9883612
USPPI
Patient Information about
GARDASIL® (pronounced "gard-Ah-sill")
Generic name: [Human Papillomavirus Quadrivalent (Types 6,11,16, and 18) Vaccine, Recombinant]
Read this inform ation w ith care before getting GARDASIL
.1
You (the person getting GARDASIL) w ill need 3 doses
of the vaccine. It is im p o rta n t to read this leaflet w hen
you get each dose. This leaflet does not take the place of
talking w ith your health care p rovider about GARDASIL.
W hat is GARDASIL?
GARDASIL is a vaccine (injection/shot) that is used
fo r girls and w om en 9 through 26 years of age to help
protect against the fo llo w in g diseases caused by Human
P apillom avirus (HPV):
• Cervical cancer
• Vulvar and vaginal cancers
• G enital w arts
• A bnorm al and precancerous cervical, vaginal, and
vulvar lesions
o
The diseases listed above have m any causes, and
GARDASIL only protects against diseases caused
by certain kinds of HPV (called Type
6
, Type 11,Type 16,
and Type 18). M ost of the tim e, these 4 types o f HPV
are responsible fo r the diseases listed above,
o GARDASIL cannot protect you fro m a disease that is
caused by other types of HPV, other viruses, or bacteria,
o GARDASIL does not treat HPV infection,
o You cannot get HPV or any of the above diseases
fro m GARDASIL.
GARDASIL is used fo r boys and m en 9 through 26 years
of age to help protect against genital w arts.
W hat im p ortan t inform ation about GARDASIL should
I know?
• You should continue to get routine cervical cancer
screening.
• GARDASIL m ay not fu lly protect everyone w ho gets
the vaccine.
• GARDASIL w ill not protect against HPV types that
you already have.
W ho should not get GARDASIL?
You should not get GARDASIL if you have, or have had:
• an allergic reaction after getting a dose of GARDASIL.
• a severe allergic reaction to yeast, am orphous
alum inum hydroxyphosphate sulfate, polysorbate 80.
W hat should I tell my health care provider before
getting GARDASIL?
Tell your health care provider if you:
• are pregnant or planning to get pregnant. GARDASIL
is not recom m ended fo r use in pregnant w om en.
• have im m une problem s, like HIV infection, cancer, or
you take m edicines that affect your im m une system .
• have a fever over 100°F (37.8°C).
• had an allergic reaction to another dose of GARDASIL.
• take any m edicines, even those you can buy over the
counter.
Your health care p rovider w ill help decide if you should
get the vaccine.
How is GARDASIL given?
GARDASIL is a shot that is usually given in the arm muscle.
You w ill need 3 shots given on the fo llo w in g schedule:
• Dose 1: at a date you and your health care provider
choose.
• Dose 2: 2 m onths after Dose 1.
• Dose 3:
6
m onths after Dose 1.
’ R e g iste re d tra d e m a rk of M E R C K & C O ., Inc.
W h ite h o u s e S ta tio n , N J 08889, U S A
C O P Y R IG H T © 2 0 0 9 M E R C K & C O ., Inc.
A ll rig h ts re se rv e d
Fainting can happen a fte r g e ttin g GARDASIL.
S o m e tim e s people w h o fa in t can fa ll and h u rt
them selves. For this reason, your health care p rovider
m ay ask you to sit or lie dow n fo r 15 m inutes after you
get GARDASIL. Som e people w h o fa in t m ig h t shake or
becom e stiff. This m ay require evaluation or tre a tm e n t
by your health care provider.
Make sure that you get all 3 doses on tim e so that you
get the best protection. If you m iss a dose, talk to your
health care provider.
W hat are the possible side effects of GARDASIL?
The m ost com m on side effects w ith GARDASIL are:
• pain, sw elling, itching, bruising, and redness at the
injection site
• headache
• fever
• nausea
• dizziness
• vom iting
• fainting
Tell your health care provider if you have any of the
fo llo w in g problem s because these m ay be signs of an
allergic reaction:
• d iffic u lty breathing
• w heezing (bronchospasm )
• hives
• rash
Tell your health care provider if you have:
• sw ollen glands (neck, arm pit, or groin)
• jo in t pain
• unusual tiredness, weakness, or confusion
• chills
• generally feeling unw ell
• leg pain
• shortness of breath
• chest pain
• aching m uscles
• m uscle weakness
• seizure
• bad stom ach ache
• bleeding or bruising m ore easily than norm al
C ontact your health care p rovider rig h t away if you get
any sym ptom s that concern you, even several m onths
after getting the vaccine.
For a m ore com plete list o f side effects, ask your health
care provider.
W hat are the ingredients in GARDASIL?
The ingredients are proteins of HPV Types
6
, 11, 16, and
18, am orphous alum inum hydroxyphosphate sulfate,
yeast protein, sodium chloride, L-histidine, polysorbate 80,
sodium borate, and w ater fo r injection.
This leaflet is a sum m ary of inform ation about GARDASIL.
If you w ould like m ore inform ation, please talk to your
health care provider or visit w w w .g a rd a sil.co m .
Issued O ctober 2009
M anufactured and D istributed by:
MERCK & CO., Inc.
W hitehouse Station, NJ 08889, USA
21002221 (7)(612)-GRD-CON
