natgillin/translations-raw huggingface dataset:
Στην προκειµένη περίπτωση, το ευρύτερο αυτό κριτήριο θεωρήθηκε ότι µπορεί να εφαρµοσθεί εξαιτίας της υπό συνθήκες σίτισης εξαιρετικά υψηλής ενδοατοµικής µεταβλητότητας (70 - 82%) που φάνηκε από τη µελέτη.
It was considered that this wider criterion can be applied in this case because of the extremely high intra-subject variability (70- 82%) under fed conditions shown in this study.
Τα αποτελέσµατα κρίθηκαν επίσης αποδεκτά επί κλινικής βάσης, καθώς η αποτελεσµατικότητα της λανσοπραζόλης εξαρτάται σε µικρό µόνο βαθµό από τη δόση στο συγκεκριµένο εύρος θεραπευτικών δόσεων.
The results were also considered acceptable on clinical grounds as lansoprazole’ s efficacy is largely independent of dose at this therapeutic dose range.
Η τεκµηρίωση που παρουσιάστηκε στην Επιτροπή Φαρµάκων για Ανθρώπινη Χρήση (CHMP) υποδεικνύει ότι τα προϊόντα δοκιµής και αναφοράς είναι κατά βάση παρόµοια.
Both products show pronounced food effect although the generic product appears to be more affected largely because of the high intra-subject variability.
Και τα δύο προϊόντα παρουσιάζουν ευδιάκριτο αποτέλεσµα σε συνθήκες σίτισης, αν και το γενόσηµο προϊόν φαίνεται αποτελεσµατικότερο κυρίως εξαιτίας της υψηλής ενδοατοµικής µεταβλητότητας.
This is supported by two similar fed studies using the same reference drug and the same test drug with the same batch number when entirely different results are obtained and which confidence intervals were within conventionally acceptable limits.
Τα αποτελέσµατα των µελετών σίτισης δείχνουν ότι η βιοδιαθεσιµότητα του Lansoprazole όχι µόνο παρουσιάζει σαφή µείωση όταν αυτό λαµβάνεται µε τροφή, αλλά και ότι η απορρόφησή του µπορεί να είναι εξαιρετικά ακανόνιστη παρουσία τροφής.
The results of these fed studies demonstrate that Lansoprazole’ s bioavailability is not only markedly reduced when taken with food, but that its absorption, in the presence of food, can be very erratic.
6 Το Lansoprazole έχει µεγάλο θεραπευτικό παράθυρο αναφορικά µε την κλινική του αποτελεσµατικότητα και την ασφάλεια.
It also has a flat dose/ response curve i. e. its efficacy is largely independent of the dose.
Επιπλέον, η καµπύλη δόσης/ απόκρισης που παρουσιάζει είναι επίπεδη, η αποτελεσµατικότητά του είναι δηλαδή σε µεγάλο βαθµό ανεξάρτητη από τη δόση.
This means that the small difference in blood levels between the reference and test products shown under fed conditions is of no clinical significance.
7 ΠΑΡΑΡΤΗΜΑ ΙII
7 ANNEX III
ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ, ΕΠΙΣΗΜΑΝΣΗ ΚΑΙ ΦΥΛΛΟ Ο∆ΗΓΙΩΝ ΧΡΗΣHΣ
SUMMARY OF PRODUCT CHARACHTERITICS, LABELLING AND PACKAGE LEAFLET
8 Η ισχύουσα περίληψη των χαρακτηριστικών του προϊόντος, η επισήµανση και το φύλλο οδηγιών χρήσης αποτελούν τις τελικές εκδοχές που προέκυψαν, στο πλαίσιο της διαδικασίας που ακολούθησε η οµάδα συντονισµού.
