CO EFFERALGAN

Informazioni principali

  • Nome commerciale:
  • COEFFERALGAN 16CPR EFF500 30MG
  • Forma farmaceutica:
  • CPR EFFERVESCENTI/SOLUBILI
  • Composizione:
  • "500 MG + 30 MG COMPRESSE EFFERVESCENTI" 16 COMPRESSE
  • Classe:
  • C
  • Tipo di ricetta:
  • Ricetta non ripetibile, validità 30gg, ripetibile 1 volta
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Farmaco allopatico

Documenti

  • per i professionisti:
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Localizzazione

  • Disponibile in:
  • COEFFERALGAN 16CPR EFF500 30MG
    Italia
  • Lingua:
  • italiano

Altre informazioni

Status

  • Fonte:
  • AIFA - Agenzia Italiana del Farmaco
  • Numero dell'autorizzazione:
  • 038393017
  • Ultimo aggiornamento:
  • 09-08-2016

Foglio illustrativo

DENOMINAZIONE

CO-EFFERALGAN

CATEGORIA FARMACOTERAPEUTICA

Codeina, associazioni

PRINCIPI ATTIVI

Compresse rivestite con film : ogni compressa contiene

paracetamolo 500 mg, codeina fosfato 30 mg.

Compresse effervescenti : ogni compressaeffervescente contiene

paracetamolo 500 mg, codeina fosfato 30 mg.

ECCIPIENTI

Compresse rivestite con film : povidone, cellulosa

microcristallina, croscarmellosa sodica, magnesio stearato.

Agente filmante: ipromellosa(E464), titanio diossido (E171),

glicole propilenico.

Compresse effervescenti : sodio bicarbonato, sodio carbonato,

acido citrico, sorbitolo, sodio benzoato, sodio docusato,

polivinilpirrolidone, aspartame, aroma naturale pompelmo.

INDICAZIONI

Trattamento sintomatico delle affezioni dolorose (ad esempio mal

di testa, mal di denti, torcicollo, dolori articolari e

lombosacrali, dolori mestruali, piccoli interventi chirurgici).

CONTROINDICAZIONI/EFFETTI SECONDARI

Bambini di eta' inferiore ai 15 anni.

Ipersensibilita' al paracetamoloo ai componenti la formulazione.

I prodotti a base di paracetamolo sono controindicati nei

pazienti con manifesta insufficienza della glucosio-6-fosfato

deidrogenasi e in quelli affetti da grave anemia emolitica.

Grave insufficienza epatocellulare.

La codeina e' controindicata in casi di insufficienza

respiratoria.

POSOLOGIA

1-2 compresse a seconda dell'entita' del dolore 1-3 volte al

giorno adintervalli di almeno 4 ore.

In caso di grave insufficienza renale l'intervallo tra due

somministrazioni deve essere di almeno 8 ore.

Le compresse effervescenti devono essere sciolte in un bicchiere

d'acqua, secondo le indicazioni.

CONSERVAZIONE

Proteggere da umidita' e calore.

AVVERTENZE

Dosi elevate o prolungate del prodotto possono provocare una

epatopatia ad alto rischio e alterazioni, anche gravi, a carico

del rene e delsangue (paracetamolo) o dare luogo a dipendenza

(codeina).

Non somministrare durante il trattamento cronico con farmaci che

possono determinare l'induzione delle monoossigenasi epatiche o

in caso di esposizionea sostanze che possono avere tale effetto

(paracetamolo) (vedi 4.5).

Tenere fuori dalla portata dei bambini.

Il paracetamolo deve essere somministrato con cautela in soggetti

con insufficienza renale o epatica.

con insufficienza renale o epatica.

Durante il trattamento con paracetamolo prima di assumere

qualsiasialtro farmaco controllare che non contenga lo stesso

principio attivo,poiche' se il paracetamolo e' assunto in dosi

elevate si possono verificare gravi reazioni avverse.

Invitare il paziente a contattare il medico prima di associare

qualsiasi altro farmaco.

Vedere anche la voce"Interazioni".

In caso di reazioni allergiche si deve sospendere la

somministrazione.

