Lecrolyn sine

Primær information

  • Handelsnavn:
  • Lecrolyn sine 40 mg/ml øjendråber, opløsning
  • Dosering:
  • 40 mg/ml
  • Lægemiddelform:
  • øjendråber, opløsning
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Lecrolyn sine 40 mg/ml øjendråber, opløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 53827
  • Sidste ændring:
  • 22-02-2018

Indlægsseddel: sammensætning, indikationer, bivirkninger, dosering, interaktioner, bivirkninger, graviditet, amning

Indlægsseddel: Information til brugeren

Lecrolyn sine 40 mg/ml øjendråber, opløsning

Natriumcromoglicat

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

indeholder vigtige oplysninger.

Brug altid dette lægemiddel nøjagtigt som beskrevet i denne indlægsseddel eller efter de anvisninger,

lægen eller apotekspersonalet har givet dig.

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

Spørg på apoteket, hvis der er mere, du vil vide.

Kontakt lægen eller apotekspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke er

nævnt her. Se pkt. 4.

Kontakt lægen, hvis dine symptomer ikke forbedres, eller hvis de forværres efter to dage.

Oversigt over indlægssedlen

Virkning og anvendelse

Det skal du vide, før du begynder at bruge Lecrolyn sine

Sådan skal du bruge Lecrolyn sine

Bivirkninger

Opbevaring

Pakningsstørrelser og yderligere oplysninger

1.

Virkning og anvendelse

Lecrolyn sine indeholder det aktive indholdsstof, der kaldes natriumcromoglicat. Dette lægemiddel

tilhører en lægemiddelgruppe, der kaldes antiallergiske midler. Lecrolyn sine anvendes til behandling

af øjensymptomer på grund af allergi.

Medicinen virker ved at stoppe frigørelsen af de naturlige stoffer, såsom histamin, i dine øjne, der kan

give en allergisk reaktion. Tegn på en allergisk reaktion inkluderer kløende, vandige, røde eller

betændte øjne og hævede øjenlåg. Sædvanligvis påvirkes begge øjne.

Disse symptomer opstår sædvanligvis om foråret eller sommeren, når pollen fra græs eller træer får

kontakt med øjnene hos personer, der er overfølsomme over for pollen.

Du skal tale med en læge hvis dine symptomer ikke bliver bedre, eller hvis de blive værre efter to

dage.

2.

Det skal du vide, før du begynder at bruge Lecrolyn sine

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

altid lægens anvisning og oplysningerne på doseringsetiketten.

Brug ikke Lecrolyn sine:

hvis du er allergisk over for natriumcromoglicat eller et af de øvrige indholdsstoffer i Lecrolyn sine

(angivet i punkt 6).

Advarsler og forsigtighedsregler

Tal med lægen inden brugen af Lecrolyn sine, hvis du kun har symptomer i det ene øje, da allergiske

reaktioner normalt involverer begge øjne.

Brug af anden medicin sammen med Lecrolyn sine

Ved samtidig anvendelse af andre øjendråber, skal der gå mindst 15 minutter mellem anvendelsen af

forskellige dråber.

Graviditet og amning

Der er ikke påvist skadelige virkninger på fosteret. Lecrolyn sine kan anvendes under graviditeten og

amning.

Trafik- og arbejdssikkerhed

Lecrolyn sine kan ligesom andre øjendråber medføre kortvarigt sløret syn. Hvis dette sker for dig, må

du ikke føre motorkøretøj eller betjene maskiner, før dit syn er helt normalt igen.

Kontaktlinser

Lecrolyn sine indeholder ikke konserveringsmidler. Det kan derfor anvendes sammen med

kontaktlinser.

3.

Sådan skal du bruge Lecrolyn sine

Brug altid lægemidlet nøjagtigt som beskrevet i denne indlægsseddel eller efter lægens eller

apotekspersonalets anvisning. Er du i tvivl, så spørg lægen eller apotekspersonalet.

Den anbefalede dosis for børn og voksne er

1-2 dråber i hvert øje to gange dagligt

Inden inddrypning af øjendråberne:

Vask Deres hænder, inden De åbner flasken.

Når De åbner flasken første gang, så kassér den første dråbe.

Vælg en stilling, der er behagelig for dig, når du inddrypper dråberne (du kan sidde ned, ligge

på ryggen eller stå foran et spejl)

Inddrypning:

Hold flasken lige under hætten og drej hætten for at åbne flasken.

Berør ikke andre genstande med flaskens spids for at undgå forurening af opløsningen.

Læg dit hoved tilbage og hold flasken over øjet.

Træk nederste øjenlåg ned og se opad. Tryk let på flasken og lad 1 dråbe falde ned i øjet. Bemærk, at

der kan være et par sekunders forsinkelse mellem man trykker, og dråben kommer ud. Lad være at

trykke for hårdt.

Blink et par gange, så dråben spreder sig over øjet.

Ryst flasken én gang nedad for at slippe af med overskydende opløsning fra toppen. Følg

instruktionerne 2 – 4 for dryppen med Lecrolyn sine i det andet øje.

Inden låget sættes tilbage på flasken, skal den rystes én gang nedad for at holde spidsens

omgivelser tørre.

Der kan være en lille smule opløsning i flasken til slut. Det er der taget højde for ved at alle flasker

overfyldes for at sikre, at 5 ml eller 10 ml opløsning altid kan leveres.

Hvis dine øjne ikke bliver bedre, eller hvis de bliver værre efter to dage med brug af Lecrolyn sine,

skal du kontakte lægen eller apoteket.

Det er bedst at bruge øjendråberne regelmæssigt hver dag, mens der forventes høje pollenniveauer, for

at kontrollere din øjensygdom.

