Actonel EC

Uses

This is in a group of medicines called bisphosphonates. It alters the cycle of bone formation and breakdown in the body. It slows bone loss while increasing bone mass, which may prevent bone fractures. Risedronate is a prescription medicine used:

• To prevent and treat osteoporosis in postmenopausal women.
• 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.

Dosage

Actonel EC dosage

Treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures. Treatment ofestablished postmenopausal osteoporosis, to reduce the risk of hip fractures: The recommendeddose is Actonel EC 5 mg once daily or Actonel EC 35 mg once weekly on the same day each week or Actonel EC 150 mg once monthly.

Prevention of osteoporosis in postmenopausal women with increased risk of osteoporosis: Therecommended dose is Actonel EC 5 mg once daily.

To maintain or increase bone mass in postmenopausal women undergoing long-term (more than3 months): Systemic corticosteroid treatment at doses 7.5 mg/day prednisone or equivalent. Therecommended dose is Actonel EC 5 mg once daily.

Treatment of osteoporosis in men at high risk of fractures: The recommended dose is Actonel EC 35 mg once weekly. The tablet should be taken on the same dayeach week.

The absorption of Actonel EC is affected by food, thus to ensure adequate absorption patients should take Risedronate tablets at least 30 minutes before the first food, other medicinal product or drink (other than plain water) of the day. In the particular instances that before breakfast dosing is not practical, Risedronate 5 mg tablet can be taken between meals or in the evening at the same time everyday, with strict adherence to the following instructions, to ensure Actonel EC tablet is taken on an empty stomach-Between meals:

Actonel EC tablet should be taken at least 2 hours before and at least 2 hours after any food, medicinal product or drink (other than plain water). In the evening:

Actonel EC tablet should be taken at least 2 hours after the last food, medicinal product or drink (other than plain water) of the day. If a dose is missed: Risedronate 5 mg tablet: If an occasional dose is missed, Risedronate 5 mg tablet can be taken before breakfast, between meals, or in the evening according to the instructions above.

Risedronate 35 mg tablet: Patients should be instructed that if a dose is missed, just take one Risedronate 35 mg tablet on the morning after remember. Patients should then return to taking one tablet once a week on the day the tablet is normally taken. Two tablets should not be taken on the same day.

Risedronate 150 mg tablet: Patient should be instructed that if a dose is missed and the next month’s schedule dose is more than 7 days away, then should take the missed tablet in the morning after the day it is remembered. Patients should then return to taking one tablet once a month normally taken.The tablet must be swallowed whole and not sucked or chewed. To aid delivery of the tablet to the stomach Risedronate tablet is to be taken while in an upright position with a glass of plain water (120 ml or more). Patients should not lie down for 30 minutes after taking the tablet. Supplemental calcium and vitamin D should be considered if the dietary intake is inadequate.

Side Effects

Serious side effects:

• chest pain;
• difficulty or pain when swallowing;
• pain or burning under the ribs or in the back;
• new or worsening heartburn;
• severe joint, bone, or muscle pain; or
• jaw pain, numbness, or swelling.

Less serious side effects:

• mild heartburn or stomach upset;
• diarrhea, gas,or constipation;
• mild joint or back pain;
• headache.

Precaution

Take special care with Risedronate 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 EC

Before taking Risedronate talk to doctor if you:

• Are pregnant or may become pregnant. We do not know if Actonel EC can harm your unborn child.
• Are breast-feeding or plan to breast-feed. We do not know if Actonel EC can passthrough your milk and if it can harm your baby.
• Have kidney problems Actonel EC may not be right for you.
• Risedronate sodium is not intended for use in children.

During treatment, if you experience an allergic reaction (such as swelling of the face, tongue or throat, difficulty in breathing or swallowing, skin rash), you must stop taking Risedronate sodium and seek medical advice immediately. If you have stopped treatment due to hypersensitivity reactions you should not re-start therapy with Risedronate sodium.

Interaction

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription specially aspirin or other NSAIDs. Antacids, supplements, or medicines that contain aluminum, calcium, magnesium, or other minerals can interfere with how your body absorbs Actonel EC. If you use these other medicines, do not take them for at least 30 minutes after taking a Actonel EC tablet.

Pregnancy & Breastfeeding use

Pregnancy: Actonel EC is meant for use only in postmenopausal women. Therefore, Actonel EC should not be taken during pregnancy. If you take it by accident during pregnancy, stop taking it straight away and talk to your doctor.

Breast-feeding: Actonel EC is meant for use only in postmenopausal women. Therefore, breast-feeding women should not take this medicine. If you take it by accident during breast-feeding, stop taking it straight away and talk to your doctor.

Contraindication

Actonel EC tablet is contraindicated in patients with known hypersensitivity to Actonel EC and in patients with hypocalcaemia, severe renal impairment (creatinine clearance lower than 30 ml/min), during pregnancy and lactation.

Special Warning

Elderly: No dosage adjustment is necessary since bioavailability, distribution and elimination were similar in elderly (60 years of age or older) compared to younger subjects. This has also been shown in the very elderly, 75 years old and above postmenopausal population.

Renal impairment: No dosage adjustment is required for those patients with mild to moderate renal impairment. The use of Actonel EC is contra-indicated in patients with severe renal impairment (Creatinine clearance lower than 30ml/min).

Acute Overdose

Seek emergency medical attention if you think you have used too much of this medicine. Drink a full glass of milk right away. Do not make yourself vomit and do not lie down.

Overdose symptoms may include nausea, heartburn, stomach pain, diarrhea, muscle cramps, numbness or tingling, tight muscles in your face, seizure (convulsions), irritability, and unusual thoughts or behavior.

Storage Condition

Store in a cool and dry place. Protect from light & moisture. Keep out of the reach of children.

Innovators Monograph

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