qanastek/EMEA-V3 huggingface dataset:
Marketing Authorisation Holder Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB Ir- Renju Unit
Manufacturer Novartis Pharmaceuticals UK Ltd Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom
Manifattur Novartis Pharmaceuticals UK Ltd Wimblehurst Road Horsham West Sussex, RH12 5AB Ir- Renju Unit
For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
What is Comtess?
X’ inhu Comtess?
Comtess is a medicine that contains the active substance entacapone.
Comtess hu mediċina li fiha s- sustanza attiva entacapone.
What is Comtess used for?
Għal xiex jintuża Comtess?
Comtess is used to treat patients with Parkinson’ s disease.
Comtess jintuża fit- trattament ta ’ pazjenti bil- marda tal- Parkinson.
Parkinson’ s disease is a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Il- marda tal- Parkinson hija marda progressiva tal- moħħ li tikkawża rogħda, tnaqqis fil- ħeffa taċ- ċaqliq u ebusija tal- muskoli.
Comtess is used together with levodopa (either a combination of levodopa and benserazide or a combination of levodopa and carbidopa) when the patient is having ‘ fluctuations ’ towards the end of the period between two doses of their medication.
Comtess jintuża flimkien ma ’ levodopa (jew f’ taħlita ta ’ levedopa u benserazide jew taħlita ta ’ levodopa u carbidopa) meta l- pazjent ikollu ‘ tibdiliet f’ daqqa ’ lejn tmiem il- perjodu bejn iż- żewġ dożi tal - mediċina tagħhom.
Comtess is used when these fluctuations cannot be treated with the standard levodopa- containing combination alone.
Huma assoċjati ma ’ tnaqqis fl- effetti ta ’ levodopa, meta l- pazjent jesperjenza tibdiliet f’ daqqa, filli jkun ‘ on ’ u kapaċi jimxi, u filli jkun ‘ off ’ u jsibha diffiċli jimxi minn naħa għal oħra,, Comtess jintuża meta dawn it- tibdiliet f’ daqqa ma jkunux jistgħu jiġu ttrattati bil- kombinazzjoni standard biss li jkun fiha levodopa..
How is Comtess used?
Kif jintuża Comtess?
Comtess is only used in combination either with levodopa and benserazide or with levodopa and carbidopa.
Comtess jintuża biss f’ kombinazzjoni jew ma ’ levodopa u benserazide jew ma ’ levodopa u carbidopa.
When patients first add Comtess to their existing medication, they may need to take a lower daily dose of levodopa, either by changing how often they take it, or by reducing the amount of levodopa taken in each dose.
Meta l- pazjent iżid Comtess mal- mediċini eżistenti għall- ewwel darba, jistgħu jkunu jeħtieġu li d- doża ta ’ kuljum ta ’ levodopa titnaqqas, jew billi jeħduha inqas spiss jew billi jintuża ammont iżgħar ta ’ levodopa f’ kull doża.
Comtess can only be used with conventional combinations of levodopa.
Comtess jista ’ jintuża biss ma ’ kombinazzjonjiet konvenzjonali ta ’ levodopa.
How does Comtess work?
Kif jaħdem Comtess?
The active substance in Comtess, entacapone, works to restore the levels of dopamine in the parts of the brain that control movement and co-ordination.
Is- sustanza attiva f’ Comtess, entacapone, taħdem billi treġġa ’ għan- normal il- livelli ta ’ dopamina fil- partijiet tal- moħħ li jikkontrollaw il - moviment u l- ko- ordinazzjoni.
Reproduction is authorised provided the source is acknowledged. catechol-O-methyl transferase (COMT).
Reproduction is authorised provided the source is acknowledged attiv għal żmien itwal.
How has Comtess been studied?
Kif ġie studjat Comtess?
Comtess has been studied in a total of 376 patients with Parkinson’ s disease, in two six-month studies that measured the effects of adding Comtess or placebo (a dummy medicine) to the patient’ s combination of levodopa and carbidopa or levodopa and benserazide.
Comtess ġie studjat fi 376 pazjent bil- marda tal- Parkinson, f’ żewġ studji li damu sitt xhur li kejlu l - effetti taż- żieda ta ’ Comtess jew plaċebo (mediċina finta) mal- kombinazzjoni ta ’ levodopa u carbidopa jew levodopa u benserazide.
What benefit has Comtess shown during the studies?
X’ inhuma l- benefiċċji ta ’ Comtess li ntwerew f’ dawn l- istudji?
Comtess was more effective than placebo in both studies.
Comtess kien iktar effettiv mill- plaċebo fiż- żewġ studji.
In the first study, adding Comtess increased the ‘ on’ time by 1 hour and 18 minutes more than adding placebo.
Fl- ewwel studju, iż- żieda ta ’ Comtess żiedet il- ħin li jkunu ‘ on ’ b ’ siegħa u 18- il minuta iktar miż- żieda tal- plaċebo.
What is the risk associated with Comtess?
X’ inhu r- riskju assoċjat ma ’ Comtess?
The most common side effects with Comtess (seen in between 1 and 10 patients in 100) are dyskinesia (uncontrollable movements), nausea (feeling sick) and harmless urine discoloration.
L- iktar effetti sekondarji komuni ma ’ Comtess (li dehru f’ bejn pazjent wieħed u 10 minn kull 100) huma d- diskinesja (movimenti inkontrollabbli), id- dardir u tibdil fil- kulur ta ’ l- awrina li ma jagħmilx ħsara.
For the full list of all side effects reported with Comtess, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtati b’ Comtess, ara l- Fuljett ta ’ Tagħrif.
Comtess should not be used in people who may be hypersensitive (allergic) to entacapone or any of the other ingredients.
Comtess m’ għandux jintuża f’ persuni li jistgħu jkunu allerġiċi għal entacapone jew xi sustanza oħra tiegħu.
Comtess should not be used in patients with: • liver disease; • phaeochromocytoma (a tumour of the adrenal gland); • a history of neuroleptic malignant syndrome (a dangerous nervous system disorder usually caused by antipsychotic medicines) or rhabdomyolysis (breakdown of muscle fibres).
Comtess m’ għandux jintuża f’ pazjenti li jkollhom: • mard tal- fwied; • phaeochromocytoma (tumur tal- glandola adrenali); • każijiet preċedenti tas- sindromu newrolettiku malinn (disturb perikoluż tas- sistema nervuża ikkawżata minn mediċini antipsikotiċi) jew rabdomjolożi (rhabdomyolysis - tkissir tal- fibri tal - muskoli).
Comtess should not be used together with other medicines that belong to the group ‘ monoamine oxidase inhibitors ’ (a type of antidepressant).