8 The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
2
Marketing Authorisation Holder
ησήρχ ςοταµότσ όπΑ ήρηλκσ αλυοψάκ ήκιτκεθναορτσαΓ ησήρχ ςοταµότσ όπΑ ήρηλκσ
Applicant
, αλυοψάκ ήκιτκεθναορτσαΓ
Invented name
Lansocid
Pharmaceutical Form
D- 83607 Holzkirchen Industriestraße 25
Route of administration
αίδηυοΣ
HEXAL AG Industriestraße 25
ησήρχ ςοταµότσ όπΑ ήρηλκσ
Lansohexal 15 mg - Hartkapseln
Lansocid
Gastro-resistant capsule, hard
ησήρχ ςοταµότσ όπΑ ήρηλκσ
D-83607 Holzkirchen
, αλυοψάκ ήκιτκεθναορτσαΓ
Lansohexal 30 mg - Hartkapseln
Lansoprazol HEXAL 30 mg
Oral use
D- 83607 Holzkirchen Industriestraße 25
HEXAL AG Industriestraße 25
αίδναλνιΦ
Lansoprazol HEXAL
Lansoprazol HEXAL 15mg
Gastro-resistant capsule, hard
D- 83607 Holzkirchen ησήρχ ςοταµότσ όπΑ ήρηλκσ αλυοψάκ ήκιτκεθναορτσαΓ ησήρχ ςοταµότσ όπΑ ήρηλκσ
30 mg
, αλυοψάκ ήκιτκεθναορτσαΓ
Gastro-resistant capsule, hard
Lansohexal 30 mg
Oral use
- Hartkapseln 30 mg
Germany
Lansohexal 15 mg
Lansohexal 15 mg Hartkapseln
- Hartkapseln 15 mg
15 mg
,
Lansohexal 30 mg Hartkapseln
Lansoprazol HEXAL
Gastro-resistant capsule, hard
-
Finland
αίνα∆
-
ησήρχ ςοταµότσ όπΑ ήρηλκσ
Lansoprazol HEXAL
, αλυοψάκ ήκιτκεθναορτσαΓ
15mg
, αλυοψάκ ήκιτκεθναορτσαΓ
Lansoprazol HEXAL
Lansohexal 30 mg
30 mg
- Hartkapseln 30 mg
30 mg
D- 83607 Holzkirchen Industriestraße 25
Gastro-resistant capsule, hard
αίρτσυΑ
HEXAL AG Industriestraße 25
,
Lansocid
Lansohexal 15 mg ατητ
15 mg
- Hartkapseln 15 mg
Gastro-resistant capsule, hard
ςαίροφολκυκ
D-83607 Holzkirchen
ςησηγήροχ ςόδΟ
Gastro-resistant capsule, hard
ήφροµ ήκινχετοκαµραΦ όκιτκειρεΠ
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
- 3
3 SCIENTIFIC CONCLUSIONS
ςαιεδά ςητ ςοχοτάΚ ςολέµ ςοτάρΚ
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF LANSOPRAZOL HEXAL 15 MG, 30 MG GASTRO-RESISTANT CAPSULES, HARD (see Annex I)
ΑΕΜΕ ΝΟΤ ΟΠΑ ΝΑΚΗΤΣΑΙΣΥΟΡΑΠ ΥΟΠ ΣΟΤΝΟΪΟΡΠ ΥΟΤ ΝΩΚΙΤΣΙΡΗΤΚΑΡΑΧ ΝΩΤ ΣΗΨΗΛΙΡΕΠ ΣΗΤ ΗΣΗΙΟΠΟΠΟΡΤ ΝΗΤ ΑΙΓ ΙΟΓΟΛ ΙΑΚ ΑΤΑΜΣΙΡΟΠ ΑΚΙΝΟΜΗΤΣΙΠΕ ΙΙ ΑΜΗΤΡΑΡΑΠ 4
Lansoprazol HEXAL 15 mg, 30 mg, gastro-resistant capsules, hard were referred for arbitration according to Article 29 of Council Directive 2001/ 83/ EC, as amended, following concerns raised by Germany during a Mutual Recognition Procedure with Finland acting as Reference Member state.
ςοταµώρχοτυκ υοτ
• Treatment of benign gastric and duodenal ulcers associated with the use of anti-inflammatory analgesics in patients requiring continued anti-inflammatory analgesic treatment.
οτσ ιατνοζίλοβατεµ ηλόζαρποτναπ ιακ ηλόζαρποσναλ ηλόζαρπεµο νωίνοτωρπ ςαίλτνα ςίελοτσανα ιΟ
Gastric acid is central in the pathogenesis of gastroduodenal ulcers and acid inhibition has been shown to effectively heal NSAID induced ulcers.
νωτ ιακ
In patients who continue to take NSAID medication healing is delayed.
30 mg, νωτ ησόδ ητ αιγ
Patients were randomized to treatment with either ranitidine 150 mg twice daily or lansoprazole, 15 mg or 30 mg once daily for 8 weeks.
4
Healing was assessed endoscopically at 4 and 8 weeks.
