qanastek/EMEA-V3 huggingface dataset:
Do not use epinephrine, dopamine, or other sympathomimetic agents with beta-agonist activity since beta stimulation may worsen hypotension.
Tużax epinephrine, dopamine, jew sustanzi oħra simpatomimatiċi b 'attività beta- agonista għax l- istimulazzjoni beta tista' taggrava l- pressjoni baxxa.
Close medical supervision and monitoring should continue until the patient recovers.
Għandha tkompli s- superviżjoni medika mill- qrib u l- monitoraġġ jitkompla sakemm il- pazjent jirkupra.
N05A H03.
Grupp farmako- terapewtiku: antipsikoti. i: diazepines, oxazepines u thiazepines kodiċi ATC N05A H03.
In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki; < 100 nM) for serotonin 5 HT2A/ 2C, 5 HT3, 5 HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors m1-m5; α 1 adrenergic; and histamine H1 receptors.
Fi studji ta 'qabel l- użu kliniku, olanzapine wera firxa ta' affinitajiet għar- riċetturi (Ki; < 100 nM) serotoniċi 5HT2A/ 2C, 5HT3, 5HT6; dopamine D1, D2, D3, D4, D5: riċetturi muskariniċi kolinerġiċi m1- m5; ∝B1B- adrenerġiċi; u riċetturi ta 'l- istamina H1.
Animal behavioral studies with olanzapine indicated 5HT,
Studji fuq l- imġieba ta 'l- annimali li ingħataw
11 dopamine, and cholinergic antagonism, consistent with the receptor-binding profile.
11 olanzapine indikaw antagoniżmu għal 5HT, għal dopamine, u għal dak kolinerġiku, konsistenti mal- profil tar- riċettur li jorbot.
Olanzapine demonstrated a greater in vitro affinity for serotonin 5HT2 than dopamine D2 receptors and greater 5 HT2 than D2 activity in vivo, models.
Olanzapine wera affinità akbar in vitro għal serotonin 5HT2 milli għar- riċetturi ta ’ dopamine D2 u attività in vivo akbar għal 5HT2 milli għal D2.
Electrophysiological studies demonstrated that olanzapine selectively reduced the firing of mesolimbic (A10) dopaminergic neurons, while having little effect on the striatal (A9) pathways involved in motor function.
Studji elettrofiżjoloġiċi wrew illi olanzapine selettivament naqqas l- attività mesolimbiċi tan- newroni dopaminerġiċi (A10) waqt li kellu ftit effett fuq il- passaġġ (A9) tal- corpus striatum involuti fil - funzjoni motorjali.
Olanzapine reduced a conditioned avoidance response, a test indicative of antipsychotic activity, at doses below those producing catalepsy, an effect indicative of motor side-effects.
Olanzapine naqset ir- rispons kundizzjonat u ta 'skansar, test indikattiv ta' l- attività antipsikotika, f' dożi anqas minn dawk li jwasslu għall- katalepsi, riżultat indikattiv ta 'l- effett mhux mixtieq tas- sistema (motorjali).
In a multinational, double-blind, comparative study of schizophrenia, schizoaffective, and related disorders which included 1,481 patients with varying degrees of associated depressive symptoms (baseline mean of 16.6 on the Montgomery-Asberg Depression Rating Scale), a prospective secondary analysis of baseline to endpoint mood score change demonstrated a statistically significant improvement (p= 0.001) favouring olanzapine (-6.0) versus haloperidol (-3.1).
F’ studju komparattiv, double- blind u multinazzjonali ta ’ skiżofrenija, ta ’ manifestazzjonijiet skiżoaffettivi u disturbi relatati oħra li kien jinkludi 1, 481 pazjent li kellhom gravità differenti ta ’ l- assoċjati sintomi dipressivi (medja ta ’ punteġg ta ’ 16. 6 meħud fil- bidu tal- kura skond l- iskala li tivvaluta d- dipressjoni ta ’ Montgomery- Asberg), analiżi prospettiva sekondarja tat- tibdil fil- punteġġ ta ’ l- atteġġament bejn il- bidu u fl- aħħar tal- kura wriet titjib statistikament sinifikanti (p= 0. 001) favur olanzapine (- 6. 0) kontra haloperidol (- 3. 1).
Olanzapine also demonstrated comparable efficacy results to haloperidol in terms of the proportion of patients in symptomatic remission from mania and depression at 6 and 12 weeks.
Olanzapine wera wkoll riżultati effikaċji li jistgħu jiġu kumparati ma 'haloperidol fit- termini tal- proporzjon ta' pazjenti f' remissjoni sintomatika minn manija u depressjoni f '6 u 12- il ġimgħa.
In a 12-month recurrence prevention study in manic episode patients who achieved remission on olanzapine and were then randomised to olanzapine or placebo, olanzapine demonstrated statistically significant superiority over placebo on the primary endpoint of bipolar recurrence.
Fi studju ta '12- il xahar ta' prevenzjoni ta 'rikorrenza f' pazjenti b' episodju ta' manija, li Ukienu diġà ikkontrollatiU b’ olanzapine, imbagħd kienu mogħtija mingħajr għażla olanzapine jew il- plaċebo, olanzapine wera superjorita sinifikanti u statistikament superjuri fuq il- plaċebo fuq l- għan ewlieni tar- rikorrenza bipolari.
In a second 12-month recurrence prevention study in manic episode patients who achieved remission with a combination of olanzapine and lithium and were then randomised to olanzapine or lithium alone, olanzapine was statistically non-inferior to lithium on the primary endpoint of bipolar recurrence (olanzapine 30.0%, lithium 38.3%; p = 0.055).
Fit- tieni studju ta '12- il xhar dwar ir- rikorrenza preventiva f' pazjenti b' episodju ta' manija Uli kienu ikkontrollati Ub’ olanzapine u l- lithium flimkien, kienu mbgħad mqassmin mingħajr għażla u mogħtija olanzapine jew il- lithium waħdu. Olanzapine kien statistikament mhux inferjuri għall- lithium fuq l- għan ewlieni ta 'rikorrenza bipolari (olanzapine 30. 0%, lithium 38. 3%; p = 0. 055).
The magnitude of changes in fasting total cholesterol, LDL cholesterol, triglycerides, and
Il- grad ta 'tibdil fil- kolesterol totali waqt is- sawm, kolesterol tat- tip LDL,
12 prolactin (see sections 4.4 and 4.8) were greater in adolescents than in adults.
12 trigliċeridi, u prolactin (ara sezzjonijiet 4. 4 u 4. 8) kien akbar fl- adolexxenti milli fl- adulti.
Absolute oral bioavailability relative to intravenous administration has not been determined
Il- biodisponibilità 'assoluta orali relattiva għal amministrazzjoni fil- vina ma' kienitx determinata.
Cytochromes P450-CYP1A2 and P450-CYP2D6 contribute to the formation of the N-desmethyl and 2-hydroxymethyl metabolites, both exhibited significantly less in vivo pharmacological activity than olanzapine in animal studies.
