qanastek/EMEA-V3 huggingface dataset:
The inactivated enzyme is thus unavailable to hydrolyse dietary fat, in the form of triglycerides, into absorbable free fatty acids and monoglycerides.
B’ hekk l- enżima mhux attivata ma tkunx disponibbli biex tidrolizza x- xaħam tad- dieta, fl- għamla ta ’ trigliċeridi, f’ aċidi tax- xaħam ħielsa u monogliċeridi li jistgħu jiġu assorbiti.
From clinical studies, it has been estimated that orlistat 60 mg taken three times daily blocks the absorption of approximately 25% of dietary fat.
Minn studji kliniċi kien stmat li orlistat 60 mg meħud tliet darbiet kuljum jimblokka l- assorbiment ta ’ madwar 25% ta ’ xaħam meħud fid- dieta.
The effect of orlistat results in an increase in faecal fat as early as 24 to 48 hours after dosing.
Minn 24 sa 48 siegħa wara l - għoti tad- doża, l- effett ta ’ orlistat iwwassal għal żjieda ta ’ xaħam fil- purgar.
Upon discontinuation of therapy, faecal fat content returns to pre-treatment levels, usually within 48 to 72 hours.
Ġeneralment, fi żmien 48 sa 72 siegħa wara l- waqfien tat- terapija, il- kontenut ta ’ xaħam fil- purgar jirritorna għal- livelli ta ’ qabel il- kura.
Two double-blind, randomised, placebo-controlled studies in adults with a BMI ≥ 28 kg/ m2 support the efficacy of orlistat 60 mg taken three times daily in conjunction with a hypocaloric, lower-fat diet.
Żewġ studji double- blind, randomised u kkontrollati bil- plaċebo f’ adulti b’ BMI ≥28 kg/ m2 jsostnu l - effikaċja ta ’ orlistat 60 mg meħud tliet darbiet kuljum flimkien ma ’ dieta ta ’ kaloriji baxxi u b’ inqas xaħam.
The primary parameter, change in body weight from baseline (time of randomisation), was assessed for body weight over time (Table 1) and the percentage of subjects who lost ≥ 5% or ≥ 10% of body weight (Table 2).
Il- parametru primarju, bidla fil- piż tal- ġisem mil- linja bażi (ħin ta ’ randomisation), kien stmat għall- piż tal- ġisem fuq medda ta ’ żmien (Tabella 1) u l- persentaġġ ta ’ individwi li tilfu ≥5% jew ≥10% tal- piż tal- ġisem (Tabella 2).
Although weight loss was assessed during 12 months of treatment in both studies, most weight loss occurred within the first 6 months.
Fiż- żewġ studji, għalkemm it- telf fil- piż kien stmat waqt 12- il xahar ta ’ kura, l- aktar telf ta ’ piż seħħ fl- ewwel 6 xhur.
Effect of 6 months treatment on body weight measured at baseline
Effett ta ’ 6 xhur ta ’ kura fuq il- piż tal- ġisem imkejjel fil- linja bażi
Treatment group
Grupp ta ’ kura
mean change (%)
Medja ta ’ bidla relattiva (%)
change (kg)
Medja ta ’ bidla (kg)
Study 1
Studju 1
-3.24
- 3. 24
-3.11
- 3. 11 - 5. 20 a
-5.55
- 5. 55
Study 2
Studju 2
Placebo Orlistat 60 mg
Plaċebo
-1.17 -3.66
- 1. 17
-1.05 -3.59 a
- 1. 05 - 3. 59 a
-2.20
- 2. 20
-2.09
- 2. 09 - 4. 40 a
-4.60
- 4. 60
p < 0.001 versus placebo
p < 0. 001 kontra plaċebo
Table 2:
6 Tabella 2:
Responder analysis at 6 months
Analiżi ta ’ dawk li rrispondew wara 6 xhur
Lost ≥ 5% of baseline body weight (%) Placebo Orlistat 60 mg a
Telf ta ’ ≥5% ta ’ piż tal- ġisem fil - linja bażi (%) Plaċebo Orlistat 60 mg
Lost ≥ 10% of baseline body weight (%) Placebo Orlistat 60 mg
Telf ta ’ ≥10% ta ’ piż tal- ġisem fil - linja bażi (%) Plaċebo Orlistat 60 mg 21. 3 b
Study 1 Study 2 Pooled data
Studju 2
30.9 54.6 21.3 37.7 a 26.4 46.7 a
21. 3 37. 7 a
10.3 21.3 b 2.2 10.5 b 6.5 16.2 a
26. 4 46. 7 a
Comparison versus placebo: a p < 0.001; b p < 0.01
Mqabbel kontra plaċebo: a p < 0. 001; b p < 0. 01
The weight loss induced by orlistat 60 mg conferred other important health benefits after 6 months of treatment in addition to weight loss.
Wara 6 xhur ta ’ kura t- telf fil- piż ikkawżat minn orlistat 60 mg wassal għal aktar benefiċċji importanti ta ’ saħħa minbarra telf fil- piż.
The mean relative change in total cholesterol was -2.4% for orlistat 60 mg (baseline 5.20 mmol/ l) and +2.8% for placebo (baseline 5.26 mmol/ l).
Il- bidla relattiva medja fil- kolesterol totali kienet - 2. 4% għal orlistat 60 mg (5. 20 mmol/ l fil- linja bażi) u +2. 8% għal plaċebo (5. 26 mmol/ l fil- linja bażi).
The mean relative change in LDL cholesterol was -3.5% for orlistat 60 mg (baseline 3.30 mmol/ l) and +3.8% for
Il- bidla relattiva medja fil- kolesterol LDL kienet - 3. 5% għal orlistat 60 mg (3. 30 mmol/ l fil- linja bażi) u +3. 8% għal plaċebo (3. 41 mmol/ l fil- linja bażi).
For waist circumference, the mean change was -4.5 cm for orlistat 60 mg (baseline 103.7 cm) and -3.6 cm for placebo (baseline 103.5 cm).
Għaċ- ċirkonferenza tal- qadd, il- bidla medja kienet - 4. 5 cm għal orlistat 60 mg (103. 7 cm fil- linja bażi) u - 3. 6 cm għal plaċebo (103. 5 cm fil- linja bażi).
All comparisons against placebo were statistically significant.
Il- paraguni kollha kontra l- plaċebo kienu statistikament sinifikanti.
Studies in normal weight and obese volunteers have shown that the extent of absorption of orlistat was minimal.
Studji f’ voluntiera ta ’ piż normali u oħrajn ħoxnin iżżejjed urew li l- ammont ta ’ assorbiment ta ’ orlistat kien minimu.
Plasma concentrations of intact orlistat were non-measurable (< 5 ng/ ml) 8 hours following oral administration of orlistat 360 mg.
