natgillin/translations-raw huggingface dataset:
Lansopon 15 mg, 30 mg ςείγηδο ςέκιποτ ιακ
30 mg
εµ ςίενεθσα εσ νωτάµσυορκ νωτ
Gastro-resistant capsule, hard
ιακ
Oral use
ύξατεµ
Lansoprazol HEXAL 15 mg
80%
HEXAL AG
αιοµόραπ εξιεδέτακ
Hartkapseln
,
15 mg
ηνίλλικιξοµα ιακ
Gastro-resistant capsule, hard
ηνίκυµορθιραλκ νωίνοτωρπ ςαίλτνα αέλοτσανα εµ ςωίσηρεµη ςέροφ (C),
Oral use
,
Luxembourg
νωτ ηλόζανιδορτεµ ή
Industriestraße 25
αµητράραΠ λβ
D-83607 Holzkirchen
Lansopon 15 mg, 30 mg,
Hartkapseln
30 MG,
30 mg
LANSOPON 15 MG, ςιτ ιακ
Gastro-resistant capsule, hard
Lansopon
Oral use
2
2 ANNEX II
ιανίε ησόδ ηνεµώτσινυσ Η 30 mg
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF LANSOPON 15 MG, 30 MG, GASTRO-RESISTANT CAPSULES, HARD (see Annex I)
ςυοκλέ ύοκιλυτκαδακεδωδαίεπαρεΘ:
The concerns rose referred to discrepancies in comparison to the reference products on posology.
ςησηγήροχ ςοπόρτ οµορδνύΣ
Eradication of H. pyolori and peptic ulcer healing
ιακ αίγολοσο∆ Zollinger- Ellison.
Eradication of H. pylori has been shown to be a definitive cure for duodenum ulcer and most gastric ulcers.
4. 2. •
Fourteen-day, proton pump inhibitor-based triple therapy achieves better results than 7-day schedules.
ύορωλυπ υοπ οιδίρητκαβοκιλΕ οτ εµ ιατνοζίτεχσ υοπ ηκλέ όπα νυοχσάπ. υοπ ςίενεθσα εσ νώκλε νώκιτπεπ νωτ ςήπορτοπυ ςητ ηψηλόρπ νητ αιγ ιακ αίεπαρεθ ήκιτοιβιτνα
A meta-analysis of studies comparing twice daily, one-week triple therapy with a proton pump inhibitor, clarithromycin (C) and amoxycillin (A) (PCA) vs. those using proton pump inhibitor, clarithromycin and a nitroimidazole (N) (PCN) for H. pylori eradication provided evidence in support of similar H. pylori eradication efficacy.
ηληλλάτακ εµ όµσαυδνυσ εσ ιατίεγηροχ ύορωλυΠ υοτ υοίδιρητκαβοκιλΕ υοτ ησωζίρκε νητ αιΓ ησηµόρδνιλαπ ήκιγαφοσιο ορτσαγ όπα ςαδιτίγαφοσιο ςητ ηξαλύφορπ ηµσεθόρπορκαΜ
Triple therapy allows the eradication of H. pylori in more than 85% of cases in patients with peptic ulcer.
•
Benefit/ Risk considerations
. - ησηµόρδνιλαπ ήκιγαφοσιο ορτσαγ όπα ςαδιτίγαφοσιο ςητ αίεπαρεΘ
However, in order to avoid treatment failure, local antibacterial resistance patterns and local guidelines should be considered.
•
The risk/ benefit ratio of Lansopon 15 mg, 30 mg is considered to be favourable provided that appropriate information regarding H. pylori eradication therapy are included in the SPC.
. - ονέµωιαβεβιπε άκιγολονιτκα ή άκιποκσοδνε υοχάµοτσ ιακ ύοκιλυτκαδακεδωδ ςυοκλέ υοτ αίεπαρεΘ
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 posology for eradication therapy for H. pylori The Summary of Products Characteristic proposed by the applicant has been assessed based on the documentation submitted and the scientific discussion within the Committee.
.
4 the CHMP has recommended the granting of the Marketing Authorisations with amendments of the Summary of Product Characteristics as set out in Annex III for Lansopon and associated names (see Annex I).
