qanastek/EMEA-V3 huggingface dataset:
In rare cases Remeron can cause disturbances in the production of blood cells (bone marrow depression).
F’ każijiet rari Remeron jista jikkawża disturbi fil- produzzjoni taċ- ċelluli tad- demm (dipressjoni tal- mudullun tal- għadam).
Some people become less resistant to infection because Remeron can cause a temporary shortage of white blood cells (granulocytopenia).
Xi nies isiru inqas reżistenti għal infezzjonijiet minħabba li Remeron jista jikkawża nuqqas temporanju taċ- ċelluli bojod tad- demm (granuloċitopenija).
In rare cases Remeron can also cause a shortage of red and white blood cells, as well as blood platelets (aplastic anemia), a shortage of blood platelets (thrombocytopenia) or an increase in the number of white blood cells (eosinophilia). • epileptic attack (convulsions) → Stop taking Remeron and tell your doctor straight away. • a combination of symptoms such as inexplicable fever, sweating, increased heart rate, diarrhoea, (uncontrollable) muscle contractions, shivering, overactive reflexes, restlessness, mood changes and unconsciousness.
F’ każijiet rari Remeron jista jikkawża wkoll nuqqas ta ’ ċelluli ħomor u bojod tad- demm, kif ukoll platelets tad- demm (anemija aplastiku), nuqqas ta ’ platelets tad- demm (tromboċitopenija) jew żieda fin - numru taċ- ċelluli bojod tad- demm (eosinofilija). • attakk epilettiku (aċċessjonijiet) → Ieqaf tieħu Remeron u kellem lit- tabib tiegħek immedjatament. • taħlita ta ’ sintomi bħal deni inspjegabbli, għaraq, żieda fir- rata tal- qalb, dijarrea, kontrazzjonijiet tal- muskoli (inkontrollabbli), tregħid, riflessi attivi żżejjed, aġitazzjoni, bdil tal- burdata u tintilef minn sensik.
In very rare cases these can be signs of serotonin syndrome. → Stop taking Remeron and tell your doctor straight away. • thoughts of harming or killing yourself → Contact your doctor or go to a hospital straight away. • abnormal sensations in the mouth (oral paraesthesia) • swelling in the mouth (mouth oedema) • hyponatraemia • inappropriate anti-diuretic hormone secretion
F’ każijiet rari ħafna dawn jistgħu jkunu sinjali ta ’ serotonin syndrome. → Ieqaf tieħu Remeron u kellem lit- tabib tiegħek immedjatament. • ħsibijiet li tweġġa jew toqtol lilek inniffsek → kellem lit- tabib tiegħek jew mur l- isptar immedjatament. • sensazzjoni anormali fil- ħalq (parastażija orali) • nefħa fil- ħalq (edema tal- ħalq) • iponatrimija • sekrezzjoni mhux xierqa ta ’ l- ormon antidijuretiku
HOW TO STORE REMERON
KIF TAĦŻEN REMERON
Do not use Remeron after the expiry date which is stated on the carton and the blister.
Tużax Remeron wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- istrixxa.
Store in the original package in order to protect from light and moisture
Aħżen fil- pakkett oriġinali sabiex sabiex tilqa ’ mid- dawl u mill- umdita ’
54 Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
Ask your pharmacist how to dispose of medicines no longer required.
55 Staqsi lill- ispiżjar dwar kif għandek tarmi mediċini li m’ għandekx bżonn.
What Remeron contains
X’ fih Remeron
• The active substance is mirtazapine.
• Is- sustanza attiva hi mirtzapine.
Remeron 15 mg orodispersible tablets contain 15 mg mirtazapine per orodispersible tablet.
Il- pilloli li jinħallu fil- ħalq Remeron 15 mg fihom 15 mg mirtazapine għal kull pillola li tinħall fil- ħalq.
Remeron 30 mg orodispersible tablets contain 30 mg mirtazapine per orodispersible tablet.
Il- pilloli li jinħallu fil- ħalq Remeron 30 mg fihom 30 mg mirtazapine għal kull pillola li tinħall fil- ħalq.
Remeron 45 mg orodispersible tablets contain 45 mg mirtazapine per orodispersible tablet. • The other ingredients are sugar spheres, hypromellose, povidone K30, magnesium stearate, basic butylated methacrylate copolymer, aspartame (E951), anhydrous citric acid, crospovidone (type A), mannitol (E421), microcrystalline cellulose, natural and artificial orange flavour (No.
Il- pilloli li jinħallu fil- ħalq Remeron 45 mg fihom 45 mg mirtazapine għal kull pillola li tinħall fil- ħalq. • L- ingredjenti l- oħrajn huma sugar spheres, hypromellose, povidone K30, magnesium stearate, basic butylated methacrylate copolymer, aspartame (E951), anhydrous citric acid, crospovidone (type A), mannitol (E421), microcrystalline cellulose, natural u artificial orange flavour (No.
SN027512) and sodium hydrogen carbonate.
SN027512) u sodium hydrogen carbonate.
What Remeron looks like and contents of the pack
Id- Dehra ta ’ Remeron u l- kontenuti tal- pakkett:
Remeron are orodispersible tablets.
Remeron huma pilloli li jinħallu fil- ħalq.
Remeron 15 mg orodispersible tablets are round, white, standard bevelled-edge tablets coded with ‘ TZ/ 1’ on one side.
Il- pilloli li jinħallu fil- ħalq Remeron 15 mg huma tondi, bojod bit- tarf immullat standard immarkata b’ kodiċiTZ/ 1 fuq naħa waħda.
Remeron 30 mg orodispersible tablets are round, white, standard bevelled-edge tablets coded with ‘ TZ/ 2’ on one side.
