qanastek/EMEA-V3 huggingface dataset:
54 Elderly patients: no dosage adjustment of Karvezide is necessary in elderly patients.
Pazjenti anzjani: m’ hemmx bżonn aġġustar fid- doża ta ’ Karvezide f’ pazjenti anzjani.
Karvezide 150 mg/ 12.5 mg tablets irbesartan/ hydrochlorothiazide
Pilloli Karvezide 150 mg/ 12. 5 mg irbesartan/ hydrochlorothiazide
EU/ 1/ 98/ 085/ 007 14 tablets EU/ 1/ 98/ 085/ 001 28 tablets EU/ 1/ 98/ 085/ 002 56 tablets EU/ 1/ 98/ 085/ 009 56 x 1 tablets EU/ 1/ 98/ 085/ 003 98 tablets
EU/ 1/ 98/ 085/ 007 14- il pillola EU/ 1/ 98/ 085/ 001 28 pillola EU/ 1/ 98/ 085/ 002 56 pillola EU/ 1/ 98/ 085/ 009 56 x 1 pillola EU/ 1/ 98/ 085/ 003 98 pillola
Karvezide 150 mg/ 12.5 mg
Karvezide 150 mg/ 12. 5 mg
Karvezide 150 mg/ 12.5 mg tablets irbesartan/ hydrochlorothiazide
Karvezide 150 mg/ 12. 5 mg pilloli irbesartan/ hydrochlorothiazide
Karvezide 300 mg/ 12.5 mg tablets irbesartan/ hydrochlorothiazide
Pilloli Karvezide 300 mg/ 12. 5 mg irbesartan/ hydrochlorothiazide
EU/ 1/ 98/ 085/ 008 14 tablets EU/ 1/ 98/ 085/ 004 28 tablets EU/ 1/ 98/ 085/ 005 56 tablets EU/ 1/ 98/ 085/ 010 56 x 1 tablets EU/ 1/ 98/ 085/ 006 98 tablets
EU/ 1/ 98/ 085/ 008 14- il pillola EU/ 1/ 98/ 085/ 004 28 pillola EU/ 1/ 98/ 085/ 005 56 pillola EU/ 1/ 98/ 085/ 010 56 x 1 pillola EU/ 1/ 98/ 085/ 006 98 pillola
Karvezide 300 mg/ 12.5 mg
Karvezide 300 mg/ 12. 5 mg
Karvezide 300 mg/ 12.5 mg tablets irbesartan/ hydrochlorothiazide
Karvezide 300 mg/ 12. 5 mg pilloli irbesartan/ hydrochlorothiazide
Karvezide 150 mg/ 12.5 mg film-coated tablets irbesartan/ hydrochlorothiazide
Karvezide 150 mg/ 12. 5 mg pilloli miksijin b' rita irbesartan/ hydrochlorothiazide
EU/ 1/ 98/ 085/ 011 14 tablets EU/ 1/ 98/ 085/ 012 28 tablets EU/ 1/ 98/ 085/ 029 30 tablets EU/ 1/ 98/ 085/ 013 56 tablets EU/ 1/ 98/ 085/ 014 56 x 1 tablets EU/ 1/ 98/ 085/ 021 84 tablets EU/ 1/ 98/ 085/ 032 90 tablets EU/ 1/ 98/ 085/ 015 98 tablets
EU/ 1/ 98/ 085/ 011 14- il pillola EU/ 1/ 98/ 085/ 012 28 pillola EU/ 1/ 98/ 085/ 029 30 pillola EU/ 1/ 98/ 085/ 013 56 pillola EU/ 1/ 98/ 085/ 014 56 x 1 pillola EU/ 1/ 98/ 085/ 021 84 pillola EU/ 1/ 98/ 085/ 032 90 pillola EU/ 1/ 98/ 085/ 015 98 pillola
Karvezide 300 mg/ 12.5 mg film-coated tablets irbesartan/ hydrochlorothiazide
Karvezide 300 mg/ 12. 5 mg pilloli miksijin b' rita irbesartan/ hydrochlorothiazide
EU/ 1/ 98/ 085/ 016 14 tablets EU/ 1/ 98/ 085/ 017 28 tablets EU/ 1/ 98/ 085/ 030 30 tablets EU/ 1/ 98/ 085/ 018 56 tablets EU/ 1/ 98/ 085/ 019 56 x 1 tablets EU/ 1/ 98/ 085/ 022 84 tablets EU/ 1/ 98/ 085/ 033 90 tablets EU/ 1/ 98/ 085/ 020 98 tablets
EU/ 1/ 98/ 085/ 016 14- il pillola EU/ 1/ 98/ 085/ 017 28 pillola EU/ 1/ 98/ 085/ 030 30 pillola EU/ 1/ 98/ 085/ 018 56 pillola EU/ 1/ 98/ 085/ 019 56 x 1 pillola EU/ 1/ 98/ 085/ 022 84 pillola EU/ 1/ 98/ 085/ 033 90 pillola EU/ 1/ 98/ 085/ 020 98 pillola
Karvezide 300 mg/ 25 mg film-coated tablets irbesartan/ hydrochlorothiazide
Karvezide 300 mg/ 25 mg pilloli miksijin b' rita irbesartan/ hydrochlorothiazide
EU/ 1/ 98/ 085/ 023 14 tablets EU/ 1/ 98/ 085/ 024 28 tablets EU/ 1/ 98/ 085/ 031 30 tablets EU/ 1/ 98/ 085/ 025 56 tablets EU/ 1/ 98/ 085/ 028 56 x 1 tablets EU/ 1/ 98/ 085/ 026 84 tablets EU/ 1/ 98/ 085/ 034 90 tablets EU/ 1/ 98/ 085/ 027 98 tablets
EU/ 1/ 98/ 085/ 023 14- il pillola EU/ 1/ 98/ 085/ 024 28 pillola EU/ 1/ 98/ 085/ 031 30 pillola EU/ 1/ 98/ 085/ 025 56 pillola EU/ 1/ 98/ 085/ 028 56 x 1 pillola EU/ 1/ 98/ 085/ 026 84 pillola EU/ 1/ 98/ 085/ 034 90 pillola EU/ 1/ 98/ 085/ 027 98 pillola
Karvezide 300 mg/ 25 mg tablets irbesartan/ hydrochlorothiazide
Karvezide 300 mg/ 25 mg pilloli irbesartan/ hydrochlorothiazide
INFORMATION FOR THE USER Karvezide 150 mg/ 12.5 mg tablets irbesartan/ hydrochlorothiazide
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Karvezide Pilloli 150 mg/ 12. 5 mg irbesartan/ hydrochlorothiazide
What Karvezide is and what it is used for 2.
X’ inhu Karvezide u għalxiex jintuża 2.
Before you take Karvezide 3.
Qabel ma tieħu Karvezide 3.
How to take Karvezide 4.
Kif għandek tieħu Karvezide 4.
How to store Karvezide 6.
Kif taħżen Karvezide 6.