It- tnejn dehru sinifikatament anqas f' attività farmakoloġika in vivo milli olanzapine fi studji fuq l- annimali.
In healthy elderly (65 and over) versus non-elderly subjects, the mean elimination half-life was prolonged (51.8 versus 33.8 hr) and the clearance was reduced (17.5 versus 18.2 l/ hr).
F' anzjani b' saħħithom (65 u fuqhom) f' paragun ma 'pazjenti mhux anzjani, il- half life ta' l- eliminazzjoni medja twalet (51. 8 paragun ma '33. 8 siegħa) u t- tneħħija tnaqqset (17. 5 paragun ma' 18. 2 l/ hr).
Olanzapine is bound predominantly to albumin and α 1-acid-glycoprotein.
Olanzapine hija fil- biċċa ’ l kbira marbuta ma 'l- albumina u ∝B1B- aċid - glycoprotein.
Demographic differences between the adolescents and adults include a lower average body weight and fewer adolescents were smokers.
Id- differenzi demografiċi bejn l- adolexxenti u l- adulti jinkludu medja anqas ta '
13 5.3 Preclinical safety data
13 piż tal- ġisem u anqas adolexxenti kienu jpejpu.
Acute (single-dose) toxicity Signs of oral toxicity in rodents were characteristic of potent neuroleptic compounds: hypoactivity, coma, tremors, clonic convulsions, salivation, and depressed weight gain.
Tossiċità akuta (doża waħda) Sinjali ta 'tossiċità orali fir- rodenti kienu simili għas- sustanzi newrolettiċi qawwija: attività baxxa, koma, rogħda, konvulżjonijiet kloniċi, salivazzjoni, u tnaqqis fiż- żjieda tal- piż.
Repeated-dose toxicity In studies up to 3 months duration in mice and up to 1 year in rats and dogs, the predominant effects were CNS depression, anticholinergic effects, and peripheral haematological disorders.
Tossiċità ta 'dożi repetuti Fi studji sa 3 xhur fil- ġrieden u sa sena fil- firien u fil- klieb, l- effetti li ippredominaw kienu d- depressjoni CNS, effetti antikolinerġiċi, u diżordnijiet periferali ematoloġiċi.
Haematologic toxicity Effects on haematology parameters were found in each species, including dose-related reductions in circulating leukocytes in mice and non-specific reductions of circulating leukocytes in rats; however, no evidence of bone marrow cytotoxicity was found.
Effetti fuq il- parametri ematoloġiċi nstabu f' kull speċi, inklużi tnaqqis relatat mad- doża fil- lewkoċiti li jiċċirkolaw fil- ġrieden u tnaqqis mhux speċifiku fil- lewkoċiti li jiċċirkolaw fil- firien; madankollu, ma nstabet l- ebda prova ta 'ċitotossiċità tal- mudullun.
Reversible neutropenia, thrombocytopenia, or anemia developed in a few dogs treated with 8 or 10 mg/ kg/ day (total olanzapine exposure [AUC] is 12- to 15-fold greater than that of a man given a 12-mg dose).
Newtropenja, tromboċitopenja jew l- anemija riversibbli żviluppaw fi ftit klieb ittrattati b '8 jew 10 mg/ kg/ ġurnata (espożizzjoni totali ta' olanzapine [erja taħt il- kurva] hija 12 sa 15- il darba aktar minn dik ta 'raġel mogħti doża ta' 12 mg).
Reproductive toxicity Olanzapine had no teratogenic effects.
Tossiċità fuq is- sistema riproduttiva Olanzapine ma kellha ebda effetti teratoġeniċi.
Estrous cycles were affected at doses of 1.1 mg/ kg (3 times the maximum human dose) and reproduction parameters were influenced in rats given 3 mg/ kg (9 times the maximum human dose).
Iċ- ċikli estruwi kienu affettwati b' dożi ta '1. 1 mg/ kg (3 darbiet id- doża massima fil - bniedem) u l- parametri tar- riproduzzjoni kienu influwenzati fil- firien mogħtija 3 mg/ kg (9 darbiet id- doża massima fil- bniedem).
In the offspring of rats given olanzapine, delays in fetal development and transient decreases in offspring activity levels were seen.
Fil- frieħ tal- firien mogħtija olanzapine, kienu osservati dewmien fl- iżvilupp tal- fetu u tnaqqis għal xi żmien fl- attività tal- frieħ.
Mutagenicity Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and in vivo mammalian tests.
Mutaġeniċità Olanzapine ma ikkawżatx mutaġeniċità jew klastoġeniċità f' firxa sħiħata 'testijiet standard, li nkludew testijiet ta' mutazzjoni tal- mikrobi kif ukoll testijiet fuq il- mammiferi kemm in vitro kif ukoll in vivo.
Carcinogenicity Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
Kanċeroġeniċità Ibbażat fuq riżultati ta 'studji fuq il- ġrieden u l- firien, kien konkluż li olanzapine mhuwiex kanċeroġeniku.
Tablet core Lactose monohydrate, Maize starch Hydroxypropyl cellulose Magnesium stearate
Qalba tal- pillola Lactose monohydrate, Maize starch Hydroxypropyl cellulose Magnesium stearate
Tablet coat Opadry II White containing:
Kisja tal- pillola Opadry II White li fih:
Hypromellose (E464) Titanium dioxide (E171) Lactose monohydrate Polyethylene glycol 3000 Glycerol triacetate
14 Hypromellose (E464) Titanium dioxide (E171) Lactose monohydrate Polyethylene glycol 3000 Glycerol triacetate
Store below 30°C.
Aħżen f’ temperatura taħt 30°C.
Cold-formed aluminium blisters in cartons of 28 or 56 tablets per carton.
Strixxi tal- folji ta ’ l- aluminju iffurmati fil- ksieħ f’ kaxxi tal- kartun ta ’ 28 jew 56 pillola f’ kull kaxxa tal- kartun.
Neopharma Limited 57 High Street Odiham Hampshire RG29 1LF UK
Neopharma Limited 57 High Street Odiham Hampshire RG29 1LF Ir- Renju Unit
EU/ 1/ 07/ 426/ 002 – Olanzapine Neopharma – 2.5 mg – coated tablets – 56 tablets per box
EU/ 1/ 07/ 426/ 001 – Olanzapine Neopharma – 2. 5 mg – pilloli miksija – 28 pillola, kull kaxxa EU/ 1/ 07/ 426/ 002 – Olanzapine Neopharma – 2. 5 mg – pilloli miksija – 56 pillola, kull kaxxa
14 November 2007
14 ta ’ Novembru 2007
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /.
NAME OF THE MEDICINAL PRODUCT
ISEM TALPRODOTT MEDIĊINALI
Olanzapine Neopharma 5 mg coated tablets
Olanzapine Neopharma 5 mg pilloli miksija
Each coated tablet contains 5 mg olanzapine.
Kull pillola miksija fiha 5 mg ta ’ olanzapine.
