FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the experience of the clinical use of entacapone with several medicinal products, including MAO-A inhibitors, tricyclic antidepressants, noradrenaline reuptake inhibitors such as desipramine, maprotiline and venlafaxine, and medicinal products that are metabolised by COMT (e.g. catecholstructured compounds: rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine,
Maltese: Madanakollu, l-esperjenza bl-użu kliniku ta' entacapone ma' diversi prodotti mediċinali, inklużi l-inibituri MAO-A, antidepressanti triċikliċi, inibituri li jinibixxu l-assorbiment mill-ġdid ta' noradrenaline bħal desipramine, maprotiline u venlafaxine u prodotti mediċinali li jiġu metabolizzati b'COMT (eż. sustanzi bl-istruttura ta' catechol: rimiterol, isoprenaline, adrenaline, noradrenaline, dopamina, dobutamine, alpha-methyldopa, apomorphine u paroxetine), għadha limitata.
English: Usually side effects caused by Comtess are mild to moderate.
Maltese: Ġeneralment effetti sekondarji kkawżati b'Comtess ikunu minn ħfief għal moderati.
English: Orion Pharma AS Tlf.
Maltese: United Kingdom Orion Pharma (UK) Ltd.
English: Each tablet contains 200 mg of entacapone.
Maltese: Kull pillola fiha 200 mg entacapone.
English: Neuroleptic Malignant Syndrome (NMS) is a serious but rare reaction to certain medicines, and may occur especially when Comtess and other medicines to treat Parkinson's disease are suddenly stopped or the dose is suddenly reduced.
Maltese: Is-Sindrome Newrolettiku Malinn (NMS) huwa reazzjoni serja imma rari għal ċerti mediċini, u jista' jseħħ speċjalment meta Comtess u mediċini oħrajn biex jikkuraw il-marda ta' Parkinson jitwaqqfu ħesrem jew id-doża titnaqqas f'daqqa.
English: It is characterised by stiffness, muscle twitching, shaking, agitation and confusion, coma, high body temperature, increased heart rate, and unstable blood pressure;
Maltese: Il-karatteristiċi tiegħu huma riġidità, ġbid ta' muskoli, tregħid u aġitazzjoni, konfużjoni, koma, temperatura għolja tal-ġisem, żieda fir-rata tal-qalb u pressjoni tad-demm mhux stabbli;
English: What Comtess looks like and contents of the pack Comtess 200 mg film-coated tablets are brownish-orange, oval tablets with "COMT" engraved on one side.
Maltese: Comtess 200 mg pilloli miksija b'rita huma pilloli ovali ta' kulur oranġjo jagħti fil-kannella, b' "COMT" imnaqqxa fuq naħa waħda.
English: Comtess 200 mg film-coated tablets Entacapone
Maltese: Comtess 200 mg pilloli miksija b'rita entacapone
English: Comtess 200 mg film-coated tablets entacapone
Maltese: Comtess 200 mg pilloli miksija b'rita Entacapone
English: • if you are taking certain antidepressants (ask your doctor or pharmacist whether your antidepressive medicine can be taken together with Comtess);
Maltese: • jekk int qed tieħu ċerti mediċini kontra d-depressjoni (saqsi lit-tabib jew lill-ispiżjar tiegħek jekk il-mediċina tiegħek ta' kontra d-depressjoni tistax tittieħed flimkien ma' Comtess);
English: • Comtess taken with levodopa may rarely make you feel very drowsy during the day, and cause you to suddenly fall asleep;
Maltese: • Meta Comtess jittieħed ma' levodopa jista', għalkemm rari, iqabbdek ħafna ngħas matul il ġurnata, u jġiegħlek torqod f'daqqa;
English: Impulse control disorders: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments such as Comtess in association with levodopa (see section 4.4).
Maltese: Jista' jkun hemm logħob tal-ażżard patoloġiku, żieda fil-libido, ipersesswalità, infiq jew xiri kompulsiv, ikel bl-addoċċ u b'mod kompulsiv f'pazjenti mogħtija agonisti ta' dopamine u/jew trattamenti dopaminerġiċi oħrajn bħal Comtess flimkien ma' levodopa (ara sezzjoni 4.4).
