natgillin/translations-raw huggingface dataset:
22 τς πδί σς εάτ μ κά ρσ τς η ει ν η μτ η αρ χήη η pramipexole κι κ τληηατ εώ ιη υώ τν
The frequency of augmentation after longer use of pramipexole and the appropriate management of these events have not been evaluated in controlled clinical trials.
Ησμτ ί μίσ τ νφ ι κθρ η η pramipexole πρ ο κτ 34%, εδχμν ς ι ιειν ε ε η ερκ άασ τς
20 Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules.
ε η pramipexole μ αοέεμ τ μιμν αέκιη ο εό ήκιω δο αμ κυι ν ε πτλσ α η ε έη πκρσ τυ νς α τ ν ύ φ ρ αετ ώ ποότ νΜε σ τς όη τς ρϊ ω.
Therefore, medicinal products that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine and amantadine, may interact with pramipexole resulting in reduced clearance of either or both medicinal products.
ν πηο οονα όιε πέεν οηον ύε ασμ εέον ε λε δατρόηε όο η α λρφ ρύτιτδν ρπια δγύ οτν υμτχυ σ άλς ρσηι τς πυτ, 23 μιμν εργρηθ μ οοσ ν θσικί υ ή λα τμ σ κ δν σβ ρύ ε έη γήοσ α πρύε α έεεε ος άλ άο α ε ί υο οαο
Patients being treated with Oprymea and presenting with somnolence and/ or sudden sleep episodes must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e. g. operating machines) until such recurrent episodes and somnolence have resolved (see also sections 4.4, 4.5, and 4.8).
Ηεφ ν η πηίς ί ι υη έησ δσιυ ηόεεα ό mg/ η έα( βέε α άρφ μ άι υνλ ε ααξμν ε όε ψ λτρς π 1. 5
The most commonly (≥ reported adverse reactions in patients with Parkinson’ s disease more 5%) frequent with pramipexole treatment than with placebo were nausea, dyskinesia, hypotension,
έαξ τς γ γςμ οεν εφ ν τίπτσ, ια εα ν pramipexole τ λπιτι ού νρη η αω ή, πρία μ αι ευόα η δ ί ρ α η γήοα ργρ.
21 dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
πυ νφρηα σ α θνί ε
More frequent adverse drug reaction in combination with levodopa was dyskinesia.
Δ ν πρεκικ επιασ μ ζ ή προοοί.
22 There is no clinical experience with massive overdose.
δ γρ η τυΚ Σ εδίντιν νυοη τ ό ά μκ.
There is no established antidote for overdose of a dopamine agonist.
25 Α ό υος είο 900 α θνίπυβίκνασ π ποω η έα τδα λβν υχόω π ατύ πρ υ
Out of these, approximately 900 were in more advanced stages, received concomitant levodopa therapy, and suffered from motor complications.
πκρν
The total
ε απρπυ ί ι εί 500 ml/ λπό αη ν ο ετ κι
23 clearance of pramipexole is approximately 500 ml/ min and the renal clearance is approximately 400 ml/ min.
ρνς μ ω ς πβλς ζ
5.3 Preclinical safety data
τπυ ιχοσς χτ έ δ τξι όοςσύυ ε σει ς ι άε.
24 Any unused product or waste material should be disposed of in accordance with local requirements.
20 Δσ ί EU/ 1/ 08/ 469/ 011 ικα:
20 tablets:
30 Δσ ί EU/ 1/ 08/ 469/ 012 ικα:
EU/ 1/ 08/ 469/ 011 30 tablets:
60 Δσ ί EU/ 1/ 08/ 469/ 013 ικα:
EU/ 1/ 08/ 469/ 012 60 tablets:
90 Δσ ί EU/ 1/ 08/ 469/ 014 ικα:
EU/ 1/ 08/ 469/ 013 90 tablets:
100 Δσί:
EU/ 1/ 08/ 469/ 014 100 tablets:
EU/ 1/ 08/ 469/ 015 ικα
EU/ 1/ 08/ 469/ 015
12/ 9/ 2008 27 10.
12/ 9/ 2008
Oprymea 0. 7 mg δ κα ιί σ
Oprymea 0.7 mg tablets
Κ θ δ κ πρ χι mg pramipexole βσω (ω 1 mg pramipexole άαο [δ δολ ρ ή άε ι ί ει ε0. 7
Each tablet contains 0.7 mg pramipexole base (as 1 mg pramipexole dihydrochloride monohydrate).
0. 70 mg: λυάσργυάμ αο τογλμνς κε, χργέακι τ δο λυέ κι εκ, τογλ ε πσργυεέεά ρς ααμν α σι ύ περς α ς ετπ μν τ “ κ ιτ δο ιά η μα περς ο δσί.
0.70 mg: white, round, with bevelled edges, both sides scored, with imprint "P9" on both halves of one side of the tablet.
