qanastek/EMEA-V3 huggingface dataset:
In most patients, after administration of a single oral dose, onset of antihypertensive activity occurs within 2 hours, and the peak drop in blood pressure is achieved within 4– 6 hours.
F’ ħafna pazjenti, wara l- għotja ta ’ doża waħda mill- ħalq, l- attività kontra l- pressjoni għolja tibda fi żmien sagħtejn, u l- pressjoni tad- demm tinżel l- aktar fi żmien 4- 6 sigħat.
The antihypertensive effect persists over 24 hours after administration.
L- effett kontra l- pressjoni għolja jibqa jippersisti sa 24 siegħa minn meta jingħata.
During repeated administration, the maximum reduction in blood pressure with any dose is generally attained within 2– 4 weeks and is sustained during long-term therapy.
Meta jittieħed b’ mod regolari, il- pressjoni tad - demm taqa ’ l- aktar b’ kwalunkwe doża li tingħata fi żmien 2- 4 ġimgħat u tibqa tinżamm waqt terapija fit- tul.
Abrupt withdrawal of valsartan has not been associated with rebound hypertension or other adverse clinical events.
Meta valsartan jitwaqqaf f’ daqqa, il- pressjoni ma terġax titla ’ b’ effett rebound u ma jkunx hemm effetti avversi kliniċi oħrajn.
Amlodipine/ Valsartan Over 1,400 hypertensive patients received Copalia once daily in two placebo-controlled trials.
9 Amlodipine/ Valsartan ’ L fuq minn 1, 400 pazjent irċevew Copalia darba kuljum f’ żewġ provi kontrollati bi plaċebo.
Adults with mild to moderate uncomplicated essential hypertension (mean sitting diastolic blood pressure ≥ 95 and < 110 mmHg) were enrolled.
Adulti bi pressjoni għolja naturali mingħajr komplikazzjonijiet, ħafifa għal moderata (medja tal- pressjoni tad - demm dijastolika waqt li jkunu bilqiegħda ≥95 u < 110 mmHg) kienu reklutati.
Patients with high cardiovascular risks – heart failure, type I and poorly controlled type II diabetes and history of myocardial infarction or stroke within one year – were excluded.
Pazjenti b’ riskji kardjovaskulari għoljin – insuffiċjenza tal- qalb, dijabete tat- tip I u dijabete tat- tip II li mhix kontrollata u pazjenti li xi darba kellhom infart mijokardijaku jew attakk ta ’ puplesija fl- aħħar sena – kienu esklużi.
The combination of amlodipine and valsartan produces dose-related additive reduction in blood pressure across its therapeutic dose range.
Il- kombinazzjoni ta ’ amlodipine ma ’ valsartan twassal għal tnaqqis addittiv fil- pressjoni tad- demm li huwa marbut mad- doża fil- medda tad- doża terapewtika tiegħu.
The antihypertensive effect of a single dose of the combination persisted for 24 hours.
L- effett kontra l- pressjoni għolja b’ doża waħda tal- kombinazzjoni dam jippersisti għal 24 siegħa.
A multicentre, randomised, double-blind, active-controlled, parallel-group trial showed normalisation of blood pressure (trough sitting diastolic blood pressure < 90 mmHg at the end of the trial) in patients not adequately controlled on valsartan 160 mg in 75% of patients treated with amlodipine/ valsartan 10 mg/ 160 mg and 62% of patients treated with amlodipine/ valsartan 5 mg/ 160 mg, compared to 53% of patients remaining on valsartan 160 mg.
Prova f’ ħafna ċentri, randomised, double- blind, active- controlled, bi grupp parallel wasslet għal pressjoni tad- demm normali (il- pressjoni ta ’ bilqiegħeda l- aktar baxxa kienet < 90 mmHg fl- aħħar tal - prova) f’ pazjenti li ma kienux kontrollati sew b’ valsartan 160 mg f’ 75% tal- pazjenti kurati b’ amlodipine/ valsartan 10 mg/ 160 mg u 62% tal- pazjenti kurati b’ amlodipine/ valsartan 5 mg/ 160 mg, imqabbla ma ’ 53% tal- pazjenti li baqgħu fuq valsartan 160 mg.
The addition of amlodipine 10 mg and 5 mg produced an additional reduction in systolic/ diastolic blood pressure of 6.0/ 4.8 mmHg and 3.9/ 2.9 mmHg, respectively, compared to patients who remained on valsartan 160 mg only.
Meta ingħata wkoll amlodipine 10 mg u 5 mg kien hemm aktar tnaqqis fil- pressjoni tad- demm sistolika/ dijastolika ta ’ 6. 0/ 4. 8 mmHg u 3. 9/ 2. 9 mmHg, rispettivament imqabbla ma ’ pazjenti li baqgħu fuq valsartan 160 mg waħdu.
9 A multicentre, randomised, double-blind, active-controlled, parallel-group trial showed normalisation of blood pressure (trough sitting diastolic blood pressure < 90 mmHg at the end of the trial) in patients not adequately controlled on amlodipine 10 mg in 78% of patients treated with amlodipine/ valsartan 10 mg/ 160 mg, compared to 67% of patients remaining on amlodipine 10 mg.
Prova f’ ħafna ċentri, randomised, double- blind, active- controlled, bi grupp parallel wasslet għal pressjoni tad- demm normali (il- pressjoni ta ’ bilqiegħeda l- aktar baxxa kienet < 90 mmHg fl- aħħar tal - prova) f’ pazjenti li ma kienux kontrollati sew b’ amlodipine 10 mg f’ 78% tal- pazjenti kurati b’ amlodipine/ valsartan 10 mg/ 160 mg, imqabbla ma ’ 67% tal- pazjenti li baqgħu fuq amlodipine 10 mg.
The addition of valsartan 160 mg produced an additional reduction in systolic/ diastolic blood pressure of 2.9/ 2.1 mmHg compared to patients who remained on amlodipine 10 mg only.
Meta ingħata wkoll valsartan 160 mg kien hemm aktar tnaqqis fil- pressjoni tad- demm sistolika/ dijastolika ta ’ 2. 9/ 2. 1 mmHg meta imqabbla ma ’ pazjenti li baqgħu fuq amlodipine 10 mg waħdu.
Copalia was also studied in an active-controlled study of 130 hypertensive patients with diastolic blood pressure ≥ 110 mmHg and < 120 mmHg.
Copalia kien studjat ukoll fi studju active- controlled ta ’ 130 pazjent bi pressjoni għolja bil- pressjoni dijastolika ≥110 mmHg u < 120 mmHg.
In this study (baseline blood pressure 171/ 113 mmHg), an Copalia regimen of 5 mg/ 160 mg titrated to 10 mg/ 160 mg reduced sitting blood pressure by 36/ 29 mmHg as compared to 32/ 28 mmHg with a regimen of lisinopril/ hydrochlorothiazide 10 mg/ 12.5 mg titrated to 20 mg/ 12.5 mg.