Excipient(s):
Sustanza mhux attiva:
Each coated tablet contains 161.3 mg lactose monohydrate
Kull pillola miksija fiha 161. 3 mg lactose monohydrate Għallista kompleta ta ’ sustanzi mhux attivi, ara Sezzjoni 6. 1.
White, round, biconvex, coated tablets with ‘ OLZ 5’ debossing on one side and ‘ NEO’ on the other.
Pilloli bojod, tondi, bikonvessi, miksija b ’ ’ OLZ 5 ’ imnaqqxa fuq naħa waħda u ‘ NEO ’ fuq in- naħa l- oħra.
16 Children and adolescents Olanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
16 Tfal u adolexxenti Olanzapine mhux irrakkomandat għall- użu fit- tfal u fl- adolexxenti ta ’ taħt it- 18- il sena peress li m’ hemmx informazzjoni dwar is- sigurtà u l- effikaċja.
0.4%, respectively).
17 f’ pazjenti ttattati b' olanzapine, meta mqabblin ma ’ pazjenti ttrattati bil- plaċebo (1. 3% kontra 0. 4U%, rispettivament).
Neutropenia Caution should be exercised in patients with low leukocyte and/ or neutrophil counts for any reason, in patients receiving medicines known to cause neutropenia, in patients with a history of drug-induced bone marrow depression/ toxicity, in patients with bone marrow depression caused by concomitant illness, radiation therapy or chemotherapy and in patients with hypereosinophilic conditions or with
18 Newtropenja Għandha tittieħed kawtela f' pazjenti b 'numru baxx ta ’ lewkoċiti u/ jew numru baxx taċ- ċelluli newtrofili għal kwalunkwe raġuni, dawk il- pazjenti li qed jieħdu xi mediċini li huma magħrufa li jikkawżaw newtropenja, f' pazjenti b ’ passat ta' tnaqqis fil- funzjoni tal- mudullun jew tossiċità tal- mudullun minħabba t- teħid ta 'xi mediċina, f' pazjenti b' tnaqqis fil- funzjoni tal- mudullun minħabba xi marda konkomitanti, trattament bir- raġġi jew kimoterapija u f' pazjenti b' kundizzjonijiet b' numru għoli taċ- ċelluli eżinofili jew b' xi marda majeloproliferattiva.
Use in children and adolescents under 18 years of age Olanzapine is not indicated for use in the treatment of children and adolescents.
19 L- użu fit- tfal u fl- adolexxenti taħt it- 18- il sena Olanzapine mhux indikat għall- użu fil- kura tat- tfal u adolexxenti.
19 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma 'dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
20 Attività tas- CNS ġenerali Għandha tittieħed kawtela f' pazjenti li jixorbu l- alkoħol jew li jieħdu prodotti mediċinali li jistgħu jikkawżaw depressjoni tas- sistema nervuża ċentrali.
21 Very common
21
23 Long-term exposure (at least 48 weeks) The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/ LDL/ HDL cholesterol or triglycerides increased over time.
23 Espożizzjoni għal perijodu twil ta ’ żmien (għallinqas 48 ġimgħa) Il- proporzjon ta ’ pazjenti li kellhom tibdil avvers, klinikament sinifikanti fiż- żieda fil- piż, fil- glucose, fil- kolesterol totali/ LDL/ HDL jew trigliċeridi żdied maż- żmien.
24 9 Weight gain ≥ 7% of baseline body weight (kg) was very common and ≥ 15% of baseline body weight was common.
24 9 Żieda fil- piż ta '≥ 7% mil- linja bażi tal- piż tal- ġisem (kg) kienet komuni ħafna u ta' ≥ 15% mil- linja bażi tal- piż tal- ġisem kienet komuni.
N05A H03.
Grupp farmako- terapewtiku: antipsikoti. i: diazepines, oxazepines u thiazepines, kodiċi ATC N05A H03.
25 dopamine, and cholinergic antagonism, consistent with the receptor-binding profile.
25 olanzapine indikaw antagoniżmu għal 5HT, għal dopamine, u għal dak kolinerġiku, konsistenti mal- profil tar- riċettur li jorbot.
26 prolactin (see sections 4.4 and 4.8) were greater in adolescents than in adults.
26 trigliċeridi, u prolactin (ara sezzjonijiet 4. 4 u 4. 8) kien akbar fl- adolexxenti milli fl- adulti.
27 5.3 Preclinical safety data
27 piż tal- ġisem u anqas adolexxenti kienu jpejpu.
Acute (single-dose) toxicity Signs of oral toxicity in rodents were characteristic of potent neuroleptic compounds: hypoactivity, coma, tremors, clonic convulsions, salivation, and depressed weight gain.
UTossiċità akuta (doża waħda) Sinjali ta 'tossiċità orali fir- rodenti kienu simili għas- sustanzi newrolettiċi qawwija: attività baxxa, koma, rogħda, konvulżjonijiet kloniċi, salivazzjoni, u tnaqqis fiż- żjieda tal- piż.
Hypromellose (E464) Titanium dioxide (E171) Lactose monohydrate Polyethylene glycol 3000 Glycerol triacetate
28 Hypromellose (E464) Titanium dioxide (E171) Lactose monohydrate Polyethylene glycol 3000 Glycerol triacetate
28 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
EU/ 1/ 07/ 426/ 004 – Olanzapine Neopharma – 5 mg – coated tablets – 56 tablets per box
EU/ 1/ 07/ 426/ 003 - Olanzapine Neopharma – 5 mg – pilloli miksija – 28 pillola, kull kaxxa EU/ 1/ 07/ 426/ 004 - Olanzapine Neopharma – 5 mg – pilloli miksija – 56 pillola, kull kaxxa
Olanzapine Neopharma 7.5 mg coated tablets
Olanzapine Neopharma 7. 5 mg pilloli miksija
Each coated tablet contains 7.5 mg olanzapine.
Kull pillola miksija fiha 7. 5 mg ta ’ olanzapine.
Each coated tablet contains 242 mg lactose monohydrate
Kull pillola miksija fiha 242 mg lactose monohydrate Għal- lista kompleta ta ’ sustanzi mhux attivi, ara Sezzjoni 6. 1.
White, round, biconvex, coated tablets with ‘ OLZ 7.5’ debossing on one side and ‘ NEO’ on the other.
Pilloli bojod, tondi, bikonvessi, miksija b ’ ’ OLZ 7. 5 ’ imnaqqxa fuq naħa waħda u ‘ NEO ’ fuq in- naħa l- oħra.
30 Children and adolescents Olanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
30 Tfal u adolexxenti Olanzapine mhux irrakkomandat għall- użu fit- tfal u fl- adolexxenti ta ’ taħt it- 18- il sena peress li m’ hemmx informazzjoni dwar is- sigurtà u l- effikaċja.
0.4%, respectively).
31 f’ pazjenti ttattati b' olanzapine, meta mqabblin ma ’ pazjenti ttrattati bil- plaċebo (1. 3% kontra 0. 4U%, rispettivament).
32 myeloproliferative disease.
