Medicinal Products

ALENDRONIC ACID QUALIMED 70 mg

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

Compressed
Box of 4
All forms

Indication

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

Dosage ALENDRONIC ACID QUALIMED 70 mg Tablet Box of 4

The recommended dosage is 1 tablet at 70 mg once a week.
- To allow adequate absorption of alendronate :
The tablet should be taken at least half an hour before the first foods, drinks or drugs of the day are taken with a large glass of tap water. Other drinks (including mineral water), foods or certain medications may decrease the absorption of alendronate (see section on interactions).
- 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) :
. The tablet should 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 the tablet.
. The 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 section on warnings and precautions for use).
- 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 insufficiency:
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:
Alendronate has not been studied in children and should not be given to them.
- Alendronate has not been studied in the treatment of corticosteroid-induced osteoporosis.

Against indications

Hypersensitivity to alendronate or to any of the excipients.
- Diseases of the esophagus and other factors that delay esophageal transit such as stenosis and achalasia.
- Inability to stand upright or sit upright for at least 30 minutes.
- Hypocalcemia.
See also section warnings and precautions for use.
- Alendronate should not be administered to patients with renal impairment who have a glomerular filtration rate <35 ml / min (see section 4.2).
- Due to the presence of lactose, this drug is contraindicated in case of congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency.
- Use in children: alendronate has not been studied in children and should not be given to them.
- Use during pregnancy: There are no adequate data on the administration of alendronate in pregnant women. Studies in animals do not indicate directly adverse effects on pregnancy, embryo / fetal development, or postnatal development. Alendronate administered during pregnancy in rats caused obstructed labor due to hypocalcemia. Because of its indication, the use of alendronate should not be considered during pregnancy.
- Use during breastfeeding: There are no data on the passage of alendronate in breast milk. Because of its indication, the use of alendronate should not be considered in breastfeeding women.

Adverse effects Alendronic acid Qualimed

- In a 1-year clinical trial in postmenopausal women with osteoporosis, overall safety profiles with alendronate 70 mg (n = 519) and alendronate 10 mg / day (n = 370) were 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 in> = 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: Alendronate 70 mg once a week (n = 519) / Alendronate 10 mg / day (n = 370) //
3-year study: 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:
. osteo-articular or muscle 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 EVENTS HAVE ALSO BEEN REPORTED DURING CLINICAL STUDIES AND / OR SINCE MARKETING:
- Frequent (> = 1/100, <1/10) :
. Gastrointestinal:
abdominal pain, dyspepsia, constipation, diarrhea, flatulence, oesophageal ulcer (*), dysphagia (*), abdominal bloating, acid regurgitation.
. Neurological:
headache.
- Uncommon (> = 1/1000, <1/100) :
. Generals:
rash, erythema, pruritus.
. Gastrointestinal:
nausea, vomiting, gastritis, oesophagitis (*), oesophageal erosions (*), melena.
- Rare (> = 1/10000, <1/1000) :
. Generals:
* hypersensitivity reactions including urticaria and angioedema,
* transient symptoms of acute reactions type (myalgia, malaise and rarely fever) generally observed at the beginning of treatment,
* rash with photosensitivity,
* symptomatic hypocalcemia, usually on a predisposed site (see section on warnings and precautions for use).
. Gastrointestinal:
oesophageal stenosis (*), oropharyngeal ulcers (*), PUS of the upper gastrointestinal tract (perforation, ulcers, bleeding), although a cause-and-effect relationship can not be ruled out.
. Organs of the senses:
uveitis, scleritis, episcleritis.
. Musculoskeletal disorders of connective tissue and bones:
* 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.
* Frequent : severe osteoarticular or muscular pain (see section warnings and precautions for use).
. Skin and subcutaneous tissue disorders:
Very rare : isolated cases of severe skin reactions, including Stevens-Johnson Syndrome and toxic epidermal necrolysis , have been reported.
(*) See warnings and precautions for use and dosage and method of administration.
. 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 levels at <8.0 mg / dl (2.0 mmol / L) and phosphorus levels <= 2.0 mg / dl (0.65 mmol / L) ) were similar in both treatment groups.

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