qanastek/EMEA-V3 huggingface dataset:
138 administration has not been determined
Il- biodisponibilità assoluta orali relattiva għal amministrazzjoni fil- vina ma 'kienitx determinata.
Mannitol (E421) Sodium starch glycolate (type A) D-glucose Vanilla flavouring Indigo carmine lake (E132)
Mannitol (E421) Sodium starch glycolate (type A) D- glucose Benna tal- vanilla Indigo carmine lake (E132)
140 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta 'dak li hemm ġo fih
OPA/ Aluminium/ PVC-Aluminium polyester blisters in cartons of 28, 30, 35, 56 or 70 orodispersible tablets per carton.
Folji ta ’ OPA/ Aluminium/ PVC- Aluminium f’ kartun ta ’ 28, 30, 35, 56 jew 70 pillola li jinħallu fil- ħalq f’ kull kartuna.
EU/ 1/ 07/ 427/ 035 – Olanzapine Teva – 20 mg – orodispersible tablets – 28 tablets, per box EU/ 1/ 07/ 427/ 036 – Olanzapine Teva – 20 mg – orodispersible tablets – 30 tablets, per box EU/ 1/ 07/ 427/ 047 – Olanzapine Teva – 20 mg – orodispersible tablets – 35 tablets, per box EU/ 1/ 07/ 427/ 037 – Olanzapine Teva – 20 mg – orodispersible tablets – 56 tablets, per box EU/ 1/ 07/ 427/ 057 – Olanzapine Teva – 20 mg – orodispersible tablets – 70 tablets, per box
EU/ 1/ 07/ 427/ 057 – Olanzapine Teva – 20 mg – pilloli jinħallu fil- ħalq – 70 pillola, kull kaxxa.
141 ANNEX II
146 ANNESS II
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
142 A.
147 A.
Ltd Pallagi út 13, 4042 Debrecen Hungary
Ltd Pallagi út 13, 4042 Debrecen L- Ungerija
Ltd Táncsics Mihály út 82, H-2100 Gödöllo Hungary
Ltd Táncsics Mihály út 82, H- 2100 Gödöllo L- Ungerija
Sienkiewicza 25 str 99 300 Kutno Poland
Sienkiewicza 25 str 99 300 Kutno Polonja
10, 79199 Kirchzarten Germany
10, 79199 Kirchzarten Ġermanja
TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG 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 għat- Tqegħid fis- Suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta f’ verżjoni 3 f’ Modulu 1. 8. 1. ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq, qegħda f’ postha u qed tiffunzjona qabel u waqt li l- prodott qiegħed gis- suq.
143 ANNEX III
148 ANNESS III
144 A.
149 A.
CARTON OF < 28 > < 30 > < 35 > < 56 > < 70 > OLANZAPINE TEVA 2.5 mg FILM-COATED TABLETS
150 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA TA ’ < 28 > < 30 > < 35 > < 56 > < 70 > PILLOLA MIKSIJA B’ RITA TA ’ OLANZAPINE TEVA 2. 5 mg
Each film-coated tablet contains:
DIKJARAZZJONI TAS- SUSTANZA ATTIVA Kull pillola miksija b’ rita fiha:
2.5 mg Olanzapine
2. 5 mg olanzapine
Contains, among others, Lactose monohydrate
Fiha, fost oħrajn, Lactose monohydrate
< 28 > < 30 > < 35 > < 56 > < 70 > film-coated tablets
< 28 > < 30 > < 35 > < 56 > < 70 > pillola miksija b’ rita
METHOD AND ROUTE(S) OF ADMINISTRATION
MOD TA ’ KIF U MENJN JINGĦATA
146 11.
151 11.
Teva Pharma BV, Computerweg 10, 3542 DR Utrecht; The Netherlands
Teva Pharma BV, Computerweg 10, 3542 DR Utrecht; L- Olanda
Medicinal product subject to medical prescription.
Prodott mediċinali li jingħata bir- riċetta ta ’ tabib.
Olanzapine Teva 2.5 mgfilm-coated tablets
Olanzapine Teva 2. 5 mg pilloli miksija b’ rita
OLANZAPINE TEVA 2.5 mg FILM-COATED TABLET:
152 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI OLANZAPINE TEVA 2. 5 mg PILLOLI MIKSIJA B’ RITA:
BLISTER FOIL LABEL
TIKKETTA TAL- FOLJA STRIXXA
Olanzapine Teva 2.5 mg film-coated tablets
Olanzapine Teva 2. 5 mg Pillola miksija b’ rita
CARTON OF < 28 > < 30 > < 35 > < 50 > < 56 > < 70 > OLANZAPINE TEVA 5 mg FILM-COATED TABLETS
153 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA TA ’ < 28 > < 30 > < 35 > < 50 > < 56 > < 70 > PILLOLA MIKSIJA B’ RITA TA ’ 5 mg
Olanzapine Teva 5 mg film-coated tablets
Olanzapine Teva 5 mg Pilloli miksija b’ rita
Each film-coatet tablet contains:
Kull pillola miksija b’ rita fiha:
5 mg Olanzapine
5 mg Olanzapine
< 28 > < 30 > < 35 > < 50 > < 56 > < 70 > film-coated tablets
< 28 > < 30 > < 35 > < 50 > < 56 > < 70 > pillola miksija b’ rita
149 11.
154 11.
OLANZAPINE TEVA 5 mg FILM-COATED TABLET:
155 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI OLANZAPINE TEVA 5 mg PILLOLA MIKSIJA B’ RITA:
CARTON OF < 28 > < 30 > < 35 > < 56 > < 70 > OLANZAPINE TEVA 7.5 mg FILM-COATED TABLETS
156 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA TA ’ < 28 > < 30 > < 35 > < 56 > < 70 > PILLOLA MIKSIJA B’ RITA TA ’ OLANZAPINE TEVA 7. 5 mg
7.5 mg Olanzapine
7. 5 mg Olanzapine
152 11.
157 11.
