qanastek/EMEA-V3 huggingface dataset:
In patients receiving concomitant amiodarone treatment, reinforcement of clinical and ECG monitoring is warranted.
F’ pazjenti li jirċievu kura b’ amiodarone fl- istess waqt, ir- rinforz ta ’ monitoraġġ kliniku u ta ’ ECG huwa xieraq.
Convulsions have been reported in patients treated concomitantly with orlistat and antiepileptic drugs e. g. valproate, lamotrigine, for which a causal relationship to an interaction cannot be excluded.
Kienu irrapportati konvulżjonijiet f’ pazjenti kkurati b’ orlistat flimkien ma ’ mediċini kontra l- epilessija e. ż. valproate, lamotrigine, u għal dan relazzjoni kawżali għall- interazzjoni ma tistax tiġi eskluża.
Therefore, these patients should be monitored for possible changes in the frequency and/ or severity of convulsions.
Għalhekk, dawn il- pazjenti għandhom jiġu sorveljati għall- bidliet possibli fil- frekwenza u/ jew fis - severità tal- konvulżjonijiet.
Rare occurrence of hypothyroidism and/ or reduced control of hypothyroidism may occur.
Jista ’ jkun hemm l- okkorrenza rari ta ’ ipotirojdiżmu u/ jew kontroll imaqqas ta ’ ipotirojdiżmu.
The mechanism, although not proven, may involve a decreased absorption of iodine salts and/ or levothyroxine (see section 4.4).
Il - mekkanżimu, għalkemm mhux ipprovat, jista ’ jinvolvi assorbiment imnaqqas ta ’ mluħa ta ’ iodine u/ jew ta ’ levothyroxine (ara sezzjoni 4. 4).
Lack of interactions No interactions with amitriptyline, atorvastatin, biguanides, digoxin, fibrates, fluoxetine, losartan, phenytoin, phentermine, pravastatin, nifedipine Gastrointestinal Therapeutic System (GITS), nifedipine slow release, sibutramine or alcohol have been observed.
Nuqqas ta ’ interazzjonijiet Ma ġewx osservati interazzjonijiet ma ’ amitriptyline, atorvastatin, biguanides, digoxin, fibrates, fluoxetine, losartan, phenytoin, phentermine, pravastatin, Sistema Terapewtika Gastro- intestinali (GITS) ta ’ nifedipine, nifedipine b’ rilaxx bil- mod, sibutramine jew alkoħol.
The absence of these interactions has been demonstrated in specific drug-drug-interaction studies.
In- nuqqas ta ’ dawn l - interazzjonijiet intwera fi studji speċifiċi dwar l- interazzjonijiet bejn mediċina u oħra.
The absence of an interaction between oral contraceptives and orlistat has been demonstrated in specific drug-drug interaction studies.
In- nuqqas ta ’ interazzjoni bejn kontraċettivi orali u orlistat intwera fi studji speċifiċi dwar l - interazzjonijiet bejn mediċina u oħra.
An additional contraceptive method is recommended in case of severe diarrhoea (see section 4.4).
Metodu addizzjonali ta ’ kontraċezzjoni huwa rakkomandat f’ każ ta ’ dijarea severa( ara sezzjoni 4. 4).
For orlistat no clinical data on exposed pregnancies are available.
Għal orlistat m’ hemmx tagħrif kliniku dwar l- użu waqt it- tqala.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development (see section 5.3).
Studji fuq il- bhejjem ma jurux effetti ħżiena diretti jew indiretti fuq it- tqala, fuq l- iżvilupp ta ’ l - embriju/ fetu, ħlas jew żvilupp wara t- twelid (ara sezzjoni 5. 3).
As it is not known whether orlistat is secreted into human milk, orlistat is contra-indicated during breast-feeding.
Peress li mhuwiex magħruf jekk orlistat jgħaddix fil- ħalib tas- sider uman, orlistat huwa kontra- indikat waqt it- treddigħ.
Xenical has no influence on the ability to drive and use machines.
Xenical m’ għandu l- ebda effett fuq il- ħila biex issuq u tħaddem magni.
4.8 Undesirable effects Adverse reactions to orlistat are largely gastrointestinal in nature.
Reazzjonijiet avversi għal orlistat il- biċċa l- kbira huma ta ’ natura gastro- intestinali.
The incidence of adverse events decreased with prolonged use of orlistat.
L- inċidenza ta ’ reazzjonijiet avversi naqset bl- użu fit- tul ta ’ orlistat.
Adverse events are listed below by system organ class and frequency.
Avvenimenti avversi huma mniżżla taħt skond is- sistema tal- klassifika tal- organi u l- frekwenza.
Frequencies are defined as: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100), rare (≥ 1/ 10,000 to < 1/ 1,000) and very rare (< 1/ 10,000) including isolated reports.
Il - frekwenzi huma definiti bħala: komuni ħafna (≥1/ 10), komuni (≥1/ 100 sa < 1/ 10), mhux komuni (≥1/ 1, 000 sa < 1/ 100), rari (≥1/ 10, 000 sa < 1/ 1, 000) u rari ħafna (< 1/ 10, 000) inkluż rapporti iżolati.
4 The following table of undesirable effects (first year of treatment) is based on adverse events that occurred at a frequency of > 2% and with an incidence ≥ 1% above placebo in clinical trials of 1 and 2 years duration:
It- tabella li ġejja ta ’ effetti mhux mixtieqa (fl- ewwel sena ta ’ kura) hi bbażata fuq reazzjonijiet avversi li seħħew bi frekwenza ta ’ > 2% u b’ inċidenza ta ’ ≥ 1% aktar mill- plaċebo waqt provi kliniċi li damu sena u sentejn:
Adverse reaction/ event
Reazzjoni/ avveniment avvers
Headache Respiratory, thoracic and mediastinal disorders Very common:
Uġigħ ta ’ ras Disturbi respiratorji, toraċiċi u medjastinali Komuni ħafna:
Upper respiratory infection
Infezzjoni fl- apparat respiratorju ta ’ fuq
Lower respiratory infection Gastrointestinal disorders Very common:
Infezzjoni fl- apparat respiratorju t’ isfel Disturbi gastro- intestinali Komuni ħafna:
Abdominal pain/ discomfort Oily spotting from the rectum Flatus with discharge Faecal urgency Fatty/ oily stool Flatulence Liquid stools Oily evacuation Increased defecation
Uġigħ/ skonfort addominali Tbajja żejtnin mir- rektum Gass bil- ħruġ ta ’ purgar Tħoss ħtieġa urġenti biex tmur tipporga Purgar xaħmi/ żejtni Gass Purgar likwidu Purgar ta ’ żejt Purgar aktar ta ’ spiss
Rectal pain/ discomfort Soft stools Faecal incontinence Abdominal distension* Tooth disorder Gingival disorder Renal and urinary disorders Common:
Uġigħ/ skonfort fir- rektum Purgar artab Purgar mhux ikkontrollat Nefħa addominali * Disturbi fis- snien Distubi ġinġivali Disturbi fil- kliewi u fis- sistema urinarja Komuni:
Urinary tract infection Metabolism and nutrition disorders Infections and infestations
Infezzjoni fl- apparat ta ’ l- awrina Disturbi fil- metaboliżmu u n- nutrizzjoni Komuni ħafna:
Very common:
Ipogliċemija * Infezzjonijiet u infestazzjonijiet Komuni ħafna:
General disorders and administration site conditions
Influwenza Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jingħata Komuni:
Reproductive system and breast disorders
Għeja Disturbi fis- sistema riproduttiva u fis- sider Komuni:
Menstrual irregularity
Mestrwazzjoni irregolari
Common:
Disturbi Psikjatriċi Komuni:
* only unique treatment adverse events that occurred at a frequency of > 2% and with an incidence ≥ 1% above placebo in obese type 2 diabetic patients.
