qanastek/EMEA-V3 huggingface dataset:
The most commonly reported adverse reactions, occurring in more than 5% of patients treated with Remeron in randomized placebo-controlled trials (see below) are somnolence, sedation, dry mouth, weight increased, increase in appetite, dizziness and fatigue.
L- iktar effett mhux mixtieq illi ġie rrapurtat, li seħħ f’ iktar minn 5% mill- pazjenti trattati b’ Remeron fi provi plaċebo- kontrollati għallarieda (ara isfel) kienu sonnolenza, sedazzjoni, ħalq xott, żieda fil- piż, żieda fl- aptit, sturdament u għejja.
All randomized placebo-controlled trials in patients (including indications other than major depressive disorder), have been evaluated for adverse reactions of Remeron.
Il- provi kollha plaċebo- kontrollati għallarieda f’ pazjenti (inkluż indikazzjonijiet oħrajn apparti minn diżordni dipressiv qawwi), ġew evalwati għal effetti mhux mixtieqa ta ’ Remeron.
The meta-analysis considered 20 trials, with a planned duration of treatment up to 12 weeks, with 1501 patients (134 person years) receiving doses of mirtazapine up to 60 mg and 850 patients (79 person years) receiving placebo.
Il- meta- analiżi kkonċernat 20 prova, b’ durata ta ’ trattament ippjanata sa 12- il ġimgħa, b’ 1501 pazjent (134 sena ta ’ persuni) li irċevew dożi ta ’ mirtazapine sa 60 mg u 850 pazjent (79 sena ta ’ persuni) li rċevew
Extension phases of these trials have been excluded to maintain comparability to placebo treatment.
Ġew esklużi fażijiet ta ’ estenzjoni ta ’ dawn il- provi sabiex jinżamm paragun ma ’ trattament bi plaċebo.
23 Table 1 shows the categorized incidence of the adverse reactions, which occurred in the clinical trials statistically significantly more frequently during treatment with Remeron than with placebo, added with adverse reactions from spontaneous reporting.
Tabella 1turi l- inċidenza kategorizzata tal- effetti mhux mixtieqa li seħħew fi provi kliniċi b’ mod statistikament sinjifikanti iktar frekwenti waqt it- trattament b’ Remeron milli bi plaċebo, miżjuda ma ’ effetti mhux mixtieqa rrapurtati spontanjament.
The frequencies of the adverse reactions from spontaneous reporting are based on the reporting rate of these events in the clinical trials.
Il- frekwenzi tal- effetti mhux mixtieqa minn rapporti spontanji huma bbażati fuq ir- rata ta ’ rapportaġġ ta ’ dawn l- eventi fi provi kliniċi.
The frequency of adverse reactions from spontaneous reporting for which no cases in the randomized placebo-controlled patient trials were observed with mirtazapine has been classified as ‘ not known’.
Il- frekwenza ta ’ effetti avversi minn rapportaġġi spontanji li għalihom ma ġewx osservati każijiet fi provi fuq pazjenti kontrollati bi plaċebo għallarieda b’ mirtazapine ġew ikklassifikati bħala ‘ mhux magħrufa ’.
Adverse reactions of Remeron
Effetti mhux mixtieqa ta ’ Remeron
System organ class Investigations
Klassi tas- sistema organika
Very common (≥ 1/ 10) Weight increased1
Komuni ħafna (≥1/ 10)
Uncommon (≥ 1/ 1,000 to < 1/ 100)
< 1/ 100
Rare (≥ 1/ 10,000 to < 1/ 1,000)
< 1/ 1, 000)
Frequency not known
Disturbi fis- sistema
Blood and the lymphatic system disorders
Paraesteżija2
Bone marrow depression (granulocytopenia, agranulocytosis, aplastic anemia thrombocytopenia) Eosinophilia
mijoklonus
Nervous system disorders
konvulżjoniji
Somnolence1, 4 Sedation1, 4 Headache2
Sedazzjoni1, 4
Lethargy1 Dizziness Tremor
Sturdament
Paraesthesia2 Restless legs Syncope
Aġitazzjoni
Myoclonus
et (insulti)
Convulsions (insults) Serotonin syndrome Oral paraesthesia
Uġigħ ta ’ ras2
Gastrointestinal disorders
Tregħid Nawsja3
Dry mouth
fir- riġlejn sinkope
Nausea3 Diarrhea2 Vomiting2
serotonin syndrome paraesteżija orali
Oral hypoaesthesia
Disturbi gastro -
Mouth oedema
Ħalq xott
Skin and subcutaneous tissue disorders
ipoesteżija
Exanthema2
edema tal -
Musculoskeletal and connective tissue disorders
intestinali Disturbi fil- ġilda u fit- tessuti ta ’ taħt il - ġilda Disturbi muskolu - skeltrali u tal - connective tissue
Arthralgia Myalgia Back pain1
Dijarrea2 iremettar2 Raxx fil- ġilda2 (exanthema) Arthralgia Uġigħ fil - muskoli (Myalgia) Uġigħ fid - dahar1
Increase in appetite1
Żieda fl- aptit1
Hyponatraemia
Iponatrimija
Vascular disorders General disorders and administration site conditions
Pressjoni baxxa ħafna (ortostatika) Edema periferali1 għejja
Orthostatic hypotension Oedema peripheral1 Fatigue
Elevazzjonijie t fl- attivita` ta ’ serum transaminases
Hypotension2
Disturbi psikjatriċi
Hepatobiliary disorders
Ħolm anormali
Elevations in serum transaminase activities
Ideazzjoni suwiċidali6
Psychiatric disorders
Konfużjoni
Abnormal dreams Confusion Anxiety2, 5 Insomnia3, 5
Anzjeta`2, 5 Insomnja3, 5
Nightmares2 Mania Agitation2 Hallucinations Psychomotor restlessness (incl. akathisia, hyperkinesia)
Aġitazzjoni2 Alluċinazzjo nijiet Irrekwitezza psikomutur
Suicidal ideation6 Suicidal behaviour6
Akathisia, iperkinesia)
Endocrine disorders 1
• Sekrezzjoni Disturbi fis- sistema endokrinarja 1
Inappropriate antidiuretic hormone secretion
mhux xierqa ta ’ l- ormon antidijuretiku
2 In clinical trials these events occurred more frequently during treatment with placebo than with Remeron, however not statistically significantly more frequently.
Fi provi kliniċi dawn l- eventi seħħew bi frekwenza iktar sinjifikanti statistikament waqt trattament b’ Remeron milli bi plaċebo 2 Fi provi kliniċi dawn l- eventi seħħew iktar frekwentement waqt trattament bi plaċebo milli b’ Remeron, iżda mhux bi frekwenza iktar sinjifikanti statistikament.
3 In clinical trials these events occurred statistically significantly more frequently during treatment with placebo than with Remeron.
