qanastek/EMEA-V3 huggingface dataset:
How to apply Exelon transdermal patches Exelon patches are thin, opaque, plastic patches that stick to the skin.
Kif tapplika Exelon garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda Exelon garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda huma garżi rqaq, opaki tal- plastik li jeħlu mal- ġilda.
Each patch is sealed in a sachet that protects it until you are ready to put it on.
Kull garża hija ssiġillata f’ qartas li jipproteġiha sakemm tkun lest biex tilbisha.
Do not open the sachet or remove a patch until just before you apply it.
M’ għandekx tiftaħ il- qartas jew tneħħi l- garża sakemm ma tkunx ġejt biex tilbisha.
- Each patch is sealed in its own protective sachet.
- Kull garża hija ssiġillata f’ qartas protettiv tagħha.
You should only open the sachet when you are ready to apply the patch.
Għandek tiftaħ il- qartas biss meta tkun lest biex tapplika l - garża.
Cut the sachet along the dotted line with scissors and remove the patch from the sachet.
Aqta ’ l- qartas mal- linja rrigata b’ imqass u neħħi l- garża mill- qartas.
- A protective liner covers the sticky side of the patch.
- Il- parti li teħel tal- garża għandha kisja protettiva.
Peel off one side of the protective liner and do not touch the sticky part of the patch with the fingers.
Aqla naħa waħda ta ’ din il- kisja u tmissx il- parti li teħel tal- garża bis- swaba.
- Put the sticky side of the patch on the upper or lower back,
- Poġġi l- parti li teħel tal- garża fuq in- naħa ta ’ fuq jew ta ’
upper arm or chest and then peel off the second side of the protective liner.
isfel tad- dahar, parti ta ’ fuq tad- driegħ jew sider u imbagħad kompli aqla ’ t- tieni parti tal- kisja protettiva.
- Then press the patch firmly in place with the hand to make
- Imbagħad agħfas sew il- garża f’ postha b’ idejk sabiex
sure that the edges stick well.
taċċerta ruħek li t- truf jeħlu sew.
If it helps you, you may write, for example, the day of the week, on the patch with a thin ball point pen.
Jekk issibha ta ’ għajnuna, tista ’ tikteb, per eżempju, il- jum tal- ġimgħa, fuq il- garża b’ ball point irqieq.
132 The patch should be worn continuously until it is time to replace it with a new one.
139 Il- garża għandha tintlibes il- ħin kollu sakemm jasal il- ħin biex tinbidel b’ oħra ġdida.
You may wish to experiment with different locations when applying a new patch, to find ones that are most comfortable for you and where clothing will not rub on the patch.
Tista ’ tipprova postijiet differenti meta tapplika l- garża l- ġdida, sabiex issib dawk li l- aktar ikunu komdi għalik fejn il - ħwejjeġ ma jgħorkux mal- garża.
How to remove Exelon transdermal patches Gently pull at one edge of the patch to remove it completely from the skin.
Kif tneħħi l- garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda Exelon Iġbed bil- mod minn tarf wieħed tal- garża sabiex tneħħiha għal kollox mill- ġilda.
How to dispose of Exelon transdermal patches After removing a patch, fold it in half with the sticky sides on the inside and press them together.
Kif tarmi il- garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda Exelon Wara li tneħħi l- garża, itwijha fi tnejn bin- naħa li teħel fuq ġewwa u agħfashom flimkien.
Return the used patch to its sachet and dispose of it in such a way that children cannot handle it.
Poġġi l - garża użata lura fil- qartas tagħha u armiha b’ mod li t- tfal ma jkunux jistgħu jilħquha.
Do not touch your eyes with your fingers and wash your hands with soap and water after removing the patch.
Tmissx għajnejk b’ subajk u aħsel idejk bis- sapun u l- ilma wara li tneħħi l- garża.
If your community burns domestic rubbish, you can dispose of the patch with your domestic rubbish.
Jekk il- komunità tiegħek taħraq iż- żibel domestiku, tista ’ tarmi l- garża maż- żibel tad- dar.
Otherwise, return used patches to a pharmacy, preferably in the original packaging.
Inkella, ħu lura l- garżi użati fi ispiżerija, l- aħjar fil- pakkett oriġinali.
Can you wear Exelon transdermal patches when you are bathing, swimming, or in the sun? • Bathing, swimming or showering should not affect the patch.
Tista ’ tilbes il- garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda Exelon meta tkun qed tinħasel, tgħum, jew fix- xemx? • Il- ħasil, għawm jew xawer m’ għandhomx jeffettwaw il- garża.
Make sure the patch does not loosen during these activities. • Do not expose the patch to any external heat sources (e. g. excessive sunlight, saunas, solarium) for long periods of time.
Aċċerta ruħek li l- garża ma tinqalax waqt dawn l- attivitajiet. • M’ għandekx tesponi l- garża għal għejjun ta ’ sħana esterna (eż. dawl tax- xemx eċċessiv, sawna, solarju) għal perijodi twal ta ’ żmien.
What to do if a patch falls off If a patch falls off, apply a new one for the rest of the day, then replace it at the same time as usual the next day.
X’ tgħamel jekk garża tinqala Jekk garża tinqala, applika waħda ġdida għal bqija tal- jum, imbagħad ibdilha fl- istess ħin tas- soltu l - jum ta ’ wara.
When and for how long to apply Exelon transdermal patches To benefit from treatment, you must apply a new patch every day, preferably at the same time of day.
Meta u għal kemm għandek tapplika il- garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda Exelon Sabiex tikseb benefiċċju mill- kura għandek tapplika garża ġdida kuljum, l- aħjar fl- istess ħin tal- jum.
If you use more Exelon than you should If you accidentally apply more than one patch, remove all the patches from your skin, then inform your doctor that you have accidentally applied more than one patch.
Jekk tuża Exelon aktar milli suppost Jekk bi żball tapplika aktar minn garża waħda, neħħi l- garżi kollha minn mal- ġilda, imbagħad għarraf lit- tabib li bi żball applikajt aktar minn garża waħda.
Some people who have accidentally taken too much Exelon have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations.
Xi nies li ħadu bi żball wisq Exelon ħassewhom imqalla (dardir), ma jifilħux (irrimettew), dijarea, pressjoni għolja tad- demm u alluċinazzjonijiet.
Slow heart beat and fainting may also occur.
