qanastek/EMEA-V3 huggingface dataset:
Pregnancy and breast-feeding Do not take Arava if you are, or think you may be pregnant.
Tieħux l- Arava jekk inti jew taħseb li inti tqila.
Women of childbearing potential must not take Arava without using reliable contraceptives measures.
Nisa li jistgħu joħorġu tqal m’ għandhomx jieħdu l - Arava mingħajr jintuża mezz ta ’ kontraċettiv effettiv.
This may take up to 2 years.
Għid lit- tabib tiegħek jekk qiegħda tippjana li toħroġ tqila wara li twaqqaf Arava, biex tkun żgura li it - traċċi kollha ta ’ l- Arava ġew mneħħija minn ġismek qabel tipprova toħroġ tqila Dan jista ’ jieħu żmien sa sentejn.
This may be reduced to a few weeks by taking certain medicines which speed up removal of Arava from your body.
Dan jista ’ jitnaqqas għal ftit ġimgħat billi jittieħdu ċerti mediċini li jħaffu t- tneħħija ta ’ Arava minn ġismek.
In either case it should be confirmed by a blood test that Arava has been sufficiently removed from your body and you should then wait for at least another month before you become pregnant.
Kull każ għandu jkun ikkonfermat b’ test tad- demm li Arava tneħħa biżżejjed minn ġismek, u wara għandek tistenna għal mhux anqas minn xahar ieħor qabel ma toħroġ tqila.
For further information on the laboratory testing please contact the Marketing Authorisation Holder or its representative.
70 Għal aktar tagħrif fuq it- testijiet tal- laboratorju, jekk jogħġbok, ikkuntatja lid- Detentur ta ’ l - Awtorizzazzjoni għat- Tqegħid fis- Suq jew ir- rappreżentant.
67 If you suspect that you are pregnant while taking Arava or in the two years after you have stopped treatment, you must contact your doctor immediately for a pregnancy test.
Jekk tissuspetta li inti tqila waqt li qiegħda tieħu Arava, jew f’ dawk is- sentejn wara tkun waqaft il - kura, għandek tikkuntatja lit- tabib tiegħek minnufih biex tagħmel it- test tat- tqala.
If the test confirms that you are pregnant, your doctor may suggest treatment with certain medicines to speed up the removal of Arava from the body, as this may decrease the risk to your baby.
Jekk it- test jikkonferma li inti tqila ’, it- tabib jista ’ jissuġġerixxi kura b ’ xi mediċini biex jgħaġġlu t- tneħħija ta ’ Arava minn ġismek, għax dan jista ’ jnaqqas ir- riskju għat- tarbija tiegħek.
Do not take Arava when you are breast feeding, as leflunomide passes into the breast milk.
Tieħux l- Arava waqt li qiegħda tredda ’, billi l- leflunomide jista ’ jgħaddi fil- ħalib tas- sider.
Driving and using machines Arava can make you feel dizzy which may impair your ability to concentrate and react.
Sewqan u tħaddim ta ’ magni Arava jista ’ jikkawżalek sturdament li jistgħu jfixkluk milli tikkonċentra u tirreaġixxi.
If you are affected, do not drive, or use machines.
Jekk jaffettwak, issuqx jew tħaddem magni.
Important information about some of the ingredients of Arava Arava contains lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Arava Arava fih il- lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib tiegħek qallek li int intolleranti għal xi tip ta ’ zokkor, ikkuntattja lit - tabib tiegħek qabel tieħu dan il- prodott mediċinali.
HOW TO TAKE ARAVA
KIF GĦANDEK TIEĦU ARAVA
Always take Arava exactly as your doctor has told you.
Dejjem għandek tieħu l- Arava skond il- parir tat- tabib.
Arava is not recommended for use in children and adolescents below 18 years of age.
Arava mhux irrakkomandat għal użu fit- tfal u l- adoloxxenti taħt 18- il sena.
The usual starting dosage of Arava is one 100 mg tablet once daily for the first three days.
Is- soltu d- doża inizjali ta’ Arava tkun ta ’ pillola waħda ta ’ 100 mg, darba kuljum għal l- ewwel tlett ijiem.
After this, most patients need a dose of: • For rheumatoid arthritis:
Wara dan, il- maġġoranza tal- pazjenti jeħtieġu doża ta ’: • Għall- artrite rewmatika:
10 or 20 mg Arava once daily, depending on the severity of the disease. • For psoriatic arthritis:
10 mg jew 20 mg ta ’ Arava darba kuljum, skond is- severità tal- marda. • Għall- artrite psorjatika:
20 mg Arava once daily.
20 mg Arava darba kuljum.
Swallow the tablet whole and with plenty of water.
Ibla ’ l- pillola sħiħa b’ ammont suffiċjenti ta ’ ilma.
It may take about 4 weeks or longer until you start to feel an improvement in your condition.
Tista ’ tieħu madwar 4 ġimgħat jew aktar qabel ma tibda tħossok aħjar.
Some patients may even still feel further improvements after 4 to 6 months of therapy.
Xi pazjenti jistgħu wkoll ikollhom kambjament għall- aħjar wara 4 sa 6 xhur mill- bidu tal- kura.
You will normally take Arava over long periods of time.
Normalment sejjer tieħu Arava għal perijodi twal.
If you take more Arava than you should If you take more Arava than you should, contact your doctor or get other medical advice.
Jekk tieħu Arava aktar milli suppost Jekk tieħu l- Arava iżjed milli suppost, ikkuntatja lit- tabib tiegħek jew ħu parir mediku.
If possible, take your tablets or the box with you to show the doctor.
Jekk huwa possibbli, ħu l- pilloli jew il- kaxxa miegħek biex turihom (turiha) lit- tabib.
If you forget to take Arava If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose.
Jekk tinsa tieħu doża, ħudha hekk kif tiftakar, sakemm ma jkunx wasal il- ħin biex tieħu d- doża li tmiss.
Do not take a double dose to make up for a forgotten dose.
M’ għandekx tieħu doża doppja biex tpatti għal dik li tkun insejt.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, Arava can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Arava jista ’ jkollu effettisekondarji, għalkemm ma jidhrux fuq kulħadd.
Tell your doctor immediately and stop taking Arava:
71 Għid lit- tabib tiegħek minnufih u tieqaf tieħu l- Arava:
- if you experience weakness, feel light-headed or dizzy or have difficulty breathing, as these
- jekk jkollok debbulizza, sturdament jew tara kollox idur bik jew għandek diffikulta ’ bin- nifs,
may be signs of a serious allergic reaction,
billi dawn jistgħu jkunu sinjali ta ’ reazzjoni allerġika severa,
- if you develop a skin rash or ulcers in your mouth, as these may indicate severe, sometimes
- jekk tiżviluppa raxx fil- ġilda jew ulċeri f’ ħalqek, billi dawn jistgħu jindikaw reazzjonijiet
Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
severi u xi kultant fatali (e. ż. is- sindrome ta ’ Stevens- Johnson, in- nekrosi tossika u esfoljattiva tal- ġilda, eritema multiforme).
