qanastek/EMEA-V3 huggingface dataset:
Agents for the treatment of erectile dysfunction, including Tadalafil Lilly, must not be used in men with cardiac disease for whom sexual activity is inadvisable.
Sustanzi għat- trattament ta ’ disfunzjoni erettili, inkluż TADALAFIL LILLY, ma jistgħux jiġi uzati f’ irġiel li jbatu minn mard kardijaku li għalihom l- attivita ’ sesswali mhix rakkmandata.
Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease.
It- tobba għandhom iqisu r- riskju potenzjali kardijaku ta ’ attivita ’ sesswali f’ pazjenti li għandhom mard kardjovaskulari pre- eżistenti.
- patients with unstable angina or angina occurring during sexual intercourse,
- Pazjenti li jbatu minn insuffiċjenza tal- qalb meqjusa mill- Assoċjazzjoni tal- Qalb ta ’ New York
- patients with New York Heart Association Class 2 or greater heart failure in the last 6 months,
bħala Klassi 2 jew akbar, fl- aħħar 6 xhur,
Tadalafil Lilly is contraindicated in patients who have loss of vision in one eye because of non- arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).
TADALAFIL LILLY huwa kontra- indikat f’ pazjenti li tilfu d- dawl f’ għajn waħda minħabba newropatija ottika iskemika anterjuri li m’ hijiex arteritika (NAION), indipendetement mill- fatt jekk dan l- episodju kienx marbut jew le ma ’ użu preċedenti ta ’ inibitur ta ’ PDE5 (ara sezzjoni 4. 4).
3 activity.
3 Qabel ma jinbeda kwalunkwe trattament għal disfunzjoni erettili, it- tobba għandhom jikkunsidraw l - istat kardjovaskulari tal- pazjenti tagħhom, peress illi hemm grad ta ’ riskju kardijaku assoċjat ma ’ l - attivita ’ sesswali.
Tadalafil has vasodilator properties, resulting in mild and transient decreases in blood pressure (see section 5.1) and as such potentiate the hypotensive effect of nitrates (see section 4.3).
Tadalafil għandu karatteristiċi vasodilatorji, li jirriżultaw fi tnaqqis ħafif u temporajnu fil- pressjoni tad- demm (ara sezzjoni 5. 1) u b’ hekk jikkawża l- effett ipotensiv tan- nitrati (ara sezzjoni 4. 3).
Serious cardiovascular events, including myocardial infarction, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischemic attacks, chest pain, palpitations and tachycardia, have been reported either post marketing and/ or in clinical trials.
F’ pazjenti li fl- istess ħin qegħdin jieħdu mediċini kontra l- pressjoni għolja fid- demm, tadalafil jista ’ jikkawża tnaqqis fil- pressjoni tad- demm.
Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors.
Meta tinbeda l- kura bit- teħid ta ’ tadalfil darba kuljum, għandhom jingħataw l- kunsiderazzjonijiet kliniċi xierqa għal possibilità ta ’ tibdil fid- doża tat - terapija kontra l- pressjoni għolja fid- demm.
However, it is not possible to definitively determine whether these events are related directly to these risk factors, to Tadalafil Lilly, to sexual activity, or to a combination of these or other factors.
Madanakollu, mhuwiex possibbli li jiġi determinat b’ mod definitiv jekk dawn l- effetti humiex relatati direttament ma ’ dawn il- fatturi ta ’ riskju, ma ’ TADALAFIL LILLY, ma ’ attività sesswali, jew ma ’ taħlita ta ’ dawn il- fatturi jew ta ’ fatturi oħra.
Visual defects and cases of NAION have been reported in connection with the intake of Tadalafil Lilly and other PDE5 inhibitors.
Difetti fil- vista u każijiet ta ’ NAION ġew irrappurtati b’ konnessjoni mat- teħid ta ’ TADALAFIL LILLY u inibituri oħra ta ’ PDE5.
The patient should be advised that in case of sudden visual defect, he should stop taking Tadalafil Lilly and consult a physician immediately (see section 4.3).
Il- pazjent għandu jingħata parir li f’ każ ta ’ difett fil- vista għal għarrieda, għandu jieqaf jieħu TADALAFIL LILLY u jikkonsulta tabib minnufih (ara sezzjoni 4. 3).
There is limited clinical data on the safety of single-dose administration of tadalafil in patients with severe hepatic insufficiency (Child-Pugh Class C).
Hemm informazzjoni klinika limitata dwar is- sigurta 'ta' teħid ta ’ doża waħda ta’ tadalafil f’ pazjenti b’ insuffiċjenza severa tal- fwied (Child- Pugh Klassi C); It- teħid ta ’ doża darba kuljum ma ġietx evalwata f’ pazjenti b’ insuffiċjenza epatika.
If Tadalafil Lilly is prescribed, a careful individual benefit/ risk evaluation should be undertaken by the prescribing physician.
Jekk TADALAFIL LILLY jinkiteb mit- tabib, għandha ssir stima bir- reqqa tal- benefiċċji/ riskji għall- individwu mit- tabib li jippreskrivih.
Agents for the treatment of erectile dysfunction, including Tadalafil Lilly, should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
Medicini li jintuzaw għat- tratament ta ’ disfunzjoni erettili, inkluż TADALAFIL LILLY, għandhom jintuzaw b’ kawtela f’ pazjenti b’ diformazzjoni anatomika tal- pene (bħal angolazzjoni, fibrozi kavernożali jew il- marda ta ’ Peyronie), jew f’ pazjenti li għandhom kundizzjonijiet li jistgħu jippredisponuhom għal prijapiżmu (bħal sickle cell enemija, majeloma multipla jew lewkimja).
It is not known if Tadalafil Lilly is effective in patients who have undergone pelvic surgery or radical non- nerve-sparing prostatectomy.
Mhuwiex magħruf jekk TADALAFIL LILLY huwiex effettiv f’ pazjenti li għaddew minn kirurġija pelvika jew tneħħija radikali tal- prostata mingħajr ebda rigwar għan- nervituri.
In patients who are taking alpha1 blockers concomitant administration of Tadalafil Lilly may lead to symptomatic hypotension in some patients (see section 4.5).
F’ uħud mill- pazjenti li qed jieħdu imblokkaturi ta ’ alpha1, jekk jittiħed TADALAFIL LILLY fl- istess ħin jista ’ jwassal għal pressjoni baxxa sintomatika (ara sezzjoni 4. 5).
Therefore, the combination of tadalafil and doxazosin is not recommended.
Għalhekk mhuwiex irrakkomandat li tadalafil jingħata flimkien ma ’ doxazin.
Caution should be exercised when prescribing Tadalafil Lilly to patients using potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin) as increased tadalafil exposure (AUC) has been observed if the medicines are combined (see section 4.5).
