qanastek/EMEA-V3 huggingface dataset:
A long-term oral carcinogenicity study in mice showed a low incidence of duodenal tumours, considered likely related to high local concentrations in the gastrointestinal tract at a dose of 600 mg/ kg/ day.
Studju dwar il- karċinoġeniċità orali fuq tul ta ’ żmien wera inċidenza baxxa ta ’ tumuri duwodenali, x’ aktarx ikkunsidrati relatati ma ’ konċentrazzjonijiet lokali għolja fil- passaġġ gastrointestinali f’ doża ta ’ 600 mg/ kg/ kuljum.
While the mechanism of tumour formation is uncertain, the findings are unlikely to be of relevance to humans.
Waqt li l- mekkaniżmu tal - formazzjoni ta ’ tumuri mhux ċert, is- sejbiet x’ aktarx mhumiex ta ’ rilevanza għall- bnedmin.
Emtricitabine did not show any carcinogenic potential in long-term studies in rats and mice.
Emtricitabine ma wera l- ebda potenzjal karċinoġeniku fi studji fuq tul ta ’ żmien fil- firien u l- ġrieden.
Efavirenz and emtricitabine were negative in conventional genotoxic assays.
Efavirenz u emtricitabine kienu negattivi f’ assaġġi ġenotossiċi konvenzjonali.
Tenofovir disoproxil fumarate was positive in two out of three in vitro genotoxicity studies but negative in the in vivo micronucleus assay.
Tenofovir disoproxil fumarate kien pożittiv fi tnejn minn tliet studji ta ’ ġenotossiċità in vitro iżda negattiv fl- assaġġ tal - mikronukleu in vivo.
The combination of emtricitabine and tenofovir disoproxil fumarate was positive in the in vitro mouse lymphoma assay, with comparable results to those obtained for tenofovir disoproxil fumarate alone.
Il- kumbinazzjoni ta ’ emtricitabine u tenofovir disoproxil fumarate kienet pożittiva fl- assaġġ ta ’ limfoma tal- ġurdien in vitro, b’ riżultati li qablu ma ’ dawk misjuba għal tenofovir disoproxil fumarate waħdu.
The combination of emtricitabine and tenofovir disoproxil fumarate was negative in the bacterial reverse mutation assay (Ames assay).
Il- kumbinazzjoni ta ’ emtricitabine u tenofovir disoproxil fumarate kienet negattiva fl- assaġġ ta ’ mutazzjoni batterika bil- maqlub (assaġġ Ames).
Biliary hyperplasia was observed in cynomolgus monkeys given efavirenz for ≥ 1 year at a dose resulting in mean AUC values approximately 2-fold greater than those in humans given the recommended dose.
33 Iperplasija biljari kienet osservata f’ xadini cynomolgus li ngħataw efavirenz għal ≥ sena f’ doża li rriżultat f’ valuri medji ta ’ l- AUC madwar darbtejn akbar minn dawk fi bnedmin mogħtija fid- doża rrikkmandata.
The biliary hyperplasia regressed upon cessation of dosing.
L- iperplasija biljari marret lura kif twaqqaf l- iddożar.
Biliary fibrosis has been observed in rats.
Fibrożi biljari ġiet osservata fil - firien.
Non-sustained convulsions were observed in some monkeys receiving efavirenz for ≥ 1 year, at doses yielding plasma AUC values 4- to 13-fold greater than those in humans given the recommended dose (see sections 4.4 and 4.8).
Aċċessjonijiet mhux sostenuti kienu osservati f’ xi xadini li rċevew efavirenz għal ≥ sena, f’ dożi li taw valuri ta ’ AUC fil- plażma 4 sa 13- il darba aktar għolja minn dawk fil- bnedmin mogħtija d- doża rrikkmandata (ara sezzjonijiet 4. 4 u 4. 8).
Preclinical studies of tenofovir disoproxil fumarate conducted in rats, dogs and monkeys revealed effects on bone and a decrease in serum phosphate concentration.
Studji ta ’ qabel l- użu kliniku ta ’ tenofovir disoproxil fumarate magħmula fil- firien, klieb u xadini urew effetti fuq l- għadam u tnaqqis fil- konċentrazzjoni ta ’ fosfat fis- serum.
Bone toxicity was diagnosed as osteomalacia (monkeys) and reduced bone mineral density (rats and dogs).
Tossiċità fl- għadam kienet iddijanjostikata bħala osteomalacia (xadini) u tnaqqis fid- densità minerali ta ’ l- għadam (firien u klieb).
Findings in the rat and monkey studies indicated that there was a substance-related decrease in intestinal absorption of phosphate with potential secondary reduction in bone mineral density.
Sejbiet fi studji b’ firien u xadini indikaw li kien hemm tnaqqis relatat mas- sustanza fl - assorbiment intestinali tal- fosfat bi tnaqqis sekondarju potenzjali fid- densità minerali ta ’ l- għadam.
The mechanisms of these toxicities are not completely understood.
Il - mekkaniżmi ta ’ dawn l- effetti tossiċi mhumiex kompletament mifhuma.
32 A one month dog study using the combination of emtricitabine and tenofovir disoproxil fumarate found no exacerbation of toxicological effects compared to the separate components.
Studju ta ’ xahar fil- kelb bl- użu tal- kumbinazzjoni ta ’ emtricitabine u tenofovir disoproxil fumarate ma sab l- ebda taħrix ta ’ l- effetti tossikoloġiċi mqabbla mal- komponenti separati.
Croscarmellose sodium Hydroxypropylcellulose Magnesium stearate Microcrystalline cellulose Sodium laurilsulfate
Croscarmellose sodium Hydroxypropylcellulose Magnesium stearate Microcrystalline cellulose Sodium laurilsulfate
Film-coating:
Kisja- rita:
Iron oxide black Iron oxide red Macrogol 3350 Poly(vinyl alcohol) Talc Titanium dioxide
Iron oxide black Iron oxide red Macrogol 3350 Poly( vinyl alcohol) Talc Titanium dioxide
Keep the bottle tightly closed.
Żomm il- flixkun magħluq sew.
High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure containing 30 film-coated tablets and silica gel desiccant.
Flixkun tal- polyethene ta ’ densità għolja (HDPE) b’ għatu tal- polypropylene li ma jinfetaħx mit- tfal li fih 30 pillola miksija b’ rita u dessikant tas- silika ġel.
The following pack sizes are available: outer cartons containing 1 x 30 film-coated tablet and 3 x 30 film-coated tablet bottles.
34 Id- daqsijiet tal- pakketti li ġejjin huma disponibbli: kartun ta ’ barra li fihom flixkun ta ’ 30 pillola miksija b’ rita u kartun ta ’ barra li fihom 3 fliexken ta ’ 30 pillola miksija b’ rita.