F’ dan l- istudju (il- linja bażi tal- pressjoni tad- demm kienet 171/ 113 mmHg), b’ reġimen ta ’ Copalia ta ’ 5 mg/ 160 mg miżjuda għal 10 mg/ 160 mg naqqset il - pressjoni tad- demm ta ’ bilqiegħeda b’ 36/ 29 mmHg meta imqabbla ma ’ 32/ 28 mmHg b’ reġimen ta ’ lisinopril/ hydrochlorthiazide 10 mg/ 12. 5 mg miżjuda għal 20 mg/ 12. 5 mg.
In two long-term follow-up studies the effect of Copalia was maintained for over one year.
F’ żewġ studji follow- up fit- tul, l- effett ta ’ Copalia inżamm għal aktar minn sena waħda.
Abrupt withdrawal of Copalia has not been associated with a rapid increase in blood pressure.
Meta Copalia twaqqaf f’ daqqa, ma kienx hemm żieda f’ daqqa tal- pressjoni tad- demm.
In patients not adequately controlled on amlodipine 5 mg, amlodipine/ valsartan 5 mg/ 80 mg may achieve blood pressure control similar to amlodipine 10 mg with less oedema.
F’ pazjenti li mhumiex kontrollati sew fuq amlodipine 5 mg, amlodipine/ valsartan 5 mg/ 80 mg jista ’ jwassal għal kontroll tal- pressjoni tad- demm simili għal amlodipine 10 mg b’ anqas edima.
In patients adequately controlled on amlodipine 10 mg but who experience unacceptable oedema, amlodipine/ valsartan 5 mg/ 80 mg may achieve similar blood pressure control with less oedema.
F’ pazjenti kontrollati sew b’ amlodipine 10 mg iżda li kellhom edima inaċċettabbli, amlodipine/ valsartan 5 mg/ 80 mg jista ’ jwassal għal kontroll tal- pressjoni tad- demm simili iżda b’ anqas edima.
Age, gender and race did not influence the response to Copalia.
L- età, sess u r- razza ma kellhomx effett fuq ir- rispons għal Copalia.
Copalia has not been studied in any patient population other than hypertension.
Copalia ma kienx studjat f’ ebda popolazzjoni ta ’ pazjenti apparti dawk li jbatu minn pressjoni għolja.
Valsartan has been studied in patients with post myocardial infarction and heart failure.
Valsartan kien studjat f’ pazjenti li kienu sofrew minn infart mijokardijaku u insuffiċjenza tal- qalb.
Amlodipine has been studied in patients with chronic stable angina, vasospastic angina and angiographically documented coronary artery disease.
Amlodipine kien studjat f’ pazjenti li jsofru minn anġina kronika stabbli, anġina vażospastika u mard ta ’ l- arterja koronarja dokumentat b’ anġjografija.
Linearity Amlodipine and valsartan exhibit linear pharmacokinetics.
Linjarità Amlodipine u valsartan għandhom farmakokinetiċi linjari.
Amlodipine Absorption:
10 Amlodipine Assorbiment:
After oral administration of therapeutic doses of amlodipine alone, peak plasma concentrations of amlodipine are reached in 6– 12 hours.
Wara li jittieħdu mill- ħalq dożi terapewtiċi ta ’ amlodipine waħdu, il- konċentrazzjonijiet ta ’ amlodipine jilħqu l- quċċata tagħhom f’ 6- 12- il- siegħa.
Absolute bioavailability has been calculated as between 64% and 80%.
Il- bijodisponibilità assoluta kienet kalkulata bejn 64% u 80%.
Amlodipine bioavailability is unaffected by food ingestion.
Il- bijodisponibilità ta ’ amlodipine mhiex effettwata mill- ikel.
Volume of distribution is approximately 21 l/ kg.
Il- volum ta ’ distribuzzjoni huwa madwar 21 l/ kg.
In vitro studies with amlodipine have shown that approximately 97.5% of circulating drug is bound to plasma proteins in hypertensive patients.
Studji in vitro b’ amlodipine wrew li madwar 97. 5% tal- mediċina li tkun qed tiċċirkola jintrabat mal- proteini tal- plażma f’ pazjenti li jsofru minn pressjoni għolja.
Amlodipine is extensively (approximately 90%) metabolised in the liver to inactive metabolites.
Amlodipine huwa metabolizzat b’ mod estensiv (madwar 90%) fil- fwied għal metaboli inattivi.
Excretion:
Eskrezzjoni:
Amlodipine elimination from plasma is biphasic, with a terminal elimination half-life of approximately 30 to 50 hours.
L- eliminazzjoni ta ’ amlodipine mill- plażma tinqasam f’ żewġ fażijiet, b’ half life ta ’ eliminazzjoni terminali ta ’ madwar 30 sa 50 siegħa.
Steady-state plasma levels are reached after continuous administration for 7– 8 days.
Livelli fil- plażma jilħqu stat fiss wara l- għotja kontinwa ta ’ 7- 8- ijiem.
Ten per cent of original amlodipine and 60% of amlodipine metabolites are excreted in urine.
Għaxra fil- mija ta ’ amlodipine oriġinali u 60% tal- metaboli ta ’ amlodipine jitneħħew fl- awrina.
Valsartan Absorption:
Valsartan Assorbiment:
Following oral administration of valsartan alone, peak plasma concentrations of valsartan are reached in 2– 4 hours.
Wara li valsartan jittieħed waħdu mill- ħalq, il- konċentrazzjonijiet ta ’ valsartan fil - plażma jilħqu l- quċċata tagħhom f’ 2- 4 sigħat.
Mean absolute bioavailability is 23%.
Il- medja tal- bijodisponibilità assoluta hija 23%.
Valsartan shows multiexponential decay kinetics (t½α < 1 h and t½ß about 9 h).
Valsartan juri kinetiċi ta ’ tħassir multi- esponenzjali (t½α < 1 h t½ß madwar 9 h).
Food decreases exposure (as measured by AUC) to valsartan by about 40% and peak plasma concentration (Cmax) by about 50%, although from about 8 h post dosing plasma valsartan concentrations are similar for the fed and fasted groups.
L- ikel inaqqas l - esponiment (kif imkejjel bl- AUC) għal valsartan b’ madwar 40% u l- quċċata tal- konċentrazzjoni fil - plażma (Cmax) b’ madwar 50%, għalkemm wara 8 sigħat minn meta jkunu ħadu d- doża, il - konċentrazzjonijiet fil- plażma ta ’ valsartan ikunu simili kemm fil- gruppi li jkunu kielu kif ukoll dawk li jkunu sajmin.
This reduction in AUC is not, however, accompanied by a clinically significant reduction in the therapeutic effect, and valsartan can therefore be given either with or without food.
Madankollu, dan it- tnaqqis fl- AUC ma jurix tnaqqis klinikament sinifikanti fl- effett terapewtiku, u għalhekk valsartan jista ’ jingħata bl- ikel jew mingħajr ikel.
