qanastek/EMEA-V3 huggingface dataset:
Patients with high blood pressure The usual dose is 150 mg once a day (two tablets a day).
92 Id- doża normali hija 150 mg darba kuljum (żewġ pilloli kuljum).
The dose may later be increased to 300 mg (four tablets a day) once daily depending on blood pressure response.
Iktar tard, id- doża tista ’ tiżdied għal 300 mg (erba ’ pilloli kuljum) darba kuljum jiddependi fuq l- effett fuq il- pressjoni.
89 Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
Pazjenti bi pressjoni tad- demm għolja u b' dijabete ta 'tip 2 b’ mard tal- kliewi F’ pazjenti bi pressjoni tad- demm għolja u b’ dijabete ta ’ tip 2, 300 mg (erba ’ pilloli kuljum) hija id- doża ta ’ manteniment ippreferuta għall- kura assoċjata ma ’ mard tal- kliewi.
The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.
It- tabib jista ’ jirrikmanda doża inqas, speċjalment meta tinbeda il- kura f’ ċertu pazjenti bħal dawk fuq l- emodijalisi, u dawk ’ il fuq minn 75 sena.
The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.
L- effett massimu biex tinżel il- pressjoni tad- demm għandu jintlaħaq 4- 6 ġimgħat wara li tinbeda l - kura.
If you take more Irbesartan BMS than you should If you accidentally take too many tablets, contact your doctor immediately.
Jekk tieħu Irbesartan BMS aktar milli suppost Jekk aċċidentalment tieħu ħafna pilloli, ikkuntattja mill- ewwel lit- tabib tiegħek.
If a child swallows some tablets, contact your doctor immediately.
It- tfal ma għandhomx jieħdu Irbesartan BMS Irbesartan BMS ma għandux jingħata lil tfal ta ’ taħt it- 18- il sena. jekk tifel/ tifla jibla/ tibla xi pilloli, ikkuntattja mill- ewwel lit- tabib tiegħek.
If you forget to take Irbesartan BMS If you accidentally miss a daily dose, just take the next dose as normal.
Jekk tinsa tieħu Irbesartan BMS Jekk aċċidentalment taqbeż id- doża tal- ġurnata, ħu id- doża li jmiss bħas- soltu.
Do not take a double dose to make up for a forgotten dose.
M' għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
Like all medicines, Irbesartan BMS can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Irbesartan BMS jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Some of these effects may be serious and may require medical attention.
Xi wħud minn dawn l- effetti jistgħu jkunu serji u jista ’ jkollhom bżonn ta 'attenzjoni medika.
As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/ or tongue have been reported in patients taking irbesartan.
Bħal b’ mediċini simili, każijiet rari ta ’ reazzjonijiet allerġiċi għall- ġilda (raxx, utrikarja), kif ukoll nefħa lokalizzata tal- wiċċ, xofftejn u/ jew ilsien ġew irrapportati f’ pazjenti li jieħdu irbesartan.
If you get any of these symptoms or get short of breath, stop taking Irbesartan BMS and contact your doctor immediately.
Jekk ikollok kwalunkwe sintomu minn dawn li ġejjin jew inkella ssofri minn qtugħ ta ’ nifs, tiħux aktar Irbesartan BMS u kkuntattja lit- tabib tiegħek minnufih.
The frequency of the side effects listed below is defined using the following convention:
Il- frekwenza ta ’ l- effetti sekondarji elenkati hawn isfel hija definita bl- użu tal- konvenzjoni li ġejja:
Very common: at least 1 in 10 patients or more Common: at least 1 in 100 and less than 1 in 10 patients Uncommon: at least 1 in 1000 and less than 1 in 100 patients
Komuni ħafna: talanqas 1 minn kull 10 pazjenti jew aktar Komuni: talanqas 1 minn kull 100 pazjent u anqas minn 1 minn kull 10 pazjenti Mhux komuni: talanqas 1 minn kull 1000 pazjent u anqas minn 1 minn kull 100 pazjent
Side effects reported in clinical studies for patients treated with Irbesartan BMS were:
L- effetti sekondarji rrappurtati fl- istudji kliniċi għall- pazjenti kkurati b’ Irbesartan BMS kienu:
Very common: if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.
Komuni ħafna: jekk issofri minn pressjoni għolja tad- demm u minn dijabete ta ’ tip 2 b’ mard tal - kliewi, testijiet tad- demm jistgħu juru livell ogħla ta ’ potassju.
Common: dizziness, feeling sick/ vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme).
Komuni: sturdament, dardir/ rimettar u għeja u testijiet tad- demm jistgħu juru livelli ogħla ta ’ enzim li jkejjel il- funzjoni tal- muskolu u tal- qalb (enzim ta ’ creatine kinase).
In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.
F’ pazjenti bi pressjoni għolja tad- demm u b’ dijabete ta ’ tip 2 b’ mard tal- kliewi, kienu rrappurtati wkoll sturdament speċjalment meta tqum minn pożizzjoni mimduda jew bil- qiegħda, pressjoni baxxa tad- demm meta tqum minn pożizzjoni mimduda jew bil- qiegħda u wġigħ fil- ġogi jew fil - muskoli u livelli mnaqqsin ta ’ proteina fiċ- ċelloli tad- demm ħomor (emoglobina).
Uncommon: heart rate increased, flushing, cough, diarrhoea, indigestion/ heartburn, sexual dysfunction (problems with sexual performance), chest pain.
Mhux komuni: taħbit tal- qalb aktar mgħaġġel, fwawar, sogħla, dijarea, indiġestjoni/ qrusa fl - istonku, disfunzjoni sesswali (problemi fl- attività sesswali), uġigħ fis- sider.