32 Newtropenja Għandha tittieħed kawtela f' pazjenti b 'numru baxx ta ’ lewkoċiti u/ jew numru baxx taċ- ċelluli newtrofili għal kwalunkwe raġuni, dawk il- pazjenti li qed jieħdu xi mediċini li huma magħrufa li jikkawżaw newtropenja, f' pazjenti b ’ passat ta' tnaqqis fil- funzjoni tal- mudullun jew tossiċità tal- mudullun minħabba t- teħid ta 'xi mediċina, f' pazjenti b' tnaqqis fil- funzjoni tal- mudullun minħabba xi marda konkomitanti, trattament bir- raġġi jew kimoterapija u f' pazjenti b' kundizzjonijiet b' numru għoli taċ- ċelluli eżinofili jew b' xi marda majeloproliferattiva.
Use in children and adolescents under 18 years of age Olanzapine is not indicated for use in the treatment of children and adolescents.
33 L- użu fit- tfal u fl- adolexxenti taħt it- 18- il sena Olanzapine mhux indikat għall- użu fil- kura tat- tfal u adolexxenti.
33 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma 'dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
34 Attività tas- CNS ġenerali Għandha tittieħed kawtela f' pazjenti li jixorbu l- alkoħol jew li jieħdu prodotti mediċinali li jistgħu jikkawżaw depressjoni tas- sistema nervuża ċentrali.
35 Very common
35
37 Long-term exposure (at least 48 weeks) The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/ LDL/ HDL cholesterol or triglycerides increased over time.
37 Espożizzjoni għal perijodu twil ta ’ żmien (għallinqas 48 ġimgħa) Il- proporzjon ta ’ pazjenti li kellhom tibdil avvers, klinikament sinifikanti fiż- żieda fil- piż, fil- glucose, fil- kolesterol totali/ LDL/ HDL jew trigliċeridi żdied maż- żmien.
With long-term exposure (at least 24 weeks), approximately half of adolescent
38 9 Żieda fil- piż ta '≥ 7% mil- linja bażi tal- piż tal- ġisem (kg) kienet komuni ħafna u ta' ≥ 15% mil- linja bażi tal- piż tal- ġisem kienet komuni.
38 patients gained ≥ 15% and almost a third gained ≥ 25% of their baseline body weight.
B’ espożizzjoni għal perijodu twil ta ’ żmien (għallinqas 24 ġimgħa) kważi nofs il- pazjenti adolexxenti żiedu ≥ 15% u kważi terz żiedu ≥ 25% mill- piż bażilari tagħhom.
Olanzapine demonstrated a greater in vitro affinity for serotonin 5HT2 than dopamine D2 receptors and greater
Studji fuq l- imġieba ta 'l- annimali li ingħataw
39 5 HT2 than D2 activity in vivo, models.
39 olanzapine indikaw antagoniżmu għal 5HT, għal dopamine, u għal dak kolinerġiku, konsistenti mal- profil tar- riċettur li jorbot.
The magnitude of changes in fasting total cholesterol, LDL cholesterol, triglycerides, and prolactin (see sections 4.4 and 4.8) were greater in adolescents than in adults.
40 trigliċeridi, u prolactin (ara sezzjonijiet 4. 4 u 4. 8) kien akbar fl- adolexxenti milli fl- adulti.
40 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
41 5.3 Preclinical safety data
41 piż tal- ġisem u anqas adolexxenti kienu jpejpu.
Hypromellose (E464) Titanium dioxide (E171) Lactose monohydrate Polyethylene glycol 3000 Glycerol triacetate
42 Hypromellose (E464) Titanium dioxide (E171) Lactose monohydrate Polyethylene glycol 3000 Glycerol triacetate
42 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
EU/ 1/ 07/ 426/ 006 – Olanzapine Neopharma – 7.5 mg – coated tablets – 56 tablets per box
EU/ 1/ 07/ 426/ 005 - Olanzapine Neopharma – 7. 5 mg – pilloli miksija – 28 pillola, kull kaxxa EU/ 1/ 07/ 426/ 006 - Olanzapine Neopharma – 7. 5 mg – pilloli miksija – 56 pillola, kull kaxxa
Olanzapine Neopharma 10 mg coated tablets
Olanzapine Neopharma 10 mg pilloli miksija
Each coated tablet contains 10 mg olanzapine.
Kull pillola miksija fiha 10 mg ta ’ olanzapine.
Each coated tablet contains 322.6 mg lactose monohydrate
Kull pillola miksija fiha 322. 6 mg lactose monohydrate Għal- lista kompleta ta ’ sustanzi mhux attivi, ara Sezzjoni 6. 1.
White, round, biconvex, coated tablets with ‘ OLZ 10’ debossing on one side and ‘ NEO’ on the other.
Pilloli bojod, tondi, bikonvessi, miksija b ’ ’ OLZ 10 ’ imnaqqxa fuq naħa waħda u ‘ NEO ’ fuq in- naħa l- oħra.
44 Children and adolescents Olanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
44 Tfal u adolexxenti Olanzapine mhux irrakkomandat għall- użu fit- tfal u fl- adolexxenti ta ’ taħt it- 18- il sena peress li m’ hemmx informazzjoni dwar is- sigurtà u l- effikaċja.
0.4%, respectively).
45 f’ pazjenti ttattati b' olanzapine, meta mqabblin ma ’ pazjenti ttrattati bil- plaċebo (1. 3% kontra 0. 4U%, rispettivament).
46 myeloproliferative disease.
46 Newtropenja Għandha tittieħed kawtela f' pazjenti b 'numru baxx ta ’ lewkoċiti u/ jew numru baxx taċ- ċelluli newtrofili għal kwalunkwe raġuni, dawk il- pazjenti li qed jieħdu xi mediċini li huma magħrufa li jikkawżaw newtropenja, f' pazjenti b ’ passat ta' tnaqqis fil- funzjoni tal- mudullun jew tossiċità tal- mudullun minħabba t- teħid ta 'xi mediċina, f' pazjenti b' tnaqqis fil- funzjoni tal- mudullun minħabba xi marda konkomitanti, trattament bir- raġġi jew kimoterapija u f' pazjenti b' kundizzjonijiet b' numru għoli taċ- ċelluli eżinofili jew b' xi marda majeloproliferattiva.
Use in children and adolescents under 18 years of age Olanzapine is not indicated for use in the treatment of children and adolescents.
47 L- użu fit- tfal u fl- adolexxenti taħt it- 18- il sena Olanzapine mhux indikat għall- użu fil- kura tat- tfal u adolexxenti.
47 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma 'dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
48 Attività tas- CNS ġenerali Għandha tittieħed kawtela f' pazjenti li jixorbu l- alkoħol jew li jieħdu prodotti mediċinali li jistgħu jikkawżaw depressjoni tas- sistema nervuża ċentrali.
48 4.6 Pregnancy and lactation
4. 6 Tqala u Treddigħ
49 Very common
49
51 Long-term exposure (at least 48 weeks) The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/ LDL/ HDL cholesterol or triglycerides increased over time.
