Ir- Rumanija:
Zyrtec tbl flm 10mg Slovenia:
Zyrtec gtt por 10mg/ ml Slovenja:
Zyrtec10 mg filmsko oblozene tablete Spain:
Zyrtec10 mg/ ml peroralne kapljice, raztopina Spanja:
Alerlisin, Virlix, Reactine, Zyrtec comprimidos recubiertos con pelicula, Alerrid 10 mg comprimidos recubiertos con pelicula Sweden:
Alerlisin, Virdos, Zyrtec gotas orales en solución L- Isvezja:
[To be completed nationally]
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
68 PACKAGE LEAFLET For medicinal products available on prescription
[Biex timtela mill- pajjiż partikolari]
69 PACKAGE LEAFLET:
66 FULJETT TA ’ TAGĦRIF:
Zyrtec and associated names (see Annex I) 10 mg/ ml oral drops, solution
Zyrtec u ismijiet assoċjati miegħu (ara Anness I) 1 mg/ ml soluzzjoni orali [Ara Anness I - Biex timtela mill- pajjiż partikolari]
Cetirizine dihydrochloride is the active ingredient of Zyrtec.
Cetirizine dihydrochloride huwa s- sustanza attiva ta ’ Zyrtec u ismijiet assoċjati miegħu (ara Anness I).
In adults and paediatric patients aged 2 year and above, Zyrtec is indicated
Fl- adulti, u tfal ta ’ sentejn ‘ l fuq, Zyrtec huwa indikat
- for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
- għas- serħan minn sintomi nażali u ta ’ l- għajnejn ta ’ rinite allerġika staġjonali u perenni.
- if you have a severe kidney disease (severe renal failure with creatinine clearance below
- Jekk għandhekk mard tal- kliewi sever (falliment sever tal- kliewi bil- clearance tal- krejatinina
10 ml/ min);
inqas minn 10 ml/ min);
(other constituents), to hydroxyzine or to any piperazine derivatives (closely related active substances of other medicines).
attivi (kostitwenti oħra), għal hydroxyzine jew għal xi derattiv ta ’ piperazine (li jixbħu mill- qrib għal sustanzi attivi ta ’ mediċini oħra) (ara sezzjoni 6).
Take special care with Zyrtec If you are a patient with renal insufficiency.
- jekk inti għandek problema ereditarja rari ta ’ intolleranza għal fructose
Please ask your doctor for advice; if necessary, you will take a lower dose.
Jekk int pazjent li tbagħti minn insuffiċjenza tal- kliewi, jekk jogħġbok staqsi lit- tabib tiegħek għal parir; jekk ikun hemm bżonn, tieħu doża baxxa.
The new dose will be determined by your Doctor.
Id- doża ġdida tiġi deċiża mit- tabib tiegħek.
No interactions suceptible to have a noticeable impact have been observed between alcohol (at the blood level of 0.5 per mille corresponding to one glass of wine) and cetirizine used at the normal doses.
Iżda,
However, as it is the case with all antihistamines, it is recommended to avoid concurrent consumption of alcohol.
67 bħal fil- każ ta ’ kull mediċina ta ’ kontra l- istamina, huwa irrakkomandat li tevita il- konsum ta ’ alkoħol fl- istess ħin.
70 Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken other medicine, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Due to the profile of cetirizine, no interactions with other drugs are expected.
Minħabba il- profil ta ’ cetirizine, mhux mistenni li jkun hemm effett farmakoloġiku ma ’ mediċini oħra.
Taking Zyrtec with food and drink Food does not affect noticeabily the absorption of cetirizine.
Meta tieħu Zyrtec ma ’ l- ikel u max- xorb L- ikel m ’ għandux effett notevoli fuq l- livell t ’ assorbiment ta ’ cetirizine.
Accidental use of the drug by a pregnant women should not produce any harmful effects on the foetus.
L- użu aċċidentali tal - mediċina minn mara tqila m’ għandux iħalli ħsara fuq il- fetu.
Driving and using machines Clinical studies have produced no evidence of impaired attention, alertness and driving capabilities after taking Zyrtec at the recommended dose.
Studji kliniċi ta ’ tqabbil ma sabu ebda evidenza ta ’ impediment fl- attenzjoni, fil- viġilanża u l- abbilta` fis- sewqan wara li ttieħed Zyrtec fid- doża irrakkomandata.
If you are a sensitive patient, you may find that the simultaneous use of alcohol or other nervous depressant agents may additionally affect your attention and ability to react.
