qanastek/EMEA-V3 huggingface dataset:
Weight increase Creatinine
Żieda fil- piż Żieda fil - Creatinine phosphokinase
Renals and Urinary Disorders
60 Disturbi fil- kliewi u fis- sistema awrinarja Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Urinary Retention Urinary hesitation Dysuria Nocturia Polyuria Urine flow decreased
Żamma ta ’ l - awrina Eżitazzjoni awrinarja Disurja Awrinazzjoni eċċessiva matul il- lejl Tgħaddi ammont eċċessiv ta ’ awrina Tnaqqis fil - fluss ta ’ l - awrina
Skin and Subcutaneous Tissue Disorders
Raxx
Rash Sweating increased Night sweats
Reazzjonijiet
Photo- sensitivity reactions Increased tendency to bruise
Stevens -
Stevens- Johnson Syndrome Angio-neurotic oedema
Żieda fl -
55
ta ’
Very
Johnson
Common
għaraq
Uncommon
fotosensittività
Rare
Edima anġjo -
Very Rare
Tegħreq
Frequency not
Tendenza ogħla
common
newrotika
Dermatitis contact Urticaria Cold sweat
matul il- lejl
known
li titbenġel Dermatite minħabba kuntatt Urtikarja Għaraq kiesaħ
Infections and infestations Laryngitis Vascular Disorders
61 Larinġite Disturbi vaskulari Sinkope2
Flushing
wiċċ
Syncope2 Orthostatic hypotension2 Blood pressure increase Peripheral coldness
Ipotensjoni ortostatika2 Żieda fil - pressjoni tad - demm Ksieħ periferiku
Hypertensive crisis Hypertension
ipertensiva Ipertensjoni
General Disorders and Administration Site Conditions
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata
Psychiatric Disorders
62 Imġiba suwiċidali4
Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/ or vomiting, tremor, headache, irritability, diarrhoea, hyperhydrosis and vertigo are the most commonly reported reactions.
Sturdament, disturbi tas- sensi (fosthom parastiżja), disturbi fl- irqad, (fosthom insomnja u ħolm intens), aġitazzjoni jew ansjetà, dardir u/ jew rimettar, rogħda, wġigħ ta ’ ras, irritabilità, dijarea, iperidrożi u vertigo huma l- aktar reazzjonijiet komunement irrappurtati.
It is therefore advised that when duloxetine treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see sections 4.2 and 4.4).
Għaldaqstant, huwa rrakkomandat li meta l- kura b’ duloxetine m’ għadhiex mehtieġa, is- sospensjoni għandha tkun gradwali billi d- doża tiġi mnaqqsa bil- ftit il- ftit (ara sezzjonijiet 4. 2 u 4. 4).
In the 12 week acute phase of three clinical trials of duloxetine in patients with diabetic neuropathic pain, small but statistically significant increases in fasting blood glucose were observed in duloxetine- treated patients HbA1c was stable in both duloxetine-treated and placebo-treated patients.
Fil- fażi akuta ta ’ 12- il ġimgħa ta ’ tliet studji kliniċi ta ’ duloxetine f’ pazjenti b’ uġigħ newropatiku tad - dijabete, ġew osservati żidiet żgħar iżda statistikament sinifikanti fil- livell ta ’ glucose fid- demm waqt is- sawm f’ pazjenti fuq kura ta ’ duloxetine.
57 Cases of overdoses, alone or in combination with other medicinal products, with duloxetine doses of 4800mg were reported.
Ġew irrappurtati każijiet ta ’ dożi eċċessivi b’ dożi ta ’ duloxetine ta ’ 4800 mg, meta mgħoti waħdu jew flimkien ma ’ prodotti mediċinali oħra.
No specific antidote is known for duloxetine but if serotonin syndrome ensues, specific treatment (such as with cyproheptadine and/ or temperature control) may be considered.
63 Mhux magħruf antidotu speċifiku għal duloxetine iżda jekk jirriżulta s- sindromu ta ’ serotonin, tista ’ tiġi kkunsidrata kura speċifika (bħal b’ cyproheptadine u/ jew b’ kontroll tat- temperatura).
The efficacy of duloxetine as a treatment for diabetic neuropathic pain was established in 2 randomised, 12-week, double-blind, placebo-controlled, fixed dose studies in adults (22 to 88 years) having diabetic neuropathic pain for at least 6 months.
L- effikaċja ta ’ duloxetine bħala kura għall- uġigħ newropatiku tad- dijabete kien stabbilit f’ żewġ studji ta ’ 12- il ġimgħa, b’ dożi fissi, ikkontrollati bil- plaċebo, randomised u double- blind f’ adulti (22 sa 88 sena) li kellhom uġigħ newropatiku tad- dijabete għallinqas għal 6 xhur.
58 Duloxetine is administered as a single enantiomer.
Duloxetine huwa mgħoti bħala molekula waħda msawwra minn żewġ forom li huma bħal rifless ta 'xulxin f' mera.
These changes do not have any clinical significance.
64 L- ikel iżid il- ħin biex tintlaħaq l- ogħla konċentrazzjoni minn 6 sa 10 sigħat u jnaqqas b’ xi ftit l - ammont ta 'l- assorbiment (bejn wieħed u ieħor 11%). Dawn il- varjazzjonijiet m’ għandhom ebda sinifikat klinikament.
Female mice receiving duloxetine for 2 years had an increased incidence of hepatocellular adenomas and carcinomas at the high dose only (144 mg/ kg/ day), but these were considered to be secondary to 59 hepatic microsomal enzyme induction.
Ġrieden tas - sess femminili li rċevew duloxetine għal sentejn kellhom inċidenza ogħla ta 'adenomi u kanċer epatoċellulari fid- doża għolja biss (144 mg/ kg/ ġurnata), imma dawn kienu kkunsidrati li huma sekondarji għall- istimulazzjoni ta' l- enżima mikrożomali tal- fwied.
60 DULOXETINE BOEHRINGER INGELHEIM 60 mg is available in packs of 28 and 98 capsules.
DULOXETINE BOEHRINGER INGELHEIM 60mg issibu f’ pakketti ta ’ 28 u 98 kapsula.
