qanastek/EMEA-V3 huggingface dataset:
Patients and carers must be advised to dispose of any unopened tablets remaining from a prescription as soon as they are no longer needed.
Il- pazjenti u dawk li jieħdu ħsiebhom għandhom jiġu rakkomandati biex jarmu kull pillola mhux miftuħa li jibqa ’ minn preskrizzjoni minnufiħ hekk kif mhux meħtieġa aktar.
Any used or unused but no longer required product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Cephalon Europe 5 rue Charles Martigny F-94700 Maisons-Alfort France
Cephalon Europe 5 rue Charles Martigny F- 94700 Maisons- Alfort Franza
MARKETING AUTHORISATION NUMBER(S)
NUMRUTA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu.
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /.
Effentora 200 micrograms buccal tablets
Effentora 200 mikrogramma pilloli għall- ħalq
Each buccal tablet contains 200 micrograms fentanyl (as citrate).
Kull pillola għall- ħalq fiha 200 mikrogramma fentanyl (bħala citrate).
Each tablet contains 16 mg of sodium.
Kull pillola fiha 16 mg ta ’ sodju.
Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “ C” and on the other side with “ 2”.
Pillola b’ uċuħ ċatti, bajda, tonda bix- xfar imtajjra, fuq naħa waħda b ’ “ C ” imqabbża u fuq in- naħa l - oħra b ’ “ 2 ”.
If switching from another oral fentanyl citrate product, independent dose titration with Effentora is required as bioavailability between products differs significantly.
Jekk ħa jaqilbu minn prodott ta ’ fentanyl citrate orali ieħor, hija meħtieġa titrazzjoni ndipendenti tad- doża
15 Method of titration During titration, if adequate analgesia is not obtained within 30 minutes after the start of administration of a single tablet, a second Effentora tablet of the same strength may be used.
Metodu ta ’ titrazzjoni Waqt it- titrazzjoni, jekk ma tinkisibx analġeżija xierqa fi 30 minuta wara l- bidu ta ’ l- għoti ta ’ pillola waħda, tista ’ tintuża pillola oħra ta ’ Effentora ta ’ l- istess qawwa.
Use in the elderly (older than 65 years):
17 Użu fl- anzjani (’ l fuq minn 65 sena):
In clinical studies patients older than 65 years tended to titrate to a lower effective dose than younger patients.
Fi studji kliniċi pazjenti ’ l fuq minn 65 sena kellhom tendenza li jittitraw għal doża effettiva aktar baxxa minn pażjenti iżgħar.
16 Hepatic or renal impairment:
Indeboliment tal- fwied u renali
Hypersensitivity to the active substance or to any of the excipients.
18 Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi.
Patients without maintenance opioid therapy (see section 4.1) as there is an increased risk of respiratory depression.
Pazjenti mingħajr terapija ta ’ manteniment b’ opioid (ara sezzjoni 4. 1) minħabba li hemm riskju miżjud ta ’ depressjoni respiratorja.
This medicinal product contains 16 mg sodium per tablet.
Dan il- prodott mediċinali fih 16 mg sodium kull pillola.
Fentanyl is metabolised mainly via the human cytochrome P450 3A4 isoenzyme system (CYP3A4), therefore potential interactions may occur when Effentora is given concurrently with agents that affect CYP3A4 activity.
19 Fentanyl huwa metabolizzat primarjament permezz tas- sistema ta ’ isoenzima taċ- ċitokromju uman P450 3A4 (CYP3A4), għalhekk jistgħu jseħħu interazzjonijiet potenzjali meta Effentora jingħata flimkien ma ’ sustanzi li jaffettwaw l- attività ta ’ CYP3A4.
18 The concomitant use of other central nervous system depressants, including other opioids, sedatives or hypnotics, general anaesthetics, phenothiazines, tranquillisers, skeletal muscle relaxants, sedating antihistamines and alcohol may produce additive depressant effects.
L- użu fl- istess waqt ta ’ depressanti tas- sistema nervuża ċentrali oħra, inkluż opioids oħra, sedattivi jew ipnotiċi, anestetiċi ġenerali, phenothiazines, kalmanti, rilassanti tal- muskoli skeltrali, antistamini sedattivi u alkoħol, jista ’ jipproduċi effetti dipressanti miżjuda.
The clinical studies of Effentora were designed to evaluate safety and efficacy in treating BTP and all patients were also taking concomitant opioids, such as sustained-release morphine or transdermal fentanyl, for their persistent pain.
20 L- istudji kliniċi ta ’ Effentora kienu maħsuba biex jivvalutaw is- sigurtà u l- effikaċja fil- kura ta ’ BTP u l- pazjenti kollha kienu qed jieħdu wkoll opioids fl- istess waqt, bħal morfina li tintreħa bil- mod jew fentanyl minn ġol- ġilda, għall- uġigħ persistenti tagħhom.
19 Investigations
Investigazzjonijiet
20 Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il - ġilda
21 For treatment of overdose (accidental ingestion) in the opioid-naive person, intravenous access should be obtained and naloxone or other opioid antagonists should be employed as clinically indicated.
Għall- kura ta ’ doża eċċessiva (teħid bi żball) f’ persuna li qatt ma tkun ħadet opioids qabel, għandu jinkiseb aċċess ġol- vini u naloxone jew antagonisti tal- opioids oħra għandhom jiġu ntużati kif indikat klinikament.
Fentanyl is an opioid analgesic, interacting predominantly with the opioid µ-receptor.
23 Fentanyl huwa analġeżiku opioid, li jinteraġixxi l- aktar mar- riċettur µ tal- opioids.
22 Study 1:
Studju 1:
In the second pivotal study (study 2), the primary endpoint was SPID30, which was also statistically significant compared to placebo (p < 0.0001).
25 Fit- tieni studju pivitali (studju 2), l- mira primarja kienet SPID30, li kienet ukoll statistikament sinnifikanti meta mqabbla mal- plaċebo (p < 0. 0001).
23 Statistically significant improvement in pain intensity difference was seen with Effentora versus placebo as early as 10 minutes in Study 1 and as early as 15 minutes (earliest time point measured) in Study 2.
Deher titjib statistikament sinnifikanti fid- differenza fl- intensità tal- uġigħ b’ Effentora kontra plaċebo minn wara 10 minuti fi Studju 1 u minn wara 15- il minuta (l- aktar punt ta ’ ħin bikri mkejjel) fi Studju 2.
Serum AUC and Cmax were approximately 20% and 30% higher than plasma AUC and Cmax, respectively.