WHAT KARVEZIDE IS AND WHAT IT IS USED FOR
X’ INHU KARVEZIDE U GĦALXIEX JINTUŻA
Karvezide is a combination of two active substances, irbesartan and hydrochlorothiazide.
Karvezide hu kombinazzjoni ta ’ żewġ sustanzi attivi, irbesartan u hydrochlorothiazide.
The two active ingredients in Karvezide work together to lower blood pressure further than if either was given alone.
Iż- żewġ sustanzi attivi f’ Karvezide jaħdmu flimkien biex inaqqsu l- pressjoni iktar milli kieku jingħataw waħidhom.
Karvezide is used in the treatment of high blood pressure (essential hypertension), when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure.
Karvezide jintuża fil- kura għall- pressjoni għolja (pressjoni għolja essenzjali), meta l- kura b’ irbesartan jew hydrochlorothiazide waħedhom ma tipprovdix kontroll adattat għall- pressjoni tiegħek.
BEFORE YOU TAKE KARVEZIDE
QABEL MA TIEĦU KARVEZIDE
Do not take Karvezide if you are allergic (hypersensitive) to irbesartan and hydrochlorothiazide, or any of the other ingredients of Karvezide or to medicines chemically related to sulfonamide (ask your doctor or pharmacist for further clarification) during the last 6 months of pregnancy, see section Pregnancy and breastfeeding if you are breast-feeding if you have severe liver or kidney problems if you have difficulty in producing urine if you have a condition which is associated with persistently high calcium or low potassium levels in your blood
Tiħux Karvezide jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal irbesartan u hydrochlorothiazide jew sustanzi oħra ta 'Karvezide jew għal mediċini kimikament relatati ma ’ sulfonamide (staqsi lit- tabib jew lill- ispiżjar tiegħek għal aktar tagħrif) matul l- aħħar sitt xhur tat- tqala, ara s- sezzjoni Tqala u Treddigħ jekk qegħda tredda ’ jekk inti għandek problemi severi tal- fwied jew tal- kliewi jekk inti għandek diffikultà biex tagħmel l- awrina jekk inti għandek kondizzjoni assoċjata ma ’ livelli persistenti ta ’ calcium għoli jew potassium baxx fid- demm tiegħek
Karvezide should not be given to children and adolescents (under 18 years).
Karvezide m’ għandux jingħata lit- tfal u lill- adoloxxenti (inqas minn 18- il sena).
Take special care with Karvezide Tell your doctor if any of the following apply to you: if you get excessive vomiting or diarrhoea if you suffer from kidney problems, including kidney transplantation if you suffer from heart problems
Oqgħod attent ħafna b’ Karvezide Avża lit- tabib tiegħek jekk xi waħda minn dawn tapplika għalik: jekk ikollok rimettar jew dijarea eċċessiva jekk inti tbati minn problemi tal- kliewi, li jinkludu trapjant tal- kliewi jekk inti tbati minn problemi tal- qalb
Karvezide is not recommended in early pregnancy and may cause serious harm to your baby after 3 months of pregnancy, see section Pregnancy and breastfeeding.
Karvezide mhuwiex rakkomandat kmieni matul it- tqala u dan jista ’ jikkawża ħsara serja għat- tarbija tiegħek wara l- ewwel 3 xhur tat- tqala, ara s- sezzjoni Tqala u Treddigħ.
You should also tell your doctor: if you are on a low-salt diet if you have signs such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide (contained in Karvezide) if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal if you are going to have an operation (surgery) or be given anaesthetics
Int għandek tgħid ukoll lit- tabib tiegħek: jekk int qiegħed/ qiegħda fuq dieta nieqsa mill- melħ jekk int qed turi sinjali bħal għatx mhux tas- soltu, ħalq xott, għejja ġenerali, ngħas, uġigħ fil- muskoli jew bugħawwieġ, dardir, rimettar jew taħbit tal- qalb mgħaġġel mhux normali li jistgħu jseħħu minħabba effett eċċessiv ta ’ hydrochlorothiazide (li hemm fi Karvezide) jekk tesperjenza żieda fis- sensittività tal- ġilda għax- xemx b’ sintomi ta ’ ħruq (bħal ħmura, ħakk, nefħa, bżieżaq) li jseħħu aktar frekwenti min- normal jekk tkun se tagħmel xi operazzjoni (kirurġija) jew tkun se tirċievi anistetiku
Diuretic agents such as the hydrochlorothiazide contained in Karvezide may have an effect on other medicines.
Dijuretiċi bħal hydrochlorothiazide li jinstab f’ Karvezide jista ’ jkollhom effett fuq mediċini oħra.
Preparations containing lithium should not be taken with Karvezide without close supervision by your doctor.
Preparazzjonijiet li fihom lithium m’ għandhomx jittieħdu ma ’ Karvezide jekk ma tkunx taħt is - superviżjoni mill- viċin tat- tabib tiegħek.
Taking Karvezide with food and drink Karvezide can be taken with or without food.
Meta tieħu Karvezide ma ’ l- ikel u max- xorb Karvezide jista ’ jittieħed bi jew mingħajr ikel.
Due to the hydrochlorothiazide contained in Karvezide, if you drink alcohol while on treatment with this medicine, you may have an increased feeling of dizziness on standing up, specially when getting up from a sitting position.
Minħabba l- hydrochlorothiazide li hemm fi Karvezide, jekk tixrob l- alkoħol meta tkun qed tieħu l - kura b’ din il- mediċina, jista ’ jkollok sensazzjoni miżjuda ta ’ sturdament meta tqum bil- wieqfa, b’ mod speċjali meta tqum minn pożizzjoni bil- qiegħda.
Usually, your doctor will advise you to take another medicine instead of Karvezide, as Karvezide is not recommended in early pregnancy, and may cause serious harm to your baby if it is used after 3 months of pregnancy.
Normalment, it- tabib tiegħek jagħtik parir li tieħu mediċina oħra minflok Karvezide, minħabba li Karvezidemhuwiex rakkomandat kmieni matul it- tqala, u dan jista ’ jikkawża ħsara serja għat- tarbija tiegħek jekk jintuża wara l- ewwel 3 xhur tat- tqala.
Appropriate antihypertensive drug must usually replace Karvezide before starting a pregnancy.
Mediċina xierqa kontra l- pressjoni għolja għandha normalment
88 Your doctor will normally advise you to stop taking Karvezide as soon as you know you are pregnant.
Normalment, it- tabib tiegħek jagħtik il- parir li tieqaf tieħu Karvezide malli ssir taf li inti ħriġt tqila.
If you become pregnant during therapy with Karvezide, please inform and see your doctor without delay.
Jekk toħroġ tqila matul terapija b ’ Karvezide, jekk jogħġbok avża u ara lit- tabib tiegħek minnufih.
Karvezide is unlikely to affect your ability to drive or use machines.
Karvezide mhux suppost li jtellfek milli ssuq jew tħaddem magni.
Important information about some of the ingredients of Karvezide Karvezide contains lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Karvezide Karvezide fih il- lactose.
HOW TO TAKE KARVEZIDE
KIF GĦANDEK TIEĦU KARVEZIDE
Always take Karvezide exactly as your doctor has told you.