68 Tell your doctor immediately if you experience:
Għid lit- tabib tiegħek minnufih jekk jkollok:
- pale skin, tiredness, or bruising, as these may indicate blood disorders caused by an imbalance
- ġilda pallida, għeja, jew tbenġil, billi dawn jistgħu jindikaw il- preżenza ta ’ mard tad- demm
in the different types of blood cells which make up blood,
ikkawżat minn żbilanċ f’ diversi tipi ta ’ ċelluli tad- demm,
- tiredness, abdominal pain, or jaundice (yellow discolouration of the eyes or skin), as these
- għeja, uġigħ addominali, jew suffejra (kulur isfar ta ’ l- għajnejn u tal- ġilda), billi dawn jistgħu
may indicate serious conditions such as liver failure, which may be fatal,
jindikaw kundizzjonijiet serji bħall- insuffiċjenza tal- fwied, li tista ’ tkun fatali,
- any symptoms of an infection such as fever, sore throat or cough, as Arava may increase the
- xi sintomi ta ’ infezzjoni bħal deni, griżmejk juġgħawk jew sola, billi l- Arava jista ’ iżied iċ -
chance of a severe infection which may be life-threatening,
ċans ta ’ infezzjoni serja li tista ’ tkun fatali,
- a cough or breathing problems as these may indicate inflammation of the lung (interstitial lung
- sola jew problemi bin- nifs billi dawn jistgħu jindikaw infjammazzjoni tal- pulmun (mard
disease).
interstizjali tal- pulmun).
Common side effects (may occur in more than 1 in 100 patients but less than 1 in 10 patients)
Effetti avversi komuni (li jistgħu jinħassu iżjed minn 1 f’ kull 100 pazjent imma inqas minn 1 f’ kull 10 pazjent)
- a slight decrease in the number of white blood cells (leucopenia),
- tnaqqis żgħir fl- għadd taċ- ċelluli bojod tad- demm (lewkopenja),
- mild allergic reactions,
- reazzjonijiet allerġiċi ħfief,
- loss of appetite, weight loss (usually insignificant),
- nuqqas t’ aptit, telf fil- piż (x’ aktarx insinifikanti),
- tiredness (asthenia),
- għeja (astenja),
- headache, dizziness,
- uġigħ ta ’ ras, sturdament,
- abnormal skin sensations like tingling (paraesthesia),
- sensazzjonijiet abnormali fil- ġilda bħat- tnemnim (parasteżija),
- mild increase in blood pressure,
- żieda ħafifa fil- pressjoni tad- demm,
- diarrhoea,
- dijarrea,
- nausea, vomiting,
- tqalligħ, rimettar,
- inflammation of the mouth or mouth ulcers,
- infjammazzjoni tal- ħalq u ulċeri tal- ħalq,
- abdominal pain,
- uġigħ ta ’ żaqq,
- an increase in some liver test results,
- żieda fil- livelli ta ’ xi testijiet tal- fwied,
- increased hair loss,
- żieda fil- waqgħa tax- xagħar,
- eczema, dry skin, rash, itching,
- ekżema, ġilda xotta, raxx, ħakk,
- tendonitis (pain caused by inflammation in the membrane surrounding the tendons usually in the
- infjammazzjoni ta ’ l- għerq (uġigħ ikkawżat minn infjammazzjoni tal- membrana madwar l -
feet or hands),
għerq is- soltu fis- saqajn jew fl’ idejn),
- an increase of certain enzymes in the blood (creatine phosphokinase).
- żieda ta ’ ċerta enżimi fid- demm (creatine phosphokinase).
Uncommon side effects (may occur in more than 1 in 1,000 patients but less that 1 in 100 patients)
Effetti avversi mhux komuni (li jistgħu jinħassu iżjed minn 1 f’ kull 1, 000 pazjent imma inqas minn 1 f’ kull 100 pazjent)
- a decrease in the number of red blood cells (anaemia) and a decrease in the number of blood
- tnaqqis fl- għadd taċ- ċelluli ħomor tad- demm (anemija) u tnaqqis fl- għadd tal- plejtlets fid- demm
platelets (thrombocytopenia),
(tromboċitopenja),
- a decrease in the levels of potassium in the blood,
- tnaqqis fil- livell tal- potassju fid- demm,
- anxiety,
- ansjetà,
- taste disturbances,
- disturbi fit- tegħim,
- urticaria (nettle rash),
- urtikarja (nettle rash),
- tendon rupture,
- qtugħ ta ’ l- għerq tal- muskolu,
- an increase in the levels of fat in the blood (cholesterol and triglycerides),
- żieda fil- livelli tax- xaħam fid- demm (il- kolesterol u t- trigliċeridi),
- a decrease in the levels of phosphate in the blood.
- tnaqqis fil- livell tal- fosfat fid- demm.
Rare side effects (may occur in more than 1 in 10, 000 patients but less than 1 in 1, 000 patients)
Effetti avversi rari (li jistgħu jinħassu iżjed minn 1 f’ kull 10, 000 pazjent imma inqas minn 1 f’ kull 1, 000 pazjent)
- an increase in the numbers of blood cells called eosinophiles (eosinophilia); mild decrease in the
- żieda fl- għadd ta ’ tip ta ’ ċelluli tad- demm, hekk imsejħa eosinofiliċi (eosinophilia); tnaqqis ħafif
number of white blood cells (leucopenia); decrease in the number of all blood cells (pancytopenia),
fl- għadd taċ- ċelluli bojod tad- demm (lewkopenja); tnaqqis fl- għadd tat- tipi kollha taċ- ċelluli tad - demm (panċitopenja),
- severe increase in blood pressure,
- żieda qawwija fil- pressjoni tad- demm,
- inflammation of the lung (interstitial lung disease),
- infjammazzjoni tal- pulmun (mard interstizjali tal- pulmun),
- an increase in some liver results which may develop into serious conditions such as hepatitis
- żieda fil- livelli ta ’ xi testijiet tal- fwied li jistgħu jiżviluppaw f’ kundizzjonijiet serji bħall- epatite
and jaundice,
u s- suffejra,
- severe infections called sepsis which may be fatal,
- infezzjonijiet qawwija msejħa s- sepsis, li tista ’ tkun fatali,
- an increase of certain enzymes in the blood (lactate dehydrogenase).
- żieda ta ’ ċerta enżimi fid- demm (lactate dehydrogenase).