6.6 Special precautions for disposal
66 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
61 ANNEX II
67 ANNESS II
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT
62 A MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
DETENTUR (I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Avda. de la Industria Nº 30, 28108 Alcobendas Madrid Spain
Lilly SA Avenida de la Industria No 30 28108 Alcobendas Madrid Spanja
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in Edition 4.0 dated 30.07.2007 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 L- MAH għandu jassigura li s- sistema ta ’ farmakoviġilanza, kif deskritta fl- Edizzjoni 4. 0 tat - 30. 07. 2007 ippreżentata f’ Modulu 1. 8. 1 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis - Suq, hija stabbilita u mħaddma qabel u waqt li l- prodott tqiegħed fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in Revision 0 of 24 April 2008 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan għall- Immaniġġjar tar- Riskju L- MAH jikkommetti ruħu li jagħmel l- istudji u l- attivitajiet ta ’ farmakoviġilanza addizzjonali mniżżla fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem fir- Reviżjoni 0 ta ’ l- 24 ta ’ April 2008 tal - Pjan għall - Immaniġġjar tar- Riskju (RMP) ippreżentat f’ Modulu 1. 8. 2 ta ’ l - Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq u f’ aġġornamenti sussegwenti tal- RMP kif miftiehem mas- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Kif hemm fil- Linji Gwida tas- CHMP dwar Is- Sistemi għall- Immaniġġjar tar- Riskju għal prodotti mediċinali għall- użu fil- bniedem, l- RMP aġġornat għandu jiġi sottomess fl- istess żmien mar- Rapport Perjodiku ta ’ Aġġornament Dwar Sigurta ’ (PSUR) li jkun imiss.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Minbarra hekk, RMP aġġornat għandu jiġi sottomess • Meta tiġi miġbura xi informazzjoni ġdida li tista ’ taffetwa l- iSpeċifikazzjoni ta ’ Sigurta ’, il- Pjan ta ’ Farmakoviġilanza jew l- attivitajiet ta ’ tnaqqis ta ’ riskji attwali • Fi żmien 60 ġurnata minn meta tkun intlaħqet xi ġrajja importanti (ta ’ farmakoviġilanza jew tnaqqis ta ’ riskju) • Meta jkun mitlub mill- EMEA
PSURs
PSUR’ s
The PSUR cycle of Duloxetine Boehringer Ingelheim will correspond to the one attributed to the cross-referred product, Ariclaim, until otherwise specified.
Sakemm jiġi speċifikat mod ieħor, iċ- ċiklu tal- PSUR ta ’ Duloxetine Boehringer Ingelheim se jikkorrispondi ma ’ dak attribwit lill- prodott Ariclaim, li għalih jagħmel referenza.
63 ANNEX III
69 ANNESS III
65 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
71 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTONS FOR 40 MG HARD GASTRO-RESISTANT CAPSULES
KARTUN GĦALL- KAPSULI GASTRO- REŻISTENTI IBSIN TA ’ 40 MG
Duloxetine
DULOXETINE BOEHRINGER INGELHEIM 40 mg, kapsuli gastro- reżistenti ibsin Duloxetine
Each capsule contains 40 mg duloxetine (as hydrochloride)
Kull kapsula fiha 40 mg ta ’ duloxetine (bħala hydrochloride)
Contains sucrose See leaflet for further information
Fih is- sucrose Ara l- fuljett għal aktar informazzjoni
28 hard gastro-resistant capsules 56 hard gastro-resistant capsules 98 hard gastro-resistant capsules 140 hard gastro-resistant capsules
28 kapsula gastro- reżistenti iebsa 56 kapsula gastro- reżistenti iebsa 98 kapsula gastro- reżistenti iebsa 140 kapsula gastro- reżistenti iebsa
EXP {MM/ YYYY}.
JIS (XX/ SSSS)
Do not store above 30 °C.
Taħżinx f’ temperatura ’ l fuq minn 30°C
67 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
73 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON FOR 98 CAPSULES (40 MG) AS INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
KARTUNA GĦAL 98 KAPSULA (40 MG) BĦALA PAKKETT INTERMEDJU / PARTI MINN PAKKETT MULTIPLU (MINGĦAJR IL- KAXXA ĊELESTI)
DULOXETINE BOEHRINGER INGELHEIM 40 mg hard gastro-resistant capsules Duloxetine
DULOXETINE BOEHRINGER INGELHEIM 40 mg, kapsuli gastro- reżistenti ibsin Duloxetine
Each capsule contains 40 mg duloxetine (as hydrochloride).
Kull kapsula fiha 40 mg ta ’ duloxetine (bħala hydrochloride)
See leaflet for further information
Fih is- sucrose Ara l- fuljett għal aktar informazzjoni
98 capsules Component of a multipack comprising 2 packs, each containing 98 capsules.
98 kapsula Parti minn pakkett multiplu li fih 2 pakketti, li kull wieħed fih 98 kapsula.
EXP {MM/ YYYY}
JIS (XX/ SSSS)
68 10.
74 10.
69 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS (2X98 CAPSULES, 40 MG) WRAPPED IN FOIL (INCLUDING BLUE BOX)
TIKKETTA TA ’ BARRA MGEŻWRA MADWAR IL- PAKKETTI MULTIPLI( 2X98 KAPSULA, 40 MG) IMGEŻWRA FIL- FOJL (INKLUŻA L- KAXXA ĊELESTI)
Multipack comprising 2 packs, each containing 98 capsules.
Pakkett multiplu li fih 2 pakketti, li kull wieħed fih 98 kapsula.
Oral use Read the package leaflet before use.
Użu orali Aqra l- fuljett ta ’ tagħrif qabel l- użu.
EXP {MM/ YYYY}
JIS (XX/ SSS)
71 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS (40 mg hard gastro- resistant capsules)
77 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI (kapsuli gastro- reżistenti ibsin ta ’ 40 mg)
DULOXETINE BOEHRINGER INGELHEIM 40 mg hard gastro-resistant capsules Duloxetine
DULOXETINE BOEHRINGER INGELHEIM 40 mg kapsuli gastro- reżistenti ibsin Duloxetine
< EXP {MM/ YYYY}.
JIS {XX/ SSSS}
72 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
78 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTONS FOR 20 MG HARD GASTRO-RESISTANT CAPSULES
KARTUN GĦALL- KAPSULI GASTRO- REŻISTENTI IBSIN TA ’ 20 MG
Duloxetine
DULOXETINE BOEHRINGER INGELHEIM 20 mg, kapsuli gastro- reżistenti ibsin Duloxetine
Each capsule contains 20 mg duloxetine (as hydrochloride).
Kull kapsula fiha 20 mg ta ’ duloxetine (bħala hydrochloride)
28 hard gastro-resistant capsules 56 hard gastro-resistant capsules.
28 kapsula gastro- reżistenti iebsa 56 kapsula gastro- reżistenti iebsa
73 10.
79 10.
74 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS (20 mg hard gastro- resistant capsules)
80 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI (kapsuli gastro- reżistenti ibsin ta ’ 20 mg)
DULOXETINE BOEHRINGER INGELHEIM 20 mg hard gastro-resistant capsules Duloxetine
DULOXETINE BOEHRINGER INGELHEIM 20 mg kapsuli gastro- reżistenti ibsin Duloxetine
< EXP {MM/ YYYY}.