Some undesirable effects have been reported since marketing of Irbesartan BMS but the frequency for them to occur is not known.
93 Xi effetti sekondarji ġew irrappurtati minn mindu Irbesartan BMS tqiegħed fis- suq iżda l- frekwenza li jseħħu biha mhix magħrufa.
These undesirable effects are: headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, abnormal liver function, increased blood potassium levels, impaired kidney function, and inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis).
Dawn l- effetti mhux mixtieqa huma: uġigħ ta 'ras, disturbi fit- togħma, żarżir fil- widnejn, bugħawwieġ, uġigħ fil- ġogi u fil- muskoli, funzjoni tal- fwied anormali, livelli għoljin ta ’ potassium fid- demm, funzjoni tal- kliewi indebolita, u infjammazzjoni tal- vini ż- żgħar li taffettwa l- ġilda (kundizzjoni magħrufa bħala leukocytoclastic vasculitis).
90 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE IRBESARTAN BMS
KIF TAĦŻEN IRBESARTAN BMS
Do not use Irbesartan BMS after the expiry date which is stated on the carton and on the blister after EXP.
Tużax Irbesartan BMS wara d- data ta ’ skadenza li tidher fuq il- kartuna u fuq il- folja wara JIS.
Do not store above 30°C.
Taħżinx f’ temperatura ’ il fuq minn 30°C.
What Irbesartan BMS contains The active substance is irbesartan.
X' fih Irbesartan BMS Is- sustanza attiva hi irbesartan.
Each tablet of Irbesartan BMS 75 mg contains 75 mg irbesartan.
Kull pillola ta ’ Irbesartan BMS 75 mg fiha 75 mg ta ’ irbesartan.
The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, and poloxamer 188.
Is- sustanzi l- oħra huma microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, u poloxamer 188.
What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.
Id- dehra ta ’ Irbesartan BMS u l- kontenuti tal- pakkett Il- pilloli Irbesartan BMS 75 mg huma bojod għal offwajt, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb stampata fuq naħa waħda u n- numru 2771 imnaqqax fuq in- naħa l- oħra.
Irbesartan BMS 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Irbesartan BMS 75 mg jinstabu f’ pakketti f’ folji ta ’ 14, 28, 56 jew 98 pillola.
Unidose blister packs of 56 x 1 tablet for delivery in hospitals are also available.
Pakketti ta ’ folji ta ’ 56 x 1 pilloli ta ’ doża waħda huma disponibbli wkoll għall- użu fl- isptarijiet.
Marketing Authorisation Holder:
Id- detentur ta 'l- awtorizzazzjoni għat- tqegħid fis- suq:
SANOFI WINTHROP INDUSTRIE 1, rue de la Vierge Ambarès & Lagrave F-33565 Carbon Blanc Cedex - France
SANOFI WINTHROP INDUSTRIE 1, rue de la Vierge Ambarès & Lagrave F- 33565 Carbon Blanc Cedex - Franza
SANOFI WINTHROP INDUSTRIE 30-36 Avenue Gustave Eiffel, BP 7166 F-37071 Tours Cedex 2 - France
94 SANOFI WINTHROP INDUSTRIE 30- 36 Avenue Gustave Eiffel, BP 7166 F- 37071 Tours Cedex 2 - Franza
91 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
95 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta 'l- Aġenzija Ewropea dwar il - mediċini (EMEA) http: // www. emea. europa. eu /
93 PACKAGE LEAFLET:
97 FULJETT TA 'TAGĦRIF:
INFORMATION FOR THE USER Irbesartan BMS 150 mg tablets irbesartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Irbesartan BMS 150 mg pilloli irbesartan
94 Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Patients with high blood pressure The usual dose is 150 mg once a day.
99 Id- doża normali hija 150 mg darba kuljum.
The dose may later be increased to 300 mg (two tablets a day) once daily depending on blood pressure response.
Iktar tard, id- doża tista ’ tiżdied għal 300 mg (żewġ pilloli kuljum) darba kuljum jiddependi fuq l- effett fuq il- pressjoni.
95 Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (two tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
Pazjenti bi pressjoni tad- demm għolja u b' dijabete ta 'tip 2 b’ mard tal- kliewi F’ pazjenti bi pressjoni tad- demm għolja u b’ dijabete ta ’ tip 2, 300 mg (żewġ pilloli kuljum) hija id- doża ta ’ manteniment ippreferuta għall- kura assoċjata ma ’ mard tal- kliewi.
Some undesirable effects have been reported since marketing of Irbesartan BMS but the frequency for them to occur is not known.
100 Xi effetti sekondarji ġew irrappurtati minn mindu Irbesartan BMS tqiegħed fis- suq iżda l- frekwenza li jseħħu biha mhix magħrufa.
96 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
Each tablet of Irbesartan BMS 150 mg contains 150 mg irbesartan.
Kull pillola ta ’ Irbesartan BMS 150 mg fiha 150 mg ta ’ irbesartan.
What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 150 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2772 engraved on the other side.
Id- dehra ta ’ Irbesartan BMS u l- kontenuti tal- pakkett Il- pilloli Irbesartan BMS 150 mg huma bojod għal offwajt, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb stampata fuq naħa waħda u n- numru 2772 imnaqqax fuq in- naħa l- oħra.
Irbesartan BMS 150 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Irbesartan BMS 150 mg jinstabu f’ pakketti f’ folji ta ’ 14, 28, 56 jew 98 pillola.
