omnic ocas leaflet venlor

Theamount excreted asunchangedactivesubstanceis estimated to be about 4-6% of thedose,administered asAfterasingle doseof OmnicOcas 0,4 mgand insteadystate, elimination half-lives ofabout 19 and 15 hours, respectively, havebeen measured.Single and repeat dosetoxicitystudies wereperformed in mice, rats and dogs.Inaddition, reproduction toxicityin rats, carcinogenicityin miceand rats andThegeneral toxicityprofile, as seen withhigh doses of tamsulosin,is consistent with theknown pharmacologicalactions of theα-adrenoceptor antagonists.At veryhigh doselevelsthe ECG was altered in dogs. Omnic Ocas 0,4 increases the maximum urinary flow rate. thethroat or tongue)difficult breathingand / or itchingandrash, often as an allergic reaction (angioedema).Priapism(painful prolonged unwantederection for which immediatemedical treatment isRash, inflammation and blisteringof theskin and/ormucous membranes ofthe lips, eyes,mouth, nasal passages orgenitals (Stevens-Johnson syndrome).Not known (frequencycannot be estimated from theavailable data):-serious skinrashes(erythema multiform, dermatitis exfoliative)-Abnormal irregularheart rhythm(atrial fibrillation, arrhythmia, tachycardia), difficult-Ifyou areundergoingeyesurgerybecauseofcloudiness of the lens (cataract)orincreasedpressurein theeye(glaucoma)and arealreadytakingor havepreviouslytaken Omnic Ocas,the pupil maydilate poorlyand the iris (thecoloured circular part of theeye) maybecomeIfyouget anysideeffects, talk toyour doctor or pharmacist. Most tamsulosin is present in plasma in the form of unchanged active substance. OMNIC OCAS 0,4 mg depottabletti. ketoconazole) and moderate (e.g. * Oral use. The primary endpoint was number of patients who decreased their detrusor leak point pressure (LPP) to <40 cm H2O based upon two evaluations on the same day. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Renal function should be monitored and general supportive measures applied. The need for surgery or catheterisation is significantly delayed.

Thesefindings, which areprobablymediated byhyperprolactinemiaand onlyoccurred at highdoselevels, areregardedas irrelevant.tamsulosin hydrochloride 0.4 mg Section 1-3-1:ProductinformationThis medicinal product does notrequireanyspecial storageconditions.Aluminium/ aluminiumfoil blister packs containing10, 14,18,20, 28, 30,45,50, 56, Thedosageis 1 tablet per day.You can takeOmnicOcas withor without food, preferablyat thesametime ofeach day.Thetablet must be swallowed wholeand not becrunched orchewed.Omnic Ocas isaspeciallydesigned tablet from which theactiveingredientis graduallyreleased, oncethetablethas been ingested.It is possible thatyou observearemnant ofthetablet inyour stool.

Interaction studies have only been performed in adults. Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome. Product leaflet summary. Mosttamsulosin ispresent in plasma in the form of unchanged activesubstance.It is metabolised in theInrats, hardlyanyinduction of microsomal liverenzymes was seen to be causedbytamsulosin hydrochloride 0.4 mg Section 1-3-1:ProductinformationInvitro results suggest that CYP3A4 and also CYP2D6 areinvolved in metabolism, withpossible minor contributions to tamsulosin hydrochloridemetabolism byother CYPisozymes.Inhibition ofCYP3A4 and CYP2D6 drugmetabolizingenzymesmaylead toincreased exposureto tamsulosin hydrochloride(seesection 4.4 and 4.5). Incaseof acutehypotension occurringafter overdosagecardiovascular support should begiven.Blood pressurecan berestoredand heart rate brought back to normal bylyingthepatient down.If this doesnot help then volume expanders and,when necessary,vasopressors could beemployed.

Ejaculation disorders have been observed in short and long term clinical studies with tamsulosin. Always consultyour doctor, ifyou consider stoppingthis therapy.Ifyou haveanyfurther questions on theuse of this product, askyour doctor orpharmacist.Likeallmedicines, OmnicOcascan cause sideeffects, although noteverybodygets them.Common (less than 1 in 10, morethan 1 in 100 (1-10%)):Dizziness, particularlywhen goingto sit or standup.Abnormal ejaculation(ejaculation disorder).Thismeans that semen does not leavethe bodyvia theurethra, but instead goes into the bladder(retrogradeejaculation) orthe ejaculationvolumeis reduced orabsent (ejaculation failure).This phenomenon isharmless.Uncommon (morethan 1in 1000, less than 1 in 100 (0,1-1%)):Headache, palpitations(the heart beats morerapidlythan normaland itis also noticeable),reduced blood pressuree.g. Thisresponseis considered to benot clinicallyrelevant. Het is vooral belangrijk om uw arts te informeren als u gelijktijdig behandeld wordt met geneesmiddelen die de verwerking van Omnic Ocas uit het lichaam kunnen vertragen (zoals ketoconazol, erytromycine). However, patients should be aware of the fact that dizziness can occur. שותכל וא סועלל ןיאיאופרה בצמה רחא בוקעל ידכב תוצוחנ רשא תויתפוקת תויאופר תוקידב עצבל שי הילע ,םד ץחלב היוצר אל הדיריל םורגל לולע ו בלה בצקב תשוחת .ןופליע לש ןוימ רדחל וא אפורל דימ הנפ ,הפורתה ןמ דלי עלב תועטב םא וא רתי תנמ תלטנ םא .ךתיא הפורתה תזירא אבהו םילוח תיב,שורדה ןמזב וז ותואב רתוי רחואמ סאקוא קינמוא תחקל לוכי התא םוי תספספו הפורתה תא לוטיל תחכש םא .םוי וא אפורה םע תוצעייתה אלל הפורתב לופיטה קיספהל ןיא ,ךתואירב בצמב רופיש לח םא םג .חקורה תויעבה ,אפורה ידי לע ךל ץלמוהש הממ זחל תויושע תויאופרה .רו.לופיטה תא קיספהל לקוש התאו הדימב אפורב ץעוויה דימת.חקורב וא אפורב ץעוויה ,הפורתב שומישל עגונב תופסונ תולאש ךל שי םא .םישמתשמהמ קלחב יאוול תועפותל םורגל לולע סאקוא קינמואב שומישה .ןהמ תחא ףאמ לובסת אלו ןכתי .יאוולה תועפות תמישר ארקמל להבית לא תימואתפ םינימסתה .

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