69 Very rare side effects (may occur in less than 1 in 10,000 patients)
Effetti avversi rari ħafna (li jistgħu jinħassu inqas minn 1 f’ kull 10, 000 pazjent)
- a marked decrease of some white blood cells (agranulocytosis),
- tnaqqis immarkat fl- għadd ta ’ xi tipi ta ’ ċelluli bojod tad- demm (agranuloċitosi),
- severe and potentially severe allergic reactions,
- reazzjonijiet allerġiċi severi u potenzjalment serji,
- inflammation of the small vessels (vasculitis, including cutaneous necrotizing vasculitis),
- infjammazzjoni tal- pajpijiet żgħar tad- demm (vaskulite, li tinkludi l- vaskulite nekrotika tal -
- problems in the nerves of the arms or legs (peripheral neuropathy),
- problemi bin- nervaturi tad- dirgħajn u r- riġlejn (newropatija periferali),
- inflammation of the pancreas (pancreatitis),
- infjammazzjoni tal- frixa (pankreatite),
- sever liver injury such as liver failure or necrosis which may be fatal,
- leżjoni serja fil- fwied bħal insuffiċjenzja tal- fwied jew nekrosi li tista ’ tkun fatali,
- severe sometimes life-threatening reactions (Stevens-Johnson syndrome, toxic epidermal
- reazzjonijiet severi, x’ imdaqqiet fatali (is- sindrome ta ’ Stevens- Johnson, in- nekrosi tossika u
necrolysis, erythema multiforme).
esfoljattiva tal- ġilda, eritema multiforme).
Other side effects such as kidney failure, a decrease in the levels of uric acid in your blood, and male infertility (which is reversible once treatment with Arava is stopped) may also occur with a not known frequency.
Effetti sekondarji oħra bħal insuffiċjenza tal- kliewi, tnaqqis fil- livell ta ’ l- aċidu uriku fid- demm tiegħek u infertilita ’ maskili (li hija riversibbli ġaladarba t- trattament b’ Arava jitwaqqaf) tista ’ tiġri b’ frekwenza mhux magħrufa.
HOW TO STORE ARAVA
KIF TAĦŻEN ARAVA
Do not use Arava after the expiry date which is stated on the packaging.
Tużax l- Arava wara d- data ta ’ skadenza li tidher fuq il- kartuna ta ’ barra.
The expiry date refers to the last day of that month.
Id- data ta ’ skadenza tirreferi għal l- aħħar ġurnata ta’ dak ix- xahar.
Keep the container tightly closed
Żomm il- flixkun magħluq sew.
These measures will help to protect the environment.
Dawn il- miżuri jgħinu għall - protezzjoni ta ’ l- ambjent
What Arava contains
X’ fih Arava
- The active substance is leflunomide.
- Is- sustanza attiva hija leflunomide.
One film-coated tablet contains 10 mg of leflunomide.
Kull pillola miksija b’ rita fiha 10 mg ta ’ leflunomide
- The other ingredients are: maize starch, povidone (E1201), crospovidone (E1202), silica
- Is- sustanżi l- oħra huma: maize starch, povidone (E1201), crospovidone (E1202), silica colloidal
colloidal anhydrous, magnesium stearate (E470b), and lactose monohydrate in the tablet core as well as talc (E553b), hypromellose (E464), titanium dioxide (E171), and macrogol 8000 in the film- coating.
anhydrous, magnesium stearate (E470b), u lactose monohydrate fil- qalba tal- pillola, kif ukoll, talc (E553b), hypromellose (E464), titanium dioxide (E171), u macrogol 8000 fir- rita tal- pillola.
What Arava looks like and contents of the pack Arava 10 mg film-coated tablets are white to almost white and round with a diameter of about 7 mm.
Arava 10 mg pilloli miksija b’ rita, huma bojod jew kważi bojod tondi b’ dijametru ta ’ madwar 7 mm.
Imprint on one side:
Stampati fuq faċċata waħda:
ZBN.
ZBN
The tablets are packed in blisters or bottles.
Il- pilloli huma ppakkjati fl- istrixxi tal- fojl jew fil- fliexken.
Packs of 30 and 100 tablets are available.
Pakketti ta ’ 30 u 100 pilloli huma disponibbli.
Not all pack size may be marketed.
73 Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
Marketing Authorisation Holder Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Germany
Id- Detentur ta ’ l- Awtoriżżazzjoni għat- tqegħid fis- Suq Sanofi- Aventis Deutschland GmbH D- 65926 Frankfurt am Main, il- Ġermanja
70 Manufacturer Sanofi Winthrop Industrie 56, Route de Choisy au Bac F-60205 Compiegne Cedex, France
Il- Manifattur Sanofi Winthrop Industrie 56, Route de Choisy au Bac F- 60205 Compiegne Cedex, Franza
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok, għamel kuntatt mar- rappreżentant lokali taDetentur ta ’ l- Awtorizzazzjonigħat- Tqegħid fis- Suq.
Latvija sanofi-aventis Latvia SIA Tel: +371 67 33 24 51
Τηλ: +357 22 871600 Latvija sanofi- aventis Latvia SIA Tel: +371 67 33 24 51
United Kingdom sanofi-aventis Tel: +44 (0) 1483 505 515
Sverige sanofi- aventis AB Tel: +46 (0) 8 634 50 00 United Kingdom sanofi- aventis Tel: +44 (0) 1483 505 515
72 PACKAGE LEAFLET:
75 FULJETT TA ’ TAGĦRIF:
Steven-Johnson syndrome) or to any of the other ingredients of Arava,
ġilda, spiss akkompanjata bid- deni, uġigħ fil- ġogi, tbajja ’ ħomor tal- ġilda, jew infafet e. g. is - sindrome ta ’ Stevens- Johnson) jew għal xi wieħed mill- ingredjenti l- oħra ta ’ l- Arava,
- if you have any liver problems,
- jekk għandek xi problemi fil - fwied
- if you have any problem with your bone marrow, or if you have low numbers of red or white
- jekk għandek problema bil- mudullun tiegħek, jew jekk għandek numru baxx ta ’ ċelluli ħomor
Take special care with Arava
76 Oqgħod attent ħafna b’ Arava
- if you have ever suffered from tuberculosis (a lung disease),
- jekk qatt kellek it- tuberkulosi (marda tal- pulmun),
- if you are male and wish to father a child, as Arava can cause birth defects in new born
- jekk int pazjent raġel u tixtieq li jkollok it- tfal, billi l- Arava jista ’ jikkawża diffetti tat- twelid
73 To minimise any possible risk, men wishing to father a child should contact their doctor who may advise you to stop taking Arava and take certain medicines to speed up the removal of Arava from your body.
Biex jitnaqqas kull riskju possibbli, dawk l- irġiel li jixtiequ jkollhom it- tfal għandhom ikellmu lit - tabib li għandu/ ha mnejn j/ tagħtik parir biex twaqqaf l- Arava u tieħu ċerti mediċini biex iħaffu t - tneħħija ta ’ Arava minn ġismek.