English: In addition, Comtess taken with levodopa may make you feel very drowsy, or cause you to sometimes suddenly fall asleep.
Maltese: tiħux Comtess u supplimenti ta' ħadid fl-istess ħin.
English: Comtess 200 mg film-coated tablets
Maltese: Comtess 200 mg pilloli miksija b'rita
English: If you experience such effects at the start of treatment with Comtess you should contact your doctor who may decide to adjust your dosage of levodopa.
Maltese: Għaldaqstant, l-użu ta' Comtess fittfal jew adolexxenti ma jistax ikun irrakkomandat.
English: 6.3 Shelf- life
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Entacapone may, together with levodopa, cause dizziness and symptomatic orthostatism.
Maltese: Flimkien ma' levodopa, entacapone jista' jikkawża sturdament u ortostatiżmu sintomatiku.
English: The recommended dose of Comtess is one 200 mg tablet with each levodopa dose.
Maltese: Id-doża rrakkomandata ta' Comtess is-soltu tkun pillola waħda ta' 200 mg ma' kull doża ta' levodopa.
English: Brownish-orange, oval, biconvex film-coated tablet with "COMT" engraved on one side.
Maltese: Tista' tuża wkoll mediċini oħra biex jikkuraw il-marda ta' Parkinson fl-istess ħin.
English: EXELTIS HEALTHCARE, S.L.
Maltese: España EXELTIS HEALTHCARE, S.L.
English: Date of latest renewal: 20 April 2012
Maltese: Data tal-aħħar tiġdid: 20 ta' April 2012
English: Terminal half life (t½) is 3.5-4 hours.
Maltese: Il-half-life terminali (t½) hi ta' 3.5-4 sigħat.
English: Qualiti (Burnley) Limited Walshaw Mill Talbot Street Briercliffe
Maltese: Qualiti (Burnley) Limited Walshaw Mill Talbot Street
English: Angina pectoris, palpitations
Maltese: Angina pectoris, palpitazzjonijiet
English: • psoriasis
Maltese: • psorijasi
English: Lancashire BB10 2HW UK
Maltese: Lancashire BB10 2HW
English: EU/1/07/392/001 21 tablets EU/1/07/392/002 20 tablets EU/1/07/392/003 30 tablets EU/1/07/392/004 7 tablets
Maltese: EU/1/07/392/001 21 pillola EU/1/07/392/002 20 pillola EU/1/07/392/003 30 pillola EU/1/07/392/004 7 pillola
English: Rua Consiglieri Pedroso, n.o 121-123 - Queluz de Baixo Barcarena, 2734-501
Maltese: Rua Consiglieri Pedroso, n.o 121-123 - Queluz de Baixo
English: Bioavailability is in the order of 15%.
Maltese: Il-biodisponibiltà hija madwar 15%.
English: 35039 Marburg
Maltese: 35039 Marburg Il-Ġermanja
English: Cmax levels around 500 pg/ml in adults (18-45) versus 1200 pg/ml in elderly (55-69); AUC levels around 3,000 pg*h/mL in adults versus 5,000 pg*h/mL in the elderly.
Maltese: Livelli ta' Cmax madwar 500 pg/ml fl-adulti (18-45) kontra 1200 pg/ml fl-anzjani (55-69); livelli ta' AUC madwar 3,000 pg*h/mL fl-adulti kontra 5,000 pg*h/mL fl-anzjani.
English: SANOVA PHARMA GesmbH Tel.: +43 (01) 80104-0 e-mail: sanova.pharma@sanova.at
Maltese: +43 (01) 80104-0 e-mail: sanova.pharma@sanova.at
English: What Circadin contains - The active substance is melatonin.
Maltese: X'fih Circadin - Is-sustanza attiva hi melatonin.
English: The kinetics of melatonin are linear over the range of 2-8 mg.
Maltese: Il-kinetika ta' melatonin hija lineari tul il-firxa ta' 2-8 mg.
