Medicinal Products

ALENDRONIC ACID ALTER 70 mg

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

Coated tablet
Box of 4
All forms

Indication

Treatment of postmenopausal osteoporosis.

Alendronate reduces the risk of vertebral and hip fractures.

Dosage ALENDRONIC ACID ALTER 70 mg Film-coated tablet Box of 4

Dosage

The recommended dosage is one ALTER ALENDRONIC ACID 70 mg film-coated tablet once a week orally.

In order to allow sufficient absorption of alendronate:

· ALENDRONIC ACID ALTER should be taken on an empty stomach at least 30 minutes before the first intake of food, drinks or medication of the day and only with tap water. Other beverages (including still or sparkling mineral water) and foods, as well as some medications, may reduce the absorption of alendronate (see section 4.5 Interaction with other medicinal products and other forms of interaction ).

In order to reduce the potential for irritation and local and esophageal adverse effects, the following recommendations should be observed:

· ALENDRONIC ACID ALTER must be swallowed in the morning when getting up, accompanied by a glass of whole water (not less than 200 ml).

· Patients should not chew the tablet or allow it to dissolve in their mouth.

· Patients should not lie down until their first day of food intake, which should be at least 30 minutes after taking the tablet.

· Patients should not lie down for at least 30 minutes after taking ALEND ALTERNATE ACID.

· ALENDRONIC ACID ALTER should not be taken while sleeping or before getting up in the morning.

Patients should receive additional calcium and vitamin D if food intake is inadequate (see Warnings and Precautions ).

Use in the elderly

No dose adjustment is necessary in the elderly.

Use in case of renal failure

No dosage adjustment is required in patients with glomerular filtration (GFR) greater than 35 ml / min. Due to insufficient experience, alendronate is not recommended in patients with renal impairment where FG is less than 35 ml / min.

Use in children (under 18 years)

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

Alendronate has not been studied in the treatment of glucocorticoid-induced osteoporosis.

Against indications

· Abnormalities of the esophagus and other factors delaying esophageal transit, such as stenosis or achalasia.

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

· Hypersensitivity to the active substance or to any of the excipients.

· Hypocalcemia.

(See also Warnings and precautions for use )

Adverse effects Alendronic acid Alter

In a one-year study in postmenopausal women with osteoporosis, the overall safety profiles of alendronate 70 mg / week (n = 519) and alendronate 10 mg / day (n = 370) have been similar.

In two almost-three-year studies conducted in postmenopausal women (alendronate 10 mg: n = 196, placebo: n = 397), the overall safety profiles of alendronate 10 mg / day and a placebo were similar.

Adverse events reported by investigators as possibly, probably, or undoubtedly related to the drug are presented below if they occurred in ≥ 1% of one of the treatment groups in the one-year study, or ≥ 1% % of patients treated with alendronate 10 mg / day and at an incidence greater than that of placebo-treated patients in the three-year studies:

One year study

Three year study

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

musculoskeletal pain (bone, muscle or joint)

2.9

3.2

4.1

2.5

muscle cramp

0.2

1.1

0.0

1.0

neurologic

cephalalgia

0.4

0.3

2.6

1.5

The following adverse events have also been reported during clinical studies and / or after the placing on the market:

Common (≥ 1/100, <1/10), uncommon (≥ 1/1000, <1/100), rare (≥ 1/10 000, <1/1000), very rare (<1/10 000) including isolated cases).

Immune system disorders

Rare : hypersensitivity reactions including urticaria and angioedema;

Metabolism and nutrition disorder

Rare : symptomatic hypocalcemia, often accompanied by predisposing factors (see Warnings and Precautions section ).

Nervous system disorders

Frequent : headache.

Eye disorders

Rare : uveitis, scleritis, episcleritis

Gastrointestinal disorders

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

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

Rare : oesophageal stenosis *, oropharyngeal ulceration *, perforation, ulcers, and upper gastrointestinal bleeding (see Warnings and Precautions section ).

* See section Posology and method of administration and Warnings and precautions for use .

Skin and subcutaneous tissue disorders

Uncommon : rash, pruritus, erythema.

Rare : rash with photosensitivity.

Very rare and isolated cases : isolated cases of severe skin reactions including Stevens-Johnson syndrome and bullous erythroderma with epidermolysis.

Bone, musculoskeletal and systemic disorders

Frequent : musculoskeletal pain (bone, muscle or joint)

Rare : Osteonecrosis of the jaw has been reported in patients treated with bisphosphonates. The majority of reported cases involve cancer patients, but some cases 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). A diagnosis of cancer, chemotherapy, radiotherapy, corticosteroids and poor oral hygiene are also considered as risk factors.

Severe musculoskeletal pain (bone, muscle or joint) is another adverse effect that can occur in rare cases (see Warnings and Precautions ).

General disorders and administration site conditions

Rare : Transient symptoms similar to acute phase reactions (myalgia, malaise, as well as fever in rare cases), usually in combination at the start of treatment.

In the case of post-market use, the following reactions have been reported (frequency unknown):

Nervous system disorders:

· Stunning

Affections of the ear and labyrinth:

· fear of heights.

Musculoskeletal, systemic and bone disorders:

· Swelling of the joints.

General disorders and administration site defects:

· Asthenia,

· Peripheral edema.

Skin and subcutaneous tissue disorders:

· Alopecia.

Results of biological examinations

In clinical studies, asymptomatic, mild, and transient decreases in serum calcium and phosphate concentrations were observed in approximately 18% and 10%, respectively, of patients taking alendronate 10 mg / day versus approximately 12% and 3%, respectively. those taking a placebo. However, the incidence rates of decreasing serum calcium concentrations to a level <8.0 mg / dl (2.0 mmol / l) and phosphate to a level <2.0 mg / dl (0.65 mmol / l) were similar in both treated groups.

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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