qanastek/EMEA-V3 huggingface dataset:
Cozaar Comp. and Cozaar Comp Forte (losartan/ hydrochlorothiazide) have been included in the list of products for Summary of Products Characteristics (SPC) harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/ 83/ EC, as amended.
Cozaar Comp. u Cozaar Comp Forte (losartan/ hydrochlorothiazide) ġew inklużi fil- lista ta ’ prodotti għall- armonizzazzjoni tas- Sommarju tal- Karatteristiċi tal- Prodott (SPC) imfassal mis- CMD( h), b’ mod konformi ma ’ l- Artikolu 30( 2) tad- Direttiva 2001/ 83/ KE, kif emendata.
Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned products (and its associated names), Denmark notified the CHMP/ EMEA Secretariat of an official referral under Article 30 of Directive 2001/ 83/ EC as amended in order to resolve divergences amongst the nationally authorised SPCs and thus to harmonise its divergent SPCs across the EU.
Minħabba d- deċiżjonijiet nazzjonali diverġenti meħudin minn Stati Membri fir- rigward ta ’ l- awtorizzazzjoni tal- prodotti msemmijin hawn fuq (u l- ismijiet assoċjati tagħhom), id- Danimarka nnotifikat lis- Segretarjat tas - CHMP/ EMEA b’ referenza uffiċjali skond l- Artikolu 30 tad- Direttiva 2001/ 83/ KE kif emendata sabiex jiġu solvuti diverġenzi fost SPCs awtorizzati fuq livell nazzjonali u b’ hekk biex jiġu armonizzati SPCs diverġenti tagħha fl- UE kollha.
Losartan is an orally active angiotensin II (Ang- II) receptor antagonist acting on the AT1 receptor subtype, thus blocking the effect of Ang-II in the renin angiotensin system (RAS) cascade.
Losartan huwa antagonist tar- riċettur angiotensin II (Ang - II) attiv oralment li jaħdem fuq is- sottotip ta ’ riċettur AT1, b’ hekk jimblokka l- effett ta ’ Ang- II fil- kaskata tas- sistema ta ’ renin angiotensin (RAS).
Hydrochlorothiazide (HCTZ) is a thiazide diuretic which has also been used as an antihypertensive agent.
Hydrochlorothiazide (HCTZ) huwa dijuretiku thiazide li intuża wkoll bħala mediċina kontra l - pressjoni għolja.
The diuretic action of HCTZ reduces plasma volume, with consequent increase in plasma renin activity, increase in adolsterone secretion, increase in urinary K+ and HCO-3 loss, and decrease in plasma K+.
L- azzjoni dijuretika ta ’ HCTZ tnaqqas il- volum tal- plażma, b’ żieda konsegwenti fl - attività ta ’ renin fil- plażma, żieda fit- tnixxija ta ’ aldosterone, żieda fit- telf mill- awrina ta ’ K+ u HCO - 3, u tnaqqis ta ’ K+ fil- plażma.
The main areas of disharmony of the existing Summary of Product Characteristics were section 4.1 Therapeutic Indications, section 4.3 Contraindications, and section 4.4 Special Warnings and Precautions for Use.
L- oqsma ewlenin ta ’ nuqqas ta ’ armonija tas- Sommarju tal- Karatteristiċi tal- Prodott eżistenti kienu sezzjoni 4. 1 Indikazzjonijiet Terapewtiċi, sezzjoni 4. 3 Kontra- indikazzjonijiet, u sezzjoni 4. 4 Twissijiet Speċjali u Prekawzjonijiet għall- Użu.
Therapeutic Indications (SPC section 4.1)
Indikazzjonijiet Terapewtiċi (SPC sezzjoni 4. 1)
- Treatment of essential hypertension in patients whose blood pressure is not adequately controlled on
- Kura ta ’ pressjoni għolja essenzjali f’ pazjenti li l- pressjoni tad- demm tagħhom mhijiex ikkontrollata
hydrochlorothiazide or losartan monotherapy The efficacy and safety are established for the indication “ treatment of essential hypertension in patients whose blood pressure is not adequately controlled on hydrochlorothiazide or losartan monotherapy”.
adegwatement b’ monoterapija ta ’ hydrochlorothiazide jew ta ’ losartan L- effikaċja u s- sigurtà huma stabbiliti għall- indikazzjoni “ kura ta ’ pressjoni għolja essenzjali f’ pazjenti li l- pressjoni tad- demm tagħhom mhijiex ikkontrollata adegwatement b’ monoterapija ta ’ hydrochlorothiazide jew ta ’ losartan ”.
Therefore the CHMP considered that this indication is acceptable.
Għaldaqstant, is- CHMP ikkunsidra li din hija indikazzjoni aċċettabbli.
- As First step treatment in patients with moderate to severe hypertension and in patients with high or
- Bħala kura ta ’ l- ewwel għażla f’ pazjenti bi pressjoni għolja moderata għal severa u f’ pazjenti
very high Left Ventricular Hypertrophy The CHMP concluded that the indication for the initial therapy of hypertension with the fixed dose combination (FDC) does not have a positive benefit-risk ratio, and therefore is not acceptable.
b’ Ipertrofija Ventrikolari Xellugija għolja jew għolja ħafna Is- CHMP ikkonkluda li l- indikazzjoni għat- terapija inizjali għal pressjoni għolja bil- kombinazzjoni ta ’ doża fissa (FDC) m’ għandhiex proporzjon benefiċċju- riskju pożittiv, u għaldaqstant mhijiex aċċettabbli.
The data available do not show that a first line therapy with the FDC is of advantage as compared to a stepwise approach within the approved indication.
It- tagħrif disponibbli ma jurix li terapija ta ’ l- ewwel għażla bl- FDC hija ta ’ vantaġġ meta mqabbla ma ’ approċċ pass pass fi ħdan l- indikazzjoni approvata.
There was no relevant difference in the number of patients with severe hypertension showing a relevant BP lowering effect during the first 4 weeks.
Ma kien hemm l- ebda differenza relevanti fin - numru ta ’ pazjenti bi pressjoni għolja severa li wriet effett ta ’ tnaqqis ta ’ BP matul l- ewwel 4 ġimgħat.
More than 50% of those patients reaching the target BP on the FDC within 4 weeks did not require a combination.
Aktar minn 50% ta ’ dawk il- pazjenti li laħqu l- mira BP fuq l- FDC fi żmien 4 ġimgħat ma kellhomx bżonn ta ’ kombinazzjoni.
These patients (9.4%) would have been over-treated on a FDC on a long term basis.
Dawn il- pazjenti (9. 4%) kien ikollhom kura eċċessiva fuq FDC fuq bażi fit - tul.
When compared to only 8.2% of patients that can reach target BP somewhat faster compared to a stepwise approach, the risk benefit ratio is negative both for patients with severe and for patients with mild to moderate hypertension.
