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

Acid Alendronique Biogaran – Indications, Posology, Against indications, Undesirable effects Source RESIP-BCB
ACID ALENDRONIQUE BIOGARAN 70 Compressed Mg 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:   Biogaran

Indications

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

Posology

By oral way only.
- Posology recommended is of 70 Mg once per week.
- To allow an adequate absorption of the alendronate:
ACID ALENDRONIQUE BIOGARAN 70 Mg, compressed must be taken with jeun immediately with the rising morning, with large tap water glass only, at least half an hour before the first catch of food, drink or any other drug. The other drinks (including mineral water), the food and the drugs are likely to decrease the absorption of the alendronate (see heading interactions).
- To facilitate the passage in the stomach, and thus to reduce the possible hazard of irritation or local undesirable effects and oesophagiens (see heading warning statements and precautions for use):
. ACID ALENDRONIQUE BIOGARAN 70 Mg, compressed must be taken strictly with the rising, with large tap water glass (minimum 200 ml).
. ACID ALENDRONIQUE BIOGARAN 70 Mg, compressed must be swallowed whole. The patients should not crunch, suck the tablet or let it dissolve in their mouth because of the possible hazard of oropharyngées ulcerations.
. The patients should not lie until the absorption of the first food of the day which will have to be taken at least thirty minutes after the catch of the tablet.
. The patients should not lie during at least 30 minutes after the catch of the tablet.
. ACID ALENDRONIQUE BIOGARAN 70 Mg, compressed should not be taken with sleeping or before the rising.
- The treated patients must be supplemented out of calcium and vitamin D if their food supplies are insufficient (see heading warning statements and precautions for use).
- Use in the old patients:
The clinical studies did not reveal any difference related to the age in the profiles of effectiveness and job security of the alendronate. Consequently no modification of posology is necessary in the old patients.
- Use in the event of impaired renal function:
No modification of posology is necessary in the patients having a flow of glomerular filtration (DFG) higher than 35 ml/min. Because of a lack of experience, the alendronate is not recommended in the patients presenting an impaired renal function characterized by a DFG lower than 35 ml/min.
- Use in the event of hepatic insufficiency:
No modification of posology is necessary.
- Use in the child:
The alendronate was not studied in the child and does not have to be to him managed.
- ACID ALENDRONIQUE BIOGARAN 70 Mg, compressed was not the subject of studies on the treatment of the osteoporosis induced by corticoids.

Against indications

- Over-sensitiveness with the alendronate, others bisphosphonates or the one of the excipients.
- Diseases of the esophagus and other factors which delay the transit oesophagien such as sténose and achalasy.
- Incapacity to be held upright or in sitting position during at least 30 minutes.
- Hypocalcémie.
See heading warning statements and precautions for use.
- The alendronate is not recommended in the patients presenting an impaired renal function characterized by a flow of glomerular filtration (DFG) lower than 35 ml/min (see heading posology and mode of administration).
- Because of the presence of lactose, this drug is contra-indicated in the event of congenital galactosemy, of syndrome of malabsorption of glucose and galactose or of lactase deficit.
- Use in the child: the alendronate was not studied in the child and does not have to be to him managed.
- Use during the pregnancy: the relative informations with the use of the alendronate in the expectant mother are insufficient. The animal studies revealed effects on fetal ossification with strong amounts. The alendronate managed during the pregnancy in the rat caused a dystocie dependant on a hypocalcemy. Being given its indication, the alendronate should not be used during the pregnancy.
- Use during breast feeding: it is not known if the alendronate is excreted in the human mother’s milk. Being given its indication, the alendronate should not be used by the women who nurse.

