qanastek/EMEA-V3 huggingface dataset:
Fertility studies in rats revealed slight impairment of reproductive performance and fertility at doses of 15 mg/ kg/ day (which is higher than the therapeutic dose), probably due to sedation and lethargy.
Studji fuq il- fertilita fil- firien urew indeboliment ħafif fir- riproduttività u l- fertilità, f’ dożi ta ’ 15 mg/ kg/ jum (li hija ogħla mid- doża terapewtika) probabbilment dovuta għas- sedazzjoni u l- letarġija.
In the pregnant rat, the transfer of 14C- riluzole across the placenta to the foetus has been detected.
Waqt it- tqala fil- far, it- trasferiment ta ’ 14C- riluzole mis- sekonda għal ġol- fetu kien osservat.
In rats, riluzole decreased the pregnancy rate and the number of implantations at exposure levels at least twice the systemic exposure of humans given clinical therapy.
Fil- firien, riluzole naqqas ir- rata ta ’ tqala u n- numru ta ’ impjantazzjonijiet f’ livelli ta ’ espożizzjoni ta ’ mhux anqas minn darbtejn l- eżpożizzjoni sistemika fil- bnedmin li kienu fuq it- terapija klinika.
No malformations were seen in animal reproductive studies.
Ma ġewx osservati malformazzjonijiet fi studji riproduttivi fl- annimali.
In lactating rats, 14C-riluzole was detected in milk.
Fil- firien li qed ireddgħu, 14C- riluzole instab fil- ħalib.
Core:
Fil- qalba tal- pillola:
Dibasic calcium phosphate, anhydrous Micro crystalline cellulose Colloidal silica, anhydrous Magnesium stearate Croscarmellose sodium
Dibasic calcium phosphate, anhydrous Micro, crystalline cellulose Colloidal silica, anhydrous Magnesium stearate Croscarmellose sodium
Coating:
Ir- rita:
Hypromellose Macrogol 6000 Titanium dioxide (E171)
Hypromellose Macrogol 6000 Titanium dioxide (E171)
This medicinal product does not require any special storage conditions.
Din il- mediċina m ’ għandhiex bżonn ħażna speċjali.
Each package contains 56 tablets (4 blister cards of 14 tablets each).
Pilloli ippakkjati fi strixxi magħmula mill- pvc opak / fojl ta ’ l- aluminju Kull pakkett fih 56 pillola (4 strixxi tal- fojl b’ 14- il pillola kull waħda).
20 avenue Raymond Aron F-92165 Antony Cedex France
20, avenue Raymond Aron F- 92165 Antony Cedex Franza
date of first authorisation:
Data ta ’ l- ewwel awtorizzazzjoni:
10 June 1996 date of last renewal:
10 ta ’ Ġunju 1996 Data ta ’ l- aħħar tiġdid:
10 June 2006
10 ta ’ Ġunju 2006
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RISPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Sanofi Winthrop Industrie, 56, Route de Choisy au Bac, F-60205 Compiègne, France.
Sanofi Winthrop Industrie, 56, Route de Choisy au Bac, F- 60205 Compiègne, Franza
The Marketing Authorisation Holder will provide Periodic Safety Update Report every two years until otherwise decided by the Committee for Medicinal Products for Human Use (CHMP).
Id- detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq għandu jipprovdi Perjodikament Rapport Aġġornat dwar is- Sigurtà (PSUR) kull sentejn sakemm ikun deċiż mod ieħor mill- Kumitat dwar il - Prodotti Mediċinali għall- Użu fil- Bniedem (CHMP).
RILUTEK 50 mg film-coated tablets riluzole
RILUTEK 50 mg pilloli miksija b’ rita riluzole
Each film-coated tablet contains 50 mg of riluzole
Kull pillola miksija b’ rita fiha 50 mg ta ’ riluzole
56 film-coated tablets
56 pillola miksija b’ rita
Read the package leaflet before use Oral use
Aqra l- fuljett ta ’ tagħrif qabel l- użu Użu orali
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
Aventis Pharma S. A., 20 avenue Raymond Aron, F-92165 Antony Cedex, France
Aventis Pharma S. A., 20, avenue Raymond Aron, F- 92165 Antony Cedex, Franza
14 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
14 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
PVC/ ALUMINIUM BLISTER
FOLJA TAL- PVC/ ALUMINJU
RILUTEK 50 mg film-coated tablets Riluzole
RILUTEK 50 mg pilloli muksija b’ rita Riluzole
Read all of this leaflet carefully before you start taking this medicine.
Aqra sew dan il- fuljett kollu qabel ma tibda tieħu din il- mediċina.
if their symptoms are the same as yours.
tagħmlilhom il- ħsara, anke jekk ikollhom l- istess sintomi bħal tiegħek.
What RILUTEK is and what it is used for 2.
X’ inhu RILUTEK u għalxiex jintuża 2.
Before you take RILUTEK 3.
Qabel ma tieħu RILUTEK 3.
How to take RILUTEK 4.
Kif għandek tieħu RILUTEK 4.
How to store RILUTEK 6.
Kif taħżen RILUTEK 6.
WHAT RILUTEK IS AND WHAT IT IS USED FOR
X’ INHU RILUTEK U GĦALXIEX JINTUŻA
What RILUTEK is
X’ inhu RILUTEK?
The active substance in RILUTEK is riluzole which acts on the nervous system.
Is- sustanza attiva ta ’ RILUTEK hija riluzole li taħdem fuq is- sistema nervuża.
What RILUTEK is used for
Għalxiex jintuża RILUTEK?
RILUTEK is used in patients with amyotrophic lateral sclerosis (ALS).
RILUTEK jintuża f’ pazjenti bl- atrofija tal- muskoli dovuta għall- isklerożi laterali (ALS).
ALS is a form of motor neurone disease where attacks of the nerve cells responsible for sending instructions to the muscles lead to weakness, muscle waste and paralysis.
ALS hija forma ta ’ marda tan- newroni relatat mac- ċaqlieq tal- muskoli li tattakka ċ- ċelluli tan- nerv li jibagħtu sinjali lill- muskoli u twassal għal dgħjufija, eżawriment tal- muskoli u paralisi.
The destruction of nerve cells in motor neurone disease may be caused by too much glutamate (a chemical messenger) in the brain and spinal cord.
Il- qerda taċ- ċelluli tan- nerv fil- marda tan- newroni relatat mac- ċaqlieq tal- muskoli tista ’ tiġi kkawżata minn ħafna glutamat (forma li ġġorr informażzjoni kimika) fil- moħħ u fin- nerv qawwi li jgħaddi minn ġos- sinsla.
RILUTEK stops the release of glutamate and this may help in preventing the nerve cells being damaged.
RILUTEK iwaqqaf il- ħruġ ta ’ glutamat u dan jista ’ jgħin bien jevita li ssir ħsara liċ - ċelluli tan- nerv.
Please consult your doctor for more information about ALS and the reason why this medicine has been prescribed for you.