JIS (XX/ SSSS}
75 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
81 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Duloxetine
DULOXETINE BOEHRINGER INGELHEIM 30mg, kapsuli gastro- reżistenti ibsin Duloxetine
Each capsule contains 30 mg of duloxetine (as hydrochloride)
Kull kapsula fiha 30mg ta ’ duloxetine (bħala hydrochloride)
7 hard gastro-resistant capsules, 28 hard gastro-resistant capsules 98 hard gastro-resistant capsules
GĦAMLA FARMAĊEWTIKA U KONTENUT 7 kapsuli gastro- reżistenti ibsin 28 kapsula gastro- reżistenti iebsa 98 kapsula gastro- reżistenti iebsa
DULOXETINE BOEHRINGER INGELHEIM 30 mg
DULOXETINE BOEHRINGER INGELHEIM 30mg
77 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 30 mg hard gastro-resistant capsules
83 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
DULOXETINE BOEHRINGER INGELHEIM 30 mg hard gastro-resistant capsules Duloxetine
DULOXETINE BOEHRINGER INGELHEIM 30mg kapsuli gastro- reżistenti ibsin Duloxetine
78 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
84 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Duloxetine
DULOXETINE BOEHRINGER INGELHEIM 60mg, kapsuli gastro- reżistenti ibsin Duloxetine
Each capsule contains 60 mg of duloxetine (as hydrochloride)
Kull kapsula fiha 60mg ta ’ duloxetine (bħala hydrochloride)
28, hard gastro-resistant capsules 98, hard gastro-resistant capsules.
28, kapsula gastro- reżistenti iebsa 98, kapsula gastro- reżistenti iebsa
DULOXETINE BOEHRINGER INGELHEIM 60 mg
DULOXETINE BOEHRINGER INGELHEIM 60mg
80 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 60 mg hard gastro-resistant capsules
86 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
DULOXETINE BOEHRINGER INGELHEIM 60 mg hard gastro-resistant capsules Duloxetine
DULOXETINE BOEHRINGER INGELHEIM 60mg kapsuli gastro- reżistenti ibsin Duloxetine
81 B.
87 B.
82 PACKAGE LEAFLET:
88 FULJETT TA ’ TAGĦRIF:
DULOXETINE BOEHRINGER INGELHEIM 40 mg hard gastro-resistant capsules DULOXETINE BOEHRINGER INGELHEIM 20 mg hard gastro-resistant capsules Duloxetine (as hydrochloride)
DULOXETINE BOEHRINGER INGELHEIM 40 mg kapsuli gastro- reżistenti ibsin DULOXETINE BOEHRINGER INGELHEIM 20 mg kapsuli gastro- reżistenti ibsin Duloxetine (bħala hydrochloride)
Do not pass it on to
Tista ’ tagħmlilhom
It may harm them, even if their symptoms are the same as yours.
il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
What DULOXETINE BOEHRINGER INGELHEIM is and what it is used for 2.
X’ inhu DULOXETINE BOEHRINGER INGELHEIM u għalxiex jintuża 2.
Before you take DULOXETINE BOEHRINGER INGELHEIM 3.
Qabel ma tieħu DULOXETINE BOEHRINGER INGELHEIM 3.
How to take DULOXETINE BOEHRINGER INGELHEIM 4.
Kif għandek tieħu DULOXETINE BOEHRINGER INGELHEIM 4.
How to store DULOXETINE BOEHRINGER INGELHEIM 6.
Kif taħżen DULOXETINE BOEHRINGER INGELHEIM 6.
WHAT DULOXETINE BOEHRINGER INGELHEIM IS AND WHAT IT IS USED FOR
X’ INHU DULOXETINE BOEHRINGER INGELHEIM U GĦALXIEX JINTUŻA
DULOXETINE BOEHRINGER INGELHEIM increases the levels of serotonin and norepinephrine in the nervous system.
DULOXETINE BOEHRINGER INGELHEIM iżid il- livelli ta ’ serotonin u ta ’ norepinephrine fis - sistema nervuża.
DULOXETINE BOEHRINGER INGELHEIM is a medicine to be taken by mouth to treat Stress Urinary Incontinence (SUI) in women or to treat a condition called diabetic neuropathic pain in adults.
DULOXETINE BOEHRINGER INGELHEIM huwa prodott mediċinali li jittieħed mill- ħalq għal kura ta ’ Inkontinenza Awrinarja minħabba Sforz (SUI) fin- nisa jew għal kura ta ’ kundizzjoni li tissejjaħ uġigħ newropatiku tad- dijabete fl- adulti.
Stress urinary incontinence is a medical condition in which patients have accidental loss or leakage of urine during physical exertion or activities such as laughing, coughing, sneezing, lifting, or exercise.
Inkontinenza awrinarja minħabba sforz hija kundizjoni medika li fiha l- pazjenti jkollhom telf aċċidentali jew ħruġ ta 'awrina waqt xi sforz fiżiku jew attivitajiet bħal daħq, sogħla, għatis, irfigħ, jew eżerċizzju fiżiku.
DULOXETINE BOEHRINGER INGELHEIM is believed to work by increasing the strength of the muscle that holds back urine when you laugh, sneeze, or perform physical activities.
Huwa maħsub li DULOXETINE BOEHRINGER INGELHEIM jaħdem billi jżid is- saħħa tal- muskolu li jżomm lura l- awrina waqt li tkun qiegħed tidħaq, tgħatas, jew tagħmel xi attivitajiet fiżiċi.
The efficacy of DULOXETINE BOEHRINGER INGELHEIM is reinforced when combined with a training program called Pelvic Floor Muscle Training (PFMT).
L- effikaċja ta ’ DULOXETINE BOEHRINGER INGELHEIM tiġi rinforzata meta tkun ikkombinata ma ’ programm ta ’ taħriġ msejjaħ Taħriġ tal- Muskoli tal- Qiegħ tal- Pelvis (PFMT).
The effect of DULOXETINE BOEHRINGER INGELHEIM may be noticeable in many patients with diabetic neuropathic pain within 1 week of treatment.
F’ ħafna pazjenti b’ uġigħ newropatiku tad- dijabete, l- effett ta ’ DULOXETINE BOEHRINGER INGELHEIM jista ’ jidher fi żmien ġimgħa minn mindu tibda l- kura.
BEFORE YOU TAKE DULOXETINE BOEHRINGER INGELHEIM
QABEL MA TIEĦU DULOXETINE BOEHRINGER INGELHEIM
Do not take DULOXETINE BOEHRINGER INGELHEIM
Tieħux DULOXETINE BOEHRINGER INGELHEIM
- If you are allergic (hypersensitive) to duloxetine or any of the inactive ingredients of
- Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal duloxetine jew sustanzi oħra inattivi ta ’
- If you are taking or have taken within the last 14 days, another medicine known as a monoamine
- Jekk qiegħed/ qiegħda tieħu jew ħadt reċentement f’ dawn l- aħħar erbatax- il ġurnata, xi mediċina
oxidase inhibitor - MAOI (see section below ‘ Taking other medicines’).
oħra msejħa inibitur ta ’ monoamino oxidase (MAOI) (ara aktar ’ l isfel fis- sezzjoni: ‘ Meta tieħu medicini oħra ’)
- If you have liver disease.
- Jekk għandek mard tal- fwied
- If you are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or
- Jekk qiegħed/ qiegħda tieħu fluvoxamine li s- soltu jintuża għall- kura tad- depressjoni, ciprofloxacin
enoxacine which are used to treat some infections.
jew enoxacineli jintużaw għall- kura ta ’ xi infezzjonijiet.
- If you have severe kidney disease.
- Jekk għandek mard serju tal- kliewi
- If you suffer from uncontrolled high blood pressure.
