qanastek/EMEA-V3 huggingface dataset:
ACE inhibitors therapy exposure during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
L- espożizzjoni għat- terapija b’ impedituri ta ’ l- ACE waqt it- tieni u t- tielet trimestru hi magħrufa li tinduċi tossiċità fil- fetu uman (tnaqqis fil- funzjoni renali, oligohidramnijosi, dewmien fl - ossifikazzjoni tal- kranju) u tossiċità għal tarbija li għadha titwieled (insuffiċjenza renali, pressjoni baxxa, iperkalemja).
14 Although some dihydropyridine compounds have been found to be teratogenic in animals, data in the rat and rabbit for amlodipine provide no evidence for a teratogenic effect (see section 5.3).
Għalkemm xi sustanzi b’ dihydropyridine ntwerew li huma teratoġeniċi fl- annimali, it- tagħrif miġbur minn fuq firien u fmiek dwar amlodipine ma jipprovdi l- ebda evidenza għal effett teratoġeniku (ara sezzjoni 5. 3).
There is, however, no clinical experience with the use of amlodipine in pregnancy.
Madankollu, mhemmx esperjenza klinika bl- użu ta ’ amlodipine fit- tqala.
Accordingly, amlodipine is contraindicated during pregnancy.
Għalhekk, amlodipine hu kontraindikat waqt it- tqala.
No experience is available with the use of Lisonorm in pregnant women from adequately controlled clinical studies.
Mhemmx esperjenza disponibbli dwar l- użu ta ’ Lisonorm f’ nisa tqal minn studji kliniċi b’ kontrolli xierqa.
Consequently, Lisonorm is contraindicated in pregnancy (see section 4.3).
Sussegwentement, Lisonorm hu kontraindikat fit- tqala (ara sezzjoni 4. 3).
When pregnancy is diagnosed, treatment with Lisonorm should be stopped immediately.
Meta tqala tiġi dijanjostikata, it- trattament b’ Lisonorm għandu jitwaqqaf minnufih.
Patients planning pregnancy Lisonorm should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Pazjenti li jippjanaw għal tqala għandu jkollhom Lisonorm mibdul ma trattament ieħor ta ’ kontra l- pressjoni għolja li jkollu profil ta ’ sigurtà stabbilita għal użu fi tqala.
Lactation Lisonorm is not recommended for breast-feeding mothers, as lisinopril may be excreted in human milk (see section 4.3).
Treddigħ Lisonorm mhux rakkomandat għal ommijiet li qed ireddgħu, peress li lisinopril jista ’ jiġi eliminat fil - ħalib tal- bniedem (ara sezzjoni 4. 3).
It is not known whether amlodipine is excreted in human milk.
Mhux magħruf jekk amlodipine joħroġx fil- ħalib tal- bniedem.
Lisonorm may influence the ability to drive and operate machines (particularly during the initial period of treatment).
Lisonorm jista ’ jinfluwenza l- ħila biex issuq u tħaddem magni (b’ mod patikolari fl- istadju bikri tat - trattament).
During a controlled clinical study (n=195), the incidence of adverse reactions was not higher in subjects receiving both active substances concomitantly than in patients on monotherapy.
Waqt studju kliniku b’ kontrolli (n=195), l- inċidenza ta ’ reazzjonijiet avversi ma kenitx ogħla f’ individwi li kienu qed jirċievu iż- żewġ sustanzi attivi fl- istess ħin milli f’ dawk il- pazjenti li kienu fuq il- monoterapija.
Adverse reactions were consistent with those reported previously with amlodipine and/ or lisinopril.
Reazzjonijiet avversi kienu konsistenti ma ’ dawk rapportati qabel b’ amlodipine u/ jew lisinopril.
Adverse reactions were usually mild, transient and rarely warranted the discontinuation of treatment with Lisonorm.
Reazzjonijiet avversi kienu ġeneralment ħfief, għaddiena u rarement kienu jeħtieġu li t- trattament b’ Lisonorm jitwaqqaf.
The most common adverse reactions with the combination were headache (8%), cough (5%), and dizziness (3%).
L- aktar reazzjonijiet avversi komuni bil- kombinazzjoni kienu uġigħ ta ’ ras (8%), sogħla (5%), u sturdament (3%).
In controlled clinical trials, the following adverse reactions were reported in ≥ 1% of patients with either concomitantly administered amlodipine plus lisinopril or with amlodipine and lisinopril monotherapies (see Table below):
Fi provi kliniċi b’ kontrolli, ir- reazzjonijiet avversi li ġejjin ġew rapportati f’ ≥ 1% ta ’ pazjenti kemm meta amlodipine u lisinopril ġew mogħtija flimkien jew meta amlodipine u lisinopril ġew moħtija bħala monoterapija (ara Tabella taħt):
System Organ Class
Reazzjoni avversa
Adverse reaction
Lisinopril
Lisonorm (n=64)
(n=64)
Amlodipine (n=64)
(n=64)
Dizziness Headache
Sturdament
4.4% 8.8%
4. 6%
Cardiac disorders Respiratory, thoracic and mediastinal disorders
Disturbi respiratorji, toraċi ċi u medjastinali
Palpitation Cough
Sogħla
Frequencies are defined as follows:
Il- frekwenzi huma mfissra kif ġej:
Very common (≥ 1/ 10), Common (≥ 1/ 100 to < 1/ 10), Uncommon (≥ 1/ 1,000 to < 1/ 100), Rare (≥ 1/ 10,000 to < 1/ 1,000), Very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Komuni ħafna (≥ 1/ 10), Komuni (≥ 1/ 100 sa < 1/ 10), Mhux komuni (≥ 1/ 1, 000 sa < 1/ 100), Rari (≥ 1/ 10, 000 sa < 1/ 1, 000), Rari ħafna (< 1/ 10, 000), mhux magħruf (ma jistax jiġi stmat mit- tagħrif disponibbli).
