qanastek/EMEA-V3 huggingface dataset:
fracture, scoliosis (deviation of the vertebral column), bone deformity and fragility, hair discoloration, severe allergic reaction, somnolence, fits, nervousness, hallucination, decrease in white blood cells, gastrointestinal ulcer manifested by bleeding in the digestive tract and effect on the kidney manifested by swelling of the extremities and weight gain.
minkbejn), laxkezza tal- ġogi, uġigħ fir- riġlejn, ksur ta 'l- għadam, skoljosi (is- sinsla tad- dahar ma tibqax dritta), deformità u fraġilità ta' l- għadam, bdil fil- kulur tax- xagħar, reazzjoni allerġika severa, ħedla, attakki tal- qamar, nervożità, alluċinazzjoni, tnaqqis fl- għadd ta 'ċelloli bojod tad - demm, ulċeri gastrointestinali li jistgħu jġibu emorraġija fl- imsaren, u effett fuq il- kliewi li jimmanifesta ruħu b’ nefħa ta' l- estremitajiet u b' żieda fil- piż.
Since some of these side effects are serious, ask your or your child’ s doctor to explain their warning signs.
Minħabba li wħud minn dawn l- effetti oħra huma serji, staqsi lit- tabib tiegħek jew tat- tifel jew tifla tiegħek biex jispjegalek kif tista’ tinduna bihom kmieni kemm jista ’ jkun.
If any of the side effects gets serious, or if you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett jekk jogħġbok għarraf lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE CYSTAGON
KIF TAĦŻEN CYSTAGON
Do not use after the expiry date which is stated on the label.
31 M’ għandekx tuża wara d- data li jiskadi kif tidher fuq il- pakkett.
Do not store above 25°C and keep the container tightly closed in order to protect from light and moisture.
Taħżinx f’ temperatura ‘ l fuq minn 25°C u żomm il- kontenitur magħluq sewwa sabiex tilqa ’ mid- dawl u mill- umdità
Each hard capsule of
X’ fih CYSTAGON − Is- sustanza attiva hi cysteamine bitartrate (mercaptamine bitartrate).
CYSTAGON 50 mg contains 50 mg of cysteamine (as mercaptamine bitartrate) Each hard capsule of CYSTAGON 150 mg contains 150 mg of cysteamine (as mercaptamine bitartrate)
Kull kapsula iebsa ta ’ CYSTAGON 50 mg fiha 50 mg cysteamine (bħala mercaptamine bitartrate).
stearate/ sodium lauryl sulphate, colloidal silicon dioxide, croscarmellose sodium, capsule shells: gelatin, titanium dioxide, black ink on hard capsules (E172).
Kull kapsula iebsa ta ’ CYSTAGON 150 mg fiha 150 mg cysteamine (bħala mercaptamine bitartrate). − Is- sustanzi l- oħra huma microcrystalline cellulose, starch, pregelatinized, magnesium stearate/ sodium lauryl sulphate, colloidal silicon dioxide, croscarmellose sodium. qoxra tal- kapsula: gelatin, titanium dioxide, linka sewda fuq il- kapsuli iebsin (E172).
What CYSTAGON looks like and contents of the pack Hard Capsules
Kapsuli iebsin
- Cystagon 50 mg: white, opaque hard capsules with CYSTA 50 on the body and MYLAN on the cap.
- Cystagon 50 mg: kapsuli iebsin bojod, opaki b’ CYSTA 50 fuq il- korp u MYLAN fuq ir- ras.
Bottles of 100 or 500 hard capsules.
Fliexken ta ’ 100 jew 500 kapsuli iebsin.
All pack sizes may be not marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu fis- suq.
- Cystagon 150 mg: white, opaque hard capsules with CYSTAGON 150 on the body and MYLAN on
- Cystagon 150 mg: kapsuli iebsin bojod, opaki b’ CYSTAGON 150 fuq il- korp u MYLAN fuq ir- ras.
Orphan Europe SARL, Immeuble “ Le Wilson”, F-92058 Paris La Défense, France
Orphan Europe SARL, Immeuble “ Le Wilson ”, F- 92058 Paris La Défense, Franza
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tas - Sid ta ’ l- Awtorizzazzjoni għall- Kummerċ.
Italia Orphan Europe (Italy) Srl Via Cellini 11 I-20090 Segrate (Milano) Tel: +39 02 26 95 01 39
33 Italia Orphan Europe (Italy) Srl Via Cellini 11 I- 20090 Segrate (Milano) Tel: +39 02 26 95 01 39
This leaflet was last approved on
Dan il- fuljett kien approvat l- aħħar fis -
What is Dafiro?
X' inhu Dafiro?
Dafiro is a medicine containing two active substances, amlodipine and valsartan.
Dafiro huwa mediċina li fiha żewġ sustanzi attivi, amlodipina u valsartan.
What is Dafiro used for?
Għal xiex jintuża Dafiro?
Dafiro 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.
Dafiro jintuża f' pazjenti li għandhom ipertensjoni essenzjali (pressjoni tad- demm għolja) li mhijiex ikkontrollata adegwatament bl- amlodipina jew valsartan meħudin waħedhom.
Dafiro 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 Dafiro used?
Kif jintuża Dafiro?
Dafiro is taken by mouth as one tablet once a day with some water, with or without food.
Dafiro jittieħed mill- ħalq fi kwantità ta 'pillola waħda darba kuljum bi ftit ilma, fuq stonku vojt jew le.
The dose of Dafiro to be used depends on the doses of amlodipine or valsartan that the patient was taking before.
Id- doża ta 'Dafiro 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.
Dafiro should be used with caution in patients who have problems with their liver or biliary obstructive disorders (problems with the elimination of bile).
Dafiro għandu jintuża b' kawtela fil- pazjenti bi problemi fil- fwied jew disturbi minn ostruzzjoni biljari (problemi biex jeliminaw il- bili).
How does Dafiro work?
Kif jaħdem Dafiro?
Dafiro contains two active substances, amlodipine and valsartan.
Dafiro fih żewġ sustanzi attivi, amlodipina u valsartan.
How has Dafiro been studied?
Kif ġie studjat Dafiro?
The company also presented evidence that the levels of amlodipine and valsartan in the blood were the same in people taking Dafiro 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' Dafiro u fil- pazjenti trattati biż- żewġ mediċini separatament.
What benefit has Dafiro shown during the studies?
Liema benefiċċju wera Dafiro waqt l- istudji li ġew imwettqa?
What is the risk associated with Dafiro?
X' inhu r- riskju assoċjat ma 'Dafiro?
The most common side effects with Dafiro (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' Dafiro (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 Dafiro, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrappurtati b' Dafiro, ara l- Fuljett ta' Tagħrif.
Dafiro 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.
Dafiro 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.
Dafiro should also not be used in patients who have severe liver, kidney or bile problems, or in patients undergoing dialysis (a blood clearance technique).
Dafiro 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 Dafiro been approved?
Għaliex ġie approvat Dafiro?
The Committee for Medicinal Products for Human Use (CHMP) decided that Dafiro’ 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 'Dafiro 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 Dafiro be given marketing authorisation.
Il- Kumitat irrakkomanda li Dafiro jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Dafiro:
Aktar tagħrif dwar Dafiro:
The European Commission granted a marketing authorisation valid throughout the EU for Dafiro to Novartis Europharm Limited on 16 January 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Dafiro lil Novartis Europharm Limited fis- 16 ta 'Jannar 2007.
The full EPAR for Dafiro can be found here.
L- EPAR sħiħ għal Dafiro jista 'jiġi kkonsultat hawn.
Pharmaceutical Form Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita
Route of administration Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
Packaging Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC)
Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC)
Package size 7 tablets 14 tablets 28 tablets 30 tablets 56 tablets 90 tablets 98 tablets 280 tablets 7 tablets 14 tablets 28 tablets 30 tablets 56 tablets 90 tablets 98 tablets 280 tablets 7 tablets 14 tablets 28 tablets 30 tablets 56 tablets 90 tablets 98 tablets 280 tablets 56 x 1 tablet (unit dose) 98 x 1 tablet (unit dose) 280 x 1 tablet (unit dose) 56 x 1 tablet (unit dose) 98 x 1 tablet (unit dose) 280 x 1 tablet (unit dose) 56 x 1 tablet (unit dose) 98 x 1 tablet (unit dose) 280 x 1 tablet (unit dose) 280 tablets (4 x 70) 280 tablets (4 x 70) 280 tablets (4 x 70)
7 pilloli 14- il pillola 28 pillola 30 pillola 56 pillola 90 pillola 98 pillola 280 pillola 7 pilloli 14- il pillola 28 pillola 30 pillola 56 pillola 90 pillola 98 pillola 280 pillola 7 pilloli 14- il pillola 28 pillola 30 pillola 56 pillola 90 pillola 98 pillola 280 pillola 56 x pillola 1 (doża b’ waħda) 98 x pillola 1 (doża b’ waħda) 280 x pillola 1 (doża b’ waħda) 56 x pillola 1 (doża b’ waħda) 98 x pillola 1 (doża b’ waħda) 280 x pillola 1 (doża b’ waħda) 56 x pillola 1 (doża b’ waħda) 98 x pillola 1 (doża b’ waħda) 280 x pillola 1 (doża b’ waħda) 280 pillola (4 x 70) 280 pillola (4 x 70) 280 pillola (4 x 70)
Dafiro 5 mg/ 80 mg film-coated tablets
Dafiro 5 mg/ 80 mg pilloli miksija b’ rita
Dark yellow, round film-coated tablet with bevelled edges, imprinted with “ NVR ” on one side and “ NV” on the other side.
Pillola safra skura, tonda miksija b’ rita b’ xifer imżerżaq, ittimbrata “ NVR ” fuq naħa u “ NV ” fuq l - oħra.
Dafiro is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Dafiro huwa indikat f’ pazjenti li jkollhom pressjoni għolja li ma tkunx kontrollata b’ terapija ta ’ amlodipine jew valsartan mogħtija waħidhom.
The recommended dose of Dafiro is one tablet per day.
Id- doża ta ’ Dafiro rakkomandata hija pillola waħda kuljum.
Dafiro 5 mg/ 80 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 mg alone.
Dafiro 5 mg/ 80 mg jista ’ jingħata lill- pazjenti li ma jkollhomx pressjoni kontrollata tajjeb b’ amlodipine 5 mg jew valsartan 80 mg waħidhom.
Dafiro can be used with or without food.
Dafiro jista ’ jintuża ma ’ l- ikel jew mingħajr ikel.
It is recommended to take Dafiro with some water.
Huwa rakkomandat li Dafiro jittieħed ma ’ ftit ilma.
For convenience, patients receiving valsartan and amlodipine from separate tablets/ capsules may be switched to Dafiro containing the same component doses.
Għall- konvenjenza, pazjenti li qed jieħdu amlodipine u valsartan minn pilloli/ kapsuli separati jistgħu jinqalbu għal Dafiro li fihom l- istess dożi tal- komponenti.
Hepatic impairment Caution should be exercised when administering Dafiro to patients with hepatic impairment or biliary obstructive disorders (see section 4.4).
Indeboliment tal- fwied Għandha tintuża kawtela meta jingħata Dafiro lill- pazjenti li jsofru minn indeboliment tal- fwied jew mard ta ’ imblokkar tal- marrara (ara sezzjoni 4. 4).
2 Children and adolescents Dafiro is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.
2 Tfal u adolexxenti Dafiro mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
Sodium- and/ or volume-depleted patients Excessive hypotension was seen in 0.4% of patients with uncomplicated hypertension treated with Dafiro in placebo-controlled studies.
Pazjenti nieqsa mis- sodium u/ jew volum Pressjoni baxxa eċċessiva dehret f’ 0. 4% tal- pazjenti b’ pressjoni għolja mingħajr kumplikazzjonijiet li kienet kurata b’ Dafiro fi studji kontrollati bi plaċebo.
Correction of this condition prior to administration of Dafiro or close medical supervision at the start of treatment is recommended.
Qabel tibda l- kura b’ Dafiro huwa rakkomandat li din tiġi korretta jew inkella jkun hemm sorveljanza medika mill- qrib meta tibda l- kura.
If hypotension occurs with Dafiro, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline.
Jekk taqa ’ l- pressjoni b’ Dafiro, il- pazjent għandu jitqiegħed mindud wiċċu ‘ l fuq u jekk ikun meħtieġ, jingħata infużjoni fil- vina b’ ilma bil- melħ.
Renal artery stenosis No data are available on the use of Dafiro in patients with bilateral renal artery stenosis or stenosis to a solitary kidney.
Stenożi ta ’ l- arterja renali M’ hemmx tagħrif dwar l- użu ta ’ Dafiro f’ pazjenti b’ stenożi bilaterali ta ’ l- arterji renali jew stenożi ta ’ kilwa waħda.
Kidney transplantation To date there is no experience of the safe use of Dafiro in patients who have had a recent kidney transplantation.
Trapjant tal- kliewi Sa ’ llum għad m’ hemmx esperjenza bl- użu ta ’ Dafiro f’ pazjenti li riċentement ħadu trapjant tal- kliewi.
Particular caution should be exercised when administering Dafiro to patients with mild to moderate hepatic impairment or biliary obstructive disorders.
Għandha ssir attenzjoni partikolari meta Dafiro jingħata lill - pazjenti li jsofru minn indeboliment ħafif jew moderat jew mard ta ’ imblokkar tal- marrara.
Renal impairment No dosage adjustment of Dafiro is required for patients with mild to moderate renal impairment (GFR > 30 ml/ min/ 1.73 m2).
3 Indeboliment renali M’ hemmx bżonn ta ’ tibdil fid- dożaġġ għall- pazjenti li għandhom indeboliment ħafif għal moderat (GFR > 30 ml/ min/ 1. 73 m2).
Dafiro has not been studied in any patient population other than hypertension.
Dafiro ma kienx studjat f’ ebda popolazzjoni ta ’ pazjenti oħrajn apparti dawk li jsofru minn pressjoni għolja.
Interactions linked to valsartan Concomitant use not recommended Lithium Reversible increases in serum lithium concentrations and toxicity have been reported during concurrent use of ACE inhibitors.
4 Nuqqas ta ’ qbil marbut ma ’ valsartan L- użu fl- istess ħin mhux rakkomandat Lithium Żiediet riversibbli tal- konċentrazzjonijiet ta ’ lithium fis- serum u tossiċità kienu rappurtati bl- użu fl - istess ħin ta ’ inibituri ACE.
Interactions common to the combination No drug interaction studies were performed with Dafiro and other medicinal products.
Interazzjonijiet komuni għall- kombinazzjoni Ma sarux studji dwar nuqqas ta ’ qbil b’ Dafiro u prodotti mediċinali oħrajn.
There is no experience on the use of Dafiro in pregnant women.
M’ hemmx esperjenza bl- użu ta ’ Dafiro waqt it- tqala.
The safety of Dafiro has been evaluated in five controlled clinical studies with 5,175 patients, 2,613 of whom received valsartan in combination with amlodipine.
Is- sigurtà ta ’ Dafiro ġiet meqjusa f’ ħames studji kliniċi kontrollati b’ 5, 175 pazjent, li 2, 613 minnhom irċevew valsartan kombinat ma ’ amlodipine.
Skin and subcutaneous tissue disorders
6 Disturbi tal- ġilda u tat- tessuti ta ’ taħt il- ġilda
6 General disorders and administration site conditions
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata
Additional information on the individual components Adverse drug reactions previously reported with one of the individual components (amlodipine or valsartan) may be potential undesirable effects with Dafiro as well, even if not observed in clinical trials or during the post-marketing period.
Aktar tagħrif dwar il- komponenti individwali Reazzjonijiet avversi għall- medicina li kienu rappurtati qabel b’ wieħed mill- komponenti (amlodipine jew valsartan) jistgħu jkunu effetti mhux mixtieqa b’ Dafiro ukoll, anki jekk ma dehrux waqt il- provi kliniċi jew waqt il- perjodu ta ’ wara t- tqeghid fis- suq..
Symptoms There is no experience of overdose with Dafiro.
Sintomi M’ hemmx esperjenza ta ’ doża eċċessiva b’ Dafiro.
Clinically significant hypotension due to Dafiro overdose calls for active cardiovascular support, including frequent monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output.
Meta taqa l- pressjoni b’ Dafiro b’ mod li jkun hemm sintomi kliniċi, għandu jkun hemm support għall- qalb, inklużi monitoraġġ frekwenti tal- funzjoni tal- qalb u tas- sistema respiratorja, jittellgħu d- driegħ, u għandha ssir attenzjoni għall- volum ta ’ fluwidi li jiċċirkolaw u l- volum ta ’ awrina.
Dafiro combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines.
Dafiro jikkombina żewġ sustanzi kontra l- pressjoni għolja ma ’ mekkaniżmi kumplimentari sabiex tkun kontrollata l- pressjoni tad- demm f’ pazjenti b’ pressjoni għolja naturali: amlodipine huwa membru ta ’ klassi li huma antagonisti ta ’ calcium u valsartan ta ’ klassi ta ’ mediċini li huma antagonisti ta angiotensin II.
Amlodipine The amlodipine component of Dafiro inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Amlodipine Il- komponent amlodipine f’ Dafiro jinibixxi id- dħul mill- membrana ta ’ joni ta ’ calcium fil- muskoli tal - qalb u tal- muskoli lixxi tal- vini.
The mechanism of the antihypertensive action of amlodipine is due to a direct relaxant effect on vascular smooth muscle, causing reductions in peripheral vascular resistance and in blood pressure.
Il- mekkaniżmu ta ’ l- azzjoni kontra l- pressjoni għolja ta ’ amlodipine ġej mill- effett dirett u rilassant fuq il- muskoli lixxi tal- vini, li jikkawżaw tnaqqis fir- reżistenza fil- vini periferali u fil- pressjoni tad- demm.
The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels.
Il- proċess ta ’ kontrazzjoni tal- muskolu tal- qalb u tal- muskoli lixxi tal- vini huma t- tnejn marbuta mal- moviment ta ’ joni ta ’ calcium barra miċ- ċelluli għal ġo fihom minn kanali ta ’ joni speċifiċi.
Following administration of therapeutic doses to patients with hypertension, amlodipine produces vasodilation, resulting in a reduction of supine and standing blood pressures.
8 Wara li jingħataw dożi terapewtiċi lill- pazjenti li jsofru minn pressjoni għolja, amlodipine inaqqas il - vażodilatazzjoni, li jwassal għall- tnaqqis fil- pressjonijiet tad- demm kemm meta l- pazjent ikun mindud kif ukoll wieqaf.
Amlodipine/ Valsartan Over 1,400 hypertensive patients received Dafiro once daily in two placebo-controlled trials.
9 Amlodipine/ Valsartan ’ L fuq minn 1, 400 pazjent irċevew Dafiro darba kuljum f’ żewġ provi kontrollati bi plaċebo.
Dafiro was also studied in an active-controlled study of 130 hypertensive patients with diastolic blood pressure ≥ 110 mmHg and < 120 mmHg.
Dafiro kien studjat ukoll fi studju active- controlled ta ’ 130 pazjent bi pressjoni għolja bil- pressjoni dijastolika ≥110 mmHg u < 120 mmHg.
In this study (baseline blood pressure 171/ 113 mmHg), an Dafiro regimen of 5 mg/ 160 mg titrated to 10 mg/ 160 mg reduced sitting blood pressure by 36/ 29 mmHg as compared to 32/ 28 mmHg with a regimen of lisinopril/ hydrochlorothiazide 10 mg/ 12.5 mg titrated to 20 mg/ 12.5 mg.
F’ dan l- istudju (il- linja bażi tal- pressjoni tad- demm kienet 171/ 113 mmHg), b’ reġimen ta ’ Dafiro ta ’ 5 mg/ 160 mg miżjuda għal 10 mg/ 160 mg naqqset il - pressjoni tad- demm ta ’ bilqiegħeda b’ 36/ 29 mmHg meta imqabbla ma ’ 32/ 28 mmHg b’ reġimen ta ’ lisinopril/ hydrochlorthiazide 10 mg/ 12. 5 mg miżjuda għal 20 mg/ 12. 5 mg.
In two long-term follow-up studies the effect of Dafiro was maintained for over one year.
F’ żewġ studji follow- up fit- tul, l- effett ta ’ Dafiro inżamm għal aktar minn sena waħda.
Abrupt withdrawal of Dafiro has not been associated with a rapid increase in blood pressure.
Meta Dafiro twaqqaf f’ daqqa, ma kienx hemm żieda f’ daqqa tal- pressjoni tad- demm.
Age, gender and race did not influence the response to Dafiro.
L- età, sess u r- razza ma kellhomx effett fuq ir- rispons għal Dafiro.
Dafiro has not been studied in any patient population other than hypertension.
Dafiro ma kienx studjat f’ ebda popolazzjoni ta ’ pazjenti apparti dawk li jbatu minn pressjoni għolja.
Valsartan is highly bound to serum proteins (94 – 97%), mainly serum albumin.
Valsartan jintrabat b’ mod qawwi mal- proteini tas- serum (94- 97%), l- aktar ma ’ l- albumina tas- serum.
Amlodipine/ Valsartan Following oral administration of Dafiro, peak plasma concentrations of valsartan and amlodipine are reached in 3 and 6– 8 hours, respectively.
Amlodipine/ Valsartan Wara li Dafiro jittieħed mill- ħalq, il- quċċata tal- konċentrazzjonijiet fil- plażma ta ’ valsartan u amlodipine jintlaħqu fi 3 u 6- 8 sigħat, rispettivament.
The rate and extent of absorption of Dafiro are equivalent to the bioavailability of valsartan and amlodipine when administered as individual tablets.
Ir- rata u l- grad ta’ assorbiment ta ’ Dafiro huma ekwivalenti għal bijodisponibilità ta ’ valsartan u amlodipine meta jingħataw bħala pilloli waħidhom.
An increased incidence and severity of renal tubular basophilia/ hyalinisation, dilation and casts, as well as interstitial lymphocyte inflammation and arteriolar medial hypertrophy were found at an exposure of 8– 13 (valsartan) and 7 – 8 (amlodipine) times the clinical doses of 160 mg valsartan and 10 mg amlodipine.
Żieda fin- numru ta ’ każijiet u severità ta ’ bażofilja / hyalinisation tubulari renali, dilazzjoni u kasts, kif ukoll infjammazzjoni b’ limfoċiti fl- interstizzju u ipertrofija ta ’ l- arterjola medjali instabu b’ esponimenti ta ’ 8- 13 (valsartan) u 7- 8 (amlodipine) drabi d- dożi kliniċi ta ’ 160 mg valsartan u 10 mg amlodipine.
MARKETING AUTHORISATION NUMBER(S)
EU/ 1/ 06/ 371/ 001 EU/ 1/ 06/ 371/ 002 EU/ 1/ 06/ 371/ 003 EU/ 1/ 06/ 371/ 004 EU/ 1/ 06/ 371/ 005 EU/ 1/ 06/ 371/ 006
EU/ 1/ 06/ 371/ 001 EU/ 1/ 06/ 371/ 002 EU/ 1/ 06/ 371/ 003 EU/ 1/ 06/ 371/ 004 EU/ 1/ 06/ 371/ 005 EU/ 1/ 06/ 371/ 006 EU/ 1/ 06/ 371/ 007 EU/ 1/ 06/ 371/ 008 EU/ 1/ 06/ 371/ 025 EU/ 1/ 06/ 371/ 026 EU/ 1/ 06/ 371/ 027 EU/ 1/ 06/ 371/ 034
13 EU/ 1/ 06/ 371/ 007 EU/ 1/ 06/ 371/ 008 EU/ 1/ 06/ 371/ 025 EU/ 1/ 06/ 371/ 026 EU/ 1/ 06/ 371/ 027 EU/ 1/ 06/ 371/ 034
Dafiro 5 mg/ 160 mg film-coated tablets
Dafiro 5 mg/ 160 mg pilloli miksija b’ rita
Dark yellow, oval film-coated tablet, imprinted with “ NVR ” on one side and “ ECE” on the other side.
Pillola safra skura, ovali miksija b’ rita, ittimbrata “ NVR ” fuq naħa u “ ECE ” fuq l- oħra.
Dafiro 5 mg/ 160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 160 mg alone.
Dafiro 5 mg/ 160 mg jista ’ jingħata lill- pazjenti li ma jkollhomx pressjoni kontrollata tajjeb b’ amlodipine 5 mg jew valsartan 160 mg waħidhom.
14 Children and adolescents Dafiro is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.
15 Tfal u adolexxenti Dafiro mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
Second and third trimesters of pregnancy (see section 4.4 and 4.6).
It- tieni u t- tielet trimestri tat- tqala (ara sezzjoni 4. 4 u 4. 6
Renal impairment No dosage adjustment of Dafiro is required for patients with mild to moderate renal impairment (GFR > 30 ml/ min/ 1.73 m2).
16 Indeboliment renali M’ hemmx bżonn ta ’ tibdil fid- dożaġġ għall- pazjenti li għandhom indeboliment ħafif għal moderat (GFR > 30 ml/ min/ 1. 73 m2).
18 General disorders and administration site conditions
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata
Additional information on the individual components Adverse drug reactions previously reported with one of the individual components (amlodipine or valsartan) may be potential undesirable effects with Dafiro as well, even if not observed in clinical trials or during the post-marketing period.
Aktar tagħrif dwar il- komponenti individwali Reazzjonijiet avversi għall- medicina li kienu rappurtati qabel b’ wieħed mill- komponenti (amlodipine jew valsartan) jistgħu jkunu effetti mhux mixtieqa b’ Dafiro ukoll, anki jekk ma dehrux waqt il- provi kliniċi jew waqt il- perjodu ta ’ wara t- tqegħid fis- suq..
Amlodipine/ Valsartan Over 1,400 hypertensive patients received Dafiro once daily in two placebo-controlled trials.
Amlodipine/ Valsartan ’ L fuq minn 1, 400 pazjent irċevew Dafiro darba kuljum f’ żewġ provi kontrollati bi plaċebo.
Renal impairment The pharmacokinetics of amlodipine are not significantly influenced by renal impairment.
24 Indeboliment renali Il- farmakokinetiċi ta ’ amlodipine mhumiex effettwati b’ mod sinifikanti mill- indeboliment renli.
Coating:
25 Kisja:
MARKETING AUTHORISATION NUMBER(S)
EU/ 1/ 06/ 371/ 009 EU/ 1/ 06/ 371/ 010 EU/ 1/ 06/ 371/ 011 EU/ 1/ 06/ 371/ 012 EU/ 1/ 06/ 371/ 013 EU/ 1/ 06/ 371/ 014
EU/ 1/ 06/ 371/ 009 EU/ 1/ 06/ 371/ 010 EU/ 1/ 06/ 371/ 011 EU/ 1/ 06/ 371/ 012 EU/ 1/ 06/ 371/ 013 EU/ 1/ 06/ 371/ 014 EU/ 1/ 06/ 371/ 015 EU/ 1/ 06/ 371/ 016 EU/ 1/ 06/ 371/ 028 EU/ 1/ 06/ 371/ 029 EU/ 1/ 06/ 371/ 030 EU/ 1/ 06/ 371/ 035
26 EU/ 1/ 06/ 371/ 015 EU/ 1/ 06/ 371/ 016 EU/ 1/ 06/ 371/ 028 EU/ 1/ 06/ 371/ 029 EU/ 1/ 06/ 371/ 030 EU/ 1/ 06/ 371/ 035
Dafiro 10 mg/ 160 mg film-coated tablets
Dafiro 10 mg/ 160 mg pilloli miksija b’ rita
Light yellow, oval film-coated tablet, imprinted with “ NVR ” on one side and “ UIC” on the other side.
Pillola safra ċara, ovali miksija b’ rita, ittimbrata “ NVR ” fuq naħa u “ UIC ” fuq l- oħra.
Dafiro 10 mg/ 160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg or valsartan 160 mg alone or with Dafiro 5 mg/ 160 mg.
Dafiro 10 mg/ 160 mg jista ’ jingħata lill- pazjenti li ma jkollhomx pressjoni kontrollata tajjeb b’ amlodipine 10 mg jew valsartan 160 mg waħidhom jew b’ Dafiro 5 mg/ 160 mg.
26 Children and adolescents Dafiro is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.
28 Tfal u adolexxenti Dafiro mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
Renal impairment No dosage adjustment of Dafiro is required for patients with mild to moderate renal impairment (GFR > 30 ml/ min/ 1.73 m2).
29 Indeboliment renali M’ hemmx bżonn ta ’ tibdil fid- dożaġġ għall- pazjenti li għandhom indeboliment ħafif għal moderat (GFR > 30 ml/ min/ 1. 73 m2).
AIIRAs therapy exposure during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see also section 5.3).
31 Espożizzjoni għall- kura ta ’ AIIRAs fit- tieni u it- tielet trimestri huwa magħruf li jinduċi tossiċità tal - fetu uman (funzjoni renali mnaqqsa, oligoidramnios, ittardjar ta 'l- ossifikazzjoni tal- kranju) u tossiċità fit- trabi wara it- twelid (indeboliment renali, pressjoni baxxa, iperkalemia) (ara ukoll sezzjoni 5. 3).
Skin and subcutaneous tissue disorders
32 Disturbi tal- ġilda u tat- tessuti ta ’ taħt il- ġilda
Additional information on the individual components Adverse drug reactions previously reported with one of the individual components (amlodipine or valsartan) may be potential undesirable effects with Dafiro as well, even if not observed in clinical trials or during the post-marketing period.
Aktar tagħrif dwar il- komponenti individwali Reazzjonijiet avversi għall- medicina li kienu rappurtati qabel b’ wieħed mill- komponenti (amlodipine jew valsartan) jistgħu jkunu effetti mhux mixtieq b’ Dafiro ukoll, anki jekk ma dehrux waqt il- provi kliniċi jew waqt il- perjodu ta ’ wara t- tqeghid fis- suq..
Experimental data suggest that amlodipine binds to both dihydropyridine and non-dihydropyridine binding sites.
Il- proċess ta ’
The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels.
34 kontrazzjoni tal- muskolu tal- qalb u tal- muskoli lixxi tal- vini huma t- tnejn marbuta mal- moviment ta ’ joni ta ’ calcium barra miċ- ċelluli għal ġo fihom minn kanali ta ’ joni speċifiċi.
Amlodipine/ Valsartan Over 1,400 hypertensive patients received Dafiro once daily in two placebo-controlled trials.
35 Amlodipine/ Valsartan ’ L fuq minn 1, 400 pazjent irċevew Dafiro darba kuljum f’ żewġ provi kontrollati bi plaċebo.
MARKETING AUTHORISATION NUMBER(S)
EU/ 1/ 06/ 371/ 017 EU/ 1/ 06/ 371/ 018 EU/ 1/ 06/ 371/ 019 EU/ 1/ 06/ 371/ 020 EU/ 1/ 06/ 371/ 021
EU/ 1/ 06/ 371/ 017 EU/ 1/ 06/ 371/ 018 EU/ 1/ 06/ 371/ 019 EU/ 1/ 06/ 371/ 020 EU/ 1/ 06/ 371/ 021 EU/ 1/ 06/ 371/ 022 EU/ 1/ 06/ 371/ 023 EU/ 1/ 06/ 371/ 024 EU/ 1/ 06/ 371/ 031 EU/ 1/ 06/ 371/ 032 EU/ 1/ 06/ 371/ 033 EU/ 1/ 06/ 371/ 036
39 EU/ 1/ 06/ 371/ 022 EU/ 1/ 06/ 371/ 023 EU/ 1/ 06/ 371/ 024 EU/ 1/ 06/ 371/ 031 EU/ 1/ 06/ 371/ 032 EU/ 1/ 06/ 371/ 033 EU/ 1/ 06/ 371/ 036
Dafiro 5 mg/ 80 mg film-coated tablets amlodipine/ valsartan
Dafiro 5 mg/ 80 mg pilloli miksija b’ rita amlodipine/ valsartan
Dafiro 5 mg/ 160 mg film-coated tablets amlodipine/ valsartan
Dafiro 5 mg/ 160 mg pilloli miksija b’ rita amlodipine/ valsartan
Dafiro 10 mg/ 160 mg film-coated tablets amlodipine/ valsartan
Dafiro 10 mg/ 160 mg pilloli miksija b’ rita amlodipine/ valsartan
What Dafiro is and what it is used for 2.
X’ inhu Dafiro u għalxiex jintuża 2.
Before you take Dafiro 3.
Qabel ma tieħu Dafiro 3.
How to take Dafiro 4.
Kif għandek tieħu Dafiro 4.
Possible side effects 5.
Effetti sekondarji li jista ’ jkollu Kif taħżen Dafiro 5.
WHAT DAFIRO IS AND WHAT IT IS USED FOR
X’ INHU DAFIRO U GĦALXIEX JINTUŻA
Dafiro tablets contain two substances called amlodipine and valsartan.
Il- pilloli Dafiro fihom żewġ sustanzi li jissejjħu amlodipine u valsartan.
Dafiro is used to treat high blood pressure in patients whose blood pressure is not controlled enough with either amlodipine or valsartan on its own.
Dafiro jintuża sabiex jikkura l- pressjoni għolja f’ pazjenti li jkollhom il- pressjoni li ma tkunx qed tiġi kontrollata tajjeb biżżejjed b’ amlodipine jew valsartan waħidhom.
2.
QABEL MA TIEĦU DAFIRO 2.
BEFORE YOU TAKE DAFIRO
dihydropyridine
Do not take Dafiro − if you are allergic (hypersensitive) to amlodipine or other medicines of the dihydropyridine type, − if you are allergic (hypersensitive) to valsartan or any of the other ingredients of Dafiro.
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal valsartan jew sustanzi oħra ta ’
If you think you may be allergic, talk to your doctor before taking Dafiro. − if you have severe liver problems, such as biliary cirrhosis or cholestasis. − if you have severe kidney problems or if you are having dialysis. − during the last 6 months of pregnancy, see “ Pregnancy and breastfeeding”.
Jekk qed tieħu dijuretiċi (tip ta ’ pilloli magħrufa bħala “ tal- pipì ” li żżid l- ammont ta ’ awrina li
If any of the above applies to you, do not take Dafiro and talk to your doctor.
- Jekk qed tieħu xi mediċini jew sustanzi li jżidu l- livelli ta ’ potassium fid- demm tiegħek (eż ċerti
Take special care with Dafiro − if you have been sick (vomiting or diarrhoea).
- Jekk it- tabib qallek li l- valvoli ta ’ qalbek djiequ (magħrufa bħala “ stenożi ta ’ l- aorta ” jew
64 − if you are taking diuretics (a type of medicine also called “ water tablets ” which increases the amount of urine you produce). − if you are taking other medicines or substances that increase the level of potassium in your blood (e. g. some types of diuretics, potassium supplements or salt substitutes containing potassium). − if you have liver or kidney problems. − if you have a condition affecting the renal glands called “ primary hyperaldosteronism ”. − if you have had heart failure. − if your doctor has told you that you have a narrowing of the valves in your heart (called “ aortic or mitral stenosis”) or that the thickness of your heart muscle is abnormally increased (called “ obstructive hypertrophic cardiomyopathy”).
“ mitrijali ”) jew jekk il- ħxuna tal- muskolu ta ’ qalbek kibret aktar minn- normal (magħrufa bħala “ kardjomijopatija ipertrofika ostruttiva ”).
If any of these apply to you, tell your doctor before taking Dafiro.
Jekk xi wieħed minn dawn jgħodd għalik, tkellem mat- tabib tiegħek qabel tieħu Dafiro.
You must tell your doctor if you think that you are (or might become) pregnant.
Inti għandek tgħid lit- tabib tiegħek jekk inti taħseb li inti tqila (jew tista ’ toħroġ tqila).
Dafiro is not recommended in early pregnancy and may cause serious harm to your baby if taken after 3 months of pregnancy (see section “ Pregnancy and breast-feeding”).
Dafiro m’ huwiex rakkomandat fil- bidu tat- tqala u jista ’ jikkawża ħsara serja lit- tarbija tiegħek jekk jittieħed wara t- tielet xahar tat- tqala (ara s- sezzjoni “ Tqala u treddigħ ”).
The use of Dafiro in children and adolescents is not recommended.
L- użu ta ’ Dafiro fi tfal u adolexxenti mhuwiex rakkomandat.
Your doctor may need to change the dose or take other precautions.
F’ xi każi jista ’ jkun li jkollok twaqqaf xi wieħed mill- mediċini.
In some cases you may have to stop taking one of the medicines.
Dan jgħodd l - aktar għall- mediċini elenkati hawn taħt:
John’ s wort; − nitroglycerin and other nitrates, or other substances called “ vasodilators ”; − medicines used for HIV/ AIDS (e. g. ritonavir) or for treatment of fungal infections (e. g. ketoconazole).
- Mediċini li jintużaw għall- HIV/ AIDS (eż. ritonavir) jew għall- kura ta ’ mard tal- moffa (eż
Taking Dafiro with food and drink You can take Dafiro with or without food.
Meta tieħu Dafiro ma ’ l- ikel u max- xorb Tista ’ tieħu Dafiro ma ’ l- ikel jew mingħajru.
Dafiro and older people Caution is required when increasing the dosage.
Dafiro u pazjenti aktar anzjani Kawtela hija meħtieġa meta jkun qed jiżdied id- dożaġġ.
Usually, your doctor will advise you to take another medicine instead of Dafiro, as Dafiro is not recommended in early pregnancy, and may cause serious harm to your baby if it is used after 3 months of pregnancy.
Is- soltu, it - tabib tieghek javżak biex tieħu mediċina oħra minflokk Dafiro, għax Dafiro mhux irrakkomandat fil - bidu tat- tqala, minħabba li jista ’ jagħmel ħsara lit- tarbija tiegħek jekk jintuża wara 3 xhur tat- tqala.
An appropriate antihypertensive medication must usually replace Dafiro before starting a pregnancy.
Mediċina addattata għal kontra il- pressjoni trid tibdel lil Dafiro qabel tinbeda tqala.
Your doctor will normally advise you to stop taking Dafiro as soon as you know you are pregnant.
It- tabib tiegħek normalment javżak biex tieqaf tieħu Dafiro immedjatament kif issir taf li inti tqila.
If you become pregnant during therapy with Dafiro, please inform and see your doctor without delay.
Għid u ara lit- tabib tiegħek mingħajr dewmien jekk tinqabad tqila waqt it- terapija b’ Dafiro.
Treatment with Dafiro is not recommended during breast- feeding.
Kura b’ Dafiro mhix rakkomandata waqt it- treddigħ.
65 Ask your doctor or pharmacist for advice before taking any medicine.
Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
HOW TO TAKE DAFIRO
KIF GĦANDEK TIEĦU DAFIRO
The usual dose of Dafiro is one tablet per day. − It is advisable to take your medicine at the same time each day, preferably in the morning. − Swallow the tablets with a glass of water. − You can take Dafiro with or without food.
- Ikun aħjar li tieħu l- mediċina tiegħek fl- istess ħin kuljum, preferibbilment filgħodu
Do not exceed the prescribed dose.
- Tista ’ tieħu Dafiro ma ’ l- ikel jew mingħajr ikel.
If you take more Dafiro than you should If you have taken too many tablets of Dafiro, or if someone else has taken your tablets, consult a doctor immediately.
Jekk tieħu Dafiro aktar milli suppost Jekk ħadt iżżejjed mill- pilloli Dafiro, jew jekk xi ħadd ieħor ħa l- pilloli tiegħek, ħu parir tat- tabib tiegħek mill- ewwel.
If you forget to take Dafiro If you forget to take this medicine, take it as soon as you remember.
Jekk tinsa tieħu Dafiro Jekk tinsa ’ tieħu din il- mediċina, ħudha malli tiftakar.
Like all medicines, Dafiro can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Dafiro jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Rare (affecting less than 1 in 1,000 patients):
Rari (jaffettwaw anqas minn 1 f’ 1, 000 pazjent):
66 If any of these affect you severely, tell your doctor.
69 Jekk xi wieħed minn dawn l- effetti sekondarji jaffettwak severament, għid lit- tabib tiegħek.
HOW TO STORE DAFIRO
KIF TAĦŻEN DAFIRO
Do not use Dafiro after the expiry date stated on the carton and blister.
Tużax Dafiro wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- folja.
Do not use any Dafiro pack that is damaged or shows signs of tampering.
Tuża l- ebda pakkett ta ’ Dafiro li jkun danneġġat jew li juri sinjali ta ’ tbagħbis.
What Dafiro contains − The active substances of Dafiro are amlodipine (as amlodipine besylate) and valsartan.
X’ fih Dafiro − Is- sustanzi attivi ta ’ Dafiro huma amlodipine (bħala amlodipine besylate) u valsartan.
Each tablet contains 5 mg amlodipine and 80 mg valsartan. − The other ingredients are cellulose microcrystalline; crospovidone type A; silica, colloidal anhydrous; magnesium stearate; hypromellose; macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172).
Kull pillola fiha 5 mg amlodipine u 80 mg valsartan. − Is- sustanzi l- oħra huma cellulose microcrystalline; crospovidone type A; silica, colloidal anhydrous; magnesium stearate; hypromellose; macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172).
67 What Dafiro looks like and contents of the pack Dafiro 5 mg/ 80 mg tablets are round and dark yellow with “ NVR ” on one side and “ NV” on the other side.
70 Id- Dehra ta ’ Dafiro u l- kontentuti tal- pakkett Dafiro 5 mg/ 80 mg pilloli huma tondi u sofor skuri b ’ “ NVR ” fuq naħa u “ NV ” fuq in- naħa l- oħra.
Dafiro is available in packs containing 7, 14, 28, 30, 56, 90, 98 or 280 tablets and in multipacks comprising 4 cartons, each containing 70 tablets.
Dafiro jiġi f’ pakketti li jkun fihom 7, 14, 28, 30, 56, 90, 98 jew 280 pillola u pakketti b’ ħafna li jinkludu 4 kartuniet, kull wieħed fih 70 pillola.
68 France Novartis Pharma S. A. S.
71 France Novartis Pharma S. A. S.
70 − if you are taking diuretics (a type of medicine also called “ water tablets” which increases the amount of urine you produce). − if you are taking other medicines or substances that increase the level of potassium in your blood (e. g. some types of diuretics, potassium supplements or salt substitutes containing potassium). − if you have liver or kidney problems. − if you have a condition affecting the renal glands called “ primary hyperaldosteronism”. − if you have had heart failure. − if your doctor has told you that you have a narrowing of the valves in your heart (called “ aortic or mitral stenosis”) or that the thickness of your heart muscle is abnormally increased (called “ obstructive hypertrophic cardiomyopathy”).
“ mitrijali ”) jew jekk il- ħxuna tal- muskolu ta ’ qalbek kibret aktar minn- normal (magħrufa bħala “ kardjomijopatija ipertrofika ostruttiva ”).
71 Ask your doctor or pharmacist for advice before taking any medicine.
Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
72 If any of these affect you severely, tell your doctor.
75 Jekk xi wieħed minn dawn l- effetti sekondarji jaffettwak severament, għid lit- tabib tiegħek.
What Dafiro contains
AKTAR TAGĦRIF
Each
X’ fih Dafiro − Is- sustanzi attivi ta ’ Dafiro huma amlodipine (bħala amlodipine besylate) u valsartan.
What Dafiro looks like and contents of the pack Dafiro 5 mg/ 160 mg tablets are oval and dark yellow “ NVR” on one side and “ ECE” on the other side.
76 Id- Dehra ta ’ Dafiro u l- kontentuti tal- pakkett Dafiro 5 mg/ 160 mg pilloli huma ovali u sofor skuri b ’ “ NVR ” fuq naħa u “ ECE ” fuq in- naħa l- oħra.
73 Dafiro is available in packs containing 7, 14, 28, 30, 56, 90, 98 or 280 tablets and in multipacks comprising 4 cartons, each containing 70 tablets.
Dafiro jiġi f’ pakketti li jkun fihom 7, 14, 28, 30, 56, 90, 98 jew 280 pillola u pakketti b’ ħafna li jinkludu 4 kartuniet, kull wieħed fih 70 pillola.
76 − if you are taking diuretics (a type of medicine also called “ water tablets” which increases the amount of urine you produce). − if you are taking other medicines or substances that increase the level of potassium in your blood (e. g. some types of diuretics, potassium supplements or salt substitutes containing potassium). − if you have liver or kidney problems. − if you have a condition affecting the renal glands called “ primary hyperaldosteronism”. − if you have had heart failure. − if your doctor has told you that you have a narrowing of the valves in your heart (called “ aortic or mitral stenosis”) or that the thickness of your heart muscle is abnormally increased (called “ obstructive hypertrophic cardiomyopathy”).
“ mitrijali ”) jew jekk il- ħxuna tal- muskolu ta ’ qalbek kibret aktar minn- normal (magħrufa bħala “ kardjomijopatija ipertrofika ostruttiva ”).
77 Ask your doctor or pharmacist for advice before taking any medicine.
Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
78 If any of these affect you severely, tell your doctor.
81 Jekk xi wieħed minn dawn l- effetti sekondarji jaffettwak severament, għid lit- tabib tiegħek.
Uncommon:
Amlodipine Mhux magħruf:
Yellowing of the skin and eyes, changes in the results of some liver function tests; purple skin patches, rash and itching, stiff limbs, trembling hands.
Tnaqqis ta ’ ċelloli ħomor fid- demm, deni, uġigħ fil- gerżuma jew ulċeri fil- ħalq minħabba infezzjonijiet, fsada jew tbenġil spontanju, livell għoli ta ’ potassium fid- demm, riżultati tat - testijiet tal- fwied mhux normali, funzjonijiet tal- kliewi mnaqqsa u funzjonijiet tal- kliewi mnaqqsa b’ mod sever, nefħa l- aktar tal- wiċċ u l- gerżuma, uġigħ fil- muskoli, raxx, marki żgħar tondi ħomor jagħtu fil- vjola, deni, ħakk, reazzjoni allerġika.
What Dafiro contains − The active substances of Dafiro are amlodipine (as amlodipine besylate) and valsartan.
X’ fih Dafiro − Is- sustanzi attivi ta ’ Dafiro huma amlodipine( bħala amlodipine besylate) u valsartan.
Each tablet contains 10 mg amlodipine and 160 mg valsartan. − The other ingredients are cellulose microcrystalline; crospovidone type A; silica, colloidal anhydrous; magnesium stearate; hypromellose; macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172), iron oxide, red (E172).
Kull pillola fiha 10 mg amlodipine u 160 mg valsartan. − Is- sustanzi l- oħra huma cellulose microcrystalline; crospovidone type A; silica, colloidal anhydrous; magnesium stearate; hypromellose; macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172), iron oxide, red (E172).
79 What Dafiro looks like and contents of the pack Dafiro 10 mg/ 160 mg tablets are oval and light yellow with “ NVR” on one side and “ UIC” on the other side.
Id- Dehra ta ’ Dafiro u l- kontentuti tal- pakkett Dafiro 10 mg/ 160 mg pilloli huma ovali u sofor ċari b ’ “ NVR ” fuq naħa u “ UIC ” fuq in- naħa l- oħra.
Marketing Authorisation Holder Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom
82 Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB Ir- Renju Unit
What is DaTSCAN?
X’ inhu DaTSCAN?
DaTSCAN is a solution for injection containing the active substance ioflupane (123I).
DaTSCAN hu soluzzjoni għall- injezzjoni li jkun fiha s- sustanza attiva ioflupane (123I).