Dejjem għandek tieħu Karvezide skond il- parir tat- tabib.
Dosage The usual dose of Karvezide is one or two tablets a day.
Dożaġġ Id- doża normali ta ’ Karvezide hija pillola waħda jew tnejn kuljum.
Karvezide will usually be prescribed by your doctor when your previous treatment for high blood pressure did not provide appropriate blood pressure reduction.
Karvezide ġeneralment jiġi preskritt mit- tabib tiegħek meta l- kura li kont tieħu qabel għal kontra l- pressjoni għolja ma pprovdietx tnaqqis xieraq tal- pressjoni.
Your doctor will instruct you how to switch from the previous treatment to Karvezide.
It- tabib tiegħek igħidlek kif għandek tagħmel biex taqleb mill- kura li kont qed tieħu qabel għal Karvezide.
Method of administration Karvezide is for oral use.
Kif għandek tieħu l- mediċina Karvezide huwa għal użu orali.
You can take Karvezide with or without food.
Tista ’ tieħu Karvezide bi jew mingħajr ikel.
It is important that you continue to take Karvezide until your doctor tells you otherwise.
Huwa importanti li tkompli tieħu Karvezide sakemm it- tabib tiegħek ma jgħidlekx mod ieħor.
If you take more Karvezide than you should If you accidentally take too many tablets, contact your doctor immediately.
Jekk tieħu Karvezide aktar milli suppost Jekk aċċidentalment tieħu ħafna pilloli, għid lit- tabib tiegħek minnufih.
Children should not take Karvezide Karvezide should not be given to children under 18 years of age.
It- tfal ma għandhomx jieħdu Karvezide Karvezide ma għandux jingħata lil tfal iżgħar minn 18- il sena.
If you forget to take Karvezide If you accidentally miss a daily dose, just take the next dose as normal.
Jekk tinsa tieħu Karvezide Jekk aċċidentalment taqbeż id- doża tal- ġurnata, ħu d- doża li jmiss bħas- soltu.
Like all medicines, Karvezide can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Karvezide jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
If you get any of these symptoms or get short of breath, stop taking Karvezide and contact your doctor immediately.
92 Jekk ikollok xi sintomu minn dawn jew tesperjenza qtugħ ta ’ nifs, waqqaf Karvezide u għid lit- tabib tiegħek minnufih.
Side effects reported in clinical studies for patients treated with Karvezide were:
L- effetti sekondarji rrapportati fi studji kliniċi għal pazjenti kkurati b’ Karvezide kienu:
Some undesirable effects have been reported since the marketing of Karvezide but the frequency for them to occur is not known.
Minn meta Karvezide tqiegħed fis- suq ġew irrapportati xi effetti mhux mixtieqa iżda l- frekwenza għalihom biex iseħħu m’ hijiex magħrufa.
Additional side effects associated with the other component of Karvezide (hydrochlorothiazide) alone are: loss of appetite; stomach irritation; stomach cramps; constipation; jaundice seen as yellowing of the skin and/ or whites of the eyes; inflammation of the pancreas characterised by severe upper stomach pain, often with nausea and vomiting; sleep disorders; depression; blurred vision; lack of white blood cells, which can result in frequent infections, fever; decrease in the number of platelets (a blood cell essential for the clotting of the blood), decreased number of red blood cells (anaemia) characterised by tiredness, headaches, being short of breath when exercising, dizziness and looking pale; kidney disease; lung problems including pneumonia or build-up of fluid in the lungs; increased sensitivity of the skin to the sun; inflammation of blood vessels; a skin disease characterized by the peeling of the skin all over the body; cutaneous lupus erythematosus, which is identified by a rash that may appear on the face, neck, and scalp; allergic reactions; weakness and muscle spasm; altered heart rate; reduced blood pressure after a change in body position; swelling of the salivary glands; high sugar levels in the blood; sugar in the urine; increases in some kinds of blood fat; high uric acid levels in the blood, which may cause gout.
Effetti sekondarji addizzjonali assoċjati mal- komponent l- ieħor ta 'Karvezide (hydrochlorothiazide) waħdu huma: nuqqas ta ’ aptit; irritazzjoni ta ’ l- istonku; bugħawwiġ fl- istonku; stitikezza, suffejra li tidher bħala sfurija tal- ġilda u/ jew ta ’ l- abjad ta ’ l- għajnejn; infjammazzjoni tal- frixa kkaratterizzata b’ uġigħ sever fil- parti ta ’ fuq ta ’ l- istonku, spiss b’ dardir u rimettar; disturbi fl- irqad; dipressjoni; vista mċajpra; nuqqas ta ’ ċelloli bojod tad- demm, li jistgħu jirriżultaw f’ infezzjonijiet frekwenti, deni; tnaqqis fin- numru ta ’ plejtlits (ċellola tad- demm essenzjali għall- għaqid tad- demm), numru mnaqqas taċ- ċelloli tad- demm ħomor (anemija) ikkaratterizzat minn għejja, uġigħ ta ’ ras, qtugħ ta ’ nifs waqt eżerċizzju, sturdament u dehra pallida; mard fil- kliewi; problemi fil- pulmun inkluż pulmonite jew akkumulazzjoni ta ’ fluwidu fil- pulmun; sensittività miżjuda tal- ġilda fix- xemx; infjammazzjoni tal - vażi tad- demm; marda tal- ġilda kkaratterizzata mit- tqaxxir tal- ġilda fuq il- ġisem kollu; lupus erythematosus tal- ġilda, li hija identifikata minn raxx li jista ’ jidher fuq il- wiċċ, għonq u qorrija; reazzjonijiet allerġiċi; dgħjufija u spażmu tal- muskoli; rata tat- taħbit tal- qalb mibdula; tnaqqis fil - pressjoni tad- demm wara bidla fil- qagħda tal- ġisem; nefħa tal- glandoli tal- bżieq; livelli ta' zokkor għoljin fid- demm; zokkor fl- awrina; żidiet f' xi tipi ta 'xaħam fid- demm; livelli ta' aċidu uriku fid - demm għoljin, li jista ’ jikkawża gotta.
HOW TO STORE KARVEZIDE
KIF TAĦŻEN KARVEZIDE
Do not use Karvezide after the expiry date which is stated on the carton and on the blister after EXP.
Tużax Karvezide wara d- data ta ’ skadenza li tidher fuq il- kaxxa jew fuq il- folja wara JIS.
90 Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What Karvezide contains The active substances are irbesartan and hydrochlorothiazide.
X’ fih Karvezide Is- sustanzi attivi huma irbesartan u hydrochlorothiazide.
Each tablet of Karvezide 150 mg/ 12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Kull pillola ta ’ Karvezide 150 mg/ 12. 5 mg fiha 150 mg irbesartan u 12. 5 mg hydrochlorothiazide.
What Karvezide looks like and contents of the pack Karvezide 150 mg/ 12.5 mg tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2775 engraved on the other side.
Id- dehra ta ’ Karvezide u l- kontenuti tal- pakkett Il- pilloli Karvezide 150 mg/ 12. 5 mg huma lewn il- ħawħa, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb ibbuzzata fuq naħa waħda u n- numru 2775 fuq in- naħa l- oħra.