Tħabbit tal- qalb bil- mod u ħass ħażin jistgħu jseħħu wkoll.
If you forget to use Exelon If you find you have forgotten to apply a patch, apply one immediately.
Jekk tinsa tuża Exelon Jekk tinduna li nsejt tapplika garża, applika waħda ġdida mill- ewwel.
You may apply the next patch at the usual time the next day.
Tista ’ tapplika l- garża li jkun imissek fil- ħin tas- soltu l- jum ta ’ wara.
Do not apply two patches to make up for the one that you missed.
M’ għandekx tapplika żewġ garżi biex tpatti għal kull waħda li tkun insejt.
If you stop using Exelon Tell your doctor or pharmacist if you stop using the patch.
Jekk tieqaf tuża Exelon Għid lit- tabib jew spiżjar tiegħek jekk tieqaf tuża l- garża.
If you have not applied an Exelon patch for several days, do not apply the next one until you have talked to your doctor.
Jekk ma applikajtx garża Exelon għal bosta ġranet, tapplikax dik li jmiss sakemm ma tkun kellimt lit - tabib tiegħek.
Like all medicines, Exelon transdermal patches can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Exelon garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda jista ’ jkollhom effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
In most cases side effects will gradually disappear as your body gets used to the medicine.
Jista ’ jkun li tara effetti sekondarji aktar ta ’ spiss meta tibda tieħu l- mediċina jew iżżid għal doża ogħla.
Stomach (gastrointestinal) reactions such as feeling sick (nausea) and being sick (vomiting) are common side
F’ ħafna każijiet, l- effetti sekondarji ser jitilqu bil- mod hekk kif ġismek jidra l- mediċina.
133 effects (less than 1 in 10 patients but more than 1 in 100 patients).
140 Reazzjonijiet fl- istonku (gastro- intestinali) bħal tħossok marid (dardir) u tkun ma tiflaħx (rimettar) huma effetti sekondarji komuni (anqas minn 1 f’ kull 10 pazjenti iżda aktar minn 1 f’ kull 100 pazjent).
The other common side effects are: diarrhoea, heartburn, stomach pain, loss of appetite, weight loss, urinary tract infection, headache, weakness, tiredness, anxiety, depression, fainting, rashes, skin reactions at the application site (redness, itching, irritation, swelling), severe confusion and fever.
L- effetti sekondarji l- oħra komuni huma: dijarea, ħruq ta ’ stonku, telf ta ’ l- aptit, telf tal- piż, infezzjoni fil- passaġġ ta ’ l- awrina, uġigħ ta ’ ras, għeja, ansjetà, dipressjoni, ħass ħażin, raijiet, reazzjonijiet tal - ġilda mnejn tiġi applikata (ħmura, ħakk, irritazzjoni, nefħa), konfużjoni severa u deni.
Some side effects could become serious:
Xi effetti sekondarji jistgħu jkunu serji:
Uncommon side effects (less than 1 in 100 patients but more than 1 in 1,000 patients): problems with heart rhythm (slow heart beat) and gastric ulcer; very rare (less than 1 in 10,000 patients): stiff limbs and trembling hands.
Effetti sekondarji mhux komuni (anqas minn 1 f’ kull 100 pazjent iżda aktar minn 1 f’ kull 1, 000 pazjent): problemi bir- ritmu tal- qalb (qalb tħabbat bil- mod) u ulċera fl- istonku, rari ħafna (anqas minn 1 f’ kull 10, 000 pazjent: dirgħajn u riġlejn jibbiesu u idejn jirtodu.
If you experience any of these, remove the patch and tell your doctor straight away.
Jekk tħoss xi wieħed minn dawn, neħħi l- garża u għid lit- tabib tiegħek mill- ewwel.
Additional side effects which have been reported with Exelon capsules or oral solution are:
Effetti sekondarji oħrajn li kienu rrappurtati bil- kapsuli Exelon jew soluzzjoni orali huma:
Very common (more than 1 in 10 patients): dizziness.
Komuni ħafna (aktar minn 1 f’ kull 10 pazjenti): sturdament.
Common (less than 1 in 10 patients but more than 1 in 100 patients): agitation, drowsiness, generally feeling unwell, trembling, confusion and increased sweating.
Komuni (anqas minn 1 f’ kull 10 pazjenti iżda aktar minn 1 f’ kull 100 pazjent): aġitazzjoni, tħeddil, sensazzjoni li ma tiflaħx, tirtod, konfużjoni u żieda fl- għaraq.
Uncommon (less than 1 in 100 patients but more than 1 in 1,000 patients): difficulty in sleeping, changes in liver function tests and accidental falls.
Mhux komuni (anqas minn 1 f’ kull 100 pazjent iżda aktar minn 1 f’ kull 1, 000 pazjent): tbatija biex torqod, tibdil fit- testijiet tal- funzjoni tal- fwied u waqgħat aċċidental.
Rare (less than 1 in 1,000 patients but more than 1 in 10,000 patients): convulsions, ulcer in the intestine and chest pain (probably caused by coronary spasm).
Rari (anqas minn 1 f’ kull 1, 000 pazjent iżda aktar minn 1 f’ kull 10, 000 pazjent): konvulżjonijiet, ulċera fl- imsaren u uġigħ fis- sider (x’ aktarx ikkawżat minn spażmu fil- koronarji).
Very rare (less than 1 in 10,000 patients): irregular heart rate (e. g. fast heart rate), high blood pressure, inflammation of the pancreas (severe upper stomach pain, often with nausea and vomiting), gastrointestinal haemorrhage (blood in stools or when vomiting), hallucinations.
Rari ħafna (anqas munn 1 f’ kull 10, 000 pazjent): rata tal- qalb irregolari (eż. rata mgħaġġla tal- qalb), pressjoni tad- demm għolja, infjammazzjoni tal- frixa (uġigħ fl- istonku sever, ta ’ spiss bi tqallih u rimettar), emorraġġija gastro- intestinali (demm fl- ippurgar jew mar- rimettar), alluċinazzjonijiet.
There have also been reports about severe vomiting that can lead to a rupture of the oesophagus.
Kien hemm ukoll rapporti dwar rimettar sever li jista ’ jwassal għal tiċrit ta ’ l- esofagu.
- Do not use Exelon after the expiry date, which is stated on the box and sachet.
- Tużax Exelon wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- qartas.
