Medicinal Products

ACTONEL 75 mg

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

Coated tablet
Box of 6
All forms

Indication

Treatment of postmenopausal osteoporosis in women at high risk of fractures.

Dosage ACTONEL 75 mg Film-coated tablet Box of 6

In adults, the recommended dose is one 75 mg oral tablet, two consecutive days per month. The first tablet should be taken on the same day each month, followed by the second tablet the next day.

· Food and medications containing polyvalent cations (see section Interactions with other medicinal products and other forms of interaction ) interfere with the uptake of risedronate sodium. In order to achieve optimal absorption, patients should take ACTONEL:

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

o Still water is the only drink that must be taken with ACTONEL. Please note that some mineral waters may contain a very high calcium concentration and should not be used (see section 5.2 ).

Patients should be informed that if they forget to take ACTONEL, they should take it the next morning of the day they forget it, unless there are only 7 days left until the next monthly intake . Patients should then take ACTONEL 75 mg film-coated tablets for 2 days consecutively per month, the day the tablet should normally be taken.

· If the next dose interval is less than 7 days, patients should wait until the next scheduled monthly intake and continue to take ACTONEL 75 mg film-coated tablets 2 days consecutively per month on the scheduled dates.

· Patients should not take 3 tablets in the same week.

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

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

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

Supplementation with calcium and vitamin D should be considered if food intake is insufficient.

Elderly : no dose adjustment is necessary because 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 ).

Children and adolescents : 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 section Warnings and precautions for use ).

· 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 2-year, double-blind, multi-center study comparing risedronate sodium 5 mg daily (n = 613) and risedronate sodium 75 mg 2 consecutive days per month (n = 616) in postmenopausal osteoporotic women, the overall job security profiles were similar. The following additional adverse events, considered possibly or probably related to the product by the investigators, have been reported at a frequency of at least 1% (higher incidence in the risedronate monosodium 75 mg group compared to the risedronate 5 mg group): erosive gastritis (1.5% vs. 0.8%), vomiting (1.3% vs. 1.1%), arthralgia (1.5% vs. 1.0%), bone pain (1.1% vs. 0, 5%) and extremity pain (1.1% vs. 0.5%).

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 post-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).

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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