qanastek/EMEA-V3 huggingface dataset:
If any of these apply to you, tell your doctor before taking Copalia.
- Jekk għandek problemi severi tal- kliewi jew jekk qed tgħamel dijalisi.
You must tell your doctor if you think that you are (or might become) pregnant.
- Jekk qed tieħu xi mediċini jew sustanzi li jżidu l- livelli ta ’ potassium fid- demm tiegħek (eż ċerti
Copalia is not recommended in early pregnancy and may cause serious harm to your baby if taken after 3 months of pregnancy (see section “ Pregnancy and breast-feeding”).
- Jekk għandek problema tal- glandoli renali li tissejjaħ “ iperaldosteroniżmu primarja ”.
The use of Copalia in children and adolescents is not recommended.
Inti għandek tgħid lit- tabib tiegħek jekk inti taħseb li inti tqila (jew tista ’ toħroġ tqila).
Also tell your doctor if you have had a kidney transplant or if you had been told that you have a narrowing of your kidney arteries.
Għandek ukoll tkellem lit- tabib tiegħek jekk kellek trapjant tal- kliewi jew jekk l- arterji tal- kliewi djiequlek.
Your doctor may need to change the dose or take other precautions.
It- tabib tiegħek jista ’ jibdillek id- doża jew jieħu prekawzjonijiet oħra.
In some cases you may have to stop taking one of the medicines.
F’ xi każi jista ’ jkun li jkollok twaqqaf xi wieħed mill- mediċini.
This applies especially to the medicines listed below: − lithium (a medicine used to treat some types of depression); − potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels; − anticonvulsant agents (e. g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone), rifampicin, St.
- Pilloli kontra l- konvulżjonijiet (eż carbamazepine, phenobarbital, phenytoin, fosphenytoin,
John’ s wort; − nitroglycerin and other nitrates, or other substances called “ vasodilators”; − medicines used for HIV/ AIDS (e. g. ritonavir) or for treatment of fungal infections (e. g. ketoconazole).
- Mediċini li jintużaw għall- HIV/ AIDS (eż. ritonavir) jew għall- kura ta ’ mard tal- moffa (eż
Taking Copalia with food and drink You can take Copalia with or without food.
Meta tieħu Copalia ma ’ l- ikel u max- xorb Tista ’ tieħu Copalia ma ’ l- ikel jew mingħajru.
Copalia and older people Caution is required when increasing the dosage.
Copalia u pazjenti aktar anzjani Kawtela hija meħtieġa meta jkun qed jiżdied id- dożaġġ.
Pregnancy and breast-feeding You must tell your doctor if you think you are (or might become) pregnant.
Tqala u Treddigħ Għid lit- tabib tiegħek jekk taħseb li jista ’ jkun li ħriġt tqila jew qed tippjana li toħrog tqila.
Usually, your doctor will advise you to take another medicine instead of Copalia, as Copalia is not recommended in early pregnancy, and may cause serious harm to your baby if it is used after 3 months of pregnancy.
Is- soltu, it - tabib tieghek javżak biex tieħu mediċina oħra minflokk Copalia, għax Copalia mhux irrakkomandat fil- bidu tat- tqala, minħabba li jista ’ jagħmel ħsara lit- tarbija tiegħek jekk jintuża wara 3 xhur tat- tqala.
An appropriate antihypertensive medication must usually replace Copalia before starting a pregnancy.
Mediċina addattata għal kontra il- pressjoni trid tibdel lil Copalia qabel tinbeda tqala.
The product should not be used during the second and third trimesters of pregnancy.
Il- prodott m’ għandux jintuża waqt it- tieni u it- tielet trimestru tat- tqala.
Your doctor will normally advise you to stop taking Copalia as soon as you know you are pregnant.
It- tabib tiegħek normalment javżak biex tieqaf tieħu Copalia immedjatament kif issir taf li inti tqila.
If you become pregnant during therapy with Copalia, please inform and see your doctor without delay.
Għid u ara lit- tabib tiegħek mingħajr dewmien jekk tinqabad tqila waqt it- terapija b’ Copalia.
65 Tell your doctor if you are breast-feeding.
Għid lit- tabib tiegħek jekk qed tredda ’.
Treatment with Copalia is not recommended during breast- feeding.
Kura b’ Copalia mhix rakkomandata waqt it- treddigħ.
Driving and using machines This medicine may make you feel dizzy.
68 Sewqan u tħaddim ta ’ magni Din il- mediċina tista ’ tisturdik.
This can affect how well you can concentrate.
Dan jista ’ jaffettwa kemm tikkonċentra tajjeb.
So, if you are not sure how this medicine will affect you, do not drive, use machinery, or do other activities that you need to concentrate on.
Għalhekk, jekk m’ intix ċert kif din il- mediċina ser teffettwak, m’ għandekx issuq, tuża magni, jew tagħmel attivitajiet li għandhom bżonn konċentrazzjoni.
HOW TO TAKE COPALIA
KIF GĦANDEK TIEĦU COPALIA
Always take this medicine exactly as your doctor has told you.
Dejjem għandek tieħu din il- mediċina skond il- parir tat- tabib tiegħek.
You should check with your doctor if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib tiegħek jekk ikollok xi dubju.
This will help you get the best results and lower the risk of side effects.
Dan ser jgħinek sabiex tikseb l- aqwa riżultati u tnaqqas ir - riskju ta ’ effetti sekondarji.
The usual dose of Copalia is one tablet per day. − It is advisable to take your medicine at the same time each day, preferably in the morning. − Swallow the tablets with a glass of water. − You can take Copalia with or without food.
- Ikun aħjar li tieħu l- mediċina tiegħek fl- istess ħin kuljum, preferibbilment filgħodu
Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.
- Ibla ’ l- pilloli b’ tazza ilma.
Do not exceed the prescribed dose.
- Tista ’ tieħu Copalia ma ’ l- ikel jew mingħajr ikel.
If you take more Copalia than you should If you have taken too many tablets of Copalia, or if someone else has taken your tablets, consult a doctor immediately.
Jekk tieħu Copalia aktar milli suppost Jekk ħadt iżżejjed mill- pilloli Copalia, jew jekk xi ħadd ieħor ħa l- pilloli tiegħek, ħu parir tat- tabib tiegħek mill- ewwel.
If you forget to take Copalia If you forget to take this medicine, take it as soon as you remember.
Jekk tinsa tieħu Copalia Jekk tinsa ’ tieħu din il- mediċina, ħudha malli tiftakar.
Then take your next dose at its usual time.
Mbagħad ħu d- doża li jmiss fil- ħin tas- soltu.
However, if it is almost time for your next dose, skip the dose you missed.
Iżda, jekk ikun kważi wasal il- ħin tad- doża li jmiss, aqbeż id- doża li tkun insejt.