EU/ 1/ 07/ 427/ 008 EU/ 1/ 07/ 427/ 009 EU/ 1/ 07/ 427/ 010 EU/ 1/ 07/ 427/ 040 EU/ 1/ 07/ 427/ 050
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ EU/ 1/ 07/ 427/ 008 EU/ 1/ 07/ 427/ 009 EU/ 1/ 07/ 427/ 010 EU/ 1/ 07/ 427/ 040 EU/ 1/ 07/ 427/ 050
OLANZAPINE TEVA 7.5 mg FILM-COATED TABLET:
158 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI OLANZAPINE TEVA 7. 5 mg PILLOLI MIKSIJA B’ RITA:
154 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
159 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON OF < 7 > < 28 > < 30 > < 35 > < 50 > < 56 > < 70 > OLANZAPINE TEVA 10 mg FILM-COATED TABLETS
KARTUNA TA ’ 7 PILLOLI / < 28 > < 30 > < 35 > < 50 > < 56 > < 70 > PILLOLA MIKSIJA B’ RITA TA ’ OLANZAPINE TEVA TA ’ 10 mg
10 mg Olanzapine
10 mg Olanzapine
< 7 > < 28 > < 30 > < 35 > < 50 > < 56 > < 70 > film-coated tablets
7 pilloli / < 28 > < 30 > < 35 > < 50 > < 56 > < 70 > pillola miksija b’ rita
156 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
161 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
OLANZAPINE TEVA 10 mg FILM-COATED TABLET:
OLANZAPINE TEVA 10 mg PILLOLI MIKSIJA B’ RITA:
157 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
162 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON OF < 28 > < 30 > < 35 > < 50 > < 56 > < 70 > OLANZAPINE TEVA 15 mg FILM-COATED TABLETS
KARTUNA TA ’ < 28 > < 30 > < 35 > < 50 > < 70 > PILLOLA MIKSIJA B’ RITA TA ’ OLANZAPINE TEVA 15 mg
Olanzapine Teva 15 mg film-coated tablets
Olanzapine Teva 15 mg Pilloli miksija b’ rita
15 mg Olanzapine
15 mg Olanzapine
< 28 > < 30 > < 35 > < 50 > < 56 > < 70 > film-coated tablets
< 28 > < 30 > < 35 > < 50 > < 70 > pillola miksija b’ rita
159 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
164 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
OLANZAPINE TEVA 15 mg FILM-COATED TABLET:
OLANZAPINE TEVA 15 mg PILLOLI MIKSIJA B’ RITA:
CARTON OF < 28 > < 30 > < 35 > < 56 > < 70 > OLANZAPINE TEVA 20 mg FILM-COATED TABLETS
165 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA TA ’ < 28 > < 30 > < 35 > < 56 > < 70 > PILLOLA MIKSIJA B’ RITA TA ’ OLANZAPINE TEVA 20 mg
20 mg Olanzapine
20 mg Olanzapine
161 11.
166 11.
EU/ 1/ 07/ 427/ 020 EU/ 1/ 07/ 427/ 021 EU/ 1/ 07/ 427/ 022 EU/ 1/ 07/ 427/ 043 EU/ 1/ 07/ 427/ 053
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ EU/ 1/ 07/ 427/ 020 EU/ 1/ 07/ 427/ 021 EU/ 1/ 07/ 427/ 022 EU/ 1/ 07/ 427/ 043 EU/ 1/ 07/ 427/ 053
Olanzapine Teva 20 mg film-coated tablets
Olanzapine Teva 20 mg Pilloli miksija b’ rita
162 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
167 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
OLANZAPINE TEVA 20 mg FILM-COATED TABLET:
OLANZAPINE TEVA 20 mg PILLOLA MIKSIJA B’ RITA:
BLISTER FOIL LABEL
TIKKETTA TAL- FOLJA TA ’ L - ISTRIXXA
CARTON OF < 28 > < 30 > < 35 > < 50 > < 56 > < 70 > OLANZAPINE TEVA 5 mg ORODISPERSIBLE TABLETS
168 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA TA ’ < 28 > < 30 > < 35 > < 50 > < 56 > < 70 > PILLOLA LI TINĦALL FIL- ĦALQ TA ’ 5 mg
Olanzapine Teva 5 mg orodispersible tablets
Olanzapine Teva 5 mg pilloli li jinħallu fil- ħalq
Each orodispersible tablet contains:
Kull pillola li tinħall fil- ħalq fiha:
Contains among others:
Fiha, fost oħrajn:
D-glucose and tartrazine lake (E102)
D- glucose u tartrazine lake (E102)
< 28 > < 30 > < 35 > < 50 > < 56 > < 70 > orodispersible tablets
< 28 > < 30 > < 35 > < 50 > < 56 > < 70 > pillola li jinħallu fil- ħalq
Do not store above 30°C Store in the original package in order to protect from light and moisture.
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mid- dawl u mill- umdità.
164 11.
169 11.
Separate one blister cell from the strip.
Issepara ċellola ta ’ folja minn ma ’ l- istrixxa.
Carefully peel off the backing.
B’ attenzjoni qaxxar il- parti ta ’ wara.
Gently push the tablet out.
Bil- mod imbotta l- pillola ’ l barra.
Put the tablet in your mouth.
Qiegħed il- pillola f’ ħalqek.
It will dissolve directly in your mouth, so that it can be easily swallowed.
Din ser tinħall f’ ħalqek, biex tkun tista ’ tinbela ’ faċilment.
165 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
170 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI OLANZAPINE TEVA 5 mg PILLOLA LI TINĦALL FIL- ĦALQ:
Olanzapine Teva 5 mg orodispersible tablets
Olanzapine Teva 5 mg pilloli li jinħallu fl- ilma
166 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
171 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON OF < 28 > < 30 > < 35 > < 50 > < 56 > < 70 > OLANZAPINE TEVA 10 mg ORODISPERSIBLE TABLETS
KARTUNA TA ’ < 28 > < 30 > < 35 > < 50 > < 56 > < 70 > PILLOLA LI TINĦALL FIL- ĦALQ TA ’ OLANZAPINE TEVA TA ’ 10 mg
Olanzapine Teva 10 mg orodispersible tablets
Olanzapine Teva 10 mg pilloli li jinħallu fil- ħalq
D-glucose.
D- glucose
< 28 > < 30 > < 35 > < 50 > < 56 > < 70 > orodispersible tablets
< 28 > < 30 > < 35 > < 50 > < 56 > < 70 > pillola li tinħall fil- ħalq
It will dissolve directly in your mouth, so that it can be easily swallowed.
Din ser tinhall f’ ħalqek, biex tkun tista ’ tinbela ’ faċilment.
168 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
173 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
OLANZAPINE TEVA 10 mg ORODISPERSIBLE TABLET:
OLANZAPINE TEVA 10 mg PILLOLI LI JINĦALLU FIL- ĦALQ:
169 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
174 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON OF < 28 > < 30 > < 35 > < 50 > < 56 > < 70 > OLANZAPINE TEVA 15 mg ORODISPERSIBLE TABLETS
KARTUNA TA ’ < 28 > < 30 > < 35 > < 50 > < 60 > PILLOLA LI JINĦALLU FIL- ĦALQ TA ’ OLANZAPINE TEVA 15 mg
Olanzapine Teva 15 mg orodispersible tablets
Olanzapine Teva 15 mg pilloli li jinħallu fil- ħalq
D-glucose and sunset yellow lake (E110).
