qanastek/EMEA-V3 huggingface dataset:
Pfizer Service Company Hog Wei 10-B-1930 Zaventem Belgium
Pfizer Service Company Hog Wei 10- B- 1930 Zaventem Il- Belġju
Summary of Product Characteristics, section 4.2)
Sommarju tal- Karatteristiċi tal - Prodott sezzjoni 4. 2)
The MAH must agree the details of a controlled distribution system with the National Competent Authorities and must implement such programme nationally to ensure that, prior to prescribing, all doctors who intend to prescribe Thelin are provided with a physician information pack containing the following: • Product information • Physician information about Thelin
L- MAH għandu jiftiehem dwar id- dettalji ta ’ sistema kkontrollata ta ’ distribuzzjoni ma ’ l- Awtoritajiet Kompetenti Nazzjonali u jrid jimplimenta programm bħal dan lokalment biex jiżgura li, qabel ma jiktbu r- riċetta, it- tobba kollha li jkollhom l- intenzjoni li joħorġu riċetta ta ’ Thelin, jiġu pprovduti b’ pakkett ta ’ tagħrif għat- tobba li jkun fih dan li ġej:
15 • Patient information card • Partner of patient information card
15 • Tagħrif dwar il- prodott • Tagħrif għat- tobba dwar Thelin • Karta ta ’ tagħrif għall- pazjent • Karta ta ’ tagħrif għas- sieħeb/ a tal- pazjent/ a
• That Thelin is hepatotoxic o Need for liver function tests prior to and during treatment o Contraindication in patients with pre-existing hepatic impairment (Child-Pugh Class A-C). o Need for close monitoring if liver enzymes measure > 3 × upper limit normal (ULN): > 3 and ≤ 5 x ULN:
• Li Thelin hu epatotossiku o Il- ħtieġa ta ’ testijiet tal- funzjoni tal- fwied qabel u waqt il- kura o Kontra- indikazzjoni f’ pazjenti li kellhom indeboliment tal- fwied li kien jeżisti minn qabel (Child- Pugh Class A- C). o Il- ħtieġa ta ’ monitoraġġ mill- qrib jekk il- kejl ta ’ l- enzimi tal- fwied ikun > 3 x il- limitu normali ta ’ fuq (ULN): > 3 u ≤5 × ULN:
Confirm by another liver test within 2 weeks.
Ikkonferma billi tagħmel test ieħor tal- fwied fi żmien • ġimagħtejn.
If the aminotransferase levels return to pre-treatment values, return to monthly liver testing. > 5 and ≤ 8 x ULN:
Jekk il- livelli ta ’ aminotransferases jerġgħu lura għall- valuri ta ’ qabel bdiet il- kura, erġa mur lura għat- testijiet tal- fwied ta ’ kull xahar. > 5 u ≤ 8 x ULN:
Confirm by another liver test; if confirmed, stop treatment and monitor aminotransferase levels at least every 2 weeks until levels have normalised.
Ikkonferma billi tagħmel test ieħor tal- fwied; jekk dan ikun • ikkonfermat, waqqaf il- kura u segwi l- livelli ta ’ aminotransferases ta ’ l- inqas kull ġimagħtejn sakemm il- livelli jiġu għan- normal.
If the aminotransferase levels return to pre-treatment values, reintroducing Thelin may be considered. > 8 x ULN: treatment must be stopped and reintroduction of Thelin is not to be considered.
It- trattament għandu jitwaqqaf u m’ għandux ikun kkunsidrat li jerġa jinbeda Thelin
• Effect of Thelin on bleeding o Interaction with warfarin and vitamin K antagonists leading to an increased INR o Need to decrease established dose of vitamin K antagonist upon starting sitaxentan therapy o Start vitamin K antagonists treatment at a reduced dose if already on sitaxentan sodium o Need for regular monitoring of INR o Be aware of the potential for haemorrhage and investigate as appropriate o Increased risk of epistaxis and gingival bleeding
• L- effett ta ’ Thelin fuq il- ħruġ tad- demm o Interazzjoni ma ’ warfarin u antagonisti ta ’ vitamina K li jwasslu għal żieda fl- INR o Il- ħtieġa li tnaqqas id- doża stabbilita ta ’ l- antagonisti ta ’ vitamina K meta tibda t - terapija b’ sitaxentan o Ibda l- kura bl- antagonisti ta ’ vitamina K b’ doża mnaqqsa jekk diġà qed jingħata sitaxentan sodium o Il- ħtieġa ta ’ monitoraġġ regolari ta ’ l- INR o Kun af dwar il- potenzjal ta ’ emorraġija u investiga kif suppost o Żieda fir- riskju li tinfaraġ u ħruġ ta ’ demm ġinġivali
• That there is an interaction with ciclosporin A which may lead to higher blood concentration of Thelin and hence an increased risk of adverse reactions.
• Li hemm interazzjoni ma ’ ciclosporin A li tista ’ twassal għal konċentrazzjoni ogħla ta ’ Thelin fid- demm u għaldaqstant riskju akbar ta ’ reazzjonijiet avversi.
• That the safety database of Thelin is limited and physicians are encouraged to enrol patients in a surveillance programme to increase knowledge about the incidence of important adverse drug reactions (ADRs).
• Li d- database tas- sigurtà ta ’ Thelin hi limitata u li t- tobba huma mħeġġa biex jirreġistraw il - pazjenti fil- programm ta ’ sorveljanza biex jiżdied l- għarfien dwar l- inċidenza ta ’ reazzjonijiet
The information collected should include: o Anonymised patient details – age, sex and aetiology of PAH o Concomitant medications o Reason for discontinuation o ADRs o All serious ADRs o Increase in hepatic enzymes to > 3 × ULN o Anaemia o Haemorrhage 16
It- tagħrif miġbur għandu jinkludi: o Dettalji anonimi tal- pazjent – età, sess u etoloġija tal- PAH o Mediċini li jittieħdu fl- istess ħin o Raġuni dwar għaliex Thelin m’ għadux jingħata o ADRs ○ L- ADRs serji kollha ○ Żieda fl- enzimi tal- fwied sa > 3 x ULN ○ Anemija ○ Emorraġija ○ Tqala u r- riżultat ○ Edema pulmonari (assoċjata ma ’ mard okklużiv tal- vini) ○ Interrazzjonijiet issuspettati ○ ADRs mhux mistennija skond l- SPC.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 5 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan ta ’ Mmaniġġjar ta ’ Riskju Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq jobbliga ruħu li jwettaq studji u attivitajiet oħra ta ’ Farmakoviġilanza kif dettaljat fil pjan ta ’ Farmakoviġilanza, kif miftiehem f’ versjoni 5 tal - Pjan ta ’ mmaniġġjar tar- riskju (RMP) kif preżentat f’ Modulu 1. 8. 2 ta ’ l - applikazzjoni għat- tqegħid fis- suq u kull tiġdid tal RMP miftiehem mas- CHMP.