13 December 2007
13 ta ’ Diċembru 2007
Name and address of the manufacturers responsible for batch release
DETENTURI TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Fuq il- fuljett ta 'tagħrif stampat tal- prodott mediċinali għandu jkun hemm l- isem u l- indirizz tal - manifattur responsabbli għall- ħruġ tal- lott konċernat.
Medicinal product subject to restricted medical prescription (See Annex I:
Prodott mediċinali jingħata b' riċetta ristretta tat- tabib (Ara l- Anness I:
The MAH shall ensure that additional risk minimisation activities to address the renal safety concerns related to tenofovir disoproxil fumarate, one of the active substances contained in Atripla, are being implemented for this fixed combination like for all medicinal products containing tenofovir disoproxil fumarate.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq għandu jiżgura li attivitajiet ta ’ minimizzazzjoni tar- riskji addizzjonali sabiex jindirizzaw it- tħassib tas- sigurtà renali relatati ma ’ tenofovir disoproxil fumarate, wieħed mis- sustanzi attivi li hemm f’ Atripla, ikunu qegħdin jiġu implimentati għal din il - kombinazzjoni fissa bħal għal kull prodott mediċinali li fih tenofovir disoproxil fumarate.
The MAH must ensure that the system of pharmacovigilance, as described in version 2.0 (28/ 02/ 2008) and included in the Type II variation (EMEA/ H/ C/ 000797/ II/ 0003) is in place and functioning before and whilst the product is on the market.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 2. 0 (28/ 02/ 2008) u inkluża fil- varjazzjoni ta ’ Tip II (EMEA/ H/ C/ 000797/ II/ 0003) tkun fis- seħħ u li din tkun qed taħdem sewwa qabel u filwaqt li l - prodott ikun fis- suq.
Risk Management Plan
Pjan ta ’ Treġija tar- Riskji
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3 (February 2008) of the Risk Management Plan (RMP) presented with the first PSUR and any subsequent updates of the RMP agreed by the CHMP.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq iwiegħed li jwettaq l- istudji u l- attivitajiet ta ’ farmakoviġilanza addizzjonali deskritti fid- dettall fil- Pjan ta ’ Farmakoviġilanza, kif hemm qbil fuqu fil- verżjoni 3 (Frar 2008) tal- Pjan ta ’ Treġija tar- Riskji (RMP) ippreżentat ma ’ l- ewwel PSUR u kwalunkwe aġġornamenti sussegwenti tal- RMP li jkun sar qbil fuqhom 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 ’ treġija tar- Riskji għal prodotti mediċinali għall - użu mill- bniedem, l- RMP aġġornat għandu jiġi ppreżentat fl- istess ħin mar- Rapport ta ’ Aġġornament tas- Sigurtà Perjodika li jmiss (PSUR).
36 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
37 Barra minn hekk, għandu jiġi ppreżentat RMP aġġornat • Meta tiġi rċevuta informazzjoni ġdida li jista ’ jkollha impatt fuq l- Ispeċifikazzjoni tas- Sigurtà attwali, il- Pjan ta ’ Farmakoviġilanza jew l- attivitajiet ta ’ minimizzazzjoni tar- riskji • Fi żmien 60 jum minn meta tintlaħaq mira importanti (farmakoviġilanza jew minimizzazzjoni tar- riskji) • Fuq talba ta ’ l- EMEA
38 A.
38 ANNESS III
39 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
TIKKETTA
BOTTLE AND CARTON LABELLING
40 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Atripla 600 mg/ 200 mg/ 245 mg film-coated tablets efavirenz, emtricitabine and tenofovir disoproxil
Atripla 600 mg/ 200 mg/ 245 mg pilloli miksijin b’ rita efavirenz, emtricitabine u tenofovir disoproxil
Contains sodium.
Fiha s- sodju.
30 film-coated tablets 3 x 30 film-coated tablets
30 pillola miksija b’ rita 3 x 30 pillola miksija b’ rita
EU/ 1/ 07/ 430/ 001 30 film-coated tablets EU/ 1/ 07/ 430/ 002 3 x 30 film-coated tablets
EU/ 1/ 07/ 430/ 001 30 pillola miksija b’ rita EU/ 1/ 07/ 430/ 002 3 x 30 pillola miksija b’ rita
Atripla [outer packaging only]
Atripla [pakkett ta ’ barra biss]
42 PACKAGE LEAFLET:
42 B.
Atripla 600 mg/ 200 mg/ 245 mg film-coated tablets efavirenz, emtricitabine and tenofovir disoproxil
Atripla 600 mg/ 200 mg/ 245 mg pilloli miksija b’ rita efavirenz, emtricitabine u tenofovir disoproxil
What Atripla is and what it is used for 2.
X’ inhi Atripla u għalxiex tintuża 2.
Before you take Atripla 3.
Qabel ma tieħu Atripla 3.
How to take Atripla 4.
Kif għandek tieħu Atripla 4.
How to store Atripla 6.
Kif taħżen Atripla 6.
WHAT ATRIPLA IS AND WHAT IT IS USED FOR
X’ INHI ATRIPLA U GĦALXIEX TINTUŻA
Atripla contains three active substances that are used to treat human immunodeficiency virus (HIV) infection:
Atripla fiha tliet sustanzi attivi li jintużaw biex jittrattaw infezzjoni bil- virus ta ’ l- immunodefiċjenza (HIV) tal- bniedem:
- Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI)
- Efavirenz huwa inibitur non- nucleoside reverse transcriptase (NNRTI)
- Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI)
- Emtricitabine huwa inibitur nucleoside reverse transcriptase (NRTI)
- Tenofovir is a nucleotide reverse transcriptase inhibitor (NtRTI)
- Tenofovir huwa inibitur nucleotide reverse transcriptase (NtRTI)
Each of these active substances, also known as antiretroviral medicines, work by interfering with an enzyme (reverse transcriptase) that is essential for the virus to multiply.
Kull waħda minn dawn is- sustanzi attivi, magħrufa wkoll bħala mediċini antiretrovirali, jaħdmu billi jxekklu l- enzima (reverse transcriptase) li hija essenzjali biex il- virus jimmultiplika.
Atripla is a treatment for Human Immunodeficiency Virus (HIV) infection in adults aged 18 and over who have previously been treated with other antiretroviral medicines and have their HIV-1 infection under control for at least three months.
Atripla hija trattament għall- Virus ta ’ l- immunodefiċjenza (HIV) f’ adulti ta ’ 18- il sena u aktar li kienu ġew ittrattati b’ mediċini antiretrovirali oħra u kellhom l- infezzjoni ta ’ l- HIV- 1 tagħhom ikkontrollata għal mill- anqas tliet xhur.