The following adverse drug reactions (ADRs) have been reported during the treatment with lisinopril and amlodipine independently:
Ir- reazzjonijiet avversi għal mediċina li ġejjin (ADR) ġew irrapportati waqt it- trattament b’ lisinopril u amlodipine independentement:
ADRs with lisinopril
ADR b’ lisinopril
ADRs with amlodipine
ADR b’ amlodipine
Bone marrow depression, Agranulocytosis, Leucopenia, Neutropenia, Thrombocytopenia, Haemolytic anaemia Anaemia, Lymphadenopathies
Dipressjoni tal- mudullun, Agranuloċitosi, Lewkopenja, Newtropenja, Tromboċitopenija, Anemija emolitika Anemija, Limfadenopatiji
Autoimmune disorders
Disturbi awtoimmuni
Mood altered, Sleep disturbances
Burdata mibdula, Disturbi
Insomnia, Mood altered
Nuqqas ta ’ rqad,
Mental disorders
Disturbi mentali
Dizziness, Headache
Sturdament, Uġigħ ta ’ ras
Somnolence, Dizziness, Headache
Ħedla, Sturdament, Uġigħ ta ’ ras
Vertigo, Paraesthesia, Taste disturbance
Vertigo, Paraestesija, Disturbi fit- togħma
Syncope, Tremor, Taste perversion, Hypoaesthesia, Paraesthesia
Sinkope, Tregħid, bidla fit- togħma, Ipoestesja, Paraestesja
Eye disorders
Disturbi tal- għajnejn
Visual disturbances
Disturbi fil- vista
Tinnitus
Tinnite
Myocardial infarction (see section 4.4), Tachycardia, Palpitations,
Infart mijokardijaku (ara sezzjoni 4. 4), Takikardja, Palpitazzjonijiet,
Myocardial infarction, Ventricular tachycardia, Atrial fibrillation, Arrhythmia
Infart mijokardijaku, Takikardja ventrikulari, Fibrilazzjoni atrijali, Arritmija
Orthostatic hypotension
Pressjoni ortostatika baxxa
Cerebrovascular accident (see section 4.4), Raynaud’ s phenomenon
Aċċident ċerebrovaskulari (ara sezzjoni 4. 4), Fenomenu ta ’ Raynaud
Respiratory, thoracic and mediastinal disorders
Disturbi respiratorji, toraċiċi Komuni
Common
Sogħla
Cough
15 Sistema tal- Klassifika tal- Organi u medjastinali
Rhinitis
Frekwenza
Dyspnoea, Rhinitis
ADR b’ lisinopril
System Organ Class
ADR b’ amlodipine
Frequency
Mhux komuni
Bronchospasm, Allergic alveolitis/ Eosinophilic pneumonia, Sinusitis
Bronkospażmu, Alveolite allerġika/ Pnewmonja Eosinofilika, Sinusite
Diarrhoea, Vomiting
Dijarea, Rimettar
Abdominal pain, Nausea
Uġigħ addominali tqalliegħ
Abdominal pain, Nausea, Indigestion
Uġigħ addominali, Tqalliegħ, Indiġestjoni
Vomiting, Dyspepsia, Altered bowel habits, Dry mouth
Rimettar, Dispepsja, Imġieba tal- imsaren mibdula, Ħalq xott
Pancreatitis, Intestinal angioedema
Pankreatite, Anġjoedema intestinali
Pancreatitis, Gastritis, Gingival hyperplasia
Pankreatite, Gastrite, Iperplasja ġenġivali
Hepatobiliary disorders
Disturbi fil- fwied u
Hepatic failure, Hepatitis, Cholestatic jaundice, (see section 4.4)
Epatite, Suffejra kolestatika, (ara sezzjoni 4. 4)
Hepatitis, Jaundice, Cholestasis
Disturbi fil- ġilda u fit- tessuti
Skin and subcutaneous tissue Uncommon disorders
ta ’ taħt il- ġilda
Hypersensitivity/ angioedem Alopecia, Rash, Purpura, a of the face, extremities, Skin discolouration, lips, tongue, glottis and/ or Diaphoresis, Pruritus larynx (see section 4.4), Rash, Pruritus
tal- wiċċ, estremitajiet, xofftejn, ilsien, glottide u/ jew tal- larinġi (ara sezzjoni 4. 4), Raxx, Ħakk
Psoriasis, Urticaria, Alopecia
Psorjasi, Urtikarja, Alopeċja
Toxic Epidermal Necrolysis, Erythema multiforme, Stevens-Johnson Syndrome, Angioedema, Urticaria Erythema multiforme.
Nekrolisi Epidermali tossika, Sindromu ta ’ Stevens- Johnson, Eritema multiforme.
Pemphigus, Diaphoresis.
Pemfigus, Dijaforesi.
A syndrome has been reported that may include one or more of the following symptoms: fever, vasculitis, myalgia, arthralgia/ arthritis, positive ANA, elevated ESR value, eosinophilia and leucocytosis, rash, photosensitivity or other dermatological manifestations.
Sindromu ġie rapportat li jista ’ jinkludi wieħed jew aktar mis- sintomi li ġejjin: deni, vaskulite, uġigħ fil - muskoli, artralġja/ artrite, ANA pożittiva, valur ta ’ ESR elevat, eosinofilja u lewkoċitosi, raxx, fotosensittività u manifestazzjonijiet oħra tal- ġilda.
Musculoskeletal and connective tissue disorders
Erytema multiforme, Anġjoedema, Urtikarja
Arthralgia, Myalgia, Muscle cramps, Back pain
Disturbi fil- kliewi u fis - sistema urinarja
Renal and urinary disorders
Problemi ta ’ funzjoni fil- kliewi
Renal dysfunction
ADR b’ amlodipine
Micturition disorder, Nocturia, Increased urinary frequency
Disturbi biex tista ’ tgħaddi l- awrina, Nokturja, Żieda fil- frekwenza biex tgħaddi awrina
Acute renal failure, Uraemia
Insuffiċjenza renali akuta, Uremja
Frequency
Rari ħafna
ADRs with lisinopril
Oligurja/ Anurja
ADRs with amlodipine
Disturbi fis- sistema riproduttiva u fis- sider
Very rare
Mhux komuni
Oliguria/ Anuria
Impotenza
Reproductive system and breast disorders
Impotenza, Ginekomastja
Uncommon Rare
Rari
Impotence Gynaecomastia
Ginekomastja
Oedema, Fatigue
Edema, Għeja
Fatigue, Asthenia
Għeja, Astenja
Chest pain, Pain, Malaise, Asthenia
Uġigħ fis- sider, Uġigħ, Tħossok ma tiflaħx, Astenja
Blood urea increased, Serum creatinine increased, Hyperkalaemia, Hepatic enzymes increased
Żieda fil- livell ta ’ urea
Weight increase, Weight decrease
Żieda fil- piż, Tnaqqis
Haemoglobin decreased, Haematocrit decreased Serum bilirubin increased, Hyponatraemia
ematokrit, żieda fil- livell ta ’ bilirubin fis- serum, Iponatremja
Hepatic enzymes increased
Żieda fl- enżimi tal- fwied
Overdose can result in excessive peripheral vasodilatation with marked hypotension, circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety, and cough.
Doża eċċessiva tista ’ tirriżulta f’ vażodilazzjoni periferali eċċessiva bi pressjoni baxxa sostanzjali, xokk ċirkolatorju, disturbi fl- elettroliti, insuffiċjenza renali, iperventilazzjoni, takikardja, palpitazzjonijiet, bradikardja, sturdamenti, ansjetà, u sogħla.
Symptomatic treatment (placing the patient in a supine position, monitoring – and when necessary, support – of cardiac function, blood pressure, fluid and electrolyte balance) is recommended.
Trattament sintomatiku (tqiegħed il - pazjent wiċċu l- fuq, monitoraġġ – u meta meħtieġ, appoġġ – tal- funzjoni kardijaka, pressjoni tad - demm, bilanċ tal- fluwidi u tal- elettroliti) hu rakkomandat.
In case of serious hypotension, the lower extremities should be elevated, and when intravenous administration of fluid does not elicit sufficient response, supportive treatment added-on with administration of peripheral vasopressor agents may be necessary, unless contraindicated.
