qanastek/EMEA-V3 huggingface dataset:
There is little experience of celecoxib in renal impairment and therefore caution is advised when treating patients with renal impairment.
Ftit hemm esperjenza ta ’ l- użu ta ’ celecoxib f’ indeboliment tal- kliewi u għalhekk hija rakkomandata kawtela meta jiġu kkurati pazjenti b’ indeboliment tal- kliewi.
Severe renal impairment is a contraindication to use.
L- użu f’ indeboliment sever tal- kliewi huwa kontra- indikat.
Conventional embryo-foetal toxicity studies resulted in dose dependent occurrences of diaphragmatic hernia in rat foetuses and of cardiovascular malformations in rabbit foetuses at systemic exposures to free celecoxib approximately 3 times (rat) and 2 times (rabbit) higher than those achieved at the recommended daily human dose (800 mg).
Studji konvenzjonali ta ’ tossiċità embriju- fetali rriżultaw f’ okkorrenzi dipendenti fuq id- doża ta ’ ftuq dijaframmatiku fil- feti tal- firien u ta ’ malformazzjonijiet kardjovaskulari fil- feti tal- fniek f’ esponimenti sistemiċi għal celecoxib liberu xi 3 darbiet (firien) u darbtejn (fniek) ogħla minn dawk miksuba bid- doża ta ’ kuljum rakkomandata għall- bniedem (800 mg).
Diaphragmatic hernia was also seen in a peri-post natal toxicity study in rats, which included exposure during the organogenetic period.
Ftuq dijaframmatiku kien osservat ukoll fi studji ta ’ tossiċità peri- post natali fil- firien, li kien jinkludi esponiment fil- perjodu organoġenetiku.
In the latter study, at the lowest systemic exposure where this anomaly occurred in a single animal, the estimated margin relative to the recommended daily human dose was 2 times more than the recommended daily human dose (800 mg).
F’ dan l- istudju, fl- inqas esponiment sistemiku fejn din l- anomalija ġrat f’ annimal wieħed, il- marġini stmat f’ relazzjoni mad- doża umana rakkomandata ta ’ kuljum kienet darbtejn iktar mid- doża umana rakkomandata ta ’ kuljum ta ’ (800 mg).
In animals, exposure to celecoxib during early embryonic development resulted in pre-implantation and post-implantation losses.
Fl- annimali, l- esponiment għal celecoxib matul l- iżvilupp embrijoniku tal- bidu irrizulta f’ telf qabel u wara l- implantazzjoni.
These effects are expected following inhibition of prostaglandin synthesis.
Dawn l- effetti huma mistennija wara l- inibizzjoni tas- sintesi tal- prostaglandin.
Celecoxib was excreted in rat milk.
Celecoxib kien imneħħi fil- ħalib tal- ġrieden.
In a peri-post natal study in rats, pup toxicity was observed.
Fi studju ta ’ qabel u wara t- twelid fil- ġrieden, kienet osservata tossicità tal- frieħ.
In a two-year toxicity study an increase in nonadrenal thrombosis was observed in male rat at high doses.
Fi studju ta ’ sentejn dwar it- tossiċità kienet osservata żieda fit- trombożi nonadrenali fil- firien maskili b’ dozi għoljin.
Capsules contain: lactose monohydrate sodium lauryl sulphate povidone K30 croscarmellose sodium
Il- kapsuli fihom: lactose monohydrate sodium lauryl sulphate povidone K30 croscarmellose sodium magnesium stearate
Capsule shells contain: gelatin titanium dioxide (E171)
Il- qoxra tal- kapsula fiha: gelatin titanium dioxide (E171)
Printing ink contains: shellac propylene glycol iron oxide (E172)
Il- linka ta ’ l- istampa fiha: shellac propylene glycol iron oxide (E172)
6.5 Nature and contents of container
Taħżinx f’ temperatura ’ l fuq minn 30°C
Not all pack sizes may be marketed.
6. 5 In- natura tal- materjal tal- kontenitur u ta ’ dak li hemm ġo fih Folji ta ’ PVC opak/ Aclar/ fojl ta ’ l- aluminju Pakketti ta ’ 10 jew 60 kapsula Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
17 October 2003
17 ta ’ Ottubru 2003
Onsenal 400 mg hard capsules
Onsenal 400 mg kapsuli iebsin
Each capsule contains 400 mg of celecoxib.
Kull kapsula fiha 400 mg celecoxib Sustanzi mhux attivi:
Excipients:
Lactose Monohydrate 99. 6 mg.
Lactose Monohydrate 99.6 mgFor a full list of excipients, see section 6.1.
Għal- lista kompleta ta ’ sustanzi mhux attivi, ara 6. 1.
White, opaque capsules with two gold bands marked 7767 and 400.
GĦAMLA FARMAĊEWTIKA Kapsula iebsa Bajda, kapsuli opaki b’ żewġ faxex ħodor immarkati b’ 7767 u 400
The recommended oral dose is one 400 mg capsule twice per day, taken with food (see section 5.2).
Id- doża irrakomandata mill- ħalq hija ta ’ kapsula waħda ta ’ 400 mg darbtejn kuljum li titteħed ma ’ l - ikel (ara sezzjoni 5. 2).
Caution should be used as there is no experience in such patients at doses higher than 400 mg.
Peress li ma hemmx esperjenza klinika f’ dawn il- pazjenti b’ dożi ikbar minn 200 mg għandha tintuża kawtela.
Elderly:
16 Anzjani:
14 • Hypersensitivity to the active substance or to any of the excipients (see section 6.1). • Known hypersensitivity to sulphonamides. • Active peptic ulceration or gastrointestinal (GI) bleeding. • Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid or non steroidal anti-inflammatory drugs (NSAIDs) including COX-2 (cyclooxigenase-2) selective inhibitors. • In pregnancy and in women who can become pregnant unless using an effective method of contraception (see sections 4.5, 4.6 and 5.3) • Breast feeding (see sections 4.6 and 5.3) • Severe hepatic dysfunction (serum albumin< 25 g/l or Child-Pugh score > 10) (Class C). • Patients with renal insufficiency with estimated creatinine clearance < 30 ml/ min. • Inflammatory bowel disease. • Congestive heart failure (NYHA II-IV). • Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease
Mard tal- qalb iskematiku, mard arterjali periferali u/ jew mard ċerebrovaskulari.
NSAIDs + acetylsalicylic acid has not been demonstrated in long-term clinical trials (see 5.1).
NSAIDs + acetylsalicylic acid fi provi kliniċi fuq perjodu fit- tul (ara 5. 1).
The concomitant use of celecoxib and a non-aspirin NSAID should be avoided.