Wieħed għandu joqgħod attent meta jikteb riċetta għal TADALAFIL LILLY lill- pazjenti li qed jużaw inibituri qawwijin ta 'CYP3A4 (ritonavir, saquinavir, ketoconazole, itraconazole, u erythromycin) għaliex kien osservat esponiment akbar għal tadalafil (AUC) meta l- mediċini jingħataw flimkien (Ara sezzjoni 4. 5).
The safety and efficacy of combinations of Tadalafil Lilly and other treatments for erectile dysfunction have not been studied.
Is- sigurta ’ u l- effikaċja farmaċewtika ta ’ TADALAFIL LILLY flimkien ma ’ trattamenti oħrajn għal disfunzjoni erettili ma kinux studjati.
Tadalafil Lilly contains lactose monohydrate.
4 TADALAFIL LILLY fih l- lactose monohydrate.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Pazjenti bi problemi ereditarji rari ta ’ intoleranza għall- galactose, ta ’ nuqqas ta ’ Lapp lactase jew ta ’ malassorbiment ta’ glucose- galactose m’ għandhomx jieħdu dan il- prodott mediċinali.
4 Tadalafil is principally metabolised by CYP3A4.
Tadalafil huwa prinċipalment metaboliżżat minn CYP3A4.
Therefore, administration of Tadalafil Lilly to patients who are using any form of organic nitrate is contraindicated (see section 4.3).
Għalhekk l - għoti ta ’ TADALAFIL LILLY lil pazjenti li qed jużaw kwalunkwe forma ta ’ nitrat organiku huwa kontra- indikat (ara sezzjoni 4. 3).
Based on the results of a clinical study in which 150 subjects receiving daily doses of tadalafil 20 mg for 7 days and 0.4 mg sublingual nitroglycerin at various times, this interaction lasted for more than 24 hours and was no longer detectable when 48 hours had elapsed after the last tadalafil dose.
Ibbażat fuq ir- riżultati ta ’ studju kliniku li fih 150 individwu irċievew doża ta ’ 20 mg tadalafil kuljum għal 7 ijiem u 0. 4 mg nitrogliċerina taħt l- ilsien f’ ħinijiet diversi, din l- interazzjoni damet aktar minn 24 siegħa u ma dehritx aktar meta għaddew 48 siegħa minn l- aħħar doża ta ’ tadalafil.
Thus, in a patient prescribed any dose of tadalafil (2.5 mg – 20 mg), where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should have elapsed after the last dose of tadalafil before nitrate administration is considered.
Għalhekk, f’ pazjent li għalih ġie preskritt xi doża ta ’ tadalafil (2. 5 mg - 20 mg), fejn l- għoti tan- nitrat jitqies medikalment neċessarju f’ sitwazzjoni prekarja għall- ħajja, għall - inqas 48 siegħa għandhom jitħallew jgħaddu minn l- aħħar doża ta ’ tadalafil qabel ma jingħataw in - nitrati.
In such circumstances, nitrates should only be administered under close medical supervision with appropriate haemodynamic monitoring.
F’ dawn iċ- ċirkostanzi, in- nitrati għandhom biss jingħataw taħt sorveljanza medika stretta, b’ sorveljanza xierqa emodinamika.
In another clinical pharmacology study tadalafil (20 mg) was studied in combination with up to 4 classes of antihypertensives.
Fi studju ieħor ta ’ farmakoloġija klinika, kien studjat tadalafil (20 mg) flimkien ma ’ sa 4 klassijiet ta ’ mediċini li
In this regard, study subjects whose blood pressure was well controlled, the reduction was minimal and similar to that seen in healthy subjects.
F’ dan ir- rigward, l- individwi ta ’ l- istudju li l- pressjoni tad- demm tagħhom kienet ikkontrollata tajjeb, it- tnaqqis kien minimu u simili għal dak ta ’ individwi b’ saħħithom.
5 This effect lasts at least twelve hours and may be symptomatic, including syncope.
Dan l- effett idum għallinqas 12- il siegħa u jista ’ jkun sintomatiku u jinkludi s- sinkope.
Tadalafil Lilly is not indicated for use by women.
M ’ hemmx studji ta ’ tadalafil fin- nisa tqal.
For tadalafil no clinical data on exposed pregnancies are available.
Għall- tadalafil m’ hemmx tagħrif kliniku dwar l- użu waqt it- tqala.
Although the frequency of reports of dizziness in placebo and tadalafil arms in clinical trials was similar, patients should be aware of how they react to Tadalafil Lilly, before driving or operating machinery.
Minkejja li l- frekwenza ta ’ sturdament fir- rapporti fl- ambitu ta ’ plaċebo u tadalafil fi provi kliniċi kienet simili, il- pazjenti għandhom ikunu konxji dwar kif jirreaġixxu għal TADALAFIL LILLY, qabel ma jsuqu jew iħaddmu l- magni.
The table below lists the adverse reactions reported during placebo-controlled clinical trials for registration in patients treated with tadalafil on demand and daily dosing.
It- tabella hawn taħt turi r- reazzjonijiet avversi rrapportati waqt studji kliniċi kkontrollati bi plaċebo għar- reġistrazzjoni f’ pazjenti kkurati b’ tadalafil meta jkun hemm il- bżonn u f’ dożaġġ ta ’ kuljum.
Adverse reactions are also included that have been reported from postmarketing surveillance in patients taking tadalafil on demand.
Huma wkoll inklużi reazzjonijiet avversi li ġew irrapportati minn sorveljanza wara li l- prodott tqiegħed fis- suq f’ pazjenti li qed jieħdu tadalafil meta jkun hemm il- bżonn.
Common
Komuni (≥1/ 100 sa < 1/ 10)
(≥ 1/ 100 to <  1/ 10) (≥ 1/ 1000 to <  1/ 100)
(≥1/ 1000 sa < 1/ 100)
Blurred vision, Sensations described as eye pain, Swelling of eyelids, Conjunctival hyperaemia
Vista mċajpra, Sensazzjonijiet deskritti bħala uġigħ fl- għajn, Nefħa fil- kpiepel ta ’ l- għajnejn, 7
Visual field defect
Difett fil- kamp viżiv
Non-arteritic anterior ischemic optic neuropathy (NAION), Retinal vascular occlusion
Newropatija ottika iskemika anterjuri li m’ hijiex arteritika (NAION)
System Organ Class:
iperimja tal - konġuntiva
Ear and labyrinth System Organ Class:
Okklużjoni vaskulari tar - retina
disorders 1
Sistema tal- Klassifika ta ’ l- Organi:
Sudden deafness2
Disturbi fil- qalb
Hypotension (more commonly reported when tadalafil is given to patients who are already taking antihypertensive agents),
Ipotensjoni (irrapportata l - iżjed meta tadalafil jingħata lill- pazjenti li diġà jkunu qed jieħdu sustanzi antipertensivi), Ipertensjoni
Abdominal pain, Gastro- oesophageal reflux
Uġigħ addominali, Mard ta ’ rifluss gastro- esofagali
Skin and subcutaneous tissue disorders
Sistema tal- Klassifika ta ’ l- Organi:
Rash, Urticaria, Hyperhydrosis (sweating)
Raxx, urtikarja, Iperidrosi (għaraq) muskolu- skeltrali u tal- connective tissue
Stevens-Johnson syndrome, Exfoliative dermatitis
Sindromu ta ’ Stevens- Johnson, Dermatite esfoljattiva
Reproductive system and breast disorders
Disturbi
Prolonged erections
fis- sistema riproduttiva u fis- sider Erezzjoni fit- tul
Tadalafil is > 10,000-fold more potent for PDE5 than for PDE1, PDE2, and
Tadalafil huwa > 10, 000 darba aktar potenti għal PDE5 milli għalPDE1, PDE2 u PDE4, li huma enżimi li jinsabu fil- qalb, fil- moħħ, fil- vini u l- arterji, fil- fwied u f’ organi oħra.