10 Distribution:
Distribuzzjoni:
The steady-state volume of distribution of valsartan after intravenous administration is about 17 litres, indicating that valsartan does not distribute into tissues extensively.
Il- volum ta ’ distribuzzjoni ta ’ valsartan fi stat fiss wara li jingħata ġol- vina huwa madwar 17- il litru, li jindika li valsartan ma jinfirixx b’ mod estensiv fit- tessuti.
Valsartan is highly bound to serum proteins (94– 97%), mainly serum albumin.
Valsartan jintrabat b’ mod qawwi mal- proteini tas- serum (94- 97%), l- aktar ma ’ l- albumina tas- serum.
Valsartan is not transformed to a high extent as only about 20% of dose is recovered as metabolites.
Valsartan ma jiġix mibdul b’ mod estensiv peress li 20% tad- doża biss tiġi rkuprata bħala metaboli.
A hydroxy metabolite has been identified in plasma at low concentrations (less than 10% of the valsartan AUC).
Fil- plażma kien identifikat metabolu hydroxy f’ konċentrazzjonijiet baxxi (anqas minn 10% ta ’ l- AUC ta ’ valsartan).
This metabolite is pharmacologically inactive.
Dan il- metabolu m’ għandux attività farmakoloġika.
Valsartan is primarily eliminated in faeces (about 83% of dose) and urine (about 13% of dose), mainly as unchanged drug.
Valsartan jitneħħa l- aktar ma ’ l- ippurgar (madwar 83% tad- doża) u fl- awrina (madwar 13% tad- doża), l- aktar bħala l- mediċina mhux mibdula.
Following intravenous administration, plasma clearance of valsartan is about 2 l/ h and its renal clearance is 0.62 l/ h (about 30% of total clearance).
Wara li jingħata ġol- vina, it- tneħħija ta ’ valsartan minn ġol- plażma hija madwar 2 l/ h u t- tneħħija renali hija 0. 62 l/ h (madwar 30% tat- tneħħija totali).
The half-life of valsartan is 6 hours.
Il- half life ta ’ valsartan hija 6 sigħat.
Amlodipine/ Valsartan Following oral administration of Copalia, peak plasma concentrations of valsartan and amlodipine are reached in 3 and 6– 8 hours, respectively.
Amlodipine/ Valsartan Wara li Copalia jittieħed mill- ħalq, il- quċċata tal- konċentrazzjonijiet fil- plażma ta ’ valsartan u amlodipine jintlaħqu fi 3 u 6- 8 sigħat, rispettivament.
The rate and extent of absorption of Copalia are equivalent to the bioavailability of valsartan and amlodipine when administered as individual tablets.
Ir- rata u l- grad ta’ assorbiment ta ’ Copalia huma ekwivalenti għal bijodisponibilità ta ’ valsartan u amlodipine meta jingħataw bħala pilloli waħidhom.
Special populations Paediatric patients (age below 18 years) No pharmacokinetic data are available in the paediatric population.
Popolazzjonijiet speċjali Pazjenti pedjatriċi (età taħt it- 18- il sena) M’ hemmx tagħrif farmakokinetiku fil- popolazzjoni pedjatrika.
Elderly (age 65 years or over) Time to peak plasma amlodipine concentrations is similar in young and elderly patients.
Anzjani (età minn 65 sena ‘ l fuq) Il- ħin li jdumu biex jintlaħqu l- quċċati tal- konċentrazzjonijiet ta ’ amlodipine fil- plażma huma simili fiż- żgħażagħ u fil- pazjenti anzjani.
In elderly patients, amlodipine clearance tends to decline, causing increases in the area under the curve (AUC) and elimination half-life.
Il- medja ta ’ l -
Mean systemic AUC of valsartan is higher by 70% in the elderly than in the young therefore caution is required when increasing the dosage.
11 AUC sistemiku ta ’ valsartan ikun 70% ogħla fl- anzjani milli fiż- żgħażagħ, għaldaqstant hija meħtieġa l- kawtela meta tkun qed tiżdied id- doża.
Renal impairment The pharmacokinetics of amlodipine are not significantly influenced by renal impairment.
Indeboliment renali Il- farmakokinetiċi ta ’ amlodipine mhumiex effettwati b’ mod sinifikanti mill- indeboliment renli.
As expected for a compound where renal clearance accounts for only 30% of total plasma clearance, no correlation was seen between renal function and systemic exposure to valsartan.
Kif mistenni minn sustanza li t- tneħħija renali tagħha tgħodd biss mat- 30% tat- tneħħija totali mill- plażma, m’ hemmx korrelazzjoni bejn il- funzjoni renali u l- esponiment sistemiku għal valsartan.
Hepatic impairment Patients with hepatic insufficiency have decreased clearance of amlodipine with resulting increase of approximately 40– 60% in AUC.
Indeboliment tal- fwied Pazjenti b’ insuffiċjenza tal- fwied għandhom tneħħija ta ’ amlodipine imnaqqsa li tirriżulta f’ żieda ta ’ madwar 40- 60% fl- AUC.
On average, in patients with mild to moderate chronic liver disease exposure (measured by AUC values) to valsartan is twice that found in healthy volunteers (matched by age, sex and weight).
Il- medja ta ’ l- esponiment (imkejla bil- valuri ta ’ l- AUC) għal valsartan f’ pazjenti b’ mard kroniku tal- fwied ħafif għal moderat, hija d- doppju ta ’ dik f’ voluntiera b’ saħħithom (abbinati bl- età, sess u piż tal- ġisem).
Caution should be exercised in patients with liver disease (see section 4.2).
Għandha tintuża kawtela f’ pazjenti b’ mard tal- fwied (ara sezzjoni 4. 2).
Adverse reactions observed in animal studies with possible clinical relevance were as follows:
Reazzjonijiet avversi li dehru fi studji b’ annimali li jistgħu jkollhom rilevanza klinika kienu kif ġej:
Histopathological signs of inflammation of the glandular stomach was seen in male rats at an exposure of about 1.9 (valsartan) and 2.6 (amlodipine) times the clinical doses of 160 mg valsartan and 10 mg amlodipine.
Sinjali istopatoloġici ta ’ infjammazzjoni ta ’ l- istonku glandulari dehru f’ firien maskili b’ esponimenti ta ’ madwar 1. 9 (valsartan) u 2. 6 (amlodipine) - il darba d- dożi kliniċi ta ’ 160 mg valsartan u 10 mg amlodipine.
At higher exposures, there were ulceration and erosion of the stomach mucosa in both females and males.
B’ dożi ogħla kien hemm ulċerazzjonijiet u tmermir tal- mukoża ta ’ l- istonku f’ annimali kemm femminili kif ukoll maskili.
Similar changes were also seen in the valsartan alone group (exposure 8.5– 11.0 times the clinical dose of 160 mg valsartan).