ςησωλύοπε άτσοσοπ ατ αδάµοδβε η νηΤ αδάµοδβε η νητ αχιοτσίτνα.
After 8 weeks of treatment, healing was observed in 61 (53%) of 115, 81 (69%) of 118, and 85 (73%) of 117 patients receiving ranitidine, lansoprazole 15 mg, and lansoprazole 30 mg, respectively (P < 0.05 for ranitidine vs. both lansoprazole doses).
νωτ ιακ
At 4 weeks, the corresponding healing rates were 30%, 47% and 57%.
ηψηλίρεπ ςω εκηθύεισοµηδ( Goldstein.),
For duodenal ulcers (n=46), the healing rates were between 81%-93% at week 8 in the 3 treatment groups.
61%, P < 0. 05).
Safety was comparable between the groups.
άκιτναµησ εκηθώιτλεβ ατνογάραπ όκιτιρκκειτνα (70%
Matsukawa et al evaluated in an uncontrolled study the efficacy of lansoprazole 15 mg and 30 mg in 47 patients with NSAID induced gastroduodenal ulcers.
νανέ εµ ςυοκλέ ύοκιρτσαγ υοτ ησωλύοπε η ύορωλυπ υοτ οιδίρητκαβοκιλε όπα ηξωµίολ ναχίε ιοίοπο ιο, ιακ ΦΑΣΜ εµ ήγωγα νασηθύολοκα υοπ ςίενεθσα ςυοτΣ
Patients with duodenal ulcers (n=3) were treated for 6 weeks and patients with gastric ulcers (n=42) or multiple ulcers (n=5) for 8 weeks.
αχιοτσίτνα ςηνίδιτιναρ ςητ ιακ
Overall rate of healing according to Sakitas classification was 95%.
P < 0. 001).
The rate of S2-healing (good healing) was 35%.
υοίδιρητκαβοκιλε υοτ ησατσάτακ νητ όπα ατητράξενα ςησωλύοπε ςήλπα
Campell et al evaluated the effect of pre-treatment of Helicobacter pylori (H. pylori) infection on gastric ulcer healing rates in patients receiving NSAIDs and antisecretory medication in pooled analyses of two identical double-blind RCT comparing lansoprazole with ranitidine.
692
In total 692 patients were enrolled.
ναχίετεµµυσ άκιλονυΣ ηνίδιτιναρ ητ εµ ηλόζαρποσναλ ητ νανιρκένυσ υοπ νώτελεµ νώκινιλκ νώλφυτ. - νώλπιδ νωνέµηιοποιαχυτ νωπυτόιοµοναπ ούδ ςιεσύλανα ςέκιτωρτνεκγυσ εσ ήγωγα ήκιτιρκκειτνα
Simple healing rates (independent of H. pylori status) were at 8 weeks, 66%, 74% and 50% in the lansoprazole 15 mg, 30 mg and ranitidine groups, respectively; P < 0.001).
ιακ ΦΑΣΜ εµ ήγωγα ήκιτυεκαµραφ νασηθύολοκα υοπ ςίενεθσα εσ ςυοκλέ ύοκιρτσαγ υοτ ςησωλύοπε
In patients receiving NSAIDs with H. pylori infection gastric ulcer healing with an antisecretory agent was significantly enhanced (70% vs 61%, P < 0.05).
ύορωλυπ υοτ οιδίρητκαβοκιλε όπα ηξωµίολ ητ αιγ ςήγωγα ςηνεµύογηορπ
In a study published as an abstract (Goldstein et al), the healing rates were 64% and 76% for the 15 mg and 30 mg dose, respectively, at week 8.
ςητ ησάρδ ητ νασηγόλοιξα ά κ
At week 4 the healing rates were 44% and 51% for the 15 mg and 30 mg dose, respectively.
ησηµόνιξατ νητ εµ ανωφµύσ ςησωλύοπε ότσοσοπ όκιλονυσ οΤ ςεδάµοδβε αιγ
The proton pump inhibitors, omeprazole, lansoprazole and pantoprazole are all mainly metabolized by the cytochrome P450 isoform CYP2C19.
. νατή Sakitas ησηµόνιξατ νητ εµ ανωφµύσ ςησωλύοπε ότσοσοπ όκιλονυσ οΤ ςεδάµοδβε αιγ.
All three have a very limited potential for drug interactions at the CYP level (Unge and Andersson 1997).