5 * Effetti avversi u uniċi tal- kura li seħħew bi frekwenza ta ’ > 2% u b’ inċidenza ta ’ ≥ 1% aktar mill - plaċebo f’ pazjenti ħoxnin iżżejjed b’ dijabete tat- tip 2 biss.
In a 4 year clinical trial, the general pattern of adverse event distribution was similar to that reported for the 1 and 2 year studies with the total incidence of gastrointestinal related adverse events occurring in year 1 decreasing year on year over the four year period.
Fi prova klinika ta ’ 4 snin, ix- xejra ġenerali f’ dak li hu tqassim ta ’ effetti avversi kienet simili għal dik rappurtata għall- istudji ta ’ sena waħda u sentejn bl- inċidenza totali ta ’ effetti avversi relattivament gastro- intestinali li seħħew fl- ewwel sena jonqsu minn sena għal oħra fil- perijodu ta ’ erba ’ snin.
5 The following table of undesirable effects is based on post-marketing spontaneous reports, and therefore the frequency remains unknown:
It- tabella li ġejja ta ’ effetti mhux mixtieqa hi bbażata fuq rapporti spontanji wara t- tqegħid fis- suq, u għalhekk il- frekwenza għadha mhix magħrufa:
Investigations Increase in liver transaminases and in alkaline phosphatase.
Investigazzjonijiet Żjieda fit- transaminases u fl- alkaline phosphatase tal- fwied.
Decreased prothrombin, increased INR and unbalanced anticoagulant treatment resulting in variations of haemostatic parameters have been reported in patients treated with anticoagulants in association with orlistat (see section 4.4 and 4.5)
Tnaqqis fil- prothrombin, żjieda fl- INR u kura mhux bilanċjat kontra l- koagulazzjoni li tirriżulta f' varjazzjonijiet tal- parametri emostatiċi kienu rrapportati f’ pazjenti kkurati b’ sustanzi kontra l - koagulazzjoni f’ assoċjazzjoni ma ’ orlistat (ara sezzjoni 4. 4 u 4. 5)
Gastrointestinal disorders Skin and subcutaneous tissue disorders Immune system disorders Hepatobiliary disorders
Disturbi gastro- intestinali Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Disturbi fis- sistema immuni Disturbi fil- fwied u fil- marrara
Rectal bleeding Diverticulitis Pancreatitis Bullous eruptions Hypersensitivity (e. g. pruritus, rash, urticaria, angioedema, bronchospasm and anaphylaxis) Cholelithiasis Hepatitis that may be serious
Fsada mir- rektum Divertikulite Pankreatite Eruzzjonijiet bullużi (imsiemer) Sensittività eċċessiva (e. ż. ħakk, raxx, urtikarja, anġjoedema, bronkospażmi u anafilassi) Kolelitjasi Epatite li għandha mnejn tkun serja
Oxalate nephropathy
Nefropatija kkawżata minn oxalate
Single doses of 800 mg orlistat and multiple doses of up to 400 mg three times daily for 15 days have been studied in normal weight and obese subjects without significant adverse findings.
Dożi waħedhom ta ’ 800mg orlistat u dożi multipli sa 400 mg tliet darbiet kuljum għal 15- il ġurnata ġew studjati f’ individwi ta ’ piż normali u ta ’ ħxuna żejda mingħajr sejbiet avversi sinifikanti.
In addition, doses of 240 mg tid have been administered to obese patients for 6 months.
Barra dan, dożi ta ’ 240 mg t. i. d. ġew mogħtija għal 6 xhur lill- pazjenti bi ħxuna żejda.
The majority of orlistat overdose cases received during post-marketing reported either no adverse events or adverse events that are similar to those reported with recommended dose.
Il- biċċa l- kbira ta ’ każijiet ta ’ dożi eċċessivi ta ’ orlistat irrapportati wara t- tqegħid fis- suq jew ma rrapportaw l- ebda effetti avversi jew irrapportaw effetti avversi li huma simili għal dawk irrapportati bid- doża rakkomandata.
Should a significant overdose of orlistat occur, it is recommended that the patient be observed for 24 hours.
Jekk iseħħ każ ta ’ doża eċċessiva sinifikanti ta ’ orlistat, huwa rakkomandat li l- pazjent jiġi osservat għal 24 siegħa.
Based on human and animal studies, any systemic effects attributable to the lipase-inhibiting properties of orlistat should be rapidly reversible.
Fuq il- bażi ta ’ studji fuq il- bnedmin u l- annimali, kull effett sistematiku attribwibbli għall- proprjetajiet li jimpedixxu l- lipase ta ’ orlistat għandu jkun riversibbli malajr.
Peripherally acting antiobesity agent, ATC code A08AB01.
Sustanza kontra l- ħxuna żejda li taħdem fil- periferija, Kodiċi ATC A08AB01.
It exerts its therapeutic activity in the lumen of the stomach and small intestine by forming a covalent bond with the active serine site of the gastric and pancreatic lipases.
Jeżerċita l - attività terapewtika tiegħu fil- lumen ta ’ l- istonku u tal- musrana ż- żgħira billi jifforma rabta kovalenti mas- sit serine attiv tal- lipases gastriċi u tal- firxa.
In the 2-year studies and the 4-year study, a hypocaloric diet was used in association with treatment in both the orlistat and the placebo treated groups.
Fl- istudji ta ’ sentejn u f’ dak ta ’ erba ’ snin, ġiet użata dieta b’ kaloriji baxxi flimkienma ’ kura kemm fil - gruppi kkurati b’ orlistat kif ukoll f’ dawk bil- plaċebo.
6 Pooled data from five 2 year studies with orlistat and a hypocaloric diet showed that 37% of orlistat patients and 19% of placebo patients demonstrated a loss of at least 5% of their baseline body weight after 12 weeks of treatment.
Tagħrif li nġabar minn ħames studji ta ’ sentejn- il wieħed b’ orlistat u dieta b’ kolariji baxxi wera li 37% tal- pazjenti fuq orlistat u 19% tal- pazjenti fuq plaċebo urew tnaqqis ta ’ mill- inqas 5% tal- piż tal- ġisem tagħhom fil- linja bażi wara 12- il ġimgħa ta ’ kura.