Bidliet simili dehru anki fil- grupp ta ’ valsartan waħdu (esponimenti ta ’ 8. 5- 11. 0- il darba d- doża klinika ta ’ 160 mg valsartan).
An increased incidence and severity of renal tubular basophilia/ hyalinisation, dilation and casts, as well as interstitial lymphocyte inflammation and arteriolar medial hypertrophy were found at an exposure of 8– 13 (valsartan) and 7– 8 (amlodipine) times the clinical doses of 160 mg valsartan and 10 mg amlodipine.
Żieda fin- numru ta ’ każijiet u severità ta ’ bażofilja / hyalinisation tubulari renali, dilazzjoni u kasts, kif ukoll infjammazzjoni b’ limfoċiti fl- interstizzju u ipertrofija ta ’ l- arterjola medjali instabu b’ esponimenti ta ’ 8- 13 (valsartan) u 7- 8 (amlodipine) drabi d- dożi kliniċi ta ’ 160 mg valsartan u 10 mg amlodipine.
Similar changes were found in the valsartan alone group (exposure 8.5– 11.0 times the clinical dose of 160 mg valsartan).
Bidliet simili instabu fil- grupp ta ’ valsartan waħdu (esponiment 8. 5- 11. 0- il darba d- doża klinika ta ’ 160 mg valsartan).
11 In an embryo-foetal development study in the rat, increased incidences of dilated ureters, malformed sternebrae, and unossified forepaw phalanges were noticed at exposures of about 12 (valsartan) and 10 (amlodipine) times the clinical doses of 160 mg valsartan and 10 mg amlodipine.
Fi studju dwar l- iżvilupp ta ’ l- embriju- fetu tal- far, kien hemm numru akbar ta ’ uretri mwessa ’, sternebre malformati, u l- falanġi tas- sieq bid- dwiefer ta ’ quddiem mingħajr għadam kienu nnutati b’ esponimenti ta ’ madwar 12- il darba (valsartan) u 10 darbiet (amlodipine) id- dożi kliniċi ta ’ 160 mg valsartan u 10 mg amlodipine.
Dilated ureters were also found in the valsartan alone group (exposure 12 times the clinical dose of 160 mg valsartan).
Uretri imwassa ’ instabu wkoll fil- grupp ta ’ valsartan waħdu (esponiment 12- il darba d- doża klinika ta 160 mg valsartan).
There were only modest signs of maternal toxicity (moderate reduction of body weight) in this study.
Fl- omm kien hemm biss sinjali żgħar ħafna ta ’ tossiċità (tnaqqis moderat tal- piż tal- ġisem) f’ dan l- istudju.
The no-observed-effect-level for developmental effects was observed at 3- (valsartan) and 4- (amlodipine) fold the clinical exposure (based on AUC).
Il- livell fejn ma jidhirx effett għall- effetti ta ’ l- iżvilupp kien osservat b’ 3 - (valsartan) u 4 - (amlodipine) darbiet l- esponiment kliniku (bażat fuq l- AUC).
For the single compounds there was no evidence of mutagenicity, clastogenicity or carcinogenicity.
Għas- sustanzi waħidhom ma kienx jidher li hemm effett mutaġenetiku, klastoġenetiku jew karċinoġenetiku.
Tablet core:
Qalb tal- pillola:
Cellulose microcrystalline Crospovidone Type A Silica, colloidal anhydrous Magnesium stearate
Cellulose microcrystalline Crospovidone Type A Silica, colloidal anhydrous Magnesium stearate
Coating:
12 Kisja:
Hypromellose Titanium dioxide (E171) Iron oxide, yellow (E172) Macrogol 4000 Talc
Hypromellose Titanium dioxide (E171) Iron oxide, yellow (E172) Macrogol 4000 Talc
30 months
30 xahar
PVC/ PVDC blisters.
Folji tal- PVC/ PVDC.
One blister contains 7, 10 or 14 film-coated tablets.
Folja waħda fiha 7, 10 jew 14- il pillola miksija b’ rita.
7, 14, 28, 30, 56, 90, 98 or 280 film-coated tablets.
7, 14, 28, 30, 56, 90, 98 jew 280 pillola miksija b’ rita.
PVC/ PVDC perforated unit dose blisters.
Folji mtaqbin tal- PVC/ PVDC b’ doża waħda.
56, 98 or 280 film-coated tablets and multipacks containing 280 (4x70) film-coated tablets.
56, 98 jew 280 pillola miksija b’ rita u pakketti b’ ħafna li jkun fihom 280 (4x70) pillola miksija b’ rita.
12 6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
8.
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ 8.
MARKETING AUTHORISATION NUMBER(S)
EU/ 1/ 06/ 372/ 001 EU/ 1/ 06/ 372/ 002 EU/ 1/ 06/ 372/ 003 EU/ 1/ 06/ 372/ 004 EU/ 1/ 06/ 372/ 005 EU/ 1/ 06/ 372/ 006
EU/ 1/ 06/ 372/ 001 EU/ 1/ 06/ 372/ 002 EU/ 1/ 06/ 372/ 003 EU/ 1/ 06/ 372/ 004 EU/ 1/ 06/ 372/ 005 EU/ 1/ 06/ 372/ 006 EU/ 1/ 06/ 372/ 007 EU/ 1/ 06/ 372/ 008 EU/ 1/ 06/ 372/ 025 EU/ 1/ 06/ 372/ 026 EU/ 1/ 06/ 372/ 027 EU/ 1/ 06/ 372/ 034
13 EU/ 1/ 06/ 372/ 007 EU/ 1/ 06/ 372/ 008 EU/ 1/ 06/ 372/ 025 EU/ 1/ 06/ 372/ 026 EU/ 1/ 06/ 372/ 027 EU/ 1/ 06/ 372/ 034
Copalia 5 mg/ 160 mg film-coated tablets
Copalia 5 mg/ 160 mg pilloli miksija b’ rita
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan.
Kull pillola miksija b’ rita fiha 5 mg ta ’ amlodipine (bħala amlodipine besylate) u 160 mg valsartan.
Dark yellow, oval film-coated tablet, imprinted with “ NVR” on one side and “ ECE” on the other side.
Pillola safra skura, ovali miksija b’ rita, ittimbrata “ NVR ” fuq naħa u “ ECE ” fuq l- oħra.
Copalia 5 mg/ 160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 160 mg alone.
Copalia 5 mg/ 160 mg jista ’ jingħata lill- pazjenti li ma jkollhomx pressjoni kontrollata tajjeb b’ amlodipine 5 mg jew valsartan 160 mg waħidhom.
Elderly (age 65 years or over) In elderly patients, caution is required when increasing the dosage.
Pazjenti anzjani (età 65 sena jew aktar) F’ pazjenti anzjani, hija meħtieġa l- kawtela meta tkun qed tiżdied id- doża.