Patients must not have experienced failure of a previous HIV therapy.
Il- pazjenti ma jridux ikunu esperjenzaw falliment ta ’ terapija preċedenti kontra l- HIV.
BEFORE YOU TAKE ATRIPLA
QABEL MA TIEĦU ATRIPLA
Do not take Atripla
Tiħux Atripla
- if you are allergic (hypersensitive) to efavirenz, emtricitabine, tenofovir, tenofovir disoproxil
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal efavirenz, emtricitabine, tenofovir,
fumarate, or any of the other ingredients of Atripla listed at the end of this leaflet.
tenofovir disoproxil fumarate, jew xi sustanzi oħra ta’ Atripla elenkati fit- tarf ta ’ dan il- fuljett.
- if you have severe liver disease.
- jekk għandek mard tal- fwied sever.
- if you are currently taking any of the following medicines:
- jekk bħalissa qed tieħu xi mediċini minn dawn li ġejjin:
astemizole or terfenadine (used to treat hay fever or other allergies) bepridil (used to treat heart disease) cisapride (used to treat heartburn) ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraines and cluster headaches)
astemizole jew terfenadine (użati biex jittrattaw il- hay fever jew allerġiji oħra) bepridil (użat biex jittratta mard tal- qalb) cisapride (użat biex jittratta l- ħruq ta ’ stonku) alkalojdi ta ’ l- ergotina (per eżempju, ergotamine, dihydroergotamine, ergonovine, u methylergonovine) (użati biex jittrattaw emigranji u wġigħ ta ’ ras tat- tip cluster)
midazolam or triazolam (used to help you sleep) pimozide (used to treat certain mental conditions)
midazolam jew triazolam (użati biex jgħinuk torqod) 44
St.
pimozide (użat biex jittratta ċerti kundizzjonijiet mentali) St.
John’ s wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety)
John’ s wort (Hypericum perforatum) (rimedju tal- ħxejjex użat għad- depressjoni u l - ansjetà)
voriconazole (used to treat fungal infections)
voriconazole (użati biex jittrattaw infezzjonijiet fungali)
If you are taking any of these medicines, tell your doctor immediately.
Jekk qed tieħu xi mediċini minn dawn, għid lit- tabib minnufih.
Taking these medicines with Atripla could cause serious or life-threatening side effects or stop these medicines from working properly.
It- teħid ta ’ dawn il- mediċini ma ’ Atripla jista ’ jikkaġuna effetti sekondarji serji jew ta ’ theddida għal ħajja jew iwaqqaf lil dawn il - mediċini milli jaħdmu sewwa.
Take special care with Atripla
Oqgħod attent ħafna b’ Atripla
- Women should not get pregnant during treatment with Atripla and for 12 weeks
- Nisa m’ għandhomx joħorġu tqal waqt it- trattament b’ Atripla u għal 12- il ġimgħa minn
thereafter (see Pregnancy and breast-feeding).
dakinhar ’ il quddiem (ara Tqala u treddigħ).
- Do not give Atripla to children and adolescents under 18 years of age.
- Tagħtix Atripla lil tfal u adoloxxenti ta ’ taħt it- 18- il sena.
The use of Atripla in
L- użu ta ’ Atripla fit- tfal u l -
children and adolescents has not yet been studied.
adoloxxenti għadu ma ġiex studjat.
- You can still pass on HIV when taking this medicine, so it is important to take precautions to
- Xorta tista ’ tgħaddi l- HIV waqt li tkun qed tieħu dil- mediċina, għalhekk huwa importanti li
avoid infecting other people through sexual contact or blood transfer.
tieħu prekawzjonijiet biex tevita li tinfetta nies oħra permezz ta ’ kuntatt sesswali jew trasferiment tad- demm.
This medicine is not a cure for HIV infection.
Din il- mediċina mhix kura għal infezzjoni ta ’ l- HIV.
While taking Atripla you may still develop infections or other illnesses associated with HIV infection.
Waqt li tkun qed tieħu Atripla inti għadek tista ’ tiżviluppa infezzjonijiet jew mard ieħor assoċjat ma ’ infezzjoni ta ’ l- HIV.
- You must remain under the care of your doctor while taking Atripla.
- Waqt li tkun qed tieħu Atripla trid tibqa ’ taħt il- kura tat- tabib tiegħek.
- Tell your doctor:
- Għid lit- tabib tiegħek:
if you are taking other medicines that contain efavirenz, emtricitabine, tenofovir disoproxil, lamivudine or adefovir dipivoxil.
jekk qed tieħu mediċini oħra li fihom efavirenz, emtricitabine, tenofovir disoproxil, lamivudine jew adefovir dipivoxil.
Atripla should not be taken with any of these medicines.
Atripla m’ għandhiex tittieħed ma ’ kwalunkwe mediċina minn dawn.
if you have or have had kidney disease, or if tests have shown problems with your kidneys.
jekk għandek jew kellek mard tal- kliewi, jew jekk it- testijiet urew problemi bil- kliewi tiegħek.
Atripla is not recommended if you have moderate to severe kidney disease.
Atripla mhix irrikkmandata jekk ikollok mard tal- kliewi ħafif għal moderat.
Atripla may affect your kidneys.
Atripla tista ’ taffettwa l- kliewi tiegħek.
Before starting treatment, your doctor may order blood tests to assess kidney function.
Qabel tibda t- trattament, it- tabib tiegħek jista ’ jordnalek testijiet tad- demm biex jassessja l- funzjoni tal- kliewi.
Your doctor may also order blood tests during treatment to monitor your kidneys.
It- tabib tiegħek jista ’ ukoll jordna testijiet tad- demm waqt it- trattament biex jissorvelja l- kliewi tiegħek.
Atripla is not usually taken with other medicines that can damage your kidneys (see Taking other medicines).
Atripla ġeneralment ma titteħidx ma ’ mediċini oħra li jistgħu jagħmlu ħsara lill- kliewi tiegħek (ara Meta tieħu mediċini oħra).
If this is unavoidable, your doctor will monitor your kidney function once a week.
Jekk dan ma jistax jiġi evitat, it- tabib tiegħek jissorvelja l- funzjoni tal- kliewi tiegħek darba fil- ġimgħa.
if you have a history of mental illness, including depression, or of substance or alcohol abuse.
jekk għandek storja ta ’ mard mentali, inkluża depressjoni, jew abbuż ta ’ sustanzi jew alkoħol.
Tell your doctor immediately if you feel depressed, have suicidal thoughts or have strange thoughts (see Section 4, Possible side effects).