E' opportuno, per la presenza di codeina, non assumerebevande

alcooliche; la codeina puo' provocare aumento dell'ipertensione

intracranica.

In caso di dieta iposodica, occorre tener presente che 1

compressa effervescente di CO-EFFERALGAN contiene 380 mg di

sodio(pari a 16,5 mEq).

INTERAZIONI

Nel corso di terapie con anticoagulanti orali si consiglia di

ridurrele dosi.

Usare con estrema cautela e sotto stretto controllo durante il

trattamento cronico con farmaci che possono determinare

l'induzionedelle monoossigenasi epatiche o in caso di esposizione

a sostanze chepossono avere tale effetto (per esempio

rifampicina, cimetidina, antiepilettici quali glutetimmide,

fenobarbital, carbamazepina).

La somministrazione di paracetamolo puo' interferire con la

determinazione dellauricemia (mediante il metodo dell'acido

fosfotungstico) e con quelladella glicemia (mediante il metodo

della glucosio-ossidasi-perossidasi).

Gli effetti degli alcaloidi dell'oppio possono essere potenziati

daaltri farmaci depressori come sedativi, tranquillanti ed

antistaminici.

EFFETTI INDESIDERATI

Con l'uso di paracetamolo sono state segnalate reazioni cutanee

di vario tipo e gravita' inclusi casi di eritema multiforme,

sindrome di Stevens-Johnson e necrolisi epidermica.

Sono state segnalate reazioni diipersensibilita' quali ad esempio

angioedema, edema della laringe, shock anafilattico.

Inoltre, sono stati segnalati i seguenti effetti indesiderati:

trombocitopenia, leucopenia, anemia, agranulocitosi, alterazioni

della funzionalita' epatica ed epatiti, alterazioni a carico

delrene (insufficienza renale acuta, nefrite interstiziale,

ematuria, anuria), reazioni gastrointestinali e vertigini.

In caso di iperdosaggio,il paracetamolo puo' provocare citolisi

epatica che puo' volvere verso la necrosi massiva e

irreversibile.

Gli effetti indesiderati della codeina sono rappresentati da

sonnolenza, stipsi, nausea, vomito, broncospasmo, depressione

respiratoria.

GRAVIDANZA E ALLATTAMENTO

Non utilizzare nel primo trimestre di gravidanza e durante

l'allattamento.

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

18-7-2018

Sodium glucose co-transporter 2 inhibitors

Sodium glucose co-transporter 2 inhibitors

Safety advisory - diabetic ketoacidosis and surgical procedures

Therapeutic Goods Administration - Australia

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product ...

FDA - U.S. Food and Drug Administration

17-5-2018

BLM Issues Allergy Alert On Undeclared Egg and Milk

BLM Issues Allergy Alert On Undeclared Egg and Milk

BLM Prod.-u. Vertriebsges. mbH & Co. KG, is voluntarily recalling Priano Rosso Pesto Sauce as it may contain undeclared milk and egg. People who have an allergy or severe sensitivity to milk and egg run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

16-5-2018

Mas Food Services Co. Issues Allergy Alert on Undeclared Sulfites in The Peruchef Dry Potato

Mas Food Services Co. Issues Allergy Alert on Undeclared Sulfites in The Peruchef Dry Potato

Mas Food Services Co. of Oakland Park, FL is recalling its 15 ounce packages of The Peruchef brand dry potato because it may contain undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

8-5-2018

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

The FDA has received reports associated with the use of these devices in the treatment of unruptured brain aneurysms that suggest some events of peri-procedural stroke and/or death may have been related to procedural risks or patient selection related factors. These factors include patients who had serious co-morbidities resulting in a reduced life expectancy, or who were intolerant to required anticoagulation or anti-platelet therapy.

