Medicinal Products

ACTONEL 5 mg

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

Coated tablet
Box of 2 blister packs of 14
All forms

Indication

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

Treatment of postmenopausal osteoporosis proven to reduce the risk of hip fractures.

Prevention of osteoporosis in postmenopausal women at high risk of osteoporosis (see section 5.1 Pharmacodynamic properties ).

Maintain or increase bone mass in postmenopausal women taking long-term systemic steroids (> 3 months) at doses ≥ 7.5 mg / day prednisone or prednisone equivalent.

Dosage ACTONEL 5 mg Film-coated tablet Box of 2 blister packs of 14

In adults, the recommended dose is one 5 mg tablet per day orally. The absorption of risedronate sodium is affected by food, so, in order to ensure adequate 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.

If taking before breakfast is not practical, ACTONEL can be taken between meals or in the evening, at the same time each day, strictly following the following instructions, in order to ensure the taking of ACTONEL when the stomach is empty:

· Between meals: ACTONEL should be taken at least 2 hours before and at least 2 hours after any food, drinks (other than still water) or medication.

· In the evening: ACTONEL should be taken at least 2 hours after the last foods, drinks (other than still water) or medications of the day. ACTONEL should be taken at least 30 minutes before going to bed.

· If an intake is missed, ACTONEL may be taken before breakfast, between meals or in the evening as detailed above.

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 for 30 minutes after taking the tablet (see Warnings and Precautions ).

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.

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 : 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 severity of the majority of the adverse events observed was mild to moderate and generally did not necessitate discontinuation of treatment.

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 noted in parenthesis): 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%), oesophageal stenosis (<0.1% vs 0.0%).

Musculoskeletal and connective tissue disorders

Frequent: musculoskeletal pain (2.1% vs 1.9%)

explorations

Rare: abnormal liver tests *

* Incidence not significant in phase III studies of osteoporosis; frequency based on adverse events, laboratory tests and rechallenge results in early clinical trials.

Biological examinations

An early, transient, mild and asymptomatic decrease in plasma calcium and phosphate levels has been observed in some patients.

In addition, 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.

Skin and subcutaneous tissue damage

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

Serious liver problems. In most reported cases, patients were treated with other products 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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