qanastek/EMEA-V3 huggingface dataset:
Other forms of interaction Cholestagel did not induce any clinically significant reduction in the absorption of vitamins A, D, E or K during clinical studies of up to one year.
Forom oħra ta ’ interazzjoni Cholestagel ma ġiegħelx l- ebda tnaqqis sinifikanti kliniku fl- assorbiment tal- vitamini A, D, E jew K matul l- istudji kliniċi sa sena.
However, caution should be exercised when treating patients with a susceptibility to vitamin K or fat-soluble vitamin deficiencies, such as patients with malabsorption.
Imma, wieħed għandu joqgħod attent meta jkun qed jikkura pazjenti li għandhom suxxettibilità għal nuqqas tal- vitamina K jew tal- vitamini li jinħallu fix- xaħam, bħal pazjenti li jbatu minn malassorbiment.
In these patients, monitoring vitamin A, D and E levels and assessing vitamin K status through the measurement of coagulation parameters is recommended and the vitamins should be supplemented if necessary.
Fil- każ ta ’ dawn il- pazjenti, il- monitoraġġ tal- livelli tal- vitamina A, D u E u l- assessjar ta ’ l- istatus tal- vitamina K permezz tal- kejl tal- parametri ta ’ koaġulazzjoni tad- demm hu rrakkomandat u dożi żejda tal- vitamini għandhom jingħataw jekk hemm bżonn.
Pregnancy No clinical data are available on the use of Cholestagel in pregnant women.
Tqala M’ hemm l- ebda tagħrif kliniku dwar l- użu ta ’ Cholestagel f’ nisa tqal.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/ foetal development, parturition or postnatal development (see section 5.3).
Studji fuq l- annimali ma jurux effetti ħżiena diretti jew indiretti fuq it- tqala, fuq l- iżvilupp embrijoniku/ fetali, ħlas jew żvilupp wara t- twelid (ara sezzjoni 5. 3).
Caution should be exercised when prescribing to pregnant women.
Wieħed għandu joqgħod attent meta jikteb riċetta għal din il- mediċina għal nisa tqal.
Lactation The safety of Cholestagel has not been established in breast-feeding women.
Treddigħ Is- sigurtà ta ’ Cholestagel għadha ma ġietx stabbilita f’ nisa li qed ireddgħu.
Caution should be exercised when prescribing to breast-feeding women.
Wieħed għandu joqgħod attent meta jikteb riċetta għal din il- mediċina għal nisa li qed ireddgħu.
Cholestagel has no or negligible influence on the ability to drive and use machines.
Cholestagel m’ għandu l- ebda effett jew ftit li xejn għandu effett fuq il- ħila biex issuq u tħaddem magni.
4.8 Undesirable effects
5 4. 8 Effetti mhux mixtieqa
In controlled clinical studies involving approximately 1400 patients, the following adverse reactions were reported in patients given Cholestagel.
Fi studji kliniċi kkontrollati li kienu jinvolvu madwar 1400 pazjent, dawn ir- reazzjonijiet avversi li jidhru hawn taħt kienu rrapportati f’ ≥ 1% tal- pazjenti li ngħataw Cholestagel.
The reporting rate is classified as very common (≥ 1/ 10), common (≥ 1/ 100, < 1/ 10), uncommon (≥ 1/ 1,000, < 1/ 100), rare (≥ 1/ 10,000, < 1/ 1,000), very rare (< 1/ 10,000), including isolated.
Ir- rata ta ’ rappurtaġġ hi kklassifikata bħala komuni ħafna (≥1/ 10); komuni (≥1/ 100, < 1/ 10); mhux komuni (≥1/ 1, 000, < 1/ 100); rari (≥1/ 10, 000, < 1/ 1, 000), rari ħafna (< 1/ 10, 000) li jinkludu rapporti iżolati.
Investigations Common:
Investigazzjonijiet Komuni:
Serum triglycerides increased Uncommon: Serum transaminase increased Nervous system disorders Common:
Żieda fit- triglycerides fis- serum Mhux komuni:
Headache Gastrointestinal disorders Very common:
Żieda fit- transaminase fis- serum Disturbi fis- sistema nervuża Komuni:
Flatulence, constipation Common:
Uġigħ ta ’ ras Disturbi gastro- intestinali Komuni ħafna:
Vomiting, diarrhoea, dyspepsia,, abdominal pain, abnormal stools, nausea Musculoskeletal and connective tissue disorders Uncommon:
Gass, stitikezza Komuni: rimettar, dijarea, dispepsja, uġigħ addominali, ippurgar anormali, nawseja Disturbi muskolu- skeletrali u tal- connective tissue Mhux komuni:
Myalgia
Majalġja
The background incidence of flatulence and diarrhoea were higher in patients receiving placebo in the same controlled clinical studies.
L- inċidenza fl- isfond ta ’ gass u dijarea kienet ogħla f’ pazjenti li kienu qed jirċievu l- plaċebo fl - istess studji kliniċi kkontrollati.
Only constipation and dyspepsia were reported by a higher percentage among those receiving Cholestagel, compared with placebo.
L- istitikezza u d- dispepsja biss kienu rrappurtati minn perċentwali ogħla fost dawk li kienu qed jirċievu Cholestagel, meta mqabbla mal- plaċebo
Adverse reactions were generally mild or moderate in intensity.
L- intensità tar- reazzjonijiet avversi kienet ġeneralment ħafifa jew moderata.
5 Cholestagel in combination with statins did not result in any frequent unexpected adverse reactions compared with statins alone.
Meta ngħataw Cholestagel flimkien ma ’ statins ma kienx hemm reazzjonijiet avversi mhux mistennija frekwenti meta mqabbel ma ’ statins waħidhom.
Since Cholestagel is not absorbed, the risk of systemic toxicity is low.
Peress li Cholestagel mhux assorbit, ir- riskju ta ’ tossiċità sistemika hu baxx.
Gastrointestinal symptoms could occur.
Jista ’ jkun hemm sintomi gastrointestinali.
Doses in excess of the maximum recommended dose (4.5 g per day (7 tablets)) have not been tested.
Ma sarux testijiet b’ dożi ta ’ iktar mid- doża massima rakkomandata (4. 5 g kuljum (7 pilloli)).
Should overdosage occur, however, the chief potential harm would be obstruction of the gastrointestinal tract.
F’ każ ta ’ doża eċċessiva, il- ħsara prinċipali potenzjali hija mblukkar tas- sistema gastrointestinali.
The location of such potential obstruction, the degree of obstruction and the presence or absence of normal gut motility would determine treatment.