51 Espożizzjoni għal perijodu twil ta ’ żmien (għallinqas 48 ġimgħa) Il- proporzjon ta ’ pazjenti li kellhom tibdil avvers, klinikament sinifikanti fiż- żieda fil- piż, fil- glucose, fil- kolesterol totali/ LDL/ HDL jew trigliċeridi żdied maż- żmien.
With long-term exposure (at least 24 weeks), approximately half of adolescent
52 9 Żieda fil- piż ta '≥ 7% mil- linja bażi tal- piż tal- ġisem (kg) kienet komuni ħafna u ta' ≥ 15% mil- linja bażi tal- piż tal- ġisem kienet komuni.
52 patients gained ≥ 15% and almost a third gained ≥ 25% of their baseline body weight.
B’ espożizzjoni għal perijodu twil ta ’ żmien (għallinqas 24 ġimgħa) kważi nofs il- pazjenti adolexxenti żiedu ≥ 15% u kważi terz żiedu ≥ 25% mill- piż bażilari tagħhom.
53 5 HT2 than D2 activity in vivo, models.
53 olanzapine indikaw antagoniżmu għal 5HT, għal dopamine, u għal dak kolinerġiku, konsistenti mal- profil tar- riċettur li jorbot.
The magnitude of changes in fasting total cholesterol, LDL cholesterol, triglycerides, and prolactin (see sections 4.4 and 4.8) were greater in adolescents than in adults.
54 trigliċeridi, u prolactin (ara sezzjonijiet 4. 4 u 4. 8) kien akbar fl- adolexxenti milli fl- adulti.
55 5.3 Preclinical safety data
55 piż tal- ġisem u anqas adolexxenti kienu jpejpu.
Hypromellose (E464) Titanium dioxide (E171) Lactose monohydrate Polyethylene glycol 3000 Glycerol triacetate
56 Hypromellose (E464) Titanium dioxide (E171) Lactose monohydrate Polyethylene glycol 3000 Glycerol triacetate
56 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
Cold-formed aluminium blisters in cartons of 7, 28 or 56 tablets per carton.
Strixxi tal- folji ta ’ l- aluminju iffurmati fil- ksieħ f’ kaxxi tal- kartun ta ’ 7, 28 jew 56 pillola f’ kull kaxxa tal- kartun.
EU/ 1/ 07/ 426/ 009 – Olanzapine Neopharma – 10 mg – coated tablets – 56 tablets per box
EU/ 1/ 07/ 426/ 007 - Olanzapine Neopharma – 10 mg – pilloli miksija – 7 pillola, kull kaxxa EU/ 1/ 07/ 426/ 008 - Olanzapine Neopharma – 10 mg – pilloli miksija – 28 pillola, kull kaxxa EU/ 1/ 07/ 426/ 009 - Olanzapine Neopharma – 10 mg – pilloli miksija – 56 pillola, kull kaxxa
Olanzapine Neopharma 15 mg coated tablets
Olanzapine Neopharma 15 mg pilloli miksija
Each coated tablet contains 15 mg olanzapine.
Kull pillola miksija fiha 15 mg ta ’ olanzapine.
Each coated tablet contains 315 mg lactose monohydrate
Kull pillola miksija fiha 315 mg lactose monohydrate Għal- lista kompleta ta ’ sustanzi mhux attivi, ara Sezzjoni 6. 1.
Blue, elliptical, convex, coated tablets with ‘ NEO’ debossed on one side and plain on the other side.
Pilloli blu, ellittiċi, konvessi, miksija, b ’’ NEO ’ imnaqqxa fuq naħa waħda u xejn fuq in- naħa l- oħra.
59 Children and adolescents Olanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
59 Tfal u adolexxenti Olanzapine mhux irrakkomandat għall- użu fit- tfal u fl- adolexxenti ta ’ taħt it- 18- il sena peress li m’ hemmx informazzjoni dwar is- sigurtà u l- effikaċja.
0.4%, respectively).
Kien hemm żieda ta ’ 3 darbiet akbar ta ’ CVAE f’ pazjenti ttattati b' olanzapine, meta mqabblin ma ’ pazjenti ttrattati bil- plaċebo (1. 3% kontra 0. 4U%,
60 CVAE in association with olanzapine treatment.
60 rispettivament).
61 myeloproliferative disease.
61 Newtropenja Għandha tittieħed kawtela f' pazjenti b 'numru baxx ta ’ lewkoċiti u/ jew numru baxx taċ- ċelluli newtrofili għal kwalunkwe raġuni, dawk il- pazjenti li qed jieħdu xi mediċini li huma magħrufa li jikkawżaw newtropenja, f' pazjenti b ’ passat ta' tnaqqis fil- funzjoni tal- mudullun jew tossiċità tal- mudullun minħabba t- teħid ta 'xi mediċina, f' pazjenti b' tnaqqis fil- funzjoni tal- mudullun minħabba xi marda konkomitanti, trattament bir- raġġi jew kimoterapija u f' pazjenti b' kundizzjonijiet b' numru għoli taċ- ċelluli eżinofili jew b' xi marda majeloproliferattiva.
Use in children and adolescents under 18 years of age Olanzapine is not indicated for use in the treatment of children and adolescents.
62 L- użu fit- tfal u fl- adolexxenti taħt it- 18- il sena Olanzapine mhux indikat għall- użu fil- kura tat- tfal u adolexxenti.
62 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma 'dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
63 Attività tas- CNS ġenerali Għandha tittieħed kawtela f' pazjenti li jixorbu l- alkoħol jew li jieħdu prodotti mediċinali li jistgħu jikkawżaw depressjoni tas- sistema nervuża ċentrali.
63 4.6 Pregnancy and lactation
4. 6 Tqala u Treddigħ
64 Very common
64
66 Long-term exposure (at least 48 weeks) The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/ LDL/ HDL cholesterol or triglycerides increased over time.
66 Espożizzjoni għal perijodu twil ta ’ żmien (għallinqas 48 ġimgħa) Il- proporzjon ta ’ pazjenti li kellhom tibdil avvers, klinikament sinifikanti fiż- żieda fil- piż, fil- glucose, fil- kolesterol totali/ LDL/ HDL jew trigliċeridi żdied maż- żmien.
With long-term exposure (at least 24 weeks), approximately half of adolescent
67 9 Żieda fil- piż ta '≥ 7% mil- linja bażi tal- piż tal- ġisem (kg) kienet komuni ħafna u ta' ≥ 15% mil- linja bażi tal- piż tal- ġisem kienet komuni.
67 patients gained ≥ 15% and almost a third gained ≥ 25% of their baseline body weight.
B’ espożizzjoni għal perijodu twil ta ’ żmien (għallinqas 24 ġimgħa) kważi nofs il- pazjenti adolexxenti żiedu ≥ 15% u kważi terz żiedu ≥ 25% mill- piż bażilari tagħhom.
68 5 HT2 than D2 activity in vivo, models.
