qanastek/EMEA-V3 huggingface dataset:
35 administered to adults at a dose of 45 mg daily (nine times the clinical dose) for ten days, no prolongation of QTc interval was seen.
35 klinika farmakoloġika, li fiha ingħata desloratadine b’ doża ta ’ 45 mg kuljum (disa ’ darbiet id- doża klinika) għal għaxart ijiem, ma kienx hemm żieda fit- tul ta ’ l- intervall QTc.
In controlled clinical trials, at the recommended dose of 5 mg daily for adults and adolescents, there was no excess incidence of somnolence as compared to placebo.
Fi provi kliniċi bid- doża rakkomandata ta ’ 5 mg kuljum għall- adulti u adolexxenti, il- każi ta ’ dawk li qabadhom ngħas żejjed ma kienux aktar meta mqabbla mal- plaċebo.
In a single dose study performed in adults, desloratadine 5 mg did not affect standard measures of flight performance including exacerbation of subjective sleepiness or tasks related to flying.
Fi prova b’ doża waħda li seħħet fl- adulti, desloratadine 5 mg ma effettwax il- miżuri standard tal- prestazzjoni tat- titjir fl- ajru inkluż żieda fin- ngħas jew il- ħila biex jiġu esegwiti proċeduri relatati mat- titjir fl- ajru.
In adult and adolescent patients with allergic rhinitis, Aerius tablets were effective in relieving symptoms such as sneezing, nasal discharge and itching, as well as ocular itching, tearing and redness, and itching of palate.
F’ pazjenti adulti u adolexxenti b’ rajnajtis allerġiku, il- pilloli Aerius kienu effettivi biex iserrħu sintomi bħal għatis, tnixxija mill- imnieħer u ħakk, kif ukoll ħakk, dmugħ u ħmura fl- għajnejn, u ħakk fis- saqaf tal- ħalq.
Aerius effectively controlled symptoms for 24 hours.
Il- pilloli Aerius ikkontrollaw is- sintomi b’ mod effettiv għal 24 siegħa.
In addition to the established classifications of seasonal and perennial, allergic rhinitis can alternatively be classified as intermittent allergic rhinitis and persistent allergic rhinitis according to the duration of symptoms.
Minbarra l- klassifikazzjonijiet stabbiliti ta ’ l- istaġun u perenni, rajnajtis allerġiku jista ’ minflok ikun ikklassifikat bħala rajnajtis allerġiku intermittenti u rajnajtis allerġiku persistenti, skond kemm idumu s- sintomi.
Aerius tablets were effective in alleviating the burden of seasonal allergic rhinitis as shown by the total score of the rhino-conjunctivitis quality of life questionnaire.
Il- pilloli Aerius kienu effettivi biex iserrħu il- problemi relatati ma ’ rajnajtis allerġiku ta ’ l- istaġun kif jidher mill- punteġġ totali tal- kwestjonarju fuq il- kwalità tal- ħajja b’ rajno- konġunktivite.
Desloratadine plasma concentrations can be detected within 30 minutes of desloratadine administration in adults and adolescents.
Il- konċentrazzjonijiet fil- plażma ta ’ desloratadine ikunu jistgħu jitkejjlu fi żmien 30 minuta minn meta jingħata f’ adulti u adolexxenti.
The degree of accumulation of desloratadine was consistent with its half-life (approximately 27 hours) and
Il- grad ta ’ akkumulu ta ’ desloratadine kien jaqbel mal- half- life tiegħu (madwat 27 siegħa) u l- frekwenza ta ’ dożaġġ ta ’ darba
36 a once daily dosing frequency.
36 kuljum.
The prevalence of this poor metaboliser phenotype was comparable for adult (6%) and paediatric subjects 2- to 11-year old (6%), and greater among Blacks (18% adult, 16% paediatric) than Caucasians (2% adult, 3% paediatric) in both populations.
Il- prevalenza ta ’ dan il- finotajp ta ’ metabolizzatur batut seta ’ jitqabbel ma ’ l- individwi adulti (6%) u dawk pedjatriċi minn 2 - sa 11- il sena (6%), u ogħla fis- Suwed (18% adulti, 16% pedjatriċi) milli fil- Kawkażi (2% fl- adulti, 3% pedjatriċi).
The effects of desloratadine in poor metabolizers < 2 years of age have not been studied.
L- effetti ta ’ desloratadine f’ metabolizzaturi dgħajfin ta ’ anqas minn sentejn ma kienux studjati.
There is no evidence of clinically relevant active substance accumulation following once daily adult and adolescent dosing of desloratadine (5 mg to 20 mg) for 14 days.
M’ hemmx evidenza ta ’ akkumulu tas- sustanza attiva li jista ’ jkollu rilevanza klinika wara li jingħata dożaġġ ta ’ desloratadine darba kuljum lill- adulti u adolexxenti (5 mg sa 20 mg) għal 14- il ġurnata.
As Aerius oral solution contains the same concentration of desloratadine, no bioequivalence study was required and it is expected to be equivalent to the syrup and tablet.
Peress li s- soluzzjoni orali għandha l- istess konċentrazzjoni ta ’ desloratadine, ma kienx hemm bżonn li jsir studju ta ’ bioekwivalenza għax hu mistenni li jkun l- istess għall- mistura u għall- pillola.
In separate single dose studies, at the recommended doses, paediatric patients had comparable AUC and Cmax values of desloratadine to those in adults who received a 5 mg dose of desloratadine syrup.
Fi studji separati b’ doża waħda, bid- dożi rrakkomandati, il- pazjenti pedjatriċi kellhom valuri ta ’ AUC u Cmax ta ’ desloratadine li jistgħu jitqabblu ma ’ dawk ta ’ adulti li rċevew doża ta ’ 5 mg ta ’ mistura desloratadine.
sorbitol, propylene glycol, sucralose E 955, hypromellose 2910, sodium citrate dihydrate, natural and artificial flavour (bubblegum), citric acid anhydrous, disodium edetate, purified water
sorbitol, propylene glycol, sucralose E 955, hypromellose 2910, sodium citrate dihydrate, essenza naturali u artifiċjali (babbilgam), citric acid anhydrous, disodium edetate, ilma purifikat
Store in the original package.
Aħżen fil- pakkett oriġinali
Aerius oral solution, is supplied in 30, 50, 60, 100, 120, 150, 225 and 300 ml size Type III amber glass bottles closed with a plastic child resistant (C/ R) screw closure having a multi-ply polyethylene-faced liner.
Aerius soluzzjoni orali, jiġi fi fliexken tal- ħġieġ kannella jagħti fl- oranġjo tat- Tip III ta ’ daqsijiet ta ’ 30, 50, 60, 100, 120, 150, 225 u 300 ml magħluq bi plastik reżistenti għat- tfal (C/ R) b’ kisi b’ ħafna faċċaturi ta ’ ply polythylene.