3 Fi provi kliniċi dawn l- eventi seħħew bi frekwenza iktar sinjifikanti statistikament waqt trattament bi plaċebo milli b’ Remeron 4 N. B.
24 5 Upon treatment with antidepressants in general, anxiety and insomnia (which may be symptoms of depression) can develop or become aggravated.
Riduzzjoni fid- doża ġeneralment ma twassalx għal sonnolenza/ sedazzjoni imma jista ’ jippreġudika l- effikaċja antidipressanti 5 Bi trattament b’ anti dipressanti in ġenerali, jistgħu jiżviluppaw jew jiġu aggravati l- anzjeta` jew insomnja (li jistgħu jkunu sintomi ta ’ dipressjoni).
Under mirtazapine treatment, development or aggravation of anxiety and insomnia has been reported.
Bi trattament ta ’ mirtazapine ġew irrapurtati żvilupp jew aggravar tal- anzjet` jew insomnja.
6 Cases of suicidal ideation and suicidal behaviours have been reported during mirtazapine therapy or early after treatment discontinuation (see section 4.4).
6 Każijiet ta ’ ideazzjoni suwiċidali u imġieba suwiċidali ġew irrapurtati waqt terapija b’ mirtazapine jew kmieni wara li twaqqaf it- trattament (ara sezzjoni 4. 4).
In laboratory evaluations in clinical trials transient increases in transaminases and gamma- glutamyltransferase have been observed (however associated adverse events have not been reported statistically significantly more frequently with Remeron than with placebo).
F’ evalwazzjonijiet fil- laboratorju fi provi kliniċi ġew osservati żidiet għaddiena fi transaminases u gamma- glutamyltransferase (iżda ma ġewx irrapurtati eventi avversi assoċjati statistikament sinjifikanti iktar frekwenti b’ Remeron milli bi plaċebo).
Present experience concerning overdose with Remeron alone indicates that symptoms are usually mild.
L- esperjenza preżenti konċernanti doża eċċessiva b’ Remeron waħdu tindika li s- sintomi s- soltu jkunu ħfief.
Depression of the central nervous system with disorientation and prolonged sedation have been reported, together with tachycardia and mild hyper- or hypotension.
Ġew irrapurtati dipressjoni tas- sistema nervuża ċentrali b’ diżorjentazzjoni u sedazzjoni prolongata flimkien ma ’ takikardija u iper - jew ipotenzjoni ħafifa.
However, there is a possibility of more serious outcomes (including fatalities) at dosages much higher than the therapeutic dose, especially with mixed overdoses.
Iżda, hemm il- possibilita` ta ’ eventi iktar serji (inkluż mwiet) f’ dożi ħafna iktar għolja mid- doża terapewtika, speċjalment b’ dożi eccessivi mħalltin.
Cases of overdose should receive appropriate symptomatic and supportive therapy for vital functions.
Każijiet ta ’ dożi eċċessivi għandhom jirċievu terapija approprijata sintomatika u ta ’ appoġġ għal funzjonijiet vitali.
Activated charcoal or gastric lavage should also be considered.
Għandu jiġi kkunsidrat ukoll faħam attivat jew ħasil gastriku.
Pharmacotherapeutic group: other antidepressants, ATC code:
Anti- depressanti, Kodiċi ATC:
Mirtazapine is a centrally active presynaptic α 2-antagonist, which increases central noradrenergic and serotonergic neurotransmission.
Mirtazapine hija α2- antagonist presinattiku attiv ċentralment, li żżid in- newrotrażmissjoni noradrenerġika u serotonerġika ċentrali.
The enhancement of serotonergic neurotransmission is specifically mediated via 5-HT1 receptors, because 5-HT2 and 5-HT3 receptors are blocked by mirtazapine.
It- tkabbir ta ’ newrotrażmissjoni serotonerġiku huwa speċifikament medjat via riċetturi 5- HT1, peress illi r- riċetturi 5- HT2 u 5- HT3 huma imblukkati b’ mirtazapine.
Both enantiomers of mirtazapine are presumed to contribute to the antidepressant activity, the S(+) enantiomer by blocking α 2 and 5-HT2 receptors and the R(-) enantiomer by blocking 5-HT3 receptors.
5. 2 Tagħrif farmakokinetiku
After oral administration of Remeron, the active substance mirtazapine is rapidly and well absorbed (bioavailability ≈ 50%), reaching peak plasma levels after approx. two hours.
Wara amministrazzjoni orali ta ’ Remeron, is- sustanza attiva mirtazapine hija assorbita rapidament u tajjeb (bijodisponibilita` ≈ 50%), tilħaq l- ogħla livelli plażma wara madwar sagħtejn.
85%.
L- irbit ta ’ mirtazapine mal- proteini tal- plażma huwa ta ’ madwar 85%.
The mean half-life of elimination is 20-40 hours; longer half-lives, up to 65 hours, have occasionally been recorded and shorter half-lives have been seen in young men.
Iż- żmien ta ’ eliminazzjoni medja sabiex is- sustanza attiva tinżel għal nofs il- valur oriġinali tagħha hija 20- 40 siegħa; żminijet biex jinżel il - valur għal nofs itwal, sa 65 siegħa, okkażżjonalment ġew irreġistrati u żminijiet biex jinżel il- valur
The half-life of elimination is sufficient to justify once-a-day dosing.
29 għal nofs iqsar intwerew f’ ġuvintur żgħażagħ.
Steady state is reached after 3-4 days, after which there is no further accumulation.
Stat stabbli huwa milħuq wara 3- 4 ijiem, li wara ma jkunx hemm iżjed akkumulazzjoni.
Mirtazapine displays linear pharmacokinetics within the recommended dose range.
Mirtazapine turi farmakokinetika lineari fil- medda tad - doża rrakomandata.
Food intake has no influence on the pharmacokinetics of mirtazapine.
It- teħid tal- ikel m’ għandux influwenza fuq il- farmakokinetika ta ’ mirtazapine.
Mirtazapine is extensively metabolized and eliminated via the urine and faeces within a few days.
Mirtazapine hija metabolizzata estensivament u eliminata via l- awrina u l- ippurgar fi żmien ftit ġranet.
Major pathways of biotransformation are demethylation and oxidation, followed by conjugation.
Triqat maġġuri tal- bijotrasformazzjoni huma demetilizzjoni u ossidazzjoni, segwiti b’ konjugazzjoni.
In vitro data from human liver microsomes indicate that cytochrome P450 enzymes CYP2D6 and CYP1A2 are involved in the formation of the 8-hydroxy metabolite of mirtazapine, whereas CYP3A4 is considered to be responsible for the formation of the N-demethyl and N-oxide metabolites.