FDA - U.S. Food and Drug Administration

11-7-2012

The Pharmaceutical Inspection Co-operation Scheme

The Pharmaceutical Inspection Co-operation Scheme

New document has been published

Europe - EFSA - European Food Safety Authority EFSA Journal

2-7-2018

Verifica urgente - Officina Farmaceutica: Zhejiang Huahai Pharmaceutical (Cina) (02/07/2018)

Verifica urgente - Officina Farmaceutica: Zhejiang Huahai Pharmaceutical (Cina) (02/07/2018)

Richiesta alle Aziende Farmaceutiche detentrici dell’Autorizzazione all’Immissione in Commercio per il mercato italiano di medicinali ad uso umano e/o alle Aziende produttrici di medicinali destinati al mercato comunitario o all'esportazione in Paesi terzi contenenti VALSARTAN come materia prima farmacologicamente attiva e/o intermedio di produzione fornita dal produttore: ZHEJIANG HUAHAI PHARMACEUTICAL Co. Ltd (Cina).

Italia - AIFA - Agenzia Italiana del Farmaco

19-6-2018

Maviret (AbbVie Deutschland GmbH and Co. KG)

Maviret (AbbVie Deutschland GmbH and Co. KG)

Maviret (Active substance: glecaprevir / pibrentasvir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3916 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4430/T/11

Europe -DG Health and Food Safety

11-6-2018

Viekirax (AbbVie Deutschland GmbH and Co. KG)

Viekirax (AbbVie Deutschland GmbH and Co. KG)

Viekirax (Active substance: ombitasvir / paritaprevir / ritonavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3766 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3839/T/45

Europe -DG Health and Food Safety

4-6-2018

Venclyxto (AbbVie Deutschland GmbH and Co. KG)

Venclyxto (AbbVie Deutschland GmbH and Co. KG)

Venclyxto (Active substance: venetoclax) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3633 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4106/T/12

Europe -DG Health and Food Safety

4-6-2018

Exviera (AbbVie Deutschland GmbH and Co. KG)

Exviera (AbbVie Deutschland GmbH and Co. KG)

Exviera (Active substance: dasabuvir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3628 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3837/T/38

Europe -DG Health and Food Safety

29-5-2018

Norvir (AbbVie Deutschland GmbH and Co. KG)

Norvir (AbbVie Deutschland GmbH and Co. KG)

Norvir (Active substance: Ritonavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3340 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/127/T/149

Europe -DG Health and Food Safety

25-5-2018

Kaletra (AbbVie Deutschland GmbH and Co. KG)

Kaletra (AbbVie Deutschland GmbH and Co. KG)

Kaletra (Active substance: lopinavir / Ritonavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3282 of Fri, 25 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/368/T/169

Europe -DG Health and Food Safety

16-5-2018

EU/3/14/1305 (AbbVie Deutschland GmbH and Co. KG)

EU/3/14/1305 (AbbVie Deutschland GmbH and Co. KG)

EU/3/14/1305 (Active substance: Humanised recombinant monoclonal antibody against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F) - Transfer of orphan designation - Commission Decision (2018)3022 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/065/14/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/17/1954 (AbbVie Deutschland GmbH and Co. KG)

EU/3/17/1954 (AbbVie Deutschland GmbH and Co. KG)

EU/3/17/1954 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3028 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/131/17/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1767 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1767 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1767 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3027 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/121/16/T01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1766 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1766 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1766 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3026 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/122/16/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1667 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1667 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1667 (Active substance: Rovalpituzumab tesirine) - Transfer of orphan designation - Commission Decision (2018)3025 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/015/16/T02

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1649 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1649 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1649 (Active substance: Humanised recombinant IgG4 anti-human tau antibody) - Transfer of orphan designation - Commission Decision (2018)3024 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/239/15/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1617 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1617 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1617 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3023 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/205/15/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/830 (AbbVie Deutschland GmbH and Co. KG)

EU/3/10/830 (AbbVie Deutschland GmbH and Co. KG)

EU/3/10/830 (Active substance: Veliparib) - Transfer of orphan designation - Commission Decision (2018)3021 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/10/T/02

Europe -DG Health and Food Safety

15-5-2018

Synagis (AbbVie Deutschland GmbH and Co. KG)

Synagis (AbbVie Deutschland GmbH and Co. KG)

Synagis (Active substance: palivizumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3064 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/257/T/116

Europe -DG Health and Food Safety

3-4-2018

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (Active substance: 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) - Transfer of orphan designation - Commission Decision (2018)2056 of Tue, 03 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/124/12/T/01

Europe -DG Health and Food Safety