SANOFI WINTHROP INDUSTRIE 30-36 Avenue Gustave Eiffel, BP 7166 F-37071 Tours Cedex 2 - France
101 SANOFI WINTHROP INDUSTRIE 30- 36 Avenue Gustave Eiffel, BP 7166 F- 37071 Tours Cedex 2 - Franza
98 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
102 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
100 PACKAGE LEAFLET:
104 FULJETT TA 'TAGĦRIF:
INFORMATION FOR THE USER Irbesartan BMS 300 mg tablets irbesartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Irbesartan BMS 300 mg pilloli irbesartan
101 Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Patients with high blood pressure The usual dose is 150 mg once a day.
106 Id- doża normali hija 150 mg darba kuljum.
The dose may later be increased to 300 mg once daily depending on blood pressure response.
Iktar tard, id- doża tista ’ tiżdied għal 300 mg darba kuljum jiddependi fuq l- effett fuq il- pressjoni.
102 Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease.
Pazjenti bi pressjoni tad- demm għolja u b' dijabete ta 'tip 2 b’ mard tal- kliewi F’ pazjenti bi pressjoni tad- demm għolja u b’ dijabete ta ’ tip 2, 300 mg hija id- doża ta ’ manteniment ippreferuta għall- kura assoċjata ma ’ mard tal- kliewi.
Some undesirable effects have been reported since marketing of Irbesartan BMS but the frequency for them to occur is not known.
107 Xi effetti sekondarji ġew irrappurtati minn mindu Irbesartan BMS tqiegħed fis- suq iżda l- frekwenza li jseħħu biha mhix magħrufa.
103 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
Each tablet of Irbesartan BMS 300 mg contains 300 mg irbesartan.
Kull pillola ta ’ Irbesartan BMS 300 mg fiha 300 mg ta ’ irbesartan.
What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 300 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2773 engraved on the other side.
Id- dehra ta ’ Irbesartan BMS u l- kontenuti tal- pakkett Il- pilloli Irbesartan BMS 300 mg huma bojod għal offwajt, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb stampata fuq naħa waħda u n- numru 2773 imnaqqax fuq in- naħa l- oħra.
Irbesartan BMS 300 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Irbesartan BMS 300 mg jinstabu f’ pakketti f’ folji ta ’ 14, 28, 56 jew 98 pillola.
SANOFI WINTHROP INDUSTRIE 30-36 Avenue Gustave Eiffel, BP 7166 F-37071 Tours Cedex 2 - France
108 SANOFI WINTHROP INDUSTRIE 30- 36 Avenue Gustave Eiffel, BP 7166 F- 37071 Tours Cedex 2 - Franza
105 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
109 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
107 PACKAGE LEAFLET:
111 FULJETT TA 'TAGĦRIF:
INFORMATION FOR THE USER Irbesartan BMS 75 mg film-coated tablets irbesartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Irbesartan BMS 75 mg pilloli miksijin b’ rita irbesartan
108 Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Irbesartan BMS is unlikely to affect your ability to drive or use machines.
Sewqan u tħaddim ta ’ magni Mhux mistenni li Irbesartan BMS itellfek milli issuq jew tħaddem magni.
Patients with high blood pressure The usual dose is 150 mg once a day (two tablets a day).
113 Id- doża normali hija 150 mg darba kuljum (żewġ pilloli kuljum).
109 Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
Pazjenti bi pressjoni tad- demm għolja u b' dijabete ta 'tip 2 b’ mard tal- kliewi F’ pazjenti bi pressjoni tad- demm għolja u b’ dijabete ta ’ tip 2, 300 mg (erba ’ pilloli kuljum) hija id- doża ta ’ manteniment ippreferuta għall- kura assoċjata ma ’ mard tal- kliewi.
If you accidentally take too many tablets, contact your doctor immediately.
Jekk tieħu Irbesartan BMS aktar milli suppost Jekk aċċidentalment tieħu ħafna pilloli, ikkuntattja mill- ewwel lit- tabib tiegħek.
If you accidentally miss a daily dose, just take the next dose as normal.
Jekk tinsa tieħu Irbesartan BMS Jekk aċċidentalment taqbeż id- doża tal- ġurnata, ħu id- doża li jmiss bħas- soltu.
Some undesirable effects have been reported since marketing of Irbesartan BMS but the frequency for them to occur is not known.
114 Xi effetti sekondarji ġew irrappurtati minn mindu Irbesartan BMS tqiegħed fis- suq iżda l- frekwenza li jseħħu biha mhix magħrufa.
110 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax.
Is- sustanzi l- oħra huma lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax.
What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 75 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2871 engraved on the other side.
Id- dehra ta ’ Irbesartan BMS u l- kontenuti tal- pakkett Il- pilloli Irbesartan BMS 75 mg huma bojod għal offwajt, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb stampata fuq naħa waħda u n- numru 2871 imnaqqax fuq in- naħa l- oħra.
Irbesartan BMS 75 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 film- coated tablets.
Irbesartan BMS 75 mg miksijin b’ rita jinstabu f’ pakketti f’ folji ta ’ 14, 28, 56, 84 jew 98 pillola miksija b’ rita.
Unidose blister packs of 56 x 1 film-coated tablet for delivery in hospitals are also available.
Pakketti ta ’ folji ta ’ 56 x 1 pilloli ta ’ doża waħda huma disponibbli wkoll għall- użu fl- isptarijiet.
SANOFI WINTHROP INDUSTRIE 30-36 Avenue Gustave Eiffel, BP 7166 F-37071 Tours Cedex 2 - France
115 SANOFI WINTHROP INDUSTRIE 30- 36 Avenue Gustave Eiffel, BP 7166 F- 37071 Tours Cedex 2 - Franza
111 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
116 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
113 PACKAGE LEAFLET:
118 FULJETT TA 'TAGĦRIF:
INFORMATION FOR THE USER Irbesartan BMS 150 mg film-coated tablets irbesartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Irbesartan BMS 150 mg pilloli miksijin b’ rita irbesartan
114 Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Patients with high blood pressure The usual dose is 150 mg once a day.