All packages except the 150 ml package are supplied with a measuring spoon marked for doses of 2.5 ml and 5 ml.
Jiġi b’ kuċċarina mediċinali tal- plastik jew siringa għad- dożaġġ (għall - pakkett ta ’ 150 ml biss) b’ marki għad- dożi ta ’ 2. 5 ml u 5 ml.
For the 150 ml package, a measuring spoon or an oral measuring syringe is provided, marked for doses of 2.5 ml and 5 ml.
Għall- pakkett ta ’ 150 ml, il- kejl jista ’ jsir jew b’ kuċċarina tal- kejl jew b’ siringa, immarkati għad- dożi tat- 2. 5 ml u 5 ml.
39 ANNEX II
39 ANNESS II
Name and address of the manufacturer responsible for batch release for film coated tablets
Isem u indirizz tal- manifattur responsabbli għall- ħruġ tal- lott għal pilloli miksija b’ rita
Name and address of the manufacturer responsible for batch release for oral lyophilisate
Isem u indirizz tal- manifattur responsabbli għall- ħruġ tal- lott għal mistura
Name and address of the manufacturer responsible for batch release for syrup
Isem u indirizz tal- manifattur responsabbli għall- ħruġ tal- lott għal lajofiliżejt li jittieħed mill- ħalq
Name and address of the manufacturer responsible for batch release for orodispersible tablet
Isem u indirizz tal- manifattur responsabbli għall- ħruġ tal- lott għal pillola li tinħall fil- ħalq
Name and address of the manufacturer responsible for batch release for oral solution
Isem u indirizz tal- manifattur responsabbli għall- ħruġ tal- lott għas- soluzzjoni orali
Following the renewal of the Marketing Authorisation, the Marketing Authorisation Holder will submit periodic safety update reports at two-yearly intervals unless otherwise decided by the CHMP.
Wara t- tiġdid ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq, id- Detentur ta ’ l- Awtorizzazzjoni għat - Tqegħid fis- Suq ser jissottometti rapporti perjodiċi dwar tagħrif ġdid fuq is- sigurtà f’ intervalli ta ’ sentejn sakemm ma jkunx deċiż mod ieħor mis- CHMP.
41 ANNEX III
41 ANNESS III
BOX OF 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 90, 100 TABLETS
KAXXA TA ’ 5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90, 100 DOŻI/ A TA ’ PILLOLA WAĦDA
Aerius 5 mg film-coated tablets desloratadine
Aerius 5 mg pillola miksija b’ rita desloratadine
Includes:
Jinkludi:
Lactose See leaflet for further information.
Lactose Għal aktar tagħrif ara l- fuljett.
1 film-coated tablet 2 film-coated tablets 3 film-coated tablets 5 film-coated tablets 7 film-coated tablets 10 film-coated tablets 14 film-coated tablets 15 film-coated tablets 20 film-coated tablets 21 film-coated tablets 30 film-coated tablets 50 film-coated tablets 90 film-coated tablets 100 film-coated tablets
Pillola 1 miksija b’ rita 2 pilloli miksijin b’ rita 3 pilloli miksijin b’ rita 5 pilloli miksijin b’ rita 7 pilloli miksijin b’ rita 10 pilloli miksijin b’ rita 14- il pillola miksija b’ rita 15- il pillola miksija b’ rita 20 pillola miksija b’ rita 21 pillola miksija b’ rita 30 pillola miksija b’ rita 50 pillola miksija b’ rita 90 pillola miksija b’ rita 100 pillola miksija b’ rita
Oral use Read the package leaflet before use.
Ibla ’ l- pillola sħiħa bl- ilma Jittieħed mill- ħalq Aqra l- fuljett ta ’ tagħrif qabel l- użu.
SP Europe Rue de Stalle 73 B-1180 Bruxelles, Belgium
Id- Detentur Ta ’ L- Awtorizzazzjoni Għat- Tqegħid Fis- Suq SP Europe Rue de Stalle 73 B- 1180 Bruxelles, Il- Belġju
1 tablet 2 tablets 3 tablets 5 tablets 7 tablets 10 tablets 14 tablets 15 tablets 20 tablets 21 tablets 30 tablets 50 tablets 90 tablets 100 tablets
Pillola 1 2 pilloli 3 pilloli 5 pilloli 7 pilloli 10 pilloli 14- il pillola 15- il pillola 20 pillola 21 pillola 30 pillola 50 pillola 90 pillola 100 pillola
Aerius 5 mg tablet desloratadine
Aerius pillola 5 mg desloratadine
BOTTLE OF 30 ML, 50 ML, 60 ML, 100 ML, 120 ML, 150 ML, 225 ML, 300 ML
FLIXKUN TA ’ 30 ML, 50 ML, 60 ML, 100 ML, 120 ML, 150 ML, 225 ML, 300 ML
Aerius 0.5 mg/ ml syrup desloratadine
Aerius 0. 5 mg/ ml mistura desloratadine
Each ml of syrup contains 0.5 mg desloratadine.
Kull ml mistura fih 0. 5 mg desloratadine.
Includes:
Tinkludi:
Propylene glycol, sorbitol, sucrose, orange colour E110.
Propylene glycol, sorbitol, sukrożju, kulur oranġjo E110.
See leaflet for further information.
Għal aktar tagħrif ara l- fuljett.
syrup 30 ml with 1 spoon 50 ml with 1 spoon 60 ml with 1 spoon 100 ml with 1 spoon 120 ml with 1 spoon 150 ml with 1 spoon 150 ml with 1 oral syringe 225 ml with 1 spoon 300 ml with 1 spoon
mistura 30 ml b’ kuċċarina 1 50 ml b’ kuċċarina 1 60 ml b’ kuċċarina 1 100 ml b’ kuċċarina 1 120 ml b’ kuċċarina 1 150 ml b’ kuċċarina 1 150 ml b’ siringa waħda għall- ħalq 1 225 ml b’ kuċċarina 1 300 ml b’ kuċċarina 1
Oral use Read the package leaflet before use.
Jittieħed mill- ħalq Aqra l- fuljett ta ’ tagħrif qabel l- użu.
Store in the original package.
Taħżinx f’ temperatura ’ l fuq minn 30°C Aħżen fil- pakkett oriġinali.
30 ml with 1 spoon 50 ml with 1 spoon 60 ml with 1 spoon 100 ml with 1 spoon 120 ml with 1 spoon 150 ml with 1 spoon 150 ml with 1 oral syringe 225 ml with 1 spoon 300 ml with 1 spoon
30ml b’ kuċċarina 1 50 ml b’ kuċċarina 1 60 ml b’ kuċċarina 1 100 ml b’ kuċċarina 1 120 ml b’ kuċċarina 1 150 ml b’ kuċċarina 1 150 ml b’ siringa orali 1 225 ml b’ kuċċarina 1 300 ml b’ kuċċarina 1
BOX OF 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 100 DOSES OF ORAL LYOPHILISATE
KAXXA TA ’ 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 100 DOŻI WAĦDA TA ’ LAJOFILIŻEJT LI JITTIEĦED MILL- ĦALQ
Aerius 5 mg oral lyophilisate desloratadine
Aerius 5 mg ta ’ lajofiliżejt li jittieħed mill- ħalq desloratadine
Each dose of oral lyophilisate contains 5 mg desloratadine.
