Phenoxymethylpenicillinkalium "EQL Pharma"

Primær information

  • Handelsnavn:
  • Phenoxymethylpenicillinkalium "EQL Pharma" 800 mg filmovertrukne tabletter
  • Dosering:
  • 800 mg
  • Lægemiddelform:
  • filmovertrukne tabletter
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Phenoxymethylpenicillinkalium "EQL Pharma" 800 mg filmovertrukne tabletter
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 53668
  • Sidste ændring:
  • 22-02-2018

Indlægsseddel

INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN

Phenoxymethylpenicillinkalium EQL Pharma

800 mg filmovertrukne tabletter

Phenoxymethylpenicillinkalium

Læs denne indlægsseddel grundigt, inden du begynder at tage dette lægemiddel, da den

indeholder vigtige oplysninger.

Gem indlægssedlen. Du kan få brug for at læse den igen.

Spørg lægen eller apoteketspersonalet, hvis der er mere, du vil vide.

Lægen har ordineret Phenoxymethylpenicillinkalium EQL Pharma til dig personligt. Lad derfor

være med at give det til andre. Det kan være skadeligt for andre, selvom de har de samme

symptomer, som du har.

Kontakt lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke

er nævnt her.

Oversigt over indlægssedlen

Virkning og anvendelse

Det skal du vide, før du begynder at tage Phenoxymethylpenicillinkalium EQL Pharma

Sådan skal du tage Phenoxymethylpenicillinkalium EQL Pharma

Bivirkninger

Opbevaring

Pakningsstørrelser og yderligere oplysninger

1.

VIRKNING OG ANVENDELSE

Phenoxymethylpenicillinkalium EQL Pharma er et smalspektret antibiotikum af penicillintypen.

Phenoxymethylpenicillinkalium EQL Pharma anvendes til behandling af

betændelser i

bihuler, øre,

hals, bronkier og lunger.

2.

DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE

PHENOXYMETHYLPENICILLINKALIUM EQL PHARMA

Lægen kan have foreskrevet anden anvendelse eller dosering end angivet i denne information. Følg

altid lægens anvisning og oplysningerne på doseringsetiketten.

Tag ikke Phenoxymethylpenicillinkalium EQL Pharma

hvis du er allergisk over for phenoxymethylpenicillinkalium eller et af de øvrige indholdsstoffer

(se pkt. 6).

hvis du er overfølsom over for penicilliner eller andre antibiotika (beta-lactamer).

Advarsler og forsigtighedsregler

Før du begynder at tage denne medicin skal du fortælle din læge

hvis du lider af allergi eller har astma

hvis du er overfølsom over for anden medicin mod infektioner (cefalosporiner og penicillin)

Kontakt straks lægen eller skadestuen, hvis du får:

voldsom eller langvarig, blodig diaré, når du bruger eller har brugt

Phenoxymethylpenicillinkalium EQL Pharma. Det kan være tegn på en alvorlig tarmbetændelse.

pludselige overfølsomhedsreaktioner f.eks. hududslæt, åndedrætsbesvær, hævelse af ansigt, læber

og hals og besvimelse (anafylaktiske reaktioner). Opstår symptomerne inden for minutter til timer,

skal du straks ringe 112. Kan være livsfarligt.

Vedvarende diare eller opkastning

Andre forholdsregler

Ved længere tids behandling bør din læge kontrollere din lever- og nyrefunktion samt undersøge, om

der er ændringer i blodets sammensætning ved en blodprøvekontrol.

Oplys altid ved blodprøvekontrol og urinprøvekontrol, at du er i behandling med

Phenoxymethylpenicillinkalium EQL Pharma. Det kan påvirke prøveresultaterne.

Brug af anden medicin sammen med Phenoxymethylpenicillinkalium EQL Pharma

Fortæl det altid til lægen eller på apoteket, hvis du bruger anden medicin eller har brugt det for nylig.

Dette gælder også medicin, som ikke er købt på recept, medicin købt i udlandet, naturlægemidler,

stærke vitaminer og mineraler samt kosttilskud.