The expiry date
Id- data ta ’ skadenza
refers to the last day of the month.
tirreferi għal l- aħħar ġurnata ta ’ dak ix- xahar.
- Do not store above 25°C.
- Taħżinx f’ temperatura ’ l fuq minn 25°C.
- Keep the transdermal patch in the sachet until use.
- Żomm il- garżi li tipprovdi mediċina li tgħaddi minn ġol- ġilda fil- qartas sakemm tiġi biex tużha.
- Do not use any patch that is damaged or shows signs of tampering.
- M’ għandek tuża l- ebda garża li tkun danneġġata jew turi sinjali ta ’ tbabis.
- The active substance is rivastigmine.
- Is- sustanza attiva hija rivastigmine.
Exelon 4.6 mg/ 24 h transdermal patches:
Exelon 4. 6 mg/ 24 siegħa garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda:
Each patch releases 4.6 mg of rivastigmine per 24 hours is 5 cm2 and contains 9 mg of rivastigmine.
Kull garża terħi 4. 6 mg ta ’ rivastigmine kull 24 siegħa hija 5 cm2 u fiha 9 mg rivastigmine.
Exelon 9.5 mg/ 24 h transdermal patches:
Exelon 9. 5 mg/ 24 siegħa garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda:
Each patch releases 9.5 mg of rivastigmine per 24 hours is 10 cm2 and contains 18 mg of rivastigmine.
Kull garża terħi 9. 5 mg ta ’ rivastigmine kull 24 siegħa hija 10 cm2 u fiha 18 mg rivastigmine.
- The other ingredients are: polyethylene terephthalate film lacquered, alpha-tocopherol,
- Is- sustanzi l- oħra huma: rita ta ’ polyethylene terephthalate bil- lakka, alpha- tocopherol,
poly(butylmethacrylate, methyl-methacrylate), acrylic copolymer, silicone oil, dimethicone, polyester film fluoropolymer-coated.
poly( butylmethacrylate, methyl- methacrylate), acrylic copolymer, żejt tas- silicone, dimethicone, rita ta ’ polyester miksi bi fluoropolymer.
What Exelon looks like and contents of the pack Each transdermal patch is a thin patch consisting of three layers.
Id- Dehra ta ’ Exelon u l- kontenuti tal- pakkett Kull garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda hija garża rqieqa li fiha tliet saffi.
The outer layer is beige and labelled with the following:
Is- saff ta ’ barra huwa bex u tikkettat b’ dawn li jmiss:
- “ Exelon”, “ 4.6 mg/ 24 h” and “ AMCX”,
- “ Exelon ”, “ 4. 6 mg/ 24 h ” u “ AMCX ”,
- “ Exelon”, “ 9.5 mg/ 24 h” and “ BHDI”.
- “ Exelon ”, “ 9. 5 mg/ 24 h ” u “ BHDI ”.
134 One transdermal patch is sealed in one sachet.
Garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda waħda tkun issiġillata f’ qartas wieħed.
The patches are available in packs containing 7 or 30 sachets and in multipacks containing 60 (2x 30) or 90 (3x 30) sachets.
Il- garżi jiġu f’ pakketti li jkun fihom 7 jew 30 qartas u f’ pakketti b’ ħafna li jkun fihom 60 (2x 30) jew 90 (3x 30) qartas.
Not all pack sizes may be marketed in your country.
Jista ’ jkun li mhux il- pakketti kollha jkunu mqegħda fis- suq f’ pajjiżek.
Manufacturer Novartis Pharma GmbH Roonstraße 25 D-90429 Nuremberg Germany
Manifattur Roonstraße 25 D- 90429 Nuremberg Il- Ġermanja
Slovenija Novartis Pharma Services Inc.
142 Slovenija Ireland Novartis Pharma Services Inc.
What is Exforge?
X' inhu Exforge?
Exforge is a medicine containing two active substances, amlodipine and valsartan.
Exforge huwa mediċina li fiha żewġ sustanzi attivi, amlodipina u valsartan.
What is Exforge used for?
Għal xiex jintuża Exforge?
Exforge is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled on either amlodipine or valsartan taken alone. ‘ Essential ’ means that the high blood pressure is not caused by any other condition.
'Essenzjali' tfisser li l - pressjoni għolja ma tkunx ikkawżata minn xi kundizzjoni oħra.
Exforge is not recommended for use in patients below 18 years of age.
Exforge mhuwiex rakomandat għall - użu f' pazjenti taħt l- età tat- 18- il sena.
How is Exforge used?
Kif jintuża Exforge?
Exforge is taken by mouth as one tablet once a day with some water, with or without food.
Exforge jittieħed mill- ħalq fi kwantità ta 'pillola waħda darba kuljum bi ftit ilma, fuq stonku vojt jew le.
The dose of Exforge to be used depends on the doses of amlodipine or valsartan that the patient was taking before.
Id- doża ta 'Exforge li għandha tintuża tiddependi mid- doża ta' amlodipina jew valsartan li l- pazjent kien qiegħed jieħu qabel.
Exforge should be used with caution in patients who have problems with their liver or biliary obstructive disorders (problems with the elimination of bile).
Exforge għandu jintuża b' kawtela fil- pazjenti bi problemi fil- fwied jew disturbi minn ostruzzjoni biljari (problemi biex jeliminaw il- bili).
How does Exforge work?
Kif jaħdem Exforge?
Exforge contains two active substances, amlodipine and valsartan.
Exforge fih żewġ sustanzi attivi, amlodipina u valsartan.
How has Exforge been studied?
Kif ġie studjat Exforge?
The company also presented evidence that the levels of amlodipine and valsartan in the blood were the same in people taking Exforge and people taking the separate medicines.
Barra minn dan il- kumpanija ppreżentat tagħrif li juri li l- livelli ta 'amlodipina u valsartan fid- demm kienu l- istess fil- pazjenti ttrattati b' Exforge u fil- pazjenti trattati biż- żewġ mediċini separatament.
What benefit has Exforge shown during the studies?
X' benefiċċju wera Exforge waqt l- istudji li ġew imwettqa?
What is the risk associated with Exforge?
X' inhu r- riskju assoċjat ma 'Exforge?
The most common side effects with Exforge (seen in between 1 and 10 patients in 100) are headache, nasopharyngitis (inflammation of the nose and throat), influenza (flu), various types of oedema (swelling), fatigue (tiredness), flushing (reddening), asthenia (weakness) and hot flushes.