Il- pilloli li jinħallu fil- ħalq Remeron 30 mg huma tondi, bojod bit- tarf immullat standard immarkata b’ kodiċiTZ/ 2 fuq naħa waħda.
Remeron 45 mg orodispersible tablets are round, white, standard bevelled-edge tablets coded with ‘ TZ/ 4’ on one side.
Il- pilloli li jinħallu fil- ħalq Remeron 45 mg huma tondi, bojod bit- tarf immullat standard immarkata b’ kodiċiTZ/ 4 fuq naħa waħda.
The orodispersible tablets are packed in a child-resistant perforated unit dose blister.
Il- pilloli li jinħallu fil- ħalq huma ppakkjati fi strixxa reżistenti għat- tfal b’ sarbut toqob għal dożi waħdiet.
For Remeron 15, 30 and 45 mg orodispersible tablets the following pack sizes are available:
Għal pilloli li jinħallu fil- ħalq Remeron 15, 30 u 45 mg huma disponibbli s- segwenti daqsijiet:
6, 18, 30, 48, 90, 96 and 180 orodispersible tablets (not all pack sizes may be marketed).
6, 18, 30, 48, 90, 96 u 180 pilloli li jinħallu fil- ħalq (mhux id- daqsijiet kollha tal- pakketti jistgħu jitqiegħdu fuq is- suq).
This medicinal product is authorised in the Member States of the EEA under the following names [not applicable for art 30 referral]
[mhux applikabbli għal art 30 referenza]
This leaflet was last revised/ approved in.
Dan il- fuljett kien approvat l- aħħar f ’
56 1.
56 SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT
Remeron and associated names (see Annex I) 15 mg film-coated tablets Remeron and associated names (see Annex I) 30 mg film-coated tablets Remeron and associated names (see Annex I) 45 mg film-coated tablets
Remeron u ismijiet assoċjati miegħu (Ara Anness I) pilloli miksija b’ rita 15 mg Remeron u ismijiet assoċjati miegħu (Ara Anness I) pilloli miksija b’ rita 30 mg Remeron u ismijiet assoċjati miegħu (Ara Anness I) pilloli miksija b’ rita 45 mg
Each Remeron 15 mg film-coated tablet contains 15 mg of mirtazapine.
Kull pillola miksija b’ rita Remeron 15 mg fiha 15 mg ta ’ mirtazapine.
Each Remeron 30 mg film-coated tablet contains 30 mg of mirtazapine.
Kull pillola miksija b’ rita Remeron 30 mg fiha 30 mg ta ’ mirtazapine.
Each Remeron 45 mg film-coated tablet contains 45 mg of mirtazapine.
Kull pillola miksija b’ rita Remeron 45 mg fiha 45 mg ta ’ mirtazapine.
Each Remeron 15 mg film-coated tablet contains 109 mg lactose (as monohydrate).
Kull pillola miksija b’ rita Remeron 15 mg fiha 109 mg lattosju (bħala monoidrat).
Each Remeron 30 mg film-coated tablet contains 217 mg lactose (as monohydrate).
Kull pillola miksija b’ rita Remeron 30 mg fiha 217 mg lattosju (bħala monoidrat).
Each Remeron 45 mg film-coated tablet contains 325 mg lactose (as monohydrate).
Kull pillola miksija b’ rita Remeron 45 mg fiha 325 mg lattosju (bħala monoidrat).
15 mg film-coated tablet:
Pillola miksija b’ rita ta ’ 15 mg:
Oval, biconvex, yellow, scored and marked with ‘ Organon’ on one side-and a code on the other side (TZ/ 3).
Ovali, konvessa miż- żewġ naħat, safra, immarkata tul in- nofs u mmarkata ‘ Organon ’ fuq naħa waħda u kodiċi fuq in- naħa l- oħra (TZ/ 3).
The tablet can be divided into equal halves.
Il- pillola tista ’ tinqasam f’ żewġ nofsijiet ugwali.
30 mg film-coated tablet:
Pillola miksija b’ rita ta ’ 30 mg:
Oval, biconvex, red-brown, scored and marked with ‘ Organon’ on one side-and a code on the other side (TZ/ 5).
Ovali, konvessa miż- żewġ naħat, kanella ħamranija, immarkata tul in- nofs u mmarkata ‘ Organon ’ fuq naħa waħda u kodiċi fuq in- naħa l- oħra (TZ/ 5).
45 mg film-coated tablet:
Pillola miksija b’ rita ta ’ 45 mg:
Oval, biconvex, white and marked with ‘ Organon’ on one side-and a code on the other side (TZ/ 7).
Ovali, konvessa miż- żewġ naħat, bajda u mmarkata ‘ Organon ’ fuq naħa waħda u kodiċi fuq in- naħa l - oħra (TZ/ 7).
57 The recommended dose is the same as that for adults.
58 Id- doża rrakkomandata hija l- istess bħal tal- adulti.
Renal impairment The clearance of mirtazapine may be decreased in patients with moderate to severe renalimpairment (creatinine clearance < 40 ml/ min).
Indeboliment renali It- tneħħija ta ’ mirtazapine jista jkun imnaqqas f’ pazjenti b’ indeboliment renali moderata għal qawwija (tneħħija ta ’ creatinine < 40 ml/ min).
Remeron may also be given in two divided doses (once in the morning and once at night-time, the higher dose should be taken at night).
Remeron jista ’ jingħata wkoll f’ żewġ dożi maqsuma (waħda filgħodu u waħda filgħaxija, id- doża ogħla għanda tingħata filgħaxija).
The tablets should be taken orally, with fluid, and swallowed without chewing.
Il- pilloli għandhom jittieħdu mill- ħalq, ma xi fluwidi, u jinbelgħu mingħajr ma jintmagħdu.