F’ każ ta ’ pressjoni baxxa serja, l - estremitajiet ta ’ taħt għandhom jiġu elevati, u meta l- għoti ta ’ fluwidu fil- vina ma jwassalx għal rispons suffiċjenti, trattament ta ’ appoġġ bl- għoti ta ’ sustanzi li jikkaġunaw tidjieq tal- vażi periferali jistgħu jkunu meħtieġa, ħlief meta dawn ikunu kontraindikati.
If available, treatment with angiotensin II infusion may also be considered.
Jekk disponibbli, trattament b’ infużjoni ta ’ angiotensin II jista ’ jiġi kkonsidrat ukoll.
Intravenous administration of calcium gluconate may be beneficial in reversing the effects of calcium channel blockade.
L- għoti ġol- vina ta ’ calcium gluconate jista ’ jkun ta ’ siwi sabiex jreġġa ’ lura l- effetti tal- imblokk tal- kanali tal- kalċju.
Since amlodipine is slowly absorbed, gastric lavage can be useful in some cases.
Peress li amlodipine jiġi assorbit bil- mod, il- ħasil gastriku jista ’ jkun utli f’ xi każijiet.
Lisinopril can be removed from the systemic circulation by haemodialysis.
Lisinopril jista ’ jitneħħa miċ- ċirkolazzjoni sistemika b’ emodijalisi.
Amlodipine, however, is highly protein-bound and, therefore, dialysis is not likely to be of benefit (see section 4.4.)
Madankollu, amlodipine, jintrabat b’ affinità kbira ma ’ proteini u għalhekk id- dijaliżi x’ aktarx ma tkunx ta ’ siwi (ara sezzjoni 4. 4.)
5.1 Pharmacodynamic properties
17 5. 1 Tagħrif farmakodinamiku
Lisonorm is a fixed dose combination containing the active substances lisinopril and amlodipine.
Lisonorm huwa kombinazzjoni ta ’ dożi fissi bis- sustanzi attivi lisinopril u amlodipine.
18 Lisinopril Lisinopril is an angiotensin converting enzyme (ACE) inhibitor, which results in reduction of plasma angiotensin II and consequently aldosterone levels and elevates those of vasodilatory bradykinin.
Lisinopril Lisinopril huwa impeditur għall- enżimi li jikkonvertu angiotensin, li jikkaġuna tnaqqis ta’ angiotensin II fil- plażma u sussegwentement tal- livelli ta ’ aldosterone u jgħolli dawk tal- vażodilatur bradykinin.
It reduces peripheral vascular resistance and systemic blood pressure.
Hu jnaqqas ir- reżistenza vaskulari periferali u l- pressjoni tad- demm sistematika.
These changes may be accompanied by an increase in cardiac output at unchanged heart frequency, as well as an increase in renal blood flow.
Dawn il- bidliet jistgħu jkunu akkumpanjati b’ żieda fil- ħruġ kardijaku mingħajr tibdil fil- frekwenza tal- qalb, kif ukoll f’ żieda fl- influss tad- demm fil- kliewi.
In hyperglycaemic patients, lisinopril contributes to the restoration of impaired endothelial function.
F’ pazjenti ipergliċemiċi, lisinopril jikontribwixxi sabiex il - funzjoni endoteljali indebolita tiġi restorata.
The antihypertensive effect of lisinopril usually ensues 1 hour after administration and peaks after 6 hours.
L- effett kontra l- pressjoni għolja ta ’ lisinopril ġeneralment iseħħ siegħa wara l- għoti u tilħaq il - massimu wara 6 sigħat.
Its duration of action is 24 hours – also depending on dose.
It- tul taż- żmien kemm iddum taħdem hu ta ’ 24 siegħa – skond id- doża wkoll.
The antihypertensive efficacy of lisinopril is also maintained on the long term.
L- effikaċja kontra l- pressjoni għolja ta ’ lisinopril hija mantenuta wkoll fuq perijodu ta ’ żmien twil.
Abrupt discontinuation of lisinopril treatment is not associated with any substantial rebound effect (blood pressure elevation).
Twaqqif f’ daqqa tat- trattament b’ lisinopril mhux assoċjat ma ’ xi effett sostanzjali ta ’ rebound (pressjoni tad- demm li togħla).
Although its primary effect is mediated by the renin-angiotensin-aldosterone system, lisinopril is also effective in hypertensive patients with low plasma renin activity.
Lisinopril huwa effettiv ukoll f’ pazjenti li għandhom pressjoni għolja b’ attività baxxa ta ’ renin fil - plażma.
In addition to its direct blood pressure lowering effect, lisinopril mitigates albuminuria by modifying the haemodynamic conditions and tissue structure in the renal glomeruli.
Barra mill- effett dirett fuq il- pressjoni tad- demm, lisinopril jimmitiga l- albuminurja billi jimmodifika l- kundizzjonijiet emodinamiċi u l- istruttura tat- tessuti fil- glomeruli renali.
In controlled clinical trials conducted in diabetic patients, no changes of blood glucose level and no increase in the incidence of hypoglycaemia were ascertained.
Fi provi kliniċi b’ kontrolli li saru fuq pazjenti dijabetiċi, ma kienx hemm bidliet fil- livell ta ’ żokkor fid- demm u ebda żieda fl- inċidenza ta ’ ipogliċemija ma ġiet aċċertata.
Amlodipine Amlodipine is a dihydropyridine-type calcium channel blocker.
Amlodipine Amlodipine huwa imblokkatur tal- kanali tal- kalċju tat- tip dihydropyridine.
It inhibits the influx of calcium into myocardial and vascular smooth muscle cells through the inhibition of slow calcium ion channels of the cell membranes.
Hu jimpedixxi l- influss ta ’ kalċju f’ ċelluli mijokardjali u f’ ċelluli ta ’ muskoli lixxi vaskulari permezz ta ’ l- impediment ta ’ kanali tardivi ta ’ ijoni tal- kalċju tar- riti ċellulari.
Amlodipine reduces the tone of smooth muscle in arterioles and hence the peripheral vascular resistance which lowers systemic blood pressure.
Amlodipine inaqqas it- ton tal- muskoli lixxi f’ arterjoli u dan jikkawża reżistenza vaskulari periferali li tbaxxi l- pressjoni tad- demm sistematika.
Amlodipine exerts antianginal effect through the dilation of peripheral arterioles as well as through reduction of cardiac afterload, without resulting in reflex tachycardia, and accordingly, energy consumption and oxygen demand of cardiac muscle decrease.
Amlodipine jeżerċita effett antianġinali permezz tat- twessiegħ ta ’ l- arterjoli periperali kif ukoll permezz ta ’ tnaqqis ta ’ afterload kardijaku, mingħajr ma jirriżulta f’ takikardja riflessiva, u b’ riżultat t’ hekk, il- konsum ta ’ l- enerġija u d- domanda għall- ossiġnu tal- muskolu kardijaku jonqsu.
Amlodipine may dilate coronary vessels (arteries and arterioles); it improves oxygen supply to the myocardium both in intact and in ischaemic regions.
Amlodipine jista ’ jwessa ’ l- vażi koronarji (arterji i arterjoli); ittejjeb il- forniment ta ’ ossiġnu lil mijokardjum kemm fir- reġjuni intatti u iskemiċi.
