qanastek/EMEA-V3 huggingface dataset:
Driving and using machines It should be taken into account that some people feel dizzy and sleepy after taking EMEND.
Sewqan u tħaddim ta 'magni Għandu jiġi kkunsidrat li xi persuni jistordu jew jitħedlu wara li jieħdu EMEND.
The recommended oral dose of EMEND is one 125 mg capsule 1 hour before you start your chemotherapy treatment on Day 1 and one 80 mg capsule each morning for the 2 days following your chemotherapy treatment.
Id- doża orali rakkomandata ta 'EMEND hi kapsula waħda ta' 125 mg minn ħalqek siegħa qabel ma tibda t- terapija tal- kimoterapija tiegħek u kapsula waħda ta '80 mg kull filgħodu għal jumejn fuq xulxin wara t- trattament kimoterapewtiku tiegħek.
Your doctor may substitute fosaprepitant 115 mg (which is converted to aprepitant in your body) for oral EMEND (125 mg) on Day 1 only of your treatment.
It- tabib tiegħek jista ’ jissostitwixxi EMEND (125 mg) li jittieħed mill- ħalq ma ’ fosaprepitant 115 mg (li huwa maqlub għal aprepitant f’ ġismek) għal EMEND (125 mg) li jittieħed mill- ħalq f’ Jum 1 biss tal - kura tiegħek.
Fosaprepitant is given via an intravenous infusion (a drip), 30 minutes prior to chemotherapy.
Fosaprepitant jingħata permezz ta ’ infużjoni ġol- vini (dripp), 30 minuta qabel kemjoterapija, f’ Jum 1 biss.
You will still need to take one 80 mg capsule by mouth of EMEND each morning for the 2 days following your chemotherapy treatment.
Jeħtieġ li xorta waħda tieħu kapsula waħda ta ’ 80 mg ta ’ EMEND mill - ħalq kull filgħodu għall- jumejn ta ’ wara l- kura tiegħek bil- kemjoterapija.
If you take more EMEND than you should Do not take more capsules than the doctor recommends.
Jekk tieħu EMEND aktar milli suppost Tieħux aktar kapsuli mill- ammont rakkomandat mit- tabib.
If you do take too many capsules, contact your doctor immediately.
Jekk tieħu aktar kapsuli milli suppost, għarraf lit- tabib tiegħek minnufih.
If you forget to take EMEND If you have missed a dose, contact your doctor for advice.
Jekk tinsa tieħu EMEND Jekk insejt tieħu xi doża, ikkuntattja lit- tabib tiegħek għal parir.
The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data).
Il- frekwenza ta ’ effetti sekondarji possibbli elenkati taħt hija definite permezz tal- konvenzjoni li ġejja: komuni ħafna (taffettwa aktar minn utent 1 minn kull 10) komuni (taffettwa 1 sa 10 utent minn kull 100) mhux komuni (taffettwa 1 sa 10 utent minn kull 1, 000) rari (taffettwa 1 sa 10 utent minn kull 10, 000) rari ħafna (taffettwa inqas minn utent 1 minn kull 10, 000) mhux magħrufa (il- frekwenza ma tistax tiġi stmata mit- tagħrif disponibbli).
80 Common side effects are: burping, constipation, diarrhoea, dizziness, weakness, tiredness, headache, hiccups, indigestion, loss of appetite, and increased liver enzymes.
84 Effetti sekondarji komuni: tifwieq, stitikezza, dijarrea, sturdament, għejja, uġigħ ta 'ras, sulluzzu, indiġestjoni, jonqos l- aptit, u żieda fl- enżimi tal- fwied.
Uncommon side effects are: abnormal dreaming, acne, anxiousness, bacterial infection, bloating, blood in the urine, chest discomfort, cough, difficulty thinking, disorientation, dry mouth, eye discharge and itching, euphoria (feeling of extreme happiness), excessive sweating, excessive thirst, fever with increased risk of infection, fungal infection, heartburn, high sugar levels in the blood, hot flush, increased painful or burning urination, inflammation of the small intestine and colon, itching, low sodium levels in the blood, lowering of red blood cells, mucus in back of throat, muscle cramp or pain, nausea, oily skin, passing wind, presence of red blood cells in the urine, rash, reddening of the face, ringing in the ear, sensitivity to light, severe constipation, slow heartbeat, sneezing, sore throat, sores in mouth, sores on skin, stomach pain, stomach ulcer, swelling, taste disturbance, throat irritation, vomiting, and weight gain or loss.
Effetti sekondarji oħra mhux komuni: ħolm mhux normali, akne, ansjetà, infezzjoni batterika, tinfiħ, demm fl- awrina, skumdità fis- sider, sogħla, diffikultà biex taħseb, disorjentazzjoni, ħalq niexef, tnixxija mill- għajn u ħakk, ewforja, għariq b' mod eċċessiv, għatx kbir ħafna, deni b' riskju ogħla ta 'infezzjoni, infezzjoni fungali, qrusa ta' l- istonku, livelli għoljin taz- zokkor fid- demm, ħmurija tas - sħana, awrina b' aktar uġigħ jew bil- ħruq, ħakk, livelli tas- sodju baxxi fid- demm, għadd imnaqqas fiċ - ċelloli tad- demm, mukus fil- parti ta 'wara tal- griżmejn, bugħawwieġ jew uġigħ, nawsea, ġilda żejtnija, tbasbis, raxx, ħmurija tal- wiċċ, ċempil fil- widnejn, sensittività għad- dawl, qalb tħabbat bil- mod, għatis, uġigħ fil- ġriżmejn, pustumetti fil- ħalq, uġigħ fil- ġilda, uġigħ fl- istonku, ulċera fl- istonku, tinfiħ, disturb fit- togħma, rimettar, u żieda jew tnaqqis fil- piż.
Stevens-Johnson syndrome (rare severe skin reaction), angioedema (swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing), serious constipation, small bowel not working properly (sub-ileus), and urticaria (hives).
Sindromu ta 'Stevens - Johnson (reazzjoni severa rari fuq il- ġilda), anġjodema (nefħa fil- wiċċ, fix- xofftejn, fil- ħalq, fl- ilsien u fil- griżmejn li tista' tikkaġuna diffikultà biex wieħed jibla 'jew jieħu n- nifs), stitikezza serja, l- intestin iż- żgħir ma jaħdimx tajjeb (sub- ileus) u urtikarja (infafet).
The other ingredients are: sucrose, microcrystalline cellulose (E 460), hydroxypropyl cellulose (E 463), sodium laurilsulfate, gelatin, titanium dioxide (E 171), shellac, potassium hydroxide, and black iron oxide (E 172).
Is- sustanzi l- oħra huma: sukrożju, microcrystalline cellulose (E 460), hydroxypropyl cellulose (E 463), sodium laurilsulfate, gelatin, titanium dioxide (E 171), xellak, potassium hydroxide u black iron oxide (E 172).
