Alendronic Acid Once weekly 70mg Tablets tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

alendronic acid

Available from:

Accord Healthcare Limited

ATC code:

M05BA04

INN (International Name):

alendronic acid

Dosage:

70mg

Pharmaceutical form:

tablets

Units in package:

(4/1x4/), in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2015-09-15

Summary of Product characteristics

Alendronic Acid Once weekly 70 mg Tablets
Summary of Product Characteristics
1. NAME OF THE MEDICINAL PRODUCT
Alendronic Acid Once weekly 70 mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 70mg alendronic acid (as alendronate sodium)
Excipients: Each tablet contains 272.070 mg of Lactose Anhydrous
For a full list of excipients see section 6.1
3. PHARMACEUTICAL FORM
Tablet
White to off- white, oval, biconvex, tablet, debossed with 'AHI' on
one side and plain on other
side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of post-menopausal osteoporosis. Alendronic acid reduces the
risk of vertebral and
hip fractures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dosage is one 70 mg tablet once weekly.
_To permit adequate absorption of alendrnic acid: _
Alendronic acid Tablet 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 alendronic acid (see
section 4.5).
To facilitate delivery to the stomach and thus reduce the potential
for local and oesophageal
irritation/adverse experiences (see section 4.4):
• Alendronic acid Tablet should only be swallowed upon arising for
the day with a full glass of
water (not less than 200 ml or 7 fluid ounce).
• Patients should not chew or crush 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 Tablet 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).
_Use in the elderly:_ In clinical studies there was no age-related
difference i