qanastek/EMEA-V3 huggingface dataset:
Hepatic impairment (i. e. cirrhosis or active liver disease) (see sections 4.2 and 4.4).
Disturbi fil- fwied (i. e. ċirrożi jew marda attiva fil- fwied) (ara sezzjonijiet 4. 2 u 4. 4).
Concomitant use of potent CYP1A2 inhibitors (e. g. fluvoxamine, ciprofloxacin) (see section 4.5).
Użu flimkien ta ’ impedituri qawwija CYP1A2 (bħal fluvoxamine, ciprofloxacin) (ara sezzjoni 4. 5).
Use in children and adolescents:
Użu fit- tfal u adoloxxenti:
Thymanax is not recommended in the treatment of depression in patients under 18 years of age since safety and efficacy of Thymanax have not been established in this age group.
Thymanax mhux rakkomandat għall- kura ta ’ dipressjoni f’ pazjenti ta ’ taħt it- 18 – il sena minħabba li s- sigurta` u l- effikaċja ta ’ Thymanax mhumiex stabbiliti f’ dan il- grupp.
In clinical trials among children and adolescents treated with other antidepressants, suicide-related behaviour (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed compared to those treated with placebo.
Fi provi kliniċi fost tfal u adoloxxenti kkurati b’ anti- dipressanti oħra, imġieba relatata ma ’ suwiċidju (attentati suwiċidali u ħsibijiet ta ’ suwiċidju), u ostilita` (aggressjoni, imġieba opposta u rabja predominanti) kienu osservati iktar frekwenti meta mqabbla ma dawk li kienu kkurati bi plaċebo.
Use in elderly patients with dementia:
Użu f’ pazjenti anzjani bid- dimenzja:
Thymanax should not be used for the treatment of major depressive episodes in elderly patients with dementia since the safety and efficacy of Thymanax have not been established in these patients.
Thymanax ma jistax jintuża għall- kura ta ’ episodji dipressivi maġġuri f’ pazjenti anzjani bid- dimenzja minħabba li s- sigurta` u l- effikaċja ta ’ Thymanax ma ġewx stabbiliti f’ dawn il- pazjenti.
Mania / Hypomania:
Manija/ Ipomanija:
Thymanax should be used with caution in patients with a history of mania or hypomania and should be discontinued if a patient develops manic symptoms.
Thymanax għandu jintuża b’ attenzjoni f’ pazjenti li għandhom storja ta ’ manija jew ipomanija u għandu jiġi imwaqqaf jekk il- pazjent jiżviluppa sintomi manijaċi.
Suicide/ suicidal thoughts:
Suwiċidju/ Ħsibijiet suwiċidali:
Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide- related events).
Id- dipressjoni hija assoċċjata ma żieda fir- riskju ta ’ ħsibijiet suwiċidali, ħsara fuq l- individwu nnifsu u suwiċidju (episodji relatati ma ’ suwiċidju).
This risk persists until significant remission occurs.
Dan ir- riskju jibqa` sakemm iseħħ tnaqqis tal- marda b’ mod sostanzjali.
As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
Billi t- titjib fil- marda jista ’ ma jseħħx fl- ewwel ftit ġimgħat jew iżjed tal- kura, il- pazjenti għandhom jiġu osservati mill- viċin sakemm iseħħ titjib fil- marda.
It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Ġeneralment l- esperjenza klinika turi li r- riskju ta ’ suwiċidju jista ’ jiżdied fl- ewwel fażi tal- fejqan.
Patients with a history of suicide-related events or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
Hu magħruf, li pazjenti bi storja ta ’ episodji relatati ma ’ suwiċidju jew dawk li jesibixxu gradi sinifikanti ta ’ ħsieb suwiċidali qabel il- bidu tal- kura, ikunu f’ riskju ikbar ta ’ ħsibijiet suwiċidali jew attentati suwiċidali u għandhom jiġu osservati b’ kawtela waqt il- kura.
A meta-analysis of placebo- controlled clinical trials of antidepressants in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo, in patients less than 25 years old.
Meta- analiżi ta ’ provi kliniċi b` anti- dipressanti ikkontrollati bi plaċebo f’ pazjenti adulti b’ disturbi psikjatriċi juru żieda fir- riskju ta ’ imġieba suwiċidali b’ anti- dipressanti meta mqabbla ma ’ plaċebo, f’ pazjenti ta ’ taħt il - 25 sena.
Close supervision of patients and in particular those at high risk should accompany treatment especially in early treatment and following dose changes.
Superviżjoni mil- qrib tal- pazjenti u b’ mod partikulari ta’ dawk li qegħdin fl- riskju kbir għandha tingħata waqt il- kura speċjalment fil- bidu tat- trattament u wara bidliet fid- doża.
Patients (and caregivers of patients) should be alerted to the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Pazjenti (u dawk li jieħdu ħsieb il- pazjenti) għandha tinġibdilhom l- attenzjoni għall- bżonn ta ’ kontroll ta ’ żviluppi kliniċi li jaggravaw, imġieba jew ħsibijiet suwiċidali u tibdil mhux tas- soltu fl- imġieba u li jfittxu parir mediku immedjat jekk jidhru dawn is- sintomi.
Combination with CYP1A2 inhibitors (see sections 4.3 and 4.5) Combination with potent CYP1A2 inhibitors is contraindicated.
Użu flimkien ma ’ impedituri qawwija CYP1A2 huwa kontra- indikat.
Caution should be exercised when prescribing Thymanax with moderate CYP1A2 inhibitors (e. g. propranolol, grepafloxacine, enoxacine) which may result in increased exposure of agomelatine.
Kawtela għandha tittieħed meta jiġi preskriv Thymanax ma ’ impedituri moderati CYP1A2 (e. z propranolol, grepafloxacine, enoxacine) li jista` jirrizulta f’ zieda ta ’ esponiment t’ agomelatine.
Increased serum transaminases:
Żieda tas- serum transaminasi:
In clinical studies, elevations of serum transaminases (> 3 times the upper limit of the normal range) have been observed in patients treated with Thymanax particularly on a 50 mg dose (see section 4.8).
Fi studji kliniċi, żidiet fil- livell tas- serum transaminasi (> 3 darbiet mill- għola limitu tal- livell normali) ġew osservati f’ pazjenti b’ Thymanax b’ mod partikolari b ’ 50 mg (ara sezzjoni 4. 8).
When Thymanax was discontinued in these patients, the serum transaminases usually returned to normal levels.
Meta Thymanax kien imwaqqaf f’ dawn il- pazjenti, is- serum transaminasi normalment irritorna għal- livellijiet normali.
Any patient who develops
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
3 increased serum transaminases should have his/ her liver function tests repeated within 48 hours.