Once daily dosing of amlodipine reduces the blood pressure of hypertensive patients both in the supine and standing position throughout the 24-hour interval.
Doża ta ’ darba kuljum ta ’ amlodipine tnaqqas il- pressjoni tad- demm ta ’ pazjenti bil- pressjoni għolja kemm f’ pożizzjoni minduda b’ wiċċhom ’ il fuq u kemm bilwieqfa tul l- intervall ta ’ 24 siegħa.
Due to the slow onset of action, acute hypotension does not occur.
Minħabba li jdum biex jaħdem, pressjoni baxxa akuta ma sseħħx.
Calcium channel blocking activity, for example elicits direct arterial dilation accompanied by sodium and water retention.
L- attività ta ’ imblokk tal- kanali tal- kalċju, pereżempju teliċita twessiegħ arterjali dirett akkumpanjat b’ żamma ta ’ sodju u ilma.
Compensatory activation of the renin-angiotensin-aldosterone system (RAAS) should be expected and therefore, counter-regulatory mechanisms activated by ACE inhibitors may contribute to the restoration of physiological responses to increased salt intake.
Attivazzjoni kompensatorja tas- sistema renin- angiotensin- aldosterone (RAAS) hija mistennija u għalhekk, mekkaniżmi kontraregolatorji attivati minn impedituri tal- ACE jistgħu jikontribwixxu għar- restorazzjoni ta ’ risponsi fiżjoloġiċi għal żieda fit- teħid ta ’ mluħa.
Lisinopril Following oral administration, peak plasma concentrations occur after approximately 6 hours; its bioavailability is 29%.
Lisinopril Wara l- għoti mill- ħalq, il- konċentrazzjonijiet massimi fil- plażma iseħħu wara madwar 6 sigħat; il- bijodisponibilità tiegħu hi ta ’ 29%.
Lisinopril does not bind to plasma proteins other than ACE; it is not metabolized in the organism and is excreted unchanged in the urine.
Lisinopril ma jintrabatx ma ’ proteini fil- plażma għajr ACE; ma jiġix metabolizzat fl- organiżmu u jiġi eliminat mingħajr tibdil strutturali fl- awrina.
The effective half-life of lisinopril is 12.6 hours.
Il- half- life effettiv ta ’ lisinopril hu 12. 6 sigħat.
The major elimination of non protein-bound fraction is accompanied by that of ACE-bound lisinopril at a slower rate, and this can result in prolonged antihypertensive action.
L- eliminazzjoni ewlenija tal- porzjon li ma jintrabatx ma ’ proteini tiġi akkumpanjata ma ’ dik ta ’ lisiopril marbut ma ’ ACE b’ rata aktar baxxa, u dan jista ’ jikkaġuna azzjoni mtawwla kontra l- pressjoni għolja.
The elimination of lisinopril is prolonged in renal impairment and therefore, dose reduction may be necessary (see section 4.2).
18 L- eliminazzjoni ta ’ lisinopril hi mtawwla b’ indeboliment tal- kliewi u għalhekk, tnaqqis fid- doża jista ’ jkun meħtieġ (ara sezzjoni 4. 2).
Lisinopril can be removed from the plasma by dialysis.
Lisinopril jista ’ jiġi eliminat mill- plażma waqt id- dijaliżi.
19 Amlodipine is slowly and almost completely absorbed from the gastrointestinal tract following oral administration.
Amlodipine Amlodipine huwa assorbit bil- mod u kważi b’ mod sħiħ mill- passaġġ gastrointestinali wara t- teħid orali.
Its absorption is unaffected by the consumption of food.
L- assorbiment tiegħu mhux affettwat mill- konsum tal- ikel.
Peak plasma concentration (Cmax) occurs 6 to 10 hours after dosing.
Il- konċentrazzjoni massima fil - plażma (Cmax) isseħħ bejn 6 sa 10 sigħat wara li tingħata d- doża.
The bioavailability of amlodipine is 64 to 80%; its volume of distribution is approximately 20 l/ kg.
Il- bijodisponibilità ta ’ amlodipine hi ta ’ bejn 64 sa 80%; il- volum ta ’ distribuzzjoni hi madwar 20 l/ kg.
In the systemic circulation 95 to 98% of amlodipine is bound to plasma protein.
Fiċ- ċirkolazzjoni sistemika 95 sa 98% ta ’ amlodipine huwa marbut ma ’ proteini fil- plażma.
Amlodipine is extensively metabolized by the liver to inactive metabolites with 10% of the unchanged parent compound and 60% of metabolites are excreted in the urine.
Amlodipine huwa metabolizzat estensivament mill- fwied għal metaboliti inattivi b’ 10% tas- sustanza originali mhux mibdula u 60% tal- metaboliti eliminati fl- awrina.
Elimination from the plasma is biphasic with a terminal elimination half-life of about 30-50 hours.
L- eliminazzjoni mill- plażma hi bifażika b’ half- life ta ’ eliminazzjoni terminali ta ’ madwar 30- 50 siegħa.
Steady-state plasma levels are reached after 7 to 8 days of consecutive daily dosing.
Livelli fi stadju fiss fil- plażma jintlaħqu wara 7- 8 ijiem ta ’ dożaġġ li ttieħed kuljum b’ mod konsekuttiv.
Amlodipine is transformed into inactive metabolites in the liver primarily, with 10% of the unchanged parent compound excreted in the urine.
Amlodipine jiġi trasformat f’ metaboliti mhux attivi prinċipalment fil - fwied, b’ 10% tas- sustanza oriġinali mhux mibdula eliminata fl- awrina.
Amlodipine cannot be removed from the plasma by dialysis.
Amlodipine ma jistax jiġi mneħħi mill- plażma bid- dijaliżi.
The time to reach peak plasma concentrations (tmax) of amlodipine is similar in elderly and younger subjects.
Il- ħin biex amlodipine jilħaq l- ogħla konċentrazzjonijiet fil- plażma (tmax) huwa simili fl- anzjani u individwi iżgħar.
Amlodipine clearance tends to be lower with resulting increase in AUC and elimination half-life in the elderly.
It- tneħħija ta ’ amlodipine għandha tendenza tkun inqas li tirriżulta f’ żieda fl- AUC u l- half- life ta ’ eliminazzjoni fl- anzjani.
Amlodipine, used at similar doses in elderly or younger patients, is equally well tolerated and therefore, normal dose is recommended for older people.
Amlodipine, użat f’ dożi simili fl- anzjani jew pazjenti iżgħar, hu wkoll tollerat sew u għalhekk, doża normali hi rakkomandata għal pazjenti anzjani.
The half-life of amlodipine is prolonged in patients with hepatic impairment.
Il- half- life ta ’ amlodipine hu mtawwal f’ pazjenti b’ indeboliment epatiku.
In patients with renal impairment, changes in amlodipine plasma concentrations are not correlated with degree of renal impairment.
F’ pazjenti b’ indeboliment tal- kliewi, bidliet fil- konċentrazzjonijiet ta ’ amlodipine fil- plażma mhumiex korelatati skond il- grad ta ’ indeboliment tal- kliewi.
Fixed dose combination No pharmacokinetic interactions have been described between the active substances of Lisonorm.
Kombinazzjoni ta ’ doża fissa M’ hemmx interazzjonijiet farmakokinetiċi deskritti bejn is- sustanzi attivi ta ’ Lisonorm.
Pharmacokinetic parameters (AUC, Cmax, tmax, half-life) were not different from those observed after administration of the individual components separately.
Il- parametri farmakokinetiċi (AUC, Cmax, tmax, half- life) ma kinux differenti minn dawk osservati wara l- għoti tal- komponenti individwali mogħtija separatament.
The gastrointestinal absorption of Lisonorm is not influenced by food.
L- assorbiment gastro- intestinali ta ’ Lisonorm mhux affettwat bl- ikel.
Lisinopril Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Lisinopril Tagħrif ta ’ qabel l- użu kliniku juri li mhemm ebda periklu speċjali għal bnedmin skond studji tradizzjonali dwar is- sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni u riskju ta ’ kanċer.
Fertility was not affected in female and male rats in doses up to 300 mg/ kg (33 times the maximum recommended human daily dose when compared on a body surface area).
Il- fertilità ma kinetx affettwata fil- firien nisa u rġiel f’ dożi sa 300 mg/ kg (33 darba il- massimu tad- doża ta ’ kuljum rakkomandata għal bniedem meta mqabbla għal erja tas- superfiċi tal - ġisem).
No teratogenic effects of lisinopril were seen in mice, rats and rabbits given doses that were 55 times, 33 times and 0.15 times, respectively, the maximum recommended human daily dose.
Ma dehru ebda effetti teratoġeniċi ta ’ lisinopril fil- ġrieden, il- firien u l- fniek meta dawn ingħataw 55 darba, 33 darba u 0. 15 darbiet, rispettivament, id- doża massima ta ’ kuljum rakkomandata għal bniedem.
Amlodipine Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Amlodipine Tagħrif ta ’ qabel l- użu kliniku juri li mhemm ebda periklu speċjali għal bnedmin skond studji tradizzjonali dwar is- sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni u riskju ta ’ kanċer.
Teratogenic or other embrio/ fetotoxic effects were not found in rats and rabbits given up to 10 mg/ kg amlodipine (8 times and 23 times, respectively, the maximum recommended human daily dose of 10 mg on a mg/ m2 basis) during gestation.
Effetti teratoġeniċi jew effetti fuq l- embrijo/ fetu ma nstabux fuq firien u fniek li ngħataw sa 10 mg/ kg amlodipine (8 darbiet u 23 darba, rispettivament id doża massima rakkomandata kuljum għall- bniedem ta ’ 10 mg fuq bażi ta ’ mg/ m2) waqt it- tqala.
Amlodipine at this dose level prolonged both the gestation and labour duration.
Amlodipine f’ din id- doża tawlet kemm il- perijodu tat- tqala u tal- ħlas.
6.1 List of excipients
19 6. 1 Lista ta ’ sustanzi mhux attivi
Cellulose, microcrystalline Sodium starch glycolate (Type A) Magnesium stearate
Cellulose, microcrystalline Sodium starch glycolate (TIp A) Magnesium stearate
Store below 25°C Store in the original package in order to protect from light and moisture.
Aħżen f’ temperatura taħt 25°C Żomm fil- pakkett oriġinali sabiex tilqa ’ mid- dawl u mill- umdità.
30 tablets in white, opaque PVC/ PE/ PVDC/ Aluminium blisters.
30 pillola f’ folji bojod- opaki tal- PVC/ PE/ PVDC/ Aluminju.
[See Annex I - To be completed nationally]
[Ara Anness I - Għandu jitlesta fil- pajjiż stess]
21 LABELLING
21 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Folded Carton
Kartuna mitwija
Lisonorm (see Annex I) 10/ 5 mg tablets [See Annex I - To be completed nationally] lisinopril/ amlodipine
Lisonorm (Ara Anness I) 10/ 5 mg pilloli [Ara Anness I - Għandu jitlesta fil- pajjiż stess] lisinopril/ amlodipine
Exp
Jis
Store in the original package in order to protect from light and moisture.
Aħżen f’ temperatura taħt 25°C Żomm fil- pakkett oriġinali sabiex tilqa ’ mid- dawl u mill- umdità.
[To be completed nationally] [See Annex I - To be completed nationally]
[Għandu jitlesta fil- pajjiż stess] [Ara Anness I - Għandu jitlesta fil- pajjiż stess]
24 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
23 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
{NATURE/ TYPE}
Folja
Exp
[Jis]
Batch
[Lott]
25 PACKAGE LEAFLET
25 FULJETT TA ’ TAGĦRIF:
Lisonorm and associated names (see Annex I) 10 mg/ 5mg tablets [See Annex I - To be completed nationally] Lisinopril/ Amlodipine
Lisonorm u ismijiet assoċjati (Ara Anness I) pilloli ta ’ 10 mg/ 5mg [Ara Anness I - Għandu jitlesta fil- pajjiż stess] Lisinopril/ Amlodipine
What Lisonorm is and what it is used for 2.
X’ inhu Lisonorm u għalxiex jintuża 2.
Before you take Lisonorm 3.
Qabel ma tieħu Lisonorm 3.
How to take Lisonorm 4.
Kif għandek tieħu Lisonorm 4.
How to store Lisonorm 6.
Kif taħżen Lisonorm 6.
Further information
Aktar informazzjoni
WHAT LISONORM IS AND WHAT IT IS USED FOR
X’ INHU LISONORM U GĦAXIEX JINTUŻA
Lisonorm tablet is a combination product of amlodipine, which belongs to a group of medicines called calcium channel blockers, and lisinopril, which belongs to a group of medicines called angiotensin- converting enzyme (ACE) inhibitors.
Il- pillola Lisonorm hija prodott ikkombinat ta ’ amlodipine, li jappartjeni għal grupp ta ’ mediċini msejħa imblokkaturi tal- kanal tal- kalċju, u lisinopril, li jappartjeni għal grupp ta ’ mediċini msejħa impedituri ta ’ enżimi li jikkonvertu angiotensin (ACE).
Lisonorm is used to treat hypertension (high blood pressure).
Lisonorm jintuża biex jittratta l- pressjoni għolja (pressjoni tad- demm għolja).
You might not have any symptoms from your too high blood pressure, but it may increase the risk of certain complications (such as stroke or heart attack), if you do not take your antihypertensive medicine regularly.
Jista ’ jkun li ma jkollokx sintomi ta ’ pressjoni għolja ħafna tad- demm, imma din tista ’ żżid ir- riskju ta ’ diversi komplikazzjonijiet (bħal puplesija jew attack ta ’ qalb), jekk ma tieħux il- mediċina ta ’ kontra l- pressjoni għolja b’ mod regolari.