Τ δ κ μ οεν νυω έο ο P9 ” ασα υ μσ τς ις λυά τυ ικ υ ο ι ί πρία δ οο ηε ι τμθί
The tablet can be divided into equal halves.
υ ηόεεα ό mg/ ηεη ίς λπ π ργα ο4. 8). ψ λτρς π 1. 5
26 However, it should be noted that the incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.8).
Ό α σ ναορφί ιοOprymea σ αθν μ νσ τυParkinson κ ιε ερ ήαεά κι τν υτγγα εα τ
27 When prescribing Oprymea in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
31 τς πδί σς εάτ μ κά ρσ τς η ει ν η μτ η αρ χήη η pramipexole κι κ τληηατ εώ ιη υώ τν
The frequency of augmentation after longer use of pramipexole and the appropriate management of these events have not been evaluated in controlled clinical trials.
α εκί νααό υή τν δ, όω η ιειν κιμ ναί, εδχτια λη ει ά ον πκρν τι π α τν η οό π ς σμτ ί α αατδν νέεαν αλλπ ρσυ μ τν
28 that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine and amantadine, may interact with pramipex ole resulting in reduced clearance of either or both medicinal products.
ν πηο οονα όιε πέεν οηον ύε ασμ εέον ε λε δατρόηε όο η α λρφ ρύτιτδν ρπια δγύ οτν υμτχυ σ άλς ρσηι τς πυτ, 32 μιμν εργρηθ μ οοσ ν θσικί υ ή λα τμ σ κ δν σβ ρύ ε έη γήοσ α πρύε α έεεε ος άλ άο α ε ί υο οαο
Patients being treated with Oprymea and presenting with somnolence and/ or sudden sleep episodes must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e. g. operating machines) until such recurrent episodes and somnolence have resolved (see also sections 4.4, 4.5, and 4.8).
πυ νφρηα σ α θνί ε
29 reaction in combination with levodopa was dyskinesia.
δ γρ η τυΚ Σ εδίντιν νυοη τ ό ά μκ.
There is no established antidote for overdose 30 of a dopamine agonist.
34 Α ό υος είο 900 α θνίπυβίκνασ π ποω η έα τδα λβν υχόω π ατύ πρ υ
Out of these, approximately 900 were in more advanced stages, received concomitant levodopa therapy, and suffered from motor complications.
ρνς μ ω ς πβλς ζ
31 5.3 Preclinical safety data
κ α
32 7.
Κ Τ Χ Τ Α Ε Α Κ ΚΛ ΦΟΡΑ Α Ο ΟΣ ΗΣ Δ Ι Σ Υ Ο ΙΣ
MARKETING AUTHORISATION HOLDER
20 Δσ ί EU/ 1/ 08/ 469/ 016 ικα:
20 tablets:
30 Δσ ί EU/ 1/ 08/ 469/ 017 ικα:
EU/ 1/ 08/ 469/ 016 30 tablets:
60 Δσ ί EU/ 1/ 08/ 469/ 018 ικα:
EU/ 1/ 08/ 469/ 017 60 tablets:
90 Δσ ί EU/ 1/ 08/ 469/ 019 ικα:
EU/ 1/ 08/ 469/ 018 90 tablets:
100 Δσί:
EU/ 1/ 08/ 469/ 019 100 tablets:
EU/ 1/ 08/ 469/ 020 ικα
EU/ 1/ 08/ 469/ 020
12/ 9/ 2008 36 10.
12/ 9/ 2008
Oprymea 1. 1 mg δ κα ιί σ
Oprymea 1.1 mg tablets
Κ θ δ κ πρ χι mg pramipexole βσω (ω 1. 5 mg pramipexole άαο [δ δολ ρ ή άε ι ί ει ε1. 1
Each tablet contains 1.1 mg pramipexole base (as 1.5 mg pramipexole dihydrochloride monohydrate).
1. 1 mg: λυά σργυάμ αοτογλμνς κε, χργέα ασιδοπερςΤ δσί εκ, τογλ ε πσργυεέε άρς α αμν κ ιτ ύ λυέ. ο ικ μ οεν δ οο ηε πρία ι τμθί
The tablet can be divided into equal halves.
υ ηόεεα ό mg/ ηεη ίς λπ π ργα ο4. 8). ψ λτρς π 1. 5
34 However, it should be noted that the incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.8).
Ό α σ ναορφί ιοOprymea σ αθν μ νσ τυParkinson κ ιε ερ ήαεά κι τν υτγγα εα τ
35 When prescribing Oprymea in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
40 τς πδί σς εάτ μ κά ρσ τς η ει ν η μτ η αρ χήη η pramipexole κι κ τληηατ εώ ιη υώ τν
The frequency of augmentation after longer use of pramipexole and the appropriate management of these events have not been evaluated in controlled clinical trials.