A meta-analysis of placebo- controlled clinical trials of antidepressants in adult patients with psychiatric disorders showed an
Meta- analiżi ta ’ provi kliniċi kontrollati bi plaċebo ta ’ mediċinali anti- depressanti f’ adulti b’ mard psikjatriku wera
58 increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
59 riskju ikbar ta ’ imġieba suwiċidali b’ anti- depressanti meta pparagunat ma ’ plaċebo f’ pazjenti ta ’ taħt il- 25 sena.
Patients (and caregivers of patients) should be alerted about 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 persuni li jieħdu ħsieb il- pazjenti) għandhom jiġu imwissija dwar il- bżonn ta ’ monitoraġġ għal tiħżin kliniku, imġieba jew ħsibijiet suwiċidali u bdil insolitu fl- imġieba u għandu jintalab parir mediku immedjatament jekk jippreżentaw ruħhom dawn is - sintomi.
With regard to the chance of suicide, in particular at the beginning of treatment, only a limited number of Remeron film-coated tablets should be given to the patient.
Għar- rigward tal- possibilita` ta ’ suwiċidju, b’ mod partikolari fil- bidu tat- trattament, għanda tingħata kwantita` limitata ta ’ pilloli Remeron miksija b’ rita lill- pazjent.
Conditions which need supervision Careful dosing as well as regular and close monitoring is necessary in patients with: – epilepsy and organic brain syndrome:
Għalkemm esperjenza klinika indikat li attakki puletiċi
Although clinical experience indicates that epileptic seizures are rare during mirtazapine treatment, as with other antidepressants, Remeron should be introduced cautiously in patients who have a history of seizures.
epilettiċi huma rari waqt trattament b’ mirtazapine, bħal b’ anti- depressanti oħrajn, Remeron għandu jiġi introdott b’ attenzjoni f’ pazjenti li għandhom passat ta ’ attakki pupletiċi.
Treatment should be discontinued in any patient who develops seizures, or where there is an increase in seizure frequency. – hepatic impairment:
It - trattament għandu jitwaqqaf f’ pazjent li jiżviluppa attakki pupletiċi, jew fejn hemm żieda fi frekwenza ta ’ attakki pupletiċi.
Following a single 15 mg oral dose of mirtazapine, the clearance of mirtazapine was approximately 35% decreased in mild to moderate hepatically impaired patients, compared to subjects with normal hepatic function.
mirtazapine kien imnaqqas b’ madwar 35% f’ pazjenti bi ftit indeboliment epatiku għal moderata pparagunati ma ’ suġġetti b’ funzjoni epatika normali.
The average plasma concentration of mirtazapine was about 55 %increased. – renal impairment:
Il- konċentrazzjoni medja tal- plażma ta ’ mirtazapine żdiedet b’ madwar 55%.
Following a single 15 mg oral dose of mirtazapine, in patients with moderate (creatinine clearance < 40 ml/ min) and severe (creatinine clearance ≤ 10 ml/ min) renal impairment the clearance of mirtazapine was about 30% and 50% decreased respectively, compared to normal subjects.
renali moderata (tneħħija ta ’ creatinine < 40 ml/ min) u qawwija (tneħħija ta ’ creatinine ≤10 ml/ min) it- tneħħija ta ’ mirtazapine kien imnaqqas b’ madwar 30% u 50% rispettivament pparagunati ma ’ suġġetti normali.
The average plasma concentration of mirtazapine was about 55% and 115% increased respectively.
Il- konċentrazzjoni medja tal- plażma ta ’ mirtazapine żdiedet b’ madwar 55% u 115% rispettivament.
No significant differences were found in patients with mild renal impairment (creatinine clearance < 80 ml/ min) as compared to the control group. – cardiac diseases like conduction disturbances, angina pectoris and recent myocardial infarction, where normal precautions should be taken and concomitant medicines carefully administered. – low blood pressure. – diabetes mellitus:
Ma nstabux differenzi sinjifikanti f’ pazjenti b’ indeboliment renali ħafif (tneħħija ta ’ cretainine < 80 ml/ min) meta pparagunati mal- grupp tal - kontroll.
In patients with diabetes, antidepressants may alter glycaemic control.
- mard kardijaku bħal disturbi tal- konduzzjoni, angina pectoris u infart mijokardjali riċenti, fejn
Insulin and/ or oral hypoglycaemic dosage may need to be adjusted and close monitoring is recommended.
għandhom jittieħdu prekawzjonijiet normali u mediċini konkomitanti għandhom jiġu amministrati b’ attenzjoni.
Like with other antidepressants, the following should be taken into account: – Worsening of psychotic symptoms can occur when antidepressants are administered to patients with schizophrenia or other psychotic disturbances; paranoid thoughts can be intensified – When the depressive phase of bipolar disorder is being treated, it can transform into the manic phase.
Jista jkun hemm bżonn ta ’ aġġustament tad- dożi tal- insulina u/ jew ipoglikemiku orali u huwa rrakkomandat il- monitoraġġ mill- qrib.
Patients with a history of mania/ hypomania should be closely monitored.
bi skiżofrenja jew disturbi psikotiċi oħrajn; ħsibijiet paranojiċi jistgħu jiġu intensifikati.
Mirtazapine should be discontinued in any patient entering a manic phase. – Although Remeron is not addictive, post-marketing experience shows that abrupt termination of treatment after long term administration may sometimes result in withdrawal symptoms.
- Meta qed tiġi ttrattata l- fażi dippressiva ta ’ diżordni bipolari, din tista tiġi trasformata fil- fażi
The majority of withdrawal reactions are mild and self-limiting.
Mirtazapine għandu jitwaqqaf f’ pazjenti li jidħlu fil- fażi manika.