Jekk inti pazjent sensittiv, tista ’ ssib li l- uża ta ’ alkoħol jew mediċina depressanti tas- sistema nervuża oħra fl’ istess ħin, jista ’ jkollha effett fuq l- attenzjoni u l- abbilta` ’ tiegħek ta ’ reazzjoni.
Important information about some of the ingredients of Zyrtec Zyrtec oral drops solution contain methyl (4-hydroxybenzoate) E 218 propyl (4-hydroxybenzoate) E 216 that may cause allergic reactions (possibly delayed).
Zyrtec soluzzjoni orali fih methyl (4- hydroxybenzoate) E 218 u propyl (4- hydroxybenzoate) E 216, li jistgħu jikkawżaw reazzjonijiet allerġiċi (li jistgħu jdumu biex joħorġu).
These guidelines apply unless your Doctor has given you different instructions on how to use Zyrtec.
Dawn il- linji ta ’ gwida japplikaw sakemm it- tabib tiegħek ma jagħtikx struzzjonijiet oħra kif tuża Zyrtec Segwi dawn l- istruzzjonijiet, għaliex jekk le, Zyrtec jista ’ ma jkunx effettiv daqs kemm suppost.
Please follow these instructions, otherwise Zyrtec may not be fully effective.
Is- soluzzjoni orali tista ’ tittieħed kif inhi.
10 mg once daily as 20 drops
10 mg darba kuljum bħala 10 ml ta ’ soluzzjoni orali (2 imgħaref tal- kejl mimlijin)
5 mg twice daily as 10 drops twice daily.
5 mg darbtejn kuljum bħala 5 ml (mgħarfa waħda tal- kejl mimlija) darbtejn kuljum.
Children between 2 and 6 years old 2.5 mg twice daily administered as 5 drops twice daily
2. 5 mg darbtejn kuljum bħala 2. 5 ml soluzzjoni orali (nofs mgħarfa tal- kejl) darbtejn kuljum.
Patients with moderate to severe renal impairment Patients with moderate renal impairment are recommended to take 5 mg as 10 drops once daily.
Huwa irrakkomandat li pazjenti b’ indeboliment renali moderat jieħdu 5 mg darba kuljum.
If you feel that the effect of Zyrtec is too weak or too strong, please consult your doctor.
68 Jekk tħoss li l- effett ta ’ Zyrtec huwa debboli jew qawwi wisq, kellem lit- tabib tiegħek.
Duration of treatment The duration of treatment depends on the type, duration and course of your complaints and is determined by your doctor.
It- trattament idum skond it- tip, it- tul u n- natura tal- problema u jiġi deċiż mit- tabib tiegħek.
71 If you think you have taken an overdose of Zyrtec please inform your doctor.
Jekk taħseb li ħadt aktar Zyrtec milli suppost jekk jogħġbok igħid lit- tabib tiegħek.
Adverse effects such as confusion, diarrhoea, dizziness, tiredness, headache, ailing, dilating of pupil, itching, restlessness, sedation, somnolence, stupor, abnormal rapid heart rate, tremors and urinary retention have been reported.
Ġew rapportati effetti mhux mixtieqa bħal konfużjoni, dijareja, sturdament, għeja, uġigħ ta ’ ras, tħossok ma tiflaħx, tkabbir tal- pupilla, ħakk, irrekwitezza, sedazzjoni, ngħas tqil, sturdament, il- qalb tħabbat iżjed mis- soltu, rogħda, u ma tistax tgħaddi awrina.
If you forget to take Zyrtec Do not take a double dose to make up for forgotten dose
M’ għandekx tieħu doża doppja biex tpatti għal doża li tkun insejt tieħu.
common: dry mouth, nausea, diarrhoea uncommon:, abdominal pain,
komuni: ħalq xott, dardir, dijareja mhux komuni: uġigħ addominali
uncommon: asthenia (extreme fatigue), malaise, rare: oedema (swelling)
mhux komuni: astenja (għeja estrema), telqa, rari: edima (nefħa)
common: dizziness, headache uncommon: paresthesia (abnormal feelings of the skin),
komuni: sturdament, uġigħ ta ’ ras mhux komuni: para- esteżija (sensazzjoni abnormali fil- ġilda) rari: aċċessjonijiet, mard tal- moviment, rari ħafna: sinkope, rogħda, disġewsja( tibdil fit- togħma)
uncommon: pruritus, rash, rare: urticaria, very rare: oedema, fixed drug eruption
mhux komuni: anġjonewrotiku, ħakk, raxx, rari: urtikarja, rari ħafna: edema, eruzzjoni fissa għall- mediċina
Your doctor will then assess the severity and decide on any further measures that may be necessary.