Il- post potenzjalment imblukkat, kemm ikun imblukkat u l- preżenza jew l- assenza tal- motilità normali ta ’ l- imsaren ser jiddeterminaw x’ tip ta ’ kura għandha tingħata.
Pharmacotherapeutic group: bile acid sequestrants, ATC code:
Kategorija farmakoterapewtika: sekwestranti ta ’ l- aċidu tal- bili, Kodiċi ATC:
The mechanism of action for the activity of colesevelam, the active substance in Cholestagel, has been evaluated in several in vitro and in vivo studies.
Il- mekkaniżmu ta ’ l- azzjoni ta ’ l- attività ta ’ colesevelam, is- sustanza attiva f’ Cholestagel, ġew evalwati f’ numru ta ’ studji in vitro u in vivo.
These studies have demonstrated that colesevelam binds bile acids, including glycocholic acid, the major bile acid in humans.
Dawn l- istudji wrew li colesevelam jorbot l- aċidi tal- bili, inkluż glycocholic acid, l- aċidu principali tal- bili fin- nies.
Cholesterol is the sole precursor of bile acids.
Il- kolesterol hu l- uniku prekursur ta ’ l- aċidi tal- bili.
During normal digestion, bile acids are secreted into the intestine.
Matul id- diġestjoni normali, l- aċidi tal- bili jidħlu fl- intestini.
A major portion of bile acids is then absorbed from the intestinal tract and returned to the liver via the enterohepatic circulation.
Parti kbira ta ’ l- aċidi tal- bili imbagħad tkun assorbita mis- sistema intestinali u tirritorna fil- fwied permezz taċ- ċirkulazzjoni enteroepatika.
Colesevelam is a non-absorbed, lipid-lowering polymer that binds bile acids in the intestine, impeding their reabsorption.
Colesevelam hu polimer li mhux assorbit u li jbaxxi l- lipidi u li jorbot l- aċidi tal- bili fl- imsaren, u ma jħallihomx jerġgħu jkunu assorbiti.
The LDL-C lowering mechanism of bile acid sequestrants has been previously established as follows:
6 l- aċidu tal- bili kien stabbilit qabel kif ġej:
As the bile acid pool becomes depleted, the hepatic enzyme, cholesterol 7-α -hydroxylase, is upregulated, which increases the conversion of cholesterol to bile acids.
Hekk kif l- ammont ta ’ aċidu tal- bili jonqos sew, l- enżima epatika, cholesterol 7- α- hydroxylase, jiżdied, li jżid il- konverżjoni tal- kolesterol f’ aċidi tal- bili.
This causes an increased demand for cholesterol in the liver cells, resulting in the dual effects of increasing transcription and activity of the cholesterol biosynthetic enzyme, hydroxymethyl-glutaryl-coenzyme A (HMG-CoA) reductase, and increasing the number of hepatic low-density lipoprotein receptors.
Dan jikkaġuna żieda fil- bżonn tal- kolesterol fiċ- ċelluli tal- fwied, li jirriżulta fiż- żewġ effetti ta ’ żieda fit- transkrizzjoni u l- attività ta ’ l- enżima bijosintetika tal- kolesterol, hydroxymethyl- glutanyl- coenzyme A (HMG- CoA) reductase, u jżid in- numru ta ’ riċetturi ta ’ lipoproteini tal- fwied ta ’ densità baxxa.
A concomitant increase in very low density lipoprotein synthesis can occur.
Żjieda konkomitanti fis- sinteżi ta ’ lipoproteini ta ’ densità baxxa tista ’ tiġri.
These compensatory effects result in increased clearance of LDL-C from the blood, resulting in decreased serum LDL-C levels.
Dawn l- effetti li jikkumpensaw iwasslu għal tneħħija akbar ta ’ LDL- C mid- demm, li jwassal għal- livelli aktar baxxi ta ’ LDL- C fis- serum.
In a 6-month dose-response study in patients with primary hypercholesterolaemia receiving 3.8 or 4.5 g Cholestagel, a 15 to 18% decrease in LDL-C levels was observed, which was evident within 2 weeks of administration.
Skond studju ta ’ reazzjoni għad- doża, liema studju dam sejjer sitt xhur, kien hemm tnaqqis ta ’ bejn 15% sa 18% fil- livelli ta ’ LDL- C u dan deher fi żmien 2 ġimgħat minn meta bdiet tingħata l- kura lill- pazjenti li kienu jbatu mill- iperkolesterolimja primarja li kienu qed jirċievu 3. 8 jew 4. 5 g Cholestagel.
In addition, total-C decreased 7 to 10%, HDL-C increased 3% and triglycerides increased 9 to 10%.
Barra minn dan, total- C naqas minn 7% sa 10%, HDL- C żdid b’ 3% u t- trigliċeridi żdiedu minn 9% sa 10%.
Apo B decreased by 12%.
Apo B naqas bi 12%.
In comparison, in patients given placebo, LDL-C, total-C, HDL-C and apo-B were unchanged, while triglycerides increased 5%.
Meta ġew mqabblin ma ’ pazjenti li ngħataw il- plaċebo, LDL- C, total- C, HDL- C u apo- B baqgħu l- istess, waqt li t- trigliċeridi żdiedu b’ 5%.
Studies examining administration of Cholestagel as a single dose with breakfast, a single dose with dinner, or as divided doses with breakfast and dinner did not show significant differences in LDL-C reduction for different dosing schedules.
Studji li eżaminaw l- għoti ta ’ Cholestagel bħala doża waħda mal- kolazzjon ta ’ filgħodu, doża waħda ma ’ l- ikla ta ’ filgħaxija, jew bħala dożi maqsuma mal- kolazzjon ta ’ filgħodu u dik ta ’ filgħaxija ma wrewx l- ebda differenza sinifikanti fit- tnaqqis ta ’ LDL- C għall- skeda differenti ta ’ dożaġġ.
However, in one study triglycerides tended to increased more when Cholestagel was given as a single dose with breakfast.
Imma, fi studju wieħed, it- trigliċeridi kellhom tendenza li jiżdiedu aktar meta Cholestagel ingħata bħala doża waħda mal- kolazzjon ta ’ filgħodu.
Multi-centre, randomised, double-blind, placebo-controlled studies in 487 patients demonstrated an additive reduction of 8 to 16% in LDL-C when 2.3 to 3.8 g Cholestagel and a statin (atorvastatin, lovastatin or simvastatin) were administered at the same time.
Studji multi- centred, randomised, double - blind, ikkontrollati bil- plaċebo li kienu jinvolvu 487 pazjent urew tnaqqis addizzjonali ta ’ bejn 8% u 16% f’ LDL- C meta bejn 2. 3 g u 3. 8 g Cholestagel u statin (atorvastatin, lovastatin jew simvastatin) ngħataw flimkien.