Għid lit- tabib tiegħek immedjatament jekk tħossok imdejjaq, għandek ħsibijiet suwiċidali jew ħsibijiet strambi (ara Sezzjoni 4, Effetti sekondarji li jista ’ jkollha).
if you have a history of convulsions (fits or seizures) or if you are being treated with anticonvulsant therapy such as carbamazepine, phenobarbital and phenytoin.
jekk għandek storja ta ’ aċċessjonijiet jew jekk qed tiġi ttrattat b’ terapija kontra l - aċċessjonijiet bħal carbamazepine, phenobarbital u phenytoin.
If you are taking any of these medicines, your doctor may need to check the level of anticonvulsant medicine in your blood to ensure that it is not affected while taking Atripla.
Jekk qed tieħu xi waħda minn dawn il- mediċini, it- tabib tiegħek jista ’ jkollu bżonn jiċċekkja l- livell fid- demm tal - mediċina kontra l- aċċessjonijiet biex jassigura li mhix qed tiġi affettwata waqt li tkun qed tieħu Atripla.
Your doctor may give you a different anticonvulsant.
It- tabib tiegħek jista ’ jagħtik mediċina kontra l- aċċessjonijiet differenti.
if you have a history of liver disease, including chronic active hepatitis.
jekk għandek storja ta ’ mard tal- fwied, inkluża epatite attiva kronika.
Patients with liver disease including chronic hepatitis B or C, who are treated with combination antiretrovirals, have a higher risk of severe and potentially life-threatening liver problems.
45 kkombinati, għandhom riskju ogħla ta ’ problemi tal- fwied serji u potenzjalment ta ’ theddid għall- ħajja.
Your doctor may conduct blood tests in order to check how well your liver is working.
It- tabib tiegħek jista ’ jagħmel testijiet tad- demm sabiex jiċċekkja kemm qed jaħdem sew il- fwied tiegħek.
If you have severe liver disease, do not take Atripla (see earlier in Section 2, Do not take Atripla).
Jekk għandek mard tal- fwied sever, tiħux Atripla (ara aktar kmieni f’ Sezzjoni 2, Tiħux Atripla).
44 If you have hepatitis B infection, symptoms may become worse after discontinuation of Atripla.
Jekk għandek infezzjoni ta ’ l- epatite B, is- sintomi jistgħu jsiru agħar wara t- twaqqif ta ’ Atripla.
Your doctor may then conduct blood tests at regular intervals in order to check how well your liver is working (see Section 3, If you stop taking Atripla).
It- tabib tiegħek imbaghad jista ’ jagħmel testijiet tad- demm f’ intervalli regolari sabiex jiċċekkja kemm qed jaħdem sewwa l- fwied tiegħek (ara Sezzjoni 3, Jekk tieqaf tieħu Atripla).
-
Terapiji
Combination antiretroviral therapies (including Atripla) may raise blood sugar levels, increase blood fats (hyperlipaemia), cause changes to body fat, and resistance to insulin (see Section 4, Possible side effects).
antiretrovirali kkombinata (inkluża Atripla) jistgħu jgħollu l- livelli taz- zokkor fid- demm, iżidu x- xaħmijiet fid- demm (iperlipidimja), jikkaġunaw tibdil fix- xaħam tal- ġisem, u reżistenza għall- insulina (ara Sezzjoni 4, Effetti sekondarji li jista ’ jkollha).
-
Ġew studjati numri insuffiċjenti ta ’ pazjenti ta ’ ’ l
Insufficient numbers of patients over 65 years of age have been studied.
fuq minn 65 sena.
If you are over 65 years of age and are prescribed Atripla, your doctor will monitor you carefully.
Jekk għandek ’ il fuq minn 65 sena u tingħata Atripla b’ riċetta tat- tabib, it- tabib tiegħek jissorveljak bir- reqqa.
- Once you start taking Atripla, look out for:
La darba tibda tieħu Atripla, oqgħod attent għal:
possible signs of lactic acidosis.
- sinjali possibbli ta ’ aċidożi lattika.
Some HIV medicines, including Atripla, that contain nucleoside analogues can cause lactic acidosis (excess of lactic acid in your blood), together with an enlarged liver.
analogi tan- nukleosidi, jistgħu jikkaġunaw aċidożi lattika (eċċess ta ’ aċidu lattiku f’ demmek), flimkien ma ’ fwied minfuħ.
Deep, rapid breathing, drowsiness, and symptoms such as feeling sick (nausea), vomiting and stomach pain, might indicate the development of lactic acidosis.
Nifs mgħaġġel u fil- fond, ħedla, u sintomi bħal dardir (nawsja), rimettar u uġigħ fl- istonku, jistgħu jindikaw l- iżvilupp ta ’ aċidożi lattika.
This rare but serious side effect has occasionally been fatal.
Dan l- effett sekondarju rari iżda serju ġieli kien fatali.
Lactic acidosis occurs more often in women, particularly if they are very overweight, and people with liver disease.
Aċidożi lattika sseħħ aktar spiss fin- nisa, partikolarment jekk ikollhom ħafna piż żejjed, u nies b’ mard tal- fwied.
While you are being treated with Atripla, your doctor will monitor you closely for any signs that you may be developing lactic acidosis.
Waqt li tkun qed tiġi ttrattat b’ Atripla, it- tabib tiegħek se jissorveljak bir- reqqa għal kwalunkwe sinjali li tkun qed tiżviluppa aċidożi lattika.
If you notice any symptoms of lactic acidosis, please tell your doctor immediately.
Jekk tinnota xi sintomi ta ’ aċidożi lattika, għid lit- tabib tiegħek minnufih.
signs of dizziness, difficulty sleeping, drowsiness, difficulty concentrating or abnormal dreaming.
- sinjali ta ’ sturdament, diffikultà fl- irqad, ħedla, diffikultà fil- konċentrazzjoni jew
These side effects may start in the first 1 or 2 days of treatment and usually go away after the first 2 to 4 weeks.
Dawn l- effetti sekondarji jistgħu jibdew fl- ewwel jew fit- tieni jum tat - trattament u ġeneralment imorru wara l- ewwel ġimagħtejn sa 4 ġimgħat.
any signs of skin rash.
- kwalunkwe sinjali ta ’ raxx fil- ġilda.
Rashes may be caused by Atripla.
Raxxijiet jistgħu jkunu kkaġunati minn Atripla.
If you see any signs of a severe rash with blistering or fever, stop taking Atripla and tell your doctor at once.
Jekk tara kwalunkwe sinjal ta ’ raxx sever bl- infafet jew deni, ieqaf milli tieħu Atripla u għid lit- tabib tiegħek minnufih.
If you had a rash while taking another NNRTI, you may be at higher risk of getting a rash with Atripla.
