qanastek/EMEA-V3 huggingface dataset:
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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 jew lill- ispiżjar tiegħek.
What ABILIFY is and what it is used for 2.
X’ inhu ABILIFY u għalxiex jintuża 2.
Before you take ABILIFY 3.
Qabel ma tieħu ABILIFY 3.
How to take ABILIFY 4.
Kif għandek tieħu ABILIFY 4.
Possible side effects 5 How to store ABILIFY 6.
Effetti sekondarji li jista 'jkollu 5 Kif taħżen ABILIFY 6.
WHAT ABILIFY IS AND WHAT IT IS USED FOR
X’ INHU ABILIFY U GĦALXIEX JINTUŻA
ABILIFY is one of a group of medicines called antipsychotics.
ABILIFY jagħmel parti minn grupp ta ’ medicini li jissejħu antipsikotiċi.
It is used to treat adults who suffer from a disease characterised by symptoms such as hearing, seeing or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness.
Jintuża biex jiġu kkurati adulti li jbatu minn marda kkaratterizzata minn sintomi bħalma huma smigħ, viżta jew ħass ta 'affarijiet li mhumiex hemm, suspetti, ħsieb ħażin, diskors li ma jiftehimx u mġiba mħawwda u mingħajr emozzjoni.
People with this condition may also feel depressed, guilty, anxious or tense.
Nies li jbatu b’ din il- kundizzjoni jistgħu wkoll iħossuhom imdejqin, ħatja, u b' tensjoni.
ABILIFY is used to treat adults who suffer from 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.
ABILIFY jintuża biex jikkura adulti li jsofru minn kundizzjoni b’ sintomi bħalma huma li wieħed iħossu ferħan iżżejjed, ikollu ammonti eċċessivi ta ’ enerġija, jeħtieġ ferm inqas irqad min- normal, jitkellem malajr ħafna b’ ideat li jiġu malajr ħafna u xi kultant b’ irritabilità severa.
It also prevents this condition from returning in patients who have responded to the treatment with ABILIFY.
Jipprevjeni wkoll din il- kundizzjoni milli terġa ’ tiġi lura f’ pazjenti li jkunu rrispondew għat- trattament b’ ABILIFY.
BEFORE YOU TAKE ABILIFY
QABEL MA TIEĦU ABILIFY
Do not take ABILIFY if you are allergic (hypersensitive) to aripiprazole or any of the other ingredients of ABILIFY.
Tiħux ABILIFY jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għal aripiprazole jew sustanzi oħra ta ’ ABILIFY.
Take special care with ABILIFY Before treatment with ABILIFY, tell your doctor if you suffer from High blood sugar or family history of diabetes Seizure Involuntary, irregular muscle movements, especially in the face Cardiovascular diseases, family history of cardiovascular disease, stroke or "mini" stroke, abnormal blood pressure
Oqgħod attent ħafna b' ABILIFY Qabel trattament bi ABILIFY, avża lit- tabib tiegħek jekk tbati minn Livell għoli ta 'zokkor fid- demm jew storja ta' dijabete fil- familja tiegħek Konvulżjoni Movimenti irregoli, involontarji tal- muskoli, b' mod speċjali fil- wiċċ Mard kardjovaskulari, storja familjari ta 'mard kardjovaskulari, puplesija jew "mini" puplesija, pressjoni tad- demm mhux normali
If you notice you are gaining weight, experience any difficulty in swallowing or allergic symptoms, please tell your doctor.
Jekk tara li qed ittella 'l- piż, qed tesperjenza xi diffikultà biex tibla' jew sintomi ta ’ allerġija, jekk jogħġbok avża lit- tabib tiegħek.
If you are an elderly patient suffering from dementia (loss of memory and other mental abilities), you or your carer/ relative should tell your doctor if you have ever had a stroke or "mini" stroke.
Jekk inti pazjent anzjan li qed issofri minn dimensja (telf ta 'memorja u ta' abbiltajiet mentali oħra), inti jew minn jieħu ħsiebek/ qarib tiegħek għandkom tgħidu lit- tabib tiegħek jekk qattx kellek puplesija jew "mini" puplesija.
Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself.
142 Għid lit- tabib tiegħek minnufih jekk qed jgħaddulek ħsibijiet jew aptit li tweġġa 'lilek innifsek.
Suicidal thoughts and behaviours have been reported during aripiprazole treatment.
Ħsibijiet u imġiba ta ’ suwiċidju ġew irrapportati matul trattament b’ aripiprazole.
137 Tell your doctor immediately if you suffer from muscle stiffness or inflexibility with high fever, sweating, altered mental status, or very rapid or irregular heart beat.
Avża lit- tabib tiegħek minnufih jekk issofri minn ebusija jew nuqqas ta ’ flessibilità tal- muskoli b’ deni għoli, għaraq, status mentali li jinbidel, jew taħbit tal- qalb rapidu ħafna jew irregolari.
Children and adolescents ABILIFY is not for use in children and adolescents as it has not been studied in patients under 18 years.
Tfal u adoloxxenti ABILIFY mhuwiex tajjeb biex jittieħed mit- tfal jew minn adolexxenti għax l- użu tiegħu għadu ma ġiex studjat f’ bnedmin ta ’ taħt it- 18- il sena.
Ask your doctor or pharmacist for advice before taking ABILIFY.
Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu ABILIFY.
Blood pressure-lowering medicines:
Mediċini li jbaxxu l- pressjoni tad- demm:
ABILIFY may increase the effect of medicines used to lower the blood pressure.
ABILIFY jista ’ jqawwi l- effett tal- mediċini li jintużaw biex ibaxxu l- pressjoni.
Be sure to tell your doctor if you take a medicine to keep your blood pressure under control.
Aċċerta ruħek li tgħid lit- tabib jekk inti qiegħed/ qegħda tieħu pilloli tal- pressjoni.
Taking ABILIFY with some medicines may need to change your dose of ABILIFY.
It- teħid ta 'ABILIFY ma' xi mediċini jista 'jeħtieġ bidla fid- doża ta' ABILIFY.
It is especially important to mention the following to your doctor:
Huwa importanti ferm li inti ssemmi dawn li ġejjin lit- tabib tiegħek:
Medicines to correct heart rhythm Antidepressants or herbal remedy used to treat depression and anxiety Antifungal agents Certain medicines to treat HIV infection Anticonvulsants used to treat epilepsy
Mediċini li jikkoreġu r- rittmu tal- qalb Antidipressanti jew rimedju bi ħxejjex u\ ati sabiex jittrattaw dipressjoni u ansjetà Aġenti antifungali Ċerti mediċini sabiex jittrattaw infezzjoni ta 'HIV Antikonvulżanti wżati għat- trattament ta' l- epilepsija
Taking ABILIFY with food and drink ABILIFY can be taken regardless of meals.
Meta tieħu ma ’ l- ikel u max- xorb ABILIFY m’ għandux għalfejn jittieħed ma ’ l- ikel.
Alcohol should be avoided when taking ABILIFY.
Għandek tevita li tieħu x- xorb alkoħoliku meta qiegħed tieħu ABILIFY.
Pregnancy and breast-feeding You should not take ABILIFY if you are pregnant unless you have discussed this with your doctor.
Tqala u Treddigħ M’ għandekx tieħu ABILIFY jekk inti tqila sakemm ma ’ ħadtx parir tat- tabib tiegħek dwar dan.
Be sure to tell your doctor immediately if you are pregnant, think you may be pregnant, or if you are planning to become pregnant.
Oqgħod attenta li tgħid lit- tabib tiegħek mill- ewwel jekk inti tqila, taħseb li ħriġt tqila jew qed tippjana li jkollok tarbija.
Breast-feeding mothers should not take ABILIFY.
Ommijiet li qegħdin ireddgħu m’ għandhomx jieħdu ABILIFY.
Be sure to tell your doctor immediately if you are breast-feeding.
Għid lit- tabib tiegħek mill- ewwel jekk qegħda tredda ’.
Driving and using machines Do not drive or use any tools or machines, until you know how ABILIFY affects you.
Sewqan u tħaddim ta 'magni M' għandekx tagħmel użu minn għodda jew tħaddem magni, sakemm issir taf kif ABILIFY jaffettwak.
Important information about some of the ingredients of ABILIFY If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Tagħrif importanti dwar xi wħud mis- sustanzi ta 'ABILIFY Jekk it- tabib tiegħek qallek li tbati minn intolleranza għal xi zokkor, ikkuntattja lit- tabib tiegħek qabel tieħu din il- mediċina.
HOW TO TAKE ABILIFY
KIF GĦANDEK TIEĦU ABILIFY
Always take ABILIFY exactly as your doctor has told you.
Dejjem għandek tieħu ABILIFY skond il- parir tat- tabib.
The usual dose is 15 mg once a day.
Id- doża normali hija 15 mg darba kuljum.
However your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day.
Iżda t- tabib tiegħek jista jiktiblek doża ogħla jekk iktar baxxa, sa massimu ta ’ 30 mg kuljum.
If you have the impression that the effect of ABILIFY is too strong or too weak, talk to your doctor or pharmacist.
Jekk tħoss li l- effett ta ’ ABILIFY huwa qawwi wisq jew dgħajjef wisq, kellem lit- tabib jew spiżjar tiegħek.
Try to take the ABILIFY tablet at the same time each day.
Ipprova ħu l- pillola ABILIFY fl- istess ħin tal- ġurnata kuljum.
It does not matter whether you take it with or without food.
Ma jimpurtax jekk tieħu l- pillola ma ’ l- ikel jew fuq stonku vojt.
Always take the tablet with water and swallow it whole.
Dejjem ħu l- pillola ma ’ l- ilma u iblagħha sħiħa.
138 Even if you feel better, do not alter or discontinue the daily dose of ABILIFY without first consulting your doctor.
143 Anke jekk tħossok aħjar, ara li ma tbiddilx id- doża ta ’ ABILIFY jew tieqaf milli tieħu ABILIFY qabel ma tieħu parir mit- tabib tiegħek.
If you take more ABILIFY than you should If you realise you have taken more ABILIFY tablets than your doctor has recommended (or if someone else has taken some of your ABILIFY tablets), contact your doctor right away.
Jekk tieħu ABILIFY aktar milli suppost Jekk tinduna li ħadt iktar pilloli ta ’ ABILIFY milli qallek it- tabib (jew jekk taħseb li xi ħadd ħadlek xi pilloli ta ’ ABILIFY), kellem lit- tabib tiegħek mill- ewwel.
If you cannot reach your doctor, go to the nearest hospital and take the pack with you.
Jekk ma tistax ssib lit- tabib, mur l- isptar l - iżjed qrib tiegħek u ħu l- pakkett tal- pilloli miegħek.
If you forget to take ABILIFY If you miss a dose, take the missed dose as soon as you remember but do not take two doses in one day.
Jekk tinsa tieħu ABILIFY Jekk tinsa ’ tieħu doża, ħudha malli tiftakar iżda m’ għandekx tieħu żewġ dożi f’ ġurnata waħda.
Like all medicines, ABILIFY can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, ABILIFY jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Common side effects (greater than 1 in 100, less than 1 in 10 patients) Uncontrollable twitching or jerking movements, headache, tiredness, nausea, vomiting, an uncomfortable feeling in the stomach, constipation, increased production of saliva, light-headedness, trouble sleeping, restlessness, feeling anxious, sleepiness, shaking and blurred vision.
Effetti sekondarji komuni (iktar minn 1 minn kull 100, inqas minn 1 minn kull 10 pazjenti) Movimenti ta ’ tħarrik u kontrazzjonijiet mhux kontrollabbli, uġigħ ta ’ ras, għejja, dardir, remettar, fastidju fl- istonku, stitkezza, żieda fil- produzzjoni tal- bżieq, sturdament, diffikultà fl- irqad, nervożiżmu, ansjetà, għejja, tregħid, u vista mċajpra.
Uncommon side effects (greater than 1 in 1,000, less than 1 in 100 patients) Some people may feel dizzy, especially when getting up from a lying or sitting position, or may experience a fast heart rate.
Effetti sekondarji mhux komuni (iktar minn 1 minn kull 1, 000, inqas minn 1 minn kull 100 pazjent) Xi nies jistgħu jħossuhom storduti, speċjalment meta jqumu wara li jkunu mteddew jew qagħdu bilqiegħda, jew jistgħu iħossu qalbhom tħabbat tgħaġġel ħafna.
Some people may feel depressed.
Xi nies jistgħu jħossuhom imdejqin.
Changes in the levels of some blood cells; unusual heart beat, sudden unexplained death, heart attack; allergic reaction (e. g. swelling in the mouth, tongue, face and throat, itching, rash); high blood sugar, onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma, low sodium level in the blood; weight gain, weight loss, anorexia; nervousness, agitation, feeling anxious; thoughts of suicide, suicide attempt and suicide; speech disorder, seizure, combination of fever, muscle stiffness, faster breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate; fainting, high blood pressure, blockage of a blood vessel by a blood clot formed elsewhere in the body; spasm of the muscles around the voice box, accidental inhalation of food with risk of pneumonia, difficulty in swallowing; inflammation of the pancreas; inflammation of the liver, yellowing of the skin and white part of eyes, reports of abnormal liver test values, abdominal and stomach discomfort, diarrhoea; skin rash and sensitivity to light, unusual hair loss or thinning, excessive sweating; stiffness or cramps, muscle pain, weakness; involuntary loss of urine, difficulty in passing urine; prolonged and/ or painful erection; difficulty controlling core body temperature or overheating, chest pain, and swelling of hands, ankles or feet.
Effetti sekondarji oħra rrapportati b’ mod mhux frekwenti Tibdil fil- livelli ta 'xi ċelloli tad- demm; taħbit tal- qalb mhux normali, mewt għall- għarrieda bla spjegazzjoni, attakk tal- qalb; reazzjoni allerġika (eż. nefħa fil- ħalq, ilsien, wiċċ u gerżuma, ħakk, raxx); livell għoli ta' zokkor fid- demm, bidu jew aggravar tad- dijabete, ketoaċidożi (ketoni fid- demm u fl- awrina) jew koma, livell baxx ta 'sodju fid- demm; żjieda fil- piż, telf fil- piż, anoreksja; nervożiżmu, aġitazzjoni; tħossok ansjuż/ a; ħsibijiet ta' suwiċidju; tentattiv ta ’ suwiċidju, suwiċidju, disturbi fid - diskors, kollass, kombinazzjoni ta ’ deni, ebusija ta ’ muskoli, teħid tan- nifs aktar veloċi, għariq, telf fis - sensi u bidliet f’ daqqa fil- pressjoni tad- demm u fir- rata ta ’ taħbit tal- qalb; ħass ħażin; pressjoni għolja; imblokk ta ’ vina jew arterja b’ embolu li fforma xi mkien ieħor fil- ġisem; spażmi tal- muskoli madwar il- kaxxa vokali, bligħ aċċidentali ta 'ikel b' riskju ta' pnewmonja, diffikultà biex tibla '; infjammazzjoni tal- pankreas; infjammazzjoni tal- fwied, sfurija tal- ġilda u tal- parti bajda ta' l- għajnejn, rapporti ta 'valuri anormali ta' testijiet tal- fwied; diqa addominali u fl- istoniku, dijarea; raxx tal- ġilda u sensittività għad- dawl, telf jew tħaffif mhux normali tax- xagħar, togħroq iżżejjed; ebusija jew bugħawwiġ, uġigħ fil- muskoli, dgħjufija; telf involontarju ta 'awrina, diffikultà fil- mogħdija ta' l- awrina; erezzjoni prolongata u/ jew bl- uġigħ; u diffikultà fil- kontroll tat- temperatura tal- ġisem jew sħana eċċessiva, uġigħ fis- sider u tinfiħ ta ’ l- idejn, l- għekiesi jew is- saqajn.
In elderly patients with dementia, more fatal cases have been reported while taking aripiprazole.
F' pazjenti anzjani b' dimensja, ġew irrapportati każijiet aktar fatali mat- teħid ta 'aripiprazole.
In addition, cases of stroke or "mini" stroke have been reported.
Barra minn hekk, każijiet ta 'puplesija jew ta' "mini" puplesija ġew irrapportati.
HOW TO STORE ABILIFY
KIF TAĦŻEN ABILIFY
Keep out of the reach and sight of children.
144 Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Do not use ABILIFY after the expiry date which is stated on the blister and on the carton.
Tużax ABILIFY wara d- data ta 'skadenza li tidher fuq il- folja u l- kaxxa.
139 Store in the original package in order to protect from moisture.
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mill- umdità.
What ABILIFY contains The active substance is aripiprazole.
X' fih ABILIFY Is- sustanza attiva hi aripiprazole.
Each tablet contains 5 mg of aripiprazole.
Kull pillola fiha 5 mg ta 'aripiprazole.
The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, indigo carmine aluminium lake (E132).
Is- sustanzi l- oħra huma lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, indigo karminju aluminju aħmar skur (E132).
What ABILIFY looks like and contents of the pack ABILIFY 5 mg tablets are rectangular and blue, marked with A-007 and 5 on one side.
ABILIFY 5 mg pilloli huma rettangolari u ta ’ kulur blu bil- marka A- 007 u 5 fuq naħa waħda.
They are supplied in perforated unit dose blisters packed in cartons containing 14, 28, 49, 56, or 98 tablets.
Jiġu f’ forma ta ’ folji ta ’ doża waħda mtaqqbin, ġo pakketti f' kartun ta ’ 14, 28, 49, 56, jew 98 pilloli.
Marketing Authorisation Holder Otsuka Pharmaceutical Europe Ltd.
Id- Detentur ta 'l- Awtorizzazzjoni għat- tqegħid fis- Suq Otsuka Pharmaceutical Europe Ltd.
Manufacturer Bristol-Myers Squibb S. r. l.
Manifattur Bristol- Myers Squibb S. r. l.
Contrada Fontana del Ceraso I-03012 Anagni-Frosinone - Italy
Contrada Fontana del Ceraso I- 03012 Anagni- Frosinone - L- Italja
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta 'l- Awtorizzazzjoni għat- tqegħid fis- Suq:
140 Eesti Österreich BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT.
145 Eesti Österreich BRISTOL- MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta 'l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /
141 PACKAGE LEAFLET:
146 FULJETT TA 'TAGĦRIF:
Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself.
147 Għid lit- tabib tiegħek minnufih jekk qed jgħaddulek ħsibijiet jew aptit li tweġġa 'lilek innifsek.
142 Tell your doctor immediately if you suffer from muscle stiffness or inflexibility with high fever, sweating, altered mental status, or very rapid or irregular heart beat.
Avża lit- tabib tiegħek minnufih jekk issofri minn ebusija jew nuqqas ta ’ flessibilità tal- muskoli b’ deni għoli, għaraq, status mentali li jinbidel, jew taħbit tal- qalb rapidu ħafna jew irregolari.
143 Even if you feel better, do not alter or discontinue the daily dose of ABILIFY without first consulting your doctor.
148 Anke jekk tħossok aħjar, ara li ma tbiddilx id- doża ta ’ ABILIFY jew tieqaf milli tieħu ABILIFY qabel ma tieħu parir mit- tabib tiegħek.
Keep out of the reach and sight of children.
149 Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal.
144 Store in the original package in order to protect from moisture.
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mill- umdità.
Each tablet contains 10 mg of aripiprazole.
Kull pillola fiha 10 mg ta 'aripiprazole.
The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, red iron oxide (E172).
Is- sustanzi l- oħra huma lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, iron oxide aħmar (E172).
What ABILIFY looks like and contents of the pack ABILIFY 10 mg tablets are rectangular and pink, marked with A-008 and 10 on one side.
ABILIFY 10 mg pilloli huma rettangolari u ta ’ kulur roża bil- marka A- 008 u 10 fuq naħa waħda.
145 Eesti Österreich BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT.
150 Eesti Österreich BRISTOL- MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT.
146 PACKAGE LEAFLET:
151 FULJETT TA 'TAGĦRIF:
Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself.
152 Għid lit- tabib tiegħek minnufih jekk qed jgħaddulek ħsibijiet jew aptit li tweġġa 'lilek innifsek.
147 Tell your doctor immediately if you suffer from muscle stiffness or inflexibility with high fever, sweating, altered mental status, or very rapid or irregular heart beat.
Avża lit- tabib tiegħek minnufih jekk issofri minn ebusija jew nuqqas ta ’ flessibilità tal- muskoli b’ deni għoli, għaraq, status mentali li jinbidel, jew taħbit tal- qalb rapidu ħafna jew irregolari.
148 Even if you feel better, do not alter or discontinue the daily dose of ABILIFY without first consulting your doctor.
153 Anke jekk tħossok aħjar, ara li ma tbiddilx id- doża ta ’ ABILIFY jew tieqaf milli tieħu ABILIFY qabel ma tieħu parir mit- tabib tiegħek.
Keep out of the reach and sight of children.
154 Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal.
149 Store in the original package in order to protect from moisture.
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mill- umdità.
Each tablet contains 15 mg of aripiprazole.
Kull pillola fiha 15 mg ta 'aripiprazole.
The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, yellow iron oxide (E172).
Is- sustanzi l- oħra huma lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, iron oxide isfar (E172).
What ABILIFY looks like and contents of the pack ABILIFY 15 mg tablets are round and yellow, marked with A-009 and 15 on one side.
ABILIFY 15 mg pilloli huma tonda u ta ’ kulur safra bil- marka A- 009 u 15 fuq naħa waħda.
150 Eesti Österreich BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT.
155 Eesti Österreich BRISTOL- MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT.
151 PACKAGE LEAFLET:
156 FULJETT TA 'TAGĦRIF:
Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself.
157 Għid lit- tabib tiegħek minnufih jekk qed jgħaddulek ħsibijiet jew aptit li tweġġa 'lilek innifsek.
152 Tell your doctor immediately if you suffer from muscle stiffness or inflexibility with high fever, sweating, altered mental status, or very rapid or irregular heart beat.
Avża lit- tabib tiegħek minnufih jekk issofri minn ebusija jew nuqqas ta ’ flessibilità tal- muskoli b’ deni għoli, għaraq, status mentali li jinbidel, jew taħbit tal- qalb rapidu ħafna jew irregolari.
153 Even if you feel better, do not alter or discontinue the daily dose of ABILIFY without first consulting your doctor.
158 Anke jekk tħossok aħjar, ara li ma tbiddilx id- doża ta ’ ABILIFY jew tieqaf milli tieħu ABILIFY qabel ma tieħu parir mit- tabib tiegħek.
Keep out of the reach and sight of children.
159 Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal.
154 Store in the original package in order to protect from moisture.
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mill- umdità.
Each tablet contains 30 mg of aripiprazole.
Kull pillola fiha 30 mg ta 'aripiprazole.
What ABILIFY looks like and contents of the pack ABILIFY 30 mg tablets are round and pink, marked with A-011 and 30 on one side.
ABILIFY 30 mg pilloli huma tonda u ta ’ kulur roża bil- marka A- 011 u 30 fuq naħa waħda.
155 Eesti Österreich BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT.
160 Eesti Österreich BRISTOL- MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT.
156 PACKAGE LEAFLET:
161 FULJETT TA 'TAGĦRIF:
Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself.
162 Għid lit- tabib tiegħek minnufih jekk qed jgħaddulek ħsibijiet jew aptit li tweġġa 'lilek innifsek.
157 Tell your doctor immediately if you suffer from muscle stiffness or inflexibility with high fever, sweating, altered mental status, or very rapid or irregular heart beat.
Avża lit- tabib tiegħek minnufih jekk issofri minn ebusija jew nuqqas ta ’ flessibilità tal- muskoli b’ deni għoli, għaraq, status mentali li jinbidel, jew taħbit tal- qalb rapidu ħafna jew irregolari.
Children and adolescents ABILIFY is not for use in children and adolescents as it has not been studied in patients under 18 years.
Tfal u adoloxxenti ABILIFY mhuwiex tajjeb biex jittieħed mit- tfal jew minn adolexxenti għax l- użu tiegħu għadu ma ġiex studjat fi bnedmin ta ’ taħt it- 18- il sena.
Medicines to correct heart rhythm Antidepressants or herbal remedy used to treat depression and anxiety Antifungal agents Certain medicines to treat HIV infection Anticonvulsants used to treat epilepsy
Mediċini li jikkoreġu r- rittmu tal- qalb Antidipressanti jew rimedju bi ħxejjex użati sabiex jittrattaw dipressjoni u ansjetà Aġenti antifungali Ċerti mediċini sabiex jittrattaw infezzjoni ta 'HIV Antikonvulżanti wżati għat- trattament ta' l- epilepsija
Pregnancy and breast-feeding You should not take ABILIFY if you are pregnant unless you have discussed this with your doctor.
Tqala u Treddigħ M’ għandekx tieħu ABILIFY jekk inti tqila sakemm ma ħadtx parir tat- tabib tiegħek dwar dan.
Important information about some of the ingredients of ABILIFY Patients who cannot take phenylalanine should note that ABILIFY orodispersible tablets contain aspartame, which is a source of phenylalanine.
Tagħrif importanti dwar xi wħud mis- sustanzi ta 'ABILIFY Pazjenti li ma jistgħux jieħdu phenylalanine għandhom ikunu jafu li l- pilloli li jinħallu fil- ħalq ABILIFY għandhom l- aspartame, li huwa sors ta' phenylalanine.
May be harmful for people with phenylketonuria.
Jista 'jagħmel ħsara lil nies b' phenylketonuria.
However your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day.
Iżda t- tabib tiegħek jista jiktiblek doża ogħla jew iktar baxxa, sa massimu ta ’ 30 mg kuljum.
Try to take the ABILIFY orodispersible tablet at the same time each day.
163 Ipprova ħu l- pillola li tinħall fil- ħalq ABILIFY fl- istess ħin tal- ġurnata kuljum.
158 Do not open the blister until ready to administer.
Tiftaħx il- folja jekk m' intix lest li tużha.
For single tablet removal, open the package and peel back the foil on the blister to expose the tablet.
Biex toħroġ pillola waħda, iftaħ il- pakkett u qaxxar il- fojl minn mal- folja biex tifxef il- pillola.
Do not push the tablet through the foil because this could damage the tablet.
Timbuttax il- pillola minn ġol- fojl għax tista 'tagħmel ħsara lill - pillola.
Immediately upon opening the blister, using dry hands, remove the tablet and place the entire orodispersible tablet on the tongue.
Hekk kif tiftaħ il- folja, b' idejn nixfin, neħħi l- pillola u poġġi l- pillola li tinħall fil- ħalq kollha fuq l- ilsien.
Tablet disintegration occurs rapidly in saliva.
Fil- bżieq il- pillola tidiżintegra malajr.
The orodispersible tablet can be taken with or without liquid.
Il- pillola li tinħall fil- ħalq tista 'tittieħed ma' likwidu jew mingħajr.
Alternatively, disperse the tablet in water and drink the resulting suspension.
Inkella, ħallat il- pillola ma 'l- ilma u ixrob is- sospensjoni li jkolllok.
Even if you feel better, do not alter or discontinue the daily dose of ABILIFY without first consulting your doctor.
Anke jekk tħossok aħjar, ara li ma tbiddilx id- doża ta ’ ABILIFY jew tieqaf milli tieħu ABILIFY qabel ma tieħu parir mit- tabib tiegħek.
If you take more ABILIFY than you should If you realise you have taken more ABILIFY orodispersible tablets than your doctor has recommended (or if someone else has taken some of your ABILIFY orodispersible tablets), contact your doctor right away.
Jekk tieħu ABILIFY aktar milli suppost Jekk tinduna li ħadt iktar pilloli li jinħallu fil- ħalq ta ’ ABILIFY milli qallek it- tabib (jew jekk taħseb li xi ħadd ħadlek xi pilloli li jinħallu fil- ħalq ta ’ ABILIFY), kellem lit- tabib tiegħek mill- ewwel.
If you cannot reach your doctor, go to the nearest hospital and take the pack with you.
Jekk ma tistax issib lit- tabib, mur l- isptar l- iżjed qrib tiegħek u ħu l- pakkett tal- pilloli miegħek.
In elderly patients with dementia, more fatal cases have been reported while taking aripiprazole.
164 F' pazjenti anzjani b' dimensja, ġew irrapportati każijiet aktar fatali mat- teħid ta 'aripiprazole.
Each orodispersible tablet contains 10 mg of aripiprazole.
Kull pillola li tinħall fil- ħalq fiha 10 mg ta 'aripiprazole.
The other ingredients are calcium silicate, croscarmellose sodium, crospovidone, silicon dioxide, xylitol, microcrystalline cellulose, aspartame, acesulfame potassium, vanilla flavour, tartaric acid, magnesium stearate, red iron oxide (E172).
L- ingredjenti l- oħrajn huma calcium silicate, croscarmellose sodium, crospovidone, silicon dioxide, xylitol, microcrystalline cellulose, aspartame, acesulfame potassium, togħma ta 'vanilla, tartaric acid, magnesium stearate, iron oxide aħmar (E172).
What ABILIFY looks like and contents of the pack ABILIFY 10 mg orodispersible tablets are round and pink, marked with "A" over "640" on one side and 10 on the other.
Id- Dehra ta 'ABILIFY u l- kontenuti tal- pakkett ABILIFY 10 mg pilloli li jinħallu fil- ħalq huma tondi u ta ’ kulur roża bil- marka "A" fuq "640" fuq naħa u 10 fuq in- naħa l- oħra.
They are supplied in perforated unit dose blisters packed in cartons containing 14, 28, or 49 orodispersible tablets.
Jiġu f’ forma ta ’ folji ta ’ doża waħda mtaqqbin, ġo pakketti f' kartun ta ’ 14, 28 jew 49 pillola li tinħall fil- ħalq.
Contrada Fontana del Ceraso I-03012 Anagni-Frosinone - Italy
Contrada Fontana del Ceraso I- 03012 Anagni- Frosinone - Italja
This leaflet was last approved in
166 Dan il- fuljett kien approvat l- aħħar f '
161 Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta 'l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /
162 PACKAGE LEAFLET:
167 FULJETT TA 'TAGĦRIF:
Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself.
168 Għid lit- tabib tiegħek minnufih jekk qed jgħaddulek ħsibijiet jew aptit li tweġġa 'lilek innifsek.
163 Tell your doctor immediately if you suffer from muscle stiffness or inflexibility with high fever, sweating, altered mental status, or very rapid or irregular heart beat.
Avża lit- tabib tiegħek minnufih jekk issofri minn ebusija jew nuqqas ta ’ flessibilità tal- muskoli b’ deni għoli, għaraq, status mentali li jinbidel, jew taħbit tal- qalb rapidu ħafna jew irregolari.
Try to take the ABILIFY orodispersible tablet at the same time each day.
169 Ipprova ħu l- pillola li tinħall fil- ħalq ABILIFY fl- istess ħin tal- ġurnata kuljum.
164 Do not open the blister until ready to administer.
Tiftaħx il- folja jekk m' intix lest li tużha.
In elderly patients with dementia, more fatal cases have been reported while taking aripiprazole.
170 F' pazjenti anzjani b' dimensja, ġew irrapportati każijiet aktar fatali mat- teħid ta 'aripiprazole.
Each orodispersible tablet contains 15 mg of aripiprazole.
Kull pillola li tinħall fil- ħalq fiha 15 mg ta 'aripiprazole.
The other ingredients are calcium silicate, croscarmellose sodium, crospovidone, silicon dioxide, xylitol, microcrystalline cellulose, aspartame, acesulfame potassium, vanilla flavour, tartaric acid, magnesium stearate, yellow iron oxide (E172).
L- ingredjenti l- oħrajn huma calcium silicate, croscarmellose sodium, crospovidone, silicon dioxide, xylitol, microcrystalline cellulose, aspartame, acesulfame potassium, togħma ta 'vanilla, tartaric acid, magnesium stearate, iron oxide isfar (E172).
What ABILIFY looks like and contents of the pack ABILIFY 15 mg orodispersible tablets are round and yellow, marked with "A" over "641" on one side and 15 on the other.
Id- Dehra ta 'ABILIFY u l- kontenuti tal- pakkett ABILIFY 15 mg pilloli li jinħallu fil- ħalq huma tondi u ta ’ kulur isfar bil- marka "A" fuq "641" fuq naħa u 15 fuq in- naħa l- oħra.
This leaflet was last approved in
172 Dan il- fuljett kien approvat l- aħħar f '
167 Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta 'l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /
168 PACKAGE LEAFLET:
173 FULJETT TA 'TAGĦRIF:
Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself.
174 Għid lit- tabib tiegħek minnufih jekk qed jgħaddulek ħsibijiet jew aptit li tweġġa 'lilek innifsek.
169 Tell your doctor immediately if you suffer from muscle stiffness or inflexibility with high fever, sweating, altered mental status, or very rapid or irregular heart beat.
Avża lit- tabib tiegħek minnufih jekk issofri minn ebusija jew nuqqas ta ’ flessibilità tal- muskoli b’ deni għoli, għaraq, status mentali li jinbidel, jew taħbit tal- qalb rapidu ħafna jew irregolari.
Try to take the ABILIFY orodispersible tablet at the same time each day.
175 Ipprova ħu l- pillola li tinħall fil- ħalq ABILIFY fl- istess ħin tal- ġurnata kuljum.
170 Do not open the blister until ready to administer.
Tiftaħx il- folja jekk m' intix lest li tużha.
In elderly patients with dementia, more fatal cases have been reported while taking aripiprazole.
176 F' pazjenti anzjani b' dimensja, ġew irrapportati każijiet aktar fatali mat- teħid ta 'aripiprazole.
Each orodispersible tablet contains 30 mg of aripiprazole.
Kull pillola li tinħall fil- ħalq fiha 30 mg ta 'aripiprazole.
What ABILIFY looks like and contents of the pack ABILIFY 30 mg orodispersible tablets are round and pink, marked with "A" over "643" on one side and 30 on the other.
Id- Dehra ta 'ABILIFY u l- kontenuti tal- pakkett ABILIFY 30 mg pilloli li jinħallu fil- ħalq huma tondi u ta ’ kulur roża bil- marka "A" fuq "643" fuq naħa u 30 fuq in- naħa l- oħra.
This leaflet was last approved in
178 Dan il- fuljett kien approvat l- aħħar f '
173 Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta 'l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /
174 PACKAGE LEAFLET:
179 FULJETT TA 'TAGĦRIF:
Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself.
180 Għid lit- tabib tiegħek minnufih jekk qed jgħaddulek ħsibijiet jew aptit li tweġġa 'lilek innifsek.
175 Tell your doctor immediately if you suffer from muscle stiffness or inflexibility with high fever, sweating, altered mental status, or very rapid or irregular heart beat.
Avża lit- tabib tiegħek minnufih jekk issofri minn ebusija jew nuqqas ta ’ flessibilità tal- muskoli b’ deni għoli, għaraq, status mentali li jinbidel, jew taħbit tal- qalb rapidu ħafna jew irregolari.
However, the oral solution should not be diluted with other liquids or mixed with any food prior to administration.
Madankollu, is- soluzzjoni orali għandha tiġi dilwita ma 'likwidi oħra jew imħallta ma' xi ikel qabel tingħata.
Driving and using machines Do not drive or use any tools or machines until you know how ABILIFY affects you.
Sewqan u tħaddim ta 'magni M' għandekx tagħmel użu minn għodda jew tħaddem magni, sakemm issir taf kif ABILIFY jaffettwak.
Important information about some of the ingredients of ABILIFY Each ml of ABILIFY oral solution contains 200 mg of fructose and 400 mg of sucrose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta 'ABILIFY Kull ml ta' ABILIFY soluzzjoni orali fih 200 mg ta 'fructose u 400 mg ta' sucrose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Jekk it- tabib tiegħek qallek li tbati minn intolleranza għal xi zokkor, ikkuntattja lit- tabib tiegħek qabel tieħu din il- mediċina.
Parahydroxybenzoates may cause allergic reactions (possibly delayed).
Parahydroxybenzoates jista 'jikkawża reazzjonijiet allerġiċi (jista' jkun imdewwma).
The usual dose is 15 ml solution (corresponding to 15 mg aripiprazole) once a day.
Id- doża normali hija 15 ml soluzzjoni (li tikkorrespondi għal 15 mg aripiprazole) darba kuljum.
However your doctor may prescribe a lower or higher dose to a maximum of 30 mg (i. e.
Iżda t- tabib tiegħek jista 'jiktiblek doża ogħla jew iktar baxxa, sa massimu ta ’ 30 mg kuljum (i. e.
30 ml) once a day.
30 ml) darba kuljum.
The dose of ABILIFY oral solution must be measured using the calibrated cup or the 2 ml calibrated dropper supplied in the carton.
Id- doża ta 'ABILIFY soluzzjoni orali għandha titkejjel permezz ta' tazza kkalibrata jew tad- dropper ikkalibrat ta ’ 2 ml li huma fornuti fil- kaxxa tal- kartun.
176 If you have the impression that the effect of ABILIFY is too strong or too weak, talk to your doctor or pharmacist.
181 Jekk tħoss li l- effett ta ’ ABILIFY huwa qawwi wisq jew dgħajjef wisq, kellem lit- tabib jew spiżjar tiegħek.
Try to take the ABILIFY oral solution at the same time each day.
Ipprova ħu l- pillola ABILIFY fl- istess ħin tal- ġurnata kuljum.
However, you should not dilute with other liquids or mix with other food prior to taking ABILIFY oral solution.
Madankollu, ma għandekx tiddilwa ma 'likwidi oħra jew tħallat ma' ikel ieħor qabel tieħu ABILIFY soluzzjoni orali.
If you take more ABILIFY than you should If you realise you have taken more ABILIFY oral solution than your doctor has recommended (or if someone else has taken some of your ABILIFY oral solution), contact your doctor right away.
Jekk tieħu ABILIFY aktar milli suppost Jekk tinduna li ħadt iktar ABILIFY soluzzjoni orali milli qallek it- tabib (jew jekk taħseb li xi ħadd ħadlek xi ABILIFY soluzzjoni orali), kellem lit- tabib tiegħek mill- ewwel.
If you cannot reach your doctor, go to the nearest hospital and take the pack with you.
Jekk ma tistax issib lit - tabib, mur l- isptar l- iżjed qrib tiegħek u ħu l- pakkett tal- pilloli miegħek.
Changes in the levels of some blood cells; unusual heart beat, sudden unexplained death, heart attack; allergic reaction (e. g. swelling in the mouth, tongue, face and throat, itching, rash); high blood sugar, onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma, low sodium level in the blood; weight gain, weight loss, anorexia; nervousness, agitation, feeling anxious; thoughts of suicide, suicide attempt and suicide; speech disorder, seizure, combination of fever, muscle stiffness, faster breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate; fainting, high blood pressure, blockage of a blood vessel by a blood clot formed elsewhere in the body; spasm of the muscles around the voice box, accidental inhalation of food with risk of pneumonia, difficulty in swallowing; inflammation of the pancreas; inflammation of the liver, yellowing of the skin and white part of eyes, reports of abnormal liver test values, abdominal and stomach discomfort, diarrhoea; skin rash and sensitivity to light, unusual hair loss or thinning, excessive sweating; stiffness or cramps, muscle pain, weakness; involuntary loss of urine, difficulty in passing urine; prolonged and/ or painful erection; difficulty controlling core body temperature or overheating, chest pain, and swelling of hands, ankles or feet.
Effetti sekondarji oħra rrapportati b’ mod mhux frekwenti Tibdil fil- livelli ta 'xi ċelloli tad- demm; taħbit tal- qalb mhux normali, mewt għall- għarrieda bla spjegazzjoni, attakk tal- qalb; reazzjoni allerġika (eż. nefħa fil- ħalq, ilsien, wiċċ u gerżuma, ħakk, raxx); livell għoli ta' zokkor fid- demm, bidu jew aggravar tad- dijabete, ketoaċidożi (ketoni fid- demm u fl- awrina) jew koma, livell baxx ta 'sodju fid- demm; żjieda fil- piż, telf fil- piż, anoreksja; nervożiżmu, aġitazzjoni; tħossok anzjuż/ a; ħsibijiet ta' suwiċidju; tentattiv ta ’ suwiċidju, suwiċidju, disturbi fid - diskors, kollass, kombinazzjoni ta ’ deni, ebusija ta ’ muskoli, teħid tan- nifs aktar veloċi, għariq, telf fis - sensi u bidliet f’ daqqa fil- pressjoni tad- demm u fir- rata ta ’ taħbit tal- qalb; ħass ħażin; pressjoni għolja; imblokk ta ’ vina jew arterja b’ embolu li fforma xi mkien ieħor fil- ġisem; spażmi tal- muskoli madwar il- kaxxa vokali, bligħ aċċidentali ta 'ikel b' riskju ta' pnewmonja, diffikultà biex tibla '; infjammazzjoni tal- pankreas; infjammazzjoni tal- fwied, sfurija tal- ġilda u tal- parti bajda ta' l- għajnejn, rapporti ta 'valuri anormali ta' testijiet tal- fwied; diqa addominali u fl- istoniku, dijarea; raxx tal- ġilda u sensittività għad- dawl, telf jew tħaffif mhux normali tax- xagħar, togħroq iżżejjed; ebusija jew bugħawwiġ, uġigħ fil- muskoli, dgħjufija; telf involontarju ta 'awrina, diffikultà fil- mogħdija ta' l- awrina; erezzjoni prolongata u/ jew bl- uġigħ; u diffikultà fil- kontroll tat- temperatura tal- ġisem jew sħana eċċessiva, uġigħ fis- sider u tinfiħ ta ’ l- idejn, l- għekiesi jew is- saqajn.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
182 Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STOREABILIFY
KIF TAĦŻEN ABILIFY
Do not use ABILIFY after the expiry date which is stated on the bottle and on the carton.
Tużax ABILIFY wara d- data ta 'skadenza li tidher fuq il- flixkun u fuq il- kartuna.
This medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali ma jeħtieġx kundizzjonijiet ta 'ħżin speċjali.
Use within 6 months after first opening.
Uża fi żmien 6 xhur minn meta jinfetaħ għall- ewwel darba.
The other ingredients are disodium edetate, fructose, glycerin, lactic acid, methyl parahydroxybenzoate (E218), propylene glycol, propyl parahydroxybenzoate (E216), sodium hydroxide, sucrose, purified water, and natural orange cream with other natural flavours.
Is- sustanzi l- oħra huma disodium edetate, fructose, glycerin, lactic acid, methyl parahydroxybenzoate (E218), propylene glycol, propyl parahydroxybenzoate (E216), sodium hydroxide, sucrose, ilma ppurifikat, u krema naturali tal- larinġ ma 'benniet naturali oħra.
What ABILIFY looks like and contents of the pack ABILIFY 1 mg/ ml oral solution is a clear, colourless to light yellow liquid supplied in bottles with polypropylene child-resistant closure containing 50 ml, 150 ml or 480 ml per bottle.
Id- Dehra ta 'ABILIFY u l- kontenuti tal- pakkett ABILIFY 1 mg/ ml soluzzjoni orali hija likwidu ċar, bla kulur għal likwidu safrani ċar fornut fi fliexken b' tapp tal- polypropylene li t- tfal isibu diffiċli biex jiftħu b' 50 ml, 150 ml jew 480 ml kull flixkun.
Each carton contains one bottle and both a calibrated polypropylene measuring cup and a calibrated polypropylene low-density polyethylene dropper.
Kull kartuna fiha flixkun wieħed kif ukoll tazza kkalibrata tal- polypropylene għall- kejl u dropper ikkalibrat tal- polypropylene maghmul minn polyethylene b' densita 'baxxa.
Marketing Authorisation Holder Otsuka Pharmaceutical Europe Ltd.
Id- Detentur ta 'l- awtorizzazzjoni għat- tqegħid fis- Suq Otsuka Pharmaceutical Europe Ltd.
For any information about this medicine please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta 'l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Č eská republika BRISTOL-MYERS SQUIBB SPOL.
183 Česká republika BRISTOL- MYERS SQUIBB SPOL.
This leaflet was last approved in
184 Dan il- fuljett kien approvat l- aħħar f '
179 Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta 'l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /
180 PACKAGE LEAFLET:
185 FULJETT TA 'TAGĦRIF:
ABILIFY 7.5 mg/ ml Solution for Injection aripiprazole
ABILIFY 7. 5 mg/ ml soluzzjoni għall- injezzjoni aripiprazole
Before you use ABILIFY 3.
Qabel ma tieħu ABILIFY 3.
How to use ABILIFY 4.
Kif għandek tieħu ABILIFY 4.
How to store ABILIFY 6.
Kif taħżen ABILIFY 6.
ABILIFY solution for injection is used to treat quickly symptoms of agitation and distressing behaviour that may occur in a disease characterised by symptoms such as: hearing, seeing or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness.
Is- soluzzjoni għall- injezzjoni ABILIFYhuwa wżat għat- trattament ta 'malajr ta' sintomi ta 'aġitazzjoni u mġieba inkwetanti li jistgħu iseħħu f' marda kkaratterizzata minn sintomi bħal: smigħ, viżta jew ħsieb ta' affarijiet li mhumiex hemm, suspetti, ħsibijiet żbaljati, kliem u mġieba li ma jagħmlux sens u nuqqas ta 'emozzjoni.
People with this condition may also feel depressed, guilty, anxious or tense. feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability.
Nies li jbatu b’ din il- kundizzjoni jistgħu wkoll iħossuhom imdejqin, ħatja, u b' tensjoni. tħossok "ferħan iżżejjed", b’ ammonti eċċessivi ta ’ enerġija, u tkun teħtieġ ħafna inqas irqad mis- soltu, titkellem malajr ħafna b’ idejat jiġru u xi kultant b’ irritabbiltà severa.
ABILIFY solution for injection is given when treatment with oral formulations of ABILIFY is not appropriate.
Is- soluzzjoni għall- injezzjoni ABILIFY jingħata meta trattament b' formulazzjonijiet orali ta 'ABILIFY ma jkunx xieraq.
Your doctor will change your treatment to ABILIFY tablets, ABILIFY orodispersible tablets or ABILIFY oral solution as soon as appropriate.
It- tabib tiegħek jibdel it- trattament tiegħek għal pilloli ABILIFY, pilloli li jinħallu fil- ħalq ABILIFY jew soluzzjoni orali ABILIFY malli jkun xieraq.
BEFORE YOU USE ABILIFY
QABEL MA TIEĦU ABILIFY
Do not use ABILIFY if you are allergic (hypersensitive) to aripiprazole or any of the other ingredients of ABILIFY.
Tiħux ABILIFY jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għal aripiprazole jew sustanzi oħra ta ’ ABILIFY.
Take special care with ABILIFY Before treatment with ABILIFY, tell your doctor if you suffer from High blood sugar or family history of diabetes Seizure Involuntary, irregular muscle movements, especially in the face Cardiovascular diseases, family history of cardiovascular disease, stroke or "mini" stroke, abnormal blood pressure
Oqgħod attent ħafna b' ABILIFY Qabel trattament b’ ABILIFY, avża lit- tabib tiegħek jekk tbati minn Livell għoli ta 'zokkor fid- demm jew storja tal- familja tiegħek bid- dijabete Konvulżjoni Movimenti irregoli, involontarji tal- muskoli, b' mod speċjali fil- wiċċ Mard kardjovaskulari, storja familjari ta' mard kardjovaskulari, puplesija jew "mini puplesija, pressjoni tad- demm mhux normali
If you are an elderly patient suffering from dementia (loss of memory and other mental abilities), you or your carer/ relative should tell your doctor if you have ever had a stroke or "mini" stroke.
186 Jekk inti pazjent anzjan li qed issofri minn dimensja (telf ta 'memorja u ta' abbiltajiet mentali oħra), inti jew minn jieħu ħsiebek/ qarib tiegħek għandkom tgħidu lit- tabib tiegħek jekk qattx kellek puplesija jew "mini" puplesija.
181 Tell the doctor or nurse if you feel dizzy or faint after the injection.
Għid lit- tabib jew lin- ners jekk tħossok sturdut jew se jtih ħass ħażin wara l- injezzjoni.
You will probably need to lie down until you feel better.
Probabbli li jkollok bżonn timtedd sakemm tħossok aħjar.
The doctor may also want to measure your blood pressure and pulse.
It- tabib jista 'jkun irid ikejjel il- pressjoni tad- demm tiegħek u jieħu l- polz.
Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself.
Għid lit- tabib tiegħek minnufih jekk ikollok xi ħsibijiet jew aptit li tweġġa ’ lilek innifsek.
Suicidal thoughts and behaviours have been reported during aripiprazole treatment.
Ħsibijiet u imġiba ta ’ suwiċidju ġew irrapportati matul kura b’ aripiprazole.
Tell your doctor immediately if you suffer from muscle stiffness or inflexibility with high fever, sweating, altered mental status, or very rapid or irregular heart beat.
Avża lit- tabib tiegħek minnufih jekk issofri minn ebusija tal- muskoli jew minn nuqqas ta ’ flessibbiltà b’ deni għoli, għaraq, status mentali mibdul, jew taħbit tal- qalb rapidu ħafna jew irregolari.
A combination of ABILIFY solution for injection with medicines taken for anxiety might make you feel drowsy or dizzy.
Kombinazzjoni ta 'soluzzjoni għall- injezzjoni ABILIFY ma' mediċini li jittieħdu għall- anzjetà jistgħu iġegħluk tħossok bin- ngħas jew sturdut.
Only take other medicines while you are on ABILIFY if your doctor tells you that you can.
Meta qed tieħu ABILIFY ħu biss mediċini li t- tabib qallek li tista ’ tieħu.
Using ABILIFY with food and drink ABILIFY can be administered regardless of meals.
Meta tieħu ABILIFY ma ’ l- ikel u max- xorb ABILIFY m’ għandux għalfejn jittieħed ma ’ l- ikel.
Pregnancy and breast-feeding You should not use ABILIFY if you are pregnant unless you have discussed this with your doctor.
Tqala u Treddigħ M’ għandekx tieħu ABILIFY jekk inti tqila sakemm ma ħadtx parir tat- tabib tiegħek dwar dan.
Driving and using machines Do not drive or use any tools or machines if you feel drowsy after receiving ABILIFY solution for injection.
Sewqan u tħaddim ta 'magni Issuqx jew tużax għodod jew magni jekk tħossok bin- ngħas wara li tingħata s- soluzzjoni għall - injezzjoni Do ABILIFY.