Blister Carton
FOLJA
Thelin 100 mg film-coated tablets Sitaxentan sodium
Thelin 100 mg pilloli miksija b’ rita Sitaxentan sodium
Each tablet contains 100 mg of sitaxentan sodium
Kull pillola fiha 100 mg ta ’ sitaxentan sodium
Contains lactose monohydrate
Fih lactose monohydrate
14 film-coated tablets in blisters 28 film-coated tablets in blisters 56 film-coated tablets in blisters 84 film-coated tablets in blisters
14- il pillola miksija b’ rita fil- folji 28 pillola miksija b’ rita fil- folji 56 pillola miksija b’ rita fil- folji 84 pillola miksija b’ rita fil- folji
For oral use Read the package leaflet before use.
Jittieħed mill- ħalq Aqra l- fuljett ta ’ tagħrif qabel l- użu.
{MM/ YYYY}
(XX/ SSSS)
Encysive (UK) Limited Alder Castle House 10 Noble Street London EC2V 7QJ United Kingdom
Encysive (UK) Limited Alder Castle House 10 Noble Street London EC2V 7QJ Ir- Renju Unit
EU/ 1/ 06/ 353/ 001 (14 film-coated tablets in blisters) EU/ 1/ 06/ 353/ 002 (28 film-coated tablets in blisters) EU/ 1/ 06/ 353/ 003 (56 film-coated tablets in blisters) EU/ 1/ 06/ 353/ 004 (84 film-coated tablets in blisters)
EU/ 1/ 06/ 353/ 001 (14- il pillola miksija b’ rita f’ folji) EU/ 1/ 06/ 353/ 002 (28 pillola miksija b’ rita f’ folji) EU/ 1/ 06/ 353/ 003 (56 pillola miksija b’ rita f’ folji) EU/ 1/ 06/ 353/ 004 (84 pillola miksija b’ rita f’ folji)
To be written in braille at time of manufacture.
Għandha tinkiteb bil- braille meta ssir il- produzzjoni.
PVC/ ACLAR/ paper-backed aluminium blisters
PVC/ ACLAR / Folji ta ’ l- aluminju b’ dahar tal- karti
22 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
22 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Bottle Label (fix-a form)
Tikketta tal- Flixkun (waħħal tikketta)
Each tablet contains 100 mg of sitaxentan sodium
Kull pillola fiha 100 mg of sitaxentan sodium
Conatains lactose monohydrate
Fih lactose monohydrate
You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you.
Jista ’ jkollok bżonn terġa ’ taqrah. • Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek • Din il- mediċina ġiet mogħtija lilek.
It may harm them, even if their symptoms are the same as yours. • If any side effect becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek. • Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek..
What Thelin is and what it is used for 2.
X’ inhu Thelin u għalxiex jintuża 2.
Before you take Thelin 3.
Qabel ma tieħu Thelin 3.
How to take Thelin 4.
Kif għandek tieħu Thelin 4.
How to store Thelin 6.
Kif taħżen Thelin 6.
WHAT THELIN IS AND WHAT IT IS USED FOR
X’ INHU THELIN U GĦALXIEX JINTUŻA
Thelin is used to help lower blood pressure in the blood vessels when this pressure is raised in pulmonary arterial hypertension (PAH).
Thelin jintuża biex jgħin ibaxxi l- pressjoni tad- demm fl- arterji u l- vini tad- demm meta din il- pressjoni togħla minħabba pressjoni eċċessiva fl- arterji pulmonari (PAH).
Pulmonary arterial hypertension is the term used when the heart struggles to pump blood to the lungs.
Il- pressjoni eċċessiva fl- arterji pulmonari huwa t- terminu użat meta l- qalb tbati biex tippompja d- demm lill- pulmuni.
Thelin lowers the blood pressure by widening these vessels, so your heart can pump blood more effectively.
Thelin ibaxxi l - pressjoni tad- demm billi jwessa ’ dawn l- arterji u l- vini tad- demm, biex b’ hekk il- qalb tkun tista ’ tippompja d- demm b’ mod aktar effettiv.
This will make it easier for you to do more activities.
Dan jagħmilha aktar faċli għalik biex tkun tista ’ tagħmel aktar attivitajiet.
BEFORE YOU TAKE THELIN
QABEL MA TIEĦU THELIN
Do not take Thelin: • If you are allergic (hypersensitive) to sitaxentan sodium or any of the other ingredients in these tablets; • If you have or have had a serious liver problem; • If you have raised levels of some liver enzymes (detected by blood tests); • If you are taking Ciclosporin A (used to treat psoriasis and rheumatoid arthritis, and to prevent rejection of liver or kidney transplants); • If you are breast-feeding (please read the section ‘ Pregnancy and breast-feeding’ below); • If you are a child or adolescent under 18 years old.
Tieħux Thelin: • Jekk inti allerġiku (tbati minn sensittività eċċessiva) għal sitaxentan sodium jew sustanzi oħra f’ dawn il- pilloli; • Jekk għandek jew kellek xi problema serja tal- fwied; • Jekk għandek livelli għolja ta ’ xi enzimi tal- fwied (misjuba permezz ta ’ testijiet tad- demm); • Jekk qed tieħu Ciclosporin A (li jintuża biex jittratta l- psorjasi u l- artrite rewmatojde, u sabiex jimpedixxi li jiġu rriġettati trapjanti tal- fwied u tal- kliewi); • Jekk qed tredda ’ (jekk jogħġbok aqra t- taqsima ‘ Tqala u Treddigħ ’ aktar ’ l isfel); • Jekk int tifel/ tifla jew adoloxxent taħt it- 18- il sena.
Take special care with Thelin: • If you could get pregnant or are pregnant (please read the section “ Pregnancy and breast-feeding” below); • If you develop liver problems or symptoms that might relate to the liver (see ‘ Testing for liver problems’, below); • If you are taking or begin to take anticoagulants (e. g. warfarin, acenocoumarol, fenprocoumon or fluindione) to prevent blood clots.
Oqgħod attent ħafna b’ Thelin: • Jekk tista tinqabad tqila jew inti tqila (jekk jogħġbok aqra t- taqsima “ Tqala u Treddigħ ” aktar ’ l isfel); • Jekk jiżviluppawlek problemi tal- fwied jew sintomi li jistgħu jkunu marbuta mal- fwied (ara ‘ Ittestjar għal problemi tal- fwied ’, hawn taħt); • Jekk int qed tieħu jew ser tibda tieħu mediċini anti- koagulanti (e. g. warfarin, acenocoumarol, fenprocoumon jew fluindione) sabiex timpedixxi l- formazzjoni ta ’ emboli tad- demm.