L- użu konkomitanti ta ’ celecoxib u NSAID li mhijiex aspirina għandu jiġi eivtat
As the cardiovascular risks of celecoxib were increased with the 400 mg twice daily dose in the APC trial (section 5.1), the response of the FAP patient to celecoxib should be re-examined periodically in order to avoid unnecessary exposure in FAP patients for whom celecoxib is not effective (sections 4.2, 4.3, 4.8 and 5.1).
17 Billi r- riskji kardjovaskulari ta ’ celecoxib żdiedu bid- doża ta ’ 400 mg darbtejn kuljum fil- prova APC (sezzjoni 5. 1), ir- rispons tal- pazjent FAP għal celecoxib għandu jiġi eżaminat mill- ġdid b’ mod perjodiku sabiex jiġi evitat l- esponiment bla bżonn f’ pazjenti FAP li għalihom celecoxib ma jkunx effettiv (sezzjonijiet 4. 2, 4. 3, 4. 8 u 5. 1).
15 COX-2 selective inhibitors are not a substitute for acetylsalicylic acid for prophylaxis of cardiovascular thrombo-embolic diseases because of their lack of antiplatelet effect.
Inibituri selettivi COX- 2 mhumiex sostituti għal acetylsalicylic acid għal profilassi ta ’ mard kardjovaskulari trombo- emboliku minħabba n- nuqqas ta ’ effett tagħhom kontra l- plejtlits.
Renal and hepatic disorders NSAIDs, including celecoxib, may cause renal toxicity.
In- NSAIDs, fosthom celecoxib, jistgħu jikkawżaw effett tossiku renali.
Other Patients known to be CYP2C9 poor metabolisers should be treated with caution (see section 5.2).
18 Oħrajn Pazjenti li huma magħrufin li mhumiex metabolizzaturi daqstant tajbin ta ’ CYP2C9 għandhom jiġu ttrattati b’ kawtela (ara sezzjoni 5. 2).
Celecoxib may mask fever and other signs of inflammation.
Celecoxib jista ’ jaħbi deni u sinjali oħra ta ’ infjammazzjoni.
Onsenal 400 mg capsules contain lactose (99.6 mg).
Onsenal 400 mg kapsuli fih lactose (99. 6 mg).
16 The majority of the interaction studies have been performed with celecoxib doses of 200 mg BID (i. e. those used for osteoarthritis/ rheumatoid arthritis).
Interazzjonijiet Farmakodinamiċi Il- maġġoranza ta ’ l- istudji ta ’ interazzjoni saru b’ dożi ta ’ celecoxib 200 mg BID (i. e. dawk użati għall - artrite ta ’ l- għadam/ artrite rewmatika).
Co-administration of NSAIDs and cyclosporine D derivatives or tacrolimus have been suggested to increase the nephrotoxic effect of cyclosporin and tacrolimus.
Amministrazzjoni flimkien ta ’ NSAIDs u derivattivi taċ- ciclosporin D jew tacrolimus indikat żieda fl - effett nefrotossiku ta ’ cyclosporin u tacrolimus.
Effects of celecoxib on other medicinal products Celecoxib is a weak inhibitor of CYP2D6.
19 Effetti ta ’ celecoxib fuq mediċini oħra Celecoxib huwa inibitur dgħajjef ta ’ CYP2D6.
During celecoxib treatment, the mean plasma concentrations of the CYP2D6 substrate dextromethorphan were increased by 136%.
Waqt il- kura/ trattament b’ celecoxib, il - konċentrazzjonijiet medji tas- substrat ta ’ CYP2D6 dextromethorphan fil- plasma żdiedu b’ 136%.
The plasma concentrations of medicinal products that are substrates of this enzyme may be increased when celecoxib is used concomitantly.
Il - konċentrazzjonijiet fil- plasma ta ’ mediċini li huma substrati ta ’ din l- enzima jistgħu jiżdiedu meta celecoxib jingħata fl- istess ħin magħhom.
17 In patients with rheumatoid arthritis celecoxib had no statistically significant effect on the pharmacokinetics (plasma or renal clearance) of methotrexate (in rheumatologic doses).
F’ pazjenti bl- artrite rewmatika, celecoxib ma kellu ebda effett statistiku sinifikanti fuq il - farmakokinetiċi (tneħħija mill- plażma jew renali) ta ’ methotrexate (f’ dożi rewmatoloġiċi).
Celecoxib is excreted in the milk of lactating rats at concentrations similar to those in plasma.
20 Celecoxib joħroġ fil- ħalib ta ’ firien ireddgħu f’ konċentrazzjonijiet simili għal dawk fil- plażma.
Women who take celecoxib should not breastfeed.
Celecoxib huwa kontraindikat matul it- treddigħ.
However, patients who experience dizziness, vertigo or somnolence while taking celecoxib should refrain from driving or operating machinery.
4. 8 Effetti mhux mixtieqa
4.8 Undesirable effects Adverse reactions are listed by system organ class and ranked by frequency in Table 1, reflecting data from the following sources:
Ir- reazzjonijiet avversi huma elenkati skont is- sistema tal- klassifika tal- organi u mpoġġija skont il - frekwenza f’ Tabella 1, biex jirriflettu d- dejta mis- sorsi li ġejjin:
which an estimated > 70 million patients were treated with celecoxib (various doses, durations, and indications).
irrappurtati b’ mod spontanju matul perjodu li fih madwar > 70 miljun pazjent ingħataw kura b’ celecoxib (diversi dożi, tul ta ’ żmien, u indikazzjonijiet).