- Jekk tbati minn pressjoni għolja fid- demm li mhijiex ikkontrollata
Take special care with DULOXETINE BOEHRINGER INGELHEIM The following are reasons why DULOXETINE BOEHRINGER INGELHEIM may not be suitable for you.
Oqgħod attent ħafna b’ DULOXETINE BOEHRINGER INGELHEIM Li ġejjin huma raġunijiet għaliex DULOXETINE BOEHRINGER INGELHEIM jista ’ ma jkunx tajjeb għalik.
If any of them apply to you, talk to your doctor before you take the medicine:
Jekk xi wħud minnhom jgħoddu għalik, kellem lit- tabib tiegħek qabel ma tieħu din il - mediċina:
- You are taking other medicines to treat depression.
- Qiegħed/ qiegħda tieħu mediċini oħra biex tikkura d- depressjoni.
- You are taking a herbal treatment containing St.
- Qiegħed/ qiegħda tirċievi kura bbażata fuq il- ħxejjex li fiha St. John’ s wort (Hypericum
- You are at risk of low sodium levels.
- Qiegħed/ qiegħda f’ riskju li jitbaxxielek il- livell ta ’ sodium
- You have high blood pressure.
- Għandek pressjoni għolja tad- demm.
- You are currently being treated with another medicine which may cause liver damage.
- Qiegħed/ qiegħda tirċievi fl- istess waqt kura b’ mediċina oħra li tista ’ tikkawżalek ħsara fil -
- You are taking other medicines containing duloxetine.
- Qiegħed/ qiegħda tieħu mediċini oħra li fihom duloxetine
- You have intolerance to some sugars (see below).
- Għandek intollerenza għal xi zokkor (ara aktar ’ l isfel)
- You are considering stopping DULOXETINE BOEHRINGER INGELHEIM (see section 3).
- Għandek il- ħsieb li twaqqaf DULOXETINE BOEHRINGER INGELHEIM (ara sezzjoni 3)
DULOXETINE BOEHRINGER INGELHEIM may cause a sensation of restlessness or an inability to sit or stand still.
DULOXETINE BOEHRINGER INGELHEIM jista ’ jikkawża sensazzjoni ta ’ irrekwitezza jew l - inkapaċità li wieħed joqgħod bilqiegħda jew bilwieqfa mingħajr ma jiċċaqlaq.
Thoughts of suicide and worsening of your depression or anxiety disorderIf you are depressed and/ or have anxiety disorders you can sometimes have thoughts of harming or killing yourself.
Ħsibijiet ta ’ suwiċidju u d- dipressjoni tmur għall- agħar jew problemi ta’ ansjetà.
You may be more likely to think like this:
Jekk tbati mid - dipressjoni u/ jew għandek problemi ta ’ ansjetà, xi kultant jista ’ jkollok xi ħsibijiet li tweġġa ’ jew toqtol lilek innifsek.
- If you have previously had thoughts about killing or harming yourself.
Dawn jistgħu jiżdiedu fil- bidu li tibda tieħu l- antidipressivi, peress li dawn il - mediċini kollha jieħdu ż- żmien biex jibdew jaħdmu, issoltu xi ġimgħatejn iżda xi kultant iżjed.
Information from clinical trials has shown an increased risk of suicidal
Wisq probabbli taħseb iżjed b’ dan il- mod: – Jekk diġà kellek xi ħsibijiet biex toqtol jew tweġġa ’ lilek innifsek – Jekk inti adult/ a żgħir/ a.
behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
Tagħrif minn studji kliniċi wera li hemm żieda fir- riskju ta ’ mġiba suwiċidali f’ adulti li għandhom inqas minn 25 sena, bi problemi psikjatriċi u li kienu kkurati b’ antidipressivi.
Use in children and adolescents under 18 years of age DULOXETINE BOEHRINGER INGELHEIM should not be used for children and adolescents under the age of 18 years.
Użu fit- tfal jew f’ adolexxenti taħt it- tmintax- il sena DULOXETINE BOEHRINGER INGELHEIM m’ għandux jintuża fit- tfal u f’ adolexxenti taħt it - tmintax- il sena.
Also, you should know that patients under 18 have an increased risk of side- effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines.
Għandek tkun taf ukoll li pazjenti taħt it- 18 għandhom riskju ogħla ta ’ effetti sekondarji bħal tentattiv ta ’ suwiċidju, ħsibijiet ta ’ suwiċidju u ostilità (l- iżjed aggressjoni, Imġiba konfrontali u rabja) meta jieħdu dan it- tip ta ’ mediċini.
Also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of DULOXETINE BOEHRINGER INGELHEIM in this age group have not yet been demonstrated.
Barra minn hekk, f’ dan il- grupp ta ’ etajiet, l - effetti tas- sigurtà fit- tul għadhom ma ġewx ippruvati, f’ dak li għandu x’ jaqsam ma ’ l- iżvilupp tal - ġisem, il- maturazzjoni, u l- iżvilupp kemm konjittiv kif ukoll tal- mod ta ’ imġiba.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
90 Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed/ qiegħda tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk ta ’ mingħajr riċetta.
The main ingredient of DULOXETINE BOEHRINGER INGELHEIM, duloxetine, is used in other medicines for other conditions (depression and urinary incontinence).
Is- sustanza l- aktar importanti f’ DULOXETINE BOEHRINGER INGELHEIM, duloxetine, hija wżata f’ medicini oħra għall- kundizzjonijiet oħra (depressjoni u inkontinenza awrinarja).
Using more than one of these medicines at the same time should be avoided.
L- użu ta ’ iżjed minn wieħed minn dawn il- mediċini fl- istess żmien għandu jkun evitat.
84 Your doctor should decide whether you can take DULOXETINE BOEHRINGER INGELHEIM with other medicines.
It- tabib tiegħek irid jiddeċiedi jekk għandekx tieħu DULOXETINE BOEHRINGER INGELHEIM ma ’ mediċini oħra.
Do not start or stop taking any medicines, including those bought without a prescription and herbal remedies, before checking with your doctor.
Tibdiex tieħu jew twaqqaf xi mediċini, inklużi dawk mixtrija mingħajr riċetta tat - tabib u mediċini magħmula mill- ħxejjex, qabel ma taċċerta ruħek mat- tabib tiegħek.
Monoamine Oxidase Inhibitors (MAOI): you should not take DULOXETINE BOEHRINGER INGELHEIM with an MAOI or within 14 days of stopping an MAOI.
M’ għandekx tieħu DULOXETINE BOEHRINGER INGELHEIM ma ’ MAOI jew fi żmien 14- il ġurnata minn mindu waqaft tieħu MAOI.
Taking an MAOI together with many prescription medicines, including DULOXETINE BOEHRINGER INGELHEIM, can cause serious or even life-threatening side effects.
It- teħid ta 'xi MAOI flimkien ma' ħafna mill- mediċini mgħotija bir- riċetta, inkluż DULOXETINE BOEHRINGER INGELHEIM, jista ’ jikkawża effetti sekondarji serji jew li jkunu ta ’ periklu għall- ħajja.