The dose of these medicines may need to be adjusted by your doctor. • If you are taking a statin (e. g. pravastatin or simvastatin). • If you are taking a high dose of nifedipine.
Id- doża ta ’ dawn il- mediċini għandha mnejn tkun teħtieġ li tiġi aġġustata mit- tabib tiegħek. • Jekk qed tieħu xi statin (eż. pravastatin jew simvastatin). • Jekk qed tieħu doża qawwija ta ’ nifedipine.
26 If any of these apply to you, tell your doctor before you start taking Thelin.
26 Jekk xi wieħed minn dawn japplika għalik, għarraf lit- tabib tiegħek qabel ma tibda tieħu Thelin.
The following two blood tests will be carried out before you first take Thelin and at intervals during treatment
Ser isirulek iż- żewġ testijiet tad- demm li ġejjin, qabel ma tibda tieħu Thelin u f’ intervalli waqt il- kura.
Testing for liver problems Thelin may affect your liver.
Ittestjar għal problemi tal- fwied Thelin jista ’ jaffettwalek il- fwied.
Your doctor will take blood tests to check that your liver is working properly, before and during treatment with Sitaxentan sodium.
It- tabib tiegħek ser jeħodlok testijiet tad- demm sabiex jiċċekkja li l - fwied tiegħek qed jaħdem sew qabel u waqt il- kura b’ Sitaxentan sodium.
It is important to have these tests every month during treatment, even if you do not have any symptoms at all.
Huwa importanti li dawn it - testijiet jibqgħu jsiru kull xahar waqt il- kura, anke jekk ma jkollok l- ebda sintomu.
If you notice any of these signs: • feeling sick (nausea) • being sick (vomiting) • loss of appetite • fever • unusual tiredness • pain in the stomach (abdominal pain) • yellow colouring of the skin and eyes (jaundice) Talk to your doctor immediately.
Jekk tinnota xi wieħed minn dawn is- sinjali: • tħossok ma tiflaħx (dardir) • tkun marid (rimettar) • titlef l- aptit • deni • għeja mhux tas- soltu • uġigħ fl- istonku (uġigħ addominali) • kulur safrani fil- ġilda jew fl- għajnejn (suffejra) Kellem lit- tabib tiegħek minnufih.
These may be signs that your liver is not working properly.
Dawn jistgħu jkunu sinjali li l- fwied tiegħek mhux qed jaħdem sew.
Testing for anaemia This blood test will be done before treatment, then one month and three months after you start taking Thelin tablets.
Ittestjar għall- anemija Dan it- test tad- demm isir qabel ma tibda l- kura, imbagħad xahar wara u tliet xhur wara li tibda tieħu l- pilloli Thelin.
Following this, the test will continue to be done every three months to check for anaemia (a reduced amount of red blood cells).
Wara dan, it- test jibqa ’ jsir kull tliet xhur sabiex it- tabib jiċċekkja għall- anemija (ammont imnaqqas ta ’ ċelluli tad- demm il- ħomor).
For your own safety, it is very important that you have regular blood tests.
Għas- sigurtà tiegħek, huwa importanti ħafna li jsirulek testijiet tad- demm regolari.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew jekk dan l- aħħar ħadt xi mediċini oħra.
This includes medicines you bought without a prescription, herbal remedies and vitamins.
Dawn jinkludu mediċini li xtrajt migħajr riċetta, mediċina magħmula mill- ħxejjex u vitamini.
These medicines may interfere with the effect of Thelin.
Dawn il- mediċini jistgħu jinterferixxu ma ’ l- effett ta ’ Thelin.
Do not take Thelin if you are taking Ciclosporin A.
M’ għandekx tieħu Thelin jekk qed tieħu Ciclosporin A
Thelin should be used with caution if you are taking or begin to take Vitamin K antagonists (e. g. warfarin, acenocoumarol, fenprocoumon or fluindione).
Thelin għandu jintuża b’ attenzjoni jekk qed tieħu jew tibda tieħu antagonisti tal- Vitamina K (eż. warfarin, acenocoumarol, fenprocoumon jew fluindione).
Driving and using machines Do not drive or use any tools or machines if you feel dizzy.
Sewqan u tħaddim ta ’ magni M’ għandekx issuq jew tuża għodda jew tħaddem magni jekk tħossok stordut.
Pregnancy and breast-feeding If you are able to get pregnant, you must use effective contraception while taking Thelin.
Tqala u Treddigħ Jekk inti tista ’ tinqabad tqila, għandek tuża kontraċezzjoni effettiva waqt li qed tieħu Thelin.
Your doctor will advise you about suitable contraception.
It- tabib tiegħek għandu jagħtik parir dwar kontraċezzjoni adattata.
Your doctor may recommend monthly pregnancy tests while you are taking Thelin.
It- tabib tiegħek jista ’ jirrakkomanda testijiet tat- tqala kull xahar meta tkun qed tieħu Thelin.
If you miss a period or think you may be pregnant, contact your doctor right away.
Jekk il- pirjid ma jiġikx jew taħseb li nqbadt tqila, għarraf lit- tabib tiegħek minnufih.
Tell your doctor at once if you are or plan to become pregnant in the near future.
Jista ’ jkun li hu jew hi jkunu jridu jwaqqfuk milli tieħu Thelin.
Do not breast-feed if you are taking this medicine, it is not known if it passes into breast milk.
Għarraf lit- tabib tiegħek minnufih jekk inti tqila jew jekk qed tippjana li tinqabad tqila fil- futur qrib.
Important information about some of the ingredients of Thelin Thelin tablets contain lactose monohydrate.
M’ għandekx tredda ’ jekk qed tieħu din il- mediċina, għax mhux magħruf jekk jgħaddix fil- ħalib ta ’ l - omm.
27 3.
27 Tagħrif importanti dwar xi sustanzi ta ’ Thelin Il- pilloli Thelin fihom lactose monohydrate.
HOW TO TAKE THELIN
KIF GĦANDEK TIEĦU THELIN
The usual dose is a 100 mg tablet once a day.
Id- doża li s- soltu tingħata hi ta ’ pillola ta ’ 100 mg darba kuljum.
Always take Thelin exactly as your doctor has told you.
Dejjem għandek tieħu Thelin skond il- parir tat- tabib.
Check with your doctor or pharmacist if you are not sure. • Try to take the tablet at the same time each day to help you remember.
Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju. • Ipprova ħu l- pillola fl- istess ħin kuljum sabiex jgħinek tiftakar.