Frequency Not Known
Mhix magħrufa l -
Leucopenia, thrombocytopeni a
Lewkopenija, tromboċitopenija
Nervous system
21 Disturbi fis - sistema nervuża
Conjunctivitis, ocular haemorrhage, retinal artery or vein occlusion
Konġuntivite, emorraġija mill - għajnejn, okklużjoni tal - arterja jew tal- vina tar- retina
Ear and labyrinth
Disturbi fil - widnejn u fis - sistema labirintika
Tinnitus
Żanżin tal - widnejn
Decreased hearing
Tnaqqis fis- smigħ
Cardiac
Infart mijokardijaku2 Arritmija Disturbi fil- qalb
Heart failure, palpitations, tachycardia
Insuffiċjenza tal - qalb, palpitazzjonijiet, takikardija
Myocardial infarction2
Disturbi vaskulari
Arrhythmia
Pressjoni għolja, pressjoni għolja aggravata
Vascular
Fwawar, vaskulite
Hypertension, hypertension aggravate d
Disturbi respiratorji, toraċiċi, u medjastinali
Flushing, vasculitis
Farinġite, rinite, sogħla
Respiratory, thoracic, and mediastinal
Bronkospażmu
Pharyngitis, rhinitis, cough
Stitikezza, tifwiq,
Dyspnoea
Ulċerazzjoni
Bronchospasm
Dardir, pankreatite
Gastrointestinal
gastrointestinali
Abdominal pain, diarrhoea, dyspepsia, flatulence
addominali, dijarea, dispepsja, gass fl- istonku
Constipation, eructation, gastritis, stomatitis, vomiting, aggravation of gastrointestinal inflammation
gastrite, stomatite, rimettar, aggravazzjoni tal - infjammazzjoni gastrointestinali
Duodenal, gastric, Nausea, acute oesophageal, pancreatitis, intestinal, and gastrointestinal colonic ulceration; haemorrhage, dysphagia, colitis/ colitis aggravated intestinal perforation; oesophagitis, melaena; pancreatitis
duwodenali, gastrika, akuta, emorraġija esofagali, intestinali u gastrointestinali, tal- musrana l- ħoxna; kolite/ kolite disfaġja, perforazzjoniaggravata intestinali, esofaġite, melena, pankreatite
Abnormal hepatic function, increased SGOT and SGPT
Funzjoni abnormali epatika, żieda fis - SGOT u s- SGPT
Elevation of Hepatitis, hepatic failure hepatic enzymes jaundice
Żieda fl- enżimi Epatite, epatiċi insuffiċjenza tal - fwied, suffejra
Ecchymosis, bullous eruption, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema
Alopeċja, Ekkimożi, imsiemer, fotosensittività dermatite esfoljattiva, eritema multiformi, sindrome ta ’ Stevens- Johnson, nekroliżi epidermika tossika, anġjoedema
General
Disturbi fis - sistema
Flu-like symptoms, peripheral oedema/ fluid retention
Disturb fil - mestrwazzjoni
Adverse drug reactions spontaneously reported to the safety surveillance database over a period in which an estimated > 70 million patients were treated with celecoxib (various doses, durations, and indications).
riproduttiva u fis - sider Disturbi ġenerali Sintomi bħall - influwenza, edema periferali/ żamma tal- fluwidu 1 Reazzjonijiet avversi tal- mediċina rrappurtati b’ mod spontanju għad- dejtabejż dwar is- sorveljanza tas- sigurtà fuq perjodu li matulu xi > 70 miljun pazjent ingħataw kura b’ celecoxib (diversi dożi, tul ta ’ żmien, u indikazzjonijiet).
Respiratory, thoracic,
Disturbi respiratorji, toraċiċi, u medjastinali
20
Disturbi gastrointestinali
and
Dijarea *
mediastinal
Dardir, mard tar- rifluss gastroesofagali, divertikulu,
Gastrointestinal
Emorraġija mill- murliti, movimenti frekwenti tal- imsaren,
Diarrhoea*
23
Nausea, gastroesophageal reflux disease, diverticulum, vomiting, * dysphagia, irritable bowel syndrome
rimettar, * disfaġja, sindrome tal- imsaren irritabbli
Haemorrhoidal haemorrhage, frequent bowel movements, mouth ulceration, stomatitis
ulċera tal- ħalq, stomatite
Dermatitis allergic
Dermatite allerġika
Muscle spasms
Spażmi fil- muskoli
Ganglion
Ċista
Renal and urinary
Disturbi fil- kliewi u fis- sistema urinarja
Nephrolithiasis, blood creatinine increased
Nefrolitjasi, żieda fil - kreatinina fid- demm
Nocturia
Nokturja
Reproductive and breast General and administrative site
Disturbi fis- sistema riproduttiva u fis - sider
Benign prostatic hyperplasia, prostatitis, prostatic specific antigen increased Edema
Iperplasija beninna tal - prostata, infjammazzjoni tal - prostata, żieda fl- antiġens speċifiċi għall- prostata
Single doses up to 1400 mg and multiple doses up to 1400 mg twice daily have been administered to healthy subjects for nine days without clinically significant adverse events.
Dożi waħdenin sa 1200 mg u dożi multipli sa 1200 mg darbtejn kuljum ingħataw lil persuni b’ saħħithom għal disat ijiem mingħajr ebda episodji avversi klinikament sinifikanti.
Celecoxib is an oral, selective cyclooxygenase-2 (COX-2) inhibitor.
24 Celecoxib huwa inibitur selettiv attiv ta ’ ċiklo- ossiġenażi- 2 (COX- 2) li jittieħed mill- ħalq.
21 Cyclooxygenase is responsible for generation of prostaglandins.
Cyclooxygenase huwa responsabbli għall- ġenerazzjoni ta ’ prostaglandini.
Two isoforms, COX-1 and COX-2, have been identified.
Ġew identifikati żewġ iżoforom, COX- 1 U COX- 2.
COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation and fever.
COX- 2 hija l- iżoforma ta ’ l- enzim li nterwa li jiġi indott minn stimuli li jiffavorixxu l- infjammazzjoni u ġie postulat li huwa responsabbli b’ mod ewlieni għas- sinteżi ta ’ medjaturi prostanojdi ta ’ l- uġigħ, infjammazzjoni u deni.
Celecoxib inhibits tumour formation in preclinical models of colon cancer, which overexpress COX-2, whether induced by chemical (rat AOM model) or genetic (MIN mouse model) mutation.
Celecoxib jinibixxi formazzjoni tat- tumur f’ mudelli preklinikali ta ’ kanċer tal- kolon, li jesprimu b’ mod eċċessiv COX- 2, kemm jekk hu indott b’ mutazzjoni kimika (mudell AOM tal- firien) kif ukoll jekk indott b’ mutazzjoni ġenetika (mudell MIN tal- ġurdien)
The greatest reduction was observed in patients treated with celecoxib 16 mg/ kg/ day, which corresponds to the recommended adult FAP dose of 800 mg daily.
L- informazzjoni dwar
Safety data were reviewed in detail by a Data Safety Monitoring Committee, which concluded that celecoxib 16 mg/ kg/ day was a safe dose to recommend for further studies in juvenile FAP patients.
25 is- sigurtà ġiet eżaminata b’ reqqa minn Kumitat għall- Monitoraġġ tad- Dejta dwar is- Sigurtà, li kkonkluda li celecoxib 16 mg/ kg/ kuljum kienet doża sigura biex tiġi rakkomandata għal aktar studji f’ pazjenti FAP minorenni.
The long-term cardiovascular toxicity in children exposed to celecoxib has not been evaluated and it is unknown if the long-term risk may be similar to that seen in adults exposed to celecoxib or other COX-2 selective and non-selective NSAIDs (see section 4.4; cardiovascular effects).
It- tossiċità kardjovaskulari fuq perjodu fit- tul fi tfal esposti għal celecoxib ma ġietx evalwata u mhux magħruf jekk ir- riskju fuq perjodu fit- tul jistax ikun simili għal dak li deher f’ persuni adulti esposti għal celecoxib jew NSAIDs oħra COX- 2 selettivi u mhux selettivi (ara sezzjoni 4. 4; effetti kardjovaskulari).