Three clinical studies were conducted in 1054 patients in an at-home setting to define the period of responsiveness to tadalafil.
Saru tliet studji kliniċi fuq 1054 pazjent f’ ambjent tad- dar biex ikun definit iż- żmien ta ’ rispons għal tadalafil meta jkun hemm it- talba.
In two of these studies decreases were observed in sperm count and concentration related to tadalafil treatment of unlikely clinical relevance.
Saru tliet studji fl- irġiel biex ikun stmat l- effett potenzjali fuq l- ispermatoġenesi ta ’ tadalafil 10 mg (studju wieħed ta ’ 6 xhur) u 20 mg (studju wieħed ta ’ 6 xhur u studju wieħed ta ’ 9 xhur) mogħtija kuljum.. F’ tnejn minn dawn l- istudji ġew osservati tnaqqis fl- għadd u fil- konċentrazzjoni ta ’ sperma relatati ma ’ kura b’ tadalafil ta ’ relevanza klinika improbabbli.
In the primary efficacy studies of general populations, 81% of patients reported that tadalafil improved their erections as compared to 35% with placebo.
Fl- istudji dwar effikaċja primarja ta ’ popolazzjonijiet ġenerali, 81% tal- pazjenti sabu illi tadalafil tejjeb l- erezzjonijiet tagħhom meta mqabbel ma ’ 35% li ħadu l- plaċebo.
Also, patients with erectile dysfunction in all severity categories reported improved erections whilst taking tadalafil (86%, 83%, and 72% for mild, moderate, and severe, respectively, as compared to 45%, 42%, and 19% with placebo).
Fl- istudji dwar effikaċja primarja, 75% tal- attentati
In the primary efficacy studies, 75% of intercourse attempts were successful in tadalafil treated patients as compared to 32% with placebo.
9 għall- kopulazzjoni kienu b’ suċċess f’ pazjenti li ħadu tadalafil meta mqabbel ma ’ 32% li ħadu l - plaċebo.
In a 12-week study performed in 186 patients (142 tadalafil, 44 placebo) with erectile dysfunction secondary to spinal cord injury, tadalafil significantly improved the erectile function leading to a mean per-subject proportion of successful attempts in patients treated with tadalafil 10 or 20 mg (flexible-dose, on demand) of 48% as compared to 17% with placebo.
Fi studju li dam 12- il ġimgħa u li ġie magħmul f’ 186 pazjent (142 tadalafil, 44 plaċebo) b’ disfunzjoni erettili kawża ta ’ trawma tan- nerv li jgħaddi minn ġos- sinsla, tadalafil b’ mod sinifikanti tejjeb il - funzjoni erettili li wassal għal medja f’ kull pazjent ta ’ proporzjon ta ’ tentattivi ta ’ suċċess f’ dawk ikkurati b’ tadalfil 10 mg jew 20 mg (doża flessibbli, meta jkun hemm il- bżonn) ta ’ 48% meta mqabbel ma ’ 17% bi plaċebo.
Absorption Tadalafil is readily absorbed after oral administration and the mean maximum observed plasma concentration (Cmax) is achieved at a median time of 2 hours after dosing.
5. 2 Tagħrif farmakokinetiku
The rate and extent of absorption of tadalafil are not influenced by food, thus Tadalafil Lilly may be taken with or without food.
Ir- rata u l- grad ta ’ l- assorbiment ta ’ tadalafil mhumiex influwenzati bl- ikel, għalhekk TADALAFIL LILLY jista ’ jittieħed ma ’ l- ikel jew fuq stonku vojt.
9 The mean volume of distribution is approximately 63 l, indicating that tadalafil is distributed into tissues.
Distribuzzjoni Il- volum medju tad- distribuzzjoni huwa madwar 63 l, li jindika li tadalafil jiġi distribwit fit- tessuti.
In haemodialysis patients, Cmax was 41% higher than that observed in healthy subjects.
Fil- pazjenti fuq l- emodjaliżi, Cmax kien 41% ogħla
Hepatic insufficiency Tadalafil exposure (AUC) in subjects with mild and moderate hepatic impairment (Child-Pugh Class A and B) is comparable to exposure in healthy subjects when a dose of 10 mg is administered.
Insuffiċjenza epatika L- esponiment għal tadalafil (AUC) f’ individwi b’ insuffiċjenza ħafifa u moderata tal- fwied (Child - Pugh Klassi A u B) huwa komparabbli ma 'l- espożizzjoni f’ individwi b’ saħħithom meta tingħata doża ta' 10 mg.
There is limited clinical data on the safety of tadalafil in patients with severe hepatic insufficiency (Child- Pugh Class C).
L- informazzjoni klinika dwar is- sigurta ’ ta ’ tadalafil f’ pazjenti b’ insuffiċjenza gravi tal - fwied (Child- Pugh Klassi C); hija limitata.
If tadalafil is prescribed, a careful individual benefit/ risk evaluation should be undertaken by the prescribing physician.
Jekk jiġi preskritt tadalafil, għandha ssir evalwazzjoni b’ attenzjoni tal- benefiċċji/ riskji għall- individwu mit- tabib li jippreskrivih.
In a rat pre- and postnatal development study, the no observed effect
Informazzjoni li mhiex klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni, riskju ta ’ kanċer, effett tossiku fuq is- sistema riproduttiva, ma turi l- ebda periklu speċjali għall- bnedmin Ma kien hemm ebda evidenza ta ’ teratoġeniċita 'jew ta ’ effett tossiku fuq l- embriju jew il- fetu f’ firien jew ġrieden li rċevew sa 1000 mg/ kg/ jum tadalafil.
10 dose was 30 mg/ kg/ day.
Fi studju ta ’ l- iżvilupp ta ’ qabel u wara t- twelid tal- firien, id- doża li fiha ma ġie osservat l- ebda effett kienet ta ’ 30 mg/ kg/ jum.