English: RAD Neurim Pharmaceuticals EEC SARL 4 rue de Marivaux
Maltese: SARL 4 rue de Marivaux
English: Leukopenia, thrombocytopenia
Maltese: Lewkopenja, tromboċitopenja
English: - The other ingredients are ammonio methacrylate copolymer type B, calcium hydrogen phosphate dihydrate, lactose monohydrate, silica (colloidal anhydrous), talc and magnesium stearate.
Maltese: - Is-sustanzi l-oħra (eċċipjenti) huma ammonio methacrylate copolymer type B, calcium hydrogen phosphate dihydrate, lactose monohydrate, silica (colloidal anhydrous), talkum u magnesium stearate.
English: In clinical trials a total of 9.5% of patients receiving Circadin reported an adverse reaction compared with 7.4% of patients taking placebo.
Maltese: Fi provi kliniċi total ta' 9.5% tal-pazjenti li ngħataw Circadin irrappurtaw reazzjoni avversa meta mqabbel ma' 7.4% tal-pazjenti li kienu qed jieħdu plaċebo.
English: INFORMATION IN BRAILLE Circadin 2 mg
Maltese: Circadin 2 mg
English: Circadin contains lactose.
Maltese: Circadin fih lactose.
English: Temmler Pharma GmbH & Co. KG Temmlerstrasse 2
Maltese: Temmler Pharma GmbH & Co.
English: Circadin shortened patients' reported sleep latency by 24.3 minutes vs 12.9 minutes with placebo.
Maltese: Circadin qassar il-ħin irrappurtat li l-pazjenti jieħdu sakemm jorqdu b'24.3 minuti vs 12.9 minuti bil-plaċebo.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29 June 2007
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 29 ta' Ġunju 2007
English: Frosst Ibérica, S.A. Vía Complutense, 140 Alcalá de Henares 28805 Madrid Spain
Maltese: Ibérica, S.A. Vía Complutense, 140
English: Elimination is by renal excretion of metabolites, 89% as sulphated and glucoronide conjugates of 6-hydroxymelatonin and 2% is excreted as melatonin (unchanged active substance).
Maltese: L-eliminazzjoni isseħħ permezz ta' tneħħija renali tal-metaboliti, 89% bħala konjugati b'sulfat jew b'glucoronide ta' 6-hydroxymeltonin u 2% jitneħħa bħala melatonin (sustanza attiva mhux mibdula).
English: The principal metabolite is 6-sulphatoxy-melatonin (6-S-MT), which is inactive.
Maltese: Il-metabolita prinċipali huwa 6-sulphatoxy-melatonin (6-S-MT), li huwa inattiv.
English: Circadin contains lactose monohydrate.
Maltese: Circadin fih lactose monohydrate.
English: Experimental data suggest that isoenzymes CYP1A1, CYP1A2 and possibly CYP2C19 of the cytochrome P450 system are involved in melatonin metabolism.
Maltese: Tagħrif sperimentali jissuġġerixxi li l-isożimi CYP1A1, CYP1A2 u possibilment CYP2C19 tas-sistema taċ-ċitokromju P450 huma nvoluti fil-metaboliżmu ta' melatonin.
English: 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 established from the available data).
Maltese: Mhux komuni (≥ 1/1,000 sa <1/100); Rari (≥ 1/10,000 sa <1/1,000);
English: In clinical trials (in which a total of 1,931 patients were taking Circadin and 1,642 patients were taking placebo), 48.8% of patients receiving Circadin reported an adverse reaction compared with 37.8% taking placebo.
Maltese: Fi provi klinċi (fejn total ta' 1,931 pazjent kienu qed jieħdu Circadin u 1,642 pazjent kienu qed jieħdu plaċebo), 48.8% tal-pazjenti li kienu qed jingħataw Circadin irrappurtaw reazzjoni avversa meta' mqabbla ma' 37.8% li kienu qed jieħdu plaċebo.
English: − Fluvoxamine (used for the treatment of depression and obsessive compulsive disorder), psoralens (used in the treatment of skin disorders e.g. psoriasis), cimetidine (used in the treatment of stomach problems such as ulcers), quinolones and rifampicin (used in the treatment of bacterial infections), oestrogens (used in contraceptives or hormone replacement therapy) and carbamazepine (used in the treatment of epilepsy).
