Presentation Each film-coated tablet contains 5 mg risedronate sodium (equivalent to 4.64 mg risedronic acid).
Description Film-coated tablets.Oval yellow film-coated tablet with RSN on one side and 5 mg on the other.
Indications Treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures. Treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures. Prevention of osteoporosis in postmenopausal women with increased risk of osteoporosis.
To maintain or increase bone mass in postmenopausal women undergoing long-term (more than 3 months), systemic corticosteroid treatment at doses 7.5mg/day prednisone or equivalent.
Adult Dosage The recommended daily dose in adults is one 5 mg tablet orally. The absorption of Actonel is affected by food, thus to ensure adequate absorption patients should take Actonel:
• Before breakfast: At least 30 minutes before the first food, other medicinal product or drink (other than plain water) of the day.
In the particular instance that before breakfast dosing is not practical, Actonel can be taken between meals or in the evening at the same time everyday, with strict adherence to the following instructions, to ensure Actonel is taken on an empty stomach:
• Between meals: Actonel should be taken at least 2 hours before and at east 2 hours after any food, medicinal product or drink (other than plain water).
• In the evening: Actonel should be taken at least 2 hours after the last food, medicinal product or drink (other than plain water) of the day. Actonel should be taken at least 30 minutes before going to bed.
If an occasional dose is missed, Actonel can be taken before breakfast, between meals, or in the evening according to the instructions above.
The tablets must be swallowed whole and not sucked or chewed. To aid delivery of the tablet to the stomach Actonel is to be taken while in an upright position with a glass of plain water (120 ml). Patients should not lie down for 30 minutes after taking the tablet (See Special Precautions).
Supplemental calcium and vitamin D should be considered if the dietary intake is inadequate.
Child Dosage Safety and efficacy of Actonel have not been established in children and adolescents.
Elderly Dosage Elderly: No dosage adjustment is necessary since bioavailability, distribution and elimination were similar in elderly (>60 years of age) compared to younger subjects.
Contra Indications Known hypersensitivity to risedronate sodium or to any of the excipients. Hypocalcaemia (See Special Precautions). Pregnancy and lactation. Severe renal impairment (creatinine clearance <30ml/min).
Special Precautions Foods, drinks (other than plain water) and medicinal products
containing polyvalent cations (such as calcium, magnesium, iron and aluminium)
interfere with the absorption of bisphosphonates and should not be taken
at the same time as Actonel (See Interactions) In order to achieve the
intended efficacy, strict adherence to dosing recommendations is
necessary (See Adult Dosage)
Efficacy of bisphosphonates in the treatment of postmenopausal
osteoporosis is related to the presence of low bone mineral density (BMD
T-score at hip or lumbar spine -2.5 SD) and/or prevalent fracture.
High age or clinical risk factors for fracture alone are not reasons to
initiate treatment of osteoporosis with a bisphosphonate.
The evidence to support efficacy of bisphosphonates including Actonel
in very elderly women (>80 years) is limited.
Some bisphosphonates have been associated with oesophagitis and
oesophageal ulcerations. Therefore patients should pay attention to the dosing
instructions (See Adult Dosage). In patients who have a history of
oesophageal disorders which delay oesophageal transit or emptying e.g.
stricture or achalasia, or who are unable to stay in the upright position
for at least 30 minutes after taking the tablet, risedronate sodium
should be used with special caution because of limited clinical experience
in these patients. Prescribers should emphasise the importance of the
dosing instructions to these patients
Hypocalcaemia should be treated before starting Actonel therapy. Other
disturbances of bone and mineral metabolism (e.g. parathyroid
dysfunction, hypovitaminosis D) should be treated at the time of starting
Actonel therapy.
Osteonecrosis of the jaw, generally associated with tooth extraction
and/or local infection (including osteomyelitis) has been reported in
patients with cancer receiving treatment regimens including primarily
intravenously administered bisphophonates. Many of these patients were also
receiving chemotherapy and corticosteroids. Osteonecrosis of the jaw
has also been reported in patients with osteoporosis receiving oral
bisphosphonates.