Like all medicines, Copalia can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Copalia jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Some side effects can be serious:
Xi effetti sekondarji jistgħu jkunu serji:
A few patients have experienced these serious side effects (affecting less than 1 in 1,000 patients).
Numru żgħir ta ’ pazjenti kellhom dawn l- effetti sekondarji serji (jaffettwaw anqas minn 1 f ’ 1, 000 pazjent).
If any of the following happen, tell your doctor straight away:
Jekk ikollok xi wieħed milli ġejjin, għid lit- tabib tiegħek mill- ewwel:
Allergic reaction with symptoms such as rash, itching, swelling of face or lips or tongue, difficulty breathing, low blood pressure (feeling of faintness, light-headedness).
Reazzjoni allerġika b’ sintomi bħal raxx, ħakk, nefħa tal- wiċċ jew xofftejn jew ilsien, tbatija biex tieħu n- nifs, pressjoni tad- demm baxxa (tħoss ħass ħażin ġej, rasek ħafifa).
Other possible side effects:
Effetti sekondarji possibli oħra:
Common (affecting less than 1 in 10 patients):
Komuni (jaffettwaw anqas minn 1 f ’ 10 pazjenti):
Influenza; blocked nose, sore throat and discomfort when swallowing; headache; swelling of arms, hands, legs, ankles or feet; tiredness; redness and warm feeling of the face and/ or neck.
Influwenza; imnieħer miżdud, uġigħ fil- grieżem u tbati biex tibla ’; uġigħ ta ’ ras; nefħa tad- driegħ, idejn, riġlejn, għekiesi jew saqajn; għeja; ħmura u fawra tal- wiċċ u/ jew ta ’ l- għonq.
Uncommon (affecting less than 1 in 100 patients):
Mhux komuni (jaffettwaw anqas minn 1 f’ 100 pazjent):
Dizziness; nausea and abdominal pain; dry mouth; drowsiness, tingling or numbness of the hands or feet; vertigo; fast heart beat including palpitations; dizziness on standing up; cough; diarrhoea; constipation; skin rash, redness of the skin; joint swelling, back pain; pain in joints.
Sturdament; tqallih u uġigħ addominali; ħalq xott; tħeddil, tingiż jew jorqdulek idejk jew saqajk; vertigo; qalb tħabbat mgħaġġla bil - palpitazzjonijiet; sturdament meta tqum bil- wieqfa; sogħla; dijarea; stitikezza; raxx tal- ġilda, ħmura tal- ġilda; nefħa tal- ġogi, uġigħ fid- dahar; uġigħ fil- ġogi.
66 Rare (affecting less than 1 in 1,000 patients):
Rari (jaffettwaw anqas minn 1 f’ 1, 000 pazjent):
Feeling anxious; ringing in the ears (tinnitus); fainting; passing more urine than normal or feeling more of an urge to pass urine; inability to get or maintain an erection; sensation of heaviness; low blood pressure with symptoms such as dizziness, light- headedness; excessive sweating; skin rash all over your body; itching; muscle spasm.
Tħossok fuq ix- xwiek, tisfir fil- widnejn (żanżin tal - widnejn); jħossok ħażin; tgħaddi aktar awrina mis- soltu jew tħoss li għandek bżonn tgħaddi aktar awrina; ma jkunx jista ’ jkollok jew iżomm erezzjoni; tħossok tqil; taqalek il- presjoni tad- demm b’ sintomi bħal sturdament, rasek ħafifa; tgħereq b’ mod eċċessiv; raxx tal- ġilda ma ’ ġismek kollu; ħakk; spażmi fil- muskoli.
If any of these affect you severely, tell your doctor.
69 Jekk xi wieħed minn dawn l- effetti sekondarji jaffettwak severament, għid lit- tabib tiegħek.
Side effects with amlodipine or valsartan alone which can be serious:
Effetti sekondarji b’ amlodipine jew valsartan waħidhom li jistgħu jkunu serji:
These side effects may occur with certain frequencies, which are defined as follows: 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
Dawn l- effetti sekondarji jistgħu jiġru b’ ċerti frekwenzi, li huma definiti kif ġej: komuni ħafna: jaffettwaw iktar minn persuna 1 minn kull 10 li jużawh komuni: jaffettwaw minn persuna 1 sa 10 persuni minn kull 100 li jużawh mhux komuni: jaffettwaw minn persuna 1 sa 10 persuni minn kull 1, 000 li jużawh rari: jaffettwaw minn persuna 1 sa 10 persuni minn kull 10, 000 li jużawh rari ħafna: jaffettwaw inqas minn persuna 1 minn kull 10, 000 jużawh mhux magħruf: ma tistax tittieħed stima mid- data disponibbli
Amlodipine Common:
Amlodipine Komuni:
Hair loss; change in bowel habits, feeling bloated, indigestion, stomach discomfort after meal; stomach pain, nausea; bleeding, tender or enlarged gums; breathlessness; breast enlargement in men; runny or stuffy nose, sneezing; yellow skin and eyes, nausea, loss of appetite, light-coloured urine; high level of sugar in the blood; inability to achieve or maintain an erection; increased need to pass urine; fever, sore throat or mouth ulcers due to infections; mood swings; muscle pain; sensation of numbness or tingling in fingers and toes; severe upper stomach pain; spontaneous bleeding or bruising; rash, purplish-red spots, fever, itching; swelling mainly of the face and throat; skin reddening, blistering of lips, eyes or mouth, skin peeling.
Jaqa ’ x- xagħar; ippurgar mhux bħas- soltu, tħossok minfuħ/ a, indiġistjoni, skonfort fl - istonku wara ikla; uġigħ fl- istonku, tqalligħ; fsada, ħniek sensittivi u akbar minn normal; qtugħ ta ’ nifs; tkabbir tas- sider fl- irġiel; mnieħer inixxi jew misdud, għatis; il- ġilda u l- abjad tal- għajnejn jisfaru, tqalligħ, telf tal- aptit, awrina b’ kulur ċar; livell għoli ta ’ zokkor fid- demm; inabbilità li tikseb jew iżżomm erezzjoni; żieda fil- bżonn li tgħaddi l- awrina; deni, uġigħ fil- gerżuma jew ulċeri fil- ħalq minħabba infezzjonijiet; tibdil fil- burdata; uġigħ fil- muskoli; sensazzjoni ta ’ titrix jew tnemnim fis - swaba tal- idejn u tas- saqajn; uġigħ qawwi fin- naħa ta ’ fuq tal- istonku; fsada jew tbenġil spontanju; raxx, marki żgħar tondi ħomor jagħtu fil- vjola, deni, ħakk; nefħa l- aktar tal- wiċċ u l- gerżuma; ġilda tiħmar, infafet tax- xuftejn, l- għajnejn jew il- ħalq, ġilda titqaxxar.
Crushing chest pain, irregular heart beat, angina pain.