Cardiovascular Safety – Long-Term Studies Involving Subjects With Sporadic Adenomatous Polyps:
Sigurtà Kardjovaskulari – Studji fuq Perjodu fit- Tul li Jinvolvu Persuni b’ Polipi Adenomatużi Sporadiċi:
22 death, myocardial infarction, or stroke (adjudicated) with celecoxib compared to placebo over 3 years of treatment.
Fil- prova APC, kien hemm żieda relatata mad- doża fl- endpoint kompost ta ’ mewt kardjovaskulari, infart mijokardijaku, jew puplesija (aġġudikati) b’ celecoxib meta mqabbel ma ’ plaċebo fuq 3 snin ta ’ kura.
Celecoxib exhibits dose- and time-independent pharmacokinetics in the therapeutic dose range.
26 Celecoxib juri farmakokinetiċi indipendenti mid- doża u l- ħin fil- medda tad- doża terapewtika.
Celecoxib metabolism is primarily mediated via cytochrome P450 2C9.
Il- metaboliżmu ta ’ celecoxib huwa medjat prinċipalment permezz taċ- ċitokromu P450 CYP2C9.
Three metabolites, inactive as COX-1 or COX-2 inhibitors, have been identified in human plasma i. e., a primary alcohol, the corresponding carboxylic acid and its glucuronide conjugate.
Tliet metaboliti, inattivi bħall- inibituri COX- 1 jew COX- 2, ġew identifikati fil- plażma umana, jiġifieri alkoħol primarju, carboxylic acid korrispondenti u l- konjugat glucuronide tiegħu.
Cytochrome P450 2C9 activity is reduced in individuals with genetic polymorphisms that lead to reduced enzyme activity, such as those homozygous for the CYP2C9*3 polymorphism.
L- attività taċ - ċitokromu P450 CYP2C9 hija mnaqqsa f’ individwi li għandhom polimorfiżmi ġenetiċi li jwasslu għal attività ridotta tal- enzimi, bħal dawk omozigoti għall- polimorfiżmu ta ’ CYP2C9* 3.
In a pharmacokinetic study of celecoxib 400 mg administered once daily in healthy volunteers, genotyped as either CYP2C9*1/ *1, CYP2C9*1/ *3, or CYP2C9*3/ *3, the median Cmax and AUC 0-24 of celecoxib on day 7 were approximately 4-fold and 7-fold, respectively, in subjects genotyped as CYP2C9*3/ *3 compared to other genotypes.
Fi studju farmakokinetiku ta ’ celecoxib 200 mg mogħti darba kuljum lil voluntiera b’ saħħithom, ġenotipati bħala CYP2C9* 1 / * 1, CYP2C9* 1 / * 3, jew CYP2C9* 3 / * 3, il- Cmax u l- AUC 0- 24 medjan ta ’ celecoxib f’ jum 7 kienu bejn wieħed u ieħor 4 darbiet aktar u 7 darbiet aktar, rispettivament, f’ individwi ġenotipati bħala CYP2C9* 3 / * 3 meta mqabbel ma ’ ġenotipi oħra.
In three separate single dose studies, involving a total of 5 subjects genotyped as
Fi tliet studji separati b’ doża waħda, li kienu jinvolvu total ta ’ 5 persuni ġenotipati bħala CYP2C9* 3 / * 3, l- AUC 0- 24 ta ’ doża waħda żdiedet b’ madwar 3 darbiet meta pparagunat ma ’ metabolizzaturi normali.
In animals, exposure to celecoxib during early embryonic development resulted in pre-implantation and post-implantation losses.
27 Fl- annimali, l- esponiment għal celecoxib matul l- iżvilupp embrijoniku tal- bidu irrizulta f’ telf qabel u wara l- implantazzjoni.
Capsules contain: lactose monohydrate sodium lauryl sulphate povidone K30 croscarmellose sodium magnesium stearate
Il- kapsuli fihom: lactose monohydrate sodium lauryl sulphate povidone K30 croscarmellose sodium magnesium stearate
24 Printing ink contains: shellac propylene glycol iron oxide (E172)
Il- linka ta ’ l- istampa fiha: shellac propylene glycol iron oxide (E172) Brilliant Blue FCF E133
6.6 Nature and contents of container
Taħżinx f’ temperatura ’ l fuq minn 30°C
Not all pack sizes may be marketed.
6. 5 In- natura tal- materjal tal- kontenitur u ta ’ dak li hemm ġo fih Folji ta ’ PVC opak/ fojl ta ’ l- aluminju Pakketti ta ’ 10 jew 60 kapsula Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom
28 Ramsgate Road Sandwich Kent CT13 9NJ Ir- Renju Unit
17 October 4003
17 ta ’ Ottubru 2003
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
A DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
CONDITIONS OF THE MARKETING AUTHORISATION
B KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
Name and address of the manufacturer(s) responsible for batch release
Isem u indirizz tal- manifattur( i) responsabbli għall- ħrug tal- lott
• Pfizer Manufacturing Deutschland GmbH, Heinrich-Mack-Strasse 35, 89257 Illertissen, Germany
• Pfizer Manufacturing Deutschland GmbH, Heinrich- Mack- Strasse 35, 89257 Illertissen, Il - Ġermanja
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
OBLIGAZZJONIJIET SPEĊIFIĊI TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/ risk profile.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jtemm il- programm ta ’ studji li ġejjin fiż- żmien speċifikat u r- riżultati ta 'dawn l- istudji għandhom iservu ta' bażi għall- istima tal- profil bejn il- benefiċċju/ riskju li ssir kull sena.
Clinical aspects
Aspetti Kliniċi
The MAH commits to undertake a “ Phase III Placebo-controlled Trial with Celecoxib in Genotype Positive Subjects with Familial Adenomatous Polyposis” (A3191193 – CHIP trial )” to generate further efficacy and safety data.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq jobbliga ruħu li jorganizza “ Studju tal- Fażi III b’ Celecoxib, kkontrollat bi Plaċebo, f’ suġġetti b’ ġenotip posittiv għal Poliposi Familjali Adenomatuża ” (studju A3191193 – CHIP) ” sabiex jiġġenera iktar informazzjoni dwar effikaċja u sigurta ’.
The MAH will submit all progress reports and all safety data within the fifth Annual Re- assessment/ Renewal.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq ser jissottometti rapport ta ’ progress, inkluż l - aħħar informazzjoni dwar sigurta ’, fuq l- istudju A3191193 – studju annwali CHIP. ma ’ l - Evalwazzjoni mill- Ġdid Annwali/ Tiġdid.
The MAH will submit the full report when available..
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq ser jissottometti ir- rapport sħiħ meta dan ikun pprovdut.
