natgillin/translations-raw huggingface dataset:
When patients were identified with concurrent worsening in all three domains, results showed a statistically significant effect of memantine in preventing worsening, as twice as many placebo-treated patients as memantine-treated patients showed worsening in all three domains (21% vs. 11%, p<0.0001).
Kada je ustanovljeno istodobno pogoršanje stanja bolesnika u sva tri područja, rezultati su pokazali statistički značajan učinak memantina u sprječavanju pogoršanja, u skupini bolesnika liječenih placebom bilo je dvostruko više pogoršanja u sva tri područja nego u skupini bolesnika liječenih memantinom (21% naspram 11%, p < 0,0001).
Common Common Uncommon Very rare
Manje često Manje često
15 mg tablet week 4 and beyond 20 mg tablets once a day
3. tjedan tableta od 15 mg 4. tjedan i nadalje tableta od 20 mg jednom dnevno
LIST OF EXCIPIENTS Contains lactose and soya lecithin.
POPIS POMOĆNIH TVARI Sadrži laktozu i sojin lecitin.
What Memantine ratiopharm is and what it is used for
Što je Memantin ratiopharm i za što se koristi
A pivotal monotherapy study in a population of patients suffering from moderate to severe Alzheimer's disease (mini mental state examination (MMSE) total scores at baseline of 3-14) included a total of 252 outpatients.
Pivotalno ispitivanje monoterapije u populaciji bolesnika koji pate od umjerene do teške Alzheimerove bolesti (početne vrijednosti kratkog testa određivanja mentalnog statusa (MMSE) bile su 3-14) uključivalo je ukupno 252 ambulantna bolesnika.
The patient should take half a 10 mg film-coated tablet (5 mg) per day for 7 days.
bolesnik treba uzimati polovicu filmom obložene tablete od 10 mg (5 mg) dnevno tijekom 7 dana.
Memantine ratiopharm contains lactose and soya lecithin This medicine contains lactose.
Memantin ratiopharm sadrži laktozu i sojin lecitin Ovaj lijek sadrži laktozu.
Outer packaging for 4 week treatment initiation pack (28 tablets, week 1-4)
Vanjsko pakiranje za 4-tjedno pakiranje za početak liječenja (28 tableta, 1.-4. tjedan)
Women taking Memantine ratiopharm should not breast-feed.
Žene koje uzimaju Memantin ratiopharm ne bi trebale dojiti.
Week 3 (day 15-21): The patient should take one and a half 10 mg film-coated tablets (15 mg) per day for 7 days.
3. tjedan (15.-21. dan): bolesnik treba uzimati jednu i pol filmom obloženu tabletu od 10 mg (15 mg) dnevno tijekom 7 dana.
The following Adverse Reactions listed in the Table below have been accumulated in clinical studies with memantine and since its introduction in the market.
Sljedeće nuspojave koje su prikupljene tijekom kliničkih ispitivanja s memantinom i nakon stavljanja lijeka u promet su prikazane u tablici ispod.
Maintenance dose The recommended maintenance dose is 20 mg per day.
Doza održavanja Preporučena doza održavanja je 20 mg na dan.
Week 2 (day 8-14): The patient should take one 10 mg film-coated tablet (10 mg) per day for 7 days.
2. tjedan (8.-14. dan): bolesnik treba uzimati jednu filmom obloženu tabletu od 10 mg (10 mg) dnevno tijekom 7 dana.
Memantine ratiopharm contains lactose.
Memantin ratiopharm sadrži laktozu.
10 film-coated tablets 14 film-coated tablets 21 film-coated tablets 28 film-coated tablets 30 film-coated tablets 42 film-coated tablets 50 film-coated tablets 56 film-coated tablets 98 film-coated tablets 100 film-coated tablets 112 film-coated tablets
10 filmom obloženih tableta 14 filmom obloženih tableta 21 filmom obložena tableta 28 filmom obloženih tableta 30 filmom obloženih tableta 42 filmom obložene tablete 50 filmom obloženih tableta 56 filmom obloženih tableta 98 filmom obloženih tableta 100 filmom obloženih tableta 112 filmom obloženih tableta
● Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders,
• glavobolja, pospanost, zatvor, povišeni rezultati testova jetrene funkcije, omaglica, poremećaji ravnoteže, nedostatak zraka, visoki krvni tlak i preosjetljivost na lijek.
