qanastek/EMEA-V3 huggingface dataset:
• Urinary system disorders Common: difficulties passing urine; increased frequency in urination Uncommon: inability to pass urine
• Disturbi fis- sistema urinarja Komuni: diffikultajiet biex tagħmel awrina; żieda fil- frekwenza meta tagħmel l- awrina Mhux Komuni:
• Reproductive and sexual disorders Common: abnormal ejaculation/orgasm (males); lack of orgasm; erectile dysfunction (impotence); menstrual irregularities such as increased bleeding or increased irregular bleeding Uncommon: abnormal orgasm (females)
• Disturbi fis- sistema riproduttiva u sesswali Komuni: ejakulazzjoni/ orgażmu anormali (irġiel); nuqqas ta ’ orgażmu; disfunzjoni erettili (impotenza); irregolaritajiet fil- mestrwazzjoni, bħal żieda fil- ħruġ tad- demm jew żieda fil- ħruġ irregolari tad- demm Mhux Komuni: orgażmu anormali (nisa)
• General Common: weakness (asthenia); chills Uncommon: sensitivity to sunlight Not known: swollen face or tongue, shortness of breath or difficulty breathing, often with skin rashes (this may be a serious allergic reaction)
• Ġenerali Komuni: dgħjufija (astenja); tkexkix ta ’ bard Mhux Komuni: sensittività għad- dawl tax- xemx Mhux magħrufa: wiċċ jew ilsien minfuħin, qtugħ ta ’ nifs jew diffikultà biex tieħu n- nifs, ta ’ spiss b’ raxx tal- ġilda (din tista ’ tkun reazzjoni allerġika serja)
Efexor depot sometimes causes unwanted effects that you may not be aware of, such as increases in blood pressure or abnormal heart beat; slight changes in blood levels or liver enzymes, sodium or cholesterol.
Efexor depot xi kultant jikkawża effetti mhux mixtieqa li int tista ’ ma tkunx konxju tagħhom, bħal żieda fil- pressjoni tad- demm jew taħbit anormali tal- qalb; tibdil żgħir fil- livelli fid- demm jew ta ’ l - enzimi tal- fwied, sodium jew kolesterol.
More rarely, Efexor depot may reduce the function of platelets in your blood, leading to an increased risk of bruising or bleeding.
B’ mod aktar rari, Efexor depot jista ’ jnaqqas il- funzjoni tal - plejtlits fid- demm tiegħek, li jwassal għal żieda fir- riskju ta ’ tbenġil jew ħruġ ta ’ demm.
Therefore, your doctor may wish to do blood tests occasionally, particularly if you have been taking Efexor depot for a long time.
Għalhekk, it - tabib tiegħek jista ’ jkun jixtieq li jagħmel testijiet tad- demm okkażjonalment, partikolarment jekk tkun ilek tieħu Efexor depot għal żmien twil.
55 5.
53 5.
HOW TO STORE EFEXOR DEPOT
KIF TAĦŻEN EFEXOR DEPOT
Do not use Efexor depot after the expiry date, which is stated on the packaging.
Tużax Efexor depot wara d- data ta ’ skadenza li tidher fuq l- ippakkjar.
What Efexor depot contains
X’ fih Efexor depot
The active substance is venlafaxine.
Is- sustanza attiva hi venlafaxine.
What Efexor depot looks like and contents of the pack
Id- dehra ta ’ Efexor depot u l- kontenuti tal- pakkett
This medicinal product is authorised in the Member States of the EEA under the following names:
Dan il- prodott prodott mediċinali hu awtorizzat fl- Istati Membri ta ’ l- EEA b’ dawn l- ismijiet:
Belgium, Luxembourg
Il- Belġju, il- Lussemburgu
Czech Republic, Romania
Ir- Repubblika Ceka, ir- Rumanija
Cyprus, Greece, Estonia, Lithuania, Portugal
Ċipru, il- Greċja, l- Estonja, il- Litwanja, il - Portugall
Denmark, Finland, Iceland, Norway, Sweden France
Id- Danimarka, il- Finlandja, l- Islanda, in - Norveġja, l- Iżvezja
Ireland, Malta, United Kingdom The Netherlands
l- Irlanda, Malta, Ir- Renju Unit L- Olanda
Slovak Republic
Ir- Repubblika tas- Slovakja
*[Please note that not all listed products and strengths may be available.]
* [Jekk jogħġbok innota li mhux il- prodotti u l- qawwiet kollha jistgħu jkunu disponibbli.]
London, 02 December 2008 Doc.
Londra, 2 ta ’ Diċembru 2008 Dok.
EMEA/ CHMP/ 384876/ 2008
EMEA/ CHMP/ 674493/ 2008
OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Efexor depot and associated names
OPINJONI WARA REFERENZA SKONT L- ARTIKOLU 30 GĦAL Efexor depot u ismijiet assoċjati
International Non-Proprietary Name (INN): venlafaxine
Denominazzjoni Komuni Internazzjonali (DKI): venlafaxine
Efexor depot, 37.5 mg, 75 mg, 150 mg, hard prolonged-release capsules, is an antidepressant, indicated for the treatment of major depressive episodes, for the prevention of recurrence of major depressive episodes, for the treatment of social anxiety disorder, panic disorders with or without agoraphobia, and generalized anxiety disorder.
Efexor depot disponibbli f’ pilloli iebsin b’ rilaxx fit- tul ta ’ 37. 5 mg, 75 mg, 150 mg, huwa antidepressiv indikat għat- trattament ta ’ episodji depressivi qawwijin, għall- prevenzjoni ta ’ rikorrenza ta ’ episodji depressivi qawwijin, għat- trattament tad- disturb tal- ansjetà soċjali, disturbi ta ’ paniku bi jew mingħajr agorafobija, u disturb tal- ansjetà ġeneralizzata.
On 3 May 2007, the European Commission presented to the EMEA a referral under Article 30 of Directive 2001/ 83/ EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet of the medicinal product Efexor depot.
Fit- 3 ta ’ Mejju 2007, il- Kummissjoni Ewropea ppreżentat referenza lill- EMEA skont l- Artikolu 30 tad - Direttiva 2001/ 83/ KE, kif emendata, sabiex tarmonizza s- Sommarji tal- Karatteristiċi tal- Prodott (SPC) u t - Tikketta u l- Fuljett ta 'Tagħrif tal- prodott mediċinali Efexor depot.
The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Efexor depot approved across EU Member States, with respect to the treatment of major depressive episodes, the prevention of recurrence of major depressive episodes, the treatment of social anxiety disorder, panic disorders with or without agoraphobia, and generalized anxiety disorder.
Il- bażi tar- referenza kienet li kienu jeżistu differenzi fis- Sommarji tal- Karatteristiċi tal- Prodott (SPC) ta ’ Efexor depot approvati madwar l- Istati Membri tal- UE, f’ dak li għandu x’ jaqsam mat- trattament ta ’ episodji depressivi qawwijin, ir- rikorrenza ta ’ episodji depressivi qawwijin, it- trattament tad- disturb tal - ansjetà soċjali, disturbi ta ’ paniku bi jew mingħajr agorafobija, u disturbi ta ’ ansejtà ġeneralizzata.
This medicinal product belongs to the 2007 list of products identified for SPC harmonisation.
Dan il- prodott mediċinali jappartjeni għall- lista ta ’ prodotti tal- 2007 li huma identifikati għall - armonizzazzjoni tal- SPC.
The procedure started on 24 May 2007.
Il- proċedura bdiet fl- 24 ta ’ Mejju 2007.
The Marketing Authorisation Holder provided supplementary information on 26 September 2007.
Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq ipprovda tagħrif supplimentari fis- 26 ta ’ Settembru 2007.
During its July 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package Leaflet was acceptable and that they should be amended.
Waqt il- laqgħa tiegħu f’ Lulju 2008, is- CHMP, fid- dawl tad- dejta kumplessiva mressqa u d- diskussjoni xjentifika li saret fi ħdan il- Kumitat, kien tal- opinjoni li l- proposta għall- armonizzazzjoni tal- SPC, it - Tikketta u l- Fuljett ta ’ Tagħrif kienet aċċettabbli u li dawn għandhom jiġu emendati.
The CHMP gave a positive opinion on 24 July 2008 with a subsequent revision on 25 September 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet for Efexor depot.
Is- CHMP ta ’ opinjoni pożittiva fl- 24 ta ’ Lulju 2008 b’ reviżjoni sussegwenti fil- 25 ta ’ Settembru 2008 li kienet tirrakkomanda l- armonizzazzjoni tal- SPC, it- Tikketta u l- Fuljett ta ’ Tagħrif għal Efexor depot.
A Decision was issued by the European Commission on 28 November 2008.
Id- Deċiżjoni nħarġet mill- Kummissjoni Ewropea fit- 28 ta 'Novembru 2008.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
LISTA TA 'ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWIET TAL- PRODOTTI MEDIĊINALI, MNEJN JINGĦATAW, ID- DETENTURI TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ FL- ISTATI MEMBRI
Marketing Authorisation Holder (Invented) name
Id- Detentur ta ’ l- Awtorizzazzjoni Isem (ivvintat) għat- Tqegħid fis- Suq
Wyeth-Lederle Pharma GmbH Efectin 50 mg - Tabletten Storchengasse 1 1150 Vienna Austria
Wyeth- Lederle Pharma GmbH Efectin 50 mg - Tabletten Storchengasse 1 1150 Vienna L- Awstrija Wyeth Hellas S. A.
Efexor 126, Kyprou & 25th Martiou str., 164 52 Argyroupolis-Athens, Greece
Efexor 126, Kyprou & 25th Martiou str., 164 52 Argyroupolis- Athens, Il- Greċja Wyeth Hellas S. A.
Efexor 126, Kyprou & 25th Martiou str., 164 52 Argyroupolis-Athens, Greece
Efexor 126, Kyprou & 25th Martiou str., 164 52 Argyroupolis- Athens, Il- Greċja John Wyeth & Brother Ltd.
Efexor New Lane Havant, Hants PO9 2NG United Kingdom
Efexor New Lane Havant, Hants PO9 2NG Ir- Renju Unit John Wyeth & Brothers Ltd, New
John Wyeth & Brothers Ltd, New Efexor Lane, Havant, HANTS, P09 2NG United Kingdom
Efexor Lane, Havant, HANTS, P09 2NG Ir- Renju Unit John Wyeth & Brothers Ltd, New
John Wyeth & Brothers Ltd, New Efexor Lane, Havant, HANTS, P09 2NG United Kingdom
Efexor Lane, Havant, HANTS, P09 2NG Ir- Renju Unit
2 France
2 Franza
Wyeth Pharma GmbH Wienburgstrasse 207, D-48159 Muenster Germany
Wyeth Pharma GmbH Wienburgstrasse 207, D- 48159 Muenster Il- Ġermanja Wyeth Hellas S. A.
126, Kyprou & 25th Martiou str., 164 52 Argyroupolis-Athens, Greece
126, Kyprou & 25th Martiou str., 164 52 Argyroupolis- Athens, Il- Greċja
126, Kyprou & 25th Martiou str., 164 52 Argyroupolis-Athens, Greece
126, Kyprou & 25th Martiou str., 164 52 Argyroupolis- Athens, Il- Greċja Wyeth Hellas S. A.
126, Kyprou & 25th Martiou str., 164 52 Argyroupolis-Athens, Greece
126, Kyprou & 25th Martiou str., 164 52 Argyroupolis- Athens, Il- Greċja John Wyeth & Brothers Ltd
John Wyeth & Brothers Ltd New Lane, Havant, HANTS, P09 2NG United Kingdom
New Lane, Havant, HANTS, P09 2NG Ir- Renju Unit
4
4 L- Italja
John Wyeth & Brother Ltd trading as Wyeth Laboratories, Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH, United Kingdom
John Wyeth & Brother Ltd. li tagħmel il- kummerċ bħala Wyeth Laboratories, Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH, Ir- Renju Unit
Efexor
5
37.5 mg
In- Norveġja
Tablets
New Lane, Havant, HANTS, P09 2NG, Ir- Renju Unit WYETH FARMA S. A.
WYETH FARMA S. A.
Użu orali
De Burgos Km 23 Desvio Algete, 28700 San Sebastian de los Reyes Spain
De Burgos Km 23 Desvio Algete, 28700 San Sebastian de los Reyes Spanja WYETH FARMA S. A.
De Burgos Km 23 Desvio Algete, 28700 San Sebastian de los Reyes Spain
De Burgos Km 23 Desvio Algete, 28700 San Sebastian de los Reyes Spanja
United Kingdom
6 Ir- Renju Unit
6 United Kingdom
Ir- Renju Unit
8 SCIENTIFIC CONCLUSIONS
8 KONKLUŻJONIJIET XJENTIFIĊI
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF EFEXOR AND ASSOCIATED NAMES (SEE ANNEX I)
SOMMARJU GLOBALI TAL- EVALWAZZJONI XJENTIFIKA TA ’ EFEXOR U L- ISMIJIET ASSOĊJATI (ARA L- ANNESS I)
Efexor has been included in the list of products for Summary of Product Characteristics (SPC) harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/ 83/ EC, as amended.
Efexor ġie inkluż fil- lista ta ’ prodotti għall- armonizzazzjoni tas- Sommarju tal- Karatteristiċi tal- Prodott (SPC), miġbura mis- CMD( h), skont l- Artikolu 30( 2) tad- Direttiva 2001/ 83/ KE, kif emendat.
SPC Section 4.1 - Therapeutic Indications Following the European Commission’ s request, Section 4.1 of the Summary of Product Characteristics was harmonised to include the following therapeutic indications as worded and described below:
Sezzjoni 4. 1 tal- SPC – Indikazzjonijiet Terapewtiċi Wara talba mill- Kummissjoni Ewropea, is- Sezzjoni 4. 1 tas- Sommarju tal- Karatteristiċi tal- Prodott ġiet armonizzata biex tinkludi l- indikazzjonijiet terapewtiċi li ġejjin kif ifformulati u deskritti hawn taħt:
SPC Section 4.2 - Posology and Method of Administration The MAH was asked to harmonize the following posology texts in the SPC:
Sezzjoni 4. 2 tal- SPC – Pożoloġija u metodu ta ’ kif għandu jingħata Il- MAH intalab jarmonizza t- testi li ġejjin dwar il- pożoloġija fl- SPC:
Major Depressive Episodes: the CHMP considered that the maximum dose of 375mg/ day Efexor is safe and effective in a long term perspective and recommended that it is approved without duration limitations in the harmonised SPC.
Episodji Dipressivi Maġġuri: is- CHMP qies li d- doża massima ta ’ 375mg kuljum ta ’ Efexor hija sigura u effikaċi minn perspettiva fit- tul u rrakkomanda li din tkun approvata mingħajr limitazzjonjiet fir- rigward tat- tul ta ’ żmien fl- SPC armonizzat.
Use in elderly patients: based on published data raising the possibility of renal impairment and the potential for changes in neurotransmitter sensitivity and affinity with aging, a new wording for use in elderly patients was agreed in the SPC.
Użu fil- pazjenti anzjani: fid- dawl tat- tagħrif ippubblikat li żied il- possibilità ta ’ indeboliment tal - kliewi u l- potenzjal għal tibdiliet fis- sensitività tan- newrotrażmettitur u l- affinità maż- żieda fl- età, kien hemm qbil dwar formolazzjoni ġdida tal- kliem fl- SPC.
It was agreed that “ No specific dose adjustments are considered necessary based on patient age alone”.
Kien hemm qbil li “ L- ebda aġġustament fid - doża ma huwa meħtieġ abbażi tal- età waħedha tal- pazjent ”.
However, a recommendation to exercise caution in treating elderly patients, to use the lowest effective dose and to monitor carefully elderly patients when an increase in the dose is required was also included in the harmonized SPC.
Madankollu, fl- SPC armonizzat ġiet inkluża wkoll rakkomandazzjoni biex tiġi eżerċitata kawtela fit- trattament ta ’ pazjenti anzjani, biex tintuża l- iżgħar doża effettiva u biex issir sorveljanza bir- reqqa ta ’ pazjenti anzjani meta tkun meħtieġa żieda fid- doża.
Use in children and adolescents under the age of 18 years: it was agreed that “ Venlafaxine is not recommended for use in children and adolescents”.
Użu fit- tfal u l- adolexxenti taħt it- 18- il sena: kien hemm qbil li “ Venlafaxine mhuwiex rakkomandat għall- użu fit- tfal u fl- adolexxenti ”.
Furthermore, a statement was included in the harmonized SPC to highlight that controlled studies in children did not demonstrate efficacy of venlafaxine in the “ major depressive disorder” indication.
Barra minn hekk, ġiet inkluża stqarrija fl- SPC armonizzat biex tisħaq li l- istudji kkontrollati fit- tfal ma wrewx effikaċja ta ’ venlafaxine fl- indikazzjoni tad - “ disturb dipressiv maġġuri ”.
Use in patients with hepatic impairment: it was agreed to recommend in the SPC the individualization of dosage to overcome clearance variability between patients with hepatic impairment.
9 Użu fil- pazjenti b’ indeboliment tal- fwied: kien hemm qbil li l- SPC jirrakkomanda l - individwalizzazzjoni tad- doża biex tingħeleb il- varjabilità fit- tneħħija bejn pazjenti b’ indeboliment tal - fwied.
9 Use in patients with renal impairment: it was agreed that the individualisation of the dosage may be desirable, and this concept was introduced in the text for harmonisation.
Użu fil- pazjenti b’ indeboliment tal- kliewi: kien hemm qbil li l- individwalizzazzjoni tad- doża tista ’ tkun mixtieqa, u dan il- kunċett ġie introdott fit- test għall- armonizzazzjoni.
Withdrawal symptoms seen on discontinuation of venlafaxine: based on a proposed text for the SPC for Selective Serotonin Reuptake Inhibitors (SSRIs) / Selective Norepinephrine Reuptake Inhibitors (SNRIs) (Sections 4.2, 4.4, and 4.8) reviewed by the Pharmacovigilance Working Party, it was agreed to incorporate this text into the harmonised SPC.
Sintomi ta ’ rtirar li dehru mat- twaqqif ta ’ venlafaxine: skont test propost għall- SPC għall- Inibituri Selettivi tal- Assorbiment mill- Ġdid tas- Serotonin (SSRIs) u l- Inibituri Selettivi tal- Assorbiment mill - Ġdid tan- Norepinephrine (SNRIs) (Sezzjonijiet 4. 2, 4. 4, u 4. 8) analizzati mill- Grupp ta ’ Ħidma tal - Farmakoviġilanza, kien hemm qbil li jiġi inkorporat dan it- test fl- SPC armonizzata.
SPC Section 4.3 - Contraindications The MAH was asked to harmonize Section 4.3, for which the following differences between SPCs needed to be evaluated
Sezzjoni 4. 3 tal- SPC - Kontraindikazzjonijiet Il- MAH intalab jarmonizza s- Sezzjoni 4. 3, li għal liema kellhom jiġu evalwati d- differenzi bejn l - SPCs
However, the CHMP considered that only non-selective, irreversible MAOIs should be contraindicated and that a strong warning in Section 4.4 and Section 4.5 of the SPC should be sufficient for the reversible MAOIs.
Madankollu, is- CHMP qies li l- MAOIs irriversibbli mhux selettivi biss kellhom ikunu kontraindikati u li twissija qawwija fis- Sezzjoni 4. 4 u s- Sezzjoni 4. 5 tal- SPC għandhom ikunu suffiċjenti għall- MAOIs riversibbli.
The MAH was of the view that a contraindication in patients with uncontrolled hypertension was not warranted.
Il- MAH kien tal- fehma li ma kienx hemm bżonn ta ’ kontraindikazzjoni għall- pazjenti bi pressjoni għolja mhux ikkontrollata.
Given that strong warnings recommending the monitoring of blood pressure for all patients prior to the initiation of treatment were included in Section 4.4, the CHMP agreed that a contraindication in patients with uncontrolled hypertension was not warranted.
Ġie pprovdut rapport dwar studju ġdid li kkonkluda li l- użu ta ’ venlafaxine ma kienx assoċjat ma ’ riskju eċċessiv ta ’ mewta kardijaka f’ daqqa meta mqabbel ma ’ l- SSRIs fluoxetine u citalopram jew dusolepin f’ pazjenti b’ dipressjoni jew ansjetà.
SPC Section 4.4 - Special Warnings and Precautions for Use The MAH was asked to harmonize Section 4.4, for which the following differences between SPCs needed to be evaluated:
Sezzjoni 4. 4 tal- SPC – Twissijiet Speċjali u Prekawzjonijiet għall- Użu Il- MAH intalab jarmonizza s- Sezzjoni 4. 4, li għaliha kellhom jiġu evalwati d- differenzi li ġejjin bejn l - SPCs:
A warning on the use of Efexor in the treatment of children and adolescents under the age of 18 years was also agreed upon and introduced in Section 4.4.
Kien hemm qbil ukoll li hemm bżonn ta ’ twissija fuq l- użu ta ’ Efexor fit- trattament tat- tfal u l - adolexxenti ta ’ taħt it- 18- il sena u din ġiet introdotta fis- Sezzjoni 4. 4.
SPC Section 4.5 - Interaction with other medicinal products and other forms of interaction The MAH was asked to harmonise Section 4.5 in the Summary of Product Characteristics, for which the following differences between SPCs needed to be evaluated:
Sezzjoni 4. 5 tal- SPC – Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott Il- MAH intalab jarmonizza s- Sezzjoni 4. 5 fis- Sommarju tal- Karatterisiċi tal- Prodott, li għalihom ħtieġu li jiġu evalwati dawn id- differenzi bejn l- SPCs:
The MAH wished to maintain that all MAOIs should be contraindicated whereas the CHMP considered that only non-selective, irreversible MAOIs should be contraindicated and that a strong warning in Section 4.5 of the SPC should be sufficient for the reversible MAOIs.
10 Il- MAH xtaq li l- MAOIs kollha jibqgħu kontraindikati waqt li s- CHMP qies li għandhom jiġu kontraindikati biss il- MAOIs selettivi u riversibbli u li twissija qawwija fis- Sezzjoni 4. 5 tal- SPC għandha tkun biżżejjed għall- MAOIs riversibbli.
10 SPC Section 4.8 - Undesirable effects The MAH was asked to identify differences between the listed adverse events in the nationally approved SPCs and the MAH’ s CDS, and to organise Section 4.8 according to the MedDRA system organ class.
Sezzjoni 4. 8 tal- SPC – Effetti mhux mixtieqa Il- MAH intalab jidentifika d- differenzi bejn l- avvenimenti mhux mixtieqa elenkati fl- SPCs approvati fuq livell nazzjonali u s- CDS tal- MAH, u jorganizza s- Sezzjoni 4. 8 skont il- klassifikazzjoni tas - sistema tal- organi MedDRA.
The MAH completed both the assessment of urinary disorders and of occurrence of gastrointestinal haemorrhage and agreed to add them to the adverse reaction table.
Il- MAH lestiet kemm il- valutazzjoni tad- disturbi urinarji u tal- preżenza ta ’ emoraġija gastrointestinali u qabel li jżidhom mat- tabella tar- reazzjonijiet mhux mixtieqa.
Psychomotor restlessness was also added to the table of adverse drug reactions.
Mat - tabella tar- reazzjonijiet mhux mixtieqa żdiedet ukoll l- aġitazzjoni psikometrika.
- the Summaries of Products Characteristic, labelling, package leaflet proposed by the Marketing
- is- Sommarji tal- Karatteristiċi tal- Prodott, it- tikketta, il- fuljett ta ’ tagħrif proposti mid- Detenturi tal -
the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Efexor and associated names (see Annex I).
Is- CHMP irrakkomanda l- emendar ta ’ l- Awtorizzazzjonijiet għat- Tqegħid fis- Suq li s- Sommarju tal - Karatteristiċi tal- Prodott, it- tikketta u l- fuljett ta ’ tagħrif tagħhom huma stabbiliti fl- Anness III għal Efexor u l- ismijiet assoċjati tiegħu (ara l- Anness I).
12 SUMMARY OF PRODUCT CHARACTERISTICS
12 SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT
Efexor and associated names (see Annex I) 25 mg tablets Efexor and associated names (see Annex I) 37.5 mg tablets Efexor and associated names (see Annex I) 50 mg tablets Efexor and associated names (see Annex I) 75 mg tablets
Efexor u ismijiet assoċjati miegħu (ara Anness I) pilloli ta ’ 25 mg Efexor u ismijiet assoċjati miegħu, (ara Anness I) pilloli ta ’ 37. 5 mg Efexor u ismijiet assoċjati miegħu, (ara Anness I) pilloli ta ’ 50 mg Efexor u ismijiet assoċjati miegħu, (ara Anness I) pilloli ta ’ 75 mg
The recommended starting dose of immediate-release venlafaxine is 75 mg/ day in two or three divided doses taken with food.
Id- doża tal- bidu rakkomandata ta ’ venlafaxine li jintreħa b’ mod immedjat hi ta ’ 75 mg/ kuljum maqsumin f’ żewġ jew tliet dożi li jittieħdu ma ’ l- ikel.
If clinically warranted due to symptom severity, dose increases can be made at more frequent intervals, but not less than 4 days.
Jekk ikun klinikament meħtieġ minħabba s- severità tas- sintomi, żidiet fid- dożaġġ jistgħu jsiru f’ intervalli aktar frekwenti, iżda mhux inqas minn 4 ijiem.
Patients should be treated for a sufficient period of time, usually several months or longer.
Il- pazjenti għandhom ikunu kkurati għall- perjodu suffiċjenti ta ’ żmien, normalment diversi xhur jew iktar.
Treatment should be reassessed regularly on a case-by-case basis.
Il- kura għal perjodu itwal tista ’ tkun adattata wkoll għall- prevenzjoni ta ’ rikorrenza ta ’ episodji dipressivi maġġuri (MDE).
Longer-term treatment may also be appropriate
Fil- biċċa l- kbira tal- każijiet, id- doża rakkomandata għall- prevenzjoni ta ’ rikorrenza ta ’ MDE hi l- istess bħal dik użata fl- episodju kurrenti.
14 for prevention of recurrence of major depressive episodes (MDE).
14 L- użu f’ pazjenti anzjani
No specific dose adjustments of venlafaxine are considered necessary based on patient age alone.
L- ebda aġġustamenti speċifiċi fid- dożaġġ ta ’ venlafaxine m’ huma kkunsidrati li huma meħtieġa, ibbażat fuq l- età tal- pazjent biss.
The lowest effective dose should always be used, and patients should be carefully monitored when an increase in the dose is required.
L- inqas doża effettiva għandha dejjem tintuża, u l- pazjenti għandhom ikunu mmonitorjati bl- attenzjoni meta tkun meħtieġa żieda fid- doża.
Use in children and adolescents under the age of 18 years
L- użu fit- tfal u fl- adolexxenti taħt it- 18- il sena
Because of inter-individual variability in clearance in these patients, individualisation of dosage may be desirable.
Minħabba l- varjabilità individwali fit- tneħħija f’ dawn il- pazjenti, jista ’ jkun hemm bżonn ta ’ l - individwalizzazzjoni tad- dożaġġ.
15 It is recommended that venlafaxine immediate-release tablets be taken with food, at approximately the same time each day.
Hu rakkomandat li l- pilloli ta ’ venlafaxine li jerħu b’ mod immedjat, jittieħdu ma ’ l- ikel bejn wieħed u ieħor fl- istess ħin kuljum.
Patients treated with venlafaxine immediate-release tablets may be switched to venlafaxine prolonged-release capsules at the nearest equivalent daily dosage.
Il- pazjenti kkurati b’ pilloli ta ’ venlafaxine li jerħu b’ mod immedjat jistgħu jaqilbu għal kapsuli ta ’ venlafaxine li jerħu bil- mod fl- eqreb dożaġġ ekwivalenti ta ’ kuljum.
For example, venlafaxine immediate-release tablets 37.5 mg twice daily may be switched to venlafaxine prolonged-release capsules 75 mg once daily.
Per eżempju, pilloli ta ’ venlafaxine ta ’ 37. 5 mg li jerħu b’ mod immedjat, darbtejn kuljum, jistgħu jkunu sostitwiti ma ’ kapsuli ta ’ venlafaxine ta ’ 75 mg li jerħu bil- mod, darba kuljum.
4.3 Contraindications
15 4. 3 Kontra- indikazzjonijiet
Concomitant treatment with irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated due to the risk of serotonin syndrome with symptoms such as agitation, tremor and hyperthermia.
Il- kura fl- istess ħin b’ inibituri ta ’ monoamine oxidase irriversibbli (MAOIs) hi kontra- indikata minħabba r- riskju tas- sindrome ta ’ serotonin b’ sintomi bħal aġitazzjoni, tregħid u ipertermija.
Venlafaxine must be discontinued for at least 7 days before starting treatment with an irreversible MAOI (see sections 4.4 and 4.5).
Venlafaxine għandu jitwaqqaf għal mill- inqas 7 ijiem qabel ma tinbeda l- kura b’ MAOI irriversibbli (ara sezzjonijiet 4. 4 u 4. 5).
As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
Minħabba li t- titjib jista ’ ma jseħħx matul l- ewwel ftit ġimgħat jew aktar tal- kura, il- pazjenti għandhom ikunu mmonitorjati mill- qrib sakemm iseħħ dan it- titjib.
Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment, are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
Pazjenti bi storja medika ta ’ avvenimenti marbuta mas- suwiċidju jew dawk li juru grad sinifikanti ta ’ formazzjoni ta ’ ħsieb biex jitwettaq suwiċidju qabel il- bidu tal- kura, huma magħrufa li huma f’ riskju akbar ta ’ ħsibijiet suwiċidali jew attentati ta ’ suwiċidju, u għandhom jirċievu monitoraġġ b’ attenzjoni matul il- kura.
A meta-analysis of placebo- controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Meta- analiżi ta ’ provi kliniċi kkontrollati bil- plaċebo ta ’ mediċini kontra d- dipressjoni f’ pazjenti adulti b’ disturbi psikjatriċi, uriet żieda fir- riskju ta ’ mġiba suwiċidali bl- anti- dipressanti meta mqabbla mal- plaċebo f’ pazjenti ta ’ inqas minn 25 sena.
Efexor should not be used in the treatment of children and adolescents under the age of 18 years.
Efexor m’ għandux jintuża fil- kura ta ’ tfal u adoloxxenti ta ’ taħt it- 18- il sena.
Suicide-related behaviours (suicide attempt and suicidal thoughts) and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
Imġiba marbuta mas - suwiċidju (attentat ta ’ suwiċidju u ħsibijiet suwiċidali) u ostilità (il- biċċa l- kbira aggressjoni, imġiba li topponi, u rabja) kienu osservati b’ mod aktar frekwenti fi provi kliniċi fost it- tfal u l- adolexxenti li kienu kkurati b’ anti- dipressanti, meta mqabbla ma ’ dawk ikkurati bil- plaċebo.
If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for
Jekk, madankollu, fuq bażi tal- ħtieġa klinika, tittieħed deċiżjoni li tingħata l- kura, il- pazjent għandu jkun immonitorjat bl - attenzjoni għad- dehra ta ’ sintomi suwiċidali.
In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Flimkien ma ’ dan, m’ hemmx informazzjoni dwar is - sigurtà fit- tul fit- tfal u fl- adolexxenti fir- rigward tat- tkabbir, il- maturazzjoni, u l- iżvilupp konoxxittiv u ta ’ l- imġiba.
Serotonin syndrome
Is- sindrome ta ’ serotonin
As with other serotonergic agents, serotonin syndrome, a potentially life-threatening condition, may occur with venlafaxine treatment, particularly with concomitant use of other agents, such as MAO- inhibitors, that may affect the serotonergic neurotransmitter systems (see sections 4.3 and 4.5).
Bħal ma jiġri b’ sustanzi serotonerġiċi oħrajn, is- sindrome ta ’ serotonin, kundizzjoni li potenzjalment hi ta ’ periklu għall- ħajja, tista ’ sseħħ matul il- kura b’ venlafaxine, partikolarment bl- użu fl- istess ħin
Serotonin syndrome symptoms may include mental status changes (e. g., agitation, hallucinations, coma), autonomic instability (e. g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e. g., hyperreflexia, incoordination) and/ or gastrointestinal symptoms (e. g., nausea, vomiting, diarrhoea).
Is- sintomi tas- sindrome ta ’ serotonin jistgħu jinkludu tibdil fl- istat mentali (eż., aġitazzjoni, alluċinazzjonijiet, koma), instabilità awtonomika (eż., takikardija, pressjoni tad- demm instabbli, ipertermija), aberrazzjonijiet newromuskolari (eż., iperrefleksja, nuqqas ta ’ koordinazzjoni) u/ jew sintomi gastrointestinali (eż., nawseja, rimettar, dijarea).
17 Convulsions
Konvulżjonijiet
Elderly patients, patients taking diuretics, and patients who are otherwise volume-depleted may be at greater risk for this event.
Pazjenti anzjani, pazjenti li jkunu qed jieħdu d- dijuretiċi, u pazjenti li b’ xi mod ieħor ikollhom nuqqas fil- volum tal- likwidi tal - ġisem, jistgħu jkunu f’ riskju akbar għal dan l- avveniment.
Abnormal bleeding
17 Ħruġ anormali ta ’ demm
Medicinal products that inhibit serotonin uptake may lead to reduced platelet function.
Prodotti mediċinali li jinibixxu l- assorbiment ta ’ serotonin jistgħu jwasslu għal tnaqqis fil- funzjoni tal - plejtlits.
The risk of skin and mucous membrane bleeding, including gastrointestinal haemorrhage, may be increased in patients taking venlafaxine.
Ir- riskju ta ’ ħruġ ta ’ demm fil- ġilda u l- membrana mukuża, inkluż emorraġija gastrointestinali, jista ’ jiżdied f’ pazjenti li jkunu qed jieħdu venlafaxine.
As with other serotonin-reuptake inhibitors, venlafaxine should be used cautiously in patients predisposed to bleeding, including patients on anticoagulants and platelet inhibitors.
Kif jiġri b’ mediċini oħrajn li jinibixxu l- assorbiment mill- ġdid ta ’ serotonin, venlafaxine għandu jintuża bl- attenzjoni f’ pazjenti li huma predisposti għal ħruġ ta ’ demm, li jinkludu pazjenti li jkunu qed jieħdu mediċini kontra l - koagulazzjoni tad- demm u inibituri tal- plejtlits.
Mania/ hypomania may occur in a small proportion of patients with mood disorders who have received antidepressants, including venlafaxine.
Il- manija/ ipomanija jistgħu jseħħu fi proporzjon żgħir ta ’ pazjenti b’ disturbi fil- burdata, li rċivew anti - dipressanti, li jinkludu venlafaxine.
18 Discontinuation of treatment
It- twaqqif tal- kura
Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is abrupt (see section 4.8).
Is- sintomi ta ’ meta tieqaf tieħu l- mediċina, meta titwaqqaf il- kura, huma komuni, partikularment jekk it- twaqqif isir f’ daqqa (ara sezzjoni 4. 8).
In clinical trials, adverse events seen on treatment discontinuation (tapering and post-tapering) occurred in approximately 35% of patients treated with venlafaxine and 17% of patients taking placebo.
Fil- provi kliniċi, l- avvenimenti avversi li kienu osservati meta twaqqfet il- kura (mat- twaqqif gradwali u wara t- twaqqif gradwali) seħħew f’ madwar 35% tal - pazjenti kkurati b’ venlafaxine u fi 17% tal- pazjenti li kienu qed jieħdu l- plaċebo.
The risk of withdrawal symptoms may be dependent on several factors, including the duration and dose of therapy and the rate of dose reduction.
Ir- riskju ta ’ sintomi ta ’ meta tieqaf tieħu l- mediċina jistgħu jiddependu minn diversi fatturi, li jinkludu t- tul ta ’ żmien u d- doża tat- terapija, u r- rata ta ’ tnaqqis fid- doża.
Akathisia/ psychomotor restlessness
18 Akatisija/ nuqqas ta ’ kwiet psikomotorju fil- ġisem
Lactose intolerance
Intolleranza għal- lactose
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għal galactose, ta ’ defiċjenza tal- lactase ta ’ Lapp jew ta ’ assorbiment ħażin ta ’ glucose- galactose, m’ għandhomx jieħdu din il- mediċina.
Irreversible non-selective MAOIs Venlafaxine must not be used in combination with irreversible non-selective MAOIs.
MAOIs irriversibbli u mhux selettivi Venlafaxine m’ għandux jintuża flimkien ma ’ MAOIs mhux selettivi irriversibbli.
Venlafaxine must not be initiated for at least 14 days after discontinuation of treatment with an irreversible non-selective MAOI.
Venlafaxine m’ għandux jinbeda għal mill- inqas 14- il jum wara t- twaqqif tal- kura b’ MAOI irriversibbli u mhux selettiv.
Venlafaxine must be discontinued for at least 7 days before starting treatment with an irreversible non-selective MAOI (see sections 4.3 and 4.4).
Venlafaxine għandu jitwaqqaf għal mill- inqas 7 ijiem qabel ma tinbeda l- kura b’ MAOI mhux selettiv irriversibbli (ara sezzjonijiet 4. 3 u 4. 4).
Following treatment with a reversible MAO-inhibitor, a shorter withdrawal period than 14 days may be used before initiation of venlafaxine 19 treatment.
Wara l- kura b’ inibitur riversibbli ta ’ MAO, perjodu iqsar minn 14- il- jum mit- twaqqif tal- mediċina, jista ’ jintuża qabel il- bidu tal- kura b’ venlafaxine.
Reversible, non-selective MAOI (linezolid) The antibiotic linezolid is a weak reversible and non-selective MAOI and should not be given to patients treated with venlafaxine (see section 4.4).
MAOI riversibbli u mhux selettiv (linezolid) L- antibijotiku linezolid hu MAOI dgħajjef riversibbli u mhux selettiv u m’ għandux jingħata lil pazjenti kkurati b’ venlafaxine (ara sezzjoni 4. 4).
As with other serotonergic agents, serotonin syndrome may occur with venlafaxine treatment, particularly with concomitant use of other agents that may affect the serotonergic neurotransmitter system (including triptans, SSRIs, SNRIs, lithium, sibutramine, tramadol, or St.
Bħal ma jiġri b’ mediċini serotonerġiċi oħrajn, is- sindrome ta ’ serotonin tista ’ jseħħ bil- kura ta ’ venlafaxine, partikolarment bl- użu fl- istess ħin ta ’ mediċini li jistgħu jaffettwaw lis- sistema tan - newrotrasmettitur serotonerġiku (li jinkludu triptans, SSRIs, SNRIs, lithium, sibutramine, tramadol, jew St.
If concomitant treatment of venlafaxine with an SSRI, an SNRI or a serotonin receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
L- użu fl- istess ħin ta ’
The concomitant use of venlafaxine with serotonin precursors (such as tryptophan supplements) is not recommended (see section 4.4).
19 venlafaxine ma ’ prekursuri ta ’ serotonin (bħal supplimenti ta ’ tryptophan) mhuwiex rakkomandat (ara sezzjoni 4. 4).
CNS-active substances
Sustanzi attivi tas- CNS
Venlafaxine has been shown not to increase the impairment of mental and motor skills caused by ethanol.
Intwera li venlafaxine ma jżidx l- indeboliment tal- ħiliet mentali u tal- moviment ikkawżati mill - ethanol.
Ketoconazole (CYP3A4 inhibitor) A pharmacokinetic study with ketoconazole in CYP2D6 extensive (EM) and poor metabolisers (PM) resulted in higher AUC of venlafaxine (70% and 21% in CYP2D6 PM and EM subjects, respectively) and O-desmethylvenlafaxine (33% and 23% in CYP2D6 PM and EM subjects, respectively) following administration of ketoconazole.
Ketoconazole (Inibitur ta ’ CYP3A4) Studju farmakokinetiku b’ ketoconazole f’ metabolizzaturi estensivi (EM) u batuti (PM) ta ’ CYP2D6, irriżulta f’ AUC ogħla ta ’ venlafaxine (70% u 21% f’ individwi CYP2D6 PM u EM, rispettivament) u ta ’ O- desmethylvenlafaxine (33% u 23% f’ suġġetti CYP2D6 PM u EM, rispettivament) wara l- għoti ta ’ ketoconazole.
20 Effect of venlafaxine on other medicinal products
L- effett ta ’ venlafaxine fuq prodotti mediċinali oħra
Lithium Serotonin syndrome may occur with the concomitant use of venlafaxine and lithium (see Serotonin syndrome).
Lithium Is- sindrome ta ’ serotonin tista ’ jseħħ bl- użu fl- istess ħin ta ’ venlafaxine u lithium (ara Is- sindrome ta ’ serotonin).
Imipramine Venlafaxine did not affect the pharmacokinetics of imipramine and 2-OH-imipramine.
Imipramine Venlafaxine ma affettwax il- farmakokinetika ta ’ imipramine u 2- OH- imipramine.
Metoprolol Concomitant administration of venlafaxine and metoprolol to healthy volunteers in a pharmacokinetic interaction study for both medicinal products resulted in an increase of plasma concentrations of metoprolol by approximately 30-40% without altering the plasma concentrations of its active metabolite, α -hydroxymetoprolol.
20 Metoprolol L- għoti fl- istess ħin ta ’ venlafaxine u metoprolol lil voluntiera b’ saħħithom fi studju dwar l - interazzjoni farmakokinetika għaż- żewġ prodotti mediċinali rriżulta f’ żieda tal- konċentrazzjonijiet fil - plażma ta ’ metoprolol b’ madwar 30- 40% mingħajr l- ebda tibdil fil- konċentrazzjonijiet fil- plażma tal - metabolit attiv tiegħu, α- hydroxymetoprolol.
21 Indinavir A pharmacokinetic study with indinavir has shown a 28% decrease in AUC and a 36% decrease in Cmax for indinavir.
Indinavir Studju dwar il- farmakokinetika b’ indinavir wera tnaqqis ta ’ 28% fl- AUC u tnaqqis ta ’ 36% fis- Cmax għal indinavir.
These symptoms may be due to either serotonergic effects or exposure symptoms.
Dawn is - sintomi jistgħu jkunu kkawżati jew minħabba effetti serotonerġiċi jew minħabba effetti minħabba l - espożizzjoni.
Therefore, a decision to continue/ discontinue breast-feeding or to continue/ discontinue therapy with Efexor should be made, taking into account the benefit of breast-feeding to the child and the benefit of Efexor therapy to the woman.
Għalhekk għandha tittieħed deċiżjoni li t- treddigħ jitkompla/ jitwaqqaf jew li t- terapija b’ Efexor titkompla/ titwaqqaf, billi jkun ikkunsidrat il- benefiċċju tat- treddigħ lit- tarbija u l- benefiċċju tat- terapija ta ’ Efexor lill- mara.
Frequencies are defined as: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100), rare (≥ 1/ 10,000 to < 1/ 1,000), not known (cannot be estimated from the available data).
21 Il- frekwenzi huma definiti kif ġej: komuni ħafna (≥1/ 10), komuni (≥1/ 100 sa < 1/ 10%), mhux komuni (≥1/ 1, 000 sa < 1/ 100), rari (≥1/ 10, 000 sa < 1/ 1, 000), mhux magħrufa (ma tistax tittieħed stima mid - dejta disponibbli).
22 Body System
Sistema tal - Ġisem
Common Haematological/ Lymphatic
Sistema Ematoloġika / Limfatika
Mucous membrane bleeding, Prolonged bleeding time, Thrombocytopaenia, Blood dyscrasias, (including agranulocytosis, aplastic anaemia, neutropaenia and pancytopaenia)
Ħruġ ta ’ demm mill- membrana mukuża, Titwil fil - ħin ta ’ kemm idum ħiereġ id- demm, Tromboċitopenja, Diskrasiji tad - demm, (li jinkludu agranuloċitosi, anemija aplastika, newtropenja u panċitopenja)
Serum cholesterol increased, Weight loss
Żieda fil- kolesterol fis- serum, Telf fil - piż
Abnormal liver function tests, Hyponatraemia, Hepatitis, Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH), Prolactin increased
Testijiet tal - funzjoni tal- fwied b’ riżultat anormali, Iponatremija, Epatite, Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH), Żieda fil - Prolactin
Nervous
Sistema Nervuża
Dry mouth (10.0%), Headache (30.3%)*
Ħalq xott (10. 0%),
Abnormal dreams, Decreased libido, Dizziness, Increased muscle tonus (hypertonia), Insomnia, Nervousness, Paresthesia, Sedation, Tremor, Confusion, Depersonalisation
Sturdament, Żieda fit- tonus tal- muskoli (ipertonija), Nuqqas ta ’ rqad, Nervożità, Parestesija, Sedazzjoni, Tregħid,
Akathisia/ Psychomotor restlessness, Convulsion, Manic reaction
kwiet psikomotor ju f’ ġismek, Konvulżjon i,
Neuroleptic Malignant Syndrome (NMS), Serotonergic syndrome, Delirium, Extrapyramidal reactions (including dystonia and dyskinaesia), Tardive dyskinaesia, Suicidal ideation and behaviours**
(NMS), Sindrome Serotonerġiku, Delirju, Reazzjonijiet Extrapiramidali (li jinkludu distonja u
Special Senses
Konfużjoni,
Abnormality of accommodation, Mydriasis, Visual disturbance,
Reazzjoni
Altered taste sensation, Tinnitus
diskinesija),
Angle-closure glaucoma
Dipersonalizzazzjoni
Cardiovascular
Manika
Hypertension, Vasodilatation (mostly hot flashes/ flushes), Palpitations
Diskinesija tardiva, Ħsieb biex jitwettaq suwiċidju u mġiba suwiċidali **
Postural hypotension, Syncope, Tachycardia
Sensi Speċjali
Hypotension, QT prolongation, Ventricular fibrillation, Ventricular tachycardia (including torsade de pointes)
Anormalità ta ’ l -
Respiratory
Sensazzjoni ta ’
Yawning
Glawkoma tat- tip
Pulmonary eosinophilia
Sistema Kardjovaskular i
Digestive
Palpitazzjonijiet
Nausea (20.0%)
Takikardija
Appetite decreased (anorexia), Constipation, Vomiting
ventrikulari, Takikardija Ventrikulari (li tinkludi torsade de pointes)
Bruxism, Diarrhoea
Sistema tal - Ġisem
Pancreatitis
Komuni Ħafna
23 Body System
Komuni
Very
Mhux Komuni
Uncommon
Mhux Magħrufa
Rare
Titwib
Not Known
Nawseja (20. 0%)
Common Skin
Pankreatite
Erythema multiforme, Toxic epidermal necrolysis, Stevens- Johnson syndrome, Pruritus, Urticaria
Eritema multiforme, Nekrolisi epidermali tossika, Sindrome ta ’ Stevens- Johnson, Ħakk, Urtikarja Rabdomijolosi
Musculoskeletal
mu anormali (irġiel),
Rhabdomyolysis
Orgażmu
Urogenital
Uroġenitali
Abnormal ejaculation/ orgasm (males), Anorgasmia, Erectile dysfunction (impotence), Urination impaired (mostly hesitancy), Menstrual disorders associated with increased bleeding or increased irregular bleeding (e. g., menorrhagia, metrorrhagia), Pollakiuria
Anorgażmija, Disfunzjoni erettili (impotenza), Indeboliment meta tagħmel l- awrina (l - aktar dewmien biex tibda tagħmel l - awrina), Disturbi tal - mestrwazzjoni assoċjati ma ’ żieda fil- ħruġ tad- demm jew żieda fil- ħruġ ta ’ demm irregolari (eż., mestrwazzjoni esaġerata, tnixxija anormali tad- demm mill- ġuf), pollakijurja
Asthenia (fatigue), Photosensitivit Chills y reaction
Astenja (għeja kbira), Tkexkix ta ’ bard
Discontinuation of venlafaxine (particularly when abrupt) commonly leads to withdrawal symptoms.
It- twaqqif ta ’ venlafaxine (partikularment meta jsir f’ daqqa) ġeneralment iwassal għal sintomi ta ’ meta tieqaf tieħu l- mediċina.
Generally, these events are mild to moderate and are self-limiting; however, in some patients, they may be severe and/ or prolonged.
Għalhekk hu
It is therefore advised that when venlafaxine treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see sections 4.2 and 4.4).
23 rakkomandat li meta l- kura b’ venlafaxine ma tkunx meħtieġa aktar, għandu jsir it- twaqqif gradwali tad- doża (ara sezzjonijiet 4. 2 u 4. 4).
24 Particularly, the following adverse reactions were observed in paediatric patients: abdominal pain, agitation, dyspepsia, ecchymosis, epistaxis, and myalgia.
Partikularment, ir- reazzjonijiet avversi li ġejjin kienu osservati f’ pazjenti pedjatriċi: uġigħ ta ’ żaqq, aġitazzjoni, dispepsja, ekkimożi, tifriġ, u mijalġja.
The most commonly reported events in overdose include tachycardia, changes in level of consciousness (ranging from somnolence to coma), mydriasis, convulsion, and vomiting.
L- iktar avvenimenti rrappurtati b’ mod komuni f’ każ ta ’ doża eċċessiva jinkludu takikardija, tibdil fil- livell ta ’ koxjenza (li jvarja minn ngħas sa koma), midrijasi, konvulżjoni, u rimettar.
Prescriptions for venlafaxine should be written for the smallest quantity of the medicinal product consistent with good patient management in order to reduce the risk of overdose.
Riċetti għal venlafaxine għandhom jinkitbu għall- iżgħar kwantità tal - prodott mediċinali li hi konsistenti ma ’ immaniġġjar tajjeb tal- pazjent, sabiex jitnaqqas ir- riskju ta ’ doża eċċessiva.
Forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to be of benefit.
Dijuresi sfurzata, dijalisi, emoperfużjoni u trasfużjoni ta ’ skambju humiex mistennija li jkunu ta ’ benefiċċju.
Venlafaxine and ODV are very similar with respect to their overall action on neurotransmitter reuptake and receptor binding.
Venlafaxine u ODV huma 24 simili ħafna fir- rigward ta ’ azzjoni totali tagħhom fuq l- assorbiment mill- ġdid tan- newrotrasmettituri u t- twaħħil mar- riċettur.
25 Major depressive episodes
Episodji dipressivi maġġuri
The efficacy of venlafaxine immediate-release as a treatment for major depressive episodes was demonstrated in five randomised, double-blind, placebo-controlled, short-term trials ranging from 4 to 6 weeks duration, for doses up to 375 mg/ day.
L- effikaċja ta ’ venlafaxine li jerħi b’ mod immedjat bħala kura għal episodji dipressivi maġġuri kienet murija f’ ħames provi kliniċi randomised, double- blind u kkontrollati bil- plaċebo, li damu żmien qasir, minn 4 sa 6 ġimgħat, għal dożi sa 375 mg/ kuljum.
The efficacy of venlafaxine prolonged-release as a treatment for major depressive episodes was established in two placebo-controlled, short-term studies for 8 and 12 weeks duration, which included a dose range of 75 to 225 mg/ day.
L- effikaċja ta ’ venlafaxine li jerħi bil- mod bħala kura għal episodji dipressivi maġġuri, kienet stabbilita f’ żewġ studji kkontrollati bil- plaċebo, li damu 8 u 12- il ġimgħa, li kienu jinkludu medda ta ’ doża ta ’ 75 sa 225 mg/ kuljum.
Venlafaxine is extensively metabolised, primarily to the active metabolite, O-desmethylvenlafaxine (ODV).
Venlafaxine hu metabolizzat b’ mod estensiv, primarjament għall- metabolit attiv O- desmethylvenlafaxine (ODV).
Metabolism
25 Metaboliżmu
In vitro and in vivo studies indicate that venlafaxine is metabolised to a minor, less active metabolite, N-desmethylvenlafaxine, by CYP3A4.
Studji in vitro u in vivo jindikaw li venlafaxine ikun metabolizzat għal metabolit minuri, inqas attiv, N- desmethylvenlafaxine, minn CYP3A4.
26 Elimination
Eliminazzjoni
Patients with hepatic impairment In Child-Pugh A (mildly hepatically impaired) and Child-Pugh B (moderately hepatically impaired) subjects, venlafaxine and ODV half-lives were prolonged compared to normal subjects.
Pazjenti b’ indeboliment epatiku F’ pazjenti b’ Child- Pugh A (indeboliment epatiku ħafif) u Child- Pugh B (indeboliment epatiku moderat), il- half- lives ta ’ venlafaxine u ODV kienu itwal, meta mqabbla ma ’ individwi normali.
The oral clearance of both venlafaxine and ODV was reduced.
It - tneħħija orali kemm ta ’ venlafaxine kif ukoll ta ’ ODV kienet imnaqqsa.
Dosage adjustment is necessary in patients with severe renal impairment and in patients that require haemodialysis (see section 4.2).
L- aġġustament fid - dożaġġ hu meħtieġ f’ pazjenti b’ indeboliment renali sever u f’ pazjenti li jeħtieġu l- emodijalisi (ara sezzjoni 4. 2).
Reduced fertility was observed in a study in which both male and female rats were exposed to ODV.
26 Tnaqqis fil- fertilità kien osservat fi studju li fih kemm firien irġiel u kemm nisa kienu esposti għal ODV.
29 LABELLING
29 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
CARTON/ BOTTLE/ TABLET CONTAINER
KARTUNA/ FLIXKUN/ KONTENITUR TAL- PILLOLI
Efexor and associated names (see Annex I) 25 mg tablets
Efexor u ismijiet assoċjati miegħu (ara Anness I), pilloli ta ’ 25 mg
32 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
31 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
CARTON/ BOTTLE/ TABLET CONTAINER
KARTUNA/ FLIXKUN/ KONTENTITUR TAL- PILLOLI
Efexor and associated names (see Annex I) 37.5 mg tablets
Efexor u ismijiet assoċjati miegħu (ara Anness I), pilloli ta ’ 37. 5 mg
34 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
33 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Efexor and associated names (see Annex I) 50 mg tablets
Efexor u ismijiet assoċjati miegħu (ara Anness I), pilloli ta ’ 50 mg
36 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
35 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Efexor and associated names (see Annex I) 75 mg tablets
Efexor u ismijiet assoċjati miegħu (ara Anness I), pilloli ta ’ 75 mg