Comtess m’ għandux jintuża flimkien ma ’ mediċini oħra li jagħmlu parti mill- grupp ta ’ ‘ inibituri tal - monoamino ossidażi ’ (monoamine oxidase - tip ta ’ mediċina kontra d- dipressjoni).
Why has Comtess been approved?
Għaliex ġie approvat Comtess?
The Committee for Medicinal Products for Human Use (CHMP) decided that Comtess’ s benefits are greater than its risks as an adjunct to standard preparations of levodopa/ benserazide or levodopa/ carbidopa for use in patients with Parkinson’ s disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Comtess huma ikbar mir- riskji tiegħu meta użat bħala żieda mal- preparazzjonijiet standard ta ’ levodopa/ benserazide jew levodopa/ carbidopa għall- użu f’ pazjenti bil- marda tal- Parkinson u għal tibdiliet f’ daqqa fil- moviment fi tmiem id- doża, li ma jkunux jistgħu jiġu stabbiliti f’ dawn il - kombinazzjonijiet.
The Committee recommended that Comtess be given marketing authorisation.
Il- Kumitat irrakkomanda li Comtess jingħata l- awtorizzazzjoni għat- tqegħid fis - suq.
Other information about Comtess:
Tagħrif ieħor dwar Comtess:
The European Commission granted a marketing authorisation valid throughout the European Union for Comtess on 16 September 1998.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea għal Comtess fis- 16 ta ’ Settembru 1998.
The marketing authorisation was renewed on 16 September 2003 and on 16 September 2008.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fis- 16 ta ’ Settembru 2003 u fis- 16 ta ’ Settembru 2008.
The marketing authorisation holder is Orion Corporation.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq huwa Orion Corporation.
The full EPAR for Comtess is available here.
L- EPAR sħiħ għal Comtess jista ’ jiġi kkonsultat hawn.
Comtess 200 mg film-coated tablets
Comtess 200 mg pilloli miksijin b’ rita
Brownish-orange, oval, biconvex film-coated tablet with "COMT" engraved on one side.
Pillola miksija b’ rita ta ’ kulur oranġjo jagħti fil- kannella b’ forma ovali b ’ “ COMT ” imnaqqxa fuq naħa waħda.
One 200 mg tablet is taken with each levodopa/ dopa decarboxylase inhibitor dose.
Pożoloġija Pillola waħda ta ’ 200 mg għandha tittieħed ma ’ kull doża ta ’ levodopa/ inibitur ta ’ dopa decarboxylase.
The daily dose of levodopa should be reduced by about 10-30% by extending the dosing intervals and/ or by reducing the amount of levodopa per dose, according to the clinical condition of the patient.
Id- doża ta ’ kuljum ta ’ levodopa għandha titnaqqas b’ 10- 30%, billi wieħed jestendi l- ħin ta ’ bejn id- dożi u/ jew billi jitnaqqas l- ammont ta ’ levodopa f’ kull doża, skond il- kundizzjoni klinika tal- pazjent.
Entacapone increases the bioavailability of levodopa from standard levodopa/ benserazide preparations slightly (5-10%) more than from standard levodopa/ carbidopa preparations.
Entacapone jżid il- biodisponibilità ta ’ levodopa minn sustanzi standard ta ’ levodopa/ benserazide, ftit (5- 10%) aktar milli minn preparazzjonijiet standard ta ’ levodopa/ carbidopa.
Hence, patients who are taking standard levodopa/ benserazide preparations may need a larger reduction of levodopa dose when entacapone is initiated.
Għalhekk pazjenti li jkunu qed jieħdu sustanzi standard ta ’ levodopa/ benserazide, jista ’ jkollhom bżonn ta ’ tnaqqis akbar tad- doża ta ’ levodopa meta tibda l- kura b’ entacapone.
2 Hepatic impairment: see section 4.3.
2 Indeboliment renali:
Comtess is not recommended for use in children below age 18 due to lack of data of safety and efficacy.
Comtess mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx informazzjoni dwar is- sigurtà u l- effikaċja.
Entacapone is administered orally and simultaneously with each levodopa/ carbidopa or levodopa/ benserazide dose.
Mod ta ’ kif għandu jingħata Entacapone jittieħed mill- ħalq fl- istess ħin ma ’ kull doża ta ’ levodopa/ carbidopa jew levodopa/ benserazide.
- Hepatic impairment.
- Indeboliment tal- fwied
- Phaeochromocytoma.
- Fejokromoċitoma
- Concomitant use of a selective MAO-A inhibitor plus a selective MAO-B inhibitor and entacapone
- L- użu ta ’ inibitur selettiv ta ’ MAO- A flimkien ma ’ inibitur selettiv ta ’ MAO- B u entacapone
Because of its mechanism of action, entacapone may interfere with the metabolism of medicinal products containing a catechol group and potentiate their action.
Minħabba l- mekkaniżmu ta ’ l- azzjoni tiegħu, entacapone jista ’ jfixkel il- metaboliżmu ta ’ prodotti mediċinali li jkun fihom il- grupp catechol u jsaħħaħ l- azzjoni tagħhom.
Thus, entacapone should be administered cautiously to patients being treated with medicinal products metabolised by catechol-O- methyl transferase (COMT), e. g. rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa, and apomorphine (see also section 4.5).
Għalhekk entacapone għandu jingħata b’ kawtela lil dawk il- pazjenti li jkunu qed jiġu kkurati bi prodotti mediċinali li jiġu metabolizzati b’ catechol- O- methyl transferase (COMT), eż. rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha- methyldopa u apomorphine (ara wkoll sezzjoni 4. 5).
Hence, the precautions valid for levodopa treatment should also be taken into account for entacapone treatment.
Għalhekk il- prekawzjonijiet li għandhom jittieħdu għall- kura b’ levodopa għandhom jitqiesu wkoll waqt il- kura b’ entacapone.
Entacapone increases the bioavailability of levodopa from standard levodopa/ benserazide preparations 5-10% more than from standard levodopa/ carbidopa preparations.
Entacapone iżid il- biodisponibilità ta ’ levodopa minn preparazzjonijiet standard ta ’ levodopa/ benserazide b’ 5- 10% aktar milli minn preparazzjonijiet standard ta ’ levodopa/ carbidopa.
To reduce levodopa-related dopaminergic adverse reactions, it is often necessary to adjust levodopa
Għalhekk reazzjonijiet
3 dosage within the first days to first weeks after initiating entacapone treatment, according to the clinical condition of the patient (see sections 4.2 and 4.8).
3 dopaminerġiċi mhux mixtieqa jistgħu jkunu aktar spissi meta jiżdied entacapone mal- kura b’ levodopa/ benserazide (ara wkoll sezzjoni 4. 8).
In clinical studies, undesirable dopaminergic effects, e. g. dyskinesia, were more common in patients who received entacapone and dopamine agonists (such as bromocriptine), selegiline or amantadine compared to those who received placebo with this combination.
