natgillin/translations-raw huggingface dataset:
“Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, stroke, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).” 
“Podaci iz kliničkih ispitivanja pokazali su da je dvostruka blokada renin-angiotenzin-aldosteronskog sustava (RAAS) kombiniranom primjenom ACE inhibitora, blokatora angiotenzin II receptora ili aliskirena povezana s većom učestalošću štetnih događaja kao što su hipotenzija, hiperkalemija i smanjena bubrežna funkcija (uključujući akutno zatajenje bubrega) u usporedbi s primjenom samo jednog lijeka koji djeluje na RAAS (vidjeti dijelove 4.3, 4.4 i 5.1).”
For products containing aliskiren, the existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below 
Za lijekove koji sadrže aliskiren, postojeće informacije o lijeku se trebaju izmjeniti (umetanjem, zamjenom ili brisanjem teksta prema potrebi) da odražavaju dogovoreni tekst kao što je predviđeno u nastavku
For products containing valsartan, the existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below 
Za lijekove koji sadrže valsartan, postojeće informacije o lijeku se trebaju izmjeniti (umetanjem, zamjenom ili brisanjem teksta prema potrebi) da odražavaju dogovoreni tekst kao što je predviđeno u nastavku
The following contraindication should be reflected in this section: “The concomitant use of [Product name] with an ACE-inhibitor or an angiotensin II receptor blocker is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.4, 4.5 and 5.1).” 
U ovom dijelu potrebno je dodati sljedeću kontraindikaciju: “Istodobna primjena [naziv lijeka] s lijekovima koji sadrže aliskiren kontraindicirana je u bolesnika sa šećernom bolešću ili oštećenjem bubrega (GFR < 60 ml/min/1,73 m2) (vidjeti dijelove 4.5 i 5.1).”
Section 4.4 - Special warnings and precautions for use The following wording should be reflected in this section: “Dual blockade of the renin-angiotensin-aldosterone-system (RAAS) Hypotension, syncope, stroke, hyperkalaemia and decreased renal function (including acute renal failure) have been reported in susceptible individuals, especially if combining medicinal products that affect this system (see section 5.1). 
Hipotenzija, sinkopa, moždani udar, hiperkalemija i smanjena bubrežna funkcija (uključujući akutno zatajenje bubrega) zabilježeni su u osjetljivih pojedinaca, osobito ako su se kombinirali lijekovi koji utječu na taj sustav (vidjeti dio 5.1).
For products containing candesartan, the existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below 
Za lijekove koji sadrže kandesartan postojeće informacije o lijeku se trebaju izmjeniti (umetanjem, zamjenom ili brisanjem teksta prema potrebi) da odražavaju dogovoreni tekst kao što je predviđeno u nastavku
For angiotensin II receptor blockers with wording in section 4.1 stating that they can be used alone or in combination with other antihypertensive agents, the following cross-reference should be added: “(see sections 4.3, 4.4, 4.5 and 5.1)”. 
Za blokatore angiotenzin II receptora s tekstom u dijelu 4.1 u kojem se navodi da se mogu primjenjivati sami ili u kombinaciji s drugim antihipertenzivnim lijekovima, potrebno je dodati sljedeću referencu: “(vidjeti dijelove 4.3, 4.4, 4.5 i 5.1)”.
The following wording should be incorporated in this section: 
U ovom dijelu potrebno je navesti sljedeći tekst:
For all ACE-inhibitors with wording in section 4.1 stating that they can be used alone or in combination with other antihypertensive agents, the following cross-reference should be added: “(see sections 4.3, 4.4, 4.5 and 5.1)”. 
Za sve ACE inhibitore s tekstom u dijelu 4.1 u kojem se navodi da se mogu primjenjivati sami ili u kombinaciji s drugim antihipertenzivnim lijekovima, potrebno je dodati sljedeću referencu: “(vidjeti dijelove 4.3, 4.4, 4.5 i 5.1)”.
For all ACE-inhibitors with wording in section 4.2 stating that they can be used alone or in combination with other antihypertensive agents, the following cross-reference should be added: “(see sections 4.3, 4.4, 4.5 and 5.1)”. 
Za sve ACE inhibitore s tekstom u dijelu 4.2 u kojem se navodi da se mogu primjenjivati sami ili u kombinaciji s drugim antihipertenzivnim lijekovima, potrebno je dodati sljedeću referencu: “(vidjeti dijelove 4.3, 4.4, 4.5 i 5.1)”.