Fortæl din læge, hvis du tager eller bruger nogle af nedenstående lægemidler, da både deres virkning

og Phenoxymethylpenicillinkalium EQL Pharmas virkning kan blive ændret ved samtidig anvendelse:

Methotrexat (middel til behandling af blodkræft, psoriasis og leddegigt)

Probenecid/allopurinol (midler til behandling af urinsyregigt)

Brug af Phenoxymethylpenicillinkalium EQL Pharma

sammen med mad og drikke

Du kan tage Phenoxymethylpenicillinkalium EQL Pharma sammen med mad og drikke.

Graviditet og amning

Spørg din læge eller apoteket til råds, før du tager nogen form for medicin.

Du kan tage Phenoxymethylpenicillinkalium EQL Pharma under graviditet.

Du kan tage Phenoxymethylpenicillinkalium EQL Pharma, selvom du ammer.

Phenoxymethylpenicillinkalium EQL Pharma bliver udskilt i modermælken.

Trafik- og arbejdssikkerhed

Phenoxymethylpenicillinkalium EQL Pharma påvirker ikke arbejdssikkerheden eller evnen til at

færdes sikkert i trafikken.

Phenoxymethylpenicillinkalium EQL Pharma indeholder kalium

Phenoxymethylpenicillinkalium EQL Pharma 800 mg indeholder 2,1 mmol (81 mg) kalium pr. tablet.

3.

SÅDAN SKAL DU TAGE PHENOXYMETHYLPENICLLINKALIUM EQL PHARMA

Tag altid Phenoxymethylpenicillinkalium EQL Pharma nøjagtigt efter lægens anvisning. Er du i tvivl,

så spørg lægen eller på apoteket.

Administrationsmetode

Phenoxymethylpenicillinkalium EQL Pharma filmovertrukne tabletter er kun til oralt brug (gennem

munden).

Tabletterne er forsynet med en delekærv. Tabletterne kan deles i to lige store doser.

Voksne

Den daglige dosis afhænger af din alder, vægt, nyrefunktion og hvor svær betændelsen er. Følg lægens

anvisning.

Den sædvanlige dosering er:

800 mg 2-4 gange daglig.

Børn

Dosis afhænger af barnets vægt og hvor svær betændelsen er. Din læge vil oplyse dig om den præcise

dosis til dit barn. Følg altid lægens anvisning.

Nedsat nyrefunktion:

Det kan være nødvendigt at nedsætte dosis. Følg lægens anvisning.

Hvis du har taget for meget Phenoxymethylpenicillinkalium EQL Pharma

Kontakt lægen, skadestuen eller apoteket, hvis du har taget mere Phenoxymethylpenicillinkalium EQL

Pharma, end der står her, eller mere end lægen har foreskrevet, og du af den grund føler dig utilpas.

Tag emballagen med.

Symptomer på overdosering kan være kvalme, opkastning, diaré, bevidsthedsændring, forstyrrelser i

saltbalancen, muskeltrækninger, krampeanfald, dyb bevidstløshed (koma), alvorlig blodmangel med

gulsot og nyresvigt.

Hvis du har glemt at tage Phenoxymethylpenicillinkalium EQL Pharma

Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis. Fortsæt blot med den

sædvanlige dosis.

Hvis du holder op med at tage Phenoxymethylpenicillinkalium EQL Pharma

Du må kun holde pause eller stoppe behandlingen efter aftale med lægen. Spørg lægen eller på

apoteket, hvis der er noget, du er i tvivl om.

4.

BIVIRKNINGER

Phenoxymethylpenicillinkalium EQL Pharma kan som al anden medicin give bivirkninger, men ikke

alle får bivirkninger.

Følgende bivirkninger er blevet rapporteret:

Alvorlige bivirkninger:

Ikke almindelige bivirkninger (det sker hos mellem 1 og 10 ud af 1.000 behandlede):

Hævelse af tunge, læber og ansigt. Kontakt straks læge eller skadestue. Ring evt. 112.

Alvorligt hududslæt med betændelse og afstødning af hudens øverste lag. Kontakt læge eller

skadestue.

