nes that cause sleepiness or dizziness may make your sleepiness or dizziness worse. ®®
What are the possible side effects of INTUNIV ? ®
INTUNIV may cause serious side effects including: ®
low blood pressure
low heart rate
fainting
sleepiness
Get medical help right away, if you have any of the symptoms listed above.
The most common side effects of INTUNIV include: ®
sleepiness
tiredness
trouble sleeping
low blood pressure
nausea
stomach pain
dizziness
Tell the doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of INTUNIV . For more information, ask your doctor or pharmacist. ®
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store INTUNIV ? ®
Store INTUNIV between 59 F to 86 F (15 C to 30 C) ®oooo
Keep INTUNIV and all medicines out of the reach of children. ®
General Information about INTUNIV ®
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use INTUNIV for a condition for which it was not prescribed. Do not give INTUNIV to other people, even if they have the same symptoms that you have. It may harm them. ®®
This leaflet summarizes the most important information about INTUNIV . If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about INTUNIV that is written for health professionals. For more information, go to ®®
www.INTUNIV.comor call 1-800-828-2088.
What are the ingredients in INTUNIV ? ®
guanfacine hydrochloride Active ingredient:
hypromellose, methacrylic acid copolymer, lactose, povidone, crospovidone, microcrystalline cellulose, fumaric acid, and glycerol behenate. In addition, the 3mg and 4mg tablets also contain green pigment blend PB-1763. Inactive ingredients:
Manufactured for Shire US Inc., Wayne, PA 19087. INTUNIV is a registered trademark of Shire LLC. ©2013 Shire US Inc. This product is covered by US patents including 6,287,599; 6,811,794. Version: 08 2013
®
INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE INTUNIV (GUANFACINE) KIT
Label Image
CLOSE
INGREDIENTS AND APPEARANCE
INTUNIV
guanfacine tablet, extended release
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64725-0515(NDC:54092-515)
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
GUANFACINE HYDROCHLORIDE (UNII: PML56A160O) (GUANFACINE - UNII:30OMY4G3MK) GUANFACINE 2 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
POVIDONES (UNII: FZ989GH94E)
CROSPOVIDONE (UNII: 68401960MK)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
FUMARIC ACID (UNII: 88XHZ13131)
PRODUCT CHARACTERISTICS
Color WHITE (white) Score no score
Shape OVAL Size 12mm
Flavor&n