Fi studji kliniċi, irriżulta li reazzjonijiet dopaminerġiċi mhux mixtieqa (ez. diskineżja) kienu aktar komuni f’ pazjenti li ħadu entacapone u agonisti ta ’ dopamine (bħal bromocriptine), selegiline jew amantadine, milli f’ dawk il- pazjenti li rċevew plaċebo ma ’ din it- taħlita ta ’ mediċini.
However, the experience of the clinical use of entacapone with several medicinal products, including MAO-A inhibitors, tricyclic antidepressants, noradrenaline reuptake inhibitors such as desipramine, maprotiline and venlafaxine, and medicinal products that are metabolised by COMT (e. g. catechol-structured compounds: rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha- methyldopa, apomorphine, and paroxetine) is still limited.
Madanakollu, l- esperjenza bl- użu kliniku ta ’ entacapone ma ’ diversi prodotti mediċinali, inklużi l- inibituri MAO- A, antidepressanti triċikliċi, inibituri li jinibbixu r- riassorbiment ta ’ noradrenaline bħal desipramine, maprotiline u venlafaxine u prodotti mediċinali li jiġu metabollizzati b’ COMT (eż. sustanzi bl- istruttura ta ’ catechol: rimiterol, isoprenaline, adrenaline, noradrenaline, dopamina, dobutamine, alpha- methyldopa, apomorphine u paroxetine), għadha limitata.
Caution should be exercised when these medicinal products are used concomitantly with entacapone (see also sections 4.3 and section 4.4).
Wieħed għandu joqgħod attent meta dawn il- prodotti mediċinali jintużaw flimkien ma ’ entacapone (ara wkoll sezzjoni 4. 3).
Entacapone may be used with selegiline (a selective MAO-B inhibitor), but the daily dose of selegiline should not exceed 10 mg.
Entacapone jista ’ jintuża ma ’ selegiline (inibitur selettiv tal- MAO- B), iżda d- doża ta ’ kuljum ta ’ selegiline mgħandiex taqbeż l- 10 mg.
Entacapone and iron preparations should be taken at least 2-3 hours apart (see section 4.8).
Sustanzi ta ’ entacapone u dawk li fihom l- iron għandhom jittieħdu mill- inqas 2- 3 sigħat ’ l bod minn xulxin (ara sezzjoni 4. 8).
Entacapone binds to human albumin binding site II which also binds several other medicinal products, including diazepam and ibuprofen.
Entacapone jintrabat mas- sit II tal- għaqda ta ’ l- albumina umana, ma fejn jeħlu wkoll diversi prodotti mediċinali oħrajn li jinkludu diazepam u ibuprofen.
Clinical interaction studies with diazepam and non-steroidal anti- inflammatory medicinal products have not been carried out.
Ma sarux studji kliniċi ta ’ interazzjoni ma ’ diazepam u prodotti mediċinali anti- infjammatorji mhux sterojdi.
Due to its affinity to cytochrome P450 2C9 in vitro (see section 5.2), entacapone may potentially interfere with medicinal products with metabolism dependent on this isoenzyme, such as S-warfarin.
4 Minħabba l- affinità tiegħu għal cytochrome P450 2C9 in vitro (ara sezzjoni 5. 2), entacapone jista ’ potenzjalment jinterferixxi ma ’ prodotti mediċinali b’ metaboliżmu dipendenti fuq din l- iżoenzima, bħal ma ’ huwa S- warfarin.
The INR
Madanakollu, fi studju dwar l- interazzjonijiet, li sar f’ volontiera b’ saħħithom, entacapone ma biddilx il- livelli fil- plażma ta ’ S- warfarin, waqt li l- AUC għall R - warfarin żdied b’ medja ta ’ 18% [CI90 11– 26%].
4 values increased on average by 13% [CI90 6– 19%].
Il- valuri ta ’ l- INR żdiedu b’ medja ta ’ 13% [CI90 6- 19%].
Comtess in association with levodopa may have major influence on the ability to drive and use machines.
Comtess flimkien ma ’ levodopa jista ’ jkollu effett qawwi ħafna fuq il- ħila biex issuq u tħaddem magni.
The most frequent adverse reactions caused by entacapone relate to the increased dopaminergic activity and occur most commonly at the beginning of the treatment.
Ir- reazzjonijiet avversi li huma l- aktar frekwenti, ikkawżati b’ entacapone għandhom x’ jaqsmu ma ’ żieda fl- attivita ’ dopaminerġika u ġeneralment jidhru fil- bidu tal- kura.
Dyskinesias (27%), nausea (11%), diarrhoea (8%), abdominal pain (7%) and dry mouth (4.2%) were reported significantly more often with entacapone than with placebo in pooled data from clinical studies involving 406 patients taking the medicinal product and 296 patients taking placebo.
F’ informazzjoni miġbura minn studji kliniċi li nvolvew 406 pazjent li kienu qed jieħdu l- prodott mediċinali u 296 pazjent li kienu qed jieħdu plaċebo, irriżulta li diskineżja (27%), dardir (11%), dijarea (8%), uġigħ fl- addome (7%) u nixfa fil- ħalq (4. 2%), ġew irrapurtati bi frekwenza sostanzjalment akbar meta nuża entacapone milli meta ntuża plaċebo.
Adverse drug reactions*
5 Disturbi fis- sistema nervuża
Nervous system disorders Very common:
Komuni ħafna:
Parkinsonism aggravated, dizziness, dystonia, hyperkinesia
Diskineżja Marda ta ’ Parkinson taggrava, sturdament, distonja, iperkineżja
Nausea
Disturbi gastro- intestinali
Common:
Komuni ħafna:
Very rare:
Komuni:
Not known:
Rari ħafna:
Diarrhoea, abdominal pain, dry mouth, constipation, vomiting Anorexia Colitis
Dardir Dijarea, uġigħ fl- addome, ħalq xott, stitikezza, rimettar Anoressija Kolite
Renal and urinary disorders Very common:
Disturbi fil- kliewi u fis- sistema urinarja
Urine discoloration Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Hepatic function tests abnormal Hepatitis with mainly cholestatic features (see section 4.4.)
Testijiet tal- funzjoni epatika anormali Epatite b’ karatteristiċi li jkunu l- aktar kolestatiċi (ara sezzjoni 4. 4)
Agitation
Insomnia, hallucinations, confusion, paroniria Agitation
4.9 Overdose
Doża eċċessiva 4. 9
PHARMACOLOGICAL PROPERTIES
6 Kategorija farmakoterapewtika: aġenti dopaminerġiċi oħra, Kodiċi ATC:
Entacapone belongs to a new therapeutic class, catechol-O-methyl transferase (COMT) inhibitors.