A dental examination with appropriate preventive dentistry should be
considered prior to treatment with bisphosphonates in patients with
concomitant risk factors (e.g. cancer, chemotherapy, radiotherapy,
corticosteroids, poor oral hygiene).
While on treatment, these patients should avoid invasive dental
procedures if possible. For patients who develop osteonecrosis of the jaw
while on bisphosphonate therapy, dental surgery may exacerbate the
condition. For patients requiring dental procedures, there are no data
available to suggest whether discontinuation of bisphosphonate treatment
reduces the risk of osteonecrosis of the jaw.
Clinical judgment of the treating physician should guide the management
plan of each patient based on individual benefit /risk assessment.
This medicine contains lactose. Patients with rare hereditary problems
of galactose intolerance, the Lapp lactase deficiency or
glucose-galactose malabsorption should not take this medicine.
Interactions No formal interaction studies have been performed, however no clinically relevant interactions with other medicinal products were found during clinical trials. In the Actonel Phase III osteoporosis studies, acetyl salicylic acid or NSAID use was reported by 33% and 45% of patients respectively.
If considered appropriate Actonel may be used concomitantly with oestrogen supplementation.
Concomitant ingestion of medications containing polyvalent cations (e.g. calcium, magnesium, iron and aluminium) will interfere with the absorption of Actonel (See Special Precautions).
Actonel is not systemically metabolised, does not induce cytochrome P450 enzymes, and has low protein binding.
Pregnancy and lactation: There are no adequate data from the use of risedronate sodium in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown.
Actonel must not be used during pregnancy or by breast-feeding women.
Adverse Drug Reactions Risedronate has been studied in phase III clinical trials involving
more than 15,000 patients. The majority of undesirable effects observed in
clinical trials were mild to moderate in severity and usually did not
require cessation of therapy.
Adverse experiences reported in phase III clinical trials in
postmenopausal women with osteoporosis treated for up to 36 months with
risedronate 5mg/day (n=5020) or placebo (n=5048) and considered possibly or
probably related to risedronate are listed below using the following
convention (incidences versus placebo are shown in brackets): very common
(=1/10); common (=1/100; <1/10); uncommon (=1/1,000; <1/100); rare (=1/10,000;
<1/1,000); very rare (<1/10,000).
Nervous system disorders:
Common: headache (1.8% vs. 1.4%)
Eye disorders:
Uncommon: iritis*
Gastrointestinal disorders:
Common: constipation (5.0% vs. 4.8%), dyspepsia (4.5% vs. 4.1%), nausea
(4.3% vs. 4.0%), abdominal pain (3.5% vs. 3.3%), diarrhoea (3.0% vs.
2.7%)
Uncommon: gastritis (0.9% vs. 0.7%), oesophagitis (0.9% vs. 0.9%),
dysphagia (0.4% vs. 0.2%), duodenitis (0.2% vs. 0.1), oesophageal ulcer
(0.2% vs. 0.2%)
Rare: glossitis (<0.1% vs. 0.1%), oesophageal stricture (<0.1% vs.
0.0%),
Musculoskeletal and connective tissues disorders:
Common: musculoskeletal pain (2.1% vs. 1.9%)
Investigations (hepatobiliary):
Rare: abnormal liver function tests*
Laboratory findings: Early, transient, asymptomatic and mild decreases
in serum calcium and phosphate levels have been observed in some
patients.
The following additional adverse reactions have been reported during
post-marketing use (frequency unknown):
Eye disorders:
iritis, uveitis
Muskuloskeletal and connective tissues disorders:
osteonecrosis of the jaw
Skin and subcutaneous tissue disorders:
hypersensitivity and skin reactions, including angioedema, generalised
rash, and bullous skin reactions, some severe.
* No relevant incidences from Phase III osteoporosis studies; frequency
based on adverse event/laboratory/rechallenge findings in earlier
clinical trials.