Maltese: − Fluvoxamine (użat għall-kura tad-depressjoni u ta' disturb kompulsiv ossessiv), psoralens (użat fil-kura ta' disturbi fil-ġilda eż, psorijasi), cimetidine (użat fil-kura ta' problemi fl-istonku bħal ulċeri), quinolones u rifampicin (użat fil-kura ta' infezzjonijiet ikkawżati minn batterja), estroġeni (użati f'kontraċettivi jew terapija ta' sostituzzjoni tal-ormoni) u carbamazepine (użat fil-kura tal-epilessija).
English: A Paediatric study (n=125) with doses of 2, 5 or 10 mg prolonged-release melatonin in multiples of 1 mg minitablets (age-appropriate pharmaceutical form), with two week run in baseline period on placebo and a randomised, double blind, placebo controlled, parallel group treatment period of 13 weeks, demonstrated an improvement in total sleep time (TST) after 13 weeks of double-blind treatment; participants slept more with active treatment (508 minutes), compared to placebo
Maltese: Studju Pedjatriku (n=125) b'dożi ta' 2, 5 jew 10 mg melatonin li jintreħa bil-mod f'multipli ta' pilloli żgħar ta' 1 mg (għamla farmaċewtika xierqa għall-età), b'perjodu fuq plaċebo fil-linja bażi li dam għaddej ġimagħtejn u perjodu ta' trattament ta' 13-il ġimgħa bi grupp parallel, randomised, doubleblind, u kkontrollat bi plaċebo, wera titjib fil-ħin totali tal-irqad (TST - total sleep time) wara 13-il ġimgħa ta' trattament double-blind; il-parteċipanti raqdu aktar bit-trattament attiv (508 minuti), meta mqabbel mal-plaċebo (488 minuta).
English: • Visual impairment
Maltese: • Indeboliment fil-vista
English: Circadin with food, drink and alcohol
Maltese: Circadin ma' ikel, xorb u alkoħol
English: The active substance of Circadin, melatonin, belongs to a natural group of hormones produced by the body.
Maltese: Is-sustanza attiva ta' Circadin, melatonin, jagħmel parti minn grupp naturali ta' ormoni magħmula mill-ġisem.
English: Luxembourg/Luxemburg Takeda Belgium Tél/Tel: +32 2 464 06 11 (BE) Takeda-Belgium@takeda.com
Maltese: +32 2 464 06 11 (BE) Takeda-Belgium@takeda.com
English: Menopausal symptoms
Maltese: Sintomi tal menopawsa
English: The levels assessed in the blood of the patients at 23:00 (2 hours after administration) following 1 and 3 weeks of daily administration were 411.4 ± 56.5 and 432.00 ± 83.2 pg/ml respectively, and are similar to those found in in healthy volunteers following a single dose of Circadin 2 mg.
Maltese: Il-livelli stmati fid-demm tal-pazjenti fil-23:00 (sagħtejn wara l-amministrazzjoni) wara ġimgħa u 3 ġimgħat ta' amministrazzjoni kuljum kienu ta' 411.4 ± 56.5 u 432.00 ± 83.2 pg/ml rispettivament, u huma simili għal dawk li nstabu f'voluntiera b'saħħithom wara doża waħda ta' Circadin 2 mg.
English: • Melatonin does not induce CYP1A enzymes in vitro at supra-therapeutic concentrations.
Maltese: • Melatonin ma jinduċix l-enżimi CYP1A in vitro f'konċentrazzjonijiet supra-terapewtiċi.
English: Excipient with known effect: each prolonged-release tablet contains 80 mg lactose monohydrate.
Maltese: Eċċipjent b'effett magħruf: kull pillola li terħi l-mediċina bil-mod fiha 80 mg lactose monohydrate.
English: In a clinical trial, there was clear evidence for a transitory pharmacodynamic interaction between Circadin and zolpidem one hour following co-dosing.
Maltese: Fi prova klinika, kien hemm evidenża ċara ta' interazzjoni farmakodinamika transitorja bejn Circadin u zolpidem siegħa wara li ngħataw flimkien.