120 Id- doża normali hija 150 mg darba kuljum.
115 Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (two tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
Pazjenti bi pressjoni tad- demm għolja u b' dijabete ta 'tip 2 b’ mard tal- kliewi F’ pazjenti bi pressjoni tad- demm għolja u b’ dijabete ta ’ tip 2, 300 mg (żewġ pilloli kuljum) hija id- doża ta ’ manteniment ippreferuta għall- kura assoċjata ma ’ mard tal- kliewi.
Some undesirable effects have been reported since marketing of Irbesartan BMS but the frequency for them to occur is not known.
121 Xi effetti sekondarji ġew irrappurtati minn mindu Irbesartan BMS tqiegħed fis- suq iżda l- frekwenza li jseħħu biha mhix magħrufa.
116 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 150 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2872 engraved on the other side.
Id- dehra ta ’ Irbesartan BMS u l- kontenuti tal- pakkett Il- pilloli Irbesartan BMS 150 mg huma bojod għal offwajt, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb stampata fuq naħa waħda u n- numru 2872 imnaqqax fuq in- naħa l- oħra.
Irbesartan BMS 150 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 film- coated tablets.
Irbesartan BMS 150 mg miksijin b’ rita jinstabu f’ pakketti f’ folji ta ’ 14, 28, 56, 84 jew 98 pillola miksija b’ rita.
Unidose blister packs of 56 x 1 film-coated tablet for delivery in hospitals are also available.
Pakketti ta ’ folji ta ’ 56 x 1 pilloli ta ’ doża waħda huma disponibbli wkoll għall- użu fl - isptarijiet.
SANOFI SYNTHELABO LIMITED Edgefield Avenue - Fawdon Newcastle Upon Tyne, Tyne & Wear NE3 3TT - United Kingdom
122 SANOFI SYNTHELABO LIMITED Edgefield Avenue - Fawdon Newcastle Upon Tyne, Tyne & Wear NE3 3TT - Ir- Renju Unit
SANOFI WINTHROP INDUSTRIE 30-36 Avenue Gustave Eiffel, BP 7166 F-37071 Tours Cedex 2 - France
SANOFI WINTHROP INDUSTRIE 30- 36 Avenue Gustave Eiffel, BP 7166 F- 37071 Tours Cedex 2 - Franza
118 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
123 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
120 PACKAGE LEAFLET:
125 FULJETT TA 'TAGĦRIF:
INFORMATION FOR THE USER Irbesartan BMS 300 mg film-coated tablets irbesartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Irbesartan BMS 300 mg pilloli miksijin b’ rita irbesartan
121 Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Patients with high blood pressure The usual dose is 150 mg once a day.
127 Id- doża normali hija 150 mg darba kuljum.
122 Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease.
Pazjenti bi pressjoni tad- demm għolja u b' dijabete ta 'tip 2 b’ mard tal- kliewi F’ pazjenti bi pressjoni tad- demm għolja u b’ dijabete ta ’ tip 2, 300 mg hija id- doża ta ’ manteniment ippreferuta għall- kura assoċjata ma ’ mard tal- kliewi.
Some undesirable effects have been reported since marketing of Irbesartan BMS but the frequency for them to occur is not known.
128 Xi effetti sekondarji ġew irrappurtati minn mindu Irbesartan BMS tqiegħed fis- suq iżda l- frekwenza li jseħħu biha mhix magħrufa.
123 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 300 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2873 engraved on the other side.
Id- dehra ta ’ Irbesartan BMS u l- kontenuti tal- pakkett Il- pilloli Irbesartan BMS 300 mg huma bojod għal offwajt, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb stampata fuq naħa waħda u n- numru 2873 imnaqqax fuq in- naħa l- oħra.
Irbesartan BMS 300 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 film- coated tablets.
Irbesartan BMS 300 mg miksijin b’ rita jinstabu f’ pakketti f’ folji ta ’ 14, 28, 56, 84 jew 98 pillola miksija b’ rita.
SANOFI SYNTHELABO LIMITED Edgefield Avenue - Fawdon Newcastle Upon Tyne, Tyne & Wear NE3 3TT - United Kingdom
129 SANOFI SYNTHELABO LIMITED Edgefield Avenue - Fawdon Newcastle Upon Tyne, Tyne & Wear NE3 3TT - Ir- Renju Unit
125 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
130 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
What is Irbesartan Hydrochlorothiazide BMS?
X' inhu Irbesartan Hydrochlorothiazide BMS?
Irbesartan Hydrochlorothiazide BMS is a medicine that contains two active substances, irbesartan and hydrochlorothiazide.
Irbesartan Hydrochlorothiazide BMS huwa mediċina li fiha żewġ sustanzi attivi, irbesartan u l - idroklorotijażide (hydrochlorothiazide).
It is available as oval tablets (peach:
Huwa disponibbli f' pilloli ovali (lewn il- ħawħ:
150 mg or 300 mg irbesartan and 12.5 mg hydrochlorothiazide; pink:
150 mg jew 300 mg irbesartan u 12. 5 mg idroklorotijażide; roża:
300 mg irbesartan and 25 mg hydrochlorothiazide).
300 mg irbesartan u 25 mg idroklorotijażide).
This medicine is the same as Karvezide, which is already authorised in the European Union (EU).
Din il- mediċina hija l- istess bħal Karvezide, li hija diġà awtorizzata fl- Unjoni Ewropea (UE).
The company that makes Karvezide has agreed that its scientific data can be used for Irbesartan Hydrochlorothiazide BMS.