L- effetti sekondarji l- aktar komuni b' Exforge (li dehru f' bejn pazjent 1 u 100 minn 100) huma wġigħ ta 'ras, nasofarinġite (infjammazzjoni ta' l- imnieħer u tal- gerżuma), influwenza, tipi varji ta 'edema (nefħa), għeja kbira, ħmura, astenija (debbolizza) u fwawar.
Exforge should not be used in patients who may be hypersensitive (allergic) to amlodipine or other medicines in the ‘ dihydropyridine derivatives’ class, to valsartan, or to any of the other ingredients.
Għal- lista sħiħa ta 'l- effetti sekondarji rrappurtati b' Exforge, ara l- Fuljett ta' Tagħrif. Exforge ma għandux jintuża f' pazjenti li jistgħu jkunu ipersensittivi (allerġiċi) għall- amlodipina jew mediċini oħra tal- klassi tad - 'derivati diidropiridiniċi' (dihydropyridine derivatives), għal valsartan, jew għal kwalunkwe ingredjent ieħor.
Exforge should also not be used in patients who have severe liver, kidney or bile problems, or in patients undergoing dialysis (a blood clearance technique).
Exforge ma għandux jintuża wkoll fil - pazjenti bi problemi gravi fil- fwied, fil- kliewi jew biljari, jew fil- pazjenti li għaddejjin minn dijaliżi (teknika tat- tisfija tad- demm).
Why has Exforge been approved?
Għaliex ġie approvat Exforge?
The Committee for Medicinal Products for Human Use (CHMP) decided that Exforge’ s benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Exforge huma ogħla mir- riskji tiegħu fit- trattament ta' l- ipertensjoni essenzjali f' pazjenti li l- pressjoni tad- demm tagħhom ma tkunx ikkontrollata adegwatament b' monoterapija abbażi ta 'amlodipina jew valsartan.
The Committee recommended that Exforge be given marketing authorisation.
Il- Kumitat irrakkomanda li Exforge jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Exforge:
Aktar tagħrif dwar Exforge:
The European Commission granted a marketing authorisation valid throughout the EU for Exforge to Novartis Europharm Limited on 17 January 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Exforge lil Novartis Europharm Limited fis- 17 ta 'Jannar 2007.
The full EPAR for Exforge can be found here.
L- EPAR sħiħ għal Exforge jista 'jiġi kkonsultat hawn.
EU Number
Numru ta ’ l- EU EU/ 1/ 06/ 370/ 001 EU/ 1/ 06/ 370/ 002
Invented name
Isem inventat Exforge Exforge
Strength
Qawwa 5 mg/ 80 mg 5 mg/ 80 mg
Pharmaceutical Form
Mnejn jingħata Użu orali Użu orali
Route of Administration
Il- pakkett Folja (PVC/ PVDC) Folja (PVC/ PVDC)
Packaging
Daqs tal- pakkett 7 pilloli 14- il pillola
Package size
Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge
EU/ 1/ 06/ 370/ 001 EU/ 1/ 06/ 370/ 002 EU/ 1/ 06/ 370/ 003 EU/ 1/ 06/ 370/ 004 EU/ 1/ 06/ 370/ 005 EU/ 1/ 06/ 370/ 006 EU/ 1/ 06/ 370/ 007 EU/ 1/ 06/ 370/ 008 EU/ 1/ 06/ 370/ 009 EU/ 1/ 06/ 370/ 010 EU/ 1/ 06/ 370/ 011 EU/ 1/ 06/ 370/ 012 EU/ 1/ 06/ 370/ 013 EU/ 1/ 06/ 370/ 014 EU/ 1/ 06/ 370/ 015 EU/ 1/ 06/ 370/ 016 EU/ 1/ 06/ 370/ 017 EU/ 1/ 06/ 370/ 018 EU/ 1/ 06/ 370/ 019 EU/ 1/ 06/ 370/ 020 EU/ 1/ 06/ 370/ 021 EU/ 1/ 06/ 370/ 022 EU/ 1/ 06/ 370/ 023 EU/ 1/ 06/ 370/ 024 EU/ 1/ 06/ 370/ 025 EU/ 1/ 06/ 370/ 026 EU/ 1/ 06/ 370/ 027 EU/ 1/ 06/ 370/ 028 EU/ 1/ 06/ 370/ 029 EU/ 1/ 06/ 370/ 030 EU/ 1/ 06/ 370/ 031 EU/ 1/ 06/ 370/ 032 EU/ 1/ 06/ 370/ 033 EU/ 1/ 06/ 370/ 034 EU/ 1/ 06/ 370/ 035 EU/ 1/ 06/ 370/ 036
EU/ 1/ 06/ 370/ 013 EU/ 1/ 06/ 370/ 014 EU/ 1/ 06/ 370/ 015 EU/ 1/ 06/ 370/ 016 EU/ 1/ 06/ 370/ 017 EU/ 1/ 06/ 370/ 018 EU/ 1/ 06/ 370/ 019 EU/ 1/ 06/ 370/ 020 EU/ 1/ 06/ 370/ 021 EU/ 1/ 06/ 370/ 022 EU/ 1/ 06/ 370/ 023 EU/ 1/ 06/ 370/ 024 EU/ 1/ 06/ 370/ 025 EU/ 1/ 06/ 370/ 026 EU/ 1/ 06/ 370/ 027 EU/ 1/ 06/ 370/ 028 EU/ 1/ 06/ 370/ 029 EU/ 1/ 06/ 370/ 030 EU/ 1/ 06/ 370/ 031 EU/ 1/ 06/ 370/ 032 EU/ 1/ 06/ 370/ 033 EU/ 1/ 06/ 370/ 034 EU/ 1/ 06/ 370/ 035 EU/ 1/ 06/ 370/ 036
Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge
Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge Exforge
5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 5 mg/ 80 mg 5 mg/ 160 mg 10 mg/ 160 mg
5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 5 mg/ 80 mg 5 mg/ 160 mg 10 mg/ 160 mg
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC) blister (PVC/ PVDC)
Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC)
7 tablets 14 tablets 28 tablets 30 tablets 56 tablets 90 tablets 98 tablets 280 tablets 7 tablets 14 tablets 28 tablets 30 tablets 56 tablets 90 tablets 98 tablets 280 tablets 7 tablets 14 tablets 28 tablets 30 tablets 56 tablets 90 tablets 98 tablets 280 tablets 56 x 1 tablets (unit dose) 98 x 1 tablets (unit dose) 280 x 1 tablets (unit dose) 56 x 1 tablets (unit dose) 98 x 1 tablets (unit dose) 280 x 1 tablets (unit dose) 56 x 1 tablets (unit dose) 98 x 1 tablets (unit dose) 280 x 1 tablets (unit dose) 280 tablets (4 x 70) 280 tablets (4 x 70) 280 tablets (4 x 70)
56 pillola 90 pillola 98 pillola 280 pillola 7 pilloli 14- il pillola 28 pillola 30 pillola 56 pillola 90 pillola 98 pillola 280 pillola 56 x pillola 1 (doża b’ waħda) 98 x pillola 1 (doża b’ waħda) 280 x pillola 1 (doża b’ waħda) 56 x pillola 1 (doża b’ waħda) 98 x pillola 1 (doża b’ waħda) 280 x pillola 1 (doża b’ waħda) 56 x pillola 1 (doża b’ waħda) 98 x pillola 1 (doża b’ waħda) 280 x pillola 1 (doża b’ waħda) 280 pillola (4 x 70) 280 pillola (4 x 70) 280 pillola (4 x 70)
Exforge 5 mg/ 80 mg film-coated tablets
Exforge 5 mg/ 80 mg pilloli miksija b’ rita
Exforge is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Exforge huwa indikat f’ pazjenti li jkollhom pressjoni għolja li ma tkunx kontrollata b’ terapija ta ’ amlodipine jew valsartan mogħtija waħidhom.