Kull pazjent li jiżviluppa żieda fis- serum transaminasi għandu jkollu jirrepeti t- testijiet tal- funzjoni tal- fwied fi żmien 48 siegħa.
Therapy should be discontinued if the increase in serum transaminases exceeds 3X upper limit of normal and liver function tests should be performed regularly until serum transaminases return to normal.
Il- kura trid tiġi mwaqqfa jekk iż- żieda tas- serum transaminasi taqbeż 3X l- ogħla limitu normali u t- testijiet tal- funzjoni tal- fwied għandhom isiru regolari sakemm is- serum transaminasi jiġi lura għan- normal.
If any patient develops symptoms suggesting hepatic dysfunction liver function tests should be performed.
Jekk xi pazjent jiżviluppa sintomi li jindikaw disfunzjoni fil- fwied għandhom isiru testijiet tal- funzjoni tal- fwied.
The decision whether to continue the patient on therapy with Thymanax should be guided by clinical judgement pending laboratory evaluations.
Id- deċiżjoni jekk il- pazjent ikomplix fuq il- kura b’ Thymanax għandha tiġi ggwidata b’ ġudizzju kliniku sakemm isiru testijiet fil- laboratorju.
If jaundice is observed therapy should be discontinued.
Jekk tiġi osservata is- suffejra il- kura għandha titwaqqaf.
Caution should be exercised when Thymanax is administered to patients who consume substantial quantities of alcohol or who are treated with medicinal products associated with risk of hepatic injury.
Kawtela għandha tingħata lil dawk il- pazjenti li jikkonsmaw kwantitajiet sostanzjali ta ’ alkoħol jew li huma kkurati bi prodotti mediċinali b’ riskju ta ’ ħsara fil- fwied meta tingħata kura b’ Thymanax.
Lactose intolerance:
Intolleranza tal- lactose:
Thymanax contains lactose.
Thymanax fih il- lactose.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza ta ’ galactose, id- defiċenzja Lapp lactase jew malassorbiment ta ’ glucose- galactose ma għandhomx jieħdu dan il- prodott mediċinali.
Potential interactions affecting agomelatine:
Interazzjonijiet li potenzjalment jaffetwaw agomelatine:
Agomelatine is metabolised mainly by cytochrome P450 1A2 (CYP1A2) (90%) and by CYP2C9/ 19 (10%).
Agomelatine jiġi metabolizzat l- iżjed biċ- ċitokromu P450 1A2 (CYP1A2) (90%) u b’ CYP2C9/ 19 (10%).
Medicinal products that interact with these isoenzymes may decrease or increase the bioavailability of agomelatine.
Prodotti mediċinali li għandhom interazzjoni ma ’ dawn l- isoenżimi jistgħu jnaqqsu jew iżidu il- biovijabilita` t’ agomelatine.
Fluvoxamine, a potent CYP1A2 and moderate CYP2C9 inhibitor markedly inhibits the metabolism of agomelatine resulting in a 60-fold (range 12-412) increase of agomelatine exposure.
Fluvoxamine, impeditur ta’ CYP1A2 qawwi u ta ’ CYP2C9 moderat jimpedixxi b’ mod ċar il - metaboliżmu t ’ agomelatine u jirriżulta 60- il darba (livell 12- 412) żieda għall- effetti t’ agomelatine.
Consequently, co-administration of Thymanax with potent CYP1A2 inhibitors (e. g. fluvoxamine, ciprofloxacin) is contraindicated.
Għalhekk, l- użu ta ’ Thymanax ma ’ impedituri CYP1A2 (eż. fluvoxamine, ciprofloxacin) huwa kontra - indikat.
Combination of agomelatine with oestrogens (moderate CYP1A2 inhibitors) results in a several fold increased exposure of agomelatine.
Użu flimkien t’ agomelatine ma ‘ estroġens (impedituri moderati CYP1A2) jirriżulta f’ diversi drabi iżjed esponiment t’ agomelatine.
While there was no specific safety signal in the 800 patients treated in combination with oestrogens, caution should be exercised when prescribing agomelatine with other moderate CYP1A2 inhibitors (e. g. propranolol, grepafloxacine, enoxacine) until more experience has been gained (see section 4.4).
Filwaqt li ma kienx hemm ebda sinjal specifiku ta ’ sigurta` fit- 800 pazjent ikkurati bl- użu flimkien ma ’ estroġens, kawtela għandha tingħatha meta jiġi preskriv agomelatine ma ’ impedituri CYP1A2 moderati oħra (e. ż. propranolol, grepafloxacine, enoxacine) sakemm tinkiseb iktar esperjenza (ara sezzjoni 4. 4).
Potential for agomelatine to affect other medicinal products:
L- effet potenzjali t’ agomelatine fuq prodotti mediċinali oħra:
In vivo, agomelatine does not induce CYP450 isoenzymes.
In vivo, agomelatine ma jinduċix isoenżimi CYP450.
Agomelatine inhibits neither CYP1A2 in vivo nor the other CYP450 in vitro.
Agomelatine ma jimpedixxix la CYP1A2 in vivo lanqas CYP450 oħrajn in vitro.
Therefore, agomelatine will not modify exposure to medicinal products metabolised by CYP 450.
Għalhekk, agomelatine ma jimmodifikax l- effetti ta ’ prodotti mediċinali oħra metabolizzati b’ CYP 450.
Medicinal products highly bound to plasma protein:
Prodotti mediċinali li jingħaqdu b’ qawwa ma ’ proteini fil- plażma:
Agomelatine does not modify free concentrations of medicinal products highly bound to plasma proteins or vice versa.
Agomelatine ma jimmodifikax konċentrazzjonijiet liberi tal- prodotti mediċinali li magħqudin b’ qawwa mal- proteini fil- plażma jew viċe versa.
Other medicinal products:
Oħra:
No evidence of pharmacokinetic or pharmacodynamic interaction with medicinal products which could be prescribed concomitantly with Thymanax in the target population was found in phase I clinical trials: benzodiazepines, lithium, paroxetine, fluconazole and theophylline.
Ma nstabet l- ebda evidenza ta ’ interazzjoni farmakokinetika jew farmakodinamika ma ’ prodotti mediċinali li jistgħu jiġu preskritti flimkien ma ’ Thymanax fil- popolazzjoni immirata fi provi kliniċi f’ fażi 1: benzodiazepines, lithium, paroxetine, fluconazole u theophylline.
The combination of Thymanax and alcohol is not advisable.
Thymanax ma ’ l- alkoħol mhuwiex rakkomandat.
Electroconvulsive therapy (ECT):
Kura elettrokonvulsiva (ECT):
There is no experience of concurrent use of agomelatine with ECT.