Jekk jogħġbok, ikkonsulta lit- tabib tiegħek għal aktar informazzjoni dwar ALS u r- raġuni għal fejn din il- mediċina qed tkun preskritta lilek.
BEFORE YOU TAKE RILUTEK
QABEL MA TIEĦU RILUTEK
Do not take RILUTEK
Tieħux RILUTEK
- if you are allergic (hypersensitive) to riluzole or any of the other ingredients of RILUTEK,
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal riluzole jew sustanzi oħra ta
- if you have any liver disease or increased blood levels of some enzymes of the liver
- jekk għandek mard tal- fwied jew żieda fil- livelli fid- demm ta ’ xi enżimi tal- fwied
(transaminases),
(transaminażi),
17 Take special care with RILUTEK Tell your doctor;
17 Oqgħod attent ħafna b’ RILUTEK Għid lit- tabib tiegħek – jekk għandek xi problemi fil- fwied; sfurija tal- ġilda jew ta ’ l- abjad ta ’ għajnejk (suffejra), ħakk ma kullimkien, tħossok imdardar, tirrimetti – jekk għandek il- kliewi li m’ humiex qed jaħdmu sew – jekk għandek xi deni: jista ’ jkun minħabba li n- numru ta ’ celluli bojod fid- demm huwa baxx u għalhekk tista ’ tkun f’ riskju ogħla li jkollok infezzjoni – jekk inti għandek inqas minn 18- il sena.
The use of RILUTEK is not recommended in children
L- użu ta ’ RILUTEK m’ huwiex rakkomandat fit- tfal minħabba li m’ hemmx informazzjoni disponibbli f’ din il- popolazzjoni.
If any of the above apply to you, or if you are not sure, tell your doctor who will decide what to do.
Jekk xi wieħed minn dawn t’ hawn fuq jgħodd għalik, jew jekk m’ intix ċert, għid lit- tabib u hu jiddeċiedi x’ għandu jsir.
Pregnancy and breast-feeding You MUST NOT take RILUTEK if you are or think you may be pregnant, or if you are breast feeding.
Tqala u Treddigħ M’ GĦANDEKX tieħu RILUTEK. - jekk inti tqila jew taħseb li tista ’ tkun tqila jew qiegħda tredda ’
If you think you may be pregnant, or if you intend to breast-feed, ask your doctor for advice before taking RILUTEK.
Jekk taħseb li tista ’ tkun tqila jew jekk int bi ħsiebek tredda ’, staqsi lit- tabib għal parir qabel ma tieħu RILUTEK..
Driving and using machines You can drive or use any tools or machines, unless you feel dizzy or light headed after taking this medicine.
Sewqan u tħaddim ta ’ magni Tista ’ ssuq jew tħaddem magni sakemm ma tħossokx sturdut jew ma tħossokx f’ sikktek wara li tieħu din il- mediċina.
HOW TO TAKE RILUTEK
KIF GĦANDEK TIEĦU RILUTEK
The recommended dose is one tablet, twice a day.
Id- doża rrakkomandata hija pillola waħda darbtejn kuljum.
The tablets should be taken by mouth, every 12 hours, at the same time of the day each day (e. g. in the morning and evening).
Il- pilloli għandhom jittieħdu mill- ħalq, kull 12- il siegħa, fl- istess ħin tal- ġurnata kuljum (eż. filgħodu u filgħaxija).
If you take more RILUTEK than you should
Jekk tieħu RILUTEK aktar milli suppost
If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately.
Jekk tieħu wisq pilloli, ikkuntattja b’ mod immedjat lit- tabib tiegħek jew l- eqreb dipartiment ta ’ emerġenza ta ’ sptar.
If you forget to take RILUTEK
Jekk tinsa tieħu RILUTEK
If you forget to take your tablet, leave out that dose completely and take the next tablet at the usual time.
Jekk tinsa tieħu l- pillola tiegħek, insa dik id- doża kompletament u ħu l- pillola li jmiss fil- ħin li teħodha s- soltu.
Like all medicines, RILUTEK can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, RILUTEK jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
18 IMPORTANT Tell your doctor immediately
IMPORTANTI B’ mod immedjat, għid lit- tabib
- if you experience any fever (increase in temperature) because RILUTEK may cause a decrease
- jekk jitlagħlek id- deni (żieda fit- temperatura) għax RILUTEK jista ’ jikkawża tnaqqis fin- numru
in the number of white blood cells.
ta ’ ċelluli bojod fid- demm.
Your doctor may want to take a blood sample to check the number of white blood cells, which are important in fighting infections.
18 jivverifika n- numru ta ’ ċelluli bojod fid- demm, li huma importanti biex jiġġieldu l - infezzjonijiet.
- if you experience any of the following symptoms: yellowing of your skin or the white of your
- jekk ikollok xi wieħed minn dawn is- sintomi li ġejjien: sfurija tal- ġilda jew ta ’ l- abjad ta ’
eyes (jaundice), itching all over, feeling sick, being sick, as this may be signs of liver disease (hepatitis). Your doctor may do regular blood tests while you are taking RILUTEK to make sure that this does not occur.
Waqt li qed tieħu RILUTEK, it- tabib, b’ mod regolari, jista ’ jagħmillek xi testijiet tad- demm biex jiżgura li dan ma jseħħx.
Very common side effects (affecting more than 1 in 10 patients) of RILUTEK are:
Effetti sekondarji komuni ħafna (jolqtu iktar minn 1 minn kull 10 pazjenti) ta ’ RILUTEK huma:
- feeling sick
- tħossok imdardar
- increased blood levels of some enzymes of the liver (transaminases).
- żieda fil- livelli tad- demm ta ’ xi enzimi tal- fwied (transaminases)
Common side effects (affecting between 1 in 10 and 1 in 100 patients) of RILUTEK are: -
Effetti sekondarji komuni (jolqtu bejn 1 minn kull 10 u 1 minn kull 100 pazjent) ta ’ RILUTEK huma: - - -
numbness or tingling of
sturdament - ngħas - uġigħ ta ’ ras -
sleepiness - increase in heart beat - diarr
ħalq imtarrax jew mnemnem żieda fit- tħabbit tal- qalb uġigħ addominali
headache - abdominal pain -
rimettar dijarrea uġigħ
Uncommon side effects (affecting between 1 in 100 and 1 in 1000 patients) of RILUTEK are:
Effetti sekondarji mhux komuni (jolqtu bejn 1 minn kull 100 u 1 minn kull 1000 pazjent) ta ’ RILUTEK huma:
- allergic reactions
- reazzjonijiet allerġiċi
HOW TO STORE RILUTEK
KIF TAĦŻEN RILUTEK
Do not use RILUTEK after the expiry date which is stated on the carton and the blister.
Tużax RILUTEK wara d- data ta ’ skadenza li tidher fuq il- kaxxa u l- istrixxi.
What RILUTEK contains
X’ fih Rilutek
- The active substance is riluzole.