68 olanzapine indikaw antagoniżmu għal 5HT, għal dopamine, u għal dak kolinerġiku, konsistenti mal- profil tar- riċettur li jorbot.
The magnitude of changes in fasting total cholesterol, LDL cholesterol, triglycerides, and prolactin (see sections 4.4 and 4.8) were greater in adolescents than in adults.
69 trigliċeridi, u prolactin (ara sezzjonijiet 4. 4 u 4. 8) kien akbar fl- adolexxenti milli fl- adulti.
69 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
70 5.3 Preclinical safety data
70 piż tal- ġisem u anqas adolexxenti kienu jpejpu.
Tablet coat Opadry Blue containing:
Kisja tal- pillola Opadry Blue li fih:
Hypromellose (E464) Titanium dioxide (E171) Polyethylene glycol 6000 Indigo carmine aluminium lake (E132) Brilliant blue FCF aluminium lake (E133)
71 Hypromellose (E464) Titanium dioxide (E171) Polyethylene glycol 6000 Indigo carmine aluminium lake (E132) Brilliant blue FCF aluminium lake (E133) Iron oxide black (E172)
71 Iron oxide black (E172)
6. 2 Inkompatibilitajiet
EU/ 1/ 07/ 426/ 011 – Olanzapine Neopharma – 15 mg – coated tablets – 56 tablets per box
EU/ 1/ 07/ 426/ 010 - Olanzapine Neopharma – 15 mg – pilloli miksija – 28 pillola, kull kaxxa EU/ 1/ 07/ 426/ 011 - Olanzapine Neopharma – 15 mg – pilloli miksija – 56 pillola, kull kaxxa
73 A.
73 ANNESS II
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
SID L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Name and address of the manufacturer(s) responsible for batch release
Isem u indirizz tal- manifattur( i) responsabbli mill- ħruġ tal- lott
Neolab 57 High Street, Odiham Hants RG29 1LF United Kingdom
Neolab 57 High Street, Odiham Hants RG29 1LF Ir- Renju Unit
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 3 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza Id- Detentur ta ’ l- Awtorizzazzjoni tal- Manifattura jrid jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta f’ verżjoni 3, ippreżentata f’ Modulu 1. 8. 1. ta ’ l- Applikazzjoni ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq, tkun implimentata u taħdem qabel u waqt li l- prodott jibda jinbiegħ.
Risk Management Plan Risk Management Plan was not submitted.
Pjan dwar l- Immaniġġjar tar- Riskju Pjan dwar l- Immaniġġjar tar- Riskju ma kienx sottomess.
The application is based on a reference medicinal product for which no safety concerns requiring additional risk minimization activities have been identified.
L- applikazzjoni hi bbażata fuq prodott mediċinali ta ’ referenza li għalih ma kienu identifikati l- ebda problemi tas- sigurtà li jeħtieġu attivitajiet addizzjonali li jimminimizzaw ir- riskju.
PSURs The PSUR submission schedule for Olanzapine Neopharma tablets should follow the PSURs submission schedule for the reference medicinal product Zyprexa.
L- iskeda tas- sottomissjoni tal- PSUR għall- pilloli Olanzapine Neopharma għandha ssegwi l- iskeda tas- sottomissjoni għall- prodott mediċinali ta ’ referenza Zyprexa.
75 A.
75 ANNESS III
76 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA
CARTON OF COATED TABLETS IN BLISTERS
KARTUNA TA 'PILLOLI MIKSIJA FIL- FOLJI
Olanzapine Neopharma 2.5 mg coated tablets olanzapine
Olanzapine Neopharma 2. 5 mg pilloli miksija olanzapine
Each coated tablet contains 2.5 mg olanzapine
Kull pillola miksija fiha 2. 5mg ta ’ olanzapine
Contains lactose monohydrate, see package leaflet for further information.
Fiha lactose monohydrate ara l- fuljett ta 'tagħrif għal aktar informazzjoni.
28 coated tablets 56 coated tablets
28 pillola miksija 56 pillola miksija
Store below 30°C.
Aħżen fil- pakkett oriġinali Aħżen f’ temperatura taħt 30°C.
Neopharma Limited, 57 High Street, Odiham, Hampshire, RG29 1LF, UK Tel: +44 (0)1256 704110 Fax: +44 (0)1256 701144
Neopharma Limited, 57 High Street, Odiham, Hampshire, RG29 1LF, ir- Renju Unit Tel: +44 (0) 1256 704110 Fax: +44 (0) 1256 701144
EU/ 1/ 07/ 426/ 001, 28 coated tablets EU/ 1/ 07/ 426/ 002, 56 coated tablets
EU/ 1/ 07/ 426/ 001 28 pillola miksija EU/ 1/ 07/ 426/ 002 56 pillola miksija
78 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
79 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
COLD-FORMED ALUMINIUM BLISTER STRIPS
TIKKETTA TAL- FOLJA TAL- FOJL
79 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
80 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Olanzapine Neopharma 5 mg coated tablets olanzapine
Olanzapine Neopharma 5 mg pilloli miksija olanzapine
Each coated tablet contains 5 mg olanzapine
Kull pillola miksija fiha 5 mg ta ’ olanzapine
Contains lactose monohydrate, see package leaflet for further information.
Fiha: lactose monohydrate ara l- fuljett ta 'tagħrif għal aktar informazzjoni.
EU/ 1/ 07/ 426/ 003, 28 coated tablets EU/ 1/ 07/ 426/ 004, 56 coated tablets
EU/ 1/ 07/ 426/ 003 28 pillola miksija EU/ 1/ 07/ 426/ 004 56 pillola miksija
81 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
82 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
82 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
83 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Olanzapine Neopharma 7.5 mg coated tablets olanzapine
Olanzapine Neopharma 7. 5 mg pilloli miksija olanzapine
Each coated tablet contains 7.5 mg olanzapine
Kull pillola miksija fiha 7. 5 mg ta ’ olanzapine
EU/ 1/ 07/ 426/ 005, 28 coated tablets EU/ 1/ 07/ 426/ 006, 56 coated tablets
EU/ 1/ 07/ 426/ 005 28 pillola miksija EU/ 1/ 07/ 426/ 006 56 pillola miksija
84 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
85 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Neopharma Ltd
Neopharma Limited
85 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
86 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Olanzapine Neopharma 10 mg coated tablets olanzapine
Olanzapine Neopharma 10 mg pilloli miksija olanzapine
Each coated tablet contains 10 mg olanzapine
Kull pillola miksija fiha 10 mg ta ’ olanzapine
7 coated tablets 28 coated tablets 56 coated tablets
7 pillola miksija 28 pillola miksija 56 pillola miksija
EU/ 1/ 07/ 426/ 007, 7 coated tablets EU/ 1/ 07/ 426/ 008, 28 coated tablets EU/ 1/ 07/ 426/ 009, 56 coated tablets
EU/ 1/ 07/ 426/ 007 7 pillola miksija EU/ 1/ 07/ 426/ 008 28 pillola miksija EU/ 1/ 07/ 426/ 009 56 pillola miksija
87 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
88 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
88 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
89 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Olanzapine Neopharma 15 mg coated tablets olanzapine
Olanzapine Neopharma 15 mg pilloli miksija olanzapine
Each coated tablet contains 15 mg olanzapine
Kull pillola miksija fiha 15 mg ta ’ olanzapine
EU/ 1/ 07/ 426/ 010, 28 coated tablets EU/ 1/ 07/ 426/ 011, 56 coated tablets
EU/ 1/ 07/ 426/ 010 28 pillola miksija EU/ 1/ 07/ 426/ 011 56 pillola miksija
90 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
91 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
92 PACKAGE LEAFLET:
FULJETT TA 'TAGĦRIF
OLANZAPINE NEOPHARMA 2.5 mg coated tablets OLANZAPINE NEOPHARMA 5 mg coated tablets OLANZAPINE NEOPHARMA 7.5 mg coated tablets OLANZAPINE NEOPHARMA 10 mg coated tablets OLANZAPINE NEOPHARMA 15 mg coated tablets olanzapine
OLANZAPINE NEOPHARMA 2. 5 mg pilloli miksija OLANZAPINE NEOPHARMA 5 mg pilloli miksija OLANZAPINE NEOPHARMA 7. 5 mg pilloli miksija OLANZAPINE NEOPHARMA 10 mg pilloli miksija OLANZAPINE NEOPHARMA 15 mg pilloli miksija olanzapine
if their symptoms are the same as yours.