Tagħrif in vitro mill- mikrosomi tal- fwied uman jindika illi ċitokromju P450 enżimi CYP2D6 u CYP1A2 huma involuti fil- formazzjoni tal- metabolit 8- hydroxy ta ’ mirtazapine, filwaqt illi CYP3A4 huwa kkunsidrat bħala responsabbli għall- formazzjoni tal- metaboliti N- demetil u N- ossidu.
The demethyl metabolite is pharmacologically active and appears to have the same pharmacokinetic profile as the parent compound.
Il - metabolit demetil huwa attiv farmakoloġikament u jidher li għandu l- istess profil farmakokinetiku bħall- kompost oriġinali.
The clearance of mirtazapine may be decreased as a result of renal or hepatic impairment.
It- tneħħija ta ’ mirtazapine jista jonqos b’ riżultat ta ’ indeboliment renali jew epatiku.
25 5.3 Preclinical safety data
5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, carcinogenicity or genotoxicity.
Informazzjoni ta ’ qabel l- użu kliniku, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, riskju ta ’ kanċer, jew effett tossiku fuq il- ġeni, ma turi l- ebda periklu speċjali għall- bnedmin.
In reproductive toxicity studies in rats and rabbits no teratogenic effects were observed.
Fi studji dwar tossiċita` fuq is- sistema riproduttiva f’ firien u fniek ma ġew osservati l- ebda effetti teratoġeniċi.
At two-fold systemic exposure compared to maximum human therapeutic exposure, there was an increase in post- implantation loss, decrease in the pup birth weights, and reduction in pup survival during the first three days of lactation in rats.
F’ esposizzjoni sistemika għal darbtejn meta mqabbel ma ’ esposizzjoni terapewtika umana massima, kien hemm żieda fit- telf wara l- impjantazzjoni, tnaqqis fil- piż tat- twelid tal- ġriewi, u tnaqqis fir- rata ta ’ sopravivenza taż- żgħar fl- ewwel tlett ijiem ta ’ treddigħ fil- firien.
Mirtazapine was not genotoxic in a series of tests for gene mutation and chromosomal and DNA damage.
Mirtazapine ma kellux effett tossiku fuq il- ġeni f’ sensiela ta ’ testijiet għal mutazzjoni ġenetika u għal ħsara tal- kromosomi u DNA.
Thyroid gland tumours found in a rat carcinogenicity study and hepatocellular neoplasms found in a mouse carcinogenicity study are considered to be species-specific, non-genotoxic responses associated with long-term treatment with high doses of hepatic enzyme inducers.
Tumuri tal- glandoli tat- tirojde misjuba fil- firien fi studji dwar riskju ta ’ kanċer u neoplażmi epatoċellulari misjuba fi studji dwar riskju ta ’ kanċer magħmula fuq ġrieden huma kkunsidrati bħala speċifiċi għall- ispeċi, rispons mhux ta ’ riskju ta’ effett tossiku fuq il- ġeni assoċċjat ma ’ trattament fit- tul b’ dożi għoljin ta ’ indutturi ta ’ enżimi epatiċi.
sugar spheres hypromellose povidone K30 magnesium stearate basic butylated methacrylate copolymer aspartame (E951) citric acid, anhydrous crospovidone (type A) mannitol (E421) microcrystalline cellulose natural and artificial orange flavour (No.
sugar spheres hypromellose povidone K30 magnesium stearate basic butylated methacrylate copolymer aspartame (E951) citric acid, anhydrous crospovidone (type A) mannitol (E421) microcrystalline cellulose natural and artificial orange flavour (No.
Store in the original package in order to protect from light and moisture
30 Aħżen fil- pakkett oriġinali sabiex tilqa mid- dawl u mill- umdita`
Child-resistant, peel-to-open, rigid perforated unit dose blister, formed from a laminate of aluminum foil and plastic films sealed to a paper-based laminate of aluminum foil coated with a heat seal lacquer.
Folja ipperforata riġida reżistenti għat- tfal li tiftaħha billi tqaxxarha magħmula minn laminat ta ’ fojl tal- aliminju u riti tal- plastik ssiġillati ma ’ laminat b’ bażi tal- karta ta ’ fojl tal- aluminju miksi b ’ laker li jissiġilla s- sħana.
The plastic films contain:
Ir- riti tal- plastik fihom:
PVC (polyvinyl chloride), polyamide and polyester.
PVC (polimer ta ’ kloridu tal- vinil), poliamide u poliester.
The blisters contain 6 orodispersible tablets each.
L- istrixxi fihom 6 pilloli li jinħallu fil- ħalq kull wieħed.
The following pack sizes are available for each strength:
Is- segwenti daqsijiet ta ’ pakketti huma disponibbli għal kull qawwa:
6 (1x6), 18 (3x6), 30 (5x6), 48 (8x6) and 96 (16x6) and 180 (10x18 (3x6)) orodispersible tablets.
6 (1x6), 18 (3x6), 30 (5x6), 48 (8x6) u 96 (16x6) u 180 (10x18) (3x6) pillola li tinħall fil- ħalq.
Not all pack sizes may be marketed.
Mhux id- daqsijiet kollha tal- pakketti jistgħu jitqiegħdu fuq is- suq.
{Name and address }< {tel }> < {fax }> < {e-mail }>
[Isem u indirizz] < {telefon} > < {fax} > < {e- mail} >
27 LABELLING
31 TIKKETTA
28 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
32 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Outer carton, 15 mg
Kartuna ta ’ barra, 15 mg
Remeron and associated names (see Annex I) 15 mg orodispersible tablets [See Annex I - To be completed nationally]
Remeron u ismijiet assoċjati miegħu (Ara Anness I) pilloli li jinħallu fil- ħalq15 mg [Ara Anness I - Biex timtela mill- pajjiż partikolari]
Each orodispersible tablet contains 15 mg mirtazapine
Pillola waħda li tinħall fil- ħalq fiha 15 mg mirtazapine
Sugar spheres (containing sucrose) and aspartame (E951)
Sugar spheres (fihom sucrose) u aspartame (E951)
6 orodispersible tablets 18 orodispersible tablets 30 orodispersible tablets 48 orodispersible tablets 96 orodispersible tablets
6 pilloli li jinħallu fil- ħalq 18- il pillola li jinħallu fil- ħalq 30 pillola li jinħallu fil- ħalq 48 pillola li jinħallu fil- ħalq 96 pillola li jinħallu fil- ħalq
29 Keep out of the reach and sight of children.
33 Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Store in the original package in order to protect from light and moisture
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mid- dawl u l- umidita`
{Name and Address }< {tel }> < {fax }> < {e-mail }>
{Isem u indirizz} < {telefon} > < {fax} > < {e- mail} >
30 Remeron 15
STRUZZJONIJIET DWAR L- UŻU
31 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
INFORMAZZJONI BIL- BRAILLE
NAME OF THE MEDICINAL PRODUCT
34 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Remeron and associated names (see Annex I) 15 mg orodispersible tablets [See Annex I - To be completed nationally]
Tikketta fuq il- pakkett mazz, 15 mg
Each orodispersible tablet contains 15 mg mirtazapine
Kull pillola li tinħall fil- ħalq fiha 15 mg mirtazapine
180 orodispersible tablets
180 pillola li jinħallu fil- ħalq
32 7.