- Is- sustanza attiva hija riluzole.
Core: anhydrous dibasic calcium phosphate, micro crystalline cellulose, anhydrous colloidal silica, magnesium stearate, croscarmellose sodium; Coating: hypromellose, macrogol 6000, titanium dioxide (E171).
Il- kisja tal- pillola: hypromellose, macrogol 6000, titanium dioxide (E171).
What RILUTEK looks like and content of the pack
Id- Dehra ta ’ RILUTEK u d- daqs tal- pakkett
The tablets are film-coated, capsule-shaped and white.
Il- pilloli huma miksija b’ rita bil- forma ta ’ kapsuli bojod.
Each tablet contains 50 mg of riluzole and is engraved with “ RPR 202 ” on one side.
Kull pillola fiha 50 mg ta ’ riluzole u b ’ “ RPR 202 ” imnaqqax fuq naħa waħda.
RILUTEK is available in a pack of 56 tablets (4 blister cards of 14 tablets each) to be taken orally.
RILUTEK huwa disponibbli f’ pakkett ta ’ 56 pilloli (4 folji ta ’ 14- il pillola l- waħda) biex jittieħdu mill- ħalq.
Marketing Authorisation Holder Aventis Pharma S. A., 20 avenue Raymond Aron, F-92165 Antony Cedex, France
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq Aventis Pharma S. A., 20 avenue Raymond Aron, F- 92165 Antony Cedex, Franza
19 Manufacturer Sanofi Winthrop Industrie, 56, Route de Choisy au Bac, F-60205 Compiègne, France.
19 Manifattur Sanofi Winthrop Industrie, 56, Route de Choisy au Bac, F- 60205 Compiègne, Franza.
What is Riprazo?
X' inhu Riprazo?
Riprazo is a medicine containing the active substance aliskiren.
Riprazo hu mediċina li fiha s- sustanza attiva aliskiren.
What is Riprazo used for?
Għal x' hiex jintuża Riprazo?
Riprazo is used to treat essential hypertension (high blood pressure). ‘ Essential ’ means that no specific cause for the hypertension can be found.
Riprazo jintuża fit- trattament tal- pressjoni għolja essenzjali. ‘ Essenzjali 'tfisser li ma tkunx tista' tinstab kawża speċifika għall- pressjoni għolja.
How is Riprazo used?
Kif jintuża Riprazo?
The recommended dose of Riprazo is 150 mg once a day, either taken alone or in combination with other medicines for hypertension.
Id- doża rrakkomandatata ta 'Riprazo hi 150 mg darba kuljum, jew waħedha jew flimkien ma' mediċini oħra għall- pressjoni għolja.
Riprazo is not recommended for children, due to a lack of information on safety and effectiveness in this group.
Riprazo mhux rakkomandat għat- tfal, minħabba nuqqas ta 'tagħrif dwar is- sigurtà u l- effikaċja f' dan il- grupp.
How does Riprazo work?
Kif jaħdem Riprazo?
The active substance in Riprazo, aliskiren, is a renin inhibitor.
Is- sustanza attiva f' Riprazo, aliskiren, hi inibitur tar- renin.
How has Riprazo been studied?
Kif ġie studjat Riprazo?
The effects of Riprazo were first tested in experimental models before being studied in humans.
L- effetti ta 'Riprazo għall- ewwel ġew ittestjati f' mudeli esperimentali qabel ma ġew studjati fil - bnedmin.
Riprazo was studied in 14 main studies involving over 10,000 patients with essential hypertension.
Riprazo ġie studjat f' 14- il studju ewlieni li fihom ħadu sehem iktar minn 10, 000 pazjent bi pressjoni għolja essenzjali.
In five of the studies, the effects of Riprazo taken alone were compared with those of placebo (a dummy treatment).
F' ħamsa mill - istudji, l- effetti ta 'Riprazo meħud waħdu tqabblu ma' dawk ta 'plaċebo (trattament finta).
Riprazo, taken alone or in combination with other medicines, was also compared with other medicines for hypertension.
Riprazo, meħud waħdu jew flimkien ma 'mediċini oħra, tqabbel ma' mediċini oħra għall- pressjoni għolja.
Combination studies looked at Riprazo used with an angiotensin converting enzyme inhibitor (ramipril), an angiotensin receptor blocker (valsartan), a beta-blocker (atenolol), a calcium-channel blocker (amlodipine) and a 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
L - istudji kombinatorji ħarsu lejn l- effett ta 'Riprazo użat flimkien ma' inibitur ta 'enzim li jikkonverti l - angiotensin (ramipril), ma' sustanza li timblokka r- riċettur ta 'l- angiotensin (valsartan), ma' beta - 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
What benefit has Riprazo shown during the studies?
X' inhu l- benefiċċju ta 'Riprazo li ntwera f' dawn l- istudji?
Riprazo on its own was more effective than placebo and as effective as comparator treatments in reducing blood pressure.
Riprazo waħdu kien iktar effettiv mill- plaċebo u kien effettiv daqs it- trattamenti komparattivi fit - tnaqqis tal- pressjoni.
When the results of the five studies comparing Riprazo taken alone with placebo were looked at together, patients aged under 65 had an average fall in diastolic blood pressure of 9.0 mmHg after eight weeks of taking 150 mg Riprazo, from an average of 99.4 mmHg at the start of the study.
Meta r- riżultati tal- ħames studji li qabblu Riprazo meħud waħdu ma 'plaċebo ġew studjati flimkien, il- pazjenti li kellhom inqas minn 65 sena kellhom tnaqqis medju fil- pressjoni dijastolika ta' 9. 0 mmHg wara tmien ġimgħat jieħdu 150 mg Riprazo, minn medja ta '99. 4 mmHg fil - bidu tat- trattament.
Larger falls were seen in patients aged 65 or over and those taking higher doses of Riprazo.
Fil- pazjenti li kellhom 65 sena jew iktar u f' dawk li kienu qed jieħdu dożi ogħla ta 'Riprazo kien hemm tnaqqis ikbar fil- pressjoni.
Riprazo also reduced blood pressure in patients with diabetes, patients who were overweight, and those who were over 65 years of age.
Riprazo ġab ukoll tnaqqis fil- pressjoni fil - pazjenti bid- dijabete, pazjenti b' piż eċċessiv, u f' dawk li kellhom iktar minn 65 sena.
The studies also showed that Riprazo, when taken in combination with other medicines (especially hydrochlorothiazide), can produce additional decreases in blood pressure compared with those produced by these medicines taken without Riprazo.
L- istudji wrew ukoll li Riprazo, meta meħud flimkien ma 'mediċini oħra (speċjalment hydrochlorothiazide), jista' jwassal għal iktar tnaqqis fil- pressjoni meta mqabbel mat- tnaqqis fil - pressjoni kkawżat minn dawn il- mediċini meħuda mingħajr Riprazo.
What is the risk associated with Riprazo?