Among the various reported withdrawal symptoms, dizziness, agitation, anxiety, headache and nausea are the most
- Għalkemm Remeron mhux vizzjuż, esperjenza ta ’ wara l- tqegħid fuq is- suq turi li terminazzjoni
59 frequently reported.
60 infushom.
Even though they have been reported as withdrawal symptoms, it should be realized that these symptoms may be related to the underlying disease.
Kif avżat f’ sezzjoni 4. 2, huwa rrakkomandat illi t- trattament b’ Mirtazapine għandu jitwaqqaf b’ mod gradwali.
As advised in section 4.2, it is recommended to discontinue treatment with mirtazapine gradually. – Care should be taken in patients with micturition disturbances like prostate hypertrophy and in patients with acute narrow-angle glaucoma and increased intra-ocular pressure (although there is little chance of problems with Remeron because of its very weak anticholinergic activity). – Akathisia/ psychomotor restlessness:
f’ pazjenti glawkoma akuta narrow- angle u żieda fil- pressjoni intra- okulari (għalkemm il - possibilita` ta ’ problemi b’ Remeron hija żgħira minħabba li l- attivita` antikolinerġenika hija dgħajfa ħafna).
The use of antidepressants have been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still.
akatisja, ikkaratterizzata b’ mod suġġettiv minn nuqqas ta ’ kwiet li ma jagħtix pjaċir jew ta’ dwejjaq u bżonn ta ’ tħarrik spiss akkumpanjat minn nuqqas ta ’ abbiltà li wieħed ipoġġi bilqegħda jew ma jitħarrikx.
Lactose This medicinal product contains lactose.
Lattosju Dan il- prodott mediċinali fih il- lattosju.
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 għal galaktosju, id- defiċjenza Lapp lactase jew malassorbiment ta ’ glukows- galaktosju m’ għandhomx jieħdu din il- mediċina.
- Mirtazapine dosed at 30 mg once daily caused a small but statistically significant increase in
- Mirtazapine f’ doża ta ’ 30 mg darba kuljum ikkawżat żieda żgħira imma statistikament
As at a higher dose of
sinjifikanti fir- razzjon normalizzat internazzjonali (INR) f’ suġġetti ttrattati b’ warfarin.
60 mirtazapine a more pronounced effect can not be excluded, it is advisable to monitor the INR in case of concomitant treatment of warfarin with mirtazapine.
Minħabba l- fatt illi b’ doża ikbar ta ’ mirtazapine ma jistax jiġi eskluż effett iktar pronunċat, huwa avviżabbli illi l- INR jiġi monitorat fil- każ ta ’ trattament konkomitanti ta ’ warfarin ma ’ mirtazapine.
4.7 Pregnancy and lactation
4. 6 Tqala u effetti fuq il- ħalib tas- sider
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.
62 persuni) li irċevew dożi ta ’ mirtazapine sa 60 mg u 850 pazjent (79 sena ta ’ persuni) li rċevew plaċebo.
61 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 1 turi 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.
Bone marrow depression (granulocytopenia, agranulocytosis, aplastic anemia thrombocytopenia) Eosinophilia
Dipressjoni fil- mudullun tal- għadam (granuloċitopen ija, agranuloċitożi, anemija aplastika u tromboċitopenij a) eosinofilija.
Somnolence1, 4 Sedation1, 4 Headache2
Sonnolenza1, 4
Lethargy1 Dizziness Tremor
Paraesteżija2
Paraesthesia2 Restless legs Syncope
konvulżjoniji
Myoclonus
Sturdament
Convulsions (insults) Serotonin syndrome Oral paraesthesia
et (insulti)
Gastrointestinal disorders
Uġigħ ta ’ ras2
Dry mouth
Tregħid Nawsja3
Nausea3 Diarrhea2 Vomiting2
fir- riġlejn sinkope
Nightmares2 Mania Agitation2 Hallucinations Psychomotor restlessness (incl. akathisia, hyperkinesia)
Aġitazzjoni2 Alluċinazzjo nijiet Irrekwitezza
Suicidal ideation6 Suicidal behaviour6
Imġieba suwiċidali6
Endocrine disorders 1
63 psikomutur (inkl.
Inappropriate antidiuretic hormone secretion
Akathisia, iperkinesia)
2 In clinical trials these events occurred more frequently during treatment with placebo than with Remeron, however not statistically significantly more frequently.
Sekrezzjoni Disturbi fis- sistema mhux xierqa endokrinarja ta ’ l- ormon antidijuretiku 1 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.
62 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).
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 għal nofs iqsar intwerew f’ ġuvintur żgħażagħ.
The half-life of elimination is sufficient to justify once-a-day dosing.
Iż- żmien ta ’ eliminazzjoni biex jinżel il- valur għal nofs 64 hija suffiċjenti biex tiġġustifika dożaġġ ta ’ darba kuljum.
63 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.
Tablet core: maize starch hyprolose magnesium stearate silica, colloidal anhydrous lactose monohydrate Tablet coating: hypromellose Macrogol 8000 titanium dioxide (E171) yellow iron oxide (E172) (15 and 30 mg film-coated tablets only) red iron oxide (E172)
Il- qalba tal- pillola: maize starch hyprolose magnesium stearate silica, colloidal anhydrous lactose monohydrate Kisja tal- pillola: hypromellose Macrogol 8000 titanium dioxide (E171) yellow iron oxide (E172) red iron oxide (E172)
(30 mg film-coated tablets only)
(pilloli miksija b’ rita li fihom 15 u 30 mg biss) (pilloli miksija b’ rita li fihom 30 mg biss)
Do not store above 30 °C Store in the original package in order to protect from light and moisture
Taħżinx f’ temperatura ‘ l- fuq minn 30 °C
Remeron 15, 30 and 45 mg film-coated tablets are packed in blisters made of opaque polyvinyl chloride film and aluminium foil containing a heat-seal coating on the side in contact with the film- coated tablets.