Il - kumpanija li tipproduċi Karvezide qablet li t- tagħrif xjentifiku tagħha jista 'jintuża għal Irbesartan Hydrochlorothiazide BMS.
What is Irbesartan Hydrochlorothiazide BMS used for?
Għal xiex jintuża Irbesartan Hydrochlorothiazide BMS?
Irbesartan Hydrochlorothiazide BMS is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled on irbesartan or hydrochlorothiazide alone. ‘ Essential ’ means that the high blood pressure is not caused by any other condition.
Irbesartan Hydrochlorothiazide BMS jintuża f' pazjenti li għandhom ipertensjoni essenzjali (pressjoni tad- demm għolja) li mhijiex ikkontrollata adegwatament b' irbesartan jew bl- idroklorotijażide meħudin waħedhom.
Irbesartan Hydrochlorothiazide BMS has not been tested in patients below 18 years of age.
'Essenzjali' tfisser li l- pressjoni għolja ma tkunx ikkawżata minn xi kundizzjoni oħra.
How is Irbesartan Hydrochlorothiazide BMS used?
Kif jintuża Irbesartan Hydrochlorothiazide BMS?
Irbesartan Hydrochlorothiazide BMS is taken by mouth, with or without food.
Irbesartan Hydrochlorothiazide BMS jittieħed b' mod orali, anki fuq stonku vojt.
The dose of Irbesartan Hydrochlorothiazide BMS to be used depends on the dose of irbesartan or hydrochlorothiazide that the patient was taking before.
Id- doża ta 'Irbesartan Hydrochlorothiazide BMS li għandha tintuża tiddependi mid- doża ta' irbesartan jew ta 'idroklorotijażide li l- pazjent kien qiegħed jieħu qabel.
Doses higher than 300 mg irbesartan and 25 mg hydrochlorothiazide once a day are not recommended.
Mhuwiex rakkomandat dożaġġ ogħla minn 300 mg irbesartan jew 25 mg idroklorotijażide darba kuljum.
Irbesartan Hydrochlorothiazide BMS may be added to other treatments for hypertension.
Irbesartan Hydrochlorothiazide BMS jista 'jintuża flimkien ma' trattamenti għall- ipertensjoni.
How does Irbesartan Hydrochlorothiazide BMS work?
Kif jaħdem Irbesartan Hydrochlorothiazide BMS?
Irbesartan Hydrochlorothiazide BMS contains two active substances, irbesartan and hydrochlorothiazide.
Irbesartan Hydrochlorothiazide BMS fih żewġ sustanzi attivi, irbesartan u l- idroklorotijażide.
Irbesartan is an ‘ angiotensin II receptor antagonist’, which means that it blocks the action of a hormone in the body called angiotensin II.
Irbesartan hu tip ta '' antagonist tar- riċetturi ta 'l- anġjotensina II' li tfisser li jimblokka l- azzjoni ta 'l - ormon fil- ġisem imsejjaħ anġjotensina II.
By blocking the receptors to which angiotensin II normally attaches, irbesartan stops the hormone having an effect, allowing the blood vessels to widen.
Billi jimblokka r- riċetturi li magħhom l- anġjotensina II teħel normalment, irbesartan iwaqqaf l- ormon milli jkollu effett, b' hekk iħalli l- arterji u l- vini jitwessgħu.
Hydrochlorothiazide is a diuretic, which is another type of treatment for hypertension.
L- idroklorotijażide huwa dijuretiku, tip ieħor ta 'trattament għall- ipertensjoni.
It works by increasing urine output, reducing the amount of fluid in the blood and lowering the blood pressure.
Jaħdem billi jżid il - kwantità ta 'awrina li toħroġ mill- ġisem, inaqqas l- ammont ta' fluwidu fid- demm u jbaxxi l- pressjoni tad- demm.
The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone.
Il- kombinazzjoni taż- żewġ sustanzi attivi għandha effett ta 'żieda fit- tnaqqis tal- pressjoni tad- demm aktar minn waħda miż- żewġ mediċini waħedhom.
By lowering the blood pressure, the risk of damage caused by high blood pressure, such as having a stroke, is reduced.
Bit- tnaqqis tal- pressjoni tad- demm, jitnaqqas ir - riskju ta 'ħsara kkawżat minn pressjoni tad- demm għolja, bħal puplesija.
How has Irbesartan Hydrochlorothiazide BMS been studied?
Kif ġie studjat Irbesartan Hydrochlorothiazide BMS?
Irbesartan on its own has been approved in the EU since 1997 under the names Karvea and Aprovel.
Irbesartan waħdu ilu approvat fl- UE bl- ismijiet ta 'Karvea u Aprovel mill- 1997.
It can be used with hydrochlorothiazide to treat hypertension.
Jista 'jintuża flimkien ma' l- idroklorotijażide għat- trattament ta 'l- ipertensjoni.
The studies of Karvea/ Aprovel used with hydrochlorothiazide as separate tablets were used to support the use of Irbesartan Hydrochlorothiazide BMS.
Bħala appoġġ għall- użu ta 'Irbesartan Hydrochlorothiazide BMS, intużaw l- istudji mwettqa fuq Karvea/ Aprovel flimkien ma' l - idroklorotijażide f' pilloli separati.
Further studies were also carried out with doses of 300 mg irbesartan in combination with 25 mg hydrochlorothiazide.
Twettqu wkoll aktar studji b' dożaġġ ta '300 mg irbesartan f' kombinazzjoni ma' 25 mg idroklorotijażide.
The main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).
Il- kejl ewlieni ta 'l- effikaċja kien it- tnaqqis tal- pressjoni tad- demm dijastolika (pressjoni tad- demm mkejla bejn żewġ taħbitiet tal- qalb).