35 7.
Store in the original package in order to protect from light and moisture
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mid- dawl u mill- umdità
[See Annex I - To be completed nationally]
[Ara Anness I – Biex timtela mill- pajjiz partikolari]
GENERAL CLASSIFICATION FOR SUPPLY
KLASSIFIKAZJONI ĠENERALI TA ’ KIF JINGĦATA
33 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
36 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Blister, 15 mg
Strixxa, 15 mg
Remeron and associated names (see Annex I) 15 mg orodispersible tablets [See Annex I - To be completed nationally]
Remeron u ismijiet assoċjati miegħu (Ara Anness I) pilloli li jinħallu fil- ħalq 15 mg [Ara Anness I - Biex timtela mill- pajjiż partikolari]
TEAR
QATTA
Outer carton, 30 mg
Kartuna ta ’ barra, 30 mg
Remeron and associated names (see Annex I) 30 mg orodispersible tablets [See Annex I - To be completed nationally]
Remeron u ismijiet assoċjati miegħu (Ara Anness I) pilloli li jinħallu fil- ħalq 30 mg [Ara Anness I- Biex timtela mill- pajjiż partikolari]
Each orodispersible tablet contains 30 mg mirtazapine
Pillola waħda li tinħall fil- ħalq fiha 30 mg mirtazapine
35 Keep out of the reach and sight of children.
38 Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
[See Annex I - To be completed nationally]
[Ara Anness I- Biex timtela mill- pajjiż partikolari]
37 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
39 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Label on bundle pack, 30 mg
Tikketta fuq il- pakkett mazz, 30 mg
Remeron and associated names (see Annex I) 30 mg orodispersible tablets [See Annex I - To be completed nationally]
Remeron u ismijiet assoċjati miegħu (ara Anness I) pilloli ta ’ 30 mg li jinħallu fil- ħalq [Ara Anness I – Biex timtela mill- pajjiż partikolari]
Each orodispersible tablet contains 30 mg mirtazapine
Kull pillola li tinħall fil- ħalq fiha 30 mg mirtazapine
Remeron 30
Remeron 15
39 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
41 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Blister, 30 mg
Strixxa, 30 mg
Outer carton, 45 mg
Kartuna ta ’ barra, 45 mg
Remeron and associated names (see Annex I) 45 mg orodispersible tablets [See Annex I - To be completed nationally]
Remeron u ismijiet assoċjati miegħu (Ara Anness I) pilloli li jinħallu fil- ħalq 45 mg [Ara Anness I- Biex timtela mill- pajjiż partikolari]
Each orodispersible tablet contains 45 mg mirtazapine
Pillola waħda li tinħall fil- ħalq fiha 45 mg mirtazapine
41 Keep out of the reach and sight of children.
43 Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Label on bundle pack, 45 mg
Tikketta fuq il- pakkett mazz, 45 mg
Remeron and associated names (see Annex I) 45 mg orodispersible tablets [See Annex I - To be completed nationally]
Remeron u ismijiet assoċjati miegħu (ara Anness I) pilloli ta ’ 45 mg li jinħallu fil- ħalq [Ara Anness I – Biex timtela mill- pajjiż partikolari]
Each orodispersible tablet contains 45 mg mirtazapine
Kull pillola li tinħall fil- ħalq fiha 45 mg mirtazapine
Remeron 45
Remeron 15
Blister, 45 mg
Strixxa, 45 mg
Remeron and assoicated names (see Annex I) 45 mg orodispersible tablets [See Annex I - To be completed nationally]
Remeron u ismijiet assoċjati miegħu (Ara Anness I) pilloli li jinħallu fil- ħalq 45 mg [Ara Anness I - Biex timtela mill- pajjiż partikolari]
47 PACKAGE LEAFLET:
47 FULJETT TA ’ TAGĦRIF
INFORMATION FOR THE USER
48 FULJETT TA ’ TAGĦRIF:
What Remeron is and what it is used for 2.
X’ inhu Remeron u għalxiex jintuża 2.
Before you take Remeron 3.
Qabel ma tieħu Remeron 3.
How to take Remeron 4.
Kif għandek tieħu Remeron 4.
How to store Remeron 6.
Kif taħżen Remeron 6.
WHAT REMERON IS AND WHAT IT IS USED FOR
X’ INHU REMERON U GĦALXIEX JINTUŻA
Remeron is one of a group of medicines called antidepressants.
Remeron huwa wieħed minn grupp ta ’ mediċini msejjħa anti- depressanti.
Remeron is used to treat depressive illness.
Remeron jintuża biex jittratta mard dipressiv.
Do not take Remeron • if you are allergic (hypersensitive) to mirtazapine or any of the other ingredients of Remeron.
Tieħux Remeron • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal mirtazapine jew sustanzi oħra ta ’ Remeron.
If so, you must talk to your doctor as soon as you can before taking Remeron. • if you are taking or have recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAO-Is).
Jekk hu hekk, għandek tkellem it- tabib kemm jista jkun malajr qabel ma tibda tieħu Remeron. • jekk inti qed tieħu jew ħadt riċentement (f’ dawn l- aħħar ġimgħatejn) mediċini msejħa impedituri ta ’ monoamine oxidase (MAO- Is).
Take special care with Remeron
Oqgħod attent ħafna b’ Remeron
Use in children and adolescents under 18 years of age Remeron should normally not be used for children and adolescents under 18 years.
Użu fi tfal u addoloxxenti taħt l- eta` ta ’ 18- il sena Remeron normalment m’ għandux jintuża fi tfal u addoloxxenti taħt l- eta` ta ’ 18- il sena.
Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines.
Għandek tkun taf ukoll illi pazjenti taħt it- 18 għandhom riskju ikbar ta ’ effetti mhux mixtieqa bħal attentat ta ’ suwiċidju, ħsibijiet suwiċidali u ostilita` (b’ mod predominanti aggressjoni, imġieba antagonistika u rabja) meta jieħdu din il- klassi ta ’ mediċina.
Despite this, your doctor may prescribe Remeron for patients under 18 because he/ she decides that this is in their best interests.
Madankollu, t- tabib tiegħek jista ’ jikteb Remeron għal pazjenti taħt it- 18 minħabba li hu/ hi j/ tiddeċiedi li dan hu fl- aħjar interess tagħhom.
If your doctor has prescribed Remeron for a patient under 18 and you want to discuss this, please go back to your doctor.
Jekk it- tabib tiegħek kiteb Remeron għal pazjent taħt it- 18 u inti tixtieq tiddiskuti dan, jekk jogħġbok mur lura għand it- tabib.