Kull doża ta ’ ta ’ lajofiliżejt li jittieħed mill- ħalq fiha 5 mg desloratadine.
Contains mannitol and aspartame.
Fih mannitol u aspartame.
1 dose of oral lyophylisate 2 doses of oral lyophylisate 3 doses of oral lyophylisate 5 doses of oral lyophylisate 7 doses of oral lyophylisate 10 doses of oral lyophylisate 14 doses of oral lyophylisate 15 doses of oral lyophylisate 20 doses of oral lyophylisate 21 doses of oral lyophylisate 30 doses of oral lyophylisate 50 doses of oral lyophylisate 100 doses of oral lyophylisate
Doża 1 ta ’ lajofiliżejt li jittieħed mill- ħalq 2 dożi ta ’ lajofiliżejt li jittieħed mill- ħalq 3 dożi ta ’ lajofiliżejt li jittieħed mill- ħalq 5 dożi ta ’ lajofiliżejt li jittieħed mill- ħalq 7 dożi ta ’ lajofiliżejt li jittieħed mill- ħalq 10 dożi ta ’ lajofiliżejt li jittieħed mill- ħalq 14- il doża ta ’ lajofiliżejt li jittieħed mill- ħalq 15- il doża ta ’ lajofiliżejt li jittieħed mill- ħalq 20 doża ta ’ lajofiliżejt li jittieħed mill- ħalq 21 doża ta ’ lajofiliżejt li jittieħed mill- ħalq 30 doża ta ’ lajofiliżejt li jittieħed mill- ħalq 50 doża ta ’ lajofiliżejt li jittieħed mill- ħalq 100 doża ta ’ lajofiliżejt li jittieħed mill- ħalq
Oral use Read the package leaflet before use.
Jittieħed mill- ħalq Aqra l- fuljett tal- pakkett qabel tuża.
52 EXP
JIS
53 16.
53 16.
54 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
54 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
BOX OF 5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90, 100 ORODISPERSIBLE TABLETS
KAXXA TA ’ 5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90, 100 PILLOLI LI JINĦALLU FIL- ĦALQ
Aerius 2.5 mg orodispersible tablets desloratadine
Aerius 2. 5 mg pilloli li jinħallu fil- ħalq desloratadine
Each dose of orodispersible tablet contains 2.5 mg desloratadine.
Kull doża ta ’ pillola li tinħall fil- ħalq fiha 2. 5 mg desloratadine.
Contains mannitol and aspartame.
Fiha mannitol u aspartame.
5 orodispersible tablets 6 orodispersible tablets 10 orodispersible tablets 12 orodispersible tablets 15 orodispersible tablets 18 orodispersible tablets 20 orodispersible tablets 30 orodispersible tablets 50 orodispersible tablets 60 orodispersible tablets 90 orodispersible tablets 100 orodispersible tablets
5 pilloli li jinħallu fil- ħalq 6 pilloli li jinħallu fil- ħalq 10 pilloli li jinħallu fil- ħalq 12 pilloli li jinħallu fil- ħalq 15 pilloli li jinħallu fil- ħalq 18 pilloli li jinħallu fil- ħalq 20 pilloli li jinħallu fil- ħalq 30 pilloli li jinħallu fil- ħalq 50 pilloli li jinħallu fil- ħalq 60 pilloli li jinħallu fil- ħalq 90 pilloli li jinħallu fil- ħalq 100 pilloli li jinħallu fil- ħalq
Aerius 2.5 mg orodispersible tablet
Aerius 2. 5 mg pillola li tinħall mill- ħalq
58 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
57 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
59 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
58 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Aerius 5 mg orodispersible tablets desloratadine
Aerius 5 mg pillola li tinħall fil- ħalq desloratadine
Each dose of orodispersible tablet contains 5 mg desloratadine.
Kull doża ta ’ pillola li tinħall fil- ħalq fiha 5 mg desloratadine.
60 EXP
59 JIS
Aerius 5 mg orodispersible tablet
Aerius 5 mg pillola li tinħall mill- ħalq
61 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
60 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
62 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
61 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Aerius 0.5 mg/ ml oral solution desloratadine
Aerius 0. 5 mg/ ml soluzzjoni orali desloratadine
Includes:
Fih:
Propylene glycol, sorbitol.
Propylene glycol, sorbitol.
oral solution 30 ml with 1 spoon 50 ml with 1 spoon 60 ml with 1 spoon 100 ml with 1 spoon 120 ml with 1 spoon 150 ml with 1 spoon 150 ml with 1 oral syringe 225 ml with 1 spoon 300 ml with 1 spoon
soluzzjoni orali 30 ml b’ kuċċarina waħda 50 ml b’ kuċċarina waħda 60 ml b’ kuċċarina waħda 100 ml b’ kuċċarina waħda 120 ml b’ kuċċarina waħda 150 ml b’ kuċċarina waħda 150 ml b’ siringa waħda għall- ħalq 225 ml b’ kuċċarina waħda 300 ml b’ kuċċarina waħda
30 ml with 1 spoon 50 ml with 1 spoon 60 ml with 1 spoon 100 ml with 1 spoon 120 ml with 1 spoon 150 ml with 1 spoon 150 ml with 1 oral syringe 225 ml with 1 spoon 300 ml with 1 spoon
30 ml b’ kuċċarina waħda 50 ml b’ kuċċarina waħda 60 ml b’ kuċċarina waħda 100 ml b’ kuċċarina waħda 120 ml b’ kuċċarina waħda 150 ml b’ kuċċarina waħda 150 ml b’ siringa waħda għall- ħalq 225 ml b’ kuċċarina waħda 300 ml b’ kuċċarina waħda
64 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
63 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Store in the original package.
FULJETT TA ’ TAGĦRIF
PACKAGE LEAFLET
66 FULJETT TA ’ TAGĦRIF:
Aerius 5 mg film-coated tablets desloratadine
Aerius 5 mg pilloli miksija b’ rita desloratadine
if their symptoms are the same as yours.
il- ħsara, anki jekk ikollom l- istess sintomi bħall tiegħek.
What Aerius is and what it is used for 2.
X’ inhu Aerius u għalxiex jintuża 2.
Before you take Aerius 3.
Qabel ma tieħu Aerius 3.
How to take Aerius 4.
Kif għandek tieħu Aerius 4.
How to store Aerius 6.
