- Approval Id
- f640d58ba6ad6904
- Drug Name
- ALENDRONATE SANDOZ FILM COATED TABLETS 70MG
- Product Name
- ALENDRONATE SANDOZ FILM COATED TABLETS 70MG
- Approval Number
- SIN14582P
- Approval Date
- 2014-08-11
- Registrant
- SANDOZ SINGAPORE PTE. LTD.
- Licence Holder
- SANDOZ SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p>For oral use.</p>
<p><em>Treatment of osteoporosis in postmenopausal women and in men</em><br>
The recommended dosage is one 70 mg tablet once weekly.</p>
<p><em>To obtain satisfactory absorption of alendronate</em><br>
ALENDRONATE SANDOZ must be taken at least one-half hour before the first food, beverage, or medication of the day with plain water only. Other beverages (including mineral water), food and some medicines are likely to reduce the absorption of alendronate (see section 4.5 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>
).</p>
<p><em>To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation:</em></p>
<ul>
<li>ALENDRONATE SANDOZ should only be swallowed upon arising for the day with a <u>full</u> glass of water.</li>
<li>Patients should not lie down for at least 30 minutes <u>and</u> until after the first food of the day.</li>
<li>ALENDRONATE SANDOZ should not be taken at bedtime or before arising for the day.</li>
</ul>
<p>Failure to follow these instructions may increase the risk of esophageal adverse experiences (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>Patients should receive supplemental calcium and vitamin D, if dietary intake is inadequate (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>No dosage adjustment is necessary for the elderly or for patients with mild-to-moderate renal insufficiency (creatinine clearance 35 to 60 mL/min). ALENDRONATE SANDOZ is not recommended for patients with more severe renal insufficiency (creatinine clearance < 35 mL/min) due to lack of experience.</p>
<p><em>Pediatric Use</em><br>
ALENDRONATE SANDOZ is not indicated for use in children.</p>
<p><em>Use in the Elderly</em><br>
In clinical studies, there was no age-related difference in the efficacy or safety profiles of ALENDRONATE SANDOZ.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>Treatment of osteoporosis in postmenopausal women.</p>
<p class="tab">For the treatment of osteoporosis, ALENDRONATE SANDOZ reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures).</p>
<p>Treatment of osteoporosis in men.</p>
<p class="tab">The optimal duration of use of bisphosphonates for the treatment of osteoporosis has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<ul>
<li>Abnormalities of the esophagus which delay esophageal emptying, such as stricture or achalasia.</li>
<li>Inability to stand or sit upright for at least 30 minutes.</li>
<li>Hypersensitivity to any components of this product.</li>
<li>Hypocalcemia</li>
</ul>
<p>See also section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Atc Code
- M05BA04
- Atc Item Name
- alendronic acid
- Pharma Manufacturer Name
- SANDOZ SINGAPORE PTE. LTD.
