P atient In fo rm a tio n : ACTONEL6 (A K -to h -n e l) Tablets
ACTONEL (ris e d ro n a tc s o 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 Information carefully before you sta rt 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 of talking w ith your
healthcare provider about your m edical 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 th e m ost im p o rta n t in fo rm a tio n I sh o u ld kn o w
a bout ACTONEL?
ACTONEL may cause problems in your stom ach and
esophagus (the tube that connects the mouth and the
stomach). su;h as trouble swallowing (dysphagia),
heartburn (esophagitis), and ulcers. You might 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 side e ffe c ts . (See “ H ow sh o u ld I ta k e
ACTONEL?” ).
W hat is ACTONEL?
ACTONEL is a prescription medicine used:
•
to prevent and treat osteoporosis in postm enopausal
women.
•
to increase bone m ass in men w ith osteoporosis.
•
to prevent and treat osteoporosis in men and women
that is caised by treatm ent w ith steroid m edicines such
as prednisone.
• to treat Paget's disease of bone in men and women.
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 bone and increasing bone strength in most 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 p'ogress.
Who should not take ACTONEL?
Do not ta ke ACTONEL if you:
•
have low blood calcium (hypocalcemia)
•
cannot s it 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 yo u r d octor 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 yo u r d octor a bout a ll the m e dicines you take,
in c lu d in g p re scrip tio n and n o n p re s c rip 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 medicines 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 k e ACTONEL?
The fo llo w in g in s tru c tio n s apply to all p a tie n ts ta k in g
ACTONEL:
•
Take ACTONEL exactly as prescribed by your healthcare
provider.
• Take ACTONEL first thing in the morning before you eat
or drink anything except plain water.
• Take ACTONEL w hile you are sitting up or standing.
•
Take ACTONEL w ith 6 to 8 ounces (about 1 cup) of
plain water. L)o 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 w alk.
• 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 vitamin D supplements 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
depsnds 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.
•
25 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 m orning tw o days in a row every month.
•
150 mg tablets are blue. One tablet should be taken
once a month 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
inst'uctions.
What should I avoid while taking ACTONEL?
•
Do not eat or drink anything except w ater before you
lake ACTONEL arid for at least 30 m inutes 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 m edicines
can stop your body from absorbing (using) ACTONEL.
Therefore, do not take anything other than plain w ater at
or near the tim e 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 yo u r h e a lth ca re 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
te corrected before taking ACTONEL.
•
pain in bones, joints or m uscles, som etim 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 firs t dose.
Other possible side effects may include:
• A lle rg ic and severe s k in re a ctio n s. Tell your
healthcare provider if you develop any symptoms of
an allergic reaction including: rash (w ith or without
blisters), hives, or swelling of the face, lips, tongue,
or throat Get m e d ica l 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 if your eyes become more
sensitive to light.
Call your d o c to r fo r m e d ica l advice a bout side e ffe c ts .
You m ay re p o rt side e ffe c ts to FDA a t 1-800-FD A-1088.
H ow should I sto re ACTONEL?
• Store ACTONEL between 68°F to
77
°F (
20
°C tr
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 about ACTONEL:
Medicines are sometimes prescribed for conditions that are
not mentioned in patient information leaflets. Do not use
ACTONEL for a condition for which it was not prescribed.
Do not give AC I O N tL to other people, even if they have the
same sym ptom s you have. It may harm them.
W hat if I have o th e r q u e stio n s a b o u t ACTONEL?
This leaflet summ arizes the m ost im portant inform ation
about ACTONEL for osteoporosis. If you have more questions
about ACTONEL, ask your healthcare provider or pharmacist.
They can give you inform ation w ritten for 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, liydruxypropyl cellulose, hyprumellose.
magnesium stearate, m icrocrystalline cellulose,
polyethylene glycol, silicon dioxide, and titanium dioxide.
Dose-strength specific ingredients include: 5 mg— ferric
oxide yellow, lactose monohydrate; 30 m g— 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 alum inum lake.
A C T O N E L *1
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