P atient In fo rm a tio n : ACTONEL® (A K -to h -n e l) Tablets
ACTONEL (ris e d ro n a te so d iu m ) ta b le ts 5 m g,
ACTONEL (risedronate sodium ) ta b le ts 35 m g, ACTONEL
(rise d ro n a te sodium ) ta b le ts 75 m g, and ACTONEL
(rise d ro n a te sodium ) ta b le ts 150 m g fo r O steoporosis.
Read this inform ation carefully before you start to use your
medicine. Read the inform ation you get every tim e you
get more medicine. There may be new inform ation. This
inform ation does not take the place ol talking w ith your
healthcare provider about your medical condition or your
treatm ent. If you have any questions or are not sure about
something, ask your healthcare provider or pharm acist.
W hat is the m o st im p o rta n t in fo rm a tio n I should know
a bout ACTONEL?
ACTONEL may cause problems in your stom ach and
esophagus (the tube that connects the mouth and the
stomach), such as trouble swallowing (dysphagia),
heartburn (esophagitis), and ulcers. You m ight feel pain in
your bones, joints, or muscles (See “ W hat are the Possible
Side Effects of ACTONEL?").
You m u s t fo llo w th e in s tru c tio n s e x a c tly fo r
ACTONEL to w o rk and to lo w e r th e c h a n c e o f
s e rio u s s id e e ffe c ts . (See “ H ow sh o u ld I take
ACTONEL?” ).
W hat is ACTONEL?
ACTONEL is a prescription medicine used:
• to prevent and treat osteoporosis in postmenopausal
women.
•
to increase bone mass in men w ith osteoporosis.
• to prevent and treat osteoporosis in men and women
that is caused by treatm ent w ith steroid medicines such
as prednisone.
• to treat Paget’s disease of bone in men and wom en.
The treatm ent for Paget's disease is very different
than for osteoporosis and uses a different dose of
ACTONEL. This leaflet does not cover using
ACTONEL for Paget’s disease. If you have Paget’s
disease, ask your healthcare provider how to use
ACTONEL.
ACTONEL may reverse bone loss by stopping more loss
of hone and increasing bone strength in m ost people who
take it, even though they w on't be able to see or feel a
difference. ACTONEL helps lower the risk of breaking
bones (fractures). Your healthcare provider may measure
the thickness (density) of your bones or do other tests to
check your progress.
W ho should not take ACTONEL?
Do not ta ke ACTONEL if you:
•
have low blood calcium (hypocalcemia)
• cannot sit or stand up for 30 minutes
•
have kidneys that w ork poorly
•
have an allergy to ACTONEL. The active ingredient
in ACTONEL is risedronate sodium. (See the end
of this leaflet for a list of all the ingredients in
ACTONEL.)
Tell your d o c to r before using ACTONEL if:
• you are pregnant or may become pregnant. We do not
know if ACTONEL can harm your unborn child.
• you are breast-feeding or plan to breast-feed. We do not
know if ACTONEL can pass through your m ilk and if it
can harm your baby.
• you have kidney problems. ACTONEL may not be right
for you.
Tell your d o c to r about all the m e dicines you take,
in c lu d in g p re s c rip tio n and n o n p re scrip tio n m edicines,
v ita m in s and herbal supplem ents.
ACTONEL can interact w ith other medicines. Keep a list of
all the m edicines you take. Show it to all your healthcare
providers, including your dentist and pharm acist, each time
you get a new medicine.
How should I ta ke ACTONEL?
The fo llo w in g in s tru c tio n s a p p ly to a ll p a tie n ts ta k in g
ACTONEL:
• Take ACTONEL exactly as prescribed by your healthcare
provider.
• Take ACTONEL firs t thing in the morning before you eat
or drink anything except plain water.
•
Take ACTONEL while you are sitting up or standing.
•
Take ACTONEL w ith 6 to 8 ounces (about 1 cup) of
plain water. Do not take it w ith any other drink besides
plain water.
•
Swallow ACTONEL whole. Do not chew the tablet or
keep it in your mouth to m elt or dissolve.
• After taking ACTONEL you m ust w ait at least 30 minutes
BEFORE:
• lying down. You may sit, stand, or do norm al activities
like read the newspaper or take a walk.
• eating or drinking anything except plain water.
• taking vitam ins, calcium , or antacids. Take vitam ins,
calcium , and antacids at a different tim e of the day
from when you take ACTONEL.
• Keep taking ACTONEL for as long as your healthcare
provider tells you.
•
For ACTONEL to treat your osteoporosis or keep you
from getting osteoporosis, you have to take it exactly as
prescribed.
•
If you miss a dose of ACTONEL. call your healthcare
provider for instructions.
•
If you take more than your prescribed dose of ACTONEL,
call your healthcare provider right away.
•
Your healthcare provider may tell you to take calcium
and vitam in D supplem ents and to exercise.
W hat is m y ACTONEL schedule?