10 film-coated tablets 14 film-coated tablets 21 film-coated tablets 28 film-coated tablets 30 film-coated tablets 42 film-coated tablets 56 film-coated tablets 98 film-coated tablets 100 film-coated tablets
10 filmom obloženih tableta 14 filmom obloženih tableta 21 filmom obložena tableta 28 filmom obloženih tableta 30 filmom obloženih tableta 42 filmom obložene tablete 56 filmom obloženih tableta 98 filmom obloženih tableta 100 filmom obloženih tableta
In patients with severe renal impairment (creatinine clearance 5-29 ml/min) daily dose should be 10 mg per day.
Kod bolesnika s teškim oštećenjem bubrega (klirens kreatinina 5-29 ml/min) dnevna doza bi trebala biti 10 mg dnevno.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer packaging (Blister)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Vanjsko pakiranje (blister)
In patients with moderate renal impairment (creatinine clearance 30-49 ml/min) daily dose should be 10 mg per day.
Kod bolesnika s umjerenim oštećenjem bubrega (klirens kreatinina 30-49 ml/min), dnevna doza bi trebala biti 10 mg na dan.
Shelf life after first opening of the container: 6 months
Rok valjanosti nakon prvog otvaranja: 6 mjeseci
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
Administration of Memantine ratiopharm is not recommended in patients with severe hepatic impairment.
Ne preporučuje se primjena Memantin ratiopharma kod bolesnika s teškim oštećenjem jetre.
EXP Shelf life after first opening: 6 months.
Rok valjanosti nakon prvog otvaranja: 6 mjeseci.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer packaging (HDPE bottle)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Vanjsko pakiranje (HDPE bočica)
EU/1/13/836/013 10 film-coated tablets EU/1/13/836/014 14 film-coated tablets EU/1/13/836/015 21 film-coated tablets EU/1/13/836/016 28 film-coated tablets EU/1/13/836/017 30 film-coated tablets EU/1/13/836/018 42 film-coated tablets EU/1/13/836/019 56 film-coated tablets EU/1/13/836/020 98 film-coated tablets EU/1/13/836/021 100 film-coated tablets
EU/1/13/836/013 10 filmom obloženih tableta EU/1/13/836/014 14 filmom obloženih tableta EU/1/13/836/015 21 filmom obložena tableta EU/1/13/836/016 28 filmom obloženih tableta EU/1/13/836/017 30 filmom obloženih tableta EU/1/13/836/018 42 filmom obložene tablete EU/1/13/836/019 56 filmom obloženih tableta EU/1/13/836/020 98 filmom obloženih tableta EU/1/13/836/021 100 filmom obloženih tableta
Memantine ratiopharm should be administered orally once a day.
Memantin ratiopharm treba primjenjivati kroz usta jedanput na dan.
NAME OF THE MARKETING AUTHORISATION HOLDER ratiopharm
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET ratiopharm
No adverse reactions of memantine were noted on male and female fertility.
Nuspojave memantina vezane za plodnost muškaraca ili žena nisu bile opažene.
EU/1/13/836/001 10 film-coated tablets EU/1/13/836/002 14 film-coated tablets EU/1/13/836/003 21 film-coated tablets EU/1/13/836/004 28 film-coated tablets EU/1/13/836/005 30 film-coated tablets EU/1/13/836/006 42 film-coated tablets EU/1/13/836/007 50 film-coated tablets EU/1/13/836/008 56 film-coated tablets EU/1/13/836/009 98 film-coated tablets EU/1/13/836/010 100 film-coated tablets EU/1/13/836/011 112 film-coated tablets
EU/1/13/836/001 10 filmom obloženih tableta EU/1/13/836/002 14 filmom obloženih tableta EU/1/13/836/003 21 filmom obložena tableta EU/1/13/836/004 28 filmom obloženih tableta EU/1/13/836/005 30 filmom obloženih tableta EU/1/13/836/006 42 filmom obložene tablete EU/1/13/836/007 50 filmom obloženih tableta EU/1/13/836/008 56 filmom obloženih tableta EU/1/13/836/009 98 filmom obloženih tableta EU/1/13/836/010 100 filmom obloženih tableta EU/1/13/836/011 112 filmom obloženih tableta
● anticholinergics (substances generally used to treat movement disorders or intestinal cramps)
• antikolinergika (lijekovi koje se uglavnom koriste za liječenje poremećaja kretanja ili crijevnih grčeva) antikonvulziva (lijekovi koji se koriste za sprječavanje i ublažavanje napadaja)
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label (HDPE bottle)
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU Naljepnica (HDPE bočica)
In postmarketing experience these reactions have been reported in patients treated with memantine.