Il- pilloli miksija b’ rita Remeron 15, 30 u 45 mg huma ppakkjati fi strixxi magħmulin minn rita ta ’ polimer ta ’ kloridu tal- vinil opak u fojl tal- aluminju li fih kisja ta ’ siġill għas- sħana fuq in- naħa li tmiss mal- pilloli.
Blisters containing 7 and 10 film-coated tablets are available.
Huma disponibbli strixxi li fihom 7 u 10 pilloli miksija b’ rita.
Remeron 15, 30 and 45 mg film-coated tablets are also available in HDPE bottles with a tamper- evident LDPE cap.
Il- pilloli miksija b’ rita Remeron 15, 30 u 45 mg huma disponibbli wkoll fi fliexken HDPE b’ tapp LDPE li jurik jekk jiġi mbagħbas.
Bottles contain 250 film-coated tablets.
Il- fliexken fihom 250 pillola miksija b’ rita.
The following pack sizes are available for the 15 mg film-coated tablets in blisters:
Is- segwenti daqsijiet ta ’ pakketti huma disponibbli għal pilloli ta ’ 15 mg fi strixxi:
64 30 (3x10), 60 (6x10), 90 (9x10) and 100 (10x10) film-coated tablets; 14 (2x7), 28 (4x7), 56 (8x7), and 70 (10x7) film-coated tablets.
30 (3x10), 60 (6x10), 90 (9x10) u 100 (10x10) pilloli miksija b’ rita; u 14 (2x7), 28 (4x7), 56 (8x7), u 70 (10x7) pilloli miksija b’ rita.
The following pack sizes are available for the 30 mg film-coated tablets in blisters:
Is- segwenti daqsijiet ta ’ pakketti huma disponibbli għal pilloli ta ’ 30 mg fi strixxi:
10 (1x10), 20 (2x10), 30 (3x10), 50 (5x10), 60 (6x10), 90 (9x10), 100 (10x10), 200 (20x10) and 500 (50x10) film-coated tablets; 14 (2x7), 28 (4x7), 56 (8x7), and 70 (10x7) film-coated tablets.
10 (1x10), 20 (2x10), 30 (3x10), 50 (5x10), 60 (6x10), 90 (9x10), 100 (10x10), 200 (20x10) u 500 (50x10) pilloli miksija b’ rita; u 14 (2x7), 28 (4x7), 56 (8x7), u 70 (10x7) pilloli miksija b’ rita.
The following pack sizes are available for the 45 mg film-coated tablets in blisters:
Is- segwenti daqsijiet ta ’ pakketti huma disponibbli għal pilloli ta ’ 45 mg fi strixxi:
10 (1x10), 20 (2x10), 30 (3x10), 50 (5x10), 100 (10x10), 200 (20x10) and 500 (50x10) film-coated tablets; 14 (2x7), 28 (4x7), 56 (8x7), and 70 (10x7) film-coated tablets.
10 (1x10), 20 (2x10), 30 (3x10), 50 (5x10), 100 (10x10), 200 (20x10) u 500 (50x10) pilloli miksija b’ rita; u 14 (2x7), 28 (4x7), 56 (8x7), u 70 (10x7) pilloli miksija b’ rita.
66 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
66 TIKKETTA
Remeron and associated names (see Annex I) 15 mg film-coated tablets [See Annex I - To be completed nationally]
Remeron u ismijiet assoċjati miegħu (Ara Anness I) pilloli miksija b’ rita 15 mg [Ara Anness I - Biex timtela mill- pajjiż partikolari]
1 film-coated tablet contains 15 mg mirtazapine
Pillola waħda miksija b' rita fiha 15 mg mirtazapine
Film-coated tablet
Pilloli miksija b’ rita
30 film-coated tablets 60 film-coated tablets 90 film-coated tablets 100 film-coated tablets
30 pillola miksija b' rita 60 pillola miksija b' rita 90 pillola miksija b' rita 100 pillola miksija b' rita
14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 70 film-coated tablets
14- il pillola miksija b' rita 28 pillola miksija b' rita 56 pillola miksija b' rita 70 pillola miksija b' rita
Do not store above 30 °C Store in the original package in order to protect from light and moisture
Taħżinx f’ temperatura ‘ l- fuq minn 30 °C Aħżen fil- pakkett oriġinali sabiex tilqa ’ mid- dawl u l- umidita`
Bottle, 15 mg
Flixkun, 15 mg
Remeron and associated names (see Annex I) 15 mg film-coated tablets [See Annex I - To be completed nationally]
Remeron u ismijiet assoċjati miegħu (Ara Anness I) pilloli miksija b’ rita 15 mg [Ara Anness I- Biex timtela mill- pajjiż partikolari]
250 film-coated tablets
250 pillola miksija b' rita
SPECIAL STORAGE CONDITIONS 69 Do not store above 30 °C Store in the original package in order to protect from light and moisture
Taħżinx f’ temperatura ‘ l- fuq minn 30 °C
70 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
71 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
71 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
72 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Remeron and associated names (see Annex I) 30 mg film-coated tablets [See Annex I - To be completed nationally]
Remeron u ismijiet assoċjati miegħu (Ara Anness I) pilloli miksija b’ rita 30 mg [Ara Anness I - Biex timtela mill- pajjiż partikolari]
1 film-coated tablet contains 30 mg mirtazapine
Pillola waħda miksija b’ rita fiha 30 mg mirtazapine
10 film-coated tablets 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 90 film-coated tablets 100 film-coated tablets 200 film-coated tablets 500 film-coated tablets
10 pilloli miksija b’ rita 20 pillola miksija b’ rita 30 pillola miksija b’ rita 50 pillola miksija b’ rita 60 pillola miksija b’ rita 90 pillola miksija b’ rita 100 pillola miksija b’ rita 200 pillola miksija b’ rita 500 pillola miksija b’ rita
14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 70 film-coated tablets
14- il pillola miksija b’ rita 28 pillola miksija b’ rita 56 pillola miksija b’ rita 70 pillola miksija b’ rita