27 ANNEX III
31 ANNESS III
29 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
33 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Outer carton - 200 mg hard capsules (clear, opaque blister)
Kartuna ta ’ barra - 200 mg kapsuli iebsin (folja ċara, opaka)
Onsenal 200 mg hard capsules Celecoxib
Onsenal 200 mg kapsuli iebsin Celecoxib
Each capsule contains 200 mg celecoxib
Kull kapsula fiha 200 mg celecoxib
Lactose See leaflet for further information.
Lactose Ara l- fuljett għal aktar informazzjoni.
10 hard capsules
10 kapsuli iebsin
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
34 UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
31 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
35 TAGĦRIF LI GĦANDU JIDHER FUQ PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
See leaflet for further information.
Lactose Aqra l- fuljett għal aktar informazzjoni.
60 hard capsules
60 kapsula iebsa
BATCH NUMBER Batch {number}
NUMRU TAL - LOTT
33 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
37 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Onsenal 200 mg capsules Celecoxib
Onsenal 200 mg kapsuli Celecoxib
Pfizer Limited
Pharmacia- Pfizer EEIG
34 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
38 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Outer carton - 400 mg hard capsules
Kartuna ta ’ barra - 400 mg kapsuli iebsin
Onsenal 400 mg hard capsules Celecoxib
Onsenal 400 mg kapsuli iebsin Celecoxib
Each capsule contains 400 mg celecoxib
Kull kapsula fiha 400 mg celecoxib
BATCH NUMBER Batch {number}
Lott {numru}
36 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
40 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Outer carton - 400 mg hard capsules
Kartuna ta ’ barra – 400 mg kapsuli iebsin
38 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
42 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Onsenal 400 mg capsules Celecoxib
Onsenal 400 mg kapsuli Celecoxib
40 PACKAGE LEAFLET:
44 FULJETT TA ’ TAGĦRIF:
Onsenal 200 mg hard capsules celecoxib
Onsenal 200 mg kapsuli iebsin celecoxib
symptoms are the same as yours.
TAGĦTIHIEX lil persuni oħra.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
Tista ’ tagħmlilhom il- ħsara,
tell your doctor or pharmacist.
anki jekk ikollhom l- istess sintomi bħal tiegħek.
What Onsenal is and what it is used for 2.
X’ inhu Onsenal u għalxiex jintuża 2.
Before you take Onsenal 3.
Qabel ma tieħu Onsenal 3.
How to take Onsenal 4.
Kif għandek tieħu Onsenal 4.
How to store Onsenal 6.
Kif taħżen Onsenal 6.
WHAT ONSENAL IS AND WHAT IT IS USED FOR
X’ INHU ONSENAL U GĦALXIEX JINTUŻA
Cyclo-oxygenase-2 is an enzyme that increases at inflammatory sites and in abnormally growing cells.
Onsenal jappartjeni għal grupp ta ’ mediċini msejħa inibituri ta ’ cyclo- oxygenase- 2 (COX- 2) Cyclo- oxygenase- 2 hija enzima li tiżdied f’ siti ta ’ infjammazzjoni u f’ ċelloli li jikbru b’ mod mhux normali.
Onsenal works by inhibiting COX-2, to which such dividing cells are sensitive.
Onsenal jaħdem billi jinibixxi COX- 2, li tali ċelloli tal- qsim huma sensittivi għaliha.
As a consequence the cells die.
Bħala konsegwenza ta ’ hekk dawn iċ- ċelloli imutu.
Onsenal is used to reduce the number of gastrointestinal polyps in patients with Familial Adenomatous Polyposis (FAP).
Onsenal jintuża biex inaqqas l- ammont ta ’ polipi gastro- intestinali f’ pazjenti b’ Familial Adenomatous Polyposis (FAP).
FAP is an inherited disorder in which the rectum and colon are covered with many polyps that might develop colorectal cancer..
Il- FAP hija disturb ereditarju li fih ir- rektum u l- kolon ikunu miksija b’ ħafna polipi li jistgħu jiżviluppaw kanċer kolorettali.
Onsenal should be used along with the usual care for FAP patients such as surgery and endoscopic surveillance.
Onsenal għandu jintuża flimkien mal- kura tas- soltu għal pazjenti b’ FAP bħall - kirurġija u s- sorveljanza endoskopika.
BEFORE YOU TAKE ONSENAL
QABEL MA TIEĦU ONSENAL
Do not take ONSENAL
Tiħux Onsenal:
- if you have had an allergic reaction to any of the ingredients of Onsenal
- jekk kellek reazzjoni allerġika għal xi sustanza ta ’ Onsenal
- if you have had an allergic reaction to a group of medicines called “ sulphfonamides”.
- jekk kellek reazzjoni allerġika għal grupp ta ’ mediċini msejħa “ sulfonamidi ”.
These include
Dawn jinkludu
some antibiotics (Bactrim and Septra used in combination of sulfamethoxazole and trimethoprim), which can be used to treat infections
ċerti antibijotiċi (Bactrim u Septra użati f’ taħlita ta ’ sulfamethoxazole u trimethoprim), li jistgħu jintużaw għall- kura ta ’ l- infezzjonijiet
- if you have a stomach or duodenal ulcer, or bleeding in the stomach or intestines
- jekk għandek ulċera fl- istonku jew duwodenali, jew fsada fl- istonku jew fl- intestini
- if after taking aspirin or another anti-inflammatory medicine you have had nasal polyps or severe
- jekk wara li ħadt l- aspirina jew mediċina oħra anti- infjammatorja kellek polipi nażali jew
nasal congestion, or any allergic reaction such as an itchy skin rash, swelling, breathing difficulties or wheezing
konġestjoni nażali akuta, jew xi reazzjoni allerġika bħal raxx tal- ġilda li jġiegħlek tħokk, nefħa, diffikultà biex tieħu n- nifs jew tħarħir
- women of childbearing potential unless using an effective method of contraception
- nisa li jistgħu jinqabdu tqal sakemm ma jkunux qegħdin jużaw metodu effettiv ta ’
- if you are breast feeding
- jekk qed tredda ’
- if you have inflammation of the colon (ulcerative colitis) or intestinal tract (Crohn’ s disease)
- jekk għandek infjammazzjoni tal- kolon (kolite ulċerattiva) jew ta ’ l- apparat intestinali (marda
- if you have severe liver disease
- jekk għandek mard serju tal- fwied
- if you have severe kidney disease
- jekk għandek mard serju tal- kliewi
- if you have heart failure, established heart disease and / or cerebrovascular disease, e. g. if you have
- jekk għandek insuffiċjenza tal- qalb, mard tal- qalb stabbilit u/ jew mard ċerebrovaskulari, eż.
had a heart attack, stroke, mini-stroke (TIA) or blockages of blood vessels to the heart or brain
jekk kellek attakk tal- qalb, puplesija, puplesija ħafifa (TIA) jew imblokkar tal- vini u l- arterji għall- qalb jew il- moħħ
- if you have had an operation to clear or bypass blockages
- jekk għamilt operazzjoni biex jitneħħew jew jiġu bypassed l- imblokki
41
- jew jekk għandek jew kellek problemi biċ- ċirkolazzjoni tad- demm (mard ta ’ l- arterji periferali)
- or if you have or have had problems with blood circulation (peripheral arterial disease) or if you
jew jekk għamilt operazzjoni fl- arterji ta ’ riġlejk
have had surgery on the arteries of your legs
45 Oqgħod attent ħafna b’ Onsenal:
Take special care with ONSENAL Some people will need special care from their doctors when they are taking Onsenal.