ε η pramipexole μ αοέεμ τ μιμν αέκιη ο εό ήκιω δο αμ κυι ν ε πτλσ α η ε έη πκρσ τυ νς α τ ν ύ φ ρ αετ ώ ποότ νΜε σ τς όη τς ρϊ ω.
36 that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine and amantadine, may interact with pramipexole resulting in reduced clearance of either or both medicinal products.
ν πηο οονα όιε πέεν οηον ύε ασμ εέον ε λε δατρόηε όο η α λρφ ρύτιτδν ρπια δγύ οτν υμτχυ σ άλς ρσηι τς πυτ, 41 μιμν εργρηθ μ οοσ ν θσικί υ ή λα τμ σ κ δν σβ ρύ ε έη γήοσ α πρύε α έεεε ος άλ άο α ε ί υο οαο
Patients being treated with Oprymea and presenting with somnolence and/ or sudden sleep episodes must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e. g. operating machines) until such recurrent episodes and somnolence have resolved (see also sections 4.4, 4.5, and 4.8).
πυ νφρηα σ α θνί ε
37 reaction in combination with levodopa was dyskinesia.
δ γρ η τυΚ Σ εδίντιν νυοη τ ό ά μκ.
There is no established antidote for overdose 38 of a dopamine agonist.
43 Α ό υος είο 900 α θνίπυβίκνασ π ποω η έα τδα λβν υχόω π ατύ πρ υ
Out of these, approximately 900 were in more advanced stages, received concomitant levodopa therapy, and suffered from motor complications.
ρνς μ ω ς πβλς ζ
39 5.3 Preclinical safety data
άθω οΗίιημλτ έε ε τηpramipexole σει τν ε κ ύιη ο α φβη τοιος νρ π. δα εέη δι όι
The same study also showed that, at doses of 2 mg/ kg (of salt) and higher, pramipexole was associated with retinal degeneration in albino rats.
Τ τλυαο υό ε όε ω 2
The latter finding was not observed in pigmented rats, nor in a 2-year albino mouse carcinogenicity study or in any other species investigated.
ς
6.
λτς α μγλτ ς ε λ ι ρ
PHARMACEUTICAL PARTICULARS
π υς ο εετία τ μ
6.1 List of excipients
σ αφκύ (albino) είυς σ κ νν άλ ζ ι ε ο πυ εεήηε ε λιος
Mannitol Maize starch Pregelatinised maize starch Povidone K25 Colloidal anhydrous silica Magnesium stearate
π εή ε αέα λο ωκ μ
6.2 Incompatibilities
ί ς ο μλτθκ. ό δ
Not applicable.
κ α
40 7.
20 Δσ ί EU/ 1/ 08/ 469/ 021 ικα:
20 tablets:
30 Δσ ί EU/ 1/ 08/ 469/ 022 ικα:
EU/ 1/ 08/ 469/ 021 30 tablets:
60 Δσ ί EU/ 1/ 08/ 469/ 023 ικα:
EU/ 1/ 08/ 469/ 022 60 tablets:
90 Δσ ί EU/ 1/ 08/ 469/ 024 ικα:
EU/ 1/ 08/ 469/ 023 90 tablets:
100 Δσί:
EU/ 1/ 08/ 469/ 024 100 tablets:
EU/ 1/ 08/ 469/ 025 ικα
EU/ 1/ 08/ 469/ 025
12/ 9/ 2008 45 10.
12/ 9/ 2008
46 ΠΑ ΑΡ ΗΜΑΙ
41 ANNEX II
Τ Ο Η Δ Ι Σ Ρ Γ ΗΣ Π Υ Ν Σ Γ ΑΤ ΝΑ Δ Σ Υ ΗΤ ΠΑ Τ Δ Ι Η ΠΟ Ε ΜΕ Σ ΩΝ Ρ ΙΩΝ
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
ΟΙ ΟΙ ΗΣΑ ΕΑ ΚΥ Ο ΡΑ
CONDITIONS OF THE MARKETING AUTHORISATION
Κ Τ Χ Τ Α Ε Α Π Ρ Γ Η, Υ Ε Θ Ν ΓΑΤ Α Δ Σ Υ Η Α Ο ΟΣ ΗΣ Δ Ι Σ Α Α ΩΓ Σ Π Υ Υ ΟΣ Ι ΗΝ ΠΟ Ε ΜΕ Σ Τ Π Ρ ΙΩΝ ΩΝ Α ΤΔ
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Ό ο α αδ ύυσ τυπργ γύπυ ί ιπύυο γ τν πδσ εσ τν ατ ω. νμ κι ι θνη ο α αω ο ο ε α υεθνς ι η αοέμυη ω π ρί ν
Name and address of the manufacturer responsible for batch release
Krka, d. d., Novo mesto Šmarješ cesta 6 ka 8501 Novo mesto Σ οεί λβν α
Krka, d. d., Novo mesto Š marješ cesta 6 ka 8501 Novo mesto Slovenia
Ο ΟΡ Ι Η Α Ε Α Κ Κ ΟΦΟΡΑ
CONDITIONS OF THE MARKETING AUTHORISATION
 Ο ΟΡ Ι ΟΙ Ε Ι ΙΜΟΙ Χ ΤΚΑΜΕΤ ΔΑ Ε ΗΚΑ Τ Χ Η ΗΠΟ
 CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
Φ ρ αετ ό ρϊν ι τ οο αα ε αιτι σ ναή α μ κυι πο γ ο πί π ιί ι ρκ υτγ.