Sjældne bivirkninger (det sker hos mellem 1 og 10 ud af 10.000 behandlede):

Pludseligt hududslæt, åndedrætbesvær og besvimelse (inden for minutter til timer), pga.

overfølsomhed (anafylaktisk reaktion/shock). Ring 112. Kan være livsfarligt.

Meget sjældne bivirkninger (det sker hos færre end 1 ud af 10.000 behandlede):

Almen sløjhed, tendens til betændelse (infektioner) især halsbetændelse og feber pga. forandringer

i blodet (for få hvide blodlegemer).

Blødning fra hud og slimhinder og blå mærker pga. forandringer i blodet (for få blodplader).

Kontakt læge eller skadestue.

Alvorlig blodmangel med gulsot (hæmolytisk anæmi). Kontakt læge eller skadestue.

Ikke kendt (kan ikke estimeres ud fra forhåndenværende data):

Svær, langvarig eller blodig diaré med mavesmerter eller feber. Kontakt læge eller skadestue.

Ikke alvorlige bivirkninger:

Almindelige - meget almindelige bivirkninger (det sker hos flere end 1 ud 100 behandlede):

Udslæt

Almindelige bivirkninger (det sker hos mellem 1 og 10 ud af 100 behandlede):

Kvalme og diaré

Ikke almindelige bivirkninger (det sker hos mellem 1 og 10 ud af 1.000 behandlede):

Feber

Smerter i leddene

Opkastning

Mundbetændelse

Betændelse i tungen

Fordøjelsesbesvær

Nældefeber

Udslæt (nældefeber) og hævelser. Kan være alvorligt. Tal med lægen. Hvis der er hævelse af

ansigt, læber og tunge, kan det være livsfarligt. Ring 112.

Meget sjældne bivirkninger (det sker hos færre end 1 ud af 10.000 behandlede):

Kløe

Phenoxymethylpenicillinkalium EQL Pharma kan herudover give bivirkninger, som du normalt ikke

mærker noget til. Det drejer sig om ændringer i visse laboratorieprøver, f.eks. forandringer i blodet

(eosinofili).

Indberetning af bivirkninger

Hvis du oplever bivirkninger, bør du tale med din læge eller apoteket. Dette gælder også mulige

bivirkninger, som ikke er medtaget i denne indlægsseddel. Du eller dine pårørende kan også indberette

bivirkninger direkte til Lægemiddelstyrelsen via de oplysninger, der fremgår herunder.

Lægemiddelstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: dkma@dkma.dk

Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden

af dette lægemiddel.

5.

OPBEVARING

Opbevares utilgængeligt for børn.

Brug ikke Phenoxymethylpenicillinkalium EQL Pharma efter den udløbsdato, der står på pakningen.

Udløbsdatoen er den sidste dag i den nævnte måned.

Opbevares ved temperaturer under 30

Spørg på apoteket, hvordan du skal bortskaffe medicinrester. Af hensyn til miljøet må du ikke smide

medicinrester i afløbet, toilettet eller skraldespanden.

6.

PAKNINGSSTØRRELSER OG YDERLIGERE OPLYSNINGER

Phenoxymethylpenicillinkalium EQL Pharma

indeholder:

Aktive stoffer: phenoxymethylpenicillinkalium, hhv. 800 mg.

Øvrige indholdsstoffer:Povidon, mikrokrystallinsk cellulose, talkum, Silica colloidal anhydrous,

magnesiumstearat, hypromellose, macrogol, titaniumdioxid (E171).

Udseende og pakningsstørrelser

800 mg: Hvid til råhvid, kapselformet, 19,5 x 8,5 mm, filmovertrukne tabletter præget med "7" og "3"

på hver side af delekærven på den ene side og "F" på den anden side. Tabletten kan deles i to lige store

doser.

Phenoxymethylpenicillinkalium EQL Pharma tabletter fås i klare blisterpakninger af PVC/PE/PVdC-

aluminiumfolie.