X' inhu r- riskju assoċjat ma 'Riprazo?
The most common side effect with Riprazo (seen in between 1 and 10 patients in 100) is diarrhoea.
L- iktar effett sekondarju komuni ta 'Riprazo (li deher f' bejn pazjent wieħed u 10 minn kull 100) hi d - dijarea.
For the full list of all side effects reported with Riprazo, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrappurtati ma' Riprazo, ara l- Fuljett ta 'Tagħrif.
Riprazo should not be used by people who may be hypersensitive (allergic) to aliskiren or any of the other ingredients.
Riprazo m' għandux jintuża minn persuni li huma sensittivi żżejjed (allerġiċi) għal aliskiren jew għal xi sustanza oħra tiegħu.
Why has Riprazo been approved?
Għaliex ġie approvat Riprazo?
The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Riprazo are greater than its risks for the treatment of essential hypertension.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Riprazo fit- trattament tal- pressjoni għolja essenzjali huma ikbar mir- riskji tiegħu.
The Committee recommended that Riprazo be given marketing authorisation.
Il- Kumitat irrakkomanda li Riprazo jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Riprazo:
Tagħrif ieħor dwar Riprazo:
The European Commission granted a marketing authorisation valid throughout the European Union for Riprazo to Novartis Europharm Limited on 22 August 2007.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal Riprazo lil Novartis Europharm Limited fl- 22 ta 'Awwissu ta' l- 2007.
The full EPAR for Riprazo can be found here.
L- EPAR sħiħ għal Riprazo jinsab hawn.
Riprazo 150 mg film-coated tablets
Riprazo 150 mg pilloli miksijin b’ rita
Light-pink, biconvex, round tablet, imprinted “ IL” on one side and “ NVR” on the other side.
Pillola roża ċar, konvessa miż- żewġ naħat, tonda, ittimbrata ‘ IL ’ fuq naħa u ‘ NVR ’ fuq in- naħa l- oħra.
The recommended dose of Riprazo is 150 mg once daily.
Id- doża irrikkmandata ta ’ Riprazo hija 150 mg darba kuljum.
Riprazo may be used alone or in combination with other antihypertensive agents (see sections 4.4 and 5.1).
Riprazo jista ’ jintuża waħdu jew ma ’ aġenti oħra li jbaxxu l- pressjoni (ara sezzjonijiet 4. 4 u 5. 1).
Riprazo should be taken with a light meal once a day, preferably at the same time each day.
Riprazo għandu jittieħed ma ’ ikla ħafifa darba kuljum, l- aħjar fl- istess ħin tal- ġurnata kuljum.
Grapefruit juice should not be taken together with Riprazo.
Il- meraq tal- grejpfrut m’ għandux jittieħed flimkien ma ’ Riprazo.
Paediatric patients (below 18 years) Riprazo is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy (see section 5.2).
Pazjenti tfal (taħt it- 18- il sena) Riprazo mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja (ara sezzjoni 5. 2).
In the event of severe and persistent diarrhoea, Riprazo therapy should be stopped.
F’ każ ta ’ dijarea severa u persistenti, it- terapija b’ Riprazo għandha titwaqqaf.
Sodium and/ or volume depleted patients In patients with marked volume- and/ or salt-depletion (e. g. those receiving high doses of diuretics) symptomatic hypotension could occur after initiation of treatment with Riprazo.
Pazjenti li għandhom nuqqas ta ’ sodium u/ jew volum F’ pazjenti li jkollhom nuqqas serju ta ’ volum u/ jew melħ (eż dawk li qed jingħataw dożi għoljin ta ’ dijuretiċi) jista ’ jkun hemm sintomi ta ’ pressjoni baxxa wara li tibda l- kura b’ Riprazo.
This condition should be corrected prior to administration of Riprazo, or the treatment should start under close medical supervision.
Din il - kundizzjoni għandha tiġi korretta qabel ma jingħata Riprazo, jew il- kura għandha tinbeda taħt superviżjoni medika stretta.
Renal impairment In clinical studies Riprazo has not been investigated in hypertensive patients with severe renal impairment (serum creatinine ≥ 150 μ mol/ l or 1.70 mg/ dl in women and ≥ 177 μ mol/ l or 2.00 mg/ dl in men and/ or estimated glomerular filtration rate (GFR) < 30 ml/ min), history of dialysis, nephrotic syndrome or renovascular hypertension.
Indeboliment renali Fil- provi kliniċi, Riprazo ma ġiex investigat f’ pazjenti li għandhom il- pressjoni għolja u li jbatu minn indeboliment renali sever (krejatinina fis- serum ≥ 150 μmol/ l jew 1. 70 mg/ dl fin- nisa u ≥ 177 μmol/ l jew 2. 00 mg/ dl fl- irġiel u/ jew rata ta ’ filtrazzjoni fil- glomeruli (GFR) stmata < 30 ml/ min), li kellhom dijalisi fil- passat, sindrome nefrotika jew pressjoni għolja renovaskulari.
Caution should be exercised in hypertensive patients with severe renal impairment due to the lack of safety information for Riprazo.
Għandu jkun hemm kawtela f’ pazjenti bil- pressjoni għolja b’ indeboliment renali sever minħabba n- nuqqas ta ’ tagħrif dwar is - sigurtà li hemm għal Riprazo.
Renal artery stenosis No data are available on the use of Riprazo in patients with unilateral or bilateral renal artery stenosis, or stenosis to a solitary kidney.
Stenożi ta ’ l- arterja renali M’ hemmx tagħrif dwar l- użu ta ’ Riprazo f’ pazjenti bi stenożi ta ’ l- arterja renali unilaterali jew bilaterali, jew fi stenożi f’ kilwa waħda.
Riprazo has no known clinically relevant interactions with medicinal products commonly used to treat hypertension or diabetes.
Riprazo mhux magħruf li jagħmel interazzjonijiet li għandhom rilevanza klinika ma ’ prodotti mediċinali li jintużaw għall- kura ta ’ pressjoni għolja jew dijabete.
Co-administration of aliskiren with either valsartan (↓ 28%), metformin (↓ 28%), amlodipine (↑ 29%) or cimetidine (↑ 19%) resulted in between 20% and 30% change in Cmax or AUC of Riprazo.
Meta aliskiren jingħata ma ’ valsartan (↓28%), metformin (↓28%), amlodipine (↑29%) jew cimetidine (↑19%) is- Cmax jew AUC ta ’ Riprazo inbidlu b’ bejn 20% u 30%.
When administered with atorvastatin, steady-state Riprazo AUC and Cmax increased by 50%.
Meta ngħata ma ’ atorvastatin, l- AUC u Cmax fi stat fiss ta ’ Riprazo żdiedu b’ 50%.
Co- administration of Riprazo had no significant impact on atorvastatin, valsartan, metformin or amlodipine pharmacokinetics.
Meta Riprazo ingħata ma ’ atorvastatin, valsartan, metformin jew amlodipine dan ma kellux impatt sinifikanti fuq il- farmakokinetika tagħhom.