Karvezide 150 mg/ 12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Il- pilloli Karvezide 150 mg/ 12. 5 mg huma pprovduti f’ pakketti f’ folji ta ’ 14, 28, 56 jew 98 pillola.
Marketing Authorisation Holder BRISTOL-MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH - United Kingdom
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq BRISTOL- MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH - Ir- Renju Unit
92 Κύπρος ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε .Π .Ε.
95 Κύπρος ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε. Π. Ε.
INFORMATION FOR THE USER Karvezide 300 mg/ 12.5 mg tablets irbesartan/ hydrochlorothiazide
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Karvezide Pilloli 300 mg/ 12. 5 mg irbesartan/ hydrochlorothiazide
95 Your doctor will normally advise you to stop taking Karvezide as soon as you know you are pregnant.
Normalment, it- tabib tiegħek jagħtik il- parir li tieqaf tieħu Karvezide malli ssir taf li inti ħriġt tqila.
Dosage The usual dose of Karvezide is one tablet a day.
Dożaġġ Id- doża normali ta ’ Karvezide hija pillola waħda kuljum.
Karvezide will usually be prescribed by your doctor when your previous treatment for high blood pressure did not provide appropriate blood pressure reduction.
Karvezide ġeneralment jiġi preskritt mit - tabib tiegħek meta l- kura li kont tieħu qabel għal kontra l- pressjoni għolja ma pprovdietx tnaqqis xieraq tal- pressjoni.
If you get any of these symptoms or get short of breath, stop taking Karvezide and contact your doctor immediately.
99 Jekk ikollok xi sintomu minn dawn jew tesperjenza qtugħ ta ’ nifs, waqqaf Karvezide u għid lit- tabib tiegħek minnufih.
96 Common: affects 1 to 10 users in 100 Uncommon: affects 1 to 10 users in 1,000 Not known: frequency cannot be estimated from the available data.
Komuni: taffettwa pazjent 1 sa 10 minn kull 100 Mhux komuni: taffettwa pazjent 1 sa 10 minn kull 1, 000 Mhux magħrufa: il- frekwenza ma tistax tiġi stmata mit- tagħrif disponibbli.
Each tablet of Karvezide 300 mg/ 12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Kull pillola ta ’ Karvezide 300 mg/ 12. 5 mg fiha 300 mg irbesartan u 12. 5 mg hydrochlorothiazide.
What Karvezide looks like and contents of the pack Karvezide 300 mg/ 12.5 mg tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2776 engraved on the other side.
Id- dehra ta ’ Karvezide u l- kontenuti tal- pakkett Il- pilloli Karvezide 300 mg/ 12. 5 mg huma lewn il- ħawħa, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb ibbuzzata fuq naħa waħda u n- numru 2776 fuq in- naħa l- oħra.
Karvezide 300 mg/ 12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Il- pilloli Karvezide 300 mg/ 12. 5 mg huma pprovduti f’ pakketti f’ folji ta ’ 14, 28, 56 jew 98 pillola.
99 Κύπρος ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε .Π .Ε.
102 Κύπρος ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε. Π. Ε.
INFORMATION FOR THE USER Karvezide 150 mg/ 12.5 mg film-coated tablets irbesartan/ hydrochlorothiazide
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Karvezide 150 mg/ 12. 5 mg pilloli miksijin b' rita. irbesartan/ hydrochlorothiazide
102 Your doctor will normally advise you to stop taking Karvezide as soon as you know you are pregnant.
Normalment, it- tabib tiegħek jagħtik il- parir li tieqaf tieħu Karvezide malli ssir taf li inti ħriġt tqila.
If you become pregnant during therapy with Karvezide, please inform and see your doctor without delay.
Jekk toħroġ tqila matul terapija b ’ Karvezide, jekk jogħġbok avża u ara lit- tabib tiegħek minnufih..
If you get any of these symptoms or get short of breath, stop taking Karvezide and contact your doctor immediately.
106 Jekk ikollok xi sintomu minn dawn jew tesperjenza qtugħ ta ’ nifs, waqqaf Karvezide u għid lit- tabib tiegħek minnufih.
Do not use Karvezide after the expiry date which is stated on the carton and on the blister after EXP.
Tużax Karvezide wara d- data ta ’ skadenza li tidher fuq il- kaxxa jew fuq it- tikketta wara JIS.
104 Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
Each film-coated tablet of Karvezide 150 mg/ 12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Kull pillola miksija b' rita ta ’ Karvezide 150 mg/ 12. 5 mg fiha 150 mg irbesartan u 12. 5 mg hydrochlorothiazide.
What Karvezide looks like and contents of the pack Karvezide 150 mg/ 12.5 mg film-coated tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2875 engraved on the other side.
Id- dehra ta ’ Karvezide u l- kontenuti tal- pakkett Il- pilloli miksijin b' rita Karvezide 150 mg/ 12. 5 mg huma lewn il- ħawħa, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb ibbuzzata fuq naħa waħda u n- numru 2875 fuq in- naħa l- oħra.
Karvezide 150 mg/ 12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Il- pilloli miksijin b' rita Karvezide 150 mg/ 12. 5 mg huma fornuti fi strixxi ta '14, 28, 30, 56, 84, 90 jew 98 pillola miksija b' rita.
106 Κύπρος ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε .Π .Ε.
109 Κύπρος ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε. Π. Ε.
INFORMATION FOR THE USER Karvezide 300 mg/ 12.5 mg film-coated tablets irbesartan/ hydrochlorothiazide
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Karvezide 300 mg/ 12. 5 mg pilloli miksijin b' rita. irbesartan/ hydrochlorothiazide
109 Your doctor will normally advise you to stop taking Karvezide as soon as you know you are pregnant.
Normalment, it- tabib tiegħek jagħtik il- parir li tieqaf tieħu Karvezide malli ssir taf li inti ħriġt tqila.
If you get any of these symptoms or get short of breath, stop taking Karvezide and contact your doctor immediately.
113 Jekk ikollok xi sintomu minn dawn jew tesperjenza qtugħ ta ’ nifs, waqqaf Karvezide u għid lit- tabib tiegħek minnufih.
110 Common: affects 1 to 10 users in 100 Uncommon: affects 1 to 10 users in 1,000 Not known: frequency cannot be estimated from the available data.
Komuni: taffettwa pazjent 1 sa 10 minn kull 100 Mhux komuni: taffettwa pazjent 1 sa 10 minn kull 1, 000 Mhux magħrufa: il- frekwenza ma tistax tiġi stmata mit- tagħrif disponibbli.
Each film-coated tablet of Karvezide 300 mg/ 12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Kull pillola miksija b' rita ta ’ Karvezide 300 mg/ 12. 5 mg fiha 300 mg irbesartan u 12. 5 mg hydrochlorothiazide.
What Karvezide looks like and contents of the pack Karvezide 300 mg/ 12.5 mg film-coated tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2876 engraved on the other side.