Initiation of add-on treatment with Cholestagel subsequent to statin therapy has not been specifically studied.
Il- bidu ta ’ kura addizzjonali b’ Cholestagel wara t- terapija b’ statin ma ġiex studjat speċifikament.
Cholestagel has not been compared directly to other bile acid sequestrants in clinical trials.
Cholestagel ġie imqabbel direttament ma ’ sekwestranti oħra ta ’ l- aċidu tal- bili fi studji kliniċi.
The fenofibrate plus Cholestagel group (64 patients)
Fi studju li dam 6 ġimgħat, 129 pazjent b’ iperlipidimja mħallta kienu randomised għal fenofibrate 160 mg flimkien ma ’ 3. 8 g Cholestagel jew fenofibrate waħdu.
6 demonstrated a 10% reduction on LDL-C levels versus 2% increase for the fenofibrate group (65 patients).
Il- grupp li ngħata fenofibrate flimkien ma ’ Cholestagel (64 pazjent) wera tnaqqis ta ’ 10% fil- livelli ta ’ LDL- C kontra żieda ta ’ 2% għall- grupp ta ’ fenofibrate (65 pazjent).
Reductions were also seen for non-HDL-C, Total-C and Apo B.
It- tnaqqis kien osservat ukoll għal non- HDL- C, Total- C u Apo B.
A small 5%, non-significant increase in triglycerides was noted.
Żieda żgħira mhux sinifikanti ta ’ 5%, kienet osservata wkoll fit- triglycerides.
The effects of combination of fenofibrate and Cholestagel on the risks of myopathy or hepatotoxicity are not known.
L- effetti ta ’ kumbinazzjoni ta ’ fenofibrate u Cholestagel fuq ir- riskji ta ’ mijopatija jew epatotossiċità mhumiex magħrufa.
So far, no studies have been conducted that directly demonstrate whether treatment with Cholestagel as monotherapy or combination therapy has any effect on cardiovascular morbidity or mortality.
S’ issa, ma saru l- ebda studji li juru direttament jekk il- kura b’ Cholestagel bħala monoterapija jew terapija kombinata għandhiex kwalunkwe effett fuq il- morbożità kardjovaskulari jew il- mortalità.
Cholestagel is not absorbed from the gastrointestinal tract.
Cholestagel mhux assorbit mis- sistema gastrointestinali.
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
L- effetti fi studji mhux kliniċi kienu osservati biss f’ espożizzjonijiet li kienu kkunsidrati ogħla b’ mod suffiċjenti mill- espożizzjoni massima umana, li jindika ta ’ ftit rilevanza għall- użu kliniku.
Cellulose (E460), microcrystalline Silica, colloidal anhydrous Magnesium stearate Water, purified
Cellulose (E460), microcrystalline Silica, colloidal anhydrous Magnesium stearate
Film-coating:
Kisi b’ rita:
Hypromellose (E464) Diacetylated monoglycerides
Hypromellose (E464) Diacteylated monoglyceride
Printing ink:
Inka ta ’ l- istampar:
Iron oxide black (E172) Hypromellose (E464) Propylene glycol
Iron oxide black (E172) Hypromellose (E464) Propylene glycol
2 years.
6. 2 Inkompatibilitajiet
6.4 Special precautions for storage
Ma jgħoddx f’ dan il- kaz.
Keep the bottle tightly closed in order to protect from moisture.
Żomm il- flixkun magħluq tajjeb sabiex tilqa ’ mill- umdità.
High density polyethylene bottles with a polypropylene cap.
Fliexken tal- polyethylene ta ’ densità għolja li għandhom tapp tal- polypropylene b’ kartuna ta ’ barra.
Package sizes are:
Id- daqsijiet tal- pakkett huma:
24 tablets (1 X 24) 100 tablets (2 X 50) 180 tablets (1 X 180)
24 pillola (1 X 24) 100 pillola (2 X 50) 180 pillola (1 X 180)
7 High density polyethylene bottles with a polypropylene cap without outer carton.
Fliexken tal- polyethylene ta ’ densità għolja li għandhom tapp tal- polypropylene mingħajr il - kartuna ta ’ barra.
180 tablets (1 X 180)
180 pillola (1 X 180)
Not all pack sizes may be marketed.
Jista jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
6.6 Instructions precautions for disposal and other handling
6. 6 Prekawzjonijiet li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Genzyme Europe B. V., Gooimeer 10, NL-1411 DD Naarden, The Netherlands.
Genzyme Europe B. V., Gooimeer 10, NL- 1411 DD Naarden, l- Olanda
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /
8 ANNEX II
9 ANNESS II
Α MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U D- DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
9 A MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U D- DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Name and address of the manufacturer(s) responsible for batch release
Isem u indirizz tal- manifattur( i) responsabbli mill- ħruġ tal- lott.
B CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Not applicable.
Mhux applikabbli.
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Id- detentur ta ’ din l- awtorizzazzjoni għat- tqegħid fis- suq għandu jagħti tagħrif lill- Kummissjoni Ewropea dwar il- pjanijiet kummerċjali tal- prodott mediċinali awtorizzat b' din id- deċiżjoni.
11 A.
11 ANNESS III
12 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
TIKKETTA
OUTER CARTON AND BOTTLE LABEL (24 TABLETS)
KARTUNA TA ’ BARRA U T- TIKKETTA TAL- FLIXKUN (24 PILLOLA)
Cholestagel 625 mg film-coated tablets Colesevelam hydrochloride
Cholestagel 625 mg pilloli miksijin b’ rita Colesevelam hydrochloride
Each tablet contains 625 mg of colesevelam (as hydrochloride).
Kull pillola fiha 625 mg colesevelam (bħala hydrochloride).
24 film-coated tablets
24 pilloli miksijin b’ rita
Oral use Tablets should be taken with liquid and with a meal.
Użu orali Il- pilloli għandhom jittieħdu ma ’ xi likwidu u mal- ikel.
Gooimeer 10 1411 DD Naarden The Netherlands
Gooimeer 10 1411 DD Naarden l- Olanda
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TA ’ L- AUTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
14 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
15 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON AND BOTTLE LABEL (100 TABLETS)
KARTUNA TA ’ BARRA U T- TIKKETTA TAL- FLIXKUN (100 PILLOLA)
100 film-coated tablets
100 pilloli miksijin b’ rita
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
17 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON AND BOTTLE LABEL (180 TABLETS)
KARTUNA TA ’ BARRA U T- TIKKETTA TAL- FLIXKUN (180 PILLOLA)
180 film-coated tablets
180 pillola miksijin b’ rita
Oral use Tablets should be taken with liquid and with a meal.
