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Patient Information: ACTONEL* (AK-toh-nel) Tablets
ACTONEL (risedronate sodium tablets) 5 mg, ACTONEL (risedronate
sodium tablets) 35 mg, and ACTONEL (risedronate sodium tablets)
75 mg for Osteoporosis. Read this information carefully before you start
to use your medicine. Read the information you get every time you get
more medicine. There may be new information. This information does
not take the place of talking with your health care provider about your
medical condition or your treatment. If you have any questions or are not
sure about something, ask your health care provider or pharmacist.
What is the most important information I should know about
ACTONEL?
ACTONEL may cause problems in your stomach and esophagus (the tube
that connects the mouth and the stomach), such as trouble swallowing
(dysphagia), heartburn (esophagitis), and ulcers. You might feel pain in
your bones, joints, or muscles (See “What are the Possible Side Effects
of ACTONEL?’).
You must foHow the instructions exactly for ACTONEL to work
and to lower the chance of serious side effects. (See “How should
I take ACTONEL?”).
What is ACTONEL?
ACTONEL is a prescription medicine used:
• to prevent and treat osteoporosis in postmenopausal women (See
"What is Osteoporosis?”).
• to increase bone mass in men with osteoporosis.
• to prevent and treat osteoporosis in men and women that is caused by
treatment with steroid medicines such as prednisone.
• to treat Paget's disease of bone in men and women. The treatment
for Paget’s disease is very different than for osteoporosis and uses a
different type of ACTONEL. This leaflet does not cover using ACTONEL
for Paget's disease. If you have Paget's disease, ask your health care
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 won’t be able to see or feel a difference. ACTONEL helps lower
the risk of breaking bones (fractures). Your health care provider may
measure the thickness (density) of your bones or do other tests to check
your progress.
See the end of this leaflet for information about osteoporosis.
Who should not take ACTONEL?
Do not take ACTONEL if you:
• have low blood calcium (hypocalcemia)
• cannot sit or stand up for 30 minutes
• have kidneys that work 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 doctor 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 milk and if it can harm your baby.
• you have kidney problems. ACTONEL may not be right for you.
Tell your doctor about all the medicines you take, including
prescription and non-prescription medicines, vitamins and
herbal supplements.
ACTONEL can interact with other medicines. Keep a list of all the
medicines you take. Show it to all your health care providers, including
your dentist and pharmacist, each time you get a new medicine.
How should I take ACTONa?
The following instructions are for ACTONa 5 mg (daily), ACTONEL
35 mg (Once-a-Week), and ACTONa 75 mg (Two Consecutive Days
each Month):
• Take ACTONEL first thing in the morning before you eat or drink
anything except plain water.
• Take ACTONEL while you are sitting up or standing.
• Take ACTONEL with 6 to 8 ounces (about 1 cup) of plain water. Oo not
take it with any other drink besides plain water. Do not take it with
coffee, tea, juice, milk, or other dairy drinks.
• Swallow ACTONEL whole. Do not chew the tablet or keep it in your
mouth to melt or dissolve.
• After taking ACTONEL you must wait at least 30 minutes
BEFORE:
• lying down. You may sit. stand, or do normal activities like read the
newspaper or take a walk.
• eating or drinking anything except plain water.
• taking vitamins, calcium, or antacids. Take vitamins,
calcium, and antacids at a different time of the day from when you
take ACTONEL.
• Keep taking ACTONEL for as long as your health care provider tells you.
• For ACTONEL to treat your osteoporosis or keep you from getting
osteoporosis, you have to take it exactly as prescribed.
• Your health care provider may tell you to take calcium and vitamin D
supplements and to exercise.
What is my ACTONEL schedule?
If ypgr doctor has prescribed ACTONa 5 mg daily (a yellow tablet):
• Take 1 ACTONEL smg tablet every day in the morning.
• If you miss a dose of your ACTONEL 5 mg in the morning, do not take
it later in the day. Take only 1 ACTONEL 5 mg tablet the next morning
and continue your usual schedule of f tablet a day. Do not take 2
tablets on the same day.
If your doctor has prescribed ACTONEL 35 mo Once-a-Week (an oranoe
tablet).
• Choose 1 day of the week that you will remember and that best fits
your schedule to take your ACTONEL 35 mg. Every week, take 1
ACTONEL 35 mg tablet in the morning on your chosen day.
• If you miss a dose of your ACTONEL 35 mg in the morning, do not
take it later in the day. Take only 1 ACTONEL 35 mg tablet the next
morning and continue your usual schedule of 1 tablet on your chosen
day of the week. Do not take 2 tablets on the same day.
If your doctor has prescribed ACTONa 75 mo Two Consecutive Days
each Month (a oink tablet!:
• Choose 2 days in a row during the month that best fits your schedule
and that you will remember to take your ACTONEL 75 mg. Take 1
ACTONEL 75 mg tablet in the morning of your first chosen day.
Take the second tablet in the morning of the following day. ACTONEL
75 mg tablets should be taken on the same two consecutive days
each month.
• If you miss one or both tablets of your dose of ACTONEL 75 mg in the
morning, do not take it later in the day.