Id- dehra ta ’ Karvezide u l- kontenuti tal- pakkett Il- pilloli miksijin b' rita Karvezide 300 mg/ 12. 5 mg huma lewn il- ħawħa, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb ibbuzzata fuq naħa waħda u n- numru 2876 fuq in- naħa l- oħra.
Karvezide 300 mg/ 12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Il- pilloli miksijin b' rita Karvezide 300 mg/ 12. 5 mg huma fornuti fi strixxi ta '14, 28, 30, 56, 84, 90 jew 98 pillola miksija b' rita.
INFORMATION FOR THE USER Karvezide 300 mg/ 25 mg film-coated tablets irbesartan/ hydrochlorothiazide
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Karvezide 300 mg/ 25 mg pilloli miksijin b' rita. irbesartan/ hydrochlorothiazide
116 Your doctor will normally advise you to stop taking Karvezide as soon as you know you are pregnant.
Normalment, it- tabib tiegħek jagħtik il- parir li tieqaf tieħu Karvezide malli ssir taf li inti ħriġt tqila.
If you get any of these symptoms or get short of breath, stop taking Karvezide and contact your doctor immediately.
120 Jekk ikollok xi sintomu minn dawn jew tesperjenza qtugħ ta ’ nifs, waqqaf Karvezide u għid lit- tabib tiegħek minnufih.
117 Common: affects 1 to 10 users in 100 Uncommon: affects 1 to 10 users in 1,000 Not known: frequency cannot be estimated from the available data.
Komuni: taffettwa pazjent 1 sa 10 minn kull 100 Mhux komuni: taffettwa pazjent 1 sa 10 minn kull 1, 000 Mhux magħrufa: il- frekwenza ma tistax tiġi stmata mit- tagħrif disponibbli.
Each film-coated tablet of Karvezide 300 mg/ 25 mg contains 300 mg irbesartan and 25 mg hydrochlorothiazide.
Kull pillola miksija b' rita ta ’ Karvezide 300 mg/ 25 mg fiha 300 mg irbesartan u 25 mg hydrochlorothiazide.
What Karvezide looks like and contents of the pack Karvezide 300 mg/ 25 mg film-coated tablets are pink, biconvex, oval-shaped, with a heart debossed on one side and the number 2788 engraved on the other side.
Id- dehra ta ’ Karvezide u l- kontenuti tal- pakkett Il- pilloli miksijin b' rita Karvezide 300 mg/ 25 mg huma roża, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb ibbuzzata fuq naħa waħda u n- numru 2788 fuq in- naħa l- oħra.
Karvezide 300 mg/ 25 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Il- pilloli miksijin b' rita Karvezide 300 mg/ 25 mg huma fornuti fi strixxi ta '14, 28, 30, 56, 84, 90 jew 98 pillola miksija b' rita.
120 Κύπρος ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε .Π .Ε.
123 Κύπρος ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε. Π. Ε.
SUMMARY OF PRODUCT CHARACTERISTICS
KARATTERISTI I TAL- PRODOTT FIL- QOSOR
Kentera 3.9 mg / 24 hours, transdermal patch
Kentera 3. 9 mg / 24 sieg a, gar a li tipprovdi medi ina li tg addi minn ol - ilda (impjastru transdermali)
Each transdermal patch contains 36 mg of oxybutynin.
Kull gar a li tipprovdi medi ina li tg addi minn ol - ilda fih 36 mg ta ’ oxybutynin.
The area of the patch is 39 cm2, releasing a nominal 3.9 mg of oxybutynin per 24 hours.
L- erja ta ’ l - impjastru hija ta ’ 39 cm2, li ter i 3. 9 mg nominali ta ’ oxybutynin kull 24 sieg a.
For excipients, see section 6.1.
G al sustanzi mhux attivi, ara 6. 1.
Transdermal patch.
Gar a li tipprovdi medi ina li tg addi minn ol - ilda
Symptomatic treatment of urge incontinence and/ or increased urinary frequency and urgency as may occur in patients with unstable bladder
Kura simptomatika ta ’ impuls ta ’ l- inkontinenza u/ jew jieda fil- frekwenza urinarja u ur enza li tista ’ isse f’ pazjenti b’ bu ieqa ta ’ l- awrina instabbli
The patch should be applied to dry, intact skin on the abdomen, hip, or buttock immediately after removal from the protective sachet.
L- impjastru g andu ji i applikat fuq ilda xotta u intatta fuq l- addome, il - enbejn, jew il- warrani immedjatament wara li titne a minn ol- qartas protettiv.
A new application site should be selected with each new patch to avoid reapplication to the same site within 7 days.
Parti dida tal - isem g andha tintag el ma ’ kull applikazzjoni dida ta ’ kull impjastru did biex ti i evitata l- applikazzjoni mill - did fl- istess parti f ’ mien 7 t’ ijiem.
The recommended dose is one 3.9 mg transdermal patch applied twice weekly (every 3 to 4 days).
Id- do a rrakkomandata hija ta 'a li tipprovdi medi ina li tg addi minn ol - ilda wa da ta ’ 3. 9 mg gar li ji i applikat darbtejn fil - img a (kull 3 sa 4 t’ ijiem).
No studies have been performed in children or adolescents, therefore Kentera is not recommended for use in children or adolescents.
L- ebda studji ma saru fit- tfal jew fl- adolexxenti, g alhekk Kentera m’ hiex rakkomandata g all- u u fit - tfal jew fl- adolexxenti.
Hypersensitivity to the active substance or to any other excipients of the transdermal patch.
Sensittività e essiva g as- sustanza attiva jew g al xi sustanzi mhux attivi o ra tal- gar a li tipprovdi medi ina li tg addi minn ol - ilda.
Kentera is contraindicated in patients with urinary retention, severe gastro-intestinal condition, myasthenia gravis or narrow-angle glaucoma and in patients who are at risk for these conditions.
Kentera m’ g andhiex tintu a f’ pazjenti li g andhom ritenzjoni ta ’ l- awrina, kondizzjoni gastrointestinali serja, myasthenia gravis jew narrow- angle glaucoma u f’ pazjenti li huma f’ riskju g al dawn il- kondizzjonijiet.
4.4 Special warnings and special precautions for use
4. 4 Avvi i spe jali u prekawzjonijiet spe jali g all- u u
Kentera should be used with caution in patients with hepatic or renal impairment.
Kentera g anda jintu a b’ attenzjoni f’ pazjenti b’ mard epatiku jew renali.
The use of Kentera in patients with hepatic impairment should be carefully monitored.
L- u u ta ’ Kentera f’ pazjenti b’ mard epatiku g andu jkun osservat b’ attenzjoni.
Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with Kentera.
Kaw i o ra ta ’ ieda fil- frekwenza ta ’ l- awrina (il - qalb ma tkunx qed ta dem sewwa jew mard renali) g andhom ikunu mist arr a qabel il- kura b’ Kentera.
If urinary tract infection is present, an appropriate antibacterial therapy should be started.
Jekk xi infezzjoni fl- apparat urinarju tkun pre enti, terapija anti- batterika adattata g andha tinbeda.