M’ hemmx esperjenza ta ’ l- użu konkorrenti t’ agomelatine ma ’ ECT.
Animal studies have not shown proconvulsant properties (see section 5.3).
Studji fl- annimali ma wrewx kwalitajiet prokonvulsivi (ara sezzjoni 5. 3).
Therefore, clinical consequences of ECT concomitant treatment with Thymanax are considered to be unlikely.
Għalhekk, konsegwenzi kliniċi ta ’ kura bl- ECT flimkien mal- kura b’ Thymanax x’ aktarx ma jseħħux.
4.6 Pregnancy and lactation
4 4. 6 Tqala u treddigħ
For agomelatine, no clinical data on exposed pregnancies are available.
M’ hemm l- ebda informazzjoni klinika provduta ta ’ l- effett t’ agomelatine fuq it- tqala.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition
Studji fuq l - annimali ma jindikawx li hemm effetti ħżiena diretti jew indiretti fejn tidħol it- tqala, żvilupp ta ’ l - embriju/ fetu, ħlas jew żvilupp ta ’ wara l- ħlas (ara sezzjoni 5. 3).
It is not known whether agomelatine is excreted into human milk.
Mhux magħruf jekk agomelatine joħroġx fil- ħalib tal- bniedem.
Agomelatine or its metabolites are excreted in the milk of lactating rats.
Agomelatine jew is- sustanzi iffurmati fil- metaboliżmu joħorġu fil- ħalib ta ’ firien li qed ireddgħu.
Potential effects of agomelatine on the breast-feeding infant have not been established.
Effetti potenzjali t’ agomelatine fuq tarbija fl- ewwel snin ta ’ ħajjitha li għadha titredda` ma gewx stabbiliti.
If treatment with Thymanax is considered necessary, breastfeeding should be discontinued.
Jekk il- kura b’ Thymanax hija kkonsidrata neċessarja, it- treddigħ għandu jiġi mwaqqaf.
However, considering that dizziness and somnolence are common adverse reactions patients should be cautioned about their ability to drive a car or operate machinery.
Iżda, minħabba li l- isturdament u l- ħedla huma kkonsidrati reazzjonijiet avversi komuni il- pazjenti għandhom joqogħdu attenti fuq il- ħila tagħhom biex isuqu jew iħaddmu magni.
In clinical trials, over 3,900 depressed patients have received Thymanax.
Fi studji kliniċi, iktar minn 3900 pazjent b’ dipressjoni irċevew Thymanax.
Adverse reactions were usually mild or moderate and occurred within the first two weeks of treatment.
L- effetti avversi kienu normalment ftit jew moderati u seħħew fl- ewwel ġimagħtejn tal- kura.
The most common adverse reactions were nausea and dizziness.
L- iktar effetti avversi komuni kienu dardir u sturdament.
These adverse reactions were usually transient and did not generally lead to cessation of therapy.
Dawn l- effetti avversi kienu normalment igħaddu malajr u ġeneralment ma wasslux biex titwaqqaf it - terapija.
Depressed patients display a number of symptoms that are associated with the illness itself.
Pazjenti b’ dipressjoni juru numru ta’ sintomi li huma assoċċjati mal- marda nfisha.
It is therefore sometimes difficult to ascertain which symptoms are a result of the illness itself and which are a result of treatment with Thymanax.
Għalhekk ikun diffiċli xi kultant biex taċċerta liema sintomi huma riżultat tal- marda nfisha u liema huma riżultat tal - kura b’ Thymanax.
Adverse reactions are listed below using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Ir- reazzjonijiet avversi huma mniżżlin hawn taħt u jsegwu din il- konvnezjoni: komuni ħafna (≥ 1/ 10), komuni (≥1/ 100 sa < 1/ 10), mhux komuni (≥1/ 1000 sa 1/ 100), rari (≥1/ 10, 000 sa < 1/ 1, 000), rari ħafna (< 1/ 10, 000), mhux magħruf (ma tistax tittieħed stima mid- data disponibbli).
The frequencies have not been corrected for placebo.
Il- frekwenzi ma ġewx irregolati għal plaċebo.
Common: headache, dizziness, somnolence, insomnia, migraine Uncommon: paraesthesia
Komuni: uġigħ ta ’ ras, sturdament, ngħas, insomnja, emikranja Mhux komuni: parasteżija
Uncommon: blurred vision
Mhux komuni: vista imċajpra
Common: nausea, diarrhoea, constipation, upper abdominal pain
Komuni: dardir, dijareja, stitikezza, uġigħ addominali fil- parti ta ’ fuq
Skin and subcutaneous tissue disorders Common: hyperhidrosis Uncommon: eczema Rare: erythematous rash
Komuni: iperidrożi Mhux komuni: ekżema Rari: raxx eritematiku
Musculoskeletal and connective tissue disorders Common: back pain
Komuni: uġigħ fid- dahar
Common: fatigue
Komuni: għejja
Hepato-biliary disorders:
5 Disturbi fil- fwied u l- marrara:
Common: increases (> 3 times the upper limit of the normal range) in ALAT and/ or ASAT (i. e.
Żiediet komuni (> 3darbiet mill- ogħla limitu tal- livell normali) fl ’ ALAT u/ jew ASAT (i. e.
1.1% on agomelatine 25/ 50 mg vs.
1. 1% b ’ agomelatine 25/ 50 mg vs 0. 7% bi plaċebo).
0.7% on placebo).
Rari: epatite
Common: anxiety Frequency not known:
Komuni: anzjeta` Frekwenza mhux magħrufa:
Suicidal thoughts or behaviour (see section 4.4)
Ħsibijiet jew imġieba suwiċidali (ara sezzjoni 4. 4)
There is limited experience with agomelatine overdose.
L- esperjenza hija limitata b’ doża eċċessiva t’ agomelatine.
During the clinical development, there were a few reports of agomelatine overdose, taken alone (up to 450 mg) or in combination (up to 525 mg) with other psychotropic medicinal products.
Waqt l- iżvilupp kliniku, ġew irrapportati ftit każijiet ta’ doża eċċessiva t’ agomelatine, meħudha waħidha (sa 450 mg) jew flimkien (sa 525 mg) ma ’ xi prodotti mediċinali psikotropiċi oħra.
Signs and symptoms of overdose were limited and included drowsiness and epigastralgia.
Sinjali u sintomi ta ’ doża eċċessiva kienu limitati u inkludew ħedla u epigastralġja.
No specific antidotes for agomelatine are known.
Mhemmx antidoti speċifiċi magħrufa għal agomelatine.
Management of overdose should consist of treatment of clinical symptoms and routine monitoring.