Kun żgur li t -
Make sure that your doctor knows before you start taking Onsenal:
tabib tiegħek ikun jaf qabel ma tibda tieħu Onsenal:
- if you have conditions which increase your risk of heart disease such as high blood pressure, diabetes,
- jekk għandek kondizzjonijiet li jżidu r- riskju tiegħek ta ’ mard tal- qalb bħal pressjoni għolja tad -
high cholesterol or if you smoke you should discuss with your doctor whether Onsenal is suitable for you
demm, dijabete, kolesterol għoli jew tpejjep, inti għandek tiddiskuti mat- tabib tiegħek jekk Onsenal hux tajjeb għalik
- if you have had a stomach or duodenal (intestinal) ulcer or bleeding in the stomach or intestines
- jekk kellek ulċera fl- istonku jew duwodenali (intestinali) jew fsada fl- istonku jew fl- intestin
- if your heart, liver, or kidneys are not working well, your doctor may want to keep a regular check on
- jekk qalbek, il- fwied, jew il- kliewi tiegħek mhumiex jaħdmu sewwa, it- tabib tiegħek għandu
you
mnejn ikun irid iżomm kontroll regolari fuqek
- if you have fluid retention (such as swollen ankles or feet)
- jekk għandek żamma ta ’ fluwidu (bħal għekiesi jew saqajn minfuħin)
- if you are dehydrated, for example by sickness or diarrhoea or if you are taking diuretic treatment
- jekk inti deidratat/ a, pereżempju b’ mard jew dijarea jew jekk qed tieħu kura dijuretika (pilloli
(water tablets)
ta ’ l- ilma)
- if you have had a serious allergic reaction or a serious skin reaction to any medicines
- jekk kellek reazzjoni allerġika serja jew reazzjoni serja tal- ġilda għal xi mediċini
- if you are taking acetylsalicylic acid
- jekk qed tieħu aċidu aċitilsaliċiliku
- if you are taking anticoagulants
- jekk qed tieħu antikoagulanti
- if you have intolerance to some sugars
- jekk għandek intolleranza għal xi tipi ta ’ zokkor
- if you are being treated for an infection, because Onsenal may mask a fever which is a sign of an
- jekk qed tiġi kkurat/ a għal infezzjoni, minħabba li Onsenal jista ’ jaħbi deni li jkun sintomu ta ’
infection if you are over 65 years of age your doctor may want to keep a regular check on you
infezzjoni jekk għandek iżjed minn 65 sena, it- tabib tiegħek għandu mnejn ikun irid iżomm kontroll regolari fuqek
As with other non-steroidal, anti-inflammatory drugs (NSAIDs; eg, ibuprofen or diclofenac), this medicine may lead to an increase in blood pressure, and so your doctor may ask to monitor your blood pressure on a regular basis.
Bħal kull mediċina anti- infjammatorja, mhux sterojdi oħra (NSAIDs; eż. ibuprofen jew diclofenac), din il- mediċina tista ’ twassal għal żieda fil- pressjoni tad- demm, u għalhekk it- tabib tiegħek jista ’ jistaqsi biex jimmonitorja l- pressjoni tad- demm tiegħek fuq bażi regolari.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Before you start taking Onsenal make sure your doctor knows if you are taking:
Qabel ma tibda tieħu Onsenal kun żgur li t- tabib tiegħek jaf jekk qed tieħu:
- ACE inhibitors or Angiotensin II receptor antagonists (used for high blood pressure and heart failure)
- Inibituri ACE jew antagonisti tar- reċettur ta ’ angiotensin II (użati għall- pressjoni għolja tad -
- Acetylsalcylic acid or other anti-inflammatory medicines
demm u insuffiċjenza tal- qalb)
- Cyclosporin and tacrolimus (used for immune system suppression e. g. after transplants)
- Cyclosporin u tacrolimus (użati għat- trażżin tas- sistema immunitarja eż. wara trapjanti)
- Dextromethorphan (used as an antitussive in cough mixtures)
- Dextromethorphan (użat bħala antitussiv f’ mistura tas- sogħla)
- Diuretics (used to treat fluid retention)
- Dijuretiċi (użati għall- kura taż- żamma ta ’ fluwidu)
- Fluconazole (used to treat fungal infections)
- Fluconazole (użat għall- kura ta ’ infezzjonijiet fungali)
- Lithium (used to treat depression)
- Lithium (użat għall- kura tad- depressjoni)
- Rifampicin (used to treat bacterial infections)
- Rifampicin (użat għall- kura ta ’ infezzjonijiet batteriċi)
- Warfarin (used to prevent blood from clotting) or other anticoagulants
- Warfarin (użat biex jimpedixxi t- tagħqid tad- demm) jew antikoagulanti oħra
- Other medicines to treat depression, sleep disorders, high blood pressure or an irregular heartbeat
- Mediċini oħra għall- kura tad- depressjoni, disturbi tal- irqad, il- pressjoni għolja tad- demm jew
- Neuroleptics (used to treat some mental disorders)
- Newroleptiċi (użati għat- trattament ta ’ xi disturbi mentali)
- Methotrexate (used to treat rheumatoid arthritis, psoriasis and leukaemia)
- Methotrexate (użat għall- kura tal- artrite rewmatika, il- psorjasi u l- lewkimja)
- Carbamazepine (used to treat epilepsy/ seizures and some forms of pain or depression)
- Carbamazepine (użat għall- kura tal- epilessija/ aċċessjonijiet u xi forom ta ’ uġigħ jew
- Barbiturates (used to treat epilepsy/ seizures and some sleep disorders)
- Barbiturati (użati għall- kura tal- epilessija/ aċċessjonijiet u xi disturbi tal- irqad)
Onsenal can be taken with low dose acetylsalicylic acid (aspirin).
Onsenal jista ’ jittieħed ma ’ doża baxxa ta ’ acetylsalicylic acid (aspirina).
Ask your doctor for advice before taking both of these medicines together.