• •
5 ANNEX III
ςιεξίεδνε ςέκιτυεπαρεΘ
AMENDED SUMMARY OF PRODUCT CHARACTERISTICS OF THE REFERENCE MEMBER STATE
4. 1
Note:
ΣΕΙΡΟΦΟΡΗΛΠ ΣΕΚΙΝΙΛΚ οδεπίπε όκινθε εσ ησωρήλκολο ςορΠ
Therefore, this SPC may not necessarily represent the current text.
4.
6 1.
ηψυλάκιπε ήτυλαιδορετνε εµ αιδίριαφσ ιεχέιρεπ υοπ ςηνίταλεζ αλυοψάκ ήρηλκσ ήκυελ ςήναφαιδΑ
NAME OF THE MEDICINAL PRODUCT 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
30 mg:
Each hard capsule contains 15 or 30 mg lansoprazole.
ηψυλάκιπε ήτυλαιδορετνε εµ αιδίριαφσ ιεχέιρεπ υοπ ςηνίταλεζ αλυοψάκ ήρηλκσ ηνιρτίκ ςήναφαιδΑ.
[To be completed nationally]
ήρηλκσ
PHARMACEUTICAL FORM
15 mg,
Gastro-resistant capsule, hard
αλυοψάκ ήκιτκεθναορτσαγ
15 mg:
ηλόζαρποσναλ
Opaque, yellow hard gelatine capsule, containing pellets with enteric coating.
30 mg
30 mg:
ιεχέιρεπ αλυοψάκ ήρηλκσ εθάΚ
Opaque, white hard gelatine capsule, containing pellets with enteric coating.
ΗΣΕΘΝΥΣ ΗΚΙΤΟΣΟΠ ΙΑΚ ΗΚΙΤΟΙΟΠ
[To be completed nationally]
ήρηλκσ
CLINICAL PARTICULARS
30 mg,
4.1 Therapeutic Indications
αλυοψάκ ήκιτκεθναορτσαγ
• Treatment of duodenal and gastric ulcer confirmed by endoscopy or radiography. • Treatment of reflux oesophagitis. • Long-term prophylaxis of reflux oesophagitis. • Eradication of Helicobacter pylori concurrently given with appropriate antibiotic therapy and prevention of relapse of peptic ulcers in patients with H. pylori associated ulcers.. • Zollinger-Ellison syndrome.
I),
4.2.
αµητράραπ επέλβ ςείσαµονο ςέκιτεχσ ιακ (
In patients not fully healed within this time, the medication should be continued at the same dose for another two weeks.
Lansoprazole
Treatment of gastric ulcer:
ήρηλκσ
Treatment of reflux oesophagitis:
15 mg,
Prophylaxis of reflux oesophagitis:
αλυοψάκ ήκιτκεθναορτσαγ
15 mg once daily.
30 mg.
The dose may be increased up to 30 mg daily as necessary.
ιενίαβρεπυ αν ιεπέρπ νεδ ησόδ
7 Eradication of Helicobacter pylori:
ςωέ ςώρφαλε εµ ςίενεθσα εσ ςηλόζαρποσναλ ςητ ησηγήροχ ητσ ιατεδίδ αν ιεπέρπ ήχοσορΠ ςίενεθσα ςυοτ ςύοτυα εσ νωτ ησόδ αισήρεµη ήκιγολοισυφ ητ όπα ηρετόληψυ ιατίεγηροχ αν ιεπέρπ νεδ 30 mg
30 mg lansoprazole 2 times daily for one week in combination with one of the following three combinations: a) amoxicillin 1 g twice daily + clarithromycin 500 mg twice daily, b) clarithromycin 250 mg twice daily + metronidazole 400-500 mg twice daily, c) amoxicillin 1 g twice daily + metronidazole 400-500 mg twice daily.
. οτητίαραπα ιανίε αµητσάιδ όκινορχ οσό αιγ ιατεζίχενυσ αν ιεπέρπ αίεπαρεθ η ιακ ανέµυεκιµοταξε
Consideration should be given to official local guidance (e. g. national recommendations) regarding bacterial resistance and the appropriate use and prescription of antibacterial agents.
ιανίε ησόδ ήκιχρα ηνεµώτσινυσ
Zollinger-Ellison syndrome:
Η 60 mg
The recommended initial dose is 60 mg once daily.