Użu orali Il- pilloli għandhom jittieħdu ma ’ xi likwidu u ma ’ l- ikel.
BOTTLE LABEL (180 TABLETS) WITHOUT CARTON
TIKKETTA TAL- FLIXKUN (180 PILLOLA) MINGĦAJR IL- KARTUNA TA ’ BARRA
Keep the bottle tightly closed in order to protect from moisture.
Żomm il- flixkun magħluq tajjeb sabiex tilqa ’ mill- umdità
Cholestagel 625 mg film-coated tablets Colesevelam hydrochloride
Cholestagel 625 mg pilloli miksija b’ rita Colesevelam hydrochloride
- If you have any further questions, ask your doctor or pharmacist.
- Jekk ikollok xi mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew lill- ispiżjar tiegħek.
- This medicine has been prescribed for you.
- Din il- mediċina ġiet mogħtija għall- użu personali tiegħek.
It may harm them, even
M’ għandekx tgħaddiha lil persuni
if their symptoms are the same as yours.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollom l- istess sintomi bħall- tiegħek.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
- Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li
please tell your doctor or pharmacist.
mhumiex imniżżlin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
What Cholestagel is and what it is used for 2.
X’ inhu Cholestagel u għalxiex jintuża 2.
Before you take Cholestagel 3.
Qabel ma ’ tieħu Cholestagel 3.
How to take Cholestagel 4.
Kif għandek tieħu Cholestagel 4.
How to store Cholestagel 6.
Kif taħżen Cholestagel 6.
WHAT CHOLESTAGEL IS AND WHAT IT IS USED FOR
X’ INHU CHOLESTAGEL U GĦALXIEX JINTUŻA
Taking Cholestagel helps to lower the level of cholesterol in your blood.
Meta tieħu Cholestagel, dan jgħinek tbaxxi l- livell tal- kolesterol fid- demm tiegħek.
Your doctor should only give you Cholestagel if a diet low in fat and cholesterol did not work well enough on its own.
It- tabib tiegħek għandu jagħtik biss Cholestagel jekk id- dieta waħidha ta ’ ammonti żgħar ta ’ xaħmijiet u kolesterol, ma kinitx biżżejjed.
Cholestagel works in your intestinal system by binding bile acids produced by your liver and carrying the bile acids out of your body with your faeces.
Cholestagel jaħdem fis- sistema intestinali tiegħek billi jorbot l- aċidi tal- bili magħmula mill- fwied tiegħek u jneħħi l- aċidi tal- bili minn ġismek ma ’ l- ippurgar.
This prevents your body from recycling the bile acids from your intestines in the usual way.
Dan ma jħallix lill- ġismek jagħmel riċiklaġġ ta ’ l- aċidi tal- bili fl- imsaren tiegħek bħas- soltu.
Without the recycling process, your liver has to make additional bile acids.
Mingħajr dan il- proċess ta ’ riċiklaġġ, il - fwied tiegħek irid jagħmel aktar aċidi tal- bili.
Your liver uses cholesterol from your blood to do this, which lowers the level of cholesterol in your blood.
Il- fwied tiegħek juża l- kolesterol mid- demm tiegħek biex jagħmel dan, u b’ hekk ibaxxi l- livell tal- kolesterol f’ demmek.
Cholestagel is prescribed to treat a condition known as isolated primary hypercholesterolaemia (when cholesterol in the blood is elevated).
Cholestagel jingħata bir- riċetta tat- tabib biex jikkura kondizzjoni magħrufa bħala iperkolesterolimja primarja iżolata (meta l- kolesterol fid- demm ikun għoli).
- Cholestagel may be prescribed on its own in addition to a diet low in fat and cholesterol when
- Cholestagel għandu mnejn jingħata bir- riċetta tat- tabib waħdu flimkien ma ’ dieta li hi baxxa fix -
treatment with a statin (a class of cholesterol-lowering medicines that work in the liver) is inappropriate or not well tolerated.
xaħam u l- kolesterol meta l- kura bi statin (klassi ta ’ mediċini li jbaxxu l- kolesterol li jaħdmu fil - fwied) ma tgħoddx jew ma tkunx ittolerata tajjeb.
- Cholestagel may be used together with a statin and the diet low in fat and cholesterol when patients
- Cholestagel għandu mnejn jingħata flimkien ma ’ statin u d- dieta li jkun fiha ftit xaħam u
are not appropriately controlled by the statin on its own.
kolesterol meta l- pazjenti ma jkunux ikkontrollati b’ mod adegwat b’ statin waħdu.
BEFORE YOU TAKE CHOLESTAGEL
QABEL MA TIEĦU CHOLESTAGEL
Do not take Cholestagel
Tiħux Cholestagel
- if you are allergic (hypersensitive) to colesevelam or to any of the other ingredients of Cholestagel
- jekk inti allerġiku/ a (tbati minn sensittivita ’ eċċessiva) għal colesevelam jew sustanzi oħra
- if you have a blockage in your intestines or bile ducts (tubes that carry bile)
- jekk int għandek imblokk fl- imsaren jew fil- kanali tal- bila (tubi li minnhom tgħaddi l -
If you are prescribed Cholestagel and any other medication together you must also read the patient information leaflet that comes with that particular medicine before you start to take your medicine.
23 Jekk it- tabib jiktiblek riċetta għal Cholestagel u kwalunkwe mediċina oħra flimkien int trid taqra wkoll l- fuljett ta ’ tagħrif tal- pazjent ta ’ dik il- mediċina partikulari qabel ma tibda tieħu l- mediċina tiegħek.
22 Take special care with Cholestagel
Oqgħod attent ħafna b’ Cholestagel
- if your triglyceride levels (a blood fat) are greater than 3.4 mmol/ l
- jekk il- livelli tiegħek tat- trigliċeridi (xaħam tad- demm) huma ogħla minn 3. 4 mmol/ l
- if you have difficulty in swallowing, or have a major stomach or intestinal disorder
- jekk int issibha bi tqila biex tibla ’, jew għandek disturbi serji ta ’ l- istonku jew l- imsaren.
- if you are taking another medication called ciclosporin (a medicine used to suppress the immune
- jekk qed tieħu mediċina oħra msejħa ciclosporin (mediċina li tintuża biex trażżan is -
system)
sistema immuni).