Kif taħżen Aerius 6.
WHAT AERIUS IS AND WHAT IT IS USED FOR
X’ INHU AERIUS U GĦALXIEX JINTUŻA
Aerius is an antiallergy medicine that does not make you drowsy.
Aerius hija mediċina kontra ta ’ l- allerġija li ma traqdekx.
It helps control your allergic reaction and its symptoms.
Tgħinek tikkontrolla r- reazzjoni allerġika tiegħek u s- sintomi tagħha.
Aerius relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites).
Aerius ittaffi s- sintomi assoċjati ma ’ rajnajtis allerġiku (infjammazzjoni tal- passaġġi fl- imnieħer ikkawżata minn allerġija, per eżempju hay fever jew allerġija għad- dust mites).
These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.
Dawn is- sintomi jinkludu għatis, imnieħer inixxi jew ħakk fl- imnieħer, ħakk fis- saqaf tal- ħalq u ħakk, ħmura jew dmugħ fl- għajnejn.
Aerius is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy).
Aerius tintuża wkoll biex ittaffi s- sintomi assoċjati ma ’ urtikarja (kundizzjoni tal- ġilda ikkawżata minn allerġija).
These symptoms include itching and hives.
Dawn is- sintomi jinkludu ħakk u ħbiebeż.
Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and sleep.
Is- serħan minn dawn is- sintomi jibqa ’ ġurnata sħiħa u jgħinek terġa tibda l- attivitajiet ta ’ kuljum u fl - irqad.
BEFORE YOU TAKE AERIUS
QABEL MA TIEĦU AERIUS
Do not take Aerius
Tieħux Aerius
- if you are allergic (hypersensitive) to desloratadine, to any of the other ingredients of Aerius or
- jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal desloratadine jew sustanzi oħra ta ’
to loratadine.
Aerius jew għal loratadine.
Aerius is indicated for adults and adolescents (12 years of age and older).
Aerius jintuża għall- adulti u l- adolexxenti (minn tnax- il sena ’ l fuq).
Take special care with Aerius
Oqgħod attent ħafna b’ Aerius
- if you have poor kidney function.
- jekk il- funzjoni tal- kliewi hija batuta.
If this applies to you, or if you are not sure, please check with your doctor before taking Aerius.
Jekk dan jgħodd għalik jew jekk m’ intix ċert/ a, jekk jogħġbok aċċerta ruħek mat- tabib tiegħek qabel tieħu Aerius.
Taking other medicines There are no known interactions of Aerius with other medicines.
Meta tieħu mediċini oħra M’ hemmx tgħarif dwar interazzjonijiet ta ’ Aerius ma ’ mediċini oħra.
Taking Aerius with food and drink Aerius may be taken with or without a meal.
Meta tieħu Aerius ma ’ l- ikel u max- xorb Aerius jista jittieħed ma ’ l- ikel jew waħdu.
Pregnancy and breast-feeding 68 Ask your doctor or pharmacist for advice before taking any medicine during pregnancy and breast- feeding.
67 Tqala u Treddigħ Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina waqt it- tqala u t- treddigħ.
If you are pregnant or nursing a baby, taking Aerius is not recommended.
Jekk ħriġt tqila jew qed tredda tarbija, l- użu ta ’ Aerius mhux irrakkomandat.
Driving and using machines At the recommended dose, Aerius is not expected to cause you to be drowsy or less alert.
Sewqan u tħaddim ta ’ magni Bid- doża rrakkomandata, Aerius mhux mistenni li jraqqdek jew inaqqaslek il- ħila biex tirreaġixxi.
However, very rarely some people experience drowsiness, which may affect their ability to drive or use machines.
Madankollu, rari ħafna xi nies iqabbadhom in- ngħas, b’ mod li jaffettwalhom il- ħila biex isuqu jew iħaddmu magni.
Important information about some of the ingredients of Aerius Aerius tablets contain lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Aerius Il- pilloli Aerius fihom lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi tipi ta ’ zokkor, għamel kuntatt mat- tabib tiegħek qabel tieħu dan il- prodott mediċinali.
HOW TO TAKE AERIUS
KIF GĦANDEK TIEĦU AERIUS
Adults and adolescents (12 years of age and older): take one tablet once a day.
Adulti u adolexxenti (minn tnax- il sena ’ l fuq): ħu pillola waħda kuljum.
Swallow the tablet whole with water, with or without food.
Ibla ’ l- pillola sħiħa ma ’ l- ilma, ma ’ l- ikel jew waħidha.
Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Aerius.
Dwar it- tul tal- kura, it- tabib tiegħek ser jikkonsidra x’ tip ta ’ rajnajtis allerġiku qed tbati minnu u jiddetermina għal kemm għandek iddum tieħu Aerius.
If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less than 4 weeks), your physician will recommend you a treatment schedule that will depend on the evaluation of the history of your disease.
Jekk ir- rajnajtis allerġiku hija intermittenti (preżenza ta ’ sintomi għal anqas minn 4 ijiem fil- ġimgħa jew għal anqas minn 4 ġimgħat), it- tabib tiegħek ser jirrikkmandalek skeda ta ’ kura li tiddependi mill - passat tal- marda tiegħek.
If your allergic rhinitis is persistent (presence of symptoms for 4 days or more per week and for more than 4 weeks), your physician may recommend you a longer term treatment.
Jekk ir- rajnajtis allerġika hija persistenti (preżenza ta ’ sintomi għal 4 ijiem fil- ġimgħa jew aktar u għal aktar minn 4 ġimgħat), it- tabib tiegħek jista ’ jirrikkmandalek kura għal aktar fit- tul.
For urticaria, the duration of treatment may be variable from patient to patient and therefore you should follow the instructions of your physician.
Għall- urtikarja, it- tul tal- kura jista ’ jvarja minn pazjent għal ieħor u għalhekk għandek issegwi l - istruzzjonijiet tat- tabib tiegħek.
If you take more Aerius than you should Take Aerius only as it is prescribed for you.
Jekk tieħu Aerius aktar milli suppost Ħu Aerius biss kif ordnawlek.
No serious problems are expected with accidental overdose.
Mhux mistennija problemi serji b’ doża eċċessiva aċċidentali.
However, if you take more Aerius than you were told to, contact your doctor or pharmacist.
Madankollu, jekk tieħu aktar Aerius milli suppost, għamel kuntatt mat- tabib jew l- spiżjar tiegħek.
If you forget to take Aerius If you forget to take your dose on time, take it as soon as possible, then go back to your regular dosing schedule.
Jekk tinsa tieħu Aerius Jekk tinsa tieħu id- doża fil- ħin, ħudha malli tiftakar, imbagħad erġa ’ lura għall- iskeda regolari tiegħek.
Like all medicines, Aerius can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Aerius jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
In adults, side effects were about the same as with a dummy tablet.