What benefit has Irbesartan Hydrochlorothiazide BMS shown during the studies?
X' benefiċċji wera Irbesartan Hydrochlorothiazide BMS waqt l- istudji mwettqa?
Irbesartan Hydrochlorothiazide BMS was more effective than placebo (a dummy treatment) and than hydrochlorothiazide alone in reducing diastolic blood pressure.
Irbesartan Hydrochlorothiazide BMS irriżulta aktar effikaċi mill- plaċebo (trattament finta) u mill - idroklorotijażide meħudin waħedhom fit- tnaqqis tal- pressjoni tad- demm dijastolika.
Increasing the dose to 300 mg irbesartan and 25 mg hydrochlorothiazide may give a further decrease in blood pressure.
Żieda fid- dożaġġ għal 300 mg irbesartan u 25 mg idroklorotijażide jista 'jwassal għal tnaqqis ulterjuri fil- pressjoni tad - demm.
What is the risk associated with Irbesartan Hydrochlorothiazide BMS?
X' inhuma r- riskji assoċjati ma 'Irbesartan Hydrochlorothiazide BMS?
The most common side effects with Irbesartan Hydrochlorothiazide BMS (seen in between 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, abnormal urination, fatigue (tiredness), and increases in blood urea nitrogen (BUN, a breakdown product of protein), creatinine (a breakdown product of muscle) and creatine kinase (an enzyme found in muscle).
L- effetti sekondarji l- aktar komuni b' Irbesartan Hydrochlorothiazide BMS (li dehru f' bejn pazjent 1 u 10 minn 100) huma sturdament, nawżea (dardir) jew remettar, disturbi urinarji, għeja kbira u żieda fil - livelli tan- nitroġenu urejku tad- demm (blood urea nitrogen, BUN, prodott ta 'skart mill- proteini), tal - kreatinina (prodott ta' skart mill- muskoli) u kreatina kinażi (creatine kinase, enzima li tinsab fil - muskoli).
For the full list of all side effects reported with Irbesartan Hydrochlorothiazide BMS, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrappurtati b' Irbesartan Hydrochlorothiazide BMS, ara l- Fuljett ta' Tagħrif.
Irbesartan Hydrochlorothiazide BMS should not be used in people who may be hypersensitive (allergic) to irbesartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients.
Irbesartan Hydrochlorothiazide BMS ma għandux jintuża f' persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal irbesartan, għall- idroklorotijażide, għas- sulfonamidi, jew għal kwalunkwe ingredjent ieħor.
Irbesartan Hydrochlorothiazide BMS should also not be used in patients who have severe liver, kidney or bile problems, blood potassium levels that are too low or blood calcium levels that are too high.
Irbesartan Hydrochlorothiazide BMS ma għandux jintuża wkoll minn pazjenti li jbatu minn problemi gravi fil - fwied, kliewi jew problemi biljari, persuni li jkollhom livelli wisq baxxi ta 'potassju fid- demm, jew livelli wisq għoljin ta' kalċju fid- demm.
Care must be taken when using Irbesartan Hydrochlorothiazide BMS with other medicines that have an effect on blood potassium levels.
Irbesartan Hydrochlorothiazide BMS għandu jintuża b' kawtela meta użat ma 'mediċini oħra li jkollhom effett fuq il- livelli ta' potassju fid- demm.
The full list of these medicines is given in the Package Leaflet.
Il- lista sħiħa ta 'dawn il- mediċini hija disponibbli fil- Fuljett ta' Tagħrif.
Why has Irbesartan Hydrochlorothiazide BMS been approved?
Għaliex ġie approvat Irbesartan Hydrochlorothiazide BMS?
The Committee for Medicinal Products for Human Use (CHMP) decided that Irbesartan Hydrochlorothiazide BMS’ s benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Irbesartan Hydrochlorothiazide BMS huma ogħla mir- riskji tiegħu fit- trattament ta' l- ipertensjoni essenzjali f' pazjenti li l- pressjoni tad- demm tagħhom ma tkunx ikkontrollata adegwatament b' irbesartan jew bl- idroklorotijażide meħudin waħedhom.
The Committee recommended that Irbesartan Hydrochlorothiazide BMS be given marketing authorisation.
Il- Kumitat irrakkomanda li Irbesartan Hydrochlorothiazide BMS jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Irbesartan Hydrochlorothiazide BMS:
Aktar tagħrif dwar Irbesartan Hydrochlorothiazide BMS:
The European Commission granted a marketing authorisation valid throughout the EU for Irbesartan Hydrochlorothiazide BMS to Bristol-Myers Squibb Pharma EEIG on 19 January 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- UE kollha għal Irbesartan Hydrochlorothiazide BMS lil Bristol- Myers Squibb Pharma EEIG fid- 19 ta 'Jannar 2007.
The full EPAR for Irbesartan Hydrochlorothiazide BMS is available here.
L- EPAR sħiħ għal Irbesartan Hydrochlorothiazide BMS jista 'jiġi kkonsultat hawn.
Irbesartan Hydrochlorothiazide BMS 150 mg/ 12.5 mg tablets.
Irbesartan Hydrochlorothiazide BMS 150 mg/ 12. 5 mg pilloli.
26.65 mg of lactose monohydrate per tablet.
26. 65 mg ta ’ lactose (bħala monohydrate) kull pillola.
This fixed dose combination is indicated in patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone (see section 5.1).
Din id- doża fissa kombinata hija indikata f’ pazjenti li għandhom pressjoni għolja li mhiex kontrollata sew b ’ irbesartan jew b ’ hydrochlorothiazide waħidhom (ara sezzjoni 5. 1).
