Medicinal Products

ALENDRONIC ACID EG 10 mg

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

Compressed
Box of 28
All forms

Indication

- Treatment of postmenopausal osteoporosis.
- Alendronate reduces the risk of vertebral and hip fractures.

Dosage ALENDRONIC ACID EG 10 mg Tablet Box of 28

Orally only.
- The recommended dosage is 10 mg once a day.
- To allow adequate absorption of alendronate :
ALENDRONIC ACID 10 mg tablets should be taken on an empty stomach immediately with a large glass of tap water at least half an hour before the first intake of food, drink or any other medication. Other beverages (including mineral waters), foods and medicines 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) :
. ALENDRONIC ACID EG 10 mg, tablet should be taken strictly at sunrise, with a large glass of tap water (minimum 200 ml).
. ALENDRONIC ACID EG 10 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 10 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 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 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 hepatic insufficiency:
No dosage modification is necessary.
- Use in children:
Alendronate has not been studied in children and should not be given to them.

Against indications

- Hypersensitivity to alendronate, other bisphosphonates or any of the excipients.
- Diseases of the esophagus and other factors that delay esophageal transit such as stenosis and achalasia.
- Inability to stand or sit for at least 30 minutes.
- Hypocalcemia.
See section warnings and precautions for use.
- Alendronate is not recommended in patients with renal impairment characterized by a glomerular filtration rate (GFR) less than 35 ml / min (see section dosage and method of administration).
- Use in children: alendronate has not been studied in children and should not be given to them.
- Due to the presence of lactose, this drug is contraindicated in case of congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency.
- Use during pregnancy: information on the use of alendronate in pregnant women is insufficient. Animal studies have shown effects on fetal ossification at high doses. Alendronate administered during pregnancy in rats caused obstructed labor due to hypocalcemia. Because of its indication, alendronate should not be used during pregnancy.
- Use during breastfeeding: It is not known if alendronate is excreted in human breast milk. Given its indication, alendronate should not be used by women who are breastfeeding.

Adverse effects Alendronic acid EG

- 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 relation with the drug or undeniably related to the drug are presented below if they appeared in> = 1% of the patients treated with 10 mg / day of alendronate and at a higher frequency than in patients receiving placebo in three-year studies:
Alendronate 10 mg / day (n = 196) / placebo (n = 397).
- Gastrointestinal effects:
. abdominal pain: 6.6% / 4.8%.
. dyspepsia: 3.6% / 3.5%.
. acid regurgitation: 2.0% / 4.3%.
. nausea: 3.6% / 4.0%.
. abdominal bloating: 1.0% / 0.8%.
. constipation: 3.1% / 1.8%.
. diarrhea: 3.1% / 1.8%.
. dysphagia: 1.0% / 0.0%.
. flatulence: 2.6% / 0.5%.
. gastritis: 0.5% / 1.3%.
. gastric ulcer: 0.0% / 0.0%.
. Esophageal ulceration: 1.5% / 0.0%.
- Musculoskeletal effects:
. musculoskeletal pain (bone, muscle or joint pain): 4.1% / 2.5%.
. muscle cramps: 0.0% / 1.0%.
- Neurological effects:
headache: 2.6% / 1.5%.
THE FOLLOWING SIDE EFFECTS HAVE BEEN REPORTED DURING CLINICAL STUDIES AND / OR AFTER THE MARKETING OF ALENDRONATE:
- Neurological disorders:
Frequent (> = 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, oesophageal ulcer *, dysphagia *, abdominal bloating, acid regurgitation.
. Uncommon (> = 1/1000, <1/100) : nausea, vomiting, gastritis, oesophagitis *, oesophageal erosion *, melena.
. Rare (> = 1/10000, <1/1000) : oesophageal stenosis *, oropharyngeal ulceration *, PUS (perforations, ulcers, bleeding) of the upper gastrointestinal tract, although no causal relationship exists 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 of the jaw.
. Osteonecrosis of the jaw has been reported in bisphosphonate patients. 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 on warnings and precautions for use).
- 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.
. 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 predispositions (see Warnings and Precautions section).
* See warnings and precautions sections 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 <2.0 mmol / L and phosphatemia at <= 0.65 mmol / L were similar in both therapeutic groups.

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