D- Glucose u sunset yellow lake (E110)
Do not store above 30°C Store in the original package in order to protect from light and moisture.
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mid- dawl u l- umdità.
171 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
176 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
OLANZAPINE TEVA 15 mg ORODISPERSIBLE TABLET:
OLANZAPINE TEVA 15 mg PILLOLI LI JINĦALLU FIL- ĦALQ:
CARTON OF < 28 > < 30 > < 35 > < 56 > < 70 > OLANZAPINE TEVA 20 mg ORODISPERSIBLE TABLETS
177 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA TA ’ < 28 > < 30 > < 35 > < 56 > < 70 > PILLOLA LI TINĦALL FIL- ĦALQ TA ’ OLANZAPINE TEVA 20 mg
Olanzapine Teva 20 mg orodispersible tablets
Olanzapine Teva 20 mg pilloli li jinħallu fil- ħalq
D-glucose.
D- Glucose
< 28 > < 30 > < 35 > < 56 > < 70 > orodispersible tablets
< 28 > < 30 > < 35 > < 56 > < 70 > pillola miksija b’ rita
Do not store above 30°C Store in the original package in order to protect from light and moisture.
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mid- dawl.
173 11.
178 11.
EU/ 1/ 07/ 427/ 035 EU/ 1/ 07/ 427/ 036 EU/ 1/ 07/ 427/ 037 EU/ 1/ 07/ 427/ 047 EU/ 1/ 07/ 427/ 057
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ EU/ 1/ 07/ 427/ 035 EU/ 1/ 07/ 427/ 036 EU/ 1/ 07/ 427/ 037 EU/ 1/ 07/ 427/ 047 EU/ 1/ 07/ 427/ 057
Olanzapine Teva 20 mg orodispersible tablets
Olanzapine Teva 20 mg pilloli li jistgħu jinħallu fil- ħalq
174 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
179 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
OLANZAPINE TEVA 20 mg ORODISPERSIBLE TABLET:
OLANZAPINE TEVA 20 mg PILLOLA LI JINĦALLU FIL- ĦALQ:
BLISTER FOIL LABEL
TIKKETTA TAL- FOLJA TA ’ L- ISTRIXXA
Olanzapine Teva 20 mg orodispersible tablet
Olanzapine Teva 20 mg pilloli li jinħallu fl- ilma
175 B.
180 B.
176 PACKAGE LEAFLET:
181 FULJETT TA 'TAGĦRIF:
Olanzapine Teva 2.5 mg film-coated tablets Olanzapine Teva 5 mg film-coated tablets Olanzapine Teva 7.5 mg film-coated tablets Olanzapine Teva 10 mg film-coated tablets Olanzapine Teva 15 mg film-coated tablets Olanzapine Teva 20 mg film-coated tablets olanzapine
OLANZAPINE TEVA 2. 5 mg PILLOLI MIKSIJA B’ RITA OLANZAPINE TEVA 5 mg PILLOLI MIKSIJA B’ RITA OLANZAPINE TEVA 7. 5 mg PILLOLI MIKSIJA B’ RITA OLANZAPINE TEVA 10 mg PILLOLI MIKSIJA B’ RITA OLANZAPINE TEVA 15 mg PILLOLI MIKSIJA B’ RITA OLANZAPINE TEVA 20 mg PILLOLI MIKSIJA B’ RITA
What Olanzapine Teva is and what it is used for 2.
X’ inhi Olanzapine Teva u għalxiex tintuża 2.
Before you take Olanzapine Teva 3.
Qabel ma tieħu Olanzapine Teva 3.
How to take Olanzapine Teva 4.
Kif għandek tieħu Olanzapine Teva 4.
How to store Olanzapine Teva 6.
Kif taħżen Olanzapine Teva 6.
WHAT OLANZAPINE TEVA IS AND WHAT IT IS USED FOR
X’ INHI OLANZAPINE TEVA U GĦALXIEX TINTUŻA
Olanzapine Teva belongs to a group of medicines called antipsychotics.
Olanzapine Teva tappartjeni għall- grupp ta 'mediċini msejħa antipsikotiċi.
Olanzapine Teva 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 Teva 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 Teva 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 Teva 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 TEVA
QABEL MA TIEĦU OLANZAPINE TEVA
Do not take Olanzapine Teva
Tieħux Olanzapine Teva:
- if you are allergic (hypersensitive) to olanzapine or any of the other ingredients of Olanzapine
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal olanzapine jew għal xi sustanzi oħra
Teva.
ta ’ Olanzapine Teva.
- 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 ġewwa
(increased pressure in the eye).
l- għajn).
Take special care with Olanzapine Teva
182 Oqgħod attent ħafna b' Olanzapine Teva:
happens after you have been given Olanzapine Teva tell your doctor.
jiġri hekk wara li tkun ingħatajt Olanzapine Teva 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 tal -
177 muscle stiffness and drowsiness or sleepiness.
muskoli u ħedla jew ngħas.
- The use of Olanzapine Teva in elderly patients with dementia is not recommended as it may
- L- użu ta ’ Olanzapine Teva f’ pazjenti anzjani bid- demenzja mhux irrakkomandat għax jista ’
have serious side effects.
jkollu effetti serji mhux mixtieqa.
If you suffer from any of the following illnesses tell your doctor as soon as possible:
Jekk issoffri minn xi mard elenkat hawn taħt għid lit- tabib tiegħek mill- aktar fis possibli:
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- tabib tiegħek jekk qatt kellek xi puplesija jew puplesija “ żgħira ”.
Olanzapine Teva is not for patients who are under 18 years.
Olanzapine Teva mhux għal pazjenti li għandhom anqas minn 18- il sena.
Taking other medicines Only take other medicines while you are on Olanzapine Teva if your doctor tells you that you can.
Ħu biss mediċini oħra waqt li qed tieħu Olanzapine Teva jekk it- tabib tiegħek jgħidlek li tista ’.
You might feel drowsy if Olanzapine Teva 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 Teva 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 Teva 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 Teva.
Taking Olanzapine Teva with food and drink Do not drink any alcohol if you have been given Olanzapine Teva as Olanzapine Teva and alcohol together may make you feel drowsy.