Konċentrazzjonijiet fil- plażma ta ’ orlistat intatt ma setgħux jiġu mkejla (< 5 ng/ ml) 8 siegħat wara għoti orali ta ’ orlistat 360 mg.
In general, at therapeutic doses, detection of intact orlistat in plasma was sporadic and concentrations were extremely low (< 10 ng/ ml or 0.02 µmol), with no evidence of accumulation, which is consistent with minimal absorption.
Ġeneralment, f’ dożi terapewtiċi, l- osservazzjoni ta ’ orlistat intatt fil- plażma kienet sporadika u l - konċentrazzjonijiet kienu baxxi ferm (< 10 ng/ ml jew 0. 02 µmol), bl- ebda sinjal ta ’ akkumulazzjoni, li hija konsistenti ma ’ assorbiment minimu.
The volume of distribution cannot be determined because the active substance is minimally absorbed and has no defined systemic pharmacokinetics.
Il- volum ta ’ distribuzzjoni ma jistax jiġi determinat għaliex is- sustanza attiva tiġi assorbita b’ mod minimu 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 jwaħħlu).
Orlistat minimally partitions into erythrocytes.
Orlistat jitqassam b’ mod minimu fl- eritroċiti.
Based on animal data, it is likely that the metabolism of orlistat occurs mainly within the gastrointestinal wall.
Ibbażat fuq tagħrif mill- 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.
Ibbażat fuq studju f’ pazjenti ħoxnin iżżejjed, mill- parti żgħira ħafna tad- doża assorbita sistematikament, żewġ metaboliti ewlenin, M1 (4- member lactone ring hydrolysed) u M3 (M1 b’ N - formyl leucine moiety cleaved), kienu responsabbli għal madwar 42% tal- konċentrazzjoni totali fil - plażma.
M1 and M3 have an open beta-lactone ring and extremely weak lipase inhibitory activity (1,000- and 2,500-fold less than orlistat, respectively).
M1 u M3 għandhom ċirku beta- lactone miftuħ u attività li tinibixxi l- lipase dgħajfa ħafna (1, 000 u 2, 500 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 ta ’ inibizzjoni 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 bla ebda mportanza farmakoloġika.
Studies in normal weight and obese subjects have shown that faecal excretion of the unabsorbed active substance was the major route of elimination.
Studji f’ individwi ta ’ piż normali u oħrajn ħoxnin iżżejjed urew li t- tneħħija fil- purgar tas- sustanza attiva 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 mogħtija kienet imneħħija fil- purgar u 83% ta ’ dan bħala orlistat mhux mibdul.
The cumulative renal excretion of total orlistat-related materials was < 2% of the given dose.
7 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 biex tintlaħaq tneħħija totali (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 hija simili bejn voluntiera b’ piż normali u dawk ħoxnin iżżejjed.
Orlistat, M1 and M3 are all subject to biliary excretion.
Orlistat, M1 u M3 kollha huma suġġetti għall- eliminazzjoni mill- marrara.
Nonclinical 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 mhux klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni, riskju ta ’ kanċer, u effett tossiku fuq is- sistema riproduttiva, ma ’ turi l- ebda periklu speċjali għall- bnedmin
Capsule filling Microcrystalline cellulose (E460) Sodium starch glycolate Povidone (E1201) Sodium laurilsulfate Talc
Mili fil- kapsula Microcrystalline cellulose (E460) Sodium starch glycolate Povidone (E1201) Sodium laurilsulfate Talkum
Capsule shell Gelatin Indigo carmine (E132) Titanium dioxide (E171) Sodium laurilsulfate Sorbitan monolaurate
Qoxra tal- kapsula Ġelatina Indigo carmine (E132) Titanium dioxide (E171) Sodium laurilsulfate Sorbitan monolaurate
Capsule printing ink Shellac Iron oxide black (E172) Propylene glycol
Linka għall- istampar fuq il- kapsula Shellac Iron oxide iswed (E172) Propylene glycol
Band Gelatin Polysorbate 80 Indigo carmine (E132)
Faxxa Ġelatina Polysorbate 80 Indigo carmine (E132).
Discard any capsules stored in the carry case for more than one month.
Armi l- kapsuli maħżuna fil- kontenitur biex iġġorr għal aktar minn xahar.
Do not store above 25°C.
Taħżinx f’ temperatura ’ l fuq minn 25 °Ċ.
Keep the container tightly closed in order to protect from moisture.
Żomm il- kontenitur magħluq sew sabiex tilqa ’ mill- umdità.
HDPE bottle with child resistant closure containing 42, 60, 84 or 90 hard capsules.
8 Fliexken tal- HDPE b’ għatu reżistenti għat- tfal li fihom 42, 60, 84 jew 90 kapsula iebsa.
The bottle also contains two sealed canisters containing silica gel desiccant.
Il- flixkun fih ukoll żewġ ċilindi magħluqa li fihom silica gel bħala desikkant.
A polystyrene resin / polyurethane carry case (Shuttle) which holds 3 capsules is included in each pack.
Kontenitur biex iġġorr magħmul minn polystyrene resin / polyurethane (Shuttle) li jesa ’ 3 kapsuli huwa nkluż f’ kull pakkett.
23 July 2007 Renewal of the authorisation:
23 ta ’ Lulju 2007 Data ta ’ l- aħħar tiġdid:
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
alli 60 mg hard capsules:
alli 60 mg kapsuli iebsa:
Famar S. A., 49 KM Athens-Lamia, 190 11 Avlona, Greece
Famar S. A., 49 KM Athens- Lamia, 190 11 Avlona, Il- Greċja
Medicinal product not subject to medical prescription.
Prodott mediċinali jista ’ jingħata mingħajr riċetta tat- tabib.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in the July 2007 version 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.
Sistema ta ’ farmakoviġilanza Id- Detentur ta ’ l- Awtorizazzjoni għat- Tqegħid fis- Suq jinħtieġlu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni ta ’ Lulju 2007 li ġiet ippreżentatata fil- Modul 1. 8. 1 ta ’ l - Applikazzjoni ta ’ l- Awtorizzazzjoni tat- Tqegħid fis- Suq, hi stabbilita u qed taħdem qabel u waqt li l - prodott ikun fuq is- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the October 2008 version 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.