Medicinal product subject to medical prescription.
ΑΠΟΤ Λ Σ Τ Κ Χ ΗΣ Τ ΦΑ ΜΑ ΟΥ Ε Ε ΜΑ Ι Η Ρ Η ΟΥ Ρ Κ
 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Δ ν φ ρόεα ε εαμζτι.
Not aplicable.
 Α Λ ΟΡ Λ ΟΙ ΟΙ
 OTHER CONDITIONS
Σ σηαφ ραοπ γύνσς ύτμ αμκεαρπηη
Pharmacovigilance system
φ ραοπγύνσςόω πρ ρφτι τν κο η αμ κεαρπη η, π ς ει ά εαση έδσ DescPhSys 000001/ 15 (13 Ο τ βί 2008) πυ αοσάεαση Ε
The MAH must ensure that the system of pharmacovigilance, as described in version DescPhSys 000001/ 15 (13 October 2008) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
ί ι ς ν
PSURs
εκτση έο α λι υγίρν α εώτ πο ν ί ι τν γρ. γαετμν κιε ορεπικιν ο ρϊ ε α ση αοά
The PSUR submission schedule for Oprymea tablets should follow PSURs submission schedule for the reference medicinal product.
ΕΠ Π Α
43 ANNEX III
48 ΠΑ Α Τ Ρ Ρ ΗΜΑΙΙ Ι
LABELLING AND PACKAGE LEAFLET
ΗΣ
44 A.
49 ΑΕ Σ.
LABELLING
Υ ΜΦΑ ΙΟΝ Α Σ ΗΝΕ Ω Ε Ι Σ Σ Υ Σ Α ΝΖ Τ Ι Τ Ξ Τ ΡΚΗ Υ ΚΕ Α Ι
45 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
ΚΟΥ Ι Ι Τ BLISTERS Τ/ Γ Α Α
BOX for blisters
Ν
1.
Oprymea 0. 088 mg δ κα ιί σ Pramipexole
Oprymea 0.088 mg tablets Pramipexole
Σ Ν Ε ΗΣ Δ Α Τ Κ Υ Θ Σ Ε Ρ Σ Ι Η( Ε) Ο Σ Α Σ Σ Υ Ι (Ε)
STATEMENT OF ACTIVE SUBSTANCE(S)
Κ θ δ κ πρ χι άε ι ί ει ε0. 088 mg pramipexole ιούα ο ε
Each tablet contains 0.088 mg pramipexole equivalent to 0.125 mg pramipexole dihydrochloride monohydrate.
Κ Τ Λ ΟΣΕ Δ ΩΝ Α Α ΟΓ Κ ΟΧ
LIST OF EXCIPIENTS
ΦΑ ΜΑ ΟΤ Χ Ι Η ΜΟΡ Κ Ι ΡΕ ΟΜΕ Ο
PHARMACEUTICAL FORM AND CONTENTS
20 δ κα ιί σ
20 tablets
Τ Ο ΣΚ Ι Δ (ΟΙΧ ΗΓ Σ Σ Ρ ΠΟ Α Ο ΟΣ) ΟΡ Η Η
METHOD AND ROUTE(S) OF ADMINISTRATION
ΕΔ Κ ΠΡ Ι Ο Ι Η Σ ΜΦΩΝ ΜΕ Τ
Read the package leaflet before use.
ΙΙ Η
Oral use
Α
6.
Λ Σ Ε Α Σ Ε Η, ΗΝ ΟΠΟΙ Δ Ν Β Ε Υ ΚΑ Α Ε Λ ΠΟ Ν
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
Δ ΝΠ Ο Ε ΓΖ ΝΤ Π Ι Ι Ε Ρ Σ Γ ΙΟΥ Α Α ΔΑ
Keep out of the reach and sight of children.
Λ Η( Ε) ΕΔ Κ Σ ΙΙ Η( Ε) ΠΡ Ι Ο Ι Σ Ι), Ε ΝΕ Ν Ι ΠΑ Α Τ Τ Σ
OTHER SPECIAL WARNING(S), IF NECESSARY
ΗΗ
EXPIRY DATE
Ι
9.