What EMEND looks like and contents of the pack The 80 mg hard capsule is opaque with a white cap and body with “461” and “80 mg” printed radially in black ink on the body.
Id- dehra ta 'EMEND u d- daqs tal- pakkett Il- kapsula iebsa ta' 80 mg hi opaka b' għatu u korp bajdani b '“ 461 ” u “ 80 mg ” stampati b' mod radjali b' linka sewda fuq il- korp.
81 EMEND 80 mg hard capsules are supplied in the following pack sizes: • Aluminium blister containing one 80 mg capsule • 2-day treatment pack containing two 80 mg capsules • 5 Aluminium blisters each containing one 80 mg capsule
85 EMEND kapsuli iebsin 80 mg huma fornuti f' pakketti bid- daqsijiet li ġejjin: • Folja ta ’ l- aluminju li fihom fiha kapsula waħda 80 mg • Pakkett ta 'trattament ta' jumejn li fih żewġ kapsuli 80 mg • 5 folji ta ’ l- aluminju li kull waħda fiha kapsula waħda ta '80 mg
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
Eλλάδα BIANEΞ Α.Ε Τηλ: +3 0210 80091 11 Mailbox@vianex.gr.
86 Eλλάδα BIANEΞ Α. Ε Τηλ: +3 0210 80091 11 Mailbox@ vianex. gr.
83 PACKAGE LEAFLET:
87 FULJETT TA ’ TAGĦRIF:
EMEND 125 mg hard capsules aprepitant
EMEND kapsuli iebsin 125 mg aprepitant
You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you.
Jista jkollok bżonn terġa ’ taqrah. • Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek. • Din il- mediċina ġiet preskritta lilek.
EMEND is used in combination with other medicines to prevent nausea and vomiting caused by chemotherapy (cancer treatment).
EMEND jintuża f’ kombinazzjoni ma ’ mediċini oħrajn biex jimpedixxi nawsja u rimettar ikkawżati minn wara kirurġija.
By blocking the receptors, EMEND can prevent nausea and vomiting, which often happens during and after chemotherapy.
Billi jimblokka r- riċetturi, EMEND jista ’ jimpedixxi nawsja u rimettar, li spiss iseħħu bħala kumplikazzjoni tal- kirurġija
Tell your doctor if you are taking these medicines since your treatment must be modified before you start taking EMEND.
Għid lit- tabib tiegħek jekk tkun qed tieħu dawn il- prodotti minħabba li t- trattament tiegħek jeħtieġ jiġi mmodifikat qabel tibda tieħu EMEND.
EMEND is not for use in children and adolescents under 18 years.
EMEND ma għandux jintuża minn tfal u adoloxxenti taħt it- 18- il sena
EMEND can affect other medicines both during and after treatment with EMEND.
EMEND jista ’ jaffettwa mediċini oħra kemm matul kif ukoll wara trattament b’ EMEND.
There are some medicines that should not be taken with EMEND or that require a dosage adjustment (see also Do not take EMEND).
Hemm xi mediċini li ma għandhomx jittieħdu ma ’ EMEND jew li jeħtieġu aġġustament fid- dożaġġ (ara wkoll Tieħux EMEND).
Taking EMEND with food and drink EMEND can be taken with or without food.
Meta tieħu EMEND ma ’ ikel u xorb EMEND jista ’ jittieħed ma ’ l- ikel kif ukoll mhux ma ’ l- ikel.
84 Pregnancy and breast-feeding You should not use EMEND during pregnancy unless clearly necessary.
88 Tqala u treddigħ M' għandekx tieħu EMEND waqt it- tqala għajr jekk mhux tassew meħtieġ.
Birth control medicines (oral contraceptives) may not work adequately; another form of contraception should be used during treatment with EMEND and for up to 2 months after using EMEND.
Mediċini li jikkontrollaw it- twelid (kontraċettivi orali) jistgħu ma jaħdmux daqshekk adegwatament; għandha tintuża għamla oħra ta 'kontraċezzjoni waqt it- trattament b' EMEND u sa xahrejn wara t- teħid ta' EMEND.
The recommended oral dose of EMEND is one 125 mg capsule 1 hour before you start your chemotherapy treatment on Day 1and one 80 mg capsule each morning for the 2 days following your chemotherapy treatment.
Id- doża rakkomandata ta 'EMEND hi kapsula waħda ta' 125 mg siegħa qabel ma tibda t- terapija tal- kemjoterapija tiegħek. u kapsula waħda ta '80 mg kull filgħodu għal jumejn fuq xulxin wara t- trattament kemjoterapewtiku tiegħek.
Your doctor may substitute fosaprepitant 115 mg (which is converted to aprepitant in your body) for oral EMEND (125 mg) on Day 1 only of your treatment.
It- tabib jista ’ jissostitwixxi fosaprepitant 115 mg (li jinqeleb f’ aprepitant f’ ġismek) għal EMEND orali (125 mg) f’ Jum 1 biss tal- kura tiegħek.
Fosaprepitant is given via an intravenous infusion (a drip), 30 minutes prior to chemotherapy.
Fosaprepitant jingħata permezz ta ’ infużjoni ġol- vini (dripp), 30 minuta qabel il- kimoterapija.
You will still need to take one 80 mg capsule by mouth of EMEND each morning for the 2 days following your chemotherapy treatment.
Xorta waħda tkun teħtieġ tieħu kapsula ta ’ 80 mg ta ’ EMEND mill - ħalq kull filgħodu għal jumejn wara l- kura tiegħek għall- kimoterapija.
EMEND should be swallowed whole with some liquid.
EMEND għandu jinbela sħiħ ma ’ xi likwidu.
The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data).
89 komuni (taffettwa 1 sa 10 utent minn kull 100) mhux komuni (taffettwa 1 sa 10 utent minn kull 1, 000) rari (taffettwa 1 sa 10 utent minn kull 10, 000) rari ħafna (taffettwa inqas minn utent 1 minn kull 10, 000) mhux magħrufa (il- frekwenza ma tistax tiġi stmata mit- tagħrif disponibbli).
85 Common side effects are: burping, constipation, diarrhoea, dizziness, weakness, tiredness, headache, hiccups, indigestion, loss of appetite, and increased liver enzymes.
Effetti sekondarji komuni: tifwieq, stitikezza, dijarrea, sturdament, għejja, uġigħ ta 'ras, sulluzzu, indiġestjoni, jonqos l- aptit, u żieda fl- enżimi tal- fwied.
Stevens-Johnson syndrome (rare severe skin reaction), angioedema (swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing), serious constipation, small bowel not working properly (sub-ileus), and urticaria (hives).
Sindromu ta 'Stevens - Johnson (reazzjoni severa rari fuq il- ġilda), anġjodema (nefħa fil- wiċċ, fix- xofftejn, fil- ħalq, fl- ilsien u fil- griżmejn li tista' tikkaġuna diffikultà biex wieħed jibla 'jew jieħu n- nifs), stitikezza serja, il- musrana ż- żgħira ma taħdimx tajjeb (sub- ileus) u urtikarja (infafet).