Urinary Retention:
2 Ritenzjoni ta ’ l- awrina:
Antichloinergic products should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention.
Il- prodotti anti- koliner i i g andhom ikunu mog tija b’ attenzjoni lill- pazjenti b’ ostruzzjoni klinikament sinifikattiva fl- i bokk tal- bu ieqa ta ’ l- awrina min abba r- riskju ta ’ ritenzjoni ta ’ l- awrina.
Because anticholinergic agents such as oxybutynin may produce drowsiness, somnolence, or blurred vision, patients should be advised to exercise caution.
Min abba li s- sustanzi anti- koliner i i b al oxybutynin jistg u jipprodu u edla, ng as kbir, jew vista m ajpra, il- pazjenti g andhom jing ataw parir biex joqg odu attenti.
Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents such as oxybutynin.
Il- pazjenti g andhom ikunu infurmati li l- alko ol jista ’ j id il - edla ikkaw ata minn sustanzi anti- koliner i i b al oxybutynin.
2 Kentera should be used with caution in elderly patients, who may be more sensitive to the effects of centrally acting anticholinergics and exhibit differences in pharmacokinetics..
Kentera g anda tintu a b’ attenzjoni f’ pazjenti anzjani, li jistg u jkunu aktar sensittivi g all- effetti anti- koliner i i b’ azzjoni entrali u juru differenzi fil- farmakokineti i..
Oral administration of oxybutynin may warrant the following cautionary statements, but these events were not observed during clinical trials with Kentera:
L- g oti mill - alq ta ’ oxybutynin jista ’ ji ustifika dawn id- dikjarazzjoniet ta ’ twissija li ejjin, i da dawn l- okkorrenzi ma kinux osservati waqt l- esperimenti klini i b’ Kentera:
Gastrointestinal Disorders:
Disturbi Gastrointestinali:
Anticholinergic medicinal products may decrease gastrointestinal motility and should be used with caution in patients with gastrointestinal obstructive disorders because of the risk of gastric retention.
Prodotti medi inali anti- koliner i i jistg u jnaqqsu l- motilità gastrointestinali u g andhom jintu aw b’ attenzjoni f’ pazjenti bi disturbi gastrointestinali ostruttivi min abba r- riskju ta ’ ritenzjoni fl- istonku.
Also in conditions such as ulcerative colitis, and intestinal atony.
Ukoll f’ kondizzjonijiet b al kolite ul erattiva, u ‘ intestinal atony ’.
Anticholinergic medicinal products should be used with caution in patients who have hiatus hernia/ gastro-oesophageal reflux and/ or who are concurrently taking medicinal products (such as bisphosphonates) that can cause or exacerbate oesophagitis.
Prodotti medi inali anti- koliner i i g andhom jintu aw b’ attenzjoni f’ pazjenti li g andhom hiatus hernia / rifluss gastro- esofagali u/ jew li huma qed jie du prodotti medi inali flimkien b all- bisfosfonejts li jistg u jikkaw aw jew i arrxu l - esofa ite.
Anticholinergic medicinal products should be used with caution in patients who have autonomic neuropathy, cognitive impairment or Parkinson's disease
Il- prodotti medi inali anti- koliner i i g andhom jintu aw b’ attenzjoni f’ pazjenti li g andhom newropatija awtonomika, mard konoxxittiv jew il- marda ta ’ Parkinson.
Patients should be informed that heat prostration (fever and heat stroke due to decreased sweating) can occur when anticholinergics such as oxybutynin are used in a hot environment.
Pazjenti g andhom ikunu infurmati li telqa kbira min abba s- s ana (deni u heat stroke min abba nuqqas ta ’ g araq) tista ’ sse meta anti- koliner i i b al oxybutynin jintu aw f’ ambjent s un.
Oxybutynin may exacerbate the symptoms of hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia, hypertension and prostatic hypertrophy
Oxybutynin jista ’ j arrax is- sintomi ta ’ ipertirojdi mu, mard koronarju tal- qalb, insuffi jenza tal- qalb kon estiva, arritmji kardija i, takikardja, pressjoni g olja u ipertrofija tal- prostata.
Oxybutynin may lead to suppressed salivary secretions which could result in dental caries, parodontosis or oral candidiasis.
Oxybutynin jista ’ jwassal g al tra in fit- tnixxija tal- b ieq li jista ’ jirri ulta f’ ta sir tas- snien, paradontosi (parodontosis) jew kandidjasi tal - alq.
4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti medi inali o ra li ma jaqblux ma ’ dan il- prodott u affarjiet o ra li jistg u jibdlu l- effett farma ewtiku tal- prodott
The concomitant use of oxybutynin with other anticholinergic medicinal products or with other agents that compete for CYP3A4 enzyme metabolism may increase the frequency or severity of dry mouth, constipation, and drowsiness.
L- u u konkomitanti ta ’ oxybutynin ma ’ prodotti anti- koliner i i medi inali o ra jew ma ’ sustanzi o ra li jikkompetu g all- en ima tal- metaboli mu CYP3A4 jista ’ j id il- frekwenza jew is- severità ta ’ alq xott, stitikezza, u edla.
Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility.
Is- sustanzi anti- koliner i i jistg u potenzjalment ibiddlu l- assorbiment ta ’ xi medi ini mog tija flimkien min abba l- effetti anti- koliner i i fuq il- motilità gastrointestinali.
As oxybutynin is metabolised by cytochrome P 450 isoenzyme CYP 3A4, interactions with drugs that inhibit this isoenzyme cannot be ruled out.
Billi oxybutynin huwa metabolizzat mi - itokromju P 450 isoen im CYP 3A4, l- azzjonijiet re ipro i b’ medi ini li jinibixxu ’ l dan l- isoen im ma jistg ux ikunu esklu i.
This should be borne in mind when using azole antifungals (e. g. ketoconasole) or macrolide antibiotics (e. g. erythromycin) concurrently with oxybutynin.
Wie ed g andu j omm dan f’ mo u meta ju a medi ini antifungali tat- tip azole (e. ketoconasole) jew l- antibijoti i macrolide (e. erythromycin) flimkien ma ’ oxybutynin.
The anticholinergic activity of oxybutynin is increased by concurrent use of other anticholinergics or drugs with anticholinergic activity, such as amantadine and other anticholinergic antiparkinsonian drugs (e. g. biperiden, levodopa), antihistamines, antipsychotics (e. g. phenothiazines, butyrophenones, clozapine), quinidine, tricyclic antidepressants, atropine and related compounds like atropinc antispasmodics, dipyridamole.
L- attività anti- koliner ika ta ’ oxybutynin ti died bl- u u flimkien ma ’ anti- koliner i i o ra jew b’ medi ini b’ attività anti- koliner ika, b all- amantadine u medi ini o ra anti- koliner i i anti - parkinsonjani (e. biperiden, levodopa), anti- istamini, anti- psikoti i (e. fenotaja ins (phenothiazines), butirofinowns (butyrophenones), clozapine, quinidine, anti- dipressanti tri ikli i, atropine u ta litiet relatati b all- atropini i (atropinic) anti- spasmodi i (antispasmodics), dipyridamole.