Il- Pjan ta ’ l- Immaniġġjar tar- Riskju Id- Detentur ta ’ l- Awtorizazzjoni għat- Tqegħid fis- Suq jikkommetti ruħu li jagħmel l- istudji u l - attivitajiet addizzjonali tal- farmakoviġilanza li huma ddettaljati fil- Pjan tal- Farmakoviġilanza, hekk kif kien miftiehem fil- verżjoni ta ’ Ottubru 2008 tal- Pjan ta ’ l- Immaniġġjar tar- Riskju (RMP) li kien ippreżentat f’ Modul 1. 8. 2 ta ’ l- Applikazzjoni ta ’ l- Awtorizzazzjoni tat- Tqegħid fis- Suq u kwalunkwe aġġornamenti sussegwenti tal- RMP kif miftiehem mill- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linja Gwida tal- CHMP dwar is- Sistemi ta ’ l- Immaniġġjar tar- Riskju għall- prodotti mediċinali għall- użu uman, il- RMP aġġornat għandu jkun sottomess fl- istess ħin bħar- Rapport Perjodiku li jmiss dwar l- Aġġornament tas- Sigurtà (PSUR).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Barra minn dan, għandu jkun sottomess RMP aġġornat • Meta jasal tagħrif ġdid li jista 'jolqot l- Ispeċifikazzjoni kurrenti tas- Sigurtà, Pjan ta ’ Farmakoviġilanza jew attivitajiet ta' minimizzazzjoni tar- riskju • Fi żmien 60 ġurnata ta ’ meta jintlaħaq stadju importanti (farmakoviġilanza jew minimizzazzjoni tar- riskju) • Meta jkun hemm talba ta ’ l- EMEA
PSURs The Marketing Authorisation Holder will submit 6 monthly PSURs for one year after the Commission Decision on the extension application for alli 60 mg hard capsules then yearly for 2 years and every three years thereafter.
11 PSURs Wara d- Deċiżjoni tal- Kummissjoni dwar l- applikazzjoni ta ’ estensjoni għal alli 60 mg kapsuli iebsa, d - Detentur ta ’ l- Awtorizazzjoni għat- Tqegħid fis- Suq se jissottometti PSURs kull 6 xhur għal sena, u wara dan, kull sena għal sentejn, u minn hemm ’ l quddiem kull tliet snin.
13 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA
OUTER CARTON SLEEVE, 42, 60, 84 or 90 CAPSULES
14 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA TA ’ BARRA, 42, 60, 84 jew 90 KAPSULA
alli 60 mg hard capsules Orlistat
alli 60 mg kapsuli iebsa Orlistat
This pack includes:
Dan il- pakkett fih:
Bottle containing 42 hard capsules Bottle containing 60 hard capsules Bottle containing 84 hard capsules Bottle containing 90 hard capsules
Flixkun li fih 42 kapsula iebsa Flixkun li fih 60 kapsula iebsa Flixkun li fih 84 kapsula iebsa Flixkun li fih 90 kapsula iebsa
Carry case
Kontenitur biex iġġorr
14 Keep the container tightly closed in order to protect from moisture.
Żomm il- kontenitur magħluq sewwa sabiex tilqa ’ mill- umdità.
Glaxo Group Limited Glaxo Wellcome House Berkeley Avenue Greenford Middlesex UB6 0NN United Kingdom
Glaxo Group Limited Glaxo Wellcome House Berkeley Avenue Greenford Middlesex UB6 0NN Ir- Renju Unit
Medicinal product not subject to medical prescription.
Prodott mediċinali li m’ għandux bżonn riċetta tat- tabib.
Weight loss aid
Għajnuna biex tnaqqas il- piż
Can help you lose more weight than dieting alone.
Jista ’ jgħinek titlef aktar piż minn dieta waħedha.
alli is used for weight loss alongside reduced calorie, lower-fat meals in overweight adults, aged 18 or over.
alli huwa wżat biex jitnaqqas il- piż flimkien ma ’ ikliet b’ kaloriji mnaqqsa u b’ inqas xaħam, f’ adulti b’ piż żejjed, b’ età ta ’ 18- il sena jew aktar.
alli is clinically proven to help you lose more weight than dieting alone.
alli huwa klinikament ippruvat li jgħinek titlef aktar piż minn dieta waħedha.
The capsules work only in your digestive system to stop about a quarter of the fat in your meals from being absorbed.
Il- kapsuli jaħdmu biss fis- sistema diġestiva tiegħek biex iwaqqfu madwar kwart tax- xaħam fl- ikliet tiegħek milli jiġi assorbit.
This fat passes out of your body and may cause changes to your bowel movements.
Dan ix- xaħam jgħaddi barra mill- ġisem tiegħek u jista ’ jikkawża bidliet fil- movimenti tal- musrana tiegħek.
Eat lower-fat meals to help manage these effects.
Kul ikliet b’ inqas xaħam biex tgħin tnaqqas dawn l- effetti.
To see if alli is right for you, find your height on the chart.
Biex tara jekk alli hux tajjeb għalik, sib it- tul tiegħek fit- tabella.
If you weigh less than the weight shown for your height, do not use alli.
Jekk tiżen inqas mill- piż muri għat- tul tiegħek, tużax alli.
Height
Tul
Weight Height
Piż
Weight
1. 50m
63kg 67.25kg 71.75kg 76.25kg 81kg 85.75kg 90.75kg 95.75kg 101kg
1. 55m 1. 60m 1. 65m 1. 70m 1. 75m 1. 80m 1. 85m 1. 90m
4 '10' '5' 0 '' 5 '2' '5' 4 '' 5 '6' '5' 8 '' 5 '10' '6' 0 '' 6 '2' '
67. 25kg 71. 75kg 76. 25kg 81kg 85. 75kg 90. 75kg 95. 75kg 101kg
Being overweight increases your risk of developing several serious health problems such as diabetes and heart disease.
Li jkollok piż żejjed iżidlek ir- riskju li tiżviluppa diversi problemi serji tas- saħħa bħal dijabete u mard tal- qalb.
You should see your doctor for a check-up.
Għandek tara tabib għal vista medika.
Do not use
Tużax
• if you are under 18. • if you are pregnant or breast-feeding. • if you are taking ciclosporin. • if you are taking warfarin or any other medicines used to thin the blood. • if you are allergic to orlistat or any of the ingredients. • if you have cholestasis (condition where the flow of bile from the liver is blocked). • if you have problems absorbing food (chronic malabsorption syndrome).
• jekk għandek inqas minn 18- il sena. • jekk inti tqila jew qed tredda ’. • jekk qed tieħu ciclosporin. • jekk qed tieħu warfarin jew xi mediċini oħra wżati biex iraqqu d- demm. • jekk inti allerġiku/ a għal orlistat jew għal xi sustanzi oħra ta ’ alli. • jekk għandek kolestasi (kundizzjoni fejn in- nixxija tal- bili mill- fwied tkun imblukkata). • jekk għandek problemi biex tassorbi l- ikel (sindrome kronika ta ’ assorbiment ħażin).
Talk to your doctor or pharmacist before taking alli
Kellem lit- tabib jew lill- ispiżjar tiegħek qabel tieħu alli
• if you are taking amiodarone for heart rhythm problems. • if you are taking a medicine for diabetes.