It does not matter whether you take it with or without food.
Ma tagħmilx differenza jekk teħodhiex fuq l- ikel jew fuq stonku vojt.
Do not take more than one tablet each day.
Tieħux aktar minn pillola waħda kuljum.
You may need to take Thelin for a month or two before feeling any effect.
Għandu mnejn ikollok bżonn tieħu Thelin għal xahar jew xahrejn qabel tħoss xi effett.
If you take more Thelin than you should If you realise you have taken more Thelin tablets than your doctor has recommended (or if someone else has taken some of your Thelin tablets), contact your doctor straight away.
Jekk tieħu aktar Thelin milli suppost Jekk tinduna li ħadt aktar pilloli Thelin minn dak irrakkomandat mit- tabib tiegħek (jew jekk xi ħadd ieħor ħa xi pilloli Thelin minn tiegħek), ikkuntattja lit- tabib tiegħek minnufih.
If you cannot reach your doctor, go to the nearest hospital and take the pack with you.
Jekk ma tistax tikkuntattja lit- tabib tiegħek, mur fl- eqreb sptar u ħu miegħek il- pakkett.
If you forget to take Thelin If you miss a dose, take the missed dose as soon as you remember but do not take two tablets in one day.
Jekk tinsa tieħu Thelin Jekk tinsa tieħu doża, ħu d- doża li nsejt tieħu malli tiftakar, imma tieħux żewġ pilloli kuljum.
If you stop taking Thelin Talk to your doctor before stopping treatment.
Jekk tieqaf tieħu Thelin Kellem lit- tabib tiegħek qabel ma twaqqaf il- kura.
Like all medicines, Thelin can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Thelin jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Very common side effects (likely to affect more than 1 in 10 patients): • headache
Effetti sekondarji komuni ħafna (li x’ aktarx jaffettwaw iktar minn persuna 1 minn kull 10 pazjenti): • uġigħ ta ’ ras
Common side effects (likely to affect more than 1 in every 100 people): • swelling in the arms and legs • being unable to sleep • blocked nose and nosebleeds • bleeding from the gums • feeling and/ or being sick, difficulty in passing stools, stomach ache, indigestion and diarrhoea • flushed • cramp in muscles • dizziness • feeling tired • your blood may take longer to clot. • yellowing of the skin or eyes (jaundice) and persistent nausea and/ or vomiting may indicate changes in liver function
Effetti sekondarji komuni (li x’ aktarx jaffettwaw iktar minn persuna 1 minn kull 100 ruħ): • nefħa fid- dirgħajn u r- riġlejn • ma tistax torqod • imnieħer misdud u tinfaraġ • ħruġ ta ’ demm mill- ħanek • tħossok u/ jew tkun ma tiflaħx, issibha diffiċli biex tipporga, uġigħ fl- istonku, indiġestjoni u dijarea • fwawar • bugħawwieġ fil- muskoli • sturdament • tħossok għajjien • id- demm tiegħek jista ’ jdum aktar biex jagħqad. • kulur safrani fil- ġilda jew fl- għajnejn (suffejra) u nawżja u/ jew rimettar persistenti li jistgħu jindikaw bdil fil- funzjoni tal- fwied
Rare side effects (likely to affect less than 1 in 1000 people): • Liver damage • Rash • Anaemia (low blood count)
Effetti sekondarji rari (li x’ aktarx jaffettwaw inqas minn persuna 1 minn kull 1000 ruħ): • Ħsara fil- fwied • Raxx • Anemija (ammont imnaqqas ta ’ ċelluli tad- demm il- ħomor)
For more details on liver problems, see ‘ Testing for liver problems’ in section 2.
Għal aktar dettalji fuq problemi tal- fwied, ara ‘ Ittestjar għal problemi tal- fwied ’ f’ taqsima 2.
If any of the side effects become serious, or if you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.
28 Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għarraf lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE THELIN
KIF TAĦŻEN THELIN
Do not use Thelin after the expiry date which is stated on the blister pack, bottle or carton after EXP.
Tużax Thelin wara d- data ta ’ skadenza li tidher fuq il- folja, fuq il- flixkun jew fuq il- kartuna wara EXP.
Do not store above 25°C.
Taħżinx f’ temperatura ta ’ ’ l fuq minn 25°C.
Ask your pharmacist how to dispose of medicines you no longer require.
Staqsi lill- ispiżjar dwar kif għandek tarmi mediċini li m’ għandekx bżonn.
What Thelin contains • The active substance is sitaxentan sodium.
X’ fih Thelin • Is- sustanza attiva hi sitaxenan- sodium.
The other ingredients are: • The tablet core contains cellulose, microcrystalline (E460), lactose monohydrate, hypromellose (E464), sodium starch glycolate, magnesium stearate (E470b), anhydrous disodium phosphate (E339), ascorbyl palmitate (E304), disodium edetate and monobasic sodium phosphate (E339). • The film-coat contains stearic acid (E570b), hypromellose (E464), microcrystalline cellulose (E460), titanium dioxide (E171), yellow iron oxide dehydrate (E172), red iron oxide dehydrate (E172) and talc (E553b).
Is- sustanzi l- oħra huma: • Il- qalba tal- pillola tikkonsisti minn cellulose, microcrystalline (E460), lactose monohydrate, hypromellose (E464), sodium starch glycolate, magnesium stearate (E470b), anhydrous disodium phosphate (E339), ascorbyl palmitate (E304), disodium edetate u monobasic sodium phosphate (E339). • Il- kisi tar- rita jikkonsisti minn stearic acid (E570b), hypromellose (E464), microcrystalline cellulose (E460), titanium dioxide (E171), yellow iron oxide dihydrate (E172), red iron oxide dihydrate (E172) u talc (E553b).
What Thelin tablets look like and contents of the pack Thelin 100 mg film-coated tablets are yellow-to-orange, capsule-shaped tablets, marked with T-100 on one side.
Kif inhuma l- pilloli Thelin u l- kontenut tal- pakkett Thelin 100 mg pilloli miksija b’ rita huma ta ’ lewn isfar jagħti fl- oranġjo, f’ forma ta ’ kapsula, immarkati b’ T- 100 fuq naħa waħda minnhom.
Thelin comes in blister packs of 14, 28, 56, and 84 tablets and bottles of 28 tablets.
Thelin jiġi f’ folji ta ’ 14, 28, 56, u 84 pillola u fliexken ta ’ 28 pillola.
Not all pack sizes may be marketed.
Mhux il- pakketti tad- daqsijiet kollha jistgħu jkunu għall- bejgħ.
