What INVEGA contains
- The active substance is paliperidone Each INVEGA 1.5 mg prolonged-release tablet contains 1.5 mg of paliperidone Each INVEGA 3 mg prolonged-release tablet contains 3 mg of paliperidone. Each INVEGA 6 mg prolonged-release tablet contains 6 mg of paliperidone. Each INVEGA 9 mg prolonged-release tablet contains 9 mg of paliperidone. Each INVEGA 12 mg prolonged-release tablet contains 12 mg of paliperidone.
The other ingredients are:
Coated tablet core:
Polyethylene oxide 200K
Sodium chloride
Povidone (K29-32)
Stearic acid
Butyl hydroxytoluene (E321)
Ferric Oxide (Yellow) (E172) (3, 12 mg tablet only)
Polyethylene Oxide 7000K
Ferric Oxide (Red) (E172)
Hydroxyethyl Cellulose
Polyethylene glycol 3350
Cellulose acetateIron oxide (Black) (E172)(1.5, 9 mg tablet only)
Colour overcoat:
Hypromellose
Titanium dioxide (E171)
Polyethylene glycol 400 (1.5, 6, 9 and 12 mg tablet only)
Ferric Oxide (Yellow) (E172) (1.5, 6, 12 mg tablet only)
Ferric Oxide (Red) (E172) (1.5, 6, 9 mg tablet only)
Lactose monohydrate (3 mg tablet only)
Triacetin (3 mg tablet only)
Carnauba wax
Printing ink:
Iron oxide (Black) (E172)
Propylene glycol
Hypromellose
What INVEGA looks like and contents of the pack
INVEGA Prolonged-Release Tablets are capsule shaped. The 1.5 mg tablets are orange-brown and printed with ?PAL 1 .5?, the 3 mg tablets are white and printed with ?PAL 3?, the 6 mg tablets are beige and printed with ?PAL 6?, the 9 mg tablets are pink and printed with ?PAL 9?, and the 12 mg tablets are dark yellow and printed with ?PAL 12?. All tablets are available in the following pack sizes:
- Bottles: 30 tablet and 350 tablet high-density polyethylene bottles with child-resistant closures. Eachbottle contains two silica gel pouches which are provided to absorb moisture and keep the tablets dry.
- Blisters: 14, 28, 30, 49, 56, and 98 tablets in polyvinyl chloride laminated with polychlorotrifluoroethylene/ aluminium push-through layer (white or clear) or 14, 28, 49, 56, and 98 tablets in oriented polyamidealuminium- polyvinyl chloride/aluminium push-through layer.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Janssen-Cilag International NV,
Turnhoutseweg 30,
B-2340 Beerse,
Belgium
Manufacturer
Janssen-Cilag SpA
Via C. Janssen
04010 Borgo San Michele,
Latina
Italy
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation.
BelgiëBelgiqueBelgien JANSSEN-CILAG NVSA TélTel 32 14 64 94 11 LuxembourgLuxemburg JANSSEN-CILAG NVSA Tél Tel 32 14 64 94 11
.359 2 489 9400 Magyarország JANSSEN-CILAG Kft. Tel36 23 513-858
eská republika JANSSEN-CILAG s.r.o. Tel420 227 012 222 Malta AM MANGION LTD Tel 356 2397 6000
Danmark JANSSEN-CILAG AS Tlf 45 45 94 82 82 Nederland JANSSEN-CILAG B.V. Tel 31 13 583 73 73
Deutschland JANSSEN-CILAG GmbH Tel 49 2137-955-955 Norge JANSSEN-CILAG AS Tlf 47 24 12 65 00
Eesti Janssen-Cilag Polska Sp. z o.o. Eesti filiaal Tel 372 617 7410 Österreich Janssen-Cilag Pharma GmbH Tel 43 1 610 300
JANSSEN-CILAG ... T 30 210 80 90 000 Polska JANSSENCILAG Polska Sp. z o.o. Tel. 48 22 237 6000
España JANSSEN-CILAG, S.A. Tel 34 91 722 81 00 Portugal JANSSEN-CILAG FARMACEUTICA, LDA Tel 351 21 43 68 835
France JANSSEN-CILAG Tel 0800 25 50 75 33 1 55 00 44 44 România Johnson Johnson România SRL Tel 40 21 207 1800
Ireland JANSSEN-CILAG Ltd. Tel 44 1 494 567 567 Slovenija Johnson Johnson d.o.o. Tel 386 1401 18 30
Slovenská republika Johnson Johnson, s.r.o. Tel 421 233 552 600 Ísland JANSSEN-CILAG co Vistor hf. Sími 354 535 7000
Italia Janssen-Cilag SpA Tel 39 022510.1 SuomiFinland JANSSEN-CILAG OY PuhTel 358 207 531 300
T 357 22 755 214 Sverige JANSSEN-CILAG AB Tel 46 8 626 50 00
Latvija Janssen-Cilag Polska Sp. z o.o. filile Latvij Tel 371 6789 3561 United Kingdom JANSSEN-CILAG Ltd. Tel 44 1494 567 567
Lietuva
UAB ?Johnson & Johnson?
Tel: +370 5 278 68 88
This leaflet was last approved in MM/YYYY