• jekk qed tieħu amiodarone għall- problemi fir- ritmu tal- qalb. • jekk qed tieħu xi mediċina għad- dijabete.
Talk to your doctor or pharmacist when taking alli
Kellem lit- tabib jew lill- ispiżjar tiegħek qabel tieħu alli
• if you are taking a medicine for high blood pressure. • if you are taking a medicine for high cholesterol.
• jekk qed tieħu mediċina għall- pressjoni għolja tad- demm. • jekk qed tieħu mediċina għal kolesterol għoli.
How to use
Kif għandek tuża
• take one capsule whole with water, three times a day with each main meal containing fat. • do not take more than three capsules a day. • you should take a multivitamin (containing vitamins A, D, E and K) once a day, at bedtime. • you should not take alli for more than six months.
• ħu kapsula sħiħa waħda ma ’ l- ilma, tliet darbiet kuljum ma ’ kull ikla prinċipali li fiha x- xaħam. • tieħux aktar minn tliet kapsuli kuljum. • għandek tieħu multivitamina (li jkun fiha l- vitamini A, D, E u K) darba kuljum, qabel l- irqad. • m’ għandekx tieħu alli għal aktar minn sitt xhur.
< www.xxx.xxx >
www. alli. com. mt
INNER CARTON SLEEVE, 42, 60, 84 or 90 CAPSULES
17 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA TA ’ ĠEWWA, 42, 60, 84 jew 90 KAPSULA
Weight loss aid Can help you lose more weight than dieting alone.
Għajnuna biex tnaqqas il- piż Jista ’ jgħinek titlef aktar piż minn dieta waħedha.
For further information about the alli weight loss programme visit< www.xxx.xxx >.
Għal aktar tagħrif dwar il- programm ta ’ telf ta ’ piż alli ara www. alli. com. mt.
18 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
19 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
BOTTLE LABEL, 42, 60, 84 or 90 CAPSULES
TIKKETTA TAL- FLIXKUN, 42, 60, 84 jew 90 KAPSULA
42 hard capsules 60 hard capsules 84 hard capsules 90 hard capsules
42 kapsula iebsa 60 kapsula iebsa 84 kapsula iebsa 90 kapsula iebsa
Adults, aged 18 or over, who are overweight.
Adulti b’ età ta ’ 18- il sena jew aktar, li għandhom piż żejjed.
CARRY CASE (SHUTTLE)
KONTENITUR BIEX IĠĠORR (SHUTTLE)
alli 60 mg hard capsules Orlistat Oral use
alli 60 mg kapsuli Orlistat Użu orali
Holds 3 capsules.
Tesa ’ 3 kapsuli.
Discard any capsules stored in this case for more than one month.
Armi l- kapsuli maħżuna f’ dan il- kontenitur għal aktar minn xahar.
alli 60 mg hard capsules Orlistat
alli 60 mg kapsuli ibsin Orlistat
Read all of this leaflet carefully because it contains important information for you.
Aqra sew dan il- fuljett kollu, għax fih tagħrif importanti għalik.
This medicine is available without a prescription.
Din il- mediċina tingħata mingħajr riċetta.
However, you still need to use it carefully to get the best results from it. • Keep this leaflet.
Madankollu, xorta għandek tużha b’ għaqal biex ikollok l - aħjar effett. • Żomm dan il- fuljett.
You may need to read it again. • Ask your doctor or pharmacist if you need more information or advice. • If you do not lose weight after taking alli for 12 weeks, see your doctor or pharmacist for advice.
Jista ’ jkollok bżonn terġa ’ taqrah. • Staqsi lit- tabib jew lill- ispiżjar tiegħek jekk tkun trid aktar tagħrif jew pariri. • Jekk ma titlifx piż wara li tkun ħadt alli għal 12- il ġimgħa, kellem tabib jew spiżjar għal parir.
You may need to stop taking alli. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
Għandu mnejn ikollok tieqaf tuża alli. • Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What alli is and what it is used for
X’ inhu alli u għalxiex jintuża
Risk of being overweight How alli works
Ir- riskju li jkollok piż żejjed Kif jaħdem alli
Before you take alli
Qabel ma tieħu alli
Do not take alli Take special care with alli Taking other medicines Taking alli with food and drink Pregnancy and breast-feeding Driving and using machines
Tieħux alli Oqgħod attent b’ alli Meta tieħu mediċini oħra Meta tieħu alli ma ’ l- ikel u max- xorb Tqala u treddigħ Sewqan u tħaddim ta ’ magni
How to take alli
Kif għandek tieħu alli
Preparing to lose weight o Choose your start date o Decide on your weight loss goal o Set your calorie and fat targets
Preparazzjoni biex titlef il- piż o Għażel data meta se tibda o Iddeċiedi l- mira ta ’ telf ta ’ piż tiegħek o Stabilixxi il- miri tiegħek ta ’ kaloriji u xaħam
Taking alli o Adults 18 and over o How long should I take alli for? o If you take too much alli o If you forget to take alli
Meta tieħu alli o Adulti ta ’ 18- il sena jew aktar o Kemm għandi ndum nieħu alli? o Jekk tieħu aktar alli milli suppost o Jekk tinsa tieħu alli
Serious side effects Very common side effects Common side effects Effects seen in blood tests Learn to deal with diet-related treatment effects
Effetti sekondarji serji Effetti sekondarji komuni ħafna Effetti sekondarji komuni Effetti osservati fit- testijiet tad- demm Tgħallem ħu ħsieb l- effetti tal- kura relatati mad- dieta
How to store alli 6.
Kif taħżen alli 6.
What alli contains What alli looks like and contents of the pack Marketing authorisation holder and manufacturer Further helpful information
X’ fih alli Id- dehra ta ’ alli u l- kontenuti tal- pakkett Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- manifattur Aktar tagħrif ta ’ għajnuna
WHAT alli IS AND WHAT IT IS USED FOR
X’ INHU alli U GĦALXIEX JINTUŻA
alli is used for weight loss in adults aged 18 and over who are overweight, and have a body mass index (BMI) of 28 or above. alli should be used along with a reduced calorie, lower-fat diet.
alli jintuża għal telf tal- piż f’ adulti b’ età minn 18- il sena ’ l fuq li għandhom piż żejjed, u li għandhom indiċi tal- massa tal- ġisem (BMI) ta ’ 28 jew aktar. alli għandu jintuża flimkien ma ’ dieta ta ’ kaloriji mnaqqsa u b’ inqas xaħam.
23 BMI is a way to find out if you have a healthy weight, or are overweight, for your height.
24 Il- BMI huwa mezz biex tkun taf jekk il- piż tiegħek hux normali, jew jekk għandekx piż żejjed, għat - tul tiegħek.
The chart below will help you find out whether you are overweight and whether alli is right for you.