il- ħsara, anki jekk ikollhom l- istess sintomi bħall tiegħek.
What OLANZAPINE NEOPHARMA is and what it is used for 2.
X’ inhi OLANZAPINE NEOPHARMA u għalxiex tintuża 2.
Before you take OLANZAPINE NEOPHARMA 3.
3.
Possible side effects 5.
Kif taħżen OLANZAPINE NEOPHARMA.
WHAT OLANZAPINE NEOPHARMA IS AND WHAT IT IS USED FOR
X’ INHI OLANZAPINE NEOPHARMA U GĦALXIEX TINTUŻA
OLANZAPINE NEOPHARMA belongs to a group of medicines called antipsychotics.
OLANZAPINE NEOPHARMA tappartjeni għall- grupp ta 'mediċini msejħa antipsikotiċi.
OLANZAPINE NEOPHARMA is used to treat a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.
OLANZAPINE NEOPHARMA hija użata biex tiġi kurata marda b' sintomi bħal li tisma ', li tara jew li tħoss affarijiet li mhux qegħdin hemm, twemmin żbaljat, suspetti mhux tas- soltu, u li tingħalaq fik innifsek.
OLANZAPINE NEOPHARMA is used to treat a condition with symptoms such as feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability.
OLANZAPINE NEOPHARMA hija użata biex tiġi kkurata kundizzjoni b' sintomi bħal li tħossok fi stat ta 'ferħ eċċessiv, li jkollok ammonti ta' enerġija eċċessiva, li jkollok bżonn ħafna anqas irqgħad mis- soltu, li titkellem mgħaġġel b' ħafna ħsibijiet jiġru f' moħħok u xi kultant tista 'tirrita ruħek ħafna.
BEFORE YOU TAKE OLANZAPINE NEOPHARMA
QABEL MA TIEĦU OLANZAPINE NEOPHARMA
Do not take OLANZAPINE NEOPHARMA
Tieħux OLANZAPINE NEOPHARMA:
- if you are allergic (hypersensitive) to olanzapine or any of the other ingredients of
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal olanzapine jew għal xi sustanzi oħra
OLANZAPINE NEOPHARMA.
ta ’ OLANZAPINE NEOPHARMA.
An allergic reaction may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath.
Reazzjoni allerġika tista 'tidher bħala raxx, ħakk, wiċċ minfuħ, xofftejn minfuħa jew qtuħ ta' nifs.
- if you have been previously diagnosed with eye problems such as certain kinds of glaucoma
- jekk kont issofri qabel bi problemi fl- għajnejn bħal xi tipi ta 'glawkoma (żieda fil- pressjoni
(increased pressure in the eye).
gewwa l- għajn).
Take special care with OLANZAPINE NEOPHARMA
Oqgħod attent ħafna b' OLANZAPINE NEOPHARMA:
- Medicines of this type may cause unusual movements mainly of the face or tongue.
- Mediċini ta 'dan it- tip jistgħu jikkawżaw moviment tal- wiċċ jew ta' l- ilsien mhux tas- soltu.
If this
Jekk
happens after you have been given OLANZAPINE NEOPHARMA tell your doctor.
jiġri hekk wara li tkun ingħatajt OLANZAPINE NEOPHARMA għid lit- tabib tiegħek.
- Very rarely, medicines of this type cause a combination of fever, faster breathing, sweating,
- Rari ħafna, mediċini ta 'dan it- tip jikkawżaw taħlita ta' deni, nifs mgħaġġel, għaraq, ebusija
muscle stiffness and drowsiness or sleepiness.
tal- muskoli u ħedla jew ngħas.
If this happens, contact your doctor at once.
Jekk jiġrilek hekk għid lit tabib tiegħek minnufih.
- The use of OLANZAPINE NEOPHARMA in elderly patients with dementia is not
- L- użu ta ’ OLANZAPINE NEOPHARMA f’ pazjenti anzjani bid- demenzja mhux irrakkomandat
recommended as it may have serious side effects.
għax jista ’ jkollu effetti serji mhux mixtieqa.
If you suffer from any of the following illnesses tell your doctor as soon as possible:
94 Jekk issoffri minn xi mard elenkat hawn taħt għid lit- tabib tiegħek mill- aktar fis possibli:
• Diabetes • Heart disease • Liver or kidney disease • Parkinson’ s disease • Epilepsy • Prostate problems • A blocked intestine (Paralytic ileus) • Blood disorders • Stroke or “ mini” stroke (temporary symptoms of stroke)
• Dijabete • Mard tal- qalb • Mard tal- fwied jew tal- kliewi • Mard ta 'Parkinson • Epilessija • Problemi tal- prostata • Intestin ibblokkat (Ileus paralitiku) • Disturbi tad- demm • Puplesija jew puplesija “ ħafifa ” (sintomi temporanji ta' puplesija)
If you suffer from dementia, you or your carer/ relative should tell your doctor if you have ever had a stroke or “ mini” stroke.
Jekk tbati mid- demenzja, int jew min jieħu ħsiebek jew xi qarib għandu jgħid lit- tabUiUb tiegħek jekk qatt kellek xi puplesija jew puplesija “ żgħira ”.
OLANZAPINE NEOPHARMA is not for patients who are under 18 years.
OLANZAPINE NEOPHARMA mhux għal pazjenti li għandhom anqas minn 18- il sena.
Taking other medicines Only take other medicines while you are on OLANZAPINE NEOPHARMA if your doctor tells you that you can.