Ove su nuspojave prijavljene u postmarketinškom razdoblju kod bolesnika liječenih memantinom.
QUALITATIVE AND QUANTITATIVE COMPOSITION Memantine ratiopharm 10 mg
KVALITATIVNI I KVANTITATIVNI SASTAV Memantin ratiopharm 10 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION Memantine ratiopharm 5 mg
KVALITATIVNI I KVANTITATIVNI SASTAV Memantin ratiopharm 5 mg
The use of medicinal products called
Trebalo bi izbjegavati istodobnu primjenu lijekova koji se zovu
What Memantine ratiopharm contains - The active substance is memantine hydrochloride.
Što Memantin ratiopharm sadrži - Djelatna tvar je memantinklorid.
Do not take Memantine ratiopharm:
Nemojte uzimati Memantin ratiopharm
Memantine ratiopharm 5 mg Memantine ratiopharm 10 mg Memantine ratiopharm 15 mg Memantine ratiopharm 20 mg
Memantin ratiopharm 5 mg Memantin ratiopharm 10 mg Memantin ratiopharm 15 mg Memantin ratiopharm 20 mg
Nervous system disorders
Poremećaji živčanog sustava Često Često
Memantine ratiopharm contains the active substance memantine hydrochloride.
Memantin ratiopharm sadrži djelatnu tvar memantinklorid.
Cellulose microcrystalline (E 460), starch pregelatinised (E 1404), lactose anhydrous, colloidal anhydrous silica (E 551), magnesium stearate (E 470b).
Jezgra tablete mikrokristalična celuloza (E 460), prethodno geliran škrob (E 1404), bezvodna laktoza, koloidni bezvodni silicijev dioksid (E 551), magnezijev stearat (E 470b).
Take only one tablet per day Week 1
Uzmite samo jednu tabletu na dan 1. tjedan
PVC/PVDC-Aluminium foil blister packs Pack sizes of 10, 14, 21, 28, 30, 42, 50, 56, 98, 100, 112 film-coated tablets.
Blister pakiranja od PVC/PVDC-aluminijska folija Veličine pakiranja od 10, 14, 21, 28, 30, 42, 50, 56, 98, 100, 112 filmom obloženih tableta.
Memantine ratiopharm is available in packs of 10, 14, 21, 28, 30, 42, 56, 98 and 100 film-coated tablets.
Memantin ratiopharm dostupan je u pakiranjima 10, 14, 21, 28, 30, 42, 56, 98 i 100 filmom obloženih tableta.
PVC/PVDC-Aluminium foil blister packs Pack sizes of 10, 14, 21, 28, 30, 42, 56, 98, 100 film-coated tablets.
Blister pakiranja od PVC/PVDC-aluminijska folija Veličine pakiranja od 10, 14, 21, 28, 30, 42, 50, 56, 98, 100 filmom obloženih tableta.
Polysorbate 80 (E 433), polyvinyl alcohol (E 1203), titanium dioxide (E 171), talc (E 553b), soya lecithin (E 322), xanthan gum (E 415).
Polisorbat 80 (E 433), poli(vinilni alkohol) (E 1203), titanijev dioksid (E 171), talk (E 553b), sojin lecitin (E 322), ksantanska guma (E 415).
PVC/PVDC-Aluminium foil blister packs Pack sizes of 28 (7 +7 +7 + 7) film-coated tablets.
Veličine pakiranja od 28 (7 + 7 + 7 + 7) filmom obloženih tableta.
Memantine ratiopharm is available in packs of 10, 14, 21, 28, 30, 42, 50, 56, 98, 100 and 112 filmcoated tablets.
Memantin ratiopharm dostupan je u pakiranjima 10, 14, 21, 28, 30, 42, 50, 56, 98, 100 i 112 filmom obloženih tableta.
What Memantine ratiopharm looks like and contents of the pack The 5 mg film-coated tablets are white to off-white, capsule shaped, biconvex tablets plain on one side and debossed with “5” on the other side.
Kako Memantin ratiopharm izgleda i sadržaj pakiranja Filmom obložene tablete od 5 mg su bijele do gotovo bijele, bikonveksne tablete u obliku kapsule, glatke s jedne strane i s utisnutim “5” s druge strane.