For valsartan-containing products with wording in section 4.2 stating that they can be used alone or in combination with other antihypertensive agents, the following cross-reference should be added: “(see sections 4.3, 4.4, 4.5 and 5.1)”. 
Za lijekove koji sadrže valsartan s tekstom u dijelu 4.2 u kojem se navodi da se mogu primjenjivati sami ili u kombinaciji s drugim antihipertenzivnim lijekovima, potrebno je dodati sljedeću referencu: “(vidjeti dijelove 4.3, 4.4, 4.5 i 5.1)”.
For valsartan-containing products with wording in section 4.1 stating that they can be used alone or in combination with other antihypertensive agents, the following cross-reference should be added: “(see sections 4.3, 4.4, 4.5 and 5.1)”. 
Za lijekove koji sadrže valsartan s tekstom u dijelu 4.1 u kojem se navodi da se mogu primjenjivati sami ili u kombinaciji s drugim antihipertenzivnim lijekovima, potrebno je dodati sljedeću referencu: “(vidjeti dijelove 4.3, 4.4, 4.5 i 5.1)”.
“Your doctor may need to change your dose and/or to take other precautions: If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not <take> <use> X” and “Warnings and precautions”)” 
Ako uzimate neki blokator angiotenzin II receptora (ARB) ili aliskiren (vidjeti također informacije pod naslovima “Nemojte <uzimati> <primjenjivati> X” i “Upozorenja i mjere opreza”).”
The following wording should be incorporated in the “Heart failure” section: 
“Doziranje kod zatajenja srca”:
For candesartan-containing products with wording in section 4.1 stating that they can be used alone or in combination with other antihypertensive agents, the following cross-reference should be added: “(see sections 4.3, 4.4, 4.5 and 5.1)”. 
Za lijekove koji sadrže kandesartan s tekstom u dijelu 4.1 u kojem se navodi da se mogu primjenjivati sami ili u kombinaciji s drugim antihipertenzivnim lijekovima, potrebno je dodati sljedeću referencu: “(vidjeti dijelove 4.3, 4.4, 4.5 i 5.1)”.
Section 4.2 - Posology and method of administration For angiotensin II receptor blockers with wording in section 4.2 stating that they can be used alone or in combination with other antihypertensive agents, the following cross-reference should be added: “(see sections 4.3, 4.4, 4.5 and 5.1)”. 
Za blokatore angiotenzin II receptora s tekstom u dijelu 4.2 u kojem se navodi da se mogu primjenjivati sami ili u kombinaciji s drugim antihipertenzivnim lijekovima, potrebno je dodati sljedeću referencu: “(vidjeti dijelove 4.3, 4.4, 4.5 i 5.1)”.
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States 
Popis naziva, farmaceutskih oblika, jačina lijekova, puteva primjene, nositelja odobrenja u državama članicama
Modified-release capsule, hard 
Kapsula s prilagođenim oslobađanjem, tvrda
Coated tablet 
Obložena tableta
P.O. 
Prilog I.
Modified-release tablet 
Tableta s prilagođenim oslobađanjem
Sarotex Retard 25 mg 
Saroten retard Tabs 75 mg
--1 Inactivated influenza A virus/human, strain A/Jena/VI5258/2009(H1N1)pdm09 ≥ 16 HU* *HU = haemagglutinating units 
--1 Inaktivirani virus gripe A/ljudski Soj: A/Jena/VI5258/2009(H1N1)pdm09 ≥ 16 HU*
Annex A 
Dodatak A
Packaging Content 
Put primjene Pakovanje Sastav Veličina pakovanja
EU (MA) Number Invented name 
Izmišljeno ime
ALMIRALL, S.A. Ronda General Mitre, 
Španjolska ALMIRALL, S.A. Ronda General Mitre,
Weifa AS, Hausmannsgate 6, P.O.Box 9113 
Norveška Weifa AS, Hausmannsgate 6, P.O.Box 9113
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States 
Popis imena, farmaceutskih oblika, jačina lijekova, puteva primjene, nositelja odobrenja u zemljama članicama
Merck Medication Familiale 
Francuska Merck Medication Familiale
Unipharm JSC Traiko Stanoev str. № 3 + Sofia 1797 
Bugarska Unipharm JSC Traiko Stanoev str. № 3 + Sofia 1797
The Netherlands ratiopharm Nederland B.V. 