26 30% ogħla mill- AUC u Cmax tal- plażma, rispettivament.
24 In pharmacokinetic studies that compared the absolute and relative bioavailability of Effentora and oral transmucosal fentanyl citrate (OTFC), the rate and extent of fentanyl absorption in Effentora demonstrated exposure that was between 30% to 50% greater than that for oral transmucosal fentanyl citrate.
Fi studji farkokinetiċi li qabblu il- biodisponibiltà assoluta u relattiva ta ’ Effentora u ta ’ fentanyl citrate orali minn ġol- mukuża (OTFC), ir- rata u l- kwantità ta ’ assorbiment ta ’ fentanyl f’ Effentora wrew esponiment li kien bejn 30% sa 50% akbar minn dak għal fentanyl citrate orali minn ġol- mukuża.
25 Biotransformation The metabolic pathways following buccal administration of Effentora have not been characterised in clinical studies.
27 Biotrasformazzjoni Ir- rotot metaboliċi wara l- għoti mill- ħalq ta ’ Effentora ma ġewx ikkaratterizzati fi studji kliniċi.
26 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
Store in the original package in order to protect from moisture.
28 Aħżen fil- pakkett oriġinali sabiex tilqa ’ mill- umdita ’.
Effentora 400 micrograms buccal tablets
Effentora 400 mikrogramma pilloli għall- ħalq
Each buccal tablet contains 400 micrograms fentanyl (as citrate).
Kull pillola għall- ħalq fiha 400 mikrogramma fentanyl (bħala citrate).
Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “ C” and on the other side with “ 4”.
Pillola b’ uċuħ ċatti, bajda, tonda bix- xfar imtajjra, fuq naħa waħda b ’ “ C ” imqabbża u fuq in- naħa l - oħra b ’ “ 4 ”.
28 Method of titration During titration, if adequate analgesia is not obtained within 30 minutes after the start of administration of a single tablet, a second Effentora tablet of the same strength may be used.
Metodu ta ’ titrazzjoni Waqt it- titrazzjoni, jekk ma tinkisibx analġeżija xierqa fi 30 minuta wara l- bidu ta ’ l- għoti ta ’ pillola waħda, tista ’ tintuża pillola oħra ta ’ Effentora ta ’ l- istess qawwa.
Use in the elderly (older than 65 years):
31 Użu fl- anzjani (’ l fuq minn 65 sena):
29 Hepatic or renal impairment:
Indeboliment tal- fwied u renali
4.3 Contraindications
32 4. 3 Kontra- indikazzjonijiet
30 4.4 Special warnings and precautions for use
4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
Fentanyl is metabolised mainly via the human cytochrome P450 3A4 isoenzyme system (CYP3A4), therefore potential interactions may occur when Effentora is given concurrently with agents that affect CYP3A4 activity.
33 Fentanyl huwa metabolizzat primarjament permezz tas- sistema ta ’ isoenzima taċ- ċitokromju uman P450 3A4 (CYP3A4), għalhekk jistgħu jseħħu interazzjonijiet potenzjali meta Effentora jingħata flimkien ma ’ sustanzi li jaffettwaw l- attività ta ’ CYP3A4.
31 The concomitant use of other central nervous system depressants, including other opioids, sedatives or hypnotics, general anaesthetics, phenothiazines, tranquillisers, skeletal muscle relaxants, sedating antihistamines and alcohol may produce additive depressant effects.
L- użu fl- istess waqt ta ’ depressanti tas- sistema nervuża ċentrali oħra, inkluż opioids oħra, sedattivi jew ipnotiċi, anestetiċi ġenerali, phenothiazines, kalmanti, rilassanti tal- muskoli skeltrali, antistamini sedattivi u alkoħol, jista ’ jipproduċi effetti dipressanti miżjuda.
The clinical studies of Effentora were designed to evaluate safety and efficacy in treating BTP and all patients were also taking concomitant opioids, such as sustained-release morphine or transdermal fentanyl, for their persistent pain.
34 L- istudji kliniċi ta ’ Effentora kienu maħsuba biex jivvalutaw is- sigurtà u l- effikaċja fil- kura ta ’ BTP u l- pazjenti kollha kienu qed jieħdu wkoll opioids fl- istess waqt, bħal morfina li tintreħa bil- mod jew fentanyl minn ġol- ġilda, għall- uġigħ persistenti tagħhom.
32 Investigations
Investigazzjonijiet
33 Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il - ġilda
34 For treatment of overdose (accidental ingestion) in the opioid-naive person, intravenous access should be obtained and naloxone or other opioid antagonists should be employed as clinically indicated.
Għall- kura ta ’ doża eċċessiva (teħid bi żball) f’ persuna li qatt ma tkun ħadet opioids qabel, għandu jinkiseb aċċess ġol- vini u naloxone jew antagonisti tal- opioids oħra għandhom jiġu ntużati kif indikat klinikament.
Fentanyl is an opioid analgesic, interacting predominantly with the opioid µ-receptor.
37 Fentanyl huwa analġeżiku opioid, li jinteraġixxi l- aktar mar- riċettur µ tal- opioids.
35 Study 1:
Studju 1:
In the second pivotal study (study 2), the primary endpoint was SPID30, which was also statistically significant compared to placebo (p < 0.0001).
39 Fit- tieni studju pivitali (studju 2), l- mira primarja kienet SPID30, li kienet ukoll statistikament sinnifikanti meta mqabbla mal- plaċebo (p < 0. 0001).
36 Statistically significant improvement in pain intensity difference was seen with Effentora versus placebo as early as 10 minutes in Study 1 and as early as 15 minutes (earliest time point measured) in Study 2.
Deher titjib statistikament sinnifikanti fid- differenza fl- intensità tal- uġigħ b’ Effentora kontra plaċebo minn wara 10 minuti fi Studju 1 u minn wara 15- il minuta (l- aktar punt ta ’ ħin bikri mkejjel) fi Studju 2.
Serum AUC and Cmax were approximately 20% and 30% higher than plasma AUC and Cmax, respectively.
40 30% ogħla mill- AUC u Cmax tal- plażma, rispettivament.
37 In pharmacokinetic studies that compared the absolute and relative bioavailability of Effentora and oral transmucosal fentanyl citrate (OTFC), the rate and extent of fentanyl absorption in Effentora demonstrated exposure that was between 30% to 50% greater than that for oral transmucosal fentanyl citrate.