You will then need a blood test to make sure that Arava has been sufficiently removed from your body, and you should then wait for at least another 3 months.
Ikollok bżonn ta ’ test tad- demm biex tiżgura li l- Arava tneħħa biżżejjed minn ġo ġismek u, wara dan, għandek tistenna għal mhux inqas minn 3 xhur oħra.
Arava can occasionally cause some problems with your blood, liver or lungs.
Kultant, l- Arava jista ’ jikkawża xi problemi fid- demm, fil- kliewi u fil- pulmun.
This is especially important if you are taking: – other medicines for rheumatoid arthritis such as antimalarials (e. g. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive drugs (e. g. methotrexate) as these combinations are not advisable,
hydroxychloroquine), deheb li jingħata sew fil- muskoli kif ukoll mill- ħalq, D- penicillamine, azathioprine u mediċini oħra li jrażżnu l- istat immuni (e. ż. methotrexate), billi dawn il - prodotti nflimkien mhumiex irrakkomandati.
– a medicine called colestyramine (used to reduce high cholesterol) or activated charcoal as these medicines can reduce the amount of Arava which is absorbed by the body,
charcoal mediċinali attivat billi dawn il- mediċini jistgħu naqqsu l- ammont ta’ Arava li huma assorbiti mill- ġisem.
– phenytonin (used to treat epilepsy), Warfarin or phenprocoumon (used to thin the blood) or tolbutamide (used to treat type 2 diabetes) as these medicines may increase the risk of side effects.
- phenytoin (jintuża biex jittratta l- epilessija), warfarin u phenprocoumon (jintuża biex
If you are already taking a nonsteroidal anti-inflammatory drug (NSAID) and/ or corticosteroids, you may continue to take them after starting Arava.
Jekk inti diġa ’ qiegħed tieħu l- mediċina mhux sterojdi li jintużaw kontra l- infjammazzjoni (NSAIDs u/ jew corticosteroids, dawn jistgħu jitkomplew wara li jinbeda Arava.
Pregnancy and breast -feeding Do not take Arava if you are, or think you may be pregnant.
Tieħux l- Arava jekk inti jew taħseb li inti tqila.
Women of childbearing potential must not take Arava without using reliable contraceptives measures.
Nisa li jistgħu joħorgġu tqal m’ għandhomx jieħdu l - Arava mingħajr jintuża mezz ta ’ kontraċettiv effettiv.
Tell your doctor if you plan to become pregnant after stopping treatment with Arava, as you need to ensure that all traces of Arava have left your body before trying to become pregnant.
Għid lit- tabib tiegħek jekk qiegħda tippjana li toħroġ tqila wara li twaqqaf Arava, biex tkun żgura li it - traċċi kollha ta ’ l- Arava ġew mneħħija minn ġismek qabel tipprova toħroġ tqila.
This may take up to 2 years.
Dan jista ’ jieħu żmien sa sentejn.
In either case it should be confirmed by a blood test that Arava has been sufficiently removed from your body and you should then wait for at least another month before you become pregnant.
77 Kull każ għandu jkun ikkonfermat b’ test tad- demm li Arava tneħħa biżżejjed minn ġismek, u wara għandek tistenna għal mhux anqas minn xahar ieħor qabel ma toħroġ tqila.
For further information on the laboratory testing please contact the Marketing Authorisation Holder or its representative.
Għal aktar tagħrif fuq it- testijiet tal- laboratorju, jekk jogħġbok, ikkuntatja lid- Detentur ta ’ l - Awtorizzazzjoni għat- Tqegħid fis- Suq jew ir- rappreżentant.
74 If you suspect that you are pregnant while taking Arava or in the two years after you have stopped treatment, you must contact your doctor immediately for a pregnancy test.
Jekk tissuspetta li inti tqila waqt li qiegħda tieħu Arava, jew f’ dawk is- sentejn wara tkun waqaft il - kura, għandek tikkuntatja lit- tabib tiegħek minnufih biex tagħmel it- test tat- tqala.
If the test confirms that you are pregnant, your doctor may suggest treatment with certain medicines to speed up the removal of Arava from the body, as this may decrease the risk to your baby.
Jekk it- test jikkonferma li inti tqila ’, it- tabib jista ’ jissuġġerixxi kura b’ xi mediċini biex jgħaġġlu t- tneħħija ta ’ Arava minn ġismek, għax dan jista ’ jnaqqas ir- riskju għat- tarbija tiegħek.
Important information about some of the ingredients of Arava Arava contains lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi li jinsabu f ’ Arava Arava fih il- lactose.
Swallow the tablet whole and with plenty of water.
Ibla ’ l- pillola sħiħa b’ ammont suffiċjenti ta’ ilma.
Do not take a double dose to make up for a forgotten dose.
M’ għandekx tieħu doża doppja biex tpatti għal dik litkun insejt.
Like all medicines, Arava can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Arava jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
75 Tell your doctor immediately and stop taking Arava:
78 Għid lit- tabib tiegħek minnufih u tieqaf tieħu l- Arava:
Tell your doctor immediately if you experience:
Għid lit- tabib tiegħek minnufih jekk jkollok:
- inflammation of the mouth or mouth ulcers,
- nfjammazzjoni tal- ħalq u ulċeri tal- ħalq,
- tendonitis (pain caused by inflammation in the membrane surrounding the tendons usually in the
-, infjammazzjoni ta ’ l- għerq (uġigħ ikkawżat minn infjammazzjoni tal- membrana madwar l -
Rare side effects (may occur in more than 1 in 10, 000 patients but less than 1 in 1, 000 patients)
Effetti avversi rari( li jistgħu jinħassu iżjed minn 1 f’ kull 10, 000 pazjent imma inqas minn 1 f’ kull 1, 000 pazjent)
76
79
Very rare side effects (may occur in less than 1 in 10,000 patients)
Effetti avversi rari ħafna (li jistgħu jinħassu inqas minn 1 f’ kull 10, 000 pazjent)
Keep the container tightly closed.
Żomm il- flixkun magħluq sew.
One film-coated tablet contains 20 mg of leflunomide
Kull pillola miksija b’ rita fiha 20 mg ta ’ leflunomide
colloidal anhydrous, magnesium stearate (E470b), and lactose monohydrate in the tablet core as well as talc (E553b), hypromellose (E464), titanium dioxide (E171), macrogol 8000 and yellow ferric oxide (E172) in the film-coating.
anhydrous, magnesium stearate (E470b), u lactose monohydrate fil- qalba tal- pillola, kif ukoll, talc (E553b), hypromellose (E464), titanium dioxide (E171), macrogol 8000 u ferric oxide isfar (E172) fir- rita tal- pillola.