Nizozemska ratiopharm Nederland B.V.
Meda Pharma (France) 25 boulevard de l'amiral bruix 
Francuska Meda Pharma (France) 25 boulevard de l'amiral bruix
NOVARTIS CONSUMER HEALTH, S.A. 
Španjolska NOVARTIS CONSUMER HEALTH, S.A.
Germany Berlin-Chemie AG Glienicker Weg 125 
Njemačka Berlin-Chemie AG Glienicker Weg 125
Sweden sanofi-aventis AB Box: 14142 
Švedska sanofi-aventis AB Box: 14142
Elaiapharm2881, Route des Crêtes 
Francuska Elaiapharm 2881, Route des Crêtes
ITALFARMACO, S.A. San Rafael, 3 
Španjolska ITALFARMACO, S.A. San Rafael, 3
Pharmastra 2c, rue du marchal de lattre de tassigny 
Francuska Pharmastra 2c, rue du marchal de lattre de tassigny
Societe Cilfa Developpement 20, Rue Jean Daudin 75015 - Paris France 
Francuska Societe Cilfa Developpement 20, Rue Jean Daudin 75015 - Paris
S.C. Farmacom S.A. Str. Zizinului Nr. 112, 2200 Braşov, 
Rumunjska S.C. Farmacom S.A. Str. Zizinului Nr. 112, 2200 Braşov,
Gifrer Barbezat8 10, Rue Paul Bert Bp 165 
Francuska Gifrer Barbezat8 10, Rue Paul Bert Bp 165
Luxembourg Laboratoires SMB S.A. Rue de la Pastorale 26- 28 B 1080 
Luksemburg Laboratoires SMB S.A. Rue de la Pastorale 26- 28 B 1080
15, boulevard Charles de Gaulle 
Francuska Biogaran 15, boulevard Charles de Gaulle
Germany Dr. R. Pfleger Chemische Fabrik GmbH 
Njemačka Dr. R. Pfleger Chemische Fabrik GmbH
Arrow Generiques 26, avenue Tony Garnier 
Francuska Arrow Generiques 26, avenue Tony
Azur compositum SC Suppositorien suppository rectal use 
Azur compositum SC Suppositorien čepić rektalno
ibuprofen + codeine Nurofen Plus 
ibuprofen + kodein Nurofen Plus
Denmark Amgros I/S, Dampfærgevej 22, DK-2100 København Ø, Denmark 
Amgros I/S, Dampfærgevej 22, DK-2100 København Ø, Danska kodein
S.C. TERAPIA S.A Str. Fabricii Nr.124, Cluj-Napoca, Judeţul Cluj, 400632 
Fabricii Nr.124, Cluj-Napoca, Judeţul Cluj, 400632
INTERNACIONAL, S.A. Gran Vía Carlos III, 94 08028 Barcelona Spain 
Španjolska FERRER INTERNACIONAL, S.A. Gran Vía Carlos III, 94 08028 Barcelona
Nitrianska 100, Hlohovec 920 27 Slovak Republic codeine 
Nitrianska 100, Hlohovec 920 27 Republika Slovačka kodein
Algocod powder 
Algocod prašak
032266 Bucureşti, Romania codeinum 
032266 Bucureşti, Rumunjska kodein
LABORATORIOS ASOCIADOS NUPEL, S.L. 
Španjolska LABORATORIOS ASOCIADOS NUPEL, S.L.