Meta mqabbel ma ’ 8. 2% biss tal- pazjenti li jistgħu jilħqu l- mira BP kemmxejn aktar malajr meta mqabbla ma ’ approċċ pass pass, il- proporzjon bejn ir- riskju u l- benefiċċju huwa wieħed negattiv kemm għal pazjenti bi pressjoni għolja severa kif ukoll għal pazjenti bi pressjoni għolja ħafifa għal moderata.
As the MAH did not submit data to demonstrate a clear population that would benefit from the FDC with regards to cardiovascular outcome, the benefit/ risk of the indication in first line could be assessed and the indication is not warranted by the CHMP.
Minħabba li d- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq (MAH) ma ssottomettiex tagħrif biex juri popolazzjoni ċara li tista ’ tibbenifika mill- FDC fir- rigward ta ’ riżultat kardjovaskulari, il - benefiċċju/ riskju ta ’ l- indikazzjoni fl- ewwel għażla jista ’ jkun ivvalutat u l- indikazzjoni mhijiex awtorizzata mis- CHMP.
This is the indication currently proposed by the applicant and has been registered in 15 member states of the EU.
Waqt il- proċedura ta ’ referenza, il- MAH ippropona li tiġi emendata l- indikazzjoni li tissostitwixxi “ morbidità u mortalità kardjovaskulari ” b ’ “ attakk ta ’ puplesija ”.
The reason for this broader indication is that the LIFE study was not a placebo-controlled study, studying the effect on stroke only compared to placebo, but an actively controlled study, comparing a losartan based with an atenolol based antihypertensive treatment using a primary composite endpoint of CV death, stroke and MI.
Ir- raġuni għal din l- indikazzjoni iktar wiesgħa hija li l- istudju LIFE ma kienx studju kkontrollat bi plaċebo, li jistudja l - effett fuq attakk ta ’ puplesija biss meta mqabbel ma ’ plaċebo, iżda kien studju kkontrollat attivament, li qabbel kura kontra l- pressjoni għolja ibbażata fuq losartan ma ’ kura kontra l- pressjoni għolja ibbażata fuq atenolol permezz ta ’ l- użu ta ’ punt ta ’ tmiem primarju kompost ta ’ mewt KV, attakk ta ’ puplesija u MI.
This composite endpoint can be considered as representative for CV morbidity and mortality, and has translated into this indication in many medicinal products that have been discussed in the CHMP (e. g. statins).
Dan il- punt ta ’ tmiem kompost jista ’ jitqies rappreżentattiv għal morbidità u mortalità KV, u ġie tradott f’ din l- indikazzjoni f’ ħafna prodotti mediċinali li ġew diskussi fis- CHMP (per eżempju, statins).
At the time of the study, beta-blockade alone, or in combination with diuretics had shown to reduce rates of many CV events by 15-45%.
Fiż- żmien ta ’ l- istudju, imblokkar- beta waħdu, jew f’ kumbinazzjoni ma ’ dijuretiċi wera li jnaqqas ir - rati ta ’ ħafna episodji KV bi 15- 45%.
In the LIFE study an additional benefit was noted with regards to stroke for the losartan based strategy, and effects were similar with regard to MI and CV mortality, indicating that the demonstrated beneficial effect of beta-blockade on CV morbidity and mortality in general was also present for losartan.
Dan jindika li l- effett ta ’ benefiċċju muri ta ’ l- imblokkar- beta fuq il- morbidità u l - mortalità KV in ġenerali kien ukoll preżenti għal losartan.
Since then the beneficial effect of atenolol regarding CV morbidity and mortality has been questioned.
Minn dak iż- żmien ’ l hawn, l- effett ta ’ benefiċċju ta ’ atenolol fir- rigward tal- morbidità u tal- mortalità ġie ddubitat.
A recent review in the BMJ shows that specifically the preventive effect on stroke of atenolol is lower than for other antihypertensives; RR of 1.26 (95%CI:
Opinjoni reċenti fil- BMJ turi li l- effett preventiv ta ’ atenolol fuq l- attakk ta ’ puplesija huwa iktar baxx milli għal mediċini oħrajn kontra l- pressjoni għolja; RR ta ’ 1. 26 (95% CI:
1.15 to 1.38).
1. 15 sa 1. 38).
As a consequence the observed 25% risk reduction with losartan versus atenolol brings the protective effect of losartan on stroke in the same range as for other antihypertensives.
B’ konsegwenza ta ’ dan, it- tnaqqis fir- riskju osservat ta ’ 25% b’ losartan meta mqabbel ma ’ atenolol iġib l- effett protettiv ta ’ losartan fuq l- attakk ta ’ puplesija fl- istess medda ta ’ mediċini oħrajn kontra l- pressjoni għolja.
Therefore, whilst the proposed indication for losartan monotherapy was considered approvable after a majority vote by the CHMP plenum and is supported with the following wording: “ reduction of risk of stroke in hypertensive patients with left ventricular hypertrophy, documented by ECG”, the following considerations apply for the FDC:
Għaldaqstant, l- indikazzjoni proposta kienet ikkunsidrata approvabbli wara vot ta ’ maġġoranza mill - plenum tas- CHMP u hija appoġġjata bil- formolazzjoni li ġejja: “ tnaqqis ta ’ riskju ta ’ attakk ta ’ puplesija f’ pazjenti bi pressjoni għolja b’ ipertrofija ventrikolari xelluġija, iddokkumentata b’ ECG ”, il - kunsiderazzjonijiet li ġejjin japplikaw għall- FDC:
The CHMP was concerned that there is no evidence that supports each of the two substances in Cozaar Comp (losartan and HCTZ) having a documented contribution to the claimed indication as required by the The NfG on fixed dose combination products.
Is- CHMP kien imħasseb li ma hemm l- ebda evidenza li tappoġġja kull waħda miż- żewġ sustanzi f’ Cozaar Comp (losartan u HCTZ) billi kellu kontribuzzjoni ddokumentata għall- indikazzjoni kklejmjata kif meħtieġa mill- NfG fuq prodotti ta ’ kombinazzjoni ta ’ doża fissa.
In the losartan group 44% of the patients received HCTZ, in the atenolol group 38%.
Fil- grupp losartan 44% tal- pazjenti rċievew HCTZ, fil- grupp ta ’ atenolol 38%.
The MAH did not provide data showing that those patients receiving HCTZ had a clinical advantage with respect to clinical endpoints in comparison to those not receiving HCTZ.
Il- MAH ma pprovdiex tagħrif li juri li dawk il - pazjenti li jkunu qegħdin jirċievu HCTZ kellhom vantaġġ kliniku fir- rigward ta ’ punti ta ’ tmiem kliniċi meta mqabbla ma ’ dawk li ma jkunux qegħdin jirċievu HCTZ.
The MAH was asked to provide data on safety and efficacy for these subgroups of patients (Losartan, Atenolol, Losartan + HCTZ, Atenolol + HCTZ) in order to gain more insight into the contribution of HCTZ to the overall benefit risk ratio.