(n=5) ηκλέ άλπαλλοπ ή
Interaction with NSAIDs has not been suggested.
ηκλέ άκιρτσαγ εµ ςίενεθσα ιο ιακ ςεδάµοδβε αιγ ήγωγα νασηθύολοκα
• Prophylaxis of gastric and duodenal ulcer associated with the use of anti-inflammatory agents and relief of symptoms in patients requiring continuous anti-inflammatory therapy
ηκλέ άκιλυτκαδακεδωδ εµ ςίενεθσα ιΟ ηκλέ άκιλυτκαδακεδωδορτσαγ ΦΑΣΜ εµ ανεµόζιτεχσ.
Three published papers on the clinical evidence for prevention of NSAID related ulcers are submitted.
ςηλόζαρποσναλ ςητ ατητόκιταµσελετοπα νητ ητέλεµ ηνεµόχγελε 15 mg
Lai et al studied 123 patients with ulcer complications relating to the use of low dose aspirin and who were infected by H. pylori.
. ιΟ νωδάµο νωτ ύξατεµ ηµισίρκγυσ νατή αιελάφσα Matsukawa..
After successful healing of the ulcers and eradication of H. pylori, patients were randomized to treatment with lansoprazole 30 mg or placebo in addition to aspirin 100 mg daily for 12 months.
Η ςήγωγα ςεδάµο ςιτσ ιακ αδάµοδβε νητ
Primary endpoint was the recurrence of ulcer complications.
ύξατεµ νατνονίαµυκ ςησωλύοπε άτσοσοπ
During follow-up, 9/ 61 patient (14.8%) in the placebo group had recurrence of ulcer complications compared with 1/ 62 patients (1.6%) in the lansoprazole group (P=0.008).
νατή ςησωλύοπε άτσοσοπ αχιοτσίτνα ατ
Graham et al conducted a prospective; double blind RCT 4 among 537 patients without H. pylori infection who were long-term users of NSAIDs with a history of endoscopically documented gastric ulcer.
ςεδάµοδβε ςιτΣ ςηλόζαρποσναλ νωεσόδ ούδ νωτ ιακ ιτνανέ ηνίδιτιναρ ητ αιγ
Patients were randomized to receive placebo, misoprostol or lansoprazole 15 mg or 30 mg for 12 weeks.
4
Ulcer status was determined by endoscopy at week 4, 8, and 12.
ηλόζαρποσναλ ιακ ιακ ςίενεθσα
By week 12, the percentages of gastric ulcer-free patients were 51%, 93%, 80% and 82% for the placebo, misoprostol, lansoprazole 15 mg and lansoprazole 30 mg group, respectively.
ηλόζαρποσναλ ηνίδιτιναρ ναβαλέ υοπ ςίενεθσα 15 mg,
Antacid use was significantly less among patients in the lansoprazole groups compared with patients in the misoprostol and placebo groups.
εσ ςίενεθσα
Patients in the lansoprazole groups had significantly less abdominal pain compared with patients in the misoprostol group.
εσ ησωλύοπε115
Lai et al studied 43 patients who presented with peptic ulcer and were found to be infected with H. pylori while receiving NSAIDs.
εκηθήρηταραπ ςαίεπαρεθ ςεδάµοδβε όπα άτεΜ αδάµοδβε η νητ ιακ η νητ άτακ άκιποκσοδνε εκηθήγολοιξα ησωλύοπε Η ςεδάµοδβε αιγ αρέµη νητ άροφ αίµ
Patients with healed ulcers and H. pylori eradicated then received naproxen 750 mg daily and were randomized to receive either lansoprazole 30 mg or no treatment for 8 weeks.
8
The primary endpoint was recurrence of symptomatic and complicated ulcers during the 8 weeks.
ηλόζαρποσναλ
The cumulative incidence of symptomatic and complicated GD ulcers at week 8 was 4.5% in the lansoprazole group and 42.9% in the no treatment group (P=0.0025).
εµ ετίε αρέµη νητ ςέροφ ούδ
Benefit/ Risk considerations
ηνίδιτιναρ εµ ετίε αίεπαρεθ ηνέµηιοποιαχυτ εσ νακηθήλβοπυ 150 mg
The bibliographic data submitted by the applicant show that in patients who continue to receive NSAID medication, lansoprazole is more effective in healing gastric ulcers than H2-receptor antagonist and the healing rates are acceptable although somewhat lower than reported for omeprazole.