It- tabella taħt se tgħinek issir taf jekk għandekx piż żejjed u jekk alli hux tajjeb għalik.
Find your height on the chart.
Sib it- tul tiegħek fit- tabella.
If you weigh less than the weight shown for your height, do not take alli.
Jekk tiżen inqas mill- piż li jidher għat- tul tiegħek, tieħux alli.
1. 50 m
1. 50 m
1.55 m 1.60 m 1.65 m 1.70 m 1.75 m 1.80 m 1.85 m 1.90 m
1. 55 m 1. 60 m 1. 65 m 1. 70 m 1. 75 m 1. 80 m 1. 85 m 1. 90 m
67.25 kg 71.75 kg 76.25 kg 81 kg 85.75 kg 90.75 kg 95.75 kg 101 kg
67. 25 kg 71. 75 kg 76. 25 kg 81 kg 85. 75 kg 90. 75 kg 95. 75 kg 101 kg
Risk of being overweight
Ir- riskju li jkollok piż żejjed
These conditions may not cause you to feel unwell so you should see your doctor for a general health check.
Dawn il- kundizzjonijiet jistgħu ma jikkawżawx li tħossok ma tiflaħx għalhekk għandek tara lit- tabib tiegħek għall- vista medika ġenerali.
How alli works
Kif jaħdem alli
The active ingredient in alli is designed to target fat in your digestive system.
Is- sustanza attiva f’ alli hija maħsuba biex tattakka x- xaħam fis- sistema diġestiva tiegħek.
It stops about a quarter of the fat in your meals from being absorbed.
Hija twaqqaf madwar kwart tax- xaħam fl- ikliet tiegħek milli jiġi assorbit.
This fat will pass out of the body in your stools.
Dan ix- xaħam se joħroġ mill - ġisem tiegħek fil- purgar.
You may experience diet-related treatment effects (see Chapter 4).
Jista ’ jkollok esperjenza ta ’ effetti tal- kura relatati mad- dieta (ara Kapitlu 4).
It is therefore important that you commit to a lower-fat diet to manage these effects.
Għalhekk huwa importanti li timxi ma ’ dieta b’ inqas xaħam biex timmaniġġja dawn l- effetti.
If you do, the action of the capsules will assist your efforts by helping you to lose more weight compared to dieting alone.
Jekk tagħmel dan, l- azzjoni tal- kapsuli tgħin l- isforzi tiegħek billi tgħinek titlef aktar piż meta mqabbel ma ’ dieta waħedha.
For every 2 kg (4 lb) you lose from dieting alone, alli can help you lose 1 kg (2 lb) more.
Għal kull 2 kg li inti titlef bid- dieta waħedha, alli jista ’ jgħinek titlef 1 kg aktar.
BEFORE YOU TAKE alli
QABEL MA TIEĦU alli
Do not take alli
Tieħux alli
• If you are under 18. • If you are pregnant or breast-feeding. • If you are taking ciclosporin, used after organ transplants, for severe rheumatoid arthritis and some severe skin conditions. • If you are taking warfarin or other medicines used to thin the blood. • If you are allergic (hypersensitive) to orlistat or any of the ingredients of alli: see Chapter 6 for further information. • If you have cholestasis (condition where the flow of bile from the liver is blocked). • If you have problems absorbing food (chronic malabsorption syndrome) diagnosed by a doctor.
• Jekk għandek inqas minn 18- il sena. • Jekk inti tqila jew qed tredda ’. • Jekk qed tieħu ciclosporin, użat wara trapjanti ta ’ organi, għal artrite rewmatojda severa u xi kundizzjonijiet severi tal- ġilda. • Jekk qed tieħu warfarin jew xi mediċini oħra wżati biex iraqqu d- demm. • Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal orlistat jew jew sustanzi oħra ta ’ alli: ara Kapitlu 6 għal aktar informazzjoni. • Jekk għandek kolestasi (kundizzjoni fejn in- nixxija tal- bili mill- fwied hija mblukkata). • Jekk għandek problemi biex tassorbi l- ikel (sindrome kronika ta ’ assorbiment ħażin) iddijanjostikati minn tabib.
Take special care with alli
Oqgħod attent ħafna b’ alli
If you have diabetes.
Jekk għandek dijabete.
Tell your doctor who may need to adjust your anti-diabetic medicine.
Għid lit- tabib tiegħek għax għandu mnejn ikollu bżonn jaġġusta l- mediċina tiegħek kontra d- dijabete.
24 Taking other medicines
Meta tieħu mediċini oħra
alli may affect some medicines you have to take.
25 alli jista ’ jkollu effett fuq xi mediċini li għandek tieħu.
Do not take alli with these medicines • Ciclosporin: ciclosporin is used after organ transplants, for severe rheumatoid arthritis and some severe skin conditions. • Warfarin or other medicines used to thin the blood.
Tieħux alli ma ’ dawn il- mediċini • Ciclosporin: ciclosporin jintuża wara trapjanti ta ’ organi, għall- artrite rewmatojda severa u għal xi kundizzjonijiet severi tal- ġilda. • Warfarin jew mediċini oħra wżati biex iraqqu d- demm.
The oral contraceptive pill and alli • The oral contraceptive pill may be less effective if you get severe diarrhoea.
Il- pillola kontraċettiva orali u alli • Jekk ikollok dijarea severa l- pillola kontraċettiva orali tista ’ tkun inqas effettiva.
Use an extra method of contraception if you get severe diarrhoea.
Uża metodu addizzjonali ta ’ kontraċezzjoni jekk ikollok dijarea severa.
Multivitamins and alli • You should take a multivitamin, every day. alli can lower the levels of some vitamins absor bed by your body.
Multivitamini u alli • Għandek tieħu multivitamina kuljum. alli jista ’ jbaxxi l- livelli ta ’ xi vitamini assorbiti mill- ġisem tiegħek.
The multivitamin should contain vitamins A, D, E and K.
Il- multivitamina għandu jkun fiha l- vitamini A, D, E u K.
You should take the multivitamin at bedtime, when you will not be taking alli, to help ensure that the vitamins are absorbed.
Biex tgħin tassigura li l - vitamini jiġu assorbiti, għandek tieħu l- multivitamina, qabel torqod, meta ma tkunx qed tieħu alli.
Talk to your doctor or pharmacist before taking alli if you are taking • amiodarone, used for heart rhythm problems. • acarbose, used for diabetes.
Kellem lit- tabib jew lill- ispiżjar tiegħek qabel tieħu alli jekk qed tieħu • amiodarone, użat għall- problemi fir- ritmu tal- qalb • acarbose, użat għad- dijabete
Talk to your doctor or pharmacist when taking alli • If you are taking a medicine for high blood pressure as it may be necessary to adjust your dose. • If you are taking a medicine for high cholesterol as it may be necessary to adjust your dose.