Memantine ratiopharm 20 mg
Memantin ratiopharm 20 mg
Polysorbate 80 (E 433) Polyvinyl alcohol (E 1203) Titanium dioxide (E 171) Talc (E 553b) Soya lecithin (E 322) Xanthan gum (E 415)
Ovojnica polisorbat 80 (E 433) poli(vinilni alkohol) (E 1203) titanijev dioksid (E 171) talk (E 553b) sojin lecitin (E 322) ksantanska guma (E 415)
Cellulose microcrystalline (E 460) Starch pregelatinised (E 1404) Lactose anhydrous Colloidal anhydrous silica (E 551) Magnesium stearate (E 470b)
Jezgra tablete mikrokristalična celuloza (E 460), prethodno gelirani škrob (E 1404), bezvodna laktoza, koloidni bezvodni silicijev dioksid (E 551), magnezijev stearat (E 470b).
Take only one tablet per day Week 4
Uzmite samo jednu tabletu na dan 4. tjedan
PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet
OBLIK I SADRŽAJ Filmom obložena tableta 7 filmom obloženih tableta
Take only one tablet per day Week 2
Uzmite samo jednu tabletu na dan 2. tjedan
Memantine ratiopharm 5 mg
Memantin ratiopharm 5 mg
Take only one tablet per day Week 3
Uzmite samo jednu tabletu na dan 3. tjedan
Lactose (40 mg/film-coated tablet) and soya lecithin (0.065 mg/film-coated tablet).
Laktoza (40 mg/filmom obloženoj tableti) i sojin lecitin (0,065 mg/filmom obloženoj tableti).
Venous thrombosis/thromboembolism
Često Manje često hipertenzija venska tromboza/tromboembolija
What is Memantine ratiopharm used for
Za što se Memantin ratiopharm koristi
How to take Memantine ratiopharm
Kako uzimati Memantin ratiopharm
Memantine ratiopharm 15 mg
Memantin ratiopharm 15 mg
Memantine ratiopharm 10 mg
Memantin ratiopharm 10 mg
INFORMATION IN BRAILLE Memantine ratiopharm 20 mg
16. PODACI NA BRAILLEOVOM PISMU Memantin ratiopharm 20 mg
What Memantine ratiopharm looks like and contents of the pack White to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with “20” on the other side.
Kako Memantin ratiopharm izgleda i sadržaj pakiranja Bijele do gotovo bijele, bikonveksne tablete u obliku kapsule, s razdjelnom crtom na jednoj strani i utisnutim “20” na drugoj strani.
Lactose (120 mg/film-coated tablet) and soya lecithin (0.195 mg/film-coated tablet).
Laktoza (120 mg/filmom obloženoj tableti) i sojin lecitin (0,195 mg/ filmom obloženoj tableti).
MARKETING AUTHORISATION NUMBER(S) EU/1/13/836/022
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/836/022
Lactose (80 mg/film-coated tablet) and soya lecithin (0.13 mg/film-coated tablet).
Laktoza (80 mg/filmom obloženoj tableti) i sojin lecitin (0,13 mg/filmom obloženoj tableti).
MARKETING AUTHORISATION NUMBER(S) EU/1/13/836/023
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/836/023
Package leaflet: Information for the patient Memantine ratiopharm 20 mg film-coated tablets memantine hydrochloride
Uputa o lijeku: Informacije za bolesnika Memantin ratiopharm 20 mg filmom obložene tablete memantinklorid
What Memantine ratiopharm looks like and contents of the pack White to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with “10” on the other side.
Kako Memantin ratiopharm izgleda i sadržaj pakiranja Bijele do gotovo bijele, bikonveksne tablete u obliku kapsule s razdjelnom crtom na jednoj strani i utisnutim “10” na drugoj strani.
Package leaflet: Information for the patient Memantine ratiopharm 10 mg film-coated tablets memantine hydrochloride
Uputa o lijeku: Informacije za bolesnika Memantin ratiopharm 10 mg filmom obložene tablete memantinklorid
MARKETING AUTHORISATION NUMBER(S) EU/1/13/836/012
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/836/012
Lactose (160 mg/film-coated tablet) and soya lecithin (0.26 mg/film-coated tablet).
Laktoza (160 mg/filmom obloženoj tableti) i sojin lecitin (0,26 mg/filmom obloženoj tableti).