14, 20, 30, 40 og 100 tabletter

Indehaver af markedsføringstilladelsen og fremstiller

Indehaver af markedsføringstilladelsen

EQL Pharma AB

Stortorget 1

222 23 Lund

Sverige

Fremstiller

APL Swift Services Malta Ltd

HF26, Hal Far Industrial Estate

Hal Far Birzebbugia,

BBG 3000

Malta

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Cometriq (Ipsen Pharma)

Cometriq (Ipsen Pharma)

Cometriq (Active substance: cabozantinib) - PSUSA - Modification - Commission Decision (2018)5761 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10180/201711

Europe -DG Health and Food Safety

29-8-2018

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Active substance: aliskiren hemifumarate / hydrochlorothiazide) - Centralised - Renewal - Commission Decision (2018)5769 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/964/R/87

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Active substance: (S)-(-)-3-(4-aminophenyl)-2-methoxypropanoic acid) - Orphan designation - Commission Decision (2018)5728 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/075/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Active substance: Autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor) - Orphan designation - Commission Decision (2018)5739 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/049/18

Europe -DG Health and Food Safety

27-8-2018

Yescarta (Kite Pharma EU B.V.)

Yescarta (Kite Pharma EU B.V.)

Yescarta (Active substance: axicabtagene ciloleucel) - Centralised - Authorisation - Commission Decision (2018)5718 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4480

Europe -DG Health and Food Safety

27-8-2018

Entyvio (Takeda Pharma A/S)

Entyvio (Takeda Pharma A/S)

Entyvio (Active substance: vedolizumab) - PSUSA - Modification - Commission Decision (2018)5712 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10186/201711

Europe -DG Health and Food Safety

27-8-2018

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Active substance: Fondaparinux sodium) - PSUSA - Modification - Commission Decision (2018)5708 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/403/PSUSA/1467-201712

Europe -DG Health and Food Safety

17-8-2018

EU/3/17/1870 (Pharma Gateway AB)

EU/3/17/1870 (Pharma Gateway AB)

EU/3/17/1870 (Active substance: Thymidine and deoxycytidine) - Transfer of orphan designation - Commission Decision (2018)5403 of Fri, 17 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/317/16/T/01

Europe -DG Health and Food Safety

7-8-2018

EU/3/18/2049 (Inozyme Pharma Ireland Ltd)

EU/3/18/2049 (Inozyme Pharma Ireland Ltd)

EU/3/18/2049 (Active substance: Recombinant human ectonucleotide pyrophosphatase/phosphodiesterase 1 fused to the Fc fragment of IgG1) - Orphan designation - Commission Decision (2018)5281 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/053/18

Europe -DG Health and Food Safety

6-8-2018

Kyntheum (Leo Pharma A/S)

Kyntheum (Leo Pharma A/S)

Kyntheum (Active substance: brodalumab) - Centralised - Yearly update - Commission Decision (2018)5383 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2048 (Pharma Gateway AB)

EU/3/18/2048 (Pharma Gateway AB)

EU/3/18/2048 (Active substance: N-acetylgalactosamine-conjugated synthetic double-stranded oligomer specific to serpin family A member 1 gene) - Orphan designation - Commission Decision (2018)5280 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/061/18

Europe -DG Health and Food Safety

1-8-2018

Ucedane (Lucane Pharma)

Ucedane (Lucane Pharma)

Ucedane (Active substance: carglumic acid) - Centralised - Yearly update - Commission Decision (2018)5230 of Wed, 01 Aug 2018

Europe -DG Health and Food Safety

1-8-2018

Opdivo (Bristol-Myers Squibb Pharma EEIG)

Opdivo (Bristol-Myers Squibb Pharma EEIG)

Opdivo (Active substance: nivolumab) - Centralised - 2-Monthly update - Commission Decision (2018)5204 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3985/II/41

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety

23-7-2018

Dificlir (Astellas Pharma Europe B.V.)

Dificlir (Astellas Pharma Europe B.V.)

Dificlir (Active substance: fidaxomicin) - Centralised - Yearly update - Commission Decision (2018)4889 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

23-7-2018

Qarziba (EUSA Pharma (UK) Limited)

Qarziba (EUSA Pharma (UK) Limited)

Qarziba (Active substance: dinutuximab beta) - Centralised - Yearly update - Commission Decision (2018)4886 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

19-7-2018

Aplidin (Pharma Mar S.A.)