L- immaniġjar ta ’ doża eċċessiva jrid jikkonsisti f’ kura ta ’ sintomi kliniċi u osservazzjoni ta ’ rutina.
Medical follow-up in a specialised environment is recommended.
Segwazzjoni medika f’ ambjent speċjaliżżat hija rakkomandata.
Other antidepressants, ATC-code:
Antidippressanti oħra, kodiċi ATC:
Agomelatine is a melatonergic agonist (MT1 and MT2 receptors) and 5-HT2C antagonist.
Agomelatine huwa agonist melatonerġiku (riċetturi MT1 u MT2) u antagonist 5- HT2C.
Binding studies indicate that agomelatine has no effect on monoamine uptake and no affinity for α, β adrenergic, histaminergic, cholinergic, dopaminergic and benzodiazepine receptors.
Studji fuq it - twaħħil jindikaw li agomelatine m ’ għandu l- ebda effett fuq kemm il- monoamine jaqbad mar- riċetturi u ma għandux affinita għar- riċetturi α, β adrenergic, histaminergic, cholinergic, dopaminergic u benzodiazepine.
Agomelatine resynchronises circadian rhythms in animal models of circadian rhythm disruption.
Agomelatine jirrisinkronizza ir- ritmu circadian f’ mudelli t’ annimali li għandhom ir- ritmu circadian imħarbat.
Agomelatine increases noradrenaline and dopamine release specifically in the frontal cortex and has no influence on the extracellular levels of serotonin.
Agomelatine jżid il- ħrug tan- noradrenaline u tad- dopamine b’ mod speċifiku fil- parti ta ’ quddiem tal- moħħ u ma għandux influwenza fuq il- livelli extraċellulari ta ’ serotonin.
Agomelatine has shown an antidepressant-like effect in animal models of depression (learned helplessness test, despair test, chronic mild stress) as well as in models with circadian rhythm desynchronisation and in models related to stress and anxiety.
Agomelatine wera xebħ ta ’ effett antidippressiv f’ mudelli t’ annimali b’ dipressjoni (test nuqqas ta ’ ħeġġa mgħallma, test disperazzjoni, stress mhux qawwi kroniku) flimkien ukoll f’ mudelli b’ ritmu circadian disinkronizzat u f’ mudelli relatati ma ’ stress u anzjeta`.
In humans, Thymanax has positive phase shifting properties; it induces a phase advance of sleep, body temperature decline and melatonin onset.
Fil- bnedmin Thymanax għandu propjetajiet posittivi fil- fażi li jinbidel minn ħin għall- ieħor; jinduċi fażi avvanzata ta ’ l- irqad, tnaqqis fit- temperaturi, u bidu ta ’ melatonin.
The efficacy and safety of Thymanax in major depressive episodes have been studied in a clinical programme including 5,800 patients of whom 3,900 were treated with Thymanax.
L- effikaċja u s- sigurta` ta ’ Thymanax f’ episodji dipressivi maġġuri ġew studjati fi programm kliniku li jinkludi 5800 pazjent li minnhom 3900 kienu kkurati b’ Thymanax.
Six placebo controlled trials have been performed to investigate the short term efficacy of Thymanax in major depressive disorder: two flexible dose studies and four fixed dose studies.
Sitt provi ikkontrollati bi plaċebo saru biex jinvestigaw l- effikaċja f’ perjodu qasir ta ’ żmien ta ’ Thymanax b’ diżordni dipressiva maġġuri: żewġ studji b’ doża flessibli u erbgħa b’ doża fissa.
At the end of treatment (over 6 or 8 weeks), significant efficacy of agomelatine 25-50 mg was demonstrated in 3 of the six short-term double-blind placebo-controlled studies.
Fl- aħħar tal- kura (tul 6 sa 8 ġimgħat), effikaċja sinifikanti t ’ agomelatine 25 u 50 mg intweriet fit- 3 minn sitt studji double- blind li saru f’ perjodu ta ’ żmien qasir ikkontrollati bi plaċebo.
Agomelatine failed to differentiate from placebo in one study where the active control fluoxetine showed assay sensitivity.
Agomelatine falla milli juri xi differenza mil plaċebo f’ wieħed mill- istudji fejn il- kontroll attiv fluoxetine wera` sensittivita` mkejla.
In two other studies, it was not possible to draw any conclusions because the active controls, paroxetine and fluoxetine, failed to differentiate from placebo.
F’ żewġ studji oħra, ma kienx possibli li tilħaq konklużjonijiet minħabba li l- kontrolli attivi, paroxetine u fluoxetine fallew milli juru differenza mil plaċebo.
Efficacy was also observed in more severely depressed patients (baseline HAM-D ≥ 25) in all positive placebo-controlled studies.
Effikaċja kienet ukoll osservata f’ pazjenti li kellhom dipressjoni iktar severa (baseline HAM- D ≥ 25) fi studji kollha posittivi ikkontrollati bi plaċebo.
Response rates were statistically significantly higher with Thymanax compared with placebo.
Il- livell tar- rispons b’ Thymanax kien statistikament sinifikanti ogħla meta mqabbel ma ’ plaċebo.
The maintenance of antidepressant efficacy was demonstrated in a relapse prevention study.
Iż- żamma ta ’ l- effikaċja ta ’ l- antidippressant kienet osservata waqt studju biex tippreveni milli terġa` titfaċċa d- dipressjoni.
Patients responding to 8/ 10-weeks of acute treatment with open-label Thymanax 25-50 mg once daily were randomised to either Thymanax 25-50 mg once daily or placebo for further 6-months.
Pazjenti li rrispondew għal kura akuta ta ’ 8/ 10 ġimgħat b ’ Thymanax open- label 25- 50 mg darba kuljum kienu randomizzati għal għal jew Thymanax 25- 50 mg darba kuljum jew plaċebo għal 6 xhur oħra.
Thymanax 25- 50 mg once daily demonstrated a statistically significant superiority compared to placebo (p=0.0001) on the primary outcome measure, the prevention of depressive relapse, as measured by time to relapse.
L- inċidenza li l- marda
The incidence of relapse during the 6-months double-blind follow up period was 22% and 47% for Thymanax and placebo, respectively.
6 terġa titfaċċa waqt is- 6 xhur segwiti double- blind kienet 22% u 47% għal Thymanax u plaċebo, rispettivament.
Thymanax does not alter daytime vigilance and memory in healthy volunteers.
Thymanax ma jbiddilx l- attenzjoni ta ’ matul l- jum u l- memorja f’ voluntiera b’ saħħithom.
In depressed patients, treatment with Thymanax 25 mg increased slow wave sleep without modification of REM (Rapid Eye Movement) sleep amount or REM latency.