The recommended dose of Exforge is one tablet per day.
Id- doża ta ’ Exforge rakkomandata hija pillola waħda kuljum.
Exforge 5 mg/ 80 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 mg alone.
Exforge 5 mg/ 80 mg jista ’ jingħata lill- pazjenti li ma jkollhomx pressjoni kontrollata tajjeb b’ amlodipine 5 mg jew valsartan 80 mg waħidhom.
Exforge can be used with or without food.
Exforge jista ’ jintuża ma ’ l- ikel jew mingħajr ikel.
It is recommended to take Exforge with some water.
Huwa rakkomandat li Exforge jittieħed ma ’ ftit ilma.
For convenience, patients receiving valsartan and amlodipine from separate tablets/ capsules may be switched to Exforge containing the same component doses.
Għall- konvenjenza, pazjenti li qed jieħdu amlodipine u valsartan minn pilloli/ kapsuli separati jistgħu jinqalbu għal Exforge li fihom l- istess dożi tal- komponenti.
Hepatic impairment Caution should be exercised when administering Exforge to patients with hepatic impairment or biliary obstructive disorders (see section 4.4).
Indeboliment tal- fwied Għandha tintuża kawtela meta jingħata Exforge lill- pazjenti li jsofru minn indeboliment tal- fwied jew mard ta ’ imblokkar tal- marrara (ara sezzjoni 4. 4).
2 Children and adolescents Exforge is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.
Tfal u adolexxenti Exforge mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
Sodium- and/ or volume-depleted patients Excessive hypotension was seen in 0.4% of patients with uncomplicated hypertension treated with Exforge in placebo-controlled studies.
Pazjenti nieqsa mis- sodium u/ jew volum Pressjoni baxxa eċċessiva dehret f’ 0. 4% tal- pazjenti b’ pressjoni għolja mingħajr kumplikazzjonijiet li kienet kurata b’ Exforge fi studji kontrollati bi plaċebo.
Correction of this condition prior to administration of Exforge or close medical supervision at the start of treatment is recommended.
Qabel tibda l- kura b’ Exforge huwa rakkomandat li din tiġi korretta jew inkella jkun hemm sorveljanza medika mill- qrib meta tibda l- kura.
If hypotension occurs with Exforge, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline.
Jekk taqa ’ l- pressjoni b’ Exforge, il- pazjent għandu jitqiegħed mindud wiċċu ‘ l fuq u jekk ikun meħtieġ, jingħata infużjoni fil- vina b’ ilma bil- melħ.
Renal artery stenosis No data are available on the use of Exforge in patients with bilateral renal artery stenosis or stenosis to a solitary kidney.
Stenożi ta ’ l- arterja renali M’ hemmx tagħrif dwar l- użu ta ’ Exforge f’ pazjenti b’ stenożi bilaterali ta ’ l- arterji renali jew stenożi ta ’ kilwa waħda.
Kidney transplantation To date there is no experience of the safe use of Exforge in patients who have had a recent kidney transplantation.
Trapjant tal- kliewi Sa ’ llum għad m’ hemmx esperjenza bl- użu ta ’ Exforge f’ pazjenti li riċentement ħadu trapjant tal - kliewi.
Particular caution should be exercised when administering Exforge to patients with mild to moderate hepatic impairment or biliary obstructive disorders.
Għandha ssir attenzjoni partikolari meta Exforge jingħata lill - pazjenti li jsofru minn indeboliment ħafif jew moderat jew mard ta ’ imblokkar tal- marrara.
Renal impairment No dosage adjustment of Exforge is required for patients with mild to moderate renal impairment (GFR > 30 ml/ min/ 1.73 m2).
Indeboliment renali M’ hemmx bżonn ta ’ tibdil fid- dożaġġ għall- pazjenti li għandhom indeboliment ħafif għal moderat (GFR > 30 ml/ min/ 1. 73 m2).
Exforge has not been studied in any patient population other than hypertension.
Exforge ma kienx studjat f’ ebda popolazzjoni ta ’ pazjenti oħrajn apparti dawk li jsofru minn pressjoni għolja.
To be taken into account with concomitant use Others In monotherapy, amlodipine has been safely administered with thiazide diuretics, beta blockers, ACE inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, atorvastatin, sildenafil, anti-acid medicines (aluminium hydroxide gel, magnesium hydroxide, simeticone), cimetidine, non- steroidal anti-inflammatory medicines, antibiotics and oral hypoglycaemic medicines.