14 Children and adolescents Copalia is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.
15 Tfal u adolexxenti Copalia mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan.
F’ pazjenti b’ indeboliment tal- fwied ħafif sa moderat mingħajr kolestażi, l- ogħla doża rakkomandata ta ’ valsartan hija 80 mg.
Renal impairment No dosage adjustment of Copalia is required for patients with mild to moderate renal impairment (GFR > 30 ml/ min/ 1.73 m2).
16 Indeboliment renali M’ hemmx bżonn ta ’ tibdil fid- dożaġġ għall- pazjenti li għandhom indeboliment ħafif għal moderat (GFR > 30 ml/ min/ 1. 73 m2).
15 Primary hyperaldosteronism Patients with primary hyperaldosteronism should not be treated with the angiotensin II antagonist valsartan as their renin-angiotensin system is affected by the primary disease.
Pazjenti b’ kondizzjoni primarja b’ livelli għoljin ta ’ aldosterone Pazjenti b’ kondizzjoni primarja b’ livelli għoljin ta ’ aldosterone m’ għandhomx jiġu kurati b’ valsartan li hu antagonist ta ’ angiotensin II peress li s- sistema ta ’ renin- angiotensin tagħħom hija effettwata mill- marda naturali.
To be taken into account with concomitant use Others In monotherapy, amlodipine has been safely administered with thiazide diuretics, beta blockers, ACE inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, atorvastatin, sildenafil, anti-acid medicines (aluminium hydroxide gel, magnesium hydroxide, simeticone), cimetidine, non- steroidal anti-inflammatory medicines, antibiotics and oral hypoglycaemic medicines.
Li għandha titqies waqt l- użu fl- istess ħin Oħrajn Mogħti waħdu, amlodipine intuża b’ mod sigur ma ’ dijuretiċi thiazide, beta blockers, inibituri ACE, nitrati li jaħdmu fit- tul, nitrogliċerina ta ’ taħt l- ilsien, digoxin, warfarin, atorvastatin, sildenafil, mediċini antaċidi (ġel ta ’ l- aluminium hydroxide, magnesium hydroxide, simeticone), cimetidine, mediċini anti- infjammatorji mhux sterojdi, antibijotiċi u mediċini ipogliċemiċi orali.
Interactions linked to valsartan Concomitant use not recommended Lithium Reversible increases in serum lithium concentrations and toxicity have been reported during concurrent use of ACE inhibitors.
17 Nuqqas ta ’ qbil marbut ma ’ valsartan L- użu fl- istess ħin mhux rakkomandat Lithium Żiediet riversibbli tal- konċentrazzjonijiet ta ’ lithium fis- serum u tossiċità kienu rappurtati bl- użu fl - istess ħin ta ’ inibituri ACE.
16 Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels If a medicinal product that affects potassium levels is to be prescribed in combination with valsartan, monitoring of potassium plasma levels is advised.
Dijuretiċi li jfaddlu potassium, sustanzi ta ’ potassium, sustanzi li jintużaw flok il- melħ u sustanzi oħra li jistgħu jgħollu l- livelli ta ’ potassium Jekk prodott mediċinali li jeffettwa l- livelli ta ’ potassium se jkollu jiġi ordnat f’ taħlita ma ’ valsartan, aħjar isir monitoraġġ tal- livelli ta ’ potassium fil- plażma.
AIIRAs 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) (see also section 5.3).
Espożizzjoni għall- kura ta ’ AIIRAs fit- tieni u it- tielet trimestri huwa magħruf li jinduċi tossiċità tal - fetu uman (funzjoni renali mnaqqsa, oligoidramnios, ittardjar ta 'l- ossifikazzjoni tal- kranju) u tossiċità fit- trabi wara it- twelid (indeboliment renali, pressjoni baxxa, iperkalemia) (ara ukoll sezzjoni 5. 3).
Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
18 Jekk kien hemm espożizzjoni għal AIIRAs mit- tieni trimestru tat- tqala, huwa rakkomandat jsir kontroll bl- ultrasound tal- funzjoni renali u l- kranju.
17 indicate no adverse effects of amlodipine and other calcium receptor antagonists on the health of the foetus.
Tagħrif dwar numru limitat ta ’ esponimenti waqt it- tqala ma jurux effetti avversi ta ’ amlodipine jew antagonisti tar- riċetturi ta ’ calcium fuq is- saħħa tal- fetu.
Headache Dizziness, somnolence, dizziness postural, paraesthesia
Uġigħ ta ’ ras Sturdament, ngħas, tistordi kif tiċċaqlaq, parasteżija
Cough, pharyngolaryngeal pain
Sogħla, uġigħ tal- farinġi u tal- larinġi
Uncommon: and urinary disorders Rare:
Rari:
Diarrhoea, nausea, abdominal pain, constipation, dry mouth Pollakisuria, polyuria
Pollakisurja, tgħaddi volum kbir ta ’ awrina
Musculoskeletal and connective tissue disorders
19 Disturbi muskolu- skeltriċi u tat- tessut konnettiv
Additional information on the individual components Adverse drug reactions previously reported with one of the individual components (amlodipine or valsartan) may be potential undesirable effects with Copalia as well, even if not observed in clinical trials or during the post-marketing period.
Aktar tagħrif dwar il- komponenti individwali Reazzjonijiet avversi għall- medicina li kienu rappurtati qabel b’ wieħed mill- komponenti (amlodipine jew valsarrtan) jistgħu jkunu effetti mhux mixtieqa b’ Copalia ukoll, anki jekk ma dehrux waqt il- provi kliniċi jew waqt il- perjodu ta ’ wara t- tqegħid fis- suq.
Amlodipine Common Uncommon
Amlodipine Komuni Mhux komuni
Rarely, patients, particularly those with severe obstructive coronary artery disease, have developed increased frequency, duration or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase.
Arritmija, infart mijokardijaku, B’ mod rari, il- pazjenti, l- aktar dawk li għandhom mard sever ta ’ mblokk tal- arterja koronarja, żviluppaw żieda fil- frekwenza, fit- tul ta ’ ħin jew fil- qawwa tal- anġina jew tal- infart mijokardijaku akut meta bdew kura b’ imblukkatur tal- kanali tal- kalċju jew fiż- żmien meta żdiedet id- doża.
These adverse events may not be distinguishable from the natural history of the underlying disease.
Dawn il- każijiet avversi jistgħu ma jkunux jingħarfu mill- istorja naturali tal- istess
The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels.
Il- proċess ta ’ kontrazzjoni tal- muskolu tal- qalb u tal- muskoli lixxi tal- vini huma t - tnejn marbuta mal- moviment ta ’ joni ta ’ calcium barra miċ- ċelluli għal ġo fihom minn kanali ta ’ joni speċifiċi.
Following administration of therapeutic doses to patients with hypertension, amlodipine produces vasodilation, resulting in a reduction of supine and standing blood pressures.
Wara li jingħataw dożi terapewtiċi lill- pazjenti li jsofru minn pressjoni għolja, amlodipine inaqqas il - vażodilatazzjoni, li jwassal għall- tnaqqis fil- pressjonijiet tad- demm kemm meta l- pazjent ikun mindud 21 kif ukoll wieqaf.
Amlodipine/ Valsartan Over 1,400 hypertensive patients received Copalia once daily in two placebo-controlled trials.
Amlodipine/ Valsartan ’ L fuq minn 1, 400 pazjent irċevew Copalia darba kuljum f’ żewġ provi kontrollati bi plaċebo.
Adults with mild to moderate uncomplicated essential hypertension (mean sitting diastolic blood pressure ≥ 95 and < 110 mmHg) were enrolled.
Pazjenti b’ riskji
Patients with high cardiovascular risks – heart failure, type I and poorly controlled type II diabetes and history of myocardial infarction or stroke within one year – were excluded.
22 kardjovaskulari għoljin – insuffiċjenza tal- qalb, dijabete tat- tip I u dijabete tat- tip II li mhix kontrollata u pazjenti li xi darba kellhom infart mijokardijaku jew attakk ta ’ puplesija fl- aħħar sena – kienu esklużi.
21 A multicentre, randomised, double-blind, active-controlled, parallel-group trial showed normalisation of blood pressure (trough sitting diastolic blood pressure < 90 mmHg at the end of the trial) in patients not adequately controlled on amlodipine 10 mg in 78% of patients treated with amlodipine/ valsartan 10 mg/ 160 mg, compared to 67% of patients remaining on amlodipine 10 mg.
Prova f’ ħafna ċentri, randomised, double- blind, active- controlled, bi grupp parallel wasslet għal pressjoni tad- demm normali (il- pressjoni ta ’ bilqiegħeda l- aktar baxxa kienet < 90 mmHg fl- aħħar tal - prova) f’ pazjenti li ma kienux kontrollati sew b’ amlodipine 10 mg f’ 78% tal- pazjenti kurati b’ amlodipine/ valsartan 10 mg/ 160 mg, imqabbla ma ’ 67% tal- pazjenti li baqgħu fuq amlodipine 10 mg.
Amlodipine Absorption:
Amlodipine Assorbiment:
Distribution:
23 Distribuzzjoni:
22 Distribution:
Distribuzzjoni:
In elderly patients, amlodipine clearance tends to decline, causing increases in the area under the curve (AUC) and elimination half-life.
F’ pazjenti anzjani, it- tneħħija ta ’ amlodipine għandha t- tendenza li tonqos, li tikkawża żiediet fl- erja taħt il- kurva (AUC) u l- half life ta ’ l- eliminazzjoni.
Mean systemic AUC of valsartan is higher by 70% in the elderly than in the young therefore caution is required when increasing the dosage.
Il- medja ta ’ l - AUC sistemiku ta ’ valsartan ikun 70% ogħla fl- anzjani milli fiż- żgħażagħ, għaldaqstant hija meħtieġa l- kawtela meta tkun qed tiżdied id- doża.
Hepatic impairment Patients with hepatic insufficiency have decreased clearance of amlodipine with resulting increase of approximately 40– 60% in AUC.
24 Indeboliment tal- fwied Pazjenti b’ insuffiċjenza tal- fwied għandhom tneħħija ta ’ amlodipine imnaqqsa li tirriżulta f’ żieda ta ’ madwar 40- 60% fl- AUC.
23 In an embryo-foetal development study in the rat, increased incidences of dilated ureters, malformed sternebrae, and unossified forepaw phalanges were noticed at exposures of about 12 (valsartan) and 10 (amlodipine) times the clinical doses of 160 mg valsartan and 10 mg amlodipine.
Fi studju dwar l- iżvilupp ta ’ l- embriju- fetu tal- far, kien hemm numru akbar ta ’ uretri mwessa ’, sternebre malformati, u l- falanġi tas- sieq bid- dwiefer ta ’ quddiem mingħajr għadam kienu nnutati b’ esponimenti ta ’ madwar 12- il darba (valsartan) u 10 darbiet (amlodipine) id- dożi kliniċi ta ’ 160 mg valsartan u 10 mg amlodipine.
Coating:
Kisja:
6.3 Shelf life
25 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
24 6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Copalia 10 mg/ 160 mg film-coated tablets
Copalia 10 mg/ 160 mg pilloli miksija b’ rita
Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan.
Kull pillola miksija b’ rita fiha 10 mg ta ’ amlodipine (bħala amlodipine besylate) u 160 mg valsartan.
Light yellow, oval film-coated tablet, imprinted with “ NVR” on one side and “ UIC” on the other side.
Pillola safra ċara, ovali miksija b’ rita, ittimbrata “ NVR ” fuq naħa u “ UIC ” fuq l- oħra.
Copalia 10 mg/ 160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg or valsartan 160 mg alone or with Copalia 5 mg/ 160 mg.
Copalia 10 mg/ 160 mg jista ’ jingħata lill- pazjenti li ma jkollhomx pressjoni kontrollata tajjeb b’ amlodipine 10 mg jew valsartan 160 mg waħidhom jew b’ Copalia 5 mg/ 160 mg.
26 Children and adolescents Copalia is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.
28 Tfal u adolexxenti Copalia mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
Renal impairment No dosage adjustment of Copalia is required for patients with mild to moderate renal impairment (GFR > 30 ml/ min/ 1.73 m2).
29 Indeboliment renali M’ hemmx bżonn ta ’ tibdil fid- dożaġġ għall- pazjenti li għandhom indeboliment ħafif għal moderat (GFR > 30 ml/ min/ 1. 73 m2).
27 Primary hyperaldosteronism Patients with primary hyperaldosteronism should not be treated with the angiotensin II antagonist valsartan as their renin-angiotensin system is affected by the primary disease.
Pazjenti b’ kondizzjoni primarja b’ livelli għoljin ta ’ aldosterone Pazjenti b’ kondizzjoni primarja b’ livelli għoljin ta ’ aldosterone m’ għandhomx jiġu kurati b’ valsartan li hu antagonist ta ’ angiotensin II peress li s- sistema ta ’ renin- angiotensin tagħħom hija effettwata mill- marda naturali.
Interactions linked to valsartan Concomitant use not recommended Lithium Reversible increases in serum lithium concentrations and toxicity have been reported during concurrent use of ACE inhibitors.
30 Nuqqas ta ’ qbil marbut ma ’ valsartan L- użu fl- istess ħin mhux rakkomandat Lithium Żiediet riversibbli tal- konċentrazzjonijiet ta ’ lithium fis- serum u tossiċità kienu rappurtati bl- użu fl - istess ħin ta ’ inibituri ACE.
28 Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels If a medicinal product that affects potassium levels is to be prescribed in combination with valsartan, monitoring of potassium plasma levels is advised.
Dijuretiċi li jfaddlu potassium, sustanzi ta ’ potassium, sustanzi li jintużaw flok il- melħ u sustanzi oħra li jistgħu jgħollu l- livelli ta ’ potassium Jekk prodott mediċinali li jeffettwa l- livelli ta ’ potassium se jkollu jiġi ordnat f’ taħlita ma ’ valsartan, aħjar isir monitoraġġ tal- livelli ta ’ potassium fil- plażma.
Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
31 Jekk kien hemm espożizzjoni għal AIIRAs mit- tieni trimestru tat- tqala, huwa rakkomandat jsir kontroll bl- ultrasound tal- funzjoni renali u l- kranju.
Animal studies indicates that the valsartan/ amlodipine has reproductive toxicity in line with what has been described for valsartan and
Studji bl- annimali wrew li hemm tossiċità għas - sistema riproduttiva b’ valsartan/ amlodipine simili ma ’ dik li ġiet deskritta għal valsartan u antagonisti oħra ta ’ angiotensin II (ara sezzjoni 5. 3).
Data on a limited number of exposed pregnancies indicate no adverse effects of amlodipine and other calcium receptor antagonists on the health of the foetus.
Tagħrif dwar numru limitat ta ’ esponimenti waqt it- tqala ma jurux effetti avversi ta ’ amlodipine jew antagonisti tar- riċetturi ta ’ calcium fuq is- saħħa tal- fetu.
Musculoskeletal and connective tissue disorders
32 Disturbi muskolu- skeltriċi u tat- tessut konnettiv
30 General disorders and administration site conditions
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata
These adverse events may not be distinguishable from the natural history of the underlying disease.
33 Dawn il- każijiet avversi jistgħu ma jkunux jingħarfu mill- istorja naturali tal- istess marda li qed tiġi kkurata.
31 4.9 Overdose
4. 9 Doża eċċessiva
Following administration of therapeutic doses to patients with hypertension, amlodipine produces vasodilation, resulting in a reduction of supine and standing blood pressures.
34 Wara li jingħataw dożi terapewtiċi lill- pazjenti li jsofru minn pressjoni għolja, amlodipine inaqqas il - vażodilatazzjoni, li jwassal għall- tnaqqis fil- pressjonijiet tad- demm kemm meta l- pazjent ikun mindud kif ukoll wieqaf.
Amlodipine/ Valsartan Over 1,400 hypertensive patients received Copalia once daily in two placebo-controlled trials.
35 Amlodipine/ Valsartan ’ L fuq minn 1, 400 pazjent irċevew Copalia darba kuljum f’ żewġ provi kontrollati bi plaċebo.
33 A multicentre, randomised, double-blind, active-controlled, parallel-group trial showed normalisation of blood pressure (trough sitting diastolic blood pressure < 90 mmHg at the end of the trial) in patients not adequately controlled on amlodipine 10 mg in 78% of patients treated with amlodipine/ valsartan 10 mg/ 160 mg, compared to 67% of patients remaining on amlodipine 10 mg.
Prova f’ ħafna ċentri, randomised, double- blind, active- controlled, bi grupp parallel wasslet għal pressjoni tad- demm normali (il- pressjoni ta ’ bilqiegħeda l- aktar baxxa kienet < 90 mmHg fl- aħħar tal - prova) f’ pazjenti li ma kienux kontrollati sew b’ amlodipine 10 mg f’ 78% tal- pazjenti kurati b’ amlodipine/ valsartan 10 mg/ 160 mg, imqabbla ma ’ 67% tal- pazjenti li baqgħu fuq amlodipine 10 mg.
Amlodipine Absorption:
36 Amlodipine Assorbiment:
34 Distribution:
Distribuzzjoni:
Mean systemic AUC of valsartan is higher by 70% in the elderly than in the young therefore caution is required when increasing the dosage.
37 AUC sistemiku ta ’ valsartan ikun 70% ogħla fl- anzjani milli fiż- żgħażagħ, għaldaqstant hija meħtieġa l- kawtela meta tkun qed tiżdied id- doża.
35 In an embryo-foetal development study in the rat, increased incidences of dilated ureters, malformed sternebrae, and unossified forepaw phalanges were noticed at exposures of about 12 (valsartan) and 10 (amlodipine) times the clinical doses of 160 mg valsartan and 10 mg amlodipine.
Fi studju dwar l- iżvilupp ta ’ l- embriju- fetu tal- far, kien hemm numru akbar ta ’ uretri mwessa ’, sternebre malformati, u l- falanġi tas- sieq bid- dwiefer ta ’ quddiem mingħajr għadam kienu nnutati b’ esponimenti ta ’ madwar 12- il darba (valsartan) u 10 darbiet (amlodipine) id- dożi kliniċi ta ’ 160 mg valsartan u 10 mg amlodipine.
Coating:
38 Kisja:
Hypromellose Titanium dioxide (E171) Iron oxide, yellow (E172) Iron oxide, red (E172) Macrogol 4000 Talc
Hypromellose Titanium dioxide (E171) Iron oxide, yellow (E172) Iron oxide, red (E172) Macrogol 4000 Talc
36 6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
MARKETING AUTHORISATION NUMBER(S)
EU/ 1/ 06/ 372/ 017 EU/ 1/ 06/ 372/ 018 EU/ 1/ 06/ 372/ 019 EU/ 1/ 06/ 372/ 020 EU/ 1/ 06/ 372/ 021
EU/ 1/ 06/ 372/ 017 EU/ 1/ 06/ 372/ 018 EU/ 1/ 06/ 372/ 019 EU/ 1/ 06/ 372/ 020 EU/ 1/ 06/ 372/ 021 EU/ 1/ 06/ 372/ 022 EU/ 1/ 06/ 372/ 023 EU/ 1/ 06/ 372/ 024 EU/ 1/ 06/ 372/ 031 EU/ 1/ 06/ 372/ 032 EU/ 1/ 06/ 372/ 033 EU/ 1/ 06/ 372/ 036
39 EU/ 1/ 06/ 372/ 022 EU/ 1/ 06/ 372/ 023 EU/ 1/ 06/ 372/ 024 EU/ 1/ 06/ 372/ 031 EU/ 1/ 06/ 372/ 032 EU/ 1/ 06/ 372/ 033 EU/ 1/ 06/ 372/ 036
37 ANNEX II
40 ANNESS II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT B.
Novartis Pharma GmbH Roonstraße 25 D-90429 Nuremberg Germany
Novartis Pharma GmbH Roonstraße 25 D- 90429 Norimberga Il- Ġermanja
39 ANNEX III
42 ANNESS III
41 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
44 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON OF UNIT PACK
KARTUNA TAL- PAKKETT B’ WIEĦED
Copalia 5 mg/ 80 mg film-coated tablets amlodipine/ valsartan
Copalia 5 mg/ 80 mg pilloli miksija b’ rita amlodipine/ valsartan
Each tablet contains 5 mg amlodipine (as amlodipine besylate) and 80 mg valsartan.