Marketing authorisation holder:
Id- Detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
Encysive (UK) Limited Alder Castle House 10 Noble Street London EC2V 7QJ United Kingdom Tel: +44 (0)208 610 6942
Encysive (UK) Limited Alder Castle House 10 Noble Street London EC2V 7QJ Ir- Renju Unit Tel: +44 (0) 208 6106026
For any information about this medicinal product, please contact the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lid- detentur ta ’ l - awtorizzazzjoni għat- tqegħid fis- suq.
29 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- websajt ta ’ l- Aġenzija Ewropea dwar il - mediċini (EMEA): http: // www. emea. eu. int /.
There are also links to other websites about rare diseases and treatments.
Hemm ukoll links għall- websajtes oħra dwar mard rari u kura.
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI GĦANDHA TIĠI IMPLIMENTATA MILL- ISTATI MEMBRI
1 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
1 KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI GĦANDHA TIĠI IMPLIMENTATA MILL- ISTATI MEMBRI
The Marketing Authorisation Holder (MAH) shall ensure that, at launch, all healthcare professionals who are experienced to prescribe/ use Thymanax are provided with educational materials containing the following:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq (MAH) irid jassigura li, mat- tqiegħid fis- suq, il- professjonisti kollha tal- kura tas- saħħa li huma esperjenzati biex jippreskrivu/ jużaw Thymanax ikunu provduti b’ materjal edukattiv li jkun fih dan li ġej:
As described in the RMP, additional risk minimisation activity including educational material will be provided to prescribers.
Kif inhu deskritt fl- RMP, it- tnaqqis tar- riskju f’ attivita addizzjonali jinkludi materjal edukattiv li jkun provdut lil min jippreskrivi.
Objectives of agomelatine Educational Plan:
Oġġettiv tal- pjan edukattiv t’ agomelatine:
The prescriber educational material about Valdoxan / Thymanax will be focused on:
Il- materjal edukattiva fuq Valdoxan/ Thymanax għal min jippreskrivi ikun iffukat fuq:
- The potential risks of agomelatine
- Il- potenzjal tar- riskji t’ agomelatine
- Transaminases Elevations
- Transaminasi elevati
- Interactions with potent CYP 1A2 inhibitors (e. g. fluvoxamine, ciprofloxacin).
- Interazzjonijiet ma ’ impedituri qawwija CYP1A2 (e. ż. fluvoxamine, ciprofloxacin).
- Guidance for hepatic function screening (Need to perform liver function tests in all patients: at initiation
- Gwida għall- iskrining tal- funzjoni tal- fwied (Iridu jsiru testijiet tal- funzjoni tal- fwied fil -
of treatment, and then periodically after around six weeks (end of acute phase), twelve weeks and twenty four weeks (end of maintenance phase) and thereafter when clinically indicated;
pazjenti kollha: fil- bidu tal- kura, u imbagħad perjodikament wara madwar 6 ġimgħat (tmiem tal - fażi akuta), tnax il- ġimgħa u erbgħa u għoxrin ġimgħa (tmiem tal- fażi ta ’ manteminent) u wara dan meta klinikament indikat).
- Guidance in case of clinical symptoms or liver function tests abnormality;
- Gwida fil- każ ta sintomi kliniċi jew anormalitajiet fit- testijiet tal- funzjoni tal- fwied.
- Caution to be exercised when therapy is administered to patients who consume substantial quantities of
- Kawtela għandha tingħata meta l- kura tiġi amministrata f’ pazjenti li jikkonsmaw kwantitajiet
alcohol or who are treated with medicinal products associated with risk of hepatic injury;
sostanzjali t’ alkohol jew li huma ikkurati bi prodotti medicinali assoċċjati ma ’ risjku ta ’ ħsara tal- fwied.
- Contra-indication in patients with hepatic impairment (i. e. cirrhosis or active liver disease);
- Kontra- indikazzjoni f’ pazjenti b’ disturbi tal- fwied.
- Contra-indication in patients receiving concomitantly potent CYP1A2 inhibitors.
- Kontra- indikazzjoni f’ pazjenti li qed jirċievu ukoll impedituri qawwija CYP1A2.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
RAPPORT PUBBLIKUA EWROPEW TA ’ VALUTAZZJONI (EPAR)
EPAR summary for the public
THYMANAX Sommarju ta ’ l- EPAR għall- pubbliku
What is Thymanax?
X’ inhu Thymanax?
Thymanax is a medicine that contains the active substance agomelatine.
Thymanax huwa mediċina li fiha s- sustanza attiva agomelatine.
It is available as orange- yellow, oblong tablets (25 mg).
Jiġi bħala pilloli f’ forma rettangolari sofor fl- oranġjo (25 mg).
What is Thymanax used for?
Għal xiex jintuża Thymanax?
Thymanax is used to treat major depression in adults.
Thymanax jintuża biex jikkura dipressjoni maġġuri fl- adulti.
Major depression is a condition in which patients have mood disturbances that interfere with their everyday life.
Id- dipressjoni maġġuri hija kundizzjoni li fiha l- pazjenti jkollhom disturbi fil- burdati li jfixklu l- ħajja tagħhom ta ’ kuljum.
Symptoms often include deep sadness, feelings of worthlessness, loss of interest in favourite activities, sleep disturbances, a feeling of being slowed down, feelings of anxiety and changes in weight.
Is- sintomi spiss jinkludu dwejjaq kbar, is- sentiment li ma tiswa għal xejn, nuqqas ta ’ interess fl- attivitajiet favoriti, disturbi fl- irqad, sensazzjoni ta ’ dewmien żejjed f’ dak li tagħmel, ansjetà u bidliet fil- piż.
How is Thymanax used?
Kif jintuża Thymanax?
The recommended dose of Thymanax is one tablet once a day, taken at bedtime with or without food.
Id- doża rakkomandata ta ’ Thymanax hija ta ’ pillola waħda darba kuljum, li tittieħed qabel l- irqad mal - ikel jew fuq xejn.
If there is no improvement in symptoms after two weeks, the doctor may increase the dose to two tablets taken together at bedtime.
Jekk ma jkunx hemm titjib fis- sintomi wara ġimagħtejn, it- tabib jista ’ jżid id- doża għal żewġ pilloli meħudin flimkien f’ ħin l- irqad.
Patients with depression should be treated for at least six months to make sure that they are free of symptoms.
Il- pazjenti b‘ dipressjoni għandhom jiġu kkurati għal mill- inqas sitt xhur biex ikun żgurat li huma jkunu ħielsa mis- sintomi.
The patient’ s liver should be checked with blood tests when treatment starts, and then after around six, 12 and 24 weeks of treatment The liver should also be checked if the patient develops symptoms that could indicate liver problems.