4 Li għandha titqies waqt l- użu fl- istess ħin Oħrajn Mogħti waħdu, amlodipine intuża b’ mod sigur ma ’ dijuretiċi thiazide, beta blockers, inibituri ACE, nitrati li jaħdmu fit- tul, nitrogliċerina ta ’ taħt l- ilsien, digoxin, warfarin, atorvastatin, sildenafil, mediċini antaċidi (ġel ta ’ l- aluminium hydroxide, magnesium hydroxide, simeticone), cimetidine, mediċini anti- infjammatorji mhux sterojdi, antibijotiċi u mediċini ipogliċemiċi orali.
Interactions common to the combination No drug interaction studies were performed with Exforge and other medicinal products.
Interazzjonijiet komuni għall- kombinazzjoni Ma sarux studji dwar nuqqas ta ’ qbil b’ Exforge u prodotti mediċinali oħrajn.
Unless continued AIIRA 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.
Sakemm kura b’ AIIRA kontinwata hija ikkunsidrata essenzjali, pazjenti li qed jippjanaw 5 għal tqala għandhom jinqalbu għal kura alternattiva kontra l- pressjoni għolja li għandha profil ta ’ sigurtà stabbilit qћall- uzu fit- tqala.
There is no experience on the use of Exforge in pregnant women.
M’ hemmx esperjenza bl- użu ta ’ Exforge waqt it- tqala.
Data on a limited number of exposed pregnancies
Studji bl- annimali wrew li hemm tossiċità għas- sistema riproduttiva b’ valsartan/ amlodipine simili ma ’ dik li ġiet deskritta għal valsartan u antagonisti oħra ta ’ angiotensin II (ara sezzjoni 5. 3).
5 indicate no adverse effects of amlodipine and other calcium receptor antagonists on the health of the foetus.
Tagħrif dwar numru limitat ta ’ esponimenti waqt it- tqala ma jurux effetti avversi ta ’ amlodipine jew antagonisti tar- riċetturi ta ’ calcium fuq is- saħħa tal - fetu.
The safety of Exforge has been evaluated in five controlled clinical studies with 5,175 patients, 2,613 of whom received valsartan in combination with amlodipine.
Is- sigurtà ta ’ Exforge ġiet meqjusa f’ ħames studji kliniċi kontrollati b’ 5, 175 pazjent, li 2, 613 minnhom irċevew valsartan kombinat ma ’ amlodipine.
Oedema, pitting oedema, facial oedema, oedema peripheral, fatigue, flushing, asthenia, hot flush 6
Edima, edima li titgħattan, edima tal- wiċċ, edima periferali, għeja, issir ruxxan, astenja, fawra
Amlodipine (mg)
0 2. 5 Amlodipine 5 (mg) 10
2.3 4.8
3. 0 5. 5 8. 0 2. 3 3. 1 4. 8 10. 3 NA
5.4 2.3
2. 4 5. 4 2. 3 NA
2.4 2.1
1. 6 2. 4 2. 1 9. 0
3.9 2.4
0. 9 3. 9 2. 4 9. 5
Additional information on the individual components Adverse drug reactions previously reported with one of the individual components (amlodipine or valsartan) may be potential undesirable effects with Exforge as well, even if not observed in clinical trials or during the post-marketing period.
Aktar tagħrif dwar il- komponenti individwali Reazzjonijiet avversi għall- mediċina li kienu rappurtati qabel b’ wieħed mill- komponenti (amlodipine jew valsartan) jistgħu jkunu effetti mhux mixtieqa b’ Exforge ukoll, anki jekk ma dehrux waqt il- provi kliniċi jew waqt il- perjodu ta ’ wara t- tqegħid fis- suq.
Amlodipine Common Uncommon
7 Amlodipine Komuni Mhux komuni
Decrease in haemoglobin, decrease in haematocrit, neutropenia, thrombocytopenia, increase of serum potassium, elevation of liver function values including increase of serum bilirubin, renal failure and impairment, elevation of serum creatinine, angioedema, myalgia, vasculitis, hypersensitivity including serum sickness.
Tnaqqis fl- emoglobina, tnaqqis fl- ematocrit, newtropenja, tromboċitopenja, żieda fil - potassium tas- serum, żieda fil- valuri tal- funzjoni tal- fwied inkluż żieda fil- bilirubin tas- serum, insuffiċjenza u indeboliment tal- kliewi, livell ogħla ta ’ kreatinina fis - serum, anġjoedima, majalġja, vaskulite, sensittività eċċessiva inkluż mard tas- serum.
Symptoms There is no experience of overdose with Exforge.
Sintomi M’ hemmx esperjenza ta ’ doża eċċessiva b’ Exforge.
Clinically significant hypotension due to Exforge overdose calls for active cardiovascular support, including frequent monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output.
Meta taqa l- pressjoni b’ Exforge b’ mod li jkun hemm sintomi kliniċi, għandu jkun hemm support għall- qalb, inklużi monitoraġġ frekwenti tal- funzjoni tal- qalb u tas- sistema respiratorja, jittellgħu d- driegħ, u għandha ssir attenzjoni għall- volum ta ’ fluwidi li jiċċirkolaw u l- volum ta ’ awrina.
Exforge combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines.
Exforge jikkombina żewġ sustanzi kontra l- pressjoni għolja ma ’ mekkaniżmi kumplimentari sabiex tkun kontrollata l- pressjoni tad- demm f’ pazjenti b’ pressjoni għolja naturali: amlodipine huwa membru ta ’ klassi li huma antagonisti ta ’ calcium u valsartan ta ’ klassi ta ’ mediċini li huma antagonisti ta
Amlodipine The amlodipine component of Exforge inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Amlodipine Il- komponent amlodipine f’ Exforge jinibixxi id- dħul mill- membrana ta ’ joni ta ’ calcium fil- muskoli tal- qalb u tal- muskoli lixxi tal- vini.
Administration of valsartan to patients with hypertension results in a drop in blood pressure without affecting pulse rate.
9 L- għotja ta ’ valsartan lill- pazjenti li jsofru minn pressjoni għolja twassal għal waqa ’ fil- pressjoni tad - demm mingħajr ma jkun hemm effett fuq ir- rata tal- polz.
Amlodipine/ Valsartan Over 1,400 hypertensive patients received Exforge once daily in two placebo-controlled trials.
Amlodipine/ Valsartan ’ L fuq minn 1, 400 pazjent irċevew Exforge darba kuljum f’ żewġ provi kontrollati bi plaċebo.
Exforge was also studied in an active-controlled study of 130 hypertensive patients with diastolic blood pressure ≥ 110 mmHg and < 120 mmHg.