Germany Merck Serono GmbH Alsfelder Str. 17 
Njemačka Merck Serono GmbH Alsfelder Str. 17
Ziduri între Vii nr.22, Bucureşti, sector 3, 023324 
Rumunjska S.C. SINTOFARM S.A.Str. Ziduri între Vii nr.22, Bucureşti, sector 3, 023324
Bristol Myers Squibb3, rue Joseph Monier 92500 RueilMalmaison 
Francuska Bristol Myers Squibb3, rue Joseph Monier 92500 Rueil
49, avenue Georges Pompidou 
Francuska SANDOZ 49, avenue Georges Pompidou
Pelplińska 19 Starogard Gdański 
Farmaceutyczne POLPHARMA S.A. ul. Pelplińska 19 Starogard Gdański
Cod., suppositoria 400 mg 9.6 mg 
A.C. Cod., suppositoria 400 mg 9.6 mg
Luxembourg Mylan bvba/sprl Rozendal Businesspark Terhulpsesteenweg 6A B-1560 Hoeilaart Belgium 
Luksemburg Mylan bvba/sprl Rozendal Businesspark Terhulpsesteenweg 6A B-1560 Hoeilaart Belgija paracetamol/ kodeinfosfat
Germany MEDA Manufacturing GmbH 
Njemačka MEDA Manufacturing GmbH
Denmark Alternova A/S, Lodshusvej 11, DK4230 Skælskør, Denmark 
Alternova A/S, Lodshusvej 11, DK4230 Skælskør, Danska kodein
Bouchara Recordati 68, Rue Marjolin Bp 67 
Francuska Bouchara Recordati 68, Rue Marjolin
The Czech Republic 
Republika Češka
Germany Astellas Pharma GmbH Gearg-Brauchle-Ring 
Njemačka Astellas Pharma GmbH Gearg-Brauchle-Ring
Germany Temmler Werke GmbH Weihenstephaner Str. 
Njemačka Temmler Werke GmbH Weihenstephaner Str.
Germany ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 
Njemačka ALIUD PHARMA GmbH Gottlieb-Daimler-Str.
5 mg/5ml 200 mg/5ml suspension 
5 mg/5ml 200 mg/5ml suspenzija
3 Rue Joseph Monier 92500 Rueil Malmaison France paracetamol + codeine phosphate 
3 Rue Joseph Monier 92500 Rueil Malmaison Francuska paracetamol + kodeinfosfat
S.C. Fabiol S.A, B-dul Timişoara nr. 50, Bucureşti, 
Rumunjska S.C. Fabiol S.A, B-dul Timişoara nr. 50,
Germany Aristo Pharma GmbH Wallenroder Str. 8-10 
Njemačka Aristo Pharma GmbH Wallenroder Str. 8-10
08022 Barcelona Spain 
08022 Barcelona
Slovak Republic 
Republika Slovačka
13500 HÄMEENLINNA Finland 
Hämeenlinna 13500
Germany Stadapharm GmbH Stadastr. 
Njemačka Stadapharm GmbH Stadastr.
Germany Novartis Pharma GmbH 
Njemačka Novartis Pharma GmbH
solution for injection parenteral use 
otopina za injekciju parenteralno
Germany OPTIMED Pharma GmbH 
Njemačka OPTIMED Pharma GmbH
Via Nocera Umbra, 75 00181 Roma Italy paracetamol + codeine 'PARACETAMOLO + CODEINA ANGENERICO 
Via Nocera Umbra, 75 00181 Roma Italija paracetamol + kodein 'PARACETAMOLO + CODEINA ANGENERICO
S.C. Slavia Pharm S.R.L. 
Rumunjska S.C. Slavia Pharm S.R.L.
Norway ratiopharm Oy- Teva Group Menmber, Keilaranta 10 E, 02150 Espoo, 
Norveška ratiopharm Oy- Teva Group Menmber,
CANTABRIA PHARMA, S.L. 
Španjolska CANTABRIA PHARMA, S.L.