F’ pazjenti bid- dipressjoni il- kura b’ Thymanax 25 mg żiedet l- irqad mewġa bil- mod mingħar ma immodifikat l - ammont ta ’ l- irqad REM (Moviment mgħaġġel ta ’ l- għajnejn) jew il- perjodu ta ’ l- REM moħbi.
Thymanax 25 mg also induced an advance of the time of sleep onset and of minimum heart rate.
Thymanax 25 mg ukoll wassal għal avvanz fi- żmien għall- bidu ta ’ l- irqad u fir- rata minima tat- taħbit tal- qalb.
From the first week of treatment, onset of sleep and the quality of sleep were significantly improved without daytime clumsiness as assessed by patients.
Minn l- ewwel ġimgħa tal- kura, il- bidu ta’ l- irqad u l- kwalita` ta ’ l- irqad tjiebu b’ mod sinifikanti mingħajr turija ta’ nuqqas ta ’ ħeġġa matul il- jum kif ġew assessjati mill- pazjenti.
6 In a specific sexual dysfunction comparative study with remitted depressed patients, there was a numerical trend (not statistically significant) towards less sexual emergent dysfunction than venlafaxine for Sex Effects Scale (SEXFX) drive arousal or orgasm scores on Thymanax.
Fi studju komparattiv speċifiku fuq disfunzjoni sesswali f’ pazjenti li ma baqgħux ibgħatu bid - dipressjoni, kien hemm trend numerikali (mhux statistikament sinifikanti) lejn inqas disfunzjoni sesswali b’ Thymanax minn b’ venlafaxine għall- impulsi sesswali u orgażmi imkejla b’ punti miksuba fl- Iskala ta ’ l- Effetti Sesswali (SEXFX).
The pooled analysis of studies using the Arizona Sexual Experience Scale (ASEX) showed that Thymanax was not associated with sexual dysfunction.
Ġabra ta ’ studji analizzati permezz ta ’ Iskala Sesswali Arizona (ASEX) urew li Thymanax ma kienx assoċjat ma ’ disfunzjoni sesswali.
In healthy volunteers Thymanax preserved sexual function in comparison with paroxetine.
F’ voluntiera b’ saħħithom Thymanax żamm il- funzjoni sesswali meta mqabbel ma ’ paroxetine.
Thymanax had neutral effect on body weight, heart rate and blood pressure in clinical studies.
Thymanax kellu effett newtrali fuq il- piż tal- ġisem, ir- rata tal- qalb u l- pressjoni tad- demm fi studji kliniċi.
In a study designed to assess discontinuation symptoms by the Discontinuation Emergent Signs and Symptoms (DESS) check-list in patients with remitted depression, Thymanax did not induce discontinuation syndrome after abrupt treatment cessation.
Fi studju mfassal apposta biex ikejjel is- sintomi ta ’ diskontinwazzjoni permezz ta ’ Lista ta ’ Sinjali li joħorġu mad- Diskontinwazzjoni (DESS) f’ pazjenti li ma baqgħux ibagħtu bid- dipressjoni, Thymanax ma wassalx għal xi sindromu ta ’ diskontinwazzjoni wara li l- kura twaqqfet f’ daqqa.
Thymanax has no abuse potential as measured in healthy volunteer studies on a specific visual analogue scale or the Addiction Research Center Inventory (ARCI) 49 check-list.
Thymanax ma weriex xi abbuż potenzjali meta mkejjel fi studji fuq voluntiera b’ saħħithom fuq skala analogu viżwali speċifika jew fid - 49 lista ta ’ l- Inventarju taċ- Ċentru tar- Riċerka fuq id- Dipendenza (ARCI).
Absorption and bioavailability:
Assorbiment u biodisponibilita`:
Agomelatine is rapidly and well (≥ 80%) absorbed after oral administration.
Agomelatine jiġi assorbit malajr u tajjeb (≥ 80%) wara li jittieħed mill- ħalq.
Absolute bioavailability is low (< 5% at the therapeutic oral dose) and the interindividual variability is substantial.
Biovijabilita` assoluta hija baxxa (< 5% tad- doża orali terapewtika) u l- varjabilita` inter- individwali hija sostanzjali.
The bioavailability is increased in women compared to men.
Il - biovijabilita` tiżdied fin- nisa ikkomparata ma ’ l- irġiel.
The bioavailability is increased by intake of oral contraceptives and reduced by smoking.
Il- biovijabilita` tiżdied bit- teħid ta ’ kontraċettivi orali u titnaqqas bit- tipjip.
The peak plasma concentration is reached within 1 to 2 hours.
L- ogħla konċentrazzjoni plażma tintlaħaq fi żmien 1 sa 2 sigħat.
In the therapeutic dose-range, agomelatine systemic exposure increases proportionally with dose.
Fil- livell tad- doża terapewtika l- esponiment sistemiku għal agomelatine jiżdied proporzjonalment mad- doża.
At higher doses, a saturation of the first-pass effect occurs.
F’ dożi iktar għoljin, saturazzjoni ta ’ l- effett first- pass iseħħ.
Food intake (standard meal or high fat meal) does not modify the bioavailability or the absorption rate.
L- ikel (ikla normali jew ikla b’ ħafna xaħam) ma jimmodifikax il- biovijabilita` jew ir- rata ta ’ l - assorbiment.
The variability is increased with high fat food.
Il- varjabilita` tiżdied b- ikel b’ ħafna xaħam.
Steady state volume of distribution is about 35 l and plasma protein binding is 95% irrespective of the concentration and is not modified with age and in patients with renal impairment but the free fraction is doubled in patients with hepatic impairment.
Il- volum ta ’ distribuzzjoni fiss huwa ta ’ madwar 35 l u 1- ammont li jeħel mal- proteini tal- pażma huwa ta ’ 95% irrispettivament mill- konċentrazzjoni u mhuwiex modifikat biż- żmien u f’ pazjenti b’ disturbi fil- kliewi iżda il- frazzjoni libera tirdoppja f’ pazjenti b’ indeboliment fil- fwied.
Biotransformation:
Biotransformazzjoni:
Following oral administration, agomelatine is rapidly metabolised mainly via hepatic CYP1A2; CYP2C9 and CYP2C19 isoenzymes are also involved but with a low contribution.
Wara amministrazzjoni orali, agomelatine jiġi metaboliżżat mgħaġġel l- iktar via CYP1A2 hepatiku; isoenżimi CYP2C9 u CYP2C19 huma wkoll involuti imma b’ kontribuzzjoni baxxa.
The major metabolites, hydroxylated and demethylated agomelatine, are not active and are rapidly conjugated and eliminated in the urine.
Is- sustanzi maġġuri li joħorġu fil- metaboliżmu, agomelatine hydroxylated u demethylated, mhumiex attivi u jikkonjugaw mill- ewwel u jiġu eliminati ma ’ l- awrina.