Exforge kien studjat ukoll fi studju active- controlled ta ’ 130 pazjent bi pressjoni għolja bil- pressjoni dijastolika ≥110 mmHg u < 120 mmHg.
In this study (baseline blood pressure 171/ 113 mmHg), an Exforge regimen of 5 mg/ 160 mg titrated to 10 mg/ 160 mg reduced sitting blood pressure by 36/ 29 mmHg as compared to 32/ 28 mmHg with a regimen of lisinopril/ hydrochlorothiazide 10 mg/ 12.5 mg titrated to 20 mg/ 12.5 mg.
F’ dan l- istudju (il- linja bażi tal- pressjoni tad- demm kienet 171/ 113 mmHg), b’ reġimen ta ’ Exforge ta ’ 5 mg/ 160 mg miżjuda għal 10 mg/ 160 mg naqqset il - pressjoni tad- demm ta ’ bilqiegħeda b’ 36/ 29 mmHg meta imqabbla ma ’ 32/ 28 mmHg b’ reġimen ta ’ lisinopril/ hydrochlorthiazide 10 mg/ 12. 5 mg miżjuda għal 20 mg/ 12. 5 mg.
In two long-term follow-up studies the effect of Exforge was maintained for over one year.
F’ żewġ studji follow- up fit- tul, l- effett ta ’ Exforge inżamm għal aktar minn sena waħda.
Abrupt withdrawal of Exforge has not been associated with a rapid increase in blood pressure.
Meta Exforge twaqqaf f’ daqqa, ma kienx hemm żieda f’ daqqa tal- pressjoni tad- demm.
Age, gender and race did not influence the response to Exforge.
L- età, sess u r- razza ma kellhomx effett fuq ir- rispons għal Exforge.
Exforge has not been studied in any patient population other than hypertension.
Exforge ma kienx studjat f’ ebda popolazzjoni ta ’ pazjenti apparti dawk li jbatu minn pressjoni għolja.
Amlodipine has been studied in patients with chronic stable angina, vasospastic angina and angiographically documented coronary artery disease.
10 Amlodipine kien studjat f’ pazjenti li jsofru minn anġina kronika stabbli, anġina vażospastika u mard ta ’ l- arterja koronarja dokumentat b’ anġjografija.
Amlodipine/ Valsartan Following oral administration of Exforge, peak plasma concentrations of valsartan and amlodipine are reached in 3 and 6– 8 hours, respectively.
Amlodipine/ Valsartan Wara li Exforge jittieħed mill- ħalq, il- quċċata tal- konċentrazzjonijiet fil- plażma ta ’ valsartan u amlodipine jintlaħqu fi 3 u 6- 8 sigħat, rispettivament.
The rate and extent of absorption of Exforge are equivalent to the bioavailability of valsartan and amlodipine when administered as individual tablets.
Ir- rata u l- grad ta’ assorbiment ta ’ Exforge huma ekwivalenti għal bijodisponibilità ta ’ valsartan u amlodipine meta jingħataw bħala pilloli waħidhom.
Special populations Paediatric patients (age below 18 years) No pharmacokinetic data are available in the paediatric population.
11 Popolazzjonijiet speċjali Pazjenti pedjatriċi (età taħt it- 18- il sena) M’ hemmx tagħrif farmakokinetiku fil- popolazzjoni pedjatrika.
Mean systemic AUC of valsartan is higher by 70% in the elderly than in the young, therefore caution is required when increasing the dosage.
Il- medja ta ’ l - AUC sistemiku ta ’ valsartan ikun 70% ogħla fl- anzjani milli fiż- żgħażagħ, għaldaqstant hija meħtieġa l- kawtela meta tkun qed tiżdied id- doża.
7, 14, 28, 30, 56, 90, 98 or 280 film-coated tablets.
7, 14, 28, 30, 56, 90, 98 jew 280 pillola miksija b’ rita u pakketti b’ ħafna li jkun fihom 280 (4x70) pillola miksija b’ rita.
56, 98 or 280 film-coated tablets and multipacks containing 280 (4x70) film-coated tablets.
56, 98 jew 280 pillola miksija b’ rita.
Exforge 5 mg/ 160 mg film-coated tablets
Exforge 5 mg/ 160 mg pilloli miksija b’ rita
Exforge 5 mg/ 160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 160 mg alone.
Exforge 5 mg/ 160 mg jista ’ jingħata lill- pazjenti li ma jkollhomx pressjoni kontrollata tajjeb b’ amlodipine 5 mg jew valsartan 160 mg waħidhom.
14 Children and adolescents Exforge is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.
15 Tfal u adolexxenti Exforge mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
Renal impairment No dosage adjustment of Exforge is required for patients with mild to moderate renal impairment (GFR > 30 ml/ min/ 1.73 m2).
16 Indeboliment renali M’ hemmx bżonn ta ’ tibdil fid- dożaġġ għall- pazjenti li għandhom indeboliment ħafif għal moderat (GFR > 30 ml/ min/ 1. 73 m2).
Animal studies indicate that the valsartan/ amlodipine has reproductive toxicity in line with what has been described for valsartan and
Studji bl- annimali wrew li hemm tossiċità għas- sistema riproduttiva b’ valsartan/ amlodipine simili ma ’ dik li ġiet deskritta għal valsartan u antagonisti oħra ta ’ angiotensin II (ara sezzjoni 5. 3).
Data on a limited number of exposed pregnancies indicate no adverse effects of amlodipine and other calcium receptor antagonists on the health of the foetus.
Tagħrif dwar numru limitat ta ’ esponimenti waqt it- tqala ma jurux effetti avversi ta ’ amlodipine jew antagonisti tar- riċetturi ta ’ calcium fuq is- saħħa tal - fetu.
Skin and subcutaneous tissue disorders
19 Disturbi tal- ġilda u tat- tessuti ta ’ taħt il- ġilda
Additional information on the individual components Adverse drug reactions previously reported with one of the individual components (amlodipine or valsartan) may be potential undesirable effects with Exforge as well, even if not observed in clinical trials or during the post-marketing period.
Aktar tagħrif dwar il- komponenti individwali Reazzjonijiet avversi għall- mediċina li kienu rappurtati qabel b’ wieħed mill- komponenti (amlodipine jew valsartan) jistgħu jkunu effetti mhux mixtieqa b’ Exforge ukoll, anki jekk ma dehrux waqt il- provi kliniċi jew waqt il- perjodu ta ’ wara it- tqegħid fis- suq.