Irbesartan Hydrochlorothiazide BMS can be taken once daily, with or without food.
Irbesartan Hydrochlorothiazide BMS jista ’ jittieħed darba kuljum, ma ’ l- ikel jew waħdu.
Irbesartan Hydrochlorothiazide BMS 150 mg/ 12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone; Irbesartan Hydrochlorothiazide BMS 300 mg/ 12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Irbesartan Hydrochlorothiazide BMS 150 mg/ 12.5 mg.
Irbesartan Hydrochlorothiazide BMS 150 mg/ 12. 5 mg jista ’ jingħata f ’ pazjenti, fejn il- pressjoni mhix qed tiġi kkontrollata sew b’ hydrochlorothiazide jew irbesartan 150 mg waħidhom; Irbesartan Hydrochlorothiazide BMS 300 mg/ 12. 5 mg jista ’ jingħata lill- pazjenti li mhux qed ikunu kkontrollati b’ mod suffiċjenti b’ irbesartan 300 mg jew b’ Irbesartan Hydrochlorothiazide BMS 150 mg/ 12. 5 mg.
Irbesartan Hydrochlorothiazide BMS 300 mg/ 25 mg may be administered in patients insufficiently controlled by Irbesartan Hydrochlorothiazide BMS 300 mg/ 12.5 mg.
Irbesartan Hydrochlorothiazide BMS 300 mg/ 25 mg jista ’ jingħata lil pazjenti li ma jkunux qed jiġu kkontrollati b’ mod suffiċjenti b’ Irbesartan Hydrochlorothiazide BMS 300 mg/ 12. 5 mg.
When necessary, Irbesartan Hydrochlorothiazide BMS may be administered with another antihypertensive medicinal product (see section 4.5).
Meta neċessarju, Irbesartan Hydrochlorothiazide BMS jista jingħata ma ’ prodott mediċinali ieħor kontra l- pressjoni għolja (ara sezzjoni 4. 5).
Renal impairment: due to the hydrochlorothiazide component, Irbesartan Hydrochlorothiazide BMS is not recommended for patients with severe renal dysfunction (creatinine clearance < 30 ml/ min).
Indeboliment renali: minħabba li fih il- komponent ta ’ hydrochlorothiazide, Irbesartan Hydrochlorothiazide BMS mhux irrikmandat għall- pazjenti b’ disfunzjoni renali severa (tneħħija tal - krejatinina < 30 ml/ min).
Intravascular volume depletion: volume and/ or sodium depletion should be corrected prior to administration of Irbesartan Hydrochlorothiazide BMS.
Tnaqqis fil- volum intravaskulari: tnaqqis ta ’ volum u/ jew ta ’ sodium, għandhom jiġu ikkoreġuti qabel ma ’ jingħata Irbesartan Hydrochlorothiazide BMS.
2 Hepatic impairment:
2 Indeboliment epatiku:
Irbesartan Hydrochlorothiazide BMS is not indicated in patients with severe hepatic impairment.
Irbesartan Hydrochlorothiazide BMS mhux indikat f’ pazjenti b’ indeboliment epatiku sever.
No dosage adjustment of Irbesartan Hydrochlorothiazide BMS is necessary in patients with mild to moderate hepatic impairment (see section 4.3).
M’ hemmx bżonn aġġustar fid- doża ta ’ Irbesartan Hydrochlorothiazide BMS f’ pazjenti b’ indeboliment epatiku minn ħafif sa moderat (ara sezzjoni 4. 3).
Elderly patients: no dosage adjustment of Irbesartan Hydrochlorothiazide BMS is necessary in elderly patients.
Pazjenti anzjani: m’ hemmx bżonn aġġustar fid- doża ta ’ Irbesartan Hydrochlorothiazide BMS f’ pazjenti anzjani.
Children and adolescents: there is no experience in children and adolescents.
Tfal u adoloxxenti: m’ hemmx esperjenza fit- tfal u l- adoloxxenti.
Hypersensitivity to the active substances, to any of the excipients (see section 6.1), or to other sulfonamide-derived substances (hydrochlorothiazide is a sulfonamide-derived substance).
Sensittività eċċessiva għas- sustanzi attivi, għal xi sustanzi mhux attivi (ara sezzjoni 6. 1) jew għal xi sustanzi oħra derivati minn sulfonamide (hydrochlorothiazide hija sustanza derivata minn sulfonamide).
Severe renal impairment (creatinine clearance < 30 ml/ min), Refractory hypokalaemia, hypercalcaemia, Severe hepatic impairment, biliary cirrhosis and cholestasis.
Indeboliment renali sever (tneħħija tal- krejatinina < 30 ml/ min), Ipokalimja rifrattorja, iperkalċimja, Indeboliment epatiku sever, ċirrożi biljari u kolestażi.
Irbesartan Hydrochlorothiazide BMS has been rarely associated with symptomatic hypotension in hypertensive patients without other risk factors for hypotension.
Irbesartan Hydrochlorothiazide BMS kien rarament assoċjat ma ’ pressjoni baxxa sintomatika f’ pazjenti bi pressjoni għolja mingħajr fatturi ta ’ riskju oħra għall- pressjoni baxxa.
Such conditions should be corrected before initiating therapy with Irbesartan Hydrochlorothiazide BMS.
Dawn il- kondizzjonijiet għandhom jiġu korretti qabel tinbeda il- kura b’ Irbesartan Hydrochlorothiazide BMS.
While this is not documented with Irbesartan Hydrochlorothiazide BMS, a similar effect should be anticipated.
Għalkemm m’ hemm xejn dokumentat li dan isir b’ Irbesartan Hydrochlorothiazide BMS, effetti simili għandhom ikunu mistennija.
