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AstraZeneca

Xyrem
sodium oxybate

Package leaflet: Information for the user


Xyrem 500 mg/mL oral solution

Sodium oxybate


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.


What Xyrem looks like and contents of the pack

Xyrem is supplied in a 240 mL amber plastic bottle containing 180 mL of oral solution and closed with a child-resistant cap. When the bottle is delivered, there is a plastic covered foil seal which is on the top of the bottle, underneath the cap. Each pack contains one bottle, a press-in-bottle-adaptor (PIBA), a plastic measuring syringe and two dosing cups with child-resistant caps.

Xyrem is a clear to slightly opalescent solution.


Marketing Authorisation Holder

UCB Pharma SA, Allée de la Recherche 60, B-1070 Brussels, Belgium


Manufacturer

UCB Pharma S.A., Chemin du Foriest, B-1420 Braine l'Alleud, Belgium


You should have received a Xyrem Information Pack from your physician, which includes a booklet on how to take the medicine, a Frequently Asked Questions patient information sheet and a patient alert card.


For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:


België/Belgique/Belgien UCB Pharma SA/NV Tel/Tél: +32 / (0)2 559 92 00

Lietuva

UCB Pharma Oy Finland

Tel: + 358 9 2514 4221 (Suomija)


България

Ю СИ БИ България ЕООД

Teл.: + 359 (0) 2 962 30 49

Luxembourg/Luxemburg UCB Pharma SA/NV Tél/Tel: +32 / (0)2 559 92 00


Česká republika

UCB s.r.o.

Tel: + 420 221 773 411

Magyarország

UCB Magyarország Kft. Tel.: + 36-(1) 391 0060


Danmark

UCB Nordic A/S

Tlf: + 45 / 32 46 24 00

Malta

Pharmasud Ltd.

Tel: +356 / 21 37 64 36

Deutschland

UCB Pharma GmbH

Tel: + 49 /(0) 2173 48 4848

Nederland

UCB Pharma B.V.

Tel.: +31 / (0)76-573 11 40


Eesti

UCB Pharma Oy Finland

Tel: + 358 9 2514 4221 (Soome)

Norge

UCB Nordic A/S

Tel: +45 / 32 46 24 00


Ελλάδα

UCB Α.Ε.

Τηλ: +30 / 2109974000

Österreich

UCB Pharma GmbH Tel: +43 (0) 1 291 80 00


España

UCB Pharma, S.A.

Tel: + 34 / 91 570 34 44

Polska

UCB Pharma Sp. z o.o. Tel.: + 48 22 696 99 20


France

UCB Pharma S.A.

Tél: + 33 / (0)1 47 29 44 66

Portugal

UCB Pharma (Produtos Farmacêuticos), Lda Tel: + 351 / 21 302 5300


Hrvatska

Medis Adria d.o.o.

Tel: +385 (0) 1 230 34 46

România

UCB Pharma Romania S.R.L. Tel: +40 21 300 29 04


Ireland

UCB (Pharma) Ireland Ltd. Tel: + 353 / (0)1-46 37 395

Slovenija

Medis, d.o.o.

Tel: + 386 1 589 69 00


Ísland

Vistor hf.

Tel: +354 535 7000

Slovenská republika

UCB s.r.o., organizačná zložka Tel: + 421 (0) 2 5920 2020


Italia

UCB Pharma S.p.A. Tel: + 39 / 02 300 791

Suomi/Finland

UCB Pharma Oy Finland Puh/ Tel: + 358 9 2514 4221


Κύπρος

Lifepharma (Z.A.M.) Ltd Τηλ: + 357 22 34 74 40

Sverige

UCB Nordic A/S

Tel: + 46 / (0) 40 29 49 00


Latvija

UCB Pharma Oy Finland

Tel: + 358 9 2514 4221 (Somija)

United Kingdom (Northern Ireland)

UCB (Pharma) Ireland Ltd. Tel: + 353 / (0)1-46 37 395


This leaflet was last revised in


a.europa.eu/

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