Elimination is rapid, the mean plasma half-life is between 1 and 2 hours and the clearance is high (about 1,100 ml/ min) and essentially metabolic.
L- eliminazzjoni hija malajr, il- plażma half- life medja hija bejn 1 u 2 sigħat u t- tneħħija hija għolja (madwar 1100 ml/ min) u essenzjalment permezz tal- metaboliżmu.
Excretion is mainly (80%) urinary and in the form of metabolites, whereas unchanged compound recovery in urine is negligible.
L- eskrezzjoni hija l- iktar fl- awrina (80%) u permezz ta ’ sustanzi tal- metaboliżmu, filwaqt li l- forma mhux mibdula miġbura fl- awrina hija negliġibli.
Kinetics are not modified after repeated administration.
7 Il- kinetika mhijiex modifikata wara amministrazzjoni ripetuta.
No relevant modification of pharmacokinetic parameters in patients with severe renal impairment has been observed (n=8, single dose of 25 mg), but caution should be exercised in patients with severe or moderate renal impairment as only limited clinical data are available in these patients (see section 4.2).
L- ebda modifikazzjoni relevanti tal- parametri farmakokinetiċi f’ pazjenti b’ indeboliment tal- kliewi sever ma ġiet osservata (n=8, doża waħda ta ’ 25 mg) imma għandha tingħata attenzjoni f’ pazjenti li għandhom indeboliment tal- kliewi sever jew moderat minħabba li l- informazzjoni klinika provduta hija limitata f’ dawn il- pazjenti (ara sezzjoni 4. 2).
In a specific study involving cirrhotic patients with chronic mild (Child-Pugh type A) or moderate (Child-Pugh type B) liver impairment, exposure to agomelatine 25 mg was substantially increased (70- times and 140-times, respectively), compared to matched volunteers (age, weight and smoking habit) with no liver failure (see section 4.2, 4.3 and 4.4).
(ara sezzjoni 4. 2, 4. 3 u 4. 4).
7 Ethnic groups:
Gruppi Etniċi:
There is no data on the influence of race on agomelatine pharmacokinetics.
M’ hemmx informazzjoni fuq l- influwenza ta ’ razza fuq il- farmakokinetika t’ agomelatine.
In mice, rats and monkeys sedative effects were observed after single and repeated administration at high doses.
Fil- ġrieden, firien u xadini effetti sedattivi kienu osservati wara amminstrazzjoni unika jew ripetuta f’ dożi għoljin.
In rodents, a marked induction of CYP2B and a moderate induction of CYP1A and CYP3A were seen from 125 mg/ kg/ day whereas in monkeys the induction was slight for CYP2B and CYP3A at 375 mg/ kg/ day.
F’ annimali li jgerrmu induzzjoni qawwija ta ’ CYP2B u induzzjoni moderata ta CYP1A u CYP3A dehru minn 125 mg/ kg/ kuljum waqt li fix- xadini l- induzzjoni kienet ftit għal CYP2B u CYP3A bi 375 mg/ kg/ kuljum.
No hepatotoxicity was observed in rodents and monkeys in the repeat dose toxicity studies.
Ma gietx ossevata l- ebda tossiċita` fil- fwied f’ annimali li jgerrmu u f’ xadini waqt studji fuq it- tossiċita` b’ dożi ripetuti.
Agomelatine passes into the placenta and foetuses of pregnant rats.
Agomelatine jgħaddi fil- plaċenta u l- feti ta ’ firien tqal.
Reproduction studies in the rat and the rabbit showed no effect of agomelatine on fertility, embryofoetal development and pre- and post natal development.
Studji riproduttivi fil- far u l- fenek ma wrew l- ebda effett t’ agomelatine fuq il- fertilita`, l- iżvilupp ta ’ l - embriju u l- fetu u l- iżvilupp ta ’ qabel u wara t- tqala.
A battery of in vitro and in vivo standard genotoxicity assays concludes to no mutagenic or clastogenic potential of agomelatine.
Numru ta ’ kejl ġenotossiku li jintużaw is- soltu in vitro u in vivo ikkonkludew li agomelatine m’ għandux potenzjal mutaġeniku u klastoġeniku.
In carcinogenicity studies agomelatine induced an increase in the incidence of liver tumours in the rat and the mouse, at a dose at least 110-fold higher than the therapeutic dose.
Fi studji karċinoġenetiċi agomelatine ikkaġuna żieda fl- inċidenza ta ’ tumuri fil- fwied tal- far u tal - ġurdien b’ doża ta ’ mill- inqas 110 iktar mid- doża terapewtika.
Liver tumours are most likely related to enzyme induction specific to rodents.
Tumuri fil- fwied huma l- iktar relatati ma induzzjoni ta ’ enżimu speċifikament f’ annimali li jgerrmu.
The frequency of benign mammary fibroadenomas observed in the rat was increased with high exposures (60-fold the exposure at the therapeutic dose) but remains in the range of that of controls.
Il- frekwenza ta ’ fibroadenomas beninn tas- sider ġiet osservata fil- far u żdiedet b’ esponimenti għoljin (60 darba iktar ta ’ l- esponiment tad - doża terapewtika) imma tibqa ’ fil- livell tal- kontrolli.
Safety pharmacology studies showed no effect of agomelatine on hERG (human Ether à-go-go Related Gene) current or on dog Purkinje cells action potential.
Studji tas- sigurta` farmakoloġika ma wrew l- ebda effett t’ agomelatine fuq hERG (Ether à- go- go Related Gene Umana Relatat) kurrenti jew fuq l- azzjoni potenzjali taċ- ċelloli tal- kelb Purkinje.
Agomelatine did not show proconvulsive properties at ip doses up to 128 mg/ kg in mice and rats.
Agomelatine ma weriex karatteristiċi prokonvulżivi f’ dożi intraperitoneal sa 128 mg/ kg fil- ġrieden u l - firien.
Tablet core: − Lactose monohydrate − Maize starch − Povidone − Sodium starch glycolate type A − Stearic acid − Magnesium stearate − Silica, colloidal anhydrous
Lactose monohydrate − Maize starch − Povidone − Sodium starch glycolate type A − Stearic acid − Magnesium stearate − Silica, colloidal anhydrous −
Film-coating: − Hypromellose − Yellow iron oxide (E172) − Glycerol − Macrogol − Magnesium stearate − Titanium dioxide (E171)
Hypromellose − Iron oxide isfar (E172) − Glycerol − Macrogol − Magnesium stearate − Titanium dioxide (E171) −
Printing ink containing shellac, propylene glycol and indigotine (E132) aluminium lake.