Fl - adulti, l- effetti sekondarji kienu rrapurtati kważi daqs kemm ikun hemm b’ pillola finta.
However, fatigue, dry mouth and headache were reported more often than with a dummy tablet.
Madankollu, għejja, ħalq xott u uġigħ ta ’ ras kienu rappurtati b’ mod aktar frekwenti minn dawk li jkun hemm b’ pillola finta.
In adolescents, headache was the most commonly reported side effect.
F’ adolexxenti, l- uġigħ ta ’ ras kien l- aktar effett sekondarju rrappurtat b’ mod komuni.
During the marketing of Aerius, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) and rash have been reported very rarely.
Meta Aerius tqiegħed fuq is- suq, każijiet ta’ reazzjonijiet allerġiċi qawwija (tbatija biex tieħu n- nifs, affann, ħakk, ħbiebes, u nefħa) u raxx kienu rappurtati rari ħafna.
Cases of palpitations, rapid heartbeat, stomach pain, nausea (feeling sick), vomiting, upset stomach, diarrhoea, dizziness, drowsiness, inability to sleep, muscle pain, hallucinations, seizures, restlessness with increased body movement, liver inflammation and abnormal liver function tests have also been reported very rarely.
Każijiet ta ’ palpitazzjonijie, qalb tħabbat magħaġġla, uġigħ fl- istonku, dardir (tħossok ħażin), rimettar, stonku mqalleb, dijarea, sturdament, ngħas, nuqqas ta ’ rqad, uġigħ fil- muskoli, alluċinazzjonijiet, aċċessjonijiet, tħossok bla sabar u tiċċaqlaq aktar, infjammazzjoni tal- fwied u testijiet tal- funzjoni tal- fwied anormali kienu wkoll irrappurtati rari ħafna.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
68 Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE AERIUS
KIF TAĦŻEN AERIUS
Do not use Aerius after the expiry date which is stated on the carton and blister.
Tużax Aerius wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- folja.
Tell your pharmacist if you notice any change in the appearance of the tablets.
Għid lill- ispiżjar jekk tara xi tibdil fid- dehra tal- pilloli.
Ask your pharmacist how to dispose of medicines no longer required.
Staqsi lill - ispiżjar dwar kif għandek tarmi mediċini li m’ għandekx aktar bżonn.
What Aerius contains
X’ fih Aerius
- The active substance is desloratadine 5 mg
- Is- sustanza attiva hi desloratadine 5 mg
- The other ingredients of the tablet are calcium hydrogen phosphate dihydrate, microcrystalline
- Sustanzi oħra tal- pillola jinkludu calcium hydrogen phosphate dihydrate, microcrystalline
cellulose, maize starch, talc.
cellulose, maize starch, talc.
Tablet coating contains film coat (containing lactose monohydrate, hypromellose, titanium dioxide, macrogol 400, indigotin (E132)), clear coat (containing hypromellose, macrogol 400), carnauba wax, white wax.
Il- kisja tal- pillola għandha kisja b’ rita (li fiha lactose monohydrate, hypromellose, titanium dioxide, macrogol 400, indigotin (E132)), rita ċara (li fiha hypromellose, macrogol 400), carnauba wax, white wax.
What Aerius looks like and contents of the pack
Id- Dehra ta ’ Aerius u l- kontenuti tal- pakkett
Aerius 5 mg film-coated tablets are packed in unit dose blisters in packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 90 or 100 tablets.
Aerius pilloli ta ’ 5 mg miksija b’ rita huma ppakkjati f’ folji b’ doża individwali f’ pakketti ta ’ 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 90 jew 100 pillola.
SP Europe, Rue de Stalle 73, B-1180 Bruxelles, Belgium.
SP Europe, Rue de Stalle 73, B- 1180 Bruxelles, Il- Belġju.
SP Labo N. V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium.
Manifattur: SP Labo N. V., Industriepark 30, B- 2220 Heist- op- den- Berg, Il- Belġju.
België/ Belgique/ Belgien Rue de Stalle/ Stallestraat 73 B-1180 Bruxelles/ Brussel/ Brüssel Tél/ Tel: + 32-(0)2 370 92 11
België/ Belgique/ Belgien Rue de Stalle/ Stallestraat 73
Luxembourg/ Luxemburg Rue de Stalle 73 B-1180 Bruxelles/ Brüssel Belgique/ Belgien Tél/ Tel: + 32-(0)2 370 92 11
Luxembourg/ Luxemburg Rue de Stalle 73
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
72 PACKAGE LEAFLET:
71 FULJETT TA ’ TAGĦRIF:
Aerius 0.5 mg/ ml syrup desloratadine
Aerius 0. 5 mg/ ml mistura desloratadina
Aerius syrup is an antiallergy medicine that does not make you drowsy.
Il- mistura Aerius hija mediċina ta ’ kontra l- allerġija li ma traqdekx.
Aerius syrup relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites).
Il- mistura Aerius ittaffi s- sintomi assoċjati ma ’ rajnajtis allerġiku (infjammazzjoni tal- passaġġi fl - imnieħer ikkawżata minn allerġija, per eżempju hay fever jew allerġija għad- dust mites).
These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.
Dawn is - sintomi jinkludu għatis, imnieħer inixxi jew ħakk fl- imnieħer, ħakk fis- saqaf tal- ħalq u ħakk, ħmura jew dmugħ fl- għajnejn.
Aerius syrup is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy).
Il- mistura Aerius tintuża wkoll biex ittaffi s- sintomi assoċjati ma ’ urtikarja (kundizzjoni tal- ġilda ikkawżata minn allerġija).
- if you are allergic (hypersensitive) to desloratadine, loratadine, or to any of the other ingredients
- jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal desloratadine, loratadine, jew
of Aerius, in particular colouring agent E110.
sustanzi oħra ta ’ Aerius, b’ mod speċjali għall- kulur E110.
Aerius syrup is indicated for children 1 through 11 years of age, adolescents (12 years of age and older), and adults, including the elderly.
Il- mistura Aerius jintuża għat- tfal bejn is- sentejn u l- ħdax- il sena, l- adolexxenti (minn tnax- il sena ‘ l fuq), u l- adulti, inklużi l- anzjani.
73 Taking Aerius with food and drink Aerius may be taken with or without a meal.
72 Meta tieħu Aerius ma ’ l- ikel u max- xorb Aerius jista jittieħed ma ’ l- ikel jew mingħajr ikel.
Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine during pregnancy and breast- feeding.
Tqala u Treddigħ Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina waqt it- tqala u t- treddigħ.
If you are pregnant or nursing a baby, taking Aerius syrup is not recommended.
Jekk ħriġt tqila jew qed tredda tarbija, l- użu ta ’ il mistura Aerius mhux irrakkomandat.
Important information about some of the ingredients of Aerius You should not take Aerius syrup if you are allergic to the colouring agent E110.