Kellem lit- tabib jew lill- ispiżjar tiegħek meta qed tieħu alli • Jekk inti qed tieħu mediċina għall- pressjoni għolja tad- demm peress li jista ’ jkun hemm bżonn li d- doża tiegħek tiġi aġġustata. • Jekk inti qed tieħu mediċina għall- kolesterol għoli peress li jista ’ jkun hemm bżonn li d- doża tiegħek tiġi aġġustata.
Taking alli with food and drink
Meta tieħu alli ma ’ l- ikel u max- xorb
alli should be used along with a reduced calorie, lower-fat diet.
alli għandu jintuża flimkien ma ’ dieta b’ kaloriji mnaqqsa u b’ inqas xaħam.
Try to start this diet before beginning treatment.
Ipprova ibda din id- dieta qabel tibda l- kura.
For information on how to set your calorie and fat targets, see Further helpful information in the blue pages in Chapter 6.
Għall- informazzjoni dwar kif tissetja l- miri tiegħek ta ’ kaloriji u xaħam, ara Aktar tagħrif ta ’ għajnuna fil- paġni blu f’ Kapitlu 6.
Take alli at mealtimes.
Ħu alli fil- ħin ta ’ l- ikel.
This usually means one capsule at breakfast, lunch and dinner.
Dan ifisser kapsula waħda mal- kolazzjon, ma ’ l- ikla ta ’ nofsinhar u ma ’ l- ikla ta ’ filgħaxija.
If you miss a meal, or your meal contains no fat, do not take a capsule. alli does not work unless there's some fat in the meal.
Jekk taqbes ikla, jew l- ikla tiegħek tkun bla xaħam, tieħux kapsula. alli ma jaħdimx jekk ma jkunx hemm ftit xaħam fl- ikla.
If you eat a high-fat meal, do not take more than the recommended dose.
Jekk tiekol ikla b’ ħafna xaħam, tieħux aktar mid- doża rrakkomandata.
Taking the capsule with a meal containing too much fat may increase your chance of getting diet-related treatment effects (see Chapter 4).
Li tieħu kapsula ma ikla li fiha wisq xaħam jista ’ jżid iċ- ċans li jkollok effetti tal- kura relatati mad- dieta (ara Kapitlu 4).
Make every effort to avoid any high-fat meals while taking alli.
Għamel kull sforz biex tevità ikliet b’ ħafna xaħam waqt li qed tieħu alli.
Do not take alli if you are pregnant or breast-feeding.
Tieħux alli jekk inti tqila jew qed tredda ’.
No effect on ability to drive or use machines has been observed.
Ma kien osservat l- ebda effett fuq il- ħila biex issuq jew tħaddem magni.
HOW TO TAKE alli
KIF GĦANDEK TIEĦU alli
Preparing to lose weight
Preparazzjoni biex titlef il- piż
Choose your start date
Għażel data meta se tibda
25 Choose the day you will start taking the capsules ahead of time.
Għażel il- ġurnata li fiha se tibda tieħu l- kapsuli minn qabel.
Before you start taking the capsules, begin your reduced calorie, lower-fat diet and give your body a few days to adjust to your new eating habits.
Ibda d- dieta tiegħek b’ kaloriji mnaqqsa u b’ inqas xaħam qabel tibda tieħu l- kapsuli u agħti ftit ġranet lill- ġisem tiegħek biex jaġġusta għad - 26 drawwiet ġodda ta ’ l- ikel tiegħek.
Keep a record of what you are eating in a food diary.
Niżżel dak li qed tiekol fi djarju ta ’ l- ikel.
Food diaries are effective, because they make you aware of what you are eating, how much you eat, and give you the basis to make changes.
Djarji ta ’ l- ikel huma effettivi, għax jagħmluk konxju ta ’ x’ qed tiekol, kemm qed tiekol, u jtuk il- bażi biex tagħmel bidliet.
Decide on your weight loss goal
Iddeċidi l- mira ta ’ telf ta ’ piż tiegħek
Think about how much weight you want to lose and then set a target weight.
Aħseb dwar kemm trid titlef piż u wara stabilixxi mira ta ’ piż.
A realistic goal is to lose between 5% to 10% of your starting weight.
Mira realistika hija li titlef bejn 5% sa 10% tal- piż tal- bidu tiegħek.
The amount of weight you lose may vary from week to week.
L- ammont ta ’ piż li titlef jista ’ jvarja minn ġimgħa għal ġimgħa.
You should aim to lose weight at a gradual, steady pace of about 0.5 kg (1 lb) per week.
Inti għandek timmira li titlef il- piż b’ rata gradwali u kostanti ta ’ madwar 0. 5 kg kull ġimgħa.
Set your calorie and fat targets
Stabilixxi l- miri tiegħek ta ’ kaloriji u xaħam
To help you reach your weight-loss goal you need to set two daily targets, one for calories and one for fat.
Biex jgħinuk tilħaq il- mira tiegħek ta ’ telf ta ’ piż, għandek bżonn tistabilixxi żewġ miri ta ’ kuljum, waħda għall- kaloriji u oħra għax- xaħam.
For further advice see Further helpful information in the blue pages in Chapter 6.
Għal aktar informazzjoni ara Aktar tagħrif ta ’ għajnuna fil - paġni blu f’ Kapitlu 6.
Taking alli
Meta tieħu alli
Adults 18 and over • Take one capsule, three times a day. • Take alli at mealtimes.
Adulti ta ’ 18- il sena jew aktar • Ħu kapsula waħda, tliet darbiet kuljum. • Ħu alli fil- ħin ta ’ l- ikel.
This usually means one capsule at breakfast, lunch and dinner.
Dan ġeneralment ifisser kapsula waħda mal- kolazzjon, ma ’ l- ikla ta ’ nofsinhar u ma ’ l- ikla ta ’ filgħaxija.
Make sure your three main meals are well balanced, reduced calorie, and lower-fat. • If you miss a meal, or your meal contains no fat, do not take a capsule. alli does not work unless there's some fat in the meal. • Take alli just before, during or up to one hour after meals. • Swallow the capsule whole with water. • Do not take more than 3 capsules a day. • You can keep your daily dose of alli in the blue carry case (Shuttle) included in this pack.
Kun ċert li t- tliet ikliet prinċipali tiegħek huma bbilanċjati sew, b’ kaloriji mnaqqsa, u b’ inqas xaħam. • Jekk taqbeż ikla, jew l- ikla tiegħek tkun bla xaħam, tieħux kapsula. alli ma jaħdimx jekk ma jkunx hemm ftit xaħam fl- ikla. • Ħu alli eżatt qabel, waqt jew sa siegħa wara l- ikel. • Ibla ’ l- kapsula sħiħa ma ’ l- ilma. • Tieħux aktar minn 3 kapsuli kuljum. • Tista ’ żżomm id- doża ta ’ kuljum tiegħek ta ’ alli fil- kontenitur blu biex iġġorr (Shuttle) inkluż f’ dan il- pakkett. • Kul ikliet b’ inqas xaħam biex tnaqqas iċ- ċans li jkollok effetti tal- kura relatati mad- dieta (ara Kapitlu 4). • Ipprova kun fiżikament aktar attiv qabel tibda tieħu l- kapsuli.
