Acid Alendronique Alter – Indications, Posology, Against indications, Undesirable effects Source RESIP-BCB

Acid Alendronique Alter – Indications, Posology, Against indications, Undesirable effects Source RESIP-BCB
ACID ALENDRONIQUE ALTER 70 Compressed Mg stripped Box of 4
Generic medicine of:   FOSAMAX 70 Compressed Mg Box of 4
Therapeutic class:   Rhumatology
Active ingredients:   Acid alendronic
Statute:   Drug subjected to medical regulation
Selling price including all taxes:   20,46 €
Rate of refunding S:   65%
Laboratory:   Alter

Indications

- Treatment of the post-menopausic osteoporosis.
- The alendronate reduces the risk of vertebral fractures and the hip.

Posology

Posology:
- Posology recommended is of a stripped tablet with 70 Mg once per week by oral way.
- In order to allow a sufficient absorption of the alendronate:
ACID ALENDRONIQUE ALTER must be taken the empty stomach, at least 30 minutes before the first catch of food, drinks or drugs of the day and only using tap water. The other drinks (including mineral punt or gas water) and food, like certain drugs, are likely to reduce the absorption of the alendronate (see heading interactions).
- In order to reduce the potential of appearance of a local irritation or undesirable effects and oesophagiens, the following recommendations must be observed:
. ACID ALENDRONIQUE ALTER must be swallowed the morning at the time to rise, accompanied by whole water glass (not less than 200 ml).
. The patients should not crunch the tablet, nor to let it dissolve in their mouth.
. The patients should not lie before their first food catch of the day, which must intervene at least 30 minutes after the catch of the tablet.
. The patients should not lie during at least 30 minutes after the catch of ACID ALENDRONIQUE ALTER.
. ACID ALENDRONIQUE ALTER should not be taken at the time to lie down or before rising the morning.
- The patients must receive an additional calcium contribution and vitamin D if the food supply is insufficient (see heading warning statements and precautions for use).
- Use in the elderly:
No adaptation of posology is necessary in the elderly.
- Use in the event of impaired renal function:
No adaptation of posology is necessary in the patients presenting a glomerular filtration (FG) higher than 35 ml/min. Because of an insufficient experiment, the alendronate is not recommended in the patients presenting an impaired renal function or the FG is lower than 35 ml/min.
- Use in the child:
There is no specific indication for the use of not compressed of ACID ALENDRONIQUE ALTER in the children.

Against indications

- Over-sensitiveness with the active substance or the one of the excipients.
- Anomalies of the esophagus and other factors delaying the transit oesophagien, such as sténose or achalasy.
- Incapacity to remain upright or sitted right during at least 30 minutes.
- Hypocalcémie.
(See also heading warning statements and precautions for use).
- The alendronate is not recommended in the patients presenting an impaired renal function where the FG is lower than 35 ml/min (see heading posology and mode of administration).
- Use in the child: there is no specific indication for the use of not compressed of ACID ALENDRONIQUE ALTER in the children.
- Use during the pregnancy: there do not exist sufficiently relevant data concerning the alendronic use of acid in the expectant mother. The studies in the animal did not show direct noxious effects on gestation, the embryonic/fetal development or the postnatal development. In the rat, the acid alendronic managed during gestation involved a dystocie dependant on a hypocalcemy. Because of its indication, the acid alendronic should not be used during the pregnancy.
- Use in period of breast feeding: it is not known if the acid alendronic is excreted in the mother’s milk. Because of its indication, the acid alendronic should not be used at the woman nursing.

