What Rivastigmine HEXAL contains
- The active substance is rivastigmine hydrogen tartrate. Each ml contains rivastigmine hydrogen tartrate corresponding to rivastigmine base 2.0 mg.
- The other ingredients are sodium benzoate, citric acid, sodium citrate, quinoline yellow WS dye (E104) and purified water.
What Rivastigmine HEXAL looks like and contents of the pack
Rivastigmine HEXAL oral solution is supplied as 50 ml or 120 ml of a clear, yellow solution (2.0 mg/ml base) in an amber glass bottle with a child-resistant cap, foam liner, dip tube and self aligning plug. The oral solution is packaged with an oral dosing syringe in a plastic tube container.
Marketing Authorisation Holder
HEXAL AG
Industriestraรe 25
D-83607 Holzkirchen
Germany
Manufacturer
Novartis Pharma S.A.S.
26, rue de la Chapelle
F-68333 Huningue
France
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
BelgiรซBelgiqueBelgien Sandoz N.V. Telecom Gardens Medialaan 40 B-1800 Vilvoorde Tel 32 02 722 97 98 LuxembourgLuxemburg HEXAL AG Industriestraรe 25 D-83607 Holzkirchen TรฉlTel 49 8024 908 0 E-mail servicehexal.com
Representative office Sandoz d.d. Magyarorszรกg Sandoz Hungรกria Kft.
Business Park Sofia, buil. 8B, fl. 6 BG-1766 Sofia Tel. 359 2 970 47 48 Tรญmรกr u. 20. H-1034 Budapest Phone 36 1 430 2890 E-mail info.hungarysandoz.co
eskรก republika Sandoz s.r.o. Jeseniova 30 CZ-13000 Praha 3 E-mail office.czsandoz.com Tel 420 221 421 612 Malta V.J. Salomone Pharma Ltd. 79, Simpson Street MT-Marsa HMR14 Phone 356 21 220 174 E-mail infopharmavjsalomone.co
Danmark Sandoz AS Edvard Thomsens Vej 14 DK-2300 Kรธbenhavn S E-mail info.sandoz-dksandoz.com Nederland Sandoz B.V. Veluwezoom 22 NL-1327 AH Almere Tel 31 36 5241600 info.sandoz-nlsandoz.co
Norge Sandoz AS Edvard Thomsens Vej 14 DK-2300 Kรธbenhavn S E-mail info.sandoz-dksandoz.com Deutschland HEXAL AG Industriestraรe 25 D-83607 Holzkirchen Tel 49 8024 908 0 E-mail servicehexal.com
Eesti Sandoz d.d. Eesti filiaal, Pรคrnu mnt 105, EE-11312 Tallinn, Tel 372 6652401 รsterreich HEXAL Pharma GmbH Carlbergergasse 44 A-1235 Wien Tel 43 01 486 96 22
Polska Lek Polska Sp.z o.o. ul. Domaniewska 50 C PL - 02-672 Warszawa Phone 48 22 549 15 00 Sambrook Faaet .. aat 4 . atee GR-135 61 . t 30 -210 -85 40053 e- ysotirakousambrook.gr
Espaรฑa Bexal Farmaceutica S.A. AvOsa Mayor no 4, Area B E-28023 Aravaca Madrid E-mail sandoz.respondesandoz.com Portugal Sandoz Farmacรชutica Lda. Alameda da Beloura Edifรญcio 1, 2 andar - Escritรณrio 15 2710-693 Sintra Phone 351 21 0008782
France Sandoz SAS 49, avenue Georges Pompidou F-92593 Levallois-Perret Cedex Tel 33 1 4964 4801 Romรขnia Sandoz Pharma Services S.R.L. Victoria Business Park RO-Soseaua Bucuresti-Ploiesti 73-81 Corp 2, etaj 2, Sector 1 Phone 40 21 4075184
Ireland Rowex Ltd. Newtown IE - Bantry Co. Cork Slovenija Lek Pharmaceuticals d.d. Verovkova 57 SI-1526 Ljubljana
Tel 353 27 50077 Tel 386 1 5802111 E-mail info.leksandoz.co
รsland Sandoz AS Edvard Thomsens Vej 14 DK-2300 Kรธbenhavn S E-mail info.sandoz-dksandoz.com Slovenskรก republika Sandoz d.d. - organizanรก zloka Galvaniho 15C SK-821 04 Bratislava Tel 421 2 48 200 601
Italia Hexal S.p.A. co Sandoz S.p.A. Largo Umberto Boccioni 1 I-21040 Origgio VA Tel 39-02-96 541 SuomiFinland Sandoz AS Edvard Thomsens Vej 14 DK-2300 Kรธbenhavn S E-mail info.sandoz-dksandoz.com
Sverige Sandoz AS Edvard Thomsens Vej 14 DK-2300 Kรธbenhavn S E-mail info.sandoz-dksandoz.com .T.ate etaea td Gd 31-3042 ees f 00357 25372425 Fa 00357 25376400 e- hapanicoscytanet.com.cy
Latvija Sandoz d.d. Representative Office in Latvia Meza Str. 4 LV-1048, Riga Phone 371 67892007 United Kingdom Sandoz Ltd 37 Woolmer Way Bordon GU35 9QE UK Tel 44 0 1420 478301 E-mail uk.drugsafetysandoz.co
Lietuva
Sandoz Pharmaceuticals d.d.,
Branch Office Lithuania
Seimyniskiu Str. 3A
LT-09312 Vilnius
Phone: +370 5 2636038
This leaflet was last approved in
Instructions for Use: Rivastigmine HEXAL oral solution
1. Remove oral dosing syringe from its protective case. Push down and turn child resistant closure to open bottle.
2. Insert nozzle of syringe into opening of white stopper.
3. Withdraw prescribed amount of Rivastigmine HEXAL oral solution from bottle.
4. Before removing syringe containing prescribed dose from bottle, expel any large bubbles by depressing and withdrawing plunger a few times. The presence of a few tiny bubbles is of no importance and will not affect the dose in any way.
5. Swallow Rivastigmine HEXAL oral solution directly from the syringe or first mix in a small glass with water. Stir and drink the entire mixture.
6. After use, wipe outside of syringe with a clean tissue and replace it in its protective case. Close bottle using child resistant closure.