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Generic Name: Risedronate 5 mg Tablets (RIS-e-DROE-nate)
Brand Name: Actonel
Actonel is used for:
Preventing or treating osteoporosis (weak bones) in women who are past menopause. It is used to prevent or treat osteoporosis in patients taking corticosteroids (eg, prednisone) for a long period of time. It may also be used for other conditions as determined by your doctor.
Actonel is a bisphosphonate. It works by reducing bone breakdown and increasing bone thickness. This makes bones less likely to break.
Do NOT use Actonel if:
- you are allergic to any ingredient in Actonel
- you have blockage or narrowing of the esophagus
- you have low calcium levels in the blood or severe kidney problems
- you are unable to sit or stand in an upright position for at least
Contact your doctor or health care provider right away if any of these apply to you.
Before using Actonel :
Some medical conditions may interact with Actonel . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have kidney problems, stomach disease (eg, ulcers), or esophagus problems including difficulty swallowing
Some MEDICINES MAY INTERACT with Actonel . However, no specific interactions with Actonel are known at this time.
Ask your health care provider if Actonel
may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Actonel :
Use Actonel as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Actonel . Talk to your pharmacist if you have questions about this information.
- Take Actonel at least 30 minutes before the first food or drink of the day, other than water. To reduce the risk of possible stomach side effects, take Actonel with a full glass of water (8 oz/240 mL) while standing or sitting up. Do not take it with coffee, tea, juice, milk, or other dairy drinks. If your doctor instructs you to take Actonel differently, be sure to follow all instructions for eating, drinking, and taking antacids or other medicines. Actonel is only effective if it is taken on an empty stomach.
- DO NOT lie down for
30 minutes after taking Actonel .
- Swallow tablets whole. Do not allow the tablet to melt or dissolve in your mouth. Do not chew or suck on the tablet. Throat irritation may occur if you suck or chew the tablets.
- Calcium or iron supplements, vitamins, or antacids containing calcium, magnesium, or aluminum may interfere with the absorption of Actonel . Take these medicines at least 2 hours apart.
- Take vitamin D and calcium supplements if your dietary intake is inadequate. Take them at a different time of day than Actonel , according to your doctor"s instructions.
- If you miss a dose of Actonel in the morning, do not take it later that day. Take only 1 tablet the next morning and continue your usual schedule of 1 tablet a day. Do not take 2 tablets on the same day.
Ask your health care provider any questions you may have about how to use Actonel .
Important safety information:
medicine may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Actonel with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- It may be necessary to begin an exercise program while taking Actonel . You may also need to stop smoking or consuming alcoholic beverages. Talk with your health care provider.
- Contact your health care provider if difficulty or pain upon swallowing, upper back pain, or severe or persistent worsening of heartburn occurs.
- Actonel may cause jaw bone problems in some patients, especially those who have cancer, are using certain medicines (eg, chemotherapy, corticosteroids), or have poor dental hygiene. These problems have often been associated with dental procedures. Talk with your doctor about an appropriate dental examination before you begin treatment with Actonel . Certain dental procedures should be avoided if possible while
you are using Actonel . Ask your doctor any questions you may have about receiving dental treatments while you are using Actonel .
- Actonel may interfere with chemicals used for bone imaging. Be sure to tell your doctor that you are using Actonel if you are having bone x-rays.
- If you are having any type of surgery and cannot sit or stand upright following surgery, check with your doctor about taking Actonel .
- Lab tests, including calcium levels, may be performed while you use Actonel . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Actonel should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Actonel while you are
pregnant. It is not known if Actonel is found in breast milk. If you are or will be breast-feeding while you use Actonel , check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Actonel :
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Abnormal skin sensations; anxiety; back pain; belching; bone pain; bronchitis;
constipation; cough; depression; diarrhea; dizziness; dry mouth; feeling of a whirling motion; flu-like symptoms; gas; headache; indigestion; infection
(fever, chills, sore throat); itching; joint pain; leg cramps; muscle aches;
nausea; neck pain; runny nose; sinus swelling; sleeplessness; stomach pain;
Severe allergic reactions (rash; hives; itching; difficulty breathing;
tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain;
difficult or painful swallowing; ear infection; fainting; hernia; pneumonia;
ringing in the ears; severe or prolonged bone, joint, or muscle pain; severe, persistent, or worsening heartburn; severe stomach pain; swelling of the eye;
swelling of the legs and feet; urinary tract infection; vision changes.
This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088
(1-800-332-1088) or at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.
Proper storage of Actonel :
Store Actonel at room temperature, between 68 and 77 degrees F
(20 and 25
degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Actonel out of the reach of children and away from pets.
- If you have any questions about Actonel , please talk with your doctor, pharmacist, or other health care provider.
- Actonel is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Actonel . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.
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