Imprint on one side:
Arava 20 mg pilloli miksija b’ rita, huma ta ’ kulur safrani sa kulur safrani ċar fil- kannella, u t’ għamla trijangolari Stampati fuq faċċata waħda:
ZBO.
ZBO
Packs of 30, 50 and 100 tablets are available.
Pakketti ta ’ 30, 50 u 100 pilloli huma disponibbli.
77 Not all pack size may be marketed.
80 Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
Manufacturer Sanofi Winthrop Industrie 56, Route de Choisy au Bac F-60205 Compiegne Cedex, France
Il- Manifattur Sanofi Winthrop Industrie 56, Route de Choisy au Bac F- 60205 Compiegne Cedex, Franza
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok, għamel kuntatt mar- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjonigħat- Tqegħid fis- Suq.
79 PACKAGE LEAFLET:
82 FULJETT TA ’ TAGĦRIF:
Arava belongs to a group of medicines called anti-rheumatic medicines.
Arava jappartjeni għall- grupp ta ’ s mediċini msejħa antirewmatiċi.
Steven-Johnson syndrome) or to any of the other ingredients of Arava,
Tieħux l- Aravajekk qatt kellek xi reazzjoni allerġika għal leflunomide (speċjalment xi reazzjoni serja tal- ġilda, spiss akkompanjata bid- deni, uġigħ fil- ġogi, tbajja ’ ħomor tal- ġilda, jew infafet e. g. is - sindrome ta ’ Stevens- Johnson) jew għal xi wieħed mill- ingredjenti l- oħra ta ’ l- Arava,
- if you have any problem with your bone marrow, or if you have low numbers of red or white
- jekk għandek problema bil- mudullun tiegħek jew jekk għandek numru baxx ta ’ ċelluli ħomor
- -
- jekk qatt kellek it- tuberkulosi (marda tal- pulmun),
if you have ever suffered from tuberculosis (a lung disease), if you are male and wish to father a child, as Arava can cause birth defects in new born infants.
- jekk int pazjent raġel u tixtieq li jkollok it- tfal, billi l- Arava jista ’ jikkawża diffetti tat- twelid fit -
80 To minimise any possible risk, men wishing to father a child should contact their doctor who may advise you to stop taking Arava and take certain medicines to speed up the removal of Arava from your body.
83 Biex jitnaqqas kull riskju possibbli, dawk l- irġiel li jixtiequ jkollhom it- tfal għandhom ikellmu lit- tabib li għandu/ ha mnejn j/ tagħtik parir biex twaqqaf l- Arava u tieħu ċerti mediċini biex iħaffu t- tneħħija ta ’ Arava minn ġismek.
You will then need a blood test to make sure that Arava has been sufficiently removed from your body, and you should then wait for at least another 3 months.
I Ikollok bżonn ta ’ test tad- demm biex tiżgura li l - Arava tneħħa biżżejjed minn ġo ġismek u, wara dan, għandek tistenna għal mhux inqas minn 3 xhur oħra.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive drugs (e. g. methotrexate) as these combinations are not advisable,
hydroxychloroquine), deheb li jingħata sew fil- muskoli kif ukoll mill- ħalq, D- penicillamine, azathioprine u mediċini oħra li jrażżnu l- istat immuni (e. ż. methotrexate), billi dawn il - prodotti nflimkien mhumiex irrakkomandati.
- phenytonin (used to treat epilepsy), Warfarin or phenprocoumon (used to thin the blood) or
- phenytoin (jintuża biex jittratta l- epilessija), warfarin u phenprocoumon (jintuża biex
tolbutamide (used to treat type 2 diabetes) as these medicines may increase the risk of side effects.
iraqqa ’ d- demm) jew tolbutamide (jintuża biex jittratta dijabete mellitus tat- tip 2) billi dawn il- mediċini jistgħu żiedu r- riskju ta ’ l- effetti sekondarji
Pregnancy and breast-feeding Do not take Arava if you are, or think you may be pregnant.
Tqala u Treddigħ Tieħux l- Arava jekk inti jew taħseb li inti tqila.
Women of childbearing potential must not take Arava without using reliable contraceptives measures.
Nisa li jistgħu joħorgġu tqal m’ għandhomx jieħdu l - Arava mingħajr jintuża mezz ta ’ kontraċettiv effettiv
Tell your doctor if you plan to become pregnant after stopping treatment with Arava, as you need to ensure that all traces of Arava have left your body before trying to become pregnant.
Għid lit- tabib tiegħek jekk qiegħda tippjana li toħroġ tqila wara li twaqqaf Arava, biex tkun żgura li it - traċċi kollha ta ’ l- Arava ġew mneħħija minn ġismek qabel tipprova toħroġ tqila
81 For further information on the laboratory testing please contact the Marketing Authorisation Holder or its representative.
84 Għal aktar tagħrif fuq it- testijiet tal- laboratorju, jekk jogħġbok, ikkuntatja lid- Detentur ta ’ l - Awtorizzazzjoni għat- Tqegħid fis- Suq jew ir- rappreżentant.
If you suspect that you are pregnant while taking Arava or in the two years after you have stopped treatment, you must contact your doctor immediately for a pregnancy test.
Jekk tissuspetta li inti tqila waqt li qiegħda tieħu Arava, jew f’ dawk is- sentejn wara tkun waqaft il - kura, għandek tikkuntatja lit- tabib tiegħek minnufih biex tagħmel it- test tat- tqala.
Arava is not recommended for use in children and adolescents below18 years of age.
Arava mhux irrakkomandat għal użufit- tfal u l- adoloxxenti taħt 18- il sena.
10 or 20 mg Arava once daily, depending on the severity of the disease. • For psoriatic arthritis:
10 mg jew 20 mg ta ’ Arava darba kuljum skond is- severità tal- marda. • Għall- artrite psorjatika:
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek
Like all medicines, Arava can cause side effects, although not everybody gets them.
Bħall- kull mediċina oħra, Arava jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
82 Tell your doctor immediately and stop taking Arava:
85 Għid lit- tabib tiegħek minnufih u tieqaf tieħu l- Arava:
- tendonitis (pain caused by inflammation in the membrane surrounding the tendons usually in the
- infjammazzjoni ta ’ l- għerq (uġigħ ikkawżat minn infjammazzjoni tal- membrana madwar l- għerq
feet or hands),
is- soltu fis- saqajn jew fl’ idejn),
Rare side effects (may occur in more than 1 in 10, 000 patients but less than 1 in 1, 000 patients)
Effetti avversi rari (li jinħassu iżjed minn 1 f’ kull 10, 000 pazjent imma inqas minn 1 f’ kull 1, 000 pazjent)
number of white blood cells (leucopenia); decrease in the number of all blood cells (pancytopenia),
fl- għadd taċ- ċelluli bojod tad- demm (lewkopenja), tnaqqis fl- għadd tat- tipi kollha taċ- ċelluli tad - demm (panċitopenja),
- an increase of certain enzymes in the blood (lactate dehydrogenase).