- when taking the oral contraceptive pill at the same time or an hour before Cholestagel as it can
- meta tieħu l- pillola kontraċettiva orali kombinata fl- istess ħin jew siegħa qabel Cholestagel,
affect the effectiveness of the contraceptive.
għax dan jista ’ jaffettwa l- effettività tal- kontraċettiv.
- if you are taking anticoagulant therapy you should consult with your physician to closely monitor
- jekk qed tieħu terapija b’ mediċini li jraqqu d- demm għandek tkellem lit- tabib tiegħek biex
anticoagulation levels, as Cholestagel may affect the absorption of vitamin K and therefore interfere with the activity of warfarin, a medicine used to thin blood.
jimmonitorja mill- qrib il- livelli tal- antikoagulazzjoni, għax Cholestagel jista ’ jaffettwa l - assorbiment ta ’ vitamina K u għalhekk jinterferixxi mal- attività ta ’ warfarin, mediċina li tintuża biex traqqaq id- demm.
- if you suffer from constipation, as Cholestagel may induce or worsen this condition.
- jekk tbati mill- istitikezza, għax Cholestagel jista ’ jikkaġuna jew iħarrax din il- kundizzjoni.
This is
Dan
especially important for patients with coronary heart disease and angina pectoris
hu importanti speċjalment għal pazjenti b’ mard koronarju tal- qalb u anġina pectoris
If you think any of these apply to you, you should inform your doctor or pharmacist before taking Cholestagel.
Jekk taħseb li waħda minn dawn jgħoddu għalik, int għandek tgħarraf lit- tabib jew l- ispiżjar tiegħek qabel tieħu Cholestagel.
Cholestagel is not recommended for use in children and adolescents since its safety and efficacy have not been determined in these patients.
Cholestagel mhuwiex rakkomandat għall- użu fit- tfal u fl- adolexxenti għax is- sigurtà u l- effikaċja tagħha ma kinux stabbiliti f’ dawn il- pazjenti.
Before starting therapy with Cholestagel, your physician should make sure that certain conditions do not contribute to your elevated cholesterol levels.
Qabel tibda terapija b’ Cholestagel, it- tabib tiegħek għandu jiżgura li ċerti kondizzjonijiet ma jikkawżawx livelli għolja tal- kolesterol tiegħek.
These could include poorly controlled diabetes, untreated hypothyroidism (low levels of thyroid hormone for which no treatment is being given currently), proteins in urine (nephrotic syndrome), altered protein levels in the blood (dysproteinaemias), and blockage of the bile transport to your gall bladder (obstructive liver disease).
Dawn jinkludu dijabete li mhix ikkontrollata tajjeb, ipotirojdiżmu (livelli baxxi ta ’ l- ormon tat- tirojde li bħalissa mhix qed tingħata kura għalih) mhux ikkurat, proteina fl- awrina (sindromu nefrotiku), bidla fil- livelli tal- proteina fid- demm (disproteinimja), u imblukkar tat- trasport tal- bila għall- bużżieqa tal- marrara tiegħek (mard li jinvolvi mblukkar fil- fwied)
If your doctor suspects that Cholestagel may have an effect on the absorption of the other medication, you may be advised to take Cholestagel at least 4 hours after taking the other medication.
Jekk it- tabib tiegħek jissuspetta li Cholestagel għandu mnejn jaffetwa l- assorbiment tal- mediċini l- oħra, int għandek mnejn tingħata l- parir biex tieħu Cholestagel ta ’ l- anqas 4 sigħat wara li tieħu l - mediċina l- oħra.
Cholestagel may affect the way in which the following medicines work: • Anticoagulant therapy (medicines, such as warfarin, used to thin blood) • Thyroid replacement therapy (medicines, such as thyroxine or levothyroxine, used to treat low thyroid hormone levels) • Oral contraceptives (medicines to prevent pregnancy) It is important you take Cholestagel at least 4 hours after you take the oral contraceptive to ensure that the effectiveness of the contraceptive is not affected. • Verapamil (a medicine used to treat high blood pressure) • Antidiabetic medications (medicines, such as pioglitazone, repaglinide or glyburide used to treat diabetes) • Anti-epileptic medicines (medicines, such as phenytoin, used to treat epilepsy). • Ciclosporin (a medicine used to suppress the immune system).
Cholestagel jista’ jaffettwa l- mod kif jaħdmu dawn il- mediċini li ġejjin: • Terapija kontra l- koaġulazzjoni tad- demm (mediċini, bħal warfarin, li jintuża biex iraqqaq id- demm) • Terapija minnflok it- tirojde (mediċini bħal thyroxine jew levothyroxine li jintużaw biex jikkuraw livelli baxxi ta ’ l- ormoni tat- tirojde) • Kontraċettivi mill- ħalq (mediċini li jipprevjenju t- tqala) Hu importanti li tieħu Cholestagel mill- inqas 4 sigħat wara li tieħu l- kontraċettiv orali kombinat biex taċċerta ruħek li l- effettività tal- kontraċettiv ma tkunx affettwata. • Verapamil (mediċina li tintuża biex tikkura l- pressjoni għolja tad- demm) • Mediċini kontra d- dijabete (mediċini bħal pioglitazone, repaglinide jew glyburide li jintużaw għall- kura tad- dijabete) • Mediċini anti- epilettiċi (mediċini bħal phenytoin li jintużaw għall- kura ta ’ l- epilessija). • Ciclosporin (mediċina li tintuża biex trażżan is- sistema immuni).
If you are going to take Cholestagel and one of these medicines, your doctor may want to do tests to make sure that Cholestagel does not interfere with these medicines.
24 Jekk int qed tieħu Cholestagel u waħda minn dawn il- mediċini, it- tabib tiegħek għandu mnejn ikun irid jagħmel testijiet biex jkun ċert li Cholestagel ma jinterferixxix ma ’ dawn il- mediċini.
Additionally, if you have any condition that could cause you to have a deficiency of vitamins A, D, E or K, your doctor may want to check your vitamin levels periodically while you are taking Cholestagel.
Barra minn dan, jekk int għandek kwalunkwe kondizzjoni li tista tikkawża defiċjenza tal- vitamini A, D, E jew K, it- tabib tiegħek għandu mnejn ikun irid jiċċekkja l- livelli tal- vitamini tiegħek perjodikament waqt li int qed tieħu Cholestagel.
If necessary, your doctor may advise you to take vitamin supplements.
Jekk hemm bżonn, it- tabib tiegħek għandu mnejn jagħtik parir li għandek tieħu ammont miżjud ta ’ vitamini.
Taking Cholestagel with food and drink You should take your Cholestagel tablets with food and liquid.