ΜΑ Υ Ι ΩΝ Ρ ΚΕ Τ Κ
SPECIAL STORAGE CONDITIONS
ΟΥΠ ΟΕ Χ Τ Ι ΠΟΑ Ρ Ρ ΟΝ Α Α
Store in the original package in order to protect from light.
Ο ΟΜΑΚΑ Δ Ε ΘΥ Σ Τ ΚΑ ΟΧ ΥΤ Α Ε Α ΚΥ Λ
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Ν
11.
Ι Ι Υ Ν Η ΟΥ Τ Ο ΗΣ Δ Ι Σ Κ ΟΦΟΡΑ ΙΣ
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
12.
46 12.
ΑΙ ΡΘΜΟΣ ΙΑ Ε Α Κ ΚΛ
MARKETING AUTHORISATION NUMBER(S)
(Ο) Δ Ι Σ Υ ΟΦΟΡΑ ΙΣ 51 EU/ 1/ 08/ 469/ 001
EU/ 1/ 08/ 469/ 001
Π ρί: ατα δ
BATCH NUMBER
ΕΙ
14.
Τ Τ Ξ Ι Η ΙΘ Σ
GENERAL CLASSIFICATION FOR SUPPLY
Φ ρ αετ ό ρϊν ι τ οο αα ε αιτι σ ναή α μ κυι πο γ ο πί π ιί ι ρκ υτγ
Medicinal product subject to medical prescription.
Ο ΗΓΕ Χ Η Η Δ ΙΣ Ρ Σ Σ
INSTRUCTIONS ON USE
Π ΗΡ Λ ΟΦΟΡΕ Σ Γ Α Ι Σ Ε Ρ ΦΗBRAILLE IN BRAILLE
INFORMATION IN BRAILLE
Υ ΜΦΑ ΙΟΝ Α Σ ΗΝΕ Ω Ε Ι Σ Σ Υ Σ Α ΝΖ Τ Ι Τ Ξ Τ ΡΚΗ Υ ΚΕ Α Ι
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
30 δ κα ιί σ
30 tablets
12.
48 12.
(Ο) Δ Ι Σ Υ ΟΦΟΡΑ ΙΣ
MARKETING AUTHORISATION NUMBER(S)
53 EU/ 1/ 08/ 469/ 002
EU/ 1/ 08/ 469/ 002
Υ ΜΦΑ ΙΟΝ Α Σ ΗΝΕ Ω Ε Ι Σ Σ Υ Σ Α ΝΖ Τ Ι Τ Ξ Τ ΡΚΗ Υ ΚΕ Α Ι
49 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
60 δ κα ιί σ
60 tablets
12.
50 12.
55 EU/ 1/ 08/ 469/ 003
EU/ 1/ 08/ 469/ 003
Υ ΜΦΑ ΙΟΝ Α Σ ΗΝΕ Ω Ε Ι Σ Σ Υ Σ Α ΝΖ Τ Ι Τ Ξ Τ ΡΚΗ Υ ΚΕ Α Ι
51 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
90 δ κα ιί σ
90 tablets
57 EU/ 1/ 08/ 469/ 004
EU/ 1/ 08/ 469/ 004
Υ ΜΦΑ ΙΟΝ Α Σ ΗΝΕ Ω Ε Ι Σ Σ Υ Σ Α ΝΖ Τ Ι Τ Ξ Τ ΡΚΗ Υ ΚΕ Α Ι
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
100
100 tablets
12.
54 12.
59 EU/ 1/ 08/ 469/ 005
EU/ 1/ 08/ 469/ 005
Ε Ε Ν Ν Γ Α Ν Α Σ Ι Υ Κ Υ ΣΕ
55 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Υ ΟΥBLISTER Ή Σ Ι Τ Ι Ι Σ ΤΣ ΑΝΕ BLISTER / (Al/ Al)
BLISTER/ (Al/ Al)
Ο ΟΜΑΤ Κ Τ ΟΥΤ Α ΕΑ ΚΥ Λ ΦΟ Ι Σ
NAME OF THE MARKETING AUTHORISATION HOLDER
Η Ρ ΜΗΝ ΑΛ ΗΣ ΜΕ Ο Ι ΗΞ
EXPIRY DATE
ΗΗ
EXP
ΑΙ ΡΘΜΟΣΠΑ Τ Δ Σ Ρ ΙΑ
BATCH NUMBER
Π ρί: ατα δ 5.
Batch
61 Χ Ρ Κ ΗΡΣ Ι ΠΟ Ε Α Α Τ Ι ΤΚΑ
OTHER
Υ ΜΦΑ ΙΟΝ Α Σ ΗΝΕ Ω Ε Ι Σ Σ Υ Σ Α ΝΖ Τ Ι Τ Ξ Τ ΡΚΗ Υ ΚΕ Α Ι
56 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
Oprymea 0. 18 mg δ κ ιί σα Pramipexole
Oprymea 0.18 mg tablets Pramipexole
Κ θ δ κ πρ χι άε ι ί ει ε0. 18 mg pramipexole ιούα ο ε
Each tablet contains 0.18 mg pramipexole equivalent to 0.25 mg pramipexole dihydrochloride monohydrate.