Tagħrif importanti dwar xi sustanzi ta ’ Aerius M’ għandekx tieħu l- mistura Aerius jekk int allerġiku għal- kulur E110.
Aerius syrup contains sucrose and sorbitol.
Il- mistura Aerius fiha sukrożju u sorbitol.
Children 1 through 5 years of age: take 2.5 ml (½ of a 5 ml spoonful) of syrup once a day.
Tfal minn sena sa 5 snin: jieħdu 2. 5 ml (nofs kuċċarina tal- 5 ml) mistura darba kuljum.
Children 6 through 11 years of age: take 5 ml (one 5 ml spoonful) of syrup once a day.
Tfal minn sitt snin sa ħdax- il sena: jieħdu 5 ml (kuċċarina waħda tal- 5 ml) mistura darba kuljum.
Adults and adolescents (12 years of age and older): take 10 ml (two 5 ml spoonfuls) of syrup once a day.
Adulti u adolexxenti (minn tnax- il sena u ‘ l fuq): jieħdu 10 ml (żewġ kuċċarini tal- 5 ml) mistura darba kuljum.
In case an oral measuring syringe is provided with the bottle of syrup, you can alternatively use it to take the appropriate amount of syrup.
F’ każ li jkun hemm siringa għall- ħalq għall- kejl mal- flixkun, tista ’ tuża lilha minflok sabiex tieħu d - doża xierqa tas- mistura.
Swallow the dose of syrup, then drink some water.
Ibla ’ d- doża tal- mistura, imbagħad ixrob ftit ilma.
You can take this medicine with or without food.
Tista ’ tieħu din il- mediċina ma ’ l- ikel jew waħidha.
Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Aerius syrup.
Dwar it- tul tal- kura, it- tabib tiegħek ser jikkonsidra x’ tip ta ’ rajnajtis allerġiku qed tbati minnu u jiddetermina għal kemm għandek iddum tieħu Aerius mistura.
If you take more Aerius than you should Take Aerius syrup only as it is prescribed for you.
Jekk tieħu Aerius aktar milli suppost Ħu il- mistura Aerius biss kif ordnawlek.
However, if you take more Aerius syrup than you were told to, contact your doctor or pharmacist.
Madankollu, jekk tieħu aktar il- mistura Aerius milli suppost, għamel kuntatt mat- tabib jew l- spiżjar tiegħek.
Like all medicines, Aerius syrup can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, il- mistura Aerius jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
In most children and adults, side effects with Aerius were about the same as with a dummy solution or tablet.
Fil- parti l- kbira tat- tfal u adulti, l- effetti sekondarji b’ Aerius kienu rrapurtati kważi daqs
However, common side effects in children less than 2 years of age were diarrhoea, fever and insomnia while in adults, fatigue, dry mouth and headache were reported more often than with a dummy tablet.
Madankollu, effetti sekondarji komuni fi tfal taħt sentejn kienu dijarea, deni u nuqqas ta ’ rqad, filwaqt li fl- adulti għeja, ħalq xott u uġigħ ta ’ ras kienu rrappurtati b’ mod aktar frekwenti minn dawk li jkun hemm b’ pillola finta.
During the marketing of Aerius, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) and rash have been reported very rarely.
Meta Aerius tqiegħed fuq is- suq, każijiet ta’ rejazzjonijiet allerġiċi qawwija (tbatija biex tieħu n- nifs, affann, ħakk, ħbiebes, u nefħa) u raxx kienu rappurtati rari ħafna.
Cases of palpitations, rapid heartbeat, stomach pain, nausea (feeling sick), vomiting, upset stomach, diarrhoea, dizziness, drowsiness, inability to sleep, muscle pain, hallucinations, seizures, restlessness with increased body movement, liver inflammation and abnormal liver function tests have also been reported very rarely.
Każijiet ta ’ palpitazzjonijiet, qalb tħabbat magħaġġla, uġigħ fl- istonku, dardir (tħossok ħażin), rimettar, stonku mqalleb, dijarea, sturdament, ngħas, nuqqas ta ’ rqad, uġigħ fil- muskoli, alluċinazzjonijiet, aċċessjonijiet, tħossok bla sabar u tiċċaqlaq aktar, infjammazzjoni tal- fwied u testijiet tal- funzjoni tal- fwied anormali kienu wkoll irrappurtati rari ħafna.
Store in the original package.
Aħżen fil- pakket oriġinali.
Do not use Aerius after the expiry date which is stated on the bottle.
Tużax Aerius wara d- data ta ’ skadenza li tidher fuq il- flixkun.
Tell your pharmacist if you notice any change in the appearance of the syrup.
Għid lill- ispiżjar jekk tara xi tibdil fid- dehra tal- mistura.
- The active substance is desloratadine 0.5 mg/ ml
- Is- sustanza attiva hi desloratadine 0. 5mg/ ml
- The other ingredients of the syrup are propylene glycol, sorbitol, citric acid anhydrous, sodium
- Sustanzi oħra tal- mistura jinkludu propylene glycol, sorbitol, anhydrous citric acid, sodium
citrate, sodium benzoate, disodium edetate, purified water, sucrose, natural and artificial flavour (bubblegum), and orange colour E110.
citrate, sodium benzoate, disodium edetate, ilma purifikat, sukrożju, togħma naturali u artifiċjali (bubble gum), kulur oranġjo E110.
Aerius syrup is available in bottles of 30, 50, 60, 100, 120, 150, 225, and 300 ml, with a childproof cap.
Il- mistura Aerius jiġi fi fliexken ta ’ 30, 50, 60, 100, 120, 150, 225, u 300 ml, b’ tapp li ma jinfetaħx mit- tfal.
A measuring spoon or an oral measuring syringe is provided, marked for doses of 2.5 ml and 5 ml.
Jiġi b’ kuċċarina tal- kejl jew b’ siringa waħda għall- ħalq għall- kejl, ikkalibrati għal dożi ta ’ 2. 5 ml u 5 ml.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
74 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
76 Ísland Hörgatún 2 IS-210 Garðabær Sími: + 354 535 70 00
75 76 Ísland Hörgatún 2 IS- 210 Garðabær Sími: + 354 535 70 00
77 PACKAGE LEAFLET:
77 FULJETT TA ’ TAGĦRIF:
Aerius 5 mg oral lyophilisate desloratadine
Aerius 5 mg lajofiliżejt li jittieħed mill- ħalq desloratadine
What Aerius oral lyophilisate is and what it is used for 2.
X’ inhu Aerius lajofiliżejt li jittieħed mill- ħalq u għalxiex jintuża 2.
Before you take Aerius oral lyophilisate 3.
Qabel ma tieħu Aerius lajofiliżejt li jittieħed mill- ħalq 3.
How to take Aerius oral lyophilisate 4.
Kif għandek tieħu Aerius lajofiliżejt li jittieħed mill- ħalq 4.