Il- MAH kien mitlub jipprovdi tagħrif fuq is- sigurtà u l- effikaċja għal dawn is- sottogruppi ta ’ pazjenti (Losartan, Atenolol, Losartan + HCTZ, Atenolol + HCTZ) sabiex jifhem aħjar il- kontribuzzjoni ta ’ HCTZ fir- rigward tal- proporzjon ta ’ benefiċċju riskju totali.
In addition, a prevention indication for HCTZ alone, based on the LIFE data is not considered approvable.
Barra minn hekk, indikazzjoni ta ’ prevenzjoni għal HCTZ waħdu, ibbażata fuq id- dejta LIFE mhijiex ikkunsidrata approvabbli.
Therefore, the CHMP considered that the benefit risk for the indication Reduction in risk of cardiovascular morbidity and mortality (or risk of stroke_) in hypertensive patients with left ventricular hypertrophy is negative and this indication is not acceptable for the FDC.
Għaldaqstant, is- CHMP ikkunsidra li l- benefiċċju riskju għall- indikazzjoni Tnaqqis fir- riskju ta ’ morbidità u mortalità kardjovaskulari (jew riskju ta ’ attakk ta ’ puplesija) f’ pazjenti bi pressjoni għolja b’ ipertrofija ventrikolari xellugija hija negattiva u din l- indikazzjoni mhijiex aċċettabbli għall- FDC.
Section 4.3 Contra-indications The CHMP considered that the following contra-indications should be included in the SPC in all MSs:
Sezzjoni 4. 3 Kontra- indikazzjonijiet Is- CHMP ikkunsidra li l- kontra- indikazzjonijiet li ġejjin għandhom ikunu inklużi fl- SPC fl- MSs kollha:
Severe renal impairment; Electrolyte disturbances such as hyponatremia, hypokalemia, hypercalcemia; Hyperuricaemia; Pregnancy and lactation; LAPP lactose deficiency; Liver insufficiency; Addison’ s disease.
Indeboliment sever tal- kliewi; Disturbi ta ’ l- elettroliti bħal ma huma iponatremija, ipokalemija, iperkalċemija; Iperuriċemija; Tqala u treddigħ; defiċjenza ta ’ lactose LAPP; Indeboliment tal- fwied; Marda ta ’ Addison.
Given that the paediatric worksharing group is still ongoing, a definite working can only be implemented with respect to studies in children and adolescents after the procedure is finalised.
Diment li l- grupp pedjatriku ta ’ qsim tax- xogħol għadu għaddej, ħidma definittiva tista ’ tkun implimentata biss fir- rigward ta ’ studji fi tfal u adolexxenti wara li l- proċedura tkun ġiet iffinalizzata.
Section 4.4 Special warnings and precautions for use:
16 Sezzjoni 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu:
The CHMP considered that the following warnings should be included in the SPC in all MSs:
Is- CHMP ikkunsidra li t- twissijiet li ġejjin ħtieġu li jkunu nklużi fl- SPC fl- Istati Membri kollha:
Haemodialysis; Black patients; Obstructive valvular disease; Surgery/ anaesthesia.
Emodijaliżi; Pazjenti suwed; Mard valvulari ostruttiv; Kirurġija/ anestesija.
Given that the paediatric worksharing group is still ongoing, a definite working can only be implemented with respecto to studies in children and adolescents after the procedure is finalised.
Diment li l- grupp pedjatriku ta ’ qsim tax- xogħol għadu għaddej, ħidma definittiva tista ’ tkun implimentata biss fir - rigward ta ’ studji fi tfal u adolexxenti wara li l- proċedura tkun ġiet iffinalizzata.
16 angiotensin II receptors antagonists (AIIRAs) and recommendations on the use during the first trimester of pregnancy (EMEA/ CHMP/ PhVWP/ 474692/ 2007).
Tqala u Treddigħ Is- CHMP qies li t- test li jikkonċerna t- tqala u t- treddigħ fl- SPC (sezzjonijiet 4. 3, 4. 4 u 4. 6) jeħtieġ li jiġi emendat biex jinkludi l- effett tar- rapport PhVWP fuq Impedituri ACE u fuq antagonisti tar - riċetturi angiotensin II (AIIRAs) u rakkomandazzjonijiet fuq l- użu waqt l- ewwel trimestru tat- tqala (EMEA/ CHMP/ PhVWP/ 474692/ 2007).
Pregnancy and Lactation should be contraindicated and the appropriate wording included in sections 4.3, 4.4 and 4.6 of the SPC, and the relevant sections of the Package Leaflet.
It- Tqala u Treddigħ għandhom ikunu kontraindikati u l - formolazzjoni addattata għandha tiġi inkluża fis- sezzjonijiet 4. 3, 4. 4 u 4. 6 ta ’ l- SPC, u fis- sezzjonijiet relevanti tal- Fuljett ta ’ Tagħrif.
GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
RAĠUNIJIET GĦAL EMENDA TAS- SOMMARJI TAL- KARATTERISTIĊI TAL - PRODOTT, TIKKETTA U FULJETT TA ’ TAGĦRIF
- The scope of the referral was the harmonisation of the Summaries of Products Characteristics,
- l- iskop tar- referenza kien l- armonizzazzjoni tas- Sommarji tal- Karatteristiċi tal- Prodott, tikketti u
labelling and package leaflet.
fuljetti ta ’ tagħrif.
- The Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing
- is- Sommarji tal- Karatteristiċi tal- Prodott, tikketti u fuljetti ta ’ tagħrif proposti mid- Detenturi ta ’ l -
Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee.
Awtorizzazzjoni għat- Tqegħid fis- Suq ġew ivvalutati abbażi tad- dokumentazzjoni sottomessa u d - diskussjoni xjentifika fi ħdan il- Kumitat,
indication:
indikazzjonijiet li ġejjin:
• Treatment of hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide.
Kura ta ’ pressjoni għolja f’ pazjenti li l- pressjoni tad- demm tagħhom mhijiex ikkontrollata adegwatement b’ losartan jew b’ hydrochlorothiazide.
- the CHMP concluded that the data are not supportive of the following indications and therefore they
- is- CHMP ikkonkluda li t- tagħrif mhuwiex ta ’ appoġġ għall- indikazzjonijiet li ġejjin u għaldaqstant
should be removed from the marketing authorisation:
għandu jitneħħa mill- awtorizzazzjoni għat- tqegħid fis- suq:
• as first step treatment in patients with moderate to severe hypertension and in patients with high or very high cardiovascular risk
bħala kura ta ’ l- ewwel għażla f’ pazjenti bi pressjoni għolja moderata sa severa u f’ pazjenti b’ riskju kardjovaskulari għoli jew għoli ħafna.