Tixrobx alkoħol jekk qed tieħu Olanzapine Teva għax Olanzapine Teva u l- alkoħol flimkien jistgħu iħeddluk.
You should not be given this medicine when breast-feeding, as small amounts of Olanzapine Teva can pass into breast milk.
M' għandekx tingħata din il- mediċina meta tkun qed tredda ’, għax ammonti żgħar ta ’ Olanzapine Teva jistgħu jgħaddu fil - ħalib tas- sider.
Driving and using machines There is a risk of feeling drowsy when you are given Olanzapine Teva.
Sewqan u tħaddim ta 'magni Hemm ir- riskju li tħossok imħeddel meta tingħata Olanzapine Teva.
Important information about some of the ingredients of Olanzapine Teva Olanzapine Teva contains lactose.
Olanzapine Teva fiha lactose.
HOW TO TAKE OLANZAPINE TEVA
KIF GĦANDEK TIEĦU OLANZAPINE TEVA
Always take Olanzapine Teva exactly as your doctor has told you.
Dejjem għandek tieħu Olanzapine Teva skond il- parir tat- tabib.
Your doctor will tell you how many Olanzapine Teva tablets to take and how long you should continue to take them.
It- tabib tiegħek għandu jgħidlek kemm tieħu pilloli ta ’ Olanzapine Teva u kemm għandek iddum tieħodhom.
The daily dose of Olanzapine Teva is between 5 and 20 mg.
Id- doża ta 'kuljum ta ’ Olanzapine Teva hija bejn 5 u 20 mg.
Consult your doctor if your symptoms return but do not stop taking Olanzapine Teva unless your doctor tells you to.
Ikkonsulta mat- tabib tiegħek jekk jerġgħu jiġuk is- sintomi imma tieqafx tieħu Olanzapine Teva sakemm ma jgħidlekx it- tabib tiegħek.
You should take your Olanzapine Teva tablets once a day following the advice of your doctor.
Għandek tieħu l- pilloli Olanzapine Teva darba kuljum wara li tingħata parir mit- tabib tiegħek.
Olanzapine Teva coated tablets are for oral use.
Il- pilloli miksija ta ’ Olanzapine Teva huma għall- użu orali.
You should swallow the Olanzapine Teva tablets whole with water.
Għandek tibla 'l- pilloli Olanzapine Teva sħaħ bl- ilma.
If you take more Olanzapine Teva than you should Patients who have taken more Olanzapine Teva 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 Teva aktar milli suppost Pazjenti li ħadu iżjed Olanzapine Teva 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 Teva Take your tablets as soon as you remember.
Ħu l- pilloli tiegħek eżatt kif tiftakar.
If you stop taking Olanzapine Teva Do not stop taking your tablets just because you feel better.
Jekk tieqaf tieħu Olanzapine Teva Tieqafx tieħu l- pilloli tiegħek sempliċement għaliex tħossok aħjar.
It is important that you carry on taking Olanzapine Teva for as long as your doctor tells you.
Huwa importanti li tibqa 'tieħu Olanzapine Teva sakemm jgħidlek it- tabib tiegħek.
If you suddenly stop taking Olanzapine Teva, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur.
Jekk tieqaf tieħu Olanzapine Teva f' daqqa, jista 'jkollok sintomi bħal tasgħriq, ma tkunx tista' torqod, rogħda, ansjetà jew tqalligħ u rimettar.
Like all medicines, Olanzapine Teva can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Olanzapine Teva 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. • Tremor. • Muscle stiffness or spasm (including eye movements). • Problems with speech. • Unusual movement (especially of the face or tongue).
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.
In the early stages of treatment, some people may feel dizzy or faint (with a slow heart rate), especially when getting up from a lying or sitting position.
184 • 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. • Ħalq xott. • Raxx. • Titlef il- forzi. • Għeja esaġerata. • Retenzjoni ta 'l- ilma li twassal għal nefħa fl- idejn, għekiesi jew saqajn. • Fl- ewwel stadji tal- kura, xi persuni jistgħu jħossuhom sturduti jew mhux f' sikkithom (il- qalb tħabbat bil- mod), speċjalment waqt li jkunu qegħdin iqumu minn pożizzjoni mimduda jew minn bil- qiegħda.
Other possible side effects: frequency cannot be estimated from the available data. • Allergic reaction (e.g. swelling in the mouth and throat, itching, rash). • Diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma. • Lowering of normal body temperature. • Seizures, usually associated with a history of seizures (epilepsy). • Combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness. • Spasms of the muscle of the eye causing rolling movement of the eye. • Abnormal rhythms of the heart. • Sudden unexplained death. • Blood clots such as deep venous thrombosis of the leg or blood clot on the lung. • Inflammation of the pancreas causing severe stomach pain, fever and sickness. • Liver disease appearing as yellowing of the skin and white parts of the eyes. • Muscle disease presenting as unexplained aches and pains. • Difficulty in passing urine. • Prolonged and/or painful erection.
Effetti sekondarji oħra possibbli: ma tistax tiġi stmata frekwenza mill- informazzjoni disponibbli • Reazzjonijiet allerġiċi (eż. nefħa fil- ħalq u l- gerżuma, ħakk, raxx). • Dijabete jew dijabete li tmur għall- agħar, kultant assoċjata ma 'ketoaċidożi (ketoni fid- demm u fl- awrina) jew koma. • Titbaxxa t- temperatura normali tal- ġisem. • Aċċessjonijiet, normalment assoċjati ma' storja ta 'aċċessjonijiet (epilessija). • Taħlita ta' deni, nifs mgħaġġel, tagħriq, ebusija tal- muskoli u ħedla jew ngħas. • Spażmi tal- muskolu ta 'l- għajn li jikkawża taqlib ta' l- għajn. • Ritmi mhux normali tal- qalb. • Mewt għall- għarrieda u inspjegabbli. • Tagħqid tad- demm bħal trombożi fil- vini fondi tas- sieq jew tagħqid tad- demm fil- pulmun. • Infjammazjoni tal- frixa li tikkawża wġigħ qawwi fl- istonku, deni u taqlib. • Mard tal- fwied li jidher bħala sfurija tal- ġilda u ta 'l- abjad ta' l- għajnejn. • Mard tal- muskoli li jimmanifesta ruħu bħala wġigħ inspjegabbli. • Diffikultà biex tgħaddi l- awrina. • Erezzjoni mtawwla u/ jew bl- uġigħ.
In patients with Parkinson's disease Olanzapine Teva may worsen the symptoms.
F' pazjenti li għandhom il- marda ta 'Parkinson, Olanzapine Teva tista' tagħmel is- sintomi agħar.
Very rarely babies born to mothers who have taken Olanzapine Teva in the last stage of pregnancy (3rd trimester) may have tremors, be sleepy or drowsy.
Rarament ħafna trabi li jitwieldu lil ommijiet li ħadu Olanzapine Teva fl- aħħar stadju tat- tqala (fl- aħħar tlett xhur) jista 'jkollhom rogħda, ngħas u ħedla.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
185 Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib tiegħek.
HOW TO STORE OLANZAPINE TEVA
KIF TAĦŻEN OLANZAPINE TEVA
Do not use Olanzapine Teva after the expiry date which is stated on the carton.
Tużax Olanzapine Teva wara d- data ta ’ skadenza li tidher fuq il- kartuna.
180 Do not store above 25°C.
Taħżinx f’ temperatura ’ l fuq minn 25°C.
Store in the original package in order to protect from light.
Żomm fil- pakkett oriġinali sabiex tilqa ’ mid- dawl.
Please return left over medicine to your pharmacist.
Jekk jogħġbok agħti lura l- mediċina li tibqgħalek lill- ispiżjar tiegħek.
These measures will help to protect the environment.
Dawn il- miżuri jgħinu għall- protezzjoni ta ’ l- ambjent
What Olanzapine Teva contains
X’ fiha Olanzapine Teva
Each Olanzapine Teva 5 mg film-coated tablet contains 5 mg of the active substance.
Kull pillola miksija b’ rita ta ’ Olanzapine Teva fiha 2. 5 mg tas- sustanza attiva.
Each Olanzapine Teva 7.5 mg film-coated tablet contains 7.5 mg of the active substance.
Kull pillola miksija b’ rita ta ’ Olanzapine Teva fiha 5 mg tas- sustanza attiva.
Each Olanzapine Teva 10 mg film-coated tablet contains 10 mg of the active substance.
Kull pillola miksija b’ rita ta ’ Olanzapine Teva fiha 7. 5 mg tas- sustanza attiva Kull pillola miksija b’ rita ta ’ Olanzapine Teva fiha 10 mg tas- sustanza attiva.
Each Olanzapine Teva 15 mg film-coated tablet contains 15 mg of the active substance.
Kull pillola miksija b’ rita ta ’ Olanzapine Teva fiha 15 mg tas- sustanza attiva.
Each Olanzapine Teva 20 mg film -coated tablet contains 20 mg of the active substance.
Kull pillola miksija b’ rita ta ’ Olanzapine Teva fiha 20 mg tas- sustanza attiva
(tablet core) lactose monohydrate, Hydroxypropylcellulose,
(qalba tal- pillola) lactose monohydrate, Hydroxypropylcellulose,
Crospovidone (type A), Silica colloidal anhydrous, Microcrystalline cellulose, Magnesium stearate, (tablet coating) Hypromellose, polydextrose, glycerol diacetate, macrogol 8000, titanium dioxide (E171).
Crospovidone (tip A), Silica, colloidal anhydrous, Microcrystalline cellulose, Magnesium stearate, (kisi tal- pillola) Hypromellose, polydextrose, glycerol diacetate, macrogol 8000, titanium dioxide (E171).
- In addition, the 15 mg strength contains indigo carmine (E132) and the 20 mg strength contains
- Barra minhekk il- qawwa ta ’ 15 mg fiha wkoll indigo carmine (E132) u l- qawwa ta ’ 20 mg fiha
iron oxide red (E172)
iron oxide red (E172)
What Olanzapine Teva looks like and contents of the pack Olanzapine Teva 2. 5 mg film-coated tablet is a white, biconvex, round tablet, with the inscription “ OL 2. 5” on one side.
Id- dehra ta ’ Olanzapine Teva u l- kontenut tal- pakketti Olanzapine Teva 2. 5 mg pillola miksija b’ rita hija pillola bajda, mżaqqa u tonda, bl- intaljar “ OL 2. 5 ” fuq naħa waħda.
Olanzapine Teva 5 mg film-coated tablet is a white, biconvex, round tablet, with the inscription “OL 5” on one side.
Olanzapine Teva 5 mg pillola miksija b’ rita hija pillola bajda, mżaqqa u tonda, bl- intaljar “ OL 5 ” fuq naħa waħda.
Olanzapine Teva 7.5 mg film-coated tablet is a white, biconvex, round tablet, with the inscription “OL 7.5” on one side.
Olanzapine Teva 7. 5 mg pillola miksija b’ rita hija pillola bajda, mżaqqa u tonda, bl- intaljar “ OL 7. 5 ” fuq naħa waħda.
Olanzapine Teva 10 mg film-coated tablet is a white, biconvex, round tablet, with the inscription “OL 10” on one side.
Olanzapine Teva 10 mg pillola miksija b’ rita hija pillola bajda mżaqqa, tonda, bl- intaljar “ OL 10 ” fuq naħa waħda.
Olanzapine Teva 15 mg film-coated tablet is a light blue, biconvex, oval tablet, with the inscription “OL 15” on one side.
Olanzapine Teva 15 mg pillola miksija b’ rita hija pillola ċelesti ċara ovali u mżaqqa u ovali, bl - intaljar “ OL 15 ” fuq naħa waħda.
Olanzapine Teva 20 mg film-coated tablet is a pink, biconvex, oval tablet, with the inscription “OL 20” on one side.
Olanzapine Teva 20 mg pillola miksija b’ rita hija pillola roża ovali u mżaqqa, bl- intaljar “ OL 20 ” fuq naħa waħda.
Olanzapine Teva 2. 5 mg film-coated tablets are available in cartons of 28, 30, 35, 56 or 70 film-coated tablets.
Olanzapine Teva 2. 5 mg Pilloli miksija b’ rita jiġu f’ kartun ta ’ 28, 30, 35, 56 jew 70 pillola miksija b’ rita.
Olanzapine Teva 5 mg film-coated tablets are available in cartons of 28, 30, 35, 50, 56 or 70 film- coated tablets.
Olanzapine Teva 5 mg Pilloli miksija b’ rita jiġu f’ kartun ta ’ 28, 30, 35, 50, 56 jew 70 pillola miksija b’ rita.
Olanzapine Teva 7.5 mg film-coated tablets are available in cartons of 28, 30, 35, 56 or 70 film-coated tablets.
Olanzapine Teva 7. 5 mg Pilloli miksija b’ rita jiġu f’ kartun ta ’ 28, 30, 35, 56 jew 70 pillola miksija b’ rita.
Olanzapine Teva 10 mg film-coated tablets are available in cartons of 7, 28, 30, 35, 50, 56 or 70 film- coated tablets.
186 Olanzapine Teva 10 mg Pilloli miksija b’ rita jiġu f’ kartun ta ’ 7, 28, 30, 35, 50, 56 jew 70 pillola miksija b’ rita.
Olanzapine Teva 15 mg film-coated tablets are available in cartons of 28, 30, 35, 50, 56or 70 film- coated tablets.
Olanzapine Teva 15 mg Pilloli miksija b’ rita jiġu f’ kartun ta ’ 28, 30, 35, 50, 56 jew 70 pillola miksija b’ rita.
Olanzapine Teva 20 mg film-coated tablets are available in cartons of 28, 30, 35, 56 or 70 film-coated tablets.
Olanzapine Teva 20 mg Pilloli miksija b’ rita jiġu f’ kartun ta ’ 28, 30, 35, 56 jew 70 pillola miksija b’ rita.
181 Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq
Teva Pharma BV, Computerweg 10, 3542 DR Utrecht, The Netherlands
Teva Pharma BV, Computerweg 10, 3542 DR Utrecht, l- Olanda
Teva Pharmaceutical Works, Pallagi út 13, 4042 Debrecen, Hungary Teva Pharmaceutical Works, Táncsics Mihály út 82, H-2 100 Gödöllo, Hungary Teva Kutno S.A., Sienkiewicza 25 str, 99 300 Kutno, Poland Gry-Pharma GmbH, Kandelstr.
Teva Pharmaceutical Works, Pallagi út 13, 4042 Debrecen, Hungary Teva Pharmaceutical Works, Táncsics Mihály út 82, H- 2100 Gödöllo, Hungary Teva Kutno S. A., Sienkiewicza 25 str, 99 300 Kutno, Polonja Gry- Pharma GmbH, Kandelstr.
10, 79199 Kirchzarten, Germany TEVA UK Ltd, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom
10, 79199 Kirchzarten, Ġermanja TEVA UK Ltd, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, Renju Unit
Italia Teva Italia S.r.l.
(44) 1323 501 111 Italia Teva Italia S. r. l.
Latvija UAB “Sicor Biotech” Latvian Affiliate Telephone: +371 6714 25 63.
(44) 1323 501 111 Latvija UAB “ Sicor Biotech ” Latvian Affiliate Telephone: +371 6714 25 63.
183 This leaflet was last approved in {MM/YYYY}.
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}.
184 PACKAGE LEAFLET:
188 FULJETT TA ’ TAGĦRIF:
Olanzapine Teva 5 mg orodispersible tablets Olanzapine Teva 10 mg orodispersible tablets Olanzapine Teva 15 mg orodispersible tablets Olanzapine Teva 20 mg orodispersible tablets olanzapine
OLANZAPINE TEVA 5 mg PILLOLI LI JINĦALLU FIL- ĦALQ OLANZAPINE TEVA 10 mg PILLOLI LI JINĦALLU FIL- ĦALQ OLANZAPINE TEVA 15 mg PILLOLI LI JINĦALLU FIL- ĦALQ OLANZAPINE TEVA 20 mg PILLOLI LI JINĦALLU FIL- ĦALQ olanzapine
It may harm them, even if
Tista 'tagħmlilhom
their symptoms are the same as yours.
il- ħsara, anki jekk ikollhom l- istess sintomi bħall tiegħek.
BEFORE YOU TAKE Olanzapine Teva
QABEL MA TIEĦU OLANZAPINE TEVA
- If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of Olanzapine
- Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal olanzapine jew għal xi sustanzi oħra
- If you have been previously diagnosed with eye problems such as certain kinds of glaucoma
- Jekk kont issofri bi problemi fl- għajnejn bħal xi tipi ta 'glawkoma (żieda fil- pressjoni ġewwa l -
(increased pressure in the eye).
għajn).
Take special care with Olanzapine Teva
Oqgħod attent ħafna b' Olanzapine Teva:
muscle stiffness and drowsiness or sleepiness.
muskoli u ħedla jew ngħas.
185 If you suffer from any of the following illnesses tell your doctor as soon as possible:
189 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- tabib tiegħek jekk qatt kellek xi puplesija jew puplesija “ żgħira ”.
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 Teva 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 Teva.
Especially tell your doctor if you are taking medicines for Parkinson’s disease.
Speċjalment għid lit- tabib tiegħek jekk qed tieħu mediċini għall- marda ta 'Parkinson.
Important information about some of the ingredients of Olanzapine Teva Olanzapine Teva also contains 1 mg D-glucose.
Olanzapine Teva fiha wkoll 1 mg ta ’ D- glucose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product Olanzapine Teva 5 mg contains 0.4 mg tartrazine lake (E102) and may cause allergic reactions.
Olanzapine Teva 5 mg fiha 0. 4 mg ta ’ tartrazine lake (E102) u jista ’ jikkawża reazzjonijiet allerġiċi.
Olanzapine Teva 15 mg contains 0.2 mg sunset yellow lake (E110) and may cause allergic reactions.
Olanzapine Teva 15 mg fiha 0. 2 mg sunset yellow lake (E110) u jista ’ jikkawża reazzjonijiet allerġiċi.
HOW TO TAKE Olanzapine Teva
KIF GĦANDEK TIEĦU OLANZAPINE TEVA
You should check with your doctor 186 or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat - tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju.
Your doctor will tell you how many Olanzapine Teva tablets to take and how long you should continue to take them.
It- tabib tiegħek għandu jgħidlek kemm tieħu pilloli ta ’ Olanzapine Teva u kemm għandek iddum teħodhom.
Consult your doctor if your symptoms return but do not stop taking Olanzapine Teva unless your doctor tells you to.
Ikkonsulta mat- tabib tiegħek jekk jerġgħu jitfaċċaw is- sintomi imma tieqafx tieħu Olanzapine Teva sakemm ma jgħidlekx it- tabib tiegħek.
Olanzapine Teva orodispersible tablets are for oral use.
Olanzapine Teva pilloli li jinħallu fil- ħalq huma għall- użu orali.
Olanzapine Teva tablets break easily, so you should handle the tablets carefully.
Il- pilloli - Olanzapine Teva jinqasmu malajr, u għalhekk għandek tmiss il- pilloli b' kawtela.
Do not handle the tablets with wet hands as the tablets may break up.
Tmisx il - pilloli b' idejk imxarba għax il- pilloli jistgħu jinqasmu.
Hold the blister strip at the edges and separate one blister cell from the rest of the strip by gently tearing along the perforations around it.
Żomm l- strixxi tal- folja mit- tarf u ssepara ċellola tal- folja waħda mill- bqijja ta 'l- istrixxa billi bil- mod tqatta it- toqob ta' mad- dawra tagħha.
Carefully peel off the backing.
Qaxxar il -- wara tagħha bil- mod.
Gently push the tablet out.
Imbotta l- pillola l- barra bil- mod.
Put the tablet in your mouth.
Poġġi l- pillola ġo ħalqek.
It will dissolve directly in your mouth, so that it can be easily swallowed.
Hija tinħall direttament ġo ħalqek, sabiex tkun tista 'tinbela malajr.
You can also place the tablet in a full glass or cup of water, orange juice, apple juice, milk or coffee, and stir.
Tista 'wkoll tpoġġi l- pillola f' tazza jew kikkra mimlija bl- ilma, meraq tal- larinġ, meraq tat- tuffieħ, ħalib jew kafe, u ħawwad.
With some drinks, the mixture may change colour and possibly become cloudy.
Tieqafx tieħu il- pilloli tiegħek jekk tħossok aħjar.
Drink it straight away.
Olanzapine Teva m' hijiex għall- pazjenti li huma taħt it- 18- il - sena.
If you take more Olanzapine Teva than you should Patients who have taken more Olanzapine Teva 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 Teva aktar milli suppost Pazjenti li ħadu iżjed Olanzapine Teva 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 suddenly stop taking Olanzapine Teva, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur.
Jekk tieqaf tieħu Olanzapine Teva f' daqqa, jista 'jkollok sintomi bħal tagħriq, ma tkunx tista' torqod, rogħda, ansjetà jew tqalligħ u rimettar.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
191 Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
187 Very common side effects: affect 1 user in 10 • Weight gain. • Sleepiness. • Increases in the levels of prolactin in the blood.
Effetti sekondarji komuni ħafna: jaffettwaw 1 minn kull 10 pazjenti • Żieda fil- piż. • Ngħas. • Żidiet fil- livelli ta 'prolactin fid- demm.
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. • Tremor. • Muscle stiffness or spasm (including eye movements). • Problems with speech. • Unusual movement (especially of the face or tongue). • Constipation. • Dry mouth. • Rash. • Loss of strength. • Extreme tiredness. • Water retention leading to swelling of the hands, ankles or feet. • In the early stages of treatment, some people may feel dizzy or faint (with a slow heart rate), especially when getting up from a lying or sitting position.
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. • Ħalq xott. • Raxx. • Titlef il- forzi. • Għeja eżaġerata. • Retenzjoni ta 'l- ilma li twassal għal nefħa fl- idejn, għekiesi jew saqajn. • Fl- ewwel stadji tal- kura, xi persuni jistgħu jħossuhom sturduti jew mhux f' sikkithom (il- qalb tħabbat bil- mod), speċjalment waqt li jkunu qegħdin iqumu minn pożizzjoni mimduda jew minn bilqiegħda.
Other possible side effects: frequency cannot be estimated from the available data. • Allergic reaction (e.g. swelling in the mouth and throat, itching, rash). • Diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma. • Lowering of normal body temperature. • Seizures, usually associated with a history of seizures (epilepsy). • Combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness. • Spasms of the muscle of the eye causing rolling movement of the eye. • Abnormal rhythms of the heart. • Sudden unexplained death. • Blood clots such as deep venous thrombosis of the leg or blood clot on the lung. • Inflammation of the pancreas causing severe stomach pain, fever and sickness. • Liver disease appearing as yellowing of the skin and white parts of the eyes. • Muscle disease presenting as unexplained aches and pains. • Difficulty in passing urine. • Prolonged and/or painful erection.
Effetti sekondarji oħra possibbli: ma tistax tiġi stmata frekwenza mill- informazzjoni disponibbli • Reazzjonijiet allerġiċi (eż. nefħa fil- ħalq u l- gerżuma, ħakk, raxx). • Dijabete jew dijabete li tmur għall- agħar, kultant assoċjata ma 'ketoaċidożi (ketoni fid- demm u fl- awrina) jew koma. • Titbaxxa t- temperatura normali tal- ġisem. • Aċċessjonijiet, normalment assoċjati ma' storja ta 'aċċessjonijiet (epilessija). • Taħlita ta' deni, nifs mgħaġġel, għaraq, ebusija tal- muskoli u ħedla jew ngħas. • Spażmi tal- muskolu ta 'l- għajn li jikkawża taqlib ta' l- għajn. • Ritmi mhux normali tal- qalb. • Mewt għal għarrieda u inspjegabbli. • Tagħqid tad- demm bħal trombożi fil- vini fondi tas- sieq jew tagħqid tad- demm fil- pulmun. • Infjammazjoni tal- frixa li tikkawża wġigħ qawwi fl- istonku, deni u taqlib. • Mard tal- fwied li jidher bħala sfurija tal- ġilda u ta 'l- abjad ta' l- għajnejn. • Mard tal- muskoli li jimmanifesta ruħu bħala wġigħ inspjegabbli.
In patients with Parkinson's disease Olanzapine Teva may worsen the symptoms.
F' pazjenti li għandhom il- marda ta 'Parkinson, Olanzapine TevaS tista' tagħmel is- sintomi agħar.
188 Rarely women taking medicines of this type for a long time have started to secrete milk and have missed periods or had irregular periods.
Rari nisa li kienu qed jieħdu mediċini ta 'dawn it- tip għal żmien twil bdew inixxu l- ħalib u tilfu xi pirjid jew kellhom pirjid rregolari.
Very rarely babies born to mothers who have taken Olanzapine Teva in the last stage of pregnancy (3rd trimester) may have tremors, be sleepy or drowsy.
Rarament ħafna trabi li jitwieldu lil ommijiet li ħadu Olanzapine TevaS fl- aħħar stadju tat- tqala (fl- aħħar tlett xhur) jista 'jkollhom rogħda, ngħas u ħedla.
Store in the original package in order to protect from light and moisture.
Żomm fil- pakkett oriġinali sabiex tilqa ’ mid- dawl u mill - umdità.
The active substance is olanzapine.
- Is- sustanza attiva hi olanzapine.
Each Olanzapine Teva 5 mg orodispersible tablet contains 5 mg of the active substance.
Kull pillola ta ’ 5 mg ta ’ Olanzapine Teva li tinħall fil- ħalq fiha 5 mg tas- sustanza attiva.
Each Olanzapine Teva 10 mg orodispersible tablet contains 10 mg of the active substance.
Kull pillola ta ’ 10 mg ta ’ Olanzapine Teva li tinħall fil- ħalq fiha 10 mg tas- sustanza attiva.
Each Olanzapine Teva 15 mg orodispersible tablet contains 15 mg of the active substance.
Kull pillola ta ’ 15 mg ta ’ Olanzapine Teva li tinħall fil- ħalq fiha 15 mg tas- sustanza attiva.
Each Olanzapine Teva 20 mg orodispersible tablet contains 20 mg of the active substance.
Kull pillola ta ’ 20 mg ta ’ Olanzapine Teva li tinħall fil- ħalq fiha 20 mg tas- sustanza attiva
The other ingredients are Mannitol (E421), Sodium starch glycolate, D-glucose & vanilla flavouring.
Is- sustanzi l- oħra huma Mannitol (E421), Sodium starch glycolate, D- Glucose u benna tal- vanilla.
In addition, Olanzapine Teva 5 mg orodispersible tablet contains Tartrazine lake (E102), Olanzapine Teva 15 mg orodispersible tablet contains Sunset Yellow lake (E110) and Olanzapine Teva 20 mg orodispersible tablet contains Indigo carmine lake (E132).
Barraminhekk, il- pillola ta ’ 5 mg ta ’ Olanzapine Teva li tinħall fil- ħalq fiha Tartrazine lake (E102), il - pillola ta ’ 15 mg ta ’ Olanzapine Teva li tinħall fil- ħalq fiha Sunset Yellow lake (E110) u l- pillola ta ’ 20 mg ta ’ Olanzapine teva li tinħall fil- ħalq fiha Indigo carmine lake (E132)
What Olanzapine Teva looks like and contents of the pack Orodispersible tablet is the technical name for a tablet which dissolves directly in your mouth, so that it can be easily swallowed.
Id- dehra ta ’ Olanzapine Teva u l- kontenut tal- pakketti Pillola li tinħall fl- ilma hu isem tekniku għal pillola li tinħall direttament f’ ħalqek, sabiex tkun tista ’ tinbela ’ faċilment.
Olanzapine Teva 5 mg orodispersible tablet is a dark yellow, flat, round tablet, plain on both sides.
Olanzapine Teva 5 mg pillola li tinħall fil- ħalq hija pillola tonda ta ’ lewn safrani skur, ċatta u sempliċi fuq iż- żewġ naħat.
Olanzapine Teva 10 mg orodispersible tablet is a yellow, flat, round tablet, plain on both sides.
Olanzapine Teva 10 mg pillola li tinħall fil- ħalq hija pillola tonda ta ’ lewn safrani, ċatta u sempliċi fuq iż- żewġ naħat.
Olanzapine Teva 15 mg orodispersible tablet is a mottled orange, flat, round tablet, plain on both sides.
Olanzapine Teva 15 mg pillola li tinħall fil- ħalq hija pillola tonda ta ’ lewn oranġjo bit- tikek, ċatta u
Olanzapine Teva 20 mg orodispersible tablet is a green, flat, round tablet, plain on both sides.
Olanzapine Teva 20 mg pillola li tinħall fil- ħalq hija pillola tonda ta ’ lewn ħadrani, ċatta u sempliċi fuq żewġ naħat.
Olanzapine Teva 5 mg, 10 mg and 15 mg orodispersible tablets are available in cartons containing 28, 30, 35, 50, 56 or 70 tablets.
Il- pilloli ta ’ Olanzapine Teva li jinħallu fil- ħalq ta ’ 5 mg, 10 mg u 15 mg jiġu f’ kartun li fihom 28, 30, 35, 50, 56 jew 70 pillola.
Olanzapine Teva 20 mg orodispersible tablets are available in cartons containing 28, 30, 35, 56 or 70 tablets.
Il- pilloli ta ’ Olanzapine Teva li jinħallu fil- ħalq ta ’ 20 mg jiġu f’ kartun li fihom 28, 30, 35, 56 jew 70 pillola.
189 Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq
What is Omnitrope?
X’ inhu Omnitrope?
Omnitrope is a medicine containing the active substance somatropin.
Omnitrope hija mediċina li fiha s- sustanza attiva somatropin.
It is available as a powder and solvent, which are made up into a solution for injection (1.3 or 5 mg/ ml), or as a ready-to-use solution in a cartridge (3.3 or 6.7 mg/ ml).
Hija disponibbli bħala trab abjad u solvent f’ kunjett, li huma mħallta flimkien biex jiffurmaw taħlita għall- injezzjoni (1. 3 jew 5 mg/ ml), jew bħala taħlita lesta għall- użu f’ kartriġ (3. 3 jew 6. 7mg/ ml).
Omnitrope is a ‘ biosimilar’ medicine.
Omnitrope hija mediċina ‘ bijosimili ’.
This means that Omnitrope is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘ reference medicine’).
Dan ifisser li Omnitrope huwa simili għal mediċina bijoloġika li diġà hija awtorizzata fl- Unjoni Ewropea (UE) u li fiha l- istess sustanza attiva (magħrufa wkoll bħala ‘ mediċina ta ’ referenza ’).
The reference medicine for Omnitrope is Genotropin.
Il- mediċina ta ’ referenza għal Omnitrope hija Genotropin.
For more information on biosimilar medicines, see the question-and-answer document here.
Għal aktar informazzjoni dwar mediċini bijosimili, ara d- dokument ta ’ mistoqsija u t- tweġiba hawnhekk.
What is Omnitrope used for?
Għalxiex jintuża Omnitrope?
Omnitrope is given to improve their growth and their body composition (relationship of fat and muscle mass).
Omnitrope jintuża biex jittratta tfal: • li għandhom problemi fl- iżvilupp tagħhom minħabba li ma jkollomx biżżejjed ormoni ta ’ l - iżvilupp (GH). • meta jkunu qosra għaliex ikollhom il- kliewi qed jaħdmu ħażin (kliewi li ma jaħdmux tajjeb) jew disturb ġenetiku imsejjaħ sindromu ta ’ Turner. • meta jkunu qosra, peress li jkunu twieldu żgħar għaż- żmien ġestazzjonali tagħhom, u jkunu għadhom wisq qosra sa l- età ta ’ erba ’ snin jew aktar tard. • meta jkollhom il- kundizzjoni ġenetika msejħa sindromu ta ’ Prader- Willi; Omnitrope jingħata biex itejjeb l- iżvilupp tagħhom u l- kompożizzjoni tal- ġisem tagħhom (relazzjoni tal- massa tax - xaħam u tal- muskoli).