Undesirable effects

- Within the framework of a one year study at ménopausées women reached of osteoporosis, the profiles of total safety of the acid alendronic 70 mg/semaine (N = 519) and alendronate 10 mg/jour (N = 370) was similar.
- Within the framework of two three years studies realized according to an almost identical plan among ménopausées women (alendronate 10 Mg: N = 196, placebo: N = 397), the profiles of total safety of the alendronate 10 mg/jour and a placebo were similar.
- The undesirable events reported by the investigators as being possibly, probably or undoubtedly related to the drug are presented below if they appeared at > = 1% of one of the groups treated in the one year study, or at > = 1% of the patients treated by the alendronate 10 mg/jour and according to an incidence higher than that of the patients receiving a placebo in the three years studies:
One year study: Acid alendronic 70 Mg (N = 519)/Alendronate 10 mg/jour (N = 370) //
Three years study: Alendronate 10 mg/jour (N = 196)/Placebo (N = 397).
- Gastro-intestinal:
. 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 distension: 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%.
. dysphagie: 0,4%/0,5% // 1,0%/0,0%.
. flatulence: 0,4%/1,6% // 2,6%/0,5%.
. gastrite: 0,2%/1,1% // 0,5%/1,3%.
. gastric ulcer: 0,0%/1,1% // 0,0%/0,0%.
. ulcerate oesophagien: 0,0%/0,0% // 1,5%/0,0%.
- Musculosquelettique:
. musculosquelettic pain (bone, muscle or articulation): 2,9%/3,2% // 4,1%/2,5%.
. muscular cramp: 0,2%/1,1% // 0,0%/1,0%.
- Neurological:
cephalgia: 0,4%/0,3% // 2,6%/1,5%.
THE FOLLOWING UNDESIRABLE EVENTS ALSO WERE PAY DURING CLINICAL STUDIES AND/OR AFTER THE SETTING ON THE MARKET:
Frequent (> = 1/100, < 1/10), not very frequent (> = 1/1000, < 1/100), rare (> = 1/10000, < 1/1000), very rare (< 1/10000 including isolated cases).
- Affections of the immune system:
Rare: reactions of over-sensitiveness of which urticaria and angio-edema.
- Disorder of the metabolism and the nutrition:
Rare: symptomatic hypocalcemy, often accompanied by factors of predisposition (see heading warning statements and precautions for use).
- Affections of the nervous system:
Frequent: cephalgia.
- Ocular Affections:
Rare: uvéite, sclérite, épisclérite.
- Gastro-intestinal Affections:
. Frequent: abdominal pain, dyspepsia, constipation, diarrhea, flatulence, ulcer of the oesophage*, dysphagie*, abdominal distension, acid regurgitation.
. Not very frequent: nausea, vomiting, gastrite, oesophagite*, erosions oesophagiennes*, mélaena.
. Rare: sténose of the oesophage*, ulceration oropharyngée*, perforation, ulcers and high gastro-intestinal hemorrhage (see heading warning statements and precautions for use).
to *Voir headings posology and mode of administration and warning statements and precautions for use.
- Affections of the skin and subcutaneous fabric:
. Not very frequent: rash, prurit, erythema.
. Rare: rash with photosensitivity.
. Very rare and isolated cases: cases isolated from severe cutaneous reactions of which syndrome of Stevens-Johnson and bulleuse erythrodermy with épidermolyse.
- Osseous, musculosquelettic and systemic Affections:
. Frequent: musculosquelettic pain (bone, muscle or articulation).
. Rare: a ostéonécrose of the jaw was brought back among patients treated by bisphosphonates. The majority of the announced cases concern cancer patients, but certain cases were also reported among patients treated for osteoporosis. The ostéonécrose of the jaw is generally associated the extraction with a tooth and/or a local infection (of which osteomyelitis). A diagnosis of cancer, chemotherapy, the radiotherapy, corticoids and a bad oral hygiene are also regarded as risk factors.
. Severe musculosquelettic pains (bone, muscle or articulation) constitute another undesirable effect which can appear in rare cases (see heading warning statements and precautions for use).
- General Disorders and anomalies with the site of administration:
Rare: transitory symptoms similar to reactions of acute phase (myalgia, faintness, like fever in rare cases), generally in association at the beginning of the treatment.
- Results of the biological examinations:
At the time of the clinical studies, asymptomatic, light falls and transients of the serum phosphate and calcium concentrations were observed at approximately 18 and 10% respectively of the patients taking of the alendronate with 10 mg/jour compared to approximately 12 and 3% of those taking a placebo. However, the incidence rates of fall of the serum concentrations of calcium on a level < 8,0 mg/dl (2,0 mmol/L) and of phosphate on a level < 2,0 mg/dl (0,65 mmol/L) were similar in the two treated groups.