Solpadeine Migraine Ibuprofen & Codeine Tablets film-coated tablet oral use 
Solpadeine Migraine Ibuprofen & Codeine Tablets filmom obložena tableta
2031 GA Haarlem The Netherlands 
2031 GA Haarlem Nizozemska kodein
Aspar Pharmaceuticals Limited, 29-30 Capitol Way, Colindale, London NW9 0EQ United Kingdom 
Aspar Pharmaceuticals Limited, 29-30 Capitol Way, Colindale, London NW9 0EQ Velika Britanija kodeinfosfat + paracetamol
Talvosilen forte 1000/60 1000mg/60 mg suppository rectal use 
Talvosilen forte 1000/60 1000mg/60 mg čepić rektalno
SW1V 2SA United Kingdom ibuprofen +codeine 
SW1V 2SA Velika Britanija ibuprofen +kodein
Nitrianska 100, Hlohovec 920 27 Slovak Republic acetylsalicylic acid + codeine + caffeine 
Nitrianska 100, Hlohovec 920 27 Republika Slovačka acetilsalicilatna kiselina + kodein + kofein
125/5 ml mg + 7,5/5 ml mg syrup 
125/5 ml mg + 7,5/5 ml mg sirup
Luxembourg MEDA PHARMA 25 boulevard de l'amiral Bruix F-75016 Paris France 
Luksemburg MEDA PHARMA 25 boulevard de l'amiral Bruix F-75016 Paris Francuska paracetamol/ kodeinfosfat hemihidrat
Via Lorenzini, 8 20139 Milano Italy paracetamol + codeine phosphate 
Via Lorenzini, 8 20139 Milano Italija paracetamol + kodeinfosfat
1 mg/ml syrup 
1 mg/ml sirup
paracetamol + codeine Medocodene 30/500 Capsules 
paracetamol + kodein Medocodene 30/500 Capsules kapsula
FOURRTS (UK)PHARMACARE LIMITED, 30 Chaul End Lane, Luton, Bedfordshire, LU4 8EZ, United Kingdom 
FOURRTS (UK)PHARMACARE LIMITED, 30 Chaul End Lane, Luton, Bedfordshire, LU4 8EZ, Velika Britanija kodeinfosfat +paracetamol
25 mg/ml + 1,5 mg/ml syrup 
25 mg/ml + 1,5 mg/ml sirup
Paracetamol/Codeine PARACETAMOL CODEINE SANOFI-AVENTIS 
Francuska paracetamol/kodein PARACETAMOL CODEINE SANOFI-AVENTIS
170 09 Solna Sweden codeine hydrochloride dihydrate, papaverine hydrochloride, morphine hydrochloride, hyoscine methonitrate, noscapine hydrochloride 
170 09 Solna Švedska kodeinklorid dihidrat, papverinklorid, morfinklorid, hioscinijev metonitrat, noskapinklorid
Vitabalans Oy Varastokatu 8, Hämeenlinna FI-13500 Finland codeine + paracetamol 
Vitabalans Oy Varastokatu 8, Hämeenlinna FI-13500 Finska kodein + paracetamol
MAX REMEDIES LIMITED, Stoney Gate House, 2 Greenfield Road, Holmfirth, West Yorkshire, HD9 2JT, United Kingdom 
MAX REMEDIES LIMITED, Stoney Gate House, 2 Greenfield Road, Holmfirth, West Yorkshire, HD9 2JT, Velika Britanija kodeinfosfat +paracetamol+kofein
LABORATORIOS ERN, S.A. 
Španjolska LABORATORIOS ERN, S.A.
LABORATORIES (HOLDINGS)LIMITED, Unit 2A Sefton Business Park, Aintree, Liverpool, L30 1RD, United Kingdom 
LABORATORIES (HOLDINGS)LIMITED, Unit 2A Sefton Business Park, Aintree, Liverpool, L30 1RD, Velika Britanija kodeinfosfat +paracetamol
hard capsule 
Talvosilen Forte kapsula
20144 Milano Italy paracetamol + codeine phosphate 
20144 Milano Italija paracetamol + kodeinfosfat
Str. Prahova, Nr. 6A, Sector 1, Bucureşti 012423, România paracetamol, fosfat de codeină hemihidrat, cafeină anhidră 
Rumunjska HIPOCRATE 2000 S.R.L. Str. Prahova, Nr. 6A, Sector 1, Bucureşti 012423, Rumunjska paracetamol, kodeinfosfat hemihidrat, kofein bezvodni
Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG United Kingdom 
Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG Velika Britanija kodeinfosfat
Codeine phosphate hemihydrate + ibuprofen 
kodeinfosfat hemihidrat+ ibuprofen
Apotex Europe B.V. Darwinweg 20 
Nizozemska Apotex Europe B.V.
Viale Amelia 70 00181 Roma Italy paracetamol + codeine phosphate 
Viale Amelia 70 00181 Roma Italija paracetamol + kodeinfosfat
Germany codeinphosphathemihydrat codi OPT 
Njemačka kodeinfosfat hemihidrat codi OPT
Chefaro Ireland Limited, First Floor, Block A, The Crescent Building, Northwood Office Park, Dublin 9, Ireland 
Chefaro Ireland Limited, First Floor, Block A, The Crescent Building, Northwood Office Park, Dublin 9, Irska paracetamol kodeinfosfat kofein
Czech Republic codeine + paracetamol + fenpiverine + pitofenon 
Republika Češka kodein + paracetamol + fenpiverin + pitofenon
Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG, United Kingdom codeine phosphate 
Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG, Velika Britanija kodeinfosfat
TEVA PHARMA, S.L.U. 