Meta tieħu Cholestagel ma ’ l- ikel u max- xorb Għandek tieħu l- pilloli Cholestagel tiegħek ma ’ l- ikel u x- xorb.
23 Pregnancy and breast-feeding Tell your doctor if you are pregnant or want to become pregnant.
Tqala u treddigħ Għid lit- tabib tiegħek jekk inti tqila jew jekk trid toħroġ tqila.
Your doctor may stop your medicine.
It- tabib tiegħek jista ’ jwaqqaf il- mediċina tiegħek.
If you are prescribed Cholestagel and a statin together it is important that you tell your doctor if you are pregnant or if you are planning to become pregnant because statins must not be used during pregnancy; the patient information leaflet that comes with that particular statin should be consulted.
Jekk tingħata riċetta għal Cholestagel flimkien ma ’ statin, hu importanti li tgħid it- tabib tiegħek jekk inti tqila jew jekk qed tippjana li toħroġ tqila, għax l- istatins m’ għandhomx jintużaw waqt it- tqala; il- fuljett ta ’ tagħrif tal- pazjent li jkun ma ’ dak l- istatin partikulari għandu jiġi kkonsultat.
Tell your doctor if you are breast-feeding.
Għid lit- tabib tiegħek jekk qed tredda ’.
Driving and using machines Your ability to drive or operate machines is not affected by taking Cholestagel tablets.
Sewqan u tħaddim ta ’ magni Il- ħila tiegħek li ssuq jew tħaddem il- magni ma tkunx affettwata meta tieħu l- pilloli Cholestagel.
HOW TO TAKE CHOLESTAGEL
KIF GĦANDEK TIEĦU CHOLESTAGEL
Before starting therapy with Cholestagel, you should be advised to follow a cholesterol-lowering diet and you should continue this diet during treatment.
Qabel ma tibda t- terapija b’ Cholestagel, int suppost tingħata l- parir li toqgħod fuq dieta li tbaxxi l- kolesterol u għandek tkompli toqgħod fuq din id- dieta matul il- kura.
Always take Cholestagel exactly as your doctor has instructed you.
Dejjem għandek tieħu Cholestagel skond il- parir tat- tabib.
As described in Section 2, if you will be taking another medicine along with Cholestagel it is possible that your doctor will advise you to take this other medicine at least 1 hour prior to or at least 4 hours after taking Cholestagel.
Kif spjegajna f’ Sezzjoni 2, jekk int ser tieħu xi mediċini oħra flimkien ma ’ Cholestagel, hu possibbli lit- tabib tiegħek ser jagħtik il- parir li għandek tieħu din il- mediċina l- oħra ta ’ l- anqas siegħa qabel jew mill- inqas 4 sigħat wara li tieħu Cholestagel.
Combination therapy:
Terapija kombinata:
The usual dose for Cholestagel, when used with a statin, is 4 to 6 tablets a day by mouth.
Id- doża tas- soltu ta ’ Cholestagel, meta jintuża ma ’ statin, hi ta ’ 4 sa 6 pilloli kuljum meħuda mill - ħalq.
Your doctor may tell you to take the Cholestagel dose either once a day or twice a day; in either case Cholestagel should be taken with a meal. The dosing of the statin should follow the instructions for that particular statin.
It- tabib tiegħek jista ’ jgħidlek biex tieħu d- doża ta ’ Cholestagel jew darba kuljum jew darbtejn kuljum; fi kwalunkwe każ, Cholestagel għandu jittieħed mal- ikel.
The two medicines may be taken at the same time or at separate times according to what your doctor has prescribed.
Id- doża ta ’ statin għandha tingħata skond l- istruzzjonijiet għal dak l- istatin partikulari.
The usual dose for Cholestagel is 3 tablets taken twice a day with meals or 6 tablets a day with a meal.
Id- doża normali ta ’ Cholestagel hi ta ’ 3 pilloli li jittieħdu darbtejn kuljum ma ’ l- ikel jew 6 pilloli kuljum ma ’ l- ikla.
Your doctor may increase your dose to 7 tablets per day.
It- tabib tiegħek għandu mnejn iżidlek id- doża għal 7 pilloli kuljum.
If you take more Cholestagel than you should Please contact your doctor.
Jekk tieħu Cholestagel aktar milli suppost għandek Jekk jogħġbok ikkuntattja lit- tabib tiegħek.
Constipation or bloating could occur.
Jista ’ jkun li tkun stitiku jew tħossok minfuħ.
If you forget to take Cholestagel You may take your dose with a later meal, but never take in one day more than the total number of tablets that your doctor has prescribed to you in a single day.
Jekk tinsa tieħu Cholestagel Tista ’ tieħu d- doża tiegħek mal- ikel iktar tard, iżda m’ għandek qatt tieħu f’ ġurnata iżjed min - numru totali ta ’ pilloli li t- tabib tiegħek tak riċetta għalihom.
If you stop taking Cholestagel Your cholesterol may increase to the level it was before treatment was started.
Jekk tieqaf tieħu Cholestagel Il- kolesterol tiegħek għandu mnejn jiżdid għal- livell li kien qabel ma bdiet il- kura.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
25 Jekk ikollok aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, jekk jogħġbok staqsi lit- tabib jew lill - ispiżjar tiegħek.
Like all medicines, Cholestagel can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Cholestagel jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The following side effects have been reported in patients taking Cholestagel:
L- effetti sekondarji li ġejjin kienu rrappurtati f’ pazjenti li kienu qed jieħdu Cholestagel:
Very common (affects more than 1 user in 10): flatulence (wind), constipation.
Komuni ħafna (jaffettwaw iktar minn utent 1 minn kull 10): gass, stitikezza.
24 Common (affects 1 to 10 users in 100): vomiting, diarrhoea, indigestion, abdominal pain, abnormal stools, feeling sick, headache, raised levels of triglycerides (fats) in your blood.
Komuni (jaffettwaw minn 1 sa 10 utenti minn kull 100): rimettar, dijarea, indiġestjoni, uġigħ addominali, ippurgar anormali, tħossok imdardar, uġigħ ta ’ ras, livelli għolja ta ’ triglycerides (xaħmijiet) fid- demm tiegħek.
Uncommon (affects 1 to 10 users in 1,000): muscle pain, raised levels of liver enzymes in your blood.
Mhux komuni (jaffettwaw minn 1 sa 10 utenti minn kull 1000): uġigħ fil- muskoli, livelli għolja ta ’ enzimi tal- fwied fid- demm tiegħek.
Patients receiving Cholestagel in clinical studies were less likely to suffer flatulence (wind) and diarrhoea as patients receiving placebo (inactive tablet).