You must wait at least 14 days after you have stopped taking an MAOI before you can take DULOXETINE BOEHRINGER INGELHEIM.
Għandek tistenna ta 'l- anqas 14- il ġurnata wara li tkun waqaft tieħu xi MAOI biex tkun tista' tieħu DULOXETINE BOEHRINGER INGELHEIM.
Also, you need to wait at least 5 days after you stop taking DULOXETINE BOEHRINGER INGELHEIM before you take an MAOI.
Għandek bżonn ukoll tistenna ta 'l- anqas 5 ijiem wara li tieqaf tieħu DULOXETINE BOEHRINGER INGELHEIM biex tkun tista' tieħu xi MAOI.
CNS medicines: caution is advised when DULOXETINE BOEHRINGER INGELHEIM is taken in combination with other centrally acting medicines or substances, including alcohol and sedative medicines(benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Mediċini li jaffettwaw is- CNS: hija rakkomandata l- attenzjoni meta DULOXETINE BOEHRINGER INGELHEIM jintuża flimkien ma ’ sustanzi jew mediċini oħra li jaġixxu fuq is- sistema nervuża ċentrali, li jinkludi l- alkoħol u l- mediċini sedattivi (benzodiazepines, morfinomimetiċi, anti- psikotiċi, phenobarbital u l- antistaminiċi sedattivi).
Inform your doctor if you are taking any of these medicines.
Għarraf lit- tabib tiegħek jekk qiegħed/ qiegħda tieħu minn dawn il- medicini.
Examples of these medicines include: triptans, tramadol, tryptophan, certain antidepressants:
Sindrome ta ’ serotonin: għandek tgħid lit- tabib tiegħek jekk qiegħed/ qiegħda tieħu xi mediċini li l - mod kif jaħdmu jixbah dak ta ’ duloxetine. Eżempji ta ’ dawn il- mediċini jinkludu: triptans, tramadol, tryptophan, ċerti anti- depressivi:
SSRIs (such as paroxetine and fluoxetine), tricyclics (such as clomipramine, amitriptyline) and venlafaxine.
SSRIs (bħal paroxetine u fluoxetine), triċikliċi (bħal clomipramine, amitriptyline) u venlafaxine.
These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with DULOXETINE BOEHRINGER INGELHEIM, you should see your doctor.
Dawn il- mediċini jżidu r- riskju ta ’ effetti sekondarji; jekk ikollok xi sintomu li mhux mistenni meta qiegħed/ qiegħda tieħu xi mediċini minn dawn flimkien ma ’ DULOXETINE BOEHRINGER INGELHEIM, għandek tmur għand it- tabib tiegħek.
Taking DULOXETINE BOEHRINGER INGELHEIM with food and drink DULOXETINE BOEHRINGER INGELHEIM may be taken with or without food.
Meta tieħu DULOXETINE BOEHRINGER INGELHEIM ma ’ l- ikel u max- xorb DULOXETINE BOEHRINGER INGELHEIM jista 'jittieħed ma' l- ikel jew fuq stonku vojt.
You should take extra care if you drink alcohol while taking DULOXETINE BOEHRINGER INGELHEIM.
Għandek toqgħod iżjed attent jekk tixrob l- alkoħol waqt li tkun qiegħed/ qiegħda tieħu DULOXETINE BOEHRINGER INGELHEIM.
Pregnancy and breast-feeding Tell your doctor if you become pregnant, or you are trying to become pregnant, while you are taking DULOXETINE BOEHRINGER INGELHEIM.
Tqala u Treddigħ Għid lit- tabib tiegħek jekk issir tqila jew qiegħda tipprova ssir tqila, waqt li qiegħda tieħu DULOXETINE BOEHRINGER INGELHEIM..
You should use DULOXETINE BOEHRINGER INGELHEIM only after discussing the potential benefits and any potential risks to your unborn child with your doctor.
Għandek biss tuża DULOXETINE BOEHRINGER INGELHEIM wara li tkun iddiskutejt mat- tabib tiegħek il- benefiċċji possibbli u kull riskju possibbli għat- tarbija li għada ma twelditx.
The use of DULOXETINE BOEHRINGER INGELHEIM while breastfeeding is not recommended.
M, huwiex rakkomandat l- użu ta ’ DULOXETINE BOEHRINGER INGELHEIM waqt it- treddigħ.
Driving and using machines DULOXETINE BOEHRINGER INGELHEIM may make you feel sleepy of dizzy.
Sewqan u tħaddim ta ’ magni Tista ’ tħossok bi ngħas jew sturdut minħabba DULOXETINE BOEHRINGER INGELHEIM.
Do not drive or use any tools or machines until you know how DULOXETINE BOEHRINGER INGELHEIM affects you.
Issuqx u tagħmilx użu minn għodda jew tħaddem magni sakemm tkun taf b’ liema mod jaffettwak DULOXETINE BOEHRINGER INGELHEIM..
Important information about some of the ingredients of DULOXETINE BOEHRINGER INGELHEIM DULOXETINE BOEHRINGER INGELHEIM contains sucrose.
91 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ DULOXETINE BOEHRINGER INGELHEIM DULOXETINE BOEHRINGER INGELHEIM fih s- sucrose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk ġejt mgħarraf mit- tabib tiegħek li għandek xi intolleranza għal xi tipi ta ’ zokkor, ikkuntattja lit- tabib tiegħek qabel ma tieħu dan il - prodott mediċinali.
HOW TO TAKE DULOXETINE BOEHRINGER INGELHEIM
KIF GĦANDEK TIEĦU DULOXETINE BOEHRINGER INGELHEIM
Always take DULOXETINE BOEHRINGER INGELHEIM exactly as your doctor has told you.
Dejjem għandek tieħu DULOXETINE BOEHRINGER INGELHEIM skond kif qallek it- tabib.
You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek tiċċekkja mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju.
85 The recommended dose of DULOXETINE BOEHRINGER INGELHEIM for the treatment of Stress Urinary Incontinence is 40 mg twice a day (in the morning and late afternoon/ evening).
Id- doża rakkomandata ta ’ DULOXETINE BOEHRINGER INGELHEIM għall- kura ta ’ l- Inkontinenza Awrinarja minħabba Sforz hija ta ’ kapsula waħda ta ’ 40 mg darbtejn kuljum (filgħodu u tard wara nofsinhar/ filgħaxija).
Your doctor may decide to start your treatment with one capsule of 20 mg twice a day for two weeks before increasing the dose to 40 mg twice a day.
It- tabib jista ’ jiddeċiedi li jibdielek il- kura b’ kapsula waħda ta ’ 20 mg darbtejn kuljum għal ħmistax il- ġurnata qabel ma jżid id- doża għal 40 mg darbtejn kuljum.
The usual dose of DULOXETINE BOEHRINGER INGELHEIM for the treatment Neuropathic pain is 60 mg once a day, but your doctor will prescribe the dose that is right for you.