If the next month's scheduled doses are more than 7 davs awav do the
following:
If both tablets were missed, take the first ACTONEL 75 mg tablet on
the morning after the day it is remembered and the second tablet on
the next consecutive morning. If only one tablet is missed, take the
missed tablet on the morning after the day it is remembered. You
should then continue your usual schedule of ACTONEL 75 mg on two
consecutive days each month. Do not take more than two 75 mg
tablets within 7 days.
If the next month's scheduled doses are 1 to 7 davs awav.
you should wait until next month’s scheduled doses and then resume
taking ACTONEL 75 mg on two consecutive days each month as
originally scheduled.
• If you are not sure what to do if you miss a dose, contact your
health care provider who will be able to advise you.
What should I avoid while taking ACTONEL?
• Do not eat or dnnk anything except water before you take ACTONEL
and for at least 30 minutes after you take it.
• Do not lie down for at least 30 minutes after you take ACTONEL.
• Foods and some vitamin supplements and medicines can stop your
body from absorbing (using) ACTONEL. Therefore, do not take anything
other than plain water at or near the time you take ACTONEL.
(See “How should I take ACTONEL?”).
What are the possible side effects of ACTONEL?
Stop taking ACTONEL and tell your health care provider right
away if:
• swallowing is difficult or painful
• you have chest pain
• you have very bad heartburn or it doesn’t get better
ACTONEL may cause:
• pain or trouble swallowing (dysphagia)
• heartburn (esophagitis)
• ulcers in your stomach and esophagus (the tube that connects the
mouth and the stomach)
• pain in bones, joints or muscles, sometimes severe. Pain may start as
soon as one day or up to several months after starting ACTONEL.
The most common side effects with ACTONEL include back pain, joint
pain, upset stomach, abdominal (stomach area) pain, constipation,
diarrhea, gas, and headache. Tell your health care provider if you have
pain or discomfort in your stomach or esophagus. Rarely, severe skin
reactions may occur. Patients may get allergic reactions such as rash,
hives, or in rare cases, swelling that can be of the face, lips, tongue, or
throat, which may cause trouble breathing or swallowing.
In rare cases, patients taking ACTONEL may get eye inflammation,
usually with pain, redness and sensitivity to light.
Rarely, patients had jaw problems associated with delayed healing and
infection, often following tooth extraction.
These are not all the possible side effects of ACTONEL. You can ask
your health care provider or pharmacist about other side effects. Any
time you have a medical problem you think may be from ACTONEL. talk
to your doctor.
What is osteoporosis?
Osteoporosis is a disease that causes bones to become thinner. Thin
bones can break easily. Most people think of their hones as being solid
like a rock. Actually, bone is living tissue, just like other parts of the
body—your heart, brain, or skin, for example. Bone just happens to be
a harder type of tissue. Bone is always changing. Your body keeps your
bones strong and healthy by replacing old bone with new bone.
Osteoporosis causes the body to remove more bone than it replaces.
This means that bones get weaker. Weak bones are more likely to break.
Osteoporosis is a bone disease that is quite common, especially in older
women. However, young people and men can develop osteoporosis, too.
Osteoporosis can be prevented, and with proper therapy it can be treated.
How can osteoporosis affect me?
• You may not have any pain or other symptoms when
osteoporosis begins.
• You are more likely to break (fracture) a bone especially if you fall
because osteoporosis makes yourhones weaker. You are most likely
to break a bone in your back (spine), wrist, or hip.
• You may “shrink" (get shorter).
• You may get a “hump” (curve) in your back.
• You may have bad back pain that makes you stop some activities.
Who is at risk for osteoporosis?
Many things put people at risk for osteoporosis. The following people
have a higher chance of getting osteoporosis:
Women who:
• are going through or who are past menopause (“the change”)
• are white (Caucasian) or Asian
People who:
• are thin
• have a family member with osteoporosis
• do not get enough calcium or vitamin D
• do not exercise
• smoke
• drink alcohol often
• take bone thinning medicines (like prednisone or other corticosteroids)
for a long time
General information 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 ACTONEL to
other people, even if they have the same symptoms you have. It may
harm them.
What if I have other questions about ACTONEL?
This leaflet summarizes the most important information about ACTONEL
for osteoporosis. If you have more questions about ACTONEL, ask your
health care provider or pharmacist. They can give you information written
for health care professionals. For more information, call 1-877-ACTONEL
(toll-free) or visit our website at www.actonel.com.
What are the ingredients of ACTONEL?
ACTONEL (active ingredient): risedronate sodium.
ACTONEL (inactive ingredients): crospovidone, ferric oxide red (35 mg
and 75 mg tablets only), ferric oxide yellow (5 mg and 35 mg tablets
only), hydroxypropyl cellulose, hydroxypropyl methytceßulose, lactose
monohydrate (5 mg, 30 mg and 35 mg tablets only), magnesium stearate,
microcrystalline cellulose, polyethylene glycol, silicon dioxide, and
titanium dioxide.
ACTONEL® is marketed by:
Procter & Gamble Pharmaceuticals, Inc.
Cincinnati, Ohio 45202
and
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
MAY 2007
©2007 Procter & Gamble Pharmaceuticals, Inc.
P&G
Pharmaceuticals The Alliance for Better Bone Health
sonofi aventis
©2007 Procter & Gamble Pharmaceuticals, Inc.