ACTONEL tablets are made in 4 different dosages
(amounts). How often you should take your tablet
depends upon the dosage that your doctor has prescribed
(recommended) for you.
•
5 mg tablets are yellow. One tablet should be taken
every day in the morning.
•
35 mg tablets are orange. One tablet should be taken
once a week in the morning.
•
75 mg tablets are pink. One tablet should be taken in
the morning tw o days in a row every month.
•
150 mg tablets are blue. One tablet should be taken
once a m onth in the morning.
If you m iss your dose in the morning, do not take it later
in the day. You should call your healthcare provider for
instructions.
W hat should I avoid w h ile ta k in g ACTONEL?
•
Do not eat or drink anything except water before you
take ACTONEL and for at least 30 minutes after you take
it. (See “ How should I take ACTONEL?” ).
•
Do not lie down for at least 30 minutes after you take
ACTONEL.
•
Foods and some vitam in supplem ents and medicines
can stop your body from absorbing (using) ACTONEL.
Therefore, do not take anything other than plain w ater at
or near the time you take ACTONEL.
W hat are the possible side e ffe c ts o f ACTONEL?
Stop ta k in g ACTONEL and te ll your h ealthcare provid e r
rig h t aw ay if:
•
swallowing is difficult or painful
•
you have chest pain
•
you have very bad heartburn or it doesn’t get better
Possible serious side effects may include:
•
esophagus or stom ach problems, including ulcers, pain,
or trouble swallowing. Tell your healthcare provider
if you have pain or discom fort in your stom ach or
esophagus.
•
low calcium and other mineral disturbances. If you
already have one (or more) of these problems, it should
be corrected before taking ACTONEL.
•
pain in bones, joints or muscles, sometim es severe. Pain
may start as soon as one day or up to several months
after starting ACTONEL.
• jaw-bone problems in some people, which may include
infection and slower healing after teeth are pulled. Tell
your healthcare providers, including your dentist, right
away if you have these symptoms.
Common side effects include the following:
•
back and joint pain
•
upset stom ach and abdominal (stomach area) pain
• short-lasting, mild flu-like symptoms, which are
reported w ith the m onthly doses and usually get better
after the first dose.
Other possible side effects may include:
• A lle rg ic and severe skin re a ctio n s. Tell your
healthcare provider if you develop any symptoms of
an allergic reaction including: rash (w ith or w ithout
blisters), hives, or swelling of the face, lips, tongue,
or throat Get m edical help rig h t aw ay if you have
tro u b le b re a th in g or sw a llo w in g .
•
Eye in fla m m a tio n . Tell your healthcare provider if you
get any eye pain, redness, or it your eyes become more
sensitive to light.
Call yo u r d o cto r fo r m edical advice about side e ffe cts.
You m ay re p o rt side e ffe c ts to FDA a t 1-800-FD A -1088.
How should I sto re ACTONEL?
• Store ACTONEL between 68°E to 77°E (20°C to 25°C).
•
Keep ACTONEL and all m edicin e s o u t o f the reach of
ch ild re n .
G eneral in fo rm a tio n a bout ACTONEL:
Medicines are sometim es prescribed for conditions that are
not mentioned in patient inform ation leaflets. Do not use
ACTONEL for a condition for which it w as not prescribed.
Do not give ACTONEL to otfier people, even if they have the
same symptoms you have. It may harm them.
W hat if I have o th e r q uestions about ACTONEL?
This leaflet summarizes the m ost im portant inform ation
about ACTONEL for osteoporosis. If you have more questions
about ACTONFL, ask your healthcare provider or pharmacist.
They can give you inform ation w ritten tor healthcare
professionals. For more inform ation, call 1-877 ACTONEL
(toll-free) or visit our web site at w w w .actonel.com .
W hat are the in g re d ie n ts o f ACTONEL?
ACTONEL (active ingredient): risedronate sodium.
ACTONEL (inactive ingredients): All dose strengths contain:
crospovidone, hydroxypropyl cellulose, hypromellose.
magnesium stearate, m icrocrystalline cellulose,
polyethylene glycol, silicon dioxide, and titanium dioxide.
Dose-strength specific ingredients include: 5 m g— ferric
oxide yellow, lactose monohydrate; 30 mg— lactose
monohydrate; 35 mg— ferric oxide red, ferric oxide yellow,
lactose monohydrate; 75 m g— ferric oxide red; 150 m g—
FD&C blue #2 aluminum lake.
ACTONEL® is marketed by:
Procter & Gamble Pharmaceuticals, Inc.
Cincinnati, Ohio
45202
and
sanofi-aventis U.S. LLC
Bridgewater, NJ
08807
APRIL
2008
©2008
Procter & Gamble Pharmaceuticals, Inc.
P&G
Pharmaceuticals
/
i \ ’ A lliance fo r I id le r hone
/
le a ltb
s a n o f i a v e n t is
©2008
Procter & Gamble Pharmaceuticals, Inc.