Id- doża ta ’ DULOXETINE BOEHRINGER INGELHEIM li ssoltu tingħata għall- kura ta ’ l- uġigħ Newropatiku hija ta ’ 60 mg darba kuljum, iżda t- tabib tiegħek se jiktiblek riċetta skond id- doza li tgħodd għalik.
DULOXETINE BOEHRINGER INGELHEIM is for oral use.
DULOXETINE BOEHRINGER INGELHEIM għandu jittieħed mill- ħalq.
To help you remember to take DULOXETINE BOEHRINGER INGELHEIM, you may find it easier to take it at the same times every day.
Biex tiftakar tieħu DULOXETINE BOEHRINGER INGELHEIM, tista ’ ssibha aktar faċli li teħodha kuljum fl- istess ħinijiet.
Do not stop taking DULOXETINE BOEHRINGER INGELHEIM without talking to your doctor.
Tieqafx tieħu DULOXETINE BOEHRINGER INGELHEIM mingħajr ma tkellem lit- tabib tiegħek.
If you take more DULOXETINE BOEHRINGER INGELHEIM than you should Call your doctor or pharmacist immediately if you take more than the amount of DULOXETINE BOEHRINGER INGELHEIM prescribed by your doctor.
Jekk tieħu DULOXETINE BOEHRINGER INGELHEIM aktar milli suppost Ċempel immedjatament lit- tabib jew lill- ispiżjar tiegħek jekk tieħu aktar ammont ta 'DULOXETINE BOEHRINGER INGELHEIM minn kemm ordnalek it- tabib.
If you forget to take DULOXETINE BOEHRINGER INGELHEIM Do not take a double dose to make up for forgotten doses.
Jekk tinsa tieħu DULOXETINE BOEHRINGER INGELHEIM M’ għandekx tieħu doża doppja biex tpatti għad dożi li tkun insejt tieħu.
Do not take more than the daily amount of DULOXETINE BOEHRINGER INGELHEIM that has been prescribed for you in one day.
Tieħux iżjed mill- ammont ta 'DULOXETINE BOEHRINGER INGELHEIM li ordnalek it- tabib għal ġurnata waħda.
If you stop taking DULOXETINE BOEHRINGER INGELHEIM Do not stop taking your capsules without the advice of your doctor even if you feel better.
Jekk tieqaf tieħu DULOXETINE BOEHRINGER INGELHEIM Tieqafx tieħu l- kapsuli tiegħek mingħajr ma tieħu l- parir tat- tabib anki jekk tħossok aħjar.
If your doctor thinks that you no longer need DULOXETINE BOEHRINGER INGELHEIM he will ask you to reduce your dose over 2 weeks.
Jekk it- tabib tiegħek jaħseb li m' għadx għandek bżonn tieħu DULOXETINE BOEHRINGER INGELHEIM huwa se jgħidlek biex tnaqqas id- doża fuq perijodu ta ’ ġimgħatejn.
Some patients, who suddenly stop taking DULOXETINE BOEHRINGER INGELHEIM after more than 1 week of therapy, have had symptoms such as dizziness, tingling feelings like pins and needles, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), tremor (shakiness), headaches, feeling irritable, diarrhoea, excessive sweating or vertigo..
Xi pazjenti li waqqfu jieħdu DULOXETINE BOEHRINGER INGELHEIM f' daqqa wara iżjed minn ġimgħa ta ’ kura kellhom sintomi bħal sturdament, sensazzjonijiet ta ’ tniggiż, problemi ta ’ irqad( ħolm stramb, ħmar il- lejl, ma tkunx tista ’ torqod), iħossuhom irrekweti u aġitati, iħossuhom ansjużi, iħossuhom ħażin (tqalligħ) jew jgħamillhom ħażin (rimettar), tregħid (ċaqliq ripetut) uġigħ ta 'ras, iħossuhom irritabbli, dijarea, għaraq esaġerat jew vertigo..
These symptoms are usually not serious and disappear within a few days, but if you have symptoms that are troublesome you should ask your doctor for advice.
Normalment dawn is- sintomi mhumiex serji u jisparixxu fi ftit ġranet, imma jekk għandek sintomi li qegħdin idejquk għandek issaqsi lit- tabib tiegħek għal parir.
Like all medicines, DULOXETINE BOEHRINGER INGELHEIM can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, DULOXETINE BOEHRINGER INGELHEIM jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
These effects are normally mild to moderate and often disappear after a short time.
Normalment dawn l- effetti jkunu ħfief għal moderati u ħafna drabi jisparixxu wara ftit żmien.
Very common side effects (these can affect more than 1 in 10 patients treated)with DULOXETINE BOEHRINGER INGELHEIM when taken to treat stress urinary incontinence Feeling sick (nausea), dry mouth, and tiredness.
92 Efetti sekondarji komuni ħafna (dawn jistgħu jaffettwaw iżjed minn pazjent 1 minn kull 10 pazjenti kkurati) ta ’ DULOXETINE BOEHRINGER INGELHEIM meta jittieħed għall- kura ta ’ l- inkontinenza awrinarja minħabba sforz Tħossok ma tiflaħx (tqalligħ), nixfa fil- ħalq, u għeja.
Very common side effects (these can affect more than 1 in 10 patients treated)with DULOXETINE BOEHRINGER INGELHEIM when taken to treat diabetic neuropathic pain Feeling sick (nausea), somnolence, headache, dizziness and constipation.
Efetti sekondarji komuni ħafna (dawn jistgħu jaffettwaw iżjed minn pazjent 1 minn kull 10 pazjenti kkurati) ta ’ DULOXETINE BOEHRINGER INGELHEIM meta jittieħed għall- kura ta ’ l- uġigħ newropatiku tad- dijabete Tħossok ma tiflaħx (tqalligħ), ngħas, uġigħ ta ’ ras, sturdament u stitikezza.
Common side effects (these can affect from 1 to 10 users in 100 patients treated) • Anxiety, having abnormal dreams.
Effetti sekondarji komuni (dawn jistgħu jaffettwaw minn 1 sa 10 pazjenti minn kull 100 pazjent ikkurat) • Ansjetà, ikollok ħolm mhux normali. • Sturdament, rogħda jew tnemnin, inkluż it- tnemnin jew tingiż tal- ġilda. • Tħossok ma tiflaħx (rimettar), ħruq ta ’ stonku jew ikollok bżonn tgħaddi l- arja, tnaqqis fil- piż jew nuqqas ta ’ aptit. • Vista sfokata. • Tħoss il- qalb tħabbat f’ sidrek jew ikollok il- fwawar. • Problemi biex ikollok erezzjoni, kambjamenti fl- orgażmu jew nuqqas ta ’ ħajra għas- sess. • Raxx (ħakk) • Uġigħ fil- muskoli, riġidità fil- muskoli jew spażmu fil- muskoli
86 • Dizziness, tremor or numbness, including numbness or tingling of the skin. • Being sick (vomiting), heartburn or breaking wind, lack of appetite. • Blurred eyesight. • Feeling the heart pumping in the chest or hot flushes. • Problems getting an erection, changes in orgasm or less sex drive. • (itchy) Rash. • Muscle pain, muscle tightness or muscle spasm.