Kull pillola fiha 5 mg amlodipine (bħala amlodipine besylate) u 80 mg valsartan.
7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 90 film-coated tablets 98 film-coated tablets 280 film-coated tablets
7 pilloli miksija b’ rita 14- il pillola miksija b’ rita 28 pillola miksija b’ rita 30 pillola miksija b’ rita 56 pillola miksija b’ rita 90 pillola miksija b’ rita 98 pillola miksija b’ rita 280 pillola miksija b’ rita
7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 90 film-coated tablets 98 film-coated tablets 280 film-coated tablets 56 x 1 film-coated tablet (unit dose) 98 x 1 film-coated tablet (unit dose) 280 x 1 film-coated tablet (unit dose)
7 pilloli miksija b’ rita 14- il pillola miksija b’ rita 28 pillola miksija b’ rita 30 pillola miksija b’ rita 56 pillola miksija b’ rita 90 pillola miksija b’ rita 98 pillola miksija b’ rita 280 pillola miksija b’ rita 56 x pillola 1 miksija b’ rita (doża b’ waħda) 98 x pillola 1 miksija b’ rita (doża b’ waħda) 280 x pillola 1 miksija b’ rita (doża b’ waħda)
43 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
46 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)
KARTUNA TAN- NOFS TAL- PAKKETT B’ ĦAFNA (MINGĦAJR IL- KAXXA ĊELESTI)
70 film-coated tablets Component of a multipack comprising 4 cartons, each containing 70 tablets.
70 pillola miksija b’ rita Jagħmel parti minn pakkett b’ ħafna li jinkludi 4 kartuniet, kull wieħed b’ 70 pillola.
280 film-coated tablets (4x70)
280 pillola miksija b’ rita (4x70)
45 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
48 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON OF MULTIPACK (WITH BLUE BOX)
KARTUNA TAN- NOFS TAL- PAKKETT B’ ĦAFNA (BIL- KAXXA ĊELESTI)
280 film-coated tablets Multipack comprising 4 cartons, each containing 70 tablets.
280 pillola miksija b’ rita Pakkett b’ ħafna li jinkludi 4 kartuniet, kull wieħed b’ 70 pillola.
47 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
50 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
BLISTERS
FOLJI
48 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
51 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Copalia 5 mg/ 160 mg film-coated tablets amlodipine/ valsartan
Copalia 5 mg/ 160 mg pilloli miksija b’ rita amlodipine/ valsartan
Each tablet contains 5 mg amlodipine (as amlodipine besylate) and 160 mg valsartan.
Kull pillola fiha 5 mg amlodipine (bħala amlodipine besylate) u 160 mg valsartan.
50 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
53 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
52 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
55 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON OF MULTIPACK (WITH BLUE BOX)
KARTUNA TA ’ BARRA TAL- PAKKETT B’ ĦAFNA (BIL- KAXXA ĊELESTI)
54 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
57 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
55 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
58 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Copalia 10 mg/ 160 mg film-coated tablets amlodipine/ valsartan
Copalia 10 mg/ 160 mg pilloli miksija b’ rita amlodipine/ valsartan
Each tablet contains 10 mg amlodipine (as amlodipine besylate) and 160 mg valsartan.
Kull pillola fiha 10 mg amlodipine (bħala amlodipine besylate) u 160 mg valsartan.
57 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
60 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
59 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
62 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Each tablet contains 10 mg amlodipine (as amlodipine besylate) and 160 mg valsartan.
Kull pillola fiha 5 mg amlodipine (bħala amlodipine besylate) u 160 mg valsartan.
61 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
64 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
63 PACKAGE LEAFLET:
66 FULJETT TA ’ TAGĦRIF:
What Copalia is and what it is used for 2.
X’ inhu Copalia u għalxiex jintuża 2.
Before you take Copalia 3.
Qabel ma tieħu Copalia 3.
How to take Copalia 4.
Kif għandek tieħu Copalia 4.
Possible side effects 5.
Effetti sekondarji li jista ’ jkollu Kif taħżen Copalia 5.
WHAT COPALIA IS AND WHAT IT IS USED FOR
X’ INHU COPALIA U GĦALXIEX JINTUŻA
Copalia tablets contain two substances called amlodipine and valsartan.
Il- pilloli Copalia fihom żewġ sustanzi li jissejjħu amlodipine u valsartan.
Both of these substances help to control high blood pressure. − Amlodipine belongs to a group of substances called “ calcium channel blockers”.
- Amlodipine huwa membru ta ’ grupp ta ’ sustanzi li jissejjħu “ imblokkaturi tal- kanali ta ’
Amlodipine stops calcium from moving into the blood vessel wall which stops the blood vessels from tightening. − Valsartan belongs to a group of substances called “ angiotensin-II receptor antagonists”.
- Valsartan huwa membru ta ’ grupp ta ’ sustanzi li jissejħu “ antagonisti tar- riċetturi ta ’ angiotensin
Angiotensin II is produced by the body and makes the blood vessels tighten, thus increasing the blood pressure.
Angiotensin II jiġi iffurmat mill- ġisem u jġiegħel il- vini jingħafsu, u għalhekk jgħolli l - pressjoni tad- demm.
Valsartan works by blocking the effect of angiotensin II.
Valsartan jaħdem billi jimblokka l- effett ta ’ angiotensin II.
This means that both of these substances help to stop the blood vessels tightening.
Dan ifisser li dawn iż- żewġ sustanzi jgħinu biex iwaqqfu lill- vini tad- demm milli jingħafsu.
As a result, the blood vessels relax and blood pressure is lowered.
B’ hekk, il- vini jintreħew u l- pressjoni tad- demm titbaxxa.
Copalia is used to treat high blood pressure in patients whose blood pressure is not controlled enough with either amlodipine or valsartan on its own.
Copalia jintuża sabiex jikkura l- pressjoni għolja f’ pazjenti li jkollhom il- pressjoni li ma tkunx qed tiġi kontrollata tajjeb biżżejjed b’ amlodipine jew valsartan waħidhom.
2.
QABEL MA TIEĦU COPALIA 2.
BEFORE YOU TAKE COPALIA
Tieħux Copalia
Do not take Copalia − if you are allergic (hypersensitive) to amlodipine or other medicines of the dihydropyridine type, − if you are allergic (hypersensitive) to valsartan or any of the other ingredients of Copalia.
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal amlodipine jew mediċini oħra tat- tip
If you think you may be allergic, talk to your doctor before taking Copalia. − if you have severe liver problems, such as biliary cirrhosis or cholestasis. − if you have severe kidney problems or if you are having dialysis. − during the last 6 months of pregnancy, see “ Pregnancy and breastfeeding”.
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal valsartan jew sustanzi oħra ta ’
If any of the above applies to you, do not take Copalia and talk to your doctor.
- Jekk għandek problemi severi tal- fwied, bħal ċirrożi tal- marrara jew kolestażi.