Kien osservat li l- pazjenti li kienu qed jirċievu Cholestagel fi studji kliniċi kellhom inqas ċans li jbatu mill- gass u mid- dijarea minn dawk il- pazjenti li kienu qed jirċievu l- plaċebo (pillola inattiva).
Only constipation and indigestion were reported in higher numbers among those patients receiving Cholestagel.
L- istitikezza u l- indiġestjoni biss kienu rrappurtati b’ mod iktar frekwenti fost dawk il- pazjenti li kienu qed jirċievu Cholestagel.
All side effects were usually mild or moderate in intensity.
L- effetti sekondarji kollha kienu ta ’ intensità ħafifa jew moderata.
HOW TO STORE CHOLESTAGEL
KIF TAĦŻEN CHOLESTAGEL
Do not use after the expiry date which is stated on the carton and bottle label after “ EXP’’
Tużax wara d- data ta ’ skadenza li tidher fuq it- tikketta tal- kartuna u t- tikketta tal- flixkun wara “ JIS ’’
Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma 'l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
These measures will help to protect the environment.
Dawn il- miżuri jgħinu biex għall - protezzjoni ta ’ l- ambjent.
What Cholestagel contains
X’ fih Cholestagel
- The active substance is colesevelam hydrochloride.
- Is- sustanza attiva hi colesevelam hydrochloride.
Each tablet contains 625 mg colesevelam
Kull pillola fiha 625 mg ta ’ colesevelam
hydrochloride.
hydrochloride.
- Tablet core:
- Il- qalba tal- pillola:
- Microcrystalline cellulose (E460)
- Microcrystalline cellulose (E460)
- Silica colloidal anhydrous
- Silica colloidal anhydrous
- Purified water
- Ilma ppurifikat
- Film-coating:
- Kisja tar- rita:
- Diacetylated monoglycerides
- Diacetylated monoglycerides
- Printing ink:
- Linka tal- istampar:
- Iron oxide black (E172)
- Iron oxide black (E172)
- Propylene glycol
- Propylene glycol
What Cholestagel looks like and contents of the pack
Id- dehra ta ’ Cholestagen u l- kontenuti tal- pakkett
Cholestagel tablets are off-white, capsule-shaped film-coated tablets and imprinted with ‘ Cholestagel’ on one side.
Il- pilloli Cholestagel huma ta ’ lewn abjad jew abjad jagħti fil- griż, li għandhom forma ta ’ kapsula, miksija b’ rita, li għandhom stampat ‘ Cholestagel ’ fuq naħa waħda.
The tablets are packed in plastic bottles with child resistant closures.
Il- pilloli huma ppakkjati fi fliexken tal- plastik b’ għotjien li ma jistgħux jinfetħu mit- tfal.
Pack sizes are 24 (1 x 24), 100 (2 x 50) and 180 (1 x 180) tablets.
Id- daqsijiet tal- pakkett huma 24 (1 x 24), 100 (2 x 50) u 180 (1 x 180) pilloli.
Not all pack sizes may be marketed.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur
25 Marketing Authorisation Holder and Manufacturer
Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq
Marketing authorisation holder Genzyme Europe B. V., Gooimeer 10, 1411 DD Naarden, The Netherlands
Genzyme Europe B. V., Gooimeer 10, 1411 DD Naarden, l- Olanda
Manufacturer Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Manifattur Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, l- Irlanda
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq.
This leaflet was last approved in
Dan il- fuljett kien approvat l- aħħar f ”
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA): http: // www. emea. europa. eu /
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Jispjega kif il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l - istudji mwettqa, sabiex jasal għar- rakkomandazzjonijiet tiegħu dwar kif tintuża l- mediċina.
What is CIALIS?
X' inhu CIALIS?
CIALIS is a medicine containing the active substance tadalafil.
CIALIS huwa mediċina li fiha s- sustanza attiva tadalafil.
It is available as tablets (2.5, 5, 10 and 20 mg).
Huwa disponibbli f' pilloli (2. 5, 5, 10 u 20 mg).
What is CIALIS used for?
Għal xiex jintuża CIALIS?
CIALIS is used to treat men with erectile dysfunction (sometimes called impotence) when they cannot get, or keep, a hard penis (erection) sufficient for satisfactory sexual activity.
CIALIS jintuża fit- trattament ta 'rġiel b' disfunzjoni erettili (imssejħa wkoll impotenza) li tikkonsisti mill- inkapaċità li tintlaħaq u tinżamm erezzjoni suffiċjenti għal attività sesswali sodisfaċenti.
For CIALIS to be effective, sexual stimulation is required.
Biex CIALIS ikollu effett, tinħtieġ stimulazzjoni sesswali.
How is CIALIS used?
Kif jintuża CIALIS?
The recommended dose of CIALIS is 10 mg, taken with or without food, ‘ on demand’ at least 30 minutes before sexual activity.
Id- doża rakkomandata ta 'CIALIS hi 10 mg, meħuda fuq stonku vojt jew le,' skont il- bżonn ', tal- inqas 30 minuta qabel l- attività sesswali.
The dose may be increased to 20 mg for men who do not respond to the 10-mg dose.
Id- doża tista 'tiżdied għal 20 mg għal irġiel li ma jirrispondux għad- doża ta' 10 mg.
The maximum recommended dosing frequency is once per day, but continuous daily use of 10 or 20 mg CIALIS is not recommended.
Il- frekwenza massima rakkomandata hi darba kuljum, iżda l- użu kontinwu ta 'CIALIS, kemm b' doża ta' 10 mg kif ukoll 20 mg, kuljum mhux rakkomandat.
CIALIS can be used once a day in men who intend to use it frequently (twice a week or more), based on the doctor’ s judgement.
CIALIS jista 'jintuża darba kuljum mill- irġiel li jkun biħsiebhom jagħmlu użu frekwenti (darbtejn fil - ġimgħa jew iktar), u fuq parir tat- tabib.
The dose is 5 mg once a day, but can be lowered to 2.5 mg once a day depending on how well it is tolerated.
Id- doża hi 5 mg darba kuljum, iżda tista 'titnaqqas għal 2. 5 mg darba kuljum skont kemm tkun tollerata tajjeb.
The medicine should be taken around the same time every day and the appropriateness of the once-a-day dosing should be re-assessed regularly.
Il- mediċina għandha tittieħed kuljum fl- istess ħin tal - ġurnata u d- dożaġġ ta 'kuljum għandu jinżamm regolarment aġġornat.
Patients with severe liver problems or kidney problems should not take more than 10 mg in one dose.
Il- pazjenti li jkollhom problemi gravi fil- fwied jew fil- kliewi ma għandhomx jieħdu iktar minn 10 mg f' doża waħda.