• Reduction of cardiovascular morbidity and mortality (or risk of stroke) in hypertensive patients with left ventricular hypertrophy.
tnaqqis fil- morbidità u mortalità kardjovaskulari (jew riskju ta ’ attakk ta ’ puplesija) f’ pazjenti bi pressjoni għolja b’ ipertrofija ventrikolari xellugija.
- Pregnancy and Lactation should be contraindicated and the appropriate wording included in sections
- It- Tqala u Treddigħ għandhom ikunu kontro- indikati u l- formolazzjoni addattata għandha tiġi inkluża
4.3, 4.4 and 4.6 of the SPC, and the relevant sections of the Package Leaflet.
f’ sezzjonijiet 4. 3, 4. 4 u 4. 6 tal- SPC, u fis- sezzjonijiet relevanti tal- Fuljett ta ’ Tagħrif.
the CHMP has recommended the amendment of the Marketing Authorisation(s) for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Cozaar Comp. and associated names (see Annex I).
Is- CHMP irrakkomanda l- emenda ta ’ l- Awtorizzazzjonijiet għat- Tqegħid fis- Suq, li s- Sommarju tal - Karatteristiċi tal- Prodott, tikketta u fuljett ta ’ tagħrif għalihom huma stabbiliti fl- Anness III għal Cozaar Comp. u l- ismijet assoċjati (ara l- Anness I).
SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT, TIKKETTA, FULJETT TA 'TAGĦRIF
Cozaar Comp and associated names (see Annex I) 50 mg/ 12.5 mg film-coated tablets Cozaar Comp and associated names (see Annex I) 100 mg/ 12.5 mg film-coated tablets Cozaar Comp and associated names (see Annex I) 100 mg/ 25 mg film-coated tablets
Cozaar Comp u ismijiet assoċjati (ara Anness I) 50 mg/ 12. 5 mg pilloli miksijin b’ rita Cozaar Comp u ismijiet assoċjati (ara Anness I) 100 mg/ 12. 5 mg pilloli miksijin b’ rita Cozaar Comp u ismijiet assoċjati (ara Anness I) 100 mg/ 25 mg pilloli miksijin b’ rita
[To be implemented nationally]
[Sabiex jiġi implimentat fil- pajjiż]
Cozaar Comp 50 mg/ 12.5 mg Each tablet contains 50 mg of losartan (as potassium salt) and 12.5 mg of hydrochlorothiazide (HCTZ) as the active ingredients.
Cozaar Comp 50 mg/ 12. 5 mg Kull pillola fiha 50 mg losartan (bħala mluħa ta ’ potassju) u 12. 5 mg hydrochlorothiazide (HCTZ) bħala s- sustanzi attivi.
Cozaar Comp 100 mg/ 12.5 mg Each tablet contains 100 mg of losartan (as potassium salt) and 12.5 mg of hydrochlorothiazide (HCTZ) as the active ingredients.
Cozaar Comp 100 mg/ 12. 5 mg Kull pillola fiha 100 mg losartan (bħala mluħa ta ’ potassju) u 12. 5 mg hydrochlorothiazide (HCTZ) bħala s- sustanzi attivi.
Cozaar Comp 100 mg/ 25 mg Each tablet contains 100 mg of losartan (as potassium salt) and 25 mg of hydrochlorothiazide (HCTZ) as the active ingredients.
Cozaar Comp 100 mg/ 25 mg Kull pillola fiha 100 mg losartan (bħala mluħa ta ’ potassju) u 25 mg hydrochlorothiazide (HCTZ) bħala s- sustanzi attivi.
Excipients Cozaar Comp 50 mg/ 12.5 mg Each tablet contains 63.13 mg lactose monohydrate.
Sustanza mhux attiva:
Cozaar Comp 100 mg/ 12.5 mg Each tablet contains 88.40 mg lactose monohydrate.
Cozaar Comp 50 mg/ 12. 5 mg Kull pillola 63. 13 mg lactose monohydrate.
Cozaar Comp 100 mg/ 25 mg Each tablet contains 126.26 mg lactose monohydrate.
Cozaar Comp 100 mg/ 12. 5 mg Kull pillola 88. 40 mg lactose monohydrate Cozaar Comp 100 mg/ 25 mg Kull pillola 126. 26 mg lactose monohydrate
[To be implemented nationally]
Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1 [Sabiex jiġi implimentat fil- pajjiż]
Film coated tablets
Pilloli miksijin b’ rita.
Cozaar Comp 50 mg/ 12.5 mg Yellow, oval film-coated tablets marked 717 on one side and plain or scored on the other.
Cozaar Comp 50 mg/ 12. 5 mg Pilloli miksijin b’ rita ta ’ lewn isfar u f’ għamla ovali u mmarkati b’ 717 fuq naħa waħda u b’ xaqq jew mingħajr xaqq fuq in- naħa l- oħra.
The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Ix- xaqq qiegħed hemm biss biex jiffaċilita il- qsim tal- pillola meta wieħed jiġi biex jibla ’ u mhux biex wieħed jaqsam f’ dożi ugwali.
Cozaar Comp 100 mg/ 12.5 mg White, oval film-coated tablets marked 745 on one side and plain on the other.
Cozaar Comp 100 mg/ 12. 5 mg Pilloli miksijin b’ rita ta ’ lewn abjad u f’ għamla ovali u mmarkati b’ 745 fuq naħa waħda u mingħajr xaqq fuq in- naħa l- oħra.
Cozaar Comp 100 mg/ 25 mg Light yellow, oval film-coated tablets marked 747 on one side and plain on the other.
Cozaar Comp 100 mg/ 25 mg Pilloli miksijin b’ rita ta ’ lewn isfar ċar f’ għamla ovali u mmarkati b’ 745 fuq naħa waħda u mingħajr marka fuq in- naħa l- oħra.
20 4.1 Therapeutic indications
4. 1 Indikazzjonijiet terapewtiċi
Cozaar Comp is indicated for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide alone.
Cozaar Comp huma indikati għat- trattament ta ’ pressjoni essenzjali għolja f’ pazjenti li l- pressjoni tad - demm tagħhom mhix ikontrollata sew b’ losartan jew b’ hydrochlorothiazide waħedhom.
Cozaar Comp may be administered with other antihypertensive agents.
Cozaar Comp jista ’ jingħata ma ’ mediċini oħra ta ’ kontra l- pressjoni għolja.
Cozaar Comp tablets should be swallowed with a glass of water Cozaar Comp may be administered with or without food.
Cozaar Comp jistgħu jittieħdu ma ’ l- ikel jew fuq stonku vojt.
Hypertension Losartan and hydrochlorothiazide is not for use as initial therapy, but in patients whose blood pressure is not adequately controlled by losartan potassium or hydrochlorothiazide alone.
Losartan u hydrochlorothiazide m’ għandhomx jintużaw bħala t- terapija inizjali, imma f’ pazjenti li l- pressjoni tad- demm tagħhom mhix ikkontrollata b’ mod adegwat b’ losartan potassium jew hydrochlorothiazide waħedhom.