How does Memantine ratiopharm work
Kako djeluje Memantin ratiopharm
INFORMATION IN BRAILLE Memantine ratiopharm 5 mg
16. PODACI NA BRAILLEOVOM PISMU Memantin ratiopharm 5 mg
INFORMATION IN BRAILLE Memantine ratiopharm 10 mg
16. PODACI NA BRAILLEOVOM PISMU Memantin ratiopharm 10 mg
The 20 mg film-coated tablets are white to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with “20” on the other side.
Filmom obložene tablete od 20 mg su bijele do gotovo bijele, bikonveksne tablete u obliku kapsule, s razdjelnom crtom na jednoj strani i s utisnutim “20” na drugoj strani.
How to store Memantine ratiopharm
Kako čuvati Memantin ratiopharm
INFORMATION IN BRAILLE Memantine ratiopharm 15 mg
16. PODACI NA BRAILLEOVOM PISMU Memantin ratiopharm 15 mg
The 15 mg film-coated tablets are white to off-white, capsule shaped, biconvex tablets plain on one side and debossed with “15” on the other side.
Filmom obložene tablete od 15 mg su bijele do gotovo bijele, bikonveksne tablete u obliku kapsule, glatke s jedne strane i s utisnutim “15” s druge strane.
half a 10 mg tablet week 2
1. tjedan pola tablete od 10 mg
The 10 mg film-coated tablets are white to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with “10” on the other side.
Filmom obložene tablete od 10 mg su bijele do gotovo bijele, bikonveksne tablete u obliku kapsule, s razdjelnom crtom na jednoj strani i utisnutim “10” na drugoj strani.
Each film-coated tablet contains 15 mg memantine hydrochloride equivalent to 12.46 mg memantine.
Svaka filmom obložena tableta sadržava 15 mg memantinklorida, što odgovara 12,46 mg memantina
Each film-coated tablet contains 5 mg memantine hydrochloride equivalent to 4.15 mg memantine.
Svaka filmom obložena tableta sadržava 5 mg memantinklorida, što odgovara 4,15 mg memantina.
Memantine ratiopharm 5 mg Memantine ratiopharm 10 mg Memantine ratiopharm 15 mg Memantine ratiopharm 20 mg film-coated tablets memantine hydrochloride
Memantin ratiopharm 5 mg Memantin ratiopharm 10 mg Memantin ratiopharm 15 mg Memantin ratiopharm 20 mg filmom obložene tablete memantinklorid
Take one 20 mg tablet once day (white to off-white, capsule shaped, biconvex, with a break score on one side and debossed with “20” on the other side) for 7 days.
Uzimajte jednu tabletu od 20 mg dnevno (bijelu do gotovo bijelu, bikonveksnu tabletu u obliku kapsule, s razdjelnom crtom na jednoj strani i utisnutim “20” na drugoj strani) tijekom 7 dana.
Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.
Svaka filmom obložena tableta sadržava 10 mg memantinklorida što odgovara 8,31 mg memantina.
White to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with “20” on the other side.
Bijele do gotovo bijele, bikonveksne tablete u obliku kapsule, s razdjelnom crtom na jednoj strani i utisnutim “20” na drugoj strani.
Memantine ratiopharm 5 mg film-coated tablets Memantine ratiopharm 10 mg film-coated tablets Memantine ratiopharm 15 mg film-coated tablets Memantine ratiopharm 20 mg film-coated tablets
Memantin ratiopharm 5 mg filmom obložene tablete Memantin ratiopharm 10 mg filmom obložene tablete Memantin ratiopharm 15 mg filmom obložene tablete Memantin ratiopharm 20 mg filmom obložene tablete
Memantine ratiopharm 5 mg film-coated tablets Memantine ratiopharm 10 mg film-coated tablets Memantine ratiopharm 15 mg film-coated tablets Memantine ratiopharm 20 mg film-coated tablets memantine hydrochloride
Memantin ratiopharm 5 mg filmom obložene tablete Memantin ratiopharm 10 mg filmom obložene tablete Memantin ratiopharm 15 mg filmom obložene tablete Memantin ratiopharm 20 mg filmom obložene tablete memantinklorid
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer packaging for 4 week treatment initiation pack ( 20 mg, 7 tablets, week 4)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Vanjsko pakiranje za 4-tjedno pakiranje za početak liječenja (20 mg, 7 tableta, 4. tjedan)
PHARMACEUTICAL FORM AND CONTENTS Treatment initiation pack
Pakiranje za početak liječenja
Take one 10 mg tablet once a day (white to off-white, capsule shaped, biconvex, with a break score on one side and debossed with “10” on the other side) for 7 days.
