Treatment of osteoporosis, postmenopausal.

Alendronate reduces the risk of vertebral and hip fractures

Orally only

The recommended dosage is 70 mg once a week.
To allow adequate absorption of alendronate

ACID ALENDRONIQUE EG 70 mg tablet should be taken on an empty stomach, immediately after morning rising, with a large glass of tap water only, at least half an hour before the first intake of food, drink or anything Other medicines. Other drinks (including water, minerals), foods and medications may decrease the absorption of alendronate (see section Interactions with other medicines and other forms of interactions.)

To facilitate the passage through the stomach and thus reduce the potential risk of irritation or local and esophageal adverse effects (see Warnings and Precautions).
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· ALENDRONIC ACID EG 70 mg, tablet should be taken strictly at the rising, with a large glass of tap water (minimum 200 ml). >
· ALENDRONIC ACID EG 70 mg, tablet should be swallowed whole. Patients should not chew, suck the tablet or let it dissolve in their mouth because of the potential risk of ulcers, oropharyngeal.


· Patients should not lie down for at least 30 minutes after taking the tablet.

· ALENDRONIC ACID EG 70 mg tablet should not be taken at bedtime or before bedtime

· Treated patients should be supplemented with calcium and vitamin D if their dietary intakes are insufficient (see Warnings and Precautions for Use.)
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Use in elderly patients

Clinical studies did not reveal any differences related to age in the efficacy and safety profiles of alendronate. Therefore, no dosage changes are necessary in elderly patients.


No change in dosage is necessary in patients with glomerular filtration rate (GFR) greater than 35 ml / min. Due to lack of experience, alendronate is not recommended in patients with GFR less than 35 ml / min.

Use in patients with hepatic impairment

No change in dosage is necessary.

Use in children (under 18 years of age)

Alendronate has been studied in a small number of patients under 18 years of age, with osteogenesis imperfecta. The results are insufficient to justify its use in children

Tablet white to white, broken, oval, marked "AN; 70" on one side and ARROW logo on the other.

Pharmacotherapeutic group Bisphosphonate for the treatment of bone diseases ATC code M05B A04

The active ingredient of ALENDRONIC ACID EG 70 mg, tablet, alendronate monosodium trihydrate, is a bisphosphonate which inhibits bone resorption of osteoclasts without direct effect on the formation of bone. Preclinical studies have shown a preferential localization of alendronate to active resorption sites The activity of osteoclasts is inhibited but neither their recruitment nor their binding are impaired During the treatment with alendronate , The quality of the bone formed is normal.

Treatment of postmenopausal osteoporosis

Osteoporosis is defined as a bone mineral density (BMD) at the spine or neck of the femur at 2.5 standard deviations below the mean value of a normal youth population or by a history of fracture of the femur Bone fragility, regardless of BMD.

The therapeutic equivalence of alendronate in tablets for weekly administration (n = 519) and alendronate 10 mg daily (n = 370) was demonstrated in a multicenter study of a duration 1-year postmenopausal women with osteoporosis. The mean BMD increases in the spine at 1 year from baseline were 5.1% (95% CI: 4.8% -5.4%), in the group receiving 70 Mg once weekly and 5.4% (CI 95%: 5.0% -5.8%) in the 10 mg / day group. The mean increases in BMD in the 70 mg group once weekly and in the 10 mg mg once daily group were 2.3% and 2.9%, respectively, Of the femoral neck and 2.9% and 3.1% in the hip (femoral neck and trochanter). The two treatment groups were also similar to the increase in BMD at other sites of the skeleton.

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Alert: AFSSAPS of 05/12/2011

- The European Medicines Agency (EMA) has concluded that the appearance of atypical fractures of the femur exists for patients treated with drugs containing a biphosphonate (alendronate, clodronate, etidronate, ibandronate, pamidronate, risedronate, tiludronate , Zoledronate). This rare effect identified in 2008 for alendronate is therefore a class effect. It occurs especially during prolonged treatment.

- Atypical fractures are distinguished from fractures of the femur, "classical" by their localization and radiological characteristics. These short transverse or oblique fractures, often bilateral, may occur on any part of the femur between the lower part of the small trochanter and the supracondylar zone. They occur after minimal trauma or even without trauma.
In the event of concomitant administration, it is likely that foods and beverages (including mineral water), medicines containing calcium, antacids, as well as other oral medicines, interfere with With the absorption of alendronate.

Therefore, patients should wait at least half an hour between taking alendronate and taking other medicines orally (see Dosage and Mode of Administration.) Br>

No other drug-mediated interaction is expected. In clinical studies, a number of patients received estrogens (vaginally, cutaneously, orally) when treated with alendronate. No adverse reactions associated with this association have been observed.

Although no specific interaction studies have been performed, alendronate has been concomitantly administered in clinical studies with a wide range of commonly used drugs with no obvious clinical adverse interaction. Br>

Not applicable.

Hypocalcaemia, hypophosphatemia and undesirable events in the upper part of the gastrointestinal tract such as poor digestion, burns, stomach, esophagitis, gastritis, or ulcer may occur in case of overdose Orally.

No specific data on the management of alendronate overdosage are available. Milk or antacids should be administered to chelate alendronate. To avoid the risk of irritation, the esophagus should not induce vomiting and the patient should remain in a vertical position.
Use during pregnancy

Information on the use of alendronate in pregnant women is insufficient. Studies on the animal revealed effects on fetal ossification at high doses

Alendronate, administered during pregnancy in rats, resulted in hypocalcemic dystocia (see Preclinical Safety Data). Be advised that alendronate should not be used during pregnancy

Use during breastfeeding

It is not known whether alendronate is excreted in human milk. Because it is indicated, alendronate should not be used by women who are breast-feeding.
In a one-year clinical study in postmenopausal women with osteoporosis, overall tolerance profiles of alendronate tablets in weekly intake (n = 519), and alendronate 10 mg Per day (n '= 370) were similar.
In two clinical trials of three years duration in postmenopausal women, with a substantially identical protocol (alendronate 10 mg, n '= 196, placebo: n' = 397), the overall tolerance profiles of. Alendronate 10 mg / day and placebo were similar.

The undesirable effects presented by the investigators as being in possible or probable relation to the drug or unquestionably related to the drug are shown below if they occurred in ≥1% of patients treated with 10 mg / day; Of alendronate and at a higher frequency than in patients receiving placebo in studies over three years

1 year study

3-year study

Alendronate

Alendronate

Alendronate

Placebo

Tablet

10 mg / day

10 mg / day

(N '= 397)

One time by

(N '= 370)

(N '= 196)

%

Week

%

%

(N '= 519)

%

Gastrointestinal

Abdominal pain

3.7

3.0

6,6

4.8

Dyspepsia

2.7

2.2

3.6

3,5

Acid regurgitation

1.9

2.4

2.0

4.3

Nausea

1.9

2.4

3.6

4.0

Abdominal bloating

1.0

1,4

1.0

0.8

Constipation

0.8

1.6

3.1

1.8

Diarrhea

0.6

0.5

3.1

1.8

Dysphagia

0.4

0.5

1.0

0.0

Flatulence

0.4

1.6

2.6

0.5

Gastritis

0.2

1.1

0.5

1.3

Gastric ulcer

0.0

1.1

0.0

0.0

Oesophageal ulcer

0.0

0.0

1.5

0.0

Musculoskeletal diseases

Osteoarticular or muscular pain

2.9

3.2

4.1

2.5

Muscle cramps

0.2

1.1

0.0

1.0

Neurological

Headache

0.4

0.3

2.6

1.5

The following undesirable effects have been reported: in clinical studies and / or after the marketing of alendronate

Very common (> 1/10), frequent (≥ 1/100 to