Of these, 49% of orlistat treated patients and 40% of placebo treated patients went on to lose ≥ 10% of their baseline body weight at one year.
Minn dawn, 49% tal- pazjenti kkurati b’ orlistat u 40% tal- pazjenti kkurati bil- plaċebo baqgħu biex naqqsu ≥ 10% tal- piż tal- ġisem tagħhom fil- linja bażi wara sena waħda.
Conversely, of patients failing to demonstrate a loss of 5% of their baseline body weight after 12 weeks of treatment, only 5% of orlistat treated patients and 2% of placebo treated patients went on to lose ≥ 10% of their baseline body weight at one year.
Għall- kuntrarju, mill- pazjenti li ma rnexxilhomx juru tnaqqis ta ’ 5% tal- piż tal - ġisem tagħhom fil- linja bażi wara 12- il ġimgħa ta ’ kura, 5% biss tal- pazjenti kkurati b’ orlistat u 2% biss tal- pazjenti kkurati bil- plaċebo spiċċaw biex naqqsu ≥ 10% tal- piż tal- ġisem tagħhom fil- linja bażi wara sena.
Overall, after one year of treatment, the percentage of patients taking 120 mg orlistat who lost 10% or more of their body weight was 20% with orlistat 120 mg compared to 8% of patients taking placebo.
Meħudin flimkien, wara sena ta ’ kura, il- perċentwal ta ’ pazjenti li kienu qed jieħdu 120 mg ta ’ orlistat li naqqsu 10% jew aktar mill- piż tal- ġisem tagħhom kien 20% b’ orlistat 120 mg meta mqabbel ma ’ 8% tal- pazjenti fuq il- plaċebo.
The mean difference in weight loss with the drug compared to placebo was 3.2 kg.
Id- differenza medja fit- tnaqqis ta ’ piż bil- mediċina meta mqabbel mal- plaċebo kienet 3. 2 kg.
Data from the 4-year XENDOS clinical trial showed that 60% of orlistat patients and 35% of placebo patients demonstrated a loss of at least 5% of their baseline body weight after 12 weeks of treatment.
Tagħrif mill- prova klinika ta ’ 4 snin XENDOS wera li 60% tal- pazjenti fuq orlistat u 35% tal- pazjenti fuq plaċebo urew tnaqqis ta ’ mill- inqas 5% tal- piż tal- ġisem tagħhom fil- linja bażi wara 12- il ġimgħa ta ’ kura.
Of these, 62% of orlistat treated patients and 52% of placebo treated patients went on to lose ≥ 10% of their baseline body weight at one year.
Minn dawn, 62% tal- pazjenti kkurati b’ orlistat u 52% tal- pazjenti kkurati bil- plaċebo komplew biex naqqsu ≥ 10% tal- piż tal- ġisem tagħhom fil- linja bażi wara sena.
Conversely, of patients failing to demonstrate a loss of 5% of their baseline body weight after 12 weeks of treatment, only 5% of orlistat treated patients and 4% of placebo treated patients went on to lose ≥ 10% of their baseline body weight at one year.
Għall- kuntrarju, mill - pazjenti li ma rnexxilhomx juru tnaqqis ta ’ 5% tal- piż tal- ġisem tagħhom fil- linja bażi wara 12- il ġimgħa ta ’ kura, 5% biss tal- pazjenti kkurati b’ orlistat u 4% biss tal- pazjenti kkurati bil- plaċebo spiċċaw biex naqqsu ≥ 10% tal- piż tal- ġisem tagħhom fil- linja bażi wara sena.
After 1 year of treatment, 41% of the orlistat treated patients versus 21% of placebo treated patients lost ≥ 10% of body weight with a mean difference of 4.4 kg between the two groups.
Wara sena ta ’ kura, 41% tal- pazjenti kkurati b’ orlistat kontra 21% tal- pazjenti kkurati bil- plaċebo naqqsu ≥ 10% mill- piż b’ differenza medja ta ’ 4. 4 kg bejn iż- żewġ gruppi.
After 4 years of treatment 21% of the orlistat treated patients compared to 10% of the placebo treated patients had lost ≥ 10% of body weight, with a mean difference of 2.7 kg.
Wara 4 snin ta ’ kura 21% tal- pazjenti kkurati b’ orlistat imqabbla ma ’ 10% tal- pazjenti kkurati bil- plaċebo kienu naqqsu ≥ 10% tal- piż tal- ġisem, b’ differenza medja ta ’ 2. 7 kg.
More patients on orlistat or placebo lost baseline body weight of at least 5% at 12 weeks or 10% at one year in the XENDOS study than in the five 2-year studies.
Aktar pazjenti fuq orlistat jew plaċebo tilfu piż tal- ġisem tagħhom fil- linja bażi ta ’ mill- inqas 5% wara 12- il ġimgħa jew 10% wara sena fl- istudju XENDOS milli fil- ħames studji ta ’ sentejn.
The reason for this difference is that the five 2-year studies included a 4-week diet and placebo lead-in period during which patients lost on average 2.6 kg prior to commencing treatment.
Ir- raġuni għal din id- differenza hi li l- ħames studji ta ’ sentejn kienu jinkludu perijodu fil- bidu ta ’ 4 ġimgħat dieta u plaċebo li matulu l- pazjenti tilfu medja ta ’ 2. 6 kg qabel il- bidu tal- kura.
Data from the 4-year clinical trial also suggested that weight loss achieved with orlistat delayed the development of type 2 diabetes during the study (cumulative diabetes cases incidences:
Tagħrif mill- prova klinika ta ’ 4 snin kien jindika wkoll li t- tnaqqis tal- piż miksub b’ orlistat ittardja l - iżvilupp ta ’ dijabete tip 2 matul l- istudju (inċidenza kumulattiva ta ’ każijiet ta ’ dijabete:
3.4% in the orlistat group compared to 5.4% in the placebo-treated group).
3. 4% fil - grupp ta ’ orlistat meta mqabbel ma ’ 5. 4% fil- grupp tal- plaċebo).
The great majority of diabetes cases came from the subgroup of patients with impaired glucose tolerance at baseline, which represented 21% of the randomised patients.
Il- parti l- kbira tal- każijiet ta ’ dijabete ġew mis- sottogrupp ta ’ pazjenti b’ tolleranza mnaqqsa ta ’ glukosju fil- linja bażi, li jirrappreżentaw 21% tal- pazjenti randomised.
It is not known whether these findings translate into long-term clinical benefits.
Mhuwiex magħruf jekk dawn is- sejbiet jistgħux jiġu meħuda bħala benefiċċji kliniċi fuq perjodu ta ’ żmien twil.
In obese type 2 diabetic patients insufficiently controlled by antidiabetic agents, data from four one- year clinical trials showed that the percentage of responders (≥ 10% of body weight loss) was 11.3% with orlistat as compared to 4.5% with placebo.
F’ pazjenti ħoxnin iżżejjed u b’ dijabete tip 2 mhux kontrollati biżżejjed b’ sustanzi antidijabetiċi, tagħrif minn erba ’ provi kliniċi ta ’ sena wera li l- perċentwal ta ’ dawk li jirrispondu għall- kura (tnaqqis ta ’ ≥ 10% tal- piż tal- ġisem) kien 11. 3% b’ orlistat meta mqabbel ma ’ 4. 5% bil- plaċebo.
In orlistat-treated patients, the mean difference from placebo in weight loss was 1.83 kg to 3.06 kg and the mean difference from placebo in HbA1c reduction was 0.18% to 0.55%.
7 differenza medja mill- plaċebo fit- tnaqqis ta ’ HbA1c kienet 0. 18% sa 0. 55%.
It has not been demonstrated that the effect on HbA1c is independent from weight reduction.
Ma ntweriex li l- effett fuq HbA1c huwa indipendenti minn tnaqqis ta ’ piż.
In a multi-centre (US, Canada), parallel-group, double-blind, placebo-controlled study, 539 obese adolescent patients were randomised to receive either 120 mg orlistat (n=357) or placebo (n=182) three times daily as an adjunct to a hypocaloric diet and exercise for 52 weeks.
Fi studju multi- centre (US u Canada), parallel- group, double- blind, ikkontrollat bil- plaċebo, 539 pazjenti adoloxxenti ħoxnin iżżejjed kienu randomised biex jirċievu 120 mg orlistat (n=357) jew plaċebo (n=182) tliet darbiet kuljum bħala żjieda ma ’ dieta ta ’ koloriji baxxi u eżerċizzju għal 52 ġimgħa.
Both populations received multivitamin supplements.
Iż- żewġ popolazzjonijiet irċevew supplimenti ta ’ multivitamini.
The primary endpoint was the change in body mass index (BMI) from baseline to the end of the study.
Il- mira primarja kienet il - bidla fl- indiċi tal- massa tal- ġisem (BMI) mil- linja bażi sa l- aħħar ta ’ l- istudju.
The results were significantly superior in the orlistat group (difference in BMI of 0.86 kg/ m2 in favour of orlistat).
Ir- riżultati kienu sostanzjalment aħjar fil- grupp ta ’ orlistat (differenza fil- BMI ta ’ 0. 86 kg / m2 ’ favur Orlistat).
9.5% of the orlistat treated patients versus 3.3% of the placebo treated patients lost ≥ 10% of body weight after 1 year with a mean difference of 2.6 kg between the two groups.
9. 5% tal- pazjenti kkurati b’ orlistat kontra 3. 3% tal- pazjenti li ħadu plaċebo naqqsu ≥ 10% tal- piż tal- ġisem wara sena b’ differenza medja ta ’ 2. 6 kg bejn iż- żewġ gruppi.
The difference was driven by the outcome in the group of patients with ≥ 5% weight loss after 12 weeks of treatment with orlistat representing 19% of the initial population.
Id- differenza aċċentwat ruħha bir- riżultat tal- grupp ta ’ pazjenti bi tnaqqis ta ’ ≥ 5% tal- piż wara 12- il ġimgħa ta ’ kura b’ orlistat jirrappreżenta 19% tal- popolazzjoni tal- bidu.
The side effects were generally similar to those observed in adults.
L- effetti sekondarji ġeneralment kienu bħal dawk osservati f’ adulti.
However, there was an unexplained increase in the incidence of bone fractures (6% versus 2.8% in the orlistat and placebo groups, respectively).
Madankollu, kien hemm żjieda li ma setgħetx tiġi spjegata fl- inċidenza ta ’ ksur ta ’ għadam (6% kontra 2. 8% fil- gruppi ta ’ orlistat u plaċebo, rispettivament).
Absorption Studies in normal weight and obese volunteers have shown that the extent of absorption of orlistat was minimal.
Assorbiment Studji fuq voluntieri ta ’ piż normali u oħrajn ħoxnin iżżejjed urew li l- assorbiment ta ’ orlistat kien minimu.
Plasma concentrations of intact orlistat were non-measurable (< 5 ng/ ml) eight hours following oral administration of orlistat.
Konċentrazzjonijiet fil- plażma ta ’ orlistat intatt ma setgħux jiġu mkejla (< 5 ng/ ml) tmien sigħat wara l- għoti orali ta ’ orlistat.
Distribution The volume of distribution cannot be determined because the drug is minimally absorbed and has no defined systemic pharmacokinetics.
Distribuzzjoni Il- volum ta ’ distribuzzjoni ma jistax jiġi stabbilit għaliex il- mediċina tiġi assorbita minimament u m’ għandha l- ebda farmakokinetika sistematika definita.
In vitro orlistat is > 99% bound to plasma proteins (lipoproteins and albumin were the major binding proteins).
Orlistat in vitro huwa > 99% marbut ma ’ proteini tal- plażma (lipoproteini u albumini kienu l- aktar proteini li jintrabtu).
Orlistat minimally partitions into erythrocytes.
Orlistat jinqasam minimament f’ eritroċiti.
Metabolism Based on animal data, it is likely that the metabolism of orlistat occurs mainly within the gastrointestinal wall.
Metaboliżmu Fuq il- bażi ta ’ tagħrif minn annimali, aktarx li l- metaboliżmu ta ’ orlistat iseħħ l- aktar fil- ħajt gastro - intestinali.
Based on a study in obese patients, of the minimal fraction of the dose that was absorbed systemically, two major metabolites, M1 (4-member lactone ring hydrolysed) and M3 (M1 with N-formyl leucine moiety cleaved), accounted for approximately 42% of the total plasma concentration.
Fuq il- bażi ta ’ studju fuq pazjenti ħoxnin iżżejjed, mill- parti żgħira ħafna tad- doża assorbita sistematikament, żewġ metaboliti ewlenin, M1 (4- member lactone ring hydrolysed) u M3 (M1 ma ’ N - formyl leucine moiety cleaved), għamlu bejniethom madwar 42% tal- konċentrazzjoni totali fil- plażma.
M1 and M3 have an open beta-lactone ring and extremely weak lipase inhibitory activity (1000 and 2500 fold less than orlistat respectively).
M1 u M3 għandhom ċirku miftuħ ta ’ beta- lactone u attività inibitorja ta ’ lipase estremament dgħajfa (1000 u 2500 darba inqas minn orlistat rispettivament).
In view of this low inhibitory activity and the low plasma levels at therapeutic doses (average of 26 ng/ ml and 108 ng/ ml respectively), these metabolites are considered to be pharmacologically inconsequential.
Minħabba din l- attività inibitorja baxxa u l - livelli baxxi fil- plażma f’ dożi terapewtiċi (medja ta ’ 26 ng/ ml u 108 ng/ ml rispettivament), dawn il - metaboliti huma kkunsidrati farmakoloġikament ta ’ ebda importanza.
Elimination Studies in normal weight and obese subjects have shown that faecal excretion of the unabsorbed drug was the major route of elimination.