Uzimajte jednu tabletu od 10 mg jednom dnevno (bijelu do gotovo bijelu, bikonveksnu tabletu u obliku kapsule, s razdjelnom crtom na jednoj strani i s utisnutim “10” na drugoj strani) tijekom 7 dana.
NAME OF THE MEDICINAL PRODUCT Memantine ratiopharm 10 mg tablets memantine hydrochloride
Memantin ratiopharm 10 mg tablete memantinklorid
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer packaging for 4 week treatment initiation pack ( 10 mg, 7 tablets, week 2)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Vanjsko pakiranje za 4-tjedno pakiranje za početak liječenja (10 mg, 7 tableta, 2. tjedan)
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 5 mg memantine hydrochloride equivalent to 4.15 mg memantine.
NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 5 mg memantinklorida, što odgovara 4,15 mg memantina.
Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.
Svaka filmom obložena tableta sadržava 20 mg memantinklorida, što odgovara 16,62 mg memantina.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 15 mg memantine hydrochloride equivalent to 12.46 mg memantine.
NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 15 mg memantinklorida, što odgovara 12,46 mg memantina.
NAME OF THE MEDICINAL PRODUCT Memantine ratiopharm 20 mg tablets memantine hydrochloride
Memantin ratiopharm 20 mg tablete memantinklorid
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer packaging for 4 week treatment initiation pack ( 15 mg, 7 tablets, week 3)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Vanjsko pakiranje za 4-tjedno pakiranje za početak liječenja (15 mg, 7 tableta, 3. tjedan)
100 film-coated tablets
10 mg filmom obložene tablete
NAME OF THE MEDICINAL PRODUCT Memantine ratiopharm 10 mg film-coated tablets Memantine ratiopharm 20 mg film-coated tablets
Memantin ratiopharm 10 mg filmom obložene tablete Memantin ratiopharm 20 mg filmom obložene tablete
Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Jedna filmom obložena tableta sadrži 10 mg memantinklorida, što odgovara 8,31 mg memantina.
White to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with “10” on the other side.
Bijele do gotovo bijele, bikonveksne tablete u obliku kapsule s razdjelnom crtom na jednoj strani i utisnutim “10” na drugoj strani.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer packaging for 4 week treatment initiation pack ( 5 mg, 7 tablets, week 1)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Vanjsko pakiranje za 4-tjedno pakiranje za početak liječenja (5 mg, 7 tableta, 1. tjedan)
NAME OF THE MEDICINAL PRODUCT Memantine ratiopharm 5 mg film-coated tablets memantine hydrochloride
Memantin ratiopharm 5 mg filmom obložene tablete memantinklorid
Take one 15 mg tablet once a day (white to off-white, capsule shaped, biconvex, plain on one side and debossed with “15” on the other side) for 7 days.
Uzimajte jednu tabletu od 15 mg jednom dnevno (bijelu do gotovo bijelu, bikonveksnu tabletu u obliku kapsule, glatku s jedne strane i s utisnutim “15” s druge strane) tijekom 7 dana.
NAME OF THE MEDICINAL PRODUCT Memantine ratiopharm 20 mg film-coated tablets memantine hydrochloride
Memantin ratiopharm 20 mg filmom obložene tablete memantinklorid
NAME OF THE MEDICINAL PRODUCT Memantine ratiopharm 15 mg film-coated tablets memantine hydrochloride
Memantin ratiopharm 15 mg filmom obložene tablete memantinklorid
Take one 5 mg tablet once a day (white to off-white, capsule shaped, biconvex, plain on one side and debossed with “5” on the other side) for 7 days.
Uzimajte jednu tabletu od 5 mg jednom dnevno (bijelu do gotovo bijelu, bikonveksnu tabletu u obliku kapsule, glatku s jedne strane i s utisnutim “5” s druge strane) tijekom 7 dana.
NAME OF THE MEDICINAL PRODUCT Memantine ratiopharm 10 mg film-coated tablets memantine hydrochloride
Memantin ratiopharm 10 mg filmom obložene tablete memantinklorid
6.5 Nature and contents of container 10 mg film-coated tablets
OBLIK I SADRŽAJ Filmom obložena tableta 100 filmom obloženih tableta
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.
NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 20 mg memantinklorida, što odgovara 16,62 mg memantina.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.
NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 10 mg memantinklorida, što odgovara 8,31 mg memantina.