Uġigħ qisu qed jitgħaffeġ is- sider, taħbit irregolari tal- qalb, uġigħ tal- anġina.
Yellowing of the skin and eyes, changes in the results of some liver function tests; purple skin patches, rash and itching, stiff limbs, trembling hands.
Il- ġilda u l- abjad tal- għajnejn jisfaru, tibdiliet fir- riżultati tat- testijiet tal- funzjoni tal - fwied, rqajja vjola fil- ġilda, raxx u ħakk, riġlejn u dirgħajn iebsin, idejn jirtogħdu
Valsartan Not known:
Valsartan Mhux magħruf:
Decrease in red blood cells, fever, sore throat or mouth sores due to infections, spontaneous bleeding or bruising, high level of potassium in the blood, abnormal liver test results, decreased renal functions and severely decreased renal functions, swelling mainly of the face and the throat, muscle pain, rash, purplish-red spots, fever, itching, allergic reaction.
Tnaqqis ta ’ ċelloli ħomor fid- demm, deni, uġigħ fil- gerżuma jew ulċeri fil- ħalq minħabba infezzjonijiet, fsada jew tbenġil spontanju, livell għoli ta ’ potassium fid- demm, riżultati tat - testijiet tal- fwied mhux normali, funzjonijiet tal- kliewi mnaqqsa u funzjonijiet tal- kliewi mnaqqsa b’ mod sever, nefħa l- aktar tal- wiċċ u l- gerżuma, uġigħ fil- muskoli, raxx, marki żgħar tondi ħomor jagħtu fil- vjola, deni, ħakk, reazzjoni allerġika.
If you experience any of these, tell your doctor straight away.
Jekk tħoss xi wieħed minn dawn, għid lit- tabib tiegħek mill- ewwel.
HOW TO STORE COPALIA
KIF TAĦŻEN COPALIA
Do not use Copalia after the expiry date stated on the carton and blister.
Tużax Copalia wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- folja.
Do not use any Copalia pack that is damaged or shows signs of tampering.
Tuża l- ebda pakkett ta ’ Copalia li jkun danneġġat jew li juri sinjali ta ’ tbagħbis.
What Copalia contains − The active substances of Copalia are amlodipine (as amlodipine besylate) and valsartan.
X’ fih Copalia − Is- sustanzi attivi ta ’ Copalia huma amlodipine (bħala amlodipine besylate) u valsartan.
67 − The other ingredients are cellulose microcrystalline; crospovidone type A; silica, colloidal anhydrous; magnesium stearate; hypromellose; macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172).
Kull pillola fiha 5 mg amlodipine u 80 mg valsartan. − Is- sustanzi l- oħra huma cellulose microcrystalline; crospovidone type A; silica, colloidal anhydrous; magnesium stearate; hypromellose; macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172).
What Copalia looks like and contents of the pack Copalia 5 mg/ 80 mg tablets are round and dark yellow with “ NVR” on one side and “ NV” on the other side.
70 Id- Dehra ta ’ Copalia u l- kontentuti tal- pakkett Copalia 5 mg/ 80 mg pilloli huma tondi u sofor skuri b ’ “ NVR ” fuq naħa u “ NV ” fuq in- naħa l- oħra.
Copalia is available in packs containing 7, 14, 28, 30, 56, 90, 98 or 280 tablets and in multipacks comprising 4 cartons, each containing 70 tablets.
Copalia jiġi f’ pakketti li jkun fihom 7, 14, 28, 30, 56, 90, 98 jew 280 pillola u pakketti b’ ħafna li jinkludu 4 kartuniet, kull wieħed fih 70 pillola.
Not all pack sizes may be available in your country.
Mhux il- pakketti tad- daqsijiet kollha jistgħu jkunu għal bejgħ f’ pajjiżek.
Manufacturer Novartis Pharma GmbH Roonstraße 25 D-90429 Nuremberg Germany
Manifattur Novartis Pharma GmbH Roonstraße 25 D- 90429 Norimberga Il- Ġermanja
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
France Novartis Pharma S. A. S.
71 France Novartis Pharma S. A. S.
This leaflet was last approved in {MM/ YYYY}.
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
69 PACKAGE LEAFLET:
72 FULJETT TA ’ TAGĦRIF:
71 Tell your doctor if you are breast-feeding.
Għid lit- tabib tiegħek jekk qed tredda ’.
Driving and using machines This medicine may make you feel dizzy.
74 Sewqan u tħaddim ta ’ magni Din il- mediċina tista ’ tisturdik.
72 Rare (affecting less than 1 in 1,000 patients):
Rari (jaffettwaw anqas minn 1 f’ 1, 000 pazjent):
If any of these affect you severely, tell your doctor.
75 Jekk xi wieħed minn dawn l- effetti sekondarji jaffettwak severament, għid lit- tabib tiegħek.
Yellowing of the skin and eyes, changes in the results of some liver function tests; purple skin patches, rash and itching, stiff limbs, trembling hands.
Il- ġilda u l- abjad tal- għajnejn jisfaru, tibdiliet fir- riżultati tat- testijiet tal- funzjoni tal - fwied, rqajja vjola fil- ġilda, raxx u ħakk, riġlejn u dirgħajn iebsin, idejn jirtogħdu.
Each
X’ fih Copalia − Is- sustanzi attivi ta ’ Copalia huma amlodipine (bħala amlodipine besylate) u valsartan.
anhydrous; magnesium stearate; hypromellose; macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172).
Kull pillola fiha 5 mg amlodipine u 160 mg valsartan. − Is- sustanzi l- oħra huma cellulose microcrystalline; crospovidone type A; silica, colloidal anhydrous; magnesium stearate; hypromellose; macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172).
What Copalia looks like and contents of the pack Copalia 5 mg/ 160 mg tablets are oval and dark yellow “ NVR” on one side and “ ECE” on the other side.
76 Id- Dehra ta ’ Copalia u l- kontentuti tal- pakkett Copalia 5 mg/ 160 mg pilloli huma ovali u sofor skuri b ’ “ NVR ” fuq naħa u “ ECE ” fuq in- naħa l- oħra.
France Novartis Pharma S. A. S.
77 France Novartis Pharma S. A. S.
75 PACKAGE LEAFLET:
78 FULJETT TA ’ TAGĦRIF:
77 Tell your doctor if you are breast-feeding.
Għid lit- tabib tiegħek jekk qed tredda ’.
Driving and using machines This medicine may make you feel dizzy.
80 Sewqan u tħaddim ta ’ magni Din il- mediċina tista ’ tisturdik.
78 Rare (affecting less than 1 in 1,000 patients):
Rari (jaffettwaw anqas minn 1 f’ 1, 000 pazjent):
If any of these affect you severely, tell your doctor.
81 Jekk xi wieħed minn dawn l- effetti sekondarji jaffettwak severament, għid lit- tabib tiegħek.
What Copalia contains − The active substances of Copalia are amlodipine (as amlodipine besylate) and valsartan.
X’ fih Copalia − Is- sustanzi attivi ta ’ Copalia huma amlodipine( bħala amlodipine besylate) u valsartan.
79 − The other ingredients are cellulose microcrystalline; crospovidone type A; silica, colloidal anhydrous; magnesium stearate; hypromellose; macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172), iron oxide, red (E172).
Kull pillola fiha 10 mg amlodipine u 160 mg valsartan. − Is- sustanzi l- oħra huma cellulose microcrystalline; crospovidone type A; silica, colloidal anhydrous; magnesium stearate; hypromellose; macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172), iron oxide, red (E172).
What Copalia looks like and contents of the pack Copalia 10 mg/ 160 mg tablets are oval and light yellow with “ NVR” on one side and “ UIC” on the other side.
82 Id- Dehra ta ’ Copalia u l- kontentuti tal- pakkett Copalia 10 mg/ 160 mg pilloli huma ovali u sofor ċari b ’ “ NVR ” fuq naħa u “ UIC ” fuq in- naħa l- oħra.
France Novartis Pharma S. A. S.
83 France Novartis Pharma S. A. S.
EU number EU/ 1/ 05/ 317/ 001 EU/ 1/ 05/ 317/ 002 EU/ 1/ 05/ 317/ 003 EU/ 1/ 05/ 317/ 004 EU/ 1/ 05/ 317/ 005 EU/ 1/ 05/ 317/ 006 EU/ 1/ 05/ 317/ 007 EU/ 1/ 05/ 317/ 008 EU/ 1/ 05/ 317/ 009 EU/ 1/ 05/ 317/ 010 EU/ 1/ 05/ 317/ 011 EU/ 1/ 05/ 317/ 012 EU/ 1/ 05/ 317/ 013 EU/ 1/ 05/ 317/ 014
Numru ta ’ l- EU EMEA/ H/ C/ 598/ 001 EMEA/ H/ C/ 598/ 002 EMEA/ H/ C/ 598/ 003 EMEA/ H/ C/ 598/ 004 EMEA/ H/ C/ 598/ 005 EMEA/ H/ C/ 598/ 006 EMEA/ H/ C/ 598/ 007 EMEA/ H/ C/ 598/ 008 EMEA/ H/ C/ 598/ 009
Invented name Corlentor Corlentor Corlentor Corlentor Corlentor Corlentor Corlentor Corlentor Corlentor Corlentor Corlentor Corlentor Corlentor Corlentor
Isem inventat Corlentor Corlentor Corlentor Corlentor Corlentor Corlentor Corlentor Corlentor Corlentor
Strength 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 7.5 mg 7.5 mg 7.5 mg 7.5 mg 7.5 mg 7.5 mg 7.5 mg
Qawwa 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 7. 5 mg 7. 5 mg
Pharmaceutical form Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Għamla farmaċewtika Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita
Route of administration Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Mnejn jingħata Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
Packaging Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC)
Il- pakkett Folja (alu/ PVC) Folja (alu/ PVC) Folja (alu/ PVC) Folja (alu/ PVC) Folja (alu/ PVC) Folja (alu/ PVC) Folja (alu/ PVC) Folja (alu/ PVC) Folja (alu/ PVC)
Package size 14 tablets 28 tablets 56 tablets 84 tablets 98 tablets 100 tablets 112 tablets 14 tablets 28 tablets 56 tablets 84 tablets 98 tablets 100 tablets 112 tablets
Daqs tal- pakkett 14 pilloli 28 pilloli 56 pilloli 84 pilloli 98 pilloli 100 pilloli 112 pilloli 14 pilloli 28 pilloli
Corlentor 5 mg film-coated tablets
Corlentor 5 mg pilloli miksija b’ rita.
One film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride).
Pillola waħda miksija b’ rita fiha 5 mg ivabradine (ekwivalenti għal 5. 390 mg ivabradine hydrochloride)
63.91 mg lactose monohydrate For a full list of excipients, see section 6.1.
63. 91 mg lactose monohydrate Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Salmon-coloured, oblong, film-coated tablet scored on both sides, engraved with “ 5 ” on one face and on the other face.
Kulur is- salamun, oblunga, pillola miksija b’ rita b’ sinjal imnaqqax fuq żewġ naħat, fuq naħa waħda imnaqqax b ’ “ 5 ” u fuq in- naħa l- oħra Il- pillola tista tinqasam f’ nofsijiet ugwali.
The tablet can be divided into equal halves.
.
Symptomatic treatment of chronic stable angina pectoris in patients with normal sinus rhythm, who have a contra-indication or intolerance for beta-blockers.
Kura għas- sintomi ta ’ angina pectoris kronika stabbli f’ pazjenti b’ ritmu sinusali normali, li għandhom kontra- indikazzjoni jew intolleranza għal beta- blockers.
For the different doses film-coated tablets containing 5 mg and 7.5 mg ivabradine are available.
Għad- dożi differenti jinsabu pilloli miksija b’ rita li fihom 5 mg u 7. 5 mg ivabradine.
The usual recommended starting dose of ivabradine is 5 mg twice daily.
Id- doża ta ’ ivabradine rakkomandata normalment biex tibda hija ta ’ 5 mg darbtejn kuljum.
After three to four weeks of treatment, the dose may be increased to 7.5 mg twice daily depending on the therapeutic response.
Wara tlieta sa ’ erba ’ ġimgħat ta ’ kura, id- doża tista tiżdied għal 7. 5 mg darbtejn kuljum jiddipendi mir- reazzjoni terapewtika.
If, during treatment, heart rate decreases persistently below 50 beats per minute (bpm) at rest or the patient experiences symptoms related to bradycardia such as dizziness, fatigue or hypotension, the dose must be titrated downward including the possible dose of 2.5 mg twice daily (one half 5 mg tablet twice daily).
Jekk waqt il- kura, it- taħbit tal- qalb jonqos b’ mod persistenti b’ inqas minn 50 taħbita kull minuta (bpm) fi stat mistrieħ jew jekk il- pazjent iħoss sintomi relatati ma ’ bradikardija bħal sturdament, għejja jew ipotensjoni, d- doża għanda tiġi mnaqqsa bil- qis li tinkludi il- possibilta ta ’ doża ta ’ 2. 5 mg darbtejn kuljum (nofs pillola ta ’ 5 mg darbtejn kuljum).
Treatment must be discontinued if heart rate below 50 bpm or symptoms of bradycardia persist (see section 4.4).
Il- kura trid titwaqqaf jekk it- taħbit tal- qalb ikun ta ’ inqas minn 50 bpm jew sintomi ta ’ bradikardija jippersistu (ara sezzjoni 4. 4).
Tablets must be taken orally twice daily, i. e. once in the morning and once in the evening during meals (see section 5.2).
Il- pilloli għandhom jittieħdu mill- ħalq darbtejn kuljum i. e. darba fil- għodu u darba fil- għaxija waqt l - ikel (ara sezzjoni 5. 2).
Elderly Since ivabradine has been studied in a limited number of patients aged 75 years or more, a lower starting dose should be considered for these patients (2.5 mg twice daily i. e. one half 5 mg tablet twice daily) before up-titration if necessary.
Anzjani Billi ivabradine ġie studjat f’ mumru limitat ta ’ pazjenti ta ’ l- fuq minn 75 sena, doża mnaqqsa għandha tiġi ikkonsidrata fil- bidu tal- kura għal dawn il- pazjenti (2. 5 mg darbtejn kuljum i. e. nofs pillola ta ’ 5 mg darbtejn kuljum) qabel ma tiżdied bil- qis id- doża jekk ikun hemm bżonn.
Renal insufficiency No dose adjustment is required in patients with renal insufficiency and creatinine clearance above 15 ml/ min (see section 5.2).
Insuffiċjenza renali M’ hemmx bżonn ta ’ aġġustar fid- doża f’ pazjenti li jbatu minn insuffiċjenza renali u minn tneħħija tal - krejatinina ta ’ iktar minn 15 ml/ min (ara sezzjoni 5. 2).
No data are available in patients with creatinine clearance below 15 ml/ min.
M’ hemmx informazzjoni dwar pazjenti li għandhom tneħħija tal- krejatinina ta ’ inqas minn 15 ml/ min.
Ivabradine should therefore be used with precaution in this population.
Minħabba f’ hekk ivabradine għandu jintuża bi prekawzjoni f’ dawn in- nies.
2 Hepatic impairment No dose adjustment is required in patients with mild hepatic impairment.
2 Indeboliment tal- fwied M’ hemmx bżonn ta ’ aġġustar fid- doża f’ pazjenti li jbatu minn indeboliment ħafif tal- fwied.
Caution should be exercised when using ivabradine in patients with moderate hepatic impairment.
Prekawzjonijiet għandhom jittieħdu f’ pazjenti li jbatu minn indeboliment moderat tal- fwied meta jkunu qed jieħdu ivabradine.
Ivabradine is contra-indicated for use in patients with severe hepatic insufficiency, since it has not been studied in this population and a large increase in systemic exposure is anticipated (see sections 4.3 and 5.2).
Ivabradine huwa kontra- indikat fl- użu f’ pazjenti li jbatu minn indeboliment qawwi tal- fwied, minħabba li għadu ma ġiex studjat f’ dawn in- nies u żieda kbira fil- kxif sistemiku hija antiċipata (ara sezzjoni 4. 3 u 5. 2).
Children and adolescents Corlentor is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
Tfal u adoloxxenti Corlentor mhux irrakkomandat għall- użu fit- tfal u l- adoloxxenti peress li m’ hemmx informazzjoni dwar is- sigurtà u l- effikaċja.
- Hypersensitivity to the active substance or to any of the excipients (see section 6.1)
- Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi (ara sezzjoni 6. 1)
- Resting heart rate below 60 beats per minute prior to treatment
- Rata tat- taħbit tal- qalb mistrieħa ta ’ inqas minn 60 taħbita fil- minuta qabel il- kura
- Cardiogenic shock
- Xokk kardjoġeniku
- Acute myocardial infarction
- Infart mijokardijaku akut
- Severe hypotension (< 90/ 50 mmHg)
- Ipotensjoni severa (< 90/ 50 mmHg)
- Severe hepatic insufficiency
- Indeboliment sever tal- fwied
- Sick sinus syndrome
- Sindromu sick sinus
- Sino-atrial block
- Imblokk sino- atrijali
- Heart failure patients with NYHA functional classification III-IV due to a lack of data
- Pazjenti b’ insuffiċenzja tal- qalb bl ’ NYHA tal- klassifikazzjoni funzjonali III- IV, minħabba
- Pacemaker dependent
- Pazjenti dipendenti fuq pejsmejker
- Unstable angina
- Anġina instabbli
- AV-block of 3rd degree
- Imblokk AV tat- 3 grad
- Combination with strong cytochrome P450 3A4 inhibitors such as azole antifungals
- Użu flimkien ma ’ impedituri taċ- ċitokromu qawwi P450 3A4 bħal mediċini kontra l- fungi tat- tip
(ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone (see sections 4.5 and 5.2)
azole (ketoconazole, itraconazole), antibijotiċi tat- tip macrolide (clarithromycin, erythromycin per os, josamycin, telithromycin), impedituri HIV protease (nelfinavir, ritonavir) u nefazodone (ara sezzjoni 4. 5 u 5. 2)
- Pregnancy, lactation (see section 4.6)
- Tqala, treddigħ (ara sezzjoni 4. 6)
Cardiac arrhythmias Ivabradine is not effective in the treatment or prevention of cardiac arrhythmias and likely loses its efficacy when a tachyarrhythmia occurs (eg. ventricular or supraventricular tachycardia).
Arritmijas kardijaċi Ivabradine m’ huwiex effettiv fil- kura jew prevenzjoni ta ’ arritimijas kardijaċi u bl- istess mod jitlef l - effikaċja tiegħu meta sseħħ taki- arritmija (eż. takikardija ventrikulari jew supraventrikulari).
Ivabradine is therefore not recommended in patients with atrial fibrillation or other cardiac arrhythmias that interfere with sinus node function.
Minħabba f’ hekk ivabradine m’ huwiex irrakkomandat f’ pazjenti li jbatu minn fibrillazzjoni atrijali jew xi arritmijas kardijaċi oħra li jinterferu mal- funzjoni ta ’ sinus node.
It is recommended to regularly clinically monitor ivabradine treated patients for the occurrence of atrial fibrillation (sustained or paroxysmal), which should also include ECG monitoring if clinically indicated (e. g. in case of exacerbated angina, palpitations, irregular pulse).
Dan għandu wkoll jinkludi monitorjal ta ’ l- ECG jekk huwa klinikament indikat (eż. f’ każ ta ’ anġina eżasperata, palpitazzjonijiet, u polz irregolari).
Use in patients with AV-block of 2nd degree Ivabradine is not recommended in patients with AV-block of 2nd degree.
Użu f’ pazjenti b’ imblokk AV tat- 2 grad Ivabradine m’ huwiex rakkomandat f’ pazjenti b’ imblokk AV tat- 2 grad.
Use in patients with a low heart rate Ivabradine must not be initiated in patients with a pre-treatment resting heart rate below 60 beats per minute (see section 4.3).
Użu f’ pazjenti b’ rata tat- taħbit tal- qalb baxxa Ivabradine m’ għandux jiġi mibdi f’ pazjenti li qabel il- kura għandhom rata tat- taħbit tal- qalb waqt il - mistrieħ ta ’ inqas minn 60 taħbita fil- minuta (ara sezzjoni 4. 3).
If, during treatment, resting heart rate decreases persistently below 50 bpm or the patient experiences symptoms related to bradycardia such as dizziness, fatigue or hypotension, the dose must be titrated downward or treatment discontinued if heart rate below 50 bpm or symptoms of bradycardia persist (see section 4.2).
Jekk waqt il- kura ir- rata tat- taħbit tal- qalb mistrieħa tonqos b’ mod persistenti għal inqas minn 50 bpm jew il- pazjent iħoss xi sintomi relatati ma ’ bradikardija bħal sturdament, għeja kbira jew ipotensjoni,
3 Combination with other antianginal therapies Concomitant use of ivabradine with heart rate reducing calcium channel blockers such as verapamil or diltiazem is not recommended (see section 4.5).
Użu flimkien ta ’ mediċina ma ’ mediċini oħra kontra l- anġina Mhux irrakkomandat l- użu ta ’ ivabradine flimkien ma ’ calcium channel blockers li jbaxxu r- ritmu tat - taħbit tal- qalb bħal verapamil jew diltiazem (ara sezzjoni 4. 5).
No safety issue has been raised on the combination of ivabradine with nitrates and dihydropyridine calcium channel blockers such as amlodipine.
Ma deherx li ivabradine flimkien ma ’ nitrates u ma ’ dihydropyridine calcium channel blockers bħal amlodipine jagħmel ħsara.
Additional efficacy of ivabradine in combination with dihydropyridine calcium channel blockers has not been established (see section 5.1).
Ivabradine flimkien ma ’ dihydropyridine calcium channel blockers ma jidhirx li kellu effikaċja addizjonali.
Chronic heart failure Heart failure must be appropriately controlled before considering ivabradine treatment.
Insuffiċjenza kronika tal- qalb L- insuffiċenzja tal- qalb għandha tiġi kkontrollata sew qabel ma ’ wieħed jikkonsidra jagħti kura b’ ivabradine.
The use of ivabradine is contra-indicated in heart failure patients with NYHA functional classification III-IV, due to a lack of data on clinical efficacy and safety (see section 4.3).
L- użu ta ’ ivabradine huwa kontra- indikat f- pazjenti b’ insuffiċenzja tal- qalb ta ’ tip NYHA klassifikazzjoni III- IV, minħabba li mhemmx biżżejjed informazzjoni dwar l- effikaċja u s - sigurta` klinika (ara sezzjoni 4. 3).
Caution is needed in patients with asymptomatic left ventricular dysfunction, as well as in heart failure patients with NYHA functional classification II due to a limited number of patients studied.
Prekawzjoni għandha tittieħed f’ pazjenti li jbatu minn disfunzjoni asimptomatika tal ventrikulari xellugi, kif ukoll f’ pazjenti b’ insuffiċenzja tal- qalb ta ’ tip NYHA klassifikazzjoni funzjonari II minħabba n- numru limitat ta ’ pazjenti li gew studjati.
Stroke The use of ivabradine is not recommended immediately after a stroke since no data is available in these situations.
Attakk ta ’ puplesija Mhux irrakkomandat l- użu ta ’ ivabradine minnufih wara attakk ta ’ puplesija għax m’ hemmx informazzjoni f’ każijiet bħal dawn.
To date, there is no evidence of a toxic effect of ivabradine on the retina, but the effects of long-term ivabradine treatment beyond one year on retinal function are currently not known.
Funzjoni viżwali Ivabradine jinfluwenza il- funzjoni retinali (ara sezzjoni 5. 1) Sa llum m’ hemmx evidenza li ivabradine għandu effett tossiku fuq ir- retina, iżda l- effetti meta ivabradine jingħata fit- tul għal iktar minn sena għadhom mhux magħrufa.
Cessation of treatment should be considered if any unexpected deterioration in visual function occurs.
Wieħed għandu jikkonsidra jekk titwaqqafx il- kura jekk kemm il- darba jkun hemm deterjorament mhux mistenni fil- funzjoni visuali.
Caution should be exercised in patients with retinitis pigmentosa.
Wieħed għandu joqgħod attent f’ pazjenti li jbatu minn retinitis pigmentosa.
Precautions for use
Prekawzjonijiet għall- użu
Patients with hypotension Limited data are available in patients with mild to moderate hypotension, and ivabradine should therefore be used with caution in these patients.
Pazjenti li jbatu minn pressjoni baxxa M’ hemmx informazzjoni biżżejjed fuq pazjenti li jbatu minn pressjoni baxxa, ħafifa jew moderat u għalhekk ivabradine għandu jintuża b’ attenzjoni f’ dawn il- pazjenti.
Ivabradine is contra-indicated in patients with severe hypotension (blood pressure < 90/ 50 mmHg) (see section 4.3).
Ivabradine hu kontra- indikat f’ pazjenti b’ ipotenzjoni severa (pressjoni < 90/ 50 mm Hg) (ara sezzjoni 4. 3).
Atrial fibrillation - Cardiac arrhythmias There is no evidence of risk of (excessive) bradycardia on return to sinus rhythm when pharmacological cardioversion is initiated in patients treated with ivabradine.
Fibrillazzjoni ta ’ l- atriju - Aritmija kardijaka Mhemmx evidenza ta ’ riskju ta ’ bradikardija (eċċessiva) mar- ritorn għal sinus rhythm meta l - kardjoverżjoni farmakoloġika tinbeda f’ pazjenti li qed jieħdu ivabradine.
However, in the absence of extensive data, non urgent DC-cardioversion should be considered 24 hours after the last dose of ivabradine.
Iżda peress li m’ hemmx informazzjoni estensiva wieħed għandu jikkunsidra kardjoverżjoni- DC mhux urġenti 24 siegħa wara l - aħħar doża ta ’ ivabradine.
Use in patients with congenital QT syndrome or treated with QT prolonging medicinal products The use of ivabradine in patients with congenital QT syndrome or treated with QT prolonging medicinal products should be avoided (see section 4.5).
Użu f’ pazjenti li jbatu minn sindromi QT konġenitali jew qegħdin b’ kura bi prodotti mediċinali li jtawlu l- QT L- użu ta ’ ivabradine f’ pazjenti li jbatu minn sindromu QT konġenitali jew qegħdin b’ kura bi prodotti mediċinali li jtawlu l- QT għandu jiġi evitat (ara sezzjoni 4. 5).
If the combination appears necessary, close cardiac monitoring is needed.
Jekk l- użu ta’ dawn il- mediċini f’ daqqa jidher neċessarju, għandu jiġi kkunsidrat monitorjal kardijaku mill- viċin.
Use in patients with moderate hepatic insufficiency Caution should be exercised when using ivabradine in patients with moderate hepatic insufficiency (see section 4.2).
Użu f’ pazjenti b’ insufficienza moderata tal- fwied Għandha tittieħed prekawzjoni meta ivabradine jintuża f’ pazjenti b’ insufficienza moderata tal- fwied (ara sezzjoni 4. 2)
Use in patients with severe renal insufficiency Caution should be exercised when using ivabradine in patients with severe renal insufficiency (creatinine clearance < 15 ml/ min) (see section 4.2).
Użu f’ pazjenti b’ insufficienza renali severa Għandha tittieħed prekawzjoni meta ivabradine jintuża f’ pazjenti b’ insufficienza renali severa (tneħħija tal- krejatinina < 15 ml/ min) (ara sezzjoni 4. 2).
Excipients Since tablets contain lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
4 Sustanzi mhux attivi Minħabba li l- pilloli fihom il- lactose, pazjenti bi problemi ereditarji rari ta ’ intolleranza ta ’ galactose, defiċenzja ta ’ lactose ta ’ tip Lapp jew assorbiment ħażin ta ’ glucose- galactose m’ għandhomx jieħdu dan il- prodott mediċinali.
4 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Concomitant use not recommended QT prolonging medicinal products
L- użu flimkien mhux irrakkamandat Mediċini li jtawlu l- QT
- Cardiovascular QT prolonging medicinal products (e. g. quinidine, disopyramide, bepridil, sotalol,
- Mediċini kardjovaskulari li jtawlu l- QT (eż. quinidine, disopyramide, bepridil, sotalol, ibutilide,
ibutilide, amiodarone).
amiodarone).
- Non cardiovascular QT prolonging medicinal products (e. g. pimozide, ziprasidone, sertindole,
- Mediċini mhux kardjuvaskulari li jtawlu l- QT (eż. pimozide, ziprasidone, sertindole, mefloquine,
mefloquine, halofantrine, pentamidine, cisapride, erythromycin IV).
halofantrine, pentamidine, cisapride, erythromycin IV).
The concomitant use of cardiovascular and non cardiovascular QT prolonging medicinal products with ivabradine should be avoided since QT prolongation may be exacerbated by heart rate reduction.
għandu jigi evitat għax it- titwil tal- QT jista ’ jiżdied b’ nuqqas fir- rata tat- taħbit tal- qalb.
If the combination appears necessary, close cardiac monitoring is needed (see section 4.4).
Jekk jidher li l- użu flimkien huwa neċessarju, moniterazzjoni reqqa kardijaka hija meħtiega (ara sezzjoni 4. 4).
Cytochrome P450 3A4 (CYP3A4) Ivabradine is metabolised by CYP3A4 only and it is a very weak inhibitor of this cytochrome.
Iċ- ċitokromu P4503A4 (CYP3A4) Ivabradine jiġi metabolliżżat b’ CYP3A4 biss u hu impeditur dgħajjef ħafna ta ’ dan- iċ- ċitokromu.
Ivabradine was shown not to influence the metabolism and plasma concentrations of other CYP3A4 substrates (mild, moderate and strong inhibitors).
Ivabradine ma jinfluwenzax l- metaboliżmu u l- konċentrazzjoni fil- plażma ta ’ sustanzi oħra li fuqhom jaħdem CYP3A4 (impedituri dgħajfa, moderati u qawwija).
CYP3A4 inhibitors and inducers are liable to interact with ivabradine and influence its metabolism and pharmacokinetics to a clinically significant extent.
L- impedituri u s- sustanzi li jġiegħlu CYP 3A4 jaħdmu iżjed jista ’ jkollhom interazzjoni ma ’ ivabradine u jinfluwenzaw l- metaboliżmu u l - farmakokinetika tiegħu b’ mod klinikament sinifikanti.
Drug-drug interaction studies have established that CYP3A4 inhibitors increase ivabradine plasma concentrations, while inducers decrease them.
Studji fuq interazzjoni bejn mediċini wrew li l - impedituri ta ’ CYP3A4 iżidu l- konċentrazzjoni tal- plażma ta ’ ivabradine waqt li mediċini induċi jnaqqsuha.
Increased plasma concentrations of ivabradine may be associated with the risk of excessive bradycardia (see section 4.4).
Żieda fil- konċentrazzjoni tal- plażma ta ’ ivabradine tista ’ tigi assoċjata mar- riskju ta ’ bradikardija eċċessiva (ara sezzjoni 4. 4).
Contra-indication of concomitant use The concomitant use of potent CYP3A4 inhibitors such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone is contra-indicated (see section 4.3).
Kontra- indikazzjonijiet għall- użu flimkien L- użu flimkien ta ’ impedituri qawwija ta ’ CYP3A4 bħal antifungali ta ’ tip azole (ketoconazole, itraconazole), antibijotiċi makrolidi (clarithromycin, erythtromycin per os, josamycin, telithromycin), impedituri tal- HIV protease (nelfinavir, ritonavir) u nefazodone huma kontra- indikati (ara sezzjoni 4. 3).
The potent CYP3A4 inhibitors ketoconazole (200 mg once daily) and josamycin (1 g twice daily) increased ivabradine mean plasma exposure by 7 to 8 fold.
L- impedituri qawwija ta ’ CYP3A4 ketoconazole (200 mg darba kuljum) u josamycin (1g darbtejn kuljum) żiedu l- esponiment medju fil- plażma ta ’ ivabradine minn 7 għal 8 darbiet.
Concomitant use not recommended Moderate CYP3A4 inhibitors: specific interaction studies in healthy volunteers and patients have shown that the combination of ivabradine with the heart rate reducing agents diltiazem or verapamil resulted in an increase in ivabradine exposure (2 to 3 fold increase in AUC) and an additional heart rate reduction of 5 bpm.
L- użu flimkien mhux irrakkomandat Impedituri ta ’ CYP3A4 moderati: studji speċifiċi ta ’ interazzjoni fuq voluntiera b’ saħħithom u f’ pazjenti wrew li l- uzu flimkien ta ’ ivabradine mal- mediċini li jnaqqsu r- rata tat- taħbit tal- qalb diltiazem jew verapamil irrizulta f’ żieda fl- esponiment għal ivabradine (żieda minn 2 sa 3 darbiet fl - AUC) u nuqqas addizzjonali fir- ritmu tat- taħbit tal- qalb ta ’ 5 bpm.
The concomitant use of ivabradine with these medicinal products is not recommended (see section 4.4).
L- użu flimkien ta ’ ivabradine ma ’ dawn il- prodotti mediċinali mhux irrakkomandat (ara sezzjoni 4. 4).
Concomitant use with precautions
Prekawzjonijiet għall- użu flimkien
- Moderate CYP3A4 inhibitors: the concomitant use of ivabradine with other moderate CYP3A4
L- użu ta ’ ivabradine flimkien ma ’ impedituri ta ’ CYP3A4 moderati
inhibitors (e. g. fluconazole) may be considered at the starting dose of 2.5 mg twice daily and if resting heart rate is above 60 bpm, with monitoring of heart rate.
(eż. fluconazole) jista ’ jiġi kkunsidrat b’ doża tal- bidu ta ’ 2. 5 mg darbtejn kuljum u jekk ir- rata tat - taħbit tal- qalb mistrieħa hija ogħla minn 60 bpm, jinħtieġ li l- pazjent ikun taħt monitorjal minħabba ir- rata tat- taħbit tal- qalb.
- Grapefruit juice: ivabradine exposure was increased by 2-fold following the co-administration with
L- esponiment ta ’ ivabradine żdied b’ darbtejn meta ingħata flimkien mal- ġjus
grapefruit juice.
tal- grejpfrut.
Therefore the intake of grapefruit juice should be restricted during the treatment with ivabradine.
Għalhekk waqt il- kura b ’ ivabradine wieħed għandu jillimita kemm jieħu ġjus tal - grejpfrut
- CYP3A4 inducers:
- Mediċini li jġiegħlu CYP3A4 jaħdem iżjed:
CYP3A4 inducers (e. g. rifampicin, barbiturates, phenytoin, Hypericum
rifampicin, barbiturates, phenytoin, Hypericum perforatum [St.
perforatum [St John’ s Wort]) may decrease ivabradine exposure and activity.
5 esponiment u l- attivita` ta ’ ivabradine.
The concomitant use of CYP3A4 inducing medicinal products may require an adjustment of the dose of ivabradine.
L- użu ta ’ mediċini li jġiegħlu CYP3A4 jaħdem iżjed jista ’ jirrikjedi aġġustar fid- doża ta ’ ivabradine.
The combination of ivabradine 10 mg twice daily with St John’ s Wort was shown to reduce ivabradine AUC by half.
L- użu ta ’ ivabradine 10 mg darbtejn kuljum flimkien ma ’ St John’ s Wort wera li jnaqqas b’ nofs l- AUC ta ’ ivabradine.
The intake of St John’ s Wort should be restricted during the treatment with ivabradine.
John’ s Wort waqt il- kura b’ ivabradine.
5 Other concomitant use Specific drug-drug interaction studies have shown no clinically significant effect of the following medicinal products on pharmacokinetics and pharmacodynamics of ivabradine: proton pump inhibitors (omeprazole, lansoprazole), sildenafil, HMG CoA reductase inhibitors (simvastatin), dihydropyridine calcium channel blockers (amlodipine, lacidipine), digoxin and warfarin.
Użu flimkien ieħor Studji speċifiċi li saru fuq jekk medicinali oħra ma jaqblux ma ’ dan il- prodott urew li m’ hemm l- ebda effett klinikament sinifikanti tal- prodotti mediċinali msemmija hawn taħt fuq il- farmokokinetika u l - farmakodinamika ta ’ ivabradine: impedituri proton pump (omeprazole, lansoprazole), sildenafil, impedituri HMG COA reductase (simvastatin), dihydropyridine calcium channel blockers (amlodipine, lacidipine), digoxin u warfarin.
In addition there was no clinically significant effect of ivabradine on the pharmacokinetics of simvastatin, amlodipine, lacidipine, on the pharmacokinetics and pharmacodynamics of digoxin, warfarin and on the pharmacodynamics of aspirin.
Barra minn hekk ma kienx kemm effett klinikament sinifikanti ta ’ ivabradine fuq il- farmakokinetika ta ’ simvastatin, amlodipine, lacidipine fuq il - farmakokinetika u l- farmakodinamika ta ’ digoxin, warfarin u fuq il- farmakodinamika ta ’ aspirin.
In pivotal phase III clinical trials the following medicinal products were not restricted and therefore were routinely combined with ivabradine with no evidence of safety concerns: angiotensin converting enzyme inhibitors, angiotensin II antagonists, diuretics, short and long acting nitrates, HMG CoA reductase inhibitors, fibrates, proton pump inhibitors, oral antidiabetics, aspirin and other anti-platelet agents.
F’ fażi pivotali III tal- provi kliniċi l- prodotti mediċinali msemmija hawn taħt ma ġewx limitati u għalhekk inagħtu bħas- soltu flimkien ma ’ ivabradine mingħajr l- ebda evidenza ta ’ biża fuq is- sigurta ’: impedituri angiotensin converting enżemi, antagonisti angiotensin II, dijuretiċi, nitrates li jaħdmu fil - qosor u fit- tul, impedituri HMG CoA reductase, fibrates, impedituri proton pump, antidijabetiċi orali, aspirin u mediċini oħra anti- platelet.
The potential risk for humans is unknown.
M’ hemmx tgħarif biżżejjed dwar l- użu ta ’ ivabradine waqt it- tqala.
Therefore, ivabradine is contra-indicated during pregnancy.
Studji fuq l- annimali waqt ir - riproduzzjoni wrew effetti tossiċi fuq l- embriju u effetti teratoġeniċi (ara sezzjoni 5. 3).
Animal studies indicate that ivabradine is excreted in milk.
Studji fuq l- annimali wrew li ivabradine joħroġ fil- ħalib tas- sider.
Therefore, ivabradine is contra-indicated in breast-feeding women.
Għalhekk ivabradine huwa kontra - indikat waqt it- treddigħ.
A specific study to assess the possible influence of ivabradine on driving performance has been performed in healthy volunteers where no alteration of the driving performance was evidenced.
Studju speċifiku li sar fuq voluntiera f’ saħħithom biex isir magħruf x’ effett għandu ivabradine waqt is - sewqan wera li mgħandu l- ebda effett.
Ivabradine has no influence on the ability to drive and use machines.
Ivabradine m’ għandu l- ebda effett fuq il- ħila tas- sewqan u waqt l- użu tal- magni.
However, ivabradine may cause transient luminous phenomena consisting mainly of phosphenes (see section 4.8).
Madankollu ivabradine jista ’ jikkaġuna fenomeni mudwali temporanji l- aktar bħal ċrieki ta ’ dawl.
The possible occurrence of such luminous phenomena should be taken into account when driving or using machines in situations where sudden variations in light intensity may occur, especially when driving at night.
Wieħed għandu jikkunsidra dawn il- fenomeni waqt is- sewqan jew waqt it- tħaddim ta ’ magni speċjalment meta jkun hemm varjazzjoni fil- qawwa tad- dawl l- aktar waqt sewqan bil- lejl.
Corlentor has been studied in clinical trials involving nearly 5,000 participants.
Corlentor ġie studjat f’ provi kliniċi li involvew 5000 partiċipant.
Approximately 2,900 patients have been treated with ivabradine in phase II-III studies.
Madwar 2, 900 pazjent ġew ikkurati b’ ivabradine f’ fażi II- III ta ’ l- istudji.