The other ingredients are: sucrose, microcrystalline cellulose (E 460), hydroxypropyl cellulose (E 463), sodium laurilsulfate, gelatin, titanium dioxide (E 171), shellac, potassium hydroxide, black iron oxide (E 172), red iron oxide (E 172) and yellow iron oxide (E 172).
L- ingredjenti l- oħra huma: sukrożju, microcrystalline cellulose (E 460), hydroxypropyl cellulose (E 463), sodium laurilsulfate, gelatin, titanium dioxide (E 171), xellak, potassium hydroxide, black iron oxide (E 172), red iron oxide (E 172) u yellow iron oxide (E 172).
What EMEND looks like and contents of the pack The 125 mg hard capsule is opaque with a white body and pink cap with “462” and “125 mg” printed radially in black ink on the body.
90 Il- kapsuli iebsin ta '125 mg huma opaki b' għamla bajda u b' kappa roża b' “ 462 ” u “ 125 mg ” stampati b' mod radjali b' linka sewda fuq il- korp.
86 EMEND 125 mg hard capsules are supplied in the following pack sizes: • Aluminum blister containing one 125 mg capsule • 5 Aluminum blisters each containing one 125 mg capsule
Il- kapsuli iebsin ta 'EMEND 125 mg huma fornuti f' pakketti bid- daqsijiet li ġejjin: • Folja ta ’ l- aluminju li fiha kapsula waħda ta' EMEND 125 mg • 5 folji ta ’ l- aluminju li kull waħda fiha kapsula waħda ta 'EMEND 125 mg
Eesti Merck Sharp & Dohme OÜ Tel.: +372 613 9750 msdeesti@merck.com
Eesti Merck Sharp & Dohme OÜ Tel.: +372 613 9750
Ísland Icepharma hf.Simi: +354 540 8000 Ismail@merck.com
Simi: +354 520 8600 ISmail@ merck. com
88 PACKAGE LEAFLET:
92 FULJETT TA ’ TAGĦRIF:
EMEND 125 mg hard capsules EMEND 80 mg hard capsules aprepitant
EMEND 125 mg kapsuli iebsin EMEND 80 mg kapsuli iebsin aprepitant
Do not take EMEND • If you are allergic (hypersensitive) to aprepitant or any of the other ingredients of EMEND.
Tieħux EMEND • jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal aprepitant jew sustanzi oħra ta ’ EMEND.
Taking EMEND with food and drink EMEND can be taken with or without food.
93 Meta tieħu EMEND ma ’ ikel u xorb EMEND jista ’ jittieħed ma ’ l- ikel kif ukoll mhux ma ’ l- ikel
89 Pregnancy and breast-feeding You should not use EMEND during pregnancy unless clearly necessary.
Tqala u treddigħ M' għandekx tuża 'EMEND waqt it- tqala sakemm ma jkunx hemm bżonn li tagħmel hekk.
Birth control medicines (oral contraceptives) may not work adequately; another form of contraception should be used during treatment with EMEND and for up to 2 months after using EMEND.
Mediċini li jikkontrollaw it- twelid (kontraċettivi orali) jistgħu ma jaħdmux adegwatament; għandha tintuża għamla oħra ta 'kontraċezzjoni waqt it- trattament b' EMEND u sa xahrejn wara t- teħid ta' EMEND.
The recommended oral dose of EMEND is one 125 mg capsule 1 hour before you start your chemotherapy treatment on Day 1 and one 80 mg capsule each morning for the 2 days following your chemotherapy treatment.
Id- doża orali rakkomandata ta 'EMEND hi kapsula waħda ta' 125 mg minn ħalqek siegħa qabel ma tibda t- terapija tal- kemjoterapija tiegħek. u kapsula waħda ta '80 mg kull filgħodu għal jumejn fuq xulxin wara t- trattament kemjoterapewtiku tiegħek.
Your doctor may substitute fosaprepitant 115 mg (which is converted to aprepitant in your body) for oral EMEND (125 mg) on Day 1 only of your treatment.
It- tabib tiegħek jista ’ jissostitwixxi fosaprepitant 115 mg (li huwa maqlub għal aprepitant f’ ġismek) għal EMEND (125 mg) li jittieħed mill- ħalq f’ Jum 1 biss tal- kura tiegħek.
Fosaprepitant is given via an intravenous infusion (a drip), 30 minutes prior to chemotherapy.
Fosaprepitant jingħata permezz ta ’ infużjoni ġol- vini (dripp), 30 minuta qabel il- kemjoterapija.
You will still need to take one 80 mg capsule by mouth of EMEND each morning for the 2 days following your chemotherapy treatment.
Jeħtieġ li xorta waħda tieħu kapsula waħda ta ’ 80 mg ta ’ EMEND mill- ħalq kull filgħodu għall- jumejn ta ’ wara l- kura tiegħek bil - kemjoterapija.
If you forget to take EMEND If you have missed a dose, contact your doctor for advice.
Jekk tieħu aktar kapsuli milli suppost, għarraf lit- tabib tiegħek minnufih.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Jekk tinsa tieħu EMEND Jekk insejt tieħu xi doża, ikkuntattja lit- tabib tiegħek għal parir.
The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data).
94 Il- frekwenza ta ’ effetti sekondarji possibbli elenkati taħt hija definite permezz tal- konvenzjoni li ġejja: komuni ħafna (taffettwa aktar minn utent 1 minn kull 10) komuni (taffettwa 1 sa 10 utent minn kull 100) mhux komuni (taffettwa 1 sa 10 utent minn kull 1, 000) rari (taffettwa 1 sa 10 utent minn kull 10, 000) rari ħafna (taffettwa inqas minn utent 1 minn kull 10, 000) mhux magħrufa (il- frekwenza ma tistax tiġi stmata mit- tagħrif disponibbli).
90 Common side effects are: burping, constipation, diarrhoea, dizziness, weakness, tiredness, headache, hiccups, indigestion, loss of appetite, and increased liver enzymes.
Effetti sekondarji komuni: tifwieq, stitikezza, dijarrea, sturdament, għejja, uġigħ ta 'ras, sulluzzu, indiġestjoni, jonqos l- aptit, u żieda fl- enżimi tal- fwied.
Each 125 mg hard capsule contains 125 mg of aprepitant.
Kull kapsula ta '125 mg fiha 125 mg ta' aprepitant.
Each 80 mg hard capsule contains 80 mg of aprepitant.
Kull kapsula ta '80 mg fiha 80 mg ta' aprepitant.
The other ingredients are: sucrose, microcrystalline cellulose (E 460), hydroxypropyl cellulose (E 463), sodium laurilsulfate, gelatin, titanium dioxide (E 171), shellac, potassium hydroxide, and black iron oxide (E 172); the 125 mg hard capsule also contains red iron oxide (E 172) and yellow iron oxide (E 172).