Dose titration with the individual components (losartan and hydrochlorothiazide) is recommended.
Titrazzjoni tad- doża bil- komponenti individwali (losartan u hydrochlorothiazide) huwa rakkomandat.
When clinically appropriate direct change from monotherapy to the fixed combination may be considered in patients whose blood pressure is not adequately controlled.
Meta klinikament xieraq, bidla diretta mill- monoterapija għal kombinazzjoni fissa għandha tiġi kkonsidrata f’ pazjenti li l- pressjoni tad- demm tagħhom mhix kontrollata b’ mod adegwat.
The usual maintenance dose of Cozaar Comp is one tablet of Cozaar Comp 50 mg/ 12.5 mg (losartan 50 mg/ HCTZ 12.5 mg) once daily.
Id- doża inizjali u ta ’ manteniment ta ’ Cozaar Comp hi ta ’ pillola waħda ta ’ Cozaar Comp 50 mg/ 12. 5 mg (50 mg losartan/ 12. 5 mg HCTZ) darba kuljum.
For patients who do not respond adequately to Cozaar Comp 50 mg/ 12.5 mg, the dosage may be increased to one tablet of Cozaar Comp 100 mg/ 25 mg (losartan 100 mg/ HCTZ 25 mg) once daily.
Għal pazjenti li ma jirrispondux b’ mod adegwat għal Cozaar Comp 50 mg/ 12. 5 mg, id- doża tista ’ tiżdied għal pillola ta ’ Cozaar Comp 100 mg/ 25 mg (100 mg losartan/ 25 mg HCTZ) darba kuljum.
The maximum dose is one tablet of Cozaar Comp 100 mg/ 25 mg once daily.
Id- doża massima hi ta ’ pillola waħda ta ’ Cozaar Comp 100 mg/ 25 mg darba kuljum.
In general, the antihypertensive effect is attained within three to four weeks after initiation of therapy.
B’ mod ġenerali, l- effett mixtieq kontra l- pressjoni għolja jieħu tliet ġimgħat mill- bidu tat- terapija biex jintlaħaq.
Cozaar Comp 100/ 12.5 (losartan 100 mg/ HCTZ 12.5 mg) is available for those patients titrated to 100 mg of Cozaar Comp who require additional blood pressure control.
Cozaar Comp 100/ 12. 5 (100 mg losartan/ 12. 5 mg HCTZ) huwa disponibbli għal dawk il- pazjenti li ġew iddożati għal 100 mg ta ’ Cozaar li jeħtieġu kontroll addizzjonali għal pressjoni tad- demm tagħhom.
Use in patients with renal impairment and haemodialysis patients No initial dosage adjustment is necessary in patients with moderate renal impairment (i. e. creatinine clearance 30-50 ml/ min).
L- ebda aġġustament fid- doża mhu meħtieġ għal pazjenti li għandhom indeboliment renali moderat (i. e. tneħħija ta ’ kreatinina 30- 50 ml/ min).
Losartan and hydrochlorothiazide tablets are not recommended for haemodialysis patients.
Il- pilloli losartan u hydrochlorothiazide m’ humiex rakkomandati għal pazjenti b’ emodijaliżi.
Losartan/ HCTZ tablets must not be used in patients with severe renal impairment (i. e. creatinine clearance < 30 ml/ min) (see section 4.3).
Il- pilloli losartan/ HCTZ m’ għandhomx jintużaw f’ pazjenti b’ indeboliment renali sever (i. e. tneħħija ta ’ kreatinina < 30 ml/ min) (ara sezzjoni 4. 4).
Use in patients with intravascular volume depletion Volume and / or sodium depletion should be corrected prior to administration of Losartan/ HCTZ tablets.
Il- volum u / jew l- iżvojtar ta ’ sodju għandu jiġi kkoreġut qabel l- għoti ta ’ pilloli ta ’ losartan/ HCTZ.
Use in patients with hepatic impairment Losartan/ HCTZ is contraindicated in patients with severe hepatic impairment (see section 4.3.).
L- użu f’ pazjenti b’ indeboliment epatiku Losartan/ HCTZ huwa kontra- indikat f’ pazjenti li għandhom indeboliment epatiku sever (ara sezzjoni 4. 3).
Use in the elderly Dosage adjustment is not usually necessary for the elderly.
L- użu fl- anzjani Aġġustament fid- doża ġeneralment mhux meħtieġ fl- anzjani.
Use in children and adolescents (< 18 years) There is no experience in children and adolescents.
L- użu fi tfal u adoloxxenti (< 18- il sena) M’ hemmx esperjenza klinika fi tfal u adoloxxenti.
Therefore, losartan/ hydrochlorothiazide should not be administered to children and adolescents.
Għalhekk, losartan/ hydrochlorothiazide m’ għandux jiġi amministrat fi tfal u adoloxxenti.
• Hypersensitivity to losartan, sulphonamide-derived substances (as hydrochlorothiazide) or to any of the excipients • Therapy resistant hypokalaemia or hypercalcaemia • Severe hepatic impairment; Cholestasis and biliary obstructive disorders
• Sensittività eċċessiva għal losartan, sustanzi derivati minn sulphonamides (bħal hydrochlorothiazide) jew għal xi sustanzi mhux attivi
21 • Refractory hyponatraemia • Symtomatic hyperuricaemia/ gout • 2nd and 3rd trimester of pregnancy (see section 4.4 and 4.6) • Lactation (see section 4.6) • Severe renal impairment (i. e. creatinine clearance < 30 ml/ min) • Anuria
20 • Ipokalemja jew iperkalċemija reżistenti għat- terapija • Iponatremja rifrattorja • Iperuriċemija/ gotta rifrattorja • It- 2ni u t- 2et trimestru tat- tqala (ara sezzjonijiet 4. 4 u 4. 6) • Treddigħ (ara sezzjoni 4. 6) • Indeboliment renali sever (i. e tneħħija ta ’ kreatinina < 30 ml/ min) • Anurja.
Angiooedema Patients with a history of angiooedema (swelling of the face, lips, throat, and/ or tongue) should be closely monitored (see section 4.8).
Anġjodema Pazjenti bi storja ta ’ anġjodema (nefħa fil- wiċċ, ix- xofftejn, il- griżmejn, u / jew l- ilsien) għandhom jiġu monitorati mill- qrib (ara sezzjoni 4. 8).
Hypotension and Intravascular volume depletion Symptomatic hypotension, especially after the first dose, may occur in patients who are volume- and/ or sodium-depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Pressjoni sintomatika baxxa, speċjalment wara l- ewwel doża, tista ’ isseħħ f’ pazjenti li għandhom volum imnaqas u/ jew żvojtjar ta ’ sodju minħabba terapija dijuretika vigoruża, mluħa dijateteiċi restritti, dijarea jew remettar.