Oxybutynin may antagonize prokinetic therapies.
3 Oxybutynin jista ’ jantagonizza terapiji prokineti i.
4.6 Pregnancy and lactation
4. 6 Tqala u effetti fuq il - alib tas- sider
Pregnancy There are no adequate data on the use of oxybutynin transdermal patch in pregnant women.
Tqala M’ hemmx informazzjoni adegwata dwar l- u u tal- gar a li tipprovdi medi ina li tg addi minn ol - ilda ta ’ oxybutynin f’ nisa tqal.
Studies in animals have shown minor reproductive toxicity (see section 5.3).
Studji f’ annimali wrew tossi ità tas- sistema riproduttiva minuri (ara sezzjoni 5. 3).
Kentera should not to be used during pregnancy unless clearly necessary
Kentera m’ g andhiex tintu a waqt it- tqala lief jekk verament me tie.
3 Lactation When oxybutynin is used during lactation, a small amount is excreted in the mother’ s milk.
Treddig Meta oxybutynin jintu a waqt it- treddig, ammont g ir jo ro fil - alib ta ’ l- omm.
Breast feeding while using oxybutynin is therefore not recommended.
G alhekk, it - treddig waqt li jkun qed jintu a oxybutynin mhux rakkomandat.
Oxybutynin may cause drowsiness, blurred vision, dizziness and fatigue, therefore caution is recommended when driving or operating machines.
Oxybutynin jista ’ jikkaw a edla, vista m ajpra, sturdament u g ejja kbira, g alhekk wie ed g andu joqg od attent meta jkun qed isuq jew ju a xi magni.
The most commonly reported adverse drug reactions were application site reaction (Kentera 23.1%, placebo 7.6%).
4. 8 Effetti mhux mixtieqa L- aktar reazzjonijet avversi komuni tal- medi ina rrapurtati kienu reazzjoni fil- parti ta ’ l- applikazzjoni (Kentera 23. 1%, pla ebo 7. 6%).
Other adverse drug reactions reported were dry mouth (Kentera 8.6%, placebo 5.2%), constipation (Kentera 3.9%, placebo 2%), diarrhea (Kentera 3.2%, placebo 2%), headache (Kentera 3.0%, placebo 2.4%), dizziness (Kentera 2.3%, placebo 1.2%), and blurred vision (Kentera 2.3%, placebo 0.89%).
Reazzjonijet avversi o ra tal- medi ina rrapurtati kienu alq xott (Kentera 8. 6%, pla ebo 5. 2%), stitikezza (Kentera 3. 9%, pla ebo 2%), dijarrea (Kentera 3. 2%, pla ebo 2%), u ig ta ’ ras (Kentera 3. 0%, pla ebo 2. 4%), sturdament (Kentera 2. 3%, pla ebo 1. 2%), u vista m ajpra (Kentera 2. 3%, pla ebo 0. 89%).
Undesirable effects known to be associated with anticholinergic therapy, but not observed with Kentera during clinical studies are anorexia, vomiting, reflux oesophagitis, decreased sweating, heat stroke, decreased lacrimation, mydriasis, tachycardia, arrhythmia, disorientation, poor ability to concentrate, fatigue, nightmares, restlessness, convulsion, intraocular hypertension and induction of glaucoma, confusion, anxiety, paranoia, hallucinations, photosensitivity, erectile dysfunction.
Effetti mhux mixtieqa li huwa mag ruf li huma asso jati ma ’ terapija anti- koliner ika, i da ma kienux osservati b’ Kentera waqt studji klini i huma l- anoreksja, rimettar, esofa ite min abba r- rifluss, nuqqas ta ’ g araq, heat stroke, nuqqas tad- dmug, midrija i, takikardja, arritmja, telf tas- sens tad- direzzjoni, nuqqas ta ’ kapa ità biex tikkon entra, g eja kbira, inkubi, ma tkunx tista toqg od bi kwietek, konvul joni, pressjoni g olja intraokulari g olja u induzzjoni ta ’ glawkoma, konfu joni, ansjetà, paranojja, allu inazzjonijiet, fotosensittività, disfunzjoni erettili.
Reported Adverse Drug Reactions and rate of occurrence:
Reazzjonijet Avversi g all- Medi ina Irrapurtati u r- rata ta ’ okkorrenza:
Application site reactions
Reazzjonijet fil- parti ta ’ l- Applikazzjoni
All application site reactions -Application site pruritis -Application site erythema -Application site reaction -Application site rash
Reazzjonijet fil- partijiet kollha
23.1% 14.3% 5.7% 3.5% 3.0%
23. 1%
Very common very common common common common
komuni afna
Infections and infestations:
ta ’ l- applikazzjoni
Urinary Tract Upper Respiratory Tract Fungal Eye disorders
- akk tal - ilda fil- parti ta ’ l -
1.2% 0.2% 0.2%
14. 3%
common uncommon uncommon
komuni afna
Vision abnormalities Ear and labyrinth disorders
- Eritema fil- parti ta ’ l -
2.3%
5. 7%
Dizziness Cardiac Disorders
- Reazzjoni fil- parti ta ’ l -
2.3%
3. 5%
Palpitations Vascular disorders
- Raxx tal - ilda fil- parti ta ’ l -
0.3%
3. 0%
Hot flushes Urticaria Gastrointestinal disorders
Apparat urinarju Apparat respiratorju ta ’ fuq Fungali Disturbi f ’ l- g ajnejn
0.3% 0.4%
1. 2% 0. 2% 0. 2%
uncommon uncommon
komuni mhux komuni mhux komuni
Dry Mouth Constipation Diarrhea Nausea Abdominal Pain Dyspepsia Abdominal Discomfort Musculoskeletal disorders
Disturbi fil- widnejn u fis- sistema - labirintika
8.6% 3.9% 3.2% 2.1% 1.2% 0.4% 0.5%
Sturdament Disturbi fil- qalb
common common common common common uncommon uncommon
komuni
Back Pain
Palpitazzjonijiet
0.8%
0. 3%
4 Renal and urinary disorders
4 Disturbi vaskulari
Urinary retention Dysuria General disorders
Fwawar Urtikarja Disturbi gastrointestinali
0.3% 0.9%
0. 3% 0. 9%
Headache Somnolence Rhinitis Injury
U ig ta ’ ras Ng as kbir Rinite Ferita
3.0% 1.2% 0.5%
3. 0% 1. 2% 0. 5%
common common uncommon
komuni komuni mhux komuni
Inflicted Injury
Ferita imposta
Plasma concentration of oxybutynin declines within 1 to 2 hours after removal of transdermal system(s).
Il- kon entrazzjoni tal- pla ma ta ’ oxybutynin tonqos fi mien sieg a sa sag tejn wara t- tne ija tas - sistema( i) transdermali.
Patients should be monitored until symptoms resolve.
Il- pazjenti g andhom ikunu osservati sakemm is- sintomi jkunu ri olti.
Overdosage with oxybutynin has been associated with anticholinergic effects including CNS excitation, flushing, fever, dehydration, cardiac arrhythmia, vomiting, and urinary retention.