Ma l- ewwel sinjali ta ’ reazzjoni ta ’ sensittivita` eċċessiva, ieqaf ħu Zyrtec It- tabib tiegħek imbagħad iqis is- severita` u jiddeċiedi dwar miżuri oħra jekk ikun hemm bżonn.
Do not use Zyrtec after the expiry date which is stated on the box and bottle.
Tużax Zyrtec wara d- data ta ’ skadenza li tidher fuq il- kaxxa u l- flixkun.
This medicine does not require any special storage conditions.
Din il- mediċina m’ għandiex bżonn kundizzjonijiet speċjali.
What Zyrtec contains
X’ fih Zyrtec u ismijiet assoċjati miegħu (ara Anness I):
One ml (equals to 20 drops)
- Is- sustanza attiva ta ’ Zyrtec Soluzzjoni orali hija cetirizine dihydrochloride.
contains 10 mg of cetirizine dihydrochloride.
10 ml (= żewġ
One drop contains 0.5 mg of cetirizine dihydrochloride.
imgħaref ta ’ kejl) fih 10 mg ta’ cetirizine hydrochloride.
- The other ingredients are glycerol, propylène glycol, saccharine sodium, methyl (4-
- Is- sustanzi l- oħra huma Sorbitol (E420), glycerol, propylène glycol, saccharine sodium, methyl
hydroxybenzoate) / propyl (4-hydroxybenzoate) = E 218 / E 216, sodium acetate, acetic acid, purified water.
(4- hydroxybenzoate) / propyl (4- hydroxybenzoate) = E 218 / E 216, sustanza għat- togħma, sodium acetate, acetic acid, ilma purifikat.
What Zyrtec looks like and contents of the pack Zyrtec is supplied as a clear and colorless liquid.
- 10 ml ta ’ Zyrtec soluzzjoni orali (= żewġ imgħaref ta ’ kejl) fih: ekwivalenti ta ’ 3. 15 g ta ’
Pack with a bottle of 10, 15, 20, or 30 ml solution.
70 Pakkett oriġinali b’ flixkun ta ’ 60, 75, 100, 125, 150, jew 200 mL ta ’ soluzzjoni.
73 Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur:
Zyrtec 10 mg/ ml -Tropfen Belgium:
Zyrtec 1 mg/ ml – orale Lösung Il- Belġju:
Zyrtec Czech Republic:
Zyrtec Ċipru:
Zyrtec Estonia:
Benaday, Zyrtec L- Estonja:
Zyrtec France:
Zyrtec Franza:
Virlix, Zyrtec Germany:
Virlix, Zyrtec Il- Ġermanja:
Ziptek Hungary:
Zyrtec saft L- Ungerija:
Zyrtec cseppek Italy:
Zirtek oral solution 1mg/ ml L- Italja:
Formistin, Virlix, Zirtec 10mg/ ml gocce orali soluzione Latvia:
Zirtec 1mg/ ml soluzione orale Il- Latvja:
Virlix, Zyrtec, Cetirizine-UCB Norway:
Zyrtec In- Norveġja:
Zyrtec Poland:
Zyrtec Il- Polonja:
Zyrtec Romania:
Virlix, Zyrtec Il- Portugall:
Zyrtec gtt por 10mg/ ml Slovenia:
Zyrtec, Virlix Slovenja:
Zyrtec10 mg/ ml peroralne kapljice, raztopina Spain:
Zyrtec1 mg/ ml peroralna raztopina Spanja:
Alerlisin, Virdos, Zyrtec gotas orales en solución Sweden:
Alerlisin, Virlix, Reactine 5mg/ 5ml solución oral, Zyrtec solución oral L- Isvezja:
Zyrlex
Zyrlex Ir- Renju Unit:
74 PACKAGE LEAFLET For medicinal products available without a prescription
71 FULJETT TA ’ TAGĦRIF Għal prodott mediċinali li m’ għandux bżonn riċetta tat- tabib
75 PACKAGE LEAFLET:
72 FULJETT TA ’ TAGĦRIF:
Zyrtec and associated names (see Annex I) 10 mg/ ml oral drops, solution
Zyrtec u ismijiet assoċjati miegħu (ara Anness I) 10 mg pilloli miksija b’ rita [Ara Anness I - Biex timtela mill- pajjiż partikolari]
This medicine is available without prescription.
Din il- mediċina tingħata mingħajr riċetta.
However, you still need to use Zyrtec carefully to get the best results from it.
Madankollu, xorta għandek tieħu {Isem (Ivvintat) u ismijiet assoċjati miegħu (Ara Anness I)} b’ għaqal biex ikollok l- aħjar effett.