Eliminazzjoni Studji fuq individwi ta ’ piż normali u oħrajn ħoxnin iżżejjed juru li t- tneħħija fil- purgar tal- mediċina mhux assorbita kienet ir- rotta ewlenija ta ’ l- eliminazzjoni.
Approximately 97% of the administered dose was excreted in faeces and 83% of that as unchanged orlistat.
Madwar 97% tad- doża li tkun ingħatat ħarġet mal- purgar u 83% minn dan kien orlistat mhux mibdul.
The cumulative renal excretion of total orlistat-related materials was < 2% of the given dose.
It- tneħħija kumulattiva mill- kliewi tal- materjal kollu relatat ma ’ orlistat kienet < 2% tad- doża mogħtija.
The time to reach complete excretion (faecal plus urinary) was 3 to 5 days.
Iż- żmien sa meta tneħħa kollox (purgar u awrina) kien 3 sa 5 ijiem.
The disposition of orlistat appeared to be similar between normal weight and obese volunteers.
Id- dispożizzjoni ta ’ orlistat dehret li kienet simili bejn voluntiera b’ piż normali u dawk ħoxnin iżżejjed.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction.
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.
In animal reproductive studies, no teratogenic effect was observed.
Fi studji dwar ir- riproduzzjoni fl- annimali, ma ġie osservat l- ebda effett teratoġeniku.
In the absence of a teratogenic effect in animals, no malformative effect is expected in man.
Fin- nuqqas ta’ effett teratoġeniku fl- annimali, mhuwiex mistenni xi effett ta ’ malformazzjoni fil- bniedem.
To date, active substances responsible for malformations in man have been found teratogenic in animals when well-conducted studies were performed in two species.
Sa llum, meta studji twettqu kif għandu jkun fuq żewġ speċi nstabu sustanzi attivi li kkaġunaw malformazzjonijiet fil- bniedem kienu teratoġeniċi fl- annimali.
Capsule filling: microcrystalline cellulose (E460) sodium starch glycollate povidone (E1201)
Mili fil- kapsula: microcrystalline cellulose (E460) sodium starch glycollate povidone (E1201) sodium lauryl sulphate talkum
Capsule shell: gelatine indigo carmine (E132) titanium dioxide (E171) edible printing ink (black iron oxide, ammonium hydroxide, potassium hydroxide, shellac)
Qoxra tal- kapsula: gelatine indigo karminju (E132) titanium dioxide (E171) linka edibbli għall- istampar (iron oxide iswed, ammonium hydroxide, potassium hydroxide, shellac)
Blisters:
Strixxi tal- folja:
Do not store above 25 °C.
Taħżinx f’ temperatura ’ l fuq minn 25 °Ċ.
Store in original package in order to protect from moisture.
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mill- umdità.
Do not store above 30 °C.
Taħżinx f’ temperatura ’ l fuq minn 30 °Ċ.
Keep the container tightly closed in order to protect from moisture.
Żomm il- kontenitur magħluq sewwa biex tilqa ’ mill- umdità.
PVC/ PE/ PVDC blisters containing 21, 42 and 84 hard capsules.
Folji tal- PVC/ PE/ PVDC li fihom 21, 42 u 84 kapsula iebsa.
Glass bottles with desiccant containing 21, 42 and 84 hard capsules.
Fliexken tal- ħġieġ b’ desikkant li fihom 21, 42 u 84 kapsula iebsa.
DATE OF REVISION OF THE TEXT
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI
1 D-79639 – Grenzach-Wyhlen Germany
1 D- 79639 – Grenzach Whylen Il- Ġermanja
OUTER CARTON FOR BLISTER PACKS
KARTUNA TA ’ BARRA GĦALL- PAKKETTI BIL- FOLJI
Xenical 120 mg hard capsules Orlistat
Xenical 120mg kapsuli ibsin Orlistat
Each capsule contains 120 mg orlistat.
Kull kapsula fiha 120 mg orlistat.
21 hard capsules 42 hard capsules 84 hard capsules
21 kapsula iebsa 42 kapsula iebsa 84 kapsula iebsa
Do not store above 25 °C Store in the original package in order to protect from moisture.
Taħżinx f’ temperatura ’ l fuq minn 25 °Ċ Aħżen fil- pakkett oriġinali biex tilqa ’ mill- umdità
EU/ 1/ 98/ 071/ 001 21 capsules EU/ 1/ 98/ 071/ 002 42 capsules EU/ 1/ 98/ 071/ 003 84 capsules
EU/ 1/ 98/ 071/ 001 21 kapsula EU/ 1/ 98/ 071/ 002 42 kapsula EU/ 1/ 98/ 071/ 003 84 kapsula
16 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
16 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L - ISTRIXXI FOLJA
17 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
17 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON AND BOTTLE LABEL
KARTUNA TA ’ BARRA U TIKKETTA TAL- FLIXKUN
Xenical 120 mg hard capsules Orlistat
Xenical 120 mg kapsuli ibsin Orlistat
Do not store above 30 °C Keep the container tightly closed in order to protect from moisture
Taħżinx f’ temperatura ’ l fuq minn 30 °Ċ Żomm il- kontenitur magħluq sewwa biex tilqa ’ mill- umdità
EU/ 1/ 98/ 071/ 004 21 capsules EU/ 1/ 98/ 071/ 005 42 capsules EU/ 1/ 98/ 071/ 006 84 capsules
EU/ 1/ 98/ 071/ 004 21 kapsula EU/ 1/ 98/ 071/ 005 42 kapsula EU/ 1/ 98/ 071/ 006 84 kapsula
Xenical 120mg hard capsules Orlistat
Xenical 120mg kapsuli ibsin Orlistat
- If you have any further questions, please ask your doctor or your pharmacist.
- Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew lill- ispiżjar tiegħek.
What Xenical is and what it is used for 2.
X’ inhu Xenical u għalxiex jintuża 2.
Before you take Xenical 3.
Qabel ma tieħu Xenical 3.
How to take Xenical 4.
Kif għandek tieħu Xenical 4.
How to store Xenical 6.
Kif taħżen Xenical 6.
WHAT XENICAL IS AND WHAT IT IS USED FOR
X’ INHU XENICAL U GĦALXIEX JINTUŻA
Xenical is a medicine used to treat obesity.
Xenical huwa mediċina użata biex tikkura ħxuna żejda.
It works in your digestive system to block about one-third of the fat in the food you eat from being digested.
Jaħdem fis- sistema diġestiva tiegħek biex jipprevjeni madwar terz mix- xaħam fl- ikel li tiekol milli jiġi diġerit.
Xenical attaches to the enzymes in your digestive system (lipases) and blocks them from breaking down some of the fat you have eaten during your meal.
Xenical jeħel ma ’ l- enżimi fis- sistema diġestiva tiegħek (lipases) u jwaqqafhom milli jkissru xi ftit mix- xaħam li tkun kilt waqt l- ikla tiegħek.
The undigested fat cannot be absorbed and is eliminated by your body.
Ix- xaħam mhux diġerit ma jistax jiġi assorbit u jiġi eliminat mill- ġisem tiegħek.