BEFORE YOU TAKE LISONORM
QABEL MA TIEĦU LISONORM
Do not take Lisonorm You must not take this medicine:
Tieħux Lisonorm M’ għandekx tieħu din il- mediċina:
- if you are allergic (hypersensitive) to the active substances or any of the other ingredients of Lisonorm
- jekk inti allerġiku (tbati minn sensittività eċċessiva) għas- sustanzi attivi jew sustanzi oħra ta ’
- if you are allergic to other ACE inhibitors (such as enalapril, captopril and ramipril) or other calcium
- jekk inti allerġiku għal impedituri oħra ta ’ l- ACE (bħal enalapril, captopril u ramipril) jew
channel blockers (such as nifedipine, felodipine or nimodipine)
imblokkaturi oħra tal- kanal tal- kalċju (bħal nifedipine, felodipine jew nimodipine),
- if you have had an angioedema (symptoms such as itching, nettle rash, wheezing and swelling of the
- jekk kellek anġjoedema (sintomi bħal ħakk, urtikarja, tħarħir u nefħa tal- idejn, tal- griżmejn jew
hands, throat, mouth or eyelids), related or not to treatment with an ACE-inhibitor
tat- tbieqi tal- għajnejn), relatati jew le ma ’ trattament b’ impeditur ta’ l- ACE,
- if your blood pressure is too low (severe hypotension)
- jekk il- pressjoni tad- demm tiegħek hija baxxa wisq (pressjoni baxxa severa),
- if you have a narrowing of the aorta (aortic stenosis), of a heart valve (mitral stenosis), an increase in
- jekk għandek tidjiq tal- aorta (stenosi aortika), tal- valv tal- qalb (stenosi mitrali), żieda fil- ħxuna
the thickness of the heart muscle (hypertrophic cardiomyopathy) or cardiogenic shock (not enough blood supply to your tissues)
fil- muskolu tal- qalb (kardjomijopatija ipertrofika) jew xokk kardjoġeniku (m’ hemmx biżżejjed forniment ta ’ demm fit- tessuti tiegħek),
- if you have unstable angina (except Prinzmetal’ s angina)
- jekk għandek anġina li mhix stabbli (ħlief anġina ta ’ Prinzmetal),
- if you have suffered a heart attack (myocardial infarction) within the last 28 days
- jekk kellek attakk ta ’ qalb (infart mijokardjali) fl- aħħar 28 jum,
- if you are pregnant or think you may be pregnant
- jekk inti tqila jew taħseb li inti tqila,
Take special care with LISONORM You should check with your doctor before taking this medicine if you:
Oqgħod attent ħafna b’ LISONORM Għandek tiċċekkja mat- tabib tiegħek qabel ma tieħu din il- mediċina jekk għandek:
- have heart problems
- problemi tal- qalb
- have kidney problems
- problemi fil- kliewi
- have liver problems
- problemi fil- fwied
- are under dialysis
- ikollok id- dijalisi
- are about to have a treatment called LDL apheresis for removal of cholesterol
- ser ikollok trattament imsejjaħ aferesi ta ’ LDL għat- tneħħija ta ’ kolesterol
- are older than 65 years
- aktar minn 65 sena
- if you are on a low-salt diet and you use potassium containing salt substitutes or supplements
- jekk inti fuq dieta ta ’ melħ baxx u qed tuża melħ li fih il- potassju bħala sostitut jew supplimenti
- have diarrhoea or vomiting
- għandek id- dijarea jew qed tirrimetti
- desensitisation treatment to reduce allergy to bee or wasp stings
- trattament biex tnaqqas is- sensittività għal allerġija minn ġdim tan- naħal jew żunżan
- are taking any medicines listed below
- qed tieħu mediċini elenkati hawn taħt
Potassium-sparing diuretics (such as spironolactone, amiloride, triamterene, used to reduce fluid retention) may only be taken together with Lisonorm under close medical supervision.
Dijuretiċi li jħallux il- potassju joħroġ fl- awrina (bħal spironolactone, amiloride, triamterene, użati biex inaqqsu l- akkumulazzjoni tal- fluwidi) jistgħu jittieħdu flimkien ma ’ Lisonorm taħt superviżjoni medika attenta.
Special caution is necessary when Lisonorm is taken together with the following medicines: • diuretics (used to reduce fluid retention) • other medicines used to lower blood pressure (antihypertensives) • non-steroidal anti-inflammatory drugs (NSAIDs) such as acetylsalicylic acid (used to treat for arthritis, muscle pains, headache, inflammation, fever) • lithium, antipsychotics, used to treat mental disorders • insulin and oral antidiabetics • autonomous nervous system stimulants (sympathomimetics), such as ephedrine, phenylephrine, xylometazoline and salbutamol, used to treat congestion, cough, cold and asthma. • immunosuppressants, used to prevent transplant rejection • allupurinol, used to treat gout • narcotics, morphine and related drugs used to treat severe pain • anticancer drugs • antacids, used to treat stomach acidity • anaesthetics, used in surgery or some dental procedures.
Attenzjoni speċjali hi meħtieġa meta Lisonorm jittieħed mal- mediċini li ġejjin: • dijuretiċi (użati biex inaqqsu l- akkumulazzjoni ta ’ fluwidu) • mediċini oħra użati biex inaqqsu l- pressjoni tad- demm (mediċini kontra l- pressjoni għolja) • mediċini anti- infjammatorji mhux sterojdi (NSAID) bħal acetylsalicylic acid (użati fit- trattament ta ’ artrite, uġigħ muskolari, uġigħ ta ’ ras, infjammazzjoni, deni) • lithium, antipsikotiċi, użati biex jittrattaw disturbi mentali • insulina u mediċini ta ’ kontra d- dijabete li jittieħdu mill- ħalq • stimulanti tas- sistema nervuża awtonoma (simpatomimetiċi), bħal ephedrine, phenylephrine, xylometazoline u salbutamol, użati biex jittrattaw konġestjoni, sogħla, irjiħat u ażma. • immunosuppressanti, użati biex jipprevjenu ir- riġettazzjoni ta ’ trapjant • allupurinol, użat biex jittratta l- gotta • narkotiċi, morfina u mediċini relatati użati biex jittrattaw uġigħ qawwi • mediċini ta ’ kontra l- kanċer • antaċidi, użati biex jittrattaw l- aċidità ta ’ l- istonku • anestetiċi, użati fil- kirurġija jew f’ xi proċeduri dentali.
Tell your doctor or dentist that you are taking Lisonorm before you are given a local or general anaesthetic, given the risk of short-term drop in blood pressure • anticonvulsants (such as carbamazepine, phenobarbital and phenytoin), used to treat epilepsy • medicines used to treat bacterial (rifampicin), HIV (ritonavir) or fungal infections (ketoconazole). • herbal preparations containing St.
Għarraf lit- tabib jew dentist tiegħek li qed tieħu Lisonorm qabel ma tingħata loppju lokali jew ġenerali, minħabba r- riskju fuq perijodu ta ’ żmien qasir fil- waqgħa fil- pressjoni tad- demm • mediċini antikonvulsanti (bħal carbamazepine, phenobarbital u phenytoin), użati biex jittrattaw l- epilessija • mediċini użati biex jittrattaw infezzjonijiet ikkawżati minn batterja (rifampicin), minn HIV (ritonavir) jew minn fungi (ketoconazole). • Preparazzjonijiet ta ’ ħxejjex li fihom St.