- Ask your pharmacist if you need more information or advice.
- Staqsi lill- ispiżjar tiegħek jekk tkun trid aktar tagħrif jew pariri.
- You must contact a doctor if your symptoms worsen or do not improve after 3 days.
- Għandek tikkuntattja lit- tabib jekk is- sintomi jmorru għall- agħar jew jibqgħu kif ikunu. wara 3
What Zyrtec is and what it is used for 2.
1 X’ inhu Zyrtec u għalxiex jintuża 2.
Possible side effects 8.
Effetti sekondarji li jista ’ jkollu 5.
In adults and paediatric patients aged 1 year and above, Zyrtec is indicated
Fl- adulti, and tfal ta ’ 6 snin ‘ l fuq, Zyrtec huwa indikat
(other constituents), to hydroxyzine or to any piperazine derivatives (closely related active substances of other medicines).
- jekk inti tbagħti minn sensittività eċċessiva għal sustanzi oħra relatati strutturalment jew xi
Take special care with Zyrtec If you are a patient with renal insufficiency.
- Jekk għandek problemi ereditarji ta ’ intolleranza għal galactose, id- defiċjenza Lapp lactase jew
No interactions suceptible to have a noticeable impact have been observed between alcohol (at the blood level of 0.5 per mille corresponding to one glass of wine) and cetirizine used at the normal doses.
73 Ma ġewx osservati effetti li tinduna bihom fuq l- effett farmaċewtiku tal- prodott, bl- alkoħol (fl- livell tad- demm ta ’ 0. 5 kull ml, ekwivalenti għal tazza nbid waħda) u cetirizine f’ dożi normali.
However, as it is the case with all antihistamines, it is recommended to avoid concurrent consumption of alcohol.
Iżda, bħal fil- każ ta ’ kull mediċina ta ’ kontra l- istamina, huwa irrakkomandat li tevita il- konsum ta ’ alkoħol fl - istess ħin.
76 Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken other medicine, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Important information about some of the ingredients of Zyrtec Zyrtec oral drops solution contain methyl (4-hydroxybenzoate) E 218 propyl (4-hydroxybenzoate) E 216 that may cause allergic reactions (possibly delayed).
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Zyrtec Zyrtec pilloli miksija b’ rita fihom lactose; jekk it- tabib tiegħek qallek li għandek intolleranza għal xi tipi ta ’ zokkor, jekk jogħġbok kellem lit- tabib tiegħek qabel ma tieħu din il- mediċina.
These guidelines apply unless your Doctor has given you different instructions on how to use Zyrtec.
Dawn il- linji ta ’ gwida japplikaw sakemm it- tabib tiegħek ma jagħtikx struzzjonijiet oħra kif tuża Zyrtec.
10 mg once daily as 20 drops
Il- pilloli jridu jittieħdu ma ’ tazza likwidu.
Children between 6 and 12 years old:
Adulti u addoloxxenti ‘ l fuq minn 12- il sena:
5 mg twice daily as 10 drops twice daily.
10 mg darba kuljum bħala pillola waħda
Children between 2 and 6 years old 2.5 mg twice daily administered as 5 drops twice daily
5 mg darbtejn kuljum bħala nofs pillola darbtejn kuljum.
Patients with moderate to severe renal impairment Patients with moderate renal impairment are recommended to take 5 mg as 10 drops once daily.
Huwa irrakkomandat li pazjenti b’ indeboliment tal- kliewi moderat jieħdu 5 mg darba kuljum.
Duration of treatment The duration of treatment depends on the type, duration and course of your complaints and is determined by your doctor.
It- tul tat- trattament jiddependi fuq it- tip, it- tul u n- natura tal- problema tiegħek u jiġi deċiż mit- tabib tiegħek.
77 If you take more Zyrtec than you should If you think you have taken an overdose of Zyrtec please inform your doctor.
Jekk taħseb li ħadt aktar Zyrtec milli suppost jekk jogħġbok igħid lit- tabib tiegħek.
78 uncommon: paresthesia (abnormal feelings of the skin), rare: convulsions, movements disorders very rare: syncope, tremor, dysgeusia (altered taste)
komuni: sturdament, uġigħ ta ’ ras mhux komuni: para- esteżija (sensazzjoni abnormali fil- ġilda) rari: aċċessjonijiet, mard tal- moviment, rari ħafna: sinkope, rogħda, disġewsja (tibdil fit- togħma)
Do not use Zyrtec after the expiry date which is stated on the box and bottle.
Tużax Zyrtec wara d- data ta ’ skadenza li tidher fuq il- kaxxa u l- folja.
What Zyrtec contains
X’ fih Zyrtec):
One ml (equals to 20 drops)
- Is- sustanzi attiva ta ’ Zyrtec hija cetirizine dihydrochloride.
One drop contains 0.5 mg of cetirizine dihydrochloride.
- Is- sustanzi l- oħra huma microcrystalline cellulose, lactose, macrogol 400, magnesium stearate,
- The other ingredients are glycerol, propylène glycol, saccharine sodium, methyl (4-
hypromellose, colloidal silicon dioxide, titanium dioxide (E 171).
hydroxybenzoate) / propyl (4-hydroxybenzoate) = E 218 / E 216, sodium acetate, acetic acid, purified water.
Id- Dehra ta ’ Zyrtec u l- kontenuti tal- pakkett:
What Zyrtec looks like and contents of the pack Zyrtec is supplied as a clear and colorless liquid.
Pillola miksija b’ rita, bajda, oblunga, b ’ linja fejn tista ’ tinqasam u logo Y- Y.
Pack with a bottle of 10, 15, 20, or 30 ml solution.
Pakkett oriġinali b ’ 1, 4, 5, 7, 10, 14, 15, 20, 21, 30, 40, 45, 50, 60, 90, jew 100 pillola.
79 Marketing Authorisation Holder and Manufacturer
76 Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur:
Zyrtec 10 mg/ ml -Tropfen Belgium:
Zyrtec 10 mg – Filmtabletten Il- Belġju:
Cetirizine-UCB, Zyrtec, Virlix Bulgaria:
Reactine, Cetirizine- UCB, Zyrtec Il- Bulgarija:
Zyrtec France:
Benaday, Zyrtec Franza:
Virlix, Zyrtec Germany:
Reactine, Virlix, Cetirizine UCB 10mg, Zyrtec, Actifed Allergie cetirizine 10mg, Zyrtecset Il- Ġermanja:
Zyrtec P tropfen, Zyrtec tropfen Greece:
Zyrtec, Zyrtec P, Reactine Il- Greċja:
Zyrtec cseppek Italy:
Zirtek tablets L- Italja:
Formistin, Virlix, Zirtec 10mg/ ml gocce orali soluzione Latvia:
Formistin, Virlix, Zirtec 10 mg compresse rivestite con film Il- Latvja:
Zyrtec Poland:
Reactine, Zyrtec Il- Polonja:
Zyrtec Portugal:
Reactine, Virlix, Zyrtec, Zyrtec UCB Il- Portugall:
Zyrtec Romania:
Zyrtec, Virlix Ir- Rumanija:
Zyrtec gtt por 10mg/ ml Slovenia:
Zyrtec tbl flm 10mg Slovenja:
Zyrtec10 mg/ ml peroralne kapljice, raztopina Spain:
Zyrtec10 mg filmsko oblozene tablete Spanja:
Alerlisin, Virdos, Zyrtec gotas orales en solución Sweden:
Alerlisin, Virlix, Reactine, Zyrtec comprimidos recubiertos con pelicula, Alerrid 10 mg comprimidos recubiertos con pelicula L- Isvezja:
Zyrlex
Alerid, Zyrlex Ir- Renju Unit:
Zyrtec and associated names (see Annex I) 1 mg/ ml oral solution
Zyrtec u ismijiet assoċjati miegħu (ara Anness I) 10 mg/ ml taqtir tal- ħalq, soluzzjoni [Ara Anness I - Biex timtela mill- pajjiż partikolari]
Read all of this leaflet carefully before you start using this medicine.
Aqra sew dan il- fuljett kollu, għax fih tagħrif importanti għalik.
- If you have any further questions, ask your doctor or pharmacist.
- Staqsi lill- ispiżjar tiegħek jekk tkun trid aktar tagħrif jew pariri.
It may harm them, even
- Għandek tikkuntattja lit- tabib jekk is- sintomi jmorru għall- agħar jew jibqgħu kif ikunu. wara 3
if their symptoms are the same as yours.
ġranet.
Possible side effects 9.
Effetti sekondarji li jista ’ jkollu 5.
In adults and children aged 2 year and above, Zyrtec is indicated
Fl- adulti, tfal, trabi ta ’ sena ‘ l fuq, Zyrtec huwa indikat
(other constituents), to hydroxyzine or to any piperazine derivatives (closely related active substances of other medicines).
attivi (kostitwenti oħra), għal hydroxyzine jew għal xi derattiv ta ’ piperazine (li jixbħu mill- qrib għal sustanzi attivi ta ’ mediċini oħra).