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AstraZeneca

Thymanax
Agomelatine


Package leaflet: Information for the patient


Thymanax 25 mg film-coated tablets

agomelatine


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


before initiation

or

dose increase

around

3 weeks

around

6 weeks

around

12 weeks

around

24 weeks

Blood tests


Based on the evaluation of these tests your doctor will decide whether you should receive or continue using Thymanax (see also under “How to take Thymanax” in section 3).


Be vigilant about signs and symptoms that your liver may not be working properly

- If you observe any of these signs and symptoms of liver problems: unusual darkening of the urine, light coloured stools, yellow skin/eyes, pain in the upper right belly, unusual fatigue (especially associated with other symptoms listed above), seek urgent advice from a doctor who may advise you to stop taking Thymanax.


Effect of Thymanax is not documented in patients aged 75 years and older. Thymanax should therefore not be used in these patients.


Thoughts of suicide and worsening of your depression

If you are depressed you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about

two weeks but sometimes longer.


You may be more likely to think like this:


What Thymanax looks like and contents of the pack

Thymanax 25 mg film-coated tablets (tablet) are oblong, orange-yellow with a blue imprint of ‘company

logo’ imageon one side.

Thymanax 25 mg film-coated tablets are available in calendar blisters. Packs contain 14, 28, 56, 84 or 98 tablets. Packs of 100 film-coated tablets are also available for hospital use.

Not all pack sizes may be marketed.


Marketing Authorisation Holder Servier (Ireland) Industries Ltd Gorey road, Arklow, Co. Wicklow Ireland


Manufacturer

Les Laboratoires Servier Industrie 905, route de Saran

45520 Gidy France


Servier (Ireland) Industries Ltd Gorey road

Arklow – Co. Wicklow – Ireland


image

Anpharm Przedsiebiorstwo Farmaceutyczne S.A. 03-236 Warszawa

ul. Annopol 6B

Poland


image

Laboratorios Servier, S.L. Avda. de los Madroños, 33 28043 Madrid

Spain


image

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


België/Belgique/Belgien

S.A. Servier Benelux N.V. Tel: +32 (0)2 529 43 11

Lietuva

UAB “SERVIER PHARMA” Tel: +370 (5) 2 63 86 28


България

Сервие Медикал ЕООД Тел.: +359 2 921 57 00

Luxembourg/Luxemburg

S.A. Servier Benelux N.V. Tel: +32 (0)2 529 43 11

Česká republika

Servier s.r.o.

Tel: +420 222 118 111

Magyarország Servier Hungaria Kft. Tel: +36 1 238 7799


Danmark

Servier Danmark A/S Tlf: +45 36 44 22 60

Malta

V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 74


Deutschland

Servier Deutschland GmbH Tel: +49 (0)89 57095 01

Nederland

Servier Nederland Farma B.V. Tel: +31 (0)71 5246700


Eesti

Servier Laboratories OÜ Tel:+ 372 664 5040

Norge

Servier Danmark A/S Tlf: +45 36 44 22 60


Eλλάδα

ΣΕΡΒΙΕ ΕΛΛΑΣ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΠΕ Τηλ: +30 210 939 1000

Österreich

Servier Austria GmbH Tel: +43 (1) 524 39 99


España

DANVAL, S.A.

Tel: +34 91 748 96 30

Polska

Servier Polska Sp. z o.o. Tel: +48 (0) 22 594 90 00


France

Les Laboratoires Servier Tel: +33 (0)1 55 72 60 00

Portugal

Servier Portugal, Lda Tel.: +351 21 312 20 00


Hrvatska

Servier Pharma, d. o. o. Tel.: +385 (0)1 3016 222

România

Servier Pharma SRL Tel: +4 021 528 52 80


Ireland

Servier Laboratories (Ireland) Ltd. Tel: +353 (0)1 663 8110

Slovenija

Servier Pharma d. o. o. Tel.: +386 (0)1 563 48 11


Ísland

Servier Laboratories c/o Icepharma hf Sími: +354 540 8000

Slovenská republika Servier Slovensko spol. s r.o. Tel.:+421 (0) 2 5920 41 11


Italia

Istituto Farmaco Biologico Stroder S.r.l. Tel: +39 06 669081

Suomi/Finland

Servier Finland Oy

P. /Tel: +358 (0)9 279 80 80


Κύπρος

C.A. Papaellinas Ltd. Τηλ: +357 22741741

Sverige

Servier Sverige AB

Tel : +46 (0)8 522 508 00


Latvija

SIA Servier Latvia

United Kingdom (Northern Ireland)

Servier Laboratories (Ireland) Ltd

Tel: +371 67502039 Tel: +44 (0)1753 666409


This leaflet was last revised in