Physical activity is an important part of a weight loss programme.
Attività fiżika hija parti importanti ta ’ programm għal tnaqqis fil- piż.
Remember to check with your doctor first if you have not exercised before. • Continue to be active while taking alli and after you stop taking it.
Ftakar biex l- ewwel tiċċekkja mat- tabib tiegħek jekk qatt m’ għamilt eżerċizzju qabel. • Kompli kun attiv waqt li qed tieħu alli u wara li tieqaf tieħdu.
• alli should not be taken for more than six months. • If you do not lose weight after taking alli for 12 weeks, see your doctor or pharmacist for advice.
Kemm għandi ndum nieħu alli? • alli m’ għandux jittieħed għal aktar minn sitt xhur. • Jekk ma titlifx piż wara li tkun ilek tieħu alli għal 12- il ġimgħa, kellem lit- tabib jew lill - ispiżjar tiegħek għal parir.
You may need to stop taking alli. • Successful weight loss is not just about eating differently for a short period of time before reverting to your old habits.
Jista ’ jkollok bżonn twaqqaf l- użu ta ’ alli. • Telf ta ’ piż b’ suċċess ma jseħħx jekk tiekol b’ mod differenti għal- perijodu qasir ta ’ żmien biss u wara terġa lura għad- drawwiet antiki tiegħek.
People who lose weight and maintain the loss make lifestyle changes, which include changes to what they eat and how active they are.
Persuni li tilfu l- piż u żammew dan it- telf jagħmlu bidliet fl- istil ta ’ ħajja, li jinkludu bidliet f’ dak li jieklu u kemm ikunu attivi.
If you take too much alli
Jekk tieħu alli aktar milli suppost
Do not take more than 3 capsules a day.
Tieħux aktar minn 3 kapsuli kuljum.
If you take too many capsules, contact a doctor as soon as possible.
Jekk tieħu aktar kapsuli milli suppost, kellem tabib malajr kemm jista ’ jkun.
If you forget to take alli
Jekk tinsa tieħu alli
If you miss taking a capsule:
Jekk tinsa tieħu kapsula:
• If it is less than an hour since your last main meal, take the missed capsule. • If it is more than an hour since your last main meal, do not take the missed capsule.
• Jekk tkun għaddiet inqas minn siegħa mill- aħħar ikla prinċipali tiegħek, ħu l- kapsula li tkun insejt. • Jekk tkun għaddiet aktar minn siegħa mill- aħħar ikla prinċipali, tieħux il- kapsula li nsejt.
Wait and take the next capsule around your next main meal as usual.
Stenna u ħu l- kapsula ma ’ l- ikla prinċipali li jmiss tiegħek bħas- soltu.
Like all medicines, alli can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, alli jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Most of the common side effects related to alli (for example, wind with or without oily spotting, sudden or more frequent bowel motions and soft stools) are caused by the way it works (see Chapter 1).
Il- biċċa l- kbira ta ’ effetti sekondarji komuni relatati ma ’ alli (eżempju, gass, bi jew mingħajr tbajja żejtnin mir- rektum, purgar f’ daqqa jew aktar frekwenti u purgar artab) huma kkawżati mill- mod kif jaħdem (ara Kapitlu 1).
Eat lower-fat meals to help manage these diet-related treatment effects.
Kul ikliet b’ inqas xaħam biex tgħin timmaniġġja dawn l- effetti tal- kura relatati mad- dieta.
Serious side effects It is not known how frequently these side effects occur
Effetti sekondarji serji Il- frekwenza ta ’ dawn l- effetti sekondarja mhux magħrufa..
Severe allergic reactions • Signs of a severe allergic reaction include: severe breathing difficulties, sweating, rash, itching, swollen face, rapid heart beat, collapse.
Reazzjonijiet allerġiċi severi • Sinjali ta ’ reazzjoni allerġika severa jinkludu: diffikultajiet severi biex tieħu n- nifs, għaraq, raxx, ħakk, nefħa fil- wiċċ, rata ta ’ taħbit tal- qalb mgħaġġla, kollass.
Stop taking the capsules.
Waqqaf it- teħid tal- kapsuli.
Get medical help immediately.
Staqsi għall- għajnuna medika minnufih.
Other serious side effects • Bleeding from the back passage (rectum) • Diverticulitis (inflammation of the large intestine).
Effetti sekondarji serji oħra • Fsada mill- passaġġ ta ’ wara (rektum) • Divertikulite (infjammazzjoni tal- musrana l- kbira).
Symptoms may include lower stomach (abdominal) pain, particularly on the left side, possibly with fever and constipation • Skin blistering (including blisters that burst) • Severe stomach pain caused by gallstones • Hepatitis (inflammation of the liver).
Sintomi jistgħu jinkludu uġigħ fin- naħa t’ isfel ta ’ l- istonku (addominali), speċjalment fin- naħa tax- xellug, possibbilment b’ deni u stitikezza • Infafet fil- ġilda (inkluż infafet li jinfaqgħu) • Uġigħ sever fl- istonku kkawżat minn ġebel fil- marrara • Epatite (infjammazzjoni tal- fwied).
Symptoms can include yellow skin and eyes, itching, stomach pain and liver tenderness.
Sintomi jistgħu jinkludu ġilda u għajnejn sofor, ħakk, uġigħ fl- istonku u tenerezza fil- fwied.
Tell your doctor if you get any of these.
Għid lit- tabib tiegħek jekk tħoss xi wieħed minn dawn.
Very common side effects These may affect more than 1 in 10 people taking alli • Wind (flatulence), with or without oily spotting • Sudden bowel motions • Fatty or oily stools • Soft stools Tell your doctor or pharmacist if any of these side effects gets severe or troublesome.
Effetti sekondarji komuni ħafna Dawn jistgħu jaffettwaw aktar minn persuna waħda minn kull 10 li qed jieħdu alli • Gass (gass fl- istonku), bi jew mingħajr tbajja żejtnin mir- rektum • Purgar f’ daqqa • Purgar xaħmi jew żejtni • Purgar artab Għid lit- tabib jew lill- ispiżjar tiegħek jekk xi wieħed minn dawn l- effetti sekondarji jsir sever jew problematiku.