ςίενεθσα ιΟ ΦΑΣΜ ςιεσόδ ςέρεθατσ νυονάβµαλ αν νασύοθυολοκαξε ιοίοπο ιο ςοκλέ όκιρτσαγ
There is scarce data concerning healing rates for duodenal ulcers but duodenal ulcers are known in general to heal better than gastric ulcers following acid suppression.
εµ ςίενεθσα
The limited data as regards lansoprazole support this.
353εσ ητέλεµ ήκινιλκ ήλφυτ ήλπιδ ηνέµηιοποιαχυτ αίµ ναγαγήξειδ ά κ
Furthermore, interaction studies performed with omeprazole and several NSAIDs have not shown any interaction.
, ίερετσυθακ ησωλύοπε η
The lack of formal interaction studies with NSAIDs has to be adequately reflected in the SPC.
ςήχενυσ η ητητίαραπα ιανίε υοπ ςίενεθσα εσ νώκλε νώκιλυτκαδακεδωδ ιακ νώκιρτσαγ νώθηολακ ΦΑΣΜ ακαµράφ ηδώνοµγελφιτνα ήδιεορετσ ηµ εµ νωνεµόζιτεχσ νωτ αίεπαρεΘ
The bibliographic data submitted provide evidence to support the indications: • Treatment of NSAID-associated benign gastric and duodenal ulcers in patients requiring continuous NSAID-treatment” • Prophylaxis of NSAID-associated benign gastric and duodenal ulcers patients at risk requiring continuous NSAID-treatment”.
ςαίαβιοµα αίσακιδαιδ ητ ήτυα ςωπό υοίλυοβµυΣ
An indication that includes relief of symptoms in this population, however, is not sufficiently supported.
άτακ αίναµρεΓ η εσαρφέξε υοπ ςείχυσηνα ςιτ άτεµ εκηθήιοποπορτ υοτ ΚΕ, ςαίγηδο ςητ ορθρά οτ εµ ανωφµύσ αίσητιαιδ
Compared with placebo, lansoprazole only reduced the need for antacids in one of the studies but significant difference with regard to symptoms was not shown.
αιγ εκηθφµέπαραπ ςελυοψάκ ςέκιτκεθναορτσαγ ςέρηλκσ εσ αµητράραΠ λβ ΣΕΡΗΛΚΣ ΣΕΛΥΟΨΑΚ ΣΕΚΙΤΚΕΘΝΑΟΡΤΣΑΓ
Therefore, the benefit-risk profile of Lansoprazol HEXAL 15 mg, 30 mg in the proposed indications can be considered favourable.
(., LANSOPRAZOL ΥΟΤ ΣΗΣΗΓΟΛΟΙΞΑ ΣΗΚΙΝΟΜΗΤΣΙΠΕ ΣΗΤ ΗΨΗΛΙΡΕΠ ΗΚΙΝΕΓ
GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS Whereas, The scope of the referral was to agree on a Summary of Products Characteristics in view of the indication.
5
5 ANNEX III
HEXAL 15 MG, 30 MG, ΑΤΑΜΣΙΡΟΠ ΑΚΙΝΟΜΗΤΣΙΠΕ
AMENDED SUMMARY OF PRODUCT CHARACTERISTICS OF THE REFERENCE MEMBER STATE
42, 9%
Note:
ιακ ςηλόζαρποσναλ ςητ αδάµο νητσ
This SPC is the one that was Annexed to the Commission Decision on this Article 29 referral for lansoprazole containing medicinal products.
εµ ςίενεθσα ιΟ ςεδάµοδβε αιγ.
The text was valid at that time.
ιακ η νητ άκιποκσοδνε εκητσίροθακ ςυοκλέ υοτ ησατσάτακ η Η ςεδάµοδβε αιγ
After the Commission Decision, the Member State competent authorities will update the product information as required.
(P=0. 008). ηλόζαρποσναλ εβαλέ υοπ αδάµο νητσ
Therefore, this SPC may not necessarily represent the current text.
εµ ησιρκγύσ εσ ςυοκλέ (1. 6%)
6 1.
ςίενεθσα
NAME OF THE MEDICINAL PRODUCT
ςησηθύολοκαραπ ςητ αιεκράιδ ητ άταΚ ςυοκλέ υοτ νώκολπιπε νωτ ήπορτοπυ η νατή, 9/ 61.
Lansoprazole and associated names (see Annex I), 15 mg gastro-resistant capsule, hard Lansoprazole and associated names (see Annex I), 30 mg gastro-resistant capsule, hard
οίεµησ όκιλετ οιρύκ οΤ ςενήµ αιγ
[See Annex I - to be completed nationally]
ςηνίριπσα ηψήλ ητ νυσ οκαµράφ όκινοκιε ή 12 100 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
ιακ νώκιρτσαγ ςετνογάραπ ςιεδώνοµγελφιτνα εµ νωνεµόζιτεχσ νωτ ηξαλύφορΠ ΦΑΣΜ εµ ησαρδίπεληλλα ιεψύκορπ ιεχέ νε∆
Each hard capsule contains 15 or 30 mg lansoprazole.
•
[To be completed nationally]
Andersson 1997).
For excipients, see 6.1.
ςενεµόνιετορπ ςιτσ Lansoprazol HEXAL 15 mg, 30 mg
15 mg:
ςητ υονύδνικ ςαιελέφω ησέχσ η ςωνέµοπΕ -,
Opaque, yellow hard gelatine capsule, containing pellets with enteric coating.
•
30 mg:
εσ νώκλε νώκιλυτκαδακεδωδ ιακ νώκιρτσαγ νώθηολακ ΦΑΣΜ εµ νωνεµόζιτεχσ νωτ αίεπαρεΘ
Opaque, white hard gelatine capsule, containing pellets with enteric coating.
ςιεξίεδνε:
[To be completed nationally]
SPC (νόραπ οΤ
CLINICAL PARTICULARS
ΗΝΕΜΗΙΟΠΟΠΟΡΤ
4.1 Therapeutic Indications
Ι ΑΜΗΤΡΑΡΑΠ II 8 ςεδάµοδβε ούδ ηµόκα αιγ ησόδ αιδί. νητσ υοκάµραφ υοτ ησηγήροχ η ιατεζίχενυσ αν ιεπέρπ υοδόιρεπ ςητ ςήτυα ςότνε ςωρήλπ ιατνούεπαρεθ, εδ ιοίοπο ιο ςίενεθσα εΣ ςεδάµοδβε αιγ ςωίσηρεµη άροφ αίµ
• Treatment of duodenal and gastric ulcer confirmed by endoscopy or radiography. • Treatment of reflux oesophagitis. • Long-term prophylaxis of reflux oesophagitis. • Zollinger-Ellison syndrome. • Treatment of NSAID-associated benign gastric and duodenal ulcers in patients requiring continuous NSAID-treatment • Prophylaxis of NSAID-associated gastric and duodenal ulcer in patients at risk requiring continuous NSAID-treatment
2
The recommended dose is 30 mg once daily for 2 weeks.
ιανίε ησόδ ηνεµώτσινυσ Η 30 mg
In patients not fully healed within this time, the medication should be continued at the same dose for another two weeks.
ςυοκλέ ύοκιλυτκαδακεδωδ αίεπαρεΘ:
Treatment of gastric ulcer:
ςησηγήροχ ςοπόρτ ιακ αίγολοσο∆
The recommended dose is 30 mg once daily for 4 weeks.
εσ νώκλε νώκιλυτκαδακεδωδ ιακ νώκιρτσαγ νώθηολακ ΦΑΣΜ εµ νωνεµόζιτεχσ νωτ αίεπαρεΘ οµορδνύΣ
The ulcer usually heals within 4 weeks, but in patients not fully healed within this time, the medication should be continued at the same dose for another 4 weeks.
. - ονέµωιαβεβιπε.
7 Treatment of reflux oesophagitis:
ςιεξίεδνε ςέκιτυεπαρεΘ
The recommended dose of lansoprazole is 30 mg once daily for 4 weeks.
4.
In patients not fully healed within this time, the treatment may be continued at the same dose for another 4 weeks.
αµµήλ λβ αχοδκέ ατ αιΓ.,
Prophylaxis of reflux oesophagitis:
15
15 mg once daily.
ιεχέιρεπ αλυοψάκ ήρηλκσ εθάΚ
The dose may be increased up to 30 mg daily as necessary.
ΗΣΕΘΝΥΣ ΗΚΙΤΟΣΟΠ ΙΑΚ ΗΚΙΤΟΙΟΠ
The recommended initial dose is 60 mg once daily.
οδεπίπε όκινθε εσ ησωρήλκολο ςορΠ Ι αµητράραπ επέλΒ
The dose should be individually adjusted and the treatment should be continued for as long as necessary.
ήρηλκσ
Daily doses of up to 180 mg have been used.
30 mg,
30 mg once daily for four weeks.
αλυοψάκ ήκιτκεθναορτσαγ
In patients not fully healed the treatment may be continued for another four weeks.
αµητράραπ επέλβ ςείσαµονο ςέκιτεχσ ιακ
For patients at risk or with ulcers that are difficult to heal, a longer course of treatment and/ or a higher dose should be considered.
(
Prophylaxis of NSAID-associated gastric and duodenal ulcers in patients requiring continuous NSAID- treatment:
15 mg,
15 mg once daily.
αµητράραπ επέλβ ςείσαµονο ςέκιτεχσ ιακ (
If the treatment fails the dose 30 mg once daily should be used.
ΣΟΤΝΟΪΟΡΠ ΥΟΚΙΤΥΕΚΑΜΡΑΦ ΥΟΤ ΑΙΣΑΜΟΝΟ
Symptomatic gastro-oesophageal reflux disease:
15
The recommended dose is 15 mg or 30 mg once daily.
, ατ ιενίαβρεπυ αν ιεπέρπ νεδ ησόδ η αίγρυοτιελ ήκιταπη ηνέµωιεµ ςώρφαλε εµ ςίενεθσα ςυοτΣ αίγρυοτιελ ήκιταπη ηνέµωιεµ αιρτέµ
Individual adjustment of dosage should be considered.
αίγρυοτιελ ήκιρφεν ή ήκιταπη ηνέµωιεΜ ςιεσάτεξε ωρέτιαρεπ
If the symptoms are not relieved within 4 weeks with a daily dose of 30 mg, further examinations are recommended.
:
Impaired hepatic or renal function:
ιακ ιατνώτσινυσ
There is no need to change the dose in patients with impaired renal function.
νωτ ησόδ αισήρεµη αίµ εµ νωδάµοδβε ςότνε αταµώτπµυσ ατ νύοτσιφυοκανα 30 mg,
The normal daily dose of 30 mg should not be exceeded in these patients, however.
νεδ νάΕ ςησόδ ςητ ήγοµρασορπ ηνέµυεκιµοταξε η ιατεζάτεξε αν ιεπέρΠ αµοτνύσ ιατενάχγυτιπε
Care should be exercised in the administration of lansoprazole in patients with mildly to moderately impaired hepatic function.
νωτάµωτπµυσ νωτ ησιφύοκανα Η ςωίσηρεµη άροφ αίµ
In mildly impaired patients, the dose should not exceed 30 mg.
15 mg
In patients with moderately impaired hepatic function, the dose should be restricted to 15 mg daily.
ησηµόρδνιλαπ ήκιγαφοσιο ορτσαγ ήκιταµωτπµυΣ
Due to the lack of data in patients with severely impaired hepatic function, these patients should not be treated with lansoprazole (see section 4.4 “ Special warning and precautions for use”).
ησόδ ιατίειοποµισηρχ αν ιεπέρπ αίεπαρεθ η ιενάχγυτοπα νάΕ ςωίσηρεµη 30 mg
Lansoprazole is not recommended in children as safety and efficacy have not been established in this population.
υοπ ςίενεθσα εσ ηκλέ άκιλυτκαδακεδωδ ιακ άκιρτσαγ ΦΑΣΜ εµ νωνεµόζιτεχσ νωτ ηξαλύφορΠ
Due to delayed elimination of lansoprazole in the elderly it may be necessary to administer the treatment in doses of 15-30 mg adjusted to individual requirements.
ησόδ ηρετόληψυ η ιακ ή ςαίεπαρεθ
However, the daily dose in the elderly should not exceed 30 mg.
. ςιεθήολαΚ
The capsules are swallowed whole with liquid.
ιρχέµ ςιεσόδ ςεισήρεµη ίεθηιοποµισηρχ νυοχΈ 180 mg.
The capsules may be emptied, but the contents may not be chewed or ground.
ιατεζίµθυρ αν ιεπέρπ ησόδ Η ςωίσηρεµη άροφ αίµ
Concomitantly taken food slows down and reduces the absorption of lansoprazole.
. ιανίε ησόδ ήκιχρα ηνεµώτσινυσ Η οµορδνύΣ
This medicine has the best effect when taken into empty stomach.
60 mg
4.3.
Zollinger- Ellison:
Contraindications
οτητίαραπα ιανίε νάε ςωίσηρεµη. ιρχέµ ίεθηξυα αν ίεροπµ ησόδ Η ςωίσηρεµη άροφ αίµ
Hypersensitivity to lansoprazole or any of the excipients of the product.
.
4.4.
ςεδάµοδβε ηµόκα αιγ ησόδ αιδί
Special Warning and Precautions for Use
ιανίε ςηλόζαρποσναλ ησόδ ηνεµώτσινυσ Η 30 mg
The diagnosis of gastroduodenal ulcers and reflux oesophagitis should be confirmed by endoscopy or other appropriate diagnostic means.
ησηµόρδνιλαπ ήκιγαφοσιο ορτσαγ όπα ςαδιτίγαφοσιο ςητ αίεπαρεΘ
Reflux oesophagitis may not present as ulceration and/ or visual damage, therefore in certain cases endoscopy alone may not be sufficient.
. ςεδάµοδβε ηµόκα αιγ ησόδ αιδί νητσ υοκάµραφ υοτ ησηγήροχ η ιατεζίχενυσ αν ιεπέρπ υοδόιρεπ
8 The possibility of malignant gastric tumour should be excluded before initiating treatment of gastric ulcer with lansoprazole, because lansoprazole can mask the symptoms and delay the diagnosis.
ςυοκλέ ύοκιρτσαγ υοτ αίεπαρεΘ
Lansoprazole should be used with caution in patients with severe hepatic dysfunction.
αµωρχότυκ οτ εµ ιατεζίτεχσ υοπ νωκάµραφ P450 (CYP2C19
(See Section 4.2 “ Posology and method of administration“)
ύοµσιλοβατεµ ςοταµήτσυσ ύοκιµυζνε ςόνε ωσέµ ιατεζίλοβατεµ ηλόζαρποσναλ η ιτό υονέµοδε∆
Lansoprazole has a similar mechanism of action to omeprazole and both increase gastric pH, the following statement is made by analogy to omeprazole.
αµωρχότυκ οτ εµ ιατνοζίτεχσ υοπ ακαµράΦ
Decreased gastric acidity due to lansoprazole increases gastric counts of bacteria normally present in the gastrointestinal tract.
ςησαρδίπεληλλα ςέφροµ ςελλά ιακ ατνόϊορπ άκιτυεκαµραφ αλλά εµ ςιεσάρδιπεληλλΑ
Treatment with lansoprazole may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter.
ςανέ ιατενώρεµηνε αν.
Patients suffering from gastro-duodenal ulcers, the possibility of H. pylori infection as an etiological factor should be considered.
αιεκράιδ ητ άτακ ςησαρό ςητ ςέχαραταιδ νύοτσιναφµε νάΕ αιελάφσα νητ αιγ ανέµοδεδ άκινιλκορΠ
If lansoprazole, in combination with antibiotics, is used for eradication therapy of H. -pylori, then also instructions for the use of these antibiotics should be followed.
λβ ςίενεθσα ςυοτ ςύοτυα εσ υονύδνικ υοτ ιτνανέ ςολεφό οτ ςώρεµοτπελ ιατίεγολοιξα αν ιεπέρπ αθ (. ιακ ςαίεπαρεθ ςητ ςοχγελέ ςόκιτκατ ιατεγάξειδ αν ιεπέρπ αθ ςοτέ όπα ορετόσσιρεπ αιγ ςησηρήτνυσ
Because of limited safety data for patients on maintenance treatment for longer than 1 year, regular review of the treatment and a thorough benefit risk assessment should regularly be performed in these patients (see “ 5.3 Preclinical safety data”).
1
If visual disturbances occur during long-term use (> 1 year), an ophthalmologist should be consulted.
αίγρυοτιελσυδ ήκιταπη άιραβ εµ ςίενεθσα εσ ήχοσορπ εµ ιατίειοποµισηρχ αν ιεπέρπ ηλόζαρποσναλ Η.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
αν ιακ αταµώτπµυσ ατ ιεψύλακ αν ίεροπµ ηλόζαρποσναλ η ιτόιδ ηλόζαρποσναλ εµ ςαίεπαρεθ
Interaction with Other Medicinal Products and Other Forms of Interaction