Medicinal Products

ACTONEL 30 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 Paget's disease of bone.

Dosage ACTONEL 30 mg Film-coated tablet Box of 2 blister packs of 14

In adults, the recommended dose is one 30 mg tablet per day orally for 2 months. If, after stopping treatment, a second treatment is necessary (at least two months after stopping the initial treatment), it will then be prescribed at the same dose and for the same duration as the initial treatment.

The absorption of risedronate sodium is affected by food, too, 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 must be taken at least 2 hours before and at least 2 hours after any food, drink (other than still water) or medicine,

· 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 must 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 within 30 minutes after taking the tablet (see Warnings and Precautions ).

Calcium and vitamin D supplementation should be considered by the doctor if food intake is insufficient, especially in Paget's disease where bone turnover is significantly elevated.

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.

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 the adverse events observed were mild to moderate and generally did not require 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.

In Phase III clinical trials of Paget's disease comparing risedronate monosodium versus etidronate (61 patients in each group), the following adverse events, considered possibly or probably related to the drug by the investigators, have been reported (incidence higher in the risedronate monosodium group than in the etidronate group): arthralgia (9.8% vs 8.2%); amblyopia, apnea, bronchitis, colitis, corneal injury, leg cramps, dizziness, dry eyes, flu syndrome, hypocalcemia, myasthenia gravis, neoplasm, nocturia, peripheral edema, bone pain, chest pain, rash, sinusitis, tinnitus, and loss of weight (1.6% vs. 0.0% for all these events).

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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