What Rivastigmine Sandoz 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 Sandoz looks like and contents of the pack
Rivastigmine Sandoz 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
Sandoz Pharmaceuticals GmbH
Raiffeisenstraße 11
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:
BelgiëBelgiqueBelgien Sandoz N.V. Telecom Gardens, Medialaan 40 B-1800 Vilvoorde TélTel 32 02 722 97 97 Representative office Sandoz d.d. Business Park Sofia, buil. 8B, fl. 6 BG-1766 Sofia LuxembourgLuxemburg HEXAL AG Industriestraße 25 D-83607 Holzkirchen Tel 49 8024 908-0 E-mail servicehexal.com Magyarország Sandoz Hungária Kft. Tímár u. 20. H-1034 Budapest
Te. 359 2 970 47 47 Tel. 36 1 430 2890 E-mail info.hungarysandoz.com
eská republika Sandoz s.r.o. Jeseniova 30 CZ-13000 Praha 3 Tel 420 221 421 611 E-mail office.czsandoz.com Malta V.J. Salomone Pharma Ltd. 79, Simpson Street MT-Marsa HMR14 Phone 356 21 220 174 E-mail infopharmavjsalomone.com
Danmark Sandoz AS Edvard Thomsens Vej 14 DK-2300 København S E-mail info.sandoz-dksandoz.com Nederland Sandoz B.V. Veluwezoom 22 NL-1327 AH Almere Tel 31 36 5241600 E-mail info.sandoz-nlsandoz.com
Norge Sandoz AS Edvard Thomsens Vej 14 DK-2300 København S E-mail info.sandoz-dksandoz.com Deutschland Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11 D-83607 Holzkirchen Tel 49 8024 902 4000 E-mail infosandoz.de
Eesti Sandoz d.d. Eesti filiaal Pärnu mnt 105 EE-11312 Tallinn Tel 372 6652400 Österreich Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl Tel 43 053382000
Polska Lek Polska Sp.z o.o. ul. Domaniewska 50 C PL-02-672 Warszawa Tel 48 22 549 15 00 Sambrook Faaet .. aat 4 . atee GR-135 61 . t 30 -210 -85 40053 e- ysotirakousambrook.gr
España Sandoz Farmacéutica, SA Avda. Osa Mayor, 4 E-28023 Aravaca Madrid Tel. 34 917401280 E-mail sandoz.respondesandoz.com Portugal Sandoz Farmacêutica Lda. Alameda da Beloura Edificio 1, 2 andar - Escritório 15 P-2710-693 Sintra Tel 351 21 0008781
France Sandoz SAS 49, avenue Georges Pompidou F-92593 Levallois-Perret Cedex Tél 33 1 4964 4800 România Sandoz Pharma Services S.R.L. Victoria Business Park RO-Soseaua Bucuresti-Ploiesti 73-81 Corp 2, etaj 2, Sector 1 Tel 40 21 4075183
Ireland Rowex Ltd. Newtown IE-Bantry Co. Cork Tel 353 27 50076 Slovenija Lek Pharmaceuticals d.d. Verovkova 57 SI-1526 Ljubljana Tel 386 1 5802111 E-mail info.leksandoz.com
Ísland Sandoz AS Edvard Thomsens Vej 14 DK-2300 København S E-mail info.sandoz-dksandoz.com Slovenská republika Sandoz d.d. - organizaná zloka Galvaniho 15C SK-821 04 Bratislava Tel 421 2 48 200 600
Italia Sandoz S.p.a Largo Umberto Boccioni, 1 I-21040 Origgio VA Tel 39 02 96541 SuomiFinland Sandoz AS Edvard Thomsens Vej 14 DK-2300 København S E-mail info.sandoz-dksandoz.com
Sverige Sandoz AS Edvard Thomsens Vej 14 DK-2300 København 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 Tel 371 67892006 United Kingdom Sandoz Ltd 37 Woolmer Way Bordon GU35 9QE UK Tel 44 1420 478301 E-mail uk.drugsafetysandoz.com
Lietuva
Sandoz Pharmaceuticals d.d., Branch Office
Lithuania
Seimyniskiu Str. 3A
LT-09312 Vilnius
Tel: + 370 5 2636037
This leaflet was last approved in
Instructions for Use: Rivastigmine Sandoz 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 Sandoz 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 Sandoz 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.