- żieda ta ’ ċerta enżimi fid- demm (lactae dehydrogenase).
Other side effects such as kidney failure, a decrease in the levels of uric acid in your blood, and male infertility (which is reversible once treatment with Arava is stopped) may also occur with a not known frequency.
Effetti sekondarji oħra bħal insuffiċjenza tal- kliewi, j tnaqqis fil- livell ta ’ l- aċidu uriku fid- demm tiegħek u infertilita ’ maskili (li hija riversibbli ġaladarba t- trattament b’ Arava jitwaqqaf) tista ’ tiġri b’ frekwenza mhux magħrufa.
The expiry date refers to the last day of that month.
Id- data ta ’ skadenza tirreferi għal l- aħħar ġurnata ta’ dak ix- xahar
Store in the original package
Żomm fil- pakkett oriġinali
One film-coated tablet contains 100 mg of leflunomide.
Kull pillola miksija b’ rita fiha 100 mg ta ’ leflunomide
- The other ingredients are: maize starch, povidone (E1201), crospovidone (E1202), talc (E553b),
Sustanżi oħra jinkludu: maize starch, povidone (E1201), crospovidone
silica colloidal anhydrous, magnesium stearate (E470b), and lactose monohydrate in the tablet core as well as talc (E553b), hypromellose (E464), titanium dioxide (E171), and macrogol 8000 in the film-coating.
(E1202), talc (E553b), silica colloidal anhydrous, magnesium stearate (E470b), u lactose monohydrate fil- qalba tal- pillola, kif ukoll, talc (E553b), hypromellose (E464), titanium dioxide (E171), u macrogol 8000 fir- rita tal- pillola.
What Arava looks like and contents of the pack
Id- Dehra ta ’ Arava u l- kontenuti tal- pakkett
Arava 100 mg film-coated tablets are white to almost white and round with a diameter of about 1 cm.
Arava 100 mg pilloli miksija b’ rita, huma bojod jew kważi bojod, tondi b’ dijametru ta ’ madwar 1 cm.
The tablets are packed in blisters.
Pilloli miksija b’ rita għall- użu orali ippakkjati fl- istrixxi tal- fojl.
A pack of 3 tablets is available
Pakketti ta ’ 3 pilloli huma disponibbli.
84 Marketing Authorisation Holder Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Germany
87 Id- Detentur ta ’ l- Awtoriżżazzjoni għat- tqegħid fis- Suq Sanofi- Aventis Deutschland GmbH D- 65926 Frankfurt am Main, il- Ġermanja
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok, agħmel kuntatt mar- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjonigħat- Tqegħid fis- Suq.
Italia sanofi-aventis S. p. A.
88 Italia sanofi- aventis S. p. A.
What is Ariclaim?
X' inhu Ariclaim?
Ariclaim is a medicine containing the active substance duloxetine.
Ariclaim huwa mediċina li fiha s- sustanza attiva duloxetine.
It is available as gastroresistant capsules (20 mg: blue; 30 mg: white and blue; 40 mg: orange; 60 mg: green and blue). ‘ Gastroresistant ’ means that the capsules ’ contents pass through the stomach without being broken down until they reach the intestine.
Hija disponibbli f' kapsuli gastroreżistenti (20 mg: blu; 30 mg: bojod u blu; 40 mg: oranġjo; 60 mg: ħodor u blu).
This prevents the active substance being destroyed by the acid in the stomach.
"Gastroreżistenti" tfisser li l - kontenut tal- kapsuli jgħaddi mill- istonku u jibqa 'sħiħ sa meta jilħaq il- musrana.
What is Ariclaim used for?
Għal xiex jintuża Ariclaim?
Ariclaim is used to treat: • moderate to severe stress urinary incontinence (SUI) in women.
Ariclaim jintuża għat- trattament ta ': • l- inkontinenza urinarja minn sforz (SUI - stress urinary incontinence) minn moderata għal gravi fin- nisa.
SUI is accidental leaks of urine during physical exertion or when coughing, laughing, sneezing, lifting or exercising. • pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes).
SUI sseħħ meta l- awrina tiskappa involontarjament matul l- isforz fiżiku jew wara li tisgħol, tidħaq, tagħtas, terfa 'oġġetti jew tagħmel eżerċizzji fiżiċi. • l- uġigħ minħabba newropatija periferika dijabetika (ħsara lin- nervituri ta' l- estremitajiet li tista 'sseħħ f' pazjenti bid- dijabete).
How is Ariclaim used?
Kif jintuża Ariclaim?
For SUI, the recommended dose of Ariclaim is 40 mg twice a day.
Għal SUI, id- doża rakkomandata ta 'Ariclaim hija 40 mg darbtejn kuljum.
Some patients may benefit from starting treatment at a dose of 20 mg twice a day for two weeks before increasing to 40 mg twice a day, to reduce nausea (feeling sick) and dizziness.
Xi pazjenti jistgħu jiksbu benefiċċju minn trattament inizjali b' doża ta '20 mg darbtejn kuljum għal ġimagħtejn qabel ma jgħaddu għad- doża rakkomandata ta' 40 mg, biex inaqqsu n- nawżea (dardir) u l- isturdament.
Combining Ariclaim with pelvic floor muscle training may provide additional benefit.
Li tgħaqqad Ariclaim ma 'programm ta' eżerċizzju tal- muskolatura tal- qiegħ pelviku (pelvic floor) jista 'jagħti aktar benefiċċju.
Ariclaim can be taken with or without food.
Ariclaim jista 'jittieħed anki fuq stonku vojt.
The benefit of treatment should be re-assessed at regular intervals.
Il- benefiċċju tat- trattament għandu jiġi valutat mill- ġdid f' intervalli ta 'żmien regolari.
Ariclaim should be used with caution in elderly patients.
Ariclaim għandu jintuża b' kawtela fil- pazjenti anzjani.
The dose should be reduced gradually when stopping treatment.
Id- doża għandha titnaqqas gradwalment meta t- trattament jieqaf.
How does Ariclaim work?
Kif jaħdem Ariclaim?
It works by preventing the neurotransmitters 5-hydroxytrypamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Is- sustanza attiva f' Ariclaim, duloxetine, hija inibitur ta 'l- assorbiment mill- ġdid tas- serotonina u tan - noradrenalina (serotonin- noradrenaline re- uptake inhibitor).
Neurotransmitters are chemicals 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Dan jaħdem billi jipprevjeni lin - 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. that allow nerve cells to communicate with one another.