Il- fwied tal- pazjent għandu jiġi ċċekkjat b’ testijiet tad- demm meta tibda l- kura, u mbagħad wara madwar 6, 12 u 24 ġimgħa ta ’ kura.
Treatment should be interrupted in patients with abnormal liver enzyme levels in the blood.
Il- fwied għandu jiġi ċċekkjat ukoll jekk il- pazjent jiżviluppa sintomi li jistgħu jindikaw problemi fil- fwied.
Blood tests should then be repeated until the liver enzymes have returned to normal levels.
Il- kura għandha titwaqqaf f’ pazjenti b’ livelli anormali ta ’ enzimi tal- fwied fid- demm.
Because a benefit of Thymanax has not been shown clearly in patients aged over 65 years, it should be used with caution in this age group.
Minħabba li ma ntwera l- ebda benefiċċju b’ mod ċar ta ’ Thymanax f’ pazjenti li għandhom aktar minn 65 sena, Thymanax għandu jintuża b’ mod kawt f’ dan il- grupp ta ’ età.
It should also be used with caution in patients with moderate or severe kidney problems.
Għandu jintuża wkoll b’ mod kawt f’ pazjenti bi problemi moderati jew serji fil- kliewi.
It must not be used in patients who have liver problems.
M’ għandux jintuża f’ pazjenti li għandhom problemi fil- fwied.
How does Thymanax work?
Kif jaħdem Thymanax?
The active substance in Thymanax, agomelatine, is an antidepressant.
Is- sustanza attiva f’ Thymanax, agomelatine, hija antidipressant.
It works in two ways, both by stimulating the MT1 and MT2 receptors, which are normally activated by melatonin, and also by blocking the 5-HT 2C receptors, which are normally activated by the neurotransmitter 5-hydroxytryptamine (also called serotonin).
Hija taħdem b’ żewġ modi, kemm billi tistimula r- riċetturi MT1 u MT2, li normalment huma attivati permezz ta ’ melatonin, kif ukoll billi timblokka r- riċetturi 5- HT 2C s, li normalment huma attivati min- newrotrasmettitur 5- idrossitriptamina (imsejjaħ ukoll serotonina).
This is thought to lead to increases in the levels of dopamine and noradrenaline between nerve cells in the areas of the brain that are involved in the
Dan huwa maħsub li jwassal għal żieda fil- livelli ta ‘ dopamina u noradrenalina bejn iċ- ċelluli tan- nervituri fil- partijiet tal- moħħ li huma involuti fil- kontroll tal- burdati.
This is believed to help relieve the symptoms of depression.
Dan huwa maħsub li jgħin itaffi s- sintomi ta ’ dipressjoni.
Thymanax might also help to normalise the patient ’ s sleep patterns.
Thymanax jista ’ wkoll jgħin ireġġa ’ għan - normal l- istili tal- irqad tal- pazjent.
How has Thymanax been studied?
Kif ġie studjat Thymanax?
The effects of Thymanax were first tested in experimental models before being studied in humans.
L- effetti ta ’ Thymanax għall- ewwel ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq il- bniedem.
Thymanax has been compared with placebo (a dummy treatment) in five main short-term studies involving a total of 1,893 adults with major depression.
Thymanax tqabbel ma ’ plaċebo (kura finta) f’ ħames studji ewlenin fuq medda qasira ta ’ żmien li kienu jinvolvu total ta ’ 1, 893 adult b’ dipressjoni maġġuri.
Three of these studies included some patients treated with other antidepressants, either fluoxetine or paroxetine, as an ‘ active comparator’.
Tlieta minn dawn l- istudji kienu jinkludu pazjenti kkurati b’ antidipressanti oħrajn, jew fluoxetine jew paroxetine, bħala ‘ komparatur attiv ’.
The active comparator groups were included to check that the study was able to measure the effectiveness of medicines in treating depression.
Il- gruppi tal- komparatur attiv ġew inklużi biex jiġi vverifikat li l- istudju kien kapaċi jkejjel l - effikaċja tal- mediċini fil- kura tad- dipressjoni.
The main measure of effectiveness in these five studies was the change in symptoms after six weeks, as measured on a standard scale for depression called the Hamilton Depression Rating Scale (HAM-D).
Il- miżura ewlenija tal- effikaċja f’ dawn il- ħames studji kienet il- bidla fis- sintomi wara sitt ġimgħat, kif imkejla fuq skala standard għad- dipressjoni msejħa l - Iskala ta ’ Hamilton għal- Livell ta ’ Dipressjoni (Hamilton Depression Rating Scale - HAM- D).
The company also presented the results of a further study comparing Thymanax with sertraline (another antidepressant).
Il - kumpanija ppreżentat ukoll ir- riżultati ta ’ studju ieħor li qabbel Thymanax ma ’ sertraline (antidipressant ieħor).
Two other main studies compared the ability of Thymanax and placebo to prevent symptoms returning in 706 patients whose depression had already been controlled with Thymanax.
Żewġ studji ewlenin oħra qabblu l- kapaċità ta ’ Thymanax u plaċebo li jipprevjeni r- ritorn tas- sintomi f’ 706 pazjenti li d- dipressjoni tagħhom kienet diġà ġiet ikkontrollata b’ Thymanax.
The main measure of effectiveness was the number of patients whose symptoms returned during 24 to 26 weeks of treatment.
Il- kejl ewlieni tal - effikaċja kien l- għadd ta ’ pazjenti li s- sintomi tagħhom reġgħu feġġew matul 24 sa 26 ġimgħa ta ’ kura.
What benefit has Thymanax shown during the studies?
Liema benefiċċju wera Thymanax waqt l- istudji mwettqa?
In the short-term studies, Thymanax was seen to be more effective than placebo in the two studies where no active comparator was used.
Fl- istudji fuq perjodu ta ’ żmien qasir, Thymanax irriżulta aktar effettiv mill- plaċebo fiż- żewġ studji li fihom ma ntuża l- ebda komparatur attiv.
In the other three studies, which did include an active comparator, there were no differences in scores between the patients taking Thymanax and those taking placebo.
Fit- tliet studji l- oħra, li ma kinux jinkludu komparatur attiv, ma kien hemm l- ebda differenza fil- punti bejn il- pazjenti li ħadu Thymanax u dawk li ħadu plaċebo.
However, no effect of fluoxetine or paroxetine was seen in two of these studies, making the results difficult to interpret.
Madankollu, ma deher l- ebda effett ta ’ fluoxetine jew ta ’ paroxetine fi tnejn minn dawn l- istudji, li għamilha diffiċli biex jiġu interpretati r- riżultati.
The additional study showed that agomelatine was more effective than sertraline, with a difference in HAM-D scores of 1.68 after six weeks.