Such conditions should be corrected before the administration of Cozaar Comp tablets (see sections 4.2. and 4.3.).
Kundizzjonijiet bħal dawn għandhom jiġu kkoreġuti qabel l- għoti ta ’ pilloli ta ’ Cozaar Comp (ara sezzjonijiet 4. 2 u 4. 3).
Electrolyte imbalances Electrolyte imbalances are common in patients with renal impairment, with or without diabetes, and should be addressed.
Żbilanċi elettrolitiċi huma komuni f’ pazjenti b’ indebolient renali, bi jew mingħajr dijabete, u għandhom jiġi indirizzati.
Therefore, the plasma concentrations of potassium and creatinine clearance values should be closely monitored; especially patients with heart failure and a creatinine clearance between 30-50 ml/ min should be closely monitored.
Għalhekk, il- valuri tal- konċentrazzjonijiet ta ’ potassju u tat- tneħħija ta ’ kreatinina fil- plażma għandhom jiġu sorvelljati mill- qrib; speċjalment f’ pazjenti b’ insuffiċjenza kardijaka u bi tneħħija ta ’ kreatinina ta ’ bejn 30- 50 ml/ min.
The concomitant use of potassium sparing diuretics, potassium supplements and potassium containing salt substitutes with losartan/ hydrochlorothiazide is not recommended (see section 4.5).
L- użu konġunt ta ’ dijuretiċi li ma jinkoraġixxux it- teħid ta ’ potassju, supplimenti ta ’ potassju u sostituti mluħa li fihom il- potassju ma ’ losartan mhumiex rakkomandati (ara sezzjoni 4. 5)
Liver function impairment Based on pharmacokinetic data which demonstrate significantly increased plasma concentrations of losartan in cirrhotic patients, Cozaar Comp should be used with caution in patients with a history of mild to moderate hepatic impairment.
Minn tagħrif farmakokinetiku li juri konċentrazzjonijiet sinifikament ogħla fil- plażma ta ’ losartan f’ pazjenti b’ ċirrosi, Cozaar Comp għandu jintuża b’ kawtela f’ pazjenti li għandhom storja ta ’ indeboliment epatiku minn ħafif sa moderat.
There is no therapeutic experience with losartan in patients with severe hepatic impairment.
M’ hemmx esperjenza terpewtika b’ losartan f’ pazjenti b’ indeboliment epatiku sever.
Therefore Cozaar Comp is contraindicated in patients with severe hepatic impairment (see sections 4.2, 4.3 and 5.2).
Għalhekk Cozaar Comp huwa kontra- indikat f’ pazjenti b’ indeboliment epatiku sever (ara sezzjonijiet 4. 2, 4. 3 u 5. 2).
Renal function impairment As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function, including renal failure, have been reported (in particular, in patients whose renal function is dependent on the renin-angiotensin-aldosterone system, such as those with severe cardiac insufficiency or pre-existing renal dysfunction).
Bħala konsegwenza ta ’ l- impediment tas- sistema renin- angiotensin, bidliet fil- funzjoni renali li jinkludi insuffiċjenza renali ġew irrapportati (b’ mod partikolari f’ pazjenti li l- funzjoni renali tagħhom tiddependi fuq is- sistema ta ’ renin angiotensin aldosterone bħal dawk li għandhom insuffiċjenza kardijaka severa jew disturbi fil- funzjonament renali li kienu jeżistu minn qabel).
As with other drugs that affect the renin-angiotensin-aldosterone system, increases in blood urea and serum creatinine have also been reported in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney; these changes in renal function may be reversible upon discontinuation of therapy.
Dawn il- bidliet fil- funzjoni renali jistgħu jkunu riversibbli mal- waqfien tat- terapija.
Losartan should be used with caution in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney.
Losartan għandu jintuża b’ kawtela f’ pazjenti li għandhom stenosi bilaterali ta ’ l- arterja renali jew stenosi ta ’ l- arterja għal kilwa waħda.
Renal transplantation There is no experience in patients with recent kidney transplantation.
Trapjant tal- kliewi Għad mhemmx esperjenza f’ pazjenti li kellhom trapjant tal- kliewi riċenti.
Primary hyperaldosteronism Patients with primary aldosteronism generally will not respond to antihypertensive drugs acting through inhibition of the renin-angiotensin system.
Iperaldosteroniżmu primarju Pazjenti b’ aldosteroniżmu primarju ġeneralment mhux ser jirrispondu għal mediċini ta ’ kontra l- pressjoni li jaġixxu b’ impediment fuq is- sistema renin- angiotensin.
Therefore, the use of Cozaar Comp tablets is not recommended.
Għalhekk, it- teħid ta ’ pilloli ta ’ Cozaar Comp mhuwiex rakkomandat.
22 As with any antihypertensive agents, excessive blood pressure decrease in patients with ischaemic cardiovascular and cerebrovascular disease could result in a myocardial infarction or stroke.
21 Mard tal- qalb koronarju u mard ċerebrovaskulari Bħal fil- każ ta ’ mediċini ta ’ kontra l- pressjoni oħra, tnaqqis fil- pressjoni ta ’ demm eċċessiva f’ pazjenti b’ mard kardjovaskulari u ċerebrovaskulari iskaemiku jistgħu jirriżultaw f’ infart mijokardikjaku jew puplesija.
In patients with heart failure, with or without renal impairment, there is - as with other drugs acting on the renin-angiotensin system - a risk of severe arterial hypotension, and (often acute) renal impairment.
F’ pazjenti li għandhom insuffiċjenza tal- qalb, bi jew mingħajr indeboliment renali - bħal fil- każ ta ’ mediċini oħra li jaħdmu fuq is- sistema renin- angiotensin - hemm riskju ta ’ pressjoni baxxa fl- arterji severa, u indeboliment renali (ta ’ spiss akuta).
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyophathy As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Bħal fil- każ ta ’ vażodilaturi oħra, kawtela speċjali hija indikata f’ pazjenti li jbatu minn stenosi aortika jew mitrali jew kardjomijopatija ipertrofika ostruttiva.
Ethnic differences As observed for angiotensin converting enzyme inhibitors, losartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non- blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population.
Kif kien osservat għal impedituri ta ’ enżimi li jikkonvertu angiotensin, losartan u l- antagonisti oħra ta ’ angiotensin jidhru li huma inqas effettivi biex ibaxxu l- pressjoni għolja f’ persuni suwed milli f’ persuni mhux suwed, possibilment minħabba l- prevalenza ogħla ta ’ stati baxxi ta ’ renin fil- popolazzjoni sewda li tbati bi pressjoni għolja
Pregnancy Cozaar Comp should not be initiated during pregnancy.
Tqala Cozaar Comp m’ għandux jinbeda waqt it- tqala.