John's wort (Hypericum perforatum)
John' s wort (Hypericum perforatum)
Taking Lisonorm with food and drink Lisonorm can be taken with or without food, but alcohol should be avoided during treatment.
Meta tieħu Lisonorm mal- ikel u x- xorb Lisonorm jista ’ jittieħed kemm mal- ikel jew mingħajru, iżda l- alkoħol għandu jiġi evitat waqt it - trattament.
Pregnancy and breast-feeding Lisonorm must not be taken during pregnancy and breast-feeding.
Tqala u treddigħ Lisonorm m’ għandux jittieħed waqt it- tqala u t- treddigħ.
Driving and using machines Lisonorm can affect your ability to drive and use machinery safely.
Lisonorm jista ’ jaffettwa l- ħila tiegħek biex issuq u tħaddem inġenji b’ mod sikur.
HOW TO TAKE LISONORM
KIF GĦANDEK TIEĦU LISONORM
28 Always take Lisonorm exactly as your doctor has told you.
27 Dejjem għandek tieħu Lisonorm skond il- parir eżatt tat- tabib.
If you have the impression that the effect of Lisonorm is too strong or too weak, talk to your doctor or pharmacist.
Jekk inti mingħalik li l- effett ta ’ Lisonorm huwa qawwi wisq jew dgħajjef wisq, kellem lit- tabib jew lill- ispiżjar tiegħek.
If you take more Lisonorm than you should Contact your doctor immediately or go to the casualty department of the nearest hospital.
Jekk tieħu Lisonorm aktar milli suppost Ikkuntattja lit- tabib tiegħek immedjatament jew mur fid- dipartiment ta ’ l- emerġenza ta ’ l- eqreb sptar.
Overdose is likely to result in very low blood pressure, which has to be closely monitored, and if characteristic symptoms such as dizziness and headache occur, you should be placed lying down with the face up.
Id- doża eċċessiva x’ aktarx tirriżulta fi pressjoni baxxa ħafna tad- demm, li tkun teħtieġ li tiġi mmonitorata mill- qrib, u jekk ikun hemm sintomi karatteristiċi ta ’ dan bħal sturdament u uġigħ ta ’ ras, inti għandek titqiegħed f’ pożizzjoni ta ’ serħan għal tulek b’ wiċċek ’ il fuq.
Your doctor will take further measures.
It- tabib tiegħek ser jieħu miżuri oħra.
If you forget to take Lisonorm Do not take a double dose to make up for a forgotten tablet, to avoid the risk of overdose.
Jekk tinsa tieħu Lisonorm M’ għandekx tieħu doża doppja biex tpatti għal kull pillola li tkun insejt tieħu, sabiex tevita r- riskju ta ’ doża eċċessiva.
Take your next dose at the usual time.
Ħu l- pillola li jmiss fil- ħin li ssoltu teħodha.
Like all medicines, Lisonorm can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Lisonorm jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Frequencies 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.
Il- frekwenzi huma mfissra kif ġej: komuni ħafna: jaffettwa aktar minn persuna 1 minn kull 10 komuni: jaffettwa minn 1 sa 10 persuni minn kull 100 mhux komuni: jaffettwa minn 1 sa 10 persuni minn kull 1, 000 rari: jaffettwa minn 1 sa 10 persuni minn kull 10, 000 rari ħafna: jaffettwa inqas minn persuna 1 minn kull 10, 000 mhux magħruf: il- frekwenza ma tistax tiġi stmata mit- tagħrif disponibbli.
Common side effects in a clinical trial with Lisonorm tablets were: headache, cough, dizziness, palpitations (a quicker or irregular heart beat), and pruritus.
Effetti sekondarji komuni fi prova klinika bil- pilloli Lisonorm kienu: uġigħ ta ’ ras, sogħla, stordament, palpitazzjonijiet (taħbit ta ’ qalb aktar mgħaġġel jew irregolari), u ħakk.
Allergic (hypersensitivity) reactions may occur with the use of Lisonorm.
Reazzjonijiet allerġiċi (sensittivita eċċessiva) jistgħu jseħħu bl- użu ta ’ Lisonorm.
You must stop taking Lisonorm and seek medical attention immediately if you develop any of the following symptoms of angioedema:
Inti għandek tieqaf milli tieħu Lisonorm u tfittex l- għajnuna medika minnufih jekk tiżviluppa s- sintomi li ġejjin ta ’ anġjoedema: issibha diffiċli biex tieħu n- nifs b’ nefħa jew mingħajr nefħa fil- wiċċ, fix- xofftejn, fl- ilsien u/ jew
- difficulty in breathing with or without swelling of the face, lips, tongue and/ or throat.
fil- griżmejn.
- swelling of the face, lips, tongue and/ or throat which may cause difficulty in swallowing.
- nefħa fil- wiċċ, fix- xofftejn u/ jew fil- griżmejn li tista ’ tikkaġuna diffikultà biex tibla.
- severe itching of the skin (with raised lumps).
- ħakk qawwi fuq il- ġilda (bi bżieżaq mgħollija).
Additional side effects that have been reported with either amlodipine or lisinopril alone (the two active substances), and may also occur with Lisonorm are the following:
Effetti sekondarji addizzjonali li ġew rapportati b’ amlodipine jew b’ lisinopril waħedhom (iż- żewġ sustanzi attivi), u li jistgħu jseħħu b’ Lisonorm huma dawn li ġejjin:
Amlodipine Common side effects Headache, oedema (for example ankle swelling), feeling tired, sleepiness, feeling sick, dizziness, abdominal pain, palpitations (a quicker or irregular heart beat), nausea, flushing.
Amlodipine Effetti sekondarji komuni Uġigħ ta ’ ras, edema (pereżempju l- għaksa tintefaħ), tħossok għajjien, ngħas, tħossok ma tiflaħx, stordament, uġigħ addominali, palpitazzjonijiet (taħbit tal- qalb aktar ta ’ malajr jew irregolari), tqalligħ, fwawar.
Tell your doctor if these effects cause you any problems or if they last for more than one week.
Għarraf lit- tabib tiegħek jekk dawn l- effetti jikkaġunawlek xi problemi jew jekk idumu aktar minn ġimgħa.
Uncommon side effects Skin rash, itchy skin, indigestion, shortness of breath, muscle cramps, altered bowel habit, muscle or joint pain, back pain, chest pain, mood changes, tremor, visual disturbances, tinnitus, hypotension, difficulty in breathing, taste perversion, runny nose, increased need to urinate, dry mouth, thirst, loss of pain sensation, increased sweating, fainting, weakness, enlargement of breasts in men, impotence, weight increase, weight decrease.
Effetti sekondarji mhux komuni Raxx tal- ġilda, ħakk, indiġestjoni, qtugħ ta ’ nifs, bugħawwieġ, tibdil fid- drawwiet tal- imsaren, uġigħ fil- muskoli jew fil- ġogi, uġigħ fid- daħar, uġigħ fis- sider, bidliet fil- burdata, rogħda, disturbi fil- vista, tinnite, pressjoni baxxa, diffikultà biex tieħu nifs sew, bidla fit- togħma, imnieħer iqattar, bżonn biex
29 Very rare side effects Allergic reactions, abnormal liver function test, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), elevation of blood glucose, heart attack (myocardial infarction), irregular heartbeat (arrhythmia), cough, severe skin reactions, swelling or soreness of the gums, red patches on skin.