Renal impairment and kidney transplantation: when Irbesartan Hydrochlorothiazide BMS is used in patients with impaired renal function, a periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
Indeboliment renali u trapjant tal- kliewi: meta Irbesartan Hydrochlorothiazide BMS jintuża f’ pazjenti b’ indeboliment tal- funzjoni renali, hija rrikmandata osservazzjoni perjodika tal- livelli tal- potassium fis- serum, tal- krejatinina u tal- uric acid.
There is no experience regarding the administration of Irbesartan Hydrochlorothiazide BMS in patients with a recent kidney transplantation.
M’ hemmx esperjenza meta Irbesartan Hydrochlorothiazide BMS jingħata lill- pazjenti li riċentament kellhom trapjant tal- kliewi.
Irbesartan Hydrochlorothiazide BMS should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/ min) (see section 4.3).
Irbesartan Hydrochlorothiazide BMS m’ għandux jintuża f’ pazjenti b’ indeboliment renali sever (tneħħija tal- krejatinina < 30 ml/ min) (ara sezzjoni 4. 3).
Thiazide diuretic-associated azotemia may occur in patients with impaired renal function.
Pazjenti b’ indeboliment tal- funzjoni renali jista ’ jkollhom ażotemija assoċjata mad - dijuretiku thiazide.
There is no clinical experience with Irbesartan Hydrochlorothiazide BMS in patients with hepatic impairment.
Għad m’ hemmx esperjenza klinika b’ Irbesartan Hydrochlorothiazide BMS f’ pazjenti b’ indeboliment epatiku.
3 Primary aldosteronism: patients with primary aldosteronism generally will not respond to anti- hypertensive medicinal products acting through inhibition of the renin-angiotensin system.
3 Aldosteroniżmu primarju: pazjenti b’ aldosteroniżmu primarju ġeneralment ma jirrispondux għall - prodotti mediċinali ta ’ kontra l- pressjoni li jaħdmu billi jinpedixxu s- sistema tar- renin- angiotensin.
Therefore, the use of Irbesartan Hydrochlorothiazide BMS is not recommended.
Għalhekk, mhux irrikmandat l- użu ta ’ Irbesartan Hydrochlorothiazide BMS.
Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy; however at the 12.5 mg dose contained in Irbesartan Hydrochlorothiazide BMS, minimal or no effects were reported.
Żidiet fil- livelli tal- kolesterol u tat- trigliċeridi ġew assoċjati mat- terapija dijuretika thiazide; madankollu b’ doża ta ’ 12. 5 mg ta ’ Irbesartan Hydrochlorothiazide BMS, l- effetti li ġew irrapportati kienu minimi jew xejn.
Hyperuricaemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy.
Tista ’ sseħħ iperuriċemija jew tiħrax gotta ċara f’ xi pazjenti li jirċievu it- terapija thiazide.
Conversely, due to the irbesartan component of Irbesartan Hydrochlorothiazide BMS hyperkalaemia might occur, especially in the presence of renal impairment and/ or heart failure, and diabetes mellitus.
Għal kuntrarju, minħabba li Irbesartan Hydrochlorothiazide BMS fih irbesartan, jista jkun hemm iperkalimja speċjalment fil - preżenza ta ’ indeboliment renali u/ jew insuffiċenza tal- qalb u dijabete.
Potassium-sparing diuretics, potassium supplements or potassium-containing salts substitutes should be co-administered cautiously with Irbesartan Hydrochlorothiazide BMS (see section 4.5).
Id- dijuretiċi li ma jnaqqsux il- potassium, supplimenti tal- potassium jew sostituti li fihom il- potassium għandhom jingħataw b’ attenzjoni flimkien ma ’ Irbesartan Hydrochlorothiazide BMS (ara sezzjoni 4. 5).
Lithium: the combination of lithium and Irbesartan Hydrochlorothiazide BMS is not recommended (see section 4.5).
Lithium: mhux irrikmandat l- użu flimkien ta ’ lithium u Irbesartan Hydrochlorothiazide BMS (ara sezzjoni 4. 5).
4 Pregnancy:
4 Tqala:
Lactose: this product contains lactose.
Lactose: dan il- prodott fih il- lactose.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għall - galactose, id- defiċjenza ta ’ Lapp lactase jew assorbiment ħażin tal- glucose- galactose m’ għandhomx jieħdu dan il- prodott mediċinali.
Other antihypertensive agents: the antihypertensive effect of Irbesartan Hydrochlorothiazide BMS may be increased with the concomitant use of other antihypertensive agents.
Mediċini oħra kontra l- pressjoni għolja: l- effett ta ’ Irbesartan Hydrochlorothiazide BMS kontra l - pressjoni għolja jista ’ jiżdied meta jingħata flimkien ma ’ mediċini oħra ta ’ kontra l- pressjoni għolja.
Furthermore, renal clearance of lithium is reduced by thiazides so the risk of lithium toxicity could be increased with Irbesartan Hydrochlorothiazide BMS.
U wkoll, tneħħija renali ta ’ lithium titnaqqas b’ thiazides u għalhekk, ir- riskju ta ’ tossiċita ’ minn lithium tista ’ tiżdied b’ Irbesartan Hydrochlorothiazide BMS.
Therefore, the combination of lithium and Irbesartan Hydrochlorothiazide BMS is not recommended (see section 4.4).
Għalhekk, il- kombinazzjoni ta ’ lithium u Irbesartan Hydrochlorothiazide BMS mhiex irrikkmandata (ara sezzjoni 4. 4).
If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Jekk tinħass il- ħtieġa ta ’ din il - kombinazzjoni, hija rrikmandata osservazzjoni bir- reqqa tal- livelli tal - lithium fis- serum.