You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking
Għandek tinforma lit- tabib f’ każ illi jiżviluppaw jew jiggravaw xi sintomi imniżżla hawn meta pazjenti taħt it- 18 ikunu qed jieħdu Remeron.
Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Remeron in this age group have not yet been demonstrated.
49 konċernanti tkabbir, maturazzjoni u żvilupp konoxxittiv u ta ’ imġieba ta ’ Remeron f’ dan il- grupp ta ’ eta` għadhom ma ġewx dimostrati.
Thoughts of suicide and worsening of your depression If you are depressed you can sometimes have thoughts of harming or killing yourself.
Ħsibijiet suwiċidali u tiħżin tad- dipressjoni tiegħek Jekk inti qed tbati minn dipressjoni kultant jistgħu jgħaddulek ħsibijiet li tweġġa lilek inniffsek jew li toqtol lilek inniffsek.
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 tibda tieħu l- antidipressanti, minħabba li dawn il - mediċini kollha jieħdu xi żmien biex jaħdmu, issoltu madwar ġimgħatejn imma kultant anke iżjed.
You may be more likely to think like this: • if you have previously had thoughts about killing or harming yourself. • if you are a young adult.
Hemm iktar possibilita` li tibda taħseb hekk: • jekk fil- passat kellek ħsibijiet li toqtol lilek innifsek jew li tweġġa lilek innifsek. • Jekk inti żagħżugħ/ a.
Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant. → If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
Tagħrif minn provi kliniċi wera riskju ikbar ta ’ imġieba suwiċidali f’ adulti ta ’ eta` inqas minn 25 sena b’ kundizzjonijiet psikjatriċi li ġew trattati b’ antidipressanti. → Jekk għandek ħsibijiet li tweġġa jew toqtol lilek inniffsek, fi kwalunkwe ħin, kellem lit- tabib tiegħek jew mur l- isptar immedjatament.
You may find it helpful to tell a relative or close friend that you are depressed, and ask them to read this leaflet.
Jista jkun ta ’ għajnuna għalik li tgħid lil xi qarib jew xi ħabib li inti dipress/ a, 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.
Tista tistaqsihom jekk jaħsbux li d- dipressjoni tiegħek qed tiħżien, jew jek humiex inkwetati b’ tindil fl- imġieba tiegħek.
Also take special care with Remeron • if you have, or have ever had one of the following conditions. → Tell your doctor about these conditions before taking Remeron, if not done previously. -seizures (epilepsy).
Oqgħod attent ukoll b’ Remeron • jekk int għandek jew qatt kellek xi waħda mill- kundizzjonijiet segwenti. →Għid lit- tabib tiegħek dwar dawn il- kundizzjonijiet qabel ma tieħu Remeron, jekk ma għidtlux qabel.
If you develop seizures or your seizures become more frequent, stop taking Remeron and contact your doctor immediately; -liver disease, including jaundice.
isirulek iktar frekwenti, tibqax tieħu Remeron u kellem lit- tabib immedjatament;
If jaundice occurs, stop taking Remeron and contact your doctor immediately; -kidney disease; -heart disease, or low blood pressure; -schizophrenia.
Jekk sintomi psikotiċi, bħal ħsibijiet paranojiċi jsiru iktar frekwenti jew qawwija,
If psychotic symptoms, such as paranoid thoughts become more frequent or severe, contact your doctor straight away; -manic depression (alternating periods of feeling elated/ overactivity and depressed mood).
- mard fl- għajnejn, bħal żieda fil- pressjoni tal- għajnejn (glawkoma);
If you start feeling elated or over-excited, stop taking Remeron and contact your doctor immediately; -diabetes (you may need to adjust your dose of insulin or other antidiabetic medicines); -eye disease, such as increased pressure in the eye (glaucoma); -difficulty in passing water (urinating), which might be caused by an enlarged prostate. • if you develop signs of infection such as inexplicable high fever, sore throat and mouth ulcers. → Stop taking Remeron and consult your doctor immediately for a blood test.
imkabbra; • jekk tiżviluppa xi sinjali ta ’ infezzjoni bħal deni għoli inspjegabbli, uġigħ fil- griżmejn u ulċeri fil- ħalq. →Tibqax tieħu Remeron u kellem lit- tabib immedjatament għal test tad- demm.
In rare cases these symptoms can be signs of disturbances in blood cell production in the bone marrow.
F’ każijiet rari dawn is- sintomi jistgħu jkunu sinjali ta ’ disturbi fil- produzzjoni taċ- ċelloli tad- demm fil - mudullun tal- għadam.
While rare, these symptoms most commonly appear after 4-6 weeks of treatment. • if you are an elderly person.
Għalkemm huma rari, dawn is- sintomi ġeneralment jidhru wara 4- 6 ġimgħat ta ’ trattament. • jekk inti persuna anzjana.
You could be more sensitive to the side-effects of antidepressants.
Tista tkun iktar sensittiv għall- effetti mhux mixtieqa tal- anti - depressanti.
Taking other medicines Tell your doctor or pharmacist if you are taking (or plan to take) any of the medicines in the following list.
Meta tieħu mediċini oħra Għid lit- tabib jew lill- ispiżjar tiegħek jekk qed tieħu (jew tippjana li tieħu) xi mediċini mill- lista segwenti.
Please also tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Do not take Remeron in combination with: • monoamine oxidase inhibitors (MAO inhibitors).
Tieħux Remeron flimkien ma: • inibituri monoamine oxidase (inibituri MAO).
Also, do not take Remeron during the two weeks after you have stopped taking MAO inhibitors.
Tieħux Remeron lanqas fil- ġimgħatejn wara li tkun waqaft tieħu inibituri- MAO.
If you stop taking Remeron, do not take MAO inhibitors during the next two weeks either.
Jekk tieqaf tieħu Remeron, tieħux inibituri MAO fil - ġimgħatejn ta ’ wara lanqas.
Examples of MAO inhibitors are moclobemide, tranylcypromine (both are antidepressants) and selegiline (used for Parkinson’ s disease).
50 Eżempji ta ’ inibituri MAO huma moclobemide, tranylcypromine (it- tnejn huma anti - depressanti) u selegiline (użat għall- marda tal- Parkinsons).
49 • antidepressants such as SSRIs, venlafaxine and L-tryptophan, or triptans (used to treat migraine), tramadol (a pain-killer), linezolid (an antibiotic), lithium (used to treat some psychiatric conditions) and St.
Oqgħod attent/ a meta tieħu Remeron flimkien ma ’: • antidepressanti bħal SSRIs, venlafaxine u L- tryptophan jew triptans (użati biex jikkuraw l - emigranja), tramadol (itaffi l- uġigħ), linezolid (antibijotiku), lithium (użat biex jikkura xi kundizzjonijiet psikjatriċi) u St.
John’ s Wort – Hypericum perforatum preparations (a herbal remedy for depression).
Johns Wort – preparazzjonijiet ta ’ Hypericum perforatum (kura tal- ħxejjex għad- depressjoni).
In very rare cases Remeron alone or the combination of Remeron with these medicines, can lead to a so-called serotonin syndrome.
F’ każijiet rari ħafna Remeron waħdu jew kombinazzjoni ta ’ Remeron ma ’ dawn il- mediċini, jista jwassal għal dak li hu magħruf bħala serotonin syndrome.
Some of the symptoms of this syndrome are: inexplicable fever, sweating, increased heart rate, diarrhoea, (uncontrollable) muscle contractions, shivering, overactive reflexes, restlessness, mood changes, and unconsciousness.
Xi wħud mis- sintomi ta ’ dan is- sindromu huma: deni inspjegabbli, għaraq, żieda fir- rata tal - qalb, dijarrea, kontrazzjonijiet muskolari (inkontrollabli), tregħid, riflessi attivi żżejjed, aġitazzjoni, tibdil fil- burdata, u li tintilef minn sensik.
If you get a combination of these symptoms, talk to your doctor immediately. • the antidepressant nefazodone.
Jekk ikollok xi kombinazzjoni ta ’ dawn is- sintomi, kellem lit- tabib tiegħek immedjatament. • anti- depressant imsejjaħ nefazodone.
It can increase the amount of Remeron in your blood.
Dan jista jżid l- ammont ta ’ Remeron fid- demm tiegħek.
Inform your doctor if you are using this medicine.
Għid lit- tabib tiegħek jekk qed tuża din il- mediċina.
It might be needed to lower the dose of Remeron, or when use of nefazodone is stopped, to increase the dose of Remeron again. • medicines for anxiety or insomnia such as benzodiazepines; medicines for schizophrenia such as olanzapine; medicines for allergies such as cetirizine; medicines for severe pain such as morphine.
Jista jkun hemm bżonn li titnaqqas id- doża ta ’ Remeron, jew li terġa tiżdied id- doża ta ’ Remeron, meta jitwaqqaf l- użu ta ’ nefazodone. • mediċini għall- anzjeta` jew insomnja bħal benzodiazepines; mediċini għal skizofrenja bħal olanzapine; mediċini għall- allerġiji bħal cetrizine; mediċini għal uġigħ qawwi bħal morfina.
In combination with these medicines Remeron can increase the drowsiness caused by these medicines. • medicines for infections; medicines for bacterial infections (such as erythromycin); medicines for fungal infections (such as ketoconazole) and medicines for HIV/ AIDS (such as HIV- protease inhibitors).
F’ kombinazzjoni ma ’ dawn il- mediċini Remeron jista jżid it- tħeddil ikkawżat minn dawn il - mediċini. • mediċini għall- infezzjonijiet: mediċini għal infezzjonijiet batteriċi (bħal erythromycin), mediċini għat- trattament ta ’ infezzjonijiet fungali (bħal ketoconazole) u mediċini għal HIV/ AIDS (bħal inibituri HIV- protease).
In combination with Remeron these medicines can increase the amount of Remeron in your blood.
Flimkien ma ’ Remeron, dawn il- mediċini jistgħu jżidu l- ammont ta ’ Remeron fid- demm tiegħek.
Inform your doctor if you are using these medicines.
Għid lit- tabib tiegħek jekk qed tuża dawn il- mediċini.
It might be needed to lower the dose of Remeron, or when these medicines are stopped, to increase the dose of Remeron again. • medicines for epilepsy such as carbamazepine and phenytoin; medicines for tuberculosis such as rifampicin.
Jista jkun hemm bżonn li titbaxxa d- doża ta ’ Remeron, jew li terġa tiżdied id- doża ta ’ Remeron, meta jitwaqqfu dawn il - mediċini. • mediċini għall- epilessija bħal carbamazepine u phenytoin, u mediċini għat- tuberkolożi bħal rifampicin.
In combination with Remeron these medicines can reduce the amount of Remeron in your blood.
Flimkien ma ’ Remeron dawn il- mediċini jistgħu jnaqqsu l- ammont ta ’ Remeron fid- demm.
It might be needed to increase the dose of Remeron, or when these medicines are stopped to lower the dose of Remeron again. • medicines to prevent blood clotting such as warfarin.
Jista jkun hemm bżonn li tiżdied id- doża ta ’ Remeron, jew li terġa titnaqqas id- doża ta ’ Remeron, meta jitwaqqfu dawn il- mediċini. • mediċini kontra t- tgħaqqid tad- demm bħal warfarin.
Remeron can increase the effects of warfarin on the blood.
Remeron jista jżid l- effetti ta ’ warfarin fuq id- demm.
Inform your doctor if you are using this medicine.
Għid lit- tabib tiegħek jekk qed tuża dawn il- mediċini.
In case of combination it is advised that a doctor monitors your blood carefully.
F’ każ li dawn jittieħdu flimkien huwa għaqli li t- tabib jimmonitorja d- demm tiegħek bir- reqqa.
Taking Remeron with food and drink You may get drowsy if you drink alcohol while you are taking Remeron.
Meta tieħu Remeron ma ’ l- ikel u max- xorb Tista titħeddel jekk tixrob l- alkoħol waqt li qed tieħu Remeron.
You are advised not to drink any alcohol.
Inti avżat biex ma tixrobx l- alkoħol.
You can take Remeron with or without food.
Tista tieħu Remeron mal- ikel jew mingħajr ikel.
Limited experience with Remeron administration to pregnant women does not indicate an increased risk.
Esperjanza limitata bl- għoti ta ’ Remeron lil nisa tqal ma tindikax żieda fir- riskju.
However, caution should be exercised when used during pregnancy.
Iżda wieħed għandu joqgħod attent meta jużah waqt it- tqala.
If you are taking Remeron and you become pregnant or you plan to get pregnant, ask your doctor whether you may continue taking Remeron.
Jekk qed tieħu Remeron u tinqabad tqila jew tippjana li tinqabad tqila, staqsi lit- tabib tiegħek jekk għandekx tkompli tieħu Remeron.
If you use Remeron until, or shortly before birth, your baby should be supervised for possible adverse effects.
Jekk inti tuża Remeron sal- ħlas jew sa ftit qabel il- ħlas, it- tarbija tiegħek għandha tiġi issorveljata għal effetti avversi li jista ’ jkun hemm.
Ask your doctor whether you can breast-feed, while taking Remeron.
Staqsi lit- tabib tiegħek jekk tistax tredda waqt li qed tieħu Remeron.
Driving and using machines Remeron can affect your concentration or alertness.
Sewqan u tħaddim ta ’ magni Remeron jista jkollu effett fuq il- konċentrazzjoni jew viġilanza.
Make sure these abilities are not affected before you drive or operate machinery.
Kun żgur li l- abilitajiet tiegħek ma ġewx affettwati qabel ma ssuq jew tħaddem magni.
Important information about some of the ingredients of Remeron Remeron orodispersible tablets contain sugar spheres, containing sucrose.
51 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Remeron Il- pilloli li jinħallu fil- ħalq Remeron fihom sferi taz- zokkor, li fihom iz- zokkor ta ’ kannamieli.
If you have been told by your doctor that you have an intolerance for some sugars, contact your doctor before taking this medicinal product.
Jekk inti ġejt infurmat/ a minn xi tabib li tbati minn xi intolerranza għal ċert tipi ta ’ zokkor kellem lit- tabib qabel ma tieħu dan il- prodott mediċinali.
50 Remeron orodispersible tablets contain aspartame, a source of phenylalanine.
Il- pilloli li jinħallu fil- ħalq Remeron fihom aspartame, li huwa sors ta ’ fenilalanin.
May be harmful for people with phenylketonuria.
Jista jkun ta ’ ħsara għal pazjenti b’ fenilketonurja.
HOW TO TAKE REMERON
KIF GĦANDEK TIEĦU REMERON
Always take Remeron exactly as your doctor or pharmacist tells you to.
Dejjem għandek tieħu Remeron eżattament skond il- parir tat- tabib jew tal- ispiżjar tiegħek.
How much to take The usual starting dose is 15 or 30 mg every day.
Kemm għandek tieħu Id- doża inizjali ssoltu hija ta ’ 15 jew 30 mg kuljum.
Your doctor may advise you to increase your dose after a few days to the amount that is best for you (between 15 and 45 mg per day).
It- tabib jista jagħtik il- parir ili żżid id- doża wara xi ftit ġranet għall- ammont li hu l- aħjar għalik (bejn 15 u 45 mg kuljum).
The dose is usually the same for all ages.
Issoltu d- doża hija l - istess għall- etajiet kollha.
However, if you are an elderly person or if you have renal or liver disease, your doctor may adapt the dose.
Iżda jekk inti persuna anzjana jew jekk għandek xi mard renali jew fil- fwied, jista jkun illi t- tabib jaddattalek id- doża.
When to take Remeron → Take Remeron at the same time each day.
Meta għandek tieħu Remeron → Ħu Remeron fl- istess ħin kuljum.
It is best to take Remeron as a single dose before you go to bed.
L- aħjar tieħu Remeron bħala doża waħda qabel ma tmur torqod.
However your doctor may suggest to split your dose of Remeron – once in the morning and once at night-time before you go to bed.
Iżda t- tabib jista jissuġġerilek illi taqsam id- doża ta ’ Remeron – darba filgħodu, u darba qabel ma tmur torqod.
The higher dose should be taken before you go to bed.
Id- doża ogħla għanda tittieħed qabel ma tmur torqod.
Take the orodispersible tablet as follows Take your tablets orally.
Ħu l- pillola li tinħall fil- ħalq kif ser jingħad hawn taħt:
Do not crush the orodispersible tablet In order to prevent crushing the orodispersible tablet, do not push against the tablet pocket (Figure A).
Tfarrakx il- pillola li tinħall fil- ħalq Biex tevita li tfarrak il- pillola li tinħall fil- ħalq, timbuttax mal- qartas tal- pillola (Figura A).
Tear off one tablet pocket Each blister contains six tablet pockets, which are separated by perforations.
Qatta qartas wieħed tal- pillola Kull folja fiha sitt qratas tal- pilloli, li huma separati b’ perforazzjonijiet.
Peel off the lid Carefully peel off the lidding foil, starting in the corner indicated by the arrow (Figures 2 and 3).
Qaxxar l- għata Qaxxar bil- mod l- għata tal- fojl, billi tibda mir- rokna indikata bil- vleġġa (Figuri 2 u 3).
51 Fig.
52 Fig.
It will rapidly disintegrate and can be swallowed without water.
Din tinħall malajr u tista tinbelgħa mingħajr ilma
When can you expect to start feeling better Usually Remeron will start working after 1 to 2 weeks and after 2 to 4 weeks you may start to feel better.
Meta għandek tistenna li tibda tħossok aħjar Issoltu Remeron jibda jaħdem wara xi ġimgħa jew tnejn u wara bejn ġimgħatejn u erba ’ ġimgħat tista tibda tħossok aħjar.
It is important that, during the first few weeks of the treatment, you talk with your doctor about the effects of Remeron: → 2 to 4 weeks after you have started taking Remeron, talk to your doctor about how this medicine has affected you.
Huwa importanti illi fl- ewwel ġimgħat tat- trattament tkellem lit- tabib tiegħek fuq l- effetti ta ’ Remeron: → bejn 2 u 4 ġimgħat wara li tibda tieħu Remeron kellem lit- tabib tiegħek fuq l- effett li kellha fuqek din il- mediċina.
If you still don’ t feel better, your doctor may prescribe a higher dose.
Jekk tibqa ma tħossokx aħjar, it- tabib jista ’ jiktiblek doża ogħla.
In that case, talk to your doctor again after another 2 to 4 weeks.
F’ dak il- każ erġa kellem lit- tabib tiegħek wara bejn ġimgħatejn u erba ’ ġimgħat oħra.
Usually you will need to take Remeron until your symptoms of depression have disappeared for 4 to 6 months.
Issoltu għandek tkompli tieħu Remeron sakemm jisparixxu s- sintomi tad- dipressjoni għal bejn 4 u 6 xhur.
If you take more Remeron than you should → If you or someone else have taken too much Remeron, call a doctor straight away.
Jekk tieħu Remeron aktar milli suppost → Jekk inti jew xi ħadd ieħor jieħu Remeron aktar milli suppost, sejjaħ tabib immedjatament.
The most likely signs of an overdose of Remeron (without other medicines or alcohol) are drowsiness, disorientation and increased heart rate.
L- iktar sinjali probabbli ta ’ doża eċċessiva ta ’ Remeron (mingħajr mediċini oħrajn jew alkoħol) huma ħedla, diżorjentament, u rata mgħaġġla tal- qalb.
If you forget to take Remeron If you are supposed to take your dose once a day • If you have forgotten to take your dose of Remeron, do not take the missed dose.
Jekk inti għandek tieħu doża waħda kuljum • Jekk insejt tieħu d- doża tiegħek ta ’ Remeron, tieħux id- doża li insejt tieħu.
Just skip it.
Aqbizha.
Take your next dose at the normal time.
Ħu d- doża li jmiss fil- ħin li suppost teħodha.
If you are supposed to take your dose twice a day
Jekk inti għandek tieħu d- doża tiegħek darbtejn kuljum • jekk inti insejt tieħu d- doża ta ’ filgħodu, sempliċement ħudha ma ’ d- doża ta ’ filgħaxija.
52 • if you have forgotten to take your morning dose, simply take it together with your evening dose. • if you have forgotten to take your evening dose, do not take it with the next morning dose; just skip it and continue with your normal morning and evening doses. • if you have forgotten to take both doses, do not attempt to make up for the missed doses.
53 • jekk inti insejt tieħu d- doża ta ’ filgħaxija, teħodiex mad- doża ta ’ filgħodu li jmiss; aqbiżha u kompli bid- dożi normali ta ’ filgħodu u filgħaxija. • jekk inti insejt tieħu ż- żewġ dożi, tippruvax tpatti għad- dożi li tlift.
Skip both doses and continue the next day with your normal morning and evening doses.
Aqbeż iż- żewġ dożi u kompli l- ġurnata ta ’ wara bid- dożi normali ta ’ filgħodu u filgħaxija.
If you stop taking Remeron → Only stop taking Remeron in consultation with your doctor.
Jekk tieqaf tieħu Remeron → Ieqaf tieħu Remeron biss b’ konsultazzjoni mat- tabib tiegħek.
If you stop too early, your depression might come back.
Jekk tieqaf tieħu Remeron kmieni wisq, id- dipressjoni tista terġa tiġi lura.
Once you are feeling better, talk to your doctor.
Meta tibda tħossok aħjar, kellem lit- tabib tiegħek.
Your doctor will decide when treatment can be stopped.
It- tabib tiegħek jiddeċiedi meta jista jitwaqqaf it- trattament.
Do not suddenly stop taking Remeron, even when your depression has lifted.
Tieqafx tieħu Remeron f’ daqqa anke jekk id- dipressjoni naqqset.
If you suddenly stop taking Remeron you may feel sick, dizzy, agitated or anxious, and have headaches.
Jekk tieqaf tieħu Remeron f’ daqqa tista tħossok ma tiflaħx, sturdut/ a, aġitat/ a jew anzjuż/ a, u jista jkollok uġigħ ta ’ ras.
These symptoms can be avoided by stopping gradually.
Dawn is- sintomi jistgħu jiġu evitati billi twaqqaf b’ mod gradwali.
Your doctor will tell you how to decrease the dose gradually.
It- tabib tiegħek igħidlek kif tnaqqas id- doża bil- mod.
Like all medicines, Remeron can cause side effects, although not everybody gets these side effects.
Bħal kull mediċina oħra, Remeron jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Some side effects are more likely to occur than others.
Xi wħud mill- effetti sekondarji jistgħu jseħħu iktar minn oħrajn.
The possible side effects of Remeron are listed below and can be divided as: • • • • • •
L- effetti sekondarji possibli huma imniżżla hawn taħt u jistgħu jitqassmu hekk: • • • • • •
affects more than 1 user in 10 affects 1 to 10 users in 100 affects 1 to 10 users in 1,000 affects 1 to 10 users in 10,000 affects less than 1 user in 10,000 cannot be estimated from the available data
jaffettwaw iktar minn 1 f’ kull 10 persuni li jużawħ jaffettwaw bejn 1 sa 10 persuni li jużawħ minn 100 jaffettwaw bejn 1 sa 10 persuni li jużawħ minn 1, 000 jaffettwaw bejn 1 sa 10 persuni li jużawħ minn 10, 000 jaffettwaw inqas minn 1 persuna li tużaħ minn 10, 000 mit- tagħrif disponibbli ma jistax jiġi stmat
Very common: • increase in appetite and weight gain • drowsiness or sleepiness • headache • dry mouth
Komuni ħafna: • żieda fl- aptit u żieda fil- piż • ħedla jew ngħas • uġigħ ta ’ ras • ħalq xott
Common: • lethargy • dizziness • shakiness or tremor • nausea • diarrhoea • vomiting • rash or skin eruptions (exanthema) • pain in your joints (arthralgia) or muscles (myalgia) • back pain • feeling dizzy or faint when you stand up suddenly (orthostatic hypotension) • swelling (typically in ankles or feet) caused by fluid retention (oedema) • tiredness • vivid dreams • confusion • feeling anxious • sleeping problems
Komuni: • letarġija • sturdament • tferfir jew rogħda • nawsja • dijarrea • iremettar • raxx jew eruzzjonijiet fil- ġilda (exanthema) • uġigħ fil- ġogi (arthralgia) jew muskoli (myalgia) • uġigħ fid- dahar • tħoss sturdament jew ħass ħażin meta tqum bil- wieqfa f’ daqqa (pressjoni ortostatika baxxa ħafna) • nefħa (tipikament fl- għakiesi u fis- saqajn) ikkawżat minn ritenzjoni ta ’ fluwidi (edema) • għejja • ħolm imqanqal • konfużjoni • tħossok anzjuż/ a • problemi ta ’ rqad
Uncommon:
Mhux komuni: • tħossok ferħan iżżejjed jew emozzjonalment ‘ high ’ (manija)
53 • feeling elated or emotionally ‘ high’ (mania) → Stop taking Remeron and tell your doctor straight away. • abnormal sensation in the skin e. g. burning, stinging, tickling or tingling (paraesthesia) • restless legs • fainting (syncope) • sensations of numbness in the mouth (oral hypoaesthesia) • low blood pressure • nightmares • feeling agitated • hallucinations • urge to move
54 → Ieqaf tieħu Remeron u kellem lit- tabib tiegħek immedjatament. • sensazzjoni anormali fil- ġilda p. e. ħruq, tingiż, tagħrix jew textix (paraesteżija) • aġitazzjoni fir- riġlejn • ħass ħażin (sinkope) • sensazzjoni ta ’ tirżiħ fil- ħalq (ipoesteżija orali) • pressjoni baxxa tad- demm • ħmar il- lejl • tħossok eċitat/ a • alluċinazzjonijiet • bżonn li tiċċaqlaq
Rare: • yellow colouring of eyes or skin; this may suggest disturbance in liver function (jaundice) → Stop taking Remeron and tell your doctor straight away. • muscle twitching or contractions (myoclonus)
Rari: • kulur safrani fl- għajnejn jew fil- ġilda; dan jista jfisser xi disturbi fil- funzjoni tal- fwied (suffejra) → Ieqaf tieħu Remeron u kellem lit- tabib tiegħek immedjatament. • ġbid tal- muskoli jew kontrazzjonijiet (mijoklonus)
Not known: • signs of infection such as sudden unexplainable high fever, sore throat and mouth ulcers (agranulocytosis) → Stop taking Remeron and contact your doctor straight away for a blood test.
Mhux magħruf: • sinjali ta ’ infezzjoni bħal deni għoli inspjegabbli f’ daqqa, uġigħ fil- griżmejn u ulċeri fil- ħalq (agranuloċitożi) → Ieqaf tieħu Remeron u kellem lit- tabib tiegħek immedjatament għal test tad- demm.