72 Keep out of the reach and sight of children.
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Bottle, 30 mg
Flixkun, 30 mg
Remeron and associated names (see Annex I) 30 mg film-coated tablets [See Annex I - To be completed nationally]
Remeron u ismijiet assoċjati miegħu (Ara Anness I) pilloli miksija b’ rita 30mg [Ara Anness I - Biex timtela mill- pajjiż partikolari]
250 film-coated tablets
250 pillola miksija b’ rita
SPECIAL STORAGE CONDITIONS 75 Do not store above 30 °C Store in the original package in order to protect from light and moisture
Taħżinx f’ temperatura ‘ l- fuq minn 30 °C
76 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
76 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Remeron and associated names (see Annex I) 45 mg film-coated tablets [See Annex I - To be completed nationally]
Remeron u ismijiet assoċjati miegħu (Ara Anness I) pilloli miksija b’ rita 45 mg [Ara Anness I - Biex timtela mill- pajjiż partikolari]
1 film-coated tablet contains 45 mg mirtazapine
Pillola waħda miksija b’ rita fiha 45 mg mirtazapine
10 film-coated tablets 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 100 film-coated tablets 200 film-coated tablets 500 film-coated tablets
10 pilloli miksija b’ rita 20 pillola miksija b’ rita 30 pillola miksija b’ rita 50 pillola miksija b’ rita 100 pillola miksija b’ rita 200 pillola miksija b’ rita 500 pillola miksija b’ rita
80 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
79 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Bottle, 45 mg
Flixkun, 45 mg
250 film-coated tablets
250 pillola
SPECIAL STORAGE CONDITIONS 81 Do not store above 30 °C Store in the original package in order to protect from light and moisture
Taħżinx f’ temperatura ‘ l- fuq minn 30 °C
82 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
81 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
83 PACKAGE LEAFLET
83 FULJETT TA ’ TAGĦRIF:
Take special care with Remeron Use in children and adolescents under 18 years of age Remeron should normally not be used for children and adolescents under 18 years.
Oqgħod attent ħafna b’ Remeron 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.
You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Remeron.
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.
Barra minn hekk, l- effetti ta ’ sigurta` fit- tul konċernanti tkabbir, maturazzjoni u żvilupp konoxxittiv u ta ’ imġieba ta ’ Remeron f’ dan il- grupp ta ’ eta` għadhom ma ġewx dimostrati.
85 Thoughts of suicide and worsening of your depression If you are depressed you can sometimes have thoughts of harming or killing yourself.
84 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.
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 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.
Examples of MAO inhibitors are moclobemide, tranylcypromine (both are antidepressants) and selegiline (used for Parkinson’ s disease).
Eżempji ta ’ inibituri MAO huma moclobemide, tranylcypromine (it- tnejn huma anti - depressanti) u selegiline (użat għall- marda tal- Parkinsons).
Take care when taking Remeron in combination with: • 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
85 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.
Johns Wort – Hypericum perforatum preparations (a herbal remedy for depression).
Johns Wort – preparazzjonijiet ta ’ Hypericum perforatum (kura tal- ħxejjex għad- depressjoni).
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.
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).
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.
Important information about some of the ingredients of Remeron Remeron tablets contain lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Remeron Il- pilloli Remeron fihom il- latosju.
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.
5.
86 3.
87 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.
When to take Remeron → Take Remeron at the same time each day. It is best to take Remeron as a single dose before you go to bed.
Meta għandek tieħu Remeron → Ħu Remeron fl- istess ħin kuljum.
However your doctor may suggest you 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.
Take your tablets orally.
Ħu l- pillola mill- ħalq.
Swallow your prescribed dose of Remeron without chewing, with some water or juice.
Ibla d- doża preskritta ta ’ Remeron mingħajr ma tomgħod, ma ’ ftit ilma jew meraq.
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.
If you are supposed to take your dose twice a day • 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.
Jekk inti għandek tieħu d- doża tiegħek darbtejn kuljum • jekk inti insejt tieħu d- doża ta ’ filgħodu, sempliċement ħudha ma ’ d- doża ta ’ filgħaxija. • 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.
88 4.
87 4.
Uncommon: • 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
Mhux komuni: • tħossok ferħan iżżejjed jew emozzjonalment ‘ high ’ (manija). → 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)
In rare cases Remeron can cause disturbances in the production of blood cells (bone marrow depression).
88 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. • F’ każijiet rari Remeron jista jikkawża disturbi fil- produzzjoni taċ- ċelluli tad- demm (dipressjoni tal- mudullun tal- għadam).
In rare cases Remeron can also cause a shortage of red and white blood cells, as well as blood platelets (aplastic anemia), a shortage of blood platelets (thrombocytopenia) or an increase in the number of white blood cells (eosinophilia). • epileptic attack (convulsions) → Stop taking Remeron and tell your doctor straight away. • a combination of symptoms such as inexplicable fever, sweating, increased heart rate, diarrhoea, (uncontrollable) muscle contractions, shivering, overactive reflexes, restlessness, mood changes and unconsciousness.