Xenical is indicated in the treatment of obesity in conjunction with a low calorie intake diet.
Xenical huwa ndikat fil- kura ta ’ ħxuna żejda flimkien ma ’ dieta baxxa fil- kaloriji.
BEFORE YOU TAKE XENICAL
QABEL MA TIEĦU XENICAL
Do not take XENICAL
Tieħux XENICAL
- if you are allergic (hypersensitive) to orlistat or to any of the other ingredients of Xenical,
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal orlistat jew sustanzi oħra ta ’
- if you have chronic malabsorption syndrome (insufficient absorption of nutrients from
- jekk tbati bis- sindrome kronika ta ’ assorbiment ħażin (assorbiment mhux suffiċjenti ta ’
alimentary tract),
nutrijenti mill- apparat ta ’ mnejn jgħaddi l- ikel),
- if you have cholestasis (liver disorder)
- jekk tbati b’ kolestasi (disturbi fil- fwied),
- if you have breast-feeding
- jekk qed tredda ’.
Take special care with XENICAL Weight loss may also affect the dose of medicines taken for other conditions (e. g. high cholesterol or diabetes).
Oqgħod attent ħafna b’ XENICAL Tnaqqis fil- piż jista ’ wkoll jaffettwa d- doża tal- mediċini meħuda għal xi kundizzjonijiet oħra (e. ż. kolesterol għoli jew dijabete).
Be sure to discuss these and other medicines you may be taking with your doctor.
Kun żgur li tiddiskuti dan u mediċini oħra li għandek mnejn tkun qed tieħu mat- tabib tiegħek.
Losing weight may mean you need adjustments to the dose of these medicines.
It- tnaqqis fil- piż jista ’ jfisser li għandek bżonn tibdil fid- doża ta ’ dawn il - mediċini.
To gain the maximum benefit from Xenical you should follow the nutrition program recommended to you by your doctor.
Biex tieħu l- aħjar benefiċċju minn Xenical għandek timxi fuq il- programm ta ’ nutriment rakkomandat lilek mit- tabib tiegħek.
As with any weight-control program, over-consumption of fat and calories may reduce any weight loss effect.
Bħal kull programm ieħor għall- kontroll tal- piż, konsum żejjed ta ’ xaħmijiet u kaloriji jista ’ jnaqqas mill- effett tat- tnaqqis ta ’ piż.
This medicine can cause harmless changes in your bowel habits, such as fatty or oily stools, due to the elimination of undigested fat in your faeces.
21 Din il- mediċina tista ’ tikkawża xi tibdil li ma jagħmel l- ebda ħsara fil- ħidma ta ’ l- imsaren, bħal purgar xaħmi jew żejtni, minħabba t- tneħħija ta ’ xaħam mhux diġerit fl- ippurgar tiegħek.
The possibility of this happening may increase if Xenical is taken with a diet high in fat.
Il- possibiltà li jseħħ dan tista ’ tiżdied jekk Xenical jittieħed ma ’ dieta b’ ħafna xaħam.
21 three main meals because if Xenical is taken with a meal very high in fat, the possibility of gastrointestinal effects may increase.
Barra dan il- konsum ta ’ kuljum ta ’ xaħam għandu jitqassam l- istess fuq tliet ikliet għaliex jekk Xenical jittieħed ma ’ ikla b’ ħafna xaħam, il- possibiltà ta ’ effetti gastro- intestinali tista ’ tiżdied.
The use of an additional contraceptive method is recommended to prevent possible failure of oral contraception that could occur in case of severe diarrhoea.
L- użu ta ’ metodu addizzjonali ta ’ kontraċezzjoni huwa rrakkomandat biex jipprevjeni l- falliment possibbli ta ’ mediċini kontraċettivi orali li jista ’ jiġri f’ każ ta ’ dijarea severa.
The use of orlistat may be associated with renal stones in patients suffering from chronic kidney disease.
F’ pazjenti li jsofru minn mard kroniku tal- kliewi, l- użu ta ’ orlistat jista ’ jkun assoċjat ma ’ ġebel fil - kliewi.
Inform your doctor whether you suffer from problems with your kidney.
Għarraf lit- tabib tiegħek jekk issofri minn problemi fil- kliewi.
Use in Children Xenical is not intended to be used in children.
Użu fit- tfal Xenical mhux maħsub għall- użu fit- tfal.
This is important as using more than one medicine at the same time can strengthen or weaken the effects of the medicines.
Dan hu importanti peress li l- użu ta ’ aktar minn mediċina waħda fl- istess ħin jista ’ jqawwi jew idgħajjef l- effetti tal- mediċini.
Xenical may modify the activity of
Xenical għandu mnejn jimmodifika l- attività ta ’
• Anticoagulant drugs (e. g. warfarin).
• Mediċini kontra l- koagulazzjoni (e. ż. warfarin).
Your doctor may need to monitor your blood coagulation.
It- tabib tiegħek għandu mnejn ikollu bżonn jimmonitorja l- koagulazzjoni tad- demm tiegħek.
Co-administration with ciclosporin is not recommended.
L- għoti flimkien ma ’ ciclosporin mhux irrakkomandat.
Your doctor may need to monitor your ciclosporin blood levels more frequently than usual.
It- tabib tiegħek għandu mnejn ikollu bżonn jimmonitorja il- livelli tiegħek ta ’ ciclosporin fid- demm aktar ta ’ spiss mis - soltu.
• Iodine salts and/ or levothyroxine.
• Imluħa ta ’ iodine u/ jew levothyroxine.
Cases of hypothyroidism and/ or reduced control of hypothyroidism may occur.
Jista ’ jkun hemm każijiet ta ’ ipotirojdiżmu u/ jew tnaqqis fil- kontroll ta ’ ipotirojdiżmu.
You may ask your doctor for advice.
Tista ’ tistaqsi lit- tabib tiegħek għal parir.
Xenical reduces the absorption of supplements of some fat soluble nutrients, particularly beta-carotene and vitamin E.
Xenical inaqqas l- assorbiment ta ’ supplimenti ta ’ xi nutrijenti li jinħallu fix- xaħam, speċjalment beta - carotene u vitamina E.
You should therefore follow your doctor’ s advice in taking a well balanced diet rich in fruit and vegetables.
Għalhekk għandek timxi skond il- parir tat- tabib tiegħek billi toqgħod fuq dieta bilanċjata li tikkonsisti f' ħafna frott u ħaxix.
Your doctor may suggest you take a multivitamin supplement.
It- tabib tiegħek għandu mnejn jissuġġerixxi li tieħu suppliment ta ’ multivitamini.
Orlistat may unbalance an anticonvulsivant treatment, by decreasing the absorption of antiepileptic drugs, thus leading to convulsions.
Orlistat jista ’ jikkawża żbilanċ fil- kura kontra l- konvulżjonijiet billi jnaqqas l- assorbiment ta ’ mediċini kontra l- epilessija u b’ hekk iwassal għall- konvulżjonijiet.
Please contact your doctor if you think that the frequency and/ or severity of the convulsions have changed when taking Xenical together with antiepileptic drugs.
