Medicinal Products

ALENDRONIC ACID EVOLUGEN 70 mg

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

Compressed
Box of 12
All forms

Indication

Treatment of postmenopausal osteoporosis. ALENDRONIC ACID EVOLUGEN reduces the risk of vertebral fractures and hip.

Dosage ALENDRONIC ACID EVOLUGEN 70 mg Tablet Box of 12

The recommended dosage is 1 70 mg tablet once a week.

To allow adequate absorption of alendronate:

ALENDRONIC ACID EVOLUGEN must be taken at least half an hour before the first foods, drinks or drugs of the day are absorbed with a large glass of tap water. Other drinks (including mineral water), foods or certain 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 side effects (see section Warnings and precautions for use .)

· ALENDRONIC ACID EVOLUGEN must be taken strictly at sunrise, with a large glass of tap water (minimum 200 ml).

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

· ALENDRONIC ACID EVOLUGEN 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 a glomerular filtration rate> 35 ml / min. Due to a lack of experience, alendronate should not be administered in patients with renal impairment characterized by a glomerular filtration rate <35 ml / min.

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 allow its use in children.

ALENDRONIC ACID EVOLUGEN 70 mg has not been studied in the treatment of corticosteroid-induced osteoporosis.

Against indications

· Diseases of the esophagus and other factors that delay esophageal transit such as stenosis and achalasia.

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

Hypersensitivity to alendronate or any of the excipients.

· Hypocalcemia

See also Warnings and precautions for use .

Adverse effects Alendronic acid Evolugen

In a 1-year clinical study in postmenopausal women with osteoporosis, overall safety profiles with ALENDRONIC ACID EVOLUGEN 70 mg (n = 519) and alendronate 10 mg / day (n = 370) have been similar.

In two 3-year clinical studies in postmenopausal women (alendronate 10 mg: n = 196, placebo: n = 397) with a nearly identical protocol, overall safety profiles with alendronate 10 mg / day and placebo were similar.

Adverse events reported by the investigators as possibly, probably, or definitely related to the drug are presented below if they occurred in ≥ 1% of patients treated in any of the therapeutic groups in the study. 1 year, or ≥ 1% of patients treated with alendronate 10 mg / day with an incidence greater than that of placebo-treated patients in the 3-year studies:

1 year study

Study over 3 years

ALENDRONIC ACID EVOLUGEN
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 events have also been reported in clinical trials and / or post-marketing:

Frequent (≥1 / 100, <1/10), infrequent (≥1 / 1, 000, <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 disorders:

Rare : symptomatic hypocalcemia, usually on predisposed terrain (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, oesophageal ulcer *, dysphagia *, abdominal bloating, acid regurgitation

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

Rare : oesophageal stenosis *, oropharyngeal ulcer *, PUS (perforation, ulcer, bleeding) of the upper gastrointestinal tract (see Warnings and Precautions ).

* (See sections 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 toxic epidermal necrolysis.

Musculoskeletal, systemic and bone disorders:

Frequent : osteoarticular or muscular pains.

Rare : Cases of osteonecrosis of the jaw have been reported in patients treated with bisphosphonates. The majority of these cases involve cancer patients, but some of them 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;

severe osteoarticular or muscular pain (see section Warnings and precautions for use ).

General disorders and administration site defects:

Rare : transient symptoms of the acute reaction type (myalgia, malaise and rarely fever), usually observed at the beginning of treatment.

Since marketing, the following side effects have been reported (frequency unknown):

Nervous system disorders:

dizziness.

Affections of the ear and labyrinth:

dizziness.

Skin and subcutaneous tissue disorders:

alopecia.

Musculoskeletal disorders, systemic and desos:

swelling of the joints, stress fractures of the proximal end of the femoral shaft (see Warnings and Precautions ).

General disorders and administration site defects:

asthenia, peripheral edema.

Biological effects:

In clinical studies, asymptomatic, mild and transient decreases in serum calcium and phosphorus levels were observed in approximately 18% and 10% of patients taking alendronate 10 mg / day compared to approximately 12% and 3%, respectively. patients taking placebo. However, the incidences of decreases in serum calcium at a level <8.0 mg / dl (2.0 mmol / l) and phosphoremia at a rate ≤ 2.0 mg / dl (0.65 mmol / l) were similar in both treatment groups.

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