Inka ta ’ l- istampar li fiha shellac, propylene glycol, indigotine (E132) aluminium lake.
8 3 years.
3 snin.
Packs containing 7, 14, 28, 42, 56, 84 and 98 film-coated tablets.
Kaxxi tal- kartun (kalendarju) ippakjati f’ folji ta ’ l- aluminium/ PVC Il- pakketi fihom 7, 14, 28, 42, 56, 84 u 98 pilloli miksija b’ rita.
Packs of 100 film-coated tablets for hospital use.
Il- pakketti ta ’ 100 pillola miksija b’ rita huma diponibbli għall- użu ta ’ l- isptar.
7 MARKETING AUTHORISATION HOLDER
ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
9 DATE OF THE FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI
10 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Les Laboratoires Servier Industrie, 905, route de Saran – 45520 Gidy, France Servier (Ireland) Industries Ltd, Gorey Road - Arklow - Co.
Les Laboratoires Servier Industrie, 905, route de Saran - 45520 Gidy, Franza Servier (Ireland) Industries Ltd, Gorey Road - Arklow - Co.
Wicklow, Ireland Przedsiebiorstwo Farmaceutyczne ANPHARM S. A., ul. Annopol 6B – 03-236 Warszawa, Poland
Annopol 6B - 03- 236 Warszawa, Il - Polonja
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, ma ’ l- illoncjar, 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 deskrivit fl- RMP, it- tnaqqis tar- riskju f’ attivita addizzjonali jinkludi materjal edukattiv li jkun provdut lil min jippreskrivi.
- The potential risks of agomelatine
- Il- potenzal tar- riskji t’ agomelatine
- Guidance in case of clinical symptoms or liver function tests abnormality;
- Gwida fil- każ ta sintomi klinici jew anormalitajiet fit- testijiet tal- funzjoni tal- fwied.
alcohol or who are treated with medicinal products associated with risk of hepatic injury;
sostanzjali t’ alkohol jew li huma ikkurati bi prodotti medicinali assoccjati ma ’ risjku ta ’ ħsara tal- fwied.
- Contra-indication in patients receiving concomitantly potent CYP1A2 inhibitors.
- Kontra- indikazzjoni f’ pazjenti li qed jircievu ukoll impedituri qawwija CYP1A2.
11 • OTHER CONDITIONS
11 • KUNDIZZJONIJIET OĦRA
Pharmacovigilance system
Is- sistema ta ’ Farmakoviġilanza
The MAH must ensure that the system of pharmacovigilance, as described in version 4.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
L- MAH għandhu jassigura li s- sistema ta ’ farmakovigilanza, kif inhi ddeskrivita f’ verżjoni 4. 0 ipprezentata f’ Module 1. 8. 1 ta ’ l- applikazzjoni ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq, hija fil- post u tibda taħdem qabel u meta il- prodott ikun fuq is- suq.
Risk Management Plan
Pjan tar- riskju ta ’ l- Immaniġjar
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the version 4.0 of the Risk Management Plan (RMP) presented in the module 1.8.2 of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
L- MAH jikkommetti li jagħmel studji u attivitajiet addizzjonali ta’ farmakoviġilanza li jkunu dettaljati fil- Pjan tal- Farmakoviġilanza, kif ġie miftiehem fil- verzjoni 4. 0 tal- Pjan tar- Rskju ta ’ l- Immaniġjar (RMP) ipprezentati fil- Module 1. 8. 2 ta ’ l- applikazzjoni ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq u kull tibdil ta ’ l- RMP kif ġie miftiehem min 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).
Mal- Gwida CHMP tas- Sistemi tar- Riskju ta ’ l- Immaniġjar għal prodotti medicinali għall- uzu fil- bniedem, it- tibdil RMP għandu jigi sottomett fil- istess hin b’ rapport irrangat tas- sigurta perjodika li jmiss.
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
Ukoll, RMP irrangat għandu jigi sottomett: • meta informazzjoni ġdida ricevuta tista ’ tagħmel impatt fuq l- ispecifikazzjoni tas - sigurta` kurrenti, Pjan ta ’ Farmakovigilanza jew attivitajiet tat- tnaqqis tar- riskju. • fi zmien 60 gurnata (farmakovigilanza u tnaqqis tar- riskju) ta ’ episodju importanti milħuq. • fuq it- talba ta ’ l- EMEA
Outer carton
Il- Kartuna ta’ barra
Thymanax 25 mg film-coated tablets Agomelatine
Thymanax 25 mg pilloli miksija b’ rita Agomelatine
Each tablet contains 25 mg of agomelatine.
Kull pillola fiha 25 mg t ’ agomelatine
See package leaflet for further information.
Fiha l- lactose Ara l- fuljett ta ’ tagħrif għal aktar informazzjoni.
7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 42 film-coated tablets 56 film-coated tablets 84 film-coated tablets 98 film-coated tablets 100 film-coated tablets
7 pilloli miksija b’ rita 14 pilloli miksija b’ rita 28 pilloli miksija b’ rita 42 pilloli miksija b’ rita 56 pilloli miksija b’ rita 84 pilloli miksija b’ rita 98 pilloli miksija b’ rita 100 pilloli miksija b’ rita
BLISTER
Folji
Thymanax 25 mg tablets Agomelatine
Thymanax 25 mg pilloli Agomelatine
EXP {MM/ YYYY}
EXP (XX/ SSSS)
Lot{number}
Lot {numru}
What Thymanax is and what it is used for 2.
X’ inhu Thymanax u għalxiex jintuża 2.
Before you take Thymanax 3.
Qabel ma tieħu Thymanax 3.
How to take Thymanax 4.
Kif għandek tieħu Thymanax 4.
Possible side effects 5 How to store Thymanax 6.
Effetti sekondarji li jista ’ jkollu 5.
Further information
Kif taħżen Thymanax 6.
WHAT THYMANAX IS AND WHAT IT IS USED FOR
X’ INHU X U GĦALXIEX JINTUŻA
Thymanax belongs to a group of medicines called antidepressants and you have been given Thymanax to treat your depression.
Int ġejt mogħti Thymanax biex tikkura d- dipressjoni tiegħek.
Depression is a continuing disturbance of mood that interferes with everyday life.
Id- dipressjoni hija taħwid kontinwu tal- burdata li tinterferixxi mal- ħajja ta ’ kuljum.
The symptoms of depression vary from one person to another, but often include deep sadness, feelings of worthlessness, loss of interest in favourite activities, sleep disturbances, feeling of being slowed down, feelings of anxiety, changes in weight.