L- istudju addizzjonali wera li agomelatine kien iktar effettiv minn sertraline, b’ differenza fil- punti HAM- D ta ’ 1. 68 wara sitt ġimgħat.
In the first of the long-term studies, there was no difference between Thymanax and placebo in preventing symptoms returning during 26 weeks of treatment.
Fl- ewwel wieħed mill- istudji fuq perjodu ta ’ żmien twil, ma kien hemm l- ebda differenza bejn Thymanax u plaċebo fil- prevenzjoni tar- ritorn tas- sintomi matul 26 ġimgħa ta ’ kura.
However, the second study showed that symptoms returned in 21% of the patients taking Thymanax over 24 weeks (34 out of 165), compared with 41% of the patients taking placebo (72 out of 174).
Madankollu, it - tieni studju wera li s- sintomi reġgħu feġġew f’ 21% tal- pazjenti li kienu qed jieħdu Thymanax fuq 24 ġimgħa (34 minn 165), meta mqabbla ma ’ 41% tal- pazjenti li kienu qed jieħdu plaċebo (72 minn 174).
What is the risk associated with Thymanax?
X’ inhu r- riskju assoċjat ma ’ Thymanax?
The most common side effects with Thymanax (seen in between 1 and 10 patients in 100) are headache, dizziness, somnolence (sleepiness), insomnia (difficulty sleeping), migraine, nausea (feeling sick), diarrhoea, constipation, upper abdominal pain (tummy ache), hyperhidrosis (excessive sweating), back pain, fatigue (tiredness), increases in liver enzymes and anxiety.
L- iktar effetti sekondarji komuni b’ Thymanax (li dehru f’ bejn pazjent 1 u 10 minn kull 100) huma wġigħ ta ’ ras, sturdament, sonnolenza (ngħas), insonnja (diffikultà biex wieħed jorqod), emikranja, nawżea (dardir), dijarrea, stitikezza, uġigħ fin- naħa ta ’ fuq tal- addome (uġigħ ta ’ żaqq), iperidrożi (għaraq eċċessiv), uġigħ fid- dahar, għeja kbira, żidiet fl- enzimi tal- fwied u ansjetà.
Most side effects were mild or moderate in intensity and happened within the first two weeks of treatment.
Ħafna mill- effetti sekondarji kienu ħfief jew moderati fil- qawwa tagħhom u seħħew matul l- ewwel ġimagħtejn ta ’ kura.
Some of these side effects may be linked to the patient’ s depression rather than Thymanax itself.
Xi wħud minn dawn l- effetti sekondarji jistgħu jkunu relatati mad- dipressjoni tal- pazjent aktar milli ma ’ Thymanax innifsu.
For the full list of all side effects reported with Thymanax, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji kollha rrappurtati b’ Thymanax, ara l - Fuljett ta ’ Tagħrif.
Thymanax should not be used in people who may be hypersensitive (allergic) to agomelatine or any of the other ingredients.
Thymanax m’ għandux jintuża f’ nies li huma ipersensittivi (allerġiċi) għal agomelatine jew għal xi sustanza oħra tiegħu.
It must not be used in patients who have problems with their liver, such as cirrhosis (scarring of the liver) or active liver disease.
M’ għandux jintuża f’ pazjenti li għandhom problemi tal- fwied, bħalma hi ċ - ċirrożi (ċikatriċi fil- fwied) jew xi mard tal- fwied attiv.
It must also not be used in patients who are taking medicines that slow down the breakdown of Thymanax in the body, such as fluvoxamine (another antidepressant) and ciprofloxacin (an antibiotic).
M’ għandux jintuża wkoll f’ pazjenti li qed jieħdu mediċini li jdewmu l- assorbiment ta ’ Thymanax fil- ġisem, bħalma huma fluvoxamine (antidepressant ieħor) u ciprofloxacin (antibijotiku).
Thymanax should not be used in elderly patients with dementia.
Thymanax m’ għandux jintuża f’ pazjenti anzjani li jbatu bid- dimenzja.
Why has Thymanax been approved?
Għaliex ġie approvat Thymanax?
The Committee for Medicinal Products for Human Use (CHMP) noted that Thymanax’ s benefits in terms of treating depression might be lower than seen with other antidepressants.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) innota li l- benefiċċji ta ’ Thymanax fir- rigward tal- kura tad- dipressjoni, jistgħu jkunu inqas minn dawk ta ’ antidipressanti oħra.
However, since the medicine has a new mode of action, few side effects and a different safety profile to existing antidepressants, the Committee concluded that Thymanax could be a valuable treatment for some patients as long as their liver function is tested frequently.
Madankollu, minħabba li l- mediċina għandha mod ġdid ta ’ azzjoni, ftit effetti sekondarji u profil ta ’ sigurtà differenti minn antidipressanti oħra li jeżistu, il- Kumitat wasal għall- konklużjoni li Thymanax jista ’ jkun kura siewja għal xi pazjenti diment li l- funzjoni tal- fwied tagħhom tiġi ttestjata spiss.
Therefore, the CHMP decided that Thymanax’ s benefits are greater than its risks for the treatment of major depressive episodes in adults.
Għaldaqstant, is- CHMP iddeċieda li l- benefiċċji ta ’ Thymanax huma ikbar mir- riskji tiegħu għall- kura ta ’ episodji ta ’ dipressjoni maġġuri fl- adulti.
The Committee recommended that Thymanax be given marketing authorisation.
Il- Kumitat irrakkomanda li Thymanax jingħata awtorizzazzjoni għat- tqegħid fis- suq.
2/ 3 Which measures are being taken to ensure the safe use of Thymanax?
2/ 3 Liema miżuri qed jittieħdu sabiex jiġi assigurat użu sigur għal Thymanax?
The company that makes Thymanax will supply educational material for prescribers of Thymanax when it is launched.
Il- kumpanija li tipproduċi Thymanax sejra tipprovdi materjal edukattiv lil dawk li jippreskrivu Thymanax meta dan jitqiegħed fis- suq.
This material will explain the safety of the medicine, particularly its possible effects on the liver and its interactions with other medicines.
Dan il- materjal sejjer jispjega s- sigurtà tal- mediċina, b’ mod partikolari l- effetti sekondarji possibbli fuq il- fwied u l- interazzjonijiet tagħha ma ’ mediċini oħrajn.
Other information about Thymanax:
Informazzjoni oħra dwar Thymanax:
The European Commission granted a marketing authorisation valid throughout the European Union for Thymanax to Servier (Ireland) Industries Ltd on 19 February 2009.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għal Thymanax lil Servier (Ireland) Industries Ltd fil- 19 Frar 2009.
The full EPAR for Thymanax can be found here.