As a result no dose adjustment for Riprazo or these co-administered medicinal products is necessary.
Għalhekk, m’ hemmx bżonn ta ’ aġġustar tad- doża għal Riprazo jew ta ’ dawn il- prodotti mediċinali li jingħataw miegħu.
Digoxin bioavailability may be slightly decreased by Riprazo.
3 Il- biodisponibilità ta ’ digoxin tista ’ titnaqqas xi ftit b’ Riprazo.
3 Preliminary data suggest that irbesartan may decrease Riprazo AUC and Cmax.
Tagħrif preliminari jindika li irbesartan jista ’ jnaqqas xi ftit l- AUC u s- Cmax ta ’ Riprazo.
In experimental animals, it has been shown that P-gp is a major determinant of Riprazo bioavailability.
F’ annimali esperimentali, intwera li P- gp jiddetermina bil- kbir il- biodisponibilità ta ’ Riprazo.
John’ s wort, rifampicin) might therefore decrease the bioavailability of Riprazo.
John’ s wort, rifampicin) għalhekk jistgħu jnaqqsu l- biodisponibilità ta ’ Riprazo.
John’ s wort, rifampicin) might therefore decrease the bioavailability of Riprazo.
John’ s Wort, rifampicin) għalhekk jistgħu jnaqqsu l- bijodisponibilità ta ’ Riprazo.
Potassium and potassium-sparing diuretics Based on experience with the use of other substances that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other substances that may increase serum potassium levels (e. g. heparin) may lead to
Potassium u dijuretiċi li ma jħallux il- potassium jintilef Minn esperjenza b’ sustanzi oħrajn li jeffettwaw is- sistema renin- angiotensin, l- użu ta ’ dijuretiċi li ma jħallux il- potassium jintilef, supplimenti tal- potassium, sostituti tal- melħ li fihom il- potassium jew
4 increases in serum potassium.
4 sustanzi oħra li jistgħu jżidu l- livelli ta ’ potassium fis- serum (eż heparin) jistgħu jwasslu għal żidied tal- potassium fis- serum.
Warfarin The effects of Riprazo on warfarin pharmacokinetics have not been evaluated.
Warfarin L- effetti ta ’ Riprazo fuq il- farmakokinetika ta ’ warfarin ma kienux evalwati.
Food intake Meals with a high fat content have been shown to reduce the absorption of Riprazo substantially.
It- teħid ta ’ l- ikel Ikliet b’ kontenut ta ’ xaħam għoli ntwerew li jnaqqsu l- assorbiment ta ’ Riprazo b’ mod sostanzjali.
Riprazo was not teratogenic in rats or rabbits (see section 5.3).
Riprazo ma kienx teratoġeniku fi frien jew fniek (ara sezzjoni 5. 3).
As for any medicine that acts directly on the RAS, Riprazo should not be used during the first trimester of pregnancy or in women planning to become pregnant and is contraindicated during the second and third trimesters (see section 4.3).
Bħal kull mediċina oħra li taħdem direttament fuq ir - RAS, Riprazo m’ għandux jintuża waqt l- ewwel trimestru tat- tqala jew f’ nisa li qed jippjanaw biex joħorġu tqal u huwa kontraindikat waqt it- tieni u t- tielet trimestri (ara sezzjoni 4. 3).
If pregnancy is detected during therapy, Riprazo should be discontinued accordingly.
Jekk jinsab li hemm tqala waqt it- terapija, Riprazo għandu jitwaqqaf kemm jista ’ jkun malajr kif ikun xieraq.
Riprazo was secreted in the milk of lactating rats.
Riprazo għadda fil- ħalib ta ’ firien li kienu qed ireddgħu.
Riprazo has negligible influence on the ability to drive and use machines.
Riprazo ftit li xejn għandu influwenza fuq il- ħila biex issuq u tħaddem magni.
Riprazo has been evaluated for safety in more than 7,800 patients, including over 2,300 treated for over 6 months, and more than 1,200 for over 1 year.
Riprazo ġie evalwat għas- sigurtà f’ aktar minn 7, 800 pazjent, li kienu jinkludu aktar minn 2, 300 li ingħataw kura għal aktar minn 6 xhur, u aktar minn 1, 200 għal aktar minn sena.
Treatment with Riprazo resulted in an overall incidence of adverse reactions similar to placebo up to 300 mg.
Kura b’ Riprazo wasslet għal inċidenza globali ta ’ reazzjonijiet avversi simili għal plaċebo sa ’ 300 mg.
The incidence of cough was similar in placebo (0.6%) and Riprazo treated (0.9%) patients.
L- inċidenza tas- sogħla kienet simili f’ pazjenti ikkurati bi plaċebo (0. 6%) u b’ Riprazo (0. 9%).
Angioedema has occurred during treatment with Riprazo.
Anġjoedema seħħet waqt il- kura b’ Riprazo.
In controlled clinical trials, angioedema occurred rarely during treatment with Riprazo with rates comparable to treatment with placebo or hydrochlorothiazide.
Fi provi kliniċi kkontrollati, anġjoedema seħħet b’ mod rari waqt il- kura b’ Riprazo b’ rati li setgħu jitqabblu mal- kura bi plaċebo jew hydrochlorthiazide.
In the event of any signs suggesting an allergic reaction (in particular difficulties in breathing, or swallowing, or swelling of the face, extremities, eyes, lips and/ or tongue) patients should discontinue treatment and contact the physician.
F’ każ ta ’ kwalunkwe sinjali li jindikaw reazzjoni allerġika (l- aktar tbatija biex tieħu n- nifs jew tibla ’, jew nefħa tal- wiċċ, fl- idejn u s- saqajn, għajnejn, xofftejn u/ jew ilsien), il- pazjenti għandhom iwaqqfu l - kura u jgħamlu kuntatt mat- tabib.
Laboratory findings In controlled clinical trials, clinically relevant changes in standard laboratory parameters were uncommonly associated with the administration of Riprazo.
Sejbiet tal- laboratorju Fi provi kliniċi kkontrollati, bidliet klinikament rilevanti f’ parametri standard tal- laboratorju kienu assoċjati b’ mod mhux komuni ma ’ l- għoti ta ’ Riprazo.
In clinical studies in hypertensive patients, Riprazo had no clinically important effects on total cholesterol, high density lipoprotein cholesterol (HDL-C), fasting triglycerides, fasting glucose or uric acid.
Fi studji kliniċi f’ pazjenti bi pressjoni għolja, Riprazo ma kellux effetti klinikament importanti fuq il- kolesterol totali, lipoproteina tal- kolesterol ta ’ densità għolja (HDL- C), trigliċeridi ta ’ waqt is- sawm, glucose ta ’ waqt is- sawm jew uric acid.
Increases in serum potassium were minor and infrequent in patients with essential hypertension treated with Riprazo alone (0.9% compared to 0.6% with placebo).