Is- sintomi tad - dipressjoni ivarjaw minn persuna għal oħra, iżda ħafna drabi jinkludu dwejjaq kbar, sens ta ’ nuqqas ta ’ valur, telf ta ’ l- interess f’ attivitajiet favoriti, disturbi fl- irqad, sens li tħossok sejjer lura, sens ta ’ anzjeta`, bdil fil- piż.
BEFORE YOU TAKE THYMANAX
QABEL MA TIEĦU THYMANAX
Do not take Thymanax
Tieħux Thymanax
- if you are allergic (hypersensitive) to agomelatine or any of the other ingredients of Thymanax (see
- jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal agomelatine jew sustanzi oħra ta ’
‘ What Thymanax contains ’ in section 6).
Thymanax (ara ‘ X’ fih Thymanax ’ f’ sezzjoni 6)
- if you are taking fluvoxamine (another medicine used in the treatment of depression) or
- jekk qed tieħu fluvoxamine (mediċina oħra li tintuża għall- kura tad- dipressjoni) jew ciprofloxacin
ciprofloxacin (an antibiotic).
antibijotiku.
- if your liver does not work properly (hepatic impairment).
- Jekk il- fwied tiegħek ma jkunx qed jiffunzjona tajjeb (indeboliment tal- fwied).
Take special care with Thymanax There could be some reasons why Thymanax may not be suitable for you:
Oqgħod attent ħafna b’ Thymanax Jista ’ jkun hemm xi raġunijiet għala Thymanax ma jkunx jaqbel miegħek:
- If you have already experienced or if you develop manic symptoms (a period of abnormally high
- jekk int diġa` esperjenzajt jew tiżviluppa sintomi manijaċi (perjodu t’ eċċitament qawwi anormali
excitability and emotions) talk to your doctor before you start taking this medicine or continue with this medicine.
jew emozzjonijiet) kellem lit- tabib tiegħek qabel tibda tieħu jew tkompli din il- mediċina.
- If you are taking medicine known to affect the liver.
- jekk int qed tieħu mediċina magħrufa li taffetwa l- fwied.
Ask your doctor for advice on which medicine
Staqsi lit- tabib tiegħek għall- parir liema
that is.
hi din il- mediċina.
Some patients may get increased levels of liver enzymes in their blood during treatment with Thymanax.
Xi pazjenti jista jkollhom żidiet fil- livelli ta ’ l- enzimi tal- fwied fid- demm waqt il- kura b’ Thymanax.
19 properly at the initiation of the treatment and then periodically during treatment.
It- tabib tiegħek ghalekk irid jagħmel testijiet tal- laboratorju biex jiċċekja li l- fwied qed jahdem sew fil- bidu tal- kura u imbaghad perjodikament waqt il- kura.
Based on the evaluation of these tests the doctor will decide whether you should continue using Thymanax or not (see also under “ How to take Thymanax ” in section 3).
Ibbazata fuq l - evalwazzjoni ta ’ dawn it- testijiet it- tabib jiddeċidi jekk inti tkomplix tuża Thymanax jew le (ara ukoll taħt ‘ Kif tieħu Thymanax ’ f’ sezzjoni 3).
- If you are suffering from dementia, your doctor will make an individual evaluation of whether it is
- Jekk inti qed tbati mid- dimenzja, it- tabib tiegħek jagħmel evalwazzjoni individwali għas- sigurta`
safe for you to take Thymanax.
tiegħek meta tieħu Thymanax.
Thymanax is not intended for use in children and adolescents (under 18 years old).
Thymanax mhuwiew maħsub għall- użu fit- tfal u adoloxxenti (ta ’ taħt it - 18 – il sena).
Thoughts of suicide and worsening of your depression If you are depressed you can sometimes have thoughts of harming or killing yourself.
19 Ħsibijiet ta ’ suwiċidju u aggravar tad- dipressjoni tiegħek Jekk inti dipressat int xi drabi jista ’ jkollok ħsibijiet li tweġġa` jew toqtol lilek innifsek.
These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
Dawn jistgħu jiżdiedu meta għall- ewwel tibda l- anti- dipressanti, minħabba li dawn il- mediċini jieħdu iż- żmien biex jaħdmu, normalment madwar ġimagħtejn iżda xi drabi iktar.
You may be more likely to think like this:
Int tista ’ iktar tibda taħseb b’ dan il- mod:
- if you have previously had thoughts about killing or harming yourself.
- jekk qabel kellek ħsibijet li toqtol jew twegga` lilek innifsek.
- if you are a young adult.
- jekk int adult żgħir.
Information from clinical trials has shown an increased risk of suicidal
Informazzjoni minn provi kliniċi wrew riskju ikbar ta ’ imġieba suwiċidali
behaviour in young adults (aged less than 25 years) with psychiatric conditions who were being treated with an antidepressant.
f’ adulti zgħar ta ’ taħt il- 25 sena b’ kondizzjonijiet psikjatriċi li kienu kkurati b’ antidipressant.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
Jekk inti ikollok ħsibijiet li tweġġa` jew toqtol lilek innifsek f’ kull ħin, sejjaħ lit- tabib tiegħek jew mur l- isptar mill- ewwel.
You may find it helpful to tell a relative or close friend that you are depressed and ask them to read this leaflet.
Inti tista` issiba ta ’ għajnuna li tgħid lil xi qarib jew ħabib tal- qalb li inti dipressat u staqsihom biex jaqraw dan il- fuljett.
You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.
Inti tista tistaqsihom biex igħidulek jekk jaħsbux li d- dipressjoni tiegħek hijiex tmur għall- għar, jeww jekk humiex mħassbin bil- bdil fl- imġieba tiegħek.
You should not take Thymanax together with certain medicines (see also under “ Do not take Thymanax ” in section 2): fluvoxamine (another medicine used in the treatment of depression), ciprofloxacin (an antibiotic).
M’ għandekx tieħu Thymanax flimkien ma` ċertu mediċini (ara taħt ‘ Tieħux Thymanax ’ f’ sezzjoni 2): ’ fluvoxamine (mediċina oħra użata biex tikkura id- dipressjoni), ciprofloxacin (antibijotiku).
Taking Thymanax with food and drink Thymanax can be taken with or without food.
Meta tieħu Thymanax ma ’ l- ikel u max- xorb Thymanax jista ’ jittieħed ma ’ l- ikel jew mingħajru.
It is not advisable to drink alcohol while you are being treated with Thymanax.
Mhuwiex irrakkomandat li tixrob l- alkoħol meta int qed tiġi kkurat b’ Thymanax.
Pregnancy Talk to your doctor if you become pregnant (or plan to become pregnant) while you are taking Thymanax.
Tqala Tkellem mat- tabib tiegħek jekk toħrog tqila (jew qed tipjanja biex tinqabad tqila) waqt li tkun qed tieħu Thymanax.