Hvis du har brugt for meget Lecrolyn sine

Der er ingen kendte reaktioner på overdosering af Lecrolyn sine.

Spørg lægen eller apotekspersonalet, hvis der er noget, du er i tvivl om.

4.

Bivirkninger

Lecrolyn sine kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.

Allergiske reaktioner (overfølsomhed) er blevet indberettet. Det vides imidlertid ikke, hvor ofte dette

forekommer.

Hvis du får symptomer som udslæt, synke- eller vejrtrækningsproblemer, hævelse af læber, ansigt,

svælg, tunge eller forværring af rødme, skal du kontakte en læge.

En almindelig bivirkning (kan forekomme hos op til 1 ud af 10 personer) er lokal svien i øjnene.

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 kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale

rapporteringssystem.

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

af dette lægemiddel.

Lægemiddelstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail:

dkma@dkma.dk

5.

Opbevaring

Opbevar lægemidlet utilgængeligt for børn.

Opbevares ved temperaturer under 25 °C. Må ikke nedfryses.

Brug ikke lægemidlet efter den udløbsdato, der står på æsken og flasken efter EXP. Udløbsdatoen er

den sidste dag i den nævnte måned.

Efter første åbning af flasken kan opløsningen anvendes i

8 uger

. Flasken skal opbevares tæt

lukket.

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

medicinrester i afløbet eller skraldespanden.

6.

Pakningsstørrelser og yderligere oplysninger

Lecrolyn sine indeholder:

Aktivt stof: natriumcromoglicat. 1 ml opløsning indeholder 40 mg natriumcromoglicat.

Øvrige indholdsstoffer: glycerol, dinatriumedetat, polyvinylalkohol, vand til injektionsvæsker.

Udseende og pakningsstørrelser

Lecrolyn sine er en klar, farveløs eller let gullig opløsning.

Dispenseret i en hvid plasticflaske med hvid dråbeapplikator og blå spids og et hvidt skruelåg

af plastic.

Pakningsstørrelser: 1 x 5 ml, 2 x 5 ml, 3 x 5 ml og 1 x 10 ml

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

Indehaver af markedsføringstilladelsen og fremstiller

Santen Oy,

Niittyhaankatu 20, 33720 Tampere

Finland

Denne indlægsseddel blev senest ændret i November 2016.

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21-11-2018

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FDA - U.S. Food and Drug Administration

31-8-2018

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

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FDA - U.S. Food and Drug Administration

29-8-2018

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31-7-2018

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18-7-2018

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Opinion/decision on a Paediatric investigation plan (PIP): Rabeprazole (sodium), decision type: , therapeutic area: , PIP number: P/0401/2018

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4-2-2019

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21-1-2019

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18-12-2018

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17-12-2018


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Europe - EMA - European Medicines Agency

14-12-2018


Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

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Europe - EMA - European Medicines Agency

12-12-2018


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Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Europe - EMA - European Medicines Agency

12-12-2018


Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Europe - EMA - European Medicines Agency

10-12-2018

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (Active substance: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1?3)-beta-D-galactopyranoside) - Transfer of orphan designation - Commission Decision (2018)8628 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/048/17/T/01

Europe -DG Health and Food Safety

3-12-2018


Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Europe - EMA - European Medicines Agency

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type: , therapeutic area: , PIP number: P/0223/2018

Europe - EMA - European Medicines Agency

21-11-2018

EU/3/13/1184 (Pfizer Europe MA EEIG)

EU/3/13/1184 (Pfizer Europe MA EEIG)

EU/3/13/1184 (Active substance: (1R,3R,4R,5S)-3-O-[2-O-benzoyl-3-O-(sodium(2S)-3-cyclohexyl-propanoate-2-yl)-beta-D-galactopyranosyl]-4-O-(a-L-fucopyranosyl)-5-orothylamido-cyclohexane-1-carboxylic acid ethyl-2-amidyl-ethyloxy-2-acetyl-(8-amino-1,3,6-naphthalene-tris sodium sulfonate) amide) - Transfer of orphan designation - Commission Decision (2018)7836 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/13/T/01

Europe -DG Health and Food Safety

19-11-2018


Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Europe - EMA - European Medicines Agency

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

24-9-2018

Inhixa (Techdow Europe AB)

Inhixa (Techdow Europe AB)

Inhixa (Active substance: enoxaparin sodium) - Centralised - Variation - Commission Decision (2018)6101 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4264/X/18, 26

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

3-8-2018

Sodium oxybate

Sodium oxybate

Sodium oxybate (Active substance: Sodium oxybate) - Centralised - Art 28 - (PSUR - Commission Decision (2018)5381 of Fri, 03 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10612/201710

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Active substance: Combination of carboplatin and sodium valproate) - Orphan designation - Commission Decision (2018)5275 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/036/18

Europe -DG Health and Food Safety

11-7-2018

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Active substance: Alendronate Sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4518 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/619/T/42

Europe -DG Health and Food Safety

10-7-2018

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Active substance: Alendronate sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4477 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/759/T/39

Europe -DG Health and Food Safety

10-7-2018

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Active substance: Sodium phenylbutyrate) - Centralised - Yearly update - Commission Decision (2018)4483 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Withdrawn application:  Prohippur, sodium benzoate, Initial authorisation

Withdrawn application: Prohippur, sodium benzoate, Initial authorisation

Europe - EMA - European Medicines Agency

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

1-6-2018

Valproate

Valproate

Valproate (Active substance: medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium)) - Community Referrals - Art 31 - Commission Decision (2018)3623 of Fri, 01 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1454

Europe -DG Health and Food Safety