Jekk jogħġbok kellem lit- tabib tiegħek jekk taħseb li l- frekwenza u/ jew is- severità tal- konvulżjonijiet inbidlet meta tieħu Xenical flimkien ma ’ mediċini kontra l- epilessija.
Pregnancy and breast-feeding Taking Xenical during pregnancy is not recommended.
Tqala u treddigħ It- teħid ta ’ Xenical waqt it- tqala mhux rakkomandat.
You must not breast-feed your infant during treatment with Xenical as it is not known whether Xenical passes into human milk.
M’ għandekx tredda ’ lit- tarbija tiegħek waqt il- kura b’ Xenical għax mhux magħruf jekk Xenical jgħaddix fil- ħalib tas- sider.
Driving and using machines Xenical has no known effect on your ability to drive a car or operate machinery.
Sewqan u tħaddim ta ’ magni Xenical m’ għandu l- ebda effett magħruf fuq il- ħila biex issuq jew tħaddem magni.
HOW TO TAKE XENICAL
KIF GĦANDEK TIEĦU XENICAL
Always take Xenical exactly as your doctor has told you.
Dejjem għandek tieħu Xenical skond il- parir tat- tabib.
The usual dose of Xenical is one 120 mg capsule taken with each of the three main meals per day.
Id- doża ta ’ Xenical li ssoltu tingħata hija kapsula waħda ta ’ 120 mg ma ’ kull waħda mit- tliet ikliet prinċipali ta ’ kuljum.
It can be taken immediately before, during a meal or up to one hour after a meal.
Tista ’ tittieħed immedjatament qabel, waqt jew sa siegħa wara l- ikla.
The capsule should be swallowed with water.
Wieħed għandu jibla ’ l- kapsula ma ’ l- ilma.
22 Xenical should be taken with a well-balanced, calorie controlled diet that is rich in fruit and vegetables and contains an average of 30% of the calories from fat.
Xenical għandu jittieħed flimkien ma ’ dieta bilanċjata tajjeb u b’ kontroll ta ’ kaloriji li tkun b’ ħafna frott u ħaxix u b’ medja ta ’ 30% tal- kaloriji mix- xaħam.
Your daily intake of fat, carbohydrate and protein should be distributed over three meals.
Il- konsum tiegħek ta ’ kuljum ta ’ xaħam, karboidrati u proteini għandu jitqassam fuq tliet ikliet.
This means you will usually take one capsule at breakfast time, one capsule at lunch time and one capsule at dinner time.
Dan ifisser li ġeneralment ħa tieħu kapsula waħda ma ’ l- ikla ta ’ filgħodu, kapsula oħra ma ’ l- ikla ta ’ nofsinhar u oħra ma ’ l- ikla ta ’ filgħaxija.
To gain optimal benefit, avoid the intake of food containing fat between meals, such as biscuits, chocolate and savoury snacks.
Biex tikseb l- aħjar riżultat, evita t- teħid ta ’ ikel li jkun fih ix- xaħam bejn ikla u oħra, bħal gallettini, ċikkulata u tnaqqir ieħor li jiftaħlek l- aptit.
Xenical only works in the presence of dietary fat.
Xenical jaħdem biss meta tieħu xaħam fid- dieta tiegħek.
Therefore, if you miss a main meal or if you have a meal containing no fat, Xenical need not be taken.
Għalhekk, jekk taqbeż xi ikla prinċipali jew jekk tiekol xi ikla bla xaħam xejn, m’ għandekx għalfejn tieħu Xenical.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
Għarraf lit- tabib tiegħek jekk għal xi raġuni ma tkunx ħadt il- mediċina eżatt kif preskritta.
Otherwise, your doctor may think that it was not effective or well tolerated and may change your treatment unnecessarily.
Inkella, it - tabib jista ’ jaħseb li l- mediċina ma kienitx effettiva jew tollerata tajjeb u jista jibdillek il- kura bla bżonn.
Your doctor will discontinue the treatment with Xenical after 12 weeks if you have not lost at least 5% of your body weight as measured at the start of treatment with Xenical.
It- tabib tiegħek iwaqqaflek il- kura b’ Xenical wara 12- il ġimgħa jekk ma tkunx naqqast għall- inqas 5% mill- piż tal- ġisem tiegħek kif imkejjel fil- bidu tal- kura b’ Xenical.
Xenical has been studied in long-term clinical studies of up to 4 years duration.
Xenical ġie studjat fi studji kliniċi fuq tul ta ’ żmien li damu sa 4 snin.
If you take more XENICAL than you should If you take more capsules than you have been told to take, or if someone else accidentally takes your medicine, contact a doctor, pharmacist or hospital as you may need medical attention.
Jekk tieħu XENICAL aktar milli suppost Jekk tieħu iktar kapsuli milli jmissek tieħu, jew jekk xi ħaddieħor aċċidentalment jieħu l- mediċina tiegħek, kellem tabib, spiżjar jew sptar għax jista ’ jkollok bżonn ta ’ attenzjoni medika.
If you forget to take XENICAL If you forget to take your medicine at any time, take it as soon as you remember provided this is within one hour of your last meal, then continue to take it at the usual times.
Jekk tinsa tieħu XENICAL Jekk f’ xi ħin minnhom tinsa tieħu l- mediċina tiegħek, ħudha malli tiftakar sakemm dan ikun mhux aktat tard minn siegħa wara l- aħħar ikla, imbagħad ibqa ’ ħudha fil- ħinijiet tas- soltu.
Do not take a double dose.
Tiħux doża doppja.
If you have missed several doses, please inform your doctor and follow the advice given to you.
Jekk tkun qbiżt numru ta ’ dożi, jekk jogħġbok kellem lit- tabib u imxi fuq il- parir li jagħtik.
Do not change the prescribed dose yourself unless your doctor tells you to.
Tibdilx id- doża preskritta inti stess jekk ma jgħidlekx hekk it- tabib tiegħek.
If you have further questions on the use of this medicine, ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ din il- mediċina, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, Xenical can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Xenical jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Xenical.
Kellem lit- tabib jew lill- ispiżjar malajr kemm jista ’ jkun jekk ma tħossokx f’ siktek waqt li qed tieħu Xenical.
The majority of unwanted effects related to the use of Xenical result from its local action in your digestive system.
Il- biċċa l- kbira ta ’ effetti mhux mixtieqa konnessi ma ’ l- użu ta ’ Xenical jiġu mill- azzjoni lokali tiegħu fis- sistema diġestiva tiegħek.
These symptoms are generally mild, occur at the beginning of treatment and are particularly experienced after meals containing high levels of fat.
Dawn is- sintomi ġeneralment huma ħfief, iseħħu fil- bidu tal- kura, jgħaddu wara ftit taż- żmien u jinħassu partikolarment wara ikliet b’ ħafna xaħam.
Normally, these symptoms disappear if you continue treatment and keep to your recommended diet.
Normalment, dawn is- sintomi jgħibu jekk tkompli l- kura u ssegwi d- dieta rakkomandata tiegħek.
Very common side effects (affects more than 1 user in 10)
23 Effetti sekondarji komuni ħafna (jaffettwaw aktar minn persuna waħda minn kull 10 li qed jużawh)
Headache, abdominal pain/ discomfort, urgent or increased need to open the bowels, flatulence (wind) with discharge, oily discharge, oily or fatty stools, liquid stools, low blood sugar levels (experienced by some people with type 2 diabetes).
Uġigħ ta ’ ras, uġigħ/ skonfort addominali, bżonn urġenti jew akbar biex tipporga, gass bil- ħruġ ta ’ purgar, ħruġ ta ’ likwidu żejtni, purgar żejtni jew xaħmi, purgar likwidu, livelli baxxi ta ’ zokkor fid - demm (esperjenzati minn xi persuni b’ dijabete tip 2).
Common side effects (affects 1 to 10 users in 100)
Effetti sekondarji komuni (jaffettwaw minn persuna waħda sa 10 minn kull 100 li qed jużawh)
Rectal pain/ discomfort, soft stools, incontinence (stools), bloating (experienced by some people with type 2 diabetes), tooth/ gum disorder, irregularity of menstrual cycle, tiredness.
Uġigħ/ skonfort fir- rektum, purgar artab, purgar mhux ikkontrollat, nefħa addominali (esperjenzati minn xi persuni b’ dijabete tip 2), disturbi fis- snien/ ħanek, irregolarità fiċ- ċiklu menstrwali, għeja.
The following side effects have also been reported but their frequency cannot be estimated from the available data:
Kienu rrapportati wkoll l- effetti sekondarji li ġejjin, iżda l- frekwenza tagħhom ma tistax tiġi stmata mit- tagħrif disponibbli:
Allergic reactions.
Reazzjonijiet allerġiċi.
The main symptoms are itching, rash, wheals (slightly elevated, itchy skin patches that are paler or redder than surrounding skin), severe difficulty in breathing, nausea, vomiting and
Is- sintomi prinċipali huma ħakk, raxx, tbenġil (dbabar fil- ġilda li huma kemmxejn elevati u bil- ħakk u li huma aktar ċari jew aktar ħomor mill- ġilda tal- madwar), diffikultà severa biex tieħu n- nifs, tqalligħ, rimettar, tħossok ma tiflaħx.
Bleeding from the back passage (rectum).
Fsada mill- passaġġ ta ’ wara (rektum).
Increases in the levels of some liver enzymes may be found in blood tests, diverticulitis, gallstones, hepatitis (inflammation of the liver), pancreatitis (inflammation of the pancreas), skin blistering (including blisters that burst), effects on clotting with anti-coagulants.
Għandha mnejn tkun osservata żjieda fil- livelli ta ’ xi enżimi tal- fwied fit- testijiet tad- demm, divertikulite, ġebel fil- marrara, epatite (infjammazzjoni tal- fwied), pankreatite (infjammazzjoni tal - frixa), nfafet fil- ġilda (inkluż infafet li jinfaqgħu), effetti fuq it- tagħqid tad- demm b’ sustanzi kontra l - koagulazzjoni tad- demm.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jaggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE XENICAL
KIF TAĦŻEN XENICAL
Blister packs Do not use Xenical after the expiry date stated on the carton.
Pakketti bil- folji Tużax Xenical wara d- data ta ’ skadenza li tidher fuq il- kaxxa.
Glass bottles Do not use Xenical after the expiry date stated on the bottle.
Fliexken tal- ħġieġ Tużax Xenical wara d- data ta ’ skadenza li tidher fuq il- flixkun.
Do not store above 30 °C.
Taħżinx f’ temperatura ’ l fuq minn 30°Ċ.
Keep container tightly closed in order to protect from moisture.
Żomm il- kontenitur magħluq sewwa biex tilqa ’ mill- umdità.
What XENICAL contains
X’ fih XENICAL:
- The active substance is orlistat.
- Is- sustanza attiva hija orlistat.
Each capsule contains 120 mg of orlistat.
Kull kapsula fiha 120 mg ta ’ orlistat.
- The other ingredients are microcrystalline cellulose (E460), sodium starch glycollate, povidone
- Is- sustanzi l- oħra huma microcrystalline cellulose (E460), sodium starch glycollate, povidone
(E1201), sodium lauryl sulphate and talc.
(E1201), sodium lauryl sulphate u talkum.
The capsule shell consists of gelatine, indigo carmine (E132), titanium dioxide (E171) and edible printing ink.
Il- qoxra tal- kapsula tikkonsisti f’ ġelatina, indigo carmine (E132), titanium dioxide (E171) u linka edibbli għall- istampar.
What XENICAL looks like and contents of the pack
24 Id- dehra ta ’ XENICAL u l- kontenuti tal- pakkett:
Xenical capsules are turquoise with the imprint “ ROCHE XENICAL 120” and are supplied in blister packs and glass bottles, containing 21, 42 and 84 capsules.
Il- kapsuli Xenical huma ta ’ lewn turkważ bil- karattri “ ROCHE XENICAL 120 ” stampat fuqhom u huma disponnibli f’ pakketti bil- folji u fliexken tal- ħġieġ, li jkun fihom 21, 42 u 84 kapsula.
Manufacturer Roche Pharma AG Emil-Barrell-Str.
Il- Manifattur Roche Pharma AG Emil- Barrell- Str.
1 D-79639 – Grenzach-Wyhlen Germany
1 D- 79639 – Grenzach- Wyhlen Il- Ġermanja
24 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
60 mg
Qawwa
blister (PVC/ PE/ PCTFE/ alu)
Għamla farmaċewtika
EU/ 1/ 04/ 297/ 003
Mnejn jingħata
84 capsules
Il- pakkett
EU/ 1/ 04/ 297/ 004
Daqs tal- pakkett
EU/ 1/ 04/ 297/ 005
EU/ 1/ 04/ 297/ 001 EU/ 1/ 04/ 297/ 002 EU/ 1/ 04/ 297/ 003 EU/ 1/ 04/ 297/ 004 EU/ 1/ 04/ 297/ 005 EU/ 1/ 04/ 297/ 006 EU/ 1/ 04/ 297/ 007 EU/ 1/ 04/ 297/ 008
Xeristar
Xeristar Xeristar Xeristar Xeristar Xeristar Xeristar Xeristar Xeristar
60 mg
30 mg 60 mg 60 mg 60 mg 60 mg 30 mg 60 mg 60 mg
Gastro-resistant capsule, hard
Kapsula gastro- reżistenti, iebsa Użu orali Kapsula gastro- reżistenti, iebsa Użu orali Kapsula gastro- reżistenti, iebsa Użu orali Kapsula gastro- reżistenti, iebsa Użu orali Kapsula gastro- reżistenti, iebsa Użu orali Kapsula gastro- reżistenti, iebsa Użu orali Kapsula gastro- reżistenti, iebsa Użu orali Kapsula gastro- reżistenti, iebsa Użu orali