Fi studji farkokinetiċi li qabblu il- biodisponibiltà assoluta u relattiva ta ’ Effentora u ta ’ fentanyl citrate orali minn ġol- mukuża (OTFC), ir- rata u l- kwantità ta ’ assorbiment ta ’ fentanyl f’ Effentora wrew esponiment li kien bejn 30% sa 50% akbar minn dak għal fentanyl citrate orali minn ġol- mukuża.
38 Biotransformation The metabolic pathways following buccal administration of Effentora have not been characterised in clinical studies.
41 Biotrasformazzjoni Ir- rotot metaboliċi wara l- għoti mill- ħalq ta ’ Effentora ma ġewx ikkaratterizzati fi studji kliniċi.
39 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
Store in the original package in order to protect from moisture.
42 Aħżen fil- pakkett oriġinali sabiex tilqa ’ mill- umdita ’.
Effentora 600 micrograms buccal tablets
Effentora 600 mikrogramma pilloli għall- ħalq
Each buccal tablet contains 600 micrograms fentanyl (as citrate).
Kull pillola għall- ħalq fiha 600 mikrogramma fentanyl (bħala citrate).
Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “ C” and on the other side with “ 6”.
Pillola b’ uċuħ ċatti, bajda, tonda bix- xfar imtajjra, fuq naħa waħda b ’ “ C ” imqabbża u fuq in- naħa l - oħra b ’ “ 6 ”.
41 Method of titration During titration, if adequate analgesia is not obtained within 30 minutes after the start of administration of a single tablet, a second Effentora tablet of the same strength may be used.
Metodu ta ’ titrazzjoni Waqt it- titrazzjoni, jekk ma tinkisibx analġeżija xierqa fi 30 minuta wara l- bidu ta ’ l- għoti ta ’ pillola waħda, tista ’ tintuża pillola oħra ta ’ Effentora ta ’ l- istess qawwa.
Use in the elderly (older than 65 years):
45 Użu fl- anzjani (’ l fuq minn 65 sena):
42 Hepatic or renal impairment:
Indeboliment tal- fwied u renali
Hypersensitivity to the active substance or to any of the excipients.
46 Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi.
43 4.4 Special warnings and precautions for use
4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
Fentanyl is metabolised mainly via the human cytochrome P450 3A4 isoenzyme system (CYP3A4), therefore potential interactions may occur when Effentora is given concurrently with agents that affect CYP3A4 activity.
47 Fentanyl huwa metabolizzat primarjament permezz tas- sistema ta ’ isoenzima taċ- ċitokromju uman P450 3A4 (CYP3A4), għalhekk jistgħu jseħħu interazzjonijiet potenzjali meta Effentora jingħata flimkien ma ’ sustanzi li jaffettwaw l- attività ta ’ CYP3A4.
44 The concomitant use of other central nervous system depressants, including other opioids, sedatives or hypnotics, general anaesthetics, phenothiazines, tranquillisers, skeletal muscle relaxants, sedating antihistamines and alcohol may produce additive depressant effects.
L- użu fl- istess waqt ta ’ depressanti tas- sistema nervuża ċentrali oħra, inkluż opioids oħra, sedattivi jew ipnotiċi, anestetiċi ġenerali, phenothiazines, kalmanti, rilassanti tal- muskoli skeltrali, antistamini sedattivi u alkoħol, jista ’ jipproduċi effetti dipressanti miżjuda.
The clinical studies of Effentora were designed to evaluate safety and efficacy in treating BTP and all patients were also taking concomitant opioids, such as sustained-release morphine or transdermal fentanyl, for their persistent pain.
48 L- istudji kliniċi ta ’ Effentora kienu maħsuba biex jivvalutaw is- sigurtà u l- effikaċja fil- kura ta ’ BTP u l- pazjenti kollha kienu qed jieħdu wkoll opioids fl- istess waqt, bħal morfina li tintreħa bil- mod jew fentanyl minn ġol- ġilda, għall- uġigħ persistenti tagħhom.
45 Investigations
Investigazzjonijiet
46 Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il - ġilda
47 For treatment of overdose (accidental ingestion) in the opioid-naive person, intravenous access should be obtained and naloxone or other opioid antagonists should be employed as clinically indicated.
Għall- kura ta ’ doża eċċessiva (teħid bi żball) f’ persuna li qatt ma tkun ħadet opioids qabel, għandu jinkiseb aċċess ġol- vini u naloxone jew antagonisti tal- opioids oħra għandhom jiġu ntużati kif indikat klinikament.
Fentanyl is an opioid analgesic, interacting predominantly with the opioid µ-receptor.
51 Fentanyl huwa analġeżiku opioid, li jinteraġixxi l- aktar mar- riċettur µ tal- opioids.
48 Study 1:
Studju 1:
In the second pivotal study (study 2), the primary endpoint was SPID30, which was also statistically significant compared to placebo (p < 0.0001).
53 Fit- tieni studju pivitali (studju 2), l- mira primarja kienet SPID30, li kienet ukoll statistikament sinnifikanti meta mqabbla mal- plaċebo (p < 0. 0001).
49 Statistically significant improvement in pain intensity difference was seen with Effentora versus placebo as early as 10 minutes in Study 1 and as early as 15 minutes (earliest time point measured) in Study 2.
Deher titjib statistikament sinnifikanti fid- differenza fl- intensità tal- uġigħ b’ Effentora kontra plaċebo minn wara 10 minuti fi Studju 1 u minn wara 15- il minuta (l- aktar punt ta ’ ħin bikri mkejjel) fi Studju 2.
Serum AUC and Cmax were approximately 20% and 30% higher than plasma AUC and Cmax, respectively.
54 30% ogħla mill- AUC u Cmax tal- plażma, rispettivament.
50 In pharmacokinetic studies that compared the absolute and relative bioavailability of Effentora and oral transmucosal fentanyl citrate (OTFC), the rate and extent of fentanyl absorption in Effentora demonstrated exposure that was between 30% to 50% greater than that for oral transmucosal fentanyl citrate.
Fi studji farkokinetiċi li qabblu il- biodisponibiltà assoluta u relattiva ta ’ Effentora u ta ’ fentanyl citrate orali minn ġol- mukuża (OTFC), ir- rata u l- kwantità ta ’ assorbiment ta ’ fentanyl f’ Effentora wrew esponiment li kien bejn 30% sa 50% akbar minn dak għal fentanyl citrate orali minn ġol- mukuża.
If switching from another oral fentanyl citrate product, independent dose titration with Effentora is required as bioavailability between products differs significantly.