Effetti sekondarji rari ħafna Reazzjonijiet allerġiċi, riżultati ta ’ funzjoni abnormali tal- fwied, infjammazzjoni tal- fwied (epatite), sfurija tal- ġilda (suffejra), livelli ogħla tal- glukosju fid- demm, attakk tal- qalb (infart mijokardjali), taħbit ta ’ qalb irregolari (arritmija), sogħla, reazzjonijiet severi tal- ġilda, nefħa jew uġigħ fil- ħanek, dbabar ħomor fuq il- ġilda.
Lisinopril Common side effects Headache, dizziness or light-headedness especially when standing up quickly, diarrhoea, cough, vomiting, reduction of urine volume.
Lisinopril Effetti sekondarji komuni Uġigħ ta ’ ras, stordament jew tħoss kollox idur bik speċjalment meta tqum bilwieqfa malajr, dijarea, sogħla, rimettar, tnaqqis fil- volum tal- awrina.
Uncommon side effects Mood changes, angioedema (hypersensitivity reaction with sudden swelling of the lips, face and neck, and occasionally of the feet and hands; higher rate of angioedema in black patients than in non-black patients), change of colour (pale blue followed by redness) and/ or numbness or tingling in the fingers or toes (Raynaud’ s phenomenon), changes in the way things taste, fatigue, feeling sleepy or difficulty in going to sleep, strange dreams, rapid heartbeat, runny nose, nausea, stomach pain or indigestion, skin rash, itching, impotence, tiredness, muscle weakness).
Effetti sekondarji mhux komuni Bidliet fil- burdata, anġjoedema (sensittività eċċessiva b’ nefħa f’ daqqa tax- xofftejn, il- wiċċ, l- għonq, u kultant tas- saqajn u l- idejn; Rata ogħla ta ’ anġjoedema f’ pazjenti suwed milli f’ pazjenti mhux suwed), bidla fil- kulur (ikħal blu ċar segwit bi ħmura) u/ jew tirżih jew tnemnim tas- swaba tal- idejn jew tas - saqajn (il- fenomenu ta ’ Raynaud), bidliet fil- mod kif l- affarijiet jintegħmu, tħossok maħlub, bi ngħas jew diffikultà biex torqod, ħolm stramb, taħbit ta ’ qalb mgħaġġel, imnieħer iqattar, tqalligħ, uġigħ fl - istonku jew indiġestjoni, raxx tal- ġilda, ħakk, impotenza, għeja, debolezza tal- muskoli).
Rare side effects Confusion, acute kidney problems, dry mouth, hair loss, psoriasis, enlargement of breasts in men.
Effetti sekondarji rari Konfużjoni, problemi akuti tal- kliewi, ħalq xott, telf ta ’ xahar, psorjasi, tkabbir tas- sider fl- irġiel.
Deterioration of blood-picture: decrease of red blood cells, of platelets (thrombocytopenia), of white blood cells (neutropenia, leucopenia, agranulocytosis).
Peġġorament fl- istampa tad- demm: tnaqqis fl- għadd ta ’ ċelluli ħomor, ta ’ plejtlets (tromboċitopenija), ta ’ ċelluli tad- demm bojod (newtropenja, lewkopenja, agranuloċitosi).
This may result in prolonged bleeding, tiredness, weakness, disease of the lymph node, autoimmune disease (in which the body attacks itself).
Dan jista ’ jwassal għal emorraġija fit- tul, għeja, debolezza, mard tan- nod limfatiku, mard awtoimmuni (meta l- ġisem jattakka lilu nnifsu).
Infections are more likely.
Infezzjonijiet huma aktar probabbli.
Very rare side effects Decrease of blood glucose (hypoglycaemia), sinus pain wheezing, inflammation of the lungs, yellow skin and/ or eyes (jaundice), inflammation of the liver or pancreas, severe skin disorders (symptoms of which include redness, blistering and peeling), sweating.
Efetti sekondarji rari ħafna Tnaqqis fil- livell ta ’ zokkor fid- demm (ipogliċemija), uġigħ fis- sinus, tħarħir, infjammazzjoni tal - pulmun, ġilda u/ jew għajnejn sofor (suffejra), infjammazzjoni tal- fwied jew il- frixa, disturbi tal- ġilda severi (sintomi ta ’ dawn jinkludu ħmura, infafet u tqaxxir), għaraq.
HOW TO STORE LISONORM
KIF TAĦŻEN LISONORM
Store in the original package in order to protect from light and moisture.
Żommu fil- pakkett oriġinali sabiex tilqa ’ mid- dawl u l- umdità.
Do not use Lisonorm tablets after the expiry date which is stated on the blisters and the carton after ‘ Exp’.
Tużax il- pilloli Lisonorm wara d- data ta ’ skadenza li tidher fuq il- folji u l- kartuna wara ‘ JIS ’.
What LISONORM contains
X’ fih LISONORM
- The active substances are lisinopril and amlodipine.
- Is- sustanzi attivi huma lisinopril u amlodipine.
Each tablet contains 10 mg lisinopril (as
Kull pillola fiha 10 mg lisinopril (bħala
dihydrate) and 5 mg amlodipine (as besilate).
dihydrate) u 5 mg amlodipine (bħala besilate).
- The other ingredients are cellulose microcrystalline, sodium starch glycolate (type A) and magnesium
- Is- sustanzi l- oħra huma cellulose microcrystalline, sodium starch glycolate (tip A) u magnesium
stearate.
stearate.
30 What LISONORM looks like and contents of the pack The tablets are white or almost white, round, flat, bevel-edged tablet with a score line on one side and with an engraving „ A+L” on the reverse side.
Id- Dehra ta ’ LISONORM u l- kontenut tal- pakkett Il- pilloli huma bojod jew kważi bojod, tondi, ċatti b’ tarf ta ’ ċanfrin b’ sinjal imnaqqax fuq naħa waħda u b ’ “ A+L ” imnaqqax fuq in- naħa l- oħra.
Diameter: about 8 mm The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Is- sinjal imnaqqax qiegħed hemm biss biex tkun tista ’ taqsamha sabiex tkun tista ’ tiblagħha mingħajr tbatija u mhux biex taqsamha f’ dożi indaqs.
Packs contain 30 tablets in white, opaque PVC/ PE/ PVDC-aluminium blisters.
Il- pakketti fihom 30 pillola f’ folji tal- aluminju opaki tal- PVC/ PE/ PVDC.
Marketing Authorisation Holder and Manufacturer [See Annex I - To be completed nationally]
Id- Detentur tal- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur [Ara Anness I - Għandu jitlesta fil- pajjiż stess]
This medicinal product is authorised in the Member States of the EEA under the following names:
Dan il- prodott mediċinali huwa awtorizzat fl- Istati Membri ta ’ l- EEA taħt l- ismijiet li ġejjin: