Medicinal Products

ACTONELCOMBI 35 mg + 1000 mg / 880 IU Film-coated tablet + effervescent granules Box of 12 weekly units of 1 tablet + 6 sachets

Generic drug of the therapeutic class: Rheumatology
active ingredients: Film-coated tablet: Risédronate sodium, Sachet of effervescent granules: Calcium, Cholecalciferol
laboratory: Warner Chilcott France

Film-coated tablet + effervescent granules
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 ).

Actonelcombi is only intended for patients for whom the amount of calcium and vitamin D3 is suitable.

Dosage ACTONELCOMBI 35 mg + 1000 mg / 880 IU Film-coated tablet + effervescent granules Box of 12 weekly units of 1 tablet + 6 sachets

The weekly packaging unit consists of 1 film-coated tablet and effervescent granules of risedronate sodium 35 mg and 6 sachets of calcium / vitamin D3 in a single box.

In adults, the recommended dose is one 35 mg risedronate monosodium tablet on the first day followed by one sachet of calcium / vitamin D3 per day for the next 6 days. This weekly sequence is then repeated weekly, starting with a 35 mg monosodium risedronate tablet.

Monosodium risedronate 35 mg (slightly orange tablet):

Risedronate 35mg tablet should be taken orally on the same day each week.

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

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

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

The risedronate 35 mg tablet should be swallowed while sitting or standing with a large glass of still water (≥ 120 ml) to facilitate transit to the stomach. Patients should not lie down for 30 minutes after taking the tablet (see Warnings and Precautions ).

Calcium / vitamin D3 (sachet):

The Calcium / Vitamin D3 sachet should be taken daily for 6 days beginning the day after taking the 35 mg risedronate monotherapy pill. The contents of each bag should be poured into a glass of water, stirred and drunk immediately once the effervescence is over.

Patients should be informed that if they forget to take risedronate sodium 35 mg, they should take it the next morning according to the dosage. In this particular case, patients must take their vitamin D3 calcium sachet the next day.

Patients should be informed that they should never take the tablet and sachet the same day.

Patients should be informed that if they forget calcium / vitamin D3, they should continue to take a sachet daily from the day they become aware of their forgetfulness.

Patients should be informed that they should not take two sachets on the same day. Any unused calcium / vitamin D3 sachet at the end of the weekly cycle should not be used.

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. Administration of risedronate and calcium / vitamin D3 is contraindicated in patients with severe renal impairment (creatinine clearance <30 ml / min) (see sections Contraindications and Pharmacokinetic Properties ).

Children : The safety and effectiveness of ACTONELCOMBI have not been established 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, calcium carbonate, cholecalciferol or any of the excipients (especially soybean oil).

Hypocalcemia (see section Warnings and precautions for use ).

Hypercalcemia.

Hypercalciuria.

Diseases and / or conditions (such as prolonged immobilization) associated with hypercalcemia and / or hypercalciuria.

Nephrolithiasis.

Pregnancy and breast feeding.

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

Hypervitaminosis D.

Adverse effects Actonelcombi

Monosodium risedronate:

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 one-year, multi-center, double-blind, study comparing risedronate sodium 5 mg daily (n = 480) and risedronate sodium 35 mg weekly (n = 485) in postmenopausal osteoporotic women, overall tolerance and job security were similar. The following undesirable effects, 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%).

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.

Calcium carbonate / vitamin D3

The undesirable effects are listed below, classified according to organ systems and frequency, according to the following convention: very frequent (≥ 1/10), frequent (≥1 / 100, <1/10), infrequent ( ≥ 1/1000, <1/100), rare (≥ 1/10000, <1/1000), very rare (<1/10000)

Metabolism and nutrition disorders

Uncommon: hypercalcemia and hypercalciuria.

Gastrointestinal disorders

Rare: constipation, flatulence, nausea, abdominal pain and diarrhea.

Skin and subcutaneous disorders

Rare: pruritus, rash and urticaria.

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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