Itlob il- parir tat- tabib tiegħek qabel tieħu dawn iż- żewġ mediċini flimkien.
Taking ONSENAL with food and drink You can take Onsenal with or without food.
Meta tieħu ONSENAL ma ’ l- ikel u max- xorb Onsenal jista ’ jittieħed ma ’ l- ikel jew fuq stonku vojt.
Pregnancy and breast-feeding You must not take Onsenal if you are pregnant or if it is possible that you become pregnant.
Tqala u treddigħ M’ għandekx tieħu Onsenal jekk inti tqila jew jekk hu possibbli li toħroġ tqila.
You must not take Onsenal if you are breast feeding.
46 M’ għandekx tieħu Onsenal jekk qed tredda ’.
42 Driving and using machines If you feel dizzy or tired after taking Onsenal, do not drive or use machinery until you are feeling normal again.
Sewqan u tħaddim ta ’ magni Jekk tħossok stordut/ a jew għajjien/ a wara li tieħu Onsenal, issuqx jew tuża makkinarju sakemm terġa ’ tħossok normali.
Important information about some of the ingredients of Onsenal:
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Onsenal:
Onsenal contains lactose (a type of sugar).
Onsenal fih il- lactose (tip ta ’ zokkor).
HOW TO TAKE ONSENAL
KIF GĦANDEK TIEĦU ONSENAL
Always take Onsenal exactly as your doctor has told you.
Dejjem għandek tieħu Onsenal skond il- parir tat- tabib.
The usual dose is 400 mg twice a day.
Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju. Id- doża li s- soltu tingħata hija 400 mg darbtejn kuljum.
You will usually take two 200 mg capsules twice a day.
Ġeneralment ser tieħu żewġ kapsuli ta 200 mg darbtejn kuljum.
The maximum recommended daily dose is 800 mg.
Id- doża massima rakkomandata tal- ġurnata hi 800 mg.
If you take more ONSENAL than you should If you accidentally take too many capsules, tell your doctor or pharmacist as soon as possible.
Jekk bi żball tieħu kapsuli żejda, għid lit- tabib jew lill- ispiżjar tiegħek mill- aktar fis.
If you forget to take ONSENAL Do not take a double dose to make up for forgotten individual doses.
M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
Like all medicines, ONSENAL can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, ONSENAL jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, għid lit- tabib jew lill- ispiżjar tiegħek.
The side effects listed below were observed in arthritis patients who took medicines with the same active ingredient as Onsenal:
L- effetti sekondarji msemmija hawn isfel kienu osservati f’ pazjenti bl- artrite li ħadu mediċini bl- istess sustanza attiva bħal Onsenal:
Stop taking the capsules and tell your doctor immediately − If you have an allergic reaction such as skin rash, swelling of the face, wheezing or difficulty breathing − If you have heart problems such as pain in the chest − If you have liver failure (symptoms may include nausea (feeling sick), diarrhoea, jaundice (your skin or the whites of your eyes look yellow)) − If you have blistering or peeling of the skin − If you have severe stomach pain or any sign of bleeding in the stomach or intestines, such as passing black or bloodstained bowel movements, or vomiting blood
- Jekk għandek uġigħ qawwi fl- istonku jew xi sinjali ta ’ fsada fl- istonku jew fl- intestini, jekk
Common side effects which may affect more than 1 person in 100, are listed below
Effetti sekondarji komuni li jistgħu jaffettwaw iżjed minn persuna minn kull 100, huma elenkati hawn taħt
- Fluid build up with swollen ankles, legs and/ or hands
Akkumulazzjoni ta ’ fluwidu b’ għekiesi, saqajn u/ jew idejn minfuħin
- Urinary infections
Infezzjonijiet urinarj
- Sinusitis (sinus inflammation, sinus infection, blocked or painful sinuses), blocked or runny nose, sore
Sinożite (infjammazzjoni tas- sinus, infezzjoni tas- sinus, sinus imblukkati jew juġgħu), imnieħer
throat, coughs, colds, flu-like symptoms
imblukkat jew iqattar, uġigħ fil- griżmejn, sogħla, irjiħat, sintomi bħall- influwenza Sturdament, diffikultà biex torqod
- Dizziness, difficulty sleeping
-
- stomach ache, diarrhoea, indigestion, wind
47 Uġigħ fl- istonku, dijarea, indiġestjoni, gass
- Rash, itching
Raxx, ħakk
- Muscle stiffness
Ebusija fil- muskoli
- Worsening of existing allergies
Taħżin ta ’ allerġiji eżistenti
Uncommon side effects which may affect more than 1 person in a 1000, are listed below:
Effetti sekondarji mhux komuni li jistgħu jaffettwaw iżjed minn persuna minn kull 1000, huma elenkati hawn taħt
- Heart failure, palpitations (awareness of heart beat), fast heart rate
- Insuffiċjenza tal- qalb, palpitazzjonijiet (konxju tat- taħbita ta ’ qalbek), taħbita tal- qalb mgħaġġla
- Worsening of existing high blood pressure
- Taħżin ta ’ pressjoni tad- demm għolja eżistenti
- Abnormalities in liver-related blood tests
- Abnormalitajiet f’ testijiet tad- demm relatati mal- fwied
- Abnormalities in kidney-related blood tests
- Abnormalitajiet f’ testijiet tad- demm relatati mal- kliewi
- Anaemia (changes in red blood cells that can cause fatigue and breathlessness)
- Anemija (bidliet fiċ- ċelloli ħomor tad- demm li jistgħu jikkawżaw għeja u qtugħ ta ’ nifs)
- Anxiety, depression, tiredness, drowsiness, tingling sensations (pins and needles)
- Ansjetà, depressjoni, għeja, ngħas, sensazzjonijiet ta ’ tnemnim (tingiż)
- High levels of potassium in blood test results (can cause nausea (feeling sick), fatigue, muscle
- Livelli għoljin ta ’ potassium fir- riżultati ta ’ testijiet tad- demm (jistgħu jikkawżaw dardir
weakness or palpitations)
(tħossok ma tiflaħx), għeja, dgħufija fil- muskoli jew palpitazzjonijiet)
- Impaired or blurred vision, ringing in the ears, mouth pain and soresConstipation, burping, stomach
- Indeboliment fil- vista jew vista mċajpra, żarżir fil- widnejn, uġigħ u feriti fil- ħalq
inflammation (indigestion, stomach ache or vomiting), worsening of inflammation of the stomach or intestine.