Jekk ħa jaqilbu minn prodott ta ’ fentanyl citrate orali ieħor, hija meħtieġa titrazzjoni ndipendenti tad - doża b’ Effentora peress li l- biodisponibiltà tvarja b’ mod sinifikanti bejn il- prodotti.
However, in these patients, a starting dose higher than 100 micrograms may be considered.
Madankollu, f’ dawn il- pazjenti, tista ’ tiġi kkunsidrata doża tal- bidu ogħla minn 100 mikrogramma.
51 Biotransformation The metabolic pathways following buccal administration of Effentora have not been characterised in clinical studies.
55 Biotrasformazzjoni Ir- rotot metaboliċi wara l- għoti mill- ħalq ta ’ Effentora ma ġewx ikkaratterizzati fi studji kliniċi.
52 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
Store in the original package in order to protect from moisture.
56 Aħżen fil- pakkett oriġinali sabiex tilqa ’ mill- umdita ’.
Effentora 800 micrograms buccal tablets
Effentora 800 mikrogramma pilloli għall- ħalq
Each buccal tablet contains 800 micrograms fentanyl (as citrate).
Kull pillola għall- ħalq fiha 800 mikrogramma fentanyl (bħala citrate).
Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “ C” and on the other side with “ 8”
Pillola b’ uċuħ ċatti, bajda, tonda bix- xfar imtajjra, fuq naħa waħda b ’ “ C ” imqabbża u fuq in- naħa l - oħra b ’ “ 8 ”.
54 Method of titration During titration, if adequate analgesia is not obtained within 30 minutes after the start of administration of a single tablet, a second Effentora tablet of the same strength may be used.
Metodu ta ’ titrazzjoni Waqt it- titrazzjoni, jekk ma tinkisibx analġeżija xierqa fi 30 minuta wara l- bidu ta ’ l- għoti ta ’ pillola waħda, tista ’ tintuża pillola oħra ta ’ Effentora ta ’ l- istess qawwa.
Use in the elderly (older than 65 years):
59 Użu fl- anzjani (’ l fuq minn 65 sena):
55 Hepatic or renal impairment:
Indeboliment tal- fwied u renali
Hypersensitivity to the active substance or to any of the excipients.
60 Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi.
56 4.4 Special warnings and precautions for use
4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
Fentanyl is metabolised mainly via the human cytochrome P450 3A4 isoenzyme system (CYP3A4), therefore potential interactions may occur when Effentora is given concurrently with agents that affect CYP3A4 activity.
61 Fentanyl huwa metabolizzat primarjament permezz tas- sistema ta ’ isoenzima taċ- ċitokromju uman P450 3A4 (CYP3A4), għalhekk jistgħu jseħħu interazzjonijiet potenzjali meta Effentora jingħata flimkien ma ’ sustanzi li jaffettwaw l- attività ta ’ CYP3A4.
57 The concomitant use of other central nervous system depressants, including other opioids, sedatives or hypnotics, general anaesthetics, phenothiazines, tranquillisers, skeletal muscle relaxants, sedating antihistamines and alcohol may produce additive depressant effects.
L- użu fl- istess waqt ta ’ depressanti tas- sistema nervuża ċentrali oħra, inkluż opioids oħra, sedattivi jew ipnotiċi, anestetiċi ġenerali, phenothiazines, kalmanti, rilassanti tal- muskoli skeltrali, antistamini sedattivi u alkoħol, jista ’ jipproduċi effetti dipressanti miżjuda.
The clinical studies of Effentora were designed to evaluate safety and efficacy in treating BTP and all patients were also taking concomitant opioids, such as sustained-release morphine or transdermal fentanyl, for their persistent pain.
62 L- istudji kliniċi ta ’ Effentora kienu maħsuba biex jivvalutaw is- sigurtà u l- effikaċja fil- kura ta ’ BTP u l- pazjenti kollha kienu qed jieħdu wkoll opioids fl- istess waqt, bħal morfina li tintreħa bil- mod jew fentanyl minn ġol- ġilda, għall- uġigħ persistenti tagħhom.
58 Investigations
Investigazzjonijiet
59 Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il - ġilda
60 For treatment of overdose (accidental ingestion) in the opioid-naive person, intravenous access should be obtained and naloxone or other opioid antagonists should be employed as clinically indicated.
Għall- kura ta ’ doża eċċessiva (teħid bi żball) f’ persuna li qatt ma tkun ħadet opioids qabel, għandu jinkiseb aċċess ġol- vini u naloxone jew antagonisti tal- opioids oħra għandhom jiġu ntużati kif indikat klinikament.
Fentanyl is an opioid analgesic, interacting predominantly with the opioid µ-receptor.
65 Fentanyl huwa analġeżiku opioid, li jinteraġixxi l- aktar mar- riċettur µ tal- opioids.
61 Study 1:
Studju 1:
In the second pivotal study (study 2), the primary endpoint was SPID30, which was also statistically significant compared to placebo (p < 0.0001).
67 Fit- tieni studju pivitali (studju 2), l- mira primarja kienet SPID30, li kienet ukoll statistikament sinnifikanti meta mqabbla mal- plaċebo (p < 0. 0001).
62 Statistically significant improvement in pain intensity difference was seen with Effentora versus placebo as early as 10 minutes in Study 1 and as early as 15 minutes (earliest time point measured) in Study 2.
Deher titjib statistikament sinnifikanti fid- differenza fl- intensità tal- uġigħ b’ Effentora kontra plaċebo minn wara 10 minuti fi Studju 1 u minn wara 15- il minuta (l- aktar punt ta ’ ħin bikri mkejjel) fi Studju 2.
Serum AUC and Cmax were approximately 20% and 30% higher than plasma AUC and Cmax, respectively.
68 30% ogħla mill- AUC u Cmax tal- plażma, rispettivament.
63 In pharmacokinetic studies that compared the absolute and relative bioavailability of Effentora and oral transmucosal fentanyl citrate (OTFC), the rate and extent of fentanyl absorption in Effentora demonstrated exposure that was between 30% to 50% greater than that for oral transmucosal fentanyl citrate.
Fi studji farkokinetiċi li qabblu il- biodisponibiltà assoluta u relattiva ta ’ Effentora u ta ’ fentanyl citrate orali minn ġol- mukuża (OTFC), ir- rata u l- kwantità ta ’ assorbiment ta ’ fentanyl f’ Effentora wrew esponiment li kien bejn 30% sa 50% akbar minn dak għal fentanyl citrate orali minn ġol- mukuża.