Entacapone jagħmel parti minn klassi ġdida terapewtika, inibituri ta ’ catechol - O - methyltransferase (COMT).
Daily ON time (Mean ±SD)
Ħin ON kuljum (Medja ± SD)
Daily On time (h)
Ħin On kuljum (siegħat) Linja bażi
Entacapone (n=85)
Entacapone (n=85) 9. 3±2. 2
Placebo (n=86)
Plaċebo (n=86) 9. 2±2. 5
1 h 20 min (8.3%) CI95% 45 min, 1 h 56 min
1 siegħa 20 min (8. 3%) CI95% 45 min, 1siegħa 56
There were corresponding decreases in OFF time.
korrispondenti fil- ħin
Absorption There are large intra- and interindividual variations in the absorption of entacapone.
Karatteristiċi ġenerali tas- sustanza attiva Assorbiment Hemm differenzi intra u inter- individwali kbar fl- assorbiment ta ’ entacapone.
7 Distribution After absorption from the gastrointestinal tract, entacapone is rapidly distributed to the peripheral tissues with a distribution volume of 20 litres at steady state (Vdss).
Distribuzzjoni Wara l- assorbiment mill- passaġġ gastrointestinali,, entacapone jinfirex malajr fit- tessuti periferali b’ volum ta ’ distribuzzjoni ta ’ 20 litru fi stat fiss (Vdss).
Entacapone is extensively bound to plasma proteins, mainly to albumin.
7 Entacapone jintrabat b’ mod estensiv mal- proteini tal- plażma, prinċipalment ma ’ l- albumina.
In human plasma the unbound fraction is about 2.0% in the therapeutic concentration range.
Fil - medda ta ’ konċentrazzjonijiet terapewtiċi, il- porzjon li ma jintrabatx mal- plażma fil- bniedem jammonta għal madwar 2%.
At therapeutic concentrations, entacapone does not displace other extensively bound substances (e. g. warfarin, salicylic acid, phenylbutazone, or diazepam), nor is it displaced to any significant extent by any of these substances at therapeutic or higher concentrations.
F’ konċentrazzjonijiet terapewtiċi, entacapone ma jispostax sustanzi oħra li jintrabtu b’ mod estensiv (eż. warfarin, salicylic acid, phenylbutazone jew diazepam), lanqas ma jiġi spostat b’ xi mod sinifikanti minn xi waħda minn dawn is- sustanzi, f’ konċentrazzjonijiet terapewtiċi jew konċentrazzjonijiet ogħla.
It is estimated that 80- 90% of the dose is excreted in faeces, although this has not been confirmed in man.
Huwa stmat li minn 80 sa 90% tad- doża titneħħa ma ’ l- ippurgar, għalkemm din l- istatistika ma ġietx konfermata fil- bniedem.
Approximately 10- 20% is excreted in urine.
Madwar 10- 20% titneħħa fl- awrina.
The pharmacokinetic properties of entacapone are similar in both young and elderly adults.
Karatteristiċi fil- pazjenti Il- karatteristiċi farmakokinetiċi ta ’ entacapone huma simili kemm fiż- żgħażagħ kif ukoll fl- adulti.
Microcrystalline cellulose Croscarmellose sodium Povidone Magnesium stearate
Il- qalba tal- pillola Microcrystalline cellulose Croscarmellose sodium Povidone Magnesium stearate
8 Polyvinyl alcohol, partly hydrolysed Talc Macrogol Soybean lecithin Yellow iron oxide (E 172) Red iron oxide (E 172) Titanium dioxide (E 171)
Il- rita Polyvinyl alcohol, parti hydrolysed Talc Macrogol Soybean lecithin Iron oxide isfar (E172) Iron oxide aħmar (E172) Titanium Dioxide (E171)
6.3 Shelf- life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
White high-density polyethylene (HDPE) bottles with white tamper proof polypropylene (PP) closures containing 30, 60, 100 or 175 tablets.
Flixken bojod tal- high density polyethylene (HDPE) b’ tapp abjad tal- polyethylene li jirreżisti għat - tbagħbis li jkun fihom 30, 60, 100 jew 175 pillola.
Orion Corporation Orionintie 1 FI-02200 Espoo Finland
Orion Corporation Orionintie 1 FI- 02200 Espoo Finlandja
16.09.98 Date of last renewal:
16. 09. 1998 Data ta ’ l- aħħar tiġdid:
Detailed information on this medicine is available on the European Medicine’ s Agency (EMEA) web site: http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta 'l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu
Comtess 200 mg film-coated tablets entacapone
Comtess 200 mg pilloli miksijin b’ rita entacapone
Each tablet contains 200 mg of entacapone.
Kull pillola fiha 200 mg ta ’ entacapone.
30 film-coated tablets 60 film-coated tablets 100 film-coated tablets 175 film-coated tablets
30 pillola miksija b’ rita 60 pillola miksija b’ rita 100 pillola miksija b’ rita 175 pillola miksija b’ rita
Medicinal product subject to medical prescription.
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGĦATA
comtess 200 mg [folding box only]
Prodott mediċinali jingħata bir- riċetta tat- tabib.
Comtess 200 mg film-coated tablets Entacapone
Comtess 200 mg pilloli miksijin b’ rita Entacapone
What Comtess is and what it is used for 2.
X’ inhu Comtess u għalxiex jintuża 2.
Before you take Comtess 3.
Qabel ma tieħu Comtess 3.
How to take Comtess 4.
Kif għandek tieħu Comtess 4.
How to store Comtess 6.
Kif taħżen Comtess 6.
WHAT COMTESS IS AND WHAT IT IS USED FOR
X’ INHU COMTESS U GĦALXIEX JINTUŻA
Comtess is used together with levodopa to treat Parkinson’ s disease.
Comtess jintuża flimkien ma ’ levodopa għall- kura tal- Marda ta ’ Parkinson.
Comtess improves the therapeutic effect of levodopa in relieving the symptoms of Parkinson's disease.
Comtess itejjeb l- effetti terapewtiċi ta’ levodopa fis- serħan tas- sintomi tal- Marda ta ’ Parkinson.
Comtess has no antiparkinsonian activity without levodopa.
Comtess m’ għandu l- ebda attività kontra l- marda ta’ Parkinson mingħajr levodopa.
BEFORE YOU TAKE COMTESS
QABEL MA TIEĦU COMTESS
Do not take Comtess – if you are allergic (hypersensitive) to entacapone or any of the other ingredients of Comtess; – if you have a tumour of the adrenal gland (known as pheochromocytoma; this may increase the risk of severe high blood pressure); – if you are taking certain antidepressants (ask your doctor or pharmacist whether your antidepressive medicine can be taken together with Comtess); – if you have liver disease; – if you have ever suffered from a rare reaction to antipsychotic medicines called neuroleptic malignant syndrome (NMS) and/ or a rare muscle disorder called non-traumatic rhabdomyolysis.
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal entacapone jew sustanzi oħra ta ’
Take special care with Comtess
Comtess;
- if you are taking a medicine which may cause low blood pressure when rising from a chair or
- jekk għandek tumur fil- glandola adrenali (magħrufa bħala fejokromoċitoma, din tista ’ żżid ir -
bed;
- jekk int qed tieħu ċerti mediċini kontra d- dipressjoni (saqsi lit- tabib jew lill- ispiżjar tiegħek jekk
- if you experience diarrhoea, monitoring of your weight is recommended in order to avoid
il- mediċina tiegħek, ta ’ kontra d- dipressjoni tistax titieħed flimkien ma ’ Comtess);
potentially excessive weight loss;
- jekk għandek mard fil- fwied;
- if you experience excessive gambling or excessive sexual activity.
- jekk qed tieħu mediċina li tista ’ tbaxxilek il- pressjoni meta tqum minn fuq siġġu jew sodda;
The dose of other antiparkinsonian medicines may need to be adjusted when you start taking Comtess.
Id- doża ta ’ mediċini kontra l- Parkinson jista ’ jkollha bżonn tiġi aġġustata meta tibda tieħu Comtess.
If this happens, you should not drive or use any tools or machines (see section ” Driving and using machines”).
Jekk dan iseħħ m’ għandekx issuq jew tuża kwalunkwe magni (ara sezzjoni “ Sewqan u tħaddim ta ’ magni ”).
Children Experience with Comtess in patients under 18 years is limited.
Tfal L- esperjenza b’ Comtess f’ pazjenti li għandhom inqas minn 18- il sena hija limitata.
Therefore, the use of Comtess in children cannot be recommended.
Għalhekk l- użu ta ’ Comtess fit- tfal mhuwiex rakommandat.
Taking other medicines Comtess may increase the effects of other medicinal products (e. g. those containing rimiterol, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa, and apomorphine).
Meta tieħu mediċini oħra Comtess jista ’ jżid l- effetti ta ’ medicini oħra (eż. dawk li fihom rimiterol, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha methyldopa, u apomorphine).
Comtess may make it harder for you to digest iron.
Comtess jista ’ jagħmel aktar diffiċli biex tiddiġerixxi l- iron.
Therefore, do not take Comtess and iron supplements at the same time.
Allura, tiħux Comtess u supplimenti ta ’ iron fl- istess ħin.
Pregnancy and breast-feeding Do not use Comtess during pregnancy or if you are breast-feeding.
Tqala u Treddigħ Tużax Comtess waqt t- tqala jew jekk qed tredda ’.
Driving and using machines Comtess taken together with levodopa may lower your blood pressure, which may make you feel light-headed or dizzy.
Sewqan u tħaddim ta ’ magni Comtess meħud flimkien ma ’ levodopa jista ’ jbaxxilek il- pressjoni tad- demm, li tista ’ tikkawżalek li tħoss rasek ħafifa jew tistordi.
Comtess taken with levodopa may make you feel very drowsy, or cause you to sometimes find yourself suddenly falling asleep.
It- teħid ta ’ Comtess ma ’ levodopa jista ’ jqabdek ħafna ngħas, jew iġiegħluk xi kultant issib ruħhek qed tongħos f’ daqqa waħda.
HOW TO TAKE COMTESS
KIF GĦANDEK TIEĦU COMTESS
Always take Comtess exactly as your doctor has told you.
Dejjem għandek tieħu Comtess skond il- parir tat- tabib.
Comtess is taken together with preparations containing levodopa (either levodopa/ carbidopa preparations or levodopa/ benserazide preparations).
Comtess jittieħed flimkien ma sustanzi li fihom levodopa (jew taħlitiet ta ’ levodopa/ carbidopa jew taħlitiet ta ’ levodopa/ benserazide).
The usual dose of Comtess is one 200 mg tablet with each levodopa dose.
Id- doża ta ’ Comtess is- soltu tkun pillola waħda ta ’ 200 mg ma ’ kull doża ta ’ levodopa.
2,000 mg of Comtess.
2, 000 mg ta ’ Comtess.
If you take more Comtess than you should In the event of an overdose, consult your doctor or the nearest hospital immediately.
Jekk tieħu Comtess aktar milli suppost Fil- każ ta ’ doża aċċessiva, ikkonsulta mat- tabib tiegħek jew mur fl- eqreb sptar immedjatament.
If you forget to take Comtess If you forget to take the Comtess tablet with your levodopa dose, you should continue the treatment by taking the next Comtess tablet with your next levodopa dose.
Jekk tinsa tieħu Comtess Jekk tinsa tieħu pillola ta ’ Comtess mad- doża ta ’ levodopa, għandek tkompli l- kura billi tieħu l- pillola ta ’ Comtess li jmiss mad- doża ta ’ levodopa li jmiss.
18 If you stop taking Comtess Do not stop taking Comtess unless your doctor tells you to.
19 Tieqafx tieħu Comtess sakemm ma jkunx qallek it- tabib tiegħek.
In such a case your doctor may need to re-adjust the dosage of your other antiparkinsonian medicines.
It- tabib tiegħek għandu mnejn ikollu bżonn jibdel id- dożi tal- mediċini l- oħra kontra l- marda ta ’ Parkinson jekk tieqaf tieħu Comtess.
Abrupt discontinuation of both Comtess and other antiparkinsonian medicines may result in unwanted side effects.
It - twaqqif f’ daqqa kemm ta ’ Comtess kif ukoll tal- mediċini l- oħrajn kontra l- marda ta ’ Parkinson jista ’ jwassal għal effetti sekondarji mhux mixtieqa.
Like all medicines, Comtess can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Comtess jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Usually side effects caused by Comtess are mild to moderate.
Ġeneralment effetti oħra kkawżati b’ Comtess ikunu minn ħfief għal moderati.
Very common (affects more than 1 patient in 10) Common (affects 1 to 10 patients in 100) Uncommon (affects 1 to 10 patients in 1,000) Rare (affects 1 to 10 patients in 10,000) Very rare (affects less than 1 patient in 10,000) Not known (frequency cannot be estimated from the available data).
Komuni ħafna (jaffettwaw aktar minn 1 f’ kull 10 pazjenti) Komuni (jaffettwa 1 sa 10 pazjenti minn kull 100) Mhux komuni (jaffettwa 1 sa 10 pazjenti minn kull 1, 000) Rari (jaffettwaw 1 sa 10 pazjenti minn kull 10, 000) Rari ħafna (jaffettwaw anqas minn 1 f’ kull 10, 000 pazjent) Mhux maghrufa (il- frekwenza ma tistax tigi estimata mid- dejta disponibbli)
The exact frequencies of these side effects are not known but are based on reports received since the product has been on the market: colitis (inflammation of the colon), hepatitis and skin, hair, beard and nail discolorations.