62 EU/ 1/ 08/ 469/ 006
EU/ 1/ 08/ 469/ 006
Υ ΜΦΑ ΙΟΝ Α Σ ΗΝΕ Ω Ε Ι Σ Σ Υ Σ Α ΝΖ Τ Ι Τ Ξ Τ ΡΚΗ Υ ΚΕ Α Ι
58 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
64 EU/ 1/ 08/ 469/ 007
EU/ 1/ 08/ 469/ 007
Υ ΜΦΑ ΙΟΝ Α Σ ΗΝΕ Ω Ε Ι Σ Σ Υ Σ Α ΝΖ Τ Ι Τ Ξ Τ ΡΚΗ Υ ΚΕ Α Ι
60 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
KRKA, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Σ οεί
61 KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
EU/ 1/ 08/ 469/ 008 66 13.
EU/ 1/ 08/ 469/ 008
67 Χ Ρ Κ ΗΡΣ Ι ΠΟΥΕ Α Α Τ Ι ΤΚΑ ΚΟΥ Ι Ι Τ BLISTERS Τ/ Γ Α Α
62 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
Ο ΟΜΑ Ι Τ ΥΦΑ ΜΑ Ε Τ Κ ΠΡ ΟΝ ΟΣ
BOX for blisters
KRKA, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Σ οεί
63 KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
EU/ 1/ 08/ 469/ 009 68 13.
EU/ 1/ 08/ 469/ 009
Υ ΜΦΑ ΙΟΝ Α Σ ΗΝΕ Ω Ε Ι Σ Σ Υ Σ Α ΝΖ Τ Ι Τ Ξ Τ ΡΚΗ Υ ΚΕ Α Ι
64 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
KRKA, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Σ οεί
65 KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
EU/ 1/ 08/ 469/ 010 70 13.
EU/ 1/ 08/ 469/ 010
Ε Ε Ν Ν Γ Α Ν Α Σ Ι Υ Κ Υ ΣΕ
66 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
72 Χ Ρ Κ ΗΡΣ Ι ΠΟ Ε Α Α Τ Ι ΤΚΑ
OTHER
Υ ΜΦΑ ΙΟΝ Α Σ ΗΝΕ Ω Ε Ι Σ Σ Υ Σ Α ΝΖ Τ Ι Τ Ξ Τ ΡΚΗ Υ ΚΕ Α Ι
67 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
Oprymea 0. 35 mg δ κ ιί σα Pramipexole
Oprymea 0.35 mg tablets Pramipexole
Κ θ δ κ πρ χι άε ι ί ει ε0. 35 mg pramipexole ιούα ο ε mg μνϋρκ δ δολ ρ ή
Each tablet contains 0.35 mg pramipexole equivalent to 0.5 mg pramipexole dihydrochloride monohydrate.
KRKA, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Σ οεί
68 KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
73 EU/ 1/ 08/ 469/ 011
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69 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
75 EU/ 1/ 08/ 469/ 012
EU/ 1/ 08/ 469/ 012
Υ ΜΦΑ ΙΟΝ Α Σ ΗΝΕ Ω Ε Ι Σ Σ Υ Σ Α ΝΖ Τ Ι Τ Ξ Τ ΡΚΗ Υ ΚΕ Α Ι
71 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
KRKA, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Σ οεί
72 KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
EU/ 1/ 08/ 469/ 013 77 13.
EU/ 1/ 08/ 469/ 013
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73 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
KRKA, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Σ οεί
74 KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
EU/ 1/ 08/ 469/ 014 79 13.
EU/ 1/ 08/ 469/ 014
Υ ΜΦΑ ΙΟΝ Α Σ ΗΝΕ Ω Ε Ι Σ Σ Υ Σ Α ΝΖ Τ Ι Τ Ξ Τ ΡΚΗ Υ ΚΕ Α Ι
75 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
ΩΝ Υ ΟΛ Ι Π ΕΜΜΑ
SPECIAL STORAGE CONDITIONS
ΠΟΥΠΡ Ρ ΟΝ Α Α Ο Α Τ, Ε Σ ΝΑ Α Τ Ι Α
Store in the original package in order to protect from light.
KRKA, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Σ οεί
76 KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
EU/ 1/ 08/ 469/ 015 81 13.
EU/ 1/ 08/ 469/ 015
Ε Ε Ν Ν Γ Α Ν Α Σ Ι Υ Κ Υ ΣΕ
77 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Π ρί: ατα δ
Batch
Α Λ Σ ΟΧ Ι Λ Α Τ ΙΕΑ
OTHER
Υ ΜΦΑ ΙΟΝ Α Σ ΗΝΕ Ω Ε Ι Σ Σ Υ Σ Α ΝΖ Τ Ι Τ Ξ Τ ΡΚΗ Υ ΚΕ Α Ι
78 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
Oprymea 0. 7 mg δ κα ιί σ Pramipexole
Oprymea 0.7 mg tablets Pramipexole
σδνμ μ 1
Each tablet contains 0.7 mg pramipexole equivalent to 1 mg pramipexole dihydrochloride monohydrate.
KRKA, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Σ οεί
79 KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
EU/ 1/ 08/ 469/ 016 84 13.
EU/ 1/ 08/ 469/ 016
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80 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
86 EU/ 1/ 08/ 469/ 017
EU/ 1/ 08/ 469/ 017
Υ ΜΦΑ ΙΟΝ Α Σ ΗΝΕ Ω Ε Ι Σ Σ Υ Σ Α ΝΖ Τ Ι Τ Ξ Τ ΡΚΗ Υ ΚΕ Α Ι
82 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
88 EU/ 1/ 08/ 469/ 018
EU/ 1/ 08/ 469/ 018
Υ ΜΦΑ ΙΟΝ Α Σ ΗΝΕ Ω Ε Ι Σ Σ Υ Σ Α ΝΖ Τ Ι Τ Ξ Τ ΡΚΗ Υ ΚΕ Α Ι
84 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
Ο ΟΜΑΚΑ Δ Ε ΘΥ Σ Τ ΚΑ ΟΧ ΥΤ Α Ε Α ΚΥ Λ
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICI NAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
EU/ 1/ 08/ 469/ 019 90 13.
EU/ 1/ 08/ 469/ 019
Υ ΜΦΑ ΙΟΝ Α Σ ΗΝΕ Ω Ε Ι Σ Σ Υ Σ Α ΝΖ Τ Ι Τ Ξ Τ ΡΚΗ Υ ΚΕ Α Ι
86 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
EU/ 1/ 08/ 469/ 020 92 13.
EU/ 1/ 08/ 469/ 020
Ε Ε Ν Ν Γ Α Ν Α Σ Ι Υ Κ Υ ΣΕ
88 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
94 Χ Ρ Κ ΗΡΣ Ι ΠΟ Ε Α Α Τ Ι ΤΚΑ
OTHER
Υ ΜΦΑ ΙΟΝ Α Σ ΗΝΕ Ω Ε Ι Σ Σ Υ Σ Α ΝΖ Τ Ι Τ Ξ Τ ΡΚΗ Υ ΚΕ Α Ι
89 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
Oprymea 1. 1 mg δ κα ιί σ Pramipexole
Oprymea 1.1 mg tablets Pramipexole
Κ θ δ κ πρ χι mg pramipexole ιούα ο ε mg μ νϋρ ή ι ρχω ι άε ι ί ει ε1. 1
Each tablet contains 1.1 mg pramipexole equivalent to 1.5 mg pramipexole dihydrochloride monohydrate.
ή κ
3.
pramipexole.
LIST OF EXCIPIENTS
Κ Τ Λ ΟΣΕ Δ ΩΝ Α Α ΟΓ Κ ΟΧ
PHARMACEUTICAL FORM AND CONTENTS
Π Ε ΜΜΑ Ω ΠΟ ΠΡ Ρ Ο Τ Ι ΠΟΑ Τ, Ε
Store in the original package in order to protect from light.
95 EU/ 1/ 08/ 469/ 021
EU/ 1/ 08/ 469/ 021
Υ ΜΦΑ ΙΟΝ Α Σ ΗΝΕ Ω Ε Ι Σ Σ Υ Σ Α ΝΖ Τ Ι Τ Ξ Τ ΡΚΗ Υ ΚΕ Α Ι
91 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
EU/ 1/ 08/ 469/ 022 97 13.
EU/ 1/ 08/ 469/ 022
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93 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
EU/ 1/ 08/ 469/ 023 99 13.
EU/ 1/ 08/ 469/ 023
Υ ΜΦΑ ΙΟΝ Α Σ ΗΝΕ Ω Ε Ι Σ Σ Υ Σ Α ΝΖ Τ Ι Τ Ξ Τ ΡΚΗ Υ ΚΕ Α Ι
95 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
101 EU/ 1/ 08/ 469/ 024
EU/ 1/ 08/ 469/ 024
Υ ΜΦΑ ΙΟΝ Α Σ ΗΝΕ Ω Ε Ι Σ Σ Υ Σ Α ΝΖ Τ Ι Τ Ξ Τ ΡΚΗ Υ ΚΕ Α Ι
97 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
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EU/ 1/ 08/ 469/ 025
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99 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Λ Ο ΗΓΩΝ Ρ ΗΣ
OTHER
ΛΟ Δ Ι
100 B.
ΗΣ:
101 PACKAGE LEAFLET:
Η Ο ΡΕ Ι ΟΝ Ρ Σ Η
INFORMATION FOR THE USER
Oprymea 0. 088 mg δσ ί ικα Oprymea 0. 18 mg δσ ί ικα Oprymea 0. 35 mg δσ ί ικα Oprymea 0. 7 mg δσ ί ικα Oprymea 1. 1 mg δσ ί ικα Π α ι ξλ ρ μ εόη π
Oprymea 0.088 mg tablets Oprymea 0.18 mg tablets Oprymea 0.35 mg tablets Oprymea 0.7 mg tablets Oprymea 1.1 mg tablets Pramipexole
Δα ά τ π ο ετ άοό λρ τ φ λο δ γ ν ρ σ ς ρτύ ρίεε απ ίντ α τ τ ιβ σε ρ σκ ι λκ η ο ο ύ λ ο ηι χή η π οο α χστ ν αρεε υό ο φ
Read all of this leaflet carefully before you start taking this medicine.
ρ αο ά μ κ.
- Keep this leaflet.
σεν τ δ βστ ξν.
You may need to read it again.
- Ε ν χτ πρι ρ α οί, ρ τσε ο ιτό τ φ ραοοό α.
- If you have any further questions, ask your doctor or pharmacist.
υτγ γ υό ο ά μκ χργθκ γ α. ε π έεν δ στ τ άμ κ σ
- This medicine has been prescribed for you.
άλυ.
Do not pass it on to others.
- Ε ν ά ο αει μ τ εέγιγ εασ βρ, ήα π ρτρστ κπιαει μτ
It may harm them, even
ά κπι νπ ύ ηη νρε ί τιοα ή ν ααηή εε άοα νπ ύ ηη
if their symptoms are the same as yours.
εέγι πυ ε αα έεασο α ό φ λο δγ νπρκ λί ε αεη εώ εε ο ιτόή νρε ο δν νφρτιτ πρν ύλ οηι, α ααε θ ν νμρ στ τ γ ρ
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
φ ραοοό α. αμ κπισ ς
please tell your doctor or pharmacist.
ο α ό φ λο δ γώ πρέε
In this leaflet:
:
1.
1 Τ ε ατ Oprymea κ ιο ε α η ρσ τυ ιί ιο
What Oprymea is and what it is used for 2.
ί ι χήη ο α ν
Before you take Oprymea 3.
5 Π ς α υάστιο ώ ν φ λσ εα τ Oprymea 6 Λ ι ς λρφρε ο έ πηο οί π ς
How to take Oprymea 4.
Τ Ε Ν Ι ΟOPRYMEA Κ Ι
Possible side effects 5.
Ι ΙΑ Τ
How to store Oprymea 6.
Α ΠΟΙ ΕΝ Ι Χ Η ΗΤ Α Ι Α Η Ρ Σ ΟΥ
Further information
ο
1.
Ηδ γρ η ω νοαι ριώ ι ε υ τυ νοα ι γ ύ υοοε ο εκφ λυ ι εσ τ ν τπμν γ ν ε ρ
Oprymea belongs to a group of medicines known as dopamine agonists which stimulate dopamine receptors in the brain.
υοοε ν ρκ λίερκς σισο εκφ λ πυ οθύ τν λγο ω κνσω. πδχώ ποαενυι ώ ε τν γέα ο ο βηον ο έεχ τ ν ι εν
Stimulation of the dopamine receptors triggers nerve impulses in the brain that help to control body movements.
Τ Oprymea χη ιοο ί ιιτ θρπί τν υ πω άω τςδ π θύ νσ υ ο Parkinson. ο ρσμπιτ γ η εα ε ω σ μτ μτ ν η ιοαος ό ο τυ
Oprymea is used to treat the symptoms of primary Parkinson's disease.
Μπρία ρ σ οοηεμν τυ σ σνυ σόμ λβνόα οεν χη ι πι ί όο ο ή ε υδαμ ε εοτπ. μ θ
It can be used alone or in combination with levodopa.
Τ ΠΡ Π Ι ΑΓ ΩΡΖ Τ ΠΡΝΝ ΠΑ Ε ΕΤ OPRYMEA
BEFORE YOU TAKE OPRYMEA
Ε Ετ Oprymea ΡΤ ο
DO NOT take Oprymea
- σ πρ τσ αλρίς πρυ ι ηίςσηπα ι ξλ ή ε πι ήοε λο υττ ό
- If you are allergic (hypersensitive) to pramipexole or any of the other ingredients of Oprymea
ε εί ω η λεγ (υεεα θσα) τ ρ μπ όη σ οο δπτ ά λ σσαι
(see section 6.