Reproduction is authorised provided the source is acknowledged. newrotrasmettituri 5- idrossitriptamina (imsejħa wkoll serotonina) u n- noradrenalina milli jerġgħu jiġu assorbiti fiċ- ċelluli nervużi fil- moħħ u fis- sinsla tad- dahar.
By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters in the spaces between these nerve cells, increasing the level of communication between the cells.
Billi jimblokka l- assorbiment mill- ġdid, duloxetine iżżid l- ammont ta 'dawn in- newrotrasmettituri fl- ispazji bejn dawn iċ- ċelluli nervużi, u b' hekk iżżid il- livell ta' komunikazzjoni bejn iċ- ċelluli.
How duloxetine works in SUI is not clear but it is thought that, by increasing the levels of 5-hydroxytryptamine and noradrenaline at the level of the nerves that control the muscle of the urethra (the tube that leads from the bladder to outside), duloxetine causes a stronger closure of the urethra during urine storage.
L- azzjoni ta 'duloxetine fi SUI mhijiex ċara, iżda jitqies li, billi żżid il- livelli ta' 5- idrossitripamina e noradrenalina fil- livell tan- nervituri li jikkontrollaw il- muskolatura ta 'l- uretra (il- kanal li jgħaqqad il - bużżieqa ma' barra), duloxetine tikkawża għeluq ta 'l- uretra aktar bis- saħħa waqt il- bużżieqa timtela bl- awrina.
By closing the urethra more powerfully, Ariclaim prevents the unwanted loss of urine during physical stress such as coughing or laughing.
Billi jagħlaq l- uretra aktar bis- saħħa, Ariclaim jipprevjeni t- telf involontarju ta 'awrina waqt sforz fiżiku bħas- sogħla jew id- daħk.
Since these neurotransmitters are also involved in reducing the sensation of pain, blocking their re-uptake into nerve cells may also improve the symptoms of neuropathic pain.
Billi dawn in- newrotrasmettituri huma wkoll involuti fit- tnaqqis tas- sensazzjoni ta 'wġigħ, il- fatt li jimpedixxu l- assorbiment mill- ġdid tagħhom fiċ- ċelluli nervużi aktarx jgħin ukoll biex itaffi s- sintomi ta' l- uġigħ newropatiku.
How has Ariclaim been studied?
Kif ġie studjat Ariclaim?
For the treatment of SUI, Ariclaim has been studied in a total of 2,850 women.
Għat- trattament ta 'SUI, Ariclaim ġie studjat f' total ta' 2, 850 mara.
The four main studies involved 1,913 women and lasted 12 weeks, comparing Ariclaim (mostly as 40 mg twice a day) with placebo (a dummy treatment).
L- erba 'studji prinċipali involvew 1, 913- il mara u damu 12- il ġimgħa u qabblu Ariclaim (l- aktar bħala doża 40 mg darbtejn kuljum) mal - plaċebo (trattament finta).
The main measures of effectiveness were incontinence episode frequency (IEF, the number of episodes of incontinence per week) recorded in patient diaries and the patients’ scores on an incontinence-specific quality-of-life questionnaire (I-QOL).
Il- kejl ewlieni ta 'l- effikaċja kienu l- frekwenza ta' l- episodji ta 'inkontinenza (IEF, jiġifieri l- għadd ta' episodji ta 'inkontinenza kull ġimgħa) imniżżla fuq djarju tal- pazjenti u l - punteġġ tal- pazjenti fuq il- bażi ta' kwestjonarju ta 'kwalità tal- ħajja speċifiku għall- inkontinenza (I - QOL).
For the treatment of diabetic neuropathic pain, Ariclaim has been studied in two 12-week studies in 809 diabetic adults who had had pain every day for at least six months.
Għat- trattament ta 'l- uġigħ newropatiku dijabetiku, Ariclaim ġie eżaminat f' żewġ studji li damu 12- il ġimgħa fuq 809 adulti dijabetiċi li ħassew uġigħ kuljum għal talanqas sitt xhur.
The effectiveness of three different doses of Ariclaim was compared with that of placebo.
L- effikaċja ta 'tliet dożi differenti ta' Ariclaim tqabblet ma 'dik tal- plaċebo.
The main measure of effectiveness was the change in the severity of pain each week, as recorded by the patients on an 11-point scale in daily diaries.
Il- kejl ewlieni ta 'l- effikaċja kien il- bidla fil - gravità ta' l- uġigħ kull ġimgħa, kif imniżżel mill- pazjenti fuq skala ta '11- il punt f' djarju ta' kuljum.
What benefit has Ariclaim shown during the studies?
X' benefiċċji ta 'Ariclaim intwerew f' dawn l- istudji?
In all four studies of SUI, the patients treated with Ariclaim had fewer episodes of incontinence after 12 weeks, with about four or five fewer episodes of incontinence per week, in comparison with the number before the study.
Fl- erba 'studji kollha ta' SUI, il- pazjenti ttrattati b' Ariclaim kellhom anqas episodji ta 'inkontinenza wara 12- il ġimgħa, b' madwar erbgħa jew ħames episodji anqas kull ġimgħa meta mqabbel mal - frekwenza reġistrata l- istudju.
The IEF decreased by 52% in the Ariclaim group, compared with a decrease of 33% in the placebo-treated group.
L- IEF naqset bi 52% fil- grupp ta 'Ariclaim, kontra tnaqqis ta' 33% fil - grupp ittrattat bil- plaċebo.
The I-QOL questionnaire scores were also improved in the Ariclaim group compared with the placebo group.
Il- punteġġi tal- kwestjonarju I- QOL tjiebu wkoll fil- grupp tal- pazjenti ttrattati b' Ariclaim meta mqabbel mal- grupp ittrattat bil- plaċebo.
Ariclaim was more effective than placebo only in patients who had more than 14 incontinence episodes per week (moderate to severe SUI) at the start of the study.
Ariclaim irriżulta aktar effikaċi mill - plaċebo biss fil- pazjenti li kellhom iktar minn 14- il episodju ta 'inkontinenza fil- ġimgħa (SUI minn moderata għal gravi) fil- bidu ta' l- istudju.
For the treatment of diabetic neuropathic pain, Ariclaim at doses of 60 mg once or twice a day was more effective at reducing pain than placebo.
Għat- trattament ta 'l- uġigħ newropatiku dijabetiku, Ariclaim f' dożi ta' 60 mg darba jew darbtejn kuljum irriżulta aktar effikaċi mill- plaċebo biex inaqqas l- uġigħ.
In both studies, pain reduction was seen from the first week of treatment for up to 12 weeks, with patients taking Ariclaim having pain scores between 1.17 and 1.45 points lower than those taking placebo.