Ħu biss mediċini oħra waqt li qed tieħu OLANZAPINE NEOPHARMA jekk it- tabib tiegħek jgħidlek li tista ’.
You might feel drowsy if OLANZAPINE NEOPHARMA is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).
Jista 'jkun li tħossok imħeddel jekk tieħu OLANZAPINE NEOPHARMA flimkien ma' anti- dipressanti jew mediċini għall- ansjetà jew biex jgħinuk torqod (kalmanti).
You should tell your doctor if you are taking fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic), as it may be necessary to change your OLANZAPINE NEOPHARMA dose.
Għandek tgħarraf lit- tabib tiegħek jekk qed tieħu fluvoxamine (anti- dipressant), jew ciprofloxacin (antibijotiku), għax jista 'jkun hemm bżonn li tbiddel id- doża tiegħek ta' OLANZAPINE NEOPHARMA.
Taking OLANZAPINE NEOPHARMA with food and drink Do not drink any alcohol if you have been given OLANZAPINE NEOPHARMA as OLANZAPINE NEOPHARMA and alcohol together may make you feel drowsy.
Meta tieħu OLANZAPINE NEOPHARMA ma ’ l- ikel u max- xorb Tixrobx alkoħol jekk qed tieħu OLANZAPINE NEOPHARMA għax OLANZAPINE NEOPHARMA u l- alkoħol flimkien jistgħu iħeddluk.
Pregnancy and breast-feeding Tell your doctor as soon as possible if you are pregnant or think you may be pregnant.
Tqala u Treddigħ Għid lit- tabib tiegħek minnufih jekk inti inqbadt tqila jew jekk taħseb li inti tqila.
You should not be given this medicine when breast-feeding, as small amounts of OLANZAPINE NEOPHARMA can pass into breast milk.
M' għandekx tingħata din il- mediċina meta tkun qed tredda ’, għax ammonti żgħar ta ’ OLANZAPINE NEOPHARMA jistgħu jgħaddu fil- ħalib tas- sider.
Driving and using machines There is a risk of feeling drowsy when you are given OLANZAPINE NEOPHARMA.
Sewqan u tħaddim ta 'magni Hemm ir- riskju li tħossok imħeddel meta tingħata OLANZAPINE NEOPHARMA.
Important information about some of the ingredients of OLANZAPINE NEOPHARMA OLANZAPINE NEOPHARMA contains lactose.
OLANZAPINE NEOPHARMA fiha lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib qallek li għandek xi intolleranza għal xi tipi ta ’ zokkor, ikkuntattja lit- tabib qabel ma tieħu din il- mediċina.
HOW TO TAKE OLANZAPINE NEOPHARMA
KIF GĦANDEK TIEĦU OLANZAPINE NEOPHARMA
Always take OLANZAPINE NEOPHARMA exactly as your doctor has told you.
Dejjem għandek tieħu OLANZAPINE NEOPHARMA skond il- parir tat- tabib.
Your doctor will tell you how many OLANZAPINE NEOPHARMA tablets to take and how long you should continue to take them.
95 It- tabib tiegħek għandu jgħidlek kemm tieħu pilloli ta ’ OLANZAPINE NEOPHARMA u kemm għandek iddum tieħodhom.
The daily dose of OLANZAPINE NEOPHARMA is between 5 and 20 mg.
Id- doża ta 'kuljum ta ’ OLANZAPINE NEOPHARMA hija bejn 5 u 20 mg.
Consult your doctor if your symptoms return but do not stop taking OLANZAPINE NEOPHARMA unless your doctor tells you to.
Ikkonsulta mat- tabib tiegħek jekk jerġgħu jiġuk is- sintomi imma tieqafx tieħu OLANZAPINE NEOPHARMA sakemm ma jgħidlekx it- tabib tiegħek.
You should take your OLANZAPINE NEOPHARMA tablets once a day following the advice of your doctor.
Għandek tieħu l- pilloli OLANZAPINE NEOPHARMA darba kuljum wara li tingħata parir mit- tabib tiegħek.
OLANZAPINE NEOPHARMA coated tablets are for oral use.
Il- pilloli miksija ta ’ OLANZAPINE NEOPHARMA huma għall- użu orali.
You should swallow the OLANZAPINE NEOPHARMA tablets whole with water.
Għandek tibla 'l- pilloli OLANZAPINE NEOPHARMA sħaħ bl- ilma.
If you take more OLANZAPINE NEOPHARMA than you should Patients who have taken more OLANZAPINE NEOPHARMA than they should, have experienced the following symptoms: rapid beating of the heart, agitation/ aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness.
Jekk tieħu OLANZAPINE NEOPHARMA aktar milli suppost Pazjenti li ħadu iżjed OLANZAPINE NEOPHARMA milli suppost kellhom dawn is- sintomi li ġejjin: tħabbit mgħaġġel tal- qalb, aġitazzjoni/ aggressività, problemi biex jitkellmu, movimenti mhux tas- soltu (speċjalment tal- ħalq u ta ’ l- ilsien) u tnaqqis fil- livell ta ’ koxjenza.
If you forget to take OLANZAPINE NEOPHARMA Take your tablets as soon as you remember.
Ħu l- pilloli tiegħek eżatt kif tiftakar.
If you stop taking OLANZAPINE NEOPHARMA Do not stop taking your tablets just because you feel better.
Jekk tieqaf tieħu OLANZAPINE NEOPHARMA Tieqafx tieħu l- pilloli tiegħek sempliċement għaliex tħossok aħjar.
It is important that you carry on taking OLANZAPINE NEOPHARMA for as long as your doctor tells you.
Huwa importanti li tibqa 'tieħu OLANZAPINE NEOPHARMA sakemm jgħidlek it- tabib tiegħek.
If you suddenly stop taking OLANZAPINE NEOPHARMA, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur.
Jekk tieqaf tieħu OLANZAPINE NEOPHARMA f' daqqa, jista 'jkollok sintomi bħal tasgħriq, ma tkunx tista' torqod, rogħda, ansjetà jew tqalligħ u rimettar.
Like all medicines, OLANZAPINE NEOPHARMA can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, OLANZAPINE NEOPHARMA jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Common side effects: affect 1 to 10 users in 100 • Changes in the levels of some blood cells and circulating fats. • Increases in the level of sugars in the blood and urine. • Feeling more hungry. • Dizziness. • Restlessness.
Effetti sekondarji komuni: jaffettwaw 1 sa 10 minn kull 100 pazjent • Tibdil fil- livelli ta 'xi ċelluli tad- demm u xaħmijiet fid- demm. • Żidiet fil- livelli ta' zokkor fid- demm u fl- awrina. • Tħossok aktar bil- ġuħ. • Sturdament. • Irrekwjetezza. • Rogħda. • Ebusija tal- muskoli jew spażmi (inklużi movimenti fl- għajnejn). • Problemi fil- mod kif titkellem. • Moviment mhux tas- soltu (speċjalment tal- wiċċ jew ta ’ l- ilsien). • Stitikezza.