Undesirable effects

- In a one one year duration clinical study at ménopausées women having an osteoporosis, the total profiles of tolerance of the alendronate compressed in a weekly catch (N = 519), and the alendronate 10 Mg per day (N = 370) were similar.
- In two one three years duration clinical studies among women ménopausées with a practically identical protocol, (10 Mg of alendronate: N = 196, placebo: N = 397), the total profiles of tolerance of the alendronate 10 mg/jour and the placebo were similar.
- The undesirable effects presented by the investigators as being in possible or probable relation with the drug or incontestably related to the drug are presented below if they appeared at > = 1% of the patients treated by 10 mg/jour of alendronate and at a frequency higher than among patients receiving the placebo in the studies over three years:
Study on 1 year: Alendronate compressed once per week (N = 519)/Alendronate 10 mg/jour (N = 370) //
Study over 3 years: Alendronate 10 mg/jour (N = 196)/Placebo (N = 397).
- Gastro-intestinal:
. abdominal pains: 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%.
. nauseas: 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%.
- Musculosquelettiques:
. ostéo-articular or muscular pains: 2,9%/3,2% // 4,1%/2,5%.
. muscular cramps: 0,2%/1,1% // 0,0%/1,0%.
- Neurological:
cephalgias: 0,4%/0,3% // 2,6%/1,5%.
THE FOLLOWING UNDESIRABLE EFFECTS WERE ANNOUNCE DURING CLINICAL STUDIES AND/OR AFTER THE MARKETING OF THE ALENDRONATE:
- Central nervous system disorders:
Frequent (> = 1/100, < 1/10): cephalgias.
- Ocular Disorders:
Rare (> = 1/10000, < 1/1000): uvéite, sclérite.
- Gastro-intestinal Disorders:
. Frequent (> = 1/100, < 1/10): abdominal pains, dyspepsia, constipation, diarrhea, flatulences, ulcer oesophagien*, dysphagie*, abdominal distension, acid regurgitation.
. Not very frequent (> = 1/1000, < 1/100): nauseas, vomiting, gastrite, oesophagite*, erosion oesophagienne*, méléna.
. Rare (> = 1/10000, < 1/1000): sténose of the oesophage*, ulceration oropharyngée*, PUS (perforations, ulcers, bleeding) of the high part of the gastro-intestinal tract, although no causal relation was established.
- Cutaneous and subcutaneous Disorders:
Very rare (< = 1/10000): cases isolated from severe cutaneous reactions, including the syndrome of Stevens-Johnson and a nécrolyse épidermique poison were reported.
- Hoop nets musculosquelettic, of conjunctive, and osseous fabric:
. Frequent (> = 1/100, < 1/10): pains ostéoarticulaires or muscular.
. Unknown frequency: ostéonécrose of the jaw.
The ostéonécrose of the jaw was brought back in patients under bisphosphonates. The majority of the cases touched patients reached of cancers, but such cases were also reported in patients treated for osteoporosis. The ostéonécrose of the jaw is generally associated with dental extractions and/or local infections (including osteomyelitis). Cancers, chemotherapy, the radiotherapy, the corticosteroids and bad oral hygiene are risk factors (see heading warning statements and precautions for use).
- General Disorders and reactions on the level of the site of administration:
. Not very frequent (> = 1/1000, < 1/100): rash, prurit, erythema.
. Rare (> = 1/10000, < 1/1000): reactions of over-sensitiveness of which urticaria and angio-edema.
. Momentary symptoms such as acute reactions (myalgia, feeling of faintness general, rare cases of fever) usually in connection with the beginning of the treatment. Rash with photosensitivity.
. Symptomatic Hypocalcemy, generally in connection with predispositions (see heading warning statements and precautions for use).
to *Voir headings warning statements and precautions for use and posology and mode of administration.
- Biological Effects:
During clinical studies, discrete, transitory and asymptomatic reductions of the calcemy and phosphatemy were observed at respectively 18% and 10% of the patients taking 10 mg/jour alendronate against approximately 12% and 3% of the patients under the placebo. Nevertheless, the incidences of a reduction in the calcemy ata rate < 2,0 mmol/L and phosphatemy ata rate < = 0,65 mmol/L were similar in the two therapeutic groups.