Fiż- żewġ studji, it- tnaqqis ta 'l- uġigħ deher mill- ewwel ġimgħa ta' trattament sa perjodu massimu ta '12- il ġimgħa u l- pazjenti ttrattati b' Ariclaim kellhom punteġġ ta' wġigħ bejn 1. 17 u 1. 45 punt anqas minn dawk il- pazjenti ttrattati bil - plaċebo.
What is the risk associated with Ariclaim?
X' inhu r- riskju assoċjat ma 'Ariclaim?
The most common side effects with Ariclaim when used to treat SUI (seen in more than 1 patient in 10) are nausea, dry mouth, constipation and fatigue (tiredness).
L- effetti sekondarji l- aktar komuni b' Aricliam fit- trattament ta 'SUI (li dehru f' aktar minn pazjent 1 minn kull 10) huma nawżea, ħalq xott, stitikezza u għeja.
Most of these were mild or moderate, starting early in treatment and getting milder as treatment continued.
Fil- parti l- kbira tal- każijiet dawn kienu effetti ħfief jew moderati, li dehru fil- bidu tat- trattament u naqsu hekk kif kompla t- trattament.
The most common side effects when used to treat diabetic neuropathic pain (seen in more than 1 patient 10) are headache, somnolence (sleepiness), nausea and dry mouth.
L - effetti sekondarji l- aktar komuni fit- trattament ta 'l- uġigħ newropatiku dijabetiku (li dehru f' aktar minn pazjent 1 minn 10) huma wġigħ ta' ras, ħedla tan- ngħas, nawżea u ħalq xott.
For the full list of all side effects reported with Ariclaim, see the Package Leaflet.
Għal- lista sħiħa ta 'l - effetti sekondarji rrappurtati b' Ariclaim, ara l- Fuljett ta' Tagħrif.
Ariclaim should not be used in people who may be hypersensitive (allergic) to duloxetine or any of the other ingredients.
Ariclaim ma għandux jintuża f' persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal duloxetine jew għal xi ingredjenti oħra.
Ariclaim should not be used in patients with certain types of liver disease or with severe kidney disease.
Ariclaim ma għandux jintuża f' pazjenti b' ċerti tipi ta 'mard tal- fwied jew f' pazjenti b' mard gravi tal- kliewi.
Ariclaim should not be used with monoamine oxidase inhibitors (a group of antidepressants), fluvoxamine (another antidepressant), or ciprofloxacin or enoxacin (types of antibiotic).
Ariclaim ma għandux jintuża flimkien ma 'inibituri tal- monoamino ossidażi (monoamine oxidase inhibitors, grupp ta' antidipressivi), fluvoxamine (antidipressiv ieħor), jew ciprofloxacin jew enoxacin (tipi ta 'antibijotiċi).
Why has Ariclaim been approved?
2/ 3 Għaliex ġie approvat Ariclaim?
The Committee for Medicinal Products for Human Use (CHMP) decided that Ariclaim’ s benefits are greater than its risks for the treatment of moderate to severe SUI and of diabetic peripheral neuropathic pain in adults.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Ariclaim huma ogħla mir- riskji tiegħu għat- trattament ta' SUI minn moderata għal gravi u ta 'l- uġigħ newropatiku periferiku dijabetiku f' adulti.
The Committee recommended that Ariclaim be given marketing authorisation.
Il- Kumitat irrakkomanda li Ariclaim jingħata l - awtorizzazzjoni għat- tqegħid fis- suq.
2/ 3 Other information about Ariclaim:
Aktar tagħrif dwar Ariclaim:
The European Commission granted a marketing authorisation valid throughout the European Union for Ariclaim on 11 August 2004.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha, għal Ariclaim fil- 11 ta 'Awissu 2004.
The marketing authorisation holder is Eli Lilly Nederland BV.
Id- deterntur ta 'l- awtorizzazzjoni għat- tqegħid fis- suq huwa Eli Lilly Nederland BV.
The full EPAR for Ariclaim is available here.
L- EPAR sħiħ dwar Ariclaim jista 'jiġi kkonsultat hawn.
Capsule, hard, gastro-resistant Capsule, hard, gastro-resistant Capsule, hard, gastro-resistant Capsule, hard, gastro-resistant Capsule, hard, gastro-resistant Capsule, hard, gastro-resistant Capsule, hard, gastro-resistant Capsule, hard, gastro-resistant Capsule, hard, gastro-resistant Capsule, hard, gastro-resistant Capsule, hard, gastro-resistant Capsule, hard, gastro-resistant
Kapsula, iebsa, gastro- reżistenti Kapsula, iebsa, gastro- reżistenti Kapsula, iebsa, gastro- reżistenti Kapsula, iebsa, gastro- reżistenti Kapsula, iebsa, gastro- reżistenti Kapsula, iebsa, gastro- reżistenti Kapsula, iebsa, gastro- reżistenti Kapsula, iebsa, gastro- reżistenti Kapsula, iebsa, gastro- reżistenti Kapsula, iebsa, gastro- reżistenti Kapsula, iebsa, gastro- reżistenti Kapsula, iebsa, gastro- reżistenti
blister (PVC/ PE/ PCTFE/ alu) blister (PVC/ PE/ PCTFE/ alu) blister (PVC/ PE/ PCTFE/ alu) blister (PVC/ PE/ PCTFE/ alu) blister (PVC/ PE/ PCTFE/ alu) blister (PVC/ PE/ PCTFE/ alu) blister (PVC/ PE/ PCTFE/ alu) blister (PVC/ PE/ PCTFE/ alu) blister (PVC/ PE/ PCTFE/ alu) blister (PVC/ PE/ PCTFE/ alu) blister (PVC/ PE/ PCTFE/ alu) blister (PVC/ PE/ PCTFE/ alu)
folja (PVC/ PE/ PCTFE/ alu) folja (PVC/ PE/ PCTFE/ alu) folja (PVC/ PE/ PCTFE/ alu) folja (PVC/ PE/ PCTFE/ alu) folja (PVC/ PE/ PCTFE/ alu) folja (PVC/ PE/ PCTFE/ alu) folja (PVC/ PE/ PCTFE/ alu) folja (PVC/ PE/ PCTFE/ alu) folja (PVC/ PE/ PCTFE/ alu) folja (PVC/ PE/ PCTFE/ alu) folja (PVC/ PE/ PCTFE/ alu) folja (PVC/ PE/ PCTFE/ alu)
ARICLAIM 40 mg hard gastro-resistant capsules.
ARICLAIM 40 mg kapsuli ibsin gastro- reżistenti
ARICLAIM is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI), (see section 5.1).
4. 1 Indikazzjonijiet terapewtiċi
The recommended dose of ARICLAIM is 40 mg twice daily without regard to meals.
Id- doża rrakkomandata ta ’ ARICLAIM hija ta '40 mg darbtejn kuljum u mingħajr bżonn li tittieħed fuq l- ikel.