- Stitikezza, tifwiq, infjammazzjoni fl- istonku (indiġestjoni, uġigħ fl- istonku jew rimettar), taħżin
- Leg cramps
- Bugħawwieġ fis- saqajn
- Raised itchy rash (hives)
- Raxx jieklok (ħorriqija)
Rare side effects which may affect more than 1 person in a 10,000, are listed below
Effetti sekondarji rari li jistgħu jaffettwaw iżjed minn persuna minn kull 10, 000, huma hawn elenkati hawn taħt:
- Ulcers (bleeding) in the stomach, gullet or intestines; or rupture of the intestine (can cause stomach
- Ulċeri (fsada) fl- istonku, fil- gerżuma jew fl- intestini; jew ftuq tal- intestini (jista ’ jikkawża
ache, fever, nausea, vomiting, intestinal blockage), dark or black stools, inflammation of the gullet (can cause difficulty in swallowing), inflammation of the pancreas (can lead to stomach pain)
wġigħ fl- istonku, deni, dardir, rimettar, imblokk intestinali), ippurgar skur jew iswed, infjammazzjoni tal- gerżuma (tista ’ tikkaġuna diffikultà biex tibla ’), infjammazzjoni tal- frixa (tista ’ twassal għal uġigħ fl- istonku)
- Reduced number of white blood cells (which help protect the body from infection) and blood platelets
- Tnaqqis fin- numru ta ’ ċelloli bojod tad- demm (li jgħinu biex jipproteġu lill- ġisem mill -
(increased chance of bleeding or bruising)
infezzjonijiet) u ta ’ plejtlits tad- demm (ċans akbar ta ’ fsada jew tbenġil)
- Difficulty coordinating muscular movements
- Diffikultà biex tikkoordina l- movimenti tal- muskoli
- Feeling confused, changes in the way things taste
- Tħossok konfuż, bidliet fil- mod kif itiegħmu l- affarijiet
- Increased sensitivity to light
- Sensittività akbar għad- dawl
- Loss of hair
- Telf tax- xagħar
Additional reactions have been reported from actual use of the active ingredient of Onsenal (in post- marketing experience).
Ġew irrappurtati reazzjonijiet addizzjonali mill- użu proprju tas- sustanza attiva ta ’ Onsenal (fl - esperjenza ta ’ wara t- tqegħid fis- suq).
The frequencies of these reactions are difficult to determine but are generally considered to be very rare (affecting less than 1 person in every 10,000) − Bleeding within the brain causing death − Serious allergic reactions (including potentially fatal anaphylactic shock) which can cause skin rash, swelling of the face, lips, mouth, tongue or throat, wheezing or difficulty breathing; difficulty swallowing − Bleeding of the stomach or intestines (can lead to bloody stools or vomiting), inflammation of the intestine or colon, nausea (feeling sick) − Serious skin conditions such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (can cause rash, blistering or peeling of the skin) − Liver failure, liver damage and severe liver inflammation (sometimes fatal or requiring liver transplant).
Il- frekwenzi ta ’ dawn ir- reazzjonijiet huma diffiċli biex jiġu stabbiliti iżda ġeneralment huma kkunsidrati rari ħafna (jaffettwaw inqas minn persuna waħda minn kull 10, 000) − Fsada fil- moħħ li tikkaġuna l- mewt • Reazzjonijiet allerġiċi serji (fosthom xokk anafilattiku li jista ’ jkun fatali) li jistgħu jikkawżaw raxx tal- ġilda, nefħa tal- wiċċ, ix- xufftejn, il- ħalq, l- ilsien jew il- gerżuma, tħarħir jew diffikultà biex tieħu n- nifs; diffikultà biex tibla ’ − Fsada tal- istonku jew tal- intestini (tista ’ twassal għal ippurgar jew rimettar bid- demm), infjammazzjoni tal- intestini jew tal- musrana l- ħoxra, dardir (tħossok ma tiflaħx) − Kundizzjonijiet serji tal- ġilda bħas- sindrome ta ’ Stevens- Johnson, dermatite esfoljattiva u nekrolisi epidermika tossika (tista ’ tikkawża raxx, infafet jew tqaxxir tal- ġilda) • Insuffiċjenza tal- fwied, ħsara fil- fwied u infjammazzjoni serja fil- fwied (kultant fatali jew li teħtieġ trapjant tal- fwied).
Symptoms may include nausea (feeling sick), diarrhoea, jaundice, yellow discolouration of the skin or eyes, dark urine, pale stools, bleeding easily, itching or chills Kidney problems (possible kidney failure, inflammation of the kidneys) − Irregular heartbeat − Meningitis (inflammation of the membrane around the brain and spinal cord) − Hallucinations − Worsening of epilepsy (possible more frequent and/ or severe seizures) − Inflamed blood vessels (can cause fever, aches, purple blotches on the skin) − Blockage of an artery or vein in the eye leading to partial or complete loss of vision, conjunctivitis, eye infection (pink eye), bleeding in the eye − A reduction in the number of red and white blood cells and platelets (may cause tiredness, easy bruising, frequent nose bleeds and increased risk of infections) − Impaired sense of smell − Skin discolouration (bruising), muscle pain and weakness, painful joints
Is- sintomi jistgħu jinkludu dardir (tħossok ma tiflaħx), dijarea, suffejra, tidnis isfar tal- ġilda jew tal- għajnejn, awrina skura, ippurgar ċar, tinfasad malajr, ħakk jew kesħa Problemi fil- kliewi (insuffiċjenza possibbli tal- kliewi, infjammazzjoni tal- kliewi) − Taħbita tal- qalb irregolari − Meninġite (infjammazzjoni tal- membrana madwar il- moħħ u l- korda spinali)
44 − Menstrual disturbances − Headache, flushing − Low levels of sodium in blood test results (can cause loss of appetite, headache, nausea (feeling sick), muscle cramps and weakness)
48 − Alluċinazzjonijiet − Taħżin tal- epilessija (aċċessjonijiet li jistgħu jkunu aktar frekwenti u/ jew serji) − Vini u arterji infjammati (jistgħu jikkawżaw deni, uġigħ, tbajja ’ vjola fuq il- ġilda) − Imblokk ta ’ arterja jew vina fl- għajn li jwassal għat- telf parzjali jew komplet tal- vista, konġuntivite, infezzjoni fl- għajn (għajn roża), fsada fl- għajn − Tnaqqis fin- numru ta ’ ċelloli ħomor u bojod tad- demm u tal- plejtlits (jista ’ jikkawża għeja, titbenġel malajr, tinfaġar ta ’ spiss u riskju akbar ta ’ infezzjonijiet) − Indeboliment fis- sens tax- xamm − Tidnis tal- ġilda (tbenġil), uġigħ u dgħufija fil- muskoli, ġogi juġgħuk − Disturbi mestrwali − Uġigħ ta ’ ras, fwawar − Livelli baxxi ta ’ sodju fir- riżultati ta ’ testijiet tad- demm (jistgħu jikkawżaw telf tal- aptit, uġigħ ta ’ ras, dardir (tħossok ma tiflaħx), bugħawwieġ u dgħufija fil- muskoli)