English: • Circadin may enhance the sedative properties of benzodiazepines and non-benzodiazepine hypnotics, such as zaleplon, zolpidem and zopiclone.
Maltese: • Circadin jista' jsaħħaħ l-proprjetajiet sedattivi ta' benzodiazepines u ipnotiċi mhux benzodiazepines, bħal zaleplon, zolpidem u zopiclone.
English: Polyuria, haematuria, nocturia
Maltese: Poliurja, ematurja, nokturja
English: Each carton of tablets contains one blister strip of 7, 20 or 21 tablets, or alternatively in a carton containing two blister strips of 15 tablets each (30 tablet pack).
Maltese: Kull kartuna ta' pilloli fiha strixxa tal-folja waħda b'7, 20 jew 21 pillola, jew b'mod alternattiv f'kartuna li fiha żewġ strixxi tal-folja ta' 15-il pillola kull waħda (pakkett ta' 30 pillola).
English: Hypertriglyceridaemia, hypocalcaemia, hyponatraemia
Maltese: Ipertrigliċeridimja, ipokalċimija,
English: There is a significant first pass effect with an estimated first pass metabolism of 85%.
Maltese: Hemm effett ta' l-ewwel mogħdija sinifikanti b'metaboliżmu ta' l-ewwel mogħdija stmat għal 85%.
English: Shingles, high level of fatty molecules in the blood, low serum calcium levels in the blood, low sodium levels in the blood, altered mood, aggression, agitation, crying, stress symptoms, early morning awakening, increased sex drive, depressed mood, memory impairment, disturbance in attention, dreamy state, restless legs syndrome, poor quality sleep, ‘pins and needles' feeling, watery eyes, dizziness when standing or sitting, hot flushes, acid reflux, stomach disorder, blistering in the mouth, tongue ulceration, stomach upset, vomiting, abnormal bowel sounds, wind, excess saliva production, bad breath, abdominal discomfort, gastric disorder, inflammation of the stomach lining, eczema, skin rash, hand dermatitis, itchy rash, nail disorder, arthritis, muscle spasms, neck pain, night cramps, prolonged erection that might be painful, inflammation of the prostate gland, tiredness, pain, thirst, passing large volumes of urine, urinating during the night, increased liver enzymes, abnormal blood electrolytes and abnormal laboratory tests.
Maltese: disturbi fl-attenzjoni, tħossok f'dinja oħra, sindrome ta' riġlejn dejjem jiċċaqalqu, rqad ta' kwalità ħażina, sensazzjoni ta' tingiż u tnemnim, żieda fid-dmugħ (għajnejn idemmgħu), sturdament waqt ilwaqfien jew waqt li bilqiegħda, fwawar, rifluss tal-aċidu, disturb fl-istonku, infafet fil-ħalq, ulċeri flilsien, taqlib fl-istonku, rimettar, ħsejjes tal-musrana mhux nornali, gass, produzzjoni eċċessiva talbżieq, riħa ħażina fil-ħalq, skomdu fl-addome, disturb fl-istonku, infjammazzjoni tal-kisja tal-istonku, ekżema, raxx tal-ġilda, dermatite fl-idejn, raxx bil-ħakk, disturbi fid-dwiefer, artrite, spażmi filmuskoli, uġigħ fl-għonq, bugħawwieġ matul il-lejl, erezzjoni fit-tul li tista' tkun bl-uġigħ, infjammazzjoni tal-glandola tal-prostata, għeja, uġigħ, għatx, tgħaddi ħafna awrina, tgħaddi l-awrina matul il-lejl, żieda fl-enzimi tal-fwied, elettroliti fid-demm mhux normali u testijiet tal-laboratorju mhux normali.
English: • CYP1A2 inhibitors such as quinolones may give rise to increased melatonin exposure.
Maltese: • Inibituri ta' CYP1A2 bħal quinolones jistgħu jżidu l-espożizzjoni għal melatonin.
English: • Caution should be exercised in patients on fluvoxamine, which increases melatonin levels (by 17-fold higher AUC and a 12-fold higher serum Cmax) by inhibiting its metabolism by hepatic cytochrome P450 (CYP) isozymes CYP1A2 and CYP2C19.
Maltese: • Għandha tintuża kawtela f'pazjenti li qed jieħdu fluvoxamine, li jżid il-livelli ta' melatonin (lAUC bi 17-il darba ogħla, u Cmax fis-serum bi 12-il darba ogħla) billi jinibixxi l-metaboliżmu tiegħu mill-isożimi epatiċi taċ-ċitokromju P450 (CYP), CYP1A2 u CYP2C19.
English: − Thioridazine (for the treatment of schizophrenia) and imipramine (for the treatment of depression).
Maltese: − Thioridazine (għall-kura ta' skiżofrenija) u imipramine (għall-kura ta' depressjoni).
English: • There is a large amount of data in the literature regarding the effect of adrenergic agonists/antagonists, opiate agonists/antagonists, antidepressant medicinal products, prostaglandin inhibitors, benzodiazepines, tryptophan and alcohol, on endogenous melatonin secretion.
Maltese: • Hemm ammont kbir ta' tagħrif fil-letteratura dwar l-effett ta' agonisti/antagonisti adrinerġiċi, agonisti/antagonisti narkotiċi, prodotti mediċinali antidepressanti, inibituri ta' prostaglandin, benzodiazepines, tryptophan u alkoħol, fuq ir-reħa ta' melatonin endoġenu.
English: Pharmacotherapeutic group: Psycholeptics, melatonin receptor agonists, ATC code: N05CH01
Maltese: Psikoleptiċi, agonisti tar-riċetturi ta' melatonin, Kodiċi ATC:
English: Hepatic enzyme increased, blood electrolyes abnormal, laboratory test abnormal
Maltese: elettroliti fid demm mhux normali, testijiet tal-laboratorju mhux normali
English: Comparing the rate of patients with adverse reactions per 100 patient weeks, the rate was higher for placebo than Circadin (5.743- placebo vs. 3.013- Circadin).
Maltese: Meta tqabbel ir-rata ta' pazjenti reazzjoni avversa għal kull 100 ġimgħa ta' pazjent, ir-rata kienet ogħla għall-plaċebo milli b'Circadin (5.743- plaċebo kontra 3.013- Circadin).
English: Other medicines and Circadin
Maltese: Mediċini oħra u Circadin
English: Fidia Farmaceutici S.p.A Tel: +39 049 8232355 e-mail: info@fidiapharma.it
Maltese: Fidia Farmaceutici S.p.A Tel: +39 049 8232355
English: In addition, there were fewer dropouts in the active treatment group (9 patients; 15.0%) compared to the placebo group (21 patients; 32.3%).
Maltese: 0%) meta mqabbel mal-grupp tal-plaċebo (21 pazjent; 32.3%).
English: Irritability, nervousness, restlessness, insomnia, abnormal dreams, nightmares, anxiety
Maltese: Irritabilità, nervi, tħossok bla sabar, nuqqas ta' rqad, ħolm mhux normali, ħmar illejl, ansjetà
English: The presence of food delayed the absorption of the melatonin resulting in a later (Tmax=3.0 h versus Tmax=0.75 h) and lower peak plasma concentration in the fed state (Cmax=1020pg/ml versus Cmax=1176 pg/ml).
Maltese: Il-preżenza ta' l-ikel ittawwal l-assorbiment ta' melatonin u twassal għal konċentrazzjoni massima fil-plażma aktar tard (Tmax=3.0 h kontra Tmax=0.75 h) u aktar baxxa wara l-ikel (Cmax = 1020 kontra Cmax = 1176 pg/ml).
English: NAME OF THE MARKETING AUTHORISATION HOLDER RAD Neurim Pharmaceuticals EEC SARL
Maltese: RAD Neurim Pharmaceuticals EEC
English: • Cigarette smoking may decrease melatonin levels due to induction of CYP1A2.
Maltese: • It-tipjip tas-sigaretti jista' jnaqqas il-livelli ta' melatonin peress li jinduċi CYP1A2.