Żiediet tal- potassium fis- serum kienu minuri u mhux frekwenti f’ pazjenti bil - pressjoni għolja naturali kkurata b’ Riprazo waħdu (0. 9% imqabbla ma ’ 0. 6% bil- plaċebo).
However, in one study where Riprazo was used in combination with an ACEI in a diabetic population, increases in serum potassium were more frequent (5.5%).
Madankollu, fi studju wieħed fejn Riprazo intuża ma ’ ACEI f’ popolazzjoni ta ’ pazjenti dijabetiċi iż - żiediet tal- potassium fis- serum kienu aktar frekwenti (5. 5%).
The most likely manifestations of overdosage would be hypotension, related to the antihypertensive effect of aliskiren.
L- aktar ħaga li x’ aktarx tidher b’ doża eċċessiva ta ’ Riprazo tkun pressjoni baxxa, relatata ma ’ l- effett ta ’ aliskiren li jbaxxi l- pressjoni.
6 Hypertension In hypertensive patients, once-daily administration of Riprazo at doses of 150 mg and 300 mg provided dose-dependent reductions in both systolic and diastolic blood pressure that were maintained over the entire 24-hour dose interval (maintaining benefit in the early morning) with a mean peak to trough ratio for diastolic response of up to 98% for the 300 mg dose.
6 Pressjoni għolja F’ pazjenti bil- pressjoni għolja, l- għotja darba kuljum ta ’ Riprazo b’ dożi ta ’ 150 mg u 300 mg ikkawżaw tnaqqis dipendenti mid- doża fil- pressjoni tad- demm sistolika u dijastolika li nżammu fuq perijodu sħiħ ta ’ 24 siegħa ta ’ l- intervall bejn id- dożi (b’ hekk żammew il- benefiċċju ta ’ kmieni filgħodu) b’ medja fil- proporzjon bejn l- ogħla u l- anqas għar- rispons dijastoliku sa ’ 98% għad- doża ta ’ 300 mg.
Riprazo has been studied in 1,864 patients aged 65 years or older, and in 426 patients aged 75 years or older.
Riprazo kien studjat f’ 1, 864 pazjent ta ’ etajiet minn 65 sena ’ l fuq, u f’ 426 pazjent ta ’ etajiet minn 75 sena ’ l fuq.
Riprazo monotherapy studies have shown blood pressure lowering effects comparable to other classes of antihypertensive agents including ACEI and ARB.
Studji b’ monoterapija b’ Riprazo urew li l- effetti li jbaxxi l- pressjoni kienu jitqabblu ma ’ klassijiet oħra ta ’ aġenti li jbaxxu l- pressjoni inklużi ACEI u ARB.
Compared to a diuretic (hydrochlorothiazide - HCTZ), Riprazo 300 mg lowered systolic/ diastolic blood pressure by 17.0/ 12.3 mmHg, compared to 14.4/ 10.5 mmHg for HCTZ 25 mg after 12 weeks of treatment.
Meta mqabbel ma ’ dijuretiku (hydrochlorothiazide - HCTZ), Riprazo 300 mg naqqas il- pressjoni sistolika/ dijastolika tad- demm b’ 17. 0/ 12. 3 mmHg, imqabbel ma ’ 14. 2/ 10. 5 mmHg għal HCTZ 25 mg wara 12- il ġimgħa ta ’ kura.
In diabetic hypertensive patients, Riprazo monotherapy was safe and effective.
F’ pazjenti dijabetiċi bil- pressjoni għolja, monoterapija ta ’ Riprazo kienet sigura u effettiva.
Combination therapy studies are available for Riprazo added to the diuretic hydrochlorothiazide, the ACEI ramipril, the calcium channel blocker amlodipine, the angiotensin receptor antagonist valsartan, and the beta blocker atenolol.
Hemm studji b’ terapija ta ’ kombinazzjoni għal Riprazo miżjud mad- dijuretiku hydrochlorthiazide, l - ACEI ramipril, l- imblukkatur tal- kanali tal- calcium amlodipine, l- antagonist tar- riċettur ta ’ l - angiotensin valsartan, u l- imblukkatur beta atenolol.
Riprazo induced an additive blood-pressure-lowering effect when added to hydrochlorothiazide and to ramipril.
Riprazo ikkawża tnaqqis fil- pressjoni tad- demm akbar meta żdied ma ’ hydrochlorthiazide u ma ’ ramipril.
In patients who did not adequately respond to 5 mg of the calcium channel blocker amlodipine, the addition of Riprazo 150 mg had a blood-pressure-lowering effect similar to that obtained by increasing amlodipine dose to 10 mg, but had a lower incidence of oedema (aliskiren 150 mg/ amlodipine 5 mg 2.1% vs. amlodipine 10 mg 11.2%).
F’ pazjenti li ma kellhomx rispons xieraq għall- 5 mg ta ’ l- imblokkatur tal- kanali tal- calcium amlodipine, iż- żieda ta ’ Riprazo 150 mg kellu effett li jbaxxi l- pressjoni simili għal dak miksub meta d- doża ta ’ amlodopine tiżdied għal 10 mg iżda kien hemm anqas każijiet ta ’ edema (aliskiren 150 mg/ amlodipine 5 mg 2. 1% vs amlodipine 10 mg 11. 2%).
Riprazo in combination with the angiotensin receptor antagonist valsartan showed an additive antihypertensive effect in the study specifically designed to investigate the effect of the combination therapy.
Riprazo flimkien ma ’ l- antagonist tar - riċettur ta ’ angiotensin valsartan wera effett ta ’ tnaqqis fil- pressjoni akbar fl- istudju li kien imfassal apposta sabiex jiġi mistħarreġ l- effett tat- terapija kombinata.
In obese hypertensive patients who did not adequately respond to HCTZ 25 mg, add-on treatment with Riprazo 300 mg provided additional blood pressure reduction that was comparable to add-on treatment with irbesartan 300 mg or amlodipine 10 mg.
F’ pazjenti obeżi li għandhom il- pressjoni għolja li ma wrewx rispons xieraq għal HCTZ 25 mg, kura bl- inklużjoni ta ’ Riprazo 300 mg ipprovdiet tnaqqis addizzjonali fil- pressjoni tad- demm li seta ’ jitqabbel ma ’ kura bl- inklużjoni ta ’ irbesartan 300 mg jew amlodipine 10 mg.
In diabetic hypertensive patients, Riprazo provided additive blood pressure reductions when added to ramipril, while the combination of Riprazo and ramipril had a lower incidence of cough (1.8%) than ramipril (4.7%).
F’ pazjenti dijabetiċi li għandhom il- pressjoni għolja, Riprazo ipprovda tnaqqis addittiv tal- pressjoni tad- demm meta ngħata ma ’ ramipril, filwaqt li l- kombinazzjoni ta ’ Riprazo u ramipril kellha anqas każijiet ta ’ sogħla (1. 8%) minn ramipril (4. 7%).
Excessive hypotension was uncommonly (0.1%) seen in patients with uncomplicated hypertension treated with Riprazo alone.
Pressjoni baxxa żżejjed kienet mhux komuni (0. 1%) f’ pazjenti bi pressjoni għolja mingħajr komplikazzjoni li kienu kkurati b’ Riprazo waħdu.
In a 3-month study of 302 patients with mild stable heart failure, all of whom were receiving standard therapy for stable heart failure, addition of Riprazo 150 mg was well tolerated.
Fi studju ta ’ 3 xhur fuq 302 pazjenti b’ insuffiċjenza tal- qalb stabbli u mhux severa (Klassi funzjonali NYHA II u III), li kollha kemm huma kienu qed jirċievu terapija standard għall- insuffiċjenza tal- qalb iż- żieda ta ’ Rasliez 150 mg kienet tollerata sew.
However the clinical significance of this reduction is unknown.
Il- livelli ta ’ peptajd natrijuretiku tat- tip- B (BNP) kienu mnaqqsa b’ 25% fil- fergħa ta ’ Riprazo meta mqabbla mal- plaċebo għalkemm is- sinifikat kliniku għadu mhux magħruf.
In a 6-month study of 599 patients with hypertension, type 2 diabetes mellitus, and nephropathy, all of whom were receiving losartan 100 mg and optimised antihypertensive background therapy, addition of Riprazo 300 mg achieved a 20% reduction versus placebo in urinary albumin: creatinine ratio (UACR), i. e. from 58 mg/ mmol to 46 mg/ mmol.
Fi studju ta ’ 6 xhur ta ’ 599 pazjent bi pressjoni għolja, dijabete mellitus tat- tip 2, u nefropatija, li kollha kemm huma kienu qed jingħataw losartan 100 mg u terapija ta ’ sfond adattata għal kontra l - pressjoni għolja, iż- żieda ta ’ Riprazo 300 mg kisbet tnaqqis ta ’ 20% kontra plaċebo, i. e. minn 58 mg/ mmol għal 46 mg/ mmol, fil- proporzjon ta ’ l- albumina mal- krejatina fl- awrina (UACR).
The proportion of patients who had UACR reduced at least 50% from baseline to endpoint was 24.7% and 12.5% for Riprazo and placebo, respectively.
Il - proporzjon tal- pazjenti li kellhom tnaqqis fil- UACR b’ mill- anqas 50% mill- linja bażi sat- tragward finali kien ta ’ 24. 7% u 12. 5% għal Riprazo u l- plaċebo, rispettivament.
1.9% for placebo) of serum potassium concentration (≥ 6.0 mmol/ l), although this was not statistically significant.
Riprazo ma effettwax il - konċentrazzjoni fis- serum tal- krejatinina iżda kien assoċjat ma ’ żieda fil- frekwenza (4. 2% vs 1. 9% għal plaċebo) tal- konċentrazzjoni tal- potassium fis- serum (≥ 6. 0 mmol/ l), għalkemm dan ma kienx statistikament sinifikanti.
7 Beneficial effects of Riprazo on mortality and cardiovascular morbidity and target organ damage are currently unknown.
7 L- effetti benefiċi ta ’ Riprazo fuq il- mortalità jew morbidità kardjovaskulari u l- ħsara fl- organu milqut bħalissa mhumhiex magħrufa.
No adjustment of the initial dosage of Riprazo is required in patients with mild to severe renal impairment, however caution should be exercised in patients with severe renal impairment.
Mhux meħtieġ bdil tad - doża tal- bidu ta ’ Riprazo f’ pazjenti b’ indeboliment renali ħafif għal sever, iżda għandha tingħata attenzjoni f’ pazjenti b’ indeboliment renali sever.
9 Packs containing 7, 14, 28, 30, 50, 56, 84, 90, 98 or 280 tablets.
Pakketti li jkun fihom 7, 14, 28, 30, 50, 56, 84, 90, 98 jew 280 pillola.
Riprazo 300 mg film-coated tablets
Riprazo 300 mg pilloli miksijin b’ rita
Light-red, biconvex, ovaloid tablet, imprinted “ IU” on one side and “ NVR” on the other side.
Pillola ħamra ċar, konvessa miż- żewġ naħat, f’ għamla ovali, ittimbrata ‘ IU ’ fuq naħa u ‘ NVR ’ fuq in - naħa l- oħra.
When administered with atorvastatin, steady-state Riprazo AUC and Cmax increased by 50%.
Meta ngħata ma ’ atorvastatin, l- AUC
Digoxin bioavailability may be slightly decreased by Riprazo.
Il- biodisponibilità ta ’ digoxin tista ’ titnaqqas xi ftit b’ Riprazo.
12 Preliminary data suggest that irbesartan may decrease Riprazo AUC and Cmax.
Tagħrif preliminari jindika li irbesartan jista ’ jnaqqas xi ftit l- AUC u s- Cmax ta ’ Riprazo.
15 Hypertension In hypertensive patients, once-daily administration of Riprazo at doses of 150 mg and 300 mg provided dose-dependent reductions in both systolic and diastolic blood pressure that were maintained over the entire 24-hour dose interval (maintaining benefit in the early morning) with a mean peak to trough ratio for diastolic response of up to 98% for the 300 mg dose.
Pressjoni għolja F’ pazjenti bil- pressjoni għolja, l- għotja darba kuljum ta ’ Riprazo b’ dożi ta ’ 150 mg u 300 mg ikkawżaw tnaqqis dipendenti mid- doża fil- pressjoni tad- demm sistolika u dijastolika li nżammu fuq perijodu sħiħ ta ’ 24 siegħa ta ’ l- intervall bejn id- dożi (b’ hekk żammew il- benefiċċju ta ’ kmieni filgħodu) b’ medja fil- proporzjon bejn l- oghla u l- anqas għar- rispons dijastoliku sa ’ 98% għad- doża ta ’ 300 mg.
Riprazo did not affect the serum concentration of creatinine but was associated with an increased frequency (4.2% vs.
Riprazo ma effettwax il -
16 Beneficial effects of Riprazo on mortality and cardiovascular morbidity and target organ damage are currently unknown.
L- effetti benefiċi ta ’ Riprazo fuq il- mortalità jew morbidità kardjovaskulari u l- ħsara fl- organu milqut bħalissa mhumhiex magħrufa.
Consequently, no adjustment of the initial dose of aliskiren is required in patients with mild to severe hepatic impairment.
Mhux meħtieġ bdil tad - doża tal- bidu ta ’ Riprazo f’ pazjenti b’ indeboliment renali ħafif għal sever, iżda għandha tingħata attenzjoni f’ pazjenti b’ indeboliment renali sever.
18 Packs containing 7, 14, 28, 30, 50, 56, 84, 90, 98 or 280 tablets.
Pakketti li jkun fihom 7, 14, 28, 30, 50, 56, 84, 90, 98 jew 280 pillola.