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal ta ’ prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
11 Grootslag 1-5, NL-3991 RA, Houten The Netherlands
Grootslag 1- 5, Nl- 3991 RA, Houten L- Olanda
Avda de la Industria 30 28108 Alcobendas (Madrid) Spain
Avda. de la Industria 30 E- 28108 Alcobendas (Madrid) Spanja
Medicinal product subject to medical prescription.
Prodott medicinali jingħata bir- riċetta tat- tabib.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 2.2 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Id- Detentur ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq irid jassigura li s- sistema ta ’ farmakoviġilanza, kif deskritt fil- verżjoni 2. 2 ippreżentat fit- Taqsima 1. 8. 1 ta ’ l- Applikazzjoni għall - Awtorizzazzjoni għat- Tqegħid fis- Suq, qiegħda preżenti u qiegħda taħdem qabel ma jpoġġi l- prodott fuq is- suq u waqt li l- prodott qiegħed fis- suq.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Id- Detentur ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq jintrabat li jagħmel l- istudji u l- attivitajiet addizzjonali ta ’ farmakoviġilanza mniżżlin fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem fil- verżjoni 3 tal- Pjan dwar l- Immaniġġar tar- Riskju (PIR) ippreżentat fit- Taqsima 1. 8. 2 ta ’ l- Applikazzjoni għall - Awtorizzazzjoni għat- Tqegħid fis- Suq u f’ kull aġġornament tal- PIR li jista ’ jkun hemm u li jkun qabel miegħu is- CHMP.
The PSUR of Tadalafil Lilly is aligned with the cross-referred product, Cialis, until otherwise specified.
Sakemm jiġi speċifikat mod ieħor, il- PSUR ta ’ Tadalafil Lilly huwa bbażat fuq l- istess linji ta ’ Cialis, il- prodott li għalih jagħmel referenza.
Tadalafil Lilly 20 mg film-coated tablets tadalafil
TADALAFIL LILLY 20 mg pilloli miksijin b’ rita Tadalafil
EXPIRY DATE
Fih lactose monohydrate
EXP {MM/ YYYY}
DATA TA ’ META JISKADI
SPECIAL STORAGE CONDITIONS
JIS [XX/ SSSS]
Store in the original package in order to protect from moisture.
KUNDIZZJONIJIET SPEĊJALI TA ’ KIF JINĦAŻEN
17 10.
17 Aħżen fil- pakkett oriġinali sabiex tilqa ’ mill- umdità.
Tadalafil Lilly 20 mg
TADALAFIL LILLY 20 mg
18 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
18 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Tadalafil Lilly 20 mg tablets tadalafil
TADALAFIL LILLY 20 mg pilloli Tadalafil
Tadalafil Lilly 20 mg film-coated tablets tadalafil
TADALAFIL LILLY 20 mg pilloli miksijin b’ rita tadalafil
What Tadalafil Lilly is and what it is used for 2.
X’ inhu TADALAFIL LILLY u għalxiex jintuża 2.
Before you take Tadalafil Lilly 3.
Qabel ma tieħu TADALAFIL LILLY 3.
How to take Tadalafil Lilly 4.
Kif għandek tieħu TADALAFIL LILLY 4.
Possible side effects 5 How to store Tadalafil Lilly 6.
Kif taħżen TADALAFIL LILLY 6.
WHAT Tadalafil Lilly IS AND WHAT IT IS USED FOR
X ’ INHU TADALAFIL LILLY U GĦALXIEX JINTUŻA
Tadalafil Lilly is a treatment for men with erectile dysfunction.
TADALAFIL LILLY huwa trattament għall- irġiel b’ disfunzjoni erettili.
Tadalafil Lilly belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
TADALAFIL LILLY jagħmel parti minn grupp ta ’ mediċini msejħa inibituri tal- phosphodiesterase tip 5.
Following sexual stimulation Tadalafil Lilly works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis.
Wara l- istimolu sesswali, TADALAFIL LILLY jaħdem billi jgħin lill- arterji fil- pene tiegħek jirrilassaw, u b’ hekk jippermettu d- dħul tad- demm fil- pene tiegħek.
Tadalafil Lilly will not help you if you do not have erectile dysfunction.
TADALAFIL LILLY ma jgħinekx jekk m ’ għandekx disfunzjoni erettili.
It is important to note that Tadalafil Lilly does not work if there is no sexual stimulation.
Huwa importanti li tkun taf li TADALAFIL LILLY ma jaħdimx jekk ma jkunx hemm stimolu sesswali.
BEFORE YOU TAKE Tadalafil Lilly
QABEL MA TIEĦU TADALAFIL LILLY
Do not take Tadalafil Lilly
Tieħux TADALAFIL LILLY
- if you are allergic (hypersensitive) to tadalafil or any of the other ingredients of Tadalafil Lilly.
– jekk inti allerġiku (tbati minn sensittività eċċessiva) għal tadalafil jew għal xi sustanzi oħra ta ’ TADALAFIL LILLY
Tadalafil Lilly has been shown to increase the effects of these medicines.
TADALAFIL LILLY intwera li jżid l- effetti ta ’ dawn il- mediċini.
Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra strain on your heart.
- jekk għandek pressjoni tad- demm baxxa jew pressjoni tad- demm għolja mhux ikkontrollata.
The following are reasons why Tadalafil Lilly may also not be suitable for you.
Dawn li ġejjin huma raġunijiet għaliex TADALAFIL LILLY jista ’ ma jkunx xieraq għalik.
It is not known if Tadalafil Lilly is effective in patients who have undergone pelvic surgery or radical non-nerve-sparing prostatectomy.
M’ huwiex magħruf jekk TADALAFIL LILLY huwa effettiv f’ pazjenti li kellhom kirurġija pelvika jew prostatektomija radikali li affetwat in- nervituri.
If you experience sudden decrease or loss of vision, stop taking Tadalafil Lilly and contact your doctor immediately.
Jekk f’ daqqa waħda tesperjenza tnaqqis jew telf tal- vista, waqqaf TADALAFIL LILLY u kkuntattja t - tabib tiegħek minnufih.
Tadalafil Lilly is not intended for use by women or by adolescents under the age of 18.
TADALAFIL LILLY m’ huwiex magħmul biex jiġi użat min- nisa jew minn adolexxenti taħt it - tmintax- il sena
This is particularly important if you are treated with nitrates as you should not take Tadalafil Lilly if you are taking these medicines.
Dan huwa partikolarment importanti jekk inti tkun qed tieħu nitrati għaliex m ’ għandekx tieħu TADALAFIL LILLY jekk qed tieħu dawn il- mediċini.
Do not take Tadalafil Lilly with other medicines if your doctor tells you that you may not.
Tieħux TADALAFIL LILLY ma ’ mediċini oħra jekk it- tabib jgħidlek li ma tistax.
You should not use Tadalafil Lilly together with any other treatments for erectile dysfunction.
M ’ għandekx tuża TADALAFIL LILLY flimkien ma ’ trattamenti oħrajn għal disfunzjoni erettili.
Taking Tadalafil Lilly with food and drink You may take Tadalafil Lilly with or without food.