Španjolska TEVA PHARMA, S.L.U.
21,17 mg +325 mg tablet 
21,17 mg +325 mg tableta
28,73 mg + 325 mg tablet 
28,73 mg + 325 mg tableta
Actavis EAD 29 Atanas Dukov Str. + Sofia 1407 
Bugarska Actavis EAD 29 Atanas Dukov Str.
182 12 Danderyd Sweden codeine phosphate hemihydrate/ paracetamol 
182 12 Danderyd Švedska kodeinfosfat hemihidrat/ paracetamol
Alkaloid-Int. d.o.o. 
Slovenija Alkaloid-Int. d.o.o. Šlandrova 4,
Optipyrin suppository rectal use 
Optipyrin čepić rektalno
ENNOGEN PHARMA LIMITED, Unit G4, Riverside Industrial Estate, Riverside Way, Dartford, DA1 5BS United Kingdom 
ENNOGEN PHARMA LIMITED, Unit G4, Riverside Industrial Estate, Riverside Way, Dartford, DA1 5BS Velika Britanija kodeinfosfat +paracetamol
Actavis Group hf.Reykjavikurvegur 7678 - 220 Hafnarfjörður Iceland 
Actavis Group hf.Reykjavikurvegur 7678 - 220 Hafnarfjörður Island paracetamol /kodeinfosfat hemihidrat
Vitabalans Oy Varastokatu 8. 
Mađarska Vitabalans Oy Varastokatu 8.
BRISTOL MYERS SQUIBB, S.A. 
Španjolska BRISTOL MYERS SQUIBB, S.A.
Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG, United Kingdom paracetamol + codeine Teva UK Co-Codamol Tablets 8/500 
Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG, Velika Britanija paracetamol + kodein Teva UK Co-Codamol Tablets 8/500
Paracetamol/Codeine GAOSEDAL CODEINE, comprimé 
Francuska paracetamol/kodein GAOSEDAL CODEINE, comprimé
0,8mg, 40 mg, 13 mg, 0,5 mg, 6 mg suppository rectal use 
0,8mg, 40 mg, 13 mg, 0,5 mg, 6 mg čepić rektalno
SW1V 2SA United Kingdom paracetamol + codeine Solpadeine Max Tablets 500mg + 12.8mg film-coated tablet oral use 
SW1V 2SA Velika Britanija paracetamol + kodein Solpadeine Max Tablets 500mg + 12.8mg filmom obložena tableta
650 mg and 28,09 mg suppository rectal use 
650 mg and 28,09 mg čepić rektalno
paracetamol + codeine Tylex Tablets coated tablet 
paracetamol + kodein Tylex Tablets obložena tableta kroz usta
Luxembourg bene-Arzneimittel GmbH Herterichstraße 1-3 D-81479 München Germany 
Luksemburg bene-Arzneimittel GmbH Herterichstraße 1-3 D-81479 München Njemačka paracetamol/ kodeinfosfat hemihidrat
Paracetamol codeine teva dispersible tablet oral use 
Paracetamol codeine teva tablet za oralnu suspenziju
Codeine (Chlorhydrate de) /acétylsalicylique (acide)/ paracétamol/paracétam ol granulé 96 
Souffelweyersheim Francuska kodein (klorhidrat) / acetilsalicilatna kiselina paracetamol/ paracetamol granule 96
LABORATORIOS ALTER, S.A. 
Španjolska LABORATORIOS ALTER, S.A.
Soluble Cupanol-Co Lemon Flavour effervescent tablet 
Soluble Cupanol-Co Lemon Flavour šumeća tableta kroz usta
9GS Brentford United Kingdom codeine + paracetamol + caffeine 
9GS Brentford Velika Britanija kodein + paracetamol + kofein
GEDEON RICHTER ROMÂNIA SA Str. Cuza Vodă nr. 99105, Târgu-Mureş, Romania acid acetilsalicilic, paracetamol , fosfat de codeină hemihidrat , cafeină anhidră 
Cuza Vodă nr. 99105, Târgu-Mureş, Rumunjska acetilsalicilatna kiselina, paracetamol, kodeinfosfat hemihidrat, kofein bezvodni
Migraleve Yellow Tablets: 520mg, 8mg film-coated tablet oral use 
Migraleve Yellow Tablets: 520mg, 8mg filmom obložena tableta
Brentford TW89GS United Kingdom paracetamol, codeine, caffeine 
Brentford TW89GS United Kingdom paracetamol, kodein, kofein
GlaxoSmithKline Consumer Healthcare GSK Export Ltd. 