Once-a-day dosing is not recommended in patients with severe kidney problems, and should only be prescribed to patients with liver problems after a careful evaluation of the benefits and risks of taking the medicine.
Id- doża ta 'darba kuljum mhix rakkomandata għal pazjenti li jbatu minn problemi gravi fil- kliewi, u għal pazjenti li jbatu minn problemi fil- fwied għandha tiġi preskritta biss wara evalwazzjoni attenta tal- benefiċċji u r- riskji tat- teħid tal- mediċina.
How does CIALIS work?
Kif jaħdem CIALIS?
The active substance of CIALIS, tadalafil, belongs to a group of medicines called'phosphodiesterase type 5 (PDE5) inhibitors'.
Is- sustanza attiva f' CIALIS, tadalafil, hi parti minn grupp ta 'mediċini magħruf bħala' inibituri tal - fosfodjesterażi tat- tip 5 (PDE5) (phosphodiesterase type 5 inhibitors).
It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic GMP (cGMP).
Taħdem billi timblokka l - enzima fosfodjesterażi, li normalment tkisser sustanza magħrufa bħala GMP ċikliku (cGMP).
During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax, allowing the flow of blood into the corpora, producing the erection.
Waqt l - istimulazzjoni sesswali normali, il- pene jipproduċi s- cGMP u jwassal għar- rilassament tal - muskolatura tat- tessut artab tal- pene (il- corpora cavernosa) u jippermetti l- fluss tad- demm fil- corpora, u b' hekk jipproduċi l- erezzjoni.
By blocking the break down of cGMP, CIALIS restores erectile function.
Billi jiġi mblukkat it- tkissir tas- cGMP, CIALIS ireġġa 'l- funzjoni erettili għan- normal.
However, sexual stimulation is still needed.
Madankollu xorta tinħtieġ stimulazzjoni sesswali.
How has CIALIS been studied?
Kif ġie studjat CIALIS?
CIALIS, when taken ‘ on demand ’ before sexual activity, has been studied in six main studies including 1,328 patients.
CIALIS, meħud 'skont il- bżonn' qabel l- attività sesswali, ġie studjat f' sitt studji ewlenin li fihom ħadu sehem 1, 328 pazjent.
One of these studies contained only diabetic men.
F' wieħed minn dawn l- istudji ħadu sehem irġiel dijabetiċi biss.
Once-a-day dosing of CIALIS was studied in three further studies lasting 12 to 24 weeks and involving a total of 853 patients.
L- għoti ta 'doża ta' CIALIS darba kuljum ġiet studjata fi tliet studji oħra li damu bejn 12 u 24 ġimgħa u li fihom b' kollox ħadu sehem 853 pazjent.
In all studies, the effects of CIALIS were compared to those of placebo (a dummy treatment), and the main measure of effectiveness was the ability to get and maintain an erection.
Fl- istudji kollha, l- effetti ta 'CIALIS tqabblu ma' dawk ta 'plaċebo (trattament finta), u l- mezz ewlieni tal- kejl tal- effikaċja kien il- kapaċità li tintlaħaq u tinżamm erezzjoni.
This was recorded in two questionnaires completed at home.
Dan ġie rreġistrat f' żewġ kwestjonarji li mtlew id- dar.
What benefit has CIALIS shown during the studies?
X' inhu l- benefiċċju li wera CIALIS fl- istudji mwettqa?
CIALIS was significantly more effective than placebo in all studies.
CIALIS kien ferm iktar effikaċi mill- plaċebo fl- istudji kollha.
For one of the questionnaires, where the maximum score is 30, patients who recorded scores of about 15 before treatment, recorded scores of 22.6 or 25 after receiving CIALIS 10 mg or 20 mg, respectively.
F' wieħed mill- kwestjonarji, li fih il - punteġġ massimu kien 30, il- pazjenti li rreġistraw punteġġi ta 'madwar 15 qabel it- trattament, wara li ħadu CIALIS, b' doża ta' 10 mg jew 20 mg, irreġistraw punteġġi ta '22. 6 jew 25, rispettivament.
Overall, in the studies of general populations, 81% of patients reported that CIALIS ‘ on demand ’ improved their erections as compared to 35% of those taking placebo.
Globalment, fl- istudji fil- popolazzjonijiet ġenerali, 81% tal- pazjenti rrappurtaw li CIALIS meħud 'skont il- bżonn' tejjeb l- erezzjoni meta mqabbla ma '35% ta' dawk ittrattati bil- plaċebo.
Patients taking CIALIS once a day at doses of 2.5 or 5 mg also reported improved erections compared with those taking placebo.
Il- pazjenti li kienu qed jieħdu CIALIS darba kuljum f' dożi ta '2. 5 jew 5 mg ukoll irrappurtaw titjib fl - erezzjoni meta mqabbla ma' dawk ittrattati bil- plaċebo.
What is the risk associated with CIALIS?
X' inhu r- riskju assoċjat ma 'CIALIS?
The most common side effects (seen in more than 1 patient in 10) are headache and dyspepsia (indigestion).
L- effetti sekondarji l- aktar komuni (li dehru f' aktar minn pazjent 1 minn 10) kienu wġigħ ta 'ras u dispepsija (indiġestjoni).
For the full list of all side effects reported with CIALIS, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji rrappurtati b' CIALIS, ara l- Fuljett ta 'Tagħrif.
CIALIS should not be used in people who may be hypersensitive (allergic) to tadalafil or any of the other ingredients, or where sexual activity is inadvisable (e. g. in men with heart disease).
CIALIS ma għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal tadalafil jew għal xi sustanza tiegħu, u fil- każijiet li fihom jingħata parir li ma ssirx attività sesswali (eż. irġiel b' mard tal- qalb).
It should also not be taken by patients who have ever had loss of vision because of a problem with blood flow to the nerve in the eye (non-arteritic anterior ischemic optic neuropathy, NAION).
Lanqas ma għandu jintuża minn pazjenti li xi darba sofrew minn telf tal- vista minħabba xi problema fiċ- ċirkolazzjoni tad- demm lejn in- nervitura tal- għajn (newropatija ottika iskemika anterjuri mhux arteritika, NAION).
CIALIS should not be taken with nitrates (a type of medicine used for angina).
CIALIS ma għandux jittieħed man- nitrati (tip ta 'mediċina użata għall- anġina).
A doctor should consider the potential risks of sexual activity in men who have cardiovascular disease.
It- tabib għandu jikkunsidra r- riskji potenzjali tal- attività sesswali fl - irġiel li jkollhom mard kardjovaskulari.