95 Is- sustanzi l- oħra huma: sukrożju, microcrystalline cellulose (E 460), hydroxypropyl cellulose (E 463), sodium laurilsulfate, gelatin, titanium dioxide (E 171), xellak, potassium hydroxide u black iron oxide (E 172); il- kapsula iebsa ta '125 mg fiha wkoll red iron oxide (E 172) u yellow iron oxide (E 172).
The capsule shell may also contain sodium laurilsulfate and silica colloidal anhydrous.
Il - qoxra tal- kapsula jista 'jkun fiha wkoll sodium laurilsulfate u silica colloidal anhydrous.
91 What EMEND looks like and contents of the pack The 125 mg hard capsule is opaque with a white body and pink cap with “462” and “125 mg” printed radially in black ink on the body.
Id- dehra ta 'EMEND u d- daqs tal- pakkett Il- kapsuli iebsin ta' 125 mg huma opaki b' għamla bajda u b' kappa roża b '“ 462 ” u “ 125 mg ” stampati b' mod radjali b' linka sewda fuq il- korp.
The 80 mg hard capsule is opaque with a white cap and body with “461” and “80 mg” printed radially in black ink on the body.
Il- kapsula iebsa ta '80 mg hi opaka b' kappa u għamla bajdanija b' “ 461 ” u “ 80 mg ” stampati b' mod radjali b' linka sewda fuq il- korp.
EMEND 125 mg and 80 mg hard capsules are supplied in the following pack sizes: • 3-day treatment pack containing one 125 mg capsule and two 80 mg capsules
Il- kapsuli iebsin ta 'EMEND 125 mg u ta' 80 mg huma fornuti f' pakketti bid- daqsijiet li ġejjin: • Pakkett ta 'trattament ta' tlett ijiem li fih kapsula waħda ta ’ 125 mg u żewġ kapsuli ta '80 mg
Česká republika Merck Sharp & Dohme, IDEA, Inc. org. sl.
96 Česká republika Merck Sharp & Dohme, IDEA, Inc.
Latvija SIA “Merck Sharp & Dohme Latvija” Tel: +371 67364 224 msd_lv@merck.com
Tel: +371 7364 224 msd_ lv@ merck. com.
What is EMSELEX?
X' inhu EMSELEX?
EMSELEX are white (7.5 mg) or light peach (15 mg) round prolonged-release tablets that contain the active substance darifenacin (prolonged-release means that darifenacin is released slowly from the tablet over a few hours).
EMSELEX huwa disponibbli f' pilloli tondi ta 'lewn abjad (7. 5 mg) jew lewn il- ħawħ (15 mg) b' rilaxx imtawwal li fihom is- sustanza attiva darifenaċina (darifenacin) ("b' rilaxx imtawwal" tfisser li d - darifenaċina tinħeles bil- mod mill- pillola fi ftit sigħat).
What is EMSELEX used for?
Għal xiex jintuża EMSELEX?
EMSELEX is used in adult patients with overactive bladder syndrome to treat the urge incontinence (sudden lack of control over urination), increased urinary frequency (need to urinate frequently) and urgency (sudden urge to pass urine) that are associated with the syndrome.
EMSELEX jintuża għat- trattament ta 'l- inkontinenza minn urġenza (nuqqas ta' kontroll għal għarrieda fuq il- ħruġ ta 'l- awrina), iż- żieda fil- frekwenza (bżonn frekwenti li tagħmel l- awrina) u fl- urġenza (stimolu għal għarrieda li tagħmel l- awrina) urinarja fil- pazjenti adulti bis- sindromu tal- bużżieqa iperattiva.
How is EMSELEX used?
Kif jintuża EMSELEX?
The recommended starting dose is 7.5 mg once daily.
Id- doża inizjali rakkomandata hija 7. 5 mg darba kuljum.
For those patients requiring greater symptom relief, the dose may be increased to 15 mg.
Id- doża tista 'tiżdied għal 15 mg fil- pazjenti li jitolbu li s- sintomi jittaffewlhom aktar.
The tablets can be taken with or without food, and should be swallowed whole, with some liquid, and not chewed, divided or crushed.
Il- pilloli jistgħu jittieħdu kemm fuq stonku vojt kif ukoll le u għandhom jinbelgħu sħaħ b' xi likwidu u l- pazjenti ma għandhomx jomogħduhom, jaqsmuhom jew ifarrkuhom.
How does EMSELEX work?
Kif jaħdem EMSELEX?
The active substance in EMSELEX, darifenacin, is an anticholinergic medicine.
Is- sustanza attiva f' EMSELEX, darfenaċina, hija mediċina antikolinerġika.
It blocks a receptor in the body, the muscarinic M3 receptor, and in the bladder, this causes the muscles which pushes urine out of the bladder to relax.
Din timblokka r- riċettur muskariniku M3 preżenti fil- ġisem u b' hekk il- muskolatura tal- bużżieqa li timbotta l- awrina 'l barra tiġi rilassata.
This leads to an increased capacity of the bladder, to changes in the way the bladder contracts, and to less bladder contractions.
Dan iwassal biex il- bużżieqa tkun tesa 'aktar, għal tibdil fil- mod kif il- bużżieqa tiċkien u biex jitnaqqas l- għadd ta' kontrazzjonijiet tal- bużżieqa.
This helps EMSELEX to prevent unwanted urination.
B' dan il- mod, EMSELEX jipprevjeni l- pazjent milli jagħmel l- awrina involontarjament.
How has EMSELEX been studied?
Kif ġie studjat EMSELEX?
EMSELEX has been studied in four main studies in a total of 2,078 male and female patients with symptoms of overactive bladder.
EMSELEX ġie eżaminat f' erba 'studji ewlenin fuq total ta' 2, 078 pazjent taż- żewġ sessi b' sintomi tal - bużżieqa iperattiva.
EMSELEX was used at different dosages (from 3.75 mg to 30 mg daily) and compared with placebo (dummy treatment) or with tolterodine (another medicine used in this condition).
EMSELEX intuża b' dożi differenti (minn 3. 75 mg sa 30 mg kuljum) u tqabbel mal- plaċebo (trattament finta) jew mat- tolterodina (tolterodine, mediċina oħra użata għal din il - problema).
The main measure was the effect of the treatment on the number of incontinence episodes per week.
Il- kejl ewlieni kien l- effett tat- trattament fuq l- għadd ta 'episodji ta' inkontinenza kull ġimgħa.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. eu. int http: / /www. emea. eu. int  EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged 10.6 (68%) or 12.5 (77%) less episodes of incontinence per week, respectively, when patients receiving placebo had 7 or 7.5 (54 or 58%) less episodes per week.
L- erba 'studji magħqudin urew aktar effikaċja f' EMSELEX meta mqabbel mal- plaċebo biex inaqqas l - episodji ta' inkontinenza.
What is the risk associated with EMSELEX?
X' inhu r- riskju assoċjat ma 'EMSELEX?
The most common side effects (seen in more than 1 patient in 10) are dry mouth and constipation.
L- effetti sekondarji l- aktar komuni (li dehru f' aktar minn pazjent 1 minn kull 10) huma ħalq xott u stitikezza.
For the full list of all side effects reported with EMSELEX, please see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji kollha rrappurtati b' EMSELEX, ara l- Fuljett ta' Tagħrif.
EMSELEX should not be used in people who may be hypersensitive (allergic) to darifenacin or any of the other ingredients, and in patients with: • Urinary retention (difficulty in passing urine) • Gastric retention (when the stomach doesn ’ t empty properly) • Uncontrolled narrow-angle glaucoma (increased eye pressure even with treatment) • Myasthenia gravis (a disease of the nerves causing muscle weakness). • Severe hepatic impairment (severe liver disease). • Severe ulcerative colitis (severe inflammation of the large intestine causing ulceration and bleeding) • Toxic megacolon (a very serious complication of colitis – see above) EMSELEX should not be given to patients at the same time as medicine such cyclosporine (in transplant patients), verapamil (a heart medicine), protease inhibitors (medicines such as ritonavir, used in AIDS patients) or ketoconazole and itraconazole (used to treat fungal infections).
EMSELEX ma għandux jingħata lil pazjenti flimkien ma 'mediċini bħaċ- ċiklosporina (cyclosporine, għall- pazjenti li kellhom trapjant), il- verapamil (mediċina għall- qalb), l- inibituri tal- proteażi (mediċini bħal ritonavir, użat fil- pazjenti bl- AIDS), il- ketoconazole u l- itraconazole (użati għat- trattament ta' infezzjonijiet fungali).
Why has EMSELEX been approved?
Għaliex ġie approvat EMSELEX?
The Committee for Medicinal Products for Human Use (CHMP) concluded that EMSELEX showed an effectiveness similar to that of other anticholinergic medicines used in overactive bladder syndrome.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li EMSELEX wera effikaċja simili għal dik ta 'mediċini antikolinerġiċi oħra użati għat- trattament tas- sindromu tal - bużżieqa iperattiva.
They decided that EMSELEX’ s benefits are greater than its risks for the symptomatic treatment of urge incontinence and/ or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.
Is- CHMP iddeċieda li l- benefiċċji ta 'EMSELEX huma ogħla mir- riskji tiegħu fit - trattament sintomatiku ta' l- inkontinenza minn urġenza u/ jew taż- żieda fil- frekwenza u fl- urġenza urinarja fil- pazjenti li jbatu mis- sindromu tal- bużżieqa iperattiva.
They recommended that EMSELEX be given marketing authorisation.
Huwa rrakkomanda li EMSELEX jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about EMSELEX:
Aktar tagħrif dwar EMSELEX:
The European Commission granted a marketing authorisation valid throughout the European Union for EMSELEX to Novartis Europharm Limited on 22 October 2004.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal EMSELEX lil Novartis Europharm Limited fit- 22 ta 'Ottubru 2004.
The full EPAR for EMSELEX is available here.
L- EPAR sħiħ dwar EMSELEX jista 'jiġi kkonsultat hawn.
This summary was last updated in 03-2006.
Dan is- sommarju kien aġġornat l- aħħar fi:
Emselex 7.5 mg prolonged-release tablets
Emselex 7. 5 mg pilloli li jerħu l- mediċina bil- mod
Each tablet contains 7.5 mg of darifenacin (as hydrobromide)
Kull pillola fiha 7. 5 mg ta ’ darifenacin (bħala hydrobromide)
Prolonged-release tablets
Pilloli li jerħu l- mediċina bil- mod
White round, convex tablet, debossed with “ DF” on one side and “ 7.5” on the reverse.
Pillola tonda bajda, konvessa, imnaqqxa b ’ “ DF ” fuq naħa u “ 7. 5 ” fuq l- oħra.
Symptomatic treatment of urge incontinence and/ or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.
Għall- kura tas- sintomi ta ’ impulsi qawwija ta ’ inkontinenza u/ jew f’ persuni li jkollhom bżonn jgħamlu l- awrina aktar ta ’ spiss u b’ urġenza akbar, bħal ma jista ’ jiġri f’ dawk il- pazjenti li jkollhom bużżieqa ta ’ l- awrina attiva żżejjed.
Adults (≥ 18 years) The recommended starting dose is 7.5 mg daily.
Adulti (≥ 18- il sena) Id- doża tal- bidu rakkomandata hija ta ’ 7. 5 mg kuljum.
After 2 weeks of starting therapy, patients should be reassessed.
Wara ġimgħatejn minn meta tibda t- terapija, il - pazjenti għandhom jiġu eżaminati mill- ġdid.
For those patients requiring greater symptom relief, the dose may be increased to 15 mg daily, based on individual response.
Għal dawk il- pazjenti li jkollhom bżonn serħan akbar mis- sintomi, id- doża tista ’ tiżdied għal 15 mg kuljum, skond ir- rispons individwali.
Emselex should be taken once daily with liquid.
Emselex għandu jittieħed darba kuljum ma ’ xi likwidu.
The tablets can be taken with or without food, and must be swallowed whole and not chewed, divided or crushed.
Il- pilloli jistgħu jittieħdu ma ’ l- ikel jew fuq stonku vojt, u għandhom jinbelgħu sħaħ mingħajr ma jomogħduhom, jaqsmuhom jew ifarkuhom.
Elderly patients (≥ 65 years) The recommended starting dose for the elderly is 7.5 mg daily.
Pazjenti anzjani (≥ 65 sena) Id- doża tal- bidu rakkomandata għall- anjzani hija 7. 5 mg kuljum.
After 2 weeks of starting therapy, patients should be reassessed for efficacy and safety.
Wara ġimgħatejn minn meta tibda t - terapija, il- pazjenti għandhom jiġu eżaminati mill- ġdid għall- effikaċja u s- sigurtà.
For those patients who have an acceptable tolerability profile but require greater symptom relief, the dose may be increased to 15 mg daily, based on individual response (see section 5.2).
Għal dawk il - pazjenti li jkunu jidhru li jifilħuha sew, iżda li jkollhom bżonn serħan akbar mis- sintomi, id- doża tista ’ tiżdied għal 15 mg kuljum, skond ir- rispons individwali (ara sezzjoni 5. 2).
Children Emselex is not recommended for use in children below 18 years of age due to a lack of data on safety and efficacy.
Tfal Emselex mhux rakkomandat għall- użu fit- tfal taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
Use in renal impairment No dose adjustment is required in patients with impaired renal function.
Użu meta jkun hemm indeboliment renali M’ hemmx bżonn ta ’ tibdil fid- doża f’ pazjenti li jkollhom funzjoni renali dgħajfa.
However, caution should be exercised when treating this population (see section 5.2).
Madankollu, dawn il- pazjenti għandhom ikunu kkurati b’ attenzjoni (ara sezzjoni 5. 2).
Use in hepatic impairment No dose adjustment is required in patients with mild hepatic impairment (Child Pugh A).
Użu meta jkun hemm indeboliment tal- fwied M’ hemmx bżonn ta ’ tibdil fid- doża f’ pazjenti li jsofru minn indeboliment ħafif tal- fwied (Child- Pugh A).
However, there is a risk of increased exposure in this population (see section 5.2).
Madankollu, f’ dawn il- pazjenti hemm riskju li jkun hemm esponiment ogħla (ara sezzjoni 5. 2).
2 In patients with moderate hepatic impairment (Child Pugh B), patients should only be treated if the benefit outweighs the risk, and patients should be restricted to 7.5 mg daily (see section 5.2).
2 F’ pazjenti li jsofru minn indeboliment moderat tal- fwied (Child- Pugh B), dawn għandhom jiġu kkurati biss jekk il- benefiċju jkun akbar mir- riskju, u l- pazjenti għandhom ikunu limitati għal 7. 5 mg kuljum (ara sezzjoni 5. 2).
Patients receiving concomitant treatment with substances that are potent inhibitors of CYP2D6 or moderate inhibitors of CYP3A4 In patients receiving substances that are potent CYP2D6 inhibitors, such as paroxetine, terbinafine, quinidine and cimetidine, treatment should start with the 7.5 mg dose.
Pazjenti li fl- istess ħin ikunu qed jirċievu sustanzi li huma inibituri qawwija ta ’ CYP2D6 jew inibituri moderati ta ’ CYP3A4 F’ pazjenti li qed jieħdu sustanzi li huma inibituri potenti ta ’ CYP2D6 bħal paroxetine, terbinafine, quinidine u cimetidine, it- trattament għandu jibda bid- doża ta ’ 7. 5 mg.
The dose may be titrated to 15 mg daily to obtain an improved clinical response provided the dose is well tolerated.
Id- doża tista ’ tkun miżjuda bil - mod għall- 15 mg kuljum biex ikun hemm titjib fir- rispons kliniku bil- kundizzjoni li l- pazjent ikun jiflaħ sew għad- doża.
However, caution should be exercised.
Madankollu, dan għandu jsir b’ attenzjoni.
In patients receiving substances that are moderate CYP3A4 inhibitors, such as fluconazole, grapefruit juice and erythromycin, the recommended starting dose is 7.5 mg daily.
F’ pazjenti li qed jirċievu sustanzi li huma inibituri moderati ta ’ CYP3A4 bħal fluconazole, meraq tal - grejpfrut u erythromycin, id- doża rakkomandata tal- bidu hija 7. 5 mg kuljum.
The dose may be titrated to 15 mg daily to obtain an improved clinical response provided the dose is well tolerated.
Id- doża tista ’ tiżdied bil - mod għal 15 mg kuljum sabiex jinkiseb rispons kliniku aħjar bil- kundizzjoni li l- pazjent ikun jiflaħ sew għad- doża.
Emselex is contraindicated in patients with:
Emselex huwa kontra- indikat f’ pazjenti:
- Hypersensitivity to the active substance or to any of the excipients.
- B’ sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi.
- Urinary retention.
- Li ma jkunux jistgħu jgħaddu l- awrina
- Gastric retention.
- Li jkollhom diffikulta biex jgħaddi l- kontenut ta ’ l- istonku
- Uncontrolled narrow-angle glaucoma.
- Li jkollhom glawkoma tat- tip narrow- angle li mhijiex ikkontrollata
- Myasthenia gravis.
- Myasthenia gravis
- Severe hepatic impairment (Child Pugh C).
- Indeboliment qawwi tal- fwied (Child- Pugh C)
- Severe ulcerative colitis.
- Infljammazzjoni fil- musrana l- kbira
- Toxic megacolon.
- Megakolon tossiku
- Concomitant treatment with potent CYP3A4 inhibitors (see section 4.5).
Kura fl- istess ħin b’ inibituri qawwija ta ’ CYP3A4 (ara sezzjoni 4. 5).
Emselex should be administered with caution to patients with autonomic neuropathy, hiatus hernia, clinically significant bladder outflow obstruction, risk for urinary retention, severe constipation or gastrointestinal obstructive disorders, such as pyloric stenosis.
Emselex għandu jingħata b’ attenzjoni lill- pazjenti li jsofru minn newropatija awtonomika, ħajatus ħernja, sadd tal- ħruġ mill- bużżieqa ta ’ l- awrina li jkun klinikament sinifikanti, riskju li ma jkunux jistgħu jgħaddu l- awrina, stitikezza qawwija jew disturbi li jikkawżaw sadd fis- sistema gastro - intestinali, bħal pajlorik stenożi.
Emselex should be used with caution in patients being treated for narrow-angle glaucoma (see section 4.3).
Emselex għandu jintuża b’ attenzjoni f’ pazjenti li jsofru minn glawkoma tat- tip narrow angle (ara sezzjoni 4. 3).
Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with Emselex.
Fatturi oħra li jikkawżaw l- għemil ta ’ l- awrina b’ mod aktar frekwenti (insuffiċjenza tal- qalb jew mard tal- kliewi) għandhom jiġu eżaminati qabel trattament b’ Emselex.
If urinary tract infection is present, an appropriate antibacterial therapy should be started.
Jekk ikun hemm infezzjoni fis - sistema ta ’ l- awrina, għandha tinbeda terapija antibatterika xierqa.
Emselex should be used with caution in patients with risk of decreased gastrointestinal motility, gastro-oesophagal reflux and/ or who are concurrently taking medicinal products (such as oral bisphosphonates) that can cause or exacerbate oesophagitis.
Emselex għandu jintuża b’ attenzjoni f’ pazjenti b’ riskju ta ’ tnaqqis fil- motilità gastro- intestinali, jew fir- rifluss gastro- esofaġejali u/ jew li qed jieħdu fl- istess ħin prodotti mediċinali (bħal bisphosphonates orali) li jistgħu jikkawżaw jew jaggravaw infjammazzjoni ta ’ l- esofagu.
Safety and efficacy have not yet been established in patients with a neurogenic cause for detrusor overactivity.
Is- sigurtà u l- effikaċja għadhom ma ġewx stabbiliti f’ pazjenti li għandhom attività żejda fid- detrusor minħabba kawża newroġenika.
Effects of other medicinal products on darifenacin Darifenacin metabolism is primarily mediated by the cytochrome P450 enzymes CYP2D6 and CYP3A4.
Effetti ta ’ prodotti mediċinali oħrajn fuq darifenacin Il- metaboliżmu ta ’ darifenacin huwa primarjament medjat bl- enzimi ta ’ cytochrome P450, CYP2D6 u CYP3A4.
Therefore, inhibitors of these enzymes may increase darifenacin exposure.
Għalhekk, inibituri ta ’ dawn l- enzimi jistgħu jżidu l- esponiment ta ’ darifenacin.
3 CYP2D6 inhibitors In patients receiving substances that are potent CYP2D6 inhibitors (e. g. paroxetine, terbinafine, cimetidine and quinidine) the recommended starting dose should be 7.5 mg daily.
3 Inibituri ta ’ CYP2D6 Għal pazjenti li qed jirċievu sustanzi li huma inibituri qawwija ta ’ CYP2D6 (eż. paroxetine, terbinafine, cimetidine u quinidine), id- doża tal- bidu rakkomandata għandha tkun 7. 5 mg kuljum.
The dose may be titrated to 15 mg daily to obtain an improved clinical response provided the dose is well tolerated.
Id - doża tista ’ tkun miżjuda bil- mod għal 15 mg kuljum biex ikun hemm titjib fir- rispons kliniku bil - kundizzjoni li l- pazjent ikun jiflaħ sew għad- doża.
Concomitant treatment with potent CYP2D6 inhibitors results in an increase in exposure (e. g. of 33% with 20 mg paroxetine at the 30 mg dose of darifenacin).
Kura fl- istess ħin b’ inibituri potenti ta ’ CYP2D6 twassal għal żieda fl- esponiment (eż ta ’ 33% b’ 20 mg paroxetine, bid- doża ta ’ 30 mg darifenacin).
CYP3A4 inhibitors Darifenacin should not be used together with potent CYP3A4 inhibitors (see section 4.3) such as protease inhibitors (e. g. ritonavir), ketoconazole and itraconazole.
Ritonavir), ketoconazole u itraconazole.
Potent P-glycoprotein inhibitors such as ciclosporin and verapamil should also be avoided.
Inibituri qawwija ta ’ glikoproteina - P bħal ciclosporin u verapamil għandhom jiġu evitati wkoll.
Co-administration of darifenacin 7.5 mg with the potent CYP3A4 inhibitor ketoconazole 400 mg resulted in a 5-fold increase in steady-state darifenacin AUC.
Meta darifenacin 7. 5 mg ingħata ma ’ l - inibitur qawwi ta ’ CYP3A4 ketoconazole 400 mg, l- AUC ta ’ darifenacin fi stat fiss żdiedet b’ 5 - darbiet.
In subjects who are poor metabolisers, darifenacin exposure increased approximately 10-fold.
F’ persuni li għandhom metaboliżmu batut, l- esponiment ta ’ darifenacin żdied b’ madwar 10 - darbiet.
Due to a greater contribution of CYP3A4 after higher darifenacin doses, the magnitude of the effect is expected to be even more pronounced when combining ketoconazole with darifenacin 15 mg.
Minħabba kontribuzzjoni akbar ta ’ CYP3A4 wara li jingħataw dożi aktar għoljin ta ’ darifenacin, il- qawwa ta ’ l- effett tkun mistennija li tkun ferm akbar meta ketoconazole jingħata flimkien ma ’ darifenacin 15 mg.
When co-administered with moderate CYP3A4 inhibitors such as erythromycin, clarithromycin, telithromycin, fluconazole and grapefruit juice, the recommended starting dose of darifenacin should be 7.5 mg daily.
Meta jingħata flimkien ma ’ inibituri moderati ta ’ CYP3A4 bħal erythromycin, clarithromycin, telithromycin, fluconazole jew meraq tal- grejpfrut, id- doża tal- bidu rakkomandata għandha tkun 7. 5 mg kuljum.
The dose may be titrated to 15 mg daily to obtain an improved clinical response provided the dose is well tolerated.
Id- doża tista ’ tkun miżjuda bil- mod għal 15 mg kuljum sabiex jitjieb ir- rispons kliniku bil- kundizzjoni li l- pazjent ikun jiflaħ sew għad- doża.
Darifenacin AUC24 and Cmax from 30 mg once daily dosing in subjects who are extensive metabolisers were 95% and 128% higher when erythromycin (moderate CYP3A4 inhibitor) was co-administered with darifenacin than when darifenacin was taken alone.
L- AUC24 u s- Cmax ta ’ Darifenacinminn dużaġġ ta ’ 30 mg darba kuljum f’ persuni li għandhom metaboliżmu mgħaġġel ħafna, kienu 95% u 128% aktar għolja meta erythromycin (inibitur moderat ta ’ CYP3A4) kien mogħti ma ’ darifenacin milli meta darifenacin ittieħed waħdu.
Enzyme inducers Substances that are inducers of CYP3A4, such as rifampicin, carbamazepine, barbiturates and St John´s wort (Hypericum perforatum) are likely to decrease the plasma concentrations of darifenacin.
Sustanzi li jattivaw l- enzimi Sustanzi li jattivaw CYP3A4 bħal rifampicin, carbamazepin, barbiturates u St John’ s Wort (Hypericum perforatum) x’ aktarx inaqqsu il- konċentrazzjonijiet ta ’ darifenacin fil- plażma.
Effects of darifenacin on other medicinal products CYP2D6 substrates Darifenacin is a moderate inhibitor of the enzyme CYP2D6.
Effetti ta ’ darifenacin fuq prodotti mediċinali oħra Sottostrati ta ’ CYP2D6 Darifenacin huwa inibitur moderat ta ’ CYP2D6.
Caution should be exercised when darifenacin is used concomitantly with medicinal products that are predominantly metabolised by CYP2D6 and which have a narrow therapeutic window, such as flecainide, thioridazine, or tricyclic antidepressants such as imipramine.
Għandu jkun hemm attenzjoni meta darifenacin jingħata flimkien ma ’ prodotti mediċinali li fil- parti l- kbira tagħhom ikunu metabolizzati minn CYP2D6 u li jkollhom il- medda tal- livelli terapewtiċi żgħira ħafna, bħal flecainide, thioridazine, jew mediċini kontra d- dipressjoni tat- tip triċikliċi bħal imipramine.
The effects of darifenacin on the metabolism of CYP2D6 substrates are mainly clinically relevant for CYP2D6 substrates which are individually dose titrated.
L- effetti ta ’ darifenacin fuq il - metaboliżmu tas- sottostrat ta ’ CYP2D6 huma l- aktar rilevanti mil- lat kliniku għal sottostrati ta ’ CYP2D6 li d- dożi tagħhom ikunu miżjuda bil- mod, b’ mod individwali.
CYP3A4 substrates Darifenacin treatment resulted in a modest increase in the exposure of the CYP3A4 substrate midazolam.
Sottostrati ta ’ CYP3A4 Kura b’ darifenacin wasslet għal żieda żgħira fl- esponiment għas- sottostrat ta ’ CYP3A4, midazolam.
The interaction with midazolam lacks clinical relevance but is indicative of a slight CYP3A4 inhibition by darifenacin.
L- effett ma ’ midazolam m’ huwiex klinikament rilevanti iżda jindika li hemm impediment ħafif ta ’ CYP3A4 minn darifenacin.
Warfarin Standard therapeutic prothrombin time monitoring for warfarin should be continued.