Riprazo 150 mg film-coated tablets Aliskiren
Riprazo 150 mg pilloli miksijin b’ rita Aliskiren
Riprazo 300 mg film-coated tablets Aliskiren
Riprazo 300 mg pilloli miksijin b’ rita Aliskiren
What Riprazo is and what it is used for 2.
X’ inhu Riprazo u għalxiex jintuża 2.
Before you take Riprazo 3.
Qabel ma tieħu Riprazo 3.
How to take Riprazo 4.
Kif għandek tieħu Riprazo 4.
How to store Riprazo 6.
Kif taħżen Riprazo 6.
WHAT RIPRAZO IS AND WHAT IT IS USED FOR
X’ INHU RIPRAZO U GĦALXIEX JINTUŻA
Riprazo belongs to a new class of medicines called renin inhibitors.
Rasliez jagħmel parti minn klassi ġdida ta ’ mediċini li jissejjħu inibituri ta ’ renin.
Riprazo helps to lower high blood pressure.
Riprazo jgħin biex ibaxxi l- pressjoni tad- demm għolja.
BEFORE YOU TAKE RIPRAZO
QABEL MA TIEĦU RIPRAZO
Do not take Riprazo
Tieħux Riprazo
Take special care with Riprazo
Oqgħod attent ħafna b’ Riprazo
If any of these apply to you, tell your doctor before you take Riprazo.
Jekk xi wieħed minn dawn jgħodd għalik, għid lit- tabib tiegħek qabel tieħu Riprazo.
The use of Riprazo in children and adolescents is not recommended.
L- użu ta ’ Riprazo fi tfal u adolexxenti mhux rakkomandat.
Taking Riprazo with food and drink You should take Riprazo with a light meal once a day, preferably at the same time each day.
Meta tieħu Riprazo ma ’ l- ikel u max- xorb Għandek tieħu Riprazo ma ’ ikla ħafifa darba kuljum, l- aħjar fl- istess ħin kuljum.
You should not take Riprazo together with grapefruit juice.
M’ għandekx tieħu Riprazo mal- meraq tal- grejpfrut.
Pregnancy and breast-feeding Do not take Riprazo if you are pregnant.
Tqala u treddigħ Tieħux Riprazo jekk ħriġt tqila.
Do not breast-feed if you are taking Riprazo.
Treddax jekk qed tieħu Riprazo.
Before you drive a vehicle, use machinery, or carry out other activities that require concentration, you should make sure you know how you react to the effects of Riprazo.
Qabel issuq karozza, tħaddem makkinarju, jew tagħmel attivitajiet oħra li jeħtieġu konċentrazzjoni, għandhekk taċċerta ruħek li tkun taf x’ tip ta ’ reazjoni jkollok għall- effetti ta ’ Riprazo.
HOW TO TAKE RIPRAZO
KIF GĦANDEK TIEĦU RIPRAZO
Always take Riprazo exactly as your doctor has told you.
Dejjem għandek tieħu Riprazo skond il- parir eżatt tat- tabib.
Your doctor may prescribe Riprazo together with other medicines used to treat high blood pressure.
It- tabib tiegħek jista ’ jordnalek Riprazo ma ’ mediċini oħra li jintużaw biex jikkuraw il- pressjoni tad- demm għolja.
You should take Riprazo with a light meal once a day, preferably at the same time each day.
Għandek tieħu Riprazo ma ’ ikla ħafifa darba kuljum, l- aħjar fl- istess ħin kuljum.
You should not take Riprazo together with grapefruit juice.
M’ ghandekx tieħu Riprazo mal- meraq tal- grejpfrut.
If you take more Riprazo than you should If you have accidentally taken too many Riprazo tablets, consult a doctor immediately.
Jekk tieħu Riprazo aktar milli suppost Jekk bi żball ħadt wisq pilloli Riprazo, ikkonsulta mat- tabib tiegħek minnufih.
If you forget to take Riprazo If you forget to take a dose of Riprazo, take it as soon as you remember and then take the next dose at
Jekk tinsa tieħu Riprazo Jekk tinsa tieħu doża ta ’ Riprazo, ħudha hekk kif tiftakar u imbagħad ħu d- doża li jmissek fil- ħin tas - soltu.
Like all medicines, Riprazo can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Riprazo jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
HOW TO STORE RIPRAZO
KIF TAĦŻEN RIPRAZO
Do not use Riprazo after the expiry date which is stated on the carton and blister.
Tużax Riprazo wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- folja.
What Riprazo contains
X’ fih Riprazo
What Riprazo looks like and contents of the pack Riprazo 150 mg film coated tablets are light-pink, biconvex round tablets, imprinted “ IL” on one side and “ NVR” on the other side.
Id- Dehra ta ’ Riprazo u l- kontenuti tal- pakkett Riprazo 150 mg pilloli miksijin b’ rita huma pilloli roża ċar, konvessi miż- żewġ naħat, tondi, ittimbrati ‘ IL ’ fuq naħa u ‘ NVR ’ fuq in- naħa l- oħra.
Riprazo is available in packs containing 7, 14, 28, 30, 50, 56, 84, 90, 98 or 280 tablets.
Riprazo jiġi f’ pakketti li jkun fihom 7, 14, 28, 30, 50, 56, 84, 90, 98 jew 280 pillola.
45 its usual time.
45 Jekk tinsa tieħu Riprazo Jekk tinsa tieħu doża ta ’ Riprazo, ħudha hekk kif tiftakar u imbagħad ħu d- doża li jmissek fil- ħin tas - soltu.
What Riprazo looks like and contents of the pack Riprazo 300 mg film coated tablets are light-red, biconvex, ovaloid tablets, imprinted “ IU” on one side and “ NVR” on the other side.
Id- Dehra ta ’ Riprazo u l- kontenuti tal- pakkett Riprazo 300 mg pilloli miksijin b’ rita huma pilloli aħmar ċar, konvessi miż- żewġ naħat, f’ għamla ovali, ittimbrati ‘ IU ’ fuq naħa u ‘ NVR ’ fuq in- naħa l- oħra.
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
L- Istati Membri għandhom jiżguraw li l- kundizzjonijiet jew restrizzjonijiet kollha fir- rigward ta ’ l- użu mingħajr periklu u effettiv tal- prodott mediċinali deskritti hawn isfel huma mplimentati:
The Marketing Authorisation Holder (MAH) shall ensure that, at launch, all healthcare professionals who are expected to prescribe/ use RoActemra are provided with educational materials containing the following:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq (MAH) għandu jiżgura li mat- tqegħid fis- suq, il- professjonisti fil- qasam tas- saħħa kollha li huma mistennija jippreskrivu/ jużaw RoActemra huma pprovduti b’ materjal edukattiv li fih dan li ġej:
• Physician Information Pack • Nurse Information Pack • Patient Information Pack
• Pakkett ta ’ Informazzjoni għat- Tabib • Pakkett ta ’ Informazzjoni għall- infermier • Pakkett ta ’ Informazzjoni għall- Pazjent