Do a e essiva b ’ oxybutynin kienet asso jata ma ’ effetti anti- koliner i i li jinkludu CNS excitation, fwawar, deni, disidratazzjoni, arritmija kardijaka, rimettar, u ritenzjoni ta ’ l- awrina.
Ingestion of 100 mg oral oxybutynin chloride in association with alcohol has been reported in a 13 year old boy who experienced memory loss, and in a 34 year old woman who developed stupor, followed by disorientation and agitation on awakening, dilated pupils, dry skin, cardiac arrhythmia, and retention of urine.
L- in estjoni ta ’ 100 mg mill - alq ta ’ oxybutynin chloride flimkien ma ’ l- alko ol kienet irrappurtata f’ tifel ta ’ 13- il sena li arrab telf ta ’ memorja, u f’ mara ta ’ 34 sena li kellha stupor, segwit minn telf tas- sens tad - direzzjoni u a itazzjoni mal- qawmien mill- irqad, twessig tal- pupilli, ilda xotta, arritmja kardijaka, u retenzjoni ta ’ l- awrina.
Both patients recovered fully with symptomatic treatment.
I - ew pazjenti rkupraw kompletament b’ kura sintomatika.
No cases of overdose have been reported with Kentera.
L- ebda ka ta ’ do a e essiva ma kien irrapurtat b ’ Kentera
Pharmacotherapeutic group: urinary antispasmodic, ATC code:
Grupp farmakoterapewtiku: anti- spa modiku urinarju, kodi i ta ’ l- ATC:
Mechanism of action: oxybutynin acts as a competitive antagonist of acetylcholine at post-ganglionic muscarinic receptors, resulting in relaxation of bladder smooth muscle.
Mekkani mu ta ’ l- azzjoni: oxybutynin ja ixxi b ala antagonist kompetittiv ta ’ l- acetylcholine f ’ ri etturi muskarini i post- ganglijoni i, li jirri ulta fir- rilassament tal- muskoli lixxi tal- bu ieqa ta ’ l - awrina.
Pharmacodynamic effects:
Effetti farmakodinami i:
In patients with overactive bladder, characterised by detrusor muscle instability or hyperreflexia, cystometric studies have demonstrated that oxybutynin increases maximum urinary bladder capacity and increases the volume to first detrusor contraction.
F’ pazjenti b’ bu ieqa ta ’ l- awrina attiva afna, karatterizzata minn instabilità fil- muskolu detrusor jew iperrifleksija, studji istometri i wrew li oxybutynin i id il- kapacità massima tal- bu ieqa ta ’ l - awrina u j id il- volum g all- ewwel kontrazzjoni tad - ‘ detrusor ’.
Oxybutynin thus decreases urinary urgency and the frequency of both incontinence episodes and voluntary urination.
B’ dal- mod oxybutynin inaqqas l - ur enza u l- frekwenza urinarja kemm ta ’ episodji ta ’ inkontinenza u kemm ta ’ g amil voluntarju ta ’ l - awrina.
Oxybutynin is a racemic (50:50) mixture of R- and S-isomers.
5 Oxybutynin huwa ta lita ra imika (50: 50) ta ’ l- i omeri R u S.
Antimuscarinic activity resides predominantly in the R-isomer.
Attività anti- muskarinika tinsab l- iktar fl- isomeru R.
The R-isomer of oxybutynin shows greater selectivity for the M1 and M3 muscarinic subtypes (predominant in bladder detrusor muscle and parotid gland) compared to the M2 subtype (predominant in cardiac tissue).
L- isomeru R ta ’ oxybutynin juri selettività ikbar g as- sub- tipi muskarini i ta ’ l- M1 u l - M3 (predominanti fil- muskolu detrusor tal- bu ieqa ta ’ l- awrina u fil- glandola parotid) meta ipparagunat mas- sub- tip M2 (predominanti f’ tessut kardijaku).
The active metabolite, N-desethyloxybutynin, has pharmacological activity on the human detrusor muscle that is similar to that of oxybutynin in vitro studies, but has a greater binding affinity for parotid tissue than oxybutynin.
Il- metabolit attiv, N - desethyloxybutynin, g andu attività farmakolo ika fuq il- muskolu ‘ detrusor ’ fil- bniedem li tixba lil dik li nstabet fi studji in vitro ta ’ oxybutynin, i da g andu affinità ikbar li jing aqad mat- tessuti tal - parotid minn oxybutynin.
The free base form of oxybutynin is pharmacologically equivalent to oxybutynin hydrochloride.
Il- forma ba i libera ta ’ oxybutynin hija farmakolo ikament ekwivalenti g al oxybutynin hydrochloride.
Clinical efficacy:
Effika ja klinika:
A total of 957 patients with urge urinary incontinence were evaluated in three controlled studies comparing Kentera to either placebo, oral oxybutynin and/ or tolterodine long acting capsules.
Total ta ’ 957 pazjent b’ impuls ta ’ l- inkontinenza urinarja kienu e aminati fi tlett studji kontrollati li kienu ipparagunaw Kentera jew mal- pla ebo, oxybutynin mill - alq u/ jew mal- kapsuli ta ’ tolterodine b’ azzjoni fit- tul.
Reductions in weekly incontinence episodes, urinary frequency, and urinary void volume were evaluated.
Tnaqqis f’ episodji ta ’ inkontinenza, frekwenza urinarja, u volum tat- tbattil ta ’ l - awrina f’ temp ta ’ img a kienu e aminati.
Kentera led to consistent improvements in overactive bladder symptoms compared with placebo.
Kentera wasslet g al titjib konsistenti fis- sintomi ta ’ bu ieqa ta ’ l- awrina attiva afna meta ipparagunat mal- pla ebo.
5 5.2 Pharmacokinetic Properties
5. 2 Tag rif farmakokinetiku
Absorption Kentera has a concentration of oxybutynin sufficient to maintain continuous transport over the 3 to 4 day dosing interval.
Assorbiment Kentera g anda kon entrazzjoni ta ’ oxybutynin bi ejjed biex i omm trasport kontinwu fuq medda tal- perijodu tad- do a ta ’ minn 3 sa 4 ijiem.
Oxybutynin is transported across intact skin and into the systemic circulation by passive diffusion across the stratum corneum.
Oxybutynin huwa trasportat minn ol - ilda intatta g a - irkolazzjoni sistematika minn propagazzjoni passiva minn ol- istratum corneum.
Following the application of Kentera, oxybutynin plasma concentration increases for approximately 24 to 48 hours, reaching average maximum concentrations of 3 to 4ng/ ml.
Wara l - applikazzjoni ta ’ Kentera, il- kon entrazzjoni ta ’ oxybutynin fil- pla ma ti died g al madwar 24 sa 48 sieg a, u til aq il- medja tal- kon entrazzjonijiet massimi ta ’ bejn 3 u 4ng/ ml.
Steady-state conditions are reached during the second application of the transdermal patch.
L- istat fiss jintla aq waqt it- tieni applikazzjoni tal- gar a li tipprovdi medi ina li tg addi minn ol - ilda.