Medicinal Products

ACTONEL 35 mg

Generic drug of the therapeutic class: Rheumatology
active ingredients: Monosodium risedronate
laboratory: Warner Chilcott France

Coated tablet
Box of 4
All forms

Indication

Treatment of postmenopausal osteoporosis to reduce the risk of vertebral fractures.

Treatment of postmenopausal osteoporosis, to reduce the risk of hip fractures (see section 5.1 ).

Treatment of osteoporosis in men at high risk of fracture (see section on Pharmacodynamic properties )

Dosage ACTONEL 35 mg Film-coated tablet Box of 4

In adults, the recommended dose is one 35 mg tablet, once a week, orally. The tablet should be taken on the same day of the week, every week.

Diet interferes with the absorption of monosodium risedronate. In order to achieve optimal absorption, patients should take ACTONEL:

· Before breakfast: at least 30 minutes before the first foods, other medicines or drinks (other than still water) of the day are absorbed.

Patients should be advised that if they forget to take ACTONEL 35 mg, they should take it the day they notice it. Then they have to go back to weekly tablet intake based on the day chosen initially. They should not take two tablets the same day.

The ACTONEL tablet must be swallowed whole, without being crunched and without letting it melt in the mouth.

The ACTONEL tablet should be swallowed while sitting or standing, with a large glass of still water (≥120 ml) with low mineralization of calcium and magnesium to facilitate transit to the stomach.

Patients should not lie down within 30 minutes after taking the tablet (see Warnings and Precautions ).

Calcium and vitamin D supplementation should be considered if food intake is insufficient.

Elderly : no dose adjustment is required as bioavailability, distribution and elimination are similar in elderly (> 60 years of age) and younger subjects. This has also been demonstrated in postmenopausal women aged 75 and over.

Patients with renal impairment: No dosage adjustment is required in patients with mild to moderate renal impairment. The use of risedronate sodium is contraindicated in patients with severe renal impairment (creatinine clearance <30 ml / min) (see sections Contraindications and Pharmacokinetic Properties ).

The safety and efficacy of ACTONEL have not been demonstrated in children and adolescents.

Duration of treatment

The optimal duration of bisphosphonate therapy for osteoporosis has not been established. The need for continued treatment should be reassessed periodically on a case-by-case basis depending on the benefits and potential risks of ACTONEL, particularly after 5 or more years of treatment.

Against indications

· Hypersensitivity to risedronate sodium or to any of the excipients.

· Hypocalcemia (see Warnings and Precautions section ).

· Pregnancy and breast feeding.

· Severe renal insufficiency (creatinine clearance <30 ml / min).

Adverse effects Actonel

Risedronate sodium has been studied in Phase III clinical trials in more than 15, 000 patients.

In these clinical trials, the majority of adverse events were mild to moderate and generally did not require discontinuation.

Adverse events reported in Phase III clinical trials in postmenopausal osteoporotic women treated up to 36 months with risedronate sodium 5 mg / day (n = 5020) or placebo (n = 5048) and considered possibly or probably related to Risedronate sodium are listed below using the following convention (incidence of adverse events versus placebo in parentheses): very common (≥ 1/10), common (≥ 1/100, <1/10), infrequent (≥ 1/1000, <1/100), rare (≥ 1/10000, <1/1000), very rare (<1/10000).

Central nervous system disorders

Frequent : headache (1.8% vs. 1.4%).

Eye disorders

Uncommon : Iritis *.

Gastrointestinal disorders

Frequent : 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%), diarrhea (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%), esophageal ulcer (0.2% vs. 0.2%).

Rare : Glossitis (<0.1% vs. 0.1%), esophageal stenosis (<0.1% vs. 0.0%).

Musculoskeletal and connective tissue disorders:

Frequent : musculoskeletal pain (2.1% vs 1.9%).

explorations:

Rare : Liver test abnormalities *.

* Incidences not significant in the Phase III studies on osteoporosis; frequency based on adverse events, laboratory tests and rechallenge results in early clinical trials.

In a multicenter, double-blind, one-year study comparing risedronate sodium 5 mg daily (n = 480) and risedronate sodium 35 mg weekly (n = 485) in postmenopausal osteoporotic women Overall safety and job safety profiles were similar. The following adverse events, considered possibly or probably related to the product by the investigators, have been reported (higher incidence in the risedronate monosodium 35 mg group compared to the risedronate 5 mg group): gastrointestinal disorders (1.6% vs 1.0%) and pain (1.2% vs. 0.8%).

In a 2-year clinical study in osteoporotic men, overall safety and job safety were similar between the treatment and placebo groups. The adverse effects correspond to those previously described in postmenopausal women.

Biological examinations:

An early, transient, mild and asymptomatic decrease in serum calcium and phosphatemia has been observed in some patients.

The following additional adverse reactions have been reported since marketing (frequency unknown):

Eye disorders:

Iritis, uveitis

Musculoskeletal and connective tissue disorders:

Osteonecrosis of the jaw

Achievement of skin and subcutaneous tissues:

Hypersensitivity and skin reactions, including angioedema, generalized rash, urticaria, bullous skin reactions, sometimes severe, including isolated cases of Stevens-Johnson syndrome and toxic epidermal necrolysis.

Alopecia.

Immune system disorders:

Anaphylactic reaction.

Hepatobiliary disorders:

Severe liver problems

In most reported cases, patients were also treated with other drugs known to cause liver problems.

Since commercialization, the following adverse effects have been reported (rare frequency): atypical subtrochanteric and diaphyseal femoral fractures (class effect of bisphosphonates).

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