Unless continued Losartan/ HTCZ therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Għajr meta t- tkomplija ta ’ t- terapija b’ losartan/ HTCZ hija kkonsidrata essenzjali, pazjenti li qegħdin jippjanaw tqala għandhom jinqelbu fuq terapija alternattiva ta ’ kontra l- pressjoni għolja li għandha profil tas- sigurtà stabilit għal użu fi tqala.
When pregnancy is diagnosed, treatment with Cozaar Comp should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Meta tqala tiġi dijanjonizzata, it- trattament b’ Cozaar Comp għandu jitwaqqaf immedjatament, u jekk jixraq, terapija alternattiva għandha tinbeda (ara sezzjonijiet 4. 3 u 4. 6).
Hypotension and electrolyte/ fluid imbalance As with all antihypertensive therapy, symptomatic hypotension may occur in some patients.
Pressjoni baxxa u l- iżbilanċ ta ’ l- elettroliti/ fluwidu Bħal fil- każijiet kollha ta ’ terapija għal pressjoni għolja, il- pressjoni sintomatika baxxa tista ’ sseħħ f’ xi pazjenti.
Patients should be observed for clinical signs of fluid or electrolyte imbalance, e. g., volume depletion, hyponatremia, hypochloremic alkalosis, hypomagnesemia or hypokalemia which may occur during intercurrent diarrhea or vomiting.
Il- pazjenti għandhom jiġu osservati għal sinjali kliniċi ta ’ żbilanċ fil- fluwidu jew elettroliti, e. g., żvojtar ta ’ volum, iponatremja, alkalosi ipokloremika, ipomagnesemja jew ipokalemja li jistgħu jseħħu fl- istess waqt ta ’ dijarea jew rimettar.
Periodic determination of serum electrolytes should be performed at appropriate intervals in such patients.
Determinazzjoni perijodika ta ’ l- elettroliti fis- serum għandhom isiru f’ intervalli xierqa f’ xi pazjenti.
Dilutional hyponatraemia may occur in oedematous patients in hot weather.
F’ temp sħun jista ’ jkun hemm dilwazzjoni ta ’ iponatremja dilwita f’ pazjenti b’ edema
Metabolic and endocrine effects Thiazide therapy may impair glucose tolerance.
Effetti metaboliċi u endokrinali It- terapija b’ thiazides tista ’ timpedixxi t- tolleranza għal glukosju.
Dosage adjustment of antidiabetic agents, including insulin, may be required (see section 4.5).
Għandu mnejn ikun meħtieġ aġġustament fid- doża tal- mediċini ta ’ kontra d- dijabete (ara sezzjoni 4. 5).
Latent diabetes mellitus may become manifest during thiazide therapy.
Dijabete melittus mistura tista ’ tiġi manifestata waqt terapija b’ thiazides.
Thiazides may decrease urinary calcium excretion and may cause intermittent and slight elevation of serum calcium.
Thiazides għandhom mnejn inaqqsu l- eliminazzjoni awrinarja tal- kalċju u jistgħu jikkaġunaw il- kalċju fis- serum jogħla b’ mod għaddien.
Marked hypercalcemia may be evidence of hidden hyperparathyroidism.
Iperkalċemja notevoli tista ’ tkun xhieda ta ’ iperparatajrojdiżmu mistur.
Thiazides should be discontinued before carrying out tests for parathyroid function.
Thiazides għandhom jiġu mwaqqfa qabel ma jsiru testijiet għal funzjoni tal- paratajrojd.
Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy.
Żidied fil- livelli ta ’ kolesterol u trigliċeridi jistgħu jkunu assoċjati ma ’ terapija dijuretika ta ’ thiazides.
Thiazide therapy may precipitate hyperuricemia and/ or gout in certain patients.
It- terapija b’ thiazide tista ’ tippreċipita l- iperuriċemija u/ jew il- gotta f’ ċertu pazjenti.
Because losartan decreases uric acid, losartan in combination with hydrochlorothiazide attenuates the diuretic- induced hyperuricemia.
Peress li losartan inaqqas l- aċidu uriku, losartan flimkien ma ’ hydrochlorothiazide jimmodera l- iperuriċemija sensitizzata bid- dijuretiku.
Hepatic impairment Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, as it may cause intrahepatic cholestasis, and since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
It- thiazides għandhom jintużaw b’ kawtela f’ pazjenti b’ funzjoni epatika indebolita jew mard tal- fwied progressiv, peress li bidliet żgħar fil- bilanċ ta ’ fluwidi u elettroliti jistgħu jippreċipitaw f’ koma
Cozaar Comp is contraindicated for patients with severe hepatic impairment (see section 4.3 and 5.2).
Cozaar Comp mhux rakkomandat għal pazjenti li għandhom indeboliment epatiku sever (ara sezzjoni jiet 4. 3 u 5. 2).
23 Other In patients receiving thiazides, hypersensitivity reactions may occur with or without a history of allergy or bronchial asthma.
Oħrajn F’ pazjenti li qed jirċievu thiazides, reazzjonijiet ta ’ sensittività eċċessiva jistgħu jseħħu f’ pazjenti bi jew mingħajr storja ta ’ allerġija jew ażma bronkjali.
Exacerbation or activation of systemic lupus erythematosus has been reported with the use of thiazides.
It- tħarrix jew l- attivazzjoni ta ’ lupus eritematosi sistematika ġie rapportat bl- użu ta ’ thiazides.
Excipient Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine (see section 6.1).
(Ara sezzjoni 6. 1).
Rifampicin and fluconazole have been reported to reduce levels of active metabolite.
Rifampicin u fluconazole ġew rapportati li jnaqqsu l- livell tal- metabolit attiv.
The clinical consequences of these interactions have not been evaluated.
Il- konsegwenzi kliniċi ta ’ dawn l- effetti ma ġewx evalwati.
As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (e. g., spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium.
Bħal fil- każ ta ’ mediċini oħra li jimpedixxu angiotensin II jew l- effetti tiegħu, l- użu fl- istess ħin ta ’ mediċini oħra li jiristrinġu t- tnixxija ta ’ potassju (eż. spironolactone, triamteren, amiloride,) supplimenti tal- potassju jew sostituti ta ’ l- imluħa li fihom il- potassju jistgħu jwasslu għal żieda tal- potassju fis- serum.
Co-medication is not advisable.
L- għoti ta ’ mediċini bħal dawn mhux rakkomandat.
As with other medicines which affect the excretion of sodium, lithium excretion may be reduced.
Bħal mediċini oħra li jaffettwaw l- eliminazzjoni ta ’ sodju, l- eleiminazzjoni ta ’ litju jista ’ jitnaqqas.
Therefore, serum lithium levels should be monitored carefully if lithium salts are to be co- administered with angiotensin II receptor antagonists.
Għalhekk livelli ta ’ litju fis- serum għandhom jiġu monitorati bir- reqqa jekk mluħa tal- litju jingħataw flimkien ma ’ riċettaturi antagonisti ta ’ angiotensin II.