Meta tieħu TADALAFIL LILLY ma ’ l- ikel u max- xorb Tista ’ tieħu TADALAFIL LILLY ma ’ l- ikel jew fuq stonku vojt.
Driving and using machines Some men taking Tadalafil Lilly in clinical studies have reported dizziness.
Sewqan u tħaddim ta ’ magni Xi rġiel li ħadu TADALAFIL LILLY fl- istudji kliniċi rrapurtaw li kellhom xi sturdament.
Important information about some of the ingredients of Tadalafil Lilly:
Taghrif importanti dwar xi wħud mis- sustanzi ta ’ TADALAFIL LILLY
Tadalafil Lilly contains lactose.
22 TADALAFIL LILLY fih lactose.
HOW TO TAKE Tadalafil Lilly
KIF GĦANDEK TIEĦU TADALAFIL LILLY
Always take Tadalafil Lilly exactly as your doctor has told you.
Dejjem għandek tieħu TADALAFIL LILLY skond il- parir tat- tabib.
22 The recommended starting dose of tadalafil is one 10 mg tablet before sexual activity.
Id- doża rakkmandata tal- bidu ta ’ tadalafil hija pillola ta ’ 10 mg qabel l- attivita ’ sesswali.
If the effect of this dose is too weak your doctor may increase the dose to 20 mg.
Jekk l- effett ta ’ din id- doża huwa ħafif wisq, it- tabib tiegħek jista ’ jżidlek id- doża sa 20 mg.
Tadalafil Lilly tablets are for oral use.
Il- pilloli ta ’ TADALAFIL LILLY huma għall- użu orali.
You may take Tadalafil Lilly with or without food.
Tista ’ tieħu TADALAFIL LILLY ma ’ l- ikel jew fuq stonku vojt.
You may take a Tadalafil Lilly tablet at least 30 minutes before sexual activity.
Tista ’ tieħu pillola ta ’ TADALAFIL LILLY mill- inqas 30 minuta qabel l- attivita ’ sesswali.
Tadalafil Lilly may still be effective up to 36 hours after taking the tablet.
TADALAFIL LILLY jista ’ jibqa ’ effettiv sa 36 siegħa wara li tieħu l- pillola.
You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
Hemm bżonn li int u s - sieħba tiegħek tibdew il- logħob ta ’ qabel il- kopulazzjoni sesswali, kif kontu tagħmlu kieku ma kontx qiegħed tieħu mediċina għad- disfunzjoni erettili.
If you have taken or are planning to take Tadalafil Lilly, avoid excessive drinking (blood alcohol level of 0.08% or greater), since this may increase the risk of dizziness when standing up.
Jekk ħadt jew ser tieħu TADALAFIL LILLY, evita li tixrob alkoħol eċċessiv (livell ta ’ alkoħol fid- demm ta ’ 0. 08% jew aktar), minħabba li dan jista ’ jżid ir- riskju ta ’ sturdament meta tkun bil- wieqfa.
You should NOT take Tadalafil Lilly more than once a day.
M’ GĦANDEKX tieħu TADALAFIL LILLY aktar minn darba kuljum.
Tadalafil at doses of 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.
Tadalafil f’ dożi ta ’ 10 mg u 20 mg huwa intenzjonat għall- użu qabel attività sesswali prevista u mhux irrakkomandat għall- użu kontinwu ta ’ kuljum..
If you take more Tadalafil Lilly than you should Tell your doctor.
Jekk tieħu TADALAFIL LILLY aktar milli suppost Għid lit- tabib tiegħek.
Like all medicines, Tadalafil Lilly can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, TADALAFIL LILLY jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Very commonly reported side effect in patients taking tadalafil were headache and indigestion.
Effetti sekondarji li b’ mod komuni ħafna ġew irrapurtati f’ pazjenti li qegħdin jieħdu tadalafil kienu uġigħ ta ’ ras u indiġestjoni.
Commonly reported side effects in patients taking tadalafil include back pain, muscle aches, facial flushing, nasal congestion, dizziness, pounding heartbeat sensation, abdominal pain and reflux.
Effetti sekondarji li b’ mod komuni jiġu rrapportati f’ pazjenti li qegħdin jieħdu tadalafil jinkludu uġigħ tad- dahar. uġigħ fil- muskoli,, ħmura fil- wiċċ, imnieħer miżdud u sturdament.
Uncommon side effects are allergic reactions including rashes and hives, blurred vision, swelling of the eyelids, eye pain, red eyes, increased sweating, nose bleeds, a fast heart rate, high blood pressure, low blood pressure and chest pain.
Effetti sekondarji mhux komuni huma reazzjonijiet allerġiċi li jinkludu raxx u urtikarja, vista mċajpra, nefħa tal- kpiepel ta ’ l- għajnejn, uġigħ fl- għajnejn, għajnejn ħomor, żieda fl- għaraq, infriġ, sensazzjoni li l- qalb qiegħda tħabbat b’ mod qawwi, pressjoni għolja tad- demm, pressjoni baxxa tad- demm u uġigħ
Rare side effects in patients taking tadalafil include fainting, migraine and swelling of the face.
Effetti sekondarji rari f’ pazjenti li qegħdin jieħdu tadalafil jinkludu ħass ħażin, emikranja u nefħa fil - wiċċ
In rare instances it is possible that a prolonged and possibly painful erection may occur after taking tadalafil.
F’ każijiet rari huwa possibbli li sseħħ erezzjoni fit- tul u possibilment li tweġġa ’ wara li tieħu tadalafil.
Heart attack and stroke have also been reported rarely in men taking tadalafil.
B’ mod rari ġew ukoll irrapportati, attakk tal- qalb, puplesija, u taħbit irregolari tal- qalb f’ irġiel li ħadu tadalafil.
It is not possible to determine whether these events were directly related to tadalafil.
Mhux possibbli li jkun determinat jekk dawn l- avvenimenti kinux relatati ma ’ tadalafil.
23 Partial, sudden, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported.
B’ mod rari, ġew irrappurtati każi ta ’ tnaqqis jew telf ta ’ vista, parzjali, għal għarrieda, temporanji jew permanenti f’ għajn waħda jew fit- tnejn li huma.
Some additional side effects have been reported in men taking tadalafil that were not seen in clinical trials and their incidence is unknown.
F’ irġiel li ħadu tadalafil ġew irrapportati xi effetti sekondarji oħra li ma dehrux f’ studji kliniċi u l - inċidenza tagħhom m’ hijiex magħrufa.
Sudden decrease or loss of hearing has been reported.
Dawn jinkludu, konvulżjonijiet u telf tal- memorja li tgħaddi, xi disturbi li jkollhom effett fuq il- fluss tad- demm fl- għajnejn, taħbit irregolari tal- qalb u anġina, raxx sever tal- ġilda u mewta kardijaka għal għarrieda.
HOW TO STORE Tadalafil Lilly
KIF TAĦŻEN TADALAFIL LILLY
Do not use Tadalafil Lilly after the expiry date stated on the carton and blister.
Tużax TADALAFIL LILLY wara d- data ta ’ l- iskadenza li tidher fuq il- kartuna u l- folja.
FURTHER INFORMATION
X’ fih TADALAFIL LILLY
What Tadalafil Lilly contains The active substance is tadalafil.
Is- sustanza attiva hi tadalafil.
What Tadalafil Lilly looks like and contents of the pack Tadalafil Lilly 20 mg comes as yellow film-coated tablets.
Id- Dehra ta ’ TADALAFIL LILLY u l- kontenuti tal- pakkett TADALAFIL LILLY 20 mg jiġi bħala pilloli sofor miksijin b’ rita.
Tadalafil Lilly 20 mg is available in blister packs containing 2, 4, 8 or 12 tablets.
TADALAFIL LILLY issibu f’ pakketti b’ folji ta ’ 2, 4, 8 jew 12- il pillola.
Not all pack sizes may be marketed.
24 Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
Tél/ Tel: +32-(0) 2 548 84 84 България ТП "Ели Лили Недерланд "Б .В. - България тел. + 359 2 491 41 40 Č eská republika ELI LILLY Č R, s. r. o.
Tel: + 420 234 664 111
Tel: + 420 234 664 111 Danmark Eli Lilly Danmark A/ S Tlf: +45 45 26 61 00 Deutschland Lilly Deutschland GmbH Tel. + 49-(0) 6172 273 2222 Eesti Eli Lilly Holdings Limited.
Danmark Eli Lilly Danmark A/ S Tlf: +45 45 26 61 00 Deutschland Lilly Deutschland GmbH Tel. + 49 - (0) 6172 273 2222 Eesti Eli Lilly Holdings Limited.
Simi: + 354 540 8000 Italia Eli Lilly Italia S. p. A.
Tel: +353 - (0) 1 661 4377 Ísland Eli Lilly Danmark A/ S, Útibú á Íslandi
Tel: +386 (0)1 580 00 10 Slovenská republika Eli Lilly Slovakia, s. r. o.
Tel: + 40 21 4023000 Slovenija Eli Lilly, Podružnica Ljubljana Tel: +386 (0) 1 580 00 10 Slovenská republika Eli Lilly Slovakia, s. r. o.
Tel: + 421 220 663 111 Suomi/ Finland Oy Eli Lilly Finland Ab.
Simi: + 354 520 3400 Italia Eli Lilly Italia S. p. A.
Puh/ Tel: + 358-(0) 9 85 45 250 Sverige Eli Lilly Sweden AB Tel: +46 (0) 8 737 88 00 United Kingdom Eli Lilly and Company Limited Tel: +44-(0) 1256 315999
Tel: + 39 - 055 42571 Κύπρος Phadisco Ltd Τηλ: +357 22 715000 Latvija Eli Lilly Holdings Limited pārstāvniecība Latvijā Tel: +371 7364000 Lietuva Eli Lilly Holdings Limited atstovybė Tel. +370 (5) 2649600
What is Tamiflu?
X’ inhu Tamiflu?
Tamiflu is a medicine that contains the active substance oseltamivir.
Tamiflu huwa mediċina li fiha s- sustanza attiva oseltamivir.
It is available as capsules (yellow:
Jiġi bħala kapsuli (sofor:
30 mg; grey:
30 mg; griżi:
45 mg; yellow and grey:
45 mg; sofor u griżi:
75 mg) and as a powder to be made up into an oral suspension (12 mg/ ml).
75 mg) u bħala trab li jitħallat f’ soluzzjoni orali (12 mg/ ml).
What is Tamiflu used for?
Għal xiex jintuża Tamiflu?
Tamiflu is used to treat or prevent influenza (‘ flu’) in adults and children over the age of one year: • in the treatment of flu, it can be used in patients who have the symptoms of flu, when the influenza virus is known to be circulating in the community. • in the prevention of flu, it can be used in patients who have been in contact with someone who has flu.
Tamiflu jintuża biex jittratta u jimpedixxi l- influwenza (‘ flu ’) fl- adulti u fi tfal ta ’ aktar minn sena: • it- trattament tal- influwenza, jista ’ jintuża f’ pazjenti li għandhom is- sintomi tal- influwenza, meta jkun magħruf li l- vajrus tal- influwenza jkun qed jiċċirkola fil- komunità. • il- prevenzjoni tal- influwenza, jista ’ jintuża f’ pazjenti li kienu f’ kuntatt ma ’ xi ħadd li għandu l - influwenza.
This is generally done on a case-by-case basis, but can be done in exceptional cases as a seasonal programme, for example when the flu vaccine may not be sufficient and there is a pandemic (a global epidemic of flu).
Ġeneralment dan isir fuq bażi ta ’ każ b’ każ, iżda jista ’ jsir f’ każijiet eċċezzjonali bħala programm tal- istaġun, per eżempju meta t- tilqima tal- influwenza ma tkunx suffiċjenti u meta jkun hemm pandemija (epidemija globali tal- influwenza).
Tamiflu cannot replace flu vaccination, and its use should be based on official recommendations.
Tamiflu ma jistax jieħu post it- tilqima tal- influwenza, u l- użu tiegħu għandu jkun ibbażat fuq rakkomandazzjonijiet uffiċjali.
How is Tamiflu used?
Kif jintuża Tamiflu?
In the treatment of flu, Tamiflu must be started within two days of the onset of symptoms.
Fil- kura tal- influwenza, Tamiflu għandu jinbeda fi żmien jumejn mill- bidu tas- sintomi.
It is given as one dose twice a day for five days.
Jingħata bħala doża waħda darbtejn kuljum għal ħamest ijiem.
In the prevention of flu, Tamiflu must be started within two days of contact with someone who has flu.
Fil- prevenzjoni tal- influwenza, Tamiflu għandu jinbeda fi żmien jumejn minn kuntatt ma ’ xi ħadd bl- influwenza.
It is given as one dose once a day for at least 10 days after contact with an infected person.
Jingħata bħala doża waħda darba kuljum għal mill- inqas 10 ijiem wara kuntatt ma ’ persuna infettata.
When Tamiflu is used during a flu epidemic, this dose can be given for up to six weeks.
Meta Tamiflu jintuża waqt pandemija tal- influwenza, din id- doża tista ’ tingħata għal sitt ġimgħat.
The dose of Tamiflu is 75 mg in adults and in children who weigh more than 40 kg.
Id- doża ta ’ Tamiflu għall- adulti u għat- tfal li jiżnu aktar minn 40 kg hija ta ’ 75 mg.
For children who weigh less than 40 kg, the dose is adjusted according to their weight using the lower dose capsules (30 or 45 mg) or, for children who cannot swallow capsules, the oral suspension.
Għal tfal li jiżnu inqas minn 40 kg, id- doża hija aġġustata skont il- piż tagħhom, bl- użu ta ’ kapsuli tad- doża aktar baxxa (30 jew 45 mg) jew sospensjoni orali għal tfal li ma jistgħux jibilgħu kapsuli.
Tamiflu is not to be used in children under the age of one year.
Tamiflu m’ għandux jintuża fuq tfal iżgħar minn sena.
The doses need to be lower in patients who have kidney problems.
Id- dożi għandhom ikunu aktar baxxi f’ pazjenti li għandhom problemi tal- kliewi.
How does Tamiflu work?
Kif jaħdem Tamiflu?
The active substance in Tamiflu, oseltamivir, acts specifically on the influenza virus, blocking some of the enzymes on its surface, known as neuramidases.
Is- sustanza attiva f’ Tamiflu, Oseltamivir, taħdem speċifikament fuq il- vajrus tal- influwenza, u timblokka xi wħud mill- enzimi fil- wiċċ tiegħu, magħrufin bħala newramidażi.
When the neuramidases are blocked, the virus 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Meta n- newramidażi 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. cannot spread.
©European Medicines Agency, 2008 Reproduction is authorised provided the source is acknowledged jkunu mblokkati, il- vajrus ma jistax jinfirex.
Oseltamivir works on the neuramidases of both influenza A (the most common type) and influenza B viruses.
Oseltamivir jaħdem fuq newramidażi kemm ta ’ vajrusis tal- influwenza A (l- aktar tip komuni) u kemm tal- influwenza B.
How has Tamiflu been studied?
Kif ġie studjat Tamiflu?
The effects of Tamiflu were first tested in experimental models before being studied in humans.
L- effetti ta ’ Tamiflu kienu l- ewwel ittestjati f’ mudelli esperimentali qabel ma ġew studjati fil - bnedmin.
In humans, Tamiflu has been compared with placebo (a dummy treatment) in studies in the treatment of flu (2,413 adults and adolescents, 741 elderly patients and 1,033 children).
Fil- bnedmin, Tamiflu tqabbel ma ’ plaċebo (trattament finta) fi studji fit- trattament tal- influwenza (2, 413- il adult u adolexxent, 741 pazjent anzjan u 1, 033 tifel u tifla).
The effectiveness was measured using a score card where patients recorded their symptoms (feeling feverish, muscle pain, headache, sore throat, cough, overall discomfort and runny nose).
L- effikaċja tkejlet bl- użu ta ’ kard tal- iskor li fuqha, il- pazjenti jniżżlu s- sintomi tagħhom (iħossuhom bid- deni, uġigħ fil- muskoli, uġigħ ta ’ ras, uġigħ fil- gerżuma, sogħla, uġigħ ma ’ kullimkien u mnieħer iqattar).
In the prevention of flu, Tamiflu was studied in patients who had been exposed to the disease when one of their family members contracted flu (962 cases) or during an epidemic (1,562 subjects aged between 16 and 65 years, and 548 elderly subjects in nursing homes).
Fil- prevenzjoni tal- influwenza, Tamiflu ġie studjat f’ pazjenti li kienu esposti għall- marda meta wieħed mill- membri tal- familja tagħhom qabditu l- influwenza (962 każ) jew waqt epidemija (1, 562 suġġett, u 548 suġġett anzjan fi djar għall- kura tal- anzjani).
The studies measured the number of cases of flu, proven by laboratory tests.
L- istudji kejlu n- numru ta ’ każijiet tal- influwenza, ippruvati permezz ta ’ testijiet tal- laboratorju.
A study also looked at using Tamiflu in a family setting (277 families) for both the treatment of the person with flu, and the treatment or prevention of flu in those in contact with him or her.
Studju ħares ukoll lejn l- użu ta ’ Tamiflu fuq bażi ta ’ familja (227 familja) kemm għall- kura tal- persuna bl- influwenza, kif ukoll għall- kura jew prevenzjoni tal- influwenza f’ dawk f’ kuntatt miegħu jew magħha.
What benefit has Tamiflu shown during the studies?
X’ benefiċċji wera Tamiflu waqt l- istudji?
In the treatment studies in adults, Tamiflu reduced the duration of the illness from 5.2 days for a patient taking placebo, to 4.2 days for a patient taking Tamiflu.
Fl- istudji tal- kura fl- adulti, Tamiflu naqqas it- tul tal- marda minn 5. 2 jiem għal pazjent li qed jieħu plaċebo, għal 4. 2 jiem għal pazjent li qed jieħu Tamiflu.
The reduction in the length of the disease in children aged one to six years was 1.5 days.
It- tnaqqis fit- tul tal- marda fi tfal ta ’ etajiet bejn wieħed u sitt snin kien ta ’ 1. 5 ijiem.
In the prevention studies, Tamiflu reduced the incidence of flu among the people in contact with a flu sufferer.
Fi studji ta ’ prevenzjoni, Tamiflu naqqas l- inċidenza tal- influwenza fost in- nies f’ kuntatt ma ’ xi ħadd li qed isofri mill- influwenza.
In the study carried out during an epidemic, 1% of the people taking Tamiflu developed flu after contact, compared with 5% of those taking placebo.
Fl- istudju li sar waqt epidemija, 1% tan- nies li kienu qed jieħdu Tamiflu żviluppaw l- influwenza wara l- kuntatt, meta mqabbla ma ’ 5% ta ’ dawk li kienu qed jieħdu plaċebo.
In families with one person with flu, 7% of the family members in the household developed flu when receiving prevention with Tamiflu, compared with 20% with no prevention treatment.
F’ familji b’ persuna waħda bl- influwenza, 7% tal- membri tal- familja f’ dik id- dar żviluppaw l - influwenza waqt li kienu qed jirċievu prevenzjoni b’ Tamiflu, meta mqabbla ma ’ 20% li ħaduha mingħajr trattament ta ’ prevenzjoni.
What is the risk associated with Tamiflu?
X’ inhu r- riskju assoċjat ma ’ Tamiflu?
The most common side effects with Tamiflu in adults and adolescents (seen in more than 1 patient in 10) are headache and nausea (feeling sick).
L- aktar effetti sekondarji komuni b’ Tamiflu fl- adulti u l- adolexxenti (dehru f’ iktar minn pazjent wieħed minn 10) huma wġigħ ta ’ ras, nawżja (dardir).
In children, the side effects seen in more than 1 patient in 10 are vomiting and diarrhoea.
Fit- tfal, l- effetti sekondarji l- iktar komuni (li dehru f’ iktar minn pazjent wieħed minn 10) huma r- remettar u d- dijarrea.
For the full list of all side effects reported with Tamiflu, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrapportati b’ Tamiflu, ara l- Fuljett ta ’ Tagħrif.
Tamiflu should not be used in patients who may be hypersensitive (allergic) to oseltamivir or to any of the other ingredients.
Tamiflu m’ għandux jintuża f’ pazjenti li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal oseltamivir jew għal xi sustanza oħra tiegħu.
Why has Tamiflu been approved?
Għaliex ġie approvat Tamiflu?
Seasonal flu is normally handled using vaccination.
L- influwenza staġjonali hija normalment ikkontrollata bl- użu tat- tilqim.
The Committee for Medicinal Products for Human Use (CHMP) decided that Tamiflu’ s benefits are greater than its risks for the treatment and prevention of influenza, as an additional method in case of a pandemic or when flu vaccines are not effective against the influenza virus causing the seasonal epidemic.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Tamiflu huma akbar mir - riskji tiegħu għal użu għat- trattament u l- prevenzjoni tal- influwenza, bħala metodu addizzjonali f’ każ ta ’ pandemija jew meta tilqimiet tal- influwenza ma jkunux effettivi kontra l- vajrus tal- influwenza li jkun qed jikkaġuna epidemija staġjonali.
The Committee recommended that Tamiflu be given marketing authorisation.
Il- Kumitat irrakomanda li Tamiflu jingħata awtorizzazzjoni għat- Tqegħid fis- Suq.
Other information about Tamiflu:
Tagħrif ieħor dwar Tamiflu:
The European Commission granted a marketing authorisation valid throughout the European Union for Tamiflu to Roche Registration Limited on 20 June 2002.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea għal Tamiflu lil Roche Registration Limited fl- 20 ta ’ Ġunju 2002.
The marketing authorisation was renewed on 20 June 2007.
L- awtorizzazzjoni għat- tqegħid fis - suq ġiet imġedda fl- 20 ta ’ Ġunju 2007.
The full EPAR for Tamiflu can be found here.
L- EPAR sħiħ għal Tamiflu jista ’ jiġi kkonsultat hawnhekk.
blister (PVC/ PE/ PVDC/ alu)
folja (PVC/ PE/ PVDC/ alu)
Powder for oral suspension Capsule, hard Capsule, hard
Trab għal suspensjoni orali
bottle (glass) blister (PVC/ PE/ PVDC/ alu) blister (PVC/ PE/ PVDC/ alu)
flixkun (ħġieġ)
1 bottle 10 capsules 10 capsules
10 kapsuli
Tamiflu 30 mg hard capsule.
Tamiflu 30 mg kapsula iebsa.
For a full list of excipients, see section 6.1.
Kull kapsula iebsa fiha oseltamivir phosphate ekwivalenti għal 30 mg ta ’ oseltamivir Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Imprints are blue.
Kapsula iebsa Il- kapsula iebsa hija opaka, ta 'lewn isfar ċar u turi l- marka “ ROCHE ” u għandha kappa safra ċara, opaka li turi l- marka “ 30 mg. ” Il- marki huma ta' lewn blu.
Treatment of influenza In patients one year of age and older who present with symptoms typical of influenza, when influenza virus is circulating in the community.
Il- kura ta 'l- influwenza F’ pazjenti minn sena' l fuq li jkollhom is- sintomi tipiċi ta 'l- influwenza, meta jkun hemm il- passa tal - virus ta' l- influwenza fil- komunità.
Efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms.
L- effikaċja ntweriet meta t- trattament inbeda fi żmien jumejn mill - bidu tas- sintomi.
This indication is based on clinical studies of naturally occurring influenza in which the predominant infection was influenza A (see section 5.1).
Din l- indikazzjoni hija bbażata fuq studji kliniċi ta 'influwenza kkawżata b' mod naturali li l- infezzjoni predominanti fiha kienet l- influwenza A (ara sezzjoni 5. 1)
Prevention of influenza
Il- prevenzjoni ta 'l- influwenza
- Post-exposure prevention in individuals one year of age or older following contact with a
- Il- prevenzjoni wara l- espożizzjoni f’ individwi minn sena 'l fuq wara li jkollhom kuntatt ma' każ
clinically diagnosed influenza case when influenza virus is circulating in the community.
ta 'influwenza ddijanjostikat klinikament meta jkun hemm l- passa tal- virus ta' l- influwenza fil - komunità.
- The appropriate use of Tamiflu for prevention of influenza should be determined on a case by
- L- użu xieraq ta ’ Tamiflu għall- prevenzjoni ta 'l- influwenza għandu jiġi kkunsidrat każ b' każ
case basis by the circumstances and the population requiring protection.
skond iċ- ċirkustanzi u l- popolazzjoni li teħtieġ il- protezzjoni.
In exceptional situations (e. g., in case of a mismatch between the circulating and vaccine virus strains, and a pandemic situation) seasonal prevention could be considered in individuals one year of age or older.
F' sitwazzjonijiet mhux tas- soltu (eż., f' każi fejn l- istrains tal- vaċċin ma jaqblux ma dawk tal- virus li jkun qed jikkawza l - influwenza, u f' sitwazzjoni pandemika), il- prevenzjoni għall- istaġun tista 'tiġi kkunsidrata f’ individwi minn sena' l fuq.
Tamiflu is not a substitute for influenza vaccination.
Tamiflu mhux sostitut għat- tilqima kontra l- influwenza.
The use of antivirals for the treatment and prevention of influenza should be determined on the basis of official recommendations.
L- użu ta 'l- antivirali għall- kura u l- prevenzjoni ta' l- influwenza għandu jiġi ddeterminat a bażi ta 'rakkomandazzjonijiet uffiċjali.
Decisions regarding the use of antivirals for treatment and prophylaxis should take into consideration what is known about the characteristics of the circulating influenza viruses and the impact of the disease in different geographical areas and patient populations.
Deċiżjonijiet dwar l- użu ta ’ antivirali għall- kura u l- profilassi għandhom jieħdu f’ kunsiderazzjoni dak li huwa magħruf dwar il- karatteristiċi tal- virusis ta ’ influwenza li qed jiċċirkolaw u l- impatt tal- marda f' żoni ġeografiċi u popolazzjonijiet ta 'pazjenti differenti.
Tamiflu capsules and Tamiflu suspension are bioequivalent formulations.
Il- kapsuli u s- suspensjoni ta ’ Tamiflu huma sustanzi bioekwivalenti.
75 mg doses can be administered as either
Dożi ta '75 mg jistgħu jingħataw jew bħala
- one 75 mg capsule or
- kapsula waħda ta '75 mg jew
- one 30 mg capsule plus one 45 mg capsule or
- kapsula waħda ta '30 mg flimkien ma' kapsula waħda ta ’ 45 mg jew
- by administering one 30 mg dose plus one 45 mg dose of suspension.
- billi tingħata doża waħda ta '30 mg flimkien ma' doża ta '45 mg ta' suspenjoni.
Adults, adolescents or children (> 40 kg) who are unable to swallow capsules may receive appropriate doses of Tamiflu suspension.
Dawk l- adulti, adoloxxenti u tfal (> 40 kg) li ma jistgħux jibilgħu l- kapsuli jistgħu jieħdu dożi adattati tas- suspensjoni ta ’ Tamiflu.