Kolite (infjammazzjoni tal- kolon), epatite u telf tal- kulur tal- ġilda, x- xagħar, il- leħja u d- dwiefer.
If you experience such effects at the start of treatment with Comtess you should contact your doctor, who may decide to adjust your dosage of levodopa.
Jekk tħoss effetti bħal dawn fil - bidu tal- kura b’ Comtess għandek tkellem lit- tabib tiegħek li jista ’ jiddeċidi li jibdillek id- dużaġġ ta ’ levodopa.
Excessive daytime drowsiness has been reported in rare cases in patients receiving Comtess with levodopa and there have been isolated cases of sudden sleep onset episodes.
Telqa eċċessiva bi nhar kienet irrapurtata, f’ każijiet rari, f’ pazjenti li kienu qed jieħdu Comtess ma ’ levodopa u kien hemm każijiet iżolati ta ’ episodji ta ’ irqad f’ daqqa.
A few cases of neuroleptic malignant syndrome (NMS) and rhabdomyolysis have been reported.
Numru żgħir ta ’ każijiet ta ’ sindrome newrolettiku malinn (NMS) u rabdomajelożi kienu rrappurtati.
NMS is a rare severe reaction to medicines used to treat disorders of the central nervous system and characterised by stiffness, muscle twitching, shaking, mental changes, coma, high body temperature, increased heart rate, and unstable blood pressure.
NMS hija reazzjoni rari u severa għall- mediċini li jintużaw għall- kura ta ’ disturbi tas- sistema nervuża ċentrali u hija karatterizzata minn riġidità, ġbid ta ’ muskoli, tregħid, tibdil mentali, koma, temperatura tal- ġisem għolja, rata tal- qalb imgħaġġla u pressjoni tad- demm mhux stabbli.
19 Behavioural changes such as urge to gamble (pathological gambling) or increased sexual desire and urges (increased libido and hypersexuality) have been reported in patients receiving dopaminergic medicines including Comtess with levodopa.
20 Tibdil fil- komportament bħal xewqa kbira li tilgħab logħob ta ’ l- ażżard (logħob ta ’ l- ażżard patoloġiku) jew żieda fil- ġibda u x- xewqa għas- sess (żieda fil- libido u ipersesswalità) ġew irrappurtati f’ pazjenti li kienu qed jirċievu mediċinali dopaminerġika inkluż Comtess ma ’ levodopa.
HOW TO STORE COMTESS
KIF TAĦŻEN COMTESS
Do not use Comtess after the expiry date which is stated on the carton and on the bottle label.
Tużax Comtess wara d- data ta ’ skadenza li tidher fuq il- kartuna u fuq it- tikketta tal- flixkun.
What Comtess contains
X’ fih Comtess
- The other ingredients in the tablet core are microcrystalline cellulose, croscarmellose sodium,
- Is- sustanzi l- oħra huma microcrystalline cellulose, croscarmellose sodium, povidone,
povidone and magnesium stearate.
magnesium stearate.
- The film-coating contains partly hydrolysed polyvinyl alcohol, talc, macrogol, soybean lecithin,
- Il- kisja tar- rita fiha parti hydrolysed polyvinyl alcohol, talc, macrogol, soybean lecithin, iron
yellow iron oxide (E 172), red iron oxide (E 172) and titanium dioxide (E 171).
oxide isfar (E172), iron oxide aħmar (E172) u titanium dioxide (E171).
What Comtess looks like and contents of the pack Comtess 200 mg film-coated tablets are brownish-orange, oval tablets with "COMT" engraved on one side.
Id- Dehra ta ’ Comtess u l- kontenuti tal- pakkett Comtess 200 mg pilloli miksija b’ rita huma pilloli ovali ta ’ kulur oranġjo jagħti fil- kannella, b ’ “ COMT ” imnaqqxa fuq naħa waħda.
There are four different pack sizes (bottles containing 30, 60, 100 or 175 tablets).
Hemm erba ’ daqsijiet differenti tal- pakkett (fliexken li fihom 30, 60, 100 jew 175 pillola).
Orion Corporation Orionintie 1 FI-02200 Espoo Finland
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur Orion Corporation Orionintie 1 FI- 02200 Espoo Finlandja
Detailed information on this medicine is available on the European Medicine’ s Agency (EMEA) web site: http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta 'l- Aġenzija Ewropea dwar il - mediċini (EMEA) http: // www. emea. europa. eu
What is Copalia?
X' inhu Copalia?
Copalia is a medicine containing two active substances, amlodipine and valsartan.
Copalia huwa mediċina li fiha żewġ sustanzi attivi, amlodipina u valsartan.
It is available as tablets (dark yellow, round:
Huwa disponibbli f' pilloli (ta 'lewn isfar skur, tondi:
5 mg amlodipine and 80 mg valsartan; dark yellow, oval:
5 mg amlodipina u 80 mg valsartan; ta 'lewn isfar skur, ovali:
5 mg amlodipine and 160 mg valsartan; light yellow, oval:
5 mg amlodipina u 160 mg valsartan; ta 'lewn isfar ċar, ovali:
10 mg amlodipine and 160 mg valsartan).
10 mg amlodipina u 160 mg valsartan).
What is Copalia used for?
Għal xiex jintuża Copalia?
Copalia is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled on either amlodipine or valsartan taken alone. ‘ Essential ’ means that the high blood pressure is not caused by any other condition.
Copalia jintuża f' pazjenti li għandhom ipertensjoni essenzjali (pressjoni tad- demm għolja) li mhijiex ikkontrollata adegwatament bl- amlodipina jew valsartan meħudin waħedhom.
Copalia is not recommended for use in patients below 18 years of age.
'Essenzjali' tfisser li l - pressjoni għolja ma tkunx ikkawżata minn xi kundizzjoni oħra.
How is Copalia used?
Kif jintuża Copalia?
Copalia is taken by mouth as one tablet once a day with some water, with or without food.
Copalia jittieħed mill- ħalq fi kwantità ta 'pillola waħda darba kuljum bi ftit ilma, fuq stonku vojt jew le.
The dose of Copalia to be used depends on the doses of amlodipine or valsartan that the patient was taking before.
Id- doża ta 'Copalia li għandha tintuża tiddependi mid- doża ta' amlodipina jew valsartan li l- pazjent kien qiegħed jieħu qabel.
The patient may need to take separate tablets or capsules before switching to the combination tablet.
Huwa possibbli li, qabel ma jaqleb għall- pillola li fiha iż- żewġ sustanzi attivi, il- pazjent ikollu jieħu pilloli jew kapsuli separati.
Copalia should be used with caution in patients who have problems with their liver or biliary obstructive disorders (problems with the elimination of bile).
Copalia għandu jintuża b' kawtela fil- pazjenti bi problemi fil- fwied jew disturbi minn ostruzzjoni biljari (problemi biex jeliminaw il- bili).
How does Copalia work?
Kif jaħdem Copalia?
Copalia contains two active substances, amlodipine and valsartan.
Copalia fih żewġ sustanzi attivi, amlodipina u valsartan.
Both are anti-hypertensives that have been available separately in the European Union (EU) since the mid-1990s.
It- tnejn huma antipertensivi disponibbli separatament fl- Unjoni Europea (UE) min- nofs is- snin disgħin.
They act in similar ways to reduce blood pressure by allowing the blood vessels to relax.
Huma jaġixxu b' mod simili fit- tnaqqis tal- pressjoni tad- demm billi jipproduċu rilassament tal- vini u ta 'l- arterji.
By lowering the blood pressure, the risk caused by high blood pressure, such as having a stroke, is reduced.
Bit- tnaqqis tal- pressjoni tad - demm, jitnaqqas ir- riskju kkawżat minn pressjoni tad- demm għolja, bħal puplesija.
Amlodipine is a calcium channel blocker.
L- amlodipina hija sustanza li timblokka l- kanali tal- kalċju.
It blocks special channels on the surface of cells (calcium channels) through which calcium ions normally enter the cells.
Hija timblokka l- kanali speċjali preżenti fuq il- wiċċ taċ- ċelluli (kanali tal- kalċju) li minnhom normalment il- joni tal- kalċju jidħlu fiċ- ċelluli.
When calcium ions enter the cells in the muscles of blood vessel walls, this causes contraction.
Meta l- joni tal- kalċju jidħlu fiċ- ċelluli tal- muskolatura tal- ħitan tal- vini u ta 'l- arterji, jikkawżaw kontrazzjoni.
By reducing the flow of calcium into the cells, amlodipine prevents the cells from contracting and this helps the blood vessels to relax.
Bit- tnaqqis tal- fluss tal- kalċju fiċ- ċelluli, l- amlodipina timpedixxi l- kontrazzjoni taċ - ċelluli b' hekk dan jgħin biex il- vini u l- arterji jirrilassaw.
Valsartan is an ‘ angiotensin II receptor antagonist’, which means that it blocks the action of a hormone in the body called angiotensin II.
Valsartan hu tip ta '' antagonist tar- riċetturi ta 'l- anġjotensina II' li tfisser li jimblokka l- azzjoni ta 'l - ormon fil- ġisem imsejjaħ l- anġjotensina II.
Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels).
L- anġjotensina II hija sustanza qawwija li ddejjaq l- arterji
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. u l- vini (vasoconstrictor).
How has Copalia been studied?
Kif ġie studjat Copalia?
Because amlodipine and valsartan have been used for many years, the company presented information on the two substances from earlier studies and the scientific literature, as well as new studies that used a combination of the two active substances.
Billi l- amlodipina u valsartan ilhom ħafna snin jintużaw, il- kumpanija ppreżentat tagħrif dwar iż- żewġ sustanzi minn studji preċedenti u mil- letteratura xjentifika, kif ukoll minn studji ġodda li użaw kombinazzjoni taż- żewġ sustanzi attivi.
Five main studies involving nearly 5,200 patients, mostly with mild to moderate hypertension, were carried out.
Twettqu ħames studji ewlenin li fihom ħadu sehem 5, 200 pazjent, il- maġġoranza tagħhom b' ipertensjoni minn ħafifa għal moderata.
Two studies (involving almost 3,200 patients) compared the effectiveness of amlodipine, valsartan or a combination of both substances with the effectiveness of placebo (a dummy treatment).
Tnejn minnhom (fuq total ta '3, 200 pazjent) qabblu l - effikaċja ta' l- amlodipina, valsartan jew kombinazzjoni taż- żewġ sustanzi ma 'l- effikaċja tal- plaċebo (trattament finta).
Two studies (involving 1,891 patients) compared the effects of the combination in patients whose hypertension was not adequately controlled with either 10 mg amlodipine or 160 mg valsartan.
Żewġ studji (li involvew 1, 891 pazjent) qabblu l- effetti tal- kombinazzjoni f' pazjenti li għalihom ma kienx possibbli li l- ipertensjoni tagħhom tiġi kkontrollata adegwatament b' 10 mg amlodipina jew f' 160 mg valsartan.
The fifth, smaller study compared the effectiveness of the combination with that of lisinopril and hydrochlorothiazide (another combination used to treat hypertension) in 130 patients with severe hypertension.
Il- ħames studju, fuq skala iżgħar, qabbel l- effikaċja tal - kombinazzjoni ma 'dik ta' lisinopril u idroklorotijażide (hydrochlorothiazide, kombinazzjoni oħra użata għat- trattament ta 'l- ipertensjoni) f' 130 pazjent b' ipertensjoni gravi.
In all studies, the main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).
Fl- istudji kollha, il- kejl ewlieni ta 'l- effikaċja kien it- tnaqqis tal- pressjoni tad- demm dijastolika (pressjoni tad- demm mkejla bejn żewġ taħbitiet tal- qalb).
The blood pressure was measured in ‘ millimetres of mercury’ (mmHg).
Il- pressjoni tad- demm tkejlet f ''millimetri ta 'merkurju' (mmHg).
The company also presented evidence that the levels of amlodipine and valsartan in the blood were the same in people taking Copalia and people taking the separate medicines.
Barra minn dan il- kumpanija ppreżentat tagħrif li juri li l- livelli ta 'amlodipina u valsartan fid- demm kienu l- istess fil- pazjenti ttrattati b' Copalia u fil- pazjenti trattati biż- żewġ mediċini separatament.
What benefit has Copalia shown during the studies?
Liema benefiċċju wera Copalia waqt l- istudji li ġew imwettqa?
The combination of amlodipine and valsartan was more effective at reducing blood pressure than placebo or either valsartan or amlodipine taken alone.
Fit- tnaqqis tal- pressjoni tad- demm, il- kombinazzjoni ta 'amlodipina u valsartan irriżultat aktar effikaċi mill- plaċebo u miż- żewġ sustanzi meħudin waħedhom.
In the studies comparing the effectiveness of the combination in patients who were already taking either amlodipine or valsartan, the blood pressure in patients taking valsartan alone had fallen by 6.6 mmHg after eight weeks, compared with 9.6 and 11.4 mmHg in the patients adding 5 or 10 mg amlodipine, respectively.
L- istudji li qabblu l- effikaċja tal - kombinazzjoni fil- pazjenti li diġà kienu qegħdin jieħdu amlodipina waħedha jew valsartan waħdu wrew li, fil- pazjenti li kienu qegħdin jieħdu valsartan waħdu, il- pressjoni tad- demm niżlitilhom b' 6. 6 mmHg wara tmien ġimgħat, filwaqt li fil- pazjenti li ħadu valsartan flimkien ma '5 jew 10 mg amlodipina, it- tnaqqis kien 9. 6 u 11. 4 mmHg rispettivament.
Patients taking amlodipine alone had a fall of 10.0 mmHg, compared with 11.8 mmHg in the patients adding 160 mg valsartan.
Fil- pazjenti li ħadu l- amlodipina waħedha, it- tnaqqis kien ta '10. 0 mmHg, filwaqt li fil- pazjenti li ħadu amlodipina flimkien ma' 160 mg valsartan it- tnaqqis kien ta '11. 8 mmHg.
What is the risk associated with Copalia?
X' inhu r- riskju assoċjat ma 'Copalia?
The most common side effects with Copalia (seen in between 1 and 10 patients in 100) are headache, nasopharyngitis (inflammation of the nose and throat), influenza (flu), various types of oedema (swelling), fatigue (tiredness), flushing (reddening), asthenia (weakness) and hot flushes.
L- effetti sekondarji l- aktar komuni b' Copalia (li dehru f' bejn pazjent 1 u 100 minn 100) huma wġigħ ta 'ras, nasofarinġite (infjammazzjoni ta' l- imnieħer u tal- gerżuma), influwenza, tipi varji ta 'edema (nefħa), għeja kbira, ħmura, astenija (debbolizza) u fwawar.
For the full list of all side effects reported with Copalia, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrappurtati b' Copalia, ara l- Fuljett ta' Tagħrif.
Copalia should not be used in patients who may be hypersensitive (allergic) to amlodipine or other medicines in the ‘ dihydropyridine derivatives’ class, to valsartan, or to any of the other ingredients.
Copalia ma għandux jintuża f' pazjenti li jistgħu jkunu ipersensittivi (allerġiċi) għall- amlodipina jew mediċini oħra tal- klassi tad - 'derivati diidropiridiniċi' (dihydropyridine derivatives), għal valsartan, jew għal kwalunkwe ingredjent ieħor.
It must not be used in women who are more than three months pregnant or who are breast-feeding.
Din il- mediċina ma għandhiex tintuża minn nisa li ilhom aktar minn tliet xhur tqal jew li jreddgħu.
Its use during the first three months of pregnancy is not recommended.
Mhuwiex rakkomandat l- użu tagħha waqt l- ewwel tliet xhur tat- tqala.
Copalia should also not be used in patients who have severe liver, kidney or bile problems, or in patients undergoing dialysis (a blood clearance technique).
Copalia ma għandux jintuża wkoll fil- pazjenti bi problemi gravi fil- fwied, fil- kliewi jew biljari, jew fil- pazjenti li għaddejjin minn dijaliżi (teknika tat- tisfija tad- demm).
Why has Copalia been approved?
Għaliex ġie approvat Copalia?
The Committee for Medicinal Products for Human Use (CHMP) decided that Copalia’ s benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Copalia huma ogħla mir- riskji tiegħu fit- trattament ta' l- ipertensjoni essenzjali f' pazjenti li l- pressjoni tad- demm tagħhom ma tkunx ikkontrollata adegwatament b' monoterapija abbażi ta 'amlodipina jew valsartan.
The Committee recommended that Copalia be given marketing authorisation.
Il- Kumitat irrakkomanda li Copalia jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Copalia:
Aktar tagħrif dwar Copalia:
The European Commission granted a marketing authorisation valid throughout the EU for Copalia to Novartis Europharm Limited on 16 January 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Copalia lil Novartis Europharm Limited fis- 16 ta 'Jannar 2007.
The full EPAR for Copalia can be found here.
L- EPAR sħiħ għal Copalia jista 'jiġi kkonsultat hawn.
This summary was last updated in 06-2008.
Dan is- sommarju ġie aġġornat l- aħħar fi:
EU Number EU/ 1/ 06/ 372/ 001 EU/ 1/ 06/ 372/ 002 EU/ 1/ 06/ 372/ 003 EU/ 1/ 06/ 372/ 004 EU/ 1/ 06/ 372/ 005 EU/ 1/ 06/ 372/ 006 EU/ 1/ 06/ 372/ 007 EU/ 1/ 06/ 372/ 008 EU/ 1/ 06/ 372/ 009 EU/ 1/ 06/ 372/ 010 EU/ 1/ 06/ 372/ 011 EU/ 1/ 06/ 372/ 012 EU/ 1/ 06/ 372/ 013 EU/ 1/ 06/ 372/ 014 EU/ 1/ 06/ 372/ 015 EU/ 1/ 06/ 372/ 016 EU/ 1/ 06/ 372/ 017 EU/ 1/ 06/ 372/ 018 EU/ 1/ 06/ 372/ 019 EU/ 1/ 06/ 372/ 020 EU/ 1/ 06/ 372/ 021 EU/ 1/ 06/ 372/ 022 EU/ 1/ 06/ 372/ 023 EU/ 1/ 06/ 372/ 024 EU/ 1/ 06/ 372/ 025 EU/ 1/ 06/ 372/ 026 EU/ 1/ 06/ 372/ 027 EU/ 1/ 06/ 372/ 028 EU/ 1/ 06/ 372/ 029 EU/ 1/ 06/ 372/ 030 EU/ 1/ 06/ 372/ 031 EU/ 1/ 06/ 372/ 032 EU/ 1/ 06/ 372/ 033 EU/ 1/ 06/ 372/ 034 EU/ 1/ 06/ 372/ 035 EU/ 1/ 06/ 372/ 036
EU/ 1/ 06/ 372/ 013 EU/ 1/ 06/ 372/ 014 EU/ 1/ 06/ 372/ 015 EU/ 1/ 06/ 372/ 016 EU/ 1/ 06/ 372/ 017 EU/ 1/ 06/ 372/ 018 EU/ 1/ 06/ 372/ 019 EU/ 1/ 06/ 372/ 020 EU/ 1/ 06/ 372/ 021 EU/ 1/ 06/ 372/ 022 EU/ 1/ 06/ 372/ 023 EU/ 1/ 06/ 372/ 024 EU/ 1/ 06/ 372/ 025 EU/ 1/ 06/ 372/ 026 EU/ 1/ 06/ 372/ 027 EU/ 1/ 06/ 372/ 028 EU/ 1/ 06/ 372/ 029 EU/ 1/ 06/ 372/ 030 EU/ 1/ 06/ 372/ 031 EU/ 1/ 06/ 372/ 032 EU/ 1/ 06/ 372/ 033 EU/ 1/ 06/ 372/ 034 EU/ 1/ 06/ 372/ 035 EU/ 1/ 06/ 372/ 036
Invented name Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia
Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia Copalia