When angiotensin II antagonists are administered simultaneously with NSAIDs (i. e. selective COX-2 inhibitors, acetylsalicylic acid at anti-inflammatory doses) and non-selective NSAIDs, attenuation of the antihypertensive effect may occur.
Meta antagonisti ta ’ angiotensin II jiġu amministrati b’ mod simultaneju ma ’ NSAIDs (i. e. impedituri silettivi ta ’ COX- 2, acetylsalicylic acid f’ dożi ta ’ kontra l- infjammazzjoni) u NSAIDs mhux silettivi, jista ’ jkun hemm attenwazzjoni ta ’ l- effett kontra l- pressjoni għolja.
Concomitant use of angiotensin II antagonists or diuretics and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function.
F’ pazjenti li kellhom disturbi renali batuti li kienu jeżistu minn qabel, l- għoti flimkien ta ’ antagonisti ta ’ angiotensin II jew dijuretiċi u NSAIDs jistgħu jwasslu sabiex il- funzjoni renali tmur għall- agħar, inkluż il- possibilità ta ’ insuffiċjenza renali, u żieda fil- livell ta ’ potassju fis- serum.
The combination should be administered with caution, especially in the elderly.
Il- kombinazzjoni għandha tingħata b’ kawtela, speċjalment fl- anzjani.
Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter.
Il- pazjenti għandhom ikunu idrati sew u konsiderazzjoni għandha tingħata għal monitoraġġ tal- funzjoni renali wara l- bidu tat- terapija konkomitanti, u perijodikament wara dan.
In some patients with compromised renal function who are being treated with non-steroidal anti- inflammatory drugs, including selective cyclooxygenase-2 inhibitors, the co-administration of angiotensin II receptor antagonists may result in a further deterioration of renal function.
F’ xi pazjenti bil- funzjoni tal- kliewi kompromessa li qed jiġu trattati wkoll b’ mediċini mhux sterojdi ta ’ kontra l- infjammazzjoni, li jinkludu impedituri cyclooxygenase- 2 silettivi, l- amministrazzjoni flimkien ta ’ antagonisti għar- riċettaturi ta ’ angiotensin II jista ’ jirriżulta f’ deterjorazzjoni akbar fil - funzjoni renali.
These effects are usually reversible.
Dawn l- effetti huma ġeneralment riversibbli.
Other substances inducing hypotension like tricyclic antidepressants, antipsychotics, baclofene, amifostine:
Sustanzi oħra li jissensitizzaw l- pressjoni baxxa bħal mediċini kontra d- dipressjoni triċikliċi, antipsikotiċi, baclofene, amifostine.
Concomitant use with these drugs that lower blood pressure, as main or side-effect, may increase the risk of hypotension.
Użu konkomitanti ma ’ dawn il- mediċini li jnaqqsu l- pressjoni tad- demm, bħala l- effett prinċipali jew l- effett kollaterali jistgħu jżidu r- riskju għal pressjoni baxxa.
When given concurrently, the following drugs may interact with thiazide diuretics:
Meta jingħata flimkien ma ’ mediċini oħra, il- mediċini li ġejjin jistgħu jaffettwaw id- dijuretiċi ta ’ thiazide:
Alcohol, barbiturates, narcotics or antidepressants:
Alkoħol, barbiturati, narkotiċi jew mediċini ta ’ kontra d- dipressjoni:
Potentiation of orthostatic hypotension may occur.
23 Jista ’ jkun hemm riskju akbar ta ’ ipotensjoni ortostatika.
Antidiabetic drugs (oral agents and insulin):
Mediċini kontra d- dijabete (mediċini orali u insulina):
The treatment with a thiazide may influence the glucose tolerance.
It- trattament b’ dożi għoljin ta ’ thiazides jistgħu jinfluwenza t- tolleranza ta ’ glukosju.
Dosage adjustment of the antidiabetic drug may be required.
Għandu mnejn ikun meħtieġ aġġustament fid- doża tal- mediċina ta ’ kontra d- dijabete.
Metformin should be used with caution because of the risk of lactic acidosis induced by possible functional renal failure linked to hydrochlorothiazide.
Metformin għandu jintuża b’ kawtela minħabba r- riskju ta ’ aċidosi lattika sensitizzata bil- possibilità ta ’ insuffiċjenza renali funzjonali marbuta ma ’ hydrochlorothiazide.
24 Other antihypertensive drugs Additive effect.
Effett addittiv.
Cholestyramine and colestipol resins:
Reżini ta ’ cholestyramine u colestipol:
Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins.
L- assorbiment ta ’ hydrochlorothiazide jiġi impedut fil- preżenza ta ’ reżini ta ’ skambju anijoniċi.
Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85 and 43 percent, respectively.
Dożi waħdanin jew ta ’ reżini ta ’ cholestyramine jew ta ’ colestipol jintrabtu ma ’ hydrochlorothiazide u jnaqqsu l- assorbiment mill- passaġġ gastro- intestinali b’ madwar 85 u 43 fil- mija, rispettivament.
Corticosteroids, ACTH Intensified electrolyte depletion, particularly hypokalemia.
Kortikosterojdi, ACTH Żvojtjar elettrolitiku intensifikat, partikolarment ipokalemja.
Pressor amines (e. g., adrenaline) Possible decreased response to pressor amines but not sufficient to preclude their use.
Amini pressors (eż., adrenalina) Possibiltà ta ’ rispons imnaqqas għal amini pressor imma mhux biżżejjed biex jevita l- użu tagħhom.
Skeletal muscle relaxants, nondepolarizing (e. g., tubocurarine) Possible increased responsiveness to the muscle relaxant.
Sustanzi li jirrilassaw il- muskoli skeletriċi, mhux depolarizzanti (eż. tubocurarine) Rispons possibilment ogħla għas- sustanza li tirrilassa l- muskolu.
Lithium Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity; concomitant use is not recommended.
Litju Mhux rakkomandat l- użu konġunt ta ’ mediċini dijuretiċi li jnaqqsu t- tneħħija renali ta ’ litju u jgħollu r- riskju ta ’ tossiċità ta ’ litju.
Medicinal products used in the treatment of gout (probenecid, sulfinpyrazone and allopurinol) Dosage adjustment of uricosuric medicinal products may be necessary since hydrochlorothiazide may raise the level of serum uric acid.
Prodotti mediċinali użati fit- trattament ta ’ gotta (probenecid, sulfinpyrazone u allopurinol) Aġġustament fid- doża ta ’ prodotti mediċinali urikosuriċi jista ’ jkun meħtieġ peress li hydrochlorothiazide jista ’ jgħolli l- livell ta ’ l- aċidu uriku fis- serum.
Increase in dosage of probenecid or sulfinpyrazone may be necessary.
Żieda fid- doża ta ’ probenecid jew sulfinpyrazone jista ’ jkun meħtieġ.