F’ każijiet rari Remeron jista jikkawża wkoll nuqqas ta ’ ċelluli ħomor u bojod tad- demm, kif ukoll platelets tad- demm (anemija aplastiku), nuqqas ta ’ platelets tad- demm (tromboċitopenija) jew żieda fin - numru taċ- ċelluli bojod tad- demm (eosinofilija). • attakk epilettiku (aċċessjonijiet). → Ieqaf tieħu Remeron u kellem lit- tabib tiegħek immedjatament. • taħlita ta ’ sintomi bħal deni inspjegabbli, għaraq, żieda fir- rata tal- qalb, dijarrea, kontrazzjonijiet tal- muskoli (inkontrollabbli), tregħid, riflessi attivi żżejjed, aġitazzjoni, bdil tal- burdata u tintilef minn sensik.
In very rare cases these can be signs of serotonin syndrome. → Stop taking Remeron and tell your doctor straight away. • thoughts of harming or killing yourself → Contact your doctor or go to a hospital straight away. • abnormal sensations in the mouth (oral paraesthesia) • swelling in the mouth (mouth oedema) • hyponatraemia • inappropriate anti-diuretic hormone secretion
F’ każijiet rari ħafna dawn jistgħu jkunu sinjali ta ’ serotonin syndrome. → Ieqaf tieħu Remeron u kellem lit- tabib tiegħek immedjatament. • ħsibijiet li tweġġa jew toqtol lilek inniffsek → kellem lit- tabib tiegħek jew mur l- isptar immedjatament. • sensazzjoni anormali fil- ħalq (parastażija orali) • nefħa fil- ħalq (edema tal- ħalq) • iponatrimija • sekrezzjoni mhux xiera ta ’ l- ormon antidijuretiku
Do not use Remeron after the expiry date which is stated on the carton and the blister or bottle.
Tużax Remeron wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- istrixxa jew il- flixkun.
Do not store above 30 °C Store in the original package in order to protect from light and moisture
Taħżinx f’ temperatura ‘ l- fuq minn 30 °C Aħżen fil- pakkett oriġinali sabiex sabiex tilqa ’ mid- dawl u mill- umdita ’
What Remeron contains
X’ fih Remeron:
Remeron 15 mg film-coated tablets contain 15 mg mirtazapine per film-coated tablet.
Il- pilloli miksija b’ rita Remeron 15 mg fihom 15 mg mirtazapine għal kull pillola miksija b’ rita.
Remeron 30 mg film-coated tablets contain 30 mg mirtazapine per film-coated tablet.
Il- pilloli miksija b’ rita Remeron 30 mg fihom 30 mg mirtazapine għal kull pillola miksija b’ rita.
Remeron 45 mg film-coated tablets contain 45 mg mirtazapine per film-coated tablet. • The other ingredients are:
Il- pilloli miksija b’ rita Remeron 45 mg fihom 45 mg mirtazapine għal kull pillola miksija b’ rita. • Is- sustanzi l- oħrajn huma:
Tablet core: maize starch, hyprolose, magnesium stearate, silica, colloidal anhydrous, lactose
Il- qalba tal- pillola: maize starch, hyprolose, magnesium stearate, silica, colloidal anhydrous, lactose monohydrate Il- kisja tal- pillola: hypromellose, Macrogol 8000, titanium dioxide (E171).
90 monohydrate Tablet coating: hypromellose, Macrogol 8000, titanium dioxide (E171) The tablet core of Remeron 15 mg film-coated tablets also contains yellow iron oxide (E172) The tablet coating of Remeron 30 mg film-coated tablets also contain yellow iron oxide (E172) and red iron oxide (E 172).
89 Il- kisja tal- pilloli miksija b’ rita Remeron 30 mg fihom ukoll yellow iron oxide (E172) u red iron oxide (E172).
Remeron are film-coated tablets.
Remeron huma pilloli miksija b’ rita.
The tablet can be divided into equal halves.
Il- pilloli miksija b’ rita Remeron 15 mg huma ovali, konvessi miż- żewġ naħat, sofor, immarkati tul in - nofs u mmarkati ‘ Organon ’ fuq naħa waħda u kodiċi ‘ TZ/ 3’ fuq in- naħa l- oħra Il- pillola tista ’ tinqasam f’ nofsijiet ugwali.
Remeron 30 mg film-coated tablets are oval, biconvex, red-brown, scored and coded with ‘ Organon’ on one side and with ‘ TZ/ 5’ on the other side.
Il- pilloli miksija b’ rita Remeron 30 mg huma ovali, konvessi miż- żewġ naħat, ta ’ kulur kannella ħamrani, immarkati tul in- nofs u mmarkati ‘ Organon ’ fuq naħa waħda u kodiċi ‘ TZ/ 5’ fuq in- naħa l - oħra.
Remeron 45 mg film-coated tablets are oval, biconvex, white and coded with ‘ Organon’ on one side and with ‘ TZ/ 7’ on the other side.
Il- pillola tista ’ tinqasam f’ nofsijiet ugwali Il- pilloli miksija b’ rita Remeron 45 mg huma ovali, konvessi miż- żewġ naħat, bojod u mmarkati ‘ Organon ’ fuq naħa waħda u kodiċi ‘ TZ/ 7’ fuq in- naħa l- oħra
Remeron 15, 30 and 45 mg film-coated tablets are packed in blisters or bottles.
Il- pilloli miksija b’ rita Remeron 15, 30 u 45 mg huma ppakkjati fi strixxi jew fliexken.
For Remeron 15 mg film-coated tablets in blisters the following pack sizes are available:
Għal pilloli miksija b’ rita Remeron 15 mg fi strixxi huma disponibbli s- segwenti daqsijiet ta ’ pakketti:
30, 60, 90 and 100 tablets; 14, 28, 56 and 70 tablets; for Remeron 15 mg film-coated tablets in bottles a pack size of 250 tablets is available (not all pack sizes may be marketed).