Warfarin Il- monitoraġġ standard terapewtiku tal- ħin ta ’ prothrombin għal warfarin għandu jitkompla.
The effect of warfarin on prothrombin time was not altered when co-administered with darifenacin.
L- effett ta ’ warfarin fuq il- ħin ta ’ prothrombin ma nbidilx meta ngħata ma ’ darifenacin.
Digoxin Therapeutic drug monitoring for digoxin should be performed when initiating and ending darifenacin treatment as well as changing the darifenacin dose.
Digoxin Il- monitoraġġ terapewtiku għal digoxin għandu jsir meta tibda u tintemm il- kura b’ darifenacin, kif ukoll meta jsir tibdil fid- doża ta ’ darifenacin.
Darifenacin 30 mg once daily (two times greater than the recommended daily dose) co-administered with digoxin at steady state resulted in a small increase in digoxin exposure (AUC:
Meta 30 mg darifenacin (id- doppju tad- doża kuljum rakkomandata) ingħata ma ’ digoxin fi stat fiss, wassal għal żieda żgħira fl- esponiment għall- digoxin (AUC:
16% and Cmax:
16% u Cmax:
The increase in digoxin exposure could be caused by competition between darifenacin and digoxin for P-glycoprotein.
Iż- żieda fl- esponiment għal digoxin jista ’ jkun li tkun ġejja minn kompetizzjoni bejn darifenacin u digoxin għall- glikoproteina- P.
Other transporter-related interactions cannot be excluded.
Interazzjonijiet oħrajn relatati mas - sistemi ta ’ trasport ma jistgħux jiġu esklużi.
4 pronounced therapeutic and side effects.
4 Sustanzi antimuskariniċi Bħal ma jiġri bis- sustanzi antimuskariniċi l- oħrajn kollha, l- użu ta ’ prodotti mediċinali oħra li għandhom effetti antimuskariniċi bħal oxybutynin, tolterodine u flavoxate, jista ’ jwassal għal effetti terapewtiċi u sekondarji aktar qawwija L- effetti antikolinerġici ta ’ mediċini li jintuzaw kontra l- marda ta ’ Parkinson u mediċini kontra d- dipressjoni tat- tip triċikliċi jista ’ jkun aktar qawwi meta jingħataw ma ’ mediċini antimuskariniċi.
The potentiation of anticholinergic effects with anti- parkinson agents and tricyclic antidepressants may also occur if antimuscarinic agents are used concurrently with such medicinal products.
Madankollu ma sarux studji dwar l- effetti oħra li jista ’ jkollhom meta jingħataw ma ’ mediċini li jintużaw kontra l- marda ta ’ Parkinson jew ma ’ mediċini kontra d- dipressjoni tat- tip triċikliċi.
Pregnancy There are no studies of darifenacin in pregnant women.
Tqala M’ hemmx studji dwar l- użu ta ’ darifenacin f’ nisa waqt it- tqala.
Animal studies have shown toxicity to parturition, peri and post-natal development (see section 5.3).
Studji f’ annimali wrew tossiċità waqt il- ħlas, u fl- iżvilupp madwar u wara t- twelid (ara sezzjoni 5. 3).
Emselex is not recommended during pregnancy.
Emselex mhux rakkomandat waqt it - tqala.
Lactation Darifenacin is excreted into the milk of rats.
Treddigħ Darifenacin joħroġ fil- ħalib tal- firien.
It is not known whether darifenacin is excreted into human milk and therefore caution should be exercised before Emselex is administered to a nursing woman.
Mhux magħruf jekk darifenacin joħroġx fil- ħalib tal- mara u għalhekk għanda ssir attenzjoni meta Emselex jingħata lill- mara li tkun qed tredda ’.
No studies of the effects of Emselex on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effetti ta ’ Emselex fuq il- ħila biex issuq u tħaddem magni.
As with other antimuscarinic agents, Emselex may produce effects such as dizziness, blurred vision, insomnia and somnolence.
Bħal mediċini oħra antimuskariniċi, Emselex jista ’ jikkawża effetti bħal sturdament, tara mċajpar, nuqqas ta ’ rqad u tħeddil.
Patients experiencing these side effects should not drive or use machines.
Pazjenti li jħossu dawn l- effetti m’ għandhomx isuqu jew iħaddmu magni.
For Emselex, these side effects have been reported to be uncommon.
Għal Emselex, dawn l- effetti kienu rappurtati li ma kienux komuni.
Consistent with the pharmacological profile, the most commonly reported adverse reactions were dry mouth (20.2% and 35% for the 7.5 mg and 15 mg dose, respectively, 18.7% after flexible dose titration, and 8% - 9% for placebo) and constipation (14.8% and 21% for the 7.5 mg and 15 mg dose, respectively, 20.9% after flexible dose titration, and 5.4% - 7.9% for placebo).
Hekk kif inhu mistenni mill- profil farmakoloġiku tiegħu, r- reazzjonijiet avversi li kienu rapurtati l - aktar kienu jinkludu ħalq xott (20. 2% u 35% għad- dożi ta ’ 7. 5 mg u 15 mg rispettivament, 18. 7% wara li d- doża tkun żdiedet bil- mod, b’ mod flessibbli, u 8% - 9% għall- plaċebo) u stitikezza (14. 8% u 21% għad- doża ta ’ 7. 5 mg u 15 mg rispettivament, 20. 9% wara li d- doża tkun żdiedet bil- mod, b’ mod flessibbli, u 5. 4% - 7. 9% għall- plaċebo.
Anticholinergic effects, in general, are dose-dependent.
B’ mod ġenerali, l- effetti antikolinerġiċi huma dipendenti mid - doża.
However, the patient discontinuation rates due to these adverse reactions were low (dry mouth:
Madankollu, ir- rata ta ’ pazjenti li kellhom iwaqqfuh minħabba dawn l- effetti avversi kienet żgħira (ħalq xott:
0% - 0.9% and constipation:
0% - 0. 9% u stitikezza:
0.6% - 2.2% for darifenacin, depending on the dose; and 0% and 0.3% for placebo, for dry mouth and constipation, respectively).
0. 6% - 2. 2% għal darifenacin, skond id- doża, u 0% u 0. 3% għall - plaċebo, għall- ħalq xott u stitikezza, rispettivament).
Adverse reactions with Emselex 7.5 mg and 15 mg prolonged-release tablets
Reazzjonijiet avversi b’ Emselex 7. 5 mg u 15 mg pilloli li jerħu l- mediċina bil- mod
Frequency estimate: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100), not known (cannot be estimated from the available data)
Stima tal- frekwenza: komuni ħafna( ≥1/ 10), komuni (≥1/ 100 to < 1/ 10), mhux komuni (≥1/ 1, 000 to < 1/ 100), mhux magħruf (ma tistax tittieħed stima mid- data disponibbli)
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla skond is- serjetà tagħhom, bl- aktar serji jitniżżlu l- ewwel.