Medicinal Products

ALENDRONIC ACID EG 70 mg

Generic drug of Fosamax
Therapeutic class: Rheumatology
active ingredients: Alendronic acid
laboratory: EG Labo

Compressed
Box of 4
All forms

Indication

Treatment of postmenopausal osteoporosis.

Alendronate reduces the risk of vertebral and hip fractures.

Dosage ALENDRONIC ACID EG 70 mg Tablet Box of 4

Orally only.

The recommended dosage is 70 mg once a week.

To allow adequate absorption of alendronate:

ALENDRONIC ACID EG 70 mg tablet should be taken on an empty stomach immediately with a large glass of tap water only at least half an hour before the first intake of food, drink or any other medication. Other beverages (including mineral waters), foods and medications may decrease the absorption of alendronate (see section 4.5 ).

To facilitate the passage in the stomach, and therefore reduce the potential risk of irritation or local and esophageal adverse effects ( see section Warnings and precautions for use ):

· ALENDRONIC ACID EG 70 mg, tablet should be taken strictly at sunrise, 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 or allow the tablet to dissolve in their mouths because of the potential risk of oropharyngeal ulcers.

· Patients should not lie down until the first foods of the day are absorbed and should be taken at least 30 minutes after taking the tablet.

· 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 sunrise.

· Patients treated should be supplemented with calcium and vitamin D if their dietary intake is inadequate (see Warnings and Precautions for Use section ).

Use in elderly patients

Clinical studies have not revealed any age-related differences in the efficacy and safety profiles of alendronate. Therefore no dosage modification is necessary in elderly patients.

Use in case of renal failure

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

Use in case of liver failure

No dosage modification is necessary.

Use in children (under 18 years)

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.

Against indications

· Esophageal diseases and other factors that delay oesophageal transit such as stenosis and achalasia.

· Unable to stand or sit for at least 30 minutes.

Hypersensitivity to alendronate, other bisphosphonates or any of the excipients.

· Hypocalcemia.

See Warnings and precautions for use .

Adverse effects Alendronic acid EG

In a one-year clinical study in postmenopausal women with osteoporosis, the overall safety profile of alendronate tablets weekly (n = 519), and alendronate 10 mg daily (n = 370) have been similar.

In two three-year clinical studies in postmenopausal women with a practically identical protocol, (alendronate 10 mg: n = 196, placebo: n = 397), the overall safety profile of alendronate 10 mg / day and placebo were similar.

The undesirable effects presented by the investigators as being in a possible or probable relationship with the drug or undeniably related to the drug are presented below if they occurred in ≥1% of patients treated with alendronate 10 mg / day and higher than in patients receiving placebo in three-year studies:

1 year study

Study over 3 years

alendronate

alendronate

alendronate

Placebo

compressed

10 mg / day

10 mg / day

(n = 397)

once a

(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

osteoarticular or muscular pain

2.9

3.2

4.1

2.5

muscle cramps

0.2

1.1

0.0

1.0

neurological

headaches

0.4

0.3

2.6

1.5

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

Very common (> 1/10), frequent (≥ 1/100 to <1/10), infrequent (≥ 1000 to <1/100), rare (≥ 1/10 000 to <1/1000), very rare (<1 / 10, 000), unknown (estimate not possible with available data).

Neurological disorders:

Frequent : headache

Eye disorders:

Rare: uveitis, scleritis

Gastrointestinal disorders:

Frequent: abdominal pain, dyspepsia, constipation, diarrhea, flatulence, esophageal ulcer *, dysphagia *, abdominal bloating, acid regurgitation.

Uncommon: nausea, vomiting, gastritis, oesophagitis *, oesophageal erosion *, melena.

Rare: esophageal stenosis *, oropharyngeal ulcer *, PUS (perforations, ulcers, bleeding) of the upper gastrointestinal tract, although no causal relationship has been established.

Skin and subcutaneous disorders:

Very rare: isolated cases of severe skin reactions, including Stevens Johnson syndrome and toxic epidermal necrolysis have been reported.

Musculoskeletal, connective tissue, and bone disorders:

Frequent: osteoarticular or muscular pains.

Unknown frequency: osteonecrosis

Osteonecrosis of the jaw has been reported in patients receiving bisphosphonates. The majority of cases involved patients with cancer, but such cases have also been reported in patients treated for osteoporosis. Osteonecrosis of the jaw is usually associated with dental extractions and / or local infections (including osteomyelitis). Cancers, chemotherapy, radiotherapy, corticosteroids and poor oral hygiene are risk factors (see section Warnings and Precautions for Use ).

Fractures of fatigue of the upper end of the femur (see section Warnings and precautions for use )

General disorders and reactions at the site of administration:

Uncommon: rash, pruritus, erythema.

Rare): hypersensitivity reactions including urticaria and angioedema.

Transient symptoms such as acute reactions (myalgia, general feeling of sickness, rare cases of fever) usually related to the start of treatment. Rash with photosensitivity.

Symptomatic hypocalcemia, usually in association with predisposition (see Warnings and Precautions for Use section ).

* See sections Warnings and precautions for use . and Dosage and Method of Administration .

Biological effects:

In clinical studies, discrete, transient, and asymptomatic decreases in serum calcium and phosphatemia were observed in 18% and 10% of patients taking alendronate 10 mg / day versus approximately 12% and 3%, respectively. the placebo. Nevertheless, the incidences of a decrease in serum calcium at <2.0mmol / l and phosphatemia at a rate of 0.65mmol / l were similar in both therapeutic groups.

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