L- EPAR sħiħ għal Thymanax jista ’ jiġi kkonsultat hawn.
EU Procedure number EU/ 1/ 08/ 498/ 001 EU/ 1/ 08/ 498/ 002 EU/ 1/ 08/ 498/ 003 EU/ 1/ 08/ 498/ 004 EU/ 1/ 08/ 498/ 005 EU/ 1/ 08/ 498/ 006 EU/ 1/ 08/ 498/ 007 EU/ 1/ 08/ 498/ 008
Numru ta ’ l- EU EU/ 1/ 08/ 498/ 001 EU/ 1/ 08/ 498/ 002 EU/ 1/ 08/ 498/ 003 EU/ 1/ 08/ 498/ 004 EU/ 1/ 08/ 498/ 005 EU/ 1/ 08/ 498/ 006 EU/ 1/ 08/ 498/ 007 EU/ 1/ 08/ 498/ 008
Invented name Thymanax Thymanax Thymanax Thymanax Thymanax Thymanax Thymanax Thymanax
Isem inventat Thymanax Thymanax Thymanax Thymanax Thymanax Thymanax Thymanax Thymanax
Strength 25 mg 25 mg 25 mg 25 mg 25 mg 25 mg 25 mg 25 mg
Qawwa 25 mg 25 mg 25 mg 25 mg 25 mg 25 mg 25 mg 25 mg
Pharmaceutical form Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Għamla farmaċewtika Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita
Route of administration Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Mnejn jingħata Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
Packaging Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC)
Il- pakkett Folja (alu/ PVC) Folja (alu/ PVC) Folja (alu/ PVC) Folja (alu/ PVC) Folja (alu/ PVC) Folja (alu/ PVC) Folja (alu/ PVC) Folja (alu/ PVC)
Package size 7 14 28 42 56 84 98 100
Daqs tal- pakkett 7 14 28 42 56 84 98 100
1 1 NAME OF THE MEDICINAL PRODUCT
ISEM TAL- PRODOTT MEDIĊINALI
Thymanax 25 mg film-coated tablets
Thymanax 25 mg pilloli miksija b’ rita
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Each film-coated tablet contains 25 mg of agomelatine.
Kull pillola miksija b’ rita fiha 25 mg t ’ agomelatine.
Excipient: lactose monohydrate 61.84 mg
Sustanza mhux attiva: lactose monohydrate 61. 84 mg
3 PHARMACEUTICAL FORM
GĦAMLA FARMAĊEWTIKA
Film-coated tablet [tablet].
Pillola miksija b’ rita [pilolla].
Orange-yellow, oblong, film-coated tablet with blue imprint of company logo on one side.
Pillola rettangolari oranġjo fl- isfar miksija b’ rita bil- logo tal- kumpanija imnaqqax bil- blu fuq naħa minnhom.
4 CLINICAL PARTICULARS
TAGĦRIF KLINIKU
Treatment of major depressive episodes in adults
Kura ta ’ episodji dipressivi maġġuri fl- adulti.
The recommended dose is 25 mg once daily taken orally at bedtime.
Id- doża rakkomandata hija ta ’ 25 mg darba kuljum meħudha mil- ħalq qabel l- irqad.
After two weeks of treatment, if there is no improvement of symptoms, the dose may be increased to 50 mg once daily, i. e. two 25 mg tablets, taken together at bedtime.
Wara ġimagħtejn ta ’ kura, jekk is- sintomi ma jmorrux għall- aħjar, id- doża tista ’ tiżdied għal 50 mg darba kuljum, i. e. żewg pilloli ta ’ 25 mg, meħudhin flimkien qabel l- irqad.
Liver function tests should be performed in all patients: at initiation of treatment, and then periodically after around six weeks (end of acute phase), twelve weeks and twenty four weeks (end of maintenance phase) and thereafter when clinically indicated (see also section 4.4).
Testijiet tal- funzjoni tal- fwied għandhom isiru fil- pazjenti kollha: fil- bidu tal- kura, u imbagħad perjodikament wara madwar 6 ġimgħat (tmiem tal- fazi akuta), tnax il- ġimgħa u erbgħa u għoxrin ġimgħa (tmiem tal- fazi ta ’ manteniment) u wara dan meta klinikament indikat (ara sezzjoni 4. 4).
Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free of symptoms.
Pazjenti bid- dipressjoni għandhom jiġu kkurati għal perjodu suffiċenti ta ’ mhux inqas minn 6 xhur biex jiġi assigurat li huma ħielsa mis- sintomi.
Thymanax tablets may be taken with or without food.
Il- pilloli Thymanax jistgħu jittieħdu ma ’ l- ikel jew mingħajru.
Thymanax is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy (see section 4.4).
(ara sezzjoni 4. 4)
Efficacy has not been clearly demonstrated in the elderly (≥ 65 years).
M’ hemmx indikazzjoni ċara ta ’ effikaċja fl- anzjani (≥ 65 sena).
Only limited clinical data is available on the use of Thymanax in elderly patients ≥ 65 years old with major depressive episodes.
L- informazzjoni klinika hija limitata dwar l- użu ta ’ Thymanax f’ pazjenti anzjani ≥ 65 sena b’ episodji maġġuri dipressivi.
Therefore, caution should be exercised when prescribing Thymanax to these patients (see section 4.4).
(ara sezzjoni 4. 4).
Patients with renal impairment:
Pazjenti b’ disturbi fil- kliewi:
No relevant modification in agomelatine pharmacokinetic parameters in patients with severe renal impairment has been observed.
L- ebda modifikazzjoni relevanti f’ parametri farmakokinetiċi ta ’ agomelatine f’ pazjenti b’ disturbi fil - kliewi serji ma ġiet osservata.
However, only limited clinical data on the use of Thymanax in depressed patients with severe or moderate renal impairment with major depressive episodes is available.
Madankollu, l- informazzjoni klinika hija limitata dwar l- użu ta ’ Thymanax f’ pazjenti b’ dipressjoni li jbagħtu minn disturbi fil- kliewi serji jew moderati.
Therefore, caution should be exercised when prescribing Thymanax to these patients.
Għalhekk, għandha tingħatha attenzjoni meta Thymanax jiġi preskritt lil dawn il- pazjenti.
2 Thymanax is contraindicated in patients with hepatic impairment (see sections 4.3, 4.4 and 5.2).
Thymanax huwa kontra- indikat f’ pazjenti b’ disturbi fil- fwied (ara sezzjonijiet 4. 3, 4. 4 u 5. 2).
Treatment discontinuation:
Twaqqif tal- kura:
No dosage tapering is needed on treatment discontinuation.
Mhemmx bżonn tnaqqis ta ’ l- ammont tad- doża ftit ftit meta titwaqqaf il- kura.