Mađarska GlaxoSmithKline Consumer Healthcare GSK Export Ltd.
Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2730-055 Barcarena Portugal 
Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2730-055 Barcarena Portugal paracetamol + kodeinfosfat + buklizin hidroklorid
Codeinum phosphoricum Berlin-Chemie 
Njemačka kodeinfosfat hemihidrat Codeinum phosphoricum Berlin-Chemie
600 mg suppository rectal use 
600 mg čepić rektalno
CIPLA (EU) LIMITED, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW United Kingdom 
CIPLA (EU) LIMITED, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW Velika Britanija kodeinfosfat +paracetamol
Paracetamol/Codeine ALGISEDAL, comprimé 400 mg/25 mg, 
Francuska paracetamol/kodein ALGISEDAL, comprimé 400 mg/25 mg,
DOLODENS GRAGEAS 10 mg, 15 mg and 100 mg coated tablet 
DOLODENS GRAGEAS 10 mg, 15 mg and 100 mg obložena tableta kroz usta
28042 Madrid Spain 
28050 Madrid
400 mg and 30 mg granules for oral suspension 
400 mg and 30 mg granule za oralnu suspenziju
FARMASIERRA LABORATORIOS, S.L. 
LABORATORIOS, S.L.
S.C. LaborMed Pharma S.A.,B-dul Theodor Pallady nr. 44 B,sector 
Rumunjska S.C. LaborMed Pharma S.A.,B-dul Theodor
paracetamol + codeine Codis 500 Tablets tablet for oral solution 
paracetamol + kodein Codis 500 Tablets tableta za oralnu otopinu
81673 München Germany codeinphosphathemihydrat acetylsalicylsäure paracetamol 
81673 München Njemačka kodeinfosfat hemihidrat acetilsalicilatna kiselina paracetamol
300 mg and 14,05 mg capsule, hard oral use 
300 mg and 14,05 mg kapsula, tvrda kroz usta
Paralgin Major suppository rectal use 
Paralgin Major čepić rektalno
Denmark Takeda Pharma A/S, Langebjerg 1, DK4000 Roskilde 
Takeda Pharma A/S, Langebjerg 1, DK4000 Roskilde Danska kodein
Ospedaletto - Pisa Italy paracetamol + codeine AZSHARA 
Ospedaletto - Pisa Italija paracetamol + kodein AZSHARA
SW1V 2SA United Kingdom paracetamol + codeine Solpadeine Max 
SW1V 2SA Velika Britanija paracetamol + kodein Solpadeine Max
Tylex 30 mg / 500 mg Hard Capsules capsule, hard oral use 
Tylex 30 mg / 500 mg Hard Capsules kapsula, tvrda kroz usta
90429 Nürnberg Germany codeinphosphathemihydrat diclofenac-natrium 
90429 Nürnberg Njemačka kodeinfosfat hemihidrat diklofenaknatrij
Seton Products Ltd., Tubiton House, Medlock Street, Oldham, OL1 3HS, United Kingdom 
Seton Products Ltd., Tubiton House, Medlock Street, Oldham, OL1 3HS, Velika Britanija paracetamol kodeinfosfat doksilaminsukcinat kofein
Czech Republic bene-Arzneimittel GmbH 
Republika Češka bene-Arzneimittel GmbH
Titretta Zäpfchen suppository rectal use 
Titretta Zäpfchen čepić rektalno
Bayer Sante Familiale 33, Rue De L'industrie 74240 Gaillard France 
Francuska Bayer Sante Familiale 33, Rue De L'industrie
500 mg + 9,6 mg tablet 
500 mg + 9,6 mg tableta
Ospedaletto - Pisa Italy paracetamol + codeine ADOREA 
Ospedaletto - Pisa Italija paracetamol + kodein ADOREA