Effetti sekondarji mhux komuni( dawn jistgħu jaffettwaw minn 1 sa 10 pazjenti minn kull 1, 000 pazjent ikkurat) • Infjammazzjoni tal- gerżuma. • Tħossok aġitat, tħossok disorjentat, tħossok bi ngħas, ikollok kwalità ħażina ta ’ irqad, nuqqas ta ’ motivazzjoni jew tittewweb iżjed mis- soltu. • Ttiegħem l- affarijiet differenti mis- soltu, disturbi fl- attenzjoni jew spażmi u movimenti involontarji tal- muskoli • Tnaqqis fil- piż jew żieda fil- piż, tfewwiq, indiġestjoni jew gastroenterite. • Infjammazzjoni tal- fwied li jista ’ jikkawża wġigħ addominali, għeja jew sfurija tal- ġilda. • Vertigo, tinnitus (sensazzjoni ta ’ ħsejjes fil- widna meta ma jkunx hemm ħsejjes esterni), uġigħ fil- widnejn. • Il- ħbub ta ’ l- għajnejn ikunu ikbar (iċ- centru skur ta ’ l- għajnejn) jew disturbi fil- vista. • Ħmura fil- wiċċ, il- pressjoni tad- demm togħla, tħoss is- swaba ’ ta ’ idejk jew/ u ta ’ saqajk kesħin, tħossok se tistordi (speċjalment meta tqum bil- wieqfa malajr wisq), tħabbit mgħaġġel jew irregolari tal- qalb, tegħreq matul il- lejl, ġħaraq kiesaħ, tregħid jew ħass ħażin. • Kambjamenti fl- eġakulazzjoni, pirjids mhux tas- soltu, li jinkludu pirjids b’ ħafna demm jew li jdumu iżjed mis- soltu. • Reazzjonijiet allerġiċi, tendenza ogħla li titbenġel, nfafet jew sensittività għad- dawl tax- xemx. • Ġbid involontarju tal- muskoli. • Il- bżonn li tgħaddi l- awrina matul il- lejl jew diffikultà jew inkapaċità li tgħaddi l- awrina. • Tagħżiż tas- snien, deidrazzjoni, tħossok sħun/ kiesaħ, għatxan, rassa fil- gerżuma jew tinfaġar. • Żieda fil- livell tal- kolesterol fid- demm
Uncommon side effects (these can affect from 1 to 10 users in 1,000 patients treated) • Throat inflammation. • Feeling agitated, feeling disorientated, feeling sleepy, having a poor quality of sleep, lack of motivation or increased yawning. • Tasting things differently than usual, disturbance in attention or spasms and involuntary movements of the muscles. • Weight loss or weight gain, burping, indigestion or gastroenteritis. • Inflammation of the liver that may cause abdominal pain, tiredness or yellow coloration of the skin. • Vertigo, tinnitus (perception of sound in the ear when there is no external sound, ear pain. • Larger pupils (the dark centre of the eye) or visual disturbance. • Flushing, increase in blood pressure, feeling cold in your fingers and/ or toes, feeling dizzy (particularly when standing up too quickly), fast or irregular heart beat, night sweats, cold sweats, shivering or fainting. • Changes in ejaculation, abnormal periods, including heavy or prolonged periods • Allergic reactions, increased tendency to bruise, blisters or sensitivity to sunlight. • Muscle twitching. • Need to pass urine during the night or difficulty or inability to pass urine. • Grinding of teeth, dehydration, feeling hot/ cold, thirst, throat tightness or nose bleeds • Increased level of cholesterol in the blood.
Effetti sekondarji rari (dawn jistgħu jaffettwaw minn 1 sa 10 pazjenti minn kull 10, 000 pazjent ikkurat) • Manija (marda fejn is- sintomi huma li tkun attiv iżżejjed, ikollok ħsibijiet li jiġru bik u jonqos il- bżonn ta ’ l- irqad), ikollok l- alluċinazzjonijiet. • Żieda fil- livell taz- zokkor fid- demm, livelli baxxi ta ’ sodium fid- demm (is- sintomu huma tħossok ma tiflaħx u m’ intix f’ sikktek bil- muskoli dgħajfin jew konfuż), sindromu ta ’ sekrezzjoni insuffiċjenti ta ’ l- ormon kontra d- djuresi (SIADH). • Riħa ħażina fil- ħalq • Tiżdied il- pressjoni ġewwa l- għajn. • Sintomi tal- menopawża. • Problemi sesswali
Rare side effects (these can affect from 1 to 10 users in 10,000 patients treated) • Mania (a disorder which symptoms are over activity, racing thoughts and decrease need for sleep), experiencing hallucinations • Increased level of sugar in the blood, low levels of sodium in the blood (the symptoms are feeling sick and unwell with weak muscles or confused), syndrome of inadequate secretion of anti-diuretic hormone (SIADH). • Bad breath. • Increased pressure in the eye. • Menopausal symptoms. • Sexual problems. • Abnormal manner of walking, contraction of the jaw muscle. • Decrease of activity of the thyroid gland, chest or stomach pain. • Need to pass more urine then usual or urine flow decreased.
93 • Timxi b’ mod mhux normali, kontrazzjoni tal- muskolu tax- xedaq. • Tnaqqis fl- attività tal- glandola tat- tirojde, uġigħ fis- sider jew fl- istonku. • Il- bżonn li tgħaddi aktar awrina mis- soltu jew tnaqqis fil- fluss ta ’ l- awrina.
Other possible side effects • Experiencing aggression and anger suicidal thoughts or behaviour. • A sensation of restlessness or an inability to sit or stand still, “ Serotonin syndrome” (a rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), fits or stiffness. • Passing bright red blood in your stools vomiting blood, or black tarry stools (faeces). • Abnormal urine odour. • Yellow colouration of the skin (jaundice), hepatic failure, Stevens-Johnson syndrome, sudden swelling of skin of mucosa (angioedema).
Effetti sekondarji oħra possibbli • Tkun aggressiv/ a u irrabjat/ a, ħsibijiet jew imġiba suwiċidali. • Sensazzjoni ta ’ irrekwitezza jew l- inkapaċità li wieħed joqgħod bilqiegħda jew bilwieqfa mingħajr ma jiċċaqlaq, “ Is- Sindrome ta ’ Serotonin ” (reazzjoni rari li tista ’ tikkawża sensazzjoni ta ’ ferħ kbir, ħedla, guffaġni, irrekwitezza, sensazzjoni bħallikieku fis- sakra, deni, għaraq jew riġidità tal- muskoli), aċċessjonijiet jew ebusija. • għaddi demm ta ’ kulur aħmar qawwi ma ’ l- ippurgar, tirremetti d- demm, jew l- ippurgar ikun iswed bħall- qatran. • L- awrina jkollha riħa mhux tas- soltu. • Il- ġilda tisfar (suffejra), insuffiċjenza epatika, sindromu ta ’ Stevens- Johnson, nefħa f’ daqqa tal - ġilda jew tal- mukoża (anġjoedima)
HOW TO STORE DULOXETINE BOEHRINGER INGELHEIM
KIF TAĦŻEN DULOXETINE BOEHRINGER INGELHEIM
Do not use DULOXETINE BOEHRINGER INGELHEIM after the expiry date which is stated on the carton.
Tużax DULOXETINE BOEHRINGER INGELHEIM wara d- data ta ’ skadenza li tidher fuq il- kartuna.
Store in the original pack.
Żomm fil- pakkett oriġinali.
What DULOXETINE BOEHRINGER INGELHEIM contains The active substance is duloxetine.
Is- sustanza attiva hija duloxetine.
Each capsule contains 20 or 40 mg of duloxetine (as hydrochloride).
Kull kapsula fiha 20 mg jew 40 mg ta ’ duloxetine (bħala hydrochloride).
Capsule content: hypromellose, Hypromellose Acetate Succinate, sucrose, sugar spheres, talc, titanium dioxide (E171), triethyl citrate.
Kontenut tal- kapsula: hypromellose, hydroxypropyl methylcellulose acetate succinate, sucrose, sferi taz- zokkor, talkum, titanium dioxide (E171), triethyl citrate.
Capsule shell: gelatin, sodium lauryl sulphate, titanium dioxide (E171), indigo carmine (E132), iron oxide red and iron oxide yellow, edible black ink.
Il- Qoxra tal- kapsula: ġelatina, sodium lauryl sulphate, titanium dioxide (E171), indigo carmine (E132), iron oxide aħmar u iron oxide isfar, inkjostru iswed li jittiekel.
Edible Ink:
Inkjostru li jittiekel:
Black Iron Oxide-Synthetic (E172), Propylene glycol, Shellac.
Iron oxide sintetiku iswed (E172), propylene glycol, shellac.
What DULOXETINE BOEHRINGER INGELHEIM looks like and contents of the pack DULOXETINE BOEHRINGER INGELHEIM is a hard gastro-resistant capsule.
DULOXETINE BOEHRINGER INGELHEIM issibu bħala kapsula gastro- reżistenti, iebsa.
Each capsule of DULOXETINE BOEHRINGER INGELHEIM contains pellets of the active substance with a covering to protect them from stomach acid.
Kull kapsula ta ’ DULOXETINE BOEHRINGER INGELHEIM fiha pellits tas- sustanza attiva b’ kisja sabiex tipproteġihom mill- aċidu ta ’ l- istonku.
DULOXETINE BOEHRINGER INGELHEIM is available in 2 strengths:
DULOXETINE BOEHRINGER INGELHEIM issibu f’ żewġ dożi:
20 and 40 mg.
20 mg u 40 mg.
The 40 mg capsule has an opaque orange body imprinted with ’ 40 mg’ and an opaque blue cap, imprinted with ‘ 9545’.
Il- kapsula ta ’ 40 mg għandha l- parti prinċipali oranġjo opak stampati b ’ ‘ 40 mg ’ u għatu ċelesti opak, stampat b ’ ‘ 9545 ’.
The 20 mg capsule has an opaque blue body imprinted with ’ 20 mg’ and an opaque blue cap, imprinted with ‘ 9544’.
Il- kapsula ta ’ 20 mg għandha l- parti prinċipali ċelesti opak stampati b ’ ‘ 20 mg ’ u għatu ċelesti opak, stampat b ’ ‘ 9544 ’.
DULOXETINE BOEHRINGER INGELHEIM 40 mg is available in blister packs of 28, 56, 98, 140 and 196 (2 x 98) capsules.
DULOXETINE BOEHRINGER INGELHEIM 40 mg issibu f’ pakketti b’ folji ta ’ 28, 56, 98, 140 u 196 (2 x 98) kapsula.
DULOXETINE BOEHRINGER INGELHEIM 20 mg is available in blister packs of 28 and 56 capsules.
94 DULOXETINE BOEHRINGER INGELHEIM 20 mg issibu f’ pakketti b’ folji ta ’ 28 u 56 kapsula.
Marketing Authorisation Holder:
Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
173 D-55216 Ingelheim am Rhein, Germany.
173 D- 55216 Ingelheim am Rhein, Il- Ġermanja
De la Industria, 30, 28108 Alcobendas, Madrid, Spain.
De la Industria, 30, 28108 Alcobendas, Madrid, Spanja.
For any information about this medicine product, 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:
Italia Boehringer Ingelheim Italia S. p. A.
95 Italia Boehringer Ingelheim Italia S. p. A.
89 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 Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu.
DULOXETINE BOEHRINGER INGELHEIM 30 mg hard gastro-resistant capsules DULOXETINE BOEHRINGER INGELHEIM 60 mg hard gastro-resistant capsules Duloxetine (as hydrochloride)
DULOXETINE BOEHRINGER INGELHEIM 30 mg kapsuli gastro- reżistenti ibsin DULOXETINE BOEHRINGER INGELHEIM 60 mg kapsuli gastro- reżistenti ibsin
please tell your doctor or pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek. >
Possible side effects 5 How to store DULOXETINE BOEHRINGER INGELHEIM 6.
Kif taħżen DULOXETINE BOEHRINGER INGELHEIM 6.
DULOXETINE BOEHRINGER INGELHEIM is used in adults to treat a condition called diabetic neuropathic pain.
Fl- adulti, DULOXETINE BOEHRINGER INGELHEIM jintuża bħala kura għal kundizzjoni li tissejjaħ uġigħ newropatiku tad- dijabete.
The effect of DULOXETINE BOEHRINGER INGELHEIM may be noticeable in many patients with diabetic neuropathic pain within 1 week of treatment.
F’ ħafna pazjenti b’ uġigħ newropatiku tad- dijabete, l- effett ta ’ DULOXETINE BOEHRINGER INGELHEIM jista ’ jidher fi żmien ġimgħa minn mindu tibda l- kura..
Do not take DULOXETINE BOEHRINGER INGELHEIM − If you are allergic (hypersensitive) to duloxetine or any of the other ingredients of DULOXETINE BOEHRINGER INGELHEIM. − If you are taking or have recently taken within the last 14 days, another antidepressant medicine called a monoamine oxidase inhibitor (MAOI) (see also below in section: ‘ Taking other medicines’). − If you have liver disease. − If you have severe kidney disease. − If you are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacine which are used to treat some infections. − If you suffer from uncontrolled high blood pressure.
oħra kontra d- depressjoni msejħa inibituri ta ’ monoamino oxidase (MAOI) (ara aktar ’ l isfel fis - sezzjoni: ‘ Meta tieħu medicini oħra ’)
Take special care with DULOXETINE BOEHRINGER INGELHEIM The following are reasons why DULOXETINE BOEHRINGER INGELHEIM may not be suitable for you.
depressjoni, ciprofloxacine jew enoxacine li jintużaw għall- kura ta ’ xi infezzjonijiet
If any of them apply to you, talk to your doctor before you take the medicine:
- Jekk tbati minn pressjoni għolja fid- demm li m’ hijiex ikkontrollata
91
Jekk xi wħud minnhom jgħoddu għalik, kellem lit- tabib tiegħek qabel ma tieħu din il - mediċina: