FrancophonIA/ELRC3.0 huggingface dataset:
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Maltese: Sussegwentement l-informazzjoni tal-prodott tista' tiġi aġġornata mill-awtoritajiet kompetenti talIstati Membri, flimkien mal-Istat Membru ta' Referenza, kif xieraq, skont il-proċeduri elenkati f'Kapitlu 4 ta' Titolu III tad-Direttiva 2001/83/KE.
English: Enzyme interactions
Maltese: Interazzjonijiet mal-enzimi
English: Iron oxide reddish-brown (E172) (Only used for Plendil 5 mg and 10 mg) Iron oxide yellow (E172)
Maltese: Iron oxide reddish-brown (E172) (Li jintuża biss għal Plendil 5 mg u 10 mg) Iron oxide yellow (E172)
English: There is limited clinical trial experience of the use of felodipine in hypertensive paediatric patients (see sections 5.1 and 5.2).
Maltese: Teżisti esperjenza klinika limitata tal-użu ta' felopidine f'pazjenti pedjatriċi bi pressjoni għolja (ara sezzjonijiet 5.1 u 5.2).
English: Uncommon Tachycardia, palpitations
Maltese: Takikardija, palpitazzjonijiet
English: Cyclosporin: Felodipine does not affect plasma concentrations of cyclosporin.
Maltese: Cyclosporin: Felodipine ma jaffettwax il-konċentrazzjonijiet fil-plażma ta' cyclosporin.
English: Felodipine is metabolised in the liver by cytochrome P450 3A4 (CYP3A4).
Maltese: Felodipine huwa metabolizzat fil-fwied minn cytochrome P450 3A4 (CYP3A4).
English: The plasma protein binding of felodipine is approximately 99%.
Maltese: It-twaħħil mal-proteini fil-plażma ta' felodipine huwa ta' madwar 99 %.
English: • Acute myocardial infarction
Maltese: • Infart mijokardijaku akut
English: • Anti HIV/protease inhibitors (e.g. ritonavir)
Maltese: • Inibituri kontra l-HIV/protease (eż. ritonavir)
English: Felodipine Cmax and AUC increased 8-fold and 6-fold, respectively, when felodipine was coadministered with the strong CYP3A4 inhibitor itraconazole.
Maltese: Is-Cmax u l-AUC ta' Felodipine żdiedu 8 darbiet u 6 darbiet, rispettivament, meta felodipine ingħata flimkien mal-inibitur CYP3A4 qawwi itraconazole.
English: Peripheral oedema Fatigue
Maltese: Edema periferali
English: 4 blisters of 7 tablets
Maltese: 4 folji ta' 7 pilloli
English: Haemodynamic effects
Maltese: Effetti emodinamiċi
English: When felodipine was coadministered with carbamazepine, phenytoin or phenobarbital, the Cmax and AUC of felodipine were decreased by 82% and 96% respectively.
Maltese: Meta felodipine ngħata ma' carbamazepine, phenytoin jew phenobarbital, is-Cmax u l-AUC ta' felodipine tnaqqsu b'82% u b'96% rispettivament.
English: Medicines containing St John's wort (Hypericum perforatum) (herbal product used to treat depression) may reduce the effect of Plendil and should therefore be avoided.
Maltese: Mediċini li fihom St John's wort (Hypericum perforatum) (prodott tal-ħaxix użat biex jikkura d depressjoni) jistgħu jnaqqsu l-effett ta' Plendil u għalhekk għandhom jiġu evitati.
English: • Burning/prickling/numbness
Maltese: • Ħruq/tingiż/tnemnim
English: • carbamazepine (medicine to treat epilepsy)
Maltese: • carbamazepine (mediċina biex tikkura l-epilessija)
English: • medicines to treat HIV infection (such as efavirenz, nevirapine)
Maltese: • mediċini biex tiġi kkurata infezzjoni tal-HIV (bħal efavirenz, nevirapine)
English: • tacrolimus (medicine used in organ transplantations)
Maltese: • tacrolimus (mediċina li tintuża fit-trapjanti tal-organi)
English: It is bound pre-dominantly to the albumin fraction.
Maltese: Dan jeħel b'mod predominanti mal-frazzjoni tal-albumina.
English: Each tablet contains 2.5 mg 5 mg or 10 mg of felodipine.
Maltese: Kull pillola fiha fihom 2.5 mg, 5 mg jew 10 mg ta' felodipine.
English: • cimetidine (medicine to treat gastric ulcers)
Maltese: • cimetidine (mediċina biex tikkura l-ulċeri gastriċi)
English: In a randomised, double-blind, 3-week, parallel group study in children aged 6-16 years with primary hypertension, the antihypertensive effects of once daily felodipine 2.5 mg (n=33), 5 mg (n=33) and 10 mg (n=31) were compared with placebo (n=35).
Maltese: Fi studju tal-grupp parallel, ta' 3 ġimgħat, randomizzat, double-blind, fi tfal li kellhom bejn 6 u 16il sena bi pressjoni għolja primarja, l-effetti kontra l-pressjoni ta' felodipine 2.5 mg (n=33), 5 mg
English: According to the STOP-2 (Swedish Trial in Old Patients with Hypertension-2 study), performed in 6614 patients, aged 70-84 years, dihydropyridine calcium antagonists (felodipine and isradipine) have shown the same preventive effect on cardiovascular mortality and morbidity as other commonly used classes of antihypertensive medicinal products - ACE inhibitors, beta-blockers and diuretics.
Maltese: il pazjent, li kellhom bejn 70-84 sena, l-antagonisti tal-kalċju dihydropyridine (felodipine u isradipine) urew l-istess effett preventiv fuq il-mortalità u l-morbidità kardjovaskulari bħal klassijiet oħrajn komunement użati ta' prodotti mediċinali kontra l-pressjoni għolja - inibituri ACE, imblokkaturi beta u dijuretiċi.
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Maltese: Rapportar ta' reazzjonijiet avversi suspettati Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: • ketoconazole (medicine to treat fungi)
Maltese: • ketoconazole (mediċina biex tikkura l-fungi)
English: Headache Dizziness, paraesthesia
Maltese: Uġigħ ta' ras Sturdament, parasteżija
English: • barbiturates (medicine to treat anxiety, sleeping problems and epilepsy)
Maltese: • barbiturati (mediċina biex tikkura l-ansjetà, problemi ta' rqad u epilessija)
English: France: Flodil
Maltese: Flodil
English: • Carbamazepine
Maltese: • Phenytoin • Carbamazepine
English: • phenytoin (medicine to treat epilepsy)
Maltese: • phenytoin (mediċina biex tikkura l-epilessija)
English: In a single dose (felodipine prolonged-release 5 mg) pharmacokinetic study with a limited number of children aged between 6 and 16 years (n=12) there was no apparent relationship between the age and AUC, Cmax or half-life of felodipine.
Maltese: Fi studju farmakokinetiku b'doża waħda (felodipine ta' 5 mg li jerħi l-mediċina bil-mod) b'numru limitat ta' tfal li għandhom bejn 6 u 16-il sena (n=12) ma kien hemm ebda relazzjoni evidenti bejn letà u l-AUC, Cmax jew il-half-life ta' felodipine.
English: Reproductive system and breast disorders
Maltese: Disturbi fis-sistema riproduttiva u s-sider
English: The study failed to demonstrate the efficacy of felodipine in lowering blood pressure in children aged 6-16 years (see section 4.2)
Maltese: L-istudju naqas milli juri l-effikaċja ta' felodipine fit-tnaqqis tal-pressjoni tad-demm fi tfal li għandhom bejn 6 u 16-il sena (ara sezzjoni 4.2)
English: 3 blisters of 30 tablets
Maltese: 3 folji ta' 30 pillola
English: Very common ≥ 1/10
Maltese: Komuni ħafna ≥ 1/10
English: 1 blister of 28 tablets 2 blisters of 14 tablets 4 blisters of 7 tablets
Maltese: 28 pillola folja ta' 28 pillola 2 folji ta' 14-il pillola 4 folji ta' 7 pilloli
English: 14 tablets 20 tablets 28 tablets 30 tablets 98 tablets 100 tablets
Maltese: 14-il pillola 20 pillola 28 pillola 30 pillola 98 pillola 100 pillola
English: • Hypersensitivity to felodipine or any of the excipients listed in section 6.1
Maltese: • Sensittività eċċessiva għal felodipine jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis sezzjoni 6.1
English: This belongs to a group of medicinces called calcium antagonists.
Maltese: Dan jagħmel parti minn grupp ta' mediċini msejħa antagonisti tal-kalċju.
English: Hypersensitivity reactions, e.g. angio-oedema, fever
Maltese: Reazzjonijiet ta' sensittività eċċessiva, eż. anġjo-edema, deni
English: Pack sizes of 14, 20, 28, 30, 90, 98 and 100 tablets
Maltese: Daqs tal-pakkett ta' 20, 28, 30, 98 u 100 pillola Daqs tal-pakkett ta' 14, 20, 28, 30, 90, 98 u 100 pillola
English: Felodipine is extensively metabolised in the liver by cytochrome P450 3A4 (CYP3A4) and all identified metabolites are inactive.
Maltese: Felodipine huwa metabolizzat estensivament fil-fwied minn cytochrome P450 3A4 (CYP3A4) u lmetaboliti identifikati kollha huma inattivi.
English: 14 tablets 20 tablets 28 tablets 30 tablets 90 tablets 98 tablets 100 tablets
Maltese: 14-il pillola 20 pillola 28 pillola 30 pillola 90 pillola 98 pillola 100 pillola pillola ta' 10 mg
English: • Impotence/sexual dysfunction
Maltese: • Uġigħ fil-muskoli • Impotenza/disfunzjoni sesswali
English: Other medicines and Plendil
Maltese: Mediċini oħra u Plendil
English: Stable angina pectoris
Maltese: Anġina pectoris stabbli
English: Each tablet contains 28 mg lactose and 2.5 mg polyoxyl 40 hydrogenated castor oil.
Maltese: Kull pillola fiha 28 mg lactose u 2.5 mg polyoxyl 40 hydrogenated castor oil.
English: • Nettle rash
Maltese: • Rimettar • Raxx
English: Each tablet contains 10 mg felodipine.
Maltese: Kull pillola fiha 10 mg felodipine
English: Each tablet contains 28 mg lactose and 10 mg polyoxyl 40 hydrogenated castor oil.
Maltese: Kull pillola fiha 28 mg lactose u 10 mg polyoxyl 40 hydrogenated castor oil.
English: Pharmacotherapeutic group: calcium channel blockers, dihydropyridine derivatives; ATC code: C08CA02
Maltese: Kategorija farmakoterapewtika: imblukkaturi tal-kanal tal-kalċju, derivattivi ta' dihydropyridine;
English: The standard maintenance dose is 5 mg once daily.
Maltese: Id-doża ta' manteniment standard hija ta' 5 mg darba kuljum.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2.5 mg (or 5 mg, or 10 mg) felodipine
Maltese: Kull pillola fiha 2.5 mg (jew 5 mg, jew 10 mg) felodipine
English: 1 bottle of 100 tablets 10 blisters of 10 tablets
Maltese: 100 pillola flixkun ta' 100 pillola 10 folji ta' 10 pilloli
English: Each tablet contains 28 mg lactose and 5 mg polyoxyl 40 hydrogenated castor oil.
Maltese: Kull pillola fiha 28 mg lactose u 5 mg polyoxyl 40 hydrogenated castor oil.
English: DATE OF REVISION OF THE TEXT <{MM/YYYY}> <{DD/MM/YYYY}> <{DD month YYYY}> [To be completed nationally]
Maltese: DATA TA' REVIŻJONI TAT-TEST <{XX/SSSS}> <{JJ/XX/SSSS}> <{JJ xahar SSSS}>
English: Each tablet contains 5 mg felodipine.
Maltese: Kull pillola fiha 5 mg felodipine
English: In case of accompanying bradycardia, atropine 0.5-1 mg should be administered intravenously.
Maltese: għandu jingħata 0.5-1 mg ta' atropine ġol-vina.
English: However, there have been no reported clinical incidences of phalangeal changes in foetus/neonate exposed to felodipine in-utero, from the information maintained within the internal patient safety databases.
Maltese: Madankollu, ma ġiet irrapportata ebda inċidenza klinika ta' bidliet fil-falanaġi fil-fetu/tarbija tattwelid esposta għal felodipine fl-utru, mill-informazzjoni miżmuma fid-databases interni tas-sigurtà tal-pazjent.
English: 20 tablets 28 tablets 30 tablets 98 tablets 100 tablets
Maltese: 20 pillola 28 pillola 30 pillola 98 pillola 100 pillola pillola ta' 5 mg
English: 1 blister of 14 tablets
Maltese: 14-il pillola folja ta' 14-il pillola
English: • medicines to treat HIV protease inhibitors (such as ritonavir)
Maltese: • mediċini biex jiġu kkurati l-inibituri protease tal-HIV (bħal ritonavir)
English: Rash, pruritus Urticaria
Maltese: Dardir, uġigħ ta' żaqq
English: EXP
Maltese: Modip
English: Plendil and associated names (see Annex I) 2.5 mg prolonged-release tablets Plendil and associated names (see Annex I) 5 mg prolonged-release tablets Plendil and associated names (see Annex I) 10 mg prolonged-release tablets
Maltese: Plendil u ismijiet assoċjati (ara Anness I) 2.5 mg pilloli li jerħu l-mediċina bil-mod Plendil u ismijiet assoċjati (ara Anness I) 5 mg pilloli li jerħu l-mediċina bil-mod Plendil u ismijiet assoċjati (ara Anness I) 10 mg pilloli li jerħu l-mediċina bil-mod
English: • Unstable angina pectoris
Maltese: • Anġina pectoris mhux stabbli
English: Less than 0.5% of a dose is recovered unchanged in urine.
Maltese: Inqas minn 0.5 % tad-doża tiġi rkuprata mhux mibdula fl-awrina.
English: 7 blisters of 14 tablets
Maltese: 7 folji ta' 14-il pillola
English: 1 bottle of 30 tablets 3 blisters of 10 tablets
Maltese: 30 pillola flixkun ta' 30 pillola 3 folji ta' 10 pilloli
English: • rifampicin (medicine to treat infections)
Maltese: • rifampicin (mediċina biex tikkura l-infezzjonijiet)
English: Plendil and associated names (see Annex I) 2.5 mg [5 mg or, 10 mg] prolonged-release tablets [See Annex I - To be completed nationally] felodipine
Maltese: Plendil u ismijiet assoċjati (ara Anness I) 2.5 mg [5 mg jew, 10 mg] pilloli li jerħu l-mediċina bil mod [Ara Anness I - li għandha timtela fuq livell nazzjonali] felodipine
English: Pack sizes of 14, 20, 28, 30, 98 and 100 tablets
Maltese: Daqs tal-pakkett ta' 14, 20, 28, 30, 98 u 100 pillola Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur
English: Volume of distribution at steady state is 10 L/kg.
Maltese: Il-volum ta' distribuzzjoni fl-istat fiss huwa ta' 10 L/kg.
English: Tablet coating:
Maltese: Kisja tal-pillola:
English: PHARMACEUTICAL FORM AND CONTENTS 2.5 mg tablet
Maltese: Kull pillola fiha 2.5 mg felodipine
English: Tacrolimus: Felodipine may increase the concentration of tacrolimus.
Maltese: Felodipine jista' jżid il-konċentrazzjoni ta' tacrolimus.
English: Gingival hyperplasia, gingivitis
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Felodipine is administered as extended-release tablets, from which it is completely absorbed in the gastrointestinal tract.
Maltese: Felodipine jingħata bħala pilloli li jerħu l-mediċina bil-mod, li minnhom, huwa jiġi assorbit kompletament fil-passaġġ gastrointestinali.
English: • erythromycin (medicine to treat infections)
Maltese: • erythromycin (mediċina biex tikkura l-infezzjonijiet)
English: Cimetidine increased the felodipine Cmax and AUC by approximately 55%.
Maltese: ta' felodipine b'madwar 55%.
English: The following definitions of frequencies are used:
Maltese: Jintużaw id-definizzjonijiet tal-frekwenzi li ġejjin:
English: Reproduction studies in rabbits have shown a dose-related reversible enlargement of the mammary glands of the parent animals and dose-related digital anomalies in the foetuse.
Maltese: L-istudji tar-riproduzzjoni fil-fniek urew tkabbir riversibbli relatat mad-doża tal-glandoli mammarji tal-annimali ġenituri u anomaliji diġitali marbuta mad-doża fil-feti.
English: • Hypersensitivity reactions such as fever or swelling of the lips and tongue
Maltese: • Sensittività eċċessiva u reazzjonijiet allerġiċi:
English: The half-life of felodipine in the elimination phase is approximately 25 hours and steady state is reached after 5 days.
Maltese: Il-half-life ta' felodipine fil-fażi ta' eliminazzjoni hija madwar 25 siegħa u l-istat fiss jintlaħaq wara 5 ijiem.
English: Plendil 2.5 mg prolonged-release tablet is yellow, circular, biconvex, engraved A/FL on one side and 2.5 on the other side, with a diameter of 8.5 mm.
Maltese: imnaqqxa b'A/FL fuq naħa minnhom u b'2.5 fuq in-naħa l-oħra, b'dijametru ta' 8.5 mm.
English: In non-clinical reproductive toxicity studies there were foetal developmental effects, which are considered to be due to the pharmacological action of felodipine.
Maltese: Fi studji tat-tossiċità riproduttiva mhux kliniċi kien hemm effetti ta' żvilupp tal-fetu, li huma kkunsidrati li huma dovuti għall-azzjoni farmakoloġika ta' felodipine.
English: Plendil 10 mg prolonged-release tablet is reddish-brown, circular, biconvex, engraved A/FE on one side and 10 on the other side, with a diameter of 9.
Maltese: Plendil 10 mg hija pillola kannella fl-aħmar, tonda, ibbuzzata fuq iż-żewġ naħat li terħi l-mediċina bil mod, imnaqqxa b'A/FL fuq naħa minnhom u b'10 fuq in-naħa l-oħra, b'dijametru ta' 9 mm.
English: In the HOT (Hypertension Optimal Treatment) study, the effect on major cardiovascular events (ie, acute myocardial infarction, stroke and cardiovascular death) was studied in relation to diastolic blood pressure targets < 90 mmHg, < 85 mmHg and < 80 mmHg and achieved blood pressure, with felodipine as baseline therapy.
Maltese: Fl-istudju HOT (Kura Ottimali għal Pressjoni Għolja - Hypertension Optimal Treatment), l-effett fuq avvenimenti kardjovaskulari ewlenin (jiġifieri infart mijokardijaku akut, puplesija u mewt kardjovaskulari) ġie studjat fir-rigward tal-miri dijastoliċi tal-pressjoni tad-demm < 90 mmHg,
English: Practice good oral hygiene to help avoid your gums from swelling (see section 4).
Maltese: Għalhekk kombinazzjonijiet bħal dawn għandhom jiġu evitati (ara sezzjoni 4.5).
English: Felodipine has a natriuretic and diuretic effect due to reduced tubular reabsorption of filtered sodium.
Maltese: Ma ġie osservat ebda disturb fil-fertilità meta ngħataw dożi fil-medda terapewtika lill-firien.
English: 3 blisters of 10 tablets 1 bottle of 30 tablets
Maltese: 3 folji ta' 10 pilloli flixkun ta' 30 pillola
English: Felodipine can be used as monotherapy or in combination with ß-adrenoceptor blockers in patients with stable angina pectoris.
Maltese: mblukkaturi tal-ß-adrenoċettur f'pazjenti b'anġina pectoris stabbli.
English: Photosensitivity reactions, leucocytoclastic vasculitis
Maltese: vaskulite leukoċitoklastika
English: The primary haemodynamic effect of felodipine is a reduction of total peripheral vascular resistance, which leads to a decrease in blood pressure.
Maltese: L-effett emodinamiku primarju ta' felodipine huwa tnaqqis fir-reżistenza vaskulari periferali totali, li jwassal għal tnaqqis fil-pressjoni tad-demm.
English: Patients with rare hereditary problems of galactose intolerance or glucosegalactose malabsorption should not take this medicinal product.
Maltese: Il-pazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, jew b'assorbiment ħażin ta' glucose-galactose ma għandhomx jieħdu dan il-prodott mediċinali.
English: Interactions leading to decreased plasma concentration of felodipine Enzyme inducers of the cytochrome P450 3A4 system have been shown to cause a decrease in plasma concentrations of felodipine.
Maltese: L-inibituri tal-enzimi tas-sistema ta' cytochrome P450 3A4 intwerew li jikkawżaw tnaqqis fil konċentrazzjoni ta' felodipine fil-plażma.
English: The combination with strong CYP3A4 inducers should be avoided.
Maltese: Il-kombinazzjoni ma' inibituri qawwija ta' CYP3A4 għandha tiġi evitata.
English: • Fatigue
Maltese: Fawra
English: • Gingivitis (swollen gums)
Maltese: • Ġinġivite (ħanek minfuħ)
English: • Skin reactions due to increased sensitivity to sunlight
Maltese: Urtikarja Reazzjonijiet ta' fotosensittività,
English: High-density polyethylene bottle with a cap of polypropylene PVC/PVDC blister and Aluminum blister
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Flixkun tal-polyethylene ta' densità għolja b'għatu tal-polypropylene Folja tal-PVC/PVDC u Folja tal-aluminju Daqs tal-Pakkett
English: In case of clinically significant adverse events due to elevated felodipine exposure when combined with strong CYP3A4 inhibitors, adjustment of felodipine dose and/or discontinuation of the CYP3A4 inhibitor should be considered.
Maltese: F'każ ta' avvenimenti avversi klinikament sinifikanti minħabba espożizzjoni għolja għal felodipine meta jingħata flimkien ma' inibituri CYP3A4 qawwija, għandha tiġi kkunsidrata doża ta' felodipine u/jew it-twaqqif tal-inibitur CYP3A4.
English: The systemic availability of felodipine is approximately 15% and is independent of dose in the therapeutic dose range.
Maltese: 15% u ma tiddependix fuq id-doża fil-medda tad-doża terapewtika.
English: Felodipine is a vascular selective calcium antagonist, which lowers arterial blood pressure by decreasing systemic vascular resistance.
Maltese: Felodipine huwa antagonista vaskulari selettiv tal-kalċju, li jbaxxi l-pressjoni tad-demm fl-arterji billi jnaqqas ir-reżistenza vaskulari sistemika.
English: 6.2 Incompatibilities
Maltese: 3 LISTA
English: Enzyme inhibiting and enzyme inducing substances of cytochrome P450 isoenzyme 3A4 may exert an influence on the plasma level of felodipine.
Maltese: Sustanzi li jinibixxu u li jinduċu l-enzimi ta' cytochrome P450 isoenzyme 3A4 jistgħu jinfluwenzaw il-livell ta' felodipine fil-plażma.
English: Sympathomimetic medicinal products with predominant effect on the α1-adrenoceptor may be given if the above-mentioned measures are insufficient.
Maltese: Jistgħu jingħataw prodotti mediċinali simpatomimetiċi b'effett predominanti fuq l-α1-adrenoċettur jekk il-miżuri msemmija hawn fuq ma jkunux suffiċjenti.
English: Plendil contains castor oil, which may cause stomach upset and diarrhoea.
Maltese: Plendil fih castor oil, li jista' jikkawża taqlib fl-istonku u dijarea.
English: Do not use this medicine after the expiry date which is stated on the carton, blister and bottle after ‘EXP'.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna, folja u flixkun wara ‘JIS'.
English: This results in even felodipine plasma concentrations within the therapeutic range for 24 hours.
Maltese: Dan jirriżulta wkoll f'konċentrazzjonijiet fil-plażma ta' felodipine fil-medda terapewtika għal 24 siegħa.
English: It can be used as monotherapy or in combination with other antihypertensive medicinal products, eg, ß-adrenoceptor blockers, diuretics or ACE-inhibitors, in order to achieve an increased antihypertensive effect.
Maltese: Jista' jintuża bħala monoterapija jew flimkien ma' prodotti mediċinali oħra kontra l-pressjoni għolja, eż. imblokkaturi tal-ß-adrenoċettur, dijuretiċi jew inibituri ACE, sabiex jinkiseb effett akbar kontra l-pressjoni għolja.
English: In a study on fertility and general reproductive performance in rats treated with felodipine, a prolongation of parturition resulting in difficult labour/increased foetal deaths and early postnatal deaths was observed in the medium and high dose groups.
Maltese: Fi studju dwar il-fertilità u l-prestazzjoni riproduttiva ġenerali fil-firien ikkurati b'felodipine, ġie osservat prolongament tal-ħlas li jirriżulta fi ħlas diffiċli/żieda fl-imwiet tal-feti u mwiet bikrin wara l ħlas fil-gruppi ta' doża medja u għolja.
English: Interactions leading to increased plasma concentration of felodipine CYP3A4 enzyme inhibitors have been shown to cause an increase in felodipine plasma concentrations.
Maltese: L-inibituri tal-enzima CYP3A4 intwerew li jikkawżaw żieda fil-konċentrazzjoni ta' felodipine filplażma.
English: Plendil, like other blood-pressure lowering medicinal products, may in rare cases lead to pronounced low blood pressure which in some patients may result in an inadequate supply of blood to the heart.
Maltese: Plendil, bħal prodotti mediċinali oħra li jnaqqsu l-pressjoni tad-demm, jista' f'każijiet rari jwassal għal pressjoni tad-demm baxxa predominanti li f'xi pazjenti tista' twassal għal provvista inadegwata ta' demm lejn il-qalb.
English: The tablet is reddish-brown, circular, biconvex, engraved A/FE on one side and 10 on the other side, with a diameter of 9 mm.
Maltese: Il-pillola hija kannella fl-aħmar, tonda, ibbuzzata fuq iż-żewġ naħat, imnaqqxa b'A/FE fuq naħa minnhom u b'10 fuq in-naħa l-oħra, b'dijametru ta' 9 mm.
English: Hypotension Syncope
Maltese: Pressjoni baxxa Sinkope
English: Maximum blood plasma levels (tmax) are achieved with the prolonged-release form after 3 to 5 hours.
Maltese: (tmax) jintlaħqu bil-forma li terħi l-mediċina bil-mod wara 3 sa 5 sigħat.
English: Felodipine may also improve early renal graft function.
Maltese: M'hemm ebda riskju ta' akkumulazzjoni matul il-kura fit-tul.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: Generally, a reduction in blood pressure is evident two hours after the first oral dose and lasts for at least 24 hours and the trough/peak ratio is usually well above 50%.
Maltese: 24 siegħa u l-proporzjon massimu/minimu ġeneralment ikun kemxejn aktar minn 50%.
English: Felodipine is a high clearance medicinal product with an average blood clearance of 1200 ml/min.
Maltese: Felodipine huwa prodott mediċinali bi tneħħija għolja bi tneħħija medja mid-demm ta' 1200 ml/min.
English: Plendil contains the active substance felodipine.
Maltese: Tużax Plendil jekk inti tqila.
English: Tablet core:
Maltese: Informazzjoni għall-pazjent
English: Median (minimum - maximum)
Maltese: Medjan (minimu - massimu)