English: Irritability, nervousness, restlessness, insomnia, abnormal dreams, nightmares, anxiety, migraine, headache, lethargy (tiredness, lack of energy), restlessness associated with increased activity, dizziness, tiredness, high blood pressure, upper abdominal pain, indigestion, mouth ulceration, dry mouth, nausea, changes in the composition of your blood which could cause yellowing of the skin or eyes, inflammation of the skin, night sweats, itching, rash, dry skin, pain in extremities, menopausal symptoms, feeling of weakness, excretion of glucose in the urine, excess proteins in the urine, abnormal liver function and weight increase.
Maltese: Irritabilità, nervi, aġitazzjoni, nuqqas ta' rqad, ħolm mhux normali, ħmar il-lejl, ansjetà, emigranja, uġigħ ta' ras, letarġija (għeja, nuqqas ta' enerġija), aġitazzjoni assoċjata ma' żieda fl-attività, sturdament, għeja, pressjoni tad-demm għolja, uġigħ fil-parti ta' fuq tal-addome, indiġestjoni, ulċeri fil-ħalq, ħalq xott, tqalligħ, bidliet fil-kompożizzjoni tad-demm tiegħek li jistgħu jikkawżaw li l-ġilda jew l-għajnejn jisfaru, infjammazzjoni fil-ġilda, tegħreq ħafna matul il-lejl, ħakk, raxx, ġilda xotta, uġigħ fl-estremitajiet, sintomi tal-menopawsa, tħossok debboli, tneħħija ta' glucose fl-awrina, proteina eċċessiva fl-awrina, funzjoni tal-fwied mhux normali u żieda fil-piż.
English: There was also a reduction in sleep latency with active treatment (61 minutes) compared to placebo (77 minutes) after 13 weeks of double-blind treatment, without causing earlier wake-up time.
Maltese: Bit-trattament attiv kien hemm ukoll tnaqqis fil-ħin li wieħed jieħu biex jorqod (61 minuta) meta mqabbel mal-plaċebo (77 minuta) wara 13-il ġimgħa ta' trattament double-blind, mingħajr ma kkawża qawmien aktar kmieni.
English: The activity of melatonin at the MT1, MT2 and MT3 receptors is believed to contribute to its sleep-promoting properties, as these receptors (mainly MT1 and MT2) are involved in the regulation of circadian rhythms and sleep regulation.
Maltese: L-attività ta' melatonin fir-riċetturi MT1, MT2 U MT3 hi maħsuba li tikkontribwixxi għall-kwalitajiet tiegħu li jippromwovi l-irqad, għax dawn ir-riċetturi (l-aktar MT1 u MT2) huma nvoluti firregolazzjoni tar-ritmi ċirkadjani u l-irqad.
English: In a polysomnographic (PSG) study with a run-in of 2 weeks (single-blind with placebo treatment), followed by a treatment period of 3 weeks (double-blind, placebo-controlled, parallel group design) and a 3-week withdrawal period, sleep latency (SL) was shortened by 9 minutes compared to placebo.
Maltese: Fi studju polisomnografiku (PSG) b'espożizzjoni ta' ġimagħtejn (single-blind b'kura bil-plaċebo), segwit b'perjodu ta' kura ta' 3 ġimgħat (disinn ta' grupp ta' paragun, double-blind, ikkontrollat bil-plaċebo) u perjodu ta' rtirar ta' 3 ġimgħat, il-ħin sa l-irqad (SL) kien imnaqqas b'9 minuti meta mqabbel mal-plaċebo.
English: Reproductive system and breast disorders
Maltese: Disturbi fis sistema riproduttiva u fis
English: Hypertension
Maltese: iponatrimija
English: Migraine, headache, lethargy, psychomotor hyperactivity, dizziness, somnolence
Maltese: Emigranja, uġigħ ta' ras, letarġija, iperattività psikomotorja,
English: • Disorientation
Maltese: • Disorjentazzjoni
English: • Melatonin's metabolism is mainly mediated by CYP1A enzymes.
Maltese: • Il-metaboliżmu ta' Melatonin huwa medjat l-aktar mill-enżimi CYP1A.