Jekk kellek raxx waqt it- teħid ta ’ NNRTI ieħor, tista ’ tkun f’ riskju akbar li jkollok raxx b’ Atripla.
-
- kwalunkwe sinjali ta ’ infjammazzjoni jew infezzjoni.
any signs of inflammation or infection.
F’ xi pazjenti b’ infezzjoni ta ’
In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
l- HIV avvanzata (AIDS) u bi storja ta ’ infezzjoni opportunistika, sinjali u sintomi ta ’ infjammazzjoni minn infezzjonijiet ta ’ qabel jistgħu jseħħu wara li jinbeda trattament kontra l- HIV.
It is believed that these symptoms are due to improvement in the body’ s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Huwa maħsub li dawn is- sintomi huma minħabba titjib fir- reazzjoni immunitarja tal- ġisem, li jħalli lill- ġisem jiġġieled infezzjonijiet li jistgħu jkunu preżenti mingħajr sintomi ovvji.
If you notice any symptoms of infection, please tell your doctor at once.
Jekk tinnota xi sintomi minn dawn, jekk jogħġbok informa lit - tabib tiegħek minnufih.
-
Xi pazjenti li jkunu qed jieħdu terapija antiretrovirali kkombinata
Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
jistgħu jiżviluppaw marda ta ’ l- għadam imsejħa osteonekrosi (mewt tat- tessut ta ’ l - għadam ikkaġunata minn telf tal- provvista tad- demm lill- għadam).
The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
It- tul taż- żmien ta ’ terapija antiretrovirali kkombinata, l- użu ta ’ kortikosterojdi, il- konsum ta ’ l- alkoħol, immunosoppressjoni severa, indiċi tal- massa tal- ġisem aktar għoli, fost l- oħrajn, jistgħu jkunu xi ftit mill- ħafna fatturi ta ’ riskju għall- iżvilupp ta ’ din il- marda.
Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Sinjali ta ’ osteonekrosi huma ebusija fil- ġoġi, uġigħat (speċjalment fil- ġenb, fl- irkoppa u fl- ispalla)
If you notice any of these symptoms please inform your doctor.
Jekk tinnota xi wieħed minn dawn is- sintomi informa lit- tabib tiegħek.
Bone problems (sometimes resulting in fractures) may also occur in patients who develop damage to kidney tubule cells (see Section 4, Possible side effects).
Problemi fl- għadam (li xi kultant jirriżultaw fi ksur) jistgħu jseħħu wkoll f’ pazjenti li jiżviluppaw ħsara liċ- ċelloli tubuli tal- kliewi (ara Sezzjoni 4, Effetti sekondarji li jista ’ jkollha).
You must not take Atripla with certain medicines.
M’ għandekx tieħu Atripla ma ’ ċerti mediċini.
These are listed under Do not take Atripla, at the start of Section 2.
Dawn huma elenkati taħt Tiħux Atripla, fil- bidu ta ’ sezzjoni 2.
They include some common medicines and some herbal remedies (including St.
Dawn jinkludu xi mediċini komuni u xi rimedji tal- ħxejjex (inkluża St.
John’ s wort) which can cause serious interactions.
John’ s Wort) li tista ’ tikkaġuna interazzjonijiet serji.
45 Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra.
This includes non-prescription medicines and herbal remedies.
Dawn jinkludu mediċini mingħajr riċetta u rimedji tal- ħxejjex.
Also, Atripla should not be taken with any other medicines that contain efavirenz, emtricitabine, tenofovir disoproxil, lamivudine or adefovir dipivoxil.
Barra minn hekk, Atripla m’ għandhiex tittieħed ma ’ kwalunkwe mediċini oħra li fihom efavirenz, emtricitabine, tenofovir disoproxil, lamivudine jew adefovir dipivoxil.
Tell your doctor if you are taking other medicines which may damage your kidneys.
Għid lit- tabib tiegħek jekk qed tieħu xi mediċini oħra li jistgħu jagħmlu ħsara lill- kliewi tiegħek.
Some examples include:
Xi eżempji jinkludu:
- aminoglycosides, vancomycin (medicines for bacterial infections)
- aminoglycosides, vancomycin (mediċini għal infezzjonijiet batteriċi)
- foscarnet, ganciclovir, cidofovir (medicines for viral infections)
- foscarnet, ganciclovir, cidofovir (mediċini għal infezzjonijiet virali)
- amphotericin B, pentamidine (medicines for fungal infections)
- amphotericin B, pentamidine (mediċini għal infezzjonijiet fungali)
- interleukin-2 (to treat cancer)
- interleukin- 2 (biex jittratta l- kanċer)
Atripla may interact with other medicines.
Atripla tista ’ taħdem fuq mediċini oħra.
As a result, the amounts of Atripla or other medicines in your blood may be affected.
B’ riżultat ta ’ dan, l- ammonti ta ’ Atripla jew mediċini oħra fid- demm tiegħek jistgħu jkunu affettwati.
This may stop your medicines from working properly, or may make any side effects worse.
Dan jista ’ jtellef il- mediċini tiegħek milli jaħdmu kif suppost, jew jagħmlu xi effetti sekondarji agħar.
It is important to tell your doctor if you are taking any of the following:
Huwa importanti li tgħid lit- tabib tiegħek jekk qed tieħu kwalunkwe minn dawn li ġejjin:
- Medicines containing didanosine (for HIV infection): taking Atripla with other antiviral
- Mediċini li fihom didanosine (għal infezzjoni ta ’ l- HIV): it- teħid ta ’ Atripla ma ’ mediċini
medicines that contain didanosine can raise the levels of didanosine in your blood and may reduce CD4 cell counts.
antivirali oħra li fihom didanosine jistgħu jgħollu l- livelli ta ’ didanosine fid- demm tiegħek u jistgħu jnaqqsu l- għadd taċ- ċelloli CD4.
Inflammation of the pancreas and lactic acidosis (excess lactic acid in the blood), which sometimes caused death, have been reported rarely when medicines containing tenofovir disoproxil fumarate and didanosine were taken together.
Infjammazzjoni tal- frixa u aċidożi lattika (eċċess ta ’ aċidu lattiku fid- demm), li tista ’ xi kultant tikkaġuna l- mewt, ġew irrapportati rarament meta mediċini li fihom tenofovir disoproxil fumarate u didanosine ttieħdu flimkien.
Your doctor will carefully consider whether to treat you with medicines containing tenofovir and didanosine.
It- tabib tiegħek jikkunsidra bir- reqqa jekk jittrattakx b’ mediċini li fihom tenofovir u didanosine.