How to store Aerius oral lyophilisate 6.
Kif taħżen Aerius lajofiliżejt li jittieħed mill- ħalq 6.
WHAT AERIUS ORAL LYOPHILISATE IS AND WHAT IT IS USED FOR
X’ INHU AERIUS LAJOFILIŻEJT LI JITTIEĦED MILL- ĦALQ U GĦALXIEX JINTUŻA
Aerius oral lyophilisate is an antiallergy medicine that does not make you drowsy.
Aerius lajofiliżejt li jittieħed mill- ħalq huwa mediċina ta ’ kontra l- allerġija li ma traqdekx.
Aerius oral lyophilisate relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites).
Aerius lajofiliżejt li jittieħed mill- ħalq ittaffi s- sintomi assoċjati ma ’ rajnajtis allerġiku (infjammazzjoni tal- passaġġi fl- imnieħer ikkawżata minn allerġija, per eżempju hay fever jew allerġija għad- dust mites).
These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.
Dawn is- sintomi jinkludu għatis, imnieħer inixxi jew ħakk fl- imnieħer, ħakk fis - saqaf tal- ħalq u ħakk, ħmura jew dmugħ fl- għajnejn.
Aerius oral lyophilisate is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy).
Aerius lajofiliżejt li jittieħed mill- ħalq tintuża wkoll biex ittaffi s- sintomi assoċjati ma ’ urtikarja (kundizzjoni tal- ġilda ikkawżata minn allerġija).
BEFORE YOU TAKE AERIUS ORAL LYOPHILISATE
QABEL MA TIEĦU AERIUS LAJOFILIŻEJT LI JITTIEĦED MILL- ĦALQ
Do not take Aerius oral lyophilisate
Tieħux Aerius lajofiliżejt li jittieħed mill- ħalq
- if you are allergic (hypersensitive) to desloratadine, or any of the other ingredients of Aerius
- jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal desloratadine jew sustanzi oħra ta ’
oral lyophilisate, or to loratadine.
Aerius jew għal loratadine.
Aerius oral lyophilisate is indicated for adults and adolescents (12 years of age and older).
Aerius lajofiliżejt li jittieħed mill- ħalq huwa intiż għall- adulti u l- adolexxenti (minn tnax- il sena u ‘ l fuq).
Take special care with Aerius oral lyophilisate
Oqgħod attent ħafna b’ Aerius
78 Taking Aerius oral lyophilisate with food and drink Aerius oral lyophilisate does not need to be taken with water or liquid.
78 Meta tieħu Aerius lajofiliżejt li jittieħed mill- ħalq ma ’ l- ikel u max- xorb Aerius lajofiliżejt li jittieħed mill- ħalq m’ għandhiex bżonn tittieħed ma ’ l- ilma jew x likwidu.
Additionally, Aerius oral lyophilisate may be taken with or without a meal.
Minbarra hekk, Aerius lajofiliżejt li jittieħed mill- ħalq tista ’ tittieħed ma ’ l- ikel jew mingħajr ikel.
Important information about some of the ingredients of Aerius oral lyophilisate This product contains aspartame 1.75 mg/ dose.
Tagħrif importanti dwar xi sustanzi ta ’ Aerius lajofiliżejt li jittieħed mill- ħalq Dan il- prodott fih aspartame 1. 75 mg/ doża.
Aspartame is a source of phenylalanine, which may be harmful for people with phenylketonuria.
Aspartame jipprovdi phenylalanine, li tista ’ tkun ta ’ ħsara għal min ibati b’ finajlketonurja.
HOW TO TAKE AERIUS ORAL LYOPHILISATE
KIF GĦANDEK TIEĦU AERIUS LAJOFILIŻEJT LI JITTIEĦED MILL- ĦALQ
Before using, carefully peel open the blister and remove the dose of oral lyophilisate without crushing it.
Qabel tuża, iftaħ il- folja bil- mod u oħroġ id- doża ta ’ lajofiliżejt li jittieħed mill- ħalq mingħajr ma tgħaffiġha.
Place it in your mouth and it will disperse immediately.
Poġġiha f’ ħalqek u hi tinħall mall- ewwel.
Water or other liquid is not needed to swallow the dose.
Mhux neċessarju tieħu ilma jew likwidi oħra biex tiblagħha.
Adults and adolescents (12 years of age and older): take one dose of Aerius oral lyophilisate once a day.
Adulti u adolexxenti (minn tnax- il sena ‘ l fuq): ħu doża waħda ta ’ Aerius lajofiliżejt li jittieħed mill - ħalq darba kuljum.
Take the dose immediately after removal from the blister.
Ħu d- doża malli toħroġha minn ġol- folja.
Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Aerius oral lyophilisate.
Dwar it- tul tal- kura, it- tabib tiegħek ser jikkonsidra x’ tip ta ’ rajnajtis allerġiku qed tbati minnu u jiddetermina għal kemm għandek iddum tieħu Aerius lajofiliżejt li jittieħed mill- ħalq.
If you take more Aerius oral lyophilisate than you should Take Aerius oral lyophilisate only as prescribed for you.
Jekk tieħu Aerius lajofiliżejt li jittieħed mill- ħalq aktar milli suppost Ħu Aerius lajofiliżejt li jittieħed mill- ħalq biss kif ordnawlek.
However, if you take more Aerius oral lyophilisate than you were told to, contact your doctor or pharmacist.
Madankollu, jekk tieħu aktar Aerius lajofiliżejt li jittieħed mill- ħalq milli suppost, għamel kuntatt mat- tabib jew l- spiżjar tiegħek.
If you forget to take Aerius oral lyophilisate If you forget to take your dose on time, take it as soon as possible, then go back to your regular dosing schedule.
Jekk tinsa tieħu Aerius lajofiliżejt li jittieħed mill- ħalq Jekk tinsa tieħu id- doża fil- ħin, ħudha malli tiftakar, imbagħad erġa ’ ‘ lura għall- iskeda regolari tiegħek.
79 During the marketing of Aerius, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) and rash have been reported very rarely.
79 Meta Aerius tqiegħed fuq is- Suq, każijiet ta’ reazzjonijiet allerġiċi qawwija (tbatija biex tieħu n- nifs, affann, ħakk, urtikarja, u nefħa) u raxx kienu rappurtati rari ħafna.
HOW TO STORE AERIUS ORAL LYOPHILISATE
KIF TAĦŻEN AERIUS LAJOFILIŻEJT LI JITTIEĦED MILL- ĦALQ
Do not use Aerius oral lyophilisate after the expiry date which is stated on the carton and blister.
Tużax Aerius lajofiliżejt li jittieħed mill- ħalq wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- folja.
Tell your pharmacist if you notice any change in the appearance of Aerius oral lyophilisate.
Għid lill- ispiżjar jekk tara xi tibdil fid- dehra ta ’ Aerius lajofiliżejt li jittieħed mill- ħalq.