Common side effects These may affect up to 1 in 10 people taking alli • Stomach (abdominal) pain • Incontinence (stools) • Runny/liquid stools • More frequent bowel motions • Anxiety Tell your doctor or pharmacist if any these side effects gets severe or troublesome.
Effetti sekondarji komuni Dawn jistgħu jaffettwaw sa persuna waħda minn kull 10 li qed jieħdu alli • Uġigħ ta ’ stonku (addominali) • Inkontinenza (purgar) • Purgar likwidu • Purgar aktar ta ’ spiss • Ansjetà Għid lit- tabib jew lill- ispiżjar tiegħek jekk xi wieħed minn dawn l- effetti sekondarji jsir sever jew problematiku.
Effects seen in blood tests It is not known how frequently these effects occur • Increases in the levels of some liver enzymes • Effects on blood clotting in people taking warfarin or other blood-thinning (anti-coagulant) medicines Tell your doctor that you are taking alli when you have a blood test.
Effetti sekondarji osservati fit- testijiet tad- demm Il- frekwenza ta ’ dawn mhux magħrufa • Żjieda fil- livelli ta ’ xi enżimi tal- fwied • Effetti fuq it- tagħqid tad- demm f’ persuni li jieħdu warfarin jew mediċini oħra li jraqqu d- demm (mediċini kontra l- koagulazzjoni tad- demm) Għid lit- tabib jew lill- ispiżjar tiegħek jekk xi wieħed minn dawn l- effetti sekondarji jsir sever jew problematiku.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
28 Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
27 Learn to deal with diet-related treatment effects
Tgħallem ħu ħsieb l- effetti tal- kura relatati mad- dieta
The most common side effects are caused by the way the capsules work and result from some of the fat being passed out of your body.
L- aktar effetti sekondarji komuni huma kkawżati mill- mod kif jaħdmu l- kapsuli u jirriżultaw minn xi xaħam li jgħaddi barra mill- ġisem tiegħek.
Such effects typically occur within the first few weeks of using the capsules, before you may have learnt to limit the amount of fat in your diet.
Dawn l- effetti tipikament iseħħu fl- ewwel ftit ġimgħat ta ’ użu tal- kapsuli, qabel ma tkun tgħallimt tillimita l- ammont ta ’ xaħam fid- dieta tiegħek.
Such diet-related treatment effects may be a signal that you have eaten more fat than you should have done.
Effetti tal- kura relatati mad- dieta bħal dawn jistgħu jkunu sinjal li ħadt aktar xaħam milli kellek tieħu.
You can learn to minimise the impact of diet-related treatment effects by following these guidelines: • Start your lower-fat diet a few days, or even a week, before you begin taking the capsules. • Find out more about how much fat your favourite foods typically contain, and the size of your portions.
Tista ’ titgħallem tnaqqas l- impatt ta ’ l- effetti tal- kura relatati mad- dieta billi ssegwi dawn il- linji gwida: • Ibda d- dieta tiegħek b’ inqas xaħam ftit ġranet, jew anki ġimgħa qabel tibda tieħu l- kapsuli. • Tgħallem aktar dwar il- kontenut tipiku ta ’ xaħam ta ’ l- ikel favorit tiegħek, u d- daqs tal - porzjonijiet tiegħek.
Do not “save up” fat and calorie allowances and then splurge on a high-fat meal or dessert, as you may have done on other weight loss programmes. • Most users who experience these effects find that they can manage and control them by adjusting their diet.
Jekk issir familjari mal- porzjonijiet tnaqqas iċ- ċans li bi żball taqbeż il- mira ta ’ xaħam tiegħek. • Qassam ix- xaħam li tista ’ tieħu b’ mod ugwali bejn l- ikliet tal- ġurnata. “ Iġġemmax ” xaħam u kaloriji mill- ammont li tista ’ tieħu biex wara tieħu ikla jew deserta b’ ħafna xaħam, kif stajt għamilt meta segwejt programmi oħra ta ’ telf ta ’ piż. • Il- biċċa l- kbira ta ’ persuni li jkollhom esperjenza ta ’ dawn l- effetti jkunu jistgħu jimmaniġġjawhom u jikkontrollawhom billi jagħmlu xi bidliet fid- dieta tagħhom.
Do not be concerned if you do not experience any of these problems.
Tinkwetax jekk ma jkollokx esperjenza ta ’ dawn il- problemi.
This does not mean that the capsules aren’t working.
Dan ma jfissirx li l- kapsuli mhux qed jaħdmu.
HOW TO STORE alli
KIF TAĦŻEN alli
• Keep out of the reach and sight of children. • Do not use alli after the expiry date which is stated on the carton. • Do not store above 25°C. • Keep the container tightly closed to protect from moisture. • The bottle contains two sealed canisters containing silica gel to keep the capsules dry.
• Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal. • Tużax alli wara d- data ta ’ skadenza li tidher fuq il- kartuna. • Taħżinx f’ temperatura ’ l fuq minn 25°C. • Żomm il- kontenitur magħluq sewwa sabiex tilqa ’ mill- umdità. • Il- flixkun fih żewġ kontenituri ssiġillati li fihom silica gel biex iżommu l- kapsuli xotti.
Keep the canisters in the bottle.
Żomm il - kontenituri fil- flixkun.
Do not swallow them. • You can also keep your daily dose of alli in the blue carry case (Shuttle) included in this pack.
Tiblahomx. • Tista ’ wkoll iżżomm id- doża tiegħek ta ’ kuljum ta ’ alli fil- kontenitur blu biex iġġorr (Shuttle) inkluż f’ dan il- pakkett.
What alli contains
X’ fih alli
The active substance is orlistat.
Is- sustanza attiva hi orlistat.
Each hard capsule contains 60 mg of orlistat.
Kull kapsula iebsa fiha 60 mg ta ’ orlistat.
The other ingredients are: • Capsule filling: microcrystalline cellulose (E460), sodium starch glycolate, povidone (E1201), sodium laurilsulfate, talc. • Capsule shell: gelatin, indigo carmine (E132), titanium dioxide (E171), sodium laurilsulfate, sorbitan monolaurate, black ink (shellac, iron oxide black (E172), propylene glycol). • Capsule band: gelatin, polysorbate 80, indigo carmine (E132).
Is- sustanzi l- oħra huma: • Mili fil- kapsula: microcrystalline cellulose (E460), sodium starch glycolate, povidone (E1201), sodium laurilsulfate, talkum. • Qoxra tal- kapsula: ġelatina, indigo carmine (E132), titanium dioxide (E171), sodium laurilsulfate, sorbitan monolaurate, linka sewda (shellac, iron oxide iswed (E172), propylene glycol). • Faxxa tal- kapsula: ġelatina, polysorbate 80, indigo carmine (E132).
What alli looks like and contents of the pack
Id- Dehra ta ’ alli u l- kontenuti tal- pakkett