64 Biotransformation The metabolic pathways following buccal administration of Effentora have not been characterised in clinical studies.
69 Biotrasformazzjoni Ir- rotot metaboliċi wara l- għoti mill- ħalq ta ’ Effentora ma ġewx ikkaratterizzati fi studji kliniċi.
65 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
Store in the original package in order to protect from moisture.
70 Aħżen fil- pakkett oriġinali sabiex tilqa ’ mill- umdita ’.
66 ANNEX II
71 ANNESS II
Armagh BT63 5UA United Kingdom
Armagh BT63 5UA Ir- Renju Unit
Medicinal product subject to restricted and special medical prescription.
Prodott mediċinali jingħata b' riċetta ristretta u speċjali tat- tabib.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 1.2 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 ’ Farmokoviġilanza Id- Detentur ta ’ L- Awtorizzazzjoni għat- tqegħid fis- Suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritt f’ verżjoni 1. 2 ppreżentata f’ Modulu 1. 8. 1 ta ’ l- Applikazzjoni għal - Awtorizzazzjoni għat- tqegħid fis- Suq, hija f’ postha u qed tiffunzjoni qabel u waqt li l- prodott jitqiegħed fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.2 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- Immanniġġjar ta ’ Riskji Id- Detentur ta ’ L- Awtorizzazzjoni għat- tqegħid fis- Suq jwiegħed li jwettaq l- istudji u l- attivitajiet ta ’ farmakoviġilanza oħrajn dettaljati fil- Pjan ta ’ Farmakoviġilanza kif miftiehem f’ verżjoni 1. 2 tal- Pjan għall- Immanniġġjar ta ’ Riskji (RMP) ippreżentat f’ Modulu 1. 8. 2 ta ’ l- Applikazzjoni għal - Awtorizzazzjoni għat- tqegħid fis- Suq u kull aġġornament sussegwenti ta ’ l- RMP miftiehem mis - 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).
Skond il- Linji Gwida tas- CHMP dwar is- Sistemi għall- Immanniġġjar ta ’ Riskji għall- prodotti mediċinali għall- użu fil- bniedem, RMP aġġornat għandu jiġi ppreżentat fl- istess żmien mar- Rapport Perjodiku Aġġornat dwar is- Sigurtà (PSUR) sussegwenti.
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
• Meta tinkiseb informazzjoni ġdida li jista ’ jkollha effett fuq l- Ispeċifikazzjonijiet ta ’ Sigurtà kurrenti, Pjan ta ’ Farmakoviġilanza jew attivitajiet li jnaqqsu r- riskju • Fi żmien 60 ġurnata wara li tintlaħaq mira ta ’ mportanza (farmakoviġilanza jew tnaqqis ta ’ riskju) • Mat- talba ta ’ l- EMEA
68 ANNEX III
73 ANNESS III
70 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
75 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Effentora 100 micrograms buccal tablets Fentanyl
Effentora 100 mikrogramma pilloli għall- ħalq Fentanyl
Each buccal tablet contains 100 micrograms fentanyl (as citrate)
Kull pillola għall- ħalq fiha 100 mikrogramma ta ’ fentanyl (bħala citrate)
Contains sodium
Fih sodium
4 buccal tablets 28 buccal tablets
4 pilloli għall- ħalq 28 pillola għall- ħalq
For oromucosal use.
Użu għall- mukuża tal- ħalq.
Place in buccal cavity.
Poġġi fil- kavità tal- ħalq.
Not to be sucked, chewed or swallowed whole.
Terdax, togħmodx u tiblax sħiħa.
This product should only be used by patients already taking other opioids.
Dan il- prodott għandu jintuża biss minn pazjenti li diġà qed jieħdu opoids oħra.
Store in the original package in order to protect from moisture.
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mill- umdita ’.
Cephalon Europe, 5 rue Charles Martigny, 94700 Maisons-Alfort, France
Cephalon Europe, 5 rue Charles Martigny, 94700 Maisons- Alfort, Franza
Medicinal product subject to medical prescription
Prodott mediċinali jingħata bir- riċetta tat- tabib..
72 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
77 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
BLISTER OF 4 TABLETS
FOLJA TA ’ 4 PILLOLI
BN:
LOTT:
Tear 2.
Ċarrat 2.
Bend 3.
Ilwi 3.
Peel
Qaxxar
73 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
78 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Effentora 200 micrograms buccal tablets Fentanyl
Effentora 200 mikrogramma pilloli għall- ħalq Fentanyl
Each buccal tablet contains 200 micrograms fentanyl (as citrate)
Kull pillola għall- ħalq fiha 200 mikrogramma ta ’ fentanyl (bħala citrate)
75 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
80 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
76 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
81 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Effentora 400 micrograms buccal tablets Fentanyl
Effentora 400 mikrogramma pilloli għall- ħalq Fentanyl
Each buccal tablet contains 400 micrograms fentanyl (as citrate)
Kull pillola għall- ħalq fiha 400 mikrogramma ta ’ fentanyl (bħala citrate)
78 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
83 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
79 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
84 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Effentora 600 micrograms buccal tablets Fentanyl
Effentora 600 mikrogramma pilloli għall- ħalq Fentanyl
Each buccal tablet contains 600 micrograms fentanyl (as citrate)
Kull pillola għall- ħalq fiha 600 mikrogramma ta ’ fentanyl (bħala citrate)
81 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
86 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
82 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
87 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Effentora 800 micrograms buccal tablets Fentanyl
Effentora 800 mikrogramma pilloli għall- ħalq Fentanyl
Each buccal tablet contains 800 micrograms fentanyl (as citrate)
Kull pillola għall- ħalq fiha 800 mikrogramma ta ’ fentanyl (bħala citrate)
84 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
89 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
86 PACKAGE LEAFLET:
91 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER Effentora 100 micrograms buccal tablets Effentora 200 micrograms buccal tablets Effentora 400 micrograms buccal tablets Effentora 600 micrograms buccal tablets Effentora 800 micrograms buccal tablets Fentanyl
Effentora 100 mikrogramma pilloli għall- ħalq Effentora 200 mikrogramma pilloli għall- ħalq Effentora 400 mikrogramma pilloli għall- ħalq Effentora 600 mikrogramma pilloli għall- ħalq Effentora 800 mikrogramma pilloli għall- ħalq Fentanyl
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex
What Effentora is and what it is used for 2.
X’ inhu Effentora u għalxiex jintuża 2.
Before you use Effentora 3.
Qabel ma tuża Effentora 3.
How to use Effentora 4.
Kif għandek tuża Effentora 4.
How to store Effentora 6.
Kif taħżen Effentora 6.
WHAT EFFENTORA IS AND WHAT IT IS USED FOR
X’ INHU EFFENTORA U GĦALXIEX JINTUŻA
Effentora is a pain-relieving medicine known as an opioid, which is used to treat breakthrough pain in adult patients with cancer who are already taking other opioid pain medicines for their constant (around-the-clock) cancer pain.
Effentora huwa mediċina li ttaffi l- uġigħ magħrufa bħala opioid, li tintuża għall- kura ta ’ uġugħ li jinħass f’ pazjenti adulti bil- kanċer li diġa qed jieħdu mediċini opioid ta ’ l- uġigħ għall- uġigħ kostanti (l- ħin kollu) tal- kanċer.
Breakthrough pain is additional, sudden pain that occurs in spite of you having taken your usual opioid pain-relieving medicines.
Uġigħ li jinħass huwa uġigħ ieħor li jiġi f’ daqqa, li jseħħ minkejja li inti tkun ħadt il- mediċini opioid li jtaffu l- uġigħ tas- soltu tiegħek.
BEFORE YOU USE EFFENTORA
QABEL MA TUŻA EFFENTORA
Do not use Effentora if: • You have not been using a prescribed opioid pain medicine every day on a regular schedule, for at least a week, to control your persistent pain.
Tużax Effentora • Jekk ma kontx qed tuża mediċina opioid ta ’ l- uġigħ preskritta kuljum fuq skeda regolari, għal ta ’ l - inqas ġimgħa, għall- kontroll ta ’ l- uġigħ persistenti tiegħek.
If you have not been using these medicines you must not use Effentora, because it may increase the risk that breathing could become dangerously slow and/ or shallow, or even stop. • You are allergic (hypersensitive) to fentanyl or any of the other ingredients of Effentora. • You suffer from severe breathing problems or severe obstructive lung conditions.
Jekk ma kontx qed tuża dawn il - meidiċini m’ għandekx tuża Effentora, minħabba li jista ’ jżid ir- riskju li n- nifs jista ’ jsir bil- mod u/ jew baxx b’ mod perikoluż, jew anki jieqaf. • Jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal fentanyl jew sustanzi oħra ta ’ Effentora. • Jekk issofri minn problemi severi biex tieħu n- nifs jew kundizzjonijiet severi ta ’ ostruzzjoni tal - pulmun.
Take special care with Effentora If you have any of the following, talk to your doctor or pharmacist before starting Effentora: • Your other opioid pain medicine taken for your constant (around-the-clock) cancer pain is not stabilised yet. • You are suffering from any condition that has an effect on your breathing (such as asthma, wheezing, or shortness of breath). • You have a head injury. • You have an exceptionally slow heart rate or other heart problems. • You have liver or kidney problems, as these organs have an effect on the way in which your system breaks down the medicine. • You have low amount of fluid in the circulation or low blood pressure
Oqgħod attent ħafna b ’ Effentora Jekk inti għandek xi wieħed minn dawn li ġejjin, kellem lit- tabib jew lill- ispiżjar tiegħek qabel tibda tieħu Effentora: • Il- mediċina opioid ta ’ l- uġigħ l- oħra tiegħek li qed tittieħed għall- uġigħ kostanti (l- ħin kollu) tal - kanċer tiegħek għad ma ġietx stabbilizzata. • Jekk qed issofri minn xi kundizzjoni li għandha effet fuq in- nifs tiegħek (bħal ażżma, tħarħir, jew qtugħ ta ’ nifs).
87 Taking/ using other medicines Please tell your doctor or pharmacist before starting Effentora if you are taking or have recently taken any of the following medicines: • Any medicines which might normally make you sleepy (have a sedative effect) such as sleeping pills, medicines to treat anxiety, antihistamines, or tranquillisers. • Any medicines that might have an effect on the way in which your body breaks down Effentora, such as ritonavir, nelfinavir, amprenavir, and fosamprenavir (medicines that help control HIV infection) or other so-called CYP3A4 inhibitors such as ketoconazole, itraconazole, or fluconazole (used for treatment of fungal infections), troleandomycine, clarithromycine, or erythromycine (medicines for treatment of bacterial infections), aprepitant (used for severe nausea) and diltiazem and verapamil (medicines for treatment of high blood pressure or heart diseases). • Medicines called monoamine-oxidase (MAO) inhibitors (used for severe depression) or have done so in the past 2 weeks.
Meta tieħu/ tuża mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek qabel tibda tieħu Effentora jekk qed tieħu jew ħadt dan l- aħħar xi wieħed minn dawn il- mediċini li ġejjin: • Kull mediċina li normalment tqabbdek in- ngħas (għandha effett sedattiv) bħall- pilloli ta ’ l- irqad, mediċini għall- kura ta ’ l- ansjetà, antistamini, jew kalmanti. • Kull mediċina li jista ’ jkollha effett fuq il- mod kif ġismek ikisser Effentora, bħal ritonavir, nelfinavir, amprenavir, u fosamprenavir (mediċini li jgħinu fil- kontroll ta ’ infezzjoni ta ’ l- HIV) jew oħrajn imsejjħa inibituri ta ’ CYP3A4 bħal ketoconazole, itraconazole, jew fluconazole (wżati għall- kura ta ’ infezzjonijiet mill- moffa), troleandomycine, clarithromycine, jew erythromycine (mediċini għall- kura ta ’ infezzjonijiet mill- batterji), aprepitant (użat għal tqalligħ sever) u diltiazem u verapamil (mediċini għall- kura ta ’ pressjoni għolja jew mard tal- qalb). • Mediċini msejjħa inibituri ta ’ monoamine- oxidase (MAO) (użati għal depressjoni severa) jew ħadt dawn fl- aħħar ġimagħtejn.
Using Effentora with food or drink • Effentora may be used before or after, but not during, meals.
Meta tuża Effentora ma ’ l- ikel u max- xorb • Effentora jista ’ jintuża qabel jew wara, iżda mhux waqt l- ikel.
You may drink some water before using Effentora to help moisten your mouth, but you should not drink or eat anything while taking the medicine. • You should not drink grapefruit juice while using Effentora because it may affect the way your body breaks down Effentora. • Do not drink alcohol while using Effentora.
Tista ’ tixrob xi ftit ilma qabel tuża Effentora biex tgħin ixxarrab ħalqak, iżda m’ għandek tixrob jew tiekol xejn waqt li qed tieħu l - mediċina. • M’ għandekx tixrob meraq tal- grejpfrut waqt li qed tuża Effentora minħabba li jista ’ jkollu effett fuq il- mod kif ġismek ikisser Effentora. • Tixrobx alkoħol waqt li qed tuża Effentora.
It can increase the risk of experiencing dangerous side effects.
Dan jista ’ jżid ir- riskju li jkollok esperjenza ta ’ effetti sekondarji perikolużi.
Effentora should not be used during pregnancy unless you have discussed this with your doctor.
Effentora m’ għandux jintuża waqt it- tqala sakemm ma ddiskutejtx dan mat- tabib tiegħek.
You should not use Effentora during childbirth because fentanyl may cause respiratory depression in the new-born child.
M’ għandekx tuża Effentora waqt il- ħlas għax fentanyl tista ’ jikkawża depressjoni respiratorja fit- tarbija tat- twelid.
Fentanyl can get into breast milk and may cause side effects in the breast-fed infant.
Fentanyl jista ’ jgħaddi fil- ħalib tas- sider u jista ’ jikkawża effetti mhux mixtieqa fit- tarbija li qed terda.
Do not use Effentora if you are breast-feeding unless you have discussed this with your doctor.
Tużax Effentora jekk qed tredda ’ sakemm ma ddiskutejtx dan mat- tabib tiegħek.
Driving and using machines You should discuss with your doctor whether it is safe for you to drive, or operate machinery after taking Effentora.
Sewqan u tħaddim ta ’ magni Għandek tiddiskuti mat- tabib tiegħek jekk huwiex sikur għalik biex issuq, jew tħaddem magni wara li tieħu Effentora.
Do not drive or operate machinery if you: are feeling sleepy or dizzy; have blurred or double vision; or have difficulty in concentrating.
Issuqx u tħaddimx magni jekk int: qed tħossok bin- ngħas jew sturdut; għandek vista mċajpra jew doppja; jew għandek diffikultà biex tikkonċentra.
It is important you know how you react to Effentora before driving or operating machinery.
Huwa mportanti li int tkun taf kif tirreaġixxi għal Effentora qabel issuq jew tħaddem magni.
Important information about some of the ingredients of Effentora Each tablet of Effentora 100 micrograms contains 8 mg of sodium.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Effentora Kull pillola ta ’ Effentora 100 mikrogramma fiha 8 mg ta ’ sodium.
Each tablet of Effentora 200 micrograms, Effentora 400 micrograms, Effentora 600 micrograms and Effentora 800 micrograms contains 16 mg of sodium.
Kull pillola ta ’ Effentora 200 mikrogramma, Effentora 400 mikrogramma, Effentora 600 mikrogramma u Effentora 800 mikrogramma fiha 16 mg ta ’ sodium.
You should take this into consideration if you are on a controlled sodium diet and seek advice from your doctor.
Għandek tieħu dan f’ kunsiderazzjoni jekk inti fuq dieta ta ’ sodium ikkontrollat u tfittex parir tat- tabib tiegħek.
HOW TO USE EFFENTORA
KIF GĦANDEK TIEĦU TUŻA EFFENTORA
Effentora buccal tablets are for oromucosal use.
93 Effentora pilloli għall- ħalq huma għall- użu għall- mukuża tal- ħalq.
When you place a tablet in your mouth, it dissolves and the medicine is absorbed through the lining of your mouth, into the blood system.
Meta tpoġġi pillola f’ ħalqek, hija tinħall u l- mediċina tiġi assorbita minn ġol- kisja ta ’ ħalqek, għal ġos- sistema tad- demm.
Taking the medicine in this way allows it to be absorbed quickly to relieve your breakthrough pain.
Meta tieħu l - mediċina b’ dan il- mod tippermetti li tiġi assorbita malajr biex ittaffi l- uġigħ li jinħass tiegħek.
88 When you first start using Effentora, your doctor will work with you to find the dose that will relieve your breakthrough pain.
Dożaġġ u frekwenza Meta tibda tuża Effentora għall- ewwel darba, it- tabib tiegħek se jaħdem miegħek biex isib id- doża li ttaffilek l- uġigħ li jinħass.
It is very important that you use Effentora exactly as the doctor tells you.
Huwa mportanti ħafna li inti tuża Effentora eżatt kif jgħidlek it- tabib.
The initial dose is 100 micrograms.
Id- doża tal- bidu hija 100 mikrogramma.
During determination of your right dose, your doctor may instruct you to take more than one tablet per episode.
Waqt li qed tiġi determinata d- doża xierqa tiegħek, it- tabib tiegħek jista ’ jgħidlek biex tieħu aktar minn pillola waħda kull episodju.
Once the right dose has been determined with your doctor, use 1 tablet for an episode of breakthrough pain.
Ladarba id- doża xierqa tiġi determinata mat- tabib tiegħek, uża pillola waħda għall- episodju ta ’ uġigħ li jinħass.
If your breakthrough pain is not relieved after 30 minutes, use only 1 more tablet of Effentora at this time.
Jekk l- uġigħ li jinħass tiegħek ma jittaffiex wara 30 minuta, uża biss pillola waħda oħra ta ’ Effentora f’ dan il- ħin.
Contact your doctor if your right dose of Effentora does not relieve your breakthrough pain.
Kellem lit- tabib tiegħek jekk id- doża xierqa tiegħek ta ’ Effentora ma ttaffix l- uġigħ li jinħass tiegħek.
Your doctor will decide if your dose needs to be changed.
It- tabib tiegħek jiddeċiedi jekk hemmx bżonn li d- doża tiegħek tinbidel.
Wait at least 4 hours before treating another episode of breakthrough pain with Effentora.
Stenna ta ’ l- inqas 4 sigħat qabel tikkura episodju ieħor ta ’ uġigħ li jinħass b’ Effentora.
You must let your doctor know immediately if you are using Effentora more than four times per day, as he may change your medicine for your persistent pain.
Għandek tgħid lit- tabib tiegħek minnufiħ jekk qed tuża Effentora aktar minn erba ’ darbiet kuljum, minħabba li huwa jista ’ jbiddel il- mediċina għall- uġigħ persistenti tiegħek.
When your persistent pain is controlled again, your doctor may need to change your dose of Effentora.
Meta l- uġigħ persistenti tiegħek huwa kkontrollat għal darba oħra, it- tabib tiegħek jista ’ jkollu bżonn ibiddel id- doża tiegħek ta ’ Effentora.
For the most effective relief, let your doctor know about your pain and how Effentora is working for you, so that the dose can be changed if needed.
Għall- aktar serħan effettiv, għid lit- tabib tiegħek dwar l- uġigħ tiegħek u kif Effentora qed jaħdem għalik, biex id- doża tkun tista ’ tinbidel jekk hemm bżonn.
Do not change doses of Effentora or your other pain medicines on your own.
Tbiddilx id- dożi ta ’ Effentora jew tal- mediċini ta ’ l- uġigħ l- oħra waħdek.
Any change in dosage must be prescribed and monitored by your doctor.
Kull bidla fid- doża għandha tiġi preskritta u sorveljata mit- tabib tiegħek.
If you are not sure about the right dose, or if you have questions about taking this medicine, you should contact your doctor.
Jekk m’ intix ċert dwar id- doża t- tajba, jew jekk għandek xi mistoqsijiet dwar kif tieħu din il- mediċina, għandek tkellem lit- tabib tiegħek.
Taking the medicine • Open the blister only when you are ready to use the tablet.
Meta tieħu l- mediċina • Iftaħ il- folja biss meta tkun lest biex tuża l- pillola.
The tablet must be used immediately once removed from the blister. • Separate one of the blister units from the blister card by tearing apart at the perforations. • Bend the blister unit along the line where indicated. • Peel the blister backing to expose the tablet.
Il- pillola għandha tintuża minnufiħ ladarba titneħħa mill- folja. • Issepara waħa mill- unitajiet tal- folja minn mal- kartuna tal- folja billi ċċarrat il- perforazzjonijiet. • Ilwi l- unità tal- folja tul il- linja fejn indikat. • Qaxxar id- dahar tal- folja biex tesponi l- pillola.
Do NOT attempt to push the tablet through the blister, because this can damage the tablet.
TIPPRUVAX tinbotta l- pillola minn ġol- folja, għax dan jista ’ jagħmel ħsara lill- pillola.
• Remove the tablet from the blister unit and immediately place the entire tablet above a rear molar tooth between the upper gum and the cheek (as shown in the picture).
• Neħħi l- pillola minn ġol- unità tal- folja u minnufiħ poġġi l- pillola sħiħa fuq darsa ta ’ wara bejn il - ħanek ta ’ fuq u l- ħadd (kif muri fl- istampa).
Do not attempt to crush or split the tablet.
Tippruvax tgħaffeġ jew taqsam il- pillola.
• Do not bite, suck, chew, or swallow the tablet, as this will result in less pain relief than when taken as directed. • The tablet should be left between the cheek and gum until dissolved, which usually takes approximately 14 to 25 minutes.
94 • Tigdimx, terdgħax, togħmodx, u tiblax il- pillola, għax dan iwassal għal inqas serħan mill- uġigħ minn meta tittieħed kif muri. • Il- pillola għandha titħalla bejn il- ħadd u l- ħanek sakemm tinħall, li normalment jieħu madwar 14 sa 25 minuta. • Tista ’ tħoss sensazzjoni ta ’ tbaqbieq ħafif bejn il- ħadd u l- ħanek tiegħek hekk kif il- pillola tkun qed tinħall. • Wara 30 minuta, jekk jibqgħu fdalijiet tal- pillola, dawn jistgħu jinbelgħu ma ’ tażża ilma.
If you use more Effentora than you should • The most common side effects are feeling sleepy, sick or dizzy.
Jekk tuża Effentora aktar milli suppost • L- aktar effetti mhux mixtieqa komuni huma tħossok bin- ngħas, ma tiflaħx jew sturdut.
If you begin to feel very dizzy, or very sleepy before the tablet is completely dissolved, rinse your mouth with water and spit the remaining pieces of the tablet into a sink or toilet right away. • A serious side effect of Effentora is slow and/ or shallow breathing.
Jekk tibda ’ tħossok sturdut ħafna, jew bin- ngħas ħafna qabel ma l- pillola tkun inħallet għal kollox, laħlaħ ħalqek bl- ilma u obżoq il- fdalijiet tal- pillola fis- sink jew fil- loki minnufiħ. • Effett mhux mixtieq serju ta ’ Effentora huwa nifs bil- mod u/ jew baxx.
This can occur if your dose of Effentora is too high or if you take too much Effentora.
Dan jista ’ jseħħ jekk id - doża tiegħek ta ’ Effentora hija għolja wisq jew jekk int tieħu wisq Effentora.
If this occurs, please seek immediate medical assistance.
Jekk dan iseħħ, jekk jogħġbok fittex għajnuna medika minnufiħ.
What to do if someone accidentally takes Effentora If you think someone has accidentally taken Effentora please seek immediate medical assistance.
X’ tagħmel jekk xi ħadd bi żball jieħu Effentora Jekk taħseb li xi ħadd bi żball ħa Effentora, jekk jogħġbok fittex għajnuna medika minnufiħ.
Try to keep the person awake until emergency help arrives.
Ipprova żomm il- persuna mqajjma sakemm tasal l- għajnuna ta ’ emerġenza.
If someone has accidentally taken Effentora, they may have the same side effects as described in the section “ If you use more Effentora than you should”.
Jekk xi ħadd bi żball ħa Effentora, jista ’ jkollhom l- istess effetti mhux mixtieqa kif deskritt f’ sezzjoni “ Jekk tuża Effentora aktar milli suppost ”.
If you forget to use Effentora If the breakthrough pain is still ongoing, you may take Effentora as prescribed by your physician.
Jekk tinsa tuża Effentora Jekk l- uġigħ li jinħass għadu m’ għaddiex, tista ’ tieħu Effentora kif preskritt mit- tabib.
If the breakthrough pain has stopped, do not take Effentora until the next breakthrough pain episode.
Jekk l- uġigħ li jinħass għadda, tieħux Effentora qabel l- episodju li jmiss ta ’ uġigħ li jinħass.
If you stop using Effentora You should discontinue Effentora when no longer required.
Jekk tieqaf tuża Effentora Għandek twaqqaf Effentora meta ma jkunx meħtieġ aktar.
You should continue to take your usual opioid medicine to treat your persistent pain and you may contact your doctor to confirm its correct dose.
Għandek tkompli tieħu l- mediċina opioid tas- soltu tiegħek biex tikkura l- uġigħ persistenti u tista ’ tkellem lit- tabib tiegħek biex tikkonferma d - doża t- tabja tagħha.