What Aerius oral lyophilisate contains
X’ fih Aerius lajofiliżejt li jittieħed mill- ħalq
- The other ingredients are gelatin, mannitol, aspartame (E951), polacrilin potassium, Dye
- L- ingredjenti l- oħra huma gelatin, mannitol, aspartame (E951), polacrilin potassium, Kulur
Opatint Red (containing red iron oxide (E172) and hypromellose (E464)), flavour Tutti-Frutti, and citric acid anhydrous.
Opatint Aħmar (li fih red iron oxide (E172) u hypromellose (E464)), Togħma Tutti- Frutti, citric acid anhydrous.
What Aerius oral lyophilisate looks like and contents of the pack
Id- Dehra ta ’ Aerius lajofiliżejt li jittieħed mill- ħalq u l- kontenuti tal- pakkett
Aerius oral lyophilisate is packed in unit dose blisters in packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, and 100 doses of oral lyophilisate.
Aerius lajofiliżejt li jittieħed mill- ħalq huwa pakkjat f’ folji b’ doża individwali ġo pakketti ta ’ 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, u 100 doża.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
80 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
82 PACKAGE LEAFLET:
83 FULJETT TA ’ TAGĦRIF:
- If you any have further questions, ask your doctor or pharmacist.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
What Aerius orodispersible tablet is and what it is used for 2.
X’ inhi Aerius pillola li tinħall fil- ħalq u għalxiex jintuża 2.
Before you take Aerius orodispersible tablet 3.
Qabel ma tieħu Aerius pillola li tinħall fil- ħalq 3.
How to take Aerius orodispersible tablet 4.
Kif għandek tieħu Aerius pillola li tinħall fil- ħalq 4.
How to store orodispersible tablet 6.
Kif taħżen Aerius pillola li tinħall fil- ħalq 6.
WHAT AERIUS ORODISPERSIBLE TABLET IS AND WHAT IT IS USED FOR
X’ INHI AERIUS PILLOLA LI TINAĦALL FIL- ĦALQ U GĦALXIEX JINTUŻA
Aerius orodispersible tablet is an antiallergy medicine that does not make you drowsy.
Aerius pillola li tinħall fil- ħalq hija mediċina kontra l- allerġiji li ma traqdekx.
It helps control your allergic reaction and its symptoms.
Tgħinek tikkontrolla r - reazzjoni allerġika tiegħek u s- sintomi tagħha.
Aerius orodispersible tablet relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites).
Aerius pillola li tinħall fil- ħalq ittaffi s- sintomi assoċjati ma ’ rajnajtis allerġiku (infjammazzjoni tal - passaġġi fl- imnieħer ikkawżata minn allerġija, per eżempju hay fever jew allerġija għad- dust mites).
Aerius orodispersible tablet is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy).
Aerius pillola li tinħall fil- ħalq tintuża wkoll biex ittaffi s- sintomi assoċjati ma ’ urtikarja (kundizzjoni tal- ġilda ikkawżata minn allerġija).
BEFORE YOU TAKE AERIUS ORODISPERSIBLE TABLET
QABEL MA TIEĦU AERIUS PILLOLA LI TINĦALL FIL- ĦALQ
Do not take Aerius orodispersible tablet:
Tieħux Aerius pillola li tinħall fil- ħalq
- if you are allergic (hypersensitive) to desloratadine, or any of the other ingredients of Aerius
- jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal desloratadine, jew sustanzi oħra ta ’
orodispersible tablet, or to loratadine.
Aerius pillola li tinħall fil- ħalq, jew għal loratadine.
Aerius 2.5 mg orodispersible tablet is indicated for adults and children (6 years of age and older).
Aerius 2. 5 mg pillola li tinħall fil- ħalq tintuża għall- adulti u tfal (minn 6 snin ‘ l fuq).
Take special care with Aerius orodispersible tablet
Oqgħod attent ħafna b’ Aerius pillola li tinħall fil- ħalq
83 Taking Aerius orodispersible tablet with food and drink Aerius orodispersible tablet does not need to be taken with water or liquid.
84 Meta tieħu Aerius pillola li tinħall fil- ħalq ma ’ l- ikel u max- xorb Aerius pillola li tinħall fil- ħalq m’ għandhiex bżonn tittieħed ma ’ l- ilma jew x likwidu.
Additionally, Aerius orodispersible tablet may be taken with or without a meal.
Minbarra hekk, Aerius pillola li tinħall fil- ħalq tista ’ tittieħed ma ’ l- ikel jew mingħajr ikel.
If you are pregnant or nursing a baby taking Aerius is not recommended.
Jekk ħriġt tqila jew qed tredda tarbija, l- użu ta ’ Aerius mhux irrakkomandat.
Important information about some of the ingredients of Aerius orodispersible tablet This product contains aspartame.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Aerius pillola li tinħall fil- ħalq Dan il- prodott fih aspartame.
Aspartame is a source of phenylalanine, which may be harmful for people with phenylketonuria.
Aspartame huwa għejun ta ’ phenylalanine, li jista ’ jkun ta ’ ħsara għal nies li jbatu b’ finajlketonurja.
HOW TO TAKE AERIUS ORODISPERSIBLE TABLET
KIF GĦANDEK TIEĦU AERIUS PILLOLA LI TINĦALL FIL- HALQ
Before using, carefully peel open the blister and remove the dose of orodispersible tablet without crushing it.
Qabel tużha, iftaħ billi tneħħi l- fojl tal- folja bil- galbu u neħħi d- doża ta ’ pillola li tinħall fil- ħalq mingħajr ma tgħaffiġha.
Place it in your mouth and it will disperse immediately.
Poġġiha f’ ħalqek u tinħall mill- ewwel.
Water or other liquid is not needed to swallow the dose.
M’ hemmx bżonn ilma jew xi likwidu ieħor biex tibla d- doża.
Children 6 to 11 years of age: take one 2.5 mg Aerius orodispersible tablet once a day.
Tfal ta ’ 6 sa 11- il sena: ħu pillola 2. 5 mg Aerius li tinħall fil- ħalq ta ’ darba kuljum.
Take the dose immediately after removal from the blister.
Ħu d- doża eżatt wara li toħroġha mill- folja.
Adults and adolescents (12 years of age and older): take two 2.5 mg Aerius orodispersible tablets once a day.
Adulti u adolexxenti (12- il sena ‘ l fuq): ħu pillola waħda ta ’ 5 mg Aerius pillola li tinħall fil- ħalq darba kuljum.
Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Aerius orodispersible tablets.
Dwar it- tul tal- kura, it- tabib tiegħek ser jikkonsidra x’ tip ta ’ rajnajtis allerġiku qed tbati minnu u jiddetermina għal kemm għandek iddum tieħu l- pilloli Aerius li jinħallu fil- ħalq.