el-GRen-US

 

Name of the medicinal product: FARMEMAX

Content: Each tablet contains 70 mg alendronic acid (equivalent to 91.363 mg of sodium alendronate trihydrate).

Pharmaceutical form: Tablet

Pharmacotherapeutic group: Bisphosphonate, for the treatment of bone diseases

Packaging description: The tablets are supplied in blister packs comprising of PVC-Aluminium, in pack size of 4 tablets.

FARMEMAX belongs to a group of non-hormonal medicines called bisphosphonates. FARMEMAX prevents the loss of bone that occurs in women after they have been through the menopause, and helps to rebuild bone. It reduces the risk of spine and hip fractures.
Treatment of postmenapausal osteoporosis. FARMEMAX reduces the risk of spine and hip fractures.
  • Abnormalities of the oesophagus and other factors which delay oesophageal emptying such as stricture or achalasia
  • Inability to stand or sit upright for at least 30 minutes
  • Hypersensitivity to the active substance or to any of the excipients
  • Hypocalcaemia
The recommended dosage is one 70 mg tablet once weekly. To permit adequate absorption of alendronate: Alendronic Acid must be taken at least 30 minutes before the first food, beverage, or medicinal product of the day with plain water only. Other beverages (including mineral water), food and some medicinal products are likely to reduce the absorption of alendronate. To facilitate delivery to the stomach and thus reduce the potential for local and oesophageal irritation/adverse experiences :
  • Alendronic Acid should only be swallowed upon arising for the day with a full glass of water (not less than 200 ml).
  • Patients should only swallow Alendronic Acid whole. Patients should not crush or chew the tablet or allow the tablet to dissolve in their mouths because of a potential for oropharyngeal ulceration.
  • Patients should not lie down until after their first food of the day which should be at least 30 minutes after taking the tablet.
  • Patients should not lie down for at least 30 minutes after taking Alendronic Acid.
  • Alendronic Acid should not be taken at bedtime or before arising for the day.
Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.

Use in the elderly:
In clinical studies there was no age-related difference in the efficacy or safety profiles of alendronate. Therefore no dosage adjustment is necessary for the elderly.

Use in renal impairment:
No dosage adjustment is necessary for patients with GFR greater than 35 ml/min. Alendronate is not recommended for patients with renal impairment where GFR is less than 35 ml/min, due to lack of experience.

Paediatric patients: Alendronate sodium is not recommended for use in children under the age of 18 years due to insufficient data on safety and efficacy in conditions associated with paediatric osteoporosis. Alendronic Acid Once Weekly 70 mg has not been investigated in the treatment of glucocorticoidinduced osteoporosis.