Aplidin (Pharma Mar S.A.)

Aplidin (Active substance: plitidepsin) - Refusal of authorisation - Commission Decision (2018)4831 of Thu, 19 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4354

Europe -DG Health and Food Safety

13-7-2018

Briviact (UCB Pharma S.A.)

Briviact (UCB Pharma S.A.)

Briviact (Active substance: brivaracetam) - Centralised - 2-Monthly update - Commission Decision (2018)4715 of Fri, 13 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3898/II/10/G

Europe -DG Health and Food Safety

10-7-2018

Ninlaro (Takeda Pharma A/S)

Ninlaro (Takeda Pharma A/S)

Ninlaro (Active substance: ixazomib) - Centralised - Yearly update - Commission Decision (2018)4463 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

4-7-2018

Prialt (RIEMSER Pharma GmbH)

Prialt (RIEMSER Pharma GmbH)

Prialt (Active substance: ziconotide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4334 of Wed, 04 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/551/T/56

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2036 (PharmaKrysto Ltd)

EU/3/18/2036 (PharmaKrysto Ltd)

EU/3/18/2036 (Active substance: L-cystine bis(N'-methylpiperazide)) - Orphan designation - Commission Decision (2018)4181 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/012/18

Europe -DG Health and Food Safety

27-6-2018

Yondelis (Pharma Mar S.A.)

Yondelis (Pharma Mar S.A.)

Yondelis (Active substance: Trabectedin) - PSUSA - Modification - Commission Decision (2018)4096 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/3001/201709

Europe -DG Health and Food Safety

19-6-2018

Xyrem (UCB Pharma S.A.)

Xyrem (UCB Pharma S.A.)

Xyrem (Active substance: Sodium oxybate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3912 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/593/T/74

Europe -DG Health and Food Safety

11-6-2018

Cimzia (UCB Pharma S.A.)

Cimzia (UCB Pharma S.A.)

Cimzia (Active substance: certolizumab pegol ) - Centralised - 2-Monthly update - Commission Decision (2018)3768 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1037/II/65

Europe -DG Health and Food Safety

6-6-2018

Cepedex (CP-Pharma Handelsgesellschaft mbH)

Cepedex (CP-Pharma Handelsgesellschaft mbH)

Cepedex (Active substance: dexmedetomidine) - Centralised - Yearly update - Commission Decision (2018)3684 of Wed, 06 Jun 2018

Europe -DG Health and Food Safety

4-6-2018

Yervoy (Bristol-Myers Squibb Pharma EEIG)

Yervoy (Bristol-Myers Squibb Pharma EEIG)

Yervoy (Active substance: ipilimumab) - Centralised - 2-Monthly update - Commission Decision (2018)3618 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2213/II/55

Europe -DG Health and Food Safety

4-6-2018

Sprycel (Bristol-Myers Squibb Pharma EEIG)

Sprycel (Bristol-Myers Squibb Pharma EEIG)

Sprycel (Active substance: Dasatinib) - Centralised - Yearly update - Commission Decision (2018)3619 of Mon, 04 Jun 2018

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2025 (Pharma Gateway AB)

EU/3/18/2025 (Pharma Gateway AB)

EU/3/18/2025 (Active substance: Modified mRNA encoding human methylmalonyl-coenzyme A mutase encapsulated into lipid nanoparticles) - Orphan designation - Commission Decision (2018)3393 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/017/18

Europe -DG Health and Food Safety

28-5-2018

Incresync (Takeda Pharma A/S)

Incresync (Takeda Pharma A/S)

Incresync (Active substance: alogliptin / pioglitazone) - Centralised - Renewal - Commission Decision (2018)3347 of Mon, 28 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2178/R/23

Europe -DG Health and Food Safety

28-5-2018

Vipidia (Takeda Pharma A/S)

Vipidia (Takeda Pharma A/S)

Vipidia (Active substance: alogliptin) - Centralised - Renewal - Commission Decision (2018)3345 of Mon, 28 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2182/R/19

Europe -DG Health and Food Safety