Amlodipine Common Uncommon
20 Amlodipine Komuni Mhux komuni
Administration of valsartan to patients with hypertension results in a drop in blood pressure without affecting pulse rate.
22 L- għotja ta ’ valsartan lill- pazjenti li jsofru minn pressjoni għolja twassal għal waqa ’ fil- pressjoni tad - demm mingħajr ma jkun hemm effett fuq ir- rata tal- polz.
Amlodipine has been studied in patients with chronic stable angina, vasospastic angina and angiographically documented coronary artery disease.
23 Amlodipine kien studjat f’ pazjenti li jsofru minn anġina kronika stabbli, anġina vażospastika u mard ta ’ l- arterja koronarja dokumentat b’ anġjografija.
Elderly (age 65 years or over) Time to peak plasma amlodipine concentrations is similar in young and elderly patients.
24 Anzjani (età minn 65 sena ‘ l fuq) Il- ħin li jdumu biex jintlaħqu l- quċċati tal- konċentrazzjonijiet ta ’ amlodipine fil- plażma huma simili fiż- żgħażagħ u fil- pazjenti anzjani.
Cellulose microcrystalline Crospovidone Type A Silica, colloidal anhydrous Magnesium stearate
Cellulose microcrystalline Crospovidone Type A Silica, colloidal anhydrous
Exforge 10 mg/ 160 mg film-coated tablets
Exforge 10 mg/ 160 mg pilloli miksija b’ rita
Exforge 10 mg/ 160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg or valsartan 160 mg alone or with Exforge 5 mg/ 160 mg.
Exforge 10 mg/ 160 mg jista ’ jingħata lill- pazjenti li ma jkollhomx pressjoni kontrollata tajjeb b’ amlodipine 10 mg jew valsartan 160 mg waħidhom jew b’ Exforge 5 mg/ 160 mg.
Elderly (age 65 years or over) In elderly patients, caution is required when increasing the dosage.
28 Pazjenti anzjani (età 65 sena jew aktar) F’ pazjenti anzjani, hija meħtieġa l- kawtela meta tkun qed tiżdied id- doża.
26 Children and adolescents Exforge is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.
Tfal u adolexxenti Exforge mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan.
29 F’ pazjenti b’ indeboliment tal- fwied ħafif sa moderat mingħajr kolestażi, l- ogħla doża rakkomandata ta ’ valsartan hija 80 mg.
To be taken into account with concomitant use Others In monotherapy, amlodipine has been safely administered with thiazide diuretics, beta blockers, ACE inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, atorvastatin, sildenafil, anti-acid medicines (aluminium hydroxide gel, magnesium hydroxide, simeticone), cimetidine, non- steroidal anti-inflammatory medicines, antibiotics and oral hypoglycaemic medicines.
30 mediċini antaċidi (ġel ta ’ l- aluminium hydroxide, magnesium hydroxide, simeticone), cimetidine, mediċini anti- infjammatorji mhux sterojdi, antibijotiċi u mediċini ipogliċemiċi orali.
Oedema, pitting oedema, facial oedema, oedema peripheral, fatigue, flushing, 30
Edima, edima li titgħattan, edima tal- wiċċ, edima periferali, għeja, issir ruxxan, astenja, fawra
asthenia, hot flush Immune system disorders
Disturbi tas- sistema immuni
Additional information on the individual components Adverse drug reactions previously reported with one of the individual components (amlodipine or valsartan) may be potential undesirable effects with Exforge as well, even if not observed in clinical trials or during the post-marketing period.
Aktar tagħrif dwar il- komponenti individwali Reazzjonijiet avversi ghall- medicina li kienu rappurtati qabel b’ wieħed mill- komponenti (amlodipine jew valsartan) jistgħu jkunu effetti mhux mixtieqa b’ Exforge ukoll, anki jekk ma dehrux waqt il- provi kliniċi jew waqt il- perjodu ta ’ wara t- tqeghid fis- suq.
Amlodipine Common Uncommon
33 Amlodipine Komuni Mhux komuni
Arrhythmia, myocardial infarction, Rarely, patients, particularly those with severe obstructive coronary artery disease, have developed increased frequency, duration or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase.
Arritmija, infart mijokardijaku, B’ mod rari, il- pazjenti, l- aktar dawk li għandhom mard sever ta ’ mblokk tal- arterja koronarja, żviluppaw żieda fil- frekwenza, fit- tul ta ’ ħin jew fil- qawwa tal- anġina jew tal- infart mijokardijaku akut meta bdew kura b’ imblukkatur tal- kanali tal- kalċju jew fiż- żmien meta żdiedet id- doża.
Administration of valsartan to patients with hypertension results in a drop in blood pressure without affecting pulse rate.
35 L- għotja ta ’ valsartan lill- pazjenti li jsofru minn pressjoni għolja twassal għal waqa ’ fil- pressjoni tad - demm mingħajr ma jkun hemm effett fuq ir- rata tal- polz.
Amlodipine has been studied in patients with chronic stable angina, vasospastic angina and angiographically documented coronary artery disease.
36 Amlodipine kien studjat f’ pazjenti li jsofru minn anġina kronika stabbli, anġina vażospastika u mard ta ’ l- arterja koronarja dokumentat b’ anġjografija.
Elderly (age 65 years or over) Time to peak plasma amlodipine concentrations is similar in young and elderly patients.
37 Anzjani (età minn 65 sena ‘ l fuq) Il- ħin li jdumu biex jintlaħqu l- quċċati tal- konċentrazzjonijiet ta ’ amlodipine fil- plażma huma simili fiż- żgħażagħ u fil- pazjenti anzjani.
Exforge 5 mg/ 80 mg film-coated tablets amlodipine/ valsartan
Exforge 5 mg/ 80 mg pilloli miksija b’ rita amlodipine/ valsartan
Exforge 5 mg/ 160 mg film-coated tablets amlodipine/ valsartan
Exforge 5 mg/ 160 mg pilloli miksija b’ rita amlodipine/ valsartan
Exforge 10 mg/ 160 mg film-coated tablets amlodipine/ valsartan
Exforge 10 mg/ 160 mg pilloli miksija b’ rita amlodipine/ valsartan
What Exforge is and what it is used for 2.
X’ inhu Exforge u għalxiex jintuża 2.