ALENDRONATE MEVON FILM-COATED TABLET 70 MG [SIN15412P]

Product Info

ALENDRONATE MEVON FILM-COATED TABLET 70 MG

[SIN15412P]

Indication

4.1 Therapeutic indications

Treatment of postmenopausal osteoporosis.
For the treatment of osteoporosis, Alendronate MEVON reduces the risk of vertebral compression fractures and hip fractures.

Dosing

4.2 Posology and method of administration

The recommended dosage is one 70 mg tablet once weekly. The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of Alendronate MEVON on an individual basis.

To permit adequate absorption of alendronate:

Alendronate MEVON must be taken at least 30 minutes before the first food, beverage, or medicinal products 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 (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

To facilitate the delivery to the stomach and thus reduce the potential for local and oesophageal irritation/ adverse experiences (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information):

– Alendronate MEVON should only be swallowed upon arising for the day with a full glass of water (not less than 200 ml);

– Patients should only swallow Alendronate MEVON 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 Alendronate MEVON;

– Alendronate MEVON 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 (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 mild to moderate renal insufficiency (creatinine clearance 35 – 60 ml/min). Alendronate is not recommended for patients with more severe renal impairment (creatinine clearance < 35 mL/min) due to lack of experience.

Paediatric patients: Alendronate 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 (also see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Alendronate MEVON 70 mg, once weekly, has not been investigated in the treatment of glucocorticoid-induced osteoporosis.

Contraindications

4.3 Contraindications

– hypersensitivity to alendronate or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information;
– abnormalities of the oesophagus and other factors which delay oesophageal emptying such as constriction or achalasia;
– inability to stand or sit upright for at least 30 minutes;
– hypocalcaemia.

See also section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.