- Other medicines used for HIV infection: the following protease inhibitors: amprenavir,
- Mediċini oħra użati f’ infezzjoni ta ’ l- HIV: l- inibituri protease li ġejjin: amprenavir,
indinavir, lopinavir/ ritonavir, ritonavir, or ritonavir boosted atazanavir or saquinavir.
indinavir, lopinavir/ ritonavir, ritonavir, jew ritonavir qawwew atazanavir jew saquinavir.
Your doctor may consider giving you an alternative medicine or changing the dose of the protease inhibitors.
It - tabib tiegħek jista ’ jikkunsidra li jagħtik mediċina alternattiva jew ibiddel id- doża ta ’ l- inibituri protease.
- Medicines used to lower blood fats (also called statins): atorvastatin, pravastatin, simvastatin.
- Mediċini użati biex ibaxxu x- xaħmijiet fid- demm (imsejħa wkoll statins): atorvastatin,
Atripla can reduce the amount of statins in your blood.
Atripla tista ’ tnaqqas l- ammont ta ’ statins fid- demm tiegħek.
Your doctor will check your cholesterol levels and will consider changing the dose of your statin, if needed.
It- tabib tiegħek jiċċekkja l- livelli tal- kolesterol tiegħek u jikkunsidra li jbiddel id- doża ta ’ l- istatin tiegħek, jekk meħtieġ.
- Medicines used to treat convulsions/ seizures (anticonvulsants): carbamazepine, phenytoin,
- Mediċini użati biex jittrattaw aċċessjonijiet (antikonvulsanti): carbamazepine, phenytoin,
phenobarbital.
phenobarbital.
Atripla can reduce the amount of the anticonvulsant in your blood.
Atripla tista ’ tnaqqas l- ammont ta ’ mediċina kontra l- aċċessjonijiet fid- demm tiegħek.
Carbamazepine can reduce the amount of efavirenz, one of the components of Atripla, in your blood.
Carbamazepine tista ’ tnaqqas l- ammont ta ’ efavirenz, wieħed mill- komponenti ta ’ Atripla, fid- demm tiegħek.
Your doctor may need to consider giving you a different anticonvulsant.
It- tabib tiegħek jista ’ jikkunsidra li jagħtik mediċina kontra l - aċċessjonijiet differenti.
- Medicines used to treat bacterial infections, including tuberculosis and AIDS-related
- Mediċini użati biex jittrattaw infezzjonijiet batteriċi, inklużi tuberkolożi u l- kumpless relatat
mycobacterium avium complex: clarithromycin, rifabutin, rifampicin.
ma ’ l- AIDS u mycobacterium avium: clarithromycin, rifabutin, rifampicin.
Your doctor may need to consider changing your dose or giving you an alternative antibiotic.
It- tabib tiegħek jista ’ jikkunsidra li jbiddillek id- doża jew jagħtik antibijotiku alternattiv.
In addition, your doctor may consider giving you an additional dose of efavirenz to treat your HIV infection.
Barra minn hekk, it - tabib tiegħek jista ’ jikkunsidra jagħtik doża addizzjonali ta ’ efavirenz biex jittratta l- infezzjoni ta ’ l- HIV tiegħek.
- Medicines used to treat fungal infections (antifungals): itraconazole.
- Mediċini użati biex jittrattaw infezzjonijiet fungali (antifungali): itraconazole.
Atripla can reduce the
Atripla tista ’
amount of itraconazole in your blood.
tnaqqas l- ammont ta ’ itraconazole fid- demm tiegħek.
Your doctor may need to consider giving you a different antifungal.
It- tabib tiegħek jista ’ jikkunsidra li jagħtik antifungali differenti.
- Hormonal contraceptives (e. g. the pill or contraceptive implant).
- Kontraċettivi ormonali (eż. il- pillola jew impjant kontraċettiv).
Because the potential for
Minħabba li l- potenzjal ta ’
efavirenz, a component of Atripla, to interact with hormonal contraceptives has not been fully studied, a reliable method of barrier contraception (for example, a condom) should always be used in addition to the hormonal contraceptive (see Section Pregnancy and breast-feeding).
efavirenz, komponent ta ’ Atripla, li jinteraġixxi ma ’ ormoni kontraċettivi ma ġiex studjat bi sħiħ, metodu sikur ta ’ kontraċezzjoni tat- tip barriera (per eżempju, kondom) għandu jintuża dejjem flimkien ma ’ kontraċettiv ormonali (ara sezzjoni Tqala u treddigħ).
- Methadone, a medicine used to treat opiate addiction, as your doctor may need to change your
- Methadone, mediċina użata biex tittratta l- vizzju ta ’ l- opijati, għax it- tabib tiegħek jista ’ jkun
methadone dose.
jeħtieġ li jbiddillek id- doża tiegħek tal- methadone.
- Sertraline, a medicine used to treat depression, as your doctor may need to change your dose of
- Sertraline, mediċina użata biex tittratta d- depressjoni, għax it- tabib tiegħek jista ’ jkun jeħtieġ li
sertraline.
jbiddillek id- doża ta ’ sertraline.
- Diltiazem or similar medicines (called calcium channel blockers): when you start taking
- Diltiazem jew mediċini simili (imsejħa imblokkaturi tal- kanal tal- kalċju): meta tibda tieħu
Atripla, your doctor may need to adjust your dose of the calcium channel blocker.
Atripla, it- tabib tiegħek jista ’ jkun jeħtieġ li jbiddillek id- doża ta ’ l- imblokkatur tal- kanal tal - kalċju.
- Medicines containing tacrolimus (a medicine used to prevent organ transplant rejection, also
- Mediċini li fihom tacrolimus (mediċina użata għall- prevenzjoni tar- rifjut tat- trapjant ta ’
called immunosuppressant).
organu, imsejħa wkoll immunosoppressant).
When you start or stop taking Atripla your doctor will closely monitor your plasma levels of tacrolimus and may need to adjust its dose.
Meta tibda tieħu jew tieqaf tieħu Atripla, it- tabib tiegħek ser jimmonitorja mill- qrib il- livelli ta ’ tacrolimus fil- plażma u jista ’ jkun li jkollu bżonn li jagħmel aġġustament fid- doża.
46 Pregnancy and breast-feeding
Tqala u treddigħ
Women should not get pregnant during treatment with Atripla and for 12 weeks thereafter.
In- nisa m’ għandhomx joħorġu tqal waqt it- trattament b’ Atripla u għal 12- il ġimgħa minn dakinhar ’ il quddiem.
Your doctor may require you to take a pregnancy test to ensure you are not pregnant before starting treatment with Atripla.
It- tabib tiegħek jista ’ jitolbok tagħmel test tat- tqala biex jassigura li m’ intix tqila qabel tibda trattament b’ Atripla.
If you could get pregnant while receiving Atripla, you need to use a reliable form of barrier contraception (for example, a condom) with other methods of contraception including oral (pill) or other hormonal contraceptives (for example, implants, injection).
Jekk tista ’ tinqabad tqila waqt li tkun qed tirċievi Atripla, jeħtieġ li tuża forma sikura ta ’ kontraċezzjoni tat- tip barriera (per eżempju, kondom) flimkien ma ’ metodi oħra ta ’ kontraċezzjoni li jinkludu orali (il- pillola) jew kontraċettivi ormonali oħra (per eżempju, impjanti, injezzjoni).
Efavirenz, one of the active components of Atripla, may remain in your blood for a time after therapy is stopped.
Efavirenz, wieħed mill- komponenti attivi ta ’ Atripla, jista ’ jibqa ’ f’ demmek għal xi żmien wara li titwaqqaf it- terapija.
Therefore, you should continue to use contraceptive measures, as above, for 12 weeks after you stop taking Atripla.
Għaldaqstant, inti għandek tibqa ’ tuża miżuri kontraċettivi, bħal ta ’ hawn fuq, għal 12- il ġimgħa wara li tieqaf tieħu Atripla.
Tell your doctor immediately if you are pregnant or intend to become pregnant.
Għid lit- tabib tiegħek minnufih jekk inti tqila jew għandek l- intenzjoni li toħroġ tqila.
If you are pregnant, you should take Atripla only if you and your doctor decide it is clearly needed.
Jekk inti tqila, għandek tieħu Atripla biss jekk inti u t- tabib tiegħek tiddeċiedu li hemm bżonn ċar.
Serious birth defects have been seen in unborn animals and in the babies of women treated with efavirenz during pregnancy.
Difetti serji tat- twelid dehru f’ feti ta ’ annimali u trabi ta ’ nisa ttrattati b’ efavirenz matul it- tqala.
If you have taken Atripla during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Jekk ħadt Atripla waqt it- tqala tiegħek, it- tabib tiegħek jista ’ jitlob testijiet regolari tad- demm u testijiet dijanjostiċi oħra biex jissorvelja l- iżvilupp tat- tarbija tiegħek.
Do not breast-feed during treatment with Atripla.
Treddax matul trattament b’ Atripla.
Both HIV and the ingredients of Atripla may pass through breast milk and cause serious harm to your baby.
Kemm l- HIV kif ukoll is- sustanzi ta ’ Atripla jistgħu jgħaddu minn ġol- ħalib tas- sider u jikkaġunaw ħsara serja lit- tarbija tiegħek.
Atripla may cause dizziness, impaired concentration and drowsiness.
Atripla tista ’ tikkaġuna sturdament, konċentrazzjoni mxekkla u ħedla.
If you are affected, do not drive and do not use any tools or machines.
Jekk tkun affettwat, issuqx u tużax għodod jew magni.
Important information about some of the ingredients of Atripla
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Atripla
This medicine contains 1 mmol (23.6 mg) of sodium per tablet which should be taken into consideration if you are on a controlled sodium diet.
Din il- mediċina fiha 1 mmol (23. 6 mg) ta ’ sodju għal kull pillola, ħaġa li għandha tittieħed f’ konsiderazzjoni jekk tkun fuq dieta bis- sodju kkontrollat.
HOW TO TAKE ATRIPLA
KIF GĦANDEK TIEĦU ATRIPLA
Always take Atripla exactly as your doctor has told you.
Dejjem għandek tieħu Atripla skond il- parir tat- tabib tieġhek.
The usual dose for adults is one tablet taken each day by mouth.
Id- doża li s- soltu tingħata għall- adulti hija pillola meħuda kuljum mill- ħalq.
Atripla should be taken on an empty stomach (commonly defined as 1 hour before or 2 hours after a meal).
Atripla għandha tittieħed fuq stonku vojt (definit komunament bħala siegħa qabel jew sagħtejn wara l- ikel).
Swallow Atripla whole with water.
Ibla ’ Atripla sħiħa ma ’ l- ilma.
Atripla must be taken every day.
Atripla għandha tittieħed kuljum.
It can help to take Atripla at bedtime.
Jista ’ jgħin jekk tieħu Atripla fil- ħin ta ’ l- irqad.
This may make some side effects (for example, dizziness, drowsiness) less troublesome.
Dan jista ’ jagħmel xi effetti sekondarji (per eżempju, sturdament, ħedla) anqas ta ’ inkwiet.
If your doctor decides to stop one of the components of Atripla, you may be given efavirenz, emtricitabine and/ or tenofovir disoproxil separately or with other medicines for the treatment of your HIV infection.
Jekk it- tabib tiegħek jiddeċiedi li jwaqqaf wieħed mill- komponenti ta ’ Atripla, tista ’ tingħata efavirenz, emtricitabine u/ jew tenofovir disoproxil separatament jew ma ’ mediċini oħra għat - trattament ta ’ l- infezzjoni ta ’ l- HIV tiegħek.
47 If you take more Atripla than you should
Jekk tieħu Atripla aktar milli suppost
If you accidentally take too many Atripla tablets, contact your doctor or nearest emergency department for advice.
Jekk aċċidentalment tieħu pilloli żejda ta ’ Atripla, ikkuntattja lit- tabib tiegħek jew lill- eqreb dipartiment ta ’ l- emerġenza għal parir.
Keep the tablet bottle with you so that you can easily describe what you have taken.
Żomm il- flixkun tal- pilloli miegħek sabiex tkun tista ’ tiddeskrivi faċilment dak li tkun ħadt.
If you forget to take Atripla
Jekk tinsa tieħu Atripla
It is important not to miss a dose of Atripla.
Huwa importanti li ma taqbiżx doża ta ’ Atripla.
If you do miss a dose of Atripla, take it as soon as you can, and then take your next dose at its regular time.
Jekk taqbeż doża ta ’ Atripla, ħudha kemm jista ’ jkun malajr, imbagħad ħu d- doża li jmiss fil- ħin regolari tagħha.
If it is almost time (less than 12 hours) for your next dose anyway, do not take the missed dose.
Jekk ikun wasal il- ħin (anqas minn 12- il siegħa) għad- doża li jmissek, tiħux id- doża li qbiżt.
Wait and take the next dose at the regular time.
Stenna u ħu d- doża li jmiss fil- ħin regolari.
Do not take a double dose to make up for a forgotten tablet.
M’ għandekx tieħu doża doppja biex tpatti għall- pillola li tkun insejt tieħu.
If you throw up the tablet (just after taking Atripla), you should take another tablet.
Jekk tirremetti l- pillola (eżatt wara li tkun ħadt Atripla), għandek tieħu pillola oħra.
Do not wait until your next dose is due.
Toqgħodx tistenna sakemm isir il- ħin għad- doża li jmiss.
If you stop taking Atripla
Jekk tieqaf tieħu Atripla
Don’ t stop taking Atripla without talking to your doctor.
Tiqafx tieħu Atripla mingħajr ma tkellem lit- tabib tiegħek.
Stopping Atripla can seriously affect your response to future treatment.
It- twaqqif ta ’ Atripla jista ’ jaffettwa serjament ir- reazzjoni tiegħek għal trattament futur.
If Atripla is stopped, speak to your doctor before you restart taking Atripla tablets.
Jekk titwaqqaf Atripla, kellem lit- tabib tiegħek qabel terġa ’ tibda tieħu l- pilloli Atripla.
Your doctor may consider giving you the components of Atripla separately if you are having problems or need your dose adjusted.
It- tabib tiegħek jista ’ jikkunsidra li jagħtik il- komponenti ta ’ Atripla separatament jekk qed ikollok problemi jew teħtieġ li d- doża tiegħek tiġi aġġustata.
When your supply of Atripla starts to run low, get more from your doctor or pharmacist.
Meta l- provvista tiegħek ta ’ Atripla tibda tonqos, ġib aktar mingħand it- tabib jew l- ispiżjar tiegħek.
This is very important because the amount of virus may start to increase if the medicine is stopped for even a short time.
Dan huwa importanti ħafna minħabba li l- ammont tal- virus jista ’ jibda jiżdied jekk il - mediċina tiġi mwaqqfa anke jekk għal żmien qasir.
The virus may then become harder to treat.
Il- virus imbagħad jista ’ jsir aktar diffiċli biex jiġi ttrattat.
If you have both HIV infection and hepatitis B, it is especially important not to stop your Atripla treatment without talking to your doctor first.
Jekk għandek infezzjoni kemm bl- HIV kif ukoll bl- epatite B, huwa speċjalment importanti li ma twaqqafx it- trattament b’ Atripla mingħajr ma l- ewwel tkellem lit- tabib tiegħek.
Some patients have had blood tests or symptoms indicating that their hepatitis has got worse after stopping emtricitabine or tenofovir disoproxil fumarate (two of the three components of Atripla).
Xi pazjenti kellhom testijiet tad- demm jew sintomi li jindikaw li l- epatite tagħhom marret għall- agħar wara li waqqfu emtricitabine jew tenofovir disoproxil fumarate (tnejn mit- tliet komponenti ta’ Atripla).
If Atripla is stopped your doctor may recommend that you resume hepatitis B treatment.
Jekk Atripla titwaqqaf it- tabib tiegħek jista ’ jirrakkomanda li tkompli t- trattament ta ’ l- epatite B.
You may require blood tests to check how your liver is working for 4 months after stopping treatment.
Jista ’ jkollok 49 bżonn testijiet tad- demm biex jiġi ċċekkjat kif qed jaħdem il- fwied tiegħek għal 4 xhur wara t- twaqqif tat- trattament.
In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to worsening of your hepatitis, which may be life-threatening.
F’ xi pazjenti b’ mard avvanzat tal- fwied jew ċirrożi, it- twaqqif tat- trattament mhuwiex rakkomandat għax dan jista ’ jwassal li l- epatite tiegħek tmur għall- agħar, li jista ’ jkun ta ’ theddid għall- ħajja.
Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection.
Għid lit- tabib tiegħek minnufih dwar sintomi ġodda jew mhux tas- soltu wara li twaqqaf it- trattament, partikolarment sintomi li tassoċja ma ’ infezzjoni ta ’ l- epatite B.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet fuq l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- spiżjar tiegħek.
Like all medicines, Atripla can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Atripla jista ’ jkollha effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
When treating HIV infection, it is not always possible to tell whether some of the unwanted effects are caused by Atripla or by other medicines that you are taking at the same time, or by the HIV disease itself.
Meta tkun qed tittratta infezzjoni bl- HIV, mhux dejjem possibbli tgħid jekk xi wħud mill- effetti mhux mixtieqa humiex ikkaġunati minn Atripla jew minn xi mediċini oħra li tkun qed tieħu fl- istess ħin, jew permezz tal- marda ta ’ l- HIV innifisha.
Tell your doctor if you notice any of the following side effects:
Għid lit- tabib tiegħek jekk tinnota xi wieħed mill- effetti sekondarji li ġejjin:
48 Very common side effects (These can affect more than 1 user in 10)
Effetti sekondarji komuni ħafna (Dawn jistgħu jaffettwaw aktar minn 1 minn kull 10 utenti)
- dizziness, headache, diarrhoea, feeling sick (nausea), vomiting
- sturdament, uġigħ ta ’ ras, dijarea, dardir (nawsja), rimettar
- rashes (including red spots or blotches sometimes with blistering and swelling of the skin),
- raxxijiet (inklużi tikek ħomor jew dbabar xi kultant bi nfafet u nefħa tal- ġilda), li jistgħu jkunu
which may be allergic reactions
reazzjonijiet allerġiċi.
Tests may also show:
Testijiet jistgħu juru wkoll:
- decreases in phosphate levels in the blood
- tnaqqis fil- livelli tal- fosfat fid- demm
- increased levels of creatine kinase in the blood that may result in muscle pain and weakness
- livelli miżjuda ta ’ creatine kinase fid- demm li jistgħu jirriżultaw f’ uġigħ u dgħjufija fil- muskoli.
Common side effects (These can affect 1 to 10 users in 100)
Effetti sekondarji komuni (Dawn jistgħu jaffettwaw 1 sa 10 utenti f’ kull 100)
- changes in skin colour including darkening of the skin in patches often starting on hands and
- tibdil fil- kulur tal- ġilda inkluż swidija tal- ġilda fi rqajja ’ ta ’ spiss jibdew fuq l- idejn u l- qigħan
soles of feet
tas- saqajn
- pain, stomach pain
- uġigħ, uġigħ fl- istonku
- difficulty sleeping, abnormal dreams, nightmares, sweating at night, difficulty concentrating,
- diffikultà fl- irqad, holm anormali, ħmar il- lejl, għaraq matul il- lejl, diffikultà fil -
drowsiness
konċentrazzjoni, ħedla
- feeling worried or depressed, mood being affected
- tħossok ansjuż jew depress, burdata li tkun affettwata
- problems with digestion resulting in discomfort after meals, wind (flatulence)
- problemi bid- diġestjoni li jirriżultaw fi dwejjaq wara l- ikel, gass (flatulenza)
- loss of appetite
- telf ta ’ aptit
- hot flushes
- fwawar tal- menopawsa
- feeling weak, tiredness and lack of energy
- tħossok dgħajjef, għeja u nuqqas ta ’ enerġija
- increased energy
- żieda fl- enerġija
- itching
- ħakk.