Medicinal Products

ALENDRONIC ACID ARROW 70 mg

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

Compressed
Box of 4
All forms

Indication

Treatment of postmenopausal osteoporosis.

Alendronate reduces the risk of vertebral and hip fractures.

Posology ALENDRONIC ACID ARROW 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 ARROW 70 mg tablet should be taken on an empty stomach, immediately at sunrise, with a full 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. Interactions with other medicinal products and other forms of interaction ).

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

ALENDRONIC ACID ARROW 70 mg, tablet should be taken strictly at sunrise, with a large glass of tap water (minimum 200 ml).

ALENDRONIC ACID ARROW 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 ARROW 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 ).

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 a glomerular filtration rate (dfg) greater than 35 ml / min. Due to a lack of experience, alendronate is not recommended for patients with renal impairment characterized by 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 support its use in children.

ALENDRONIC ACID ARROW 70 mg tablet has not been studied for the treatment of osteoporosis induced by corticosteroids.

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 Arrow

In a one-year clinical study in postmenopausal women with osteoporosis, the overall safety profile of alendronate 70 mg tablets once weekly (n = 519) and alendronate 10 mg daily (n = 370) were 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 day and placebo were similar.

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

1 year study

Study over 3 years

Alendronate 70 mg (n = 519)%

Alendronate 10 mg / day (n = 370)%

Alendronate 10 mg / day (n = 196)%

Placebo (n = 397)%

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:

Neurological disorders:

Common (≥ 1/100, <1/10): headache

Eye disorders:

Rare (≥ 1/10000, <1/1000): uveitis, scleritis

Gastrointestinal disorders:

Frequent (≥ 1/100, <1/10): abdominal pain, dyspepsia, constipation, diarrhea, flatulence, esophageal ulcer *, dysphagia *, abdominal bloating, acid regurgitation.

Uncommon (≥ 1/1000, <1/100): nausea, vomiting, gastritis, oesophagitis *, oesophageal erosion, melena.

Rare (≥ 1/10000, <1/1000): esophageal stenosis *, oropharyngeal ulcerations *, PUS (perforations, ulcers, bleeding) in the upper gastrointestinal tract, although no causal relationship has been established.

Skin and subcutaneous disorders:

Very rare (≤ 1/10000): Isolated cases of severe skin reactions including Stevens Johnson syndrome and toxic epidermal necrolysis have been reported.

Musculoskeletal, connective tissue, and bone disorders

Frequent : (≥ 1/100, <1/10): osteoarticular or muscular pains.

Unknown frequency : osteonecrosis

Cases of osteonecrosis of the jaw have been reported in patients treated with bisphosphonates. The majority of these cases involve cancer patients, but some have also been reported in patients treated for osteoporosis. Osteonecrosis of the jaw is usually associated with tooth extraction and / or local infection (including osteomyelitis). Cancer, chemotherapy, radiotherapy, corticosteroids and poor oral hygiene are also considered as risk factors (see Warnings and Precautions ).

General disorders and reactions at the site of administration:

Uncommon (≥ 1/1000, <1/100): rash, pruritus, erythema.

Rare (≥ 1/10000, <1/1000): Hypersensitivity reactions including urticaria and angioedema.

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

Symptomatic hypocalcemia, usually in association with predisposition (see Warnings and Precautions 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 phosphate were observed in 18% and 10% respectively, patients taking alendronate 10 mg / day versus approximately 12% and 3% of patients under the placebo. Nevertheless, the incidences of a decrease in serum calcium at <2.0 mmol / l and phosphatemia at ≤0.65 mmol / l were similar in both therapeutic groups.

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