ηλόζαδινορτεµ ςωίσηρεµη ςέροφ ούδ
The dose should be individually adjusted and the treatment should be continued for as long as necessary.
, ςωίσηρεµη ςέροφ ούδ
Daily doses of up to 180 mg have been used.
ςωίσηρεµη ςέροφ ούδ,
If the required daily dose exceeds 120 mg, it should be given in two divided doses.
ηνίλλικυξοµα α
Impaired hepatic or renal function:
ηλόζαρποσναλ
There is no need to change the dose in patients with impaired renal function.
30 mg
The normal daily dose of 30 mg should not be exceeded in these patients, however.
ιρχέµ ίεθηξυα αν ίεροπµ ησόδ Η ςωίσηρεµη άροφ αίµ
Care should be exercised in the administration of lansoprazole in patients with mildly to moderately impaired hepatic function.
30 mg
In mildly impaired patients, the dose should not exceed 30 mg.
ησηµόρδνιλαπ ήκιγαφοσιο ορτσαγ όπα ςαδιτίγαφοσιο ςητ ηξαλύφορΠ
In patients with moderately impaired hepatic function, the dose should be restricted to 15 mg daily.
:
Children:
ςεδάµοδβε ηµόκα αιγ ησόδ αιδί
Lansoprazole is not recommended in children as safety and efficacy have not been established in this population.
.
Elderly:
νητσ ίετσιχενυσ αν ίεροπµ αίεπαρεθ η υοδόιρεπ ςητ ςήτυα ςότνε ςωρήλπ ιατνούεπαρεθ εδ ιοίοπο ιο, ςίενεθσα εΣ ςεδάµοδβε αιγ ςωίσηρεµη άροφ αίµ
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.
ηνεµώτσινυσ Η 30 mg
However, the daily dose in the elderly should not exceed 30 mg.
ακαµράφ αλλά εσ ςηλόζαρποσναλ ςητ ςιεσάρ∆
The capsules are swallowed whole with liquid.
ςηλόζαρποσναλ
The capsules may be emptied, but the contents may not be chewed or ground.
ςητ ςοταµσάλπ ςιεσώρτνεκγυσ ςιτ ςώναφµε νυοσήξυα αν ότανυδ ιανίε πλ κ ςεδίλορκαµ νωεσάετωρπ
Concomitantly taken food slows down and reduces the absorption of lansoprazole.
ςίελοτσανα ηλόζανοκαρτι η ηλόζανοκοτεκ η ςωπό Α
This medicine has the best effect when taken into empty stomach.
..
4.3.
οτ νυολλέτσανα υοπ ακαµράφ αΤ CYP3 4
Hypersensitivity to lansoprazole or any of the excipients of the product.
CYP3 4Α
4.4.
οτ νυολλέτσανα υοπ ακαµράΦ
Special Warning and Precautions for Use
οισάλπαρτετ οτ ςωέ ςηλόζαρποσναλ ςητ ςοταµσάλπ.
The diagnosis of gastroduodenal ulcers and reflux oesophagitis should be confirmed by endoscopy or other appropriate diagnostic means.
υοτ ςαέλοτσανα ςανέ ηνίµαξοβυολφ Η ςηλόζαρποσναλ ςητ CYP2C19,,
Reflux oesophagitis may not present as ulceration and/ or visual damage, therefore in certain cases endoscopy alone may not be sufficient.
ςοταµσάλπ ησωρτνέκγυσ ητ νυοσήξυα αν ότανυδ ιανίε
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.
οτ νυολλέτσανα υοπ ακαµράφ αΤ CYP2C19
Lansoprazole should be used with caution in patients with severe hepatic dysfunction.
οτ νυολλέτσανα υοπ ακαµράΦ
(See Section 4.2 “ Posology and method of administration“)
. ηλόζαρποσναλ ητσ νωκάµραφ νωλλά ςιεσάρδ ιΟ. ςοταµήτσυσ ύοκιµυζνε υοιδί υοτ ωσέµ ιατνοζίλοβατεµ υοπ ακαµράφ εµ ςιεσάρδιπεληλλα νύοτσιναφµε
Lansoprazole has a similar mechanism of action to omeprazole and both increase gastric pH, the following statement is made by analogy to omeprazole.
αν νόναθιπ ιανίε
Decreased gastric acidity due to lansoprazole
αµωρχότυκ οτ εµ ιατεζίτεχσ υοπ νωκάµραφ
8 increases gastric counts of bacteria normally present in the gastrointestinal tract.
P450 (CYP2C19 ύοµσιλοβατεµ ςοταµήτσυσ ύοκιµυζνε ςόνε ωσέµ ιατεζίλοβατεµ ηλόζαρποσναλ η ιτό υονέµοδε∆
Treatment with lansoprazole may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter.
αµωρχότυκ οτ εµ ιατνοζίτεχσ υοπ ακαµράΦ
Patients suffering from gastro-duodenal ulcers, the possibility of H. pylori infection as an etiological factor should be considered.
ςησαρδίπεληλλα ςέφροµ ςελλά ιακ ατνόϊορπ άκιτυεκαµραφ αλλά εµ ςιεσάρδιπεληλλΑ ότυα νυονάβµαλ αν ιεπέρπ νεδ ςηζάτλαµοσι ςηζάρκυοσ ςαιεκράπενα ή ςηζότκαλαγ –
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.
λβ ςίενεθσα ςυοτ ςύοτυα εσ υονύδνικ υοτ ιτνανέ ςολεφό οτ ςώρεµοτπελ ιατίεγολοιξα αν ιεπέρπ (.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
pH,
4.5.
οτ νυονάξυα ούδ ιο ιακ ηλόζαρπεµο νητ εµ ςησάρδ όµσιναχηµ οιοµόραπ ιεχέ ηλόζαρποσναλ Η, ςησηγήροχ ςοπόρτ ιακ αίγολοσο∆
Drugs associated with cytochrome P450 As lansoprazole is metabolised via a drug metabolising enzyme system associated with cytochrome P450 (CYP2C19 and CYP3A4), interactions with drugs metabolised via the same enzyme system are possible.
ςοφαργάραπ επέλβ
The effects of other drugs on lansoprazole
4. 2 “
Fluvoxamine, an inhibitor of CYP2C19, increased the plasma concentrations of lansoprazole up to 4-fold.
αίγρυοτιελσυδ ήκιταπη άιραβ εµ ςίενεθσα εσ ήχοσορπ εµ ιατίειοποµισηρχ αν ιεπέρπ ηλόζαρποσναλ Η.
Drugs which inhibits CYP3A4 Drugs which inhibit CYP3A4 such as ketokonazole, itraconazole, protease inhibitors, macrolides etc may markedly increase the plasma concentrations of lansoprazole.
ησωνγάιδ ητ ιεσήρετσυθακ
Effects of lansoprazole on other drugs
αν ιακ αταµώτπµυσ ατ ιεψύλακ αν ίεροπµ ηλόζαρποσναλ η ιτόιδ ηλόζαρποσναλ εµ ςαίεπαρεθ ςητ ηξρανέ νητ όπα νιρπ υοχάµοτσ υοτ υοκγό ςυοθήοκακ υοτ ατητόναθιπ ίετσιελκοπα αν ιεπέρΠ
Ketoconazole and itraconazole The absorption of ketoconazole and itraconazole from the gastrointestinal tract is enhanced by the presence of gastric acid.
ςήκραπε ιανίε νηµ αν ίεροπµ ονόµ ιακ ησηπόκσοδνε η ςιεσώτπιρεπ ςενέµσιρο εσ ςωνέµοπε.
Administration of lansoprazole may result in subtherapeutic concentrations of ketoconazol and itraconazol and the combination should be avoided.
ήταρο ιακ ή ςοκλέ ςω ιατεζίναφµε νηµ αν ίεροπµ ησηµόρδνιλαπ ήκιγαφοσιο ορτσαγ όπα αδιτίγαφοσιο
The effect may also be present if lansoprazole is combined with other drugs with pH dependent absorption.
Η ασέµ άκιτσωνγαιδ αληλλάτακ αλλά εµ ή άκιποκσοδνε ιατενώιαβεβιπε αν ιεπέρπ αθ ησηµόρδνιλαπ. ήκιγαφοσιο ορτσαγ όπα ςαδιτίγαφοσιο ςητ ιακ νώκλε νώκιλυτκαδακεδωδορτσαγ νωτ ησωνγάιδ Η
In patients receiving digoxin, the plasma levels should therefore be monitored and the dose of digoxin adjusted if necessary.
10 νυοχέ αίοπο ατ ακαµράφ εµ ηλόζαρποσναλ η ιατεζάυδνυσ νατό ήχοσορπ ιατεδίδ αν ιεπέρπ αΘ
Drugs metabolised by CYP3A4 Lansoprazole may give rise to increased plasma concentrations of drugs metabolised by CYP3A4.
ηνίξογιδ η ιανίε ςωπό
Caution is advised when combining lansoprazole with drugs which are metabolised by this enzyme.
P- gp ςητ νωτάµωρτσοπυ νωτ ςοταµσάλπ ςιεσώρτνεκγυσ ςενέµηξυα ςατνώλακορπ ηνΐετωρπ νητ νήτυα
Tacrolimus Coadministration of lansoprazole increases the plasma concentrations of tacrolimus (a CYP3A and P-gp substrate).
εµ άροφατεµ ητ ιεζάερηπε αν ότανυδ ιανίε ηλόζαρποσναλ η ιτό ίετσιελκοπα αν ίεροπµ νε∆
Monitoring of tacrolimus plasma concentrations is advised when concomitant treatment with lanzoprazole is initiated or ended.
ηνϊετωρποκυλγ ςάροφατεµ ηνΐετωρπ νητ ιελλέτσανα αν
9 Carbamazepine Caution is adviced during cotreatment with carbamazepin (a CYP3A substrate) and lansoprazole.
ίεθηρηταραπ ιεχέ ηλόζαρποσναλ Η in vitro
The drug combination may result in increased carbamazepin concentrations as well as reduced lansoprazole concentrations.
αρώ αιµ νοτσιχάλυοτ ιατενάβµαλ αν
Phenytoin Studies have shown that the dosage of phenytoin (CYP2C19 and CYP2C9 substrate) may have to be reduced when administered concomitantly with lansoprazole.
ιεπέρπ ςηλόζαρποσναλ ησόδ η ετόπΟ
Warfarin Caution and increased monitoring frequency is advised when initiating or ending lansoprazole co- treatment in patients treated with warfarin.
ησωίεµ αιµ ίελακορπ ηλόζαρπαλ Η 14%
Theophyllin Lansoprazol gives a 14% reduction in the plasma concentrations of theophyllin.
ηνίλλυφοεΘ
Individual patients may receive a clinically relevant decrease.
ηλόζαρποσναλ
Caution is advised when combining the two drugs.
εµ ςαίεπαρεθ ςητ ησωρήλκολο ιακ ηξρανέ νοτ άτακ ςηνϊοτυνιαφ ςοταµσάλπ νωεσώρτνεκγυσ νωτ ςοχγελέ ιακ ήχοσορπ ιατνύοτιαπΑ ηλόζαρποσναλ εµ ανορχότυατ ιατίεγηροχ νατό ίεθωιεµ αν ιεπέρπ.
Clinically significant interactions of lansoprazole with nonsteroidal anti-inflammatory drugs or diazepam have not been demonstrated, though formal interaction studies with lansoprazole and NSAIDs have not been conducted.
υοτ αµωρτσόπυ ςηνϊοτυνιαφ ςητ ησόδ η ιτό ιεξίεδ νυοχέ ςετέλεΜ CYP2C19 (
Antacids and sucralfate may decrease the bioavailabilty of lansoprazole.
ηνϊοτυνιαΦ
The lansoprazole dose should therefore be taken at least an hour prior or after.
ςηλόζαρποσναλ ςιεσώρτνεκγυσ ςενέµωιεµ εσ ιακ ςησίπε ςώθακ ςηνίπεζαµαβρακ ςιεσώρτνεκγυσ.
Lansoprazole has been observed to inhibit the transport protein, P-glycoprotein (Pgp) in vitro.
ςενέµηξυα εσ ιεσήγηδο αν ίεροπµ νωκάµραφ ςόµσαυδνυσ Ο ηλόζαρποσναλ ιακ Α
It may not be excluded that lanzoprazole may affect transport via this protein giving rise to increased plasma concentrations of P-gp substrates such as digoxin.
αµωρτσόπυ ανέ ηνίπεζαµαβρακ εµ ςαίεπαρεθ ςηνορχότυατ ςητ αιεκράιδ ητ άτακ ήχοσορπ ιατίετιαπΑ (ηνίπεζαµαβραΚ ηλόζαρποσναλ εµ αίεπαρεθ ηνορχότυατ η ιατενώρηλκολο ή ιεζίχρα νατό ςυοµίλορκατ υοτ ςοταµσάλπ.
Caution should be exercised when combining lansoprazole with drugs which have a narrow therapeutic index, as the effect of lansoprazole on the metabolism of other drugs has not been extensively investigated.
νωεσώρτνεκγυσ νωτ ςοχγελέ ο ιατίετιαπΑ
The influence of this combined administration has not yet been investigated systemically.
όπα ωνάπ ιακ ςωέ ςυοµίλορκατ υοτ ήνοµαραπ 81%.
For reasons of theoretical considerations, enhanced interactions with other medicinal products must be expected as a precaution.
ησέµ ητ ιενάξυα ςηλόζαρποσναλ ςητ ήνοµαραπ Η Ρ υοτ ιακ Α
Monitoring of the serum levels of other medicinal products taken during the 1-week eradication therapy is therefore recommended.
εµ ηλόζαρποσναλ η ιατεζάυδνυσ νατό ήχοσορπ ιατίετιαπΑ Α
This concerns particularly such medicinal products also metabolized via the cytochrome P450 system.
νωκάµραφ ςοταµσάλπ ςιεσώρτνεκγυσ ςενέµηξυα ιεσέλακορπ αν ότανυδ
The following interactions between lansoprazole and one/ two antibiotics used in eradication therapy have been found so far:
ιανίε ηλόζαρποσναλ Η
Co-administered medicinal products
υοτ ωσέµ ιατνοζίλοβατεµ υοπ ακαµράΦ CYP3 4
Dosage and duration of combined administration
,,
Effect*
.
lansoprazole + clarithromycin
ηλόζανοκαρτι ιακ ηλόζανοκοτε
30 mg + 500 mg 3 times/ day for 5 days
ςηνύσοµυκγε ςητ αιεκράιδ ητ άτακ ιατάτσινυσ εδ ςηλόζαρποσναλ ςητ ησήρχ η ςωνέµοπΕ
Increased plasma levels of a clarithromycin metabolite by 16%; increased bioaivalability of lansoprazole by 19% up to 32%
ηξυτπάνα ήκιτηννεγατεµ ητ ή ότεκοτ νοτ ηξυτπάνα ήκϊυρβµε νητ ηνύσοµυκγε νητ άροφα νοσό
lansoprazole + amoxicillin lansoprazole + metronidazole
αταµύεγ ατ όπα νιρπ ιατενάβµαλ
30 mg + 1000 mg 3 times/ day for 5 days Not yet investigated
αίχυολαγ ιακ ησηύ
Decelerates uptake of amoxicillin
ηνέµσιροιρεπ εµ αµοτά εΣ ήνεθσα υοτ
lansoprazole + clarithromycin +
υοτ οπυτόνογ οτ όπα ιατνώτραξε αν όναθιπ CYP2C19
30 mg + 500 mg + 1000 mg twice daily for 5 days
30%.
Increase bioaivalability and half-life of lansoprazole by 30% each; increased plasma
ηνίλλικυξοµα
10 amoxicillin
30 mg
levels of a clarithromycin metabolite by 30%
Not yet investigated ςερέµη αιγ ςωίσηρεµη 5
*The effects of clarithromycin on the pharmacokinetics of lansoprazole are likely to be dependent on the patient’ s CYP2C19 genotype.
+ ηλόζαρποσναλ ηνίλλικυξοµα
A poor metaboliser would have more marked effects than an extensive metaboliser.
ςηνίλλικυξοµα ςητ ηψηλσόρπ νητ ιενύδαρβιπΕ ιρχέµ
The intake of food reduces the bioavailability of lansoprazole: it is recommended to take lansoprazole before the meal.
16%,
4.6.
ηνίκυµορθιραλκ
Pregnancy and Lactation
ςόνε ςοταµσάλπ αδεπίπε ανέµηξυΑ
For lansoprazole no clinical data on exposed pregnancies are available.
+ ηλόζαρποσναλ ατνόϊορπ
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development.
ςηνέµσαυδνυσ ςητ
Therefore, the use of lansoprazole during pregnancy is not recommended.
αιεκράιδ ιακ αίγολοσο∆
It is not known whether lansoprazole is excreted in human breast milk.
ςησωζίρκε αίεπαρεθ ητσ ιατνύοιοποµισηρχ υοπ α όκιτοιβιτνα ούδ
Animal studies have shown excretion of lansoprazole in milk.
νωλλά νώρο νωδέπιπε νωτ ςοχγελέ ο ιατάτσινυσ ότυα ογόλ οτ αιΓ ςηξαλύφορπ ςυογόλ αιγ ηψόπυ
A decision on whether to continue/ discontinue breast-feeding or to continue/ discontinue therapy with lansoprazole should be made taking into account the benefit of breast- feeding to the child and the benefit of lansoprazole therapy to the woman.
12
4.6.
ιακ ςηλόρετσηλοχ
Effects on Ability to Drive and Use Machines
αδεπίπε ανέµηξυΑ
Adverse drug reactions such as dizziness and fatigue may occur (see section 4.8 undesirable effects).
ησαπσύσ ήκιχγορβ,
Under these conditions the ability to react may be decreased.
, κοσ όκιτκαλυφανΑ
This should be taken into account when driving or using machines.
ησωρδίρεπυ ςότερυπ
(see section 4.8 Undesirable effects).
,,
4.8.
ησωπόΚ
Undesirable Effects
άκινεΓ
Common (> 1%)
αιορρότκαλαγ
Uncommon (0.1-1%)
αίτσαµοκιανυΓ
Rare (0.01-0.1%)
ςησαρό
Very Rare (< 0.01%)
ιγολονιρκοδνΕ
Gastrointestinal
ςητ ςέχαραταιδ ιακ
nausea, diarrhoea, stomach ache, constipation, vomiting, flatulence and dyspepsia.
ςησύεγ ςητ ςέχαραται∆
dry mouth or throat, glossitis, candidiasis of oesophagus, pancreatitis
ύοκιτεδνυσ ιακ
colitis, stomatitis and black tongue.
ςογλά
Skin and hair
ύοκιτελεκσουµ
eczema, urticaria and itching.
όκιρθρα ιακ όκϊυΜ ςογλά όκικαρωθ.
petechia, purpura, hair loss, erythema multiforme, stevens- Johnson syndrome and toxic epidermal necrolysis.
ςέχαραται∆
Nervous system
ιακ νώµλαπ αµηθσία αµηδίο όκιρεφιρεπ
headache, dizziness
αίµιαραττυκοικκοκα, ιακ αίνεποραττυκναπ
restlessness, insomnia, drowsiness, depression, hallucination, confusion, vertigo and paresthesia, somnolence, tremor.
αίλιφονιζωη
Liver and kidneys
αίµιαραττυκοικκοκα
Increase in liver enzyme levels.
αίνεποραττυκοβµορθ,
hepatitis, icterus and interstitial nephritis.
αµίΑ
11 Blood
ιακ ςορετκί αδιτίταπη ςοµόρτ αίληνπυ αίσηθσιαραπ
thrombocytopenia, eosinophilia, pancytopenia and agranulocytosis, anemia, leucopenia.
νωτ ησηξύΑ
agranulocytosis
ιακ ραπΉ
Cardiovascular
, ηψιλθάτακ ςόµγατσυν
peripheral edema, palpitation and chest pain.
αίνπϋα αίχυσηνα ησυλόρκεν
Musculoskeletal and connective tissue disorders
ςολαφέκονοπ,
muscle and joint pain
όκιρυε
Senses
ιακ οµορδνύσ αµηθύρε
zaste disturbances and visual disturbances.
Stevens - Johnson,
Endocrine disorders
ςόµσηνκ ιακ
gynecomastia, galactorrhoea.
άιλλαµ
General
,.
fatigue.
ιακ αµρέ∆
fever, hyperhidrosis, bronchial constriction, impotence and angioedema.
ιακ ςόµσιρωετεµ
anaphylactic shock, general malaise
ασσώλγ ανιαλέµ
Investigations
υογάφοσιο
Increase in cholesterol and triglyceride levels.
,
4.9.
ςοτεµέ
Overdose
ατητόιλιοκσυδ,
The effects of overdose of lansoprazole in humans are not known (although the acute toxicity is likely to be low) and, consequently, instructions for treatment cannot be given.
ιακ αδιτίταµοτσ
However, daily doses of up to 180 mg of lansoprazole have been administered in trials without significant undesirable effects.
αδιτίλοκ
Please refer to section 4.8.
ςογλά όκιχαµοτσ,
Undesirable effects for possible symptoms of lansoprazole overdose.
ατητόρηξ αίµοτσορηΞ
Lansoprazole is not significantly eliminated by haemodialysis.
αιορράιδ αίτυαν,
If necessary, gastric emptying, charcoal and symptomatic therapy is recommended.
, (> 1%)
5.
όκιρετνερτσαΓ
PHARMACOLOGICAL PROPERTIES
(0. 1- 1%)
5.1.
ςενέµσιθηνυσ
Pharmacodynamic Properties
ςεινάπσ ύλοΠ
Pharmacotherapeutic group:
ςενέµσιθηνυΣ
Proton pump inhibitors, ATC code:
ύλοΠ
A02BC03.
ςειεγρένε ςετηµύθιπενΑ
Lansoprazole is a gastric proton pump inhibitor.
επέλβ νώναχηµ όµσιριεχ οτ ή ησηγήδο νητ άτακ ηψόπυ ιατενάβµαλ αν ιεπέρπ ότυΑ ςησαρδίτνα
It inhibits the final stage of gastric acid formation by inhibiting the activity of H+/ K+ ATPase of the parietal cells in the stomach.
ατητότανυδ η ίεθωιεµ αν ότανυδ ιανίε ςεκήθνυσ ςιτ ςέτυα όπΥ ςειεγρένε ςετηµύθιπενΑ
The inhibition is dose- dependent and reversible, and the effect applies to both basal and stimulated secretion of gastric acid.
οφαργάραπ επέλβ ησωπόκ ιακ ςογγιλί ςωπό υοκάµραφ υοτ ςειεγρένεραπ νύοτσιναφµε αν ότανυδ ιανίΕ (13: ήλοβοπα ιακ ςόµσιλοβατεΜ ςενΐετωρπ εσ ιατνούεµσεδ αίοπο ατ ακαµράφ.
Lansoprazole is concentrated in the parietal cells and becomes active in their acidic environment, whereupon it reacts with the sulphydryl group of H+/ K+ATPase causing inhibition of the enzyme activity.
υοπίρεπ ιανίε ςοταµσάλπ
Effect on gastric acid secretion:
υοτ ςενΐετωρπ ςιτσ ςηλόζαρποσναλ ςητ ησεδνύσ Η ςηλόζαρποσναλ ςητ ατητόµισεθαιδοιβ ητ νυοσώιεµ.
Lansoprazole is a specific inhibitor of the parietal cell proton pump.
αν ότανυδ ιανίε ητάφλαρκυοσ η ιακ ανιξόιτνα αΤ
A single oral dose of lansoprazole 30 mg inhibits pentagastrin-stimulated gastric acid secretion by about 80%.
80- 90%.
After repeated daily administration for seven days, about 90% inhibition of gastric acid secretion is achieved.
4
It has a corresponding effect on the basal secretion of gastric acid.
ιακ ςοκλέ όκιρτσαγ εµ ςίενεθσα νωδάµοδβε ςότνε νυονώρρανα ςοκλέ όκιλυτκαδακεδωδ
A single oral dose of 30 mg reduces basal secretion by about 70%, and the patients' symptoms are consequently relieved starting from the very first dose.
υοπίρεπ ιανίε ησωίεµ η ςησηγήροχ ςηνεµόναβµαλαναπε ςερέµη ώτκο 85%.
A rapid relief of symptoms
όπα άτεΜ ησόδ ητώρπ νητ όπα ςατνώνικεξ νώνεθσα νωτ αταµώτπµυσ ατ ιατνοζίφυοκανα ςώπενυσ.
12 is obtained by 30 mg daily, and most patients with duodenal ulcer recover within 2 weeks, patients with gastric ulcer and reflux oesophagitis within 4 weeks.
70%,
5.2.
υοπίρεπ άτακ ησιρκκέ ήκισαβ ητ ιενώιεµ ςοταµότσ υοτ όπα
Lansoprazole is rapidly inactivated by gastric acid and lansoprazole is consequently administered as enteric coated granules in gelatin capsules.