30, 60, 90 u 100 pillola; 14, 28, 56 u 70 pillola; għal pilloli miksija b’ rita Remeron 15 mg fi fliexken huwa disponibbli daqs ta ’ pakkett ta ’ 250 pillola (mhux id- daqsijiet kollha tal- pakketti jistgħu jiġu mqiegħda fuq is- suq).
For Remeron 30 mg film-coated tablets in blisters the following pack sizes are available:
Għal pilloli miksija b’ rita Remeron 30 mg fi strixxi huma disponibbli s- segwenti daqsijiet ta ’ pakketti:
10, 20, 30, 50, 60, 90, 100, 200 and 500 tablets; 14, 28, 56 and 70 tablets; for Remeron 30 mg film-coated tablets in bottles a pack size of 250 tablets is available (not all pack sizes may be marketed).
10, 20, 30, 50, 60, 90, 100, 200 u 500 pillola; 14, 28, 56 u 70 pillola; għal pilloli miksija b’ rita Remeron 30mg fi fliexken huwa disponibbli daqs ta ’ pakkett ta ’ 250 pillola (mhux id- daqsijiet kollha tal- pakketti jistgħu jiġu mqiegħda fuq is- suq).
For Remeron 45 mg film-coated tablets in blisters the following pack sizes are available:
Għal pilloli miksija b’ rita Remeron 45 mg fi strixxi huma disponibbli s- segwenti daqsijiet ta ’ pakketti:
10, 20, 30, 50, 100, 200 and 500 tablets; 14, 28, 56 and 70 tablets; for Remeron 45 mg film-coated tablets in bottles a pack size of 250 tablets is available (not all pack sizes may be marketed).
10, 20, 30, 50, 100, 200 u 500 pillola; 14, 28, 56 u 70 pillola; għal pilloli miksija b’ rita Remeron 45 mg fi fliexken huwa disponibbli daqs ta ’ pakkett ta ’ 250 pillola (mhux id- daqsijiet kollha tal - pakketti jistgħu jiġu mqiegħda fuq is- suq).
[not applicable for art 30 referral]
[mhux applikabbli għal art 30 referenza]
91 SUMMARY OF PRODUCT CHARACTERISTICS
90 SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT
92 1.
91 1.
Remeron and associated names (see Annex I) 15 mg/ ml oral solution
Remeron u ismijiet assoċjati miegħu (Ara Anness I) 15 mg/ ml soluzzjoni orali
1 ml of Remeron oral solution contains 15 mg of mirtazapine.
1 ml mis- soluzzjoni orali Remeron fiha 15 mg ta ’ mirtazapine.
1 ml of Remeron oral solution contains 700 mg maltitol liquid.
1 ml mis- soluzzjoni orali Remeron fiha 700 mg maltitol likwidu.
Remeron oral solution contains 0.3% v/ v ethanol.
Remeron soluzzjoni orali għandu 3% v/ v ta ’ ethanol.
Clear, colourless-to-straw aqueous solution with a characteristic citrus-orange odour.
Soluzzjoni akweja ċara, mingħajr kulur jew kulur it- tiben b’ riħa karatteristika ta ’ ċitru- larinġ.
Renal impairment The clearance of mirtazapine may be decreased in patients with moderate to severe renal impairment (creatinine clearance < 40 ml/ min).
Indeboliment renali It- tneħħija ta ’ mirtazapine jista jkun imnaqqas f’ pazjenti b’ indeboliment renali moderata għal qawwija (tneħħija ta ’ creatinine < 40 ml/ min).
93 Mirtazapine has an elimination half-life of 20-40 hours and therefore Remeron is suitable for once daily administration.
92 Iż- żmien li jieħu mirtazapine sabiex jinżel għal nofs il- valur oriġinali tiegħu hu ta ’ 20- 40 siegħa u għalhekk Remeron huwa adattat għal amministrazzjoni ta ’ darba kuljum.
The solution should be taken orally, in a glass containing some water.
Is- soluzzjoni għanda tittieħed mill- ħalq, f’ tazza bi ftit ilma.
Preparation of the bottle Removing the screw cap from the bottle The cap should be pressed downwards while at the same time rotating it anti-clockwise.
Preparazzjoni tal- flixkun Biex taqla t- tapp tal- kamin minn mal- flixkun Għafas it- tapp tal- kamin ‘ l isfel u fl- istess ħin dawwar lejn ix- xellug.
The seal attached to the cap will break first; further pressing and turning will unscrew the cap.
L- ewwel jinkiser is- siġill ta ’ madwar it- tapp; kompli għafas u dawwar biex tħoll it- tapp.
This procedure is given in symbolic instructions on the top of the screw cap.
Din il- proċedura hija mogħtija permezz ta ’ struzzjonijiet simboliċi fuq it- tapp tal- kamin.
Applying the metering pump to the bottle After taking the pump out of the plastic bag it should be fitted onto the bottle by carefully inserting the plastic tube into the bottle opening.
Kif tqabbad il- pompa ta ’ dożaġġ mal- flixkun Wara li toħroġ il- pompa minn ġol- borża tal- plastik, din għanda titqabbad mal- flixkun billi ddaħħal it - tubu tal- plastik fil- fetħa tal- flixkun.
The pump should be pressed onto the top of the bottle and screwed until it locks tightly on the bottle.
Il- pompa għanda tingħafas għal fuq il- flixkun u tiġi invitata sakemm din tissikka sewwa fuq il- flixkun.
After a click, there should be one final tightening to ensure that the pump is securely screwed in place.
Wara l- klikk, għandek